chrisvoncsefalvay/vaers-outcomes huggingface dataset:
about 4 hours after receiving the shot, I started getting hives on my wrists and thighs. At first I thought it was bug bites but realized they were hives. They gradually got worse overnight and spread to my torso. They subsided when I used Benadryl, but peaked about 24 hours after the shot and covered my arms, torso, abdomen and legs. They subsided after 3 more Benadryl and completely went away about 8 pm that evening. I can't think of any other variables that would have contributed to the hives.
experiencing excessive ringing in my ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 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 but unknown manufacturer), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Oct2022, outcome "unknown", described as "experiencing excessive ringing in my ears".  Additional information: It was also reported that patient had been experiencing excessive ringing in ears every day ever since he/she received bivalent booster 14Oct2022. He/she was in the process of seeing specialist. 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.
Expired vaccine administered  beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered  beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was provided.  No treatment medication was provided.
Pt received Pfizer x2.  Pt tested COVID + on 8/7/21 and admitted to hospital for COVID on 8/11/2021. Pt received remdesivir and dexamethasone.
Sore arm + shoulder- got steroid inj into shoulder joint 1/19/22 + started meloxicam po qd-
On 3/25/2021, I received my second dose of Pfizer. After I got the vaccine, I was lethargic. When I woke up on 3/26/2021, my left armpit was sore and I felt off. When I woke up on 3/27/2021, the lymph nodes in my left armpit were extremely swollen. My left breast was also extremely swollen and noticeably larger than the right breast. I also had heart palpitations. These symptoms lasted for about a week before they finally went away. However, ever since this happened, the swelling of the left breast and the lymph nodes of the left armpit and the heart palpitations have recurred periodically.
Patient's parent lied when filling out vaccination request form making the patient a year older than she was and stating they had no insurance.  So we believed the patient to be 5 when she was in fact only 4.  No side effects were noted other than that standard with everyone else.
Arm is red with red blotches from shoulder to elbow on arm where vaccine was given. Also, arm is itching and warm. No pain.
he got COVID after being vaccinated; he got COVID after being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: "Covid-19" (not ongoing), notes: first time I got COVID without the vaccine it was 2 weeks; "Covid-19" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "he got COVID after being vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: third time. Clinical course: Caller requested information on PAXLOVID side effects. He got the Pfizer vaccine he had COVID, this was his third time, his doctor prescribed PAXLOVID he hadn't taken it yet but he was diagnosed on the 1st he was bit nervous about taking this because he did not know everything about it, he just thought number 1 his wife wanted to get pregnant and he didn't want to cause any trouble with the reproduction process, that was a concern, was there any major side effects. He didn't have any health issues, heart disease or cancer, diabetes or people that was normally healthy, do they had any problems with this stuff". Caller confirmed the Pfizer vaccine he got was the COVID-19 vaccine and stated: "He got both shots he didn't have any problems with it, he had no side effects." Caller stated he got COVID after being vaccinated: "he got it for 4 or 5 days, it really didn't last that long but the first time he got COVID without the vaccine it was 2 weeks." Confirmed PAXLOVID use was for a patient over the age of 18.  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.
Complaining of dizziness and a slight headache, vitals assessed, refused transport to the hospital.
throat constriction, questionable rash; seen in urgent care & released; 18JUL94 f/u low BP, fever 102.9, throat constriction; pt recovered;
Developed Varicella lesion starting 12/25/03, were tiny in number. Seen 12/27/03 with tiny clear vesicles with red base scattered on torso and extremities, had one on scalp.
This spontaneous report was received from a registered pharmacist concerning a 76 year old female patient. On 23-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in September 2013, the patient developed shingles. The patient sought medical attention. The patient was seen by her unspecified primary care provider on 30-SEP-2013, who diagnosed her with shingles. It was unspecified if any treatment was given or if any lab test were performed. The patient was not recovered form shingles at the time of report. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
The patient presented with hives after vaccination.  The clinical lead gave 25mg Benadryl and monitored the patient for an additional 30 minutes until at baseline.
MD reported that this pt recv vax 10 yr ago & exp myalgia,fibromyalgia,arthralgia, & tendinitis at that time. Symptoms persisted till 11/5/96. Per Pt, while inj being given, she exp pain in shoulder/neck/head & back.See comments
Patient death certificate lists "natural" causes, with the Immediate Cause of Death of Cardiopulmonary Arrest.
worsening migraine; mild cognitive impairment; tremors; sustained vertigo; brain fog; tingling in right hand; subjective visual disturbance/ dizzy episodes which had affected eyes; dizzy episodes; This case was reported by a lawyer and described the occurrence of migraine aggravated in a female patient who received Herpes zoster (Shingrix) for prophylaxis.  The follow-up information received via Medical record on 03 April 2020. The patient concurrent medical conditions included migraine. As per the Medical record, on 19 April 2019, the patient had GSK suspect vaccine included immunizations varicella zoster 50 yrs plus (shingrix - shingles) 0.5 ml intramuscular administered per md order. The second dose shingrix appointment scheduled. On 26 April 2019, the patient reported that he  had took a Shingles Vaccine last week, after 5 minutes while sitting in car got an allergic reaction with an episode of Vertigo that lasted 90 seconds. The patient had some dizzy episodes which had affected eyes, tremors and right hand tingling along with vertigo. The patient had Sumatriptan (Imitrex) 50 mg oral tablet take one tablet by mouth at onset of migraine headache. May repeat 1 time after 2 hours if migraine is not relieved. On 16 May 2019, the patient experience more brain fog. On 16 May 2019, the patient had MRI of brain and brain stem wo/w contrast which shows mild cognitive impairment, tremor and migraine. Since the patient had worsening migraines, at times numbness on hands/fingers, feels experiencing more brain fog. On 28 May 2019, the patient hospitalized and diagnosed with mild cognitive impairment, tremor and migraine. On 30 May 2019, the patient had a reaction to Shingrix as well subjective visual disturbance. The patient discharged on same day. On 23 April 2019, the patient had vertigo.
I did not have an adverse reaction to the vaccine. I have a family history of heart attacks on my father's side of the family and my mother's side of the family. I had a heart attack on 03/13/2023. I was hospitalized from 03/13/2023 to 03/17/2023. I have a history of high cholesterol and high blood pressure. I am scheduled to start cardiac rehabilitation in 10/2023.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Janssen product on 07/20/2021. They tested positive for COVID-19 on 11/18/2021 after having a household contact who had also had COVID-19. They also presented to emergency department on 11/18/2021 and were admitted to hospital 11/18/2021. They experienced complications of pneumonia and cardiac arrest. They died on 11/26/2021.
Pt tested positive for COVID-19 on 6/6 and as given paxlovid as outpt. Pt reported stopping this after one day due to side effects (worsening nausea and vomiting). Pt then reported worsening cough, sputum production, fatigue, weakness, low appetite and fever. Finally reported to hospital where she was found to have leukosytosis and AKI with elevated procalcitonin of 2. Pt was given one dose of remdesivir before it stopped due to her original positive date being outside the initiation window. Pt continued on dexamethasone, rocephin, azithromycin , symbicort, albuterol, mucinex, pt improved and was discharged after 4 days
Rash below (5 to 6 inches) the vaccine / shot given and the rash is red and feels hot
exp muscle aches & pains for 2 to 3 days then had very sensitive skin that moved around to various parts of the body for about 1 1/2wk a/it finally disappeared;later exp signs of bad cold, congestion & cough;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Shortly after vaccination, patient stated he was starting to feel light headedness, he felt his heart was beating fast, patient closed his eyes a few times. Patient was given water and protein bar and said he felt a little better but was still feeling dizzy and light headed, 911 was called. The EMT arrived and the patient walked out of the pharmacy with EMT.
Narrative:  Patient is a 74 y/o male. Died on 07/07/2021. Received COVID vaccines on 3/26/2021 and 04/22/2021. Likely not related to COVID vaccinations.
pt c/o light headedness taken by w/c to tented area supine to cot. instructed to purse lip breathe 0900 resting quietly- resp 14 b/p 120/70.  pt states "this happens to me every time i need a shot"  09:15 requesting to go home s/s - o dizziness reported denies light headedness standing b/p 120/70 pulse 80 apple juice given for ride home. RN
Pt had a firm, well demarcated bump (8mm x 11mm). There was no lymphatic streaking. Received vaccine on 5/19 and was reported at doctor's office on 5/22.
Subsequent to receiving rubella virus vaccine live (second generation), the pt experienced hallucinations, vomiting and a high fever and went to the ER. The pt was not admitted and was treated at home, because her parent is a physician. Two weeks post onset, the pt recovered. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: patient passed out and fell to floor and hit head on chair. was out for 30 seconds to a minute
This spontaneous report as received from a consumer (the recipient of ZOSTAVAX) refers to 83 years old male patient (caller's father) with congestive heart failure, kidney failure, penicillin allergy and IV dye allergy. It was reported that in an approximately October 2012 (reported as in October 2012 or in November 2012) the caller (the patient's daughter) received a dose of ZOSTAVAX (dose, route and lot number were not reported) and within a week or 2 weeks later (in an approximately October 2012), her father had extreme pain on his side and broke out into rash (also reported as shingles). No other co-suspects were reported. It was reported that the patient was on unspecified concomitant medications. The patient did not seek medical attention for shingles. It was also reported that in an unspecified date in 2012, the patient was hospitalized. It was reported that the patient received unspecified treatment at center where he was receiving treatment for heart problems. At the time of report the patient recovered from shingles (unspecified date in 2012). The relatedness for the patient's shingles was not reported for ZOSTAVAX. Additional information is not expected.
Injection site on left leg reddened and swollen immediately following injection per father. Mother states that it kept getting larger as time went on. Over the next few days, there was progressive redness and hardness that continues until today. Today the mother was pushing on it when white pus-like material came out.
PNEUMOVAX vaccine administered 2/24/09 Right upper arm. Two days afterward the patient called the office questioning if site reaction was normal. Patient was seen by Dr. The site was red , swollen and warm. Patient reports this resolved over the next 24 hours.
Soreness in the shoulder; This is a spontaneous report from contactable consumer via Pfizer sponsored program COVAX US Support.    A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose BNT162B2 as 1st dose, single for covid-19 immunization. On 23Feb2021, the patient actually got the two doses for the COVID-19 vaccine shot. Probably about 3 to 5 hours after the shot he experienced soreness in the shoulder. The patient asked if he could take Acetaminophen or Aspirin for soreness or other something reliever to relieve that. The outcome of event was unknown.   Information about lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.
Delayed onset 4 days after inoculation: Nausea; stomach, body and joint aches, general weakness; Delayed onset 4 days after inoculation: Nausea; stomach, body and joint aches, general weakness; Delayed onset 4 days after inoculation: Nausea; stomach, body and joint aches, general weakness; Delayed onset 4 days after inoculation: Nausea; stomach, body and joint aches, general weakness; Delayed onset 4 days after inoculation: Nausea; stomach, body and joint aches, general weakness; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9262, Expiration date unknown), via an unspecified route of administration in left arm on 21Jan2021 16:00 (at the age 69-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies. The patient was not COVID positive prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included Simvastatin (SIMVASTATIN) 20MG, fish oil (FISH OIL), acetylsalicylic acid (BABY ASPIRIN); all for unspecified indication from an unspecified date and unknown if ongoing. The patient did not receive any other vaccine in 4 weeks prior to vaccination. The patient experienced delayed onset 4 days after inoculation: Nausea; stomach, body and joint aches, general weakness on 25Jan2021 17:00. The patient did not receive any treatment for the events. The outcome of the event was reported as recovering.  No follow-up attempts are possible. No further information is expected.
hives-woke up w/hives on chest the next morning;local swelling & pain @ site temp 98.3;17OCT97;had inc swelling & surface erythema;
Pt received TD for injury on 04/02/2002. Pt report sore arm with 6"x6" swollen, warmth to area, and sore to touch. Doctor advised the pt to take Benadryl, Tylenol and apply warm compress to area for 15 mins four times a day.
SUSPECTED CLINICAL VACCINATION FAILURE; SEVERE COVID-19 POST VACCINATION; SIDE EFFECTS AFTER RECEIVING THE VACCINE; This spontaneous report received from a patient concerned a male of unspecified age, 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 not reported, batch number: 1803982 expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient had experienced several side effects after receiving the vaccine. On 27-OCT-2021, the patient experienced severe covid-19 post vaccination and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, severe covid-19 post vaccination and side effects after receiving the vaccine was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint: 90000202088.; Sender's Comments: V0- 20211130147-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Swelling, redness, heat and pain on arm from shoulder to elbow. Dr recommended to use BENADRYL, ibuprofen and application of ice to affected area.
Rapid heartbeat, chest pain, shortness of breath, swollen and painful lymph nodes, extreme fatigue
Discovered leucopenia (WBC 2.8) during beginning of May 2021 on routine labs (normal WBC counts before). Developed zoster rash on 5/23/21, started oral valcyclovir, started to have fever from 5/24/21, went to ER, diagnosed with Varicella Zoster meningitis with a PCR from spinal fluid through LP on 5/24/21. Switched to IV Acyclovir. Discharged on 5/26/21 with outpatient IV acyclovir. Still have leucopenia as of July. But i clinically recovered from infection. Awaiting hematology evaluation for leucopenia.
Fever, chills, muscle aches, ?covid arm?(rash on arm, very sore)
left arm became numb; tingling/pins needles; feeling asleep; in the area of injection about 5 inch circle of upper left arm directly in injection area; Numbness; 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), administered in arm left, administration date 13May2021 (Lot number: EW0182) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma as a child but no adult issues or treatment. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: EW0170, Lot unknown: False, administration date: Apr2021, dose number: 1, vaccine location: Left arm), administration date: Apr2021, when the patient was 47 years old, for Covid-19 immunization, reaction(s): "severe fatigue". The following information was reported: HYPOAESTHESIA (non-serious) with onset 16Aug2021, outcome "unknown", described as "left arm became numb"; PARAESTHESIA (non-serious) with onset 16Aug2021, outcome "unknown", described as "tingling/pins needles"; SOMNOLENCE (non-serious) with onset 16Aug2021, outcome "unknown", described as "feeling asleep"; VACCINATION SITE REACTION (non-serious) with onset 16Aug2021, outcome "unknown", described as "in the area of injection about 5 inch circle of upper left arm directly in injection area"; HYPOAESTHESIA (non-serious) with onset 16Aug2021, outcome "unknown", described as "Numbness". Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia, somnolence, vaccination site reaction, hypoaesthesia.  Additional information: Facility type was workplace clinic. No other vaccine in four weeks was administered. There was covid prior vaccination and was not tested for covid post vaccination. Patient took one a day vitamins in two weeks. Patient had no known allergies.   Follow-up attempts are completed. No further information is expected
got so sick; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. Shingles vaccine was discontinued. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and felt sick and refused the second shot.
Employee noticed a tender swelling at the lateral left shoulder/lateral acromion 6 cm above the injection site in addition to a small raised erythematous lesion at the site of injection.
Moderna 3/19/21, 4/16/21. Positive on 8/6/22
Within hours post vax, the pt stated that she did not feel well. She then developed flu-like symptoms. This is one of two reports from this facility of adverse experiences following receipt of vax.