chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On unknown dates in 2016 (reported as starting on or after 06-JUL-2016), patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M010440 and expiration date 09-DEC-2018, lot # M006710 and expiration date 06-DEC-2018, lot # L0151123 and expiration date 13-OCT-2018, dose and route of administration were not reported). The temperature of excursion was 31F and the time frame was 2 hours. There was no previous temperature excursion and the call was not due to a data logger. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Within the month, I noticed some heart palpitations on and off. Doctor did EKG and that was fine. We're going to go from there. I also developed low thyroid, Hypothyroidism that I was just put on medication for. They gave me Synthroid. Also, the last period I had was in May 2021. It was heavy and it lasted longer.
cough; not feeling wel; sore throat; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as unknown single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient developed a bad cough today and patient supposed to get second dose today at 5:00 and patient coughing and not feeling well and also patient developed sore throat on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Child had a seizure while in fathers car, short duration, went to hospital and had another one shortyly after.
Pain and numbness in the left arm  From the shoulder to the fingers.  Cannot raise arm, nor leave it down.  Relief with a sling.  Also, to manage pain, she is taking Tylenol every four hours.  By medical order she started diclofenac potassium 50 mg tablet.
This spontaneous report was received from a healthcare professional regarding an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions of the patients were reported. The patients were vaccinated with incorrectly stored GARDASIL 9 lot number # L013429, expiry date 21-JUL-2017) since 28-JUL-2015. Concomitant medications of the patients were unknown. No other adverse events were reported. The outcome of the incorrect product storage was unknown. No product quality complaint was reported. This is one of the five reports received from the same source. Additional information has been requested.
Pt c/o dizziness walking to car, mom states pt became weak, syncope-assist pt back to office. Pt weak, assisted to floor, BP 76/4, HR 76 mild diaphoresis noted.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 24-SEP-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J001700 and expiry date: 08-MAY-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
exposed to wife who was positive for covid and then he had HA and fever and runny nose 1/19 and did a home Ag test was positive; exposed to wife who was positive for covid and then he had HA and fever and runny nose 1/19 and did a home Ag test was positive; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Lot number: EL3247) at the age of 29 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 03Feb2021, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jan2022, outcome "recovering" and all described as "exposed to wife who was positive for covid and then he had HA and fever and runny nose 1/19 and did a home Ag test was positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.Clinical course: Patient exposed to wife who was positive for covid and then he had HA and fever and runny nose 1/19 and did a home Ag test and test was positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events vaccination failure, covid-19 and the administration of the vaccine cannot be excluded.
FEELING EXTRA HOT; SWEATING; INTERMITTENT RASH FROM SHOULDER TO ALL WAY DOWN ON BACK, RED BUMPS, LOOKS LIKE INFECTED; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, drug allergy (Flomax and Haldol) ,and non alcohol user. The patient had no history of drug abuse or illicit drug usage. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1 )( unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (Janssen, dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-NOV-2021 into left arm for prophylactic vaccination. No concomitant medications were reported.  On 12-NOV-2021 (started 3-4 days after), the patient experienced rash, from shoulder all the way down on the back, came in waves, got better, and then came back again, red bumps, looks like infected (coded as intermittent rash from shoulder to all way down on back, red bumps, looks like infected). The patient believed the rash was related to the JNJ vaccine. On an unspecified date, the patient started feeling extra hot, not feverish, but sweating in every room (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent rash from shoulder to all way down on back, red bumps, looks like infected, and the outcome of feeling extra hot and sweating was not reported. This report was non-serious.
The vaccine was maintained at proper refrigeration temperatures, but for longer than 31 days.  7/29/21 was day 31 at refrigeration temps and vaccine was given on 8/13/21.  No adverse events have been reported by patient.  Error discovered on 8/16/21
Pfizer dose given came from a bottle that expired 11/17/2021. No immediate adverse reactions are observed after approximately 30 minutes.
Pt called pharmacy morning after reporting  chest pain and tightness, body aches, headache/head pain radiating down to her neck. Symptoms were present when she woke up; pt lives alone with no transportation. Reports being able to take full breaths but doing so causes more tightness and pain. Per patient, she is on antihypertensives, "heart medications", and thyroid medication. Due to chest pain and tightness in conjunction with patient's inability to receive prompt medical attention, pt was advised to call 911 to verify chest pain did not originate from other potential conditions. Pt verbalized understanding.
Rashes; Headache; Arm pain; Extreme Pain all my left side that include head, face, neck, shoulder ,arm, leg and foot; Feeling so unwell; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old unknown gender patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 14:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. 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 vaccination. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in Mar2021, the patient experienced rashes, headache, arm pain, extreme pain all left side that included head, face, neck, shoulder, arm, leg and foot and felt so unwell. The patient had the events until the time of this report, 16Apr2021 (3 weeks after the last dose). The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rashes, headache, arm pain, extreme pain all left side that included head, face, neck, shoulder, arm, leg and foot and felt so unwell were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
After receiving the shot and getting up to walk across the room to sit down for the waiting period, I started to experience extreme dizziness and weakness. My heart rate jumped and I felt extremely hot. I thought I was going to faint. Within about 10 minutes I got an extreme headache that felt like someone was squeezing my head. I was given a heavy dose of benadryl as I was not experiencing difficulty breathing and we did not feel like I needed an epipen. After the benadryl kicked in my symptoms became less intense and I just had periodic bouts of sweating and chills. I am now on my third round of benadryl but have been able to lessen the dose, I do not anticipate having to take a fourth dose.
Did not feel good on the evening (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel good on the evening (1st dose)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MALAISE (Did not feel good on the evening (1st dose)). At the time of the report, MALAISE (Did not feel good on the evening (1st dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-408482 (Patient Link).
Around 25 minutes after vaccine, patient began to feel dizzy and stated that her tongue and throat felt scratchy and tight. Patient took a Benadryl 25 mg tablet. After about 20 more minutes patient said her chest felt tight and her left side of face was numb. She could take deep breaths easily but her shallow breaths were difficult.
Severe flushing of face and ears; Body rash; Aches; Chills; Low grade fever; Stuffy nose; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via unspecified route of administration in right arm on 03Mar2021 11:45 AM (at the age of 65-year-old) as 2nd dose, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient was not pregnant at the of the event and at the time of vaccination. The patient's medical history included antihypertensive (unspecified concomitant medication) and allergies to shrimp and sulfites in food. It was unknown if patient was diagnosed with COVID-19 prior vaccination. The patient's concomitant medications received within 2 weeks of vaccination included levothyroxine, antihypertensive (unspecified) and anti-allergy (unspecified). The patient previously received nitrofurantoin and she experienced allergy. She also previously received first dose of BNT162B2 (lot number not reported), via unspecified route of administration in right arm on 10Feb2021 11:00 AM (at the age of 65-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021 at 12:00 PM within 15 minutes (as reported) of second injection the patient experienced severe flushing of face and ears treated with 50 mg diphenhydramine oral, self-prescribed. On unspecified date in Mar2021 the patient also experienced aches, chills and low-grade fever, all within 18 hours, stuffy nose within 36 hours and body rash within 48 hours. Treatment of events aches, chills, low-grade fever, stuffy nose and body rash was reported as over the counter (OTC) allergy pill. All the events were reported as non-serious. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was unknown.  Information about lot/batch number has been requested.
J96.00 ACUTE RESPIRATORY FAILURE 1/12/2022 ARTERIOVENOUS GRAFT COMPLICATION, INIT J96.00 ACUTE RESPIRATORY FAILURE 1/12/2022 DM 2 W CKD STAGE 5 (GFR <15)
Random hives appearing on most parts of my body. A few pop up each day and then resolve in a day or two and then more pop up every day since now for the past 7 weeks or so.
8OCT96 mom called reporting that 7OCT96 approx 6-630PM pt had sz lasting 1-2min;extremities shook, eyes rolled back & then had a blank stare;pt was able to rouse from the stare;no fever sl soft brown diarrhea that lasted 1 day;APAP given;
Pt recieved vaccine yesterday morning. Pt report having chills/shakes/body aches starting at 2200 last night. Pt denies cp/sob/fever.  38 yo M w/ chronic LBP but no known chronic medical conditions, p/w approx 12 hours malaise, diffuse myalgias, rigors, chills. Decreased appetite. Got the COVID vaccine at 1000 yesterday; sx started at approx 2200 last night. No n/v/d, abd pain, CP, SOB, cough.
received a flublock flu shot on 10/15/2020, on 10/16/2020 she noticed a razor burn like rash starting on her left leg and over the course of 4 days the rash spread to both legs, both arms and both hands.  No swelling of the lips, face or tongue and rash not present on face.  Left message on patient's voicemail on 10/21/2020 to follow up.  Waiting for call back.
Dizziness started day after 1st shot lasting a few hours and occurring every few days.  By 3rd week dizziness was all day long.  The 4th week and after Shot #2  2/9/21 Lot #EN6201 dizziness lasting 24 hours a day.  Lightheadedness with occasionally headache.  Not serious vertigo or nausea.  Had MRI negative, waiting on heart monitor results from cardiologist, had hearing next, ruled out BPPV.  Taking meclzine and seems to help somewhat.  VNG test maybe next.  This is the only significant event in the last 3 months.
Swollen glands left armpit; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 09Jul2021 at 08:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism, right thyroidectomy, penicillin allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) started on unknown date for unknown indication. On 10Jul2021 at 12:30, the patient experienced swollen glands left armpit. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen glands left armpit was not recovered at the time of event.
Extreme itching and burning of skin, face, neck, skull, ears, back, limbs
father reported pt had bruising all over & fatigue lasting one month;pt has Factor V Deficiency;
Raised rash with hives on thighs. Took Benadryl will go to hospital if hives get worse
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 74 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Batch/Lot number: unknown), on 20Feb2021 as dose 2, single (Lot number: EL9266), in right arm, on 12Oct2021 as dose 3 (booster), single (Lot number: FE3590), in right arm and on 02May2022 as dose 4 (booster), single (Lot number: FK9894), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "DJD" (unspecified if ongoing); "psoriasis" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL, start date: Apr2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (22Nov2022) Negative; (26Nov2022) Positive, notes: with a home antigen test; (28Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient finished the 5 day course of Paxlovid on 21Nov. Tested negative on 22Nov. On the evening of 25Nov started mild cold symptoms, increasing to moderate cold symptoms on 26Nov. Tested Positive with a home antigen test on 26Nov. No fever, no shortness of breath, just tiredness and moderate runny nose, congestion and mild cough. Moderate cold symptoms persist and test positive 28Nov. No known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient had received Pfizer bivalent booster shot in left arm. Patient then received the Flulaval shot in right arm. They shortly passed out for a few seconds before regaining consciousness. Incident is most likely due to dehydration.
developed Esotropia 7 days after receiving the vaccine; This spontaneous report was received from a physician and refers to a 5-year-old male patient. The patient's medical history, concomitant therapies, and concurrent conditions were not provided.   On an unknown date in March 2022, the patient was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered subcutaneously (dose, dose number, strength, site of administration, lot #, and expiration date were not provided) for prevention of measles, mumps, rubella and varicella.   On an unknown date in 2022 [reported as "7 days after receiving the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)"], the patient developed esotropia. The patient still had esotropia 6 months after measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The patient was being seen by an eye specialist, and there was no surgery at that time. The patient was wearing glasses to try and correct it.  The relatedness between the suspect therapy and the event was not provided.
Raised rash, itchiness were noticed on 12th day after vaccine; persisted for 5 days then resolved in its own.
Patient recieved wrong dose- should have received 0.3ml of Pfizer adult as a booster but received 0.3ml of pediatric in error
expired dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXB28AA, expiry date 20th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 29th September 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-SEP-2022 Reporter's comment: HCP (Health care professional) reported that an expired dose of Bexsero was administered to a patient. No details of the patient were available. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Bexsero which was already expired, which led to expired vaccine used.
Swelling in her throat; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling in her throat. The patient was there for the second vaccine and the caller wanted someone to tell him what they should do as far as giving her the second vaccine. The caller said the patient was going to try to see a doctor to see if she can do the shot in a clinical setting in case she have a problem there would more likely be better interventions there. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient described body/joints hurt. 3 days later felt better but arm down past shot was red and inflamed. Getting better.
Right after injection was given to my son.  He immediately began to feel a tickle in his throat with a very strong lead taste.  He became dizzy and became dazed and confused.  A very strong metal odor was coming out of his sweat pours.