chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse (L.P.N.) concerning a 4 year old female with no medical history or drug allergies who on 12-APR-2005 was vaccinated subcutaneously with the first 0.5 ml dose of VARIVAX (Merck) (lot # 648318/0440P) and on 08-MAY-2008 was vaccinated subcutaneously with the second 0.5 ml dose of VARIVAX (Merck) (lot # 659939/1788U). Secondary suspected therapy included MMR II. Other concomitant therapy included Poliovirus vaccine (manufacturer unknown), HAVRIX and DTaP (unspecified) (+) Tetanus toxoid. Prior vaccination included PREVENAR (12-APR-2005). On 01-JUL-2008 the patient developed chicken pox. On 01-JUL-2008, the patient was seen in the office and had about 20 lesions on her back. The patient's mother reported that the patient had been running a fever, but was afebrile at the time of the office visit. At the time of this report, the patient's chicken pox persisted. No product quality complaint was involved. Additional information has been requested.
Numbness in face that spread starting at lower cheeks to forehead.  Neurological response to nervous system.  Muscle spasms, and euphoria.
Rapid and pounding heart, to the point it was hard to talk if I was moving.  Laying down for an hour and heart rate was still between 96-100. I took a beta blocker and 2 hours later my heart rate went back to normal.  Heart rate was normal afterwards.
No adverse event; HCP called to report that an adult patient was given GARDASIL 9 on 02/2022, 04/2022, and missed the dose scheduled for 08/2022. No additional AE/PQC.; This spontaneous report was received from a medical assistant refers to a 31-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown day in February 2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. On unknown day in April 2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.  It was reported that the patient missed the dose scheduled for the third dose on September 2022 (vaccine dose omission). No additional adverse event reported (no adverse event).
Steady increase of weight - gained 15 lbs after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Steady increase of weight - gained 15 lbs after 1st dose) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT INCREASED (Steady increase of weight - gained 15 lbs after 1st dose). At the time of the report, WEIGHT INCREASED (Steady increase of weight - gained 15 lbs after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: increased (High) Increased.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication was not provided.  Treatment information was not provided.  Normal weight reported was 185 to 190 lbs. Patient had the second dose on Sep-2021.
Pt recvd vax 17NOV92 & on 24NOV92 pt exp a h/a; the following day h/a persisted & rt eye was sensitive; also devel a watery, painful blister on upper lip; 26NOV92 exp vertigo, dizziness & ache in rt ear;
No adverse event reported. The patient received Pfizer on the first dose and got Moderna for the second dose
Fever, malaise, nausea, vomiting and lower abdominal pain. Could not tolerate anti nausea / fever reducer medications. Returned to pediatrician on 08/18. Received IV fluids for dehydration on 08/19. Admitted to hospital on 08/20. Received IV fluids and blood tests showing inflammation of the liver. Released 08/22 at 2:00 PM with discharge diagnosis of acute gastroenteritis.
Approximately 1/2 hour post vax. the pt started experiencing tingling around her mouth, face then turned red and started itching, tingling went to the arms and continued off and on for about a week. Pain in the hand and feet started the following day.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; ATORVASTATIN, stop date: 07Aug2022; LISINOPRIL; OMEPRAZOLE; ESCITALOPRAM; JARDIANCE; TRULICITY.  The following information was reported: DRUG INEFFECTIVE (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: (unspecified date) Positive; (13Aug2022) Positive, notes: tested positive still on  day 7 (Aug13). Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Aug2022 to 12Aug2022.  Clinical summery: The patient had no known allergies. Terrible bitter taste in mouth started 2h post Paxlovid first dose from 07Aug2022 and lasted approx. 36h post final dose to 14Aug2022. Rebound symptoms tested positive still on day 07Aug2022(13Aug2022) then mild symptoms reappeared on 17Aug2022 included sore throat, congestion in ears, runny nose.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Feb2021 09:00 (Lot number: EN66201) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing); LISINOPRIL taken for blood pressure increased (ongoing); TOPROL XL taken for tachycardia (ongoing); CRESTOR taken for blood cholesterol increased (ongoing); GABAPENTIN taken for restless legs syndrome (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "recovered" (15Nov2021), described as "sore arm".  Additional information: Had arm soreness for 17 days.  Follow-up attempts are completed. No further information is expected.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient received Paxlovid (Anti-viral) on an unspecified date in Jul2022 for COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BODYACHE; SORE THROAT; LOSING VOICE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies and no known medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced bodyache, sore throat, losing voice, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F, and COVID-19 rapid POC test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, bodyache, headache, sore throat and losing voice was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000214026. The suspected product quality complaint has been confirmed to be voided (did not meet criteria as reported complaints were adverse events) based on the PQC evaluation/investigation performed.
Vomiting (1 time) in morning, fever, chills and low temperature for 18 hours, very drowsy, slept a lot.
Arm hurt after shot, I waited the 15 minutes and nothing else happened so I went home. On way home my lips started to tingle a bit and I felt warmer over my body. I got home and felt exhausted for multiple days but on the first day I could not sleep. By the weekend I was just worn out and slept all day the following Sat and Sunday.  My arm hurt so bad I couldn?t lay on it and I even  today either have phantom arm pain or real arm pain. But I know where the shot was because I feel it. It still feels like a deep tissue bruise.
- Itchy on the place of the shot, a red rash developed around the area in oval shape after 8-9 days of the vaccine. - Brain fog, achy body, trouble taking a walk, tiredness, 1.5 times sleep hours
Chest tenderness (left side) progressing to stabbing pain. Unable to lie down. This happened over a 3-4 day period.
temperature excursion for IPOL as fridge door opened for long, temperature reached: 46.6f for a duration of 2 minutes, with no reported adverse event; administration of IPOL after temperature excursion with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235694, 2023SA235058, 2023SA236046, 2023SA235023, 2023SA234814 and 2023SA235246.  This case involves 13 years old female patient and reporter reported temperature excursion for IPV (VERO) [IPOL] as fridge door opened for long, temperature reached: 46.6f for a duration of 2 minutes, with no reported adverse event and administration of IPOL after temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella vaccine) for Prophylactic vaccination; HPV vaccine for Prophylactic vaccination; and hepatitis A vaccine (Hepatitis A) for Prophylactic vaccination.  On 11-Jul-2023, the patient received a Standard dose 5 of suspect IPV (VERO) Suspension for injection at a dose of 0.5mL total (lot W1A191M, expiry date- 16-FEB-2025) via subcutaneous route in the left arm for Immunization.  Caller reported temperature excursion for opened IPOL as fridge door opened for long, temperature reached: 46.6f for a duration of 2 minutes, with no reported adverse event (product storage error) (unknown latency) and administration of IPOL on 11-Jul-2023 after temperature excursion with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, there were no previous excursions. Human error was involved. Caller is asking if they need to re-vaccinate the patient given the opened IPOL after temperature excursion.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
The next day after I received my flu shot, the shot site was swollen/red/sore. This subsided on 11/27/2010, when I became violently ill. I threw up and suffered from diarrhea for 24 hours.
Severe injection site arm pain, especially under arm. Headache. Numbness across body. Extreme fibromyalgia flare (severe pain all over body, extreme fatigue, brain fog and depression).
5mins post vaccination pt reported "trouble breathing".  Mother believes its related to wearing a mask.  Pt taken to med bay.  No S/S of respiratory distress.  VSS.  Pt feeling better once mask is removed.  NO swelling tongue or lips.  Lung sounds clear. Symptoms subsided once mask was removed.  Pt released in stable condition.  Strong steady gait.  Instructed mother to call emergency services if pt has s/s resp distress. Vitals: 17:35 115/71, 82, 28, 100%
This spontaneous report as received from a female consumer of unknown age refers to herself. On 14-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot #, dose, route, strength and indication not reported). In July 2013, the patient experienced joint and muscle pain. The outcome of the events was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Jenssen COVID-19 Vaccine EUA My left arm was quite sore immediately after the shot. I started to feel achy after I went to bed at 10 p.m. The next morning I felt very nauseous for the whole day and  my arm was very sore. I had no appetite and just felt icky; like I might be coming down with something. I tried some ginger ale on Wednesday since Pepto Bismol wasn't helping and felt some relief instantly. This nausea and icky feeling continued every day until today, Thursday, May 6th.
Didnot received a full second dose of the vaccine; A spontaneous report was received from a consumer, concerning his wife, a 70-year-old female patient, who received Moderna's COVID-19 vaccine but did not received a full second dose of the vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26-Jan-2021, prior to the onset of event, the patient received their second of two planned doses of mRNA-1273 (lot number 011J20A) intramuscularly for COVID-19 infection prophylaxis.  The reporter stated that he and his wife had received the second dose of vaccine on 26-Jan-2021, and he received the full dose of vaccine, however, he believes that the syringe was not filled with any solution at the time of administration to patient, due to which the patient did not received a full dose of vaccine. Reporter denied consent to follow up. Treatment information was not provided  Action taken with mRNA-1273 in response to the events were not reported.  The event, did not received a full second dose of the vaccine was considered resolved on 26-Jan-2021.; Reporter's Comments: Company comment: This case concerns a 70 year old female who experienced a nonserious event of did not received a full second dose of the vaccine (PT Incomplete dose administered).  There were no reported AEs associated with this case of incomplete dose administered. Very limited information regarding this event/s has been provided at this time. Reporter denied consent to follow-up.
Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) 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.   Treatment drugs were not provided concomitant drugs were not provided   This case was linked to MOD-2021-067524, MOD-2021-221042, MOD-2021-257250 (Patient Link).
COVID test result: Positive; COVID test result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EL0142), in left arm, on 25Jan2021 as dose 2, single (Lot number: EL3247), in left arm and on 08Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FF2588) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing), notes: Other medical conditions: prediabetes, high cholesterol; "High cholesterol" (unspecified if ongoing). There were no concomitant medications in two weeks. The patient did not receive any other vaccine in four weeks. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Oct2022, outcome "unknown" and all described as "COVID test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2022) Positive.
Sustained coughing after went to bed in the evening and for the next 2 days; then wheezing and coughing with vomiting at night time for the following 8 days. On the 4th day, we took him to the doctor for the second time, and she diagnosed asthma.
Information has been received from a registered nurse concerning a 44 year old female who on 05-MAY-2010 was vaccinated with a dose of MMR II (Lot# 665596/1272Y, exp on 03-SEP-2011). On 17-MAY-2010 the patient developed a fever (101F) and on 19-MAY-2010 the patient developed a rash. The nurse was not sure if the patient was ever given MMR II in the past as she was from abroad. Nurse stated there was no physician that worked from their facility. The patient sought medical attention by calling the nurse. At the time of report the patient's status was not recovered. Additional information has been requested.
99.5 fever started on Tuesday, Weds through Thursday sustained 102.6 fever, body aches, chills, tiredness, tightness in chest, slight shortness of breath
This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age. Nurse reported that unspecified number of improperly stored ROTATEQ. Doses had been administered to unspecified number of patients. Vaccines were exposed to 50F for 48 hours. ROTATEQ was exposed to the following excursions: On 27-MAR-2014: 47F for 12 hours. On 02-APR-2014: 47F for 12 hours. On 17-APR-2014: 47F for 12 hours. On 18-APR-2014 for 12 hours. Dates of administration of lot # J013625, exp 31-MAR-2015: 02-JUN-2014, 03-JUN-2014, 04-JUN-2014 (3 doses), and 06-JUN-2014. Dates of administration of lot # J012519, exp 30-APR-2015: 22-MAY-2014, 28-MAY-2014 (2 doses), 29-MAY-2014, 05-JUN-2014, 06-JUN-2014, 09-JUN-2014, and 10-JUN-2014. No adverse effect had been observed or reported. This is one of several reports from the same reporter source. Additional information is not expected.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue, chills Narrative:  Other Relevant History:
After the second COVID shot she developed chills, sweats, scalp rash, subjective (but not measured) fever.  I am reporting  this because the symptoms persisted for about a month.
I pulled over where I proceeded to pass out and vomited on myself; swelling and itching at injection site.; swelling and itching at injection site.; I felt nauseous while driving; I pulled over where I proceeded to pass out and vomited on myself; This is a spontaneous report from a contactable other healthcare professional. A 29-year-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Jul2021 at 15:00 (at the age of 29 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing, drug hypersensitivity to penicillin from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced swelling and itching at injection site, felt nauseous while driving and vomited on herself leading to hospitalization on 07Jul2021 10:00. She was taken to the ED by ambulance after monitoring for a few hours decision was taken to discharge but upon standing she passed out again so was admitted and multiple tests were performed. The patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 nasal swab test: with negative result on 02Jun2021. Therapeutic measures were taken for adverse events with fluids. Outcome of events was not recovered.   Information about batch/lot number has been requested.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events: loss of consciousness, vaccination site swelling, vaccination site pruritus, nausea and vomiting ;and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
w/in 1hr of inj swelling began @ site;6hr later softball site rxn @ site;the following day involvement of arm to elbow up in shoulder;warm to touch;PMD gave prescription for DPH & DTC;