chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number TS425) for prophylaxis.   On 21-FEB-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-Apr-2023 The patient received unstable vaccines after a temperature excursion. The patient received unstable vaccines after a temperature excursion, which led incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Pt recvd 3 doses of Hep B vax & never tested for seroconversion; Lab eval revealed pos titer for anti-HBC; No further details were provided;
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult 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. 023H22Ab) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse 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 aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 29th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the worldwide unique case identification number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:master case
1 day after vaccines given in (L) thigh (Hep A and DTaP) child developed red, indurated area, tender, no fever. On day 2 after vaccine area measured 5x5 1/2 inch diameter and was no longer enlarging.
Adult dose of Hep A was given, should have been a pediatric dose. No symtpoms, no treatment needed.
Information has been received from a 24 year old female medical assistant who in December 2008, was vaccinated with a second dose of GARDASIL, 0.5ml.  At the time of reporting the patient was pregnant.  Follow-up information has been received from the patient concerning herself whose LMP was sometime in November 2008 and due date was sometimes in the beginning of September 2009.  This was her third pregnancy and she has 2 living children.  The patient said everything felt fine so far, except for the morning sickness.  The patient saw a new OB, who told her everything was fine.  Additional information has been requested.
This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX 1 dose in the left arm, lot # reported as MO13377 (not valid for ZOSTAVAX) (route of administration and expiration date were not reported). On unspecified date in July 2016, the patient experienced a "bullous" reaction with mild redness and soreness. The patient sought medical attention. It was unknown whether the patient was given any treatment for the events or if any lab diagnostics studies were performed. The outcome of the events was not reported. The relatedness between the events and ZOSTAVAX was not provided. Upon internal review the event of bullous reaction was considered to be medically significant. Additional information has been requested.
Presented to ED with LE swelling and increase abd girthInitially diagnosed with pneumonia started on broad-spectrum antibiotics/also noted to be in AKI with a creatinine of 2.1/ hyperuricemia, diagnosed with recurrent T-cell non-Hodgkin's lymphoma; subsequently developed COVID-19)Tx: Decadron, Vit C, lovenox, zinc; also receiving chemotherapy for lymphoma; covid symptoms remained minimal; required 2-5 LPM NC O2 during stay but back to room air by d/c;
On Friday morning, started with swollen, red, sore arm around injection site. Saturday, redness and inflammation continued to grow to about 3 inch diameter and body aches, fever started. By Saturday evening, fever of 100.3, headache, body aches continued. By Sunday, body aches were gone. Redness, swelling and sore arm has continued through Tuesday.
Red, swelling at site, sore up arm into shoulder area this occurred in arm with influenza; pneumonia vaccine was given. Azithromycin prescribed.
Swollen arm, arm feverish, headaches, very tired - symptoms lasted 4-5 days.
pt. developed erythema at site of vaccination, are measured 2" across was nontender
pt recvd vax;got SOB,felt like could not move,throat closing up;took vaporizer & inhaler;proventil;
Headache started about 6 hours after vaccine, followed by body aches, fever and chills. Lasted about 24 hours then residual headache and body aches that gradually resolved over next 24 hours.
Pt recvd vax on 16AUG90.1 minute later pt recvd a tine test on right forearm.Immediately after both inject pt fainted & sustained minor abrasion on face.
two patients presenting adverse effects 10-14 days post 1st dose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (two patients presenting adverse effects 10-14 days post 1st dose) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (two patients presenting adverse effects 10-14 days post 1st dose). At the time of the report, VACCINATION COMPLICATION (two patients presenting adverse effects 10-14 days post 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
This report describes headache in a male vaccinee of unspecified age who received Lyme disease vaccine OspA recombinant (Lymerix). This report was received from the vaccinee and had not been verified by a physician or other health care professional. Medical history, concurrent conditions, and concurrent medications were unknown. On an unspecified date, the vaccinee received his first injection of Lymerix. Reportedly, 36 hours later, the vaccinee experienced "severe headache and vomiting". The vaccinee reported that the he went to the emergency room, where he was kept for his symptoms which lasted 12 hours. The vaccinee stated that he received a second injection of Lymerix. Reportedly, the symptoms did not recur, because he took unspecified "pain killers" 24 hours before and after the second Lymerix injection as prescribed by his doctor. As of 04/26/02, the events had resolved. The adverse events "headache" does not meet serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/00 letter. As of 4/26/02, the events had resolved.
24 hours after the vaccination, was a "zombie" did not drink or eat or take morning medications. Did not know if she had taken any meds (she had not). After getting her to drink fluids, eat some food, and take morning blood pressure medications, about 6 hours later, she started to act more normal.
Arms, legs and hips went almost totally numb. Lost large amount of cognitive AND physical ability.
Admitted with Covid-19 infection with PNA and acute hypoxic respiratory failure. Patient required BiPAP and high-flow nasal cannula but was eventually able to be transitioned to 3L O2 at rest and 4L with activity. Patient received Remdesivir, steroids. Discharged home with home o2.
4/28/09 fever 102 degrees - 103 degrees axillary, cranky saw Dr (PMD)  5/01/09 Rash face, neck, chest, underarms, abdomen & back - progressed thru day red & blotchy.  On 5/2/09 face swollen.  Called PMD advised BENADRYL.  Rash remains on back & abdomen but has improved.
Booster; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. After 3 vaccines the patient got a COVID-19. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19".  The lot number for bnt162b2 was not provided and will be requested during follow up.
After giving the shot immediately the arm started to swell and get red. Then the rash started to travel down the arm within minutes. Her heart rate was raised per patient but when took hr and bp-- 138/81 and 90 beats per minute so although not low wasn't vastly out of normal range
Broke out with hives all over my body approximately 30 hours after administration. Took 6 BENADRYL 25 mg Liqui-Gels over the next 24 hours.
9/23/23: 10:45AM vaccination received. Onset of symptoms 4:30PM: severe fatigue, fever and chills, mild to moderate muscle and joint pain, mild headache, and mild soreness at injection site.  9/24/22: Nausea, malodorous diarrhea, post nasal drip and sinus congestion, profound fatigue, moderate to severe diffuse joint and muscle pain; moderate soreness, redness, swelling, and itching at injection site; restlessness, tachycardia and palpitations, sharp chest pains, fever and chills, moderate headache.    9/25/23: Moderate fatigue. Mild diffuse joint and muscle pain. Mild soreness, redness, and itching at injection site.  Nausea, restlessness, fever and chills, diarrhea, postnasal drip, sinus congestion, and headache resolved.  9/26/23: All above symptoms resolved.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "skin issue" (unspecified if ongoing), notes: skin issue. Concomitant medication(s) included: PREDNISONE taken for skin disorder, start date: 27Jun2022. The following information was reported: COVID-19 (medically significant) with onset 10Jul2022, outcome "unknown", described as "tested positive for COVID"; DRUG INEFFECTIVE (medically significant) with onset 10Jul2022, outcome "unknown", described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive. Clinical course: Patient reported that tested positive for COVID on the evening of Sunday (10Jul2022). Patient received three Pfizer-BNT vaccine shots to date. Symptoms were fatigue, sore throat, cough, sneezing/congestion. Patient was prescribed 5 days of prednisone the week of 27Jun2022 to treat a skin issue. Patient take no other medications.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache "Pressure in my face" Narrative: NO MEDICAL ATTENTION WAS SOUGHT 2/2/ REPORTED "Bad headache pressure in my face."
about 10  days after receiving the vaccine started with new onset A. Fib and shortness of breath especially on exertion. I am in work up for same Holter monitor, ECHO, ETT and f/u with cardiology
SINUS DISORDER; NASAL SINUS DISCHARGE; FEELING UNWELL; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included there was no reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced sinus disorder. On MAR-2021, the subject experienced nasal sinus discharge. On MAR-2021, the subject experienced feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling unwell, sinus disorder and nasal sinus discharge was not reported. This report was non-serious.
10 minutes after receiving vaccine, developed itchy throat, headache, and shortness of breath. Took albuterol around 20 minutes after receiving vaccine with almost complete resolution of symptoms.
Indicated that within a hour after receiving vaccines 11/2/2015 she developed raised red lesions on arm. Fever to 103. She did not present to medical facility until 11/4/15. Verbalized history of large localized reaction with other vaccines.
Delayed cutaneous hypersensitivity: itchiness, firmness, redness at injection site beginning 7 days after administration.
Information has been received from a pharmacy student concerning a 20 year old white female who in May 2007, was vaccinated with a first dose of Gardasil (lot # unknown). There was no concomitant medication. The patient developed a widespread rash and itching 24 hours after administration of her first dose of Gardasil. Medical attention was sought. The patient was evaluated at a local emergency room and was treated with a steroid injection as well as a course of oral steroids. At the time of reporting on an unknown date the patient recovered from the widespread rash and itching. No further information was available. Follow-up information was received. The patient  had no illness at the time of the vaccination and a drug allergy to penicillin. The patient was vaccinated on 12-JUN-2007 (previously reported as May 2007) with a first dose of GARDISIL at 10:45AM. On 13-Jun-2007, the patient had hives around stomach, legs, arms and face at 2:00PM. The physician gave a BENADRYL shot. On 21-JUN-2007 the patient recovered. Additional information is not expected.
36 hours after injections uncontrollably chills for 2 hours, temp of 102.8. Continued temp of 102 for 2 days, no appetite severe fatigue ending up with severe dehydration resulting in urgent and ER visits. Received 2 liters of I V fluids. Continue also now with low grade temp in evening, nausea and diarrhea
Fever and papular rash over trunk, back and front. Few on face. Fever of 103.4.
Fever immediately after vaccine. Went away then returned on 4/26 for 6 full days. During time of fever developed multiple painful sores on lips and mouth. Still have sores as of today 5/3/21
Injection site reaction - local inflammation and swelling the size of a half-dollar coin per patient. Red, swollen and Itchy. Late onset (started a few days after dose administration). Patient calling MD and using cortisone cream & Benadryl to mitigate current reaction. No sign of anaphylaxis per patient report.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Shingrix for prophylaxis. On 14th June 2018, the patient received the 1st dose of Shingrix. On 14th June 2018, less than a day after receiving Shingrix, the patient experienced pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and injected limb mobility decreased to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on the left arm. The patient stated that, he had left arm pain which lingered with limited mobility in arm, since the day of vaccine administration, for 3 months at the time of reporting. The patient would like information on this adverse event.
Elevated temperature = 103.0 (reported) w/ sore arm/ then employee reported she had the chills for 2-3 days
3x days pain at injection site  3x days headaches 3x days loss of appetite 2x days fever 2x days debilitating neck pain  fully recovered 4 days after injection
Cyanosis of lips and fingernail beds and toenail beds the day following vaccine booster.
Massive hemorrhaging during subsequent menstruation for 7 days. Couldn't leave house. Changed Ultra tampon every 45-60 mins. Next menstruation after that (3 weeks later), massive hemorrhaging also.
I woke up with a swollen and itchy upper and lower lip. Also, the area under the tongue is swollen and sore. I have not used a different product or eaten any different foods. I am taken Benadryl and it seems to be helping.
101F fever; Hands shaking; Headache; Stomach pains; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (101F fever), TREMOR (Hands shaking), HEADACHE (Headache), ABDOMINAL PAIN UPPER (Stomach pains) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (101F fever), TREMOR (Hands shaking) and HEADACHE (Headache). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pains) and FATIGUE (fatigue). On 03-Mar-2021, PYREXIA (101F fever), TREMOR (Hands shaking) and HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This spontaneous report as received from a nurse refers to a 33 year old patient of unknown age and gender. Concurrent conditions included tobacco user and diabetes mellitus. No medical history, allergy/drug reactions and concomitant medications were reported. On 07-JUN-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L035882 expiry date: 19-APR-2017 (dosing details and route of administration were not reported). No adverse effects were reported. It was reported that the vaccine was exposed to the temperature 55F for 30 minutes. The previous temperature excursion was 32.9F for 17 hours. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
exposure to freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 48-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 24BM2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th September 2021, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The reporter called due to their discovery that patient was inadvertently administered on 16th September 2021 the vaccines that were in the temperature excursion, which led to incorrect storage of drug. The MI agent informed pharmacist the vaccines should be discarded due to exposure to freezing temperatures 31.5 Fahrenheit for 13 hours. The reporter did not consent to follow up. This is 1 of 7 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021198147:same reporter US-GLAXOSMITHKLINE-US2021198142:same reporter US-GLAXOSMITHKLINE-US2021198144:same reporter US-GLAXOSMITHKLINE-US2021198148:same reporter US-GLAXOSMITHKLINE-US2021198149:same reporter US-GLAXOSMITHKLINE-US2021198148:same reporter