chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dehydration, Diarrhoea
Clinical narrative: Diarrhea after ROTARIX with mild dehydration. Diarrhea x 6 days so far. CULTURELLE was prescribed. Mom was advised to come back to office if not resolved by 4/26/13.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Relevant medical history was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular. Lot number was not provided. Concomitant therapies included either FLUZONE or FLUVIRIN. On an unknown date, reported as over 18 months ago, the patient experienced red rashes and itchiness which pharmacist determined was hives. The outcome of red rashes and itchiness which pharmacist determined was hives was reported as recovered/resolved. The reporter causality was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed wide band of shingles one week after vaccination.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: "Red, hot, swollen arm."
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site mass, Muscle twitching
Clinical narrative: Developed a 2.5 inch lump on the left arm at the site of meningitis vaccine.  Reported muscle twitches for the 2 days prior to the lump developing.
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: Waken up by excruciating stomach pain, and possibly constipation. I don't have a thermometer to check my temperature.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Neuralgia
Clinical narrative: Pt has redness around injection site (left arm), a hard knot where injection was given.  Pt also complains of "nerve pain" running down his left arm three weeks after injection (4/23/13).
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Breath sounds abnormal, Crying, Eye movement disorder, Hypotonia, Lip disorder
Clinical narrative: At 9:02 am mother called and was worried about pt's lip doing a funny thing, immediately spoke to mother concerning pt, and stated that pt's lip had been doing something funny and had been crying and sounded a little congested and rattling, but had received shots yesterday and been put on Zantac for reflux, pt's eyes had not been moving, but now were closed she thought she was tired from crying, noticed earlier that her forehead looked purple but better now and her buttocks looked a little purple but didn't know why, stated her lip was getting better now, but her brother had tried saying her names but pt. did not focus her eyes on him just looked straight ahead, asked if pt was having distressed breathing and mom stated no, breathing fine, advised mom to bring pt. now to see Dr. and have pt looked at, ask pt. again if pt was having any distressed breathing, mom stated no, mother called back after getting off the phone with her at approximately 9:05am, mom called back 2 approximately 2 minutes after hanging up with her and told me that baby was not breathing and limp, advised to call 911 and told me she had, told her to start CPR, mom stated already had started CPR, wanted to know how many compressions, told mom 15 compressions with 2 breaths, advised papaw was doing breaths and she was doing compressions, advised to keep doing CPR till ambulance arrived, mom stated looked like the stomach was rising, keep doing CPR don't stop, ask her to check for pulse, explained to where to check for pulse on infant, brachial pulse, but stated she was trying but couldn't feel anything, advised keep doing CPR, don't stop, the nurses here again called for an ambulance and told us they were 2 in route but didn't know where they were located at, advised keep doing CPR, mom stated thought she heard some gargling, Dr took over phone call.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Respiratory arrest, Respiratory tract congestion, Resuscitation, Skin discolouration, Unresponsive to stimuli
Clinical narrative: At 9:02 am mother called and was worried about pt's lip doing a funny thing, immediately spoke to mother concerning pt, and stated that pt's lip had been doing something funny and had been crying and sounded a little congested and rattling, but had received shots yesterday and been put on Zantac for reflux, pt's eyes had not been moving, but now were closed she thought she was tired from crying, noticed earlier that her forehead looked purple but better now and her buttocks looked a little purple but didn't know why, stated her lip was getting better now, but her brother had tried saying her names but pt. did not focus her eyes on him just looked straight ahead, asked if pt was having distressed breathing and mom stated no, breathing fine, advised mom to bring pt. now to see Dr. and have pt looked at, ask pt. again if pt was having any distressed breathing, mom stated no, mother called back after getting off the phone with her at approximately 9:05am, mom called back 2 approximately 2 minutes after hanging up with her and told me that baby was not breathing and limp, advised to call 911 and told me she had, told her to start CPR, mom stated already had started CPR, wanted to know how many compressions, told mom 15 compressions with 2 breaths, advised papaw was doing breaths and she was doing compressions, advised to keep doing CPR till ambulance arrived, mom stated looked like the stomach was rising, keep doing CPR don't stop, ask her to check for pulse, explained to where to check for pulse on infant, brachial pulse, but stated she was trying but couldn't feel anything, advised keep doing CPR, don't stop, the nurses here again called for an ambulance and told us they were 2 in route but didn't know where they were located at, advised keep doing CPR, mom stated thought she heard some gargling, Dr took over phone call.
Age: 63.0
Sex: M
Vaccine: MEN, YF
Symptoms: Cough, Headache, Malaise, Pyrexia
Clinical narrative: Started with malaise; but fever on 4/21 to 100F; moderate frontal headache 4/21 with fever to 103.9F on 4/22 with mild, dry cough, without other signs or symptoms.  Rx: naprosyn with response.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture, Chest X-ray, Culture urine, Full blood count, Hypotonia
Clinical narrative: Approx 2-3 hours after receiving PPSV vaccine the headstart called mother due to her "shaking" during her sleep, she was found to have a 101.1 fever and was taken to ER. In ER she was lethargic & hypotonic, O2 sats of 95%, HR 142, RR 42, BP 108/48. Was given oxygen via face mask at 2L and acetaminophen 200mg. After approx 90min of monitoring, her condition improved and she was discharged to home.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Lethargy, Metabolic function test, Pyrexia, Streptococcus test, Tremor
Clinical narrative: Approx 2-3 hours after receiving PPSV vaccine the headstart called mother due to her "shaking" during her sleep, she was found to have a 101.1 fever and was taken to ER. In ER she was lethargic & hypotonic, O2 sats of 95%, HR 142, RR 42, BP 108/48. Was given oxygen via face mask at 2L and acetaminophen 200mg. After approx 90min of monitoring, her condition improved and she was discharged to home.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Urine analysis
Clinical narrative: Approx 2-3 hours after receiving PPSV vaccine the headstart called mother due to her "shaking" during her sleep, she was found to have a 101.1 fever and was taken to ER. In ER she was lethargic & hypotonic, O2 sats of 95%, HR 142, RR 42, BP 108/48. Was given oxygen via face mask at 2L and acetaminophen 200mg. After approx 90min of monitoring, her condition improved and she was discharged to home.
Age: 0.18
Sex: F
Vaccine: FLU3, HEPAB, MNQ, TDAP
Symptoms: Dyspnoea, Headache, Respiratory tract congestion
Clinical narrative: H/A, FEELING CONGESTED, DYSPNEA SHORTNESS OF BREATH.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pain, Pyrexia
Clinical narrative: CLIENT COMPLAINED OF SORENESS AT SITE AND LOW GRADE FEVER FOR TWO HOURS WHICH WAS TREATED WITH TYLENOL.  CLIENT REPORTS SORENESS IN RIGHT BICEP OF ARM WHICH RADIATES TO ELBOW.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Coordination abnormal, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: 04/19/2013 5:00 Pm some swelling and pain at injections site. 04/20/2013 12:00 PM Pain and swelling at injection site intensified, very red and sore. 7:00 PM headache and tired. 8:00 PM Paleness, muscle weakness, loss of coordination, heachache worsened. 04/21/2013 7:00 AM nausea, throwing up, headache continued muscle weakness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Muscular weakness, Nausea, Pallor, Vomiting
Clinical narrative: 04/19/2013 5:00 Pm some swelling and pain at injections site. 04/20/2013 12:00 PM Pain and swelling at injection site intensified, very red and sore. 7:00 PM headache and tired. 8:00 PM Paleness, muscle weakness, loss of coordination, heachache worsened. 04/21/2013 7:00 AM nausea, throwing up, headache continued muscle weakness.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, RVX
Symptoms: Crying
Clinical narrative: Inconsolable, intense crying for hours.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Abnormal behaviour, Aggression, Psychomotor hyperactivity, Speech disorder
Clinical narrative: He had uncontrollable hyperactivity. Blurting nonsensible statements and thoughts. Very loud, amped up, rough, abrasive behavior. This behavior is extremely atypical for my child who is mild mannered and a calm person. I have never seen him behave this way, ever in all of his existence.  He was this way the entire next day following vaccine.  2nd day post vaccine, he had mellowed some with sporadic moments throughout day of this erratic behavior. By third day, he had calmed to his normal personality.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Foetal death, Ultrasound scan
Clinical narrative: FETAL DEATH.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. In April 2013, the patient was vaccinated with an expired dose of ZOSTAVAX (Lot # not reported) that expired at the end of March 2013. There were no complaints. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative referred to a 16 year old (age at the time of the report) female patient who on unknown date started therapy with GARDASIL (Lot # 0306AA, exp. 10-MAY-2013). On 06-MAR-2013 was vaccinated with dose No. 2 of GARDASIL and on 10-APR-2013 the patient was vaccinated with dose No. 3 of GARDASIL. No adverse effect was reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: DTAP, HEPA, TYP, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a registered nurse referring to a 20 year old female patient who on 12-APR-2013, was vaccinated with a first dose of VARIVAX (Merck) (supplied lot# H018454, expiration date, 09-OCT-2014). Concurrent therapies included HEPATYRIX and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. No pertinent medical history provided. Registered nurse reported that subsequently after receiving the dose of VARIVAX (Merck), the patient had a positive pregnancy test. The pregnancy outcome was outcome pending. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from the consumer mother refers to a 26 year old female patient. No information regarding the patient's medical history was provided. In April 2012 (reported as about 1 year ago) the patient was vaccinated with GARDASIL dose 1, subdermally. No dosage information was provided. No concomitant medication was reported. On date of this report the patient's mother questions how to proceed. She was advised to see a health care professional. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a 66 year old male consumer reporting on himself with codeine allergy and no pertinent medical history. In September 2011 (reported as sometime in September, 2011), the patient was vaccinated with ZOSTAVAX (Lot# not provided) intramuscular (dose not reported). No other co suspects were reported. No concomitant therapy. The patient reported that ZOSTAVAX was administered to him as an intramuscular injection, which is an other than indicated route of administration. The patient developed pain in the arm around the injection site that radiates throughout his entire arm. The patient sought medical attention for this on multiple, unspecified occasions. Treatment was not given for the events. Lab diagnostics were not performed. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tearfulness
Clinical narrative: 4/11/13 MOP report R. leg Red warm, swollen, approx 2 inches in diameter. Child tearful. 100 mg ibuprofen given 8pm & 7am. Provide Rx KEFLEX 8:30am 4/12/13.
Age: 18.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: Diarrhoea
Clinical narrative: Diarrhea after taking 3rd dose.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified amount of patients of unknown ages. On unknown dates the patients were intramuscular vaccinated with 0.8 ml or 0.7 ml doses of GARDASIL instead of the recommended 0.5 ml dose. No adverse effects reported. The patients had sought unspecified medical attention. Additional information is not expected.
Age: 0.51
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Within 5 minutes of vaccine patient developed hives.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Painful, red, swollen area around the injection site. Symptoms started the day after injection given. Patient visited MD who gave antibiotics for possible Staph infection.
Age: 43.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Lymph node pain, Lymphadenopathy, Rash erythematous, Rash pruritic
Clinical narrative: Got injections at 3 PM around 7 PM noticed (R) lymph node sore & swollen then rash occurred on (R) buttocks, red, raised & itchy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Oral herpes
Clinical narrative: Shingles/herpes zoster infection on lip. Rx: Valacyclovir 1 gm TID x 7 days.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Confusional state, Dyskinesia, Fall, Loss of consciousness, Pallor
Clinical narrative: Patient received ADACEL, MENVEO and GARDASIL today. 30-45 seconds after receiving GARDASIL, she began jerking and passed out and fell out of her chair. She was given juice and a cool towel for her head. She woke up confused and pale but was alert. She was observed for 20 min and released to go home.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: 15 hours after KINRIX vax was injected into (R) arm, pt. demonstrated 3 inch redness, swelling, and hardness. No rash or fever. Pt. is able to move arm but painful to touch/movement. No treatment needed but icing and pain medication.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 16-APR-2013, the patient was inadvertently vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously and 0.5 ml of PROQUAD (Merck) (lot number and expiry date unspecified), subcutaneously. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacterial infection, Injection site erythema
Clinical narrative: Case number PHHY2013US012310 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 477146) on 08 Feb 2013 and a non-significant follow up report from the QA department on 19 Apr 2013 and a follow up report from the QA department received on 23 Apr 2013. This was also a quality complaint report (QA reference number: 211309). This report refers to a 54-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1204901) on left arm and PNEUMOVAX (batch number: H010515) on right arm both intramuscularly on 30 Oct 2012. On 01 Nov 2012, the patient went to doctor to get "pneumonia shot" from her doctor and was found that her arm was red running down to her elbow from the flu shot. It was reported that she had a bacterial infection from the flu shot and started treatment with antibiotics. Outcome of the events were reported as recovered. Seriousness and causality of the events was not reported. No further information was available. The batch review report (211309) received from quality assurance department on 23 Apr 2013. Based on the document review, it was stated that the concerned FLUVIRIN with batch number 1204901 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up report from the QA department on 19 Apr 2013: QA reference number was updated. Follow up report from the QA department received on 23 Apr 2013: QA investigation summary was updated.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pyrexia, Rash
Clinical narrative: Case number PHHY2013US012318 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 477751) on 08 Feb 2013, with a follow up received from the Quality assurance department on 23 Apr 2013. This report refers to a 34-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1206901) and PNEUMOVAX (batch number: H009826) both intramuscularly on 06 Dec 2012. The evening of the same day, she noticed a rash. The next day the rash was worse and she had a fever, the following day went in for treatment, physician suspected cellulitis. Based on the batch review report received from quality assurance department on 23 Apr 2013, it was stated that the concerned FLUVIRIN batch number 1206901 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Outcome of the events were reported as condition unchanged. Seriousness and causality of the events was not reported. No further information was available. Follow up received from the QA department on 23 Apr 2013: Updated Batch review report.
Age: 0.47
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Condition aggravated, Fatigue, Irritability, Medication error, Pyrexia
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an approximately 5 month old male patient with no drug reactions or allergies. The medical history of the patient included ear infection. The patient was diagnosed with a fever and an ear infection at an office visit on 14-JAN-2013. At that office visit, ROCEPHIN injection was prescribed but the patient was inadvertently vaccinated with a dose of GARDASIL (lot number and expiry date reported as H010649 and 20-FEB-2015 respectively, dose unspecified), intramuscularly on 14-JAN-2013. There was no concomitant medication. The child presented back to the office on 15-JAN-2013 and still had a fever. The patient sought medical attention. The patient was then admitted to a hospital as the mother of the patient was concerned that the wrong product was administered. The patient was treated with intravenous fluids and ROCEPHIN. At the request of the parent, the patient was transferred to another hospital on 17-JAN-2013. Approximately on an unknown date in 2013, blood culture and a urine culture were performed and the result was unknown. An infectious disease consult was conducted on 18-JAN-2013 due to the prolonged fever of the patient. The consult noted that the GARDASIL did not contribute to the persistent fever because of the mechanism of action of GARDASIL and the child was febrile before the vaccination. Approximately On an unknown date in 2013, the patient had recovered. Additional information has been requested.
Age: 0.47
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an approximately 5 month old male patient with no drug reactions or allergies. The medical history of the patient included ear infection. The patient was diagnosed with a fever and an ear infection at an office visit on 14-JAN-2013. At that office visit, ROCEPHIN injection was prescribed but the patient was inadvertently vaccinated with a dose of GARDASIL (lot number and expiry date reported as H010649 and 20-FEB-2015 respectively, dose unspecified), intramuscularly on 14-JAN-2013. There was no concomitant medication. The child presented back to the office on 15-JAN-2013 and still had a fever. The patient sought medical attention. The patient was then admitted to a hospital as the mother of the patient was concerned that the wrong product was administered. The patient was treated with intravenous fluids and ROCEPHIN. At the request of the parent, the patient was transferred to another hospital on 17-JAN-2013. Approximately on an unknown date in 2013, blood culture and a urine culture were performed and the result was unknown. An infectious disease consult was conducted on 18-JAN-2013 due to the prolonged fever of the patient. The consult noted that the GARDASIL did not contribute to the persistent fever because of the mechanism of action of GARDASIL and the child was febrile before the vaccination. Approximately On an unknown date in 2013, the patient had recovered. Additional information has been requested.
Age: 0.47
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Accidental exposure to product, Blood culture, Condition aggravated, Culture urine, Pyrexia
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an approximately 5 month old male patient with no drug reactions or allergies. The medical history of the patient included ear infection. The patient was diagnosed with a fever and an ear infection at an office visit on 14-JAN-2013. At that office visit, ROCEPHIN injection was prescribed but the patient was inadvertently vaccinated with a dose of GARDASIL (lot number and expiry date reported as H010649 and 20-FEB-2015 respectively, dose unspecified), intramuscularly on 14-JAN-2013. There was no concomitant medication. The child presented back to the office on 15-JAN-2013 and still had a fever. The patient sought medical attention. The patient was then admitted to a hospital as the mother of the patient was concerned that the wrong product was administered. The patient was treated with intravenous fluids and ROCEPHIN. At the request of the parent, the patient was transferred to another hospital on 17-JAN-2013. Approximately on an unknown date in 2013, blood culture and a urine culture were performed and the result was unknown. An infectious disease consult was conducted on 18-JAN-2013 due to the prolonged fever of the patient. The consult noted that the GARDASIL did not contribute to the persistent fever because of the mechanism of action of GARDASIL and the child was febrile before the vaccination. Approximately On an unknown date in 2013, the patient had recovered. Additional information has been requested.
Age: 0.47
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning an approximately 5 month old male patient with no drug reactions or allergies. The medical history of the patient included ear infection. The patient was diagnosed with a fever and an ear infection at an office visit on 14-JAN-2013. At that office visit, ROCEPHIN injection was prescribed but the patient was inadvertently vaccinated with a dose of GARDASIL (lot number and expiry date reported as H010649 and 20-FEB-2015 respectively, dose unspecified), intramuscularly on 14-JAN-2013. There was no concomitant medication. The child presented back to the office on 15-JAN-2013 and still had a fever. The patient sought medical attention. The patient was then admitted to a hospital as the mother of the patient was concerned that the wrong product was administered. The patient was treated with intravenous fluids and ROCEPHIN. At the request of the parent, the patient was transferred to another hospital on 17-JAN-2013. Approximately on an unknown date in 2013, blood culture and a urine culture were performed and the result was unknown. An infectious disease consult was conducted on 18-JAN-2013 due to the prolonged fever of the patient. The consult noted that the GARDASIL did not contribute to the persistent fever because of the mechanism of action of GARDASIL and the child was febrile before the vaccination. Approximately On an unknown date in 2013, the patient had recovered. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Influenza, Pneumonia
Clinical narrative: This serious consumer report (initial receipt: 08-Apr-2013) concerns a female patient, who had a medical history of sinus surgery in 1993. Last year the patient received a flu shot (brand name, manufacturer and batch number were not reported). She also received an unspecified pneumonia shot at an unspecified time. In Jan-2013, Feb-2013 and Mar-2013, the patient had pneumonia. She also had the flu in Feb-2013. She went to the ER (Emergency Room) and was admitted at a hospital for pneumonia and flu in Feb-2013 and also admitted at a hospital for pneumonia from 01-Mar-2013 to 08-Mar-2013. She had been on antibiotics from Jan-2013 to Apr-2013 and was on prednisolone which gave her side effects, saying it 'blows you up'. X-ray was performed. The event outcome was not reported.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Influenza, Pneumonia, X-ray
Clinical narrative: This serious consumer report (initial receipt: 08-Apr-2013) concerns a female patient, who had a medical history of sinus surgery in 1993. Last year the patient received a flu shot (brand name, manufacturer and batch number were not reported). She also received an unspecified pneumonia shot at an unspecified time. In Jan-2013, Feb-2013 and Mar-2013, the patient had pneumonia. She also had the flu in Feb-2013. She went to the ER (Emergency Room) and was admitted at a hospital for pneumonia and flu in Feb-2013 and also admitted at a hospital for pneumonia from 01-Mar-2013 to 08-Mar-2013. She had been on antibiotics from Jan-2013 to Apr-2013 and was on prednisolone which gave her side effects, saying it 'blows you up'. X-ray was performed. The event outcome was not reported.
Age: 0.4
Sex: F
Vaccine: HEP, OPV, PER, RVX, TD
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Severe fever, vomiting, diarrhea.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Patient, called nurses desk, requesting a nurse, the nurse went to the room, and observed hives, over the patients face and buttocks.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Rash on bottoms of feet and legs.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: T. 98.4 deg approx 12 hours after vaccine admin, left upper arm became erythematous and slightly swollen. Anithistamine and cold pack given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial infection
Clinical narrative: Pt. called and stated she got a bacterial infection from the vaccine she received on 4/16/13.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. On 01-APR-2013 the patient was vaccinated subsequently with a 0.65 ml dose of ZOSTAVAX (lot # H021292, expired date: 28-FEB-2014). Concomitant therapies included MEDROL dose pack, betamethasone cream and VALTREX. On 08-APR-2013, the patient developed rash about a week after receiving vaccine ZOSTAVAX. Patient developed rash on her abdomen on one side of her body, neck, head and wrist and rashes are red and itchy. Patient went to a minute clinic when rash first appeared and she was prescribed VALTREX because nurse who saw patient thought that it was shingles. However, patient subsequently followed up with her family physician and dermatologist as well and it was determined that rashes were not shingles rash but rather some sort of allergic reaction to ZOSTAVAX. The patient did office visit for medical attention. The event was treated with betamethasone cream and VALTREX. At the time of the report, the patient was not recovered from the event. Pharmacist stated that patient got HIVES from AVELOX and erythromycin gel. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. On 01-APR-2013 the patient was vaccinated subsequently with a 0.65 ml dose of ZOSTAVAX (lot # H021292, expired date: 28-FEB-2014). Concomitant therapies included MEDROL dose pack, betamethasone cream and VALTREX. On 08-APR-2013, the patient developed rash about a week after receiving vaccine ZOSTAVAX. Patient developed rash on her abdomen on one side of her body, neck, head and wrist and rashes are red and itchy. Patient went to a minute clinic when rash first appeared and she was prescribed VALTREX because nurse who saw patient thought that it was shingles. However, patient subsequently followed up with her family physician and dermatologist as well and it was determined that rashes were not shingles rash but rather some sort of allergic reaction to ZOSTAVAX. The patient did office visit for medical attention. The event was treated with betamethasone cream and VALTREX. At the time of the report, the patient was not recovered from the event. Pharmacist stated that patient got HIVES from AVELOX and erythromycin gel. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test, Incomplete course of vaccination, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On an unknown date the patient was intended to be vaccinated with a dose of MMR II, (lot#, expiration date and route not reported). When it was discovered the flip-cap was missing from one of the ten vials of MMR II the health care professional did not wanted to use any of the vials and the patient missed a dose. A product quality complained (PQC) was filed. The patient was in the office to get the vaccinations needed to attend college and would return next week. Patient also received titration titre bloodwork to determine if she needed one dose or two. No adverse event (AE) symptoms were indicated. This is one of the several reports from the same source. Follow-up information received on 22-APR-2013. On 22-APR-2013, a phone call was placed to the office of the office manager. The receptionist transferred the call to the voicemail of the office manager. A voicemail message was left with the office manager to please call back regarding the multiple patients and MMR II. All telephone attempts to obtain follow-up information has been unsuccessful. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 72 year old male patient. On 14-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). On an unknown date, the patient complained of burning sensation and stinging. The outcome of the reported events were unknown. This is one of the 8 reports received from the same reporter. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to 73 years old female patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). On an unspecified date, the patient complained of burning sensation and stinging. The outcome of the reported events were unknown. This is one of the 8 reports received from the same reporter. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a 67 years old male consumer refers to himself. The patient's medical history included carpal tunnel surgery. The patient did not have drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (lot number not provided) two to two and a half years ago. Concomitant medications included allopurinol and unspecified blood pressure medications. A month to 6 weeks ago, approximately in March 2013, the patient developed shingles. The shingles was diagnosed at a routine physical where because of a rash the doctor noticed. The patient said that he did feel like a bug bit him, but said there was no itching or pain, and the rash had "faded". The patient noted the healthcare professional (HCP) said that his lack of some more painful symptoms may be attributable to the ZOSTAVAX vaccination. No treatment was given for adverse event. No lab diagnostics studies were performed. The patient did not sought medical attention. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Myalgia
Clinical narrative: Myalgia, right deltoid pain, possible fever (patient never confirmed this). Symptoms improving as of 4/24/13.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Body temperature increased, Chills, Fatigue
Clinical narrative: Temp 104.2, redness & swelling at injection site, headache, stomach ache, tired, chills, body aches, sore joints.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Temp 104.2, redness & swelling at injection site, headache, stomach ache, tired, chills, body aches, sore joints.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen at injection site.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Pruritus, Swelling
Clinical narrative: REMOVED BANDAID AND NOTICED SHE HAD SOME SWELLING, REDNESS AND ITCHING.  WAS OFFERED AN APPOINTMENT ON 4/23/13 FOR EVAL BUT WAS NOT NEARBY - CAME IN TO OFFICE FOR EVAL ON 4/24/13 APPROX 10:20AM - WAS TREATED FOR ALLERGIC REACTION - ICE, ZYRTEC AND KEFLEX (IN CASE AN INFECTION).
Age: 5.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Facial pain, Lymphadenopathy, Pyrexia, Streptococcus test
Clinical narrative: Swelling of the face, fever, face pain on cheeks, swelling of lymph glands, redness on face.
Age: 5.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Swelling face
Clinical narrative: Swelling of the face, fever, face pain on cheeks, swelling of lymph glands, redness on face.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Insomnia, Pain in extremity
Clinical narrative: Horrible headache, unable to sleep and headache next day.  Arm sore...expected that.  Could be hypothyroidism.
Age: 36.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Depressed level of consciousness, Erythema, Eye movement disorder, Musculoskeletal stiffness, Pallor
Clinical narrative: Patient was laying down in exam room for immunizations. 1st injection MMR given s/p RA without incident. Upon 2nd immuniz. Hep B, RA, pt. became unresponsive, unarousable, eyes rolled back, became very pale and dry, pt. sat up, turned very red, laid back down and began widespread shaking of entire body, legs, arms. Stiffened limbs, then started to arouse. This lasted approx 2-3 minutes.
Age: 36.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Patient was laying down in exam room for immunizations. 1st injection MMR given s/p RA without incident. Upon 2nd immuniz. Hep B, RA, pt. became unresponsive, unarousable, eyes rolled back, became very pale and dry, pt. sat up, turned very red, laid back down and began widespread shaking of entire body, legs, arms. Stiffened limbs, then started to arouse. This lasted approx 2-3 minutes.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Fall, Herpes zoster, Pain in extremity, X-ray
Clinical narrative: This spontaneous report was received from a 70 year old female patient reporting on herself with penicillin allergy and high blood pressure who in April 2010 "three years ago" was vaccinated with a dose of ZOSTAVAX, 0.65 mL one shot (route and lot # not provided). Concomitant therapies included FLEXERIL, TRAMADOL HYDROCHLORIDE, an unspecified hypertensive medication and LYRICA. In March 2013 "about three weeks ago", the patient developed a tremendous pain in her thigh on the right side located between the knee and crotch and which was so tender that it hurt even when it was barely touched. The patient stated that her primary care physician diagnosed this leg pain as shingles event though she had not developed any rash. on 13-APR-2013, the patient fell on her left side when re-entering her home after being outdoors. Due to the pain in her right leg, the patient received a blood test and an X-ray, results were not provided. The patient indicated that these tests were not performed, because of the fall; they were performed because of the shingles. The patient mentioned that she was going for another blood test to confirm if she had a case of the shingles. The patient sought medical attention, she saw her physician and was treated with tramadol. At the time of reporting, the outcome of the event was recovering. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Abscess limb, Incisional drainage
Clinical narrative: Pt stated lg abscess to Lt deltoid. Admitted to hospital, I and D done.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site mass, Pain
Clinical narrative: Vaccine given in left arm (DAPTACEL) on 4/11/13. Parent called center on 4/12/13 concerned with "golf ball sized" lump at area of vaccine. Parent advised to ice x 2 days then apply heat to area after 2 days. Spoke with mom on 4/15/13 who states "lump" is better and pt no longer complains of pain.
Age: 27.0
Sex: M
Vaccine: TD
Symptoms: Back pain, Body temperature increased, Myalgia, Neck pain
Clinical narrative: Low grade, temp, myalgia, back/neck pain.
Age: 1.26
Sex: M
Vaccine: HIBV
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Right thigh with localized reaction: 20mm x 12mm redness, tenderness, firm and warm to touch. Temp. 103.4 degrees F Ax. Reports fevers to 101 degrees F with past vaccinations.
Age: 1.26
Sex: M
Vaccine: HIBV
Symptoms: Local reaction
Clinical narrative: Right thigh with localized reaction: 20mm x 12mm redness, tenderness, firm and warm to touch. Temp. 103.4 degrees F Ax. Reports fevers to 101 degrees F with past vaccinations.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Musculoskeletal stiffness, Pain, Tenderness
Clinical narrative: This medically confirmed spontaneous report (initial receipt 17-Dec-2012) concerns a 54 year old female patient. Concomitant medications included fluticasone nasal spray. On 04-Dec-2012, the patient received AFLURIA (batch: P50608) via intramuscular route in the deltoid in the left arm at a dose of 0.5 ml. The patient had no previous doses of AFLURIA. On 05-Dec-2012, the patient developed local pain and tenderness with a stiff arm (including loss of range of motion) following vaccination with AFLURIA. The patient had restricted range of motion in the left arm. She was unable to lift her arm for several weeks after. The reporter indicated that the range of motion had improved, but the patient currently still could not fully extend the arm or raise the arm above the shoulder in the arm that was vaccinated with AFLURIA, due to the stiff arm (including pain and tenderness). On 30-Jan-2013 the range of motion in the patients arm was improving. The event outcome was recovering. Reporter's comments: The reporter considered events to be serious as it resulted in persistent or significant disability/incapacity. Follow-up #1 (30-Jan-2013): current status of patient. Follow up #2 (15-Apr-2013): upgraded to serious, reporter assessment, injection site (left arm).
Age: 31.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Fri swelling, redness both sites with pain & itching immediately following vaccines. Mon still red & swollen but improving slowly. Vaccine sites too low (not in deltoids).
Age: 31.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site swelling
Clinical narrative: Fri swelling, redness both sites with pain & itching immediately following vaccines. Mon still red & swollen but improving slowly. Vaccine sites too low (not in deltoids).
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin reaction, Skin warm
Clinical narrative: Received pneumococcal vaccine on 4/17/13 in left deltoid. Lt arm very red, hot and swollen today and painful. Prednisone, ZYRTEC given.
Age: 37.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: States rash started on forearms only on Sat. evening. Small bumps rash noted both arms.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Dizziness, Muscle rigidity, Staring, Unresponsive to stimuli
Clinical narrative: Pt. felt dizzy; sat down; said vision blurry, body was rigid, Hands clammy, Unresponsive, Would not answer questions, He yawned 3 times. Eyes glazed over. EMT arrived. BP 70/52. He threw up. The he came out of it. Started talking.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred, Vomiting, Yawning
Clinical narrative: Pt. felt dizzy; sat down; said vision blurry, body was rigid, Hands clammy, Unresponsive, Would not answer questions, He yawned 3 times. Eyes glazed over. EMT arrived. BP 70/52. He threw up. The he came out of it. Started talking.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Bump at injection site, swelling in left arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash macular
Clinical narrative: This spontaneous report as received from a 70 year old female patient regarding herself who had no drug reactions or allergies. Pertinent medical history was none. On 03-OCT-2007, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) in the left arm. Concomitant medication was none. On 15-MAR-2013, the patient developed a painful blotchy rash behind her left ear and hairline. The patient sought medical attention for the same and visited the physician's office on 18-MAR-2013 and was diagnosed with shingles. Laboratory test was not performed. The physician had prescribed valacyclovir, 1 pill for 10 day. The pain had subsided within 3 days and the rash was slowly disappearing. Approximately on 17-MAR-2013 (reported as within 3 days), the event pain was recovered. The outcome of shingles and blotchy rash behind her left ear and hairline was reported as recovering/resolving. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Swelling and pain on (R) arm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Swelling, redness, and pain in (R) arm.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt described pain ranging from (L) neck down to (L) arm. States also numbness and tingling did not report earlier due to expected pain from injection. Now after one month, still painful - believe from neuritis.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Case number PHEH2013US009035 is an initial spontaneous report received from a consumer on 14 Feb 2013: This case refers to a 66-year-old male patient. His concurrent conditions included of hemorrhoids, high blood pressure, high cholesterol, and colonoscopy every three years. He was vaccinated with influenza vaccine (manufacturer and batch number: not reported, hence conservatively taken as pandemic or seasonal INN) on an unspecified date and experienced an allergic reaction. The seriousness, outcome and causality were not reported. No other information was available.
Age: 53.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 53 year old patient (gender not reported) who was vaccinated with RECOMBIVAX HB (lot # not reported) on 24-JAN-2007, 01-FEB-2007 and 15-FEB-2007. No adverse symptoms reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Guillain-Barre syndrome, Hallucination, Pain
Clinical narrative: Loss of strength, couldn't walk, collapsed. hallucinations, terrible pain, weeks in hospital recovering, very slow recovery. Therapy home health, meals.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Loss of strength, couldn't walk, collapsed. hallucinations, terrible pain, weeks in hospital recovering, very slow recovery. Therapy home health, meals.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to 79 year old male of patient. On 20-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). On an unspecified dates, the patient complained of burning sensation and stinging. The outcome of the reported events were unknown. This is one of the 8 reports received from the same reporter. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Arthralgia, Asthenia, Fatigue, Full blood count normal
Clinical narrative: 1 month of symptoms starting 10 days after her 2nd HPV vaccine Gardisal (1st HPV on 2/24/12, 2nd 2/25/13) multiple joint pain, intermittent migratory joint pain and abdominal pain, weakness and fatigue lasting about a month. 10 days after vaccine ago woke up in the night with bilateral knee pain with mild swelling; over the next few days had bilateral ankle and wrist pain. The joint pain seemed to migrate to different areas, moving around every 5-10 minutes, no more than 1 hour in one particular joint. The swelling was present over the wrist / ankles / knees, resolved in around 2 weeks.  The pain seems to persist however until 1 month. Cold water tends to help the pains. Upon waking the morning she has no pain or no stiffness.  She has been waking up in the middle of the night with pain, but less so this week than last week. Chest, back, abdominal pain present  5 days after the joint pains. Each pain was brief in duration. Chest pain is resolved. Abdominal pain is bilateral periumbilical, but improved. No diarrhea / vomiting / blood in stool.