chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; headache; palpitation; chills; Fatigued; took my temperature orally and ran a fever of 101.7; first dose of bnt162b2 on 18Dec2020 at 12:30 PM, second dose on 05Jan2021 at 16:00; first dose of bnt162b2 on 18Dec2020 at 12:30 PM, second dose on 05Jan2021 at 16:00; soreness/body aches; initially had injection site pain; This is a spontaneous report from a contactable nurse (patient). A 24-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), intramuscularly on 05Jan2021 at 16:00 on Left arm at single dose for COVID-19 immunization in hospital. Medical history included Atopic Dermatitis and had Known allergies with Nickel, Cobalt, Dust Mites, Grass pollen. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) intramuscularly on 18Dec2020 at 12:30 PM on Left arm at single dose for COVID-19 immunization at age of 24-year-old. The patient initially had injection site pain and soreness on 05Jan2021. On 06Jan2021 she went to work and was fatigued with body aches, nausea, headache, palpitation and chills during her shift at 07:00 AM. She came home and took her temperature orally and ran a fever of 101.7 that evening on 06Jan2021. She took acetaminophen and managed to lower the fever. As of today 08Jan2021, current complaints were fatigue, body aches, and a headache. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as a result of event fever included acetaminophen. The outcome of the events fatigue, body aches and headache was not recovered; outcome of event Fever was recovered on 08Jan2021; outcome of the other events was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
experienced the development of new rashes on my hands, arms, wrist and on my stomach; that I recognized as Granuloma Annulare; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9267), via an unspecified route of administration in arm left on 16Feb2021 at 13:30 (at the age of 74-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included pre-diabetes, controlled High Blood Pressure and Asthma. The known allergies of the patient were reported as yes. The Other mediation in two weeks were reported as yes. The patient previously received first dose of BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9263), via an unspecified route of administration in arm left on 26Jan2021 at 13:30 (at the age of 74-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient was not pregnant at the time of vaccination. The patient reported that she had a skin condition for years called Granuloma Annulare it has been under control for months. On Wednesday 17Feb at 17:45, one day after receiving 2nd Cvid Vaccine she experienced the development of new rashes on her hands, arms, wrist and on her stomach that she recognized as Granuloma Annulare. Therapeutic measures were not taken as a result of events. The outcome of the events was reported as not resolved.   Follow-up attempts are completed. No further information is expected.
Morning of May 19 I woke up feeling like I was having a heart attack and admitted myself into the ER. They ran a series of scans and blood tests and found it to be inconclusive but said some healthy, young people experienced inflammation around the heart - myocarditis. Proceeding release from the ER, I saw two heart specialists and they said I was healthy and did not want to admit any evidence related to the vaccine.
She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask.  Aching in left arm, in chest and in right arm pit.  Very dry eyes and bloodshot. Sweating and very warm.  Temperature 1-11-21 96.2°F
Little cough; Runny nose; Tested positive for covid; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient received his first COVID dose on 17Mar2021, afterwards the patient was not feeling well and on 29Mar2021, the tested positive for COVID-19. The patient reported that having mild symptoms, runny nose and a light cough. The patient reported that while the patient's isolation was completed. The patient was still had a little bit of a cough, but the patient was due for his second shot next day and asked if the patient should get it or wait. Call was not transferred to unit because the call was hanging up and Created Manual AE Form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient felt "wimpy and whiny" (his words), then fell to the ground.  Never had loss of consciousness or eye closure.
No additional details; expired PNEUMOVAX 23 vaccine was administered to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   The pharmacist reported that on 06-OCT-2021, the patient was administered with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) expiration date 21-JUN-2021 for prophylaxis (dosage, route of administration, anatomical location and lot number were not reported). No additional information.
This spontaneous report as received from a physician and a health care worker refers to a 15 month old patient of unknown gender. The patient's concurrent conditions or  medical history were not reported. On 26-JAN-2015 the patient was vaccinated with the first dose of MMR II (dose, route, anatomical location, lot number and expiration date were not reported) and on 07-FEB-2015, developed an unspecified rash and pyrexia. The patient was seen in the emergency department that same day and was released without being admitted (on the same day), with a prescription for unspecified antibiotics. On 09-FEB-2015, the patient presented to the physician's office, the patient's mother reported that the rash had worsened but the fever however had subsided. The physician reported that the rash might be measles but he was unable to make a determination at the time of the report. The health care worker inquired how long after administration can titers be drawn to determine measles immunity and if measles immunity created an IgG or IgM response. No lab diagnostics were performed. Additional information has been requested.
All over body aches & stiffness X2 days Spreading Rash at injection site started after 2 days & current. Swelling, inflammation  & pain injection site - 1 day after current. Intermittent nausea shortly after eating 2 days after & continues. Fever 4 hours after lasting 24 hours Extreme fatigue 4 hours after lasting 2 1/2 days
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 3:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 3:59 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  For batch no. 019B21A, The excursion time on initial supply was 10am, temperature was 35, total 150 doses were administered for that day, vaccine was not frozen prior to administration. Vaccine moved to fridge on 23-Mar-2021 and moved to clinic on 27-Mar-2021. 15 vials were sent to the clinic. BUD date was 22-Apr-2021. Vials only punctured right before administration.  For batch no. 014M20A, The excursion time on initial supply was 09 am, temperature was 27 and total 152 doses were administered for that day. At 01 pm, temperature was 26. Vaccine was not frozen prior to administration. Vaccine moved to fridge on 24-Feb-2021 and moved to clinic on 27-Feb-2021. 20 vials were sent to the clinic. BUD date was 26-Mar-2021. Vials only punctured right before administration.  For batch no. 014M20A, Vial was stored on cooler 1, on 28-Oct-2021, Excursion duration At 9 AM: 27, 9 AM: 32 and 01 PM: 26.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Received second booster on April12th..on April 17th got tintinitus.
Acute abdominal pain, presented to ED 04/06/2021, CT revealed abnormal presentation of bowel requiring immediate diagnostic laparoscopy with lysing of adhesion, bowel was flipped on itself per surgeon. Bowel was viable and did not require resection.
Muscle and joint pains, swelling below the fingers, burning and aching from the fingers to the shoulders. It may her Chronic Pain Syndrome worse and she believes it is full blown in her left hand and arm.  Went to the ER.
Pt was given Tdap 1/18/13; Hepatitis A #2 & Influenza 2/19/13; started 1st VIVOTIF 2/20/13 in morning et that day developed cough & tightness in throat - no sore throat or fever. Saw Dr here 2/21/13 & was given BENADRYL 25 mg po qid & stop VIVOTIF. Symptoms subsided. A few days later developed same other cold symptoms - ? upper respiratory infection? No fever.
pt recv vax; rt arm; swelled up; elbow joint swelled, turned very red; was very hot to the touch, very painful to the touch; MD said it was  due to the shot;ATBs x 14 days;was running T 101;
at least 10 patients who were 1-2 years past their due date for dose three; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on an unknown date) and Twinrix (2nd dose received 1-2 years before the date of reporting).   On an unknown date, the patients did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 26-May-2022 Reporter's comments: The nurse reported that she had been seen at least 10 patients who were 1-2 years past their due date for dose three of Twinrix. The consent to follow up was given. Additional Supportive Information: Till the time of reporting, the patients did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Caller received her first Pfizer covid vaccine on April 1st and the on April 2nd, was diagnosed with the covid-19 virus.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown) via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received her first Pfizer covid vaccine on 01Apr2021. On 02Apr2021, the patient was diagnosed with the covid-19 virus. Patient received monoclonal antibody therapy to treat the virus. Patient wanted to know when she should get her second vaccination, given these events. Patient stated just read about another lady who received her first covid vaccine (manufacturer unknown) and then the next day tested positive for Covid as well. The outcome of the event unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient states that she has an itchy rash from the injection site all the way down her arm to the elbow.
Information has been regarding a case in litigation. This report referred to an approximately 69 years old female patient, referring to herself. Information about medical history and concurrent condition was unknown. The patient had no drug reactions or allergies. Concomitant therapies included unspecified thyroid medication. On an unknown date around 2012, the patient was vaccinated with ZOSTAVAX (dose, strength, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date around 2012, the patient had a stroke. The patient reported it was unknown if the stroke occurred before or after administration of ZOSTAVAX. On an unknown date around 2016, the patient developed shingles. The patient went to the emergency room at an unspecified location and was given treatment and was discharged from the emergency room.  There was no lab diagnostics or studies performed.The outcome of the events was reported as recovered. The causality assessment was not provided by the reporter. Upon internal review, stroke was determined to be medically significant.
A 2-month-old patient received an extra dose of IPOL with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via consumer non-health care professional (Reference number- 00797653) and transmitted to Sanofi on 05-Oct-2021.  This case involves a two-month-old patient (unknown gender) who received an extra dose of POLIOMYELITIS VACCINE (INACTIVATED) (IPV) (IPOL) (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect IPV (VERO) (lot number: T1D482M; expiry date: 25-Jul-2022) via unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to extra dose administered (latency same day).  No other adverse event was reported.  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. 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.
diarrhea; after first shot she got gastrointestinal problems; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA and ABDOMINAL DISCOMFORT (after first shot she got gastrointestinal problems) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and ABDOMINAL DISCOMFORT (after first shot she got gastrointestinal problems). At the time of the report, DIARRHOEA (diarrhea) and ABDOMINAL DISCOMFORT (after first shot she got gastrointestinal problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Glaucoma Eyedrops every morning one drop in each eye. No treatment medications were reported.   This case was linked to MOD-2021-346869 (Patient Link).
Chills for about 2 hours Exhaustion for 4 hours Slight fever for 2 separate 3 hour instances
Parent came back with her 13 year old daughter for booster dose. After the denial, she questioned how her 16 year old son could get it. As of 12/07/2021, booster age eligibility remains 18+. She said  her son was doing great.
Thirty minutes after shot, patient was nauseated which lasted for two days. On the third day, patient had a sore throat and cold like symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of needle injury in a 30-year-old female patient who received RABAVERT (batch number 587011AA, expiry date 30th April 2019). This case was associated with a product complaint. On 7th July 2016, the patient received RABAVERT. On 7th July 2016, immediately after receiving RABAVERT, the patient experienced needle injury. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the needle injury was recovered/resolved and the outcome of the pharmaceutical product complaint was unknown. The reporter considered the needle injury to be related to RABAVERT. Additional details were provided as follows: This case was reported by a pharmacist, who herself was the patient. The reporter stated that she was unable to remove the green reconstitution needle of RABAVERT vaccine and she ended up stabbing herself in the right index finger (needle stick injury) while trying to removed the needle. She then threw the syringe away in the sharps container. The defect was discovered during preparation of the syringe. There was no damage to the package and the reporter had herself opened the box. The reporter was an experienced user and she had administered the product for a couple of months. This vaccine was not administered to the intended patient. The reporter stated that she experienced a similar situation later that same day when she prepared another RABAVERT vaccine for administration but one of her technician's was able to remove the green reconstitution needle. The reporter indicated that a lot of force was required to remove the needle however, she was able to administer the vaccine to the intended patient. This syringe was disposed of in the sharps container, too.
Apparent enlarged papillae ( Large buds on back of tongue ), sores on roof of mouth, apparent swelling of throat / difficulty swallowing.
developed a  pink rash with itchiness around the injection site; developed a  pink rash with itchiness around the injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9263), via an unspecified route of administration on 22Jan2021 at single dose (upper left arm) for COVID-19 immunisation. Medical history included acid reflux and high blood pressure. Concomitant medications included metoprolol succinate (TOPROL XL), amlodipine, pantoprazole and an unspecified high blood pressure medication. The patient reported that she received the first dose of COVID-19 vaccine on Friday 22Jan2021 and she stated that she has no reaction at all the day she received the injection. She reported that 24 hours later, on 23Jan2021, she developed a pink rash with itchiness around the injection site and it was about an inch and a half in diameter. She stated that it lasted about 24 hours and was now fading and getting better. Patient stated that she would not call the them critical side effects, they were minor side effects. Patient described them as pink itching rash around the injection site. It was basically 24 hours it lasted. It started 24 hours after the injection and lasted 24 hours before it started fading, the patient still have it but it's fading away now and patient confirmed that the events were improving. The patient did not received therapy for the events. She was concerned that if she receives the second dose of the COVID-19 vaccine it could be worse and wants to know if she should receive the second dose. Patient was worried that in 3 weeks she will take the next second dose she might have an increased side effects. Outcome of events was recovering.
minor oral surgery (oral care, "minor thing in the mouth"); This spontaneous case was reported by a consumer and describes the occurrence of ORAL SURGERY (minor oral surgery (oral care, "minor thing in the mouth")) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.  The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN, Travaprost and CLINDAMYCIN for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced ORAL SURGERY (minor oral surgery (oral care, "minor thing in the mouth")). At the time of the report, ORAL SURGERY (minor oral surgery (oral care, "minor thing in the mouth")) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ORAL SURGERY (minor oral surgery (oral care, "minor thing in the mouth")) to be possibly related.  No treatment information was provided.   The patient is scheduled to receive his 2nd dose on 02Apr2021.
PT WAS GIVEN ZOSTER VACCINE INSTEAD OF VARICELLA. NO REACTIONS WERE REPORTED BY PATIENT, AFTER VACCINE WAS ADMINISTERED.