chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Gait disturbance, Hypoaesthesia, Lumbar puncture abnormal, Multiple sclerosis
Clinical narrative: Began having a dizzy spell that progressively became worse over a few days that turned into months that was later accompanied by numbness and difficulty walking. Also had severe congestion one week after vaccination.
Age: 38.0
Sex: F
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging abnormal, Respiratory tract congestion
Clinical narrative: Began having a dizzy spell that progressively became worse over a few days that turned into months that was later accompanied by numbness and difficulty walking. Also had severe congestion one week after vaccination.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Fatigue, Headache, Hypersensitivity, Immediate post-injection reaction
Clinical narrative: Headache immediately after vaccination, then body aches and other "flu-like symptoms". Day 2 with swollen cheeks and mouth, aches continued. Day 3-4 developed shortness of breath (SOB). To emergency department. Diagnosed with allergic reaction and sent home with Benadryl. Day 5 with slight SOB, continued aches and fatigue. Day 6-7 with decreasing symptoms.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Influenza like illness, Oedema mouth, Pain, Swelling face
Clinical narrative: Headache immediately after vaccination, then body aches and other "flu-like symptoms". Day 2 with swollen cheeks and mouth, aches continued. Day 3-4 developed shortness of breath (SOB). To emergency department. Diagnosed with allergic reaction and sent home with Benadryl. Day 5 with slight SOB, continued aches and fatigue. Day 6-7 with decreasing symptoms.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on right side of chest, not raised or itching.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: None at this time.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Erythema, Pyrexia
Clinical narrative: Multiple blisters on buttocks and genital area started to appear 2 days after vaccination, several of which burst and are red and angry looking. Fever of 102.6F (rectal) 9 days after the vaccination which required 1 dose of Tylenol.
Age: 0.51
Sex: M
Vaccine: HIBV
Symptoms: Agitation, Crying, Emotional distress, Hyperhidrosis, Staring
Clinical narrative: At 7 p.m. Was sweating, temp was normal 99.4.  Then starting eerie Shrieking and shaking, trembling, inconsolable. Staring blankly with glazed eyes at 12 a.m..  Shrieking unusual cry again every hour throughout the night until given Tylenol, then every 2 hours. Sweaty and agitated. After 8 a.m. Woke up for the day and seemed OK. Normal since.
Age: 0.51
Sex: M
Vaccine: HIBV
Symptoms: Tremor
Clinical narrative: At 7 p.m. Was sweating, temp was normal 99.4.  Then starting eerie Shrieking and shaking, trembling, inconsolable. Staring blankly with glazed eyes at 12 a.m..  Shrieking unusual cry again every hour throughout the night until given Tylenol, then every 2 hours. Sweaty and agitated. After 8 a.m. Woke up for the day and seemed OK. Normal since.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles. Treatment: Vasatrex and Gabapentin.
Age: 1.11
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Local swelling, Vaccination complication
Clinical narrative: On 8/17 a hard red lump was noticed at the site of injection of Varicella vaccine.  The morning of 8/18 a hard lump was spotted on her groin and child was brought to the doctor who stated it to be a reaction to vaccine.  On 8/20 another smaller lump appeared on the groin.  All lumps are still present and not presenting any pain.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Excessive eye blinking, Tic
Clinical narrative: Eye blinking tic type behavior.
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea so far for several days, vomiting.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Shortly after receiving vaccine left arm became itchy, burning, painful, and extremely swollen - went to ER & was admitted & kept for 2 days then transferred to larger hospital (infectious disease) for 4 more days.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash
Clinical narrative: The employee developed a rash to arms, torso and legs after receiving TDAP vaccine 6/5/12. Was seen in emergency room and was prescribed Dexamethasone 0.75mg Dospak tapering dose. The rash and itching diminished with the Dexamethasone.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Varicella given on 7/26/12 L) arm - Pt. had swelling, redness, and pain the following day.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: Vaso vagal after flu shot - he did watch sister get shots.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported redness, pain, and swelling at the site of injection. She had tingling feelings in her fingertips and her legs felt weak. She had fever & chills which were treated with TYLENOL. She missed work 1 day. She noticed the pain the morning after the shot & it lasted for 6 days. She took BENADRYL and on the 7th day reported feeling much better.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscular weakness, Paraesthesia, Pyrexia
Clinical narrative: Patient reported redness, pain, and swelling at the site of injection. She had tingling feelings in her fingertips and her legs felt weak. She had fever & chills which were treated with TYLENOL. She missed work 1 day. She noticed the pain the morning after the shot & it lasted for 6 days. She took BENADRYL and on the 7th day reported feeling much better.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, PNC13
Symptoms: Rash pruritic
Clinical narrative: Pt had DTaP, INFLUENZA, pneumococcal, polio vaccine on 8/9/12. 36 hrs later pt broke out in itchy rash starting on chest, spreading to face, arms, back.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Lip blister, Oral herpes, Rash, Rash pruritic
Clinical narrative: 3rd day after vaccination, cold sores along bottom lip, cluster of blisters along lower lip, clusters of 'bumps' on forehead, itchy spots on face.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Irritability, Muscle twitching, Tremor
Clinical narrative: Developed episodes of shaking, twitching of arms throughout the night after receiving vaccines. Resolved by the next morning. No treatment given. No other change in behavior. Somewhat more fussy.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Injection site red and irritated, noted 24hrs after injection. Instructed to give TYLENOL and apply cool compresses.
Age: 4.0
Sex: M
Vaccine: HIBV
Symptoms: Erythema, Local swelling
Clinical narrative: Sl. red raised dime size area, adjacent pink raised oblong area anterior to each of these a smaller, lighter faintly red irregular area. Instructed to give ZYRTEC.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Full blood count normal, Injection site erythema, Injection site haematoma, Injection site pallor, Injection site reaction
Clinical narrative: 3 cm oval erythemic/blanching lesion with central bruising (L) thigh. Started 8/14/12. Monitor for fever, discharge.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: 3 cm oval erythemic/blanching lesion with central bruising (L) thigh. Started 8/14/12. Monitor for fever, discharge.
Age: 0.24
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lethargy, Pallor, Unresponsive to stimuli
Clinical narrative: Patient became pale, lethargic, unresponsive possible seizure activity within minutes of receiving vaccinations. Responded to stimulation. Blowby O2 took several minutes to recover.
Age: 1.15
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: HIB was ordered & HEP. B was given.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site rash
Clinical narrative: 2 white bumps around where vaccine was administered. Pt also has a red area about 2x4. She says it doesn't itch & is not painful. Pt will start to use Hydrocortisone cream.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site induration, Local reaction
Clinical narrative: Localized indurated reaction at imm site starting 8 days after vaccination. Tx with ice, topical corticosteroids. NSAIDS.
Age: 19.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Balance disorder, Blood pressure decreased, Presyncope, Syncope
Clinical narrative: Fainted, loss of balance, decreased BP vasovagal response.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Computerised tomogram, Condition aggravated, Migraine
Clinical narrative: Got GARDASIL shot 02/21/12. Had flare of abdominal migraines after vaccine. Went to urgent care & ER. Had extensive work up including CT scan. Saw pediatric GI. Also went to neurology.
Age: 52.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Significant erythema, swelling and pain from injection site on (L) deltoid to proximal forearm (past elbow).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling, Pyrexia, Skin ulcer
Clinical narrative: Swollen/hard at the injection site fever x 1 week. Her fever started one week after the vaccine and lasted for one week. Patient experienced sores across her abdomen. Upon reporting the adverse reaction to the pharmacist, she was referred to see her PCP.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dysphonia, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: My injection sit became very red, swollen to size of half- dollar and skin started to weep and was very itchy. I also experienced hoarseness with a slight cough and a raspiness when I spoke. I received this vaccine on 8/2/2012. I experienced these symptoms within 2 hours of injection. As of this date (8/13/12) I still have the swollen area on my arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Oedema
Clinical narrative: My injection sit became very red, swollen to size of half- dollar and skin started to weep and was very itchy. I also experienced hoarseness with a slight cough and a raspiness when I spoke. I received this vaccine on 8/2/2012. I experienced these symptoms within 2 hours of injection. As of this date (8/13/12) I still have the swollen area on my arm.
Age: 61.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Local reaction
Clinical narrative: Local reaction at injection site. Skin became very hard and warm. This affected area grew in size for roughly one week before it got better. Left arm (site of ZOSTAVAX).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Cellulitis Rt arm red and hot to touch 8/19/12 ROCEPHIN 1000 mg given. Will start taking oral Cephalexin 500mg Bid x 10 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: (L) upper arm with large approx. 4" in diameter red, raised circular rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphonia, Cough, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: (1) LUE 8/10/12 approx. 6 AM redness, heat, slight itch at injection site. Pain in LUE 8/10-8/11/12 which resolved. LUE redness & heat diminished and resolved 8/14/12. (2) Cough, scratchy throat onset 8/14/12, loss of voice 8/15/12. Improved. (3) "Spots" left anterior, upper chest and left neck onset 8/18/12, resolved in 1 day. "Spots" base of neck, right side, onset 8/20/2012. Improved. Afebrile.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Throat irritation
Clinical narrative: (1) LUE 8/10/12 approx. 6 AM redness, heat, slight itch at injection site. Pain in LUE 8/10-8/11/12 which resolved. LUE redness & heat diminished and resolved 8/14/12. (2) Cough, scratchy throat onset 8/14/12, loss of voice 8/15/12. Improved. (3) "Spots" left anterior, upper chest and left neck onset 8/18/12, resolved in 1 day. "Spots" base of neck, right side, onset 8/20/2012. Improved. Afebrile.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Patient's mom called to say that right at the injection site there is a lump that has gotten larger over time. The lump didn't show up till a few days after injection however the area is red, bumpy and itchy now.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture, Body temperature increased, C-reactive protein, Chest X-ray, Cough
Clinical narrative: Elevated temperature beginning on evening after immunization were given. Cough beginning on 08/08/2012.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Full blood count
Clinical narrative: Elevated temperature beginning on evening after immunization were given. Cough beginning on 08/08/2012.
Age: 18.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Fall, Muscle twitching, Syncope
Clinical narrative: Patient received vaccine & had syncope - fell to floor & started twitching, lasted about 10 seconds. 911 was called.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Itching all over the body - scalp, arms, groin.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling
Clinical narrative: Local swelling & redness.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash developed over chest and arms & legs lasted 36 degrees - took BENADRYL OTC meds.
Age: 81.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Rash erythematous
Clinical narrative: Vaccinated Wednesday. Saturday red spot appeared 3 inches in diameter at injection site -> others across body.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Varicella was given on 8-17-12. On 8-18-12 developed redness and swelling at site. Mom took to urgent care on 8-19-12 and was given BENADRYL and prednisone. Arm better 8-20-12.
Age: 2.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Convulsion, Pyrexia
Clinical narrative: Short seizure followed by fever 104 degrees max - relieved with antipyretic. Mother declined to bring child to doctors.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Became itchy at vaccine site & developed x 2 hours. On (R) arm.
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 7.5 - 8.5 redness, swelling BENADRYL no fever or itching, no SOB.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Joint injury, Pallor
Clinical narrative: Patient was given 2 vaccines, one in each arm. After administration, patient asked to lay down, her face went pale, lips pale, she got up & attempted to lay on exam table. She hit her knees on empty garbage can. PH & mother helped her to floor no fall but guide to floor.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Rash generalised
Clinical narrative: 8/20/12 - father of child called to report child developed generalize rash later in the day after receiving her immunization. He reported child is alert, active and without fever. States plans to take infant to doctor today.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Pt w/ fatigue, body aches, sore throat after injection.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager (healthcare worker) refers to a 15 months old male patient. The patient was vaccinated with a dose of M-M-R II (lot # reported as 667245/0961Z, expiration date 21-JUL-2012) on 31-JUL-2012. It was reported that the patient was vaccinated with expired M-M-R II. No adverse effects reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Neck pain
Clinical narrative: This spontaneous report as received from a physician refers to a 77 years old male patient. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot number not reported) on 27-JUL-2012. On 31-JUL-2012 the patient experienced headache, nausea, fatigue and body aches in the neck area. The patient had sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse refers to a patient who was vaccinated with the first 0.5 ml dose of GARDASIL IM in 2010 and did not received the second dose of GARDASIL on time. No adverse effects reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This spontaneous report has been received from a pharmacist refers to a 76 years old female patient. The patient was vaccinated with a dose of 23-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 25-JUL-2012 the patient developed a local injection site reaction after vaccination with ZOSTAVAX. There was a "round angry are" around the injection site. The patient sought medical attention by contacting the pharmacist. BENADRYL and hydrocortisone cream were given to patient for AE treatment. The patient was recovered on 28-JUL-2012. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Urticaria
Clinical narrative: This spontaneous report has been received from a pharmacist refers to a 68 years old female patient with no Pertinent Medical History or drug allergy. The patient was vaccinated with a dose of ZOSTAVAX on 15-FEB-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-JUL-2012 the patient developed shingles with blisters and "whelps". The patient sought medical attention by seeing physician and ZOVIRAX was given to patient for the AE treatment. The outcome of shingles with blisters and "whelps" was reported as not recovered/not resolved. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 years old male patient. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # 671609/1165AA) subcutaneous on 28-APR-2012. No other co-suspects were reported. No concomitant medications were reported. Approximately on 05-MAY-2012 "one week later" the patient developed shingles. The patient sent a letter to the pharmacy's corporate office, and the pharmacist was notified "today" on 02-AUG-2012. The patient was fine now and shingles was resolved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 months old male patient. The patient was inadvertently vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# 0562AE, exp 20-MAR-2013) subcutaneously on left thigh instead of VARIVAX (Merck), due to staff error on 13-AUG-2012. No adverse effects was reported. It was unknown if the patient sought medical attention. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to one or two sisters of unknown age. The patient was vaccinated with dose 1,2 and 3 of GARDASIL (lot # not reported) in July 2010, July 2011 and July 2012, respectively. No adverse effect was reported. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to one of two sisters of unknown age. The patient was vaccinated with dose 1 and 2 of GARDASIL (lot # not reported) in July 2011 and July 2012, respectively. No adverse effect was reported. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 years old female patient. The patient was vaccinated with dose 1 and 2 of GARDASIL (lot # not reported) on 27-JUL-2011 and 27-SEP-2012, respectively. On 13-AUG-2012, the patient was in physician's practice, requesting to received her third dose of GARDASIL (lot # not reported). No adverse effect has been observed or reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Eye irritation, Syringe issue
Clinical narrative: This spontaneous report as received from a registered nurse concerning her approximately 30 years old female colleague, who on 30-JUL-2012 had VARIVAX (lot # not provided) splashed, in both eyes, due to staff error. The nurse stated that when her colleague went to administer a VARIVAX (merck) she thought the syringe came apart and vaccine splashed in her eyes, and were burning. Both eyes were flushed with water, but the reporter stated that maybe not long enough. The nurse stated they would flush patient's eyes with water again, and had her follow up with a health care provider. At the time of the report outcome of eyes burning was unknown. Nurse stated no adverse event occurred with the patient who was getting the vaccine. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Pyrexia
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 12 years old male patient, who on 29-JUL-2012 was vaccinated with the second dose of VARIVAX (Merck) subcutaneously (dose not reported) (lot # 671083/0826AA, exp. 02-JUN-2013). No concomitant medications involved. On 29-JUL-2012 (also reported as on 28-JUL-2012) the patient developed 101 degree fever, as well as pain, redness and blisters around the injection site. The reporter mentioned the patient's first dose of VARIVAX (Merck) was on 16-JUL-2001 and he was unaware of any adverse symptoms after this dose was administered. No treatment was given for the events. No diagnostic laboratory studies were performed. The patient sought medical attention via office visit. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a 57 years old female consumer with drug allergy to penicillin and iodine refers to herself. The patient's historical drug included pneumonia shot a few months before the ZOSTAVAX vaccine. The patient was vaccinated subcutaneously with single dose 0.65 ml ZOSTAVAX (lot number unknown) on 16-JUN-2012. No other co-suspects were reported. Concomitant medications included warfarin. On 16-JUN-2012 the patient experienced serve knee pain, along her knee caps immediately following her injection with ZOSTAVAX. The pain had continued and she had also developed severe headache. The patient had sought unspecified medical attention. Treatment with ibuprofen and hydrocodone were given for adverse events. No laboratory diagnostics studies were performed. The outcome of the events was recovering. Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Skin exfoliation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 years old male patient at the time of reporting. The patient had no pertinent medical history or drug reactions/allergies. The pharmacist reported that patient who was vaccinated with ZOSTAVAX (lot number not reported) vaccination site unknown about 3 months ago in May 2012 in another pharmacy, has been experienced itching and scaly skin around injection site area on an unknown date. Patient would get itching of the area periodically and then skin will become scaly around the same time. The patient had sought medical attention via speaking to pharmacist. No treatment was given. The outcome was reported as not recovered/not resolved at the time of reporting. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haematoma
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to her 12 year old daughter. On an unspecified date the patient was vaccinated IM with a dose of GARDASIL (lot # not reported). It was unknown if this was the first or the second dose. Subsequently the patient experienced a hematoma and bruising at the injection site. The patient received unspecified treatment and the event improved. At the time of reporting, the outcome of hematoma and bruising at the injection site was reported as recovering. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated intramuscularly with the second dose of 0.5 ml of GARDASIL (Lot #: 665768/1377Y, expiry date 29-JUN-2012) on 09-AUG-2012. The first dose of GARDASIL (dose, route, lot # unknown) was on 24-MAY-2012. No adverse effect reported. Additional information is not available.
Age: 47.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report has received from an other health professional refers to a 47 years old female patient. The patient vaccinated with GARDASIL on 17-APR-2012 at age of 47. It was unknown if the patient sought medical attention and if treatment was given to patient. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated on 31-JUL-2012 with lot # (670542/0619AA) ZOSTAVAX that expired on 26-JUL-2012 and not experiencing any known symptoms. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age with medical history of panic attacks. The patent was vaccinated intramuscularly with the second dose of 0.5 ml GARDASIL on 27-JUL-2012. On 30-JUL-2012 the patient experienced intermittent, occasional tingling of both arms. On 31-JUL-2012, the patient also developed occasional tingling of both hands and both thighs. The physician stated the symptoms were intermittent and were not progressing. No treatment was given for the AE. There was no lab diagnostics studies performed. At the time of reporting, the outcome of the patient was not recovered. The patient sought medical attention by calling the office. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse (L.P.N.) refers to a patient of unknown age. The patient was vaccinated intradermally with a dose of 0.01 ml PNEUMOVAX23 (lot # not reported) on 01-AUG-2012. The patient was supposed to get purified protein derivative (PPD) as ordered by the physician. The patient is not experiencing any known symptoms. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 16 year old male patient who on 26-JUN-2012 was inadvertently vaccinated with two doses of GARDASIL (Lot # unspecified). This was human error. It was unknown if the patient was sought medical attention. No adverse symptoms noted. Follow up information has been received from nurse practitioner. It was reported that the same patient was accidentally vaccinated with 2 dose of GARDASIL (Lot #1696AA) intramuscularly in left deltoid on 26-JUN-2012. Concomitant medications included BOOSTRIX (Lot # AC52B074) vaccinated intramuscularly in right deltoid on 26-JUN-2012 and Naproxen. No adverse event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a approximately 14 years old female patient. The patient had no pertinent medical history or drug reactions/allergies. The physician reported that the patient completed her first series of RECOMBIVAX HB) (Lot# and exp date unspecified)vaccination site unknown as an infant but blood titers were low at office visit in 2008 and so physician administered a second three-dose vaccine series for RECOMBIVAX HB (5/0.5; one dose 0.5ml) (Lot # 666186/1483Y; Expired date 666186/1483Y) intramuscularly in October 2008, second dose in July 2009 and third dose in July 2010. Physician stated that patient still had negative and low titers at the patient's office visit on 07-AUG-2012. The patient sought medical attention via contacting physician. The patient was performed with routine blood work and chickenpox titers diagnostics (no result provided). No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site atrophy, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old male patient who on 22-MAY-2012 was vaccinated with his first dose of PNEUMOVAX 23 (lot # 672369/1850AA exp date: 28-JUL-2013). On 22-MAY-2012 the patient experienced swelling, pain and hard indentation at the injection site. The patient went to the E/R. The patient was treated with BENADRYL. It was also reported that therapy with PNEUMOVAX 23 was discontinued and not reintroduced. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a registered nurse refers to a 74 year old male patient (retired) with none illness during vaccination who on 24-MAY-2012 at 11:00 previously reported as 22-MAY-2012) was vaccinated intramuscularly in left deltoid with a first dose of PNEUMOVAX 23 dose not reported) lot# 672369/1850AA. It was reported that on 25-MAY-2012 patient had swollen, red and hot to touch left arm. He had difficulty with moving his arm. Patient required doctor visit. The patient was treated pain management antihistamines for adverse event. The patient was recovered for swollen, red hot to touch left arm and his difficulty with moving with the arm on 01-JUN-2012. Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old male patient who on 22-MAY-2012 was vaccinated with his first dose of PNEUMOVAX 23 (lot # 672369/1850AA exp date: 28-JUL-2013). On 22-MAY-2012 the patient experienced swelling, pain and hard indentation at the injection site. The patient went to the E/R. The patient was treated with BENADRYL. It was also reported that therapy with PNEUMOVAX 23 was discontinued and not reintroduced. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a registered nurse refers to a 74 year old male patient (retired) with none illness during vaccination who on 24-MAY-2012 at 11:00 previously reported as 22-MAY-2012) was vaccinated intramuscularly in left deltoid with a first dose of PNEUMOVAX 23 dose not reported) lot# 672369/1850AA. It was reported that on 25-MAY-2012 patient had swollen, red and hot to touch left arm. He had difficulty with moving his arm. Patient required doctor visit. The patient was treated pain management antihistamines for adverse event. The patient was recovered for swollen, red hot to touch left arm and his difficulty with moving with the arm on 01-JUN-2012. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a licensed practical nurse (LPN) referred to approximate 5 patients. The reporter stated that there had been approx 5 cases of syncope in patient receiving GARDASIL (lot # not reported) in the last 10 days and it may be lot related. At the time of reporting, the outcome of the patients was unknown. It was unknown if the patient sought medical attention. Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of children. The patients were vaccinated with a dose of improperly stored VAQTA (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old female patient with hypothyroidism, high cholesterol and Gastrooesophageal reflux disease (GERD) and no drug reactions/allergies. The patient was vaccinated SC with a dose of ZOSTAVAX (lot # reported as "H009779", exp date: 27-MAR-2013) on 05-AUG-2012. No other co-suspects were reported. Concomitant medications included SYNTHROID, ZOCOR, PRILOSEC and omega-3 marine triglycerides ("fish oil"). On 05-AUG-2012 ("later that evening") the patient developed a red, hot area at the site of injection that was 3 inches in diameter. The patient came into pharmacy for medical attention. No treatment information was given for the events. No lab diagnostics studies were performed. At the time of the report, the patient was recovering. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a 60 years old retired female nurse refers to herself. The patient was vaccinated with a dose of ZOSTAVAX "4 years ago", in JUL-2008, and the physician who gave it to her at that time might have stored the ZOSTAVAX at room temperature. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was vaccinated with the first and second dose of GARDASIL (Lot # unspecified) on 20-JAN-2011 and 19-APR-2011. No other co-suspects were reported. No concomitant medications were reported. At time of the report the patient was in the office to receive the final dose of GARDASIL (Lot # unspecified) on 09-AUG-2012. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of children. The patients were vaccinated with a dose of improperly stored PNEUMOVAX23 (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Culture cervix, Injection site anaesthesia, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report as received from a office manager refers to a 24 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with dose 1 and dose 2 GARDASIL (lot # reported a s"0624AE", exp date: 16-DEC-2014) on 01-JUN-2012 and 02-AUG-2012. No either co-suspects were reported. There was no concomitant medication. On approximately 03-AUG-2012 ("1 to 2 days later") the patient developed a hard lump, pain and numbness at the injection site that seemed to be persisting and moving down the patient's arm. The patient contacted physician's office for medical attention. No treatment was given for the events. Vaginal culture and PAP smear was performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Smear cervix
Clinical narrative: This spontaneous report as received from a office manager refers to a 24 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with dose 1 and dose 2 GARDASIL (lot # reported a s"0624AE", exp date: 16-DEC-2014) on 01-JUN-2012 and 02-AUG-2012. No either co-suspects were reported. There was no concomitant medication. On approximately 03-AUG-2012 ("1 to 2 days later") the patient developed a hard lump, pain and numbness at the injection site that seemed to be persisting and moving down the patient's arm. The patient contacted physician's office for medical attention. No treatment was given for the events. Vaginal culture and PAP smear was performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report as received from a office manager refers to a 24 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with dose 1 and dose 2 GARDASIL (lot # reported a s"0624AE", exp date: 16-DEC-2014) on 01-JUN-2012 and 02-AUG-2012. No either co-suspects were reported. There was no concomitant medication. On approximately 03-AUG-2012 ("1 to 2 days later") the patient developed a hard lump, pain and numbness at the injection site that seemed to be persisting and moving down the patient's arm. The patient contacted physician's office for medical attention. No treatment was given for the events. Vaginal culture and PAP smear was performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of adults. The patients were vaccinated with a dose of improperly stored PNEUMOVAX23 (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a Bachelor of Science in Nursing refers to a patient who was vaccinated with the third dose of VAQTA on 08-AUG-2012 in the morning. The patient received the first dose of VAQTA in 2003 and the second in 2006. No symptoms were reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain, Tenderness
Clinical narrative: This spontaneous report as received from a nurse refers to one of three patients of unknown age. On an unspecified date the patients was vaccinated with a dose of PNEUMOVAX23 (Lot#, dose and route not reported, but the three patients got the vaccine from the same lot number). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients experienced a greater tenderness, which was tender to the point of being painful. The patients sought for unspecified medical attention. This is one of several reports received from a same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of adults. The patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a female patient of unknown age. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (Lot # unspecified) intramuscularly in September -2011. No other co-suspects were reported. No concomitant medications were reported. On 09-AUG-2012 the patient would received her second dose of 0.5 ml GARDASIL (Lot # unspecified) intramuscularly at time of the report. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of children. The patients were vaccinated with a dose of improperly stored GARDASIL (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager (healthcare worker) refers to a 15 months old male patient. The patient was vaccinated with a dose of M-M-R II (lot # reported as 0667245/0961Z, expiration date 21-JUL-2012) on 25-JUL-2012. It was reported that the patient was vaccinated with expired M-M-R II. No adverse effects reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients. The patients were vaccinated with unspecified dose of M-M-R II (Lot#, dose and route not reported), date unspecified. "Later" on unspecified date the patients had low or negative titers to one of more components of the vaccine. It was not known if the patients sought for medical attention. At the time of this report the patients' statuses were unknown. This is one of several reports received from a same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided all available.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to her 18 years old daughter with possibly sulfa allergy and with no pertinent medical history. The patient was vaccinated with unspecified number of doses M-M-R II (Lot#, dose and route not reported) through a health department sometime in the past when she was a child (date unspecified). Concomitant therapy included unspecified allergy medication. The patient's titers were currently showing that she was "nonimmune" to rubella, date unspecified. The patient visited office for medical attention. At the time of this report the patient's status was noimmune to rubella. This is one of several reports received from a same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of adults. The patients were vaccinated with a dose of improperly stored VAQTA (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of adults. The patients were vaccinated with a dose of improperly stored GARDASIL (dose, route and lot number not provided) on unknown date "within the past 13 months". No other co-suspects were reported. Concomitant medications were reported. No adverse effects  reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of children. The patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (dose, route and lot number not provided) on unknown dates "within the past 13 months". No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.