chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received second dose of Moderna vaccine on 3/6/21. On 5/17/21 I experienced an unknown rash and lip swelling. I was given a steroid injection and steroid creme. The doctor said there was a slight chance this reaction resulted from my COVID vaccination.
Meningococcal ACWY was ordered initially, but MCV4 was given instead.  Mistake by Medical Assistant.
(1) Pain at injection site (3 days) (2) Fatigue  (at 12-48 hours after vaccination)  (3) Nausea  (at 12-36 hours after vaccination) (4) Elevated temperature  (at 24-36 hours after vaccination) (5) Dyspnea (self-limited) (at around 30 hours after vaccination)
3 large red welts little raised; tender to touch and not itchy; mild fever of 100.5 F; chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (mild fever of 100.5 F), CHILLS (chills), HEADACHE (bad headache), URTICARIA (3 large red welts little raised) and VACCINATION SITE PAIN (tender to touch and not itchy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PYREXIA (mild fever of 100.5 F), CHILLS (chills) and HEADACHE (bad headache). On an unknown date, the patient experienced URTICARIA (3 large red welts little raised) and VACCINATION SITE PAIN (tender to touch and not itchy). On 12-Apr-2021, PYREXIA (mild fever of 100.5 F), CHILLS (chills) and HEADACHE (bad headache) had resolved. At the time of the report, URTICARIA (3 large red welts little raised) and VACCINATION SITE PAIN (tender to touch and not itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment include: Tylenol were reported   This case was linked to US-MODERNATX, INC.-MOD-2021-077279 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077279:
suspected vaccination failure; Got it right now; Sores; This case was reported and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and skin ulcer. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and skin ulcer were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and skin ulcer to be related to Shingles vaccine.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated that he/she had shinges at the time of reporting even after having the vaccines. The patient stated that there was no muscle pain, just the sores and that they were clearing up. This case was considered as suspected vaccination failure as laboratory test confirmation and time to onset for the event was unknown at the time of reporting.
1st booster dose administered before 5 months from 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster dose administered before 5 months from 2nd dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 037F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster dose administered before 5 months from 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster dose administered before 5 months from 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Received 100mcg Moderna COVID-19 3rd dose rather than approved 50mcg dose.
Pt recvd 2 doses of Recomb & lab eval revealed a pos anti-HBc titer & a weakly pos HBsAg titer;
This patient is reported to have multiple sclerosis, diplopia, bilateral internuclear ophthalmoplegia, right-sided paraesthesias, expressive aphasia, cognitive deficit, sensory deficit, spastic paraparesis, fatigue, and myalgia. Subject BIT010001, a 33 year old male, with no previous medical conditions, received the 6th dose of Anthrax vaccine (lot # FAV047) on 05/09/00. The patient was taking no concomitant medications at the time of the event. The patient had no previous reactions to the Anthrax vaccines. Approximately two weeks after the 6th Anthrax vaccine, the patient experienced flu-like symptoms with fatigue, and myalgia without fever, which completely resolved within 24 hours. In July 2000, the patient reported a 3 week history of intermittent diplopia. In early October 2000, he experienced right-sided paraesthesias. In early December 2000, he began having difficulty with finding his words. From 12/21/00 to 02/05/01, he had persistent sensory deficits with deteriorating motor function. As of March 2001, deficits have slightly improved, though the patient remains completely bedridden. The patient was treated with multiple courses of high doses of steroids, intravenous immunoglobulin, interferon beta 1-6, and mitoxantrone. The patient was hospitalized at WRAMC on 12/21/00 and remains hospitalized.  Follow up received on 6/20/01 states the pt has died from multiple organ failure. He had been receiving high doses of immune-modulating drugs which suppressed his immune system. An autopsy will be performed and the results will be provided in a follow-up report when the information is available.
Tested COVID-19 positive, resulted in hospital admission and ARDS. Symptoms included fever, shortness of breath, diarrhea, and confusion or mental status.
Day one 3/12:  starting at about 4 pm: 102 fever, chills, muscle aches, headache.  Was able to keep fever down with Tylenol and Advil.   Day two 3/13:  low grade fever, chills, weakness, muscle aches, body pain
Stiffness in left shoulder with pain that gradually increased until it has progressed to chronic pain, weakness with very limited range of motion.
Eight days after I received my first Moderna shot my arm started itching at the shot ssite; Get red where you got the shot eight days later; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Eight days after I received my first Moderna shot my arm started itching at the shot ssite) and VACCINATION SITE ERYTHEMA (Get red where you got the shot eight days later) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Eight days after I received my first Moderna shot my arm started itching at the shot ssite) and VACCINATION SITE ERYTHEMA (Get red where you got the shot eight days later). At the time of the report, VACCINATION SITE PRURITUS (Eight days after I received my first Moderna shot my arm started itching at the shot ssite) and VACCINATION SITE ERYTHEMA (Get red where you got the shot eight days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.    No treatment medications were reported.
Frequent urination days after receiving first dose vaccine; urgent urination days after receiving first dose vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in left arm on 06Feb2021 at 10:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient was allergic to the drug benzole peroxide. Concomitant medications were not reported. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient underwent lab tests and procedures which included nasal swab test in Mar2021 and tested negative. The patient had also received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in left arm in Mar2021 as a single dose for COVID-19 immunisation. On 10Feb2021, at 10:00 the patient had experienced frequent urination and urgent urination after receiving the first dose vaccine. No treatment was received for the adverse events. The clinical outcome of the events frequent urination and urgent urination was not recovered at the time of report. No follow-up attempts are possible; No further information is expected.
Seizures; Seizure; A spontaneous report was received from a physician assistant  concerning a patient of unknown age who experienced seizures.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.       On 11JAN2021, approximately 16 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    On 26JAN2021 and 29JAN2021, the patient experienced seizures. The patient does not have history of seizures. The patient was transported to the ER for treatment and they had a consult with a neurologist on 08FEB2021. The neurologist advised the patient that it would be ok to get the second dose of the vaccine.  The events seizures, was considered resolved on 26 Jan 2021 and 29 Jan 2021.; Reporter's Comments: This case concerns a male patient, who experienced a serious unexpected event of seizure (twice) after receiving first dose of mRNA-1273 (Lot# unknown).  Very limited information has been provided at this time. Further information has been requested.
Narrative:  COVID infection following completion of COVID vaccine series 03/30/21 COVID vaccine dose #1 04/20/21 COVID vaccine date #2 06/04/21 Pt presents to ED reporting body aches and headache that started 10 days ago; states he had a fever and chills last night and felt very weak; CXR WNL; COVID NEGATIVE; admitted to IM 06/05/21 Pt states L leg has been "weeping" for the last week and has been red, swollen and painful with history of leg infections and osteomyelitis; treated with vanco and zosyn 06/08/21 Pt discharged with doxycycline 06/29/21 Pt presents to ED c/o dyspnea upon exertion x2 weeks and increased urinary frequency; reports left knee and ankle pain x3 days; admitted to medicine 07/01/21 Pt discharged with cefdinir 07/28/21 Pt presents to ED c/o nonproductive cough x2-3 weeks and bilateral foot pain; COVID POSITIVE; discharged home with rx for DM/guaifenesin, zinc, vitamin C, vitamin D, acetaminophen 07/31/21 Pt states symptoms of cough, fatigue, sore throat started 07/21 but now is asymptomatic
Narrative: 81 year old male admitted on June 16 2022 with productive cough x 2 days. He had received Moderna vaccine x 4 on January 29 2021, March 1 2021, October 1 2021, and June 10 2022. He was treated with remdesivir 200 mg IV x 1 then 100 mg daily x 4 days. He was discharged back to long term care July 6 2022 after quarantine was complete.
4cm x 5cm erythema under L arm painful, joint pain L shoulder. Temp 99 deg.
none covid 19 vaccine expired 11/22/2022 Given 12/09/2022
This spontaneous report was received from a other health professional refers to an unspecified patients of unknown age and gender. 02-AUG-2014, doses of RECOMBIVAX HB were exposed to an unsupported temperature excursion of -1C for "5 to 16 hours". On an unspecified dates since 02-AUG-2014, RECOMBIVAX HB (lot # J012567; expiration date: 30-JAN-2016) (dose and route were not reported) were administered to unspecified patients. No adverse effect has been observed or reported. Additional information has been requested.
Within 8 hours post vax, pt had a seizure which resulted in left sided hemiparesis which resolved over 24-48 hours. Pt also had swelling an redness at site of DTaP injection.
Member has persistent altered sense of taste and smell following vaccination.  Started ~5 days after vaccination.  Unchanged through clinic encounter today on 9 March 2021.
This spontaneous report was received from a medical assistant and refers to a an approximately 20 unspecified patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N022978, expiry date 12-SEP-2018 (dose, route of administration were dot reported) for prophylaxis. The doses of vaccine were stored in unspecified out of range temperature in an unspecified time frame. Previous temperature excursions were detected over 30 days. Digital data logger was involved. No adverse effects were reported. Additional information was received from the medical assistant on 19-JAN-2018. Identifiers for some of the patients were provided. The following temperature excursions were reported for the lot number N022978 of VARIVAX: Temperature excursions between 6°F to 14°F (-14°C to -10°C) on 23-NOV-2017 (3 hours),  26-NOV-2017 (3 hours), 28-NOV-2017 (3.5 hours), 01-DEC-2017 (3 hours), 04-DEC-2017 (3 hours), 07-DEC-2017 (2 hours), 10-DEC-2017 (2 hours), 13-DEC-2017 (2 hours), 16-DEC-2017 (2 hours) and on 18-DEC-2017 (1 hour);  and between 15°F to 46°F (-9°C to 8°C) on 24-NOV-2017 (4 hours),  25-NOV-2017 (3 hours), 27-NOV-2017 (4 hours), 29-NOV-2017 (3 hours), 30-NOV-2017 (3.5 hours), 02-DEC-2017 (3 hours), 03-DEC-2017 (3.5 hours), 05-DEC-2017 (3 hours), 06-DEC-2017 (2.5 hours), 08-DEC-2017 (2.5 hours), 09-DEC-2017 (2.5 hours), 11-DEC-2017 (2 hours), 12-DEC-2017 (2 hours), 14-DEC-2017 (1.5 hour), 15-DEC-2017 (2 hours), and on 17-DEC-2017 (2.5 hours). The vaccines underwent a total of 69 hours of temperature exposure. Additionally, the reporter stated that one of the patients was vaccinated on 05-JAN-2018. This is one of several cases reported by the same reporter.; Sender's Comments: US-009507513-1801USA006569:Original Case : 1801USA006569.
Tinnitus (high pitched tone) in right ear started the morning after vaccination and has continued to date. Noticeable and annoying but tolerable. Note I've had tinnitus a few times in the past, though I believe this is the longest it's persisted.
A spontaneous report had been received from a Pharmacist concerning a patient of unknown age and unknown gender. Lack of relevant history. No concomitant medications reported. The patient had received Nasal FLUMIST QUADRIVALENT on 29-Feb-2016. It was reported that the FLUMIST expired on 24th February. One child received the FLUMIST vaccine on 29-Feb-2016. The outcome of the event of use of expired product was unknown. The reporter assessed the event of use of expired product to be non-serious.
pt recv vax 1DEC95 & 26FEB96 pt devel chicken pox;pt had two sores the morning of 26FEB96 & later the same day became covered w/lesions;no further details were provided
Infant developed nasal congestion on 9/17/06 and fever 101. Mother noticed shortness of breath in infant. (/18/06 exam showed nasal congestion with clear nasal discharge. Infant did no require any medication.
Patient was seated in the waiting area, fell off chair. Patient complained of feeling dizzy and faint. Patient hit head on floor.
SORE THROAT; NASAL CONGESTION; STOMACH DISCOMFORT; FEVER; HEADACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, treatment medications included: ibuprofen. On 02-JAN-2022, the patient experienced sore throat, nasal congestion, stomach discomfort, fever, and headaches. Laboratory data included: COVID-19 antigen test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, nasal congestion, stomach discomfort, fever, and headaches on 03-JAN-2022. This report was non-serious.
feels dizzy while sitting; blood pressure was elevated; This is a spontaneous report from a contactable pharmacist. A 65-year-old unknown gender patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EI9261) via intramuscular route of administration in the arm left on 09Feb2021 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, diverticulitis, penicillin allergy and syncope 2 days prior to the vaccine. Concomitant medications included sodium picosulfate (DULCOLAX). The patient previously received ciprofloxacin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not 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 09Feb2021, the patient felt dizzy while sitting. His blood pressure was elevated at 179/100 mmHg. Heart rate and oxygen saturation were within normal limits. Retook blood pressure a second time 165/91 mmHg. Third blood pressure 165/87 mmHg. Fourth blood pressure 164/84 mmHg. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events felt dizzy while sitting and blood pressure elevated were recovered on unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night.; Extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night.; Extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night.; This is a spontaneous report received from a contactable consumer. A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 08May2021 as single dose in left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included severe ovarian cysts, PTSD, food allergy and past drug event was bactrim. Concomitant medications included benadryl, ibuprofen, naproxen, acetaminophen. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After vaccination the patient experienced extremely sore muscles 6 inches from injection site, severe fatigue, vivid nightmares the following night on 08May2021. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Immunocompromised patient wanted to have Prevenar 13 already received the Pneumovax 23; This spontaneous report was received from a pharmacist, referring to a 62 year old patient of unknown gender with leukemia. No information was provided regarding the patient's medical history and concomitant medications.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). Other suspect therapy included pneumococcal 13v conj vaccine (crm197)(PREVENAR 13) both vaccines were for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  On an unknown date, the immunocompromised patient wanted to have pneumococcal 13v conj vaccine (crm197)(PREVENAR 13) already received the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(off label use).
03/18/2021 FIRST COVID19 VACCINE 04/08/2021 SECOND COVID19 VACCINE 04/09/2021 FELT DIZZY AND FAINTED BREIFLY IN THE MORNING 05/03/2021 AT NIGHT, SLUGISH SPEACH, DIZZY, HIGH BLOOD PRESSURE 05/04/2021 WENT TO EMERGENCY ROOM AND HOSPITAIZED (STROKE)
Began 05/09/2001 with red spots and blisters, pruritic, temp of 99.8 (ear) (sibling had v-2 7/00 after Varivax 04/06/99).
sore arm - left arm; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (sore arm - left arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm - left arm). At the time of the report, VACCINATION SITE PAIN (sore arm - left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.  No treatment information was provided.
acute left-sided trigeminal neuropathy manifested by left-sided facial numbness and paresthesia
A spontaneous report was received from a 47-year-old, female patient concerning herself , who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen lymph node under the same arm which got vaccinated (Vaccination site lymphadenopathy).  The patient's medical history was not provided by the reporter. No Concomitant medications present.   On 31 Jan 2020, prior to the onset of the events, the patient received their shot (Lot number: 300042460) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient experienced swollen lymph node under the same arm which she got vaccinated (Vaccination site lymphadenopathy). Its not confirmed whether it is of Moderna COVID-19 vaccine. The patient took rest.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome events, swollen lymph node was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.