chrisvoncsefalvay/vaers-outcomes huggingface dataset:
caller can't remember if he took tylenol or ibuprofen during the vaccination series; This is a spontaneous report from a Pfizer-sponsored. A contactable male consumer (patient) reported that: A contactable male consumer (patient) of an unspecified age received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date  single dose for COVID-19 immunization. The patient's medical history and concomitant medicines were not reported. The patient previously had first doseof covid-19 vaccine. Caller is done with the 2 doses of Pfizer vaccine but the caller can't remember if he took Tylenol or ibuprofen during the vaccination series. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
daughter sick first tested positive 15May2022 / AG positive 16May2022; daughter sick first tested positive 15May2022 / AG positive 16May2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 39-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3247), on 24Mar2021 as dose 2, single (Lot number: EL3247) and on 17Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15May2022, outcome "unknown" and all described as "daughter sick first tested positive 15May2022 / AG positive 16May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive; (16May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Reporter stating events as non serious. Prior to the vaccination, the patient was diagnosed with COVID-19 was unknown reported.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events vaccination failure and Covid 19  cannot be completely excluded.
At time of visit, client nervous, anxious, hands clammy, After immun. appeared pale c/o nausea no emesis, c/o fingers numb. Observed him for a while, left with mother. 11/23/09 school nurse called to report reaction . Client in school.
body aches; headache; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry unknown), via an unspecified route of administration on 22Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches and headache on an unknown date.  The outcome of the events was unknown.   No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2022 as dose 4 (booster), single (Lot number: fic9729) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Lot number: 011l20a), in left arm, on 03Feb2021 as dose 2, single (Lot number: 030l20a), in left arm and on 16Aug2021 as dose 3 (booster), single (Lot number: 0939902), in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "bp" (unspecified if ongoing); "depression" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Interchange of vaccine product" (unspecified if ongoing). Concomitant medication(s) included: PRIMIDONE; ATORVASTAN; WELLBUTRIN; CELEXA [CELECOXIB]; MONTELUKAST; CITALOPRAM; LISINOPRIL; ZINC; VITAMIN D3; RESVERATROL [REYNOUTRIA JAPONICA;VITIS VINIFERA]; VIT C. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) negative, notes: tested on Friday, after 5 day treatment with Paxlovid; (05Jun2022) negative, notes: tested on Sunday, after 5 day treatment with Paxlovid; (07Jun2022) Positive, notes: tested positive again; (2022) Positive, notes: unknown date. Therapeutic measures were taken as a result of drug ineffective, covid-19. The clinical course was reported as the patient stated that she was fully vaccinated with Pfizer's COVID-19 Vaccine and tested positive for COVID-19. The patient came down with COVID-19 on 26May2022. Her doctor prescribed Paxlovid and she took it for 5 days. Treatment start date was 26May2022 and stop date was 31May2022. Afterwards She had 2 negative tests on friday and sunday. However, today on 07Jun2022 she tested positive again and she was not feeling good. She would like to report this COVID rebound and reported that her head was killing her. She also has a runny nose and some ear pain when she coughs.  No follow-up attempts are needed. No further information is expected.
Patient was given COVID19 Pfizer vaccine in her left arm on 02/08/2021. She presented  on 3/20/21 to the office stating she needed her second Moderna vaccine which she received.  She did not bring her proof of vaccination card with her.  It was later discovered that she had previously received the Pfizer vaccine and should have had Pfizer for her second dose.  She had no reaction to the  vaccine in the clinic
?delayed cutaneous hypersensitivity? or COVID arm. Raised, red bump approx. 1.5? in diameter and mild itchiness at injection site
Extreme fatigue, body aches, chills, sweating, passed out while showering the next day
Fatigue muscle aches and nausea 24 hours after dose and lasted 24 hours  Then I had 2 menstrual cycles 2 weeks apart.  I am normally very regular at every 26 days for my cycle.  I also had the shingles vaccine 4 days after this one. I am reporting for that 2.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a non-contactable consumer (patient's daughter) reported that a female patient (aged 102, no unit reported) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 at a single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's daughter was calling on behalf of her mother, aged 102, received vaccine a week ago last Sunday (03Jan2021), and was tested positive for Covid the next day (04Jan2021). The patient was due for her second vaccine and wanted to know if her mother is still eligible to receive vaccine.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained.
REC'D CALL FROM PT'S SON, PT HAS BEEN ON HOSPICE CARE AND PASSED 1/26/21. DOES NOT BELIEVE THIS IS RELATED TO VACCINE ADMINISTRATION, BUT WANTED TO REPORT TO US.
Full body rash / hives that has moved around the body from head to toe.  Progressing throughout the time period.
4 in by 3 in lump at the injection site along with redness; Soreness at injection site; Felt pain, soresness at injection site; A spontaneous report was received from a health care professional concerning of an unknown age female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain, soreness at injection site and 4 in by 3 in lump at the injection site along with redness.   The patient's medical history included drug allergy to NSAIDs. No relevant concomitant medications were reported.   On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) via unknown route for prophylaxis of COVID-19.  On 26 Dec 2020, the patient stated she felt pain and soreness at injection site. On 04 Jan 2021, ten day later, the patient noticed 4 in by 3 in lump at the injection site along with redness. The lump was firm to touch.  No treatment information provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, pain and soreness at injection site, was resolved.  The outcome for the events, 4 in by 3 in lump at the injection site along with redness, 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 events, a causal relationship cannot be excluded.
The patient is not experiencing any side effects at this time; 12 month old female patient was accidently given GARDASIL 9 vaccine this morning; This spontaneous report has been received from a nurse and refers to a 12-month-old female patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 21-SEP-2023, the patient was accidentally vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis at 12 months of age (Product administered to patient of inappropriate age). (strength, lot #, expiry date, and route of administration were not provided). The patient had not experienced any adverse events.
unilateral loss of hearing; white noise; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (unilateral loss of hearing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (unilateral loss of hearing) (seriousness criterion medically significant) and TINNITUS (white noise). At the time of the report, DEAFNESS UNILATERAL (unilateral loss of hearing) and TINNITUS (white noise) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case is linked to cases 2019SA071898, 2019SA073918 and 2019SA073919 (same reporter). This case involves a 53 years old patient (gender not reported) who was vaccinated with 0.1 ml dose of FLUZONE (batch number: UI998AD and expiry date: 30-Jun-2019) via intradermal route in left forearm instead of receiving TUBERSOL on 13-Mar-2019 and experienced itching at the injection site. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unspecified date, the patient developed a non-serious itching at the injection site following the vaccination. It was also a case of actual medication error due to wrong vaccine administered. No Lab data was reported. Final diagnosis was itching at the injection site. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Initial soreness, overall achiness, severe indigestion, about 3 hrs, no tx sought as subsided.
flares of heat in odd spots on body, mostly chest and upper back, sometomes in face, sometimes the bottom of feet; severe burning in esophagus and into stomach; severe burning in esophagus and into stomach; chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 17Dec2021, outcome "unknown"; OESOPHAGEAL PAIN (non-serious), DYSPEPSIA (non-serious) all with onset 19Dec2021, outcome "unknown" and all described as "severe burning in esophagus and into stomach"; HOT FLUSH (non-serious), outcome "unknown", described as "flares of heat in odd spots on body, mostly chest and upper back, sometomes in face, sometimes the bottom of feet". The events "flaresm of heat in odd spots on body, mostly chest and upper back, sometomes in face, sometimes the bottom of feet" required physician office visit. The events "chest pain" and "severe burning in esophagus and into stomach" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: No one could figure out what had happened to the patient. She had seen a GI (gastrointestinal) and had an endoscopy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax 31JUL93 & exp pruritus of the lt palm & arm which resolved in a few minutes w/o treatment;
Information has been received from a RN concerning a 6 y/o female with no relevant medical history and no known allergies who  on 11Jul97 between 8:30AM -12PM was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. On 11Jul97, between 8:30AM-12PM, concomitant medication included a SC first dose in the right arm ofmeasles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) an IM fourth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) and an IM fourth dose of Hib conj vaccine. There were no other concomitant medications.   There was no illness at the time of vaccination. The father of the child reported that on 12May03, the pt had developed chickenpox after receiving the chickenpox vaccine. There was no relevant diagnostic or laboratory tests performed. It was noted that the male sibling "had more pox" than the female. It was also noted that the pt had a "mild case". The pt did not see a physician and she was not hospitalized (previously reported as unspecified medical attention was sought). Subsequently, the pt recovered.  There was no product quality complaint involved. No further information was available. No further information is expected. The reporter also mentioned that a male sibling experienced a similar reaction after vaccination with varicella virus vaccine live.
acute hypoxic respiratory failure; This literature-study case was reported in a literature article and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Concurrent medical conditions included Hypertension and Lung cancer.    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 ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Acute hypoxic respiratory failure. It is unknown if an autopsy was performed. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) to be possibly related.    Treatment medications were not reported Concomitant medications were not reported  Company Comment: This case concerns a 81-year-old, male patient, with medical history of hypertension and lung cancer, who experienced the fatal event of Acute respiratory failure. The event occurred on an unknown date after receiving an unknown dose number of the Moderna COVID 19 vaccine. The rechallenge is not applicable considering the outcome of the events. The medical history of hypertension and lung cancer remains as a confounder. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.   This case was linked to MOD-2021-371501, MOD-2021-371537, MOD-2021-371538, MOD-2021-371539, MOD-2021-371540, MOD-2021-371542, MOD-2021-371543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety 03-Nov-2021 included an Email with a regulatory authority and  contains significant information.; Sender's Comments: This case concerns a 81-year-old, male patient, with medical history of hypertension and lung cancer, who experienced the fatal event of Acute respiratory failure. The event occurred on an unknown date after receiving an unknown dose number of the Moderna COVID 19 vaccine. The rechallenge is not applicable considering the outcome of the events. The medical history of hypertension and lung cancer remains as a confounder. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.; Reported Cause(s) of Death: acute hypoxic respiratory failure
Information has been received from a health professional concerning a 4 year old female who on 25-JUL-2007 was vaccinated subcutaneously into right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 657757/0641U), a fourth dose of diphtheria toxoid (+) pertussis acellular I-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid, intramuscularly into the right thigh (GSK) (Lot # AC14B046AA), a first dose, into the left thigh, of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 656038/0204U) and a third dose, subcutaneously into the left thigh, of poliovirus vaccine inactivated (unspecified) (SP) (Lot # Z1069). On 27-JUL-2007 the patient developed a two inch raised red hard area at the injection site on the right thigh. At the time of reporting the patient's status was unknown. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected.
was inadvertently given third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 20-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 1st dose on 6th May 2022) and Bexsero (received 2nd dose on 6th June 2022).   On 7th November 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 7th November 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The healthcare professional reported that patient received 2 doses of Bexsero then was inadvertently given a third dose.  The reporter did not had the lot number or expiration date information for any of the doses at the time of reporting. The reporter did not want contact information saved in database but did give permission to follow-up with her via phone.   The contact information would be sent in email from case. The reporter consent to follow up. Additional Supportive Information: The patient received extra Bexsero dose, which led to extra dose administered.
Patient felt drowsy after the episode with few seconds of shallow breathing. Lasting for about 2-3 minutes.
Three teeth and gums on right side of mouth hurt for 24 hours a few days following the 1st vaccine. I had rapid heartbeat for 2 1/2 weeks after the first dose and almost did not return for the 2nd dose because of this.
1/19/22 pt brought to hospital as a transfer from another Hospital after being treated for COVID; positive COVID test on 1/17/22; was treated with dexamethasone; generalized weakness, cough, SOB, decrease in oral intake; did not require O2 initially, but quickly declined requiring 15 L O2 with O2 sats in 80s; pt desired to transition to comfort care and she passed away in the hospital
A minute or two after patient received vaccine he was on his way to the post vaccination waiting area he passed out and fell against a display where he slid to the ground. Within a minute of this event and getting to the patient he was already conscious although lethargic and kept closing his eyes. Over the next 5-10 minutes he became much more responsive and eventually stood up and had a seat in a chair. EMS was already called and came to check on him and eventually they let him go and he indicated he was fine and continued to finish his shopping.
Swollen red left upper arm: circumferential swelling, 5cm> right arm.