chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a Practice Manager via company representative referring a patient of unknown age who on 05-FEB-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J014401, exp date 26-NOV-2014 (dose and route not provided). On an unknown date the patient experienced a reaction. The outcome of reporting was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a Practice Manager via company representative referring a patient of unknown age who on 26-FEB-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J014401, exp date 26-NOV-2014 (dose and route not provided). On an unknown date the patient experienced a reaction. The outcome of reaction was unknown. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 21-MAR-2014, the patient was inadvertently administered with a dose of MMR II (lot # 0497AE), 0.5 ml, subcutaneously that had expired on 07-MAR-2014. No adverse effects report. No PQC involved. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's current conditions or medical history were not reported. Approximately on 03-MAR-2014, reported as "11 days ago" the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route, lot number and expiration date were not reported). The pharmacist reported that after received ZOSTAVAX the patient developed redness and swelling at the injection site (approximately 03-MAR-2014). It was also reported that "it had all cleared up now" (in March 2014). Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a 64 year old female patient regarding herself (who is presently 70 years old). On an unknown date, at 58 years of age the patient was vaccinated with dose 1 of PNEUMOVAX 23 and a second dose of PNEUMOVAX 23 at the age of 64 years old. No adverse effect reported. This is 1 of several reports from the same reporter. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red swollen area at injection site, warm to touch.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Headache, Local swelling, Neck pain, Pyrexia
Clinical narrative: Swelling, hot at infection site, red raised like well at infection site, sore neck, bad headache, constant fever over 99.9.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Skin warm
Clinical narrative: Swelling, hot at infection site, red raised like well at infection site, sore neck, bad headache, constant fever over 99.9.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Hypersomnia, Narcolepsy, Nuclear magnetic resonance imaging, Sleep disorder, Sleep study abnormal
Clinical narrative: I noticed my son falling asleep throughout the day, talking and laughing in his sleep. Also I was receiving reports from his teachers that he was sleeping in class. He was taken to the ER. Several sleep studies and a MRI was performed. The daytime study showed that he has narcolepsy. He is now on medication to help him stay awake.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Sleep talking, Somnolence
Clinical narrative: I noticed my son falling asleep throughout the day, talking and laughing in his sleep. Also I was receiving reports from his teachers that he was sleeping in class. He was taken to the ER. Several sleep studies and a MRI was performed. The daytime study showed that he has narcolepsy. He is now on medication to help him stay awake.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction
Clinical narrative: Large local reaction involving entirety of upper arm, despite NSAID pretx, cold-compress mgmt at home.  Pt examined 7 days out with continued large local reaction, requiring IM steroids.
Age: 1.05
Sex: F
Vaccine: MMRV, UNK
Symptoms: Alopecia, Alopecia totalis
Clinical narrative: Complete Loss of Hair onset within the first 3 days of the immunizations.  (Alopecia Totalis).  Total hair loss onset rapidly over the course of of the following weeks.
Age: 1.39
Sex: F
Vaccine: HEPA
Symptoms: Alopecia
Clinical narrative: Patient began losing patches of hair (alopecia) in areas of her scalp that previously had hair.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Alopecia
Clinical narrative: Patient began losing patches of hair onset a few days after the administration of the immunization and continued to lose round patches ranging from .5 to 3 inches in diameter.
Age: 1.55
Sex: M
Vaccine: DTAP, HEPA, PPV
Symptoms: Abnormal behaviour, Injection site erythema, Injection site mass, Injection site warmth, Irritability
Clinical narrative: Large red, hot lump at shot site, fever, fussiness, vomiting, behavior change such as sudden screaming for no reason (not hurt from falling or something). Treated with warm bath, Tylenol, holding him and trying to keep him calm.
Age: 1.55
Sex: M
Vaccine: DTAP, HEPA, PPV
Symptoms: Pyrexia, Screaming, Vomiting
Clinical narrative: Large red, hot lump at shot site, fever, fussiness, vomiting, behavior change such as sudden screaming for no reason (not hurt from falling or something). Treated with warm bath, Tylenol, holding him and trying to keep him calm.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site pain, Injection site rash, Skin mass, Swelling
Clinical narrative: Patient reported soreness and rash at injection site extending 1-2 inches out from the injection site. She noted swelling and a round hard lump under the skin. She called her physician, who recommended NSAID therapy to reduce inflammation. She responded well to Aleve and the adverse effects have resolved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Patient complaining of itchy round slightly swollen red area about 3 inches in diameter. On examination, provider noticed, R lateral thigh with 2 inch raised blanching red circular area with no excoriations, slightly warm. Patient given Benadryl and ibuprofen.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Swelling
Clinical narrative: Patient complaining of itchy round slightly swollen red area about 3 inches in diameter. On examination, provider noticed, R lateral thigh with 2 inch raised blanching red circular area with no excoriations, slightly warm. Patient given Benadryl and ibuprofen.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chest X-ray normal, Chills, Culture urine negative, Influenza like illness
Clinical narrative: High fever (102+) even with Motrin, chills, extreme pain in arm, spreading to surrounding muscles. Cellulitis onset morning of 3/12/14, continued to spread until 3/15/14 after over 48 hours on antibiotics. Flu like symptoms associated with cellulitis, including continued fever, chills, body aches.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: High fever (102+) even with Motrin, chills, extreme pain in arm, spreading to surrounding muscles. Cellulitis onset morning of 3/12/14, continued to spread until 3/15/14 after over 48 hours on antibiotics. Flu like symptoms associated with cellulitis, including continued fever, chills, body aches.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Pneumonia
Clinical narrative: I was getting sicker and sicker with uncontrollable coughing. I was prescribed a Ventolin inhaler and Advair diskus to control asthmatic symptoms, though I don't have asthma. It progressively got worse and turned into pneumonia by November 2009.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Influenza, Local swelling
Clinical narrative: PATIENT REPORTED THAT ARM WAS SWOLLEN AND RED THE DAY AFTER INJECTION AND SHE LATER IN YEAR DEVELOPED THE FLU.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: AFTER INJECTING HALF THE DOSE THE PLUNGER IN THE SYRINGE GOT STUCK SO TRIED TO SLIGHTLY MOVE SYRINGE TO MOVE NEEDLE BACK AND I GOT SPRAYED IN FACE AND LEFT EYE WITH VACCINE.  PT DID NOT RECIEVE FULL DOSE OF VACCINE.  I TOOK CARE OF PT AND HAD HIM WAIT WHILE I RETURNED TO PHARMACY TO FLUSH EYE WITH WATER FOR A FEW MINUTES AND THEN RETURNED TO TALK WITH PT LETTING HIM KNOW HE MAY NEED TO RETURN FOR ANOTHER DOSE OF ZOSTER VACCINE.  I WENT TO OPTICAL DEPT AND DR FLUSHED EYE WITH SALINE, LOOKED AT MY EYE, AND CALLED IN ANTI-VIRAL DROPS FOR ME. I AM TO RETURN TO EYE DR NEXT WEEK FOR FOLLOW-UP.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: AFTER INJECTING HALF THE DOSE THE PLUNGER IN THE SYRINGE GOT STUCK SO TRIED TO SLIGHTLY MOVE SYRINGE TO MOVE NEEDLE BACK AND I GOT SPRAYED IN FACE AND LEFT EYE WITH VACCINE.  PT DID NOT RECIEVE FULL DOSE OF VACCINE.  I TOOK CARE OF PT AND HAD HIM WAIT WHILE I RETURNED TO PHARMACY TO FLUSH EYE WITH WATER FOR A FEW MINUTES AND THEN RETURNED TO TALK WITH PT LETTING HIM KNOW HE MAY NEED TO RETURN FOR ANOTHER DOSE OF ZOSTER VACCINE.  I WENT TO OPTICAL DEPT AND DR FLUSHED EYE WITH SALINE, LOOKED AT MY EYE, AND CALLED IN ANTI-VIRAL DROPS FOR ME. I AM TO RETURN TO EYE DR NEXT WEEK FOR FOLLOW-UP.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Low grade fever, injection site itching, redness, area warm to touch.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a consumer refers to a 12 year old female patient who is her daughter. No medical history or drug reactions were reported. On an unknown date in October 2013, the patient was vaccinated with a dose of recalled GARDASIL (lot # J007354, expiry: 20-FEB-2016). No concomitant medications were reported. On an unknown date in October 2013, within one hour of vaccination the patient developed swelling and itching at injection site. Patient took ALLEGRA. No laboratory tests were performed. No medical attention was sought. The symptoms had resolved and the patent recovered from swelling and itching at injection site on an unspecified date. Causality was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report was received from a company representative's neighbor regarding his co-worker who is a female patient in mid 20's years of age. On an unknown date, the patient was vaccinated with what they believe was a dose of PNEUMOVAX 23 and had quite a bit of swelling post vaccination. The outcome of swelling post vaccination was reported as recovered/resolved. Causality was not reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Nausea
Clinical narrative: This spontaneous report was received from a other health care worker via company representative refers to a 17 year old male patient. On an unknown date, the patient was vaccinated with third dose of GARDASIL (lot number, expiry date was unknown). On an unknown date, the patient experienced headache and nausea after taking the third shot. The outcome of headache and nausea was reported as not recovered/not resolved. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a physician refers to a 65 year old female patient. On 08-MAR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry was not reported) in the left arm. On an unknown date in MAR-2014, the patient developed shingles. On 18-MAR-2014, the patient visited the physician. On 13-MAR-2014 (reported as 5 days ago) the patient had shingles rash on her upper right back. Patient was treated with VALTREX. The outcome of the events were unknown. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a consumer refers to a female patient (her sister in law) of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was unknown). After previously had shingles 3 times. There was no mention of any side effect with this vaccine misuse. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient developed a rash/swelling/redness on lower half of arm from pneumonia and flu shot.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Seizure.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling, Lymphadenopathy, Pain in extremity
Clinical narrative: Started with swollen glands on the side and back of my neck, then I couldn't bend my fingers, hands and joints in the fingers are swollen and painful. The most pain is when I bend my fingers.
Age: 1.31
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: CSF glucose normal, CSF protein decreased, CSF white blood cell count negative, Chest X-ray abnormal, Diarrhoea
Clinical narrative: Patient received 15mo vaccines (Dtap, Hib, PCV) on 3/26/14.  That night, he had a 2 minute generalized tonic clonic seizure at home.  Was seen in the local ER where he was noted to have a fever of 100.4. Rapid flu, rapid strap, and rapid RSV were negative.  CXR showed possible pneumonia, so he was given a dose of Rocephin and prescribed Augmentin (which mom did not fill that night).  Discharged home and around 5am he had another 2 min. generalized tonic clonic seizure.  Returned to the ER where he was noted to have a fever to 103. Lumbar puncture was performed and was negative for meningitis.  He was transferred to another hospital for observation.  He continued to have fevers while we observed him and also developed watery diarrhea.  He was discharged home on 3/28 since he was at his neurologic baseline and was eating/drinking well. Repeat CXR here was negative for pneumonia, so we did not continue antibiotics.
Age: 1.31
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Grand mal convulsion, Haematocrit normal, Haemoglobin normal, Influenza virus test negative, Platelet count normal
Clinical narrative: Patient received 15mo vaccines (Dtap, Hib, PCV) on 3/26/14.  That night, he had a 2 minute generalized tonic clonic seizure at home.  Was seen in the local ER where he was noted to have a fever of 100.4. Rapid flu, rapid strap, and rapid RSV were negative.  CXR showed possible pneumonia, so he was given a dose of Rocephin and prescribed Augmentin (which mom did not fill that night).  Discharged home and around 5am he had another 2 min. generalized tonic clonic seizure.  Returned to the ER where he was noted to have a fever to 103. Lumbar puncture was performed and was negative for meningitis.  He was transferred to another hospital for observation.  He continued to have fevers while we observed him and also developed watery diarrhea.  He was discharged home on 3/28 since he was at his neurologic baseline and was eating/drinking well. Repeat CXR here was negative for pneumonia, so we did not continue antibiotics.
Age: 1.31
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Pyrexia, Red blood cells CSF positive, Respiratory syncytial virus test negative, Streptococcus test negative, Urine analysis normal
Clinical narrative: Patient received 15mo vaccines (Dtap, Hib, PCV) on 3/26/14.  That night, he had a 2 minute generalized tonic clonic seizure at home.  Was seen in the local ER where he was noted to have a fever of 100.4. Rapid flu, rapid strap, and rapid RSV were negative.  CXR showed possible pneumonia, so he was given a dose of Rocephin and prescribed Augmentin (which mom did not fill that night).  Discharged home and around 5am he had another 2 min. generalized tonic clonic seizure.  Returned to the ER where he was noted to have a fever to 103. Lumbar puncture was performed and was negative for meningitis.  He was transferred to another hospital for observation.  He continued to have fevers while we observed him and also developed watery diarrhea.  He was discharged home on 3/28 since he was at his neurologic baseline and was eating/drinking well. Repeat CXR here was negative for pneumonia, so we did not continue antibiotics.
Age: 1.31
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: White blood cell count normal
Clinical narrative: Patient received 15mo vaccines (Dtap, Hib, PCV) on 3/26/14.  That night, he had a 2 minute generalized tonic clonic seizure at home.  Was seen in the local ER where he was noted to have a fever of 100.4. Rapid flu, rapid strap, and rapid RSV were negative.  CXR showed possible pneumonia, so he was given a dose of Rocephin and prescribed Augmentin (which mom did not fill that night).  Discharged home and around 5am he had another 2 min. generalized tonic clonic seizure.  Returned to the ER where he was noted to have a fever to 103. Lumbar puncture was performed and was negative for meningitis.  He was transferred to another hospital for observation.  He continued to have fevers while we observed him and also developed watery diarrhea.  He was discharged home on 3/28 since he was at his neurologic baseline and was eating/drinking well. Repeat CXR here was negative for pneumonia, so we did not continue antibiotics.
Age: 1.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Exanthema subitum, Pyrexia, Rash generalised, Rash morbilliform, Rhinorrhoea
Clinical narrative: 48 hours post immunizations. Mild URI symptoms rhinorrhea and Fever with tmax 103.5 degrees lasting x 3 days then fever broke and had morbilliform rash starting on neck, spreading to torso, face and extremities.  Symptoms follow roseola infantum very well.   Pediarix, HIB, Pneumococcal vaccines given 3/24/14.
Age: 1.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Upper respiratory tract infection
Clinical narrative: 48 hours post immunizations. Mild URI symptoms rhinorrhea and Fever with tmax 103.5 degrees lasting x 3 days then fever broke and had morbilliform rash starting on neck, spreading to torso, face and extremities.  Symptoms follow roseola infantum very well.   Pediarix, HIB, Pneumococcal vaccines given 3/24/14.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Pyrexia
Clinical narrative: Chills, headache, fatigue, lack of appetite and fever.  High fever to 103.6 for first three days; fever of 102 for 2 days, fever of 100 for 2 days.  Thereafter low-grade fever 100 or less for 4 days.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Urine analysis
Clinical narrative: Chills, headache, fatigue, lack of appetite and fever.  High fever to 103.6 for first three days; fever of 102 for 2 days, fever of 100 for 2 days.  Thereafter low-grade fever 100 or less for 4 days.
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report received from Nurse practitioner via company representative refers to a female patient of an unknown age. Patient concurrent and medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL (start date, dose, therapy route lot# unspecified). Dose and lot information were not provided. The patient was administered an unknown number of doses of GARDASIL on unspecified dates and patient was recently admitted to an unspecified hospital. The symptoms and diagnosis were not provided. Reporter's causality was not provided. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 24 hrs after vaccine -> developed redness/swelling (baseball size) around injection site.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 22-JAN-2013 the patient was vaccinated with VARIVAX dose 1, 0.5 ml, (lot number and expiry date unknown) subcutaneous. No concomitant medications were reported. On 22-Jan-2013, 12-Sep-2013, and 04-Mar-2104 the patient was administered VARIVAX. No adverse events were reported. There was no product quality issue reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Burning sensation, Herpes zoster, Laboratory test, Pain in extremity
Clinical narrative: This spontaneous report was received from a consumer refers to a 54 year old female patient who is a ovarian cancer survivor and skin cancer survivor. No drug reactions were reported. On 09-JAN-2014, the patient was vaccinated with a dose of ZOSTAVAX. Concomitant therapies included hydrochlorothiazide, zolpidem tartrate, guanfacine hydrochloride, allopurinol, influenza virus vaccine (Manufacturer unknown) and DIAZIDE and ZOLPIDAN. On 10-JAN-2014, the patient experienced shingles. The patient stated that she experienced tingling all over her body one day after receiving the ZOSTAVAX from the physician. Two days after the vaccination, she felt as though her "blood was burning". Three day after the vaccination, she woke with a rash about the size of her open hand located just above her left hip. Four days after the vaccination, there was a second rash area about three inches away from the first one. The rash had a discharge. Consumer experienced severe leg and arm pain. Patient sought medical attention. Patient saw a physician on 13-JAN-2014 and he confirmed it was the shingles. Blood tests and other tests were performed-results not reported. Patient received oxycodone as treatment. The rash went away about a week ago but the leg and arm pain continues. The outcome of shingles was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash, Secretion discharge
Clinical narrative: This spontaneous report was received from a consumer refers to a 54 year old female patient who is a ovarian cancer survivor and skin cancer survivor. No drug reactions were reported. On 09-JAN-2014, the patient was vaccinated with a dose of ZOSTAVAX. Concomitant therapies included hydrochlorothiazide, zolpidem tartrate, guanfacine hydrochloride, allopurinol, influenza virus vaccine (Manufacturer unknown) and DIAZIDE and ZOLPIDAN. On 10-JAN-2014, the patient experienced shingles. The patient stated that she experienced tingling all over her body one day after receiving the ZOSTAVAX from the physician. Two days after the vaccination, she felt as though her "blood was burning". Three day after the vaccination, she woke with a rash about the size of her open hand located just above her left hip. Four days after the vaccination, there was a second rash area about three inches away from the first one. The rash had a discharge. Consumer experienced severe leg and arm pain. Patient sought medical attention. Patient saw a physician on 13-JAN-2014 and he confirmed it was the shingles. Blood tests and other tests were performed-results not reported. Patient received oxycodone as treatment. The rash went away about a week ago but the leg and arm pain continues. The outcome of shingles was unknown. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 5 month old patient. On 26-MAR-2014, the 5 months old patient was vaccinated with GARDASIL (dose, route and frequency were not reported). No symptoms were reported. No further details were provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient pertinent medical history included diabetes. Drug reactions/allergies were reported to be for HUMALOG, NOVOLOG, VICTOZ and SYMLIN. On 21-MAR-2014 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included insulin (unspecified brand, unspecified manufacturer). On 21-MAR-2014 the patient received a dose of ZOSTAVAX and then approximately on an unknown date in March 2014, the patient experienced injection site reaction, injection site is red and swollen and injection site is red and swollen. The area involved had the circumference size of a tennis ball. There was no rash. The patient does not have any pain, itching or discomfort. The pharmacist told the patient to take BENADRYL and to apply hydrocortisone cream on the area. The outcome of injection site reaction and injection site is red and swollen was reported as not recovered/not resolved. The patient sought medical attention reported as called pharmacist on 26-MAR-2014. Action taken with the suspect product was unknown. The reporter causality was not provided. No product quality complaint was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a consumer refers to a 60 year old female patient. The patient had all around seasonal allergies and animal allergies. The patient was allergic to Sulfa. On 21-MAR-2014, the patient was vaccinated with ZOSTAVAX in the upper left arm (dose and frequency were not reported). Concomitant therapies included ALLEGRA and ZYRTEC (also reported as the patient doesn't take these medications on regular basis). On 21-MAR-2014, 1 day after onset of therapy, the patient experienced to feel dizzy, swelling at the injection site and redness at the injection site. It was reported that the injection site was as large and red as an apple the following day. It was now down to the size of a plum. The patient stated that she was not sure whether her dizziness was from the injection or from the allergies because she suffers from seasonal and animal allergies. The outcome of the events was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Axillary mass, Chills, Hyperhidrosis, Pain
Clinical narrative: This spontaneous report as received from a clinical medical assistant refers to a 50 year old female patient. On 18-MAR-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J013345, expired date 11-JAN-2015) (0.5 ml, subcutaneously in the right arm). Caller stated client was vaccinated with PNEUMOVAX 23 and experienced adverse event which began in the evening of 19-MAR-2014. Client called the doctor office to complain of a golf ball size lump under the arm, chills, body aches, warm to touch, sweats, and weakness. Client was scheduled to be seen in the office today. At the time of the report, the outcome of the events were not recovered. The causality between PNEUMOVAX to the events were not reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report as received from a clinical medical assistant refers to a 50 year old female patient. On 18-MAR-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J013345, expired date 11-JAN-2015) (0.5 ml, subcutaneously in the right arm). Caller stated client was vaccinated with PNEUMOVAX 23 and experienced adverse event which began in the evening of 19-MAR-2014. Client called the doctor office to complain of a golf ball size lump under the arm, chills, body aches, warm to touch, sweats, and weakness. Client was scheduled to be seen in the office today. At the time of the report, the outcome of the events were not recovered. The causality between PNEUMOVAX to the events were not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a field representative via a pharmacist refers to a patient of unknown age and gender who was also a pharmacy technician. The patient's medical history and concurrent medications were not reported. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (dose and route not provided) (lot # J001004, expired date 24-APR-2014). Concomitant therapy was not reported. On an unspecified date the patient developed redness at the injection site. The patient did not seek medical attention. At the time of the report the outcome of the event was unknown. The relationship between event redness at the injection site and ZOSTAVAX was not reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Laceration, Suture insertion, Syncope, Tooth fracture
Clinical narrative: Case number PHHY2013US012160 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 475247) on 08 Feb 2013 and a follow up report received from the QA department (QA reference number: 210540) on 24 Mar 2014: This report refers to a 13-year-old male patient. His medical history was not reported and his concomitant medications included FOCALIN, clonidine, STRATTERA and risperidone. He was vaccinated with FLUVIRIN (batch number: 123123) in to the left arm on 28 Oct 2012. Eight minutes after vaccination, he started to go look for item in store (drug), walked approximately 15 feet and fainted. He required 11 stitches under chin and had a chipped tooth. He came to the pharmacy office and was taken to emergency room (ER). Final outcome was reported as complete recovery as on 11 Nov 2012. No further information about causality and seriousness was provided. Batch review report (reference number: 210540) received from quality assurance department on 24 Mar 2014. Based on the document review, it was stated that the concerned FLUVIRIN batch number 123123 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from the QA department on 24 Mar 2014: QA batch review report was updated.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Upper respiratory tract congestion, Upper respiratory tract infection
Clinical narrative: Case number PHHY2013US012179 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 475325) on 08 Feb 2013 with a follow up report received from the Quality Assurance department (QA reference number: 215626) on 24 Mar 2014. This case refers to a 61-year-old female patient. Her concomitant medications included of Bystolic, Premarin, omeprazole and lovastatin. A day prior to vaccination she felt achy but was not that sick. She was vaccinated with FLUVIRIN (batch number: 123123, expiry date: 30 Jun 2013) intramuscularly in her left arm on 11 Oct 2012. At the day of vaccination she felt ok. On 12 Oct 2012 she woke up with sore throat that lasted a couple of days, and then on day 4 had "head of chest congestion for "awhile". She went to urgent care and was diagnosed with upper respiratory tract infection and received antibiotic amoxicillin on day 9. as of 07 Nov 2012 the events were slowly resolving. The seriousness and causality was not reported. Based on the review performed, this product batch (123123) was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up report was received from the Quality Assurance department (QA reference number: 215626) on 24 Mar 2014: The expiry date and the batch review report were updated.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, VIIth nerve paralysis
Clinical narrative: Case number PHHY2014US006514 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 514455) on 20 Jan 2014 with a follow up report received on 25 Mar 2014. This report refers to a 38 year old female patient. The patient was pregnant (18 weeks of gestation). Her concomitant medications included Prenatal vitamins. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 14 Oct 2013. On 17 Nov 2013, she experienced Bell's palsy. The event progressed to complete right sided facial paralysis over 3 to 4 days. She went to emergency room and started prednisone treatment within 72 hours of onset. The outcome of the event was reported as condition unchanged as of 23 Nov 2013. The seriousness and causality were not reported. Upon receipt of follow up received on 25 Mar 2014, it was reported that as the reporter was anonymous, no further information was provided and the case was considered as lost to follow up. Follow up report received on 25 Mar 2014: Lost to follow up information was updated.
Age: 55.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Erythema, Local swelling
Clinical narrative: Case number PHHY2014US012854 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 514802) website on 03 Feb 2014 with a follow up report received from the Quality Assurance department (QA reference number: 279096) on 25 Mar 2014. This case refers to a 55 year old female patient. Her past medical history was not reported. Her concomitant medications included BENICAR and metformin. On 16 Nov 2013, the patient was vaccinated with MENVEO (batch number: not reported) intramuscularly in the left arm. On 19 Nov 2013, her arm turned red and was swollen up. She was diagnosed with cellulitis and was hospitalized for 3 days. The patient had not recovered as of 26 Nov 2013. The causality of the events was not reported. Since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of MENVEO, it was concluded that MENVEO manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliance production, testing and supply processes for MENVEO. From this conclusion there was no reason or explanation to account for the reported adverse event. Follow up report received from the Quality Assurance department (QA reference number: 279096) on 25 Mar 2014: The annual product review of MENVEO was updated.
Sex: U
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous report as received from a nurse refers to a congenital anomaly in a foetus subject of unspecified gender. The mother's concurrent medical conditions included depression and shellfish allergy. The fetus was also exposed to Ondansetron and Prenatal vitamins transplacentally, which the mother took concurrently. The mother had bilateral ear surgery; details not provided. The mother was noted to have no passive smoke exposure. On 04-OCT-2013 the 16-year old mother of the fetal subject received unspecified dose of GARDASIL lot # J003727, Expiration Date: 07-NOV-2015, (.5 ml, transplacentary, unknown), a dose of BOOSTRIX lot# E5957, (.5 ml, transplacentary, unknown), unspecified dose of Meningococcal B c vaccine, lot# M12132 (.5 ml, transplacentary, unknown), unspecified dose of VARVIVAX, lot# J003713, (.5 ml, transplacentary, unknown). The mother's last menstrual period (LMP) occurred on 20-AUG-2013. The nurse reported the mother was exposed to with BOOSTRIX, GARDASIL, Meningococcal B C vaccine and VARIVAX at three to four weeks gestation, during the 1st trimester, however based on LMP she was calculated to be 6 weeks gestation. Estimated date of delivery was calculated to be 27-May-2014. On 04-OCT-2013, the pregnancy test confirmed pregnancy. On an unspecified date, within months of vaccination with BOOSTRIX, GARDASIL, Meningococcal B C vaccine and VARIVAX, the fetus experienced congenital anomaly and maternal vaccine exposure. The nurse reported there was a possibility of congenital anomaly, specific details were not provided. At the time of reporting the outcome of the congenital anomaly was unspecified, the mother's pregnancy was ongoing. For the mother's case please see case A1061427A. Additional information has been requested.
Sex: U
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Ear operation, Exposure during pregnancy, Foetal disorder, Pregnancy test positive
Clinical narrative: This spontaneous report as received from a nurse refers to a congenital anomaly in a foetus subject of unspecified gender. The mother's concurrent medical conditions included depression and shellfish allergy. The fetus was also exposed to Ondansetron and Prenatal vitamins transplacentally, which the mother took concurrently. The mother had bilateral ear surgery; details not provided. The mother was noted to have no passive smoke exposure. On 04-OCT-2013 the 16-year old mother of the fetal subject received unspecified dose of GARDASIL lot # J003727, Expiration Date: 07-NOV-2015, (.5 ml, transplacentary, unknown), a dose of BOOSTRIX lot# E5957, (.5 ml, transplacentary, unknown), unspecified dose of Meningococcal B c vaccine, lot# M12132 (.5 ml, transplacentary, unknown), unspecified dose of VARVIVAX, lot# J003713, (.5 ml, transplacentary, unknown). The mother's last menstrual period (LMP) occurred on 20-AUG-2013. The nurse reported the mother was exposed to with BOOSTRIX, GARDASIL, Meningococcal B C vaccine and VARIVAX at three to four weeks gestation, during the 1st trimester, however based on LMP she was calculated to be 6 weeks gestation. Estimated date of delivery was calculated to be 27-May-2014. On 04-OCT-2013, the pregnancy test confirmed pregnancy. On an unspecified date, within months of vaccination with BOOSTRIX, GARDASIL, Meningococcal B C vaccine and VARIVAX, the fetus experienced congenital anomaly and maternal vaccine exposure. The nurse reported there was a possibility of congenital anomaly, specific details were not provided. At the time of reporting the outcome of the congenital anomaly was unspecified, the mother's pregnancy was ongoing. For the mother's case please see case A1061427A. Additional information has been requested.
Sex: U
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Congenital anomaly, Foetal exposure during pregnancy, Pregnancy
Clinical narrative: This spontaneous report as received from a nurse refers to a congenital anomaly in a foetus subject of unspecified gender. The mother's concurrent medical conditions included depression and shellfish allergy. The fetus was also exposed to Ondansetron and Prenatal vitamins transplacentally, which the mother took concurrently. The mother had bilateral ear surgery; details not provided. The mother was noted to have no passive smoke exposure. On 04-OCT-2013 the 16-year old mother of the fetal subject received unspecified dose of GARDASIL lot # J003727, Expiration Date: 07-NOV-2015, (.5 ml, transplacentary, unknown), a dose of BOOSTRIX lot# E5957, (.5 ml, transplacentary, unknown), unspecified dose of Meningococcal B c vaccine, lot# M12132 (.5 ml, transplacentary, unknown), unspecified dose of VARVIVAX, lot# J003713, (.5 ml, transplacentary, unknown). The mother's last menstrual period (LMP) occurred on 20-AUG-2013. The nurse reported the mother was exposed to with BOOSTRIX, GARDASIL, Meningococcal B C vaccine and VARIVAX at three to four weeks gestation, during the 1st trimester, however based on LMP she was calculated to be 6 weeks gestation. Estimated date of delivery was calculated to be 27-May-2014. On 04-OCT-2013, the pregnancy test confirmed pregnancy. On an unspecified date, within months of vaccination with BOOSTRIX, GARDASIL, Meningococcal B C vaccine and VARIVAX, the fetus experienced congenital anomaly and maternal vaccine exposure. The nurse reported there was a possibility of congenital anomaly, specific details were not provided. At the time of reporting the outcome of the congenital anomaly was unspecified, the mother's pregnancy was ongoing. For the mother's case please see case A1061427A. Additional information has been requested.
Sex: U
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Foetal disorder, Pregnancy test positive
Clinical narrative: This spontaneous report as received from a nurse refers to a congenital anomaly in a foetus subject of unspecified gender. The mother's concurrent medical conditions included depression and shellfish allergy. The fetus was also exposed to Ondansetron and Prenatal vitamins transplacentally, which the mother took concurrently. The mother had bilateral ear surgery; details not provided. The mother was noted to have no passive smoke exposure. On 04-OCT-2013 the 16-year old mother of the fetal subject received unspecified dose of GARDASIL lot # J003727, Expiration Date: 07-NOV-2015, (.5 ml, transplacentary, unknown), a dose of BOOSTRIX lot# E5957, (.5 ml, transplacentary, unknown), unspecified dose of Meningococcal B c vaccine, lot# M12132 (.5 ml, transplacentary, unknown), unspecified dose of VARVIVAX, lot# J003713, (.5 ml, transplacentary, unknown). The mother's last menstrual period (LMP) occurred on 20-AUG-2013. The nurse reported the mother was exposed to with BOOSTRIX, GARDASIL, Meningococcal B C vaccine and VARIVAX at three to four weeks gestation, during the 1st trimester, however based on LMP she was calculated to be 6 weeks gestation. Estimated date of delivery was calculated to be 27-May-2014. On 04-OCT-2013, the pregnancy test confirmed pregnancy. On an unspecified date, within months of vaccination with BOOSTRIX, GARDASIL, Meningococcal B C vaccine and VARIVAX, the fetus experienced congenital anomaly and maternal vaccine exposure. The nurse reported there was a possibility of congenital anomaly, specific details were not provided. At the time of reporting the outcome of the congenital anomaly was unspecified, the mother's pregnancy was ongoing. For the mother's case please see case A1061427A. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Back pain, Local swelling, Malaise
Clinical narrative: Arm swelling, elbow pain, back pain - occurred 15 minutes after the HPV vaccine injection. Given BENADRYL 25mg P.O. Repeated 30 minutes later. No urticaria or respiratory distress.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Back pain, Local swelling
Clinical narrative: Arm swelling, elbow pain, back pain - occurred 15 minutes after the HPV vaccine injection. Given BENADRYL 25mg P.O. Repeated 30 minutes later. No urticaria or respiratory distress.
Age: 1.04
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood test normal, Convulsion, Electroencephalogram normal
Clinical narrative: 10 days after MMR shot -> low grade fever. Mom gave TYLENOL and fever was gone. 13 days after MMR shot -> emesis x1. 14 days after MMR shot -> emesis x1 then ok. 15 days after MMR shot sl. febrile and then seizure.
Age: 1.04
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood test, Convulsion, Electroencephalogram, Pyrexia, Vomiting
Clinical narrative: 10 days after MMR shot -> low grade fever. Mom gave TYLENOL and fever was gone. 13 days after MMR shot -> emesis x1. 14 days after MMR shot -> emesis x1 then ok. 15 days after MMR shot sl. febrile and then seizure.
Age: 20.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Headache, Pruritus generalised
Clinical narrative: This spontaneous report as received from a other health professional refers to a 20 year old male patient with "penicillin, KEFLEX and amoxicillin and AUGMENTIN allergy. The patient's medical history included hives, motor vehicle accident, spleen was removed and concussion. The patient stated that a 20 year old male patient was administered all 3 doses of GARDASIL (0.5mL one dose, IM): 1st dose (lot: J003727, exp: 07-NOV-2015) given on 05-SEP-2013, 2nd dose (lot: J006236, exp: 25-FEB-2016) given on 07-NOV-2013 and 3rd dose (lot: H020901, exp: 05-JU-2015) given on 04-MAR-2014. Nurse reported that the patient experienced headaches after the second dose of GARDASIL which subsided shortly after on an unspecified date. But the nurse reported that the patient again experienced headaches after the third dose of GARDASIL which have not subsided, and also experienced a rash all over his body. Nurse also mentioned that the patient had prior history of being involved in a Motor Vehicle Accident in which his spleen was removed on 09-MAY-2013 and had symptoms of concussion from this accident. The patient was received MOTRIN and CLARITIN as treatment. None lab was performed. None concomitant drug was reported. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Headache, Rash generalised
Clinical narrative: This spontaneous report as received from a other health professional refers to a 20 year old male patient with "penicillin, KEFLEX and amoxicillin and AUGMENTIN allergy. The patient's medical history included hives, motor vehicle accident, spleen was removed and concussion. The patient stated that a 20 year old male patient was administered all 3 doses of GARDASIL (0.5mL one dose, IM): 1st dose (lot: J003727, exp: 07-NOV-2015) given on 05-SEP-2013, 2nd dose (lot: J006236, exp: 25-FEB-2016) given on 07-NOV-2013 and 3rd dose (lot: H020901, exp: 05-JU-2015) given on 04-MAR-2014. Nurse reported that the patient experienced headaches after the second dose of GARDASIL which subsided shortly after on an unspecified date. But the nurse reported that the patient again experienced headaches after the third dose of GARDASIL which have not subsided, and also experienced a rash all over his body. Nurse also mentioned that the patient had prior history of being involved in a Motor Vehicle Accident in which his spleen was removed on 09-MAY-2013 and had symptoms of concussion from this accident. The patient was received MOTRIN and CLARITIN as treatment. None lab was performed. None concomitant drug was reported. Additional information has been requested.
Age: 0.58
Sex: M
Vaccine: HIBV
Symptoms: Crying, Dermatitis diaper, Diarrhoea, Faeces discoloured, Mucous stools
Clinical narrative: Diarrhea - green stool with mucous. Persistent for more than 48 hours and resulted in nappy rashes that caused the patient cried in pain. Unusual crying is also observed. No treatment is given at the time of reporting as parents have not seek medical intervention.
Age: 0.58
Sex: M
Vaccine: HIBV
Symptoms: Pain
Clinical narrative: Diarrhea - green stool with mucous. Persistent for more than 48 hours and resulted in nappy rashes that caused the patient cried in pain. Unusual crying is also observed. No treatment is given at the time of reporting as parents have not seek medical intervention.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age. On an unknown date the patient received ZOSTAVAX (dose, route of administration, lot#, indication unspecified). On an unknown date the patient developed shingles after receiving ZOSTAVAX and passed away on an unspecified date. The outcome of shingles after receiving ZOSTAVAX was reported as fatal. The cause of death was reported as shingles. Autopsy results were not provided. This case is linked to 2 more reports from same reporter. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death
Clinical narrative: Patient died.
Age: 1.0
Sex: M
Vaccine: HEP
Symptoms: Cytogenetic analysis, Electroencephalogram, Erythema, Metabolic function test, Pyrexia
Clinical narrative: Swelling of his face, face was red, fever, tremors.