chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives everywhere, further described as on the torso; arms; neck; chest; feet; and just the chin area of her face; This is a spontaneous report from a contactable nurse. A 36-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) injection, lot number EL0140, expiration date Mar2021, unspecified route of administration, on 29DEC2020 10:00 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization.  Medical history was none. There were no concomitant medications. nurse reported that they had their Pfizer Clinic on 29Dec2020 and she had a nurse that started having hives on 02Jan2020 after having received the Pfizer COVID- 19 Vaccine on 29Dec2020. The patient reported as everywhere, further described as on the torso; arms; neck; chest; feet; and just the chin area of her face. It was bothersome. Her second dose is scheduled to be administered on 19Jan2021, but she was not sure if she will or will not continue with therapy and receive the second dose. The patient was thinking it could be related but was unsure. Outcome of the event was unknown (reported as unknown but ongoing, hives come and go).
PT describes itchy sensation initially - worsening at 4 days post vax and progressing to head, swelling and increased itching. PT states swelling and itching have increased through today (9 days post vax). Referred to provider.
Acute pain in the lower abdomen, between the pelvic bone and the bottom of the ribs. Severe for 3 days, then subsided over the following 7 days.   Hurt when pressed on and certain bending positions.  No blood in stools or urine. Pain was not relieved by bowel movements or urination. No constipation, or trouble/pain urinating.
This spontaneous report as received from a pharmacist refers to a 59 year old female patient (reporter's wife). The patient's concurrent condition included rheumatoid arthritis. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency and route of administration were not reported). The patient was taking an unspecified medication for rheumatoid arthritis. On an unknown date, about a week after vaccination, pharmacist's wife developed rash around injection site. Rash did not spread to any other parts of body and rash subsided within a couple of days without any treatment on an unknown date. The patient did not seek medical attention. Causality assessment was not reported. Additional information has been requested.
Myopericarditis, extreme fever (105+ degree), muscular soreness, acute coronary syndrome
Hives all over body and face, extreme itching all over body, raised and swollen skin
dizzy  vomiting broke out in sweat,  Went to Urgent Clinic, they did ekg, cat scan of head, and blood work. Could not find anything wrong with any of test. Gave some meds for dizziness and nausea.  Still not any better on next week and went to regular Dr, he could not find anything and gave more of the same meds.
double vision; muscle weakness; very tired and weak; very tired and weak; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: ER8731; Expiration date: Unknown) via an unspecified route of administration (Age at vaccination 79-year) in right arm on 16Apr2021 at 12:00 as dose 1, single for COVID-19 immunization. Medical history included ongoing cataract in left eye, ongoing neuropathy in his feet, stroke from Sep2020 and ongoing, coronary bypass surgery from 2005 to an unknown date. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) the patient was not administered with any other vaccinations. On 18Apr2021 the patient experienced very tired and weak, on an unspecified date the patient experienced double vision and muscle weakness. The patient was not hospitalized for the adverse events. It was not provided if AEs required a visit to Emergency Room/Physician Office. It was reported that "Caller was 79 y/o male. Caller received his first dose of the Pfizer Covid vaccine on 16Apr2021. His second dose was due tomorrow 06May2021 and he wanted to know if he should get it based off of his side effects. He stated he developed double vision after his vaccine dose, which had now resolved, and he had on-going fatigue and muscle weakness since the vaccine. He stated he had been in rehab for a stroke that occurred in Sep2020 and now his rehab stay had been extended for 6 weeks due to his muscle weakness. Caller stated he had the first dose of the Pfizer Covid vaccine on 16Apr2021, stated he had a reaction to it. Stated about 3 hours after the vaccine he started to feel very tired and weak, stated it started to get better and then got worse again, stated the past 3 days it had been really bad. Stated he had been going to rehab for a stroke and he was about to get discharged, then he got this vaccine and these symptoms had put him back about 2-3 months. Today he woke up and was more tired than he had ever been. Scheduled to have the second shot tomorrow, wanted to know should he get the second dose. The last few days it had gone downhill. Caller also stated he had taken 4-15 pills a day, had coronary bypass surgery in 2005, takes blood pressure, blood thinner, neuropathy medication, no further information provided." The clinical outcome of the event double vision was resolved on an unspecified date; outcome of muscle weakness was unknown; while, the outcome of other events was not resolved.  No follow-up attempts are needed. No further information is expected.
CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known drug allergies and no dug abuse/illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the patient experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills. This report was non-serious.
Resident was given Moderna COVID vaccine dose #1 on 7/7/2021 around 10:40 am and was found deceased on 7/8/2021 at 4:10 pm.  Member had no acute illnesses/adverse reactions identified prior to death.
36hrs later she developed diffuse petechial rash including mucosal involvement as well as large local reactions at the sites of injection. Platelet count was 2.  Evaluated by Hematology.
Allergy: pt rec'd flu shot by community health. At approx 230pm. Approx 1 hr later pt states she was home felt throat closing, difficulty swallowing & voice hoarse. Pt came to u/c for eval. Tx with 50mg BENADRYL & 150 mg ZANTAC PO, O2 3L & monitor.
Administration of expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired dose). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up received and Contains no new information.
gave 3 doses from a vial that was in the refrigerator for 33 days; we gave 3 doses from a vial that was in the refrigerator for 33 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days) and PRODUCT STORAGE ERROR (gave 3 doses from a vial that was in the refrigerator for 33 days) in a 23-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     Patient had no allergies and no history of acute or chronic illnesses at the time of vaccination.     On 23-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (gave 3 doses from a vial that was in the refrigerator for 33 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we gave 3 doses from a vial that was in the refrigerator for 33 days) and PRODUCT STORAGE ERROR (gave 3 doses from a vial that was in the refrigerator for 33 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. Dose administered after 30-day Use By Date or after manufacturer date of expiry. The vial was Initially stored in the refrigerator .The vial did not undergo any temperature excursions.  No treatment medication was provided.
After receiving each dose of the COVID vaccine (Pfizer) I started to swell in my body. After receiving the fourth dose, it seemed to be the worst case. I also tested positive for COVID-19 the day after receiving my fourth dose. The swelling this time started in my arms this time and my legs. It seems to be in my extremities. My pants were tight on both my legs, but not my waist. I was unable to put my rings on my fingers. My face became swollen as well. My doctor thought it may have been my medications and he changed the dosage on one of them. My doctor is also concerned that there may be an issue with my heart. I need to schedule an echocardiogram and have the results sent to my doctor. The swelling is starting to finally go down and I have lost 15 pounds of water from the swelling.
Shivering as if cold, loss of appetite, muscle aches throughout torso and neck. Treated with rest and water.
very very very sick with it/ sicker than when I was with COVID; fever for 3 days, close to 102; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very very very sick with it/ sicker than when I was with COVID) and PYREXIA (fever for 3 days, close to 102) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 27-Feb-2021. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very very very sick with it/ sicker than when I was with COVID) and PYREXIA (fever for 3 days, close to 102). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (very very very sick with it/ sicker than when I was with COVID) and PYREXIA (fever for 3 days, close to 102) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. On an unknown date, Body temperature: 102 (High) had fever for 3 days.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication taken by the patient included hormone cream.
bursitis of the rotator cuff; terrible pain at the site of the injection; This is a spontaneous report from a contactable consumer(patient). An 82-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: not reported), dose 2 via unspecified route of administration on 04Feb2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown) on unspecified date as DOSE 1, SINGLE for COVID-19 Immunization and experienced pain. On 04feb2021 the patient had experienced terrible pain at the site of the injection that started when the band aid was put on it and it was exactly there. It was reported that she had underlying problems that were dormant, and the vaccine exacerbated the problem. Since 04Feb2021, she has been in agony and done Physical Therapy. Caller stated they said it is bursitis of the rotator cuff, bit she is in agony every day and it is her right hand and she is useless without it. The outcome of the event terrible pain at the site of the injection was not recovered and the event bursitis of the rotator cuff is unknown.   Information on the lot/batch number has been requested.  Follow up (01Sep2021): No follow-up attempts are possible. No further information is expected.
Sore arm/Ice & rest.   Lethargic, Nausea/Bland diet.
the vaccine may be already expired at the moment of vaccination; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number ED2EN, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th January 2018, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 29th January 2018, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comments: A medical assistant provided a lot number of Boostrix vaccine because a patient was administered with the vaccine and the vaccine might be already expired at the moment of vaccination. The consent to follow up was granted. Additional Supportive Information: As patient received expired vaccine, which led to expired vaccine used.
NECK PAIN; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included myocardial infarction, and concurrent conditions included high cholesterol, high blood pressure, alcohol use every once in a while, and cigarette smoker, and other pre-existing medical conditions included the patient did not have any known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced neck pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain. This report was non-serious.
25 cm size, warm, red, indurated area at shot size, local reaction not likely infection.
symptoms of Rheumatoid Arthritis; Toes and Feet Swelling; Pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (symptoms of Rheumatoid Arthritis) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (symptoms of Rheumatoid Arthritis) (seriousness criterion medically significant), PERIPHERAL SWELLING (Toes and Feet Swelling) and PAIN (Pain). At the time of the report, RHEUMATOID ARTHRITIS (symptoms of Rheumatoid Arthritis) outcome was unknown and PERIPHERAL SWELLING (Toes and Feet Swelling) and PAIN (Pain) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen.  The reporter's causality for an events PERIPHERAL SWELLING and PAIN with Humira was no reasonable possibility and not provided for RHEUMATOID ARTHRITIS.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with relevant medical condition of ankylosing spondylitis, who experienced the unexpected and serious (due to medically significant) AESI of Rheumatoid arthritis, which occurred related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for ankylosing spondylitis. Non-serious events of Pain and Peripheral swelling could be related to Rheumatoid arthritis. No information disclosed about diagnostic tests performed, clinical course or treatments received. Underlying ankylosing spondylitis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with relevant medical condition of ankylosing spondylitis, who experienced the unexpected and serious (due to medically significant) AESI of Rheumatoid arthritis, which occurred related to an unspecified dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for ankylosing spondylitis. Non-serious events of Pain and Peripheral swelling could be related to Rheumatoid arthritis. No information disclosed about diagnostic tests performed, clinical course or treatments received. Underlying ankylosing spondylitis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 12-JAN-2017, the patient was vaccinated with a dose of expired VAQTA lot # L036300, expiry date 04-NOV-2016, intramuscularly (anatomical location and dose were not reported). No adverse effects were reported. Additional information has been requested.
when he received the MMRII vaccination, "it was quite painful"; This spontaneous report was received from a field representative on behalf of the patient, who was a male physician of unknwon age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 18-SEP-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (dose, vaccination scheme frequency, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). The patient reported that when he received the vaccination, "it was quite painful" (vaccination site pain).   At the time of reporting, the outcome of vaccination site pain was unknown. The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and vaccination site pain was unknown.
When administering FLUZONE 0.5ml to left deltoid muscle, the vaccine met some resistance, so I withdrew the needle and stuck it back in about 1 inch away and it went in fine. Today, he reports that his arm got sore 48 hours later, and continued to be sore to this day. Since it hurts to use it, he has been trying not to use it. When he pushes with the arm, he gets a sharp pain. Twenty four hours after the injection, he had to leave work because he "couldn't think straight" and got chills followed by hot flashes.
I know that I was exposed to COVID-19 on 05/29/2022. A friend contacted my husband and I on Tuesday 05/31/2022 to inform us that he had tested positive. I took an at home COVID-19 test which was negative but then I had begun having cold like symptoms like stuffiness and runny nose on 06/01/2022. I took another at home test which came back positive. I basically stayed in bed for the next three or four days to avoid exposing my husband further. I had extreme tiredness and ran a fever of 100.4. I had a very sore throat that lasted 3 or 4 days. By around 6/07 I had texted my doctor who responded to inform me that she would send a prescription for PAXLOVID to my pharmacy. The pharmacy took two days to get it in so I did not begin taking it until 06/08. I began to feel improvement in my symptoms right before beginning the PAXLOVID, but went ahead and took the full round of antiviral. My symptoms have basically gone with the exception of some occasional fatigue.
Pale lips, sweating, dizziness. BPs 90/56 (pulse 78), 128/84 (pulse 92), O2 sats 98%. Given apple juice, water, and graham crackers.
Patient presented to vaccine site for second Pfizer vaccine. Patient conveys that he developed facial edema and lower extremity edema approximately 24 hours post Pfizer vaccine. He did not seek medical care. The symptoms resolved over the course of the week. No respiratory issues.
An area of redness 2" x 3" inches in diameter. Itchy, sore & a streak of red running to elbow.
sore throat, head cold, light fever, cough, tickle in throat, about strangle, tired & felt bad, hard to breath, hard to breath deep, chills one noc, lt arm sore;
pt was waiting after receiving shot, loss consciousness and head tipped back, off duty paramedic who was in waiting room jumped to assist and put her head strait and she regained consciousness . we called 911, pt started to look better then she vomited and stated she felt better. fire department came and checked her out. She refused to go to hospital and was able to walk out.
fever, chills, achiness, dizziness, diarrhea, fast heartbeat Side effects began about 8:00 pm, about 9 hours after receiving the injection. Symptoms treated with ibuprofen and rest at home. Symptoms improved the next day. By 5:00 pm on 3/6/21, just fatigue remains.