chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patients did not have drug reactions. On unknown dates, the patients were vaccinated with improperly store doses of M-M-R II lot number L039551 (rHA), expiration date 07-OCT-2017; lot number M015931 (rHA), expiration date 30-MAR-2018 (dose and route were not reported) for prophylaxis. It was unknown the lot and expiration date of the properly stored sterile water diluent used to reconstitute the doses of M-M-R II. The temperature exposure was 47-77°F (49°F) for 30 hours. Previous temperature excursion was not reported, and a data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA003211:Original Case: 1704USA003069; US-009507513-1704USA003069:Original Case: 1704USA003069; US-009507513-1704USA003212:Original Case: 1704USA003069.
Due to the improper storage of the Pfizer vaccine, the injections patient received are considered invalid. Mother is notified that revaccination will be needed, but not required.
Sent home from work after receiving vaccine. I immediately developed sore throat.  First 3 days I was miserable and then this whole week everything has bad. Outside of ears were burning. Stomach turned immediately. I thought I was going to vomit. Top of my head started spinning. I am still foggy. Breathing was never altered.
Information was received from a registered nurse regarding a female patient, age unknown, who on 01FEB-2011, received her first dose of GARDASIL 0.5 ml, intramuscular. On 28-OCT-2013, the patient was reported to be currently in the office to receive the second dose of GARDASIL. No adverse effect reported. Additional information has been requested.
No adverse event; Patient received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 monovalent vaccine in June of 2022. The vaccine expired in March 27, 2022).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.     This case was linked to US-MODERNATX, INC.-MOD-2023-731892 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731892:
Pain and swelling in right axillary; Pain and swelling in right axillary; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female nurse reported for self (not pregnant) not pregnant at time of vaccination received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 (Lot number: 301558A) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer, diabetes, hypothyroidism" (unspecified if ongoing); "Breast cancer, diabetes, hypothyroidism" (unspecified if ongoing); "Breast cancer, diabetes, hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 29Sep2021 20:00, outcome "recovering" and all described as "Pain and swelling in right axillary". Therapeutic measures were not taken as a result of axillary pain, swelling.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient received other medications within 2 weeks of vaccination. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Child complained of pain at injection site.  A swollen, red lump appeared and grew to 8 mm in size.  Doctor told us it was a hypersensitivity to the vaccine.  Symptoms resided 3 days.
Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 17-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Patient tested positive for C-19 on 16Sep2021; Patient tested positive for C-19 on 16Sep2021/mild cough and scratchy throat for 2-3 days; This is a spontaneous report from a contactable Pharmacist. A 14-years-old non pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: FA6780, Expiry date: unknown), via unspecified route of administration on 29Jul2021 (age at vaccination 14 years and non-pregnant at the time of vaccination) as DOSE 2, SINGLE and first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: FA6780, Expiry date: unknown), via intramuscular, administered in arm right on 08Jul2021 (age at vaccination 14 years and non-pregnant at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included known allergies seasonal allergies, pet dander. The patient's concomitant medications were not reported. Hospital was facility where the most recent COVID-19 vaccine was administered. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. It was reported that the patient received both doses of PFE covid vaccine (08Jul2021-lot FA6780, 29Jul2021 lot FA6780). Patient tested positive for C-19 on 16Sep2021 with mild cough, scratchy throat for 2-3 days. Patient was fine now. The patient underwent covid test post vaccination (nasal Swab, covid test date on16Sep2021, covid test result was positive). The patient did not receive any treatment for the events. The outcome of event was recovered in 2021.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be completely excluded.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored VARIVAX (Merck), (dose, route, lot number and expiration date not reported) which was exposed to -13.5 C for 45 minutes. No adverse effects were reported. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concurrent medical conditions included irritable bowel syndrome and hyperlipidemia. Concomitant products included CYMBALTA, IMITREX, VALIUM, vitamin D, CELEXA, AMBIEN, LINZESS, PERCOCET, VAGIFEM and VICODIN. On 30th January 2018, the patient received SHINGRIX (intramuscular). On 1st February 2018, 2 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unchanged. The reporter considered the shingles to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient required emergency room visit. The patient received SHINGRIX vaccine on left arm. Shingles occurred 2 days after the SHINGRIX was administered. At the time of reporting the patient again had shingles.
Bilateral SN hearing loss; Ear fullness; Tinnitus; Dysautonomia; Vestibular neuritis; Heart rate increased; Blood pressure issues; Vision changes; Rash; Hyperthyroidism; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), intramuscular in left arm, on 11Jan2021 at 01:15 PM (13:15) (at the age of 48 years), as dose 2, single, for COVID-19 immunization. The patient's medical history included asthma, seasonal allergies, and allergies to sulfa drugs. The patient's concomitant medications included cetirizine hydrochloride (ZYRTEC), Montelukast sodium (SINGULAIR), and fluticasone propionate/ salmeterol xinafoate (ADVAIR). The patient previously received the first dose of BNT162B2 (Lot Number: EJ1685) on 21Dec2020 at 01:15 PM at the age of 48 years (intramuscular in left arm) for COVID-19 immunization and experienced no reaction on exposure to previous vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Feb2021, the patient experienced bilateral SN hearing loss, ear fullness, tinnitus, dysautonomia, vestibular neuritis, heart rate increased, blood pressure issues, vision changes, rash, and hyperthyroidism. The adverse events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Treatment was received for the adverse events including steroids, oral and intratympanic medications, and beta blockers. The events were considered serious as disabling or incapacitating. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.; Sender's Comments: Based on plausible temporality  the causal role of the BNT162B2 vaccine cannot be excluded for the reported events.  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
Information has been received from a registered nurse concerning a 5 year old white female patient who on 13Dec1999 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. The patient was seen in the clinic on 23Mar2003 with a mild case of chickenpox and strep throat. The child was noted to be fully recovered on 10Apr2003. Unspecified medical attention was sought. Follow up information indicated that on 24Mar2003 the patient complained of a "rash" and a sore throat. It was noted that she had scattered papulvesicular lesions on her face, trunk, arms, and back. Some of the lesions had crusted. She also was noted to have a positive strep throat culture. The physician "thought rash most likely chickenpox". The outcome was reported as recovered. The nurse reported that two other siblings developed an allergic reaction to amoxicillin and an ear infection, previously reported as chickenpox and general malaise and developed a mild case of chickenpox. No further information is expected.
mother called day after vaccination to report child woke in a.m. complaining of headache, stomachache, fever of 101, and achiness
Pediatric monovalent vaccine was incorrectly administered for adult patient anticipating adult bivalent dose
Sore arm at injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and INJECTION SITE PAIN (Sore arm at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE, ATORVASTATIN, LISINOPRIL, AMLODIPINE, BUPROPION, TRAZODONE, FENOFIBRATE, MONTELUKAST and FLUTICASONE for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced FATIGUE (Fatigue). On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (Sore arm at injection site). At the time of the report, FATIGUE (Fatigue) outcome was unknown and INJECTION SITE PAIN (Sore arm at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient and their husband both received their first dose of vaccine together and their husband had some symptoms as well.  Treatment medication used for the event soreness at the vaccination site included Tylenol.   This case was linked to MOD-2021-100569 (E2B Linked Report).; Sender's Comments:  MOD-2021-100569:Husband's case
1st dose of Covid Vaccine Moderna administered not realizing that Moderna was not yet approved for 12&^ No adverse reaction at this time
WEAK; TIRED; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced weak. On MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from weak, and tired. This report was non-serious.
shortness of breath; hip pain /  pain in her hips; pain in both legs / pain in her legs; she had to use a walker; swelling in both arms /  swelling in both legs; redness around injection site; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included knee operation, hip surgery and shingles.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a day after receiving Shingrix, the patient experienced swelling arm, injection site erythema, shortness of breath, pain in hip, leg pain and walking difficulty. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the swelling arm, injection site erythema, shortness of breath, pain in hip, leg pain and walking difficulty were recovered/resolved.   It was unknown if the reporter considered the swelling arm, injection site erythema, shortness of breath, pain in hip, leg pain and walking difficulty to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix vaccine in left arm and the same night after receiving the injection had swelling in both arms, redness around injection site, shortness of breath, and hip pain and all these lasted until just before the patient received the second dose of Shingrix. The pain in both legs and swelling in both legs that began the same and was still ongoing at time of reporting.  The patient applied ice to the sites of swelling.  Patient reported she had to use a walker due to the pain in her hips and legs. The patient reported she went to the ER after vaccination due to swelling in her legs.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR210794:same reporter
Pt recvd 3 doses of Engerix-B 15MAR91, 17APR91 & 6NOV91 & it was determined that pt did not respond to vax series; pt taking meds for hypertension; 4th & 5th doses of Engerix-B administered 27DEC91 & 23JAN92;
celiac disease; Her immune system is extremely compromised.; possible metabolic disorder that has yet to be fully diagnosed; This is a spontaneous report from a contactable nurse. A 22-year-old female patient (reporter's niece) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, on an unknown date, as Dose 1, single and Dose 2, single; both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced celiac disease and a possible metabolic disorder that had yet to be fully diagnosed. It was reported that, patient's immune system was extremely compromised. The outcome of the events was unknown.  Information about Lot/batch number has been requested.; Sender's Comments: Based on the limited information, a causal association between the reported event of coeliac disease and suspect drug bnt162b2 cannot be excluded. 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.
Patient was given Recombivax instead of Quadracel.  He previously had completed Hep B series, so this was an extra dose.
The patient reported L arm pain/soreness about 5 hours after the injection.  She had been injected at 2:30pm on 02/15/22.  The following day, 02/16/22, at around 1am (<12 hours after injection), the patient woke with nausea, vomiting, and abd pain which continued throughout the morning.  She was seen and treated in urgent care at the health center with IV fluids and zofran which improved her symptoms.
The patient did not have reaction he was fully vaccinated  on 2/20/21  was COVID positive on 7/14/21. The patient is reporting no fever and feeling fine. "feels like a head cold"
My arm is is swollen at the injection site, there is a red rash at the injection site, there is a very hard lump underneath the injection site, the site is warm, and I have had an on-and-off fever.
I recently got a second booster moderna  or 4th shot; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (I recently got a second booster moderna  or 4th shot) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (I recently got a second booster moderna  or 4th shot). At the time of the report, EXTRA DOSE ADMINISTERED (I recently got a second booster moderna  or 4th shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported by the reporter.
Pt's left leg from hip to knee became swollen with red "blotchy" rash. Pt received vaccine on 3/2/00, mother noticed swelling 3/3/00. Mother called nurse at MD's office. The nurse said to put ice on it and notify health department. Mother called health department on 3/6/00 and reported it. States symptoms are improved but still slightly swollen.
This spontaneous case reported by a consumer, describes the occurrence of eye pruritus (itchy eyes) and eye swelling (swollen eyes) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced eye pruritus (itchy eyes) and eye swelling (swollen eyes). At the time of the report, eye pruritus (itchy eyes) and eye swelling (swollen eyes) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
1205pm patient felt dizzy and nauseous, instructed to lie down. 1206pm patient given apple juice as requested by mom. 1210pm patient vomited. 1210 BP checked. 1211 glucose checked. 1226 symptoms resolved without intervention.
Intussusception occurred on 10/11/2014. Admitted to Hospital, air enema reduction, discharged home on 10/12/2014. Patient is now well.
Rash to anterior chest and left arm that resulted in painful lesions that became locally infected. There is subsequent left arm pain that radiates down the arm where rash is present.
18FEB92 pt seen by MD for URI; 12MAR92 to MD w/generalized weakness dx thyroid storm subacute thyroiditis;
Case number PHEH2013US005306 is an initial spontaneous report received from a medical assistant on 25 Feb 2013 with the follow-up received on 25 mar 2013. This report refers to a 15-year-old female patient. it was reported that she was vaccinated intramuscularly with 0.5 ml of MENVEO (batch number: M12013, expiry date: 28 Feb 2014) that experienced temperature excursion on 25 Feb 2013. The first temperature excursion happened on 23 Jan 2013 and the vaccine was in a temperature of 54 F for less than 4 hours. it was reported that MENVEO had a temperature excursion. She did not experience any adverse events as a result of the temperature excursion. She would be revaccinated. No further information was reported. Follow-up received on 25 Mar 2013: Updated reporter comments.
Sore are, fatigue and 100.9 degree fever for 6-8hrs after vaccination.  Red, swollen and itchy rash appeared 9 days after the injection and lasted for 72 hrs.