chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got Covid; got Covid; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dosage of vaccine on 25Feb2021 and was supposed to receive the second dose somewhere between the 18Mar2021 and 21Mar2021, but the patient got Covid on an unspecified date. The patient was supposed to go back and get it another week to take the second dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021277020 same reporter/drug/event, different patient
About 3 hours after getting the vaccine, my tongue started to swell; My throat hurt; My throat hurt as well near the lymph nodes.; rash appeared on my neck; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW01J8) via an unspecified route of administration on 15Apr2021 (at the age of 29-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, known allergies to latex, pollen and ragweed. Concomitant medications included diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL), fexofenadine hydrochloride (ALLEGRA) and unspecified vitamins; all for unspecified indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021 at 16:30, about 3 hours after getting the vaccine, the patient experienced tongue started to swell and a rash appeared on neck and throat hurt as well near the lymph nodes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events tongue started to swell and a rash appeared on neck and throat hurt as well near the lymph nodes and included treatment with prednisone. The clinical outcome of the events tongue started to swell and a rash appeared on neck and throat hurt as well near the lymph nodes were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-AUG-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" with lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 33 Fahrenheit (F) Degrees (0.555555556 Celsius)for a total of 1560 hours and also at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 336 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
No additional AE information; the vaccines went through the temperature excursion on 16-FEB-2021; This spontaneous report refers to a 4-year-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-FEB-2021, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL, lot # T024286, expiration date: 15-JUL-2022 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. On 16-FEB-2021, the dose of the vaccine was exposed to temperature excursion at -10 Celsius degrees (C) for 1 hour 15 minutes. There was no information about previous temperature excursion. The call was not due to digital data logger. No additional adverse event was reported.
Initially high temperature, muscle aches, flu-like feeling.  By 11 PM severe back spasms from shot site to spine. By 4 AM considered going to ER. Fever and extreme muscle pain continued for 2 days, then fatigue and lesser aches for 2 more days. Missed 1 1/2 days of work after weekend. Have never reacted this way to vaccine before. Not allergic to eggs.
After 12 hours of dose rigors, fever, shaking, weakness, malaise, flu-like symptoms all which lasted from Mon. to Thur. On Friday Sept 14, 2018 still had redness at injection site, weakness (flu-like symptoms), malaise. Per patient husband is physician and gave TYLENOL, MOTRIN and BENADRYL.
Fever to 103.8 the evening and day following the vaccine.  Twitching during sleep.  Fever resolved on 06/11/10.  (Vaccine given 6/7). Update.  Patient developed a rash on 6/12/10.  Suspect Roseola.
Unable to create wheel on first try, administered a second time on left forearm and wheel was successfully administered.
Almost immediately following vax, the pt experienced erythema around injection site, irregular flat border, 2" long and 1 1/2" in diameter. When area pressed taut 2 bleb-like formations that were 2x3 cm appeared. Pt was able to ambulate, but not usual pattern. Mother stated "walked like she was drunk". Mother was instructed to apply cool moist pad and give Tylenol.
I had visible inflammation, redness, swelling about the size of a softball on my arm (after the 2nd dose), and also had smaller red inflamed areas around the upper arm.  Two weeks after the second dose my upper left arm felt like it had the "flu" in it -achy and uncomfortable.  It hasn't gone away.  It hurts to push open a door, or to turn the steering wheel.  The pain is not constant, just when exerted myself to do even basic things.
Felt soreness run down left arm, left leg, left side of neck and tongue.  This was the first couple hours after.  Than felt achy all over.   Next day having fever, body aches and weakness.
102 degree fever Severe headache for more than 12 hours Swollen, red eyelid diagnosed as stye 1 day after
running a slight fever; received her 1st dose of the Moderna Covid-19 Vaccine on 24Apr2021, but never got the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (running a slight fever) and PRODUCT DOSE OMISSION ISSUE (received her 1st dose of the Moderna Covid-19 Vaccine on 24Apr2021, but never got the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (running a slight fever) and PRODUCT DOSE OMISSION ISSUE (received her 1st dose of the Moderna Covid-19 Vaccine on 24Apr2021, but never got the 2nd dose). At the time of the report, PYREXIA (running a slight fever) and PRODUCT DOSE OMISSION ISSUE (received her 1st dose of the Moderna Covid-19 Vaccine on 24Apr2021, but never got the 2nd dose) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
no additional AE reported; MMR II was improperly stored and administered.; This spontaneous report has been received from a nurse practitioner (also reported as nurse prescriber) referring to a patient of unknown age and unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 23-JUN-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) for prophylaxis (lot # S037497, expiration date 20-NOV-2021; strength, dose, and route were not reported). The product was stored at 55 Fahrenheit (F) from 08-JUN-2021 to 03-AUG-2021, the reporter was unable to provide total time out of range (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Headaches bodyaches chills   Right Axillary lymphadenitis  Pain in hands bilaterally
From 330 until 1030 pm I FELT great, no soreness by injection sight, no signs at all of any side effects BUT by 1030 pm, 7 hours after the shot I was ICE cold, teeth chattering, and could not get warm at all. NO FEVER but major body aches and soreness. AFter the chills wore off I was in a sweat..this pattern of chills, vs soaking sweats continued throughout the night. Add to that dry heaves due to nausea but no vomiting. The dry heaves just added to the muscle pains that I already had. I was in bed until 5 pm the next day, no energy, sore body aches to the point that my skin hurt. still no soreness in my arm at all. I finally had the strength to get out of bed at 5pm took a shower and ate 2 pieces of toast to combat the nausea. Fast forward next day, felt fine and arm was mildly sore at injection sight. SO glad J and J is only one dose.. I would have dreaded a second day like that.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient received a dose of PROQUAD lot # M019232 with an expiration date of 17-OCT-2017 (exact dose, route of administration, anatomical location and albumin status were not provided), instead of M-M-R-II. Information regarding a sterile diluent was not provided. The nurse confirmed that the event was a result of human error and not a result of product confusion. The nurse stated that she did not read the package label prior to administration. No adverse effects were reported.  Additional information has been requested.
Developed fever, rash within 72 hours of injection. Taken to doctor, dx chicken pox. Had "bad case" previous illness of chicken pox in 1999.
Patient had vaccines on 01/21/2019, mom called and stated that the patient developed high fever up to 104 (plus 1) and redness on the Right site of the injection. The patient has had febrile seizures in the past from vaccinations per mother. Advised her to give Ibuprofen and TYLENOL every 3 hours, alternating for at least the next 24 hours, and can also give BENADRYL to help with the redness. And to call our office if the patient gets worse.
Pain from area of TDP shot, limited use of left arm due to high pain radiating from inside arm.
swollen and painful lymph gland in the left  armpit of the arm that recieved the shot, swollen and painful left side of neck and lymph gland. Muscle aches, fatigue, and slight nausea. symptoms lasting approx.36 hours
Patient complains of itching, abdominal pain, body aches, eyelid swelling throat itching, mild shortness of breath and rash all over body.  Patient received epi pen, benadryl 25 mg, solumedrol 120 mg, pepcid 20 mg IV,
muscle aches; headache; sore throat; vertigo; metallic taste; borderline fever; nausea; diarrhea; neck ache; This is a spontaneous report from a contactable consumer (patient). A 74-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration, in left arm 06Feb2021 12:45 (at the age of 74-years-old) as 1st dose, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history was not reported. The patient was allergicto medications, food, or other products, iodine, sulfa, penicillin, codeine and cephalosporins were reported. Concomitant medications received within 2 weeks of vaccination included atorvastatin, sertraline, acetylsalicylic acid (BABY ASPIRIN) and calcium all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 06Feb2021 14:45, the patient experienced muscle aches, headache, sore throat, vertigo, metallic taste, borderline fever, nausea, diarrhea and neck ache. All events reported as non-serious. The patient did not receive any treatment for the event. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
My husband had stork like symptom on 16APR, starting at 11:30 am. He was in a conference call, and suddenly felt dizzy, voice change, drooling, sleepy. When he came downstairs, he could not hold himself, and I noticed his mouth was tilted to the left with drooling, and weakness on his left side. We had him sitting in the chair and I drove him to the ER immediately.
High fever, immediate loss of words, loss of weight, development of sensory issues and immediate loss of eye contact.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, GARDASIL underwent a temperature excursion. On 27-AUG-2014, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Pain at Injection Site an hour after, at 8pm chills began and very harsh sweating occurred, sweating lasted for two days enough to soak the sheets and underside of scalp. Back and joint pain when waking up and through the day, but could be subsided with ibuprofen.
Patient was over the age of 50, Menactra was given but Menomune should have been given.
This is patient's second pregnancy. She was given a dose of Tdap as recommended in third trimester on 1/16/19. Then, at her next prenatal visit, the prior dose was overlooked by the ordering provider and a second dose of the same vaccine was recommended and administered. The patient did not recall or realize she had already received the vaccine, and the medical assistant who administered the shot also did not notice that it had already been given two weeks prior. The patient did NOT have any reaction from the shot, but just received an additional dose.
The patient received the unauthorized vaccine/ patient was not age 12 at the time that the vaccine was administered/incorrect birthday was given by the parent.
Information has been received from a registered nurse, via a company representative, concerning a 38 year old female, with pulmonary hypertension secondary to ASD, Atherosclerotic heart disease, and unknown drug reaction/allergies, who on 2/28/06 was vaccianted route unknown with a second dose of Pneumococcal 23v polysaccharide vaccine lot unknown. Concomitant therapy included epoprostenol sodium Flolan. The nurse reported that on 10/14/04 the pt was vaccinated with a first dose of Pneumococcal 23v polysaccharide vaccine. The nurse reported that the pt developed a severe topical reaction after the second vaccination with Pneumococcal 23v polysaccharide vaccine. The follow up information received from the nurse confirmed that on the morning of 3/2/06 the pts arm became very red, painful and swollen. Subsequently on an unspecified date, the pt recovered. The nurse noted that the pt had other health issues and may have been immunocompromised at that time. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
01/27/22 Covid symptoms started with headache and sore throat. I did end up feeling achy off and on for two days but it wasn't bad. I did end up with a little bit of a cough but nothing major. Symptoms lasted about 3-4 days altogether. I stayed in isolation for 10 days. I also had postnasal drip but not like a runny nose. I tested positive on 01/21/22 with a home test, but also went to urgent care to get re tested and it was positive- I didn't get any steroids or antibiotics.
3/17/2021 Gums were red and tender graduated toinside lips as well. Burning with no lesions. Dry chapped lips occurred after a few days with symptoms inside of mouth remaining the same.  Inside and outside of mouth extremely dry. This is still remaining with no change or signs of healing. As of today 4/5/2021 all is the same.
Bad headache; Fever; Chills; loss of appetite; fatigue; Nausea; Vomiting; has been in bed all day; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's husband) via a sales representative. A 44-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Apr2021 as dose 2, single for covid-19 immunization. Patient's relevant medical history and concomitant medications were not reported. It was reported that patient got her second dose of the bnt162b2 vaccine on 21Apr2021. On 22Apr2021, patient woke up early morning with fever, chills, loss of appetite, fatigue. She had been in bed all day, had nausea and vomiting along with a bad headache. Outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 (intramuscular; dose, lot # and expiration date were not reported). On 09-JUN-2016, the patient was vaccinated with the second dose of GARDASIL 9 (intramuscular; dose, lot # and expiration date were not reported). On 03-AUG-2016, the patient was vaccinated with the third dose of GARDASIL 9 (intramuscular; dose, lot # and expiration date were not reported). It was reported that the last dose of GARDASIL 9 was given early and was meant to be scheduled for November 2016. No adverse effect was reported. Additional information has been requested.
Sore muscles, followed by fever, chills, vertigo, headache, bone pain, exhaustion.
No additional AE reported; administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 1-year-old male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-DEC-2022,  doses of hepatitis A vaccine, Inactivated (VAQTA) underwent a temperature excursion of 47.9 Fahrenheit degrees for 47 minutes, a data logger was involved.  On 27-DEC-2022, the patient was vaccinated with an improperly stored first dose of hepatitis A vaccine, Inactivated (VAQTA) pre-filled syringe, administered intramuscularly on the left thigh, lot #W017343, expiration date: 13-DEC-2023 (strength and dose were not provided) as prophylaxis (product storage error). No adverse event was reported.  This of one of several cases reported by the same reporter. ; Sender's Comments:  US-009507513-2301USA009943:
she was hauled off, they thought she had a TIA, which she did not and that may not have been related; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL3247, Expiration Date: 21May2021) for covid-19 immunisation. The patient's relevant medical history included: "Sunburn" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "she was hauled off, they thought she had a TIA, which she did not and that may not have been related".  The reporter considered "she was hauled off, they thought she had a tia, which she did not and that may not have been related" not related to BNT162b2.  Additional information: With the first COVID-19 Vaccine, she was hauled off, they thought she had a TIA, which she did not and that may not have been related. With the TIA, she states who knows, she doesn't think that was true either That vaccine did something to her She received a letter from Pfizer with a reference number: # Confirmed she previously filed a report with Pfizer and complained.  Follow-Up (16Aug2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: The company does not attribute the 'they thought she had a TIA' (PT: Transient ischaemic attack) to BNT162b2 (BNT162B2). The diagnosis is to be confirmed.,Linked Report(s) : US-PFIZER INC-202200403402 Same reporter/patient/ product and different dose/event;US-PFIZER INC-202201057761 Same reporter/patient/ product and different dose/event;US-PFIZER INC-202201037982 Same reporter/patient/ product and different dose/event;
Approximately two hours after receiving the vaccine I began to experience mucus drainage in my throat. The day after vaccination I had a sore throat and congestion that felt similar to a cold. Symptoms began to weaken three days after vaccination and by day 5 I had recovered almost completely.
arm warm to touch;40cm welt-red & raised @ inj site x 10 days;
Administered vaccination past expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccination past expiration) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccination past expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccination past expiration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
c/o throat discomfort Tx: Albuterol + Atrovent by PN; SoluMedrol 125mg IVP improves with treatment and discharge home at 10:30am
On March 12, I experienced some pain in left hand.  By the next day, my hand was somewhat swollen, stiff and I had trouble grasping items.  The pain was worse on March 14, to the point that I could barely move my hand.  My arm from below my elbow  was also sore.  I took Tylenol and, later, aspirin.  My hand was swollen and the veins appeared dark through the skin.  My hand felt cold and applying warm compresses helped ease the. pain.  By March 15, the pain started to go away and by March 16, my hand and arm were back to normal.
Fatigue, feeling dizzy, not having good vision, leg cramping/hurting, HA, and SOB.  She was diagnosed with myocardial Infarction  in the ER with SOB adverse effect of the vaccine.  She has no prior cardiac history
Patient developed lines of hives on back which were very itchy about 5 minutes after vaccination.  Gave a 25mg tablet of diphenhydramine with water.  Watched for extra time (10 more minutes) and patient began to improve.  Advised mother to continue diphenhydramine at home as needed and report.