chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; chills; body aches/ sore; nausea; sore swollen glands; sore arm; I got shingles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 (Batch/Lot number: unknown) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine"; Codeine, reaction(s): "Known allergies: Codeine based medication makes me nauseous". Vaccination history included: Bnt162b2 (lot number=EN6207 , dose number=2, location=Left arm), administration date: 31Jul2021, when the patient was 62 years old, for Covid-19 Immunization, reaction(s): "sore arm"; Bnt162b2 (lot number=EN6202, dose number=1), administration date: 06Feb2021, when the patient was 62 years old, for Covid-19 Immunization, reaction(s): "Sore arm". The following information was reported: PYREXIA (non-serious) with onset 26Jan2022, outcome "not recovered", described as "fever"; CHILLS (non-serious) with onset 26Jan2022, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 26Jan2022, outcome "not recovered", described as "body aches/ sore"; NAUSEA (non-serious) with onset 26Jan2022, outcome "not recovered", described as "nausea"; LYMPHADENOPATHY (non-serious) with onset 26Jan2022, outcome "not recovered", described as "sore swollen glands"; PAIN IN EXTREMITY (non-serious) with onset 26Jan2022, outcome "not recovered", described as "sore arm"; HERPES ZOSTER (non-serious) with onset 26Jan2022, outcome "not recovered", described as "I got shingles". The events "fever", "chills", "body aches/ sore", "nausea", "sore swollen glands", "sore arm" and "i got shingles" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pyrexia, chills, pain, nausea, lymphadenopathy, pain in extremity, herpes zoster.  Additional information: The patient got her first two shots with no problems other than a sore arm. When she gets her booster, she got a fever; chills; body aches; nausea; sore, swollen glands; and a sore arm. She was not alarmed but figured it was an immune response. However, within the month she got shingles. She believed that had she not gotten this booster, she would not have gotten shingles. The patient did not received any other vaccine in four weeks and other medications in two weeks. Treatment received as Valacyclovir, Gabapentin, and Lyrica.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a registered nurse concerning 3 patients who were vaccinated with a dose of GARDASIL.  It was reported that the patients were between the ages of 14-19 years old and in the last 3 weeks have experienced fainting and/or site pain that lasts up to 5 to 7 days after vaccination with GARDASIL.  The nurse did not specify if the 3 patients experienced both the fainting and pain or one or the other.  The patient's status was not reported.  No further information is available.
Sore body, fever, and lethargy night of 1/11/22. Ended symptoms on 1/12/22. Then on the night of 1/21/22, developed itchy hives that appear randomly on entire body, even palms and soles of feet. Sore throat and congestion that lasted for a week. Hives come and go on random areas of the body still up to today's date, 2/6/22.
Information has been received from a physician concerning a 24 year old female who in May 2008, was vaccinated with the third dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  Subsequently, after vaccination the patient experienced generalized urticaria.  As of 15-SEP-2008, generalized urticaria persisted.  The patient sought medical attention.  She was seen by the physician.  Additional information has been requested.
I had prior episode with shingles in rt. knee about 10 years ago. A week after shot started with burning pain in same knee. I have started the anti-viral. Hope it keeps it from full blown attack.
Severe fatigue in legs and some fatigue in arms/head  began the day after vaccines were administered (10/27).  Over the next few days, I began to feel tingling all over the body and muscle twitches all over the body.  This is accompanied by feelings of electric currents running under the skin, strange sensations in the stomach, and high anxiety.  All symptoms continue.
I have developed tinnitus since receiving the vaccine. It is a constant ringing in my ears.
Initial report was received from a consumer through another manufacturer under manufacturer report number 2012215588 on 31 October 2012. A patient (age, gender and date of birth not reported) had received an injection of FLUZONE, Sanofi Pasteur Inc., (lot number, route, site, and date of administration not reported) and an injection of PREVNAR 13, Pfizer, (lot number, route, site, and date of administration not reported) and an unspecified amount of time later experienced a febrile seizure. No additional information was available. Outcome was not reported. Documents held by sender: None.
Injected FLUAD in Left Arm Deltoid, once injected patients arm swelled up at injection site (looked like a bruise). This took place in a matter of seconds. Patient stated she did have allergic reactions to a couple of antibiotics (penicillin and sulfa) and bovine. Patient waited for about 10-15 minutes before leaving pharmacy, she stated she was feeling fine and the injection caused a local reaction.
Tachycardia starting approximately 45 minutes after injection. A total of 8 episodes followed through the next 52 hour period where my resting heart rate would jump to 140-160 BPM with no activity or stimulation. At these times it would feel difficult to breathe.
passed out / fell; passed out / fell; developed a nose bleed that would not stop; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. Medical history included high blood pressure, diabetic, stage 3 kidney disease, known allergies to penicillin. The patient's concomitant medications were not reported. It was reported that patient got the shot on Thursday morning (04Feb2021) and later that evening reported as at 10:00pm, the patient developed a nose bleed that would not stop. By 10:30pm  she passed out/fell, site car management was called and she was sent to the ER where she stayed for evaluations for 2 days. The reporter does not think the Covid shot was connected to the event. No treatment was given to the patient. The patient had no covid prior to  vaccination and was not tested for covid post vaccination. The patient was recovering from the events at the time of the report.   Information about lot/batch number has been requested.
chills; headache; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2021, the patient received the 2nd dose of Shingrix. In May 2021, less than a week after receiving Shingrix, the patient experienced chills and headache. On an unknown date, the outcome of the chills and headache were unknown.   It was unknown if the reporter considered the chills and headache to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication. The patient received Shingrix vaccine and experienced chills and a headache. The patient wanted to if this was something to be concerned about or should it dissipate fairly soon.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that GARDASIL (dose and route not reported, lot # J010396, expired date: 16-FEB-2015) was administered to a 23 year old patient on 25-FEB-2014. This case was linked to 1405USA01165, 1405USA001164, 1405USA001163, 1405USA001162, 1405USA001166 and 1403USA007265. Additional information has been requested.
Post shot extreme heaviness in arms, rapid heartbeat, difficultly walking around block that I was walking daily previously, out of breath, heart pounding
A report has been received from a health professional, concerning a patient of unknown age and gender. No concomitant medication was provided. The patient's concurrent disease included epilepsy. On an unknown date, the patient received FLUMIST QUADRIVALENT (intranasal). The patient experienced seizure which required hospitalization. In the hospital the H3 strain was isolated. The outcome of the event of seizure was unknown. The company physician considered the event of seizure as serious due to hospitalization. The reporter and the company physician considered that there was no causal relationship between seizure and FLUMIST QUADRIVALENT.
two days after receiving the vaccine was diagnosed with COVID 19; This is a spontaneous report from contactable Nurse via Pfizer Sales Representative. A patient of unspecified age and gender received (dose number not mentioned) of BNT162B2 (COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration about three weeks ago as SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported. On an unspecified date, two days after receiving the vaccine, the patient was diagnosed with covid 19 and wants to know if they can receive their scheduled second COVID vaccine tomorrow. The outcome of the events was unknown.
Pt. was seen convulsing briefly after the injection while waiting in the chair.  Pt. also fainted and came to shortly after 1 minute.  A&O x 3, BP slightly lower than baseline, pt. was clammy, sweating, very pale.  Provider assessed the pt. and advised that she be seen at hospital due to the adverse reaction.  Pt. was taken by ambulance to the hospital.
48 hours after injection, had swelling from shoulder to elbow, red, tight, painful to touch. Spread to wrist and hot.
pt recvd vax 14APR93 c/o swelling, redness of lt leg & pain-doesn't like to walk; also c/o red blotchy rash that comes & goes especially p/sleeping; no apparent itch; some fever low; no apparent distress; dx hives;
12-30-20 1st dose Pfizer exp 3-21.  1-2-21 Noticed heart racing at night, waking/gasping for air, swollen fingers. 1-8-21 symptoms cont called BJC COVID vaccine hot line to report.  Symptoms lessened by end of Jan 21.  Sporadic heart racing and pounding, but more rare through Jul 21.  Visited physician 5-20-21 for physical, discussed symptoms.  6-25-21 requested 2nd dose exemption.  Heart racing starting more frequent Aug through Sept 21.  10-15-22 visited physician, issues tapered off shortly after and before any testing.  2-10-22 heart racing and pounding issues began again.  Heavy pounding and sore the next day.  Propping self up and deep breaths no longer relieved. 2-14-22 called nurse hot line.
Difficulty breathing and swallowing, dry mouth Narrative:  Employee vaccinated in COVID Vaccine Clinic, within 10 minutes developed throat tightness and difficulty swallowing with a dry mouth.
Suspected Vaccination failure; shingles several times plus right now; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case reported by the patient herself/himself. The age at vaccination was not reported. The patient stated that he/she got the Shingles vaccine twice and had shingles several times, plus right at the time of reporting. The patient stated vaccines did not work and stated be honest. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Twelve hours after the second shot, I had convulsions; About 5 hours after the second shot, my lips started to swell; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; I had a pain that started in my left armpit, shot down to my inner elbow, and caused my whole arm to get rigid; Then my body would jerk and I groaned; Then my body would jerk and I groaned; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0169) at left arm on 24Apr2021 09:45 AM at second dose, single for COVID-19 immunisation. Medical history included chronic rhinitis and Lyme disease. Patient previously received Morphine, cefzil and grass. Patient previously received the first dose of BNT162B2 on 03Apr2021 09:45 AM (lot number: EP7533) on Left arm for Covid-19 Immunization. Concomitant medication included loratadine, astaxanthin (BIOASTIN), spirulina spp. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 5 hours after the second shot (also reported as 24Apr2021 22:00), her lips started to swell. she took her allergy medicine and she felt better. Twelve hours after the second shot, she had convulsions. she had a pain that started in her left armpit, shot down to her inner elbow, and caused her whole arm to get rigid. Then her body would jerk and she groaned. It stopped and started in intervals, with calm in between. It was unknown prior to vaccination, if the patient diagnosed with COVID-19. Not tested for COVID-19. Outcome of the events was recovering.   Follow-up information requested.
Extreme headache, progressed to fever, chills, myalgia, fatigue, strep infection, bronchitis.
fluid in lungs after booster; memory was not good; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA (fluid in lungs after booster) in a female 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.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Concurrent medical conditions included Psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE ).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PULMONARY OEDEMA (fluid in lungs after booster) (seriousness criterion medically significant) and MEMORY IMPAIRMENT (memory was not good). At the time of the report, PULMONARY OEDEMA (fluid in lungs after booster) and MEMORY IMPAIRMENT (memory was not good) outcome was unknown.            No concomitant medication was provided. Treatment medication was not provided by the reporter.  Patient stated that she was getting old but it seems like memory was not good. Her physician was doing some additional testing.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for SKYRIZI for the event(s) of fluid in lungs after booster and memory was not good was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company Comment: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest of Pulmonary oedema (fluid in lungs), after receiving a booster dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected, serious (medically significant) adverse event of special interest of Pulmonary oedema (fluid in lungs), after receiving a booster dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
About 5-7 days after shot pt developed cough, fever, lethargy. Visited emergency room and was diagnosed with bronchitis. Patient was treated with antibiotic (unknown to reporter) and still has residual cough. Pt feels that bronchitis was direct result of shot at Walgreens b/c sister in different state experienced similar reaction.
PATIENT CALLED THE PHARMACY TODAY AND COMPLAINED OF TINGLING IN HER FEET. SHE SAID IT STARTED AFTER SECOND DOSE OF PFIZER SHOT IN MARCH 2021 BUT DIDNT THINK IT WAS RELATED TO VACCINE. SHE RECEIVED HER BOOSTER ON 11/2/2021 AT THE STORE AND NOW NOTICES IT EVEN MORE. SHE DID NOT MENTION IT AT THE TIME OF BOOSTER OR WHEN FILLING OUT THE PRE VACCINATION CHECKLIST, SO I WAS  NOT AWARE.  I TOLD HER TO CALL HER DOCTOR AND LET HER KNOW WHAT WAS GOING ON AND THAT I WOULD FILE AN ADVERSE EVENT REPORT.
Fever, chills, shivering, headache, began ~8:00PM on the day of injection, continued all night and most of the next day. Symptoms seemed to decrease, but not disappear, on the evening of the next day. In addition, injection site was quite sore, making movement of arm painful. The injection was almost painless.
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for Vaccination.    No Medical History information was reported.   On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related.    No concomitant medications information was reported.  No treatment medications were provided.   This case was linked to MOD-2021-370191 (Patient Link).
Patient had stated no illness at time of injection and stated no reaction at end of her shift.  Next day patient called stating she had a headache prior to receiving injection and had worsened throughout the day c/o swelling all night and now had body aches, patient to see PCP.
Symptoms began ~8-9 hours after shot including moderate fever,  severe body aches, chills  nausea, headaches, sinus congestion lasting 36-48 hours. Missed work 1/19-1/21.
This spontaneous report was received from a healthcare professional refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL injection  (dose, route, frequency and lot # unspecified). No medical history and concomitant medications were provided. It was reported that the dose administered on an unknown date was an improperly stored vaccine administered to patient. But was unsure which ones, may have been M-M-R II, PEDVAXHIB or GARDASIL. No adverse effects reported at this time. No further details provided. There was no product quality complaint involved. The outcome of incorrect product storage and no adverse event was unknown. This case is linked to: 1505USA014703 and 1505USA004646 (same patient link). Additional information has been requested.
Pregnant patient got the first dose and second dose; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient got the first dose and second dose) in a 27-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies to medications, food and other products.  The patient's past medical history included Pregnancy (Live , pre-term birth at < or = 37 weeks of gestation). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Aug-2021. On 26-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient got the first dose and second dose). On 24-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant patient got the first dose and second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2020, Pregnancy test: pregnancy positive (Positive) pregnancy positive. On an unknown date, Investigation: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) Everything normal in 3 ultrasounds.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not have history of substance abuse. Treatment medication was not reported.