chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pain, Pruritus
Clinical narrative: Itching started first, I expected soreness it was a little sore, next morning arm was red a slightly swollen at the injection site, more discomfort (all things I expected), next day swelling tripled in size, hot to the touch, could not longer move my arm, itching out of control, saw doctor on this day.
Age: 0.73
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, Decreased appetite, Injection site erythema, Injection site swelling, Insomnia
Clinical narrative: Within a couple of hours after the Pentacel shot my son's leg turned very red and swollen at the injection shot and he started screaming. Nothing would stop him from crying, he was inconsolable and would not eat or sleep. The crying lasted 4 or 5 hours and then he fell asleep for the night. He slept the whole night. I checked on him several times because he didn't even wake up to eat. In the morning he was a little fussy but much better then the day before.
Age: 0.73
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Irritability, Screaming
Clinical narrative: Within a couple of hours after the Pentacel shot my son's leg turned very red and swollen at the injection shot and he started screaming. Nothing would stop him from crying, he was inconsolable and would not eat or sleep. The crying lasted 4 or 5 hours and then he fell asleep for the night. He slept the whole night. I checked on him several times because he didn't even wake up to eat. In the morning he was a little fussy but much better then the day before.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the unspecified number of patients were vaccinated intramuscularly with a dose of GARDASIL (0.5ml, lot # and expiration date were not reported) that underwent a temperature excursion. No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: MENHIB
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health professional refers to a 21 year old female patient. The reporter reported the out of range temp logs and the vaccine hemophilus B conjugate vaccine (meningococcal protein conjugate (manufacturer unknown) (dose, frequency, lot number and route were unknown) that had been administered to the patient in the right deltoid. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Abnormal behaviour, Agitation, Childhood disintegrative disorder, Computerised tomogram head, Crying
Clinical narrative: She on 07/26 suddenly became agitated, began moaning and crying, then quick repetitive movements involving twisting right to left without stopping, she held onto objects with the left hand without dropping them. She would not focus with verbal, tactile, or photo stimuli. She quit cruising, could crawl, did not play in bathtub, she was not making her usual baby babble or verbal response, she appeared not to be focusing or tracking with her eyes. That night/early morning she only slept 10 hours then 20 hours. She continued to do this until 07/28 with gradually less severe symptoms. She slept only 2 hours the night of 07/27. Also she was having tongue thrusting and lip smacking repetitively. She finally on 07/28 afternoon fairly well had returned to her baseline. She slept her usual 8 hours that night. Appetite was definitely off and fed poorly. Pupils were midpoint and poorly reactive through this time. No fever was found.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Decreased appetite, Decreased eye contact, Disturbance in attention, Electroencephalogram, Full blood count
Clinical narrative: She on 07/26 suddenly became agitated, began moaning and crying, then quick repetitive movements involving twisting right to left without stopping, she held onto objects with the left hand without dropping them. She would not focus with verbal, tactile, or photo stimuli. She quit cruising, could crawl, did not play in bathtub, she was not making her usual baby babble or verbal response, she appeared not to be focusing or tracking with her eyes. That night/early morning she only slept 10 hours then 20 hours. She continued to do this until 07/28 with gradually less severe symptoms. She slept only 2 hours the night of 07/27. Also she was having tongue thrusting and lip smacking repetitively. She finally on 07/28 afternoon fairly well had returned to her baseline. She slept her usual 8 hours that night. Appetite was definitely off and fed poorly. Pupils were midpoint and poorly reactive through this time. No fever was found.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Hypersomnia, Insomnia, Lumbar puncture, Metabolic function test, Moaning
Clinical narrative: She on 07/26 suddenly became agitated, began moaning and crying, then quick repetitive movements involving twisting right to left without stopping, she held onto objects with the left hand without dropping them. She would not focus with verbal, tactile, or photo stimuli. She quit cruising, could crawl, did not play in bathtub, she was not making her usual baby babble or verbal response, she appeared not to be focusing or tracking with her eyes. That night/early morning she only slept 10 hours then 20 hours. She continued to do this until 07/28 with gradually less severe symptoms. She slept only 2 hours the night of 07/27. Also she was having tongue thrusting and lip smacking repetitively. She finally on 07/28 afternoon fairly well had returned to her baseline. She slept her usual 8 hours that night. Appetite was definitely off and fed poorly. Pupils were midpoint and poorly reactive through this time. No fever was found.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Nuclear magnetic resonance imaging brain, Pupillary light reflex tests abnormal, Stereotypy, Tardive dyskinesia, Tongue paralysis
Clinical narrative: She on 07/26 suddenly became agitated, began moaning and crying, then quick repetitive movements involving twisting right to left without stopping, she held onto objects with the left hand without dropping them. She would not focus with verbal, tactile, or photo stimuli. She quit cruising, could crawl, did not play in bathtub, she was not making her usual baby babble or verbal response, she appeared not to be focusing or tracking with her eyes. That night/early morning she only slept 10 hours then 20 hours. She continued to do this until 07/28 with gradually less severe symptoms. She slept only 2 hours the night of 07/27. Also she was having tongue thrusting and lip smacking repetitively. She finally on 07/28 afternoon fairly well had returned to her baseline. She slept her usual 8 hours that night. Appetite was definitely off and fed poorly. Pupils were midpoint and poorly reactive through this time. No fever was found.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, VARZOS
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient came in for vaccines: Menactra, Gardasil and Varicella. Doctor ordered them correctly.   Patient received: Zostavax instead of the Varicella.  Staff member gave it in error.  The Menactra and Gardasil were correctly given.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness, swelling, and warmth at site of vaccination (R vastus lateralis).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: L LEG 20MM LUMP AND REDNESS AT SITE OF VARICELLA VACCINE.
Age: 1.1
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 13 month old patient of an unknown gender. On 16-JUN-2014, the patient was vaccinated with M-M-R II dose 1 (lot number: 0684AE, exp date 02-APR-2014)(dose and route were not reported) that expired on 02-APR-2014. No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, concerning a 22 year old female patient. Medical history and concurrent conditions were not reported. On 08-AUG-2014, the patient was vaccinated with the fourth dose of GARDASIL (dose, lot number and expiration date were not reported), intramuscularly. Concomitant therapies included hormonal contraceptives (unspecified). The physician reported that an anonymous patient received a fourth dose of GARDASIL, on 08-AUG-2014, after already completing the three dose series of injections. The patient, who had had already completed the three dose series from her primary care office; however, she explained to her Obgyn (name and demographics unspecified)) that she had only had two doses of GARDASIL and was then given a forth dose, in error. The patient did not experience any symptomatic adverse reactions. Patient did not seek medical attention or received treatment for the adverse event. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old patient of an unknown gender. On 12-JUN-2014, the patient was vaccinated with M-M-R II dose 1 (lot number: 0684AE, exp date 02-APR-2014)(dose and route were not reported) that expired on 02-APR-2014. No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No information about medical history, concurrent conditions were reported. On an unknown date the patient was vaccinated with PROQUAD (Merck). No concomitant medications were reported. The nurse reported that 5 doses of PROQUAD (Merck), that had been improperly stored, were inadvertently administered to unspecified patients of unspecified dates. No adverse effects reported. There was no product quality complaint. This is one of the two reports from the same reporter (MARRS # 1408USA007660). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. The patient's pertinent medical history and concurrent conditions were not reported. On 09-AUG-2014 the patient was vaccinated with PNEUMOVAX23 (Dose/Frequency: 0.5 milliliter (ml), intramuscular (IM))(lot# H014561, expiration date: 21-MAR-2014). No adverse effects were reported. No product quality complaint (PQC) was reported for PNEUMOVAX23. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: HEPA, MMR, TDAP, VARCEL
Symptoms: Blood test normal, Convulsion, Pyrexia, Vomiting
Clinical narrative: Fever 102.7, vomiting then seizure that lasted about 9 minutes. Child was transported by ambulance to hospital and recovered in the ER. Given Motrin and blood work which was normal. Child had been taking Ibuprofen since immunization but last dose at 7 am had worn off and fever went up quickly.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Asthenia, Condition aggravated, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old male patient with degenerative arthritis and unspecified cardiac condition. The patient had no drug reactions/allergies. On 24-JUL-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # K000329, expiration date 06-MAR-2015), subcutaneous (dose and strength not reported) which was about one month after he had an active case of the shingles. Concomitant medications included unknown number of unspecified medications. The pharmacist reported that the patient stated that on an unspecified date (in approximately July 2014) after he received the ZOSTAVAX (almost immediately), he began to feel weak, achey and sore. The patient additionally stated that he experienced pain and tingling in the spots in which he had the active case of the shingles only one month prior on his side and his face. The pharmacist reported that the patient saw his primary care physician who ordered an X-ray in which showed his preexisting degenerative arthritis in his joints, therefore made the diagnosis of a flare up of his arthritis. The pharmacist thought that this patient was actually experienced these symptoms from the ZOSTAVAX and it might be another zoster out break brought on by the ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray abnormal
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old male patient with degenerative arthritis and unspecified cardiac condition. The patient had no drug reactions/allergies. On 24-JUL-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # K000329, expiration date 06-MAR-2015), subcutaneous (dose and strength not reported) which was about one month after he had an active case of the shingles. Concomitant medications included unknown number of unspecified medications. The pharmacist reported that the patient stated that on an unspecified date (in approximately July 2014) after he received the ZOSTAVAX (almost immediately), he began to feel weak, achey and sore. The patient additionally stated that he experienced pain and tingling in the spots in which he had the active case of the shingles only one month prior on his side and his face. The pharmacist reported that the patient saw his primary care physician who ordered an X-ray in which showed his preexisting degenerative arthritis in his joints, therefore made the diagnosis of a flare up of his arthritis. The pharmacist thought that this patient was actually experienced these symptoms from the ZOSTAVAX and it might be another zoster out break brought on by the ZOSTAVAX. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Muscular weakness
Clinical narrative: Right leg weakness.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Irritability, Muscular weakness, Myalgia, Upper respiratory tract congestion
Clinical narrative: Fatigue, achy muscles throughout whole body, weakness in legs, upper respiratory congestion, irritable.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain, Pyrexia, Swelling
Clinical narrative: Redness, swelling, hardness, low grade fever, soreness.
Age: 62.0
Sex: M
Vaccine: TDAP, TYP
Symptoms: Death, Influenza like illness
Clinical narrative: Patient found deceased in his home. He had reported flu like symptoms to a family member via phone day before.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Pain, Swelling
Clinical narrative: Initial report was report was received on 07 August 2014 from a health care professional. A 51 year-old female (date of birth not reported) had received on 22 July 2014 an intramuscular left deltoid injection of ADACEL, lot number U4874AA and one day later on 23 July 2014, experienced severe swelling and pain. The patient was evaluated by a physician and was diagnosed with cellulitis. Treatment included BENADRYL and MEDROL pack. The patient had no illness at the time of vaccination. Past medical history was not provided. Relevant diagnostic tests were not reported. Outcome was unknown. The reporter for this case is the same as for case 2014SA108506 and 2014SA108507. Documents held by sender: none.
Age: 9.0
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of 9 years old. No information about medical history, concurrent conditions and concomitant medications were reported. On 04-AUG-2014 the patient was inadvertently vaccinated with expired dose of RECOMBIVAX HB Lot# 1741AA, expiration date 27-JUN-2014, route intramuscular. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of several patient reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (healthcare worker) refers to an unknown number of patients of unknown age and gender. The certified medical assistant reported excursion affecting VARIVAX of -0.4C for a 4 hour period (date unspecified). Excursion was supported. It was reported that on an unknown date the doses of VARIVAX (route, dose and lot# not reported) (also reported as dose and therapy route for VARIVAX products would be as stated in prescribing information as the office had not had any administration errors) had been administered post excursion, however certified medical assistant did not have access to any specific information as their computer systems were not up to date. No adverse effects or concerns noted by any patients. The patients did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 11-AUG-2014 the patient was vaccinated with a dose of expired VARIVAX lot# G007580, expiration date 04-AUG-2014 (dose, route and site of administration were not reported). No adverse effects were reported. Additional information is not expected, as there is no consent to contact the reporting pharmacist.
Age: 1.1
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 13 month old patient of an unknown gender. On 11-JUN-2014, the patient was vaccinated with M-M-R II dose 1 (lot number: 0684AE, exp date 02-APR-2014)(dose and route were not reported) that expired on 02-APR-2014. No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Skin Inspection:  R anterior thigh:  erythematous, maculopapular, circular rash, swollen, TTP, mild warmth, nonfluctuant.  9x11 cm diameter.  No pustules, vesicles, or drainage. Borders outlined w/marker for parental monitoring of rash for enlargement.  No other rash noted on extremities or trunk.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Rash maculo-papular
Clinical narrative: Skin Inspection:  R anterior thigh:  erythematous, maculopapular, circular rash, swollen, TTP, mild warmth, nonfluctuant.  9x11 cm diameter.  No pustules, vesicles, or drainage. Borders outlined w/marker for parental monitoring of rash for enlargement.  No other rash noted on extremities or trunk.
Age: 5.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Skin Inspection:  R lateral thigh:  faint 5 mm gray colored bruise (presumed to be vaccine injection site).  Surrounding bruise, w/majority of affected area being lateral/posterior to injection site, is erythematous, maculopapular rash in circular shape, ~ 7x8 cm diameter.  Mild warmth and swelling of affected area stated above.  See pictures attached to this note.  Borders outlined w/marker for parental monitoring of rash for enlargement.  2-3 mm erythematous, papular lesions on waistline (#8-10), upper back, chest and few on arms (total of approx 8-10 different lesions scattered on other named locations).  No vesicular or pustular heads. Palpation:  nonfluctuant.
Age: 5.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rash maculo-papular, Rash papular, Skin lesion
Clinical narrative: Skin Inspection:  R lateral thigh:  faint 5 mm gray colored bruise (presumed to be vaccine injection site).  Surrounding bruise, w/majority of affected area being lateral/posterior to injection site, is erythematous, maculopapular rash in circular shape, ~ 7x8 cm diameter.  Mild warmth and swelling of affected area stated above.  See pictures attached to this note.  Borders outlined w/marker for parental monitoring of rash for enlargement.  2-3 mm erythematous, papular lesions on waistline (#8-10), upper back, chest and few on arms (total of approx 8-10 different lesions scattered on other named locations).  No vesicular or pustular heads. Palpation:  nonfluctuant.
Age: 64.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on left side.  Numbness on arm traveling down to leg.
Age: 64.0
Sex: F
Vaccine: YF
Symptoms: Induration, Nodule, Oedema, Skin warm, Tenderness
Clinical narrative: Hot to touch, Hard Nodule, Tender, Edematous.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Asthenia, Diarrhoea, Dizziness, Dysphonia, Pallor
Clinical narrative: Hoarseness, paleness, weakness, dizziness, diarrhea. These symptoms are ongoing. Mom states will take child to physician.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Asthenia, Diarrhoea, Dizziness, Dysphonia, Immediate post-injection reaction
Clinical narrative: Hoarseness, paleness, weakness, dizziness, diarrhea. These symptoms are ongoing. Mom states will take child to physician.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Palpitations
Clinical narrative: Hoarseness, paleness, weakness, dizziness, diarrhea. These symptoms are ongoing. Mom states will take child to physician.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Asthenia, Diarrhoea, Dizziness, Dysphonia, Pallor
Clinical narrative: Right after patient received her vaccinations she immediately got dizzy. Then approximately an hour later she complained of feeling weak, her heart was racing, and she felt dizzy again. Then a couple of hours later, approx 1:15 PM, she became hoarse. Every day since receiving her vaccinations she cannot eat anything without needing to run to the bathroom because of diarrhea.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Asthenia, Diarrhoea, Dizziness, Dysphonia, Immediate post-injection reaction
Clinical narrative: Right after patient received her vaccinations she immediately got dizzy. Then approximately an hour later she complained of feeling weak, her heart was racing, and she felt dizzy again. Then a couple of hours later, approx 1:15 PM, she became hoarse. Every day since receiving her vaccinations she cannot eat anything without needing to run to the bathroom because of diarrhea.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL, TDAP, VARCEL
Symptoms: Palpitations
Clinical narrative: Right after patient received her vaccinations she immediately got dizzy. Then approximately an hour later she complained of feeling weak, her heart was racing, and she felt dizzy again. Then a couple of hours later, approx 1:15 PM, she became hoarse. Every day since receiving her vaccinations she cannot eat anything without needing to run to the bathroom because of diarrhea.
Age: 85.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Herpes zoster, Injection site erythema, Injection site joint pain, Laboratory test abnormal
Clinical narrative: Began with extreme soreness in vacination shoulder that evening redness in areas of vacination and soon developed into rash over arm and hand. On 7/14/14 he called we called his regular doctor who saw him that day and was told the rash was the result of the shot. He had an appointment with his dermatologist on 7/29 at 9:40 he saw him and his condition was immediately diagnosed and lab work later confirmed was shingles.  He has been weak and unable to use arm and hand.
Age: 85.0
Sex: M
Vaccine: TD
Symptoms: Musculoskeletal disorder, Rash, Vaccination complication
Clinical narrative: Began with extreme soreness in vacination shoulder that evening redness in areas of vacination and soon developed into rash over arm and hand. On 7/14/14 he called we called his regular doctor who saw him that day and was told the rash was the result of the shot. He had an appointment with his dermatologist on 7/29 at 9:40 he saw him and his condition was immediately diagnosed and lab work later confirmed was shingles.  He has been weak and unable to use arm and hand.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abdominal discomfort, Chills, Cold sweat, Fatigue, Feeling abnormal
Clinical narrative: "Just not feeling good". Having chills, but no fever, feels clammy, slight upset stomach, looks washed out.
Age: 21.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: IMMEDIATELY AFTER INJECTION DONOR BECAME LIGHTHEADED,THEN INFORMED NURSE THAT SHE WAS ALSO LIGHTHEADED ON DONOR FLOOR BUT DIDNT REPORT TO PHLEBOTOMIST OR NURSE UNTIL AFTER RECEIVING INJECTION AND THE LAST TIME SHE HAD EATEN WAS 4 HRS PRIOR TO COMING TO CTR LH 8-13-14.
Age: 0.98
Sex: M
Vaccine: HIBV, PPV, HIBV, PNC13
Symptoms: Diet refusal, Dyspnoea, Hypotonia, Injection site pain, Irritability
Clinical narrative: Baby was irritable and fussy, site of injection was sore.  Baby got very hot-fever of 103-gave ibuprofen and fever came down-baby was limp, seemed life-less and had fast/short/labored breathing.  Baby would not eat/nurse/drink.  Symptoms lasted for 18 hours at that intensity, but are now low grade fever and moving a little.
Age: 0.98
Sex: M
Vaccine: HIBV, PPV, HIBV, PNC13
Symptoms: Pyrexia, Respiratory rate increased
Clinical narrative: Baby was irritable and fussy, site of injection was sore.  Baby got very hot-fever of 103-gave ibuprofen and fever came down-baby was limp, seemed life-less and had fast/short/labored breathing.  Baby would not eat/nurse/drink.  Symptoms lasted for 18 hours at that intensity, but are now low grade fever and moving a little.
Age: 0.98
Sex: M
Vaccine: HIBV, PPV, HIBV, PNC13
Symptoms: Diet refusal, Lethargy, Unresponsive to stimuli
Clinical narrative: Baby was irritable and fussy, site of injection was sore.  Baby got very hot-fever of 103-gave ibuprofen and fever came down-baby was limp, seemed life-less and had fast/short/labored breathing.  Baby would not eat/nurse/drink.  Symptoms lasted for 18 hours at that intensity, but are now low grade fever and moving a little.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Pt says she has had diarrhea the entire day.  She never has diarrhea before.
Age: 0.63
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: (L) leg red and warm to touch, small hard lump at injection site dtap. Child took nap areas improved mom thought about cancelling.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Syncope
Clinical narrative: Patient had a brief episode of feeling weak and faint 5 minutes after he received HPV vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: 2 days post vaccination patient developed hives, redness and swelling at site. Also had a headache and fever of 102 degrees.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No concurrent conditions or medical history were provided. On 05-AUG-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiry date unspecified) at physician office. No concomitant medications were reported. The pharmacist reported that on 07-AUG-2014, the patient experienced redness "about the size of a tangerine" and pain at the injection site after receiving ZOSTAVAX. The patient sought medical attention - she saw the pharmacist, but no treatment was given. The outcome of the events was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Injection site induration, Injection site pain, Rash
Clinical narrative: Rash at right arm just below vaccination site. Also induration ans tenderness at injection site.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Administered Menveo vaccine at ~ 11:50 am. Told patient and her mother to walk around the store for a little bit to make sure she was okay. After 5 minutes of walking, mother ran back to the counter and asked for help, stating her daughter had passed out. When I saw the daughter, the patient was starting to sit up and did not realize what had happened. I asked her if she was okay breathing, which she stated yes. She then said she was just feeling faint and the color from her face was gone, so I gave the patient water. I took the patient's blood pressure a couple minutes later, and it was 69/54. I asked the patient if she had eaten before the vaccination and she said no. I gave the patient a snack and waited for a few minutes to take her blood pressure again. After she had eaten, her blood pressure rose to 106/69. The color was coming back to her face. Her mother had stated she was very anxious prior to receiving the vaccine. I told her to wait a few more minutes, and I would take her blood pressure one more time. The patient sat for another 10 minutes, I returned to take another blood pressure reading, and it was around 100/69. The patient said she was fine and the patient and her mother had left the store. I told the mother if it happens again, to go to the emergency room. I called back around 1:45pm to check on the patient, and the mother had stated that she gave the patient a full meal, and that she would check her blood pressure again at home to make sure she was ok.
Sex: U
Vaccine: MNQ
Symptoms: Autoimmune disorder
Clinical narrative: Case number PHEH2014US015504 is an initial spontaneous report received from a health care professional on 31 Jul 2014. This report refers to an adolescent patient whose age and gender was not reported. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with a booster dose of MENVEO (batch number: not reported) on an unspecified date. It was reported that 2 weeks after vaccination, the patient was presented with autoimmune symptoms (not further specified). The event outcome, seriousness and causality were not reported.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age. Since 25-JUL-2014, the patients were vaccinated with GARDASIL (lot#, expiration date, route, frequency and dose were unknown) which had been improperly stored. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No information about medical history, drug reactions and allergies was specified. Medical assistant reported that a patient was administered an improperly stored dose of VARIVAX (lot#, dose, frequency, route, indication not reported) on 07-AUG-2014. No concomitant medications were reported. No adverse events were reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (healthcare worker) refers to an unspecified number of patients of unknown age and gender. The certified medical assistant reported excursion affecting PROQUAD (merck) of -0.4 C for a 4 hours period (date unspecified). Excursion was supported. It was reported that on an unknown date the doses of PROQUAD (merck) (route, dose and lot # not reported) (also reported as dose and therapy route for PROQUAD (merck) products would be as stated in prescribing information as the office had not had any administration errors) had been administered post excursion, however certified medical assistant did not had access to any specific information as their computer systems were not up to date. No adverse effects or concerns noted by any patients. The patients did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to three unspecified patients of unknown age. On 04-AUG-2014 the three patient was inadvertently vaccinated with expired doses of RECOMBIVAX HB intramuscular. Lot# was 1741AA, and the vaccine was expired on 27-JUN-2014. No adverse effects reported. Follow up information was received from the medical assistant. The reporter provided the patient identifiers with the name and date of birth. This report refers to a 8 week old patient of unknown gender. This case is linked to 1408USA002323 (same reporter link). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a 62 year old female patient. The patient's medical history included previous case of the shingles and allergy to sulfonamide antibiotic. On 30-JUL-2014 the patient was vaccinated with ZOSTAVAX lot # J012658, expiry date 10-JAN-2015, 0.65 ml, subcutaneous in the left arm. Concomitant therapies included estradiol and NEXIUM. The patient stated that around 4 hours after injection, she had a burning sensation around the injection site. She stated that it was red, hot, swollen, and about 3 inches in diameter. She also stated that the redness had gone away, but she now has a 5 inch bruise. Patient stated that she is experiencing headaches daily starting 03-AUG-2014. No lab diagnostics studies were performed. The patient sought medical attention. There was no product quality complaint. No treatment was given for the event. The outcome of the events was reported as recovering/resolving. The causality of the event was not specified by the reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to a 62 year old female patient. The patient's medical history included previous case of the shingles and allergy to sulfonamide antibiotic. On 30-JUL-2014 the patient was vaccinated with ZOSTAVAX lot # J012658, expiry date 10-JAN-2015, 0.65 ml, subcutaneous in the left arm. Concomitant therapies included estradiol and NEXIUM. The patient stated that around 4 hours after injection, she had a burning sensation around the injection site. She stated that it was red, hot, swollen, and about 3 inches in diameter. She also stated that the redness had gone away, but she now has a 5 inch bruise. Patient stated that she is experiencing headaches daily starting 03-AUG-2014. No lab diagnostics studies were performed. The patient sought medical attention. There was no product quality complaint. No treatment was given for the event. The outcome of the events was reported as recovering/resolving. The causality of the event was not specified by the reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a consumer via a company representative refers to a patient of unkonwn age and gender, who was related in an unspecified way to the reporter. Information regarding concurrent conditions and medical history was not provided. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not provided) that was expired by 1 day. The lot# and expiration date were unspecified. No known adverse effects was reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old patient of an unknown gender. On 29-JUL-2014, the patient was vaccinated with M-M-R II (HSA) dose 1 (lot number: 0684AE), exp date 02-APR-2014 (dose and route were not reported) that expired on 02-APR-2014. No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient. On 01-AUG-2014 the patient was vaccinated with a single dose of ZOSTAVAX, subcutaneous (dosage and lot# not reported). On 02-AUG-2014, the patient developed a red, itchy welt at the injection site. The patient called the pharmacy on 04-AUG-2014 to report the reaction was getting worse. No treatment was given, none of lab test was performed. The outcome of event was not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. No information about medical history, concurrent conditions was reported. On an unknown date the patient was vaccinated with VARIVAX (Merck). No concomitant medications were reported. The nurse reported that 5 doses of VARIVAX (Merck), that had been improperly stored, were inadvertently administered to unspecified patients on unspecified dates. No adverse effects reported. There was no product quality complaint. This is one of the two reports received from the same reporter (MARRS # 1408USA007972). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness to (R) deltoid region 2 days after vaccine.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Patient was administered vaccines and about 10 minutes later on her way our of the pharmacy she became light headed and fainted. She showed no signs of allergic reaction and was not injured. Monitored her on site for an additional 30 minutes then counseled on signs and symptoms of anaphylaxis and syncope and told her what to do it either happened then sent her home. Followed up with patient at 7:50 pm 8/12/19 and she was doing fine.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Erythema, Paraesthesia
Clinical narrative: Tingling right arm 15 minutes after injection. Redness on right forearm 30 mins. after injection. Vitals taken an observed for 30 additional minutes, symptoms subsided,
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Mild erythema.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Oval lesion 4 x 2 1/2 inches on (R) upper thigh. OTC treatment.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Convulsion, Hypotonia, Motor developmental delay, Pyrexia
Clinical narrative: Vaccines given 8/6/14 1253 per mom. At 5AM pt had fever (mom said 106 degrees) and seizure reported 10 minutes at home. Baby taken to ER. MD there reported T 101.6 no seizures while there was quiet. Later drank formula - discharged with ibuprofen q8h.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Vaccines given 8/6/14 1253 per mom. At 5AM pt had fever (mom said 106 degrees) and seizure reported 10 minutes at home. Baby taken to ER. MD there reported T 101.6 no seizures while there was quiet. Later drank formula - discharged with ibuprofen q8h.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction
Clinical narrative: Within 24 hrs of the vaccination, she experienced a "quarter-sized" tough area on the skin at the injection site. Within 48 hrs the area became larger and red/inflamed.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: Patient had pain in right arm the day of shot which improved. The next day she was having stiffness in the (R) neck and tingling from neck to ear on right side.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Flushing
Clinical narrative: After I received the shot I started walking down an aisle at pharmacy and got a head rush and became lightheaded. Went and sat down by pharmacy till I felt somewhat better. Went on w/ the day but didn't really feel better till hours later. Next morning again felt lightheaded. Hours later, better.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine administered IM (R) deltoid on 8/11. On 8/12/14 mom noticed upper (R) arm taut, red, swollen and warm - went to the ER. Follow-up with Dr. on 8/13/14. Started on cephalexin x7 days.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash morbilliform, Rash pruritic, Rash vesicular, Urticaria
Clinical narrative: Same day of ZOSTAVAX injection he started with hives, welts across my backside. He continues with welts/hives and fine, red raised itchy rash that has now spread to lateral and medial thighs and tops of feet. He and his wife reports rash as a chicken pox or measles type rash. They deny any fluid filled papules. Vet denies any fever.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Condition aggravated, Systemic lupus erythematosus
Clinical narrative: Pt w/a lupus flare per mother.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching and erythema at injection site the evening of the vaccine administration. Spreading erythema two days after injection at the injection site with some swelling. Pt reports no pain, no fever or shortness of breath. Recommendation cetirizine 10mg daily as needed for itching, erythema and swelling. Observe site and call if symptoms worsen.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Pallor, Presyncope
Clinical narrative: No illness at time of visit. Pt came in for 3 injections. After first 2 injections were given, pt leaned forward and passed out. Mother and nurse caught patient when leaning forward (no fall). Pt laid back on exam table, was coherent within 2-3 seconds. Pt was very pale. Pt's feet elevated and given juice to drink. Pt laid on table for a while, sat up for a while and stood after with no incident, left in good condition. 3rd injection held off for now per provider. Patient in office 35 min post-injection for monitoring. Provider believed pt had a vaso-vagal response to getting vaccines.
Age: 54.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Feeling hot, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Nausea, feverish, hot, and swelling at injection site.
Age: 0.16
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Eye movement disorder, Musculoskeletal stiffness
Clinical narrative: Mother stated patients eyes began to "roll back in head", had stiff neck and stiff right arm after immunizations that resolved in 1 to 2 hours after immunizations.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 29-JUL-2014, the patient was vaccinated with ZOSTAVAX, SQ, single dose (lot # J003359; Exp Date: 21-JUN-2014). Co-suspect or concomitant therapies were not reported. The vaccine was expired at the time of administration. No adverse effects reported. Additional information is not expected since reporter did not give consent to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date, (Oka/Merck) VARIVAX underwent a temperature excursion and on an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous. No adverse effect report. At the time of the report the action taken with (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant refers to a patient of unknown age and gender. On 06-AUG-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB (Lot # not reported, exp. date 05-APR-2014) (dose and route not reported). Concomitant therapy was not reported. No adverse event was reported. Additional information is not expected, since the reporter does not wish to be contacted.
Sex: F
Vaccine: HPV4
Symptoms: Thyroid disorder
Clinical narrative: This spontaneous report was received from a field representative who was informed by an employee that her daughter was having some "thyroid problems". On an unknown date, the employee's daughter was vaccinated with GARDASIL via an unknown route of administration. Past medical history and concomitant medications were not reported. On an unknown date the patient experienced thyroid problems. The outcome of thyroid problems is unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a respiratory therapist refers to a one amount 23 unspecified patients, age and gender were unknown. Medical history was not reported. The respiratory therapist informed that between 01-FEB-2014 through 31-MAY-2014 the patient was vaccinated with PNEUMOVAX 23, lot number, T013345 expiration date 11-JAN-2015 (route, strength and dosage were not reported) which was improperly stored. Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) filed. The action taken was assessed as not applicable. The causality was assessed as not related to the suspect therapy. This is one of several reports received from the same reporter. Follow up information has been received. Lot number T013345 is an invalid lot numbers for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) concerning an unspecified number of patients (gender and age unspecified) which reported that the patients received improperly doses of M-M-R II (dose, route and lot # unspecified) between 16-JUN-2014 and 13-JUL-2014. No adverse symptoms reported. This is one of several reports from the same source. Additional information has been requested.