chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired dose administered to pregnant patient; Expired dose administered to pregnant patient; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 38-year-old female patient who received Flu Seasonal QIV  (FluLaval Tetra 2020-2021 season) (batch number DD352, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2022, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was 17th March 2023. The patient received FluLaval Tetra 2020-2021 season at an unknown time during the pregnancy. On 20th October 2022, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy and expired vaccine used were unknown. The pregnancy was ongoing.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The office manager called to inquired that any adverse effects to look for or if the patient needs to be revaccinated. The reporter confirmed that the Flulaval was administered in their facility. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Flulaval in right deltoid during her pregnancy, which led to vaccine exposure during pregnancy and expired vaccine used. Suspect was coded as Flulaval tetra 2020-2021 season as both Flualval tetra and Flulaval quadrivalent both are same in terms of active ingredient and also considering the expiration date.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown ages and genders (reported as "two or three"). The patients' concurrent conditions and medical histories were not reported. On unspecified dates in January 2018 (reported as "since 26-JAN-2018"), the patients were vaccinated with improperly stored doses of PNEUMOVAX23 lot # N024385, expiration date 18-MAY-2019 (doses, routes and frequencies were not reported) for prophylaxis. It was reported that the improperly stored PNEUMOVAX23 were stored at a temperature below 32 Fahrenheit degrees (F) (average temperature of 29 F) during 9 hours. There were no previous temperature excursions. The report was due to a digital data logger. No adverse effects reported. No product quality complaint (PQC) was involved.
Information has been received from a pharmacist concerning a patient who was vaccinated with Gardasil. Subsequently the patient experienced an unspecified adverse experience. No further information was provided. Additional information has been requested.
This spontaneous report was received from a health care professional refers to unspecified number patients of unknown demographics. On an unknown date the patients were vaccinated with GARDASIL 9 (lot # K026246; expiry date: 28-JAN-2017) (dose, route and frequency unspecified). Concomitant therapy was not reported. On an unknown date the patients were administered improperly stored vaccine. No adverse effects reported. The outcome of incorrect product storage was unknown. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
The vaccine did not prevent shingles as intended; subsequently contracted a persistent strain of herpes zoster or shingles; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In or around 13-OCT-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended (Vaccination failure), and the pt subsequently contracted a persistent strain of herpes zoster or shingles. On or about 16-OCT-2015, the pt was treated by the physician who vaccinated her, for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving the vaccine for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was mot reported. The events were reported to be related to zoster vaccine live (ZOSTAVAX).
Patient experienced lower lip swelling and tingling.  Patient given 12.5 mg of Benadryl and monitored for 30 minutes.  Symptoms resolved.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand: Pfizer/BioNTech, Vaccine dose number: 5, 4 / Vaccine brand other: Moderna, Vaccine dose number: 3, 2, 1; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 13:00 as dose 5 (booster), single (Lot number: Gh9703) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17May2022 at 14:00 as dose 4 (booster), single (Lot number: Fn2908), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Jan2021 at 12:00 as dose 1, single (Lot number: 042l20a), in left arm, on 27Feb2021 at 12:00 as dose 2, single (Lot number: 002a21a), in right arm and on 02Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 011f21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Smoker" (unspecified if ongoing). Concomitant medication(s) included: NAC [ACETYLCYSTEINE], start date: 13Jan2020, stop date: 09Mar2023; QUERCETIN, start date: 13Jan2020, stop date: 09Mar2023; VITAMIN C [ASCORBIC ACID], start date: 13Jan2020, stop date: 09Mar2023; ZINC, start date: 13Jan2020, stop date: 09Mar2023. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Percocet, reaction(s): "Known allergies: Percocet"; Demerol, reaction(s): "Known allergies: Demerol". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17May2022, outcome "unknown", described as "Vaccine brand: Pfizer/BioNTech, Vaccine dose number: 5, 4 / Vaccine brand other: Moderna, Vaccine dose number: 3, 2, 1"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid rebound 7 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient received Paxlovid from 27Feb2023 to 28Feb2023 for treatment of COVID-19.
expired dose administered; no adverse effect; This spontaneous report was received from a licensed practical nurse (LRN) referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions/ allergies were not reported.  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) with lot # R030115 and expiry date 29-DEC-2019 for prophylaxis (strength, dose, route and anatomical location not reported). On an unknown date, the patient received an expired dose of hepatitis a vaccine, inactivated (VAQTA) (expired product administered). The patient had no adverse events. No product quality complaint involved in this report.
A couple of days after receiving my dose, he started having lower abdominal pain. It was getting worse, and he started having severe nausea and pain. It was so bad that he was screaming. He went to the ER where they performed a CT scan. He was rushed into surgery because there was a rupture of diverticula. He had to get a colostomy it went necrotic so they had to perform a ileostomy. He had three surgeries within thirteen days. He had to get an NT tube to clear out his stomach. He was on a wound vac. He had part of his colon removed. We were not able to keep a bag on because he experienced a lot of leakage.
local reaction @ inject site; pain, swelling, inc warmth, induration, lump (w/o abcess); no fever;
The morning after the first inoculation I woke up at 7:30 am with severe chest pain . It would hurt to inhale and exhale and I was short of breath, possibly due to the not being able to inhale without pain. Breathing was shallow as to not cause pain. I administered hydrocodone 15 mg PO q6h for pain. I told my pulmonologist who stated it sounded like pleuritis. He stated I should go to the hospital if the pain comes back . I admit I did not follow this order as I felt the pain med resolved it and did not want to go to an ER if it wasn?t critical. The chest pain lasted 96 hours and then resolved . The pain was severe enough to wake me from my sleep multiple times. That was the only AE associated with the first shot . The second shot had many more side effects , Severe nausea , emesis , diarrhea , migraine headache , high fever , shaking , and sinus discharge. The chest pain also came back and I did the same regiment of pain meds to treat the severe pain. These side effects lasted 7 days and then resolved .
mild headache; fatigue; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199) via an unspecified route of administration, administered in left arm on 03Mar2021 at 11:50 (at the age of 67years) as 2nd single dose for COVID-19 immunisation. Medical history included systemic lupus erythematosus from 1974 ongoing, asthma from 2016 ongoing, heart disease from 2002 ongoing, rheumatoid arthritis from 1975 ongoing and joint surgery from 1975 ongoing. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number:Unknown) via an unspecified route of administration on 10-FEB-2021 as single dose for COVID-19 immunisation. On 03Mar2021 the patient experienced mild headache and fatigue recovered 8 hours after injection. Reporter seriousness reported as not serious. Patient received no treatment for the events. The patient underwent lab tests and procedures which included regular blood drawn for SLE and normal- abnormal results depending on flare ups. The outcome of the events was recovered on 03Mar2021.  No follow-up attempts are possible; information about lot/batch number available.
Chills, low grade fever, body aches, fatigue, brain fog, skin sensitivity  Use of Acetaminophen and Ibuprofen
Redness and pruritus of bilat upper extremities, followed by throat tightness with mildly enlarged tonsils Approximately 10 minutes after vax administration. . Benadryl 50mg IM administered  . S/S resolved 30minutes post benadryl. Monitored for additional 30 minutes post benadryl administration. Monitored for 1 hour total.
Allergic reaction; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program . A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Apr2021 as dose 1, single for COVID-19 immunization. The patient's medical history included allergy to shellfish and shrimps. The patient's concomitant medications were not reported. On an unspecified date on 2021 following vaccination, the patient had experienced a slight allergic reaction. The patient's doctor wanted to enquire whether she could receive second dose vaccination which was due on 11May2021. The outcome of the event was unknown at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt presents to ED with SOB; tested positive for COVID; admitted with AHRF secondary to COVID pneumonia; worsening hypoxia and increasing need for O2 pt was transferred to ICU and intubated; he developed a pneumothorax requiring a chest tube; his condition continued to decline and he was made comfort care; he passed away in the hospital
Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and UNDERDOSE (patient received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant medication details not reported by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter. This case contains information about patient 3rd out of 18 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 04-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot #, expiration date and route not reported). Additional information has been requested.
Headache, fatigue, body aches, chills about 24 hours after injection. Took acetaminophen. Side effects only lasted for about 12 hours.
Child received influenza vaccine at approx. 10AM on 10/17/07 and after 1 day she had redness and induration approx 3" diameter that lasted for 48 hours. No treatment was provided. At time of vaccination, the parent reported no medication intake, no allergies, and no vaccines in the prior 4 weeks.
Initial and follow up information has been received from a health professional concerning a 11 year old adopted white male with an allergy to penicillin, and no prior medical history, who on 14-JUL-1997 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck) ("Lot # 0081E"). At the time of vaccination the patient was afebrile, but had otitis media, and a candida rash. On 01-AUG-2007, at 16:00, the patient developed a moderate red papular rash with pustules, on the back, chest, all extremities, and ears, which developed in crops. The patient had been in the mountains, and reportedly the park ranger thought it was poison oak. The first day of onset the patient was afebrile, and very itchy. The impression of the treating physician was atypical chickenpox. The patient was treated with hydroxyzine hydrochloride (ATARAX) 25 mg 1-2 tabs bid prn, diphenhydramine hydrochloride (BENADRYL) prn, and "Abx" soap. At the time of reporting the patient's status was unknown. Additional information has been requested.
After I get the second dose of vaccine, I assume my body began it's immune response immediately.  I felt fine.  But 5 days later my whole body was sore as a result of inflammed kidneys.   A week later my kidney function was at 18%.  While I have a history of IgA nephropathy, I have no other medical conditions and had not had any kidney episodes in over 2 years (I don't get sick.)  But the immune response from the covid vaccine resulted in significantly dimished kidney function - considerably worse than any previous episode.  The theory is that the vaccine triggered an immune response causing IgA to build up in my kidneys at a much higher rate than any previous time.
Pt received Hep-A and Prevnar and within minutes, post vax, pt vomited and fainted.
First symptom felt like something was caught in throat, then nausea and profuse sweating, exhaustion, headache, slight fever, lasted from 10:00 p.m. 10/28 to 10/30, a.m.
Patient had bruising of left upper arm where injection occurred. Bruise lasted for 2 weeks. Went away for a couple days and returned again.
ACTHIB being reconstituted with sterile water with no adverse event; Initial information received on 07-Dec-2021 regarding an unsolicited valid  non-serious case from nurse via regulatory agency (under reference number 00888121).  This case involves a 7 months old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] that was being reconstituted with sterile water (product preparation issue) .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) via unknown route in unknown administration site for prophylactic vaccination on an unknown date.  On 03-Dec-2021, the patient received a third 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ587AA and expiry date: 17-Sep-2022) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (same day latency).  It was reported " (Registered Nurse) RN calling in regards to ACTHIB being reconstituted with sterile water. Caller would like advise to know how to proceed after product was administered to a patient."  At 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 holder's compliance with the requirements set out in the guidelines. 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.
Experienced 2 strokes after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Experienced 2 strokes after vaccination) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Experienced 2 strokes after vaccination) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 14 days due to CEREBROVASCULAR ACCIDENT. The patient was treated with Surgery (Brain surgery) for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Experienced 2 strokes after vaccination) outcome was unknown.            No concomitant medication was given. No treatment medication was given.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow up received and contains no new information.; Sender's Comments: This case concerns a 57-year-old, male patient with no relevant medical history, who experienced the unexpected event of Cerebrovascular Accident. The event occurred at unspecified interval after the second dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Swelling and redness from deltoid to elbow of right arm.  DTaP/HIB given subcutaneously in error.
pt recv vax 23SEP97 & pt was uncertain as to when sx began but reported axillary soreness, swelling & tenderness on 29SPE97;
Severe (L) arm/shoulder pain 6 days after vaccine. Decreased ROM. No relief with warm compresses, anti-inflammatories. Treated w/T#3, percocet, steroid injection at clinic. Then given DILANDID and TORADOL at ER. Now 90% improved 1 month after.