chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 10/1/2015 at about 1:04PM, Mother of patient reported that patient had a seizure that lasted about a minute. The shaking was slow and her eyes rolled up. She was unsure of her temperature at the time of the incident. EMS evaluated her and determined to call her PCP for follow up, but did not warrant a trip to the ER. She mentioned that patient is still tired, but alert and oriented. "She should be active and playing now because she just woke up, but she is tired".
7 days post vaccine patient had cellulitis at injection site and had developed Bells Palsy.
Pt recvd Engerix-B vax on 12MAR91 & w/in 30 min of receiving vax had anaphylactic rxn; violent h/a, BP inc to 144/88, & tightness of neck; Pt refused tx w/Demerol & vax series was not continued;
This case was reported by a physician via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. In March 2018, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated that she was notified via text message from her ex-husband (patient) that a radio personality was on the radio stating that he developed a fever after receiving SHINGRIX this weekend. The call was transferred to collect adverse event. The caller was a pharmaceutical employee. No other information was available to be provided or documented about this call.
Patient is a 93-year-old male who presents with complaints of a 1 week history of left upper extremity swelling. He states that initially the swelling began in his hand, and in the last 3-4 days has progressed into his left forearm and upper arm. He had a COVID vaccination in his left upper arm 8 days before the swelling began. Patient was referred  for a left upper extremity ultrasound. Ultrasound result was negative for DVT. Patient education provided. Recommend Ace wrap to left upper extremity or swelling, elevation, and ice therapy. Recommend follow-up appointment in 1 week with PCP for recheck. If left upper extremity swelling persist would recommend further imaging studies for evaluation. Recommend he call or be seen sooner if he develops worsening swelling, pain, redness, or warmth.   On 4/19 patient still reporting swelling 1 month later, repeated US to R/o DVT.  US shows DVT of the distal subclavian vein.
hey, i had my covid vaccine at pharmacy and a few hours later all my body turned red and itchy I have no idea what is happening to me . the next day i went to see my doctor and he gives me a steroid shot thinking it will help me but it doesn't. a week later a went to see a dermatologist but he just gives me some cream that I bought at the pharmacy .righ now I can't even take a shower and there are all black spots over my body including my face. The last time I went to get a job and my employer don't want to hire me because they can't figure out what going on with my skin. they just told me i will be working with chemicals so they don't want to put my life in danger.i had ever have any skin problem in my my life .all these problems began a few hours after the shot.
4 years old had physical on 11/19/2003, received DTAP #4 on the left deltoid.  Complained of swelling, redness and pain after shot.  Local reaction to immunization.  Temperature 97.9 treated with ice packs and resting.
Patient received a 3rd booster vaccine. Received 1st booster (0.25 mL) in 10/2021, then received a 2nd booster in 4/2022, and received a 3rd booster on 7/18/22. Experienced no side effects from any of the vaccines.
This spontaneous report as received from a other health professional refers to a 18 year old female patient. The patient had no medical history and drug reactions or allergies. On 14-OCT-1997, the patient was vaccinated with a first doses of MMR II (lot number and expiration date were not reported) 0.5 ml, subcutaneous. On 31-OCT-2000, the patient was vaccinated with a second dose of MMR II (lot number and expiration date were not reported) 0.5 ml, subcutaneous. Secondary suspects and concomitant therapies were not reported. On 09-JAN-2015, the patient had serologic tests done and the result was seronegative at 9.0 (units not provided). On 16-JAN-2015 the patient was vaccinated with a third dose of MMR II (lot number and expiration date were not reported), 0.5 ml, subcutanoeus. On 06-MAR-2015, the patient had serologic tests done and the result was seronegative at 10.6 (units not provided). On 18-APR-2015, the patient had serologic tests done and the result was still seronegative at 9 (units not provided). The outcome of antibody test negative was unknown. The relatedness between adverse event and MMR II was not reported. Additional information has been requested.
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 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 16:00 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 13Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 02Dec2021 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 29Apr2022 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolaemia" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, start date: 01Jan2022, stop date: 02Jan2023; CALTRATE [CALCIUM CARBONATE], start date: 01Jan2022, stop date: 02Jan2023; CENTRUM WOMEN 50+, start date: 01Jan2022, stop date: 02Jan2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient not received any treatment for adverse event. Patient had no Known allergies, Patient received other medication in 2 weeks.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 20 years, in left arm 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: strong positive. Therapeutic measures were taken as a result of covid-19. The patient received Paxlovid for covid-19 from 05Aug2022 to 10Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
61-year-old male with PMH of ESRD-HD dependent s/p previous failed renal transplant 2016, HTN, gout, osteoarthritis, low back problems, and anemia who tested positive for COVID-19 on Sunday 12/26. He had dialysis that day and also came to the ED and received 1 unit of PRBCs. Since that time he is not had dialysis, he states his dialysis center could not accommodate him and he did not want to drive up North. He has had progressive shortness of breath over the last 2 days which is significantly worse this morning prompting his visit to the ED.
PATIENT RECIEVED VACCINE AND 30 MINUTES LATER RETURNED TO NURSES COMPLAINING OF A CONGESTED NOSE WITH DRAINAGE, SNEEZING, COUGH AND CHEST TIGHTNESS. VITALS WERE OBTAINED AND WHERE STABLE AND WITHIN NORMAL RANGE. PATIENT STILL COMPLAINING OF FEELING WORSE SO EMS WAS CALLED. UPON ARRIVAL EMS OBTAINED PULSE OX AND 100% O2 WAS DELIVERED VIA NON RE-BREATHER MASK. PATIENT WAS THEN LOADED AND TRANSPORTED FOR TREATMENT AT CLINIC.
I got symptoms of congestion, sore throat, and fatigue. I went to the nearest urgent care where I tested positive for RSV. My grandson had recently had it, and I'm sure I contracted it from him. While I was there, my physician listened to my heart and told me I needed to go to the emergency room. Once I arrived there, they said I looked anemic and felt out of breath. The doctor ran IVs and fluids and ran a swab to confirm RSV infection. They determined my EKG looked abnormal/irregular, I had pneumonia left lung and sepsis infection in my blood. Once I was admitted, they put me on antibiotics and administering potassium and magnesium. My hemoglobin was extremely low and fell further while I was there. They did a blood transfusion as well later as well as echocardiogram with CT scan of my heart. A CTA scan followed the next day where they concluded I had a left branch bundled clot in my heart. My heart looked healthy besides the bundle that appeared in the scans. After the transfusion and the infection cleared up, I was discharged on the 03/17/2023. During my follow-up today (04/24/2023), my hemoglobin levels are back to normal and all is well again.
Initially noticed 2 small patches of raised bumps- 1 on the back, 1 on the abdomen.  At first were concerned it was bug bites.  However, over the course of the next hour they rapidly grew in size and soon there were over a dozen large patches.  The skin in the affected areas was red with raised bumps within.  Patient did not complain of pain or other symptoms and did not have a fever.  Rushed patient to the facility where given the flu vaccine.  A nurse evaluated patient and said it was hives.  Received an oral steroid to reduce swelling.  The dr. called this morning to 'go on record' that it could not be the vaccine but went on to say that they had no idea what could cause it.  Patient has NEVER had hives in the last 2 years.  Has not eaten or been exposed to any new substances in the last few days so there is no other possible cause other than the flu vaccine.
got coronavirus after having the Covid-19 vaccine shots; got coronavirus after having the Covid-19 vaccine shots; This is a spontaneous report from a Pfizer-sponsored program. This spontaneous report from a contactable consumer reporting same events under the same suspect product for 10 patients. This is one of 10 reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The reporter had talked to 10 people that got coronavirus after having the Covid-19 vaccine shots.  The reporter stated that she doesn't believe in this stuff and doesn't trust it.  The reporter did not provide details for any of the patients that got coronavirus after having the Covid-19 vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021527957 same drug/AE, different patient
This case was reported by a physician via a representative and described the occurrence of swelling in legs in a subject of unspecified age and gender who was vaccinated with DTaP (manufacturer unspecified), IPV. On an unspecified date the subject received unspecified dose of DTaP (unknown, unknown thigh) and unspecified dose of IPV (unknown, unknown thigh). At an unspecified time after vaccination with DTaP and IPV, the subject experienced swelling of legs. At the time of reporting the event was resolved. The reporter stated that this event happened years ago when they used unknown DTaP vaccine with separate IPV vaccine, injected into the same leg. An unknown number of subjects experienced limb (leg) swelling. When they switched to administering the DTaP in one leg and the IPV in the other leg, the limb (leg) swelling no longer occurred. The event was associated with giving both DTaP and IPV in the same leg.
Information has been received from a consumer concerning her kindergarten age daughter who was vaccinated with a dose of ATTENUVAX. The patient experienced high fever after receiving the vaccine. This is one of several reports from the same source. Additional information is not expected.
Herpes outbreak in anal area; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an intramuscular route of administration  in the left arm on 09Apr2021 at 12:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an intramuscular route of administration  in the left arm on 19Mar2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not received any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:00, the patient experienced herpes outbreak in anal area. The patient had not had an outbreak in 20 years and never in that area. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with acyclovir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event herpes outbreak in anal area was recovered on an unknown date.
my husband had a widow maker heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A male patient received BNT162b2 (BNT162B2), as dose 4 (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: Bnt162b2 (Dose: 1), for Covid-19 Immunization; Bnt162b2 (Dose:2), for Covid-19 Immunization; Bnt162b2 (Dose:3), for Covid-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 08Feb2021, outcome "unknown", described as "my husband had a widow maker heart attack".  Clinical Course: The reporter stated that her husband had a widow maker heart attack on 08Feb2021 after his second booster was given, he had been out of work for quite some time after that do you have a investigator working on any cases that has been reported. She needed some assistance on what to do, she was the only one working and she couldn't afford to make all his bills and herself and the gov would not approve disability please look in to this matter, she can send the vaccination card and all of his medical records.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Ringing in ears; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received bnt162b2, via an unspecified route of administration in left arm on 17Dec2020 16:00 (first dose, lot number: EJ1685, expire: unknown) at single dose, via an unspecified route of administration in left arm on 08Jan2021 09:00 (second dose, lot number: EL3246, expire: Apr2021) at single dose for COVID-19 immunization. Medical history included very frequent yeast infections that started about eight years ago, hypothyroidism from an unknown date and unknown if ongoing (she has been on medication her whole life). Concomitant medication included thyroid (ARMOUR THYROID) at 90 mg daily for hyperthyroidism (she has been on this particular medication about a year, but she has been on thyroid medication her whole life). The patient experienced ringing in ears on an unspecified date. She got two doses of Pfizer vaccine. It may be a coincidence. She started having intermittent ringing in ears and now it had been constant for 3 or 4 days in a row. She had continuous ringing in her ear and has never had problems with her ears before. It wasn't going away. She was at the point to go to the doctor. She honestly didn't know the date. She noticed it intermittently about the time she got the COVID vaccine. She didn't really pay much attention. She got the second shot about the time it started constantly. She couldn't say 100%, maybe it was coincidental. Caller clarified that she noticed intermittent ringing in the ears about the same time of the first dose. She noticed constant ringing about the same time as the second dose. She would rate seriousness criteria at a five, in the middle. It is not requiring hospitalization, but she would seek medical treatment if it didn't go away. The outcome of event was not resolved. Vaccination facility type was hospital. No additional vaccines administered on same date of the Pfizer suspect. The events were not required a visit to emergency room nor physician office at this time, but she was considering seeing her doctor or an ENT. No AE following prior vaccinations. No relevant tests.
Reconstituted vaccine with bacteriostatic Sodium Chloride. Customer is understands error and is not interested in revaccination.
Patient was ready to leave after the required 15-minute wait time post-vaccination; however, when he stood up, he fainted. He regained consciousness immediately after healthcare providers came to his aid. He was diaphoretic and stated he didn't realize he had fainted. His blood pressure was very low and we gave him a bottle of water to drink and called the paramedics. After he was evaluated, he decided not to go to the ER and was picked up by a family member. After seeing him recently, he stated that the incident occurred because he had not eaten very much before getting the vaccine in addition to being anxious.
Cried high pitch, restless, lost speech eye contact, played in the floor, regression.
Immediate itching. 24 hours after: swelling, hot, redness, soreness. 36 hours after: swelling down arm to below elbow, hot, red, sore, still itching.
This spontaneous report was received from a medical assistant, concerning a 27 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. In approximately 2010, when the patient was 19 years old, she received 2 doses of GARDASIL 9 or GARDASIL (strength, lot #, expiration date, dose, route of administration or anatomical location were not provided) for prophylaxis. On 25-JUL-2018, the patient presented to the medical assistant office and stated that she missed her third dose of GARDASIL 9 or GARDASIL; and would like to received GARDASIL 9 (inappropriate schedule of drug administration); but the dose was not administered yet (incomplete course of vaccination). No adverse effects were reported.
Blacked out; feel light headed; unbalanced; Having trouble to focus with my eyes; Head feels full; Lymph nodes in head, neck and under arms swollen; very high blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:45 (Batch/Lot Number: EN6207) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Six days after the vaccine (on 23Mar2021 10:15 ), the patient started to feel light headed, unbalanced. Blacked out on March 23rd for a very short time. Having trouble to focus with his eyes. Head feels full. Lymph nodes in head, neck and under arms swollen. Very high blood pressure and now needing medication for that. These last two weeks have been a nightmare and thinking he was going to die and was in the Emergency room. No treatment was received for the events. Event blacked out seriousness was medically significant. The events outcome was not recovered.
The patient reports a very sore arm immediately; Red at the injection site; The patients first Covid-19 vaccine is a Pfizer vaccine/The patient received her first Moderna Covid-19 vaccine on July 13, 2021; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (The patient reports a very sore arm immediately), INJECTION SITE ERYTHEMA (Red at the injection site), COVID-19 IMMUNISATION (The patients first Covid-19 vaccine is a Pfizer vaccine/The patient received her first Moderna Covid-19 vaccine on July 13, 2021) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in an elderly female patient who received mRNA-1273 (Spikevax) (batch nos. 092D21A and 085D21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Pfizer (First COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Pfizer.   On 13-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Dec-2021, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (The patient reports a very sore arm immediately), INJECTION SITE ERYTHEMA (Red at the injection site), COVID-19 IMMUNISATION (The patients first Covid-19 vaccine is a Pfizer vaccine/The patient received her first Moderna Covid-19 vaccine on July 13, 2021) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, PAIN IN EXTREMITY (The patient reports a very sore arm immediately), INJECTION SITE ERYTHEMA (Red at the injection site), COVID-19 IMMUNISATION (The patients first Covid-19 vaccine is a Pfizer vaccine/The patient received her first Moderna Covid-19 vaccine on July 13, 2021) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided.  The patients first Covid-19 vaccine is a Pfizer vaccine. After first Moderna Covid-19 vaccine, the patient reported a very sore arm immediately and red at the injection site. After second Moderna Covid-19 vaccine, the patient reported a sore arm and redness at the injection site.   This case was linked to US-MODERNATX, INC.-MOD-2023-746609 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746609:Master case (bivalent dose)