chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 26-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Erythema swelling (dia ab 2 x 2 cm) noted ab 42 hours after vaccine administration, some pruritus - no pain. Resolution (complete) on 03-01-15 approximately 6 AM.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 11-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 05-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 04-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified multiple number of patients of unknown demographics. patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified multiple patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. The reporter stated that, (Oka/Merck) VARIVAX was exposed to temperatures outside of recommended condition (incorrect product storage). No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with (Oka/Merck) VARIVAX was not reported. Product quality issue was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: Information has been received from a 50 year old male patient enrolled in market research, concerning himself. Patient medical history and current condition was not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, frequency, lot # and expiration date were not reported). Other co-suspects and concomitant medication was not reported. It was reported that the patient got sick the last he got PNEUMOVAX 23 (dates unspecified). The action taken of PNEUMOVAX 23 and the outcome of the event was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: TYP, YF
Symptoms: Blood glucose, Dizziness, Electrocardiogram, Nausea
Clinical narrative: Patient received typhoid (TYPHIM Vi) vaccine first she was fine. Although she was nervous to get vaccinated then received yellow fever (YF-VAX) and felt very dizzy and nausea.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Concurrent conditions and medical history were not reported. On 24-FEB-2015 the patient was vaccinated with a dose ZOSTAVAX subcutaneous injection, 0.65 ml subcutaneously (batch/lot# and expiration date not reported). Concomitant therapies were not reported. The pharmacist informed that the patient called to report that she developed a red injection site rash on 25-FEB-2015, which extended to her elbow on the next day, 26-FEB-2015. It was also reported that on that day, the patient developed an injection site swelling "up to the size of a baseball". The outcome of the events was reported as not recovered. The pharmacist did not provide a causality assessment. The reported stated that there was no intervention in order to prevent serious criteria, the patient did not die, the events did not cause a significant disability or incapacity, no hospitalization was required, the experience was not life-threatening and it was not an overdose. Also, no Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 12-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 20-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 16-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 17-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.19
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a 10 week old patient. On 27-FEB-2015 the patient, who was indicated for a dose of hepatitis B vaccine, was vaccinated with a dose of VAQTA injection (lot # reported as K010912, expiration date 13-NOV-2015, dose and route not reported) in error. No adverse effect was observed or reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 30-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 07-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 13-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 28-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 08-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 14-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 05-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, the VARIVAX (Merck) was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 23-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2025, the varicella virus vaccine  (Merck) was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with varicella virus vaccine live (Merck) was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a nurse practitioner referring to a 24 year old female patient. The patient had no pertinent medical history and no drug allergies. On 28-JAN-2015 the patient was vaccinated with a dose of VARIVAX (Merck) injection (dose, route and lot number were not reported). Other suspect therapies included a dose of M-M-R II (dose, route and lot number were not reported) on the same date. There was no concomitant therapy. Subsequently the patient was determined to be pregnant with last menstrual period (LMP) of 29-JAN-2015 and estimated date of delivery (EDD) of 05-NOV-2015. A home pregnancy test performed on an unknown date in 2015 was positive and then a prenatal ultrasound in the office confirmed the pregnancy. No problems reported. It was reported that no treatment was given to the patient. At the time of this report, the patient had a gestation of 4 weeks. The pregnancy outcome was unknown. Additional information is not expected since the reporter is not allowed to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 10-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, the VARIVAX (Merck) was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 30-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, the VARIVAX (Merck) was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 06-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2015, the PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition (incorrect product storage). No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient noted swelling and redness (Cellulitis) of L. arm on 2/18/2015.  He sought care on both 2/18/2015 & 2/19/2015.  Patient was treated with antibiotics without incident and has had no further problems. Routine f/u not recommended.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Baseball size Swelling, redness, soreness and warmth at injection site.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Salivary gland enlargement
Clinical narrative: Swollen sailvary glands, lymph lodes in neck and behind ears.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nodule, Pruritus, Swelling
Clinical narrative: RED, RAISED, KNOT THAT ITCHES.
Age: 29.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Headache and raised, swollen, itchy red area at injection site about 3.5 by 4 inches.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Breast milk substitute intolerance, Diarrhoea, Urticaria, Vomiting
Clinical narrative: My wife fed our daughter Enfamil formula and within minutes she developed hives on the face and neck; she also vomited twice and had diarrhea. The hives continued to cover her entire body. Within 15-20 minutes of the feeding we took her to the emergency room where she was injected with Epinephrine. They also gave her through an IV Benadril, steroids, and something to settle her stomach. Before the IV they first attempted to administer the Benadryl and steroids through the mouth but she vomited it up. It should be noted that for the first two months of our daughter life she took Enfamil daily without any problems as my wife's milk was delayed in coming in. We are reporting this because we are unsure if there is a correlation, if not a causation, between the vaccination she received just two days before and the adverse reaction to Enfamil, which had not previously been a problem.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Warm, white center red around, painful and itchy around injection site. Seen by clinic, diagnosed as cellulitis. Treated with cephalexin.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin infection, Skin warm
Clinical narrative: Swollen arm, red, warm, skin infection treated with antibiotic cephalexin.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt. stated several days later arm was sore and had difficulty moving arm. Immunization was given on 2/16/15. Pt called pharmacy on 3/8/15 stating her arm still hurt. Advised pt to see Dr.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) referring to a patient of unknown age and gender. There were no current or historical conditions reported. Sometime in DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route not provided). On 03-MAR-2015 the patient was vaccinated with another dose of ZOSTAVAX (lot#, expiration date, dose and route not provided) which was an extra dose administered. There were no concomitant medications reported. No adverse effects reported. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Blood test, Culture, Face oedema, Inappropriate schedule of drug administration, Oedema peripheral
Clinical narrative: Information has been received from a medical assistant referring to a 4 week old male patient without pertinent medical history and drug reactions/allergies. On 15-JAN-2015 the patient was vaccinated with the first dose of RECOMBIVAX HB 5mcg/0.5 ml (0.5 ml, intramuscular in the right leg, lot# was unspecified) and on 13-FEB-2015, the patient was vaccinated with the second dose of RECOMBIVAX HB 5mcg/0.5 ml, lot# K012875, expiration date unspecified, 0.5 ml, intramuscular in the right leg (inappropriate schedule of drug administration). There was no concomitant therapy. On the following day of second vaccination, 14-FEB-2015, the patient developed symptoms on his hands, feet and face. Symptoms included rash, oedema and swelling. The patient was taken to the emergency room where he had blood work and cultures done (results were not provided) but the emergency room did not provide any treatment. He was not hospitalized. When the patient returned to the physical's office on 16-FEB-2015, the physician determined that the patient had recovered from his symptoms in February 2015. The medical assistant said the physician would like a lot check for lot # K012875. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Peripheral swelling, Rash, Swelling face
Clinical narrative: Information has been received from a medical assistant referring to a 4 week old male patient without pertinent medical history and drug reactions/allergies. On 15-JAN-2015 the patient was vaccinated with the first dose of RECOMBIVAX HB 5mcg/0.5 ml (0.5 ml, intramuscular in the right leg, lot# was unspecified) and on 13-FEB-2015, the patient was vaccinated with the second dose of RECOMBIVAX HB 5mcg/0.5 ml, lot# K012875, expiration date unspecified, 0.5 ml, intramuscular in the right leg (inappropriate schedule of drug administration). There was no concomitant therapy. On the following day of second vaccination, 14-FEB-2015, the patient developed symptoms on his hands, feet and face. Symptoms included rash, oedema and swelling. The patient was taken to the emergency room where he had blood work and cultures done (results were not provided) but the emergency room did not provide any treatment. He was not hospitalized. When the patient returned to the physical's office on 16-FEB-2015, the physician determined that the patient had recovered from his symptoms in February 2015. The medical assistant said the physician would like a lot check for lot # K012875. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site pain
Clinical narrative: Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with M-M-R II (lot#, expiration date, dose and route were unknown). On an unknown dates the patients experienced injection site pain. The reporter did not mention a specific patient or a specific incident, but just made a general comment. The outcome of injection site pain was unknown. Additional information is not expected as the reporter declined to provide any additional information.
Age: 1.3
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 15 month old patient (gender not reported). On 24-FEB-2015 the patient was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot # not reported) subcutaneously and on 03-MAR-2015 the patient was vaccinated with a second 0.5 ml dose of VARIVAX (Merck) subcutaneously. No adverse effects were reported. Additional information has been requested.
Age: 101.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a pharmacist referring to a 101 year old female patient without medical history and concurrent condition. In 2005, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not provided). Concomitant medication was none. In February 2015 ("last month"), the patient experienced pneumonia and recovered on an unspecified date in 2015. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diplopia, Eye swelling, Eyelid function disorder, Eyelid oedema
Clinical narrative: Case number PHHY2015US016857, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 548742) website on 03 Feb 2015 with a follow up information received from the quality assurance department on 24 Feb 2015. This report refers to an 87 year old female patient. Medical history was not reported. Concurrent conditions included high blood pressure, nocturnal seizures, underactive thyroid, high cholesterol, diabetes and atrial fibrillation. Her vaccination history included administration of a seasonal influenza vaccine (manufacturer and batch number: not reported) two years ago, following which she experienced eye shingles (see case number: PHHY2015US016908). This polymedicated patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in left arm on 05 Sep 2014. On 08 Sep 2014, her eye started to swell. She went to the ophthalmologist who thought that the patient had stye. Her eye continued to swell and completely closed in 4 to 5 days. She went to the ophthalmologist who immediately sent her to an emergency room. She was hospitalized. Multiple scans of her eye, head and body were done. She was finally diagnosed with third cranial nerve damage. No treatment was given as it was supposed to get better with time. She could not open her eye due to swelling. Her pupil was not straight and she experienced double vision, weakness and nausea. She was hospitalized for 8 days. Final outcome of the event was unknown. Causality was not reported. Upon follow receipt on 24 Feb 2015 from quality assurance department, it was stated that the initially reported batch number 145236 was not valid FLUVIRIN lot number and hence a QA investigation would not be performed. Follow up information received from the quality assurance department on 24 Feb 2015: Batch investigation could not be performed as the reported batch number was not valid.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Hordeolum, IIIrd nerve injury, Nausea, Pupillary disorder, Scan
Clinical narrative: Case number PHHY2015US016857, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 548742) website on 03 Feb 2015 with a follow up information received from the quality assurance department on 24 Feb 2015. This report refers to an 87 year old female patient. Medical history was not reported. Concurrent conditions included high blood pressure, nocturnal seizures, underactive thyroid, high cholesterol, diabetes and atrial fibrillation. Her vaccination history included administration of a seasonal influenza vaccine (manufacturer and batch number: not reported) two years ago, following which she experienced eye shingles (see case number: PHHY2015US016908). This polymedicated patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in left arm on 05 Sep 2014. On 08 Sep 2014, her eye started to swell. She went to the ophthalmologist who thought that the patient had stye. Her eye continued to swell and completely closed in 4 to 5 days. She went to the ophthalmologist who immediately sent her to an emergency room. She was hospitalized. Multiple scans of her eye, head and body were done. She was finally diagnosed with third cranial nerve damage. No treatment was given as it was supposed to get better with time. She could not open her eye due to swelling. Her pupil was not straight and she experienced double vision, weakness and nausea. She was hospitalized for 8 days. Final outcome of the event was unknown. Causality was not reported. Upon follow receipt on 24 Feb 2015 from quality assurance department, it was stated that the initially reported batch number 145236 was not valid FLUVIRIN lot number and hence a QA investigation would not be performed. Follow up information received from the quality assurance department on 24 Feb 2015: Batch investigation could not be performed as the reported batch number was not valid.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Whole body scan
Clinical narrative: Case number PHHY2015US016857, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 548742) website on 03 Feb 2015 with a follow up information received from the quality assurance department on 24 Feb 2015. This report refers to an 87 year old female patient. Medical history was not reported. Concurrent conditions included high blood pressure, nocturnal seizures, underactive thyroid, high cholesterol, diabetes and atrial fibrillation. Her vaccination history included administration of a seasonal influenza vaccine (manufacturer and batch number: not reported) two years ago, following which she experienced eye shingles (see case number: PHHY2015US016908). This polymedicated patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly in left arm on 05 Sep 2014. On 08 Sep 2014, her eye started to swell. She went to the ophthalmologist who thought that the patient had stye. Her eye continued to swell and completely closed in 4 to 5 days. She went to the ophthalmologist who immediately sent her to an emergency room. She was hospitalized. Multiple scans of her eye, head and body were done. She was finally diagnosed with third cranial nerve damage. No treatment was given as it was supposed to get better with time. She could not open her eye due to swelling. Her pupil was not straight and she experienced double vision, weakness and nausea. She was hospitalized for 8 days. Final outcome of the event was unknown. Causality was not reported. Upon follow receipt on 24 Feb 2015 from quality assurance department, it was stated that the initially reported batch number 145236 was not valid FLUVIRIN lot number and hence a QA investigation would not be performed. Follow up information received from the quality assurance department on 24 Feb 2015: Batch investigation could not be performed as the reported batch number was not valid.
Age: 47.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Back pain, Hypoaesthesia, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Severe pain, numbness, tingling in shoulder, arm and neck. Reduced range of motion in same. Ongoing for over 3 months. Urgent care visit, family doctor, orthopedics and PT, neurology. Ongoing.
Age: 47.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Hypoaesthesia, Joint range of motion decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Severe pain, numbness, tingling in shoulder, arm and neck. Reduced range of motion in same. Ongoing for over 3 months. Urgent care visit, family doctor, orthopedics and PT, neurology. Ongoing.
Age: 47.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Paraesthesia
Clinical narrative: Severe pain, numbness, tingling in shoulder, arm and neck. Reduced range of motion in same. Ongoing for over 3 months. Urgent care visit, family doctor, orthopedics and PT, neurology. Ongoing.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Zostavax given that was expired by 5 days.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Zostavax that was 5 days expired. No adverse effect noted.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Zostavax given that was expired by 5 days. No adverse effect noted.
Age: 32.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Computerised tomogram abnormal, Erythema, Fasciitis, Malaise, Mobility decreased
Clinical narrative: Swelling, pain, erythema, high grade fevers; limited range of movement arm.
Age: 32.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Myositis, Nuclear magnetic resonance imaging abnormal, Pain, Pyrexia, Swelling
Clinical narrative: Swelling, pain, erythema, high grade fevers; limited range of movement arm.
Age: 1.6
Sex: F
Vaccine: HEPA
Symptoms: Dyskinesia, Electroencephalogram normal, Immediate post-injection reaction
Clinical narrative: Patient with episodes of sudden jerking movements immediately following Hep A vaccination. VS WNL. Patient transported to ED via 911 due to history of febrile seizures. Hospital report: EEG normal - "clinically not suggestive of seizures."
Age: 16.0
Sex: M
Vaccine: HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Presyncope, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Vasovagal reaction at time of vaccine administration, then developed red raised, urticarial rash from head to umbilicus.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain
Clinical narrative: Moderate pain in injected shoulder, pain was so severe the patient could not shift into 5th gear of manual vehicle. As the evening progressed, patient could not reasonably lift arm initially above shoulder height and then above elbow height. Patient experienced pain that radiated from shoulder to the back of the deltoid. Patient continued to experience pain for 5+ days but continued to decrease every day. Pain was so significant patient could not workout whether lifting weights or running (as running required arm to swing). This was patient's 10th anthrax shot, this reaction was not seen on prior injections.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Headache, Local swelling, Musculoskeletal pain, Neck pain
Clinical narrative: Severe pain and swelling in armpit area, hot to touch, pain and swelling in neck and shoulder area.  Low grade fever and bad headache, tingling in right hand and throbbing in arm.  Saw Dr Sat morning because pain was intense, he took one look at it and sent me to ER.  I had an ultra sound done for a possible DVT which was negative.  I was given pain meds and sent home and was to watch for other symptoms.  I still have severe pain and swelling and no real changes in my symptoms today.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Severe pain and swelling in armpit area, hot to touch, pain and swelling in neck and shoulder area.  Low grade fever and bad headache, tingling in right hand and throbbing in arm.  Saw Dr Sat morning because pain was intense, he took one look at it and sent me to ER.  I had an ultra sound done for a possible DVT which was negative.  I was given pain meds and sent home and was to watch for other symptoms.  I still have severe pain and swelling and no real changes in my symptoms today.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Ultrasound scan normal
Clinical narrative: Severe pain and swelling in armpit area, hot to touch, pain and swelling in neck and shoulder area.  Low grade fever and bad headache, tingling in right hand and throbbing in arm.  Saw Dr Sat morning because pain was intense, he took one look at it and sent me to ER.  I had an ultra sound done for a possible DVT which was negative.  I was given pain meds and sent home and was to watch for other symptoms.  I still have severe pain and swelling and no real changes in my symptoms today.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Agitation, Anger, Dyspnoea, Erythema, Papule
Clinical narrative: Raised, erythematous, warm papule approximately 9 by 6 cm; agitated, angry behavior; difficulty catching breath.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Skin warm, Swelling
Clinical narrative: Raised, erythematous, warm papule approximately 9 by 6 cm; agitated, angry behavior; difficulty catching breath.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Abasia, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Leg was extremely sore, to the point that he refused to walk on it.  The following day he had a red spot on his leg and then by 48 hours the spot had grown significantly and was very hard and sore.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pain in extremity, Pyrexia
Clinical narrative: Fever of 102, sore injection spot and red area about 2 square inches with a little rash. AS OF TODAY 03/09/2015 fever is down but arm is sore and red rash.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Fever of 102, sore injection spot and red area about 2 square inches with a little rash. AS OF TODAY 03/09/2015 fever is down but arm is sore and red rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Encephalitis, Headache, Herpes zoster, Meningitis
Clinical narrative: Vaccinated with ZOSTAVAX on August 27, 2014. Sept. 11th, around 10pm I got queasy stomach and went to bed. I woke up with headache and body pain, stiff neck on the 12th. Went to Clinic on 13 & 14 Sept. Ended up in hospital on the 14th, from the clinic. Then I do not remember much of anything until the 25th Sept, 2014.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: Vaccinated with ZOSTAVAX on August 27, 2014. Sept. 11th, around 10pm I got queasy stomach and went to bed. I woke up with headache and body pain, stiff neck on the 12th. Went to Clinic on 13 & 14 Sept. Ended up in hospital on the 14th, from the clinic. Then I do not remember much of anything until the 25th Sept, 2014.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Small knot at injection site. Varue soreness in (R) deltoid muscle area. Redness to knot.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site induration
Clinical narrative: Injection site developed induration measuring 8x3 cm, after 20 minutes area decreased in size.
Age: 12.0
Sex: M
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 10 cm width x 8 cm hight area of redness with firm 2 cm center. Warm to touch.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Pain at site of injection. Redness just below site of injection. Feeling achy all over.
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Breast swelling, Peripheral swelling
Clinical narrative: Mum called left message to call her back. Returned her call & she informed us of patient's swollen right arm and right breast. We asked if she was able to take picture & send to us. She did. Right arm & breast swollen next day 3/9/2015. We asked that she take patient to the ER at hospital.
Age: 41.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Slightly itchy nontender red circular rash at injection site of Yellow fever vaccine right tricep approx 3.8cm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Diarrhoea, Erythema, Nausea, Pyrexia, Rash
Clinical narrative: PARENTS REPORTED THAT A FEW HOURS FOLLOWING MMRV AND D-TAP-IPV VACCINE, FEVER, NAUSEA, VOMITING, DIARRHEA, RASH TO PALMS/SOLES, REDNESS TO CHEST. REPORTED TO ED 1 MAR 2015, MOTRIN, ZOFRAN, AND BENADRYL GIVEN IN ED.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Viral infection, Viral rash, Vomiting
Clinical narrative: PARENTS REPORTED THAT A FEW HOURS FOLLOWING MMRV AND D-TAP-IPV VACCINE, FEVER, NAUSEA, VOMITING, DIARRHEA, RASH TO PALMS/SOLES, REDNESS TO CHEST. REPORTED TO ED 1 MAR 2015, MOTRIN, ZOFRAN, AND BENADRYL GIVEN IN ED.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Flushing, Headache, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Received Trumenba at Pfizer sponsored at mass vaccination clinic. At midnight he began to feel feverish, headache, myalgia.  Better in AM with ASA x 2.  At 1700 on 03/05/2015 presents at Health Center with erythema covering complete left deltoid, 3 X 5.5 inches along with intermittent full body flushing.
Age: 1.39
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on back and injection site that lasted for approx. 1 1/2 hours. Mother gave him Tylenol.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Anaphylactic reaction, Aphasia, Blood test, Condition aggravated, Disturbance in attention
Clinical narrative: Went limp and was staring into space.  Couldn't get his attention.  Later, his limbs kept going stiff and jerking.  He stopped rolling over that day.  He stopped pushing up on his arms that day.  He stopped babbling that day.  He didn't regain any of those skills until he was almost 11 months old.  He started developing severe recurring ear infections within a week.  He developed severe eczema.  His GERD was out of control.  He developed an anaphylactic allergy to eggs that sent him to the ER the first time he tried eggs at 9 months, and we also found out he was allergic to peanuts.  He developed progressive infantile scoliosis and laryngomalacia.