chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 62-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. The vial was initially stored in the refrigerator on 14-Mar-2022. The vial did not undergo any temperature excursions. No concomitant medication reported. No treatment medication details reported.
Chest Pains 24 hours after vaccine. Lasted two days. No Treatment. Went away on its own.  Sharp Stomach Cramps 48 hours after vaccine- 04/09-No Treatment. Ended 04/13.  Irregular Menstrual Cycle. Period not due for 3 weeks and started in middle of birth control packet (Lo Loestrin Fe (doesn't usually have a normal flow of blood on birth control)- 04/11 coupled with fatigue and headache. It is 04/13 and am currently still bleeding.
Fatigue; Headache; Upper Body Pain; Elevated Temperature (98.8F - High for Her; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive COVID-19 test), ASTHMA (Asthma), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Upper Body Pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Upper Body Pain) and PYREXIA (Elevated Temperature (98.8F - High for Her). On 22-Jan-2021, the patient experienced COVID-19 (Positive COVID-19 test). On an unknown date, the patient experienced ASTHMA (Asthma). At the time of the report, COVID-19 (Positive COVID-19 test), ASTHMA (Asthma), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Upper Body Pain) and PYREXIA (Elevated Temperature (98.8F - High for Her) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The consumer is reports being diagnosed with Asthma and takes "Teva" (Albuterol) to alleviate her flare ups.  Concomitant and treatment information not provided
Severe crying, high fever 102.5, body stiffening, WBC elevated 24,000, wheezing, decreased Sa O2 (85%). Nebulization, lab work, hospital observation.  7/17/2008 MR received for ER visit 6/09/2008 with DX: Febrile Illness, possible vaccine reaction.  Acute respiratory distress. Infant presented with acute onset of markedly increased temp, wheezing, respiratory distress and severe screaming which developed several hours after receiving 4 mon vax. Given neb en route with improvement noted. Observed o/n and d/c in am.
Pt described only having these effects after the second vaccine (not the first) in the series and wanted to help contribute to post marketing data. She reported adverse effects of malaise, fatigue, and very sore arm at injection site that she states she did not have the fatigue or malaise after the first shot of the series. These adverse effects are consistent with the adverse effects known of the vaccine but she only got them on the second dose.
Information has been received from a licensed practical nurse concerning a 6 year old female who has partial seizure activity and associated migraine headache. On 10/15/1996, she was vaccinated with varicella vaccine in the lower left thigh. The pt was seen in the dr's office on 05/02/2001 with a headache, low grade fever and greater than 50 vesicular lesions. She was diagnosed with chicken pox and recovered after seven days. Additional info is not expected.
This spontaneous report as received from a consumer on behalf of daughter refers to many of her friend's children (anonymous). On an unspecified date the patients were vaccinated with M-M-R II (lot # not reported). On an unknown date the patients have had behavioral changes after receiving the vaccinations. The outcome of behavioral changes were unknown. Additional information is not expected.
I woke up about 3am with a fever and freezing to death. I was very lethargic. As the days progressed, I became very weak and wanted to sleep all of the time. I lost my appetite, taste and smell. I was tested for COVID on 1/12 and found out I was positive the next day. I was out of work for 2 weeks and returned to work on 1/25/21. I got an infusion on 1/20 so I can't get my 2nd dose until 90 days after that date.
SEVERE SWELLING IN BOTH CHEEKS AND NECK AREA.  ACHES IN NECK, CHEEKS AND EARS.  EXTREME DISCOMFORT, STUFFINESS, AND TIGHTNESS IN NECK AREA.
BNT162B2: Treatment of COVID-19; BNT162B2: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for 1 day for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "BNT162B2: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fever: started around 10pm the night of and went on until around 11am the next day Nausea:on and off for 24 hours  Body aches: 24 hours Faint:12 hours
Upon request of Rabies shot I went out to ask what # shot was. He said this would be his 2nd for his dog bite. I checked & realized we don't give this shot per Pharmacy Policy. They need to see an MD anyways to get Igg! I denied 2nd shot! Drug Co. said pt. is going to be fine!
received her second dose of Moderna by LPN. She received her vaccination at 0857. Patient complains of facial tingling on left side of left side of face, under her eye. Blood pressure taken at 0900 146/93, HR 68. At 0914 Pt stated that it has went down to 20%. At 0936, Pt BP 139/90. Pt states she feels fine. Pt left at 0939.
dose administered to patient after more than 1 temperature excursion; dose administered to patient 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 (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 11:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:49 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient 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.   Age of patient was reported as 51.38 for dose administered on 31-Mar-2021 and 51.30 for dose administered on 03-Mar-2021. No concomitant medications were reported.  Batch number 030B21A administered on 31-Mar-2021 underwent temperature excursion with temperature of 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021.  Batch number 014M20A administered on 03-Mar-2021 underwent temperature excursion with temperature range of 51 to 35 degrees Fahrenheit at 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Pt vaccinated with Influenza Vaccine 3-4 days after, pt had a seizure like episode at home, was found unresponsive and hospitalized. Admitted to ICU for 5 days. Treatment included oxygen and IV fluids. Discharged, admitted to Nursing Home.
Face numbness an hour or two after shot,  small difficulty closing lips to swallow ( resolved fully in about 3 hours) Pain in fingers/toes started intermittently- strong throbbing pain.  Mostly in toes  Pain changed over days to raw nerve pain in all toes that would activate with slightest brush of sheet.  Burning in feet delveloped.  About a week out burning in most of both arms as well.  No resolution of symptoms.
This spontaneous report was received from a nurse referring to one of two 5 months old patients (twins) the gender was unknown. The patient's medical history or concurrent conditions were not reported. On 28-SEP-2016, on 28-OCT-2016 and on 27-MAR-2017, a day before the patient was 6 months old, the patient was vaccinated with the first, second an third respectively doses of RECOMBIVAX HB the route was not reported (which had the lot # M039642, expiration date 03-JUL-2019). On unknown dates, and also on 27-MAR-2017, the patient was vaccinated with the first, second and third doses of ROTATEQ orally (which had the lot # M042822, expiration date 19-JUN-2018 or M039068, expiration date 19-APR-2018) both vaccines for prophylaxis. No adverse effects were reported. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012538:
Diarrhea; Body Aches; Nausea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MYALGIA (Body Aches), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), MYALGIA (Body Aches), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 16-Mar-2021, DIARRHOEA (Diarrhea), MYALGIA (Body Aches), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
This spontaneous report as received from a pharmacy student refers to a patient of unknown age. This case was linked to case 1302USA011365 (same reporter). On 11-FEB-2013 the patient was vaccinated with live ZOSTAVAX (lot # 671455/1256AA, expiration date 11-JAN-2012). On 11-FEB-2013 the patient received expired live ZOSTAVAX. No adverse event was reported. Additional information has been requested.
Swollen R arm from shoulder to elbow, mildly pink, not warm or tender given Advil and Benadryl
Pt vax w/ MMR; devel urticaria on both thighs + scattered purpura on shoulders.
Patient's husband reported wife's reaction as follows: Next day, patient was so weak that she could not get out of bed and needed to be carried out of the bath tub. Also experienced shallow breathing, inalertness, and severe fatigue for 3 days after immunization administration. No swelling, fever, or infection symptoms reported.
PT RECIEVED INJECTION ON 9-16; REPORTED ARM SORNESS AT INJECTION SITE AND SYNCOPE ON 9-17. PT PASSED OUT AND INJURED LEG DURING FALL. PT WAS TAKEN TO THE HOSPITAL WHERE TESTS WERE RUN.
Pt comes with generalized weakness, cough, and increased shortness of breath for 1 weak.  He tested positive for COVID 6 days ago.  CXR consistent with COVID-19 pneumonia.
Pt inadvertently received Moderna vaccine for second dose.  Her first dose was Pfizer on 02/10/2021.   She initially could not find her card, and thought she had received Moderna.   She reports no side effects at all.
I was about 5 weeks pregnant at time of vaccination, expected due date was June 2022. A miscarriage resulted within a month of receiving the Covid vaccine. On October 22 I went to urgent care due to vaginal bleeding and was told that I had a miscarriage. MD stated the miscarriage did not occur that day as evidenced by my HCG levels.
Patient received both H1N1 and Seasonal vaccines at 12:25 PM. Didn't experience AE until approximately 4pm when patient began feeling unusual - Unusual feelings included: voice changes, coughing, lower neck and chest pains and tightening. Was taken to hospital and treated with IV BENADRYL & SOLU-MEDROL.
Irregular menstrual bleeding on Nexplanon. Currently now having monthly period and spotting, which I did not experience before the shot.
feeling hot, sweating, dizziness, blurred vision, paleness, darkening of vision, nausea. Patient was given cold compress on back of neck. symptoms began improving.  Patient leaned forward to put head in friends lap. She communicated her symptoms clearly the entire time. Patient fully recovered.
Pain and difficulty urinating, large amount of blood in urine, continuing for 40 hours.
This spontaneous report was received from a pharmacist via Pfizer concerning a 55 year old female patient. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dosing regimen, route, lot# and expiry date not reported). On an unspecified date, the patient experienced pseudocellulitis. It was reported that the symptoms had resolved after a week or so. The reporter's causality assessment was not provided.
Patient is 17 months out from 1st dose / 2nd dose still valid or should she restart; This case was reported by a other health professional via Shingrix GSK interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose of Shingrix, 17 months ago prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of vaccination, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter enquired if the second dose was still valid or the patient  should restart the series.
ARM NUMBNESS; ARM BURNING; SWELLING DOWN ARM TO FINGER TIPS; DIZZINESS UPON STANDING; HEADACHE; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported, the company was not able to follow up. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced arm numbness. On 15-MAR-2021, the subject experienced arm burning. On 15-MAR-2021, the subject experienced swelling down arm to finger tips. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced dizziness upon standing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm numbness, arm burning, swelling down arm to finger tips, and dizziness upon standing, and the outcome of headache was not reported. This report was non-serious.
Chills; Redness at the injection site (right arm); This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness at the injection site (right arm)) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness at the injection site (right arm)). At the time of the report, CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness at the injection site (right arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
Patient reported swelling, redness in cheeks ~2 hours after administration, which was observed. Treatment was refused.
Shingles on his scalp; This case was reported by a consumer via other manufacturer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received Shingrix. On 21st September 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter representative reported an adverse event with Shingrix vaccine. The patient received Shingrix in the pharmacy and got a Shingles on his scalp. The reporter told her to report it to Glenmark. When asked for NDC, the reporter reported that the patient received injection in his arm. The reporter asked for the telephone number of GlaxoSmithKline and asked if we distribute the product. No additional information obtained.
He feels like heat on his head, he feels warm on his head; It was just seasonal fever; This is a spontaneous report received from a contactable reporter(s) (Physician), Program ID:. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), administration date: 2021, for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Manufacturer Unknown), administration date: 2021, for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset Apr2022, outcome "recovered" (Apr2022), described as "He feels like heat on his head, he feels warm on his head"; PYREXIA (non-serious) with onset Apr2022, outcome "recovered" (Apr2022), described as "It was just seasonal fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling abnormal, pyrexia.  Additional information: He was calling because he was reporting an adverse event after getting the third dose the booster shot, he feels like heat on his head, he feels warm on his head. Consumer (physician) stated, he has been through a regular doctor for, he did not quite understand what was said, he took this shot at the pharmacy. Consumer stated, no, he beat it for about 15 to 20 minutes, he rub with some alcohol on his forehead and it went away, so it was just seasonal fever like you know and you know it did not last that about 20 minutes, after when he rub alcohol on it went away, it was clear colour rubbing alcohol, he rub it across his forehead and then around his neck and hypothroatic gland around back his neck so, it went away. Consumer stated, no, if only he was taking medication, what medication should he not take If he took the Pfizer shot booster shot. Consumer stated, that was about that all about he wanted to ask, he had so Pfizer came up on his phone and he saw somebody might had call him concerning this shot and see what kind reaction he had, to see that was what he was thinking and by time he got to his phone and it stopped ringing so, he just thought he had to call Pfizer back and see if anyone call him so that was his real reason for calling. He was at his primary physician today and he said, you know he did not go down for that he went down for something there, but everything was ok. Consumer stated, no, that would be okay. Further probing could not be initiated as consumer was not willing to complete the report. Hence limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Breathing issues and shortness of breath during exertion (playing softball) starting on 6/5/21 has had chest pains, once start running and stuff gets hard to breath, once exerts herself. 2 weeks ago got her covid shot, dad thinks what it is. that was on a wednesday. that saturday june 6th, second game couldn't breath