chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional. This case involves a six-month-old male patient who received a 0.5 mL dose of expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ148AA and expiry date: 19-Feb-2021) via an intramuscular route in a right thigh for prophylactic vaccination on 22-Feb-2021 (Expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 85-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 3rd May 2018, the patient received SHINGRIX. On 3rd May 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema and injection site hemorrhage. In May 2018, the patient experienced injection site bruising. In May 2018, the outcome of the injection site erythema and injection site hemorrhage were recovered/resolved. On an unknown date, the outcome of the injection site bruising was recovering/resolving. The reporter considered the injection site erythema, injection site bruising and injection site hemorrhage to be almost certainly related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX at the reporter's facility, but by a different healthcare professional (HCP). The patient experienced bleeding and redness both at the injection site. Two hours after receiving SHINGRIX, the patient experienced bruising at the injection site, which persisted on the day of reporting, but improved.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in November 2018, between 02-NOV-2018 and 16-NOV-2018, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (Oka/Merck) subcutaneously (dose was not provided, lot# R017945, expiration date 24-JUN-2020) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effect. The digital data logger was involved. The vaccine experienced temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (15.1 degrees Fahrenheit) for 1 hour. There were no previous temperature excursions. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1811USA009254: US-009507513-1811USA009255: US-009507513-1811USA009256: US-009507513-1811USA009257: US-009507513-1811USA009258: US-009507513-1811USA009259: US-009507513-1811USA009260: US-009507513-1811USA009142
comes on like a hangover; started having a headache / pain/ like it burns off a little bit, however it becomes better or worse; This spontaneous case was reported by a consumer and describes the occurrence of HANGOVER (comes on like a hangover) and HEADACHE (started having a headache / pain/ like it burns off a little bit, however it becomes better or worse) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in November 2021 and Headache (Had a headache with his covid for 11-12 days).    On 18-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Nov-2022, the patient experienced HANGOVER (comes on like a hangover) and HEADACHE (started having a headache / pain/ like it burns off a little bit, however it becomes better or worse). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HANGOVER (comes on like a hangover) and HEADACHE (started having a headache / pain/ like it burns off a little bit, however it becomes better or worse) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by the reporter. On 09-Mar-2021, the patient received first dose of MODERNA COVID-19 VACCINE, with the batch no 013A21A and on 06-Apr-2021, received second dose of MODERNA COVID-19 VACCINE, with the batch no 047A21A. It was reported that sometimes felt like it burns off a little bit, however it became better or worse at seemingly random times. This pain was rated at a 3 to a 5 currently, but he had considered going to the ER at times. He never had a reaction with the previous 2 shots. Had tried Advil, Tylenol, and migraine medications.
A nurse described the occurrence of rash in a 33 y.o. female who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject had no medical history, concurrent conditions, or concurrent medications. The subject received her 1st injection of Engerix-B in 1998. She received her 2nd injection on 10/02/02. "A few days" after the 2nd injection, she developed a "mild" rash that resolved after an unspecified period of time. On 11/4/02, the subject received her 3rd injection of Engerix-B (lot ENG5291A4). Two days later, she developed a rash on both forearms. She was seen by a physician. The reporting nurse considered the rash to be possibly related to Engerix-B administration. As of 12/5/02, the rash had "improved".
A spontaneous report was received from a health care professional (HCP) concerning three to four patients who received COVID-19 vaccine and experienced the inappropriate dose of vaccine administered.  The patients' medical history was not provided. Concomitant products were not provided.  On an unknown date, the patients received their doses (Lot number unknown) for prophylaxis of COVID-19 infection.   The HCP stated that the patients received invalid doses (0.3ml each) and they called back the patients to give them the rest of the dose (0.2ml).   Treatments of these events were not provided.  The event inappropriate dose of vaccine administered was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered (Lot number unknown) with no associated AEs.
SWELLING IN BACK OF THROAT; SWELLING AROUND TONSILS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 10-JUN-2021, the subject experienced swelling in back of throat. On 10-JUN-2021, the subject experienced swelling around tonsils. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling in back of throat and swelling around tonsils was not reported. This report was non-serious.
Received shot 9-13-11 at 4:15 - shot was not painful at time received nor did arm get sore. No pain/soreness ever experienced - patients states day to day and hour later started tingling from shoulder to wrist & has been tingling ever since (tingling started in shoulder & moved down).
Patient called the Health Department on 11/19/19, to tell us that the day after her flu shot, she began to feel dizzy. The dizziness has continued to this date, and she did vomit once on 11/12/19. She has had no other symptoms, and has been seen and treated by her family physician (Name unknown)
3 hours after receiving seasonal influenza vaccine developed sharp and throbbing pain at the injection site which radiated to the outer elbow, 6-8/10. Four hours after receiving the vaccine, felt malaise, weakness in the affected arm, decreased appetite, and use of arm. Didn't sleep well, due to arm discomfort and malaise, woke up with malaise, arm pain, lightheaded on change of position, "hot eyes," decreased appeatite, two loose stools. Took Motrin 600mg and Alleve orally with improvement.
Narrative:  Pt presented to facility ER 8/22/2022. HPI: Patient presenting to the ER for evaluation of weakness. Patient states over the last year or so after dialysis he feels very weak. Patient feels very fatigued with no energy and sleeps most of the day. Patient states he has chronic short of breath but no acute on chronic shortness of breath or chest pain. Patient denies any nausea vomiting fever chills or abdominal pain. Patient states he has had a cough for the last couple days and wheezing started last night where he used a breathing treatment. Patient states he did have Covid back in April 2021. Pt admitted 8/22/22 through 8/25/22 with principle diagnosis = mild COVID-19. ADDITIONAL DIAGNOSES: chronic obstructive pulmonary disease exacerbation coronary artery disease Chronic combined systolic and diastolic congestive heart failure end stage renal disease on hemodialysis benign prostatic hypertrophy chronic normocytic anemia diabetes mellitus type 2 HOSPITAL COURSE: Pt admitted to the floor. dx covid 19. cxr with persistent hazy density at the peripheral left lung base. pt started on cefepime and dexamethazone. unable to start remdesivir due to ESRD on HD. continued chronic medications. pt with some improvement in 24 hours. stopped antibiotics. changed from dexamethasone to prednisone. pt held overnight again due to significant wheezing. pt tolerating medications. no hypoxia noted. pt stable for d/c to home with prednisone.
Pt was vaccinated for Influenza on 10/28/2022 and presented to the office very ill with Influenza A on 12/1/2022. She tested positive for Influenza A in the office.
No additional AE were reported; received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 21-MAR-2022, the patient was vaccinated with an improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 1 dose, lot #U026217, expiration date: 02-NOV-2023 (strength, exact dose, site and route of administration were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose orally, lot #U026664, expiration date: 24-FEB-2023 or lot#1741817 expiration date: 30-JUL-2022 (strength, exact dose, site of administration were not provided), both of them for prophylaxis (Product storage error). The reporter was not sure, which specific lot# of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient. On an unknown date, before the administration, vaccines underwent temperature excursion at 34.3 degrees Fahrenheit (F) for 55 minutes. No previous excursions were reported. No adverse events were reported (No adverse event).  This is one of several cases from the same reporter.
the  is not able to schedule any more vaccination appointments.; This case is considered as invalid as there is no indication that the patient experienced an event under BNT162b2.  This is a spontaneous report from a contactable consumer. This consumer reported for a 87-year-old male patient (Father).  An 87-year-old male patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EK9231, Expiration date: 30Apr2021), via unspecified route, administered in left arm on 12Jan2021 (at the age of 87-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Alzheimer's disease and concomitant medications were not reported. The second dose of vaccination was scheduled on 02Feb2021, but they had to cancel that appointment because the caller's father was in the hospital from a fall he had where he bruised his hip and bruised his rib. Caller states that the facility said they are not able to make any more appointments for him at that moment. Caller is wondering if there are consequences of, or a danger in, getting the second dose outside of the recommended timeframe. The patient lab data includes Magnetic resonance imaging on an unspecified date which showed some spots. it was indicated that there were some spots from a past stroke. Patient received no other vaccine on the same day the COVID vaccine. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (12May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Amendment: This follow up is being submitted to amend previously reported information: Case reassessed as invalid. This case is being deleted from the database for the following reason: Non-existence of an adverse event.
NOTATION-both doses included; the 1st dose was 8/23/2018 but with the same reactions.  headache, low grade fever, muscle pain/aches, tired.
Trumenba vaccination in an otherwise healthy 9 month old infant.; swelling at area of injection; fever; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID.  A 9-month-old patient received meningococcal group b Rlp2086 (TRUMENBA), at the age of 9 months as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Trumenba vaccination in an otherwise healthy 9 month old infant."; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling at area of injection"; PYREXIA (non-serious), outcome "unknown", described as "fever". Additional information: The patient asked if there was any data regarding the safety or possible side effects from Trumenba vaccination in an otherwise healthy 9 month old infant. As per agent, this product was administered to a 9 month old patient who experienced fever and swelling at area of injection. HCP asking for potential side effects after administration to a 9 month old. The caller states a "full dose" of the product was accidently given to an infant last week, a 9 month old. Do we have any information regarding potential side effects for the infant? When asking to clarify "full dose" caller states "it was the one that we normally give to the 11 year olds. I went online and found some studies that Pfizer did with half a dose on infants but I couldn't find anything on a full dose. It was the same dose the 11 year olds were given." When asked what dose he gives an 11 yar old caller states "I'm not in the office right now. My nurse does it so whatever the standard dose is, that we would give to 11 year olds." He's 99% sure they gave 0.5mL dose.   The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
Patient c/o dry cough and mild, frontal headache after receiving COVID-19 vaccine today.  Denies any shortness of breath, dizziness, vision blurriness, or swelling or itching.
This spontaneous report was received from a health care worker referring to a 11 year old female patient. No medical history was reported. Approximately on 23-DEC-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9, dose, route and frequency: unknown, lot number: L016429, expiry date 09-AUG-2017. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient was sitting on the post-vaccination area chair , when he slid on the side on the floor . Patient fainted , his companion called for help , pharmacy personnel run to help , called 911,  patient was conscious , he  was told to take mask out and asked for water.  His face was red . He admitted that he is afraid of needles. He continued to sit on the chair for next 10 min and was fine when he left the store.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 13-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Patient vomited after approximately 5 minutes he had received Pfizer 1st dose vaccine. Patient left by ambulance at the mother's request for further observation. Pt left in no distress.  Patient went to Hospital by ambulance unit.
Got really sick (ER); Pain under sternum (ER); Diagnosed with gallstones (ER); Gallbladder duct obstructed, is going to remove the gallbladder (ER); Sore arm (ER); This serious case was reported by a consumer via call center representative and described the occurrence of gallbladder obstruction in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAR-2023, the patient received the 1st dose of Shingrix (left arm). On 01-MAR-2023, less than a day after receiving Shingrix, the patient experienced gallbladder obstruction (Verbatim: Gallbladder duct obstructed, is going to remove the gallbladder (ER)) (serious criteria GSK medically significant), pain in arm (Verbatim: Sore arm (ER)), sternal pain (Verbatim: Pain under sternum (ER)) and gallstones (Verbatim: Diagnosed with gallstones (ER)). On 01-MAR-2023 11:00, the patient experienced sickness (Verbatim: Got really sick (ER)). The patient was treated with analgesic, nos (Pain Medication). The outcome of the gallbladder obstruction and gallstones were not reported and the outcome of the pain in arm, sickness and sternal pain were unknown.   It was unknown if the reporter considered the gallbladder obstruction, pain in arm, sickness, sternal pain and gallstones to be related to Shingrix.     It was unknown if the company considered the gallbladder obstruction, pain in arm, sickness, sternal pain and gallstones to be related to Shingrix.   Additional Information: GSK Receipt date: 21-MAR-2023 The reporter reported that male patient that received his first dose of Shingrix 1-MAR-2023, and reports that his arm was sore right after the injection, but it was not bad.  The patient reported that around 11pm that same night, 1-MAR-2023, he got really sick, and experienced the worst pain he had ever had under his sternum, and that he went to the ER and stayed overnight until the afternoon of 2-MAR-2023.  The patient reports that he had a number of test done while he was in the ER, including a CT Scan, an Ultra Sound, and a Nuclear Medicine test that he could not remember exactly what it was called, and he was diagnosed with gall stones. The patient reports that the duct from his gall bladder was obstructed.  The patient also reports that he was given a pain medication (unknown product) during the Nuclear Medicine test, and he had no pain the rest of the day. The patient is going to have his gall bladder removed. The reporter did not consent to follow-up.
She stated that after vaccination, she was feeling numbness in arms and tongue.  No difficulty breathing, appeared well, in no acute distress.  No throat swelling.  Heart rate 70, SpO2 99%.  She medicated herself with 25mg of Benedryl PO.  Instructed to go to ER if difficulty breathing or throat swelling occurred.   She was accompanied by support person to drive her home.
Starting 3/15/21 and continuing today, 3/16/21 (the time this was authored), I have noticed that I continue to have brain-fog after the second COVID vaccine.  Not sure if this is normal or will go away.
Itchy, red, bumpy rash on fingers, back of hand, top of foot/near big toe that started a little over a week after 1st dose and is still active 6 days later.   Rash is aggravated by heat.
Case number PHEH2017US005869, is an initial spontaneous report received from a consumer on 23 Feb 2017. This report refers to a female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with influenza virus vaccine unknown INN (unknown whether seasonal or pandemic, manufacturer and batch number: not reported) on an unknown date. On an unspecified date, the patient experienced flu. The outcome of the event was reported as unknown. The seriousness and causality of the event were not reported. Consent to contact was not provided.