chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/19/2022 Employee called the Vaccine Support line to report symptoms post COVID-19 Pfizer booster. Vaccine Name - Pfizer Vaccine Date - 1.18.2022 / Location: Left Deltoid Booster Dose - Yes Date of Symptom Onset - 1.18.2022 Symptoms - Pain to L arm, scratchy throat, clammy feeling, fatigue Home Remedies - Ibuprofen, 600 mg, 1 tablet, taken once Tuesday, 1/18/22 Any Improvement - Yes
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was severe sepsis.
Information has been received from a physician concerning a 25 year old female teacher with no know drug allergy who on 01-APR-2009 was vaccinated with the first dose of GARDASIL IM 0.5 ml into deltoid (lot # 661846/1312X). On 05-APR-2009 the patient started vomiting every 0.5 hour for 12 hours accompanied with a fever. The patient felt better better but still felt dehydrated. The patient was able to eat at the report time. Additional information has been requested.
improperly stored vaccine administered to patient; This spontaneous report has been received from a physician concerning a 66 year old patient with unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 24-AUG-2020, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T009744, expiration date on 28-JAN-2022, 0.5 milliliter for prophylaxis (product storage error). Dose number, route of administration and anatomical location were not provided.  It was reported that on an unspecified date, the vaccine was exposed to a temperature of 48.39 Fahrenheit degrees for 1 hour and 45 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T009744; expirationdate: 28-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Headache; Pain is moving to her armpit and her left side of back; Pain is moving to her armpit and her left side of back; Two hours after vaccine, pain from shoulder to hand; Couldnt move her arm due to pain, four hours after vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MOVEMENT DISORDER (Couldnt move her arm due to pain, four hours after vaccine), BACK PAIN (Pain is moving to her armpit and her left side of back), AXILLARY PAIN (Pain is moving to her armpit and her left side of back), ARTHRALGIA (Two hours after vaccine, pain from shoulder to hand) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced MOVEMENT DISORDER (Couldnt move her arm due to pain, four hours after vaccine), AXILLARY PAIN (Pain is moving to her armpit and her left side of back) and ARTHRALGIA (Two hours after vaccine, pain from shoulder to hand). On 22-Mar-2021, the patient experienced BACK PAIN (Pain is moving to her armpit and her left side of back). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, MOVEMENT DISORDER (Couldnt move her arm due to pain, four hours after vaccine), BACK PAIN (Pain is moving to her armpit and her left side of back), AXILLARY PAIN (Pain is moving to her armpit and her left side of back), ARTHRALGIA (Two hours after vaccine, pain from shoulder to hand) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Headache. Mild headache post vaccine for 2 days. Then post vaccine about 6-7 days severe headache lasting for over 30 days. Headaches now come and go multiple times per day but never quite go away.  Historically I have very rarely had headaches. My first Covid Vaccines were Pfizer and no reaction whatsoever. The Vaccine on June 15, 2023 was Moderna. OTC meds like aspirin, ibuprofen or tylenol do not help. No other symptoms.
Rash over the left  scapula with burning and itching and weeping.  Came on approximately 24 to 36 hours after immunization.
Rash that started on hands/arms and scalp and then covered entire body excluding face. The next day had trouble swallowing and talking/throat was swelling up so went to urgent care which then directed her to hospital for treatment. Given IV medications and sent home with prednisone, pepcid and benadryl treatment for anaphylactic reaction
Throwing up; Cold; chilled; feeling horrible; achy body; headache; no energy; extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A adult non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 22Apr2021 13:15 as dose 2, single for COVID-19 immunization. No other vaccine was received in four weeks. Other medication in two weeks. No COVID prior vaccination and not tested post vaccination. There are no known allergies. Medical history included osteoarthritis from an unknown start and stop date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:30 as dose 1, single for COVID-19 immunization and experienced ocular migraine. The patient experienced throwing up, cold, chilled, feeling horrible, achy body, headache, no energy and extreme fatigue on 22Apr2021 22:15. The patient underwent lab tests and procedures which included ophthalmological examination: unknown on an unspecified date. The adverse events were considered as non-serious. AE was resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of throwing up, cold, chilled, feeling horrible, achy body, headache, no energy and extreme fatigue included eye exam. The outcome of the events throwing up, cold, chilled, feeling horrible, achy body, headache, no energy and extreme fatigue recovered on 23Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient presented to the ED and was subsequently hospitalized on 3/19/21; within 6 weeks of receiving COVID vaccination.
Smallpox administered 29 Apr 05.  Member noted non-pyretic body rash day #14.
Irregular heart beat; Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administration date 27Jul2021 (Lot number: FA7984) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: HEART RATE IRREGULAR (non-serious) with onset Jul2021, outcome "recovered" (2021), described as "Irregular heart beat"; CHEST PAIN (non-serious) with onset Jul2021, outcome "recovered" (2021), described as "Chest pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller was a caregiver, calling about the Pfizer covid 19 vaccine. Caller reported that her 14 year old son has a condition. Caller said her son received the first dose of the vaccine about four weeks ago. He experienced an irregular heart beat and chest pain for two days, and then two additional days. Caller said the second dose is due now. Caller asked if there was an option for splitting the second dose or giving a lesser amount than usual for the second dose. Caller asked if there was any information on if delaying the second dose reduces the side effects. Caller mentioned that she was aware in withheld and withheld the doses are given 6 weeks apart and in withheld 8 weeks apart. Response: Provided off label response to caller. She was an occupation therapist. Confirmed that this was the first dose, given on 27Jul2021 with a lot: FA7984. This started about 24 hours after getting the dose and confirms it was for 2 days, stopped for a bit and then lasted another 2 days. At this point, it has completely resolved. She states she is nervous about him getting the second vaccine. Caller asked if kids experience side effects from the first dose are they more likely to experience side effects with the second dose.  No follow-up attempts are possible. No further information was expected.
This spontaneous report was received from patient's mother via company representative refers to a 11 year old male patient. Medical history was not reported. In September 2013 the patient was vaccinated with the first dose of GARDASIL the second dose was administered in November 2013 and the third dose was administered on 27-MAR-2014, the lot number, expiration date, strength and route were not reported for all of them. Concomitant therapy was not reported. The consumer informed that approximately on 10-APR-2014 (also reported as two weeks after the third dose) her son felt weak and fatigued and patches of his hair began to fall out. Also informed that she took her son to see a dermatologist who diagnosed her son with alopecia. A topical ointment was used on the patient's scalp to prevent further hair loss, therefore the patient began receiving shots in his scalp. The consumer also stated that on approximately August 2014, her son just got three warts on his hand and he was still tired, which was causing him significant distress. The reporter considered that the events caused significant disability or incapacity to the patient. The outcome of the events was not recovered. Additional information is not expected because the reporter refuse the contact with the physician.
Patient had fever and body aches 1 day after receiving vaccine.  Patient had pain, swelling and bruising  near and around the injection site 2 days after injection, along with swelling and pain on chest near breast area. Patient is currently taking Tylenol and will begin using ice packs or cold compress as well.
Information has been received from a physician and a nurse concerning a 17 year old female who was vaccinated with Gardasil (lot number unknown).  Right after administration of the vaccine, the patient experienced hot flashes, reddening of the face, dizziness and sweating on her head.  The patient's outcome was not reported.  Additional information has been requested.
Woke up in the night with extreme chills, layered up to warm myself and fell back asleep.  I then woke up soaking wet in a sweat.. the following morning I was very dizzy, stumbling around with bad balance. Throughout the day the headaches continued with blurred  vision. Extreme aches and pains followed , specifically on my left side. The pain is coming in waves, It feels like it?s behind my eyes.  Temperature as of today (Thursday) read 100.5. I?m very fatigued with brain fog and severe muscle aches
Headache, fever over 100 degrees. Weakness, loss of appetite for almost 2 weeks now.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; 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) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 12:25 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 12:25 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 63.87 years.  No concomitant product use was reported.  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 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored on cooler 1, on 08-Feb-2021, excursion time at 9 am 36, at 10 am 29, at 11 am 35, at 12 am 38, at 1 pm 43, at 2 pm 42, at 3 pm 42, at 4 pm.   On 08-Feb-2021, total doses given for the day was 30, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 02-Feb-2021, vial was moved to clinic on 08-Feb-2021. 3 vials were moved to clinic. Vaccine BUD date was 04-Mar-2021.  Vials only punctured right before administration.  No treatment information was provided.
PENTACEL was reconstituted with regular diluent (sterile water). The nurse did not grab the correct diluent from the PENTACEL box.
Severe Vaginal discharge and Vaginal pain, 48 hours after vaccination shot. Contacted local Health for a virtual appointment via smartphone. My local Health Clinician agreed that my symptoms are consistent with a vaginal yeast infection. She prescribed a Diflucan tablet and she called it into my pharmacy so I can pick it up tomorrow.
received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired vaccine) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired vaccine). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Non-significant follow up updated reporter details
On Tuesday patient reports a lump at vaccination site accompanied by redness, warmth & itching. She called me at the pharmacy on Wednesday (9/21) to report this. I recommended she take diphenhydramine 25mg, ibuprofen 600mg and use ice as needed for the warmth and itching. Also she was going to take a CLARITIN 10mg the next morning. I followed up with her Thursday (9/22) afternoon. She reported the warmth and itching had subsided but the lump was still present. She was going to call her primary care physician today (9/23) to let him know and to ask if she should be seen or wait thru the weekend.
12/09/21 presents to FBC Triage for "SVD (spontaneous vaginal delivery)" PMHx "chicken pox".
Had fever and aches on day 2 or 1/19/2021 . Fever up to 102. Resolved day 3 1/20/2021.
like a flu; suffer migraines; Cough; have temperature; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like a flu), MIGRAINE (suffer migraines), COUGH (Cough), PYREXIA (have temperature) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (like a flu), MIGRAINE (suffer migraines), COUGH (Cough), PYREXIA (have temperature), CHILLS (chills) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (like a flu), MIGRAINE (suffer migraines), COUGH (Cough), PYREXIA (have temperature), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            Concomitant medication of the patient was not reported.   After the headache, the patient put some fresh water in the head. Treatment information for rest of the events were not reported by the reporter.   This case was linked to MOD-2021-416050 (Patient Link).
Symptoms started approximately 30 minutes after administering the vaccine.  She first had a runny nose around 12:15 pm and then a cough started.  Shortly after her eyes became red and then had shortness of breath and tightness in her chest.  Her pulse (~168 bpm) was taken around 12:30 and an EpiPen was given 1:34 pm.  She was observed for the next 4 hours.  Her vitals were taken every 15 minutes for the first hour following the epipen.  After the Epipen she was given Loratadine 10mg, then a snack and water to take 10 mg prednisone and 20 mg omeprazole.   After 3 pm she started to cough again and her vitals were taken every 5 minutes. She was released at 4:30 pm, and took another 10 mg Prednisone before leaving.
Patient is a 50 y.o. female patient of Provider Not in System with history of PE/DVT, Alcohol abuse, Anemia, FMS, Hyperaldosteronism, Lymphedema, Neuropathy, presented with alcohol withdrawal and covid.   Covid-19 Virus Infection Date of onset of symptoms: 12/29 Symptoms present on admission: sore throat, cough, rhinorrhea, diarrhea, nausea Date of covid positive test: 12/30 Vaccination status: Incompletely vaccinated Imaging: CXR no acute finding Oxygen requirements on admission: none Current oxygen requirements: none Medical therapy: not indicated.  Patient requesting to be initiated on Paxilovid. States that she had severe COVID a year ago which required her to be hospitalized.  Consult ID for further recommendation. Started on Remdesivir 01/03 Consultants following: ID Anticipated special isolation end date: 1/8   Alcohol withdrawal Pt states she had two "seizures" at home described as shaking although no acidosis on chem Has had phenobarb detox several times before but continues to drink Completed phenobarb taper Also complaining of increased anxiety which likely is triggering her alcohol consumption. BH consulted. Appreciate assistance. Continue Seroquel for anxiety   Hyponatremia Hypokalemia improved   Transaminitis AST 54, ALT 50; likely due to alcohol Improved   Leg pain Hx of lymphedema, neuropathy and DVT Lower extremity Dopplers negative for DVT Continue home dose of torsemide and as needed Norco for pain   Morbid obesity BMI 54.07; LSM recommended Needs sleep study
magnesium was a bit low; vomiting; Severe nausea/queasy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD MAGNESIUM DECREASED (magnesium was a bit low), VOMITING (vomiting) and NAUSEA (Severe nausea/queasy) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced BLOOD MAGNESIUM DECREASED (magnesium was a bit low), VOMITING (vomiting) and NAUSEA (Severe nausea/queasy). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency; SODIUM CHLORIDE (intravenous) for Adverse event, at an unspecified dose and frequency; CALCIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE (LACTATED RINGERS) for Adverse event, at an unspecified dose and frequency; MAGNESIUM OXIDE for Adverse event, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency. On 28-Mar-2021, BLOOD MAGNESIUM DECREASED (magnesium was a bit low) and VOMITING (vomiting) had resolved. At the time of the report, NAUSEA (Severe nausea/queasy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company Comment: This case concerns a 23-year-old female patient with no details on relevant medical history, who experienced the unexpected non serious events of Nausea, Vomiting and the unexpected non serious event of Blood magnesium decreased after mRNA- 1273 Moderna vaccine. The onset of the events occurred aproximatedly 1 day after the first dose of mRNA- 1273 vaccine. Patient was observed in the emergency department for two to three hours, fluids and magnesium were replaced and ondansetron was given. The rechallenge is not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Upon internal review on 16-Nov-2021, Company comment was added in the case.; Sender's Comments: This case concerns a 23-year-old female patient with no details on relevant medical history, who experienced the unexpected non serious events of Nausea, Vomiting and the unexpected non serious event of Blood magnesium decreased after mRNA- 1273 Moderna vaccine. The onset of the events occurred aproximatedly 1 day after the first dose of mRNA- 1273 vaccine. Patient was observed in the emergency department for two to three hours, fluids and magnesium were replaced and ondansetron was given. The rechallenge is not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
After getting shot in the morning was very tired by 9PM. went to bed.  Tues morn had flu-like symptoms and only got out of bed to go to the bathroom. Severe symptoms lasted 24 hours.  Took 7 days to get total strength back