chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling light headedness; Fever; hangover type feeling in head; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 10:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Apr2021, right after receiving the vaccine, the patient experienced light headedness, fever and hangover type feeling. After 10 days, fever and light headedness were gone but patient still got hangover type feeling in head and it was mostly in front part of head. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of events fever and light-headedness were recovered on an unspecified date in 2021. The clinical outcome of event hangover type feeling in head was not recovered at the time of report.  No follow up attempts are needed. Information about lot/batch number cannot be obtained.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
My adverse event started after receiving the 4th dose. It happened within 20 minutes. My left arm was sore, and painful to touch. It lasted for 10 days. I also noticed a knot on my elbow. It was very painful to do anything or to lift. Between my thumb and index finger it was all black and bruised. I used a heating pad on my elbow for the knot. I thought it was normal but it concerned me when it took long time to heal. There wasn't much to do about it. I didn't seek care from my doctor. It resolved by itself.
chills; headache; exhausted; sore at injection site and left underarm; sore at injection site and left underarm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 17:45 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "penicillin" (unspecified if ongoing), notes: known allergies: allergic to penicillin. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (administration date=24Mar2021,, administration_time=05:45 PM,, vaccine_location=Left arm,, dose 1), administration date: 24Mar2021, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 13Apr2021 09:00, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 13Apr2021 09:00, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 13Apr2021 09:00, outcome "recovering", described as "exhausted"; VACCINATION SITE PAIN (non-serious), AXILLARY PAIN (non-serious) all with onset 13Apr2021 09:00, outcome "recovering" and all described as "sore at injection site and left underarm". Therapeutic measures were not taken as a result of chills, headache, fatigue, vaccination site pain, axillary pain.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Treatment was not received for the adverse event. Patient did not receive any other vaccine within four weeks. Patient did not receive any other medications in two weeks. Patient was not tested for covid post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt fine for 3 day; on 22MAR91 sleeping - sitter checked her & found her w/vomitus around her mouth & blue; Mom says she has runny nose the night prior to event; CPR was given there & in ambulance & ER but w/o result;
diarrhea for 36 hours; severe chills with fever that lasted about 3 hours; severe chills with fever that lasted about 3 hours; body aches, headache, and fatigue which lasted about 24 hours; body aches, headache, and fatigue which lasted about 24 hours; body aches, headache, and fatigue which lasted about 24 hours; This is a spontaneous report from a contactable Nurse (patient) reporting for self. A 56-year-old non- pregnant female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3812) via an unspecified route of administration in arm left on 19Aug2021 at 09:45 as single dose for COVID-19 immunisation. Medical history included COVID-19, hypertension, depression, factor V leiden mutation, Sulfonamide allergy and Latex allergy, all from an unknown date and unknown if ongoing. Concomitant medications included propranolol, hydrochlorothiazide and bupropion all taken for an unspecified indication, start and stop date were not reported. The patient previously took Rocephin, Vioxx and experienced allergy. Patient had not taken any other vaccines in four weeks and not taken other medications. Patient had COVID-19 prior to vaccination and not been tested post vaccination. On 20Aug2021 at 12:00 pm, 14 hours after vaccination patient experienced severe chills with fever that lasted about 3 hours body aches, headache, and fatigue which lasted about 24 hours. Then 3 days after the vaccination, had diarrhea for 36 hours on 22Aug2021. Therapeutic measures were taken as result of events included acetaminophen, and Imodium. The outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
24 hrs after DTaP/ MMR II, developed redness, swelling and induration around site, about 10 cm around. Started on PO bachrim for presumed cellultis. 0 improvement in 24 deg --> evaluated by Pedid in ED all meds d/c'ed.
Patient reported of fever early morning of 10/2. Started running fever of 102 degrees F. After notifying MD, they were instructed to stay hydrated and to take TYLENOL to reduce fever. In the afternoon, patient noticed red swollen spot on right arm 5 inches by 7 inches.
About a day or two after receiving the shot, my child got a runny nose. She now has a cough and her voice is hoarse in addition to the runny nose.
Started to hit his face, no eye contact, extremely aggressive less than 24 hours after last does of MMR. He had to see a psychologist and still does has behavioral issues. Added to database.
Information has been received from a physician concerning a 12 week old female who on 14-NOV-2006 was vaccinated with a dose of Rotateq (lot #655174/0848F), single dose, oral. Concomitant medication was not reported. On 08-DEC-2006, 24 days after administration of Rotateq, the patient developed rotavirus gastroenteritis. On an unspecified date, a stool culture was performed with results not reported. The patient was treated with hyoacyamine sulfate (LEVSIN), diet and oral fluids. The symptoms resolved on 11-DEC-2006 and the patient completely recovered from rotavirus gastroenteritis. Additional information has been requested.
Site of shots, arm swelled, formed a huge knot and large area of arm turned red. Spiked a fever for 3 days of over 102 degrees. Severe headache for 3 days. Severe muscle aches in entire body. Swelling under arm - like mumps. (-) diarrhea. But missed work on Friday and was so sick on Sat, Sun. and still having ill effects on Monday.
Information has been received from a health professional concerning an 11 year old white female with no allergies or medical history who on 09/05/2001 was vaccinated subcutaneously with a first dose varicella virus vaccine live.  There was no illness at the time of vaccination.  On 07/29/2004 the patient experienced vesicles on the trunk, back, and buttock.  It was noted that they were in various states.  The patient was seen by a nurse practitioner, symptomatic care was given and the patient recovered.  No laboratory tests were done.  Additional information is not expected.
Patient experienced swelling and redness at site of injection and was advised to use topical and oral BENADRYL.
Mom called and stated rash to both arms at injection site.  Rash to abdomen, chest, and back.
After receiving the first and second vaccine in this series, the patient experienced behavior that was out of the ordinary to include agitation, loss of appetite, and waking up screaming. After the first vaccination in the series these effects lasted for approximately one month. The patient had a visit with the pediatrician within a few weeks of the first vaccination and effects were thought to be related to a viral illness.
pt recv vax 22OCT96 in AM;evening 22OCT96 pt was brought to office w/following s/sx: extreme irritability for greater than 3hr, redness, tenderness to touch, & swelling of lt thigh;leg tender to movement;no fever, no rash, neuro exam WNL
Pt received  booster, waited 15 min observation then left. Pt came back stating her tongue was swelling. Vitals were normal. Pt then had trouble swallowing and difficulty breathing.  911 called, epi administered, and Dr monitored until ambulance arrived.  Pt taken to ED via ambulance.
The patient states that she had injection site pain. The pain began to radiate down the arm and up towards the neck. The patient was experiencing a headache. It was recommended that she take some TYLENOL and maybe place an ice pack on soreness if needed. If the pain persisted or got worse, it was recommended she see a doctor.
No additional adverse event; the patient was inadvertently administered a dose of VAQTA that was expired; This spontaneous report was received from a medical assistant and refers to a 11-week-old male patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 16-JUN-2020, the patient was inadvertently administered a dose of hepatitis a vaccine, inactivated (VAQTA) lot # S001832, expiration date 12-MAY-2020 (strength, exact dose and route of administration were not reported) for prophylaxis. No product quality complaint (PQC). No adverse events. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Fever, headache, joint pain and rash around eye... no medical treatment sought and condition has improved.
felt light headed and nausea immediately following vaccine  then felt left eye was dry and throat dry  then about 1 hour latter felt throat was tight and dry
Extremely itchy scalp for first hour. Then 3 days of hives, followed by ongoing dermatographia. Urticaria, pruritis.
Waking up with a sore at the site of injection; swollen arm at site of injection; that feels numb where injection was given; experienced soreness in left arm, body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (experienced soreness in left arm, body aches), VACCINATION SITE PAIN (Waking up with a sore at the site of injection), VACCINATION SITE SWELLING (swollen arm at site of injection) and VACCINATION SITE ANAESTHESIA (that feels numb where injection was given) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, ATORVASTATIN, VITAMIN B COMPLEX (VIT B COMPLEX) and BIOTIN for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced MYALGIA (experienced soreness in left arm, body aches). On 04-May-2021, the patient experienced VACCINATION SITE PAIN (Waking up with a sore at the site of injection), VACCINATION SITE SWELLING (swollen arm at site of injection) and VACCINATION SITE ANAESTHESIA (that feels numb where injection was given). At the time of the report, MYALGIA (experienced soreness in left arm, body aches), VACCINATION SITE PAIN (Waking up with a sore at the site of injection), VACCINATION SITE SWELLING (swollen arm at site of injection) and VACCINATION SITE ANAESTHESIA (that feels numb where injection was given) 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 did not provide any causality assessments.   Treatment product details not provided.
Pt has a rash on her face that is swollen and itching. Pt has blister on both hands. Pt tested Positive for Covid-19 on12/23/2020.
Extreme swelling, pain and redness at the injection site.  3? x 3? area. Showed up 8 days following the shot. Very hot to the touch. Fever of 101.
On day of admission patient was feeling fatigued and was at work when she had a syncopal episode.  She hit the back of her head. It is recommended that she stop her Plavix and warfarin until she follow-ups with neurosurgery in 2 weeks with a head CT previous. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Felt extreme nausea around 5:45 am, experienced dry heaving, fever, and sudden sensation of bm cramping for about 15 minutes. Fainted from a sitting position and woke up on the floor with a 2 inch knot on forehead and bruise on right shoulder from the fall. Believe I was passed out for 5-10 minutes. Experienced second wave of sudden nausea and cramping around 7 am.
This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unspecified date, the patient was vaccinated with one dose of improperly stored VARIVAX (Merck) injection (lot # L002217, expiration date: 21-JAN-2017) (dose and route of administration were not reported) following last temperature excursion of 7 degrees Fahrenheit for 48 hours. No adverse effects were reported. Details concerning previous temperature excursions were also provided: one at 18 degrees Fahrenheit for 15 hours and the other up to 14 degrees Fahrenheit for 323 hours and 7 minutes. This is one of two reports received from the same source. Additional information has been requested.
Pt c/o fatigue about 5 minutes after injection, then c/o "heart feels hot." Clarified that the "hot" feeling wasn't in chest/breast. B/P was 145/81; P was 86 and SpO2 was 98%. Denied shortness of breath or pain.  Pt provided with water and ice pack to left chest/axilla.  Stayed for approx 30 minutes reported feeling better. B/P was 150/80.
Patient here for scheduled 2nd dose of Pfizer Covid 19 vaccine.  Dose was given and an additional dose was inadvertently given a few moments later.  Doctor was notified and spoke with patient. Patient was monitored for 40 minutes and had no symptoms.  No problems were noted with patient and contact information was given to patient to contact us if there were any issues.  Doctor will be calling this afternoon to check on patient.
sore arm; This is a spontaneous report from two contactable physicians (patient) via Pfizer Sales Representative. Both physicians reported same event for 2 patients.   A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. It was reported patient had a sore arm. The two physicians both had the vaccine at the same time. The adverse event took place after Pfizer Product use. Outcome of the event was unknown.   Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044462 same reporter/drug, different patient/event
hard nodule at injection site; the shot was also very painful; rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site induration, injection site pain and rash. On an unknown date, the outcome of the injection site induration was recovered/resolved and the outcome of the injection site pain and rash were unknown.   It was unknown if the reporter considered the injection site induration, injection site pain and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the family member between ages of 55 to 60 received 1st dose of Shingrix. The patient developed a hard nodule in the left arm deltoid muscle which persisted for a few weeks and also the shot was very painful. The patient also developed a rash. The pharmacist did not know where the location of the rash or how long it lasted.  The pharmacist would call back with follow up information regarding the rash and when the patient received the injection. The reporter did not consent to follow up.
Had flu shot in the morning and by afternoon was very tired. Went to bed and had chills, muscle aches and pains, severe headache, weakness, possible fever but felt too bad to check it. Symptoms improved over 2-3 days but kept coming back milder. After 9 days, started to feel much better. However, have continual periods of severe leg weakness and aches as well as headache. Did use Tylenol on day 2 which helped with the headache. Have had flu shots for over 30 years and this was the first time I had a reaction. Also was the first time I had the Fluzone.
Information has been received from a registered nurse concerning a 12 year old white female with no medical history and no allergies who on 4/24/98 was vaccinated with a first dose of varicella virus vaccine live (lot # 624450/1423E). Concomitant medications the same day included a first dose of hepatitis B virus vaccine (lot # 623680/0747E) and a second dose of MMR (lot # 620880/0476E). On 6/8/04, the patient was seen with a mild case of chicken pox. It was noted that the patient had been exposed 2 weeks prior to her outbreak. The patient was treated with diphenhydramine and colloidal oatmeal baths. No product quality complaint was involved. Follow up information indicated that the patient's chicken pox started on 6/7/04. She presented to the office on 6/8/04 with an itchy rash with individual erythematous lesions. There was a cluster on buttock area near L4-L5 that spreads out towards the left and right hip. There were also scattered lesions on both upper this and lesions in the lower back area that have a vesicle appearance. The patient was instructed with in home care and was instructed to stay out of school until all lesions have scabbed over. No labs or diagnostic tests were done. It was reported that the patient recovered. It was also reported that two other patients were vaccinated with a dose of varicella virus vaccine live and developed chicken pox (WAES0406USA02749 and 0406USA02750). Additional information is not expoected.
headache, fatigue, muscle ache. extreme sensitive soreness of injection site, slightly raised.
Swollen lips.   Tongue is numb.  Itchy and puffy eyes.   Coughing.   Runny nose.  Chills.  Ache.
Head and nasal congestion; Head and nasal congestion; ear ache; body aches; fatigue; sore arm; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 22Jan2021,16:30 at SINGLE DOSE (first dose, left arm) for COVID-19 immunization. Medical history included allergies: Latex from an unspecified date. Patient did not have COVID-19 prior vaccination. Patient is not pregnant. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced head and nasal congestion, ear ache, body aches, fatigue and, sore arm all on 23Jan2021 01:00. No treatment was given. Patient was not tested for COVID-19 post vaccination. Outcome of the events was recovering.
Headache, tired, could not stay awake, chills, fever of 102, dizzy, sore muscles, sick at stomach, vomited... started 3/5/2021 early morning, felt some better by 3/6/2021 in the morning, but still headache, sore muscles, and tired, felt significantly better morning of 3/7/2021. On 3/7/2021 injection site on left arm became red, swollen, warm, and itchy about the size of a hand, also had a similar spot on thigh about size of golf ball. Arm very sore. Redness, swelling, and warmth on arm and thigh getting better within 24-36 hours after appearing. By 3/8/2021 all symptoms seem to be gone or extremely minor.
Vomiting, vertigo, fainting, migraine, nausea, body aches, fatigue
Initial injection was extremely painful with burning and stinging. Swelling, redness and pain at injection site approximately one hour after injection. Pain and redness spread around the injection site for the next 24 hours. Subsequently, had muscle pain, fever and loss of appetite for the next 24 hours. Used an ice pack on injection site for the next 48 hours. Injection site and surrounding area was red, swollen and painful for about 5 days. All symptoms were gone after one week following the injection.