chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pain and SOB 1d after shot in pt w/ h/o CP and SOB.
1st Shot on 3/18/2021 - delayed adverse reaction, 24 hours later developed anaphylaxis to everything I ate for 3/5 days.  Difficulty swallowing water.  This ended on 3/22/2021.  2nd Shot on 4/14/21 - for two days normal expected reactions, joint pain, sore arm, chills, etc.  This went away and I went to work on 4/16/21.  Then at 2 pm on 4/16/21, my arm swelled to twice its size and I developed a rash at the injection site.  That is when the adverse reaction began with relentless itching from head to toe, non-stop, 24/7.  It has been a month now, and am still experiencing these symptoms.  I am unable to work.  I have been going to an allergy specialist every week and receiving Dupixent shots and taking Gabapentin every 4 hours around the clock.  on 5/11/21 the itching seemed to be going away and I was getting better, but today 5/13/21 it has returned with a vengeance.  I am again itching from head to toe like fire ants all over my body.  It never stops.
Covid arm - large red rash, 4 to 5 quarters in size, itchy, large bump
Severe left axillary lymphadenopathy approximately 3 weeks duration developed after the booster. However, since the first vaccine in February 2021. I have had a sudden onset of high blood pressure, palpitations, tachycardia, chest pains and SOB of varying degrees and duration that has resulted in ER and PCP visits throughout the year without an exact cause found. Most recent ER visit I had in April 2022 chest pains, SOB, Palpitations, very high blood pressure and a D-Dimer of 1,165. Chest x-ray, EKG, CTA Chest normal. All labs/testing negative for heart disease. Recent mammogram & Abdominal US done 5/2022 normal. Drs decided ?stress? even though I was under no stress this latest episode.
COULD NOT DRINK WATER; LOSING HER VOICE/CANT SPEAK MORE; GETS SHORTNESS OF BREATH ON EXERTION; VERY ANXIOUS TO BE CONTACTED; HEAVINESS IN CHEST; HEADACHE; PAIN UNDERNEATH LEFT ARM; TROUBLE BREATHING,FELT LIKE GASPING FOR AIR,SHORTNESS OF BREATH/WINDED EASILY; PAIN IN RIGHT SIDE OF CHEST; TROUBLE SLEEPING; SORE THROAT; This spontaneous report received from a patient concerned a 52 year old female. 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: 206a21a, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced trouble sleeping. On 08-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced trouble breathing, felt like gasping for air, shortness of breath/winded easily. On 09-APR-2021, the subject experienced pain in right side of chest. On 09-APR-2021, the subject experienced pain underneath left arm. On an unspecified date, the subject experienced could not drink water, losing her voice/cant speak more, gets shortness of breath on exertion, very anxious to be contacted, heaviness in chest, and headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 12-APR-2021, had not recovered from pain in right side of chest, trouble breathing ,felt like gasping for air, shortness of breath/winded easily, pain underneath left arm, trouble sleeping, and headache, and the outcome of could not drink water, losing her voice/cant speak more, gets shortness of breath on exertion, very anxious to be contacted and heaviness in chest was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
88-year-old woman with significant past medical history of COPD/asthma, pulmonary hypertension, atrial fibrillation on Coumadin, coronary artery disease and prediabetes presents on transfer from Hospital for Covid pneumonia.  Patient had been previously vaccinated and contracted Covid from her daughter.  Started developing fevers and chills with cough and progressive shortness of breath.  Went to Hospital today where she was found to have Covid pneumonia with acute hypoxemic respiratory failure.  While at hospital patient fell and a CT scan of the head was obtained which was negative for bleed.  Patient was placed on 4 L of oxygen with improvement in her oxygen saturation.   Patient currently feels comfortable without shortness of breath on 4 L of oxygen by nasal cannula.  Denies chest pain, nausea vomiting, diarrhea, abdominal pain.
Slight numbness in face beginning approximately two hours after injection.  Approximately three hours after injection, felt disoriented and had difficulty breathing while seated in the passenger seat of car; immediately diverted toward nearest hospital.  Five to ten minutes later, experienced an extremely elevated heart rate and a burning sensation in chest with continued difficulty breathing.  Heart rate began to decline and breathing began to normalize when approaching the emergency room, so did not seek treatment.  Waited for an hour outside emergency room before departing without treatment with no further symptoms other than fatigue and discomfort resulting from the episode.    I had a similar but milder and more immediate (~15-20 minutes after injection) reaction to a quadrivalent influenza vaccine in October 2020; other than that, I have never experienced an adverse reaction to a vaccine.
Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1284) intramuscularly at right arm on 06Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies to opiate derivatives and penicillin. Concomitant medication included clopidogrel, sertraline, simvastatin. The patient previously received first dose of bnt162b2 (lot number: ELC5730) intramuscularly at right arm on 18Dec2020 13:00 at single dose for COVID-19 immunization. The patient experienced fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue, all on 07Jan2021 01:30. No treatment received. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Hemoglobin was obtained on 12/5/17 as part of this patient's well child check. She had influenza shot #2 at the appropriate time interval 11/27/17. Hemoglobin was 10.3 g/dL. I subsequently added a CBC to the same blood draw and this patient had a pancytopenia: WBC = 3.6 K, and plts = 132 K/uL. The patient was not sick at the time and was not exhibiting any adverse reactions otherwise. Follow up CBC with reticulocyte count, Vitamin B12 and Folate were normal one week later.
During noc was incontinent of urine which was unusual; found 8AM in bed eyes fixed, pupils enlarged, unresponsive; mom picked up pt began to convuls, w/no control of bowel & bladder; 911 called taken to hosp by ambulance; fever to 102;  h/a
when pressing the plunger, more than a drop but less than ½ the dose escaped between; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of incomplete dose administered in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: when pressing the plunger, more than a drop but less than ½ the dose escaped between).  The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 5-Sept-2023 The pharmacist reported that they gave an Arexvy shot to a gentleman and the vaccine tech had a syringe malfunction. The reporter consented to follow-up. When pressing the plunger, more than a drop but less than half the dose escaped between the interface between the needle and the barrel while the remainder was injected into the patient, which led to incomplete dose administered.
Patient had COVID-19 vaccine and approximately 20 minutes later could not seem to talk.  She was not reactive by speech  while on site at facility and blood pressure was 170/110.  She was not given an epi-pen but was sent to hospital by transport.
This initial spontaneous report was received from a 67-year-old female patient with no pertinent medical history, concurrent conditions, drug reactions/allergies.  She was taking no concomitant medications. On 19-MAR-2018, the patient was vaccinated with ZOSTAVAX (dose, site and route of administration, lot number and expiration date were not reported) as routine vaccination. The patient reported she had severe side effects after having the vaccination. On 21-MAR-2018, she got a little rash on her hip. On 23-MAR-2018, she got a rash on her leg and face and had a tingle feeling in her leg. On 24-MAR-2018, she experienced tired, dizzy, tightness in chest (also reported as chest pain), and breathing problems. The patient further reported that she was in a lot of pain, she could not sleep, could not drive and was frustrated (exact onset date not specified considered to be 2018). She reported that "this almost killed her." No lab diagnostics/studies were performed. On 26-MAR-2018, the patient sought medical attention by visiting physician's office. She was treated with valacyclovir hydrochloride (VALTREX), acetaminophen (+) oxycodone hydrochloride (PERCOCET), gabapentin (NEURONTIN) ,and prednisone. The outcomes of tightness in chest/chest pain, rash, dizziness, fatigue, breathing problems, and tingle feeling in leg were not reported. At the time of the report, she had not recovered from pain, could not sleep, could not drive, and being frustrated. The causality between the events and ZOSTAVAX was considered related. The patient felt ZOSTAVAX should not be on the market because she had so many severe side effects after receiving the vaccination. She reported she may be getting a lawyer. When asked if she felt any of the events were life-threatening, the patient responded "yes, chest pain". Additional information has been requested.
I got the shot felt a little funny waited 30 min went home It felt funny saw hives in the back in the arm. reported to ER and they took me in right away. They put an IV and they offer epinephrine. I refuse. IV Benadryl. They hives started going away. They also gave me steroid (prednisone). Was there for about 4hrs until they let me go home. The hive stayed away.
Consistent 102 degree fever for 30 hours (fever reducer taken) followed by miscarriage on Wednesday March 17th 2021 (at 8.5 weeks pregnant).
Muscle aches, fever peaked at 101.8F about 17 hours post injection. Still elevated 37 hours post injection, about 2 degrees above normal temp 99.6F vs 97.7F), pain at inject site, still present 3.5 days post injection
This spontaneous report as received from a registered nurse refers to a 4 year old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 06-SEP-2016, the patient was vaccinated with improperly stored M-M-R II lot # M004305 (dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/insurance. The temporary temperature excursion occurred in the fridge on 01-SEP-2016 however, it was not discovered until 26-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: US-009507513-1609USA014830: US-009507513-1610USA004339.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. The patient was vaccinated with lot # (670542/0619AA) ZOSTAVAX (single dose, Subcutaneous) on 23-AUG-2012 which had expired on 26-JUL-2012. No adverse effects reported. No other co-suspects were reported. No concomitant medications were reported. The outcome of expired vaccine used is unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
On the ninth day after I received the vaccination, I noticed an itch at the vaccination site on my left arm. The area around the site was and still is reddish in color. Above the site was a blueish mark as in a bruise. As of today, day ten, the mark has turned brown. I have treated the itchy area with hydrocortisone, over-the-counter strength.
Rash on right leg-4 lesions red and starting to crust right groin.
Injection site reaction. Left lateral thigh with 2 areas of redness, one about 2 inches and the other about one inch. Both warm and tender to touch.
Fever (101.5) Chills Hot/cold flashes with sweat Muscle and joint aches
pt recvd vax & lt side of face hurts & has chills;pt currently is being evaluated for Gilbert's disease (benign familial cholemia);pt has been under unusual stress last several months;c/o muscle aches,bone feel sore,weakness x 9-10 days;E
expired Quadracel was administered, no AE; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four years old patient who was vaccinated with an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number not reported and expiry date: 14-Nov-2019) via unknown route in unknown administration site on 04-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  It was actual medication error case due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Entire Leg swelled from hip to knee about 5 hours after the injection.  It  turned bright red, she screamed Inconsolably for an hour.   She had Diarrhea then for a week following the injection.
I had chills, fever up to 101.4, body aches, severe headache that lasted approximately 24 hours
Narrative: Patient received one dose of covid vaccine. Patient had active lung cancer. Patient passed away in home, no further details related to death. Reporting per Network instructions.
dizzy, nausea, vomiting, and diarrhea for three days now.
Felt so weak; Didn't feel like eating; Felt a lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt so weak), DECREASED APPETITE (Didn't feel like eating) and FATIGUE (Felt a lot of fatigue) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced FATIGUE (Felt a lot of fatigue). On 13-Jan-2021, the patient experienced ASTHENIA (Felt so weak) and DECREASED APPETITE (Didn't feel like eating). On 11-Jan-2021, FATIGUE (Felt a lot of fatigue) had resolved. On 14-Jan-2021, ASTHENIA (Felt so weak) and DECREASED APPETITE (Didn't feel like eating) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information mentions a nutrition drink. Lab tests were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax 17JUL95 & 13MAY96 pt devel 60 lesions on body;it was unk whether the pt had devel a fever;
Temperature read 99 degrees upon arising. Elevated through out the day to a high of 100.2 at 9pm. Left armpit swollen & itchy. Dull headache all day.  All joints in entire body ached entire day. Tired feeling all day and night. Slept 4-6:30 pm and 9:30 pm to 1:30 am the following morning. Temperature down to 99.2 degrees at 1:30 am. Difficulty raising left arm more than 45 degrees.
Localized redness, swelling, warmth and pain (left, anterior thigh) at DTaP site. Diagnosed as cellulitis.
Pt received her vaccine at 11;30.  At 11:40 Pt states that after her vaccine she feels shaky. She denies any lightheadedness states that she just feels shaky. Pt states that she did not eat today before her vaccine. Her BP was 124/88. She was given an orange juice.  Pt stayed for 40 minutes after her vaccine. At 12:10 the pt states that she no longer felt shaky and was able to leave at this time.
Injection site red, swollen, painful. By 05/14/2016 rash began on back and side. Painful and itchy.
The pt developed hives on 3/20/01 with a large area of erythema at the site of Prevnar injection.
SEVERE MUSCLE CRAMPS ALL OVER BODY; BODY ACHE; DIARRHEA; RED HIVES ON FACE; CHILLS; FEVER; This spontaneous report received from a patient via a company representative 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: UNKNOWN expiry: UNKNOWN) 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 severe muscle cramps all over body, body ache, diarrhea, red hives on face, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, body ache, diarrhea, severe muscle cramps all over body and red hives on face was not reported. This report was non-serious.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years for Covid-19 immunisation. The patient's relevant medical history included: "Mild IBS" (unspecified if ongoing), notes: Mild IBS; "Known Allergies: Shellfish" (unspecified if ongoing); "Known Allergies: Sulfa" (unspecified if ongoing), notes: Known Allergies: Sulfa; "Known Allergies: Latex" (unspecified if ongoing); "Known Allergies: Tomatoes" (unspecified if ongoing), notes: Known Allergies: Tomatoes; "Known Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The 1st three Pfizer COVID19 vaccines did not do anything to my arm, except a little sore". Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination: Metoprolol, Low dose Aspirin, Vitamins. The 1st three Pfizer COVID19 vaccines did not do anything to arm, except a little sore. This last dose was imperceptible the first day, but the next 3 days, She has had a 50-cent piece sized red area and lump and pain when she lay on it at night. She put an ice pack on it. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient not has been tested for COVID-19. Device Date mentioned as 21Apr2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT GOT MMR VACCINE ON 05-09-19 AND SHE HAD A FEVER AND BROKE OUT IN A HEAD TO TOE RASH ON 5-20-19.
Feeling tired, headache several hours after injection and stomach ache several hours after injection lasting until 10:00 AM following day. Took aspirin for headache.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; EXPIRED VACCINE WAS GIVEN; This spontaneous report received from a health care professional concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19 sars-cov2-igg, igm and iga (Immunoglobulin G  Immunoglobulin M, Immunoglobulin A) The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: 25/MAY/2021) dose was not reported, 1 total dose administered on 27-MAY-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. Vaccine stored in appropriate temperature condition and 30 minutes to an hour as an estimation removed from storage On 27-MAY-2021, the patient administered the expired vaccine was given and had a negative antibody test (unspecified date),  Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine was given and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184136 The suspected product quality complaint has been confirmed to be void:y based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210660757 -COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine 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
Bruise at injection site, bruise under injection site, bruise on opposite arm, reddened palms, feeling of tingling in the area of the neck, occasional pain in a leg.
22JUL92 recvd 1st Engerix-B & 48 hrs later on 24JUL92 devel urticaria on neck which spread to palms & feet; seen by MD;