chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEP, MNQ, TDAP
Symptoms: Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal
Clinical narrative: Per chart docmumention:18 yo (17 at onset) AA E2 with S/S left shoulder pain/weakness suspect HNPP with onset approximately 8 days after Vaccine receipt on  6 June hep B (lot #SKB 539T3), IIV (CSL U55306), TDaP (SKB AH4LF), MCV4 (PMC U510AA), and ADENOVIRUS (BRR 34600234A). Per notes neurology 18 JUL the symptoms came on gradually over the course of 24h with the worst of them being on the second day after onset. Since then, they improved slightly initially (when he got 6-day course of steroids) but then worsened again. He is very limited by this. Had a nerve conduction study which showed globally abnormal nerve conduction throughout. He denies any preceding viral illness. R provider signs/symptoms were most consistent with a left brachial plexopathy, primarily involving axillary and suprascapular nerve conduction study, have high suspicion for HNNP, with peripheral palsy potentially being cause by continuous wearing of over-the-shoulder camel back. Also on the differential is an inflammatory polyneuropathy, potentially triggered by immunizations, exposure to new pathogens, or increase physical activity. Patient initially declined HNPP genetic testing, but subsequent testing demonstrated positive gene deletion PMP22 consistent with HNPP.
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEP, MNQ, TDAP
Symptoms: Blood chloride normal, Blood creatinine normal, Blood folate normal, Blood glucose normal, Blood potassium normal
Clinical narrative: Per chart docmumention:18 yo (17 at onset) AA E2 with S/S left shoulder pain/weakness suspect HNPP with onset approximately 8 days after Vaccine receipt on  6 June hep B (lot #SKB 539T3), IIV (CSL U55306), TDaP (SKB AH4LF), MCV4 (PMC U510AA), and ADENOVIRUS (BRR 34600234A). Per notes neurology 18 JUL the symptoms came on gradually over the course of 24h with the worst of them being on the second day after onset. Since then, they improved slightly initially (when he got 6-day course of steroids) but then worsened again. He is very limited by this. Had a nerve conduction study which showed globally abnormal nerve conduction throughout. He denies any preceding viral illness. R provider signs/symptoms were most consistent with a left brachial plexopathy, primarily involving axillary and suprascapular nerve conduction study, have high suspicion for HNNP, with peripheral palsy potentially being cause by continuous wearing of over-the-shoulder camel back. Also on the differential is an inflammatory polyneuropathy, potentially triggered by immunizations, exposure to new pathogens, or increase physical activity. Patient initially declined HNPP genetic testing, but subsequent testing demonstrated positive gene deletion PMP22 consistent with HNPP.
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEP, MNQ, TDAP
Symptoms: Blood sodium normal, Blood thyroid stimulating hormone, Blood urea normal, Brachial plexopathy, Carbon dioxide increased
Clinical narrative: Per chart docmumention:18 yo (17 at onset) AA E2 with S/S left shoulder pain/weakness suspect HNPP with onset approximately 8 days after Vaccine receipt on  6 June hep B (lot #SKB 539T3), IIV (CSL U55306), TDaP (SKB AH4LF), MCV4 (PMC U510AA), and ADENOVIRUS (BRR 34600234A). Per notes neurology 18 JUL the symptoms came on gradually over the course of 24h with the worst of them being on the second day after onset. Since then, they improved slightly initially (when he got 6-day course of steroids) but then worsened again. He is very limited by this. Had a nerve conduction study which showed globally abnormal nerve conduction throughout. He denies any preceding viral illness. R provider signs/symptoms were most consistent with a left brachial plexopathy, primarily involving axillary and suprascapular nerve conduction study, have high suspicion for HNNP, with peripheral palsy potentially being cause by continuous wearing of over-the-shoulder camel back. Also on the differential is an inflammatory polyneuropathy, potentially triggered by immunizations, exposure to new pathogens, or increase physical activity. Patient initially declined HNPP genetic testing, but subsequent testing demonstrated positive gene deletion PMP22 consistent with HNPP.
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEP, MNQ, TDAP
Symptoms: Gene mutation identification test positive, HIV test negative, Hereditary neuropathy with liability to pressure palsies, Inflammation, Nerve conduction studies abnormal
Clinical narrative: Per chart docmumention:18 yo (17 at onset) AA E2 with S/S left shoulder pain/weakness suspect HNPP with onset approximately 8 days after Vaccine receipt on  6 June hep B (lot #SKB 539T3), IIV (CSL U55306), TDaP (SKB AH4LF), MCV4 (PMC U510AA), and ADENOVIRUS (BRR 34600234A). Per notes neurology 18 JUL the symptoms came on gradually over the course of 24h with the worst of them being on the second day after onset. Since then, they improved slightly initially (when he got 6-day course of steroids) but then worsened again. He is very limited by this. Had a nerve conduction study which showed globally abnormal nerve conduction throughout. He denies any preceding viral illness. R provider signs/symptoms were most consistent with a left brachial plexopathy, primarily involving axillary and suprascapular nerve conduction study, have high suspicion for HNNP, with peripheral palsy potentially being cause by continuous wearing of over-the-shoulder camel back. Also on the differential is an inflammatory polyneuropathy, potentially triggered by immunizations, exposure to new pathogens, or increase physical activity. Patient initially declined HNPP genetic testing, but subsequent testing demonstrated positive gene deletion PMP22 consistent with HNPP.
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEP, MNQ, TDAP
Symptoms: Peripheral nerve palsy, Polyneuropathy, Protein total normal, Vitamin B12 normal
Clinical narrative: Per chart docmumention:18 yo (17 at onset) AA E2 with S/S left shoulder pain/weakness suspect HNPP with onset approximately 8 days after Vaccine receipt on  6 June hep B (lot #SKB 539T3), IIV (CSL U55306), TDaP (SKB AH4LF), MCV4 (PMC U510AA), and ADENOVIRUS (BRR 34600234A). Per notes neurology 18 JUL the symptoms came on gradually over the course of 24h with the worst of them being on the second day after onset. Since then, they improved slightly initially (when he got 6-day course of steroids) but then worsened again. He is very limited by this. Had a nerve conduction study which showed globally abnormal nerve conduction throughout. He denies any preceding viral illness. R provider signs/symptoms were most consistent with a left brachial plexopathy, primarily involving axillary and suprascapular nerve conduction study, have high suspicion for HNNP, with peripheral palsy potentially being cause by continuous wearing of over-the-shoulder camel back. Also on the differential is an inflammatory polyneuropathy, potentially triggered by immunizations, exposure to new pathogens, or increase physical activity. Patient initially declined HNPP genetic testing, but subsequent testing demonstrated positive gene deletion PMP22 consistent with HNPP.
Age: 72.0
Sex: U
Vaccine: FLU4, PNC13
Symptoms: Feeling cold, Pain
Clinical narrative: Pt. confined to bed, aches, cold, can not get warm.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Muscular weakness, Pain in extremity, X-ray limb normal
Clinical narrative: PREVNAR 13 and flu vaccine administered 10/17/16. Patient presented to office on 11/7/16 c/o pain at injection site. She presented again on 12/16/16 c/o pain weakness (L) arm.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Constipation, Haematochezia, Lethargy, Vomiting
Clinical narrative: Vaccines including ROTATEQ administered 12/15/16 became "constipated, vomited several x (bilious) x 1-2 days, lethargic, presented to our office this AM with "currant jelly" stool - to ED.
Age: 19.0
Sex: F
Vaccine: ADEN_4_7, FLU3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Alanine aminotransferase increased, Antinuclear antibody, Aspartate aminotransferase increased, Blood bilirubin, C-reactive protein normal
Clinical narrative: 19 yo female with S/S numbness, weakness of left leg and (R) leg thigh 4-5 days after receipt of hep A (lot# G499B SKB), IIV (U55306 CSL), adenovirus (#34600212 BRR), MCV4P (#U5180AA PMC), Tdap (#AH4LF SKB) and varicella (#L036831 MSD). Vaccines were received 3 JUN 2016. Symptoms included cramping in legs and sudden weakness with a (R) foot drop. She had an EMG on 07 JUL 16 which demonstrated upper extremity sensory and motor latencies, and loss of sensory and motor responsiveness to her lower extremities. She received 5 days of IVIG and Is currently receiving PT services. Last progress notes state some improvement in hamstring but otherwise plateaued. Genetic testing positive for HNPP. We have been unable to contact this patient for further assessment, info based on chart review.
Age: 19.0
Sex: F
Vaccine: ADEN_4_7, FLU3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Cytogenetic analysis abnormal, Electromyogram abnormal, Hereditary neuropathy with liability to pressure palsies, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: 19 yo female with S/S numbness, weakness of left leg and (R) leg thigh 4-5 days after receipt of hep A (lot# G499B SKB), IIV (U55306 CSL), adenovirus (#34600212 BRR), MCV4P (#U5180AA PMC), Tdap (#AH4LF SKB) and varicella (#L036831 MSD). Vaccines were received 3 JUN 2016. Symptoms included cramping in legs and sudden weakness with a (R) foot drop. She had an EMG on 07 JUL 16 which demonstrated upper extremity sensory and motor latencies, and loss of sensory and motor responsiveness to her lower extremities. She received 5 days of IVIG and Is currently receiving PT services. Last progress notes state some improvement in hamstring but otherwise plateaued. Genetic testing positive for HNPP. We have been unable to contact this patient for further assessment, info based on chart review.
Age: 19.0
Sex: F
Vaccine: ADEN_4_7, FLU3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Motor dysfunction, Muscle spasms, Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: 19 yo female with S/S numbness, weakness of left leg and (R) leg thigh 4-5 days after receipt of hep A (lot# G499B SKB), IIV (U55306 CSL), adenovirus (#34600212 BRR), MCV4P (#U5180AA PMC), Tdap (#AH4LF SKB) and varicella (#L036831 MSD). Vaccines were received 3 JUN 2016. Symptoms included cramping in legs and sudden weakness with a (R) foot drop. She had an EMG on 07 JUL 16 which demonstrated upper extremity sensory and motor latencies, and loss of sensory and motor responsiveness to her lower extremities. She received 5 days of IVIG and Is currently receiving PT services. Last progress notes state some improvement in hamstring but otherwise plateaued. Genetic testing positive for HNPP. We have been unable to contact this patient for further assessment, info based on chart review.
Age: 19.0
Sex: F
Vaccine: ADEN_4_7, FLU3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Peroneal nerve palsy, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Sensory disturbance, Treponema test negative
Clinical narrative: 19 yo female with S/S numbness, weakness of left leg and (R) leg thigh 4-5 days after receipt of hep A (lot# G499B SKB), IIV (U55306 CSL), adenovirus (#34600212 BRR), MCV4P (#U5180AA PMC), Tdap (#AH4LF SKB) and varicella (#L036831 MSD). Vaccines were received 3 JUN 2016. Symptoms included cramping in legs and sudden weakness with a (R) foot drop. She had an EMG on 07 JUL 16 which demonstrated upper extremity sensory and motor latencies, and loss of sensory and motor responsiveness to her lower extremities. She received 5 days of IVIG and Is currently receiving PT services. Last progress notes state some improvement in hamstring but otherwise plateaued. Genetic testing positive for HNPP. We have been unable to contact this patient for further assessment, info based on chart review.
Age: 19.0
Sex: F
Vaccine: ADEN_4_7, FLU3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Urine analysis normal
Clinical narrative: 19 yo female with S/S numbness, weakness of left leg and (R) leg thigh 4-5 days after receipt of hep A (lot# G499B SKB), IIV (U55306 CSL), adenovirus (#34600212 BRR), MCV4P (#U5180AA PMC), Tdap (#AH4LF SKB) and varicella (#L036831 MSD). Vaccines were received 3 JUN 2016. Symptoms included cramping in legs and sudden weakness with a (R) foot drop. She had an EMG on 07 JUL 16 which demonstrated upper extremity sensory and motor latencies, and loss of sensory and motor responsiveness to her lower extremities. She received 5 days of IVIG and Is currently receiving PT services. Last progress notes state some improvement in hamstring but otherwise plateaued. Genetic testing positive for HNPP. We have been unable to contact this patient for further assessment, info based on chart review.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Blister, Local reaction
Clinical narrative: Local Reaction - 2 blisters formed near injection site. Given Triamcinolone cream 12/19/16. D.S% apply TID.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient had to go to the Emergency room because her arm was red and swollen.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Feeding disorder, Gastrooesophageal reflux disease, Lactose intolerance, Pyrexia
Clinical narrative: Diarrhea (acute) -fever (TYLENOL, every 4-6hrs). Diarrhea (chronic, 5 months) -feeding difficulties (ongoing). Lactose intolerance. Sucrose intolerance (chronic). Reflux.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Sucrose intolerance
Clinical narrative: Diarrhea (acute) -fever (TYLENOL, every 4-6hrs). Diarrhea (chronic, 5 months) -feeding difficulties (ongoing). Lactose intolerance. Sucrose intolerance (chronic). Reflux.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to 13 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, (reported as "between 09-SEP-2016 and 06-OCT-2016"), the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 lot # M000592 and expiry date: 12-OCT-2017 (dose and route were not reported) for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of several reports received from the same reporter. Follow up information has been received on 22-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from the Licensed practical nurse on 06-DEC-2016, who stated that a 68 year old patient was vaccinated on 06-OCT-2016 with a dose of PNEUMOVAX 23 (volume/dose reported as 0.5). Additional information has been requested. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376: US-009507513-1610USA003097: US-009507513-1610USA004377: US-009507513-1612USA006597: US-009507513-1612USA006598.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Cold sweat, Erythema, Malaise, Nausea
Clinical narrative: This is a spontaneous report from a contactable pharmacist reporting on behalf of his mother. A 68-year-old female patient received PREVNAR 13, intramuscular, in left arm, on 09Dec2016, at 0.5 ml single, for immunisation. The patient medical history and concomitant medications were none. The patient was very sick, experienced fever, chills, nausea, vomiting, cold sweat, arm was red, all on 09Dec2016 in the afternoon, with outcome of not recovered. The patient was treated for sickness, fever, chills, nausea, vomiting, cold sweat. Treatment included oral TYLENOL 325 mg tablet every 46 hours but the patient still had the same adverse reactions and it was the same (persisting). Doctor visit was required for all the reported adverse events. The reporter considered that red arm was related to the suspect vaccine.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable pharmacist reporting on behalf of his mother. A 68-year-old female patient received PREVNAR 13, intramuscular, in left arm, on 09Dec2016, at 0.5 ml single, for immunisation. The patient medical history and concomitant medications were none. The patient was very sick, experienced fever, chills, nausea, vomiting, cold sweat, arm was red, all on 09Dec2016 in the afternoon, with outcome of not recovered. The patient was treated for sickness, fever, chills, nausea, vomiting, cold sweat. Treatment included oral TYLENOL 325 mg tablet every 46 hours but the patient still had the same adverse reactions and it was the same (persisting). Doctor visit was required for all the reported adverse events. The reporter considered that red arm was related to the suspect vaccine.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Red, swollen Left arm from shoulder down to elbow with vesicles around area of injection.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives on truck and below elbows, nothing near injection site.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLU3, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 16.0
Sex: M
Vaccine: HPV4, MEN, VARCEL
Symptoms: Seizure, Tremor
Clinical narrative: Given Gardasil (1st shot), Varicella booster, Meningococcal booster.  Not sure which order.  After second shot administered, son said he was feeling lightheaded.  I thought maybe he might faint so after his third shot, I held onto his head just in case he fainted and fell over.  He began to tighten all his muscles and tremor while I held him.  The nurse called for help and we laid him on the floor.  He stopped convulsing after about 15 seconds and he was given water and oxygen until he was able to get up on his own accord.  We were given a room with a place for him to lay down until he was steady enough to walk without help.  I am taking him to Doctor this afternoon.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Ear discomfort, Injection site rash, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: A rash scattered on his thighs and around his GU region x3 days. It started small - just on his inner thigh in 2-3 bumps - and spread quickly in the last 3 days to include his thigh fold and knee. It does not seem to bother him in terms of itching or pain. He has mild rhinorrhea and congestion. He has also been tugging at his ears.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Front left bicep sore.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: Rash on the back of injection arm and on leg.  Fever, chills, and aches.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, headache, body aches.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. Since 10-NOV-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lots # L025598 exp date 13-JAN-2017, L004255 exp date 01-FEB-2017, M007125 exp date 06-OCT-2017 and M046919 exp date 17-FEB-2018) (dose and route not reported) orally. The vaccines were exposed to 33.8 °F for 1 hour 25 minutes. A data logger was reported. No adverse experiences were reported. This is one of several reports received from the same source. Lot number L004255 has been verified to be an invalid lot number for rotavirus vaccine, live, oral, pentavalent. Additional information has been requested.; Sender's Comments: US-009507513-1612USA001949: US-009507513-1612USA001950: US-009507513-1612USA001951: US-009507513-1612USA001952:
Age: 27.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 27 year old patient (gender unknown). The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 20-OCT-2016, the patient was vaccinated with improperly stored dose of VAQTA (dose and route were not reported) lot #M012261 and expiry date: 01-FEB-2018 (volume/dose reported as 1), for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA004376: US-009507513-1610USA003097: US-009507513-1610USA004377.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 4 month old patient (gender unknown). The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 21-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M006112 expiration date:16-NOV-2016, orally; (volume/dose reported as 2) for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376:US-009507513-1610USA004377: US-009507513-1612USA006675: US-009507513-1612USA006674: US-009507513-1612USA006673: US-009507513-1612USA006676: US-009507513-1610USA003097.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 9 week old patient (gender unknown). The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 17-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M006112 expiration date:16-NOV-2016, orally; (volume/dose reported as 2) for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376: US-009507513-1610USA004377: US-009507513-1612USA006675: US-009507513-1610USA003097: US-009507513-1612USA006673: US-009507513-1612USA006676: US-009507513-1612USA006672.
Age: 0.33
Sex: M
Vaccine: DTAP, IPV, RVX
Symptoms: Crying, Extraocular muscle paresis, Pyrexia, Seizure, Vaccination complication
Clinical narrative: My baby had a fever of a 101 degrees, excessive vomiting, weak eyes, excessive crying, and two seizures.
Age: 0.33
Sex: M
Vaccine: DTAP, IPV, RVX
Symptoms: Vomiting
Clinical narrative: My baby had a fever of a 101 degrees, excessive vomiting, weak eyes, excessive crying, and two seizures.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Increasing redness and swelling around the site of injection. In first 24 to 48 hours patient started on oral Benadryl and local cold packs. On day 3 brought in to follow up. Mother says it is larger, measured: 10cm x 15cm, tender, erythematous, swollen ill-defined area on right upper thigh where she received DTaP. Otherwise eating and behaving as usual, no fever. Due to continued enlargement, started on oral antibiotics.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, HIBV, MMRV, PNC13
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Rash, skin eruption on upper part of the body starting from waist up. Itching and red started at night.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Full body rash that is consistent with either Rubella or the Measles.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Herpes zoster disseminated, Polymerase chain reaction positive, Rash, Rash vesicular, Varicella virus test positive
Clinical narrative: Vesicular rash on back, chest, face - disseminated zoster.
Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Blood immunoglobulin G normal, Polymerase chain reaction positive, Rash generalised, Skin lesion, Varicella
Clinical narrative: Vesicular rash on back, chest, face - disseminated zoster.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Eyelid oedema, Fatigue, Hypersensitivity, Pruritus generalised, Visual impairment
Clinical narrative: Approximately at around 10:30 AM, following the administration of an MCV4 #2 and HPV #1 vaccines, the 16 year old client developed moderate swelling to his right inner eye lid that interfered with his vision and generalized itching. He also complained of feeling tired. He returned with his mother and sister to the health department where it was determined that he was having an allergic reaction and Epinephrine and Benadryl were administered intramuscularly and he was kept under observation for a period of 60 minutes. His vital signs were stable: Blood Pressure was 120/72, Pulse was 70 beats per minute, Respirations were 16 per minute. Upon assessment at about 15 minutes following the administration of Benadryl and Epinephrine, swelling and general itching was significantly subsiding. Mother was asked if her son had an attending physician and she replied that he did not; as a result, she was referred to the clinic's social worker who determined that he qualified for CHIP. Mother was advised to follow up with attending physician and establish a medical home. Mother was contacted at 2:30 PM and she advised me that her son had fully recovered. She was still advised to follow up with her son's physician. She verbalized understanding. It was also advised to defer any future HPV vaccines until it was established what caused the allergic reaction.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, swelling, itching at injection site. Pt self-treating with hydrocortisone cream. Visited her PCP to have them look at it.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Edema erythema and tenderness entire lateral arm extending almost to elbow, extensor surface.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Large local reaction. Erythema and induration at injection site 8 x 5 cm.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown date, the patients were vaccinated with unspecified number of doses, that were stored in a freezer, of VARIVAX (lots #, expiration dates, dosages and therapy routes were not provided), for prophylaxis. Concomitant therapies were not informed. The doses of VARIVAX were exposed to a temperature from 5F to 10F during an unknown time frame.  It was unknown if a data logger was used to track the temperature. There were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received on 30-NOV-2016 from a medical assistant referring to a 46 year old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 22-SEP-2016, the patient was vaccinated with vaccinated with RECOMBIVAX HB (lot number and expiration not reported) dose 1 for prophylaxis. On 02-NOV-2016, the patient was vaccinated with vaccinated with RECOMBIVAX HB (lot number and expiration not reported) dose 2 for prophylaxis. On 30-NOV-2016, the patient was vaccinated with an earlier than scheduled dose 3 of RECOMBIVAX HB (lot number and expiration not reported) for prophylaxis. No adverse effects reported. No further information is available. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (concentration, route, dose, frequency and anatomical place of vaccination were not reported) which had a lot # of M021407, an expiration date of 30-APR-2018, for prophylaxis. The doses were exposed to a temperature of 35F, for a time frame of 2 hours and it was reported because a data logger. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009486: US-009507513-1612USA009487: US-009507513-1612USA009485.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (concentration, route, dose, frequency and anatomical place of vaccination were not reported) which had a lot # of M008551, an expiration date of 02-JUN-2018, for prophylaxis. The doses were exposed to a temperature of 35F, for a time frame of 2 hours and it was reported because a data logger. No adverse effects reported. This is one of several reports from the same reporter Additional information has been requested.; Sender's Comments:  US-009507513-1612USA009486: US-009507513-1612USA009487: US-009507513-1612USA003458:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally (concentration, dose and frequency were not reported) which had a lot # reported as "M022371", an expiration date of 18-FEB-2018, for prophylaxis. The doses were exposed to a temperature of 35F, for a time frame of 2 hours and it was reported because a data logger. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA003458: US-009507513-1612USA009487: US-009507513-1612USA009485:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (concentration, route, dose, frequency and anatomical place of vaccination were not reported) which had a lot # of M015290, an expiration date of 20-SEP-2017, for prophylaxis. The doses were exposed to a temperature of 35F, for a time frame of 2 hours and it was reported because a data logger. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA009486: US-009507513-1612USA003458: US-009507513-1612USA009485:
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report obtained from a contactable medical assistant through a Pfizer sales representative. This medical assistant reported for her son. A male patient of an unspecified age, race and ethnicity received the first dose of TRUMENBA, (NDC number: 00005-0100) 0.5 ml, single dose, on an unknown date, in Aug2016, for immunization. Relevant medical history and concomitant medications were unknown.  On an unspecified date, in Aug2016, the patient's thighs were swollen for almost for three days. The patient completely recovered from the event on an unknown date, in Aug2016.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Limb discomfort, Peripheral swelling
Clinical narrative: Patient reported red, uncomfortable, slightly swollen left arm to myself Mon, Dec 12TH.  Discomfort was relieved with cold packs and rest.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediate swelling at injection site. Patient received  25mg po diphenhydramine and cold compress to injection site.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Erythema, Fatigue, Injection site induration
Clinical narrative: Fever, chills, nausea, Muscle hurt all over, Arm swelled and was hard around the injection site, Pain radiated under arm, redness for days and hardness. Sick even today 12/19/2016 intradermal flu vaccine.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Myalgia, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Fever, chills, nausea, Muscle hurt all over, Arm swelled and was hard around the injection site, Pain radiated under arm, redness for days and hardness. Sick even today 12/19/2016 intradermal flu vaccine.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever, chills, nausea, Muscle hurt all over, Arm swelled and was hard around the injection site, Pain radiated under arm, redness for days and hardness. Sick even today 12/19/2016 intradermal flu vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Dysphonia, Musculoskeletal stiffness, Somnolence, Viral infection
Clinical narrative: Crying. Hoarse Cry and Voice. Sleepy and Crying for days. Stiff.
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Heart rate increased, Hypoaesthesia oral, Nausea, Oxygen saturation decreased
Clinical narrative: Case number PHEH2016US032023, is an initial spontaneous report received from a consumer on 07 Dec 2016. This report refers to a female patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185887, expiry date: Apr 2017) at a dose of 0.5 ml intramuscularly on 07 Oct 2016. On the same day after vaccination, the patient experienced lips tingly and numb, throat was closing up, and felt like she was going to faint, the patient oxygen level dropped and heart rate elevated. It was reported that, at hospital they gave EPIPEN (x2), SOLU-MEDROL (x2) and ZOFRAN for nausea on an unknown date. The patient said, never had a reaction like this to the flu vaccine. The outcome of the event throat constriction was reported as complete recovery on an unknown date and for tingling lips and feeling faint was reported as complete recovery on 07 Oct 2016 and for other events it was not reported. The seriousness of the events throat constriction, paraesthesia oral and syncope was reported as serious (life threatening) and for other events it was not reported by the consumer. The causality of the events was not reported. The seriousness assessment of the events oxygen saturation decreased, heart rate increased and nausea was upgraded based on information available in the source document. Following an internal review done for the data received on 07 Dec 2016, the following significant correction was done: Updated EPIPEN, SOLU-MEDROL and ZOFRAN should be coded as treatment medications (earlier captured as concomitant medications), added event nausea and removed it from current condition, all events arrangement based on seriousness criteria.
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia oral, Throat tightness
Clinical narrative: Case number PHEH2016US032023, is an initial spontaneous report received from a consumer on 07 Dec 2016. This report refers to a female patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185887, expiry date: Apr 2017) at a dose of 0.5 ml intramuscularly on 07 Oct 2016. On the same day after vaccination, the patient experienced lips tingly and numb, throat was closing up, and felt like she was going to faint, the patient oxygen level dropped and heart rate elevated. It was reported that, at hospital they gave EPIPEN (x2), SOLU-MEDROL (x2) and ZOFRAN for nausea on an unknown date. The patient said, never had a reaction like this to the flu vaccine. The outcome of the event throat constriction was reported as complete recovery on an unknown date and for tingling lips and feeling faint was reported as complete recovery on 07 Oct 2016 and for other events it was not reported. The seriousness of the events throat constriction, paraesthesia oral and syncope was reported as serious (life threatening) and for other events it was not reported by the consumer. The causality of the events was not reported. The seriousness assessment of the events oxygen saturation decreased, heart rate increased and nausea was upgraded based on information available in the source document. Following an internal review done for the data received on 07 Dec 2016, the following significant correction was done: Updated EPIPEN, SOLU-MEDROL and ZOFRAN should be coded as treatment medications (earlier captured as concomitant medications), added event nausea and removed it from current condition, all events arrangement based on seriousness criteria.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Nausea
Clinical narrative: Swelling non specific, erythema and tenderness at injection site, muscle aches. Nausea. Vomiting.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Vomiting
Clinical narrative: Swelling non specific, erythema and tenderness at injection site, muscle aches. Nausea. Vomiting.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site pain, Rash
Clinical narrative: Skin rash and chills pain at injection site.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Rash
Clinical narrative: Rash on both legs, hip to knee.
Age: 30.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Patient developed clustered vesicular rash in umbilical area less than 48 hrs after vaccination. Rash was determined to be shingles and started treatment. (VALTREX).
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Pallor, Syncope, Tremor
Clinical narrative: Pt fainted for a minute or two, was pale, shaking and grasping for air and was dizzy. Paramedics came, evaluated vital signs and BS; everything was ok at that time.
Age: 73.0
Sex: F
Vaccine: FLUA3, PPV, TDAP
Symptoms: Chest discomfort, Dyspnoea, Immediate post-injection reaction
Clinical narrative: Patient requested and received 3 vaccines and immediately reported feeling short of breath and some chest tightness. EMS was called and patient received breathing treatment after which she stated that she felt much better.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia
Clinical narrative: Parents reported at today's MD appointment that patient had 1 episode of blood in stool on day 3 after receiving Rotavirus vaccine.
Age: 62.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Initial unsolicited report received from a nurse on 06 December 2016. This case involves a 62-years-old male patient who was vaccinated with FLUZONE QIV intramuscularly (batch number: U5595CB, expiry date: 30 June 2017; dose, dose in series were not reported) in the left deltoid on 17 October 2016. Illness at the time of vaccination was reported as 'no'. The patient was Type 2 diabetic, had hypertension and hyperlipidemia. No further information regarding medical history and concomitant medications were not reported. On 26 October 2016, nine days following the vaccination, the patient was diagnosed with Guillain Barre Syndrome. It was reported that the patient had been transferred to different hospitals and was on a ventilator. At the time of reporting, he was off the ventilator now, had little movement in his arms and legs and was unable to walk and undergoing through inpatient rehabilitation. The patient as hospitalized for an unspecified time-period. Laboratory data was not provided. The patient was undergoing in-patient rehabilitation at the time of reporting. No further corrective treatment was reported. The outcome of the event was reported as not recovered. List of documents held by sender: none. Sender's Comments: Guillain Barre syndrome is listed with INFLUENZA QUADRIVAL A-B VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 62.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Abasia, Guillain-Barre syndrome, Mechanical ventilation, Mobility decreased
Clinical narrative: Initial unsolicited report received from a nurse on 06 December 2016. This case involves a 62-years-old male patient who was vaccinated with FLUZONE QIV intramuscularly (batch number: U5595CB, expiry date: 30 June 2017; dose, dose in series were not reported) in the left deltoid on 17 October 2016. Illness at the time of vaccination was reported as 'no'. The patient was Type 2 diabetic, had hypertension and hyperlipidemia. No further information regarding medical history and concomitant medications were not reported. On 26 October 2016, nine days following the vaccination, the patient was diagnosed with Guillain Barre Syndrome. It was reported that the patient had been transferred to different hospitals and was on a ventilator. At the time of reporting, he was off the ventilator now, had little movement in his arms and legs and was unable to walk and undergoing through inpatient rehabilitation. The patient as hospitalized for an unspecified time-period. Laboratory data was not provided. The patient was undergoing in-patient rehabilitation at the time of reporting. No further corrective treatment was reported. The outcome of the event was reported as not recovered. List of documents held by sender: none. Sender's Comments: Guillain Barre syndrome is listed with INFLUENZA QUADRIVAL A-B VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 83.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Immediate post-injection reaction, Influenza like illness
Clinical narrative: Flu symptoms immediately after shot-lasting 10 days.
Age: 83.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Immediate post-injection reaction, Influenza
Clinical narrative: Flu symptoms immediately after shot-lasting 10 days.
Age: 1.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Aphasia
Clinical narrative: Mother stated that patient was speaking then for 1 month pt did not speak.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a male pharmacist (also reported as a physician) of unknown age concerning himself. The patient's information about concurrent condition, medical history and concomitant therapy information was not provided. On 30-NOV-2016, the patient received an expired dose of ZOSTAVAX (lot# L028281, expiration date 28-OCT-2016) (dose and route were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Eyelid oedema, Malaise, Pruritus generalised
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 85-year-old female patient received PREVNAR 13 (lot M06900, exp.date Apr2017, NDC number: 00005197101) at 0.5ml single dose on 16Dec2016, via intramuscular route on the left arm at the pharmacy for immunization. The patient medical history and concomitant medication were not reported. On 03Nov2016, the patient got an influenza vaccine. On 17Dec2016 the patient stated that her eyes are puffy and kind of itchy, she felt itchy all over but yet she did not have any kind of rash, does not feel well, does not have fever, had no difficulty breathing, had no swelling in the lips or tongue or throat. The outcome of the events was unknown. Patient took BENADRYL at about 8:30 in the morning.
Age: 85.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Dry eye, Eye swelling, Malaise, Pruritus generalised
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 85-year-old female patient received PREVNAR 13 (lot M06900, exp.date Apr2017, NDC number: 00005197101) at 0.5ml single dose on 16Dec2016, via intramuscular route on the left arm at the pharmacy for immunization. The patient medical history and concomitant medication were not reported. On 03Nov2016, the patient got an influenza vaccine. On 17Dec2016 the patient stated that her eyes are puffy and kind of itchy, she felt itchy all over but yet she did not have any kind of rash, does not feel well, does not have fever, had no difficulty breathing, had no swelling in the lips or tongue or throat. The outcome of the events was unknown. Patient took BENADRYL at about 8:30 in the morning.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Rash
Clinical narrative: Parents noted rash on upper front torso of infant 5 minutes after receiving oral Rotavirus. Pt received Benadryl and was monitored for 30 minutes. Rash resolved prior to their departure.
Age: 40.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Condition aggravated, Guttate psoriasis
Clinical narrative: Received Varicella immunization and influenza vaccine at the same time. Caused massive guttate psoriasis outbreak which had previously been dormant for at least 10 years. Had chickenpox as a child, found no need for chickenpox  (not shingles) vaccination in a 40 y/o person.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Injection site pain, Joint manipulation, Limb mass, Pain in extremity
Clinical narrative: No issues until two weeks after shot.  Woke up on a with severe arm pain in upper arm near inoculation site Sunday two weeks and a couple of days after receiving the shot. Could not take on or off shirts without yelling.  After concluding I did not sleep wrong one night and arm pain progressed throughout my arm through the week and dressing was still a one arm operation I went to a doctor one week after initial pain began on Monday 12/19 and received osteopathic manipulation to relieve the tension.  A large bump had formed in my upper arm and needed to be broken down to allow my left arm to function again. It's too early to determine if treatment will relieve all arm pain. 12/20/16.
Age: 17.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: FEVER OVER 101 DEGREES, NAUSEA/VOMITING TREATED WITH BEDREST, FLUIDS AND IBUPROFEN. SYMPTOMS DISSIPATED OVER THE COURSE OF THE NEXT 24 HOURS WITH SEVERAL BREAKING/RESURGENCES OF FEVER.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Limb discomfort, Mobility decreased, Pain in extremity
Clinical narrative: Soreness, extreme pain, limited mobility, burning sensation, discomfort down entire arm.