chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient presented to emergency department on 2/9/22 with  chest congestion, cough, body aches chills fever st loss of taste and smell, runny nose st, fatigue weakness patient was admitted for further management of covid 19 patient was found to be covid-19 positive on 2/9/22 patient did not require treatment for symptoms associated with covid 19 infection patient was discharged to home on 2/12/22
No additional adverse events reported; VARIVAX was administered yesterday to one patient / Names of vaccines involved (...) VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 04-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # T032321, expiration date 22-SEP-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported). Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 7.7 degrees of Fahrenheit for 1 hour and 18 minutes. There was no previous temperature excursion reported. No additional adverse events reported.  On 13-AUG-2021, an inbound call was received from the medical assistant. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given the 1st dose of the Moderna Covid-19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given the 1st dose of the Moderna Covid-19 vaccine). On 28-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given the 1st dose of the Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Patient complains of shouldar pain since flu vaccine administration. Patient has been to MD for xrays (which show no sign of injury). Patient recieving care from MD.
This spontaneous report as received from a consumer refers to a 73 year old female patient with sulfa allergy. There was no pertinent medical history. On 22-OCT-2013 the patient was vaccinated with ZOSTAVAX in the left arm (dose and route were not provided). There were no concomitant medications. On 22-OCT-2013, a few hours after vaccination, the patient experienced pain at the injection site. On the next day, 23-OCT-2013, the patient experienced redness, extreme tiredness and swelling. The patient received treatment with ADVIL (dose and manufacturer not specified). The patient did not seek medical attention. No lab diagnostics studies were performed. The outcome of redness, pain at the injection site, extreme tiredness and swelling was reported as not recovered/not resolved. Additional information has been requested.
Immunization on left arm with redness around site, on back and neck. 30 mg of BENADRYL given with.
30min after shot-BOOSTRIX mom returned to office with patient. She said he got nauseated in the car, became pale, flailed with his arms & passed out for short time. No loss of control. BP-113/73 pale, alert/cooperative. No V/tired. Rested on side in office for 30min. Appt for EEG made (negative). Appt with neurologist available.
Osteoarthritis aggravated; Nodule on extremity; Tiredness; Low grade fever; Headache; Fall; Leg injury; Bruising; Knee injury; Skin abrasion; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (Knee injury), SKIN ABRASION (Skin abrasion), OSTEOARTHRITIS (Osteoarthritis aggravated), LIMB INJURY (Leg injury) and CONTUSION (Bruising) in a 58-year-old female patient 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 ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced JOINT INJURY (Knee injury), SKIN ABRASION (Skin abrasion), LIMB INJURY (Leg injury), CONTUSION (Bruising) and FALL (Fall). In September 2021, the patient experienced FATIGUE (Tiredness), PYREXIA (Low grade fever) and HEADACHE (Headache). On an unknown date, the patient experienced OSTEOARTHRITIS (Osteoarthritis aggravated) and NODULE (Nodule on extremity). At the time of the report, JOINT INJURY (Knee injury), SKIN ABRASION (Skin abrasion), OSTEOARTHRITIS (Osteoarthritis aggravated), LIMB INJURY (Leg injury), CONTUSION (Bruising), NODULE (Nodule on extremity), FALL (Fall), FATIGUE (Tiredness), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: low grade fever.         On unknown dates, the patient experienced osteoarthritis worsened and knots in hands. In 2021, the patient experienced felt down/hurt both legs and knees/ended up getting bruising and hands scrapped. In September 2021, the patient experienced tired, low grade fever and headache. Case level outcome was reported as worsened. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.
Patient was found down by neighbor.  Brought to hospital and found to have ischemic stroke of left thalamus and basal ganglia per Head CT.  CTA  was performed and did not show any evidence of occlusion.  CT chest/abd/pelvis was performed and negative for any metastases. Patient is still drowsy and unable to be taken off the ventilator.
5 Minutes after receiving his 1st dose of the Pfizer vaccine, pt told his wife he was not feeling well and slumped over.  He was trying to cough and was having a difficult time breathing.  He was not able to answer any questions.  We contacted 911 and quickly administered an EPIPEN 0.3mg.  Patient was responsive after that.
Patient reported Bell's Palsy-like symptoms. A drooping face, numbness, twitching/spasms of the tongue. This lasted for a few weeks, the patient reported.
Hx: Sustained head injury 11/10/11. Came to school health center 11/14/11 for rest due to headache, general malaise. Asked for flu vaccine before leaving. Developed (or had) 101.9 degree temp. that night (11/14/11).
pt recvd vax 1JUN93 crying spell for 2 mins; pt was in a daze then became limp;
resumed my normal activities in the afternoon and began noticing in the evening while casually sitting on couch intermittent skipped heart beats , sporadic not set pattern and this lasted for about 2 weeks before subsiding - now only occur occasionally
Dizziness; mild headache; This is a spontaneous report from a contactable consumer (patient) that a 65-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) via an unspecified route of administration on 25Feb2021 at 13:30 (65-year-old at vaccination), at single dose at left arm, for covid-19 immunization. The patient's medical history included blood pressure. The patient did not have allergies to medication, food, or other products. Concomitant medications included unspecified medication for blood pressure. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at upper left arm at single dose for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced dizziness and mild headache on 26Feb2021 at 04:00. Seriousness was reported as no, there was no result in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapability, no abnomaly/birth defect. Therapeutic measures were taken as a result of the events and included naproxen sodium (ALEVE). The outcome of the events was recovered in Feb2021.
no voice due to swelling in her throat; hives; redness; Swelling; allergic reaction; cannot speak; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), ERYTHEMA (redness), SWELLING (Swelling), PHARYNGEAL SWELLING (no voice due to swelling in her throat) and SPEECH DISORDER (cannot speak) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (History of allergies.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. In January 2021, the patient experienced SPEECH DISORDER (cannot speak). On 22-Jan-2021, the patient experienced URTICARIA (hives), ERYTHEMA (redness), SWELLING (Swelling) and HYPERSENSITIVITY (allergic reaction). On an unknown date, the patient experienced PHARYNGEAL SWELLING (no voice due to swelling in her throat). The patient was treated with PREDNISONE for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. At the time of the report, URTICARIA (hives), ERYTHEMA (redness), SWELLING (Swelling), PHARYNGEAL SWELLING (no voice due to swelling in her throat), SPEECH DISORDER (cannot speak) and HYPERSENSITIVITY (allergic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Severe headache, nausea, lump around injection site, sore/itchy arm
Swelling in arm. Visited MD office, Dr observed swelling, told her to take ibuprofen - on ADACEL arm.
3.5x5cm area of redness/ induration/ swelling and warmth in right deltoid area began on 7/8/04 at 1500. Minimal progression in size when seen in office at 0900 on 7/9/04. Given Benadryl and Ibuprofen.
Started with rash to bilateral lower legs on 4/5/2021, petechial in nature, no itching/pain
Breakthrough case admission after 3 vaccines Moderna 3/27/21 Lot# 018B21A;  Moderna 4/24/21 Lot# 043B21A;  Moderna 11/11/21 Lot# 033F21
Patient stated she developed a rash at the injection site. She received two vaccines at the same day and said the rash was at the bottom of the two injections. The Adacel was IM given on the upper arm and the Zostavax was the lower injection site. Patient stated on 7/29/15 that the rash was coin size with no blisters. Patient did not develop a fever, no trouble breathing or any signs of anaphylaxis.
This is to report an adverse reaction in my nursing baby.  Starting the first afternoon after my vaccination, she broke out in a rash on her face and neck which later spread to her upper/middle trunk and also became a diaper rash.  She was fussy and had loose bowels for 5-7 days. And  bowel consistency still hasn?t returned to normal after 1 month. The rash is still here and will wax & wane and continue as I nurse her. Rash had a burn appearance initially and skin would open and peel. The rash sometimes looks like and behaves like exzema but also other times as the skin has healed, we see a spider-like capillary design under her almost healed skin which will then flare and erupt again.  It appears to be an inflammatory response.  Same baby had a similar reaction on a much much smaller scale after the first shot 28 days prior. (Dec. 20, 2021)  We are still battling this 1 month later.
went into coma; had no energy; was knocked out/ was in bed for 30hrs; very tired; This spontaneous case was reported by a consumer and describes the occurrence of COMA (went into coma) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu-like illness in March 2021.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COMA (went into coma) (seriousness criterion medically significant), ASTHENIA (had no energy), KNEE DEFORMITY (was knocked out/ was in bed for 30hrs) and FATIGUE (very tired). At the time of the report, COMA (went into coma), ASTHENIA (had no energy), KNEE DEFORMITY (was knocked out/ was in bed for 30hrs) and FATIGUE (very tired) outcome was unknown.            No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter  This case concerns a 61 year-old, male subject with no significant medical history, who experienced the unexpected event of coma and non-serious events of asthenia, knee deformity and fatigue. The event occurred on an unknown date. The rechallenge is not applicable in this case. The reporter's assessment is not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 61 year-old, male subject with no significant medical history, who experienced the unexpected event of coma and non-serious events of asthenia, knee deformity and fatigue. The event occurred on an unknown date. The rechallenge is not applicable in this case. The reporter's assessment is not provided. The benefit-risk relationship of the vaccine is not affected by this report
Patient admitted following a syncopal episode which was found to be likely due to dehydration, orthostatic hypotension, and post-operative pain after ORIF.
Headache, Myalgia, RespDepression, CHILLS AND PAIN Narrative:
Tired; numb and limpy; numb and limpy; This is a spontaneous report based on information received by Pfizer from  non-contactable consumer or other non hcp. A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 25Feb2021 (age at vaccination was 64 years) as dose 1, single for COVID-19 immunization. The patient's medical history included mycotic allergy, white blood cell count decreased and disorientation from an unknown date and unknown if ongoing. Concomitant medication included ocrelizumab, furosemide, spironolactone, baclofen, lubiprostone (AMITIZA) and isoleucine, leucine, levocarnitine, valine (BCAA & L CARNITINE) taken for an unspecified indication, start and stop date were not reported. On 25Feb2021 the patient experienced tired, numb and limpy. The patient underwent lab tests and procedures which included white blood cell count which showed low result (Low white blood cells, Disoriented) on an unspecified date. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient stated that the puncture site where vaccine was applied is really sore. He also stated and show me his right armpit was inflamed or/and swollen. Patient stated that it is really painful.
the blister has been crusted up and was aggravating; The crusty area has pus attached to it and left a deep hole in her lip; lips were swollen; fever blister; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 05:00 as dose 3 (booster), 15 ug single (Lot number: GH9697) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure abnormal"; "COVID", start date: 24Apr2022 (not ongoing), notes: She had been sick for 5 days when she tested positive for COVID. Concomitant medication(s) included: VALSARTAN taken for blood pressure abnormal (ongoing). Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: BLISTER INFECTED (non-serious) with onset 07Oct2022 at 06:00, outcome "unknown", described as "The crusty area has pus attached to it and left a deep hole in her lip"; ORAL HERPES (non-serious) with onset 07Oct2022 at 06:00, outcome "unknown", described as "fever blister"; LIP SWELLING (non-serious) with onset 07Oct2022 at 06:00, outcome "unknown", described as "lips were swollen"; SCAB (non-serious) with onset 11Oct2022, outcome "not recovered", described as "the blister has been crusted up and was aggravating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blister infected. Additional information: 2 and a half days after getting the 3rd booster dose, around 6 AM Friday morning (07Oct2022), she noticed that her lips were swollen and noticed 3 huge blisters on her lip and not on the cluster and was advised by her doctor that it might have been a fever blister. Today (11Oct2022), the blister has been crusted up and was aggravating for her since she never had anything like this happen to her in her life. The crusty area has pus attached to it and left a deep hole in her lip. She attempted to send a picture over to her physician but for some reason the air was not good for pictures; she was asking if this could be a side effect of her shot; he did not think so at the time but sent medication over for a fever blister. She is curious because this thing eventually just crusted up and made a huge scab on her lip, the scab this morning (11Oct2022) fell off on it is own and underneath it was pus and the hole in her lip is several layers deep. It confused her that the 3rd booster dose was her 5th shot (as reported, pending clarification).  Follow-Up (14Oct2022): Follow-up attempts are completed. No further information is expected.
the syringe was left out beyond the use date and time. No one discarded them at the end of the day and the medical assistant gave it beyond the use date and time.
Local soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Local soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (PCN-Pain meds), Depression and Hypothyroidism. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) from 02-Jan-2012 to an unknown date for Depression, THYROID for Hypothyroidism.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MYALGIA (Local soreness). At the time of the report, MYALGIA (Local soreness) outcome was unknown.            No treatments information was provided.   This case was linked to MOD-2021-363387, MOD-2021-305281 (Patient Link).
Pt c/o dizziness and nausea. Vitals 170/80 BP, HR 129. Given OJ and water. Observed for 30 minutes. Symptoms greatly improved. Last set of vitals 160/84, HR 99. Left with husband.
FEVER, HOT FLASHES AND A TIGHT FEELING IN THE UPPER CHEST REGION.  EVENT LASTED FOR 2 HOURS.
Pt. received her second DTap on 4/19/2023. Dad does not think that there was any initial reaction but pt. thinks there was some initial redness and itching. Two days ago mom notes there was some swelling and a hive like lesion that was itchy but nothing more significant. Yesterday when she woke up there was some redness but no hives and no itching. Later in the day yesterday the school nurse called mom due to significant redness and swelling at the site. Pt. states the area was burning and sore tender to touch and warm. It was a little itchy as well. There has been no fever and no systemic symptoms. Mom called this office and was instructed to give benadryl and start cephalexin for cellulitis.   Pt. notes improvement in her symptoms after both the benadryl and the antibiotics. Per triage nurse call, mom marked the redness and swelling with a sharpie to monitor redness. Pt. and dad deny any fever or other symptoms. Pt. feels much better today.   Of note dad notes several siblings have had various significant reactions to tetanus vaccines in the past and both mom and dad are concerned this is a significant reaction to tetanus for pt.
This is in follow-up to report(s) previously submitted on 5/14/2008: 7/8/2008. Information has been received from a mother concerning her 17 year old daughter with depression and no known drug allergies, who on 28-MAR-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified), LEXAPRO and ABILIFY.  The patient also received MENACTRA on the same day she received GARDASIL.  Four days after receiving her first dose of GARDASIL the patient tested HPV positive.  Medical attention was sought via telephone.  The patient had not recovered.  No product quality complaint was involved.  Follow up information received from the physician indicated that the patient received her GARDASIL in another physician's office. Follow up information was received on 01-JUL-2008. A health care professional reaported that the patient received the dose of GARDASIL at another office. She also reported that the patient was seen at their office on 31-MAR-2008 for an annual pap smear which came back with positivefor HPV. The laboratory results were as follow: Cervical HPV came back positive: hybrid capture 2 tests for high risk HPV types 16/18/31/33/35/39/45/51/52/56/58/59/66. Chlamydia PCR and gonorrhoeae were not detected. Additional information is not expected. This is in follow-up to report(s) previously submitted on 5/14/2008. Follow up information received from the physician indicated that the patient received her GARDASIL in another physician's office. Additional information has been requested.
This spontaneous report as received from a nurse refers to multiple unspecified patients. No information regarding the patients' concurrent conditions, medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, oral liquid (dose was not provided; lot # L027076 and expiration dates: 25-MAY-2017). No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010369: US-009507513-1612USA003300: US-009507513-1612USA003298.
Warm sensation, sweating and feeling "jittery." Lasted for 1 hour. Reassured. Resolved spontaneously.
Influenza vaccine administered at school. I do not have any of the info re: lot #, manufacturer, dose number. Appears to have been administered at Right Deltoid.
Pt. received Var shot 2/17/17. On 3/1/17, pt. had rash that looked like pus filled blisters, very itchy, fever 101-103 F since 2/28/17. Pt. came in 3/1/17 and confirmed Dx varicella with Dr. Pt. was stable. Pt. returned to Dr. and was given ABX, acyclovir and VIROPTIC Drops, on 3/3/17.