chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pain; This is a spontaneous report from a non contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, dose number unknown, via an unspecified route of administration in Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Aug2021, the week after vaccination, the patient experienced chest pain and stated he didn't know if it was like myocarditis and didn't know what it was. The event outcome was unknown at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Total body muscular aching, chills, can't think straight; loss of appetite The flu like symptoms abated 24 hours later; but still not thinking straight.
uterine cramping Narrative: Mild Uterine Cramping (was 4 days away from next menstrual cycle)-lasted 15 minutes
Tested positive for the COVID virus; Tested positive for the COVID virus; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 14:30 (Lot number: EW0196) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included in two weeks: ATORVASTATIN; ASPIRINE; TAMSULOSIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 17Feb2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 18Dec2021, outcome "recovering" and all described as "Tested positive for the COVID virus"; IMMUNISATION (medically significant) with onset 16Nov2021 14:30, outcome "unknown", described as "booster". The events "tested positive for the covid virus", "tested positive for the covid virus" and "booster" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) positive, notes: Nasal Swab PCR. Therapeutic measures were not taken as a result of drug ineffective, covid-19, immunisation.  Clinical course: No other vaccine taken in four weeks. No covid prior vaccination. Covid tested positive post vaccination. No known allergies.  Follow-up attempts are completed. No further information is expected
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
shortness of breath; random light headedness; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ew0186), administered in left arm on 29Jun2021 12:00 PM (at the age of 32-year-old) as dose 2, single for COVID-19 immunization. Vaccination facility type was reported as pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ew0180), administered in left arm on 08Jun2021 12:00 PM (at the age of 32-year-old) as dose, 1 single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jul2021 the patient experienced random light headedness and shortness of breath both reported as non-serious. No treatment was received due to the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was not resolved.  Follow-up (04Aug2021): Follow-up attempts are completed. No further information is expected.
Thyroid shut down Inflammation  Chronic pain Prescription totals 5 different meds  Pain Management specialist  Immunology specialist
On 8/13/03 mother in clinic for other services and reports ER visit on 7/12/03 due to redness and swelling of upper L arm. Denies fever continued normal activities, eating, sleeping etc.
Fever 101; chills; headache; ache; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via unspecified route of administration in the left arm on 27Mar2021 at 12:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid nodule (benign). The patient had known allergies to sulfa drugs and lamisil. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) started on an unknown date for thyroid medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed for COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 28Mar2021 at 00:00 (12 hours after the vaccination), the patient experienced fever 101 (unspecified unit), chills, ache and headache. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever 101, chills, ache and headache were resolving at the time of this report.   No follow up attempts are needed. No further information is expected.
Information has been received from a consumer concerning a 5 year old female with a slight fever and no known drug allergies who on 8/14/01 was vaccinated in the thigh with a 2nd dose of MMRII. Concomitant therapy included vaccination on the same day with poliovirus vaccine and DPT. The consumer reported that the pt's fever continued and she experienced severe swelling at the injection site on her thigh. The next day in school, on 8/14/01, was sent home from school because she fell asleep on the playground and complained that she could not walk. By the next day, on 8/15/01, the swelling got worse and 2 red lines traveled up her leg. She went to the ER and was admitted for 2 days with an infection. The pt was treated with an unspecified antibiotic, Benadryl and ibuprofen (Motrin) and sent home (date unknown). The pt still complains of pain and have a hard time walking. Additional information has been requested.
He got his vaccine, he felt achy, kind of weak at about 4:00 PM on the day of the vaccine.  Later on he took his temperature and it was 99 range.  It then went up to 101.4 that evening, but he felt very hot.  He felt very hot, face was red.  Somebody brought him over a thermometer and checked it again and it was 101.7, felt terrible and he took Tylenol.  The next day he felt achy like he had the flu, a headache, body aches and weakness, nauseous as well.  Then the next morning it was 102.3.  It fluctuated throughout the day.  Then later it went to 102.7 at 9:00 PM.  Then about 2 hours later before he went to bed it came down to 101.  Then he woke up on Sunday morning 3/28/21 his temperature was normal, he was exhausted from the fever.   He felt run down for a few days after that, knocked out and the nausea came back on 4/3/21.  No reaction at the injection site, just standard arm soreness, rash below the area of injection that lasted for about a week and went away.   He is still more tired than usual this week, but doesn't know if that's related to the vaccine or not.    The right arm 8 days later he got a rash at the injection site and a little bump that felt swollen.  That also ended up going away after a day or so.
This spontaneous report as received from a nurse refers to a 4 year old female patient. Patient had none relevant medical history. No drug reactions or allergies were reported. On 12-FEB-2015, the patient was vaccinated with a first dose of MMR II (lot # K011317, expiration date: 13-AUG-2016) dose 1, 0.5 ml, subcutaneously. Concomitant medication was not reported. On 12-FEB-2015, also reported as "over the weekend", the patient developed a fever of 103.4F, she was lethargic with no appetite and was unable to sleep. The patient's mother called the office and spoke with the physician, but any recommended treatment was unspecified. She stated that the patient developed a rash on her torso, which spread to her back, abdomen and then her face. She stated that the physician performed "blood work and tested her CBC, which came back normal" (on an unknown date in February 2015). No product quality complaint (PQC) was involved. On 23-FEB-2015, the patient recovered from fever (the patient's fever was gone). The outcome of the other events was reported as recovering. The reporting nurse stated that the rash was still present but was very "faint". The relatedness between the events and MMR II was not reported. Additional information has been requested.
Swelling, itching at injection site and hand for 3 weeks, dizziness, chills, fever of 102F, severe nausea
I believe I had an allergic reaction on the injection sights from where I had previously received the Juvederm. I had swelling and a rash on the cheeks.
mom brought pt into show rx: 20AUG96 had vax & mom stated pt voided frequently 21AUG96 the last noc & this AM lt arm w/swelling, redness, tenderness & warmth to 2" diameter area below inj site;pt w/o any further signs & sx;
Initially had the pain in the arm, went to bed and woke up at 3-4 AM with shaking, body aches all over and just washed out feeling and weak.   The symptoms are going away, still weak but feeling better.  He took 3 Tylenol at 3:00 AM.   Shaking has gone, body aches are not as bad as they were but still occasionally has some.  Pain in the arm is subsiding as well.
It started with a sore throat, cough, runny nose, congestion, headache, body aches and fever at its 101 degrees. I started to have some chest pain and shortness of breath on February 24, 2023, so I went to the emergency room. They ran some test and a chest x-ray which was clear. I was given TYLENOL and I slept. I was discharged. I was not prescribed any medication at that point, but my symptoms were pretty bad. I had symptoms for another week before I went to my doctor for the wheezing and shortness of breath. I was prescribed an albuterol inhaler. My other symptoms were improved by this time. It took about a month to recover from all symptoms.
Pt received Pfizer vaccine about 8:35 am, starting with itching, throat itching and cough at about 8:55 am.  25 mg Benadryl given.  Nurse alert called and patient taken to urgent care on site for further evaluation and treatment. No further treatment.  Member dc to home in stable condition at 1030am same day.
The pt complained of sore arm from 11/00 through 3/01 and occasionally still sore at the injection site. The pt states that she can no longer reach her right arm across her back and up to her left shoulder. She states she used to be able to do this. A follow up report received 10/12/2001 adds: Pt continues to have diminished range of motion when reaching behind her back to scratch her left shoulder blade. Has not explored with her physician the usefulness of seeing a physical therapist who could suggest range of motion exercises. Pt was reassured that pts do complain after having all type injections.
Crushing joint pain began late evening on 1/10/21 with swollen lymph nodes under the arms.
Unable to catch breath at time, especially when trying to go to sleep at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 13Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Liver Transplant" (unspecified if ongoing); "previous covid-19" (unspecified if ongoing); "high blood Pressure" (unspecified if ongoing); "kidney damage from tacrolimus" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies"; Tacrolimus, reaction(s): "kidney damage". The following information was reported: NOCTURNAL DYSPNOEA (non-serious) with onset 14Oct2023, outcome "recovered" (16Oct2023), described as "Unable to catch breath at time, especially when trying to go to sleep at night". Therapeutic measures were not taken as a result of nocturnal dyspnoea.  Additional information: The patient was unable to catch breath at time, especially when trying to go to sleep at night. That last about 3 days. The patient had no COVID prior vaccination (as reported) and the patient was not COVID tested post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
On the fifth day following immunization in the afternoon patient began to experience pain in the central chest area which increased with occasional sharp increases in pain intensity.  Patient was seen at hospital @ 2200 , no prior problems, no family history of heart attack, heart disease or other related problems. Pain continued for approximately one week following ER visit then subsided.  Normal progression of vaccination site.
patient developed lumpy rash on both arms neck and side. Dr prescribed hydroxyzine hcl and triaminolone cream . patient reports the medication helped itching but rash increased with lumps the diameter of golf balls
Pt was leaving ballroom after 15 min observation. Pt fainted, went down onto knees, then fell forward. Onsite EMTs helped pt into chair after he regained consciousness (15 sec). Pt was helped into w/c, brought to observation area outside ballroom. Pt was awake and able to answer questions, appeared pale and sweaty, stated he felt like he was going to vomit. Denied SOB, stated he felt less lightheaded. Pt then vomited sm amt x 1. Patient denied ever having vasovagal response to injections. Pt stated he had been hungover this morning and had not eaten or drank much today. VS were taken (BP 90/40, HR 80, RR 14). Pt was given water. Pt was observed for an additional 20 min, color visibly improved, pt stated he was feeling better. Pt refused transport to ED for further assessment. EMT suggested calling home for a ride, pt called sister and she agreed to pick him up. VS retaken before pt left, WNL (BP 105/70, BMP 59, SpO2 95). Pt left w/ family after 30 min.
Patient received PNEUMOVAX 23 2-25-16; reports: redness, edema, warm to touch - temp 97.6 - (L) arm swollen 2x normal size from deltoid to elbow. Sent to emergency room.
Bell's palsy; Rheumatoid arthritis flare up; Fatigue; Numbness in toes; Heartburn; Allergic respiratory symptom; Fibromyalgia; Mobility decreased; This is a solicited report from the marketing program Facilitated Collect based on information received by Pfizer from AbbVie (manufacturer control number: 21K-163-4062444-00), received from a contactable consumer (patient).   A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 23Jul2021 (Batch/Lot number was not reported) as dose 1, single at 49 years old, and intramuscular on 13Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported), at unspecified dose for Moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient previously took Humira for rheumatoid arthritis and experienced misfire with a pen exploded and sprayed the in the eyes and face. On an unspecified date in 2021, after both the 1st and 2nd dose of bnt162b2, the patient experienced Bell's palsy, rheumatoid arthritis flare up, numbness in toes, fatigue, heartburn, allergic respiratory symptom, fibromyalgia, and mobility decreased. The action taken in response to the events for adalimumab was unknown. The outcome of the event rheumatoid arthritis flare up was recovered on an unspecified date in 2021, for the event fatigue was recovering, for the event mobility decreased was unknown, while for the rest of the events was not recovered. The reporter's causality for adalimumab with event rheumatoid arthritis flare up was reasonable possibility, for the event mobility decreased was not reported while for the rest of the events was no reasonable possibility. The reporter's causality for bnt162b2 with all the events was not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on a temporal association and know drug safety profile, the causal association between the events Bell's palsy and fatigue and the suspect drug BNT162B2 cannot be totally excluded. The other events are more likely intercurrent or due to development of underlying medical condition and are assessed as unrelated to the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
Dark red, hot to touch, swelling from shoulder to forearm, blisters on skin, bruising inside arm due to swelling.  Urgent care pediatrician said it was the worse local reaction to the flu shot she's ever seen.
Pt called next day complaining of pain in her axilla area, and down left side into breast area, she denies any redness or swelling at the site of the injection.
Dizziness, Headache, Myalgia, Arthralgia, Rash & NauseaVomiting Narrative:
7x10cm area of dependent erythema down to deltoid. No fevers, chills, N/S.
There was no adverse events, the patient received the wrong vaccination for his age group.  Pfizer is the only approved Covid-19 Vaccination for 12 year olds at this time.
On 4/5/2023, I developed a sore throat. On 4/6/2023, I had body aches, chills, a headache, and likely a fever. If I had a fever, I don't know what the temperature was, as I do not have a thermometer. That morning, I had all those symptoms, plus loss of taste. I took a home antigen test and got a positive result. I called my doctor's office that afternoon to check into getting PAXLOVID. That afternoon, I had a telehealth visit with a NP from the clinic. She prescribed PAXLOVID, which I ended up not taking. I only planned to take it if my symptoms worsened over the weekend, which they did not. On 4/8/2023, the only symptom I had was a runny nose. On 4/9/2023, the only symptom I had was a cough. I isolated for five days and then wore a mask in public for five days afterwards. I had a lingering cough, which I treated with MUCINEX. On 4/25/2023, I had a routine blood pressure check at the doctor's office. While I was there, the NP heard some wheezing in the left lung. I underwent a chest X-ray, which showed normal results. I then continued taking MUCINEX every day until about 5/4/2023. Ever since then, I have been fine.
Information had been received on 11-JAN-2017 from a 67 year old female patient who on 10-JAN-2017 was vaccinated with one dose of PNEUMOVAX23 (lot# M029681, expiration date 22-JAN-2018) for unspecified indication. The patient reported that she experienced fever, nausea, "feeling sick", the inability to move her right arm, and pain at the injection site after receiving PNEUMOVAX23. She stated that she started feeling the side effects a few hours after receiving the vaccine. Patient's present status was recovering. Patient talked with physician and received unspecified treatment for her adverse events. No further adverse event information was provided. Additional information has been requested.
Chills, fever (102), extreme body aches, dizziness, swelling and redness at injection site. Chills, fever and extreme body aches lasted full 24 hours.  Day 3 after vaccine still have swollen and soreness at injection site, and dizziness. Treated with fluids and natural remedies.
Over night had a low grade fever. At 10am had 102.2 fever. At 3pm had a 103.3 fever.  No other symptoms but high grade fever.
The injection site on left arm was too high.  It was not 3 fingers below the shoulder.  The patient felt pain during the injection, which she thought was unusual.  Next, on night of injection and night of day 2 of injection, she experienced high fever (102 F).  There was redness on the arm, and she bruising at injection site.  She discussed experience with MD office when she was getting a routine vit b 12 shot, and the staff informed her that injection site was too high.  She reported the error to pharmacy on 8/26.  The pharmacist apologized for the error and advised the patient to monitor for shoulder pain, that is common with this type of error.  On 8/26, the bruise was still evident, redness/swelling in deltoid area was not present, shoulder pain was not evident, and patient was able to rotate shoulder as usual.
JOINT PAIN; HEADACHE; NAUSEA; FEVER; TREMORS/ UNCONTROLLED SHAKING; JAW CLENCHING; This spontaneous report received from a patient concerned a 22 year old male. 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: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced jaw clenching. On 07-APR-2021 19:30, the subject experienced tremors/ uncontrolled shaking. On 07-APR-2021 19:30, the subject experienced fever. On 07-APR-2021 20:00, the subject experienced nausea. On 07-APR-2021 23:00, the subject experienced joint pain. On 07-APR-2021 23:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremors/ uncontrolled shaking, and jaw clenching, and had not recovered from headache, nausea, joint pain, and fever. This report was non-serious.
The day after my appointment, I woke up with an intense headache. Felt like my entire head was under pressure, and I was somewhat sensitive to light. I tried to take a nap, but it didn?t make the headache go away. However the pain went away by itself around 11pm. I didn?t take any pain relievers.
Headache, Myalgia, Arthralgia, Injection site pain and swelling, pain at shoulder, could hardly get OOB next morning due to back pain Narrative:  Other Relevant History:
On the day of vaccine, patient went to emergency room with the symptom of shortness of breath.
redness, swelling, tenderness (14 x 13cm) around inj site @ rt deltoid area assoc w/fever to 103, inc WBC to 24000 & sed rate of 105;redness dec on IV oxacillin & warm soaks, but migrated distally to elbow;