chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sneezing; Itchy throat; runny nose; This is a spontaneous report from a Pfizer-sponsored program, via contactable consumer (patient).  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 16Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 17Mar2021, the patient experienced sneezing, Itchy throat, and runny nose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Rash on chest/trunk 6 days p/inject w/MMR/TD;
Immunizations given 1/7/02. Rash/fever 102.7 degrees F. question Rubeola rash from vaccine
Patient reported bleeding from the site at the time of the injection, and reported 0 pain. She said she felt a knot at the injection site, and a bump developed over the next few days. She also had a large bruise at the injection site. the bruise was approx. 3.5" by 1.5" on Thursday, October 5 (5 days after administration).
This was an administration error with no known adverse effects. The vaccine was administered after being stored at room temperature for 4 hours. The storage and handling requirements state that the vaccine should have been discarded once it had reached two hours at room temperature.
pt had pneumonia vax & hlth dept 28OCT96 & around 7PM pt exp a fever rt arm swollen, warm to touch & t101;
Patient developed severe viral like illness with fever, vomiting and diarrhea 48 hours after vaccine. Went to Emergency room for treatment.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 02-SEP-2014 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, frequency, lot # and indication were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
fever and body aches starting @ 1 am the next day, including pain in spine and minor headache, felt like shingles lite (without the itching) Then, 11:50 pm next day: itchy bumps began appearing over body, hands and feet itched profusely for 24 hours until benadryl administered, symptoms diminished consecutively each day,
After having the COVID-19 shot I started having severe diarrhea with bad cramping and pain. I had been to the ER with these issues and they progressively got worse. I even had some instances where I had an accident and went without realizing it. I went to see my gastroenterologist and they tried me on a restrictive diet to see if I was having allergies to something. The better my diet was the worse my symptoms were. I was eventually sent to an allergist and we did a ton of testing to see what was going on and then also tested different foods to see what my reaction was. I had seen a radiologist and they did a CT scan, I had a colonoscopy and we biopsied things to test as well. The allergist stated that I was having Pollen Cross Reactivity which is also known as Oral Allergy Syndrome. None of this was an issue before I had the vaccine but it has been a huge impact on my life and health.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 6-year-old patient of unknown gender. On 27-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot number N034554 (expiration date 05-DEC-2019). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 20-JAN-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis. On 02-MAR-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.      The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002944: US-009507513-2104USA002963: US-009507513-2104USA002975: US-009507513-2104USA002974: US-009507513-2104USA002976: US-009507513-2104USA002972: US-009507513-2104USA002971: US-009507513-2104USA002970: US-009507513-2104USA002973: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Pt came back a few minutes after vaccine, and she had itching and swelling around her ears. It was red and swollen. Pt took a Benadryl, and it started to get better.
Headache first and 2nd day. A week later woke me up 2 nights in a row but only lasted 12-15 minutes. Skipped heart beats day after and the next am, none since. Rash of red irregular dots about the size of a pencil eraser with bumpy raised flesh directly on veins. started 2 weeks after, lasted 4 days, loss of appetite, much more intense joint pain and sleeplessness which comes and goes.
nausea, & vomiting;feeling terrible;no other details provided;did not want to fill out forms;
The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 3 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 06-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Received a 3rd COVID-19 shot, for Item 21 it will state None of the Above for outcome since we were unable to get a hold of anyone at the facility to report the incident.
Headache beginning 45 mins after second shot, lasting 5 days. Severe headache within 4 hours. No treatment. Severe nausea and vomiting beginning 10 pm night of shot or 10 hrs. later, lasting about 12 hours. Extreme chills  beginning 10 pm or 910 hrs. after shot. Couldn't hold food down 48 hours. Extreme fatigue beginning 10 pm or 10 hrs after shot, lasting 38 hrs. Slept 14 hours straight after first 24 hours. Symptoms began to subside (except headache) 48 hours after second shot. Headache lasted 120 hours. Began to eat light solids 48 hrs later,  began to eat normally 5th day or 120 hrs later. I did not use any treatment or call a Doctor.
Patient complained about persisting pain and some small pocket of swelling of the left arm.  He states this started 2-3 days after receiving his vaccine and was still present after 3.5 weeks.
I experienced on the very first day extreme fatigue. I had persistent cough. This lasted significantly for a couple of weeks. I actually still have a slight lingering cough. I still am experiencing shortness of breath. No fever, sore throat. I was prescribed Paxlovid. I usually could walk 3-5  miles a day and now can only do maybe half of that as well as half of my regular workout regimen.
Pt received vaccines late afternoon, played sports in early evening, and during the night began to experience fever(102.9) and chills. These continued through the night and into the next day with fever breaking during the afternoon.
At 1310  patient reported lightheadedness, dizzy and throbbing to right temple.  BP 136/87, P 60, R 20, SpO2 100%.  At 1328 BP 146/88, P 72, R 20, SpO2 100%.  Reports feeling dizzy, & tired.  At 1336 Per RN, will monitor another 15 min since pt. c/o feeling woozy when standing.  At 1341 Tingling in upper right chest area.  Escorted to BR via w/c to urinate.  At 1350 patient reports symptoms have resolved. BP 148/89, P 74, R 20.  Reports can drive self home.
Extreme vertigo upon waking  First day, stopped after a few hours and able to return to normal activities by 11 am Second day, symptoms were less severe but more persistent, unable to resume normal activities (I am reporting from the second day)
Sudden sensorineural hearing loss & tinnitus in right ear. Hearing loss assessed multiple times & still is persistent to this day.  I have received multiple steroid injections in my right ear with no improvement.
A healthcare professional reported that a 67 year old female received an injection of TD Toxoids Adsorbed, Purogenated on 8/7/00. Within 24 hours, the pt developed an injection site reaction characterized by redness, swelling and warmth. The pt recovered. The reporter indicated that 4 pts experienced this event following receipt of TD Toxoids Adsorbed, Purogenated lot 471039; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
We tested positive after receiving the first vaccination; This is a spontaneous report from a contactable male consumer reported for himself and his wife, this is second of 2 cases, for the female patient (wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, "On 07May of this year I took the covid-19 vaccination. Two days later I was very sick. When was tested and come to find out I had the virus, the Covid- 19 virus. Okay we together, my wife and I have done the 14 day quarantine which ended this past Saturday on 29th. So my question is should we take the second vaccination, since how we tested positive after receiving the first vaccination." The patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021635316 same reporter/product, different patient / event.
Received shot in pharmacy at 11:40 am. Picked up a few groceries and was in car by 12:15 pm. Noticed the tip of my nose was pink/red upon taking mask off. Didn?t think much of it. No other sx. Drove home.  By 12:30 pm, I was checking my nose and the very tip was slightly swollen. It was bizarre. By 12:49 pm, I took a few pictures. My husband also confirmed that my nose was swollen at the tip. It felt different than normal to touch and the skin was shiny in the area instead of pink/red. Called my doctors office and spoke with my RN, who advised me that she had heard of this before and to take Claritin 10 mg. Between 1:15pm1:30pm, I notice my gums were all the sudden swollen, but only in the center of my mouth. This lasted a few hours, where upon my gums became sensitive until the next day. Took Benedryl 25 mg at bedtime and the swelling is still not gone from my nose over 48 hours later.
PATIENT CAME INTO PHARMACY AND WANTED THE PFIZER VACCINE , SHE FILLED OUT THE ONLINE FORM AND THEN WAS ASKED ON THE INTAKE SCREENING AND CONSENT FORM IF THIS WAS HER FIRST DOSE TO WHICH SHE  ANSWERED YES THIS WAS HER FIRST DOSE AND HAD NEVER HAD A DOSE BEFORE. SHE WAS GIVEN THE DOSE  STYED THE REQUIRED TIME AND LEFT THE STORE. UPON RECORDING THE FIRST DOSE I HAD FOUND THAT SHE HAD GOTTEN THE FIRST AND SECOND DOSE 1/22/21 PFIZER LOT #EL3246  AND PFIZER LOT#EL3246 ON 2/12/2021 . WE TRIED REACHING OUT TO HER BUT SHE  STILL CLAIMS THAT SHE HAD NEVER GOTTEN THE DOSES.
Temperature 102F, pale, limp and lethargic. Cried 3-4 hours at a time non-stop. Give plenty of fluids.
1/2dollar size red circle @ injection site. Low grade fever Runny nose, itchy watery eyes, earache, allergy symptoms. Fatigue.
Meningitis; Difficulty breathing; This is a spontaneous report from a Pfizer-sponsored Program. This is the second of 2 reports. A contactable consumer reported a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot number and expiration date were not reported), dose 2 via an unspecified route of administration on 16Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: Unknown), dose 1, via an unspecified route of administration on 26Mar2021 as DOSE 1, SINGLE for COVID-19 immunization with no reported adverse effects.On an unspecified date, the patient experienced difficulty breathing. It was mentioned the patient had meningitis on an unspecified date. Clinical outcome of the events meningitis and difficulty breathing was unknown.   Information on lot/batch number has been requested.
[after booster dose]a bout of gastroparesis; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED GASTRIC EMPTYING ([after booster dose] bout of gastroparesis) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 040H21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Gastroparesis (she got a bout of gastroparesis. She gets it occasionally, but it's usually triggered by the weirdest thing, like eating chicken, so she gave up eating chicken 20 years ago. Close to a week and a half ago, she had the booster, and the next day she woke up with another bout of gastroparesis.) and Ehlers-Danlos syndrome.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMPAIRED GASTRIC EMPTYING ([after booster dose] bout of gastroparesis) (seriousness criterion medically significant). At the time of the report, IMPAIRED GASTRIC EMPTYING ([after booster dose] bout of gastroparesis) outcome was unknown.            No concomitant product was provided. No treatment information was provided. Company comment: This Spontaneous case concerns a 54-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Impaired gastric emptying. The event occurred after receiving the booster dose of mRNA-1273 vaccine, exact time interval cannot be assessed as event date is not available. Rechallenge was positive, as it was reported that the same occurred after the second dose of mRNA-1273 vaccine. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-428354 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 54-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Impaired gastric emptying. The event occurred after receiving the booster dose of mRNA-1273 vaccine, exact time interval cannot be assessed as event date is not available. Rechallenge was positive, as it was reported that the same occurred after the second dose of mRNA-1273 vaccine. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.
Incorrect brand given for second dose. Received Moderna for first dose and Pfizer for second dose.
burning; itching; tight sensation; eczema; rash; big goose egg; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), INJECTION SITE SWELLING (big goose egg), INJECTION SITE WARMTH (hot to the touch), SKIN BURNING SENSATION (burning) and PRURITUS (itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was not provided by reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LOSARTAN, PRIMIDONE and ROSUVASTATIN for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced RASH (rash), INJECTION SITE SWELLING (big goose egg) and INJECTION SITE WARMTH (hot to the touch). On 13-Jan-2021, the patient experienced SKIN BURNING SENSATION (burning), PRURITUS (itching), MUSCLE TIGHTNESS (tight sensation) and ECZEMA (eczema). On 10-Jan-2021, RASH (rash), INJECTION SITE SWELLING (big goose egg) and INJECTION SITE WARMTH (hot to the touch) had resolved. On 20-Jan-2021, SKIN BURNING SENSATION (burning), PRURITUS (itching), MUSCLE TIGHTNESS (tight sensation) and ECZEMA (eczema) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included ketoconazole shampoo and Clobetasol propionate.
The Vaccinator initiated a dose to the patient but realized the syringe was empty, which  was in the batch of syringes that were just filled.  He immediately  reported to the pharmacist filling the syringes.  After the report was made, the vaccinator inspected the new syringe and administered it to the patient.  The patient was contacted Monday to see how they were feeling.  Patient reported that she had muscle pain and a headache from the Moderna dose received.
Starting the first day my arm was very sore.  It was hot, swollen and hard. The discomfort was so significant I was unable to sleep at all the first night.  The pain and discomfort continued for 5 days before slowly lessening. It was so significant the first 24 hours I couldn't lift my arm. I had a mild fever for a couple of days.   I am 6.5 days out now and have a terrible sore throat.  I can barely talk or swallow and it's extremely painful.
Body ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced MYALGIA (Body ache) and CHILLS (chills). At the time of the report, MYALGIA (Body ache) and CHILLS (chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medications were reported No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up information received on 21-Jul-2021 and included events outcome was updated from unknown to recovered.
On 10/8/12, 2 days post flu vax, developed, Menieres attack (h/o Menieres), this episode, severe, veritgo, tinnitus, hearing loss/moderate drop, nausea, double vision. Needed one week off work. Was not treated with Prednisone, as was in previous Menieres episodes as caution of autoimmune reaction to flu vax. Meniere episode, strongest one since 2009, lasting with residual effects approx. 3 weeks, tinnitus, imbalance, nausea, left ear hearing drop.
ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/11/2023 AV BLOCK AV BLOCK, HIGH DEGREE