chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had my first dose of Covid vaccine, Pfizer 30ug at 3:40pm on 4/8/21. 1 day after my first dose I started have low fever(98.8-99.2f). 2 days after my first dose of Covid vaccine my left breast start being painful and start whole body ache. 4 days after first dose my left breast start having an half egg size painful touchable lump with red, warm and swelling.  I started taking Acetaminophen 10 mg bid. 4 days on 4/11 till today after first dose  for both pain control and reducing body temperature.  I used to have granulomatous mastitis on my right breast which is self limited and I had not have this problem for one year. Although the mechanism is still unclear but some theory of this disease is more like an autoimmune  problem.   I doubt somehow this vaccine has too strong immunogenicity, or at least which is too strong for me. I was getting Pfizer which is 30ug I think.  Possibility: 1 Too large dose for my body size (120 lb) 2 Some adjuvant in this Pfizer vaccine induces too strong cellular immune response which may initiate or help for some none Covid specific antibody production, unfortunately for some patients who have autoimmune disease are triggered by this vaccine then they may start producing autoimmune antibody which start self attacking.
Treatment for asthma before and after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Treatment for asthma before and after getting the vaccine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHMA (Treatment for asthma before and after getting the vaccine). The patient was treated with PREDNISONE ongoing since an unknown date for Asthma, at an unspecified dose and frequency; CORTISONE ongoing since an unknown date for Asthma, at an unspecified dose and frequency and MEPOLIZUMAB (NUCALA) ongoing since an unknown date for Asthma, at an unspecified dose and frequency. At the time of the report, ASTHMA (Treatment for asthma before and after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reporter by the reporter.
- feeling that right side of throat not open all the way - swollen raised area above left eyebrow/forehead - raised area right chin - treated with Medrol dose pack and diphenhydramine
Body aches and febrile illness same day as vaccine administration. Fever of hands and feet the following day that subsequently spread throughout bilateral lower extremities and trunk.  Upon evaluation in hospital emergency department, found to meet criteria for sepsis without apparent source of infection. Tachycardia, hypotension, mildly elevated white count and absolute lymphopenia with bandemia. Clinical case highly suspicious for MIS-A.
Case number PHEH2014US025055, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 42 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion.
Dizziness, Headache, Fever,  pain at injection site  Narrative:
Now she has diminished breathing.; This is a spontaneous report from a contactable consumer (patient's mother). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration in Arm Left on 20Aug2021 (last Friday, at the age of 22-years old) as dose 1, single for COVID-19 immunisation. Medical history included PMPD (unspecified), mild asthma, insulin resistance, ileostomy, thyroid disease, allergies to various foods (the list is very long) and flu B. Concomitant medication included progesterone taken for birth control and anti-anxiety (unspecified). The reporter stated that the patient did not took prior vaccination (4 weeks). The reporter stated that she believed her daughter had the severe reaction to the Pfizer vaccine. She (the patient) received it on last Friday (she did not know, what the time was; it was like after breakfast or before lunch) and now she diminished breathing (24Aug2021), she went to urgent care today. Reporter further stated she needs to know what to do, her daughter was having hard time breathing from their vaccination so, what the next step so far, how do she get medical help for her daughter, her school was making her mandatory vaccinate, how could she, get her medical assumption, she knew was am doing all the right things by reporting it but, Frankly, that was not very helpful and needed assistance. The due date for second shot for the patient was on Monday or Friday (must be on 03Oct2021). The patient was put on nebulizer 4 times a day as well as the rescue inhaler (intent treatment). The reporter stated that symptoms worsened, improved and were persisting. The patient underwent lab test which included covid test: negative and flu test: positive both on an unspecified date. The outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up. Information on the lot/batch number has been requested.
This case was reported by a nurse and described the occurrence of arm swelling in a kindergarten-aged child who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The patient's medical history, concurrent conditions, and concurrent medications were not reported. In May 2003, the patient received an injection of Infanrix. In May 2003, at an unspecified time post immunization, the patient developed arm swelling. The patient was seen by the physician. The event was unresolved as of 5/15/03. The nurse considered the event was possibly related to vaccination with Infanrix
Whelp on (R) thigh at site on injection. No spread. No wheezing or generalized urticaria.
hot arm; itchy arm; 30 weeks pregnant; tender arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (30 weeks pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (30 weeks pregnant). On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (30 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.   This case was linked to MOD-2021-018462 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Internal review on 20JUL2021 resulted in updates to pregnancy details.
flare up of rheumatoid arthritis (RA); dry mouth; dry eyes; bilateral hand pain; extreme fatigue; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASL2021147334).  This serious solicited report was reported to Amgen on 21/SEP/2021 by a consumer from a commercial program and involves a 61 years old female patient who had a bilateral hand pain/ her symptoms are a flare up of RA/ dry mouth, dry eyes/ extreme fatigue [PT: rheumatoid arthritis] while receiving Enbrel with Single Dose Prefilled Syringe. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. The patient's concomitant medications included covid-19 vaccine. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date. On an unknown date in 2021 three weeks ago, the patient received the COVID19 vaccine and developed a dry mouth, dry eyes, bilateral hand pain and extreme fatigue which continue. She believed that her symptoms were a flare up of rheumatoid arthritis (RA). No treatment information was received. The outcome of the events rheumatoid arthritis was reported as not recovered/not resolved. Action taken with Enbrel and Single Dose Prefilled Syringe was continued for the events rheumatoid arthritis. The causal relationship between the events rheumatoid arthritis and Enbrel with Single Dose Prefilled Syringe was not provided by the consumer. Follow up has been requested for lot number only.  Amgen comment: This individual case report does not change the safety profile of the product.  The reporter's assessment of the causal relationship of the events with the suspect product etanercept and BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  Amgen's Causality Assessment: The events of Rheumatoid arthritis flare up was considered as unrelated to etanercept.; Sender's Comments: Based on the reported information and based on the temporal association, there is a reasonable possibility that the events are causally related to BNT162B2. Events  are assessed as unrelated to etanercept .
Client had flu vaccine at 9:35am about 10 mins later had tightness in chest, dizziness, pulse below 50. paramedics were called, by the time they arrived client felt better. Paramedic said B/P 134/80 and pulse 76 client taken to ER by ambulance. Flu vaccine was given in left deltoid no sign of reaction from the shot. No redness, swelling, rash. Client was admitted to Hospital-ER said clients condition was not related to flu shot.
muscle pain in the back of the legs, chills, fever, headache, dizziness, tiredness. It started around 12am and went until 1pm when I took tylenol.
May 17, 2021 presented to the emergency room with lower right leg pain around 9 pm. Diagnosed with thrombophlebitis.
Information has been received from a licensed practical nurse through the Pregnancy Registry for GARDASIL concerning a 16 year old, female smoker, with no previous pregnancies, who on 20-FEB-2007 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 654389/0961F).  On 23-APR-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot # 655205/1426F).  On 22-AUG-2007, the patient was vaccinated intramuscularly with her third dose of GARDASIL (Lot # 655620/0171U) and in addition was vaccinated with a VAQTA vaccine (MSD; not lot # reported).  On 24-AUG-2007 the patient was seen at the doctor's office for a urine pregnancy test which was positive (LMP 13-JUN-2007).  On 12-SEP-2007, the patient had an ultrasound for the purpose of dating which was normal and indicated that the fetus was 12 weeks and 4 days gestation.  From November 2007 to January 2008, the patient was taking vitamins with iron daily.  On 07-NOV-2007, the patient had an ultrasound for Level II screening which had the fetus at 20 weeks and 1 day gestation and showed an eccentric cord insertion (not further specified).  The patient also has an MSAFP for screening purposes and the results were within normal limits.  On 31-Jan-2008, the patient gave birth to a live 3 lb, 12 oz female infant (32 weeks and 6 days from LMP).  It was also reported that the patient had preterm delivery at 32 weeks and 4 days.  The baby had Apgar scores of 7 and 8, and there were no congenital anomalies.  No additional information is expected.
Child was given 0.5 ml FLUVIRIN for 4 yrs old and up instead of FLUZONE for 6 - 35 mo of age on accident. NO treatment needed, child asymptomatic.
Pt. stated that she felt nauseated. Applied cold compress to her neck. BP 142/94, P 68, R20 equal bilateral unlabored, O2 Sat 99% on . Pt stated that she had not eaten today. Gave pt. a bottle of water. Pt. said that she felt better. Stated no more nausea. Pt. cleared and sent home at 10:55. BP 133/87, P56, R 20, O2 Sat 99% RA. Lung sounds clear, no shortness of breath. Instructed to go to local ER if nausea or any adverse reactions occur off site after discharge. Cleared by RN.
Headache; So tired she could not sit-up; Heartburn (like her esophagus was burning); body pain; Fever(101.8); Shivering so bad she bit her tongue and could not control her jaw/ chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (So tired she could not sit-up), DYSPEPSIA (Heartburn (like her esophagus was burning)), PAIN (body pain) and PYREXIA (Fever(101.8)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (In August-September, 2020).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (Headache), FATIGUE (So tired she could not sit-up), DYSPEPSIA (Heartburn (like her esophagus was burning)), PAIN (body pain), PYREXIA (Fever(101.8)) and CHILLS (Shivering so bad she bit her tongue and could not control her jaw/ chills). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and TYLENOL at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), FATIGUE (So tired she could not sit-up), DYSPEPSIA (Heartburn (like her esophagus was burning)), PAIN (body pain), PYREXIA (Fever(101.8)) and CHILLS (Shivering so bad she bit her tongue and could not control her jaw/ chills) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.
Gave patient a 12 year + bivalent booster. Should have received a 5-11 booster.
12 days post vax, the pt started having a reaction. She had a little rash on her chest, moved to back, then legs and arms. She had a fever of 102. On 4/29/00, she had one seizure.
GUILLAIN-BARRE SYNDROME; GOT OUT OF BED ONE NIGHT AND HIT THE FLOOR; DEATH; This spontaneous report received from a consumer via a company representative via social media 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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, about two weeks later, the patient got out of bed one night and hit the floor, patient's legs were paralyzed, underwent many tests and was diagnosed with Guillain-barre syndrome and was hospitalized (date unspecified). The number of days of hospitalization was not reported. Patient had nightmare and was bedridden. On an unspecified date, the patient died from an unknown cause of death. It was unknown if an autopsy was performed or not. Reporter stated that, "Same thing happened to someone I worked with." It was reported "My very best friend in the world could not wait to get the covid vaccine back in 2020. She had to wait until her age group was available, she was 63. She was finally okayed. About two weeks later she got out of bed one night and hit the floor. Her legs were paralyzed. After finally going to a few doctors she was hospitalized. Many tests later she was diagnosed with Gillian Barre' Syndrome. After living a nine month nightmare she passed away. J.and J.was contacted but nothing was done. A perfectly healthy woman went to a bedridden person who was sick everyday for the remainder of her life. So,so sad." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre syndrome and got out of bed one night and hit the floor was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20221237321.; Sender's Comments: V0: 20221245268- Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable. 20221245268- Guillan-Barre syndrome. The event has a unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration. 20221245268- Got out of bed one night and hit  the floor- The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
NECK PAIN; "VERY BAD PAIN" ON THE SAME SHOULDER IN WHICH ARM SHE "GOT THE SHOT"; This spontaneous report received from a patient 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: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-APR-2021, the subject experienced neck pain. On 11-APR-2021, the subject experienced "very bad pain" on the same shoulder in which arm she "got the shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from "very bad pain" on the same shoulder in which arm she "got the shot", and neck pain. This report was non-serious.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 21-OCT-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
pt was taken to Er approx 10 hrs p/vax t104 had not been given any APAP was adm to hosp for observance for 2 days;
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Pain Numbness of arm right after injection and afterwards, arm and collarbone neck back area
From telephone contact received on 10/30/02, it was reported that a 55 year old female had been vaccinated with Fluzone (lot number U0913AA) in the left deltoid. The date of vaccination was not reported. 3 to 4 days after vaccination, the patient complained of her elbow being sore. The patient also developed an area of rash that was itchy on the top of her left foot. These symptoms reportedly resolved within one week without any treatments.
Five to ten minutes after Td shot pt. had seizure in car with mother. Pt. reported dizziness, ears ringing, confusion upon arousal. Pt. reporting body aches, fatigue, vomiting after seizure. Mother took patient to hospital, doctor said most likely a reaction to vaccine. Mother reports patient had febrile seizures as infant, none since and none related to vaccines.
This spontaneous report was received from a health care worker refers to a 24 year old patient of unknown gender. Past medical history and concurrent conditions were not reported. The health care worker stated that, the patient was vaccinated with PROQUAD (Merck) (dose, strength, dose number, vaccination site, route, # lot, expiry date unspecified) (inappropriate schedule of drug administration). Concomitant medications were not provided. Product quality complaint (PQC) was not reported. No adverse effects were reported. Further information was not provided. Additional information has been requested.
This child tolerated 2m vaccines well and then with 4m vaccines developed thigh abscess, which was treated with bactrim with some improvement but recurred, then with 6m vaccines had the same reaction on the opposite leg. Concern for contaminated vaccines vs tampering with vaccine. Abscesses have now required drainage and IV antibiotics for resolution.