chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pneumonia after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), outcome "unknown", described as "Pneumonia after vaccination". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache and insomnia within a few hours of injection. Injection site arm pain, can?t lift arm, swollen, red. Total body joint pain, worse in ankles and neck. Fatigue, dizziness.
Weakness; Lethargy; hands and fingers are numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: Not Provided) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "Weakness"; LETHARGY (non-serious), outcome "unknown", described as "Lethargy"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "hands and fingers are numb".  Additional information included: Caller was calling about the Pfizer COVID 19 vaccine. She said she had the first one on Thursday seem to be ok after and Friday and Saturday but then she started feeling like she was having a reaction, she was having some weakness, lethargy and just today her hands were numb, her fingers were numb. She asked that, was something that had been reported with the vaccine.  No follow-up attempts are possible. No further information is expected.
disabling migraines/ it was like someone hit him in the head with a sledge hammer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "disabling migraines/ it was like someone hit him in the head with a sledge hammer".  Additional information: The reporter reported that her brother cannot take the covid vaccines and had the first Pfizer covid vaccine but had disabling migraines and he refused to get another one and it was like someone hit him in the head with a sledge hammer; caller declined to complete a report on her brother. Reporter details: Declined email.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
7-31-14 - Had well ck-up. 7-31-14 - 2 immunizations given at 11:40 am - Tdap (BOOSTRIX) given in left arm and Meningitis (MENVEO) in right arm. About 1 min past while recking B/P and an 8 cm blotchy red rash appeared at injection site, small bump. Dr advised ZYRTEC 10 mg p.o. at 11:45 am. BP's LA - 100/80 RA -94/60. Ice pack to left arm for 10-15 min. About 11:55, reaction down to about size of quarter. Small bump still felt. Dr notified. B/P reck'd LA - 96/76, RA 96/64. Ok to leave.
8-10 hrs post injection bad arm pain; with in 16-24 hours cold symptoms that are getting worse; we are now over a week a later and still runny nose; sore throat; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 47-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL3246), at age 47 years, via an unspecified route of administration on the left arm, on 16Jan2021 13:15, at single dose, for COVID-19 vaccination. Medical history included low level diabetic, knee issues and milk allergy from an unspecified date. Patient had not had COVID prior to vaccination. Patient had not had other vaccine in four weeks. Concomitant medication included calcium (CALCIUM), fish oil (FISH OIL), glucosamine sulfate (GLUCOSAM), methylsulfonylmethane (MSM [METHYLSULFONYLMETHANE]), magnesium (MAGNESIUM) , cetirizine hydrochloride (ZYTREC) from unspecified dates. The patient previously took ASPRIN and was sensitive to it on an unspecified date. It was reported that on 16Jan2021 21:30, 8-10 hrs post injection bad arm pain, like yellow fever shot, then with in 16- 24 hours cold symptoms that are getting worse, at the time of report, over a week a later and still runny nose, and sore throat, no symptoms prior to shot. There was no treatment for the events. Patient was not tested for COVID post vaccination. Facility type vaccine: Doctor's office/urgent care. The outcome of the events was recovering.
Metal taste in mouth immediately, voice horse x7 days, nose bleeds when i blow it x7 days
On both hands have intensive redness since first day of vaccination. And today 5 days after vaccination various red spots appears on both arms
Cough; Runny nose; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), RHINORRHOEA (Runny nose) and MYALGIA (Body ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 20-Mar-2021, the patient experienced COUGH (Cough), RHINORRHOEA (Runny nose) and MYALGIA (Body ache). At the time of the report, COUGH (Cough), RHINORRHOEA (Runny nose) and MYALGIA (Body ache) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Pt recvd Hep B vax on 17JUL91 & on 19JUL91 devel tiny bumps on face, cheeks, chest & neck; 2 days later rxn appeared on stomach & thighs; pt was seen by dermatologist & tx w/Tavist & hydrocortisone cream; pt later recovered;
Was feeling really bad; Was doing stuff and forget about what he was doing/Went to work and was gapping up; went to work and was gapping up; Localized pain where the shot was; Fever of 100°F; Headache and when walks around has a ponding feeling on the head; head ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Was feeling really bad), MEMORY IMPAIRMENT (Was doing stuff and forget about what he was doing/Went to work and was gapping up), ABNORMAL BEHAVIOUR (went to work and was gapping up), VACCINATION SITE PAIN (Localized pain where the shot was) and PYREXIA (Fever of 100°F) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Available) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-May-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 an unknown date, the patient experienced VACCINATION COMPLICATION (Was feeling really bad), MEMORY IMPAIRMENT (Was doing stuff and forget about what he was doing/Went to work and was gapping up), ABNORMAL BEHAVIOUR (went to work and was gapping up), VACCINATION SITE PAIN (Localized pain where the shot was), PYREXIA (Fever of 100°F), HEADACHE (Headache and when walks around has a ponding feeling on the head) and HEADACHE (head ache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Was feeling really bad), MEMORY IMPAIRMENT (Was doing stuff and forget about what he was doing/Went to work and was gapping up), ABNORMAL BEHAVIOUR (went to work and was gapping up), VACCINATION SITE PAIN (Localized pain where the shot was), PYREXIA (Fever of 100°F), HEADACHE (Headache and when walks around has a ponding feeling on the head) and HEADACHE (head ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Body temperature: 100 (Inconclusive) 100 degree Fahrenheit.         No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Mild head/neck upper back ache; Mild head/neck upper back ache; Mild head/neck upper back ache; Mild nausea; Lymphadenopathy axillary and shoulder/neck; Injection arm soreness; Reduced appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 43-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 14:00 (Lot number: EP6995) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR [ATORVASTATIN]; PROTONIX [OMEPRAZOLE]; ALIGN; CENTRUM ACTIVE; FIBER. Vaccination history included: Bnt162b2 ({product=COVID, 19, brand=Pfizer, lot_number=EL3247, lot_unknown=False, administration_date=09/03/2021, administration_time=02:00 PM, vaccine_location=Left arm, dose_number=1}]), administration date: 09Mar2021, for Covid-19 immunization at workplace clinic. The following information was reported: HEADACHE (non-serious), NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 31Mar2021 14:00, outcome "unknown" and all described as "Mild head/neck upper back ache"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "unknown", described as "Injection arm soreness"; DECREASED APPETITE (non-serious) with onset 31Mar2021, outcome "unknown", described as "Reduced appetite"; NAUSEA (non-serious) with onset 31Mar2021 14:00, outcome "unknown", described as "Mild nausea"; LYMPHADENOPATHY (non-serious) with onset 31Mar2021, outcome "unknown", described as "Lymphadenopathy axillary and shoulder/neck". Therapeutic measures were not taken as a result of headache, neck pain, back pain, pain in extremity, decreased appetite, nausea, lymphadenopathy.  Additional information: All began 24 hrs post vax and lasted for 30 hrs post onset. Reporter considered events as non-serious. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no treatment received to the Adverse events. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It is Not aware if patient had any Allergies to medications, food, or other products. other medications that patient received within 2 weeks of vaccination included Vitamin C+D.  No follow-up attempts are possible. No further information is expected.
Information has been received from a consumer concerning a 3 and 1/2 year old male with no known drug allergies and reportedly no medical history who in August 2002, was vaccinated SC with a 0.5ml dose of MMR. Concomitant therapy that day included varicella virus vaccine live, poliovirus vaccine inactivated (unspecified). It was reported that in August 2002, the patient developed a fever up to 104 degrees, which started 9 days after vaccination and lasted for 3 days. The patient also developed a rash on his face, neck, and stomach. It was reported that the patient had received MMR, varicella virus vaccine live, and poliovirus vaccine inactivated all in the same day. The patient sought unspecified medical attention. Subsequently, the patient recovered from fever up to 104 degrees, rash on face, rash on neck, and rash on stomach. Additional information has been requested.
This spontaneous report as received from a physician, and refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 07-DEC-2021, the patient was vaccinated inadvertently with an expired dose of measles, mumps, and rubella (Wistar ra 27-3) virus vaccine, live(M-M-R II), dose: 0.5 ml, lot # S039319, expiration date: 04-DEC-2021 as prophylaxis (anatomical location and route of administration were not provided) (expired product administered). No temperature excursion involved and no additional information was provided. No adverse event was reported.
feel really bad; Fever of 100-101 F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel really bad) and PYREXIA (Fever of 100-101 F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced FEELING ABNORMAL (feel really bad) and PYREXIA (Fever of 100-101 F). At the time of the report, FEELING ABNORMAL (feel really bad) and PYREXIA (Fever of 100-101 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, Body temperature: 100-101 (High) 100-101 F.         No concomitant medication details was reported. No treatment medication details was reported. Patient said even if it was half dose, she is sick as the first time.   Reporter did not allow further contact
PATIENT HAD PAIN AND A ZOSTER LIKE LESION IN THE BACK. THE LESION DISAPPEARS IN 48 HOURS.
30 y/o F who 2 minutes after receiving her vaccination, she reported feeling lightheaded. She was taken to a private section of the arena and monitored.
I started to have difficulty swallowing nine months after the second dose. Two weeks after the third dose of Moderna I got a senior Flu Shot. Some Myasthenia Gravis Class I symptoms have manifested.  In the past my symptoms were mostly visual. After getting the shot I had a fever and flu-like symptoms for 36 hours. Three weeks after the covid vaccine my swallowing got much worse, and my vocal cords are raspy. I could not swallow liquids at all. I saw my doctor and he thought the vaccine had caused problems with my condition. I have been prescribed Mestinon 60mg twice a day. My symptoms have improved.
This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. On 16-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # H018510, expiry date 15-JAN-2014) (route and dosing regimen unknown) one time. On an unknown date approximately in 2013 the patient experienced a varicella-zoster like reaction on the forearm, and the reaction was a raised bump about the size of a golf ball. The patient was treated with ACYCLOVIR (manufacturer unknown). The outcome of the event was unknown. The relatedness of the event to the therapy with ZOSTAVAX was unknown. Additional information has been requested.
pt recvd Tempra & t102.3 by 8PM 8APR93; kept fever til 12APR93 cont w/Tempra; pt vomitted & vomitted again; gave cool bath; no further problems was not seen by MD;
No additional adverse events; patients received improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, concomitant therapies, previous drug reactions or allergies were not reported.  On unspecified date since 08-JAN-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (therapy type: digital data logger) for prophylaxis with lot # S017635 with expiration date reported and established as 12-MAY-2020; and lot # 1658254 with expiration date reported and established as 17-NOV-2020. Both lot numbers provided were verified to be valid for rotavirus vaccine, live, oral, pentavalent. No strength, dose, frequency, or anatomical location was reported.  Temperature excursion (product storage error) was reported as follows: temperature total time and highest temperature was above 47 degrees Fahrenheit / 9 degrees Celsius, (9.1 degrees Celsius); timeframe was 45 minutes with previous temperature excursion of 24 degrees Fahrenheit / -4 degrees Celsius and the number of cycles below 24 degrees Fahrenheit / -4 degrees Celsius (5.2 degrees Celsius) were with a timeframe of 20 minutes, 1 cycle. The product storage error was identified via a data logger. No additional adverse events. No product quality complaint was reported. No further information provided.  This is one of seven reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA009323: US-009507513-2001USA006234: US-009507513-2001USA009326: US-009507513-2001USA009325: US-009507513-2001USA009327: US-009507513-2001USA009324:
Patient came to ED with shortness of breath.  Patient admitted with Covid pneumonia and O2 sat in the 80s after Covid booster.
multiple outbreaks of herpes zoster; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On or about 21-OCT-2011, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a healthcare provider for multiple outbreaks of herpes zoster, resulting from the pt's use of zoster vaccine live (ZOSTAVAX). The outcome of the event was not reported. The reporter considered the event of multiple outbreaks of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Its black and blue; A lot of itching on left arm where they gave me the injection; it's still sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLORATION (Its black and blue), VACCINATION SITE PRURITUS (A lot of itching on left arm where they gave me the injection) and VACCINATION SITE PAIN (it's still sore) 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 SITE DISCOLORATION (Its black and blue), VACCINATION SITE PRURITUS (A lot of itching on left arm where they gave me the injection) and VACCINATION SITE PAIN (it's still sore). At the time of the report, VACCINATION SITE DISCOLORATION (Its black and blue) and VACCINATION SITE PRURITUS (A lot of itching on left arm where they gave me the injection) outcome was unknown and VACCINATION SITE PAIN (it's still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment medication was not provided by the reporter.
Inadvertently administered a 5th dose (3rd booster).  Patient did not have vaccine card at time of administration and we had no access to his out of state immunization record.  Patient brought card in next day and realized he had received his second booster on 4/26/22. No side effects reported.  Patient received Pfizer 12/16/20, 1/5/21, 10/5/21, 4/26/22 and 7/26/22
high temp 103.8; mild rash-that turned into rash that covered entire body, coughing-glassy eyed look
3rd dose of COVID Moderna vaccine given 11/9/21, #939905; 4th dose of COVID Moderna vaccine given 8/10/22, #052b22a; pt resides in SNF (Health and Rehab Center and is followed by hospice; 10/3/22 pt had a positive COVID test; no cough or SOB, O2 saturation 95-98% on RA; poor appetite; pt began to have increased confusion and urinary continence; she expired in the SNF
12/30/99 Pt rcv'd varivax 1 day post borhter presented w/ varicella lesions. 1/7/00 Pt exp varicella leisons (approx 500), temp of 102. Lesions remained until 1/12/00.
Vaccine lot 069H21A met the 30-day thawed expiration on 2/20/22 from 5 doses were administered; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine lot 069H21A met the 30-day thawed expiration on 2/20/22 from 5 doses were administered) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose - 2) and Pfizer (Dose - 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 28-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine lot 069H21A met the 30-day thawed expiration on 2/20/22 from 5 doses were administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine lot 069H21A met the 30-day thawed expiration on 2/20/22 from 5 doses were administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was non-immunocompromised and no known history of COVID. No concomitant medications were provided by the reporter.      No treatment medications were provided by the reporter.  Patient received the booster vaccine as part of an outpatient visit. There was no report of adverse event.   This case was linked to MOD-2022-504341 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "fatty liver" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Penicillins" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: Patient took Antiviral drug Paxlovid from 05Jul2022 to 09Jul2022 for treatment of COVID-19. On 20Jul2022 at 07:00 AM, patient experienced rebound symptoms 8 days after testing negative and symptoms was recovering.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.