chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mini stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 87 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Heart Condition" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Hives"; Septra, reaction(s): "Hives". Vaccination history included: BNT162b2 (Dose 1, Lot number CR8730 or ER8730), administration date: 26Mar2021, for COVID-19 immunization, reaction(s): "No adverse effect"; BNT162b2 (Dose 2, Lot number EW0161), administration date: 16Apr2021, for COVID-19 Immunization, reaction(s): "No adverse effect"; Flu vaccine, for Immunization. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset Nov2021, outcome "unknown", described as "mini stroke". Therapeutic measures taken as a result of transient ischaemic attack included clopidogrel; the patient stated that "she started it, probably in Nov2021 at 75 mg once daily when she had the stroke but, may have been after that. Indication: they say it's a life saver when you have a stroke".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200604654 same patient, different events after different doses of the vaccine
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022 at 2:34 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Feb-2022 at 2:34 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 18-FEB-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Patient ethnicity reported. Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021. No treatment medication was reported by reporter.
It started with an itchy throat and the next morning I had a sore throat and then it progressed to the point that I couldn't swallow or eat anything for about three days. My fever went up to 101.6 degrees. I had chills. I had diarrhea. On the third day I took a COVID-19 at home test and it was positive. I texted my PCP and also my lung transplant doctor. Because of my lung transplant, my PCP told me to take AUGMENTIN and then also for pain control, they prescribed tramadol. My lung transplant doctor put me on 20 days of isolation. Basically I stayed in bed for about two weeks. Beginning the third week, I started to walk inside the house and get around. I lost 13 pounds. After three weeks, I started slowly regaining strength and almost back to original weight.
This spontaneous report was received from a medical assistant and refers to a currently 4-year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date, the patient was vaccinated with improperly stored doses of Oka/Merck VARIVAX subcutaneously, lot # N026073 with expiration date on 20-SEP-2019 (dose and site of administration were not reported) and (wistar ra 27-3) M-M-R II subcutaneously, lot # N023150 with expiration date on 24-AUG-2019 and lot # N011005 with expiration date on 05-APR-2019 (dose and site of administration were not reported) for prophylaxis. Administered doses of Ooka/Merck VARIVAX experienced the temperature excursion of 8.3 degrees Celsius for 1 hour 23 minutes. Administered doses of (wistar ra 27-3) M-M-R II experienced the temperature excursion of 9.5 degrees Celsius for 1 hour 36 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004564: US-009507513-1808USA004566: US-009507513-1808USA002162.
12/13/21 mild pain at injection site (left arm), sensitive stomach  12/14/21 mild pain at injection site, moderate pain in left armpit, sensitive stomach, low energy/exhaustion, chills 12/15/21 severe pain in left armpit, swollen lymph nodes, low energy/exhaustion, mild headache 12/16/21 moderate pain in left armpit, swollen lymph nodes, mild headache, low energy/exhaustion,
Had both vaccines during the first trimester (first dose at 8 weeks, second dose at 12 weeks ). Experienced significant increase in my exhaustion that lasted about five days each time. Developed a cold and sinus infection after the first dose. Also developed significant nausea briefly.
This spontaneous report was received from a nurse, referring to unspecified patient's of unknown age and gender. Patient's medical history and concurrent condition was not reported. On unknown dates in July 2015 the patients were vaccinated with improperly stored RECOMBIVAX HB lot # K024552, expiry date 22-OCT-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt exp varicella;the reporting nurse noted that pt had over 100 generalized lesions in between fingers, in ears, in mouth & all over body;
minimum pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 42 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "minimum pain". Therapeutic measures were taken as a result of pain.  Additional information: The patient had cold compress to ease the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
(R) delt 24 hour later pain at site of injection. Pt reports decreased ROM with pain radiating to back of shoulder pain, tingling, numbness in (R) 2nd and 3rd fingers unable to sleep x 2wks. Dull pain all the time.
Pain on vaccinated area, redness, itching a day after vaccine given. Headache one week after vaccine given, Diarrhea 13 days after vaccination.
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Information on pertinent medical history and drug reactions/allergies were not reported. The nurse reported that on 09-JAN-2019, one patient received improperly stored VARIVAX. The VARIVAX was reconstructed with properly stored diluent MRK Injection lot# N030404 with expiry date of 16-JUL-2020. No adverse effect was reported. Names of vaccines involved VARIVAX lot# R022116 with expiry date of 02-AUG-2020, R022113 with expiry date of 02-AUG-2020 and R018931 with expiry date of 02-JUL-2020. The nurse did not have the specific lot/expiration given to the patient available, but it was one of these. Temperature/time frame: 6 F to 14 F (09.93 F) 2 hours and 8 minutes and 15 F to 46 F (17 F) for 1 hour and 15 minutes. There was no previous temperature excursion. The call was because of data logger. No product quality complaint (PQC) was present.
4th Covid shot 5/22/22 Reaction date: 5/26/22 The night of 5/26/22 I thied to get up to go to the bathroom. I didn?t have the strength to get to the toilet. I was on the floor for about three hours and wound up peeing half in and half out of the shower.  I finally was able to get to the den. I was still weak and when I tried to get up I lost my balance and fell between my chair and the wall into a plastic bin. After another 1-1/2 hours I shimmed to the small bathroom pooping all the way.  My elbow is raw and my backside.  The 24th I felt just a little better but dind't feel I should drive to clinic.  I set up a video appointment. I?ve been weak before but this was horrible.I have never had any reaction to any shots including Covid shots 1-2-3.  I don?t know if this means anything but I had my 4th Covid-19?s shot on the 22nd. My normal weight is about 170 lbs but I?m down to 155 lbs.
cramping in her stomach; IBS may be acting up; nausea; dry mouth at night; pain at the injection site; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cramping in her stomach, nausea, dry mouth.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Don't have this with her) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) cramping in her stomach, nausea, dry mouth.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), cramping in her stomach, nausea, dry mouth was unknown.
Product beyond use date was 11/9/2022 and this product was used on 11/21/2022.  Writer contacted Pfizer and CDC.  No adverse reactions expected, advised to repeat dose ASAP.
DIED TWO WEEKS AFTER THE VACCINATION; This spontaneous report received from a parent via a company representative concerned a 52 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Two weeks after the vaccination on 23-APR-2021, patient had died from an unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On 23-APR-2021 the patient died. This report was serious (Death).; Sender's Comments: V0: 20220400589- covid-19 vaccine ad26.cov2.s-Died two weeks after the vaccination. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Her muscles are still swollen 3-4 inches to the side; It broke out into a rash; Arm is still swelling; Very itchy/3 inches down from the shot site of the upper left arm; The shot location has turned kind of greenish at the injection site; It has gotten very hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (The shot location has turned kind of greenish at the injection site), VACCINATION SITE WARMTH (It has gotten very hot), MUSCLE SWELLING (Her muscles are still swollen 3-4 inches to the side), VACCINATION SITE PRURITUS (Very itchy/3 inches down from the shot site of the upper left arm) and VACCINATION SITE RASH (It broke out into a rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE DISCOLOURATION (The shot location has turned kind of greenish at the injection site), VACCINATION SITE WARMTH (It has gotten very hot), VACCINATION SITE PRURITUS (Very itchy/3 inches down from the shot site of the upper left arm) and VACCINATION SITE SWELLING (Arm is still swelling). On an unknown date, the patient experienced MUSCLE SWELLING (Her muscles are still swollen 3-4 inches to the side) and VACCINATION SITE RASH (It broke out into a rash). At the time of the report, VACCINATION SITE DISCOLOURATION (The shot location has turned kind of greenish at the injection site), VACCINATION SITE WARMTH (It has gotten very hot), VACCINATION SITE PRURITUS (Very itchy/3 inches down from the shot site of the upper left arm) and VACCINATION SITE RASH (It broke out into a rash) outcome was unknown and MUSCLE SWELLING (Her muscles are still swollen 3-4 inches to the side) and VACCINATION SITE SWELLING (Arm is still swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   On 22Aug2021, patient pressed the vaccination site to feel what was going on, just touched it and aggravated it more.  No treatment information was provided.
patient presented to the ED with a rash to her stomach, back, back of legs, and left arm on 7/31/22 after having recieved a Pfizer booster on 7/25/2022.  No new clothes, detergent, food.  Has been out in the heat.  Has not had any sleepovers recently.  Rash causes no itching nor pain.  Its presentation is not suggestive of viral or bacterial or fungal etiology.  No treatment given at that time as it was expected to resolve on its own.  Patient presented to the Clinic on 8/30/2022 because the rash was still present, but was not causing any pain or itching.  Provider thought it may also be related to the vaccine, as did a dermatologist on 9/1/2022.  Patient was scheduled to follow up with the dermatologist on 9/15/22 but has not returned.  Called the patient's mother 12/15/2022 to see if the rash had resolved.  She said it has, rash is gone but there is spotty discoloration of her skin in those areas.  Skin is lighter than it had been prior to the rash.  Patient did not get her primary series here, but her primary series was Pfizer and no reactions were reported.
This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps) and SLEEP DISORDER (disturbed sleep) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps) and SLEEP DISORDER (disturbed sleep). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) and SLEEP DISORDER (disturbed sleep) outcome was unknown. Treatment details not provided. concomitant product details not provided.
Flush/ Hot Narrative:  6 minutes after receiving 1st Pfizer dose of Covid 19 medical student felt flush and clammy. He stated he wasn't feeling well and felt light headed. Also reported had not eating this am. Reported he had a panic attack in the past at age 14 after receiving flu vaccine. Stated he believed this was a panic attack. Bp 95/52, HR 58, resp 26 and Spo2 98% upon initiation of incident at 10:15am. At 10:20am pt VS 99/61, Hr 59 and spo2 99. Provided cold packs to neck and forehead and juice. Rapid response was called for final disposition. 10:24am VS 121/74, H4 59 and R 22. Remained in observation for full 30 minutes prior to leaving. No other care. Student stated feeling fine upon leaving facility.
Patient brought to the ED on 4/15/2021 at 0330 with increased weakness.  Patient takes Sinemet every 3 hours and last Sinemet dose was sometime late on 4/14/2021.  Patient stated the medication wore off sooner than it should have.  Patient was discharged to home on 4/15 at 0551.   Patient was seen again in the ED on 7/17/2021 at 2100 for weakness.  Again, brought in by EMS.  No medications were given in the ED.  Patient discharged to home on 4/17/2021 at 2345.
This spontaneous report as received from a health care worker refers to a patient of unknown age. On an unknown date, the patient was vaccinated in error with a dose of ZOSTAVAX (dose, route and lot # not reported). No adverse effect was reported. Additional information has been requested.
"bit black and blue mark" on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Dec2022 as dose number unknown (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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious), outcome "not recovered", described as ""bit black and blue mark" on the injection site".  Additional information: This consumer is the patient who got the shot of Pfizer Booster for Covid 21Dec2022 and has had a big black and blue mark on their arm and it's still there. Yes the patient also the reporter.  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.
Within 2 minutes of vaccine receipt the patient became agitated. She was noted to have erythematous macules on her upper back consistent with hives. Her heart rate and respiration rates were normal. She was observed initially as the family reported that she gets hives with all injections. However, about 2 minutes later she began to retch and stated that her throat was burning and she couldn't breathe. She was administered 0.3mg of epinephrine via an autoinjector. Her shortness of breath and throat burning symptoms resolved almost immediately. She was then given 10mg of Cetirizine PO and transported via local EMS for evaluation at the Hospital ED.
Developed hives with large welps all over body, large amount swelling in feet and in neck and face.  Itching and generalized discomfort from swelling.
Extreme fatigue and tiredness lasting three days. Hives around neck front to back, chest down to breasts, back down to lower shoulders.
Patient  received Covid 19 Pfizer vaccine.  Approximately 5 minutes later father came and got pharmacist stating that patient was not doing well.  Pharmacist immediately went out to check on him.  Mother was giving him puffs of albuterol inhaler when pharmacist arrived.  Patient was awake but lethargic.  Dad was on phone with 911.  Pharmacist asked patient if they would like some water, patient agreed.  Pharmacist went and got water out of fridge.  Once pharmacist returned patient lost consciousness again.  Pharmacist checked pulse which was there.  Patient quickly regained consciousness. 911 phone dispatcher recommended using epi-pen due to past allergies to bee stings.  Dad had his Auvi-Q with him.  Which was administered by the pharmacist.  Firefighters arrived and checked pulse and BP.  Paramedics arrived and took him to the hospital for further evaluation.
vaccination site swelling; muscle pain; Nauseous; near syncope; joint pain; Dizziness; Felt like I had the flu but with worse pain and without any upper respiratory symptoms; random pain throughout body.; Pain in the gut; vaccination site arm pain; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via unspecified route of administration in the left arm on 24Mar2021 at 11:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, hyperlipidemia, herpes 1 and 2. The patient was allergic to morphine, hydrocodone, jalapenos and kiwi skin. Concomitant medications included beta blocker (unspecified), statin (unspecified), valacyclovir (MANUFACTURER UNKNOWN) from an unknown date taken for herpes simplex type 1 and 2. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 12:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 24Mar2021 at 12:30, the patient experienced pain at the injection site (vaccination site pain) arm pain started about an hour after injection. On 25Mar2021, the patient experienced swelling at injection site so bad she could not move her arm (vaccination site swelling); and on 25Mar2021, the patient experienced  muscle pain and joint pain were bad enough to keep from doing regular activities, random pain throughout body such as in her gut. Nauseous when the patient attempted physical activity. Felt like the patient had the flu but with worse pain and without any upper respiratory symptoms. Pain kept the patient up at night. The patient also experienced dizziness and near syncope. Arm pain started about an hour after injection, other symptoms started second day and lasted until she woke up on 3rd day. The patient did not receive any treatment for the adverse events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of vaccination site pain, vaccination site swelling, muscle pain, joint pain, pain, nauseous, flu, dizziness and near syncope was resolved on 26Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Started with cough about 1/5 hours later, achy.  At 3 hours eyes were bloodshot and had facial/mouth swelling.  Had pain/parestiesisas in mouth and teeth.  Mucous build up in eyes.  Took benadryl, Aspirin, and Oxycodone for pain.  Woke next AM to no pain but still had gum and facial swelling.  Felt "stuffy" most of day but all symptoms resolved.
Red, slightly raised, tender, hot area .5cm x 4cm. Chest xray obtained, westcort cream aid to site. Benadryl 25mg aid or Claritin.
24 hours after vaccinated  Unable to stay awake first 24 hours, Large Herpes on mouth lasted two weeks, migraine triggered for four days, right hand thumb, pointer and middle fingers numb didn?t have feeling again for 2 weeks, ringing in ears began and never has stopped and never present before vaccinated, severe muscle  pain especially back by kidneys, vomiting and diarrhea
Swollen, red itchy arm with a hard lump approximately 2 inches by 4 inches.