chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner, referring to multiple unspecified patients of unknown age and gender. Information about current condition, concomitant medication and medical history were not provided. On unspecified dates, unspecified patients were vaccinated with unspecified number of doses of improperly stored ROTATEQ (M042169 with expiration date 22-JUN-2018; M044395 with expiration date 31-MAY-2018; concentration, dose, route and frequency were unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored at 47 degrees Fahrenheit(F) to 77F (51F) for 1 hour 20 minutes, and 32F to 35F (34F) for 3 hours and 46 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009616: US-009507513-1707USA009417:
Patient received the Moderna vaccine, and upon waiting the 15 minutes post vaccination, she had a reaction where she seemed to have a panic attack and vomited.  Patient had no known allergies, only advised that she was afraid of needles.  She did not come alone, she was with her mom for the fact she knew she might get really nervous with getting the immunization.  She was alert and ok during the whole process and left in good spirits. She stayed for more than 30minutes.  We had her wait until she felt ok to go home with her mom.  Management also stopped by make sure she was ok.  Tried to call her tonight to see how she was and left a message.
shingles infection; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On 15th February 2019, 143 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The lot number and expiation date not specified. The patient experienced shingles. The patient has not received the second dose of Shingrix yet due to the shingles. The patient was still recovering from Shingles.  The reporter was consented for follow up.
The morning after the shot, I woke up sore all over with chills and a fever. It felt like the flu. I took acetaminophen and my fever went down. By the next morning I was fine.
pale, BP 98/60, P80, numbness in rt arm & rt side of face;fatigued;had nothing to eat all day;took food & fluids by 245PM color improved, more alert, BP 98/60, P 60;no further complaints of numbness;29MAY98 mom reports pt doing well;
Headache; Swelling at the injection site; Nausea; A spontaneous report was received from a consumer, a 48 year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced nausea, headache, and swelling at the injection site.    The patient's medical history, as provided by the reporter included inflammatory arthritis and autoimmune disorder. Products known to have been used by the patient, within two weeks prior to the event, included leflunomide.    On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (batch number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020 and experienced nausea after the vaccine. She stated that she also experienced swelling at the injection site and it is not getting better. The patient reported that on 25 Dec 2020, she had a headache. She stated that the nausea was worse on 26 Dec 2020.   No treatment medication was taken at the time.   Action taken with mRNA-1273 in response to the events was not reported.   The events, nausea, headache, and swelling at the injection site, were considered not resolved.; Reporter's Comments: This case concerns a 48-year-old female who experienced NS expected events of injection site swelling, headache, nausea.  Event onset the same day as the first dose of mRNA-1273. Treatment not reported. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
received dose 1 on 6/17/2001 (birth) and dose 2 on 01/25/2002; received dose 1 on 6/17/2001 (birth) and dose 2 on 01/25/2002.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 19-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 17th June 2001).   On 25th January 2002, the patient received the 2nd dose of Engerix B. On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long and incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.  Additional information was provided as follows: The patient who was going to College and was required Engerix B vaccination but looking on his records patient received dose 1 on 17th June 2001 and dose 2 on 25th January 2002 which led to lengthening of vaccination schedule. The patient did not received 3rd dose of Engerix B which led to incomplete course of vaccination. The pharmacist wanted to enquire that if the patient need to restart vaccination course. The reporter consented for follow up.
This is a spontaneous report from a contactable consumer (patient's wife). A 63-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot#, expiry date not reported), at the age of 63, via an unspecified route of administration, on Mar 22, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date in Mar 2021 (5 hours after the vaccination), patient's eyes got puffy (swelling), stuffy nose, and itchy throat (which did not swell and never closed). The events lasted half an hour; everything went away 30 minutes later. Patient took Benadryl for the events. Patient was told that the second dose was more potent. Reportedly, patient went for the second shot but unable to get it because he had a reaction to the first one. His primary doctor wrote a letter to say he can get the shot. He has another appointment to get the dose. His wife called the CDC. They told her if within 4 hours he had wheezing, hives, difficulty breathing, swelling; then it would not be recommended. The outcome of itchy throat not recovered; whereas other events recovered on an unspecified date in 2021. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information is expected. Sender's comments: Linked report(s): US-PFIZER INC-2021410153 similar report from same reporter.
Right ear fullness Right ear hearing loss Extreme dizziness Brain fog Vertigo Lightheadedness Fatigue
2 hours after shots: woozy, felt heart skipping beats. Took pulse and it was in the 50?s. (Mine is normally in 70s) That day and for weeks after: intense heart palpitations, like heart was in my throat. Not like anxiety palpitations (which I have experienced) About a week and a half after: heart squeezing affect. Like someone teaching in and grabbing my heart. Back abs shoulder pain. I originally assumed this was anxiety, though I have never experienced this before. (Chest tightening) About a week or two after shot: freezing cold hands and feet. Also tingling hands and feet. Some tingling in my face.   I was not able to see my doctor for tests until May.
injection site swelling; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling and headache. On an unknown date, the outcome of the injection site swelling and headache were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and headache to be related to Shingrix.  Additional details were provided as follows On 1st June 2020 around 5.30 PM, the patient received the vaccine. On 2nd June 2020, the patient woke up in the morning with swelling at the injection site and a headache.  The reporter consented to follow up.
headache; buzzing in the head; fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for tolerance of 1st dose refer case US2020221342).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, noises in head and fatigue. On an unknown date, the outcome of the headache, noises in head and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache, noises in head and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had fatigue, buzzing in the head, and headache after receiving the 2nd dose of Shingrix and these resolved within a couple of days. The reporter did not consent to follow-up. This case is 1 of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221335:same reporter US-GLAXOSMITHKLINE-US2020221335:same reporter US-GLAXOSMITHKLINE-US2020221342:1st dose, same patient
Fatigue, HA and dizziness. Treatment: Tylenol and Motrin with no improvement. Outcome: Patient report dizziness with turning of head and standing up.
Deep Tissue pain in site injection 3 months after vaccine - Pain strong enough to wake me in middle of night
The COVID  vaccine (Lot number FH8028 with expiration of 2/28/22) was given after it's beyond use date of 1/15/2022. Outcomes of giving the vaccine after the unknown.
She presnted symptoms related to UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Jan2021 (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: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "She presnted symptoms related to UTI".  Additional information: Patient stated that 3 months later the same issue occurred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SIDE EFFECTS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced side effects. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FF8839) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Allergy: sulfa drugs" (unspecified if ongoing); "known allergies: peanuts" (unspecified if ongoing); "known allergies: tree nuts" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; ALLEGRA; OMEPRAZOLE; AMLODIPINE BESYLATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Tested positive for Covid; (2022) negative, notes: after 8-9 days was testing negative; (2022) Positive, notes: started to have covid-like symptoms again and now testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: product: COVID 19 Treatment, treatment start date: 08Jul2022, Treatment stop date: 13Jul2022, indication: Treatment of COVID-19. Tested positive for Covid, took full 5day dose of Paxlovid. Symptoms improved greatly and after 8-9 days was testing negative. other medication in 2weeks product reported as vitamins.
I am in excellent health, take no prescription drugs, am not overweight, but have many allergies to pollen, molds, dust, cat and dog.  I became very sick the day after injection with flu symptoms.  I had fever and chills, headache, nausea, vomiting and diarrhea.  I was extremely weak having to stay in bed for 1 full day and half of another.  Fever and headache went away on second day, but nausea, diarrhea, and weakness lasted 4 days.   Today is the 5th day and all has gone away except I have little energy and cannot fully resume my normal activities, such as regular exercise.
lost 19 pounds over the past 2 weeks, lethargic, unable to move muscle weakness of whole body for a week
A spontaneous report has been received from a consumer. The report concerns a patient, Male consumer, Height: 71.0 Inches; Weight: 215.0 Pounds, who had been receiving Nasal FLUMIST QUADRIVALENT unknown dose, yearly for FLU PREVENTION. The patient's medical history included ALLERGIC REACTIONS TO INJECT-ABLE FLU VACCINE. The patient received FLUMIST QUADRIVALENT on an unknown date for FLU PREVENTION. The patient experienced ARM PAIN AT THE INJECTION SITE, ARM SWELLING AT THE INJECTION SITE and SCARED. The patient recovered from the event of ARM PAIN AT THE INJECTION SITE and ARM SWELLING AT THE INJECTION SITE on an unspecified date and At the time of reporting, the event of SCARED was ongoing. The report was considered to be non-serious by company physician.
swollen lymph nodes; pain on the injection side in my lower neck it feels like a bump; pain on the injection side in my lower neck it feels like a bump; I have the same pain in my armpit with the same bump feeling; I have the same pain in my armpit with the same bump feeling; fever; This is a spontaneous report received from a non-contactable consumer (patient). This 39-year-old female patient received a dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number EW0185) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she thought she possibly developed swollen lymph nodes because she had pain on the injection side in her lower neck and it felt like a bump; she also had the same pain in her armpit with the same bump feeling. She also reported a fever between 100 and 101. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of pain on the injection side in her lower neck it felt like a bump, she had the same pain in her armpit with the same bump feeling, and fever were unknown.  No follow-up attempts are possible. No further information is expected.
pt recv vax 5FEB96 & 18SEP97 pt devel 20 lesions;tx w/DPH;pt was febrile, comfortable & still being treated;
ITCHY; NOT GOING AWAY; GETTING BIGGER , 3 BY 3 INCHES IN DIAMETER; GETTING WORSE; some kind of rash, circular in nature at the site of injection; A spontaneous report was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events some kind of rash, circular in nature at the site of injection, itchy, not going away, getting bigger , 3 by 3 inches in diameter, getting worse.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) some kind of rash, circular in nature at the site of injection, itchy. On an unknown date, the patient experienced the event(s) , not going away, getting bigger , 3 by 3 inches in diameter, getting worse.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), some kind of rash, circular in nature at the site of injection, itchy, not going away, getting bigger , 3 by 3 inches in diameter, getting worse was unknown.
Redness around injection site, fist size. Felt tired and weak, aches lasting about 24 hours. Day naps and 8 hr night sleep.
Pt. states he passed out 3 times, 1st time ~ @ 2:45 pm ( 1 hr. 15 min. after vaccines administered); he also experienced muscle ache & dizziness, trouble breathing & swallowing & couldn't sleep until 5 am; felt better in am next day but still dizzy
Found my son in bed at 8:00 am. Had urinated in bed, not responsive, could not walk, or communicate with me.
headache; 6 hours after Phizer COVID 19 Booster vaccine I started getting chills; 100 degree fever; sinus pain; hearing loss; loud tinnitus in both ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 at 11:00 as dose 3 (booster), single (Lot number: FJ4991) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Birt Hoggs Dube Syndrome" (unspecified if ongoing); "Valley Fever" (unspecified if ongoing); "Egg white allergy" (unspecified if ongoing), notes: Allergy: Egg white allergy; "if covid prior vaccination : yes" (unspecified if ongoing), notes: if covid prior vaccination : yes. Concomitant medication(s) included: ARMOUR THYROID. Vaccination history included: BNT162b2 (Dose 2, COVID-19,, lot number=301458A,, administration date=28Sep2021,time=11:00 AM,, vaccine location=Left arm,), administration date: 28Sep2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, COVID 19,, lot number=FC3184,, administration date=06Sep2021, time=12:00 PM,, vaccine location=Left arm), administration date: 06Sep2021, when the patient was 72-year-old, for COVID-19 immunization. The following information was reported: PYREXIA (disability) with onset 10Apr2022 at 17:00, outcome "recovered" (12Apr2022), described as "100 degree fever"; CHILLS (disability) with onset 10Apr2022 at 17:00, outcome "recovered" (12Apr2022), described as "6 hours after Phizer COVID 19 Booster vaccine I started getting chills"; HEADACHE (disability) with onset 10Apr2022 at 17:00, outcome "recovered" (12Apr2022); DEAFNESS (disability) with onset 10Apr2022 at 17:00, outcome "not recovered", described as "hearing loss"; TINNITUS (disability) with onset 10Apr2022 at 17:00, outcome "not recovered", described as "loud tinnitus in both ears"; SINUS PAIN (disability) with onset 10Apr2022 at 17:00, outcome "recovered" (12Apr2022). The events "headache", "6 hours after phizer covid 19 booster vaccine i started getting chills", "100 degree fever", "sinus pain", "hearing loss" and "loud tinnitus in both ears" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: (22Jun2022) Unknown results; Body temperature: (unspecified date) 100 degree, notes: 100 degree fever; SARS-CoV-2 test: (18Jul2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of headache, chills, pyrexia, sinus pain, deafness, tinnitus.  Clinical course: Covid prior vaccination reported as yes. Covid tested post vaccination reported yes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are needed. No further information is expected.
I became dizzy shortly after getting the vaccine approx 20 min. At around 10 pm that night started getting a cough and was having trouble swallowing.  My dizziness became worse and I started to feeling my heart skipping and pounding in my chest.
Diagnosed with cellulitis in left arm, by urgent care, on 1/15/17.
patient claims she cannot move her arm pass her shoulders due to soreness and pain for the past 27 days.
Lightheaded nausea dizzy, tingling face down arms and legs. Approx time till pt could safely sit up 25 minutes. HR 60-80, - SOB, pt scared, + diff breathing
Parent reported pt only had 1 dose of covid vaccine, Nurse checked in system vaccine record showed pt had 1 dose of covid19 vaccine Dad brought vaccine record back to the office after visit and nurse noticed that pt already received the 2nd dose of covid vaccine. pt received the booster 5 weeks earlier than protocol.
Chest tightness, shortness of breath, dizziness, fever requiring ER evaluation for cardiac symptoms
Generalized itchiness beginning at 0930. Took zrytec at 1145. Continued itchiness during day but lessened. Took benadryl at 2130. No itchiness next morning.
Redness and a ring after the first dose; Bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness and a ring after the first dose) and VACCINATION COMPLICATION (Bad reaction) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ENALAPRIL, METFORMIN, GABAPENTIN (NEURONTIN), LEVOTHYROXINE SODIUM (LEVOXYL), GEMFIBROZIL, IBUPROFEN, VITAMIN C [ASCORBIC ACID], ZINC, FISH OIL, VITAMIN D NOS and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness and a ring after the first dose) and VACCINATION COMPLICATION (Bad reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form and HYDROCORTISONE ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, ERYTHEMA (Redness and a ring after the first dose) and VACCINATION COMPLICATION (Bad reaction) 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.   This case was linked to MOD-2021-213292 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow-up received on 31-Jul-2021 included no new information.