chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Metrorrhagia 24 hours post vaccine.; Period was not due for at least one more week.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 14May2021 at 08:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease,  COVID-19 and allergy to gluten. The patient did not take any concomitant medication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 23Apr2021 at 08:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 08:15, 24 hours post vaccine the patient experienced metrorrhagia and Period was not due for at least one more week. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event metrorrhagia and irregular periods was recovering.   No follow-up attempts are needed. No further information is expected.
Approximately 15 minutes post injection, PT began complaining of severe itching on back and shoulders, but not about the injection site.  PT promptly began to itch himself aggressively. No visible rashes or hives appeared anywhere; no involvement of the face, lips, or throat. Staff at the care facility in which the PT resides attested to this being a typical behavior of this patient when he is experiencing stress or anxiety. Nevertheless, the patient was monitored until his agitation subsided. Epinephrine was not administered.
breakout; This case was reported by a consumer via call center representative and described the occurrence of skin breakout in a an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced skin breakout. On an unknown date, the outcome of the skin breakout was unknown.   It was unknown if the reporter considered the skin breakout to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not provided, but selected as an adult as per vaccine indication. The reporter reported that, the nurse at his doctor's office told him that, she had seen cases of the patients breaking out after getting Shingrix vaccine.
covid vaccine breakthrough case  dose 1 Moderna 2/17/21 007M20A dose 2 Moderna 3/17/21 006B21A dose 3 Moderna 10/29/21 939904
Day 1 after shot: body aches, headache, blurry vision. Day 2 and beyond: excruciating abdominal pains, no appetite, inability to have a bowel movement or even pass gas. Had I known this level of agony would happen, I would have refused the vaccine, and I will NOT take the J&J again.
Burning sensation in mouth; Several canker sores; Red spots in mouth; inflammation on throat; Sore throat; Lymph glands swollen; sore on the neck; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) in the right arm on 20Mar2021 at 17:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included controlled high blood pressure. The patient had a history of allergy to penicillin and sulfa. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and olmesartan (MANUFACTURER UNKNOWN) for high blood pressure. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 19:00, 5 days after the vaccination, the patient experienced burning sensation in mouth, several canker sores appeared on day 6, 7 and 8 (date of this report), red spots in mouth and appearance of inflammation on throat, sore throat, lymph glands swollen and sore on the neck. The patient did not receive any treatment for the reported events. Adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events burning sensation in mouth, canker sores, red spots in mouth, inflammation on throat, sore throat, swollen lymph glands and sore on the neck was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Client called client reporting rash on arm where vaccine was given. States rash first appeared today and has been having soreness and redness since vaccination date on 06/18/13. Denies fever, complains of itching at rash site.
No signs or symptoms, vaccine was administered 4 months too soon after first dose. Patient will get next dose in May when he is due and that dose will complete the Hep A series.
Suffering pain on left upper arm which received flu shots.  Having difficulty to raise or use left arm.
Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.       No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be related.    No concomitant and treatment medications were reported.  Company comment: This literature non study case concerns an adult patient of unknown gender, with no reported medical history, who experienced the expected, serious (medically significant) AESI of Myocarditis, unknown days after receiving an unspecified dose of mRNA-1273 vaccine. No information on risk factors, detailed clinical course, investigations, treatment of the event, outcome and details pertaining to vaccination schedule was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-657553; Sender's Comments: This literature non study case concerns an adult patient of unknown gender, with no reported medical history, who experienced the expected, serious (medically significant) AESI of Myocarditis, unknown days after receiving an unspecified dose of mRNA-1273 vaccine. No information on risk factors, detailed clinical course, investigations, treatment of the event, outcome and details pertaining to vaccination schedule was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-657553:Same Article Patient 1
High fever, joint aches, chills (next day), left arm edema, redness, hot to touch and edema great enough to hide elbow. One week later pt still feels tired.
This spontaneous report has been received from a medical assistant and refers to a 4-year-old male patient. The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 10-DEC-2022, a PROQUAD suffered a temperature excursion and was administered intramuscularly to the patient for prophylaxis on 14-DEC-2022 (product storage error) (lot number W019628 has been determined to be valid for PROQUAD, expiration date reported and established as 14-JUN-2024) (strength was not provided). Sender's Comments: US-009507513-2304USA007979: US-009507513-2303USA002114.
Patient woke up with a fever of 101.  Vomited around 9:00 am.  Was stumbling as if drunk all day until bedtime.  Fever persisted and ranged from 100-102 until around 6pm.  His twin brother received same vaccines and did not have any issues.  Flu Vaccine (Mist) and Prevnar (4th dose).
After 1st dose, she had body aches.; She also had headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (After 1st dose, she had body aches.) and HEADACHE (She also had headaches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL (COREG) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Apr-2021, the patient experienced MYALGIA (After 1st dose, she had body aches.) and HEADACHE (She also had headaches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (After 1st dose, she had body aches.) and HEADACHE (She also had headaches) 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.   This case was linked to MOD-2021-329004 (Patient Link).; Sender's Comments: This case concerns a 59-year-old, female patient with no relevant medical history, who experienced the expected non-serious events of headache and myalgia. The events occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the outcome of the events of myalgia and headache is unknown (no specific information if they were resolved after the second dose according to source document narrative). The events are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from chills on 17-MAR-2021. This report was non-serious.
Sore arm. First dose soreness lasted about 4 days. This is the second day, so far with second dose.
Vomiting, diarrhea over the course of a few hours, then significant blood loss in bowel movements over the next week.
On May 17, 1999 the pt experienced a rash, fever x 7 days and more than 100 lesions with scarring. The pt sought unspecified medical treatment. Additionally it was noted that 7 other pt's experienced similar reactions.
Patient to emergency room on 9/4/21 with complaint of shortness of breath x1 week w/ occasional cough. Positive test confirmed 9/5 @ 0215
Pt given vaccination on 8/27/07 in (LA) Sq. Now with 7cm x 6 cm area of erythema with mild induration
After receiving the second dose of  0.3ml of the Pfizer vaccine, the patient remain seated  and began to feel nauseous. After 5 mins, the patient passed out while seated and hit her head on the side of the barrier. At the time the patient exibited signs of a seizures and was placed on on her side. After she became coherent, she was sat up and grabbed the pharmacist arm. She was asked questions (Does she know where she is, Does she remember the pharmacist, Does she remeber her name). The patient was assited back into the chair. Upon arrival of the EMS she was examined and discharged to go home.
Dizziness when changing positions - especially when getting up from lying down.  Has lasted until today (Oct 12).  I plan to call my primary doctor today.
mom called clinic 7NOV96 in AM pt recv vax on 29OCT96 & now has closed, raised scattered red bumps w/one open blister;appetite good;playing;cranky @ noc;c/o itching;spoke w/MD prescribed DPH;advised to contact office if inc temp, list
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 08-Jan-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 78th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Real puffy; Tuesday night shoulder was terrible; Just a little sore on tuesday; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Just a little sore on tuesday), SKIN SWELLING (Real puffy) and ARTHRALGIA (Tuesday night shoulder was terrible) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Just a little sore on tuesday) and ARTHRALGIA (Tuesday night shoulder was terrible). On 04-Feb-2021, the patient experienced SKIN SWELLING (Real puffy). At the time of the report, VACCINATION SITE PAIN (Just a little sore on tuesday), SKIN SWELLING (Real puffy) and ARTHRALGIA (Tuesday night shoulder was terrible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported.  Treatment medication was not provided.
got the vaccine, 2 years later got shingles/Suspected Vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-Jun-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient got the vaccine, 2 years later patient got the shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
started as a 10cm by 5cm red raised itchy rash with visible hives and "deep itching" has now spread to patients back in  the matter of 40 minutes from administration. No respiratory symptoms
On the morning of March 6th I noticed that a rash started on left side of abdomen under my arm and spread to back as well as around to chest under and on bottom of left breast.  Itchy and sore.  Tender to the touch.  Appearance of small blisters and very red in color.  Also having tenderness in my left armpit.  I do have photos from the first day as well as today.
Pt woke up with pain, swelling @ injection site. Area firm, hot to touch. Seen by Provider @ clinic & was given Keflex for treatment
The patient experienced pronounced bleeding and then a small lump formed after the bleeding stopped at the injection site.
Both Ears started feeling full and ringing or buzzing around 30-40 minutes after second injection. 8 days later I still have the fullness and buzzing/ringing in right ear.
Pt did not have any adverse events, but pt got a 3rd Shingrix shot.  Pt already completed series of 2 shots in 2019 (1st: 5/21/19 and 2nd: 8/05/19).
A few weeks after receiving booster vaccine, patient began to develop chest pain. Went to primary care provider office, Dr for treatment and was advised to report to ER. Daughter took her to ER. There she was evaluated and found to have elevated troponin levels. Patient was then prepped and taken to Cath Department for a left heart catheterization where she was found to be free of disease .
This case was reported by a physician via call center representative and described the occurrence of needle stick/puncture in a healthcare professional who administered RABAVERT for prophylaxis. On 25th July 2018, the patient received RABAVERT. On 25th July 2018, immediately after receiving RABAVERT, the patient experienced needle stick/puncture. On an unknown date, the outcome of the needle stick/puncture was unknown. Additional information was received as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that while administering the vaccine the healthcare professional stuck themselves with the needle. The healthcare professional did not receive any of the vaccine and was not exposed to the vaccine, but was stuck with the needle. This case has been linked to the case US2018140145, reported by the same reporter.
patient received a dose that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 27-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E40, expiry date 1st October 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th November 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 5th November 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 information was provided as follows: The patient received an expired dose of Boostrix which led to expired vaccine used. The reporter consented to follow up.
Severe pain and numbness in Left arm , forearm and hand. It lasted for one day.
Pentacel was given even though patient was over 5 years of age.  No adverse reaction occurred.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 09-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
RECEIVED DTAP IN LEFT DELTOID ON 3/20/06.  ON 3/22/06 DEVELOPED SEVERE LOCAL REACTION-4"X4.5" AREA OF REDNESS AND EDEMA AT SITE. TREATED WITH LOCOID LIPOCREAM.
On 11/27/01, the pt received her 1st injection of Engerix-B. At 07:00, on 11/28/01, the pt presented to the clinic stating that she did not feel well and her left arm was painful. She stated that she felt "extremely weak in the evening on 11/29/01. She stated that she woke up at 03:00 on 11/28/01, feeling cold and clammy. She went to work on 11/28/01, still feeling weak. She was diaphoretic and complained of feeling cold and clammy. She was "barely able to move", and felt like she was "going to fall". She was transported to the ER for evaluation. The ER physician made a dx of "viral illness versus reaction/adverse effect and instructed her to stay out of work for 2 days. Her physician instructed her not to receive any more doses of the vaccine. The reporter considered the events to be moderate in intensity and possibly related to Engerix-B administration. The reporter considered the events disabling/incapacitating. The events resolved on 11/30/01.
Itching in back (trunk) and arms, down to legs. Patient took Benadryl and recovered. EMS cleared patient.