chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain in jaw, Vision blurred
Clinical narrative: This serious spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 730001), concerns a 52-year-old adult female patient. The patient's historical conditions included dumping syndrome, peptic ulcer disease, femoral neck cyst, drug induced pancreatitis and drug induced seizures (lidocaine). Historical drugs with adverse events included: ALFENTA (severe itching, vomiting and nausea) for which the patient was treated with 75 mg BENADRYL (75mg) and was in post-anaesthesia care unit (PACU), TEQUIN (severe abdominal pain, nausea and vomiting), Clindamycin (rash, nausea and vomiting), Gabapentin (chest pains), SUFENTA (severe itching) (scratched skin off), MIDRIN and PAMPRIN (pancreatitis), STADOL and Nickel (contact dermatitis), lidocaine (seizures), LAMICTAL (severe abdominal pains), COMPAZINE (Bell's palsy), CELEBREX (truncal rash on right side of body), MAXALT (weakness, mouth blisters, severe malaise), Niacin (projectile vomiting and chest pain), DONNATAL, TAGAMET, and acetyl salicylic acid (ASA) (Hives for which hospitalization had occurred), DEMEROL (anaphylaxis requiring intubation), Latex (respiratory distress and contact dermatitis), sulfa drug (rash), Penicillin (PCN) delayed reaction then truncal rash which lasted for 10 days. The patient's current conditions included asthma, migraines, Raynaud's disease, bil polyneuropathy UE, carpal tunnel syndrome, hypoglycaemia, Meckel's diverticulum, right Piriformis syndrome, Sphincter of Oddi dysfunction (unsuccessful ERCP), Fibromyalgia, cold sore (3 weeks prior), C3-C6 disc problem and right snapping hip syndrome (since unspecified dates). The patient was allergic to REGLAN, NUBAIN, VICODIN, PHENERGAN, TIGAN, TOFRANIL, MOTRIN, TORADOL, bil, Morphine, codeine, Penicillin, sulfa drugs, food (cantaloupe, monosodium glutamate (MSG), chocolate, caffeine, milk) and Latex, adhesive (EKG pads, tape band-aids-contact dermatitis). It was reported that fentanyl and MARCAINE showed positive skin test and the patient had seasonal allergies. The patient's concomitant medications included ASTELIN, SINGULAIR, ZYRTEC, Vitamin E, Vitamin D, Nitrofurantoin, VESICARE, Mirabegron, TYLENOL, Sinus, PROTONIX, BIOTENE, Calcium and Vitamin D, IMITREX and ZOFRAN for an unknown indication. On 01-Dec-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On the same day, after the administration of vaccine, the patient was taken to the emergency room as she experienced blurred vision, severe headache, numbness in tongue that deviated to left cranial nerve 7, 9, 12 involvement. The patient experienced pain behind right ear that extend into jaw and eye and down into neck and shoulder. The outcome of the events (cranial nerve disorder, shoulder pain, vision blurred, eye pain and headache) was reported as not recovered.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Balance disorder, Gait inability, Impaired driving ability, Nausea, Neuritis
Clinical narrative: Vestibular neuronitis with 70% loss of function to the Left 8th cranial nerve.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Vestibular neuronitis with 70% loss of function to the Left 8th cranial nerve.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Auditory nerve disorder, Vestibular function test, Vestibular neuronitis
Clinical narrative: Vestibular neuronitis with 70% loss of function to the Left 8th cranial nerve.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: (R) thigh swelling and then development of painless rash, started at or near injection site of MMR and Varicella shots roughly 9 days after injection.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain, Dizziness, Fatigue, Headache
Clinical narrative: Sudden onset of nausea, abdominal pain, profuse sweating, fever-like symptoms approximately 3.5 hours after taking dose. When I stood up about 10 minutes after the onset of symptoms I felt light headed and dizzy, with ringing in my ears. The ringing faded when I sat down and put my head between my knees. Those that I was with said that had become pale. After an hour most of the feverish symptoms had faded but I continued to experience worsening abdominal pain. Up to three hours after initial symptoms, I continued to feel light headed upon standing. Symptoms had mostly subsided 4 hours later although abdominal discomfort, fatigue, and a headache persisted through the rest of the day.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Hyperhidrosis, Nausea, Pallor, Pyrexia, Tinnitus
Clinical narrative: Sudden onset of nausea, abdominal pain, profuse sweating, fever-like symptoms approximately 3.5 hours after taking dose. When I stood up about 10 minutes after the onset of symptoms I felt light headed and dizzy, with ringing in my ears. The ringing faded when I sat down and put my head between my knees. Those that I was with said that had become pale. After an hour most of the feverish symptoms had faded but I continued to experience worsening abdominal pain. Up to three hours after initial symptoms, I continued to feel light headed upon standing. Symptoms had mostly subsided 4 hours later although abdominal discomfort, fatigue, and a headache persisted through the rest of the day.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 16 year old patient of unknown gender. Information on the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date approximately in 2013 (reported as 'at the age of 11'), the patient was vaccinated with 2 doses of GARDASIL injection (strength, dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On 16-AUG-2017, the patient was vaccinated with 1 dose of GARDASIL 9 injection (strength, dose, route of administration, lot# and expiration date were not reported) for prophylaxis (interchange of vaccine products). On 28-FEB-2018, the patient was vaccinated with a second dose of GARDASIL 9 injection (strength, dose and route of administration were not reported) (lot# N021732 and expiration date: 01-FEB-2020) for prophylaxis. No adverse effects were reported. No further information was available. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a child patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA injection 25/0.5 (unspecified unit), 0.5 ml once intramuscularly (lot # M033611 and expiration date: 02-MAR-2018) for prophylaxis. No adverse effect reported. There was no product quality complaint (PQC) reported. No further information was obtained. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1803USA002039: US-009507513-1803USA002040.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a child patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB injection 5/0.5 microgram/ml, 0.5 ml once intramuscularly (lot # L048848 and expiration date: 09-AUG-2018) for prophylaxis. No adverse effect reported. There was no product quality complaint (PQC) reported. No further information was obtained. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1803USA001879: US-009507513-1803USA002040.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, drug reactions and allergies. The patient concomitant medication included sterile diluent (MRK), which was used to reconstitute the vaccines VARIVAX and PROQUAD. Since 13-FEB-2018, patients were vaccinated with doses of VARIVAX (dose, units, frequency and route not reported) (lot numbers N017395, expiration date: 07-JUN-2019; N026700, expiration date: 20-SEP-2019 and N021722, expiration date: 10-AUG-2019) and patient was also vaccinated with dose of PROQUAD (dose, units, frequency and route not reported) (lot numbers N025926, expiration date: 08-MAR-2019 and N019251. Expiration date: 20-DEC-2018) which were improperly stored at a temperature from 6 (Fahrenheit) F to 14 F (8.4F) for 1 hour 42 minutes. No adverse events were reported. On 01-MAR-2018, reporter contacted in regards to the temperature excursion, no further information was received until the time of report upon conduct evaluation. Reporter stated that there was no previous excursion. Digital data logger was involved. No product quality complaint involved. This is a non-valid case due to lack of patient identifiers.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a 5 month old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with ROTATEQ per oral (dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis at 5 months. No adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent. On 05-FEB-2018 the patient was vaccinated with one dose of improperly stored VARIVAX (lot # N023960, expiry date: 01-SEP-2019), (dose, frequency and route were not reported) for prophylaxis. It was reported that the VARIVAX was exposed to temperature of 6 degree Fahrenheit (F) to 14 F for 36 minutes. No adverse effects reported. Product quality complaint was not involved. There was no previous temperature excursion reported. The digital data logger was involved. Sender's Comments: US-009507513-1803USA003566: US-009507513-1803USA003698: US-009507513-1803USA003697: US-009507513-1803USA003696: US-009507513-1803USA003699: US-009507513-1803USA003695.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. On 08-FEB-2018 the patient was vaccinated with one dose of improperly stored VARIVAX (lot # N023960, expiry date: 01-SEP-2019), (dose, frequency and route were not reported) for prophylaxis. It was reported that the vaccine was reconstituted with a properly stored sterile diluent (manufacturer unknown). VARIVAX was exposed to temperature of 6 degree Fahrenheit (F) to 14 F for 36 minutes. No adverse effects reported. Product quality complaint was not involved. There was no previous temperature excursion reported. The digital data logger was involved. Sender's Comments: US-009507513-1803USA003566: US-009507513-1803USA003698: US-009507513-1803USA003697: US-009507513-1803USA003686: US-009507513-1803USA003699: US-009507513-1803USA003695.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. On 08-FEB-2018 the patient was vaccinated with one dose of improperly stored VARIVAX (lot # N023960, expiry date: 01-SEP-2019), (dose, frequency and route were not reported) for prophylaxis. It was reported that the vaccine was reconstituted with a properly stored sterile diluent (manufacturer unknown). VARIVAX was exposed to temperature of 6 degree Fahrenheit (F) to 14 F for 36 minutes. No adverse effects reported. Product quality complaint was not involved. There was no previous temperature excursion reported. The digital data logger was involved. Sender's Comments: US-009507513-1803USA003566: US-009507513-1803USA003698: US-009507513-1803USA003686: US-009507513-1803USA003696: US-009507513-1803USA003699: US-009507513-1803USA003695.
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Initial unsolicited report received from physician on 23-Feb-2018. This case involves a male patient (age not reported) who was vaccinated with a dose of TDAP Vaccine (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history revealed that, the patient had penicillin allergy. Concomitant medications includes Albuterol, ADCAL, FLONASE, Aspirin, Glipizide, metformin, simvastatin, trazodone and LYRICA. On an unspecified date, following the vaccination, the patient experienced rash. Lab data and corrective treatment were not reported. The patient's event outcome was not reported. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Initial information received from a consumer on 20-Feb-2018. This case involves a 57-year-old female patient who was vaccinated with FLU VACCINE (Batch number, expiry date, dose, dose series route and site of administration were not reported) on an unknown date. The patient also received 150 mg injection of ALIROCUMAB (PRALUENT) from Jul-2016. The patient's medical history and concomitant medication was not reported. On an unknown date, following vaccination the patient experienced allergic reaction to Flu vaccine and hence visited ER. Patient's lab test was not reported. The patient had been treated with steroids. Outcome of event was reported as unknown. The company assessed the causal relationship with FLU VACCINE as possible. List of documents held by sender: none.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Nausea
Clinical narrative: He reported severe nausea and chest pain that occurred about 3 hours after getting the vaccine. His wife reported nausea after receiving the same vaccine.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Palpitations
Clinical narrative: She reported severe nausea and a sense of a racing heart, her husband reported similar symptoms (see report #134759).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Patient complained of arm pain on they day of vaccination and continued to complain of pain throughout the night, was seen in the office on the following day and noted to have R deltoid with 2 inch round erythematous, slightly warm, slightly tender area around previous injection site; no fluctuance or drainage. Was directed by the provider to give: MOTRIN Q 6-8 hrs, BENADRYL PRN, ice pack PRN and monitor for increased swelling, redness, pain, red streaking, drainage.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) arm red and swollen tender deltoid.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Rash
Clinical narrative: General malaise and rash on the torso and arms.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Fussiness and irritability, tactile temp at home, wouldn't take / spit out Tylenol so brought to ER.  ER physician documented fever with no other signs or symptoms, normal exam.  No labs or imaging done. Temp recorded in ER as 102.3 at 3am. Both acetaminophen and ibuprofen suppositories were given in ER, defervesced, and then he tolerated PO before being discharge.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient has severe pain, swelling, redness on left arm from shoulder to elbow. Redness on arm, chest and neck. Patient was given Rx for KEFLEX 500mg TID x 10 days.
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Pt was inadvertently given Dtap instead of Tdap.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 25 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 05-MAR-2018, the patient was vaccinated with an expired dose of GARDASIL 9 lot M011840, expiration date 01-FEB-2018, for prophylaxis (strength, dose, route and frequency were not reported). The vaccine did not have temperature excursion. No adverse effects reported.
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure to product, Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous report was received from a female patient (who is also a pharmacist) of unknown age regarding herself. On 06-MAR-2018, the patient was inadvertently squirted reconstituted M-M-R II vaccine into her eye when attempting to remove an air bubble (accidental exposure to product, occupational exposure while preparing product for administration, exposure via eye contact). No adverse effects reported. The patient also reported as she was symptom free but she was intended to follow-up with her physician just to be safe.
Sex: M
Vaccine: PPV, PNC, PPV
Symptoms: Guillain-Barre syndrome
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. A male patient of an unspecified age, race and ethnicity received, on an unknown date, pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) at single dose, for immunization (unsure if the patient received PREVNAR 13 or PNEUMOVAX). Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient, after receiving pneumococcal vaccination, eventually developed Guillain-Barre syndrome. Clinical outcome of the event was unknown at time of this report.   The information on the lot number has been requested.; Sender's Comments: There is no plausible mechanism to implicate PREVENAR 13 to the occurrence of the serious event "Guillian-barre syndrome" due to the information currently available.  More information such as medical history and concomitant medications are needed for fully medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Laboratory test, Lower respiratory tract infection, Malaise, Upper respiratory tract infection
Clinical narrative: Got hives and upper and lower respiratory infc. kept hives and sick for a week. Went to (Hospital-ER) called Dr. there. Got prednisone pills and shot of 125 mg and BENARDYL, ZANTAC 50 mg, called in (ATARAX 25 mg) and SINGULAIR 10 mg.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Got hives and upper and lower respiratory infc. kept hives and sick for a week. Went to (Hospital-ER) called Dr. there. Got prednisone pills and shot of 125 mg and BENARDYL, ZANTAC 50 mg, called in (ATARAX 25 mg) and SINGULAIR 10 mg.
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Arthralgia, Arthritis
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of arthus reaction in a 23-year-old male patient who received BEXSERO. Concomitant products included BEXSERO. On 9th February 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 11th February 2018, 2 days after receiving BEXSERO, the patient experienced arthus reaction (serious criteria GSK medically significant), Still's disease (serious criteria GSK medically significant) and palpable purpura. On 12th February 2018, the patient experienced abdominal pain, pleuritic pain and breathing abnormally deep. In February 2018, the patient experienced joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth. On an unknown date, the outcome of the arthus reaction, Still's disease, palpable purpura, abdominal pain, pleuritic pain, breathing abnormally deep, joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth were unknown. It was unknown if the reporter considered the arthus reaction, Still's disease, palpable purpura, abdominal pain, pleuritic pain, breathing abnormally deep, joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of BEXSERO on 9th January 2018 and no other vaccines were administered. The patient 3 days post second dose of BEXSERO on 12th February 2018 presented for care to student health with the following history. The patient developed 48 hours post vaccination with palpable purpura on right leg then next day also on left leg and abdominal pain as well as sensation of pleuritic pain with deep inspiration but no shortness of breath, remarkable for palpable purpura on bilateral shins, painful joints in lower extremities with no arthritis and no acute abdomen. The CBC INR cryoglobulin labs was done. ANA ANCA hep B CRP C3 and 4 HepC write fullform was pending. The patient returned for follow up on 16th Feb 2018 with evident remaining but fading purpuric rash and transient arthralgias of lower extremities. The patient could barely walk due to inflamed lower extremity joints but also new with red hot swollen wrists and fingers. The rheumatologist consulted who saw him and diagnosed Arthus reaction and suggested adding Parvovirus titer (IgG plus IgM negative) and ferritin to rule out Still's disease was still pending. The follow up was pending with rheumatologist.
Sex: M
Vaccine: MENB
Symptoms: C-reactive protein, Complement factor C3, Complement factor C4, Cryoglobulins absent, Erythema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of arthus reaction in a 23-year-old male patient who received BEXSERO. Concomitant products included BEXSERO. On 9th February 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 11th February 2018, 2 days after receiving BEXSERO, the patient experienced arthus reaction (serious criteria GSK medically significant), Still's disease (serious criteria GSK medically significant) and palpable purpura. On 12th February 2018, the patient experienced abdominal pain, pleuritic pain and breathing abnormally deep. In February 2018, the patient experienced joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth. On an unknown date, the outcome of the arthus reaction, Still's disease, palpable purpura, abdominal pain, pleuritic pain, breathing abnormally deep, joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth were unknown. It was unknown if the reporter considered the arthus reaction, Still's disease, palpable purpura, abdominal pain, pleuritic pain, breathing abnormally deep, joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of BEXSERO on 9th January 2018 and no other vaccines were administered. The patient 3 days post second dose of BEXSERO on 12th February 2018 presented for care to student health with the following history. The patient developed 48 hours post vaccination with palpable purpura on right leg then next day also on left leg and abdominal pain as well as sensation of pleuritic pain with deep inspiration but no shortness of breath, remarkable for palpable purpura on bilateral shins, painful joints in lower extremities with no arthritis and no acute abdomen. The CBC INR cryoglobulin labs was done. ANA ANCA hep B CRP C3 and 4 HepC write fullform was pending. The patient returned for follow up on 16th Feb 2018 with evident remaining but fading purpuric rash and transient arthralgias of lower extremities. The patient could barely walk due to inflamed lower extremity joints but also new with red hot swollen wrists and fingers. The rheumatologist consulted who saw him and diagnosed Arthus reaction and suggested adding Parvovirus titer (IgG plus IgM negative) and ferritin to rule out Still's disease was still pending. The follow up was pending with rheumatologist.
Sex: M
Vaccine: MENB
Symptoms: Feeling hot, Full blood count normal, Gait disturbance, Hepatitis B virus test, Hepatitis C virus test
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of arthus reaction in a 23-year-old male patient who received BEXSERO. Concomitant products included BEXSERO. On 9th February 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 11th February 2018, 2 days after receiving BEXSERO, the patient experienced arthus reaction (serious criteria GSK medically significant), Still's disease (serious criteria GSK medically significant) and palpable purpura. On 12th February 2018, the patient experienced abdominal pain, pleuritic pain and breathing abnormally deep. In February 2018, the patient experienced joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth. On an unknown date, the outcome of the arthus reaction, Still's disease, palpable purpura, abdominal pain, pleuritic pain, breathing abnormally deep, joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth were unknown. It was unknown if the reporter considered the arthus reaction, Still's disease, palpable purpura, abdominal pain, pleuritic pain, breathing abnormally deep, joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of BEXSERO on 9th January 2018 and no other vaccines were administered. The patient 3 days post second dose of BEXSERO on 12th February 2018 presented for care to student health with the following history. The patient developed 48 hours post vaccination with palpable purpura on right leg then next day also on left leg and abdominal pain as well as sensation of pleuritic pain with deep inspiration but no shortness of breath, remarkable for palpable purpura on bilateral shins, painful joints in lower extremities with no arthritis and no acute abdomen. The CBC INR cryoglobulin labs was done. ANA ANCA hep B CRP C3 and 4 HepC write fullform was pending. The patient returned for follow up on 16th Feb 2018 with evident remaining but fading purpuric rash and transient arthralgias of lower extremities. The patient could barely walk due to inflamed lower extremity joints but also new with red hot swollen wrists and fingers. The rheumatologist consulted who saw him and diagnosed Arthus reaction and suggested adding Parvovirus titer (IgG plus IgM negative) and ferritin to rule out Still's disease was still pending. The follow up was pending with rheumatologist.
Sex: M
Vaccine: MENB
Symptoms: Hyperventilation, International normalised ratio normal, Joint swelling, Palpable purpura, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of arthus reaction in a 23-year-old male patient who received BEXSERO. Concomitant products included BEXSERO. On 9th February 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 11th February 2018, 2 days after receiving BEXSERO, the patient experienced arthus reaction (serious criteria GSK medically significant), Still's disease (serious criteria GSK medically significant) and palpable purpura. On 12th February 2018, the patient experienced abdominal pain, pleuritic pain and breathing abnormally deep. In February 2018, the patient experienced joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth. On an unknown date, the outcome of the arthus reaction, Still's disease, palpable purpura, abdominal pain, pleuritic pain, breathing abnormally deep, joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth were unknown. It was unknown if the reporter considered the arthus reaction, Still's disease, palpable purpura, abdominal pain, pleuritic pain, breathing abnormally deep, joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of BEXSERO on 9th January 2018 and no other vaccines were administered. The patient 3 days post second dose of BEXSERO on 12th February 2018 presented for care to student health with the following history. The patient developed 48 hours post vaccination with palpable purpura on right leg then next day also on left leg and abdominal pain as well as sensation of pleuritic pain with deep inspiration but no shortness of breath, remarkable for palpable purpura on bilateral shins, painful joints in lower extremities with no arthritis and no acute abdomen. The CBC INR cryoglobulin labs was done. ANA ANCA hep B CRP C3 and 4 HepC write fullform was pending. The patient returned for follow up on 16th Feb 2018 with evident remaining but fading purpuric rash and transient arthralgias of lower extremities. The patient could barely walk due to inflamed lower extremity joints but also new with red hot swollen wrists and fingers. The rheumatologist consulted who saw him and diagnosed Arthus reaction and suggested adding Parvovirus titer (IgG plus IgM negative) and ferritin to rule out Still's disease was still pending. The follow up was pending with rheumatologist.
Sex: M
Vaccine: MENB
Symptoms: Pleuritic pain, Still's disease, Type III immune complex mediated reaction
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of arthus reaction in a 23-year-old male patient who received BEXSERO. Concomitant products included BEXSERO. On 9th February 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 11th February 2018, 2 days after receiving BEXSERO, the patient experienced arthus reaction (serious criteria GSK medically significant), Still's disease (serious criteria GSK medically significant) and palpable purpura. On 12th February 2018, the patient experienced abdominal pain, pleuritic pain and breathing abnormally deep. In February 2018, the patient experienced joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth. On an unknown date, the outcome of the arthus reaction, Still's disease, palpable purpura, abdominal pain, pleuritic pain, breathing abnormally deep, joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth were unknown. It was unknown if the reporter considered the arthus reaction, Still's disease, palpable purpura, abdominal pain, pleuritic pain, breathing abnormally deep, joint pain, joint inflammation, walking difficulty, swelling of wrists, swelling of fingers, erythema of extremities and localized feeling of warmth to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of BEXSERO on 9th January 2018 and no other vaccines were administered. The patient 3 days post second dose of BEXSERO on 12th February 2018 presented for care to student health with the following history. The patient developed 48 hours post vaccination with palpable purpura on right leg then next day also on left leg and abdominal pain as well as sensation of pleuritic pain with deep inspiration but no shortness of breath, remarkable for palpable purpura on bilateral shins, painful joints in lower extremities with no arthritis and no acute abdomen. The CBC INR cryoglobulin labs was done. ANA ANCA hep B CRP C3 and 4 HepC write fullform was pending. The patient returned for follow up on 16th Feb 2018 with evident remaining but fading purpuric rash and transient arthralgias of lower extremities. The patient could barely walk due to inflamed lower extremity joints but also new with red hot swollen wrists and fingers. The rheumatologist consulted who saw him and diagnosed Arthus reaction and suggested adding Parvovirus titer (IgG plus IgM negative) and ferritin to rule out Still's disease was still pending. The follow up was pending with rheumatologist.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Deltoid muscle ache for 40 hours, beginning right after injection; flu like symptoms (chills, sweats, muscular aches all over, fatigue, restless sleep, lack of appetite) beginning 6 hours after injection and lasting 24 hours. Stayed in bed for 19 hours.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Poor quality sleep
Clinical narrative: Deltoid muscle ache for 40 hours, beginning right after injection; flu like symptoms (chills, sweats, muscular aches all over, fatigue, restless sleep, lack of appetite) beginning 6 hours after injection and lasting 24 hours. Stayed in bed for 19 hours.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin swelling, Skin warm
Clinical narrative: Patient was seen for a wellness exam on 3/1/2018 and administered a pneumoccocal immunization. Patient report she noticed increased pain the next day but assumed it was just normal. She did not examine her skin until the next day and reports it was pink and bumpy and by the evening it warm significantly warm to touch and color red and spreading. She called her daughter who is a nurse who advised her to mark the area with a pen to outline redness. The patient never had fever or any other symptoms. By the next day the third it was starting to resolve.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Immediate post-injection reaction, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain and tingling down left arm immediately after flu shot. Ongoing symptoms including weakness and pain in left deltoid.
Age: 0.25
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: Pt developed hives. NO: labored breathing/wheezing/worsening cough/vomiting/diarrhea/fever.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Flushing, Headache, Migraine, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX (patient had no reaction), pneumonia vaccine (patient had no reaction) and Tdap vaccine (patient had no reaction). Concurrent medical conditions included blood pressure and hyperlipidemia. Concomitant products included Atorvastatin and lisinopril. ON 19th February 2018, the patient received SHINGRIX. On 19th February 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 20th February 2018, the patient experienced headache, muscle pain, fever, pain, chills, migraine and facial flushing. The patient was treated with ibuprofen. On 20th February 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the muscle pain, fever, pain and chills were recovered/resolved and the outcome of the migraine was unknown and the outcome of the facial flushing and pain in arm were not recovered/not resolved. The reporter considered the headache, muscle pain, fever, pain, chills and migraine to be probably related to SHINGRIX. It was unknown if the reporter considered the facial flushing and pain in arm to be related to SHINGRIX. Additional information was reported as follows: The patient's arm hurt after vaccine administration. On 20th February 2018 morning, when the patient woke up, he had headache, muscle aches, pain and fever. One day after vaccination the patient experienced headache, muscle pain, fever, pain, chills, migraine and facial flushing. The body temperature was 99.8 degree F, the temperature was high for the patient as his temperature was usually below normal. The patient had chills and was covered in blanket. The patient took ibuprofen and had migraine earlier on the morning of reporting date. The patient's pharmacist. The batch number and the expiry date were not reported.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX (patient had no reaction), pneumonia vaccine (patient had no reaction) and Tdap vaccine (patient had no reaction). Concurrent medical conditions included blood pressure and hyperlipidemia. Concomitant products included Atorvastatin and lisinopril. ON 19th February 2018, the patient received SHINGRIX. On 19th February 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 20th February 2018, the patient experienced headache, muscle pain, fever, pain, chills, migraine and facial flushing. The patient was treated with ibuprofen. On 20th February 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the muscle pain, fever, pain and chills were recovered/resolved and the outcome of the migraine was unknown and the outcome of the facial flushing and pain in arm were not recovered/not resolved. The reporter considered the headache, muscle pain, fever, pain, chills and migraine to be probably related to SHINGRIX. It was unknown if the reporter considered the facial flushing and pain in arm to be related to SHINGRIX. Additional information was reported as follows: The patient's arm hurt after vaccine administration. On 20th February 2018 morning, when the patient woke up, he had headache, muscle aches, pain and fever. One day after vaccination the patient experienced headache, muscle pain, fever, pain, chills, migraine and facial flushing. The body temperature was 99.8 degree F, the temperature was high for the patient as his temperature was usually below normal. The patient had chills and was covered in blanket. The patient took ibuprofen and had migraine earlier on the morning of reporting date. The patient's pharmacist. The batch number and the expiry date were not reported.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Blood creatine phosphokinase increased, C-reactive protein increased, Differential white blood cell count normal, Full blood count normal
Clinical narrative: Left leg pain and localized swelling, headache, stomach ache and fever 101 degrees 4 hours after receiving vaccines. Patient referred to orthopedics and lab work done.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Headache, Injection site pain, Pyrexia, Red blood cell sedimentation rate normal, Swelling
Clinical narrative: Left leg pain and localized swelling, headache, stomach ache and fever 101 degrees 4 hours after receiving vaccines. Patient referred to orthopedics and lab work done.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea exertional, Fatigue
Clinical narrative: 3/1/18 Patient called stated has been having shortness of breath on exertion/exercise; feels that she tires out easily. We called her doctor (primary care) and they were going to call her.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Tendonitis
Clinical narrative: Patient reports tendonitis. The details of timing are unknown to me.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old male patient who received SHINGRIX. In February 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 26th February 2018, 5 hrs after receiving SHINGRIX, the patient experienced fever, injection site pain, tiredness and headache. The patient was treated with ADVIL. In February 2018, the outcome of the fever and headache were recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the tiredness was recovering/resolving. The reporter considered the fever, injection site pain, tiredness and headache to be almost certainly related to SHINGRIX. Addition details were provided as follows: The patient received SHINGRIX on the right arm. About 5 to 6 hours after vaccination, the patient experienced fever, administration site soreness, tiredness and headache. The patient took 1 ADVIL to help manage symptoms. Fever and headache were lasted for about 30 hours. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication was reported as sterile diluent. On 19-FEB-2018, the patient was vaccinated with expired dose of VARIVAX (dose, units and frequency not reported) (lot # M004328 and expiration date: 26-JAN-2018) subcutaneously. No adverse effects and no additional information was provided. No product quality complaint was involved. Follow-up information was received from a registered nurse on 01-MAR-2018. The reporter confirmed that the patient did not experience any redness, swelling or fever and that the medication error happened during the dispensing and administration processes. Additionally, the reporter stated that the adverse events were previously reported to the doctor as well as the manufacturer and reported the expiration date for VARIVAX as 24-JAN-2018 with no digital data logger involved.
Sex: U
Vaccine: PNC13
Symptoms: Headache
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13 at single dose, for immunization. Medical history and concomitant medications were not reported. The patient experienced headache the day after vaccination, on an unspecified date. Event outcome was unknown. Information on the batch number has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Swelling
Clinical narrative: Pt received PPV23 in office and called to report redness, swelling, and pain at injection site 4 hours later. Patient stated the swelling and pain made it difficult to raise her left arm above her shoulder. Denied SOB, fever or hives. RN in office advised 600mg ibuprofen and ice as tolerated. Case discussed with Dr. who agreed with RN plan of care. Patient called back to office morning of 3/5/2018 and stated that over the weekend the swelling had spread from her upper arm to her chest. Pt stated she felt nauseated but denied any additional symptoms. Swelling, redness, and pain dissipated by PM 3/5/2018 and completely resolved by 3/6/2018. Follow-up phone call made to patient 3/9/2018 where patient stated she had been previously vaccinated with PPV23 1/2017 from old PCP. Both patient and provider unaware of previous vaccination at the time of 3/2/2018 injection.
Sex: F
Vaccine: RAB
Symptoms: Nausea, Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of nausea in a 23-year-old female patient who received RABAVERT. Concomitant products included RABAVERT and RABAVERT. On an unknown date, the patient received the 3rd dose of RABAVERT. On an unknown date, less than a day after receiving RABAVERT, the patient experienced nausea and vomiting. On an unknown date, the outcome of the nausea and vomiting were unknown. It was unknown if the reporter considered the nausea and vomiting to be related to RABAVERT. Additional details were provided as follows: It was unknown whether the patient received RABAVERT for pre or post exposure prophylaxis. The age at vaccination was not reported. On an unknown date, the patient received 1st and 2nd dose of RABAVERT. After receiving RABAVERT, patient experienced nausea and vomiting within 24 hours of injection. This was 1 of 3 cases reported by the same reporter for same patient.
Age: 35.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Abdominal pain upper, Cough, Diarrhoea, Dyspnoea, Muscle spasms
Clinical narrative: Back spasms, stomach cramps, diarrhea, coughing, swelling of airway, shortness of breath - started at 9:30 pm - 7 hours after vaccination. Treatment - BENADRYL, steroid injection, Albuterol, Prednisone.
Age: 35.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Pharyngeal oedema
Clinical narrative: Back spasms, stomach cramps, diarrhea, coughing, swelling of airway, shortness of breath - started at 9:30 pm - 7 hours after vaccination. Treatment - BENADRYL, steroid injection, Albuterol, Prednisone.