chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of diarrhea (patient had diarrhea, it was bad), abdominal discomfort (patient had waves come over abdomen/started in one side and then went to the other side), pain in extremity (sore arm) and pyrexia (patient must have had fever, but didn't control the temperature) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 025D21A) for COVID-19 immunization. No medical history reported. On Oct 25, 2021, patient received the third (booster) dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 25, 2021, patient experienced  diarrhea (patient had diarrhea, it was bad), abdominal discomfort (patient had waves come over abdomen/started in one side and then went to the other side), pain in extremity (sore arm) and pyrexia (patient must have had fever, but didn't control the temperature). On Oct 25, 2021, diarrhea (patient had diarrhea, it was bad), abdominal discomfort (patient had waves come over abdomen/started in one side and then went to the other side) and pyrexia (patient must have had fever, but didn't control the temperature) resolved. At the time of the report, pain in extremity (sore arm) outcome: unknown. The patient took blood pressure medication as concomitant. No treatment information reported. This case linked to MOD-2021-364473 (patient link).
had high temp 1 1/2 to 2hrs p/shot given, unrelieved by APAP, & swollen leg
Patient has a headache; eyes hurt, weak, vomiting and fever since 4/6/2022.
nausea; fatigue; full body rash; loss of appetite; vomiting; unable to keep liquids down; Bloodwork shows elevated liver enzymes; This is a spontaneous report from a contactable consumer. A 65-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in the left arm on 14Apr2021 at 14:00 as single dose (at the age of 65-year-old) for COVID-19 immunization. Medical history included elevated blood pressure and cholesterol. Concomitant medication included atorvastatin calcium (LIPITOR), unspecified BP meds (MANUFACTURER UNKNOWN), vitamin D nos (VITAMIN D); all since unknown dates and for unknown indications. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05May2021 at 15:00, patient experienced nausea, fatigue, full body rash, loss of appetite, vomiting, unable to keep liquids down and bloodwork showing elevated liver enzymes. The patient underwent lab tests and procedures which included blood test or work which showed elevated liver enzymes on 05May2021. The patient received treatment for the reported events which included, bloodwork, Benadryl and cortisone cream. The adverse events resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events nausea, fatigue, body rash, loss of appetite, vomiting, unable to keep liquids down and bloodwork showing elevated liver enzymes were not recovered at the time of this report.   The lot number for the vaccine [BNT162b2], was not provided and will be requested during follow up.
idiopathic sudden hearing loss on left ear; severe headache on my left head for full 3 days after the 2nd Vaccine; tinnitus on my left ear on and off; felt extreme fatigue and tired; This is a spontaneous report from a contactable other healthcare professional (reporting for herself).  A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), dose 2, via an unspecified route of administration, administered in left arm on 02Feb2021 10:00 A.M. at the age of 49 years old, as a single dose, for COVID-19 immunization. The patient's medical history included hypertension. The patient had no known allergies and no prior COVID vaccination. The patient was not also tested with COVID post vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 vaccine for COVID-19 immunization and experienced minor headache. On 08Feb2021, the patient reported that she experienced severe headache on her left head for full 3 days after the 2nd Vaccine. The patient had a minor headache when she had the first vaccine, but it lasted only a day and it was mild one. About 1 week after the 2nd vaccine, the patient had a tinnitus on her left ear on and off. She thought it was because she was tired. For some reason after the 2nd shot, the patient felt extreme fatigue and tired. The left ear ringing was happening more frequently and getting loud. The patient went to urgent care and also went to ENT, and there it was found out that she was having an idiopathic sudden hearing loss on left ear. The patient was treated with oral steroid and injection but the hearing sensory was not coming back yet. The outcome of the events was not recovered.   Information about lot/batch has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on idiopathic sudden hearing loss cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Information has been received from a physician concerning a 7 year old pt who on 07/17/1997 was vaccinated with a dose of varicella virus vaccine live . On 07/07/02 the pt experienced a case of breakthrough varicella. There  were less than 50 lesions. Unspecified medical attention was sought, but there was no tx or hospitalization. No product quality complaint was involved. This is one pt out of 39 others (WAES 0407USA01446 and 0409USA01855 through 0409USA01878 amd  0409USA01880 through 0409USA01893) experienced breakthrough varicella after vaccination with varicella virus vaccine. Additional inoformation is not expected.
Awoke p/napping crying-wouldn't walk or eat; swelling @ inject site; called MD who instructed parent to apply cold compress & give APAP; parents took pt to ER because of inconsolable crying; t102 45" p/APAP cont low grade today;
On 6/22/10 in the pm pt noticed a rash on arm of the TWINRIX vaccine, the rash is below where vaccine was given, site is red, raised area no pain no pruritis "itching" per patient.
This spontaneous case was reported by a patient and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 046B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). On 16-May-2021, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) had resolved.  No concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-162370.
Headache starting 1 hour after injection, lasting 36 hours. Light fever. Trouble sleeping. Trouble concentrating.
C/O L arm pain post flu shot. C/O numbness/tingling and decreased ROM. Took Advil without relief. Medrol dose pack without relief. Referred to neurologist. Ordered Bextre, Neurontin and PT> Stopped taking Neurontin. Thinks shot was given "too high."
28APR99 2 days post vax c/o inc malaise, tiredness, body aching, palpitations, rash both forearms (no other bodily rash);rx w/atarax;11MAY99 seen again by MD for persistent rash of the forearms non pruritic, burning;rx w/med;
On 1/13/2021,  resident had sudden emesis. Immediately following emesis he was noted without a pulse and pronounced deceased. No acute symptoms noted prior to this episode. Resident does have a significant cardiac history.
Patient is a 36 year old female in the observation area post COVID 19 vaccination presents for urticaria and pruritus of chest and neck. Vital signs stable. Physical exam shows urticaria on neck and upper chest. No angioedema, SOB, CP. Otherwise Physical exam unremarkable with no wheezes, stridor, hypotension. Pt already took benadryl 50 mg PO at home at 10am prior vaccination because of previous itching from 1st COVID 19 vaccine. Solmedrol and cetirizine given and resolved symptoms.   Discussed the allergic reaction of COVID 19 vaccine and needing referral to Allergy consult evaluation for clearance for booster shot or next COVID 19 vaccine. ED precautions given for SOB, chest pain, and angioedema Pt understood and agreed with plan Pt sent home with family to transport Sent home stable and in no distress.
Headache; Aching joints; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 22Apr2021 at 15:00 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included shellfish allergy (shellfish and crustaceans). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ibuprofen (MOTRIN) from an unknown date for an unknown indication. On 05May2021, two weeks after vaccination, the patient experienced headache and aching joints which was continuing for over a week. Therapeutic measures were not taken as a result of the events headache and aching joints. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache and aching joints were not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 13May2021 at 15:00 (at the age of 53-years-old), as a single dose for COVID-19 immunisation.    No follow-up attempts are needed. No further information is expected.
I did not have a reaction to the vaccine. In 11/2022, I developed recurring headaches and happening more frequently. In 01/2023, I had a lump in my left breast. It was determined they didn't see anything concerning with the lump, so we are monitoring.
Developed Atrial Fibrillation, recorded by the pacemaker.  It was from 6 min to 1 min and less in duration, slowly subsiding.  After 4 days it fased out.
Angina MI Narrative:  Employee presented to ED with chest pain. Cath showed 99% blockage of LAD and diagonal. Employee transferred to another hospital for w/u for CABG. Prior to assessment for CABG, employee coded. Urgent cath. with multiple stents placed. At time of reporting of event, employee was recovering. Cardiologist instructed employee to complete COVID vaccination series which was done on 1/20/2021.
large body rash, extreme itching affecting back, hands, thighs, ears, scalp, legs etc.
allergic reaction; This is a spontaneous report from Pfizer-sponsored program. A non contactable female consumer (patient) reported for herself that: A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced allergic reaction. patient had a schedule for Covid 19 vaccine tomorrow, 12May2021 and mentioned that her doctor advised her not to take it due to an allergic reaction and advised her to take rest for 2 weeks. The outcome of events was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
fever (101-102 F), tiredness, crankiness began the day after the vaccine treated with tylenol, motrin and TLC
alternating chills and feeling hot, extreme upper GI discomfort similar (or same as) heartburn
Next morning of receiving shot .. I had severe nausea, migraine headache, weakness, dizziness. Could not get out of bed for 3 straight days .. became dehydrated after vomiting and diarrhea .. water would not even stay on my stomach .. threw up the water .. started sipping Pedialite and other electrolytes .. too sick to go to the doctor was able to get enough fluids down  .. headache remained 5 days after shot in 4 days ate 1 piece of toast .. starting eating slowly on the 4th day after the shot, still not much appetite . A week into this shot I still feel  light headed and some dizziness and lots of weakness. My doctor's nurse (never got to talk personally to the doctor) says this shot shouldn't cause any thing like this -- WRONG!
A non-serious report of "throwing up" and stomach ache has been received from a consumer, patient's father, concerning a four-year-old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medication  were not reported. The patient received FLUMIST and Hepatitis B vaccines on the same day, 27-Oct-2009. The patient received a total of one dose of FLUMIST before the onset of the events given on 27-Oct-2009. On 28-Oct-2009, the patient was "throwing up" and had a stomach ache. The outcome of the event was unknown.
My symptoms started 11 days after the shot. I had non stop hives and red rashes all over my body and not just at the injection site. I have changed nothing in my routine or been exposed to any new food or detergents. I have been able to treat it with over the counter allergy medicine and Pepcid. As soon as the allergy medicine wears off all of the hives come back and continue. The hives are still there during the day, but more itchy at night.
Had first pfizer covid vaccine 9 days prior and was informed that it was no good and to come back for another shot; became very sick; flu like symptoms; vomiting; extreme body aches and pains; fever; Was unable to sleep entire first night; Had first pfizer covid vaccine 9 days prior and was informed that it was no good and to come back for another shot; This is a spontaneous report from a contactable consumer. This consumer (patient's parent) reported for a 25-year-old son (patient).  A 25-year-old male patient received the second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0153) via unspecified route on arm left at a single dose on 16Apr2021 14:45 for COVID-19 immunization. There was no history of allergies to medications, food, or other products allergy. The patient had no relevant medical history. Concomitant medication was not reported. The historical vaccine patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0164) via unspecified route on arm left at a single dose on 07Apr2021 14:45 for COVID-19 immunization. The patient receives first covid vaccine 9 days prior within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 07Apr2021 patient received first shot and was notified that the clinic mishandled vaccine and was advised by dep of health to get another shot and upon arrival informed staff he received bad dose on 7 April and they advised to get another shot on 16 April. On 16Apr2021 patient received second shot and within 8 hours became very sick with flu like symptoms including vomiting, extreme body aches and pains along with fever. Was unable to sleep entire first night and by 6AM started feeling better. The clinical outcome of the events reported as recovering.   No follow-up attempts are needed. No further information is expected.  Follow-up: (22Apr2021) This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of event onset date. Reporter received the information at 7:30 on 17April2021.  No follow-up attempts are needed. No further information is expected.
Pt had vaccines placed in right arm,  Menveo and Influenza.  Patient presents with rash at injection site. Declines pain and fever    Rash is decreasing, not as red as yesterday, patient has been applying ice to site.
Raised Bump  on face similar to a small lentil bean. Then got bigger then more on face then on neck and scalp then on back now chest also. They vary in size and redness. Some are near the eyes. He took Benadryl then after urgent care started doxycycline by late 100 mg. March 1st they are getting worse. They would not run blood work though he asked for some.
a nurse inadvertently administered MENACTRA to a patient who was supposed to receive Gardasil with no reported adverse event; had just received a dose of MENACTRA on 10Aug202, she received another dose of MENACTRA too early with no reported adverse event; Initial information received on 10-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 12 years old female patient who was inadvertently administered menactra by nurse who was supposed to receive gardasil with no reported adverse event and had just received a dose of menactra on 10aug2021, she received another dose of menactra too early with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past vaccination(s) included Menactra on 10-AUG-2021. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included Hpv Vaccine Vlp Rl1 4v (Yeast) (Gardasil) for Prophylactic vaccination.  On 09-Jun-2022, the patient received a 0.5 ml dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine lot U7208AA, expiry date: 10-Feb-2023, frequency: once unknown strength and formulation via intramuscular route in the right deltoid as immunization.  On 09-JUN-2022 the patient developed non-serious events a nurse inadvertently administered menactra to a patient who was supposed to receive gardasil with no reported adverse event (wrong product administered) and had just received a dose of menactra on 10aug2021, she received another dose of menactra too early with no reported adverse event (product use issue) latency: same day following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.    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 the guidelines. 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.
Patient received Pfizer COVID-19 vaccine second dose this morning at 8:50am and at 12:15pm started with burning sensation in the area of where the vaccine was administered. Soon after, within the hour, the area became erythematous and warm. She reported her whole left arm felt "achy". Patient took ibuprofen 600mg at 1pm as well as iced the area. She was evaluated by writer at 2:15pm. The area was noted to be erythematous, warm, and mildly swollen. The redness was outlined with skin marker and noted to be 15cm wide and 13cm in height. She denied any other symptoms.
ENLARGED LYMPH NODES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received ustekinumab (solution for infusion, route of admin not reported, batch number: Unk) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (form of admin and route of admin were not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request natch/lot/numbers. No concomitant medications were reported. On an unspecified date, the subject experienced enlarged lymph nodes. The action taken with covid-19 vaccine ad26.cov2.s, and ustekinumab was not applicable. The outcome of enlarged lymph nodes was not reported. This report was non-serious.
Use of Fluarix in pregnancy at 32 weeks / expired on June 30, 2021; Use of Fluarix in pregnancy at 32 weeks; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 27-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number YT5K7, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd July 2021, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2020-2021 season at an unknown time during the pregnancy. On 2nd July 2021, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used and vaccine exposure during pregnancy. On an unknown date, the outcome of the expired vaccine used and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Fluarix in pregnancy at 32 weeks and the vaccine was expired on 30th June 2021, which led to expired vaccine used and vaccine exposure during pregnancy. The reporter consented to follow up.
Information has been received from a physician concerning an 11 year old female with no illness at time of vaccination or pre-existing, birth defects or medical conditions who on 08-Apr-2009 at 9:00, was vaccinated SQ with the third dose of GARDASIL (lot# 661952/1129X) into her right deltoid. Concomitant vaccine received at the same date included the second dose of VARIVAX (lot #:660566/0792X via SQ into her left deltoid. On 10-Apr-2009 at 09:30, the patient experienced right deltoid red swollen and inflamed to 4 inches wide. The patient was seen by a physician. No relevant lab tests was performed. Subsequently, 7 days after onset, the patient recovered. No information is available.
Pt recvd rubella vax on 3MAY91 following delivery; vitamins & pain meds; On 14MAY91 devel a generalized erythematous pruritic rash that MD felt looked a lot like rubella; On 18MAY91 devel joint pain, arthritic pain;