chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was taken to bathroom, by caregiver of the board and care unit, after completing 15-minute recovery, post Pfizer COVID-19 booster shot. Patient did not have any complaints or symptoms, during the 15-minute recovery period. Per caregiver, after patient had large bowel movement, patient?s? eyes began rolling and she was drooling?. Caregiver called out for help. Upon arrival, health vaccination team nurses called out to patient, and patient made eye contact and was able to state full name. Patient?s skin was cool and clammy, BP = 85/53, P=55, R=16, O2 Sat= 98%, on 2L NC. Patient placed on mat on floor, alert and oriented to person and place. 911 called. Paramedics arrived at 1525 and took over care of patient. BP= 130/76, P= 64, R=18, O2 Sat=100 % on 2L NC, Blood Glucose Level = 174. Per paramedics, patient to be transported to hospital via ambulance. Patient transported at 1539 and was alert and talking during transfer. Per caregivers at board and care, patient had vasovagal/syncopal episode while in the shower, approximately 2 weeks ago
Breakthrough admission after 3 doses ; Pfizer 3/1/2 Lot# EN6202;  Pfizer 3/22/21 Lot# ER8727;  Pfizer 12/8/21 Lot# FJ8757
After DTaP & IPV in Left shoulder, developed redness/warmth/swelling over 4x4cm area
Information has been received from a physician concerning a female patient who in November 2007, an unspecified date and in July 2008 were vaccinated with the first, second and third 0.5 ml doses of GARDASIL intramuscularly respectively. The patient had received all 3 doses of GARDASIL, afterwards, on an unspecified date, she had an abnormal pap smear and tested for oncogenic HPV. She also experienced High grade cervical dysplasia. The patient sought unspecified medical attention and had unspecified treatment. At the time of the report the patient's status was unknown. Additional information has been requested.
Patient received vaccine at 18:16.  Approximately 18:50 the patient complained of numbness and tingling around her bottom lip.  Lips were noted to be slightly swollen and cyanotic.  Speech was observed to be slurred.  Diphenhydramine suspension 50 mg PO was administered.   At 19:15 patient was noted to have hives on her neck, upper chest and upper arms which continued to become more prominent.  911 was subsequently called and epinephrine administration was advised.  Epinephrine 0.3 mg IM was administered at 19:34.  Improved coloration and reduction in hives was observed after epinephrine administration. Patient was transported to the ED.
My mother complained of a severe headache within 1 hour of receiving the injection. 18 hours later she was rushed to the the ER with a Hemorrhagic stroke. Hospitalized for 3.5 days,  cognitive impairment remains, resulting in the need for rehabilitation therapy.
When taking the COVID-19 vaccine at the pharmacy, I was injected with two vaccines on the same day and time, one shot on each arm.This occurred on 03/24/2021.I also was not provided with the lot numbers one the vaccine card.When I asked for the vaccine lot numbers, I was only provided with one, I am not sure why.
Aches; Fatigue; ILL; This is a spontaneous report from the contactable consumer (patient) in response to Non-HCP let-ter. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL3244 and Expiration date: unknown) via unspecified route of administration on 15Feb2021 as 2nd dose, single dose for Covid-19 immunisation. Medical history included covid-19 from 08Nov2020 to an unknown date, ongoing arthritis (arthritis pain was still an issue). Concomitant medications was not reported. It took about 5 weeks to get over it, especially the physical and mental fatigue when patient experienced Covid-19 earlier on 08Nov2020. Patient took 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL3248) via unspecified route of administration on 28Jan2021, and the day after first shot developed chills, fever, fatigue, and greatly increased arthritis pain. After second dose of vaccination, she was quite ill the following day and laid around with aches and fatigue. As of 09Mar2021, patient had gotten better. She had her stamina back and was able to walk and exercise as before. However arthritis pain was still an issue. Her hands were previously not good, but knees, that were ok except for an occasional twinge hurt all of the time. Patient was wearing knee stabilizer to lessen the wear and tear. The outcome of events was recovering.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092526 same reporter, patient/different drug and event
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to 15 year old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to 15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to 15 year old) 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 drug details were reported.
The day after her covid vaccine, Patient got her menstrual period for the first time. She is on the younger side for this to happen. I don?t necessarily know if this is linked but did want to report it in case many other children report the same issue.
Severe fatigue, body aches, migraine, weakness, hallucinations, vivid dream
patient was adminitered Daptacel vaccine at the wrong dosing intervals at age 2, 4, 6 months and 2 years /No AE; Initial information received on 19-Jun-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a two years old male patient who vaccinated with fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (batch number and expiry date not reported) via unknown route and administration site for prophylactic vaccination, first, second and third dose at age two, four and six months age.  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided  It was an actual medication error case due to inappropriate schedule of vaccine administered.  At the time of reporting no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Patient was fully vaccinated.  Her second injection was on 1/27/21, also Pfizer, LOT EL9262. She had breakthrough COVID infection, with mild symptoms starting 7/20/21, infection confirmed on 7/22/21.   She continues to do well, with only mild symptoms to date.
On 9/23/15 gave the PREVNAR vaccine to pt in the (L) deltoid. Pt called 10/5/15 to described redness, swelling, pruritus at the site of the injection.
Dose was drawn from a vial that was outside in room temperature for more than 12 hours; dose was drawn from a vial that was outside in room temperature for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was drawn from a vial that was outside in room temperature for more than 12 hours) and PRODUCT STORAGE ERROR (dose was drawn from a vial that was outside in room temperature for more than 12 hours) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In February 2022, the patient experienced PRODUCT STORAGE ERROR (dose was drawn from a vial that was outside in room temperature for more than 12 hours). On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was drawn from a vial that was outside in room temperature for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was drawn from a vial that was outside in room temperature for more than 12 hours) and PRODUCT STORAGE ERROR (dose was drawn from a vial that was outside in room temperature for more than 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vial was initially stored in the refrigerator within the last 2-3 weeks, specific date was unknown. The date and time vial first punctured was on 24-Feb-2022 at 10:00 AM. Date and time of administration of vaccine was on 25Feb2022 around 1 PM. Vial was stored post puncture at room temperature and had not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degrees C= 46 Celsius to 77 Celsius F): 14-15 hours. It was also reported from the pharmacist that the patient had not received the primary series from their pharmacy, so the pharmacist does not have that information. The pharmacist had confirmed that the patient was within the recommended time frame to receive the booster.   No treatment medications were reported.
24 hours later felt nauseated, projectile vomited down to yellow vile. Called the doctor and told to take Tylenol and rest. Took some Emetrol and Pedialyte.  Arm was swollen from deltoid halfway down; it was hard, hot, red and couldn't move arm.  Used ice/gel packs and took 2 Ibuprofen tablets 400mg but did not help.  Slept a lot.  Can move arm a little bit but it is warm and not as swollen on deltoid.  Will follow-up with doctor in 1 month.   Recovery at 85%
A report was received from a health care professional on 12/11/03 concerning a 2 year old female vaccinee who inadvertently received 0.25ml Fluvirin vaccine on 12/09/03. On 12/9/03 the vaccinee received Fluvirin. No signs or symptoms of an adverse event were reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Name of Drug as Reported: Pfizer / BioNTech, Historical vaccine: Yes; Name of Drug as Reported: Moderna, Historical vaccine: Yes; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Known allergies:multiple antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Name of Drug as Reported: Pfizer / BioNTech, Historical vaccine: Yes; Name of Drug as Reported: Moderna, Historical vaccine: Yes". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 28Aug2023 to 02Sep2023 as Treatment of COVID-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE), Covid 19 and interchange of vaccine of products  cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300308150 same patient, different drug/event;
tingling; burning; rash on the scalp; shingles; This case was reported by a nurse via call center representative and described the occurrence of tingling in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number T44C7, expiry date 26th February 2022) for prophylaxis.   On 28th January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In January 2020, less than a day after receiving Shingrix and an unknown time after starting Valaciclovir, the patient experienced tingling, burning sensation scalp and rash. On an unknown date, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valaciclovir). On an unknown date, the outcome of the tingling, burning sensation scalp, rash and shingles were unknown.   It was unknown if the reporter considered the tingling, burning sensation scalp, rash and shingles to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and reported tingling, burning and a rash on the left frontal scalp after 20 to 22 hours.  The patient had no history of shingles. On 4th February 2020 the smear test did but wasn't able to do a culture until the next day on 5th February 2020.The patient had shingles by culture. The patient was treated  with valacyclovir and referred him to an Opthamologist. The emergency visit required. The follow up consent was granted.
Pt recvd Engerix-B vax & titers drawn 17APR91 revealed pt had low/borderline protection;
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ, orally, (dose, lot number and expiration date were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Varicella - Information has been received from a physician concerning a 9 year old black male with no past medical history who on 30 mar 2000 was vaccinated with one dose of varicella virus vaccine live im in the left deltoid lot 632610/1854j.  Concomitant therapy included vitamin dose unspecified.  On 11 Apr 2000, the patient experienced breakthrough chicken pox with 13 lesions on his body.  the reporter indicated that the patient developed a rash and had a total of 13 varicella like lesions.  It was unknown whether the patient was exposed to mild type varicella before the vaccine.  The patient was evaluated by a physician.  On an unspecified date, the patient recovered.  No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose) 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 medications were reported.Company comment: This spontaneous case concerns a patient of unknown age and gender who reported a Product dose omission issue. Patient reported that the second dose of vaccination was missed and wants to know if vaccination schedule needs to be started all over. No further relevant information was provided; however, since the patient mentions some doubts regarding COVID-19 infection, a query has been raised to confirm if the patient had COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a patient of unknown age and gender who reported a Product dose omission issue. Patient reported that the second dose of vaccination was missed and wants to know if vaccination schedule needs to be started all over. No further relevant information was provided; however, since the patient mentions some doubts regarding COVID-19 infection, a query has been raised to confirm if the patient had COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
9:30AM child received Dtap 5/17/06. Had large local reaction RA swelling, redness, itchy, oozing blisters, swelling up to shoulder and down to elbows. Seen in this office 5/19/06 for eval. Site cleaned Neosporin applied, gauze wrap, Benadryl, Motrin (10 AM 5/19/06).
Presented to Urgent Care for weakness and confusion, transferred to ED, patient had a cardiac arrest and was unable to be resuscitated
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 10:45 (Lot number: FG3527) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: OCUVITE [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;SODIUM SELENATE;TOCOPHERYL ACETATE;ZINC OXIDE]; BIOTIN. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, Dose number: 1, brand: Pfizer, lot number: EN6208, administration date: 01Apr2021, administration time: 12:00PM, vaccine location: Right arm), administration date: 01Apr2021, when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (previous dose product=COVID 19, Dose number: 2, brand: Pfizer, lot number: ER2613, administration date : 23Apr2021, administration time: 12:00PM, vaccine location: Right arm), administration date: 23Apr2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021 10:45, outcome "unknown", described as "Booster"; OROPHARYNGEAL PAIN (non-serious), COUGH (non-serious) all with onset 17Nov2021 12:00, outcome "recovered" (Nov2021) and all described as "developed a sore throat that transitioned to a mild, dry cough". Therapeutic measures were not taken as a result of oropharyngeal pain, cough.  Additional information: No other vaccine was received in four weeks. Other medications in two weeks: eye medicine. It was reported that approximately 7 to 10 days after the booster shot developed a sore throat that transitioned to a mild, dry cough which lasted a couple days. The patient had not taken any COVID vaccination prior, patient was not tested COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
1/9/17 Reported continued soreness after receiving Tdap vaccine on 12/14/16.
On 6/28/00, the pt experienced a persistent headache. He was treated with Naprosyn.
Patient received first dose Moderna 3/22/21, second dose Pfizer 5/12/2021. Screener did not turn her away on a Pfizer-only day. Scribe and vaccinator did not look at card to see what was given prior. She missed her scheduled second dose appointment (on a Monday where Moderna was being administered) and drove past the "Pfizer today" signs.
Headache for 2 days. Vertigo 4 days, then recurs at times
Headaches; Fever; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headaches) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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, the patient experienced HEADACHE (Headaches) and PYREXIA (Fever). At the time of the report, HEADACHE (Headaches) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was provided by the reporter.
This spontaneous report as received from a Registered Nurse refers to a 3 year old (child) male patient. On 17-SEP-2014 (reported as "today") the patient was vaccinated intramuscularly in the left upper thigh with an expired dose of PNEUMOVAX 23 (0.5 ml, lot # 670875/0631AA, expiration date 21-JAN-2013). No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information is not expected, because there is no consent for further contact.
the skin on my back has a peeling; This case was reported by a consumer via interactive digital media and described the occurrence of peely skin in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced peely skin. On an unknown date, the outcome of the peely skin was not recovered/not resolved.   It was unknown if the reporter considered the peely skin to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-JUN-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient's skin on back had a peeling since he/she had Shingrix. The patient asked if this was a common side effect. Additional supportive information: The follow-up would not possible, as no contact details were available.
Double Ear Infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR INFECTION (Double Ear Infection) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced EAR INFECTION (Double Ear Infection). The patient was treated with AMOXICILLIN (oral) ongoing since an unknown date for Ear infection, at a dose of 1 dosage form. At the time of the report, EAR INFECTION (Double Ear Infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reports going to the ocean a lot and prior to vaccination and states that he had water in his ears. No relevant concomitant medications were reported.