chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Knot in leg (thigh) were vaccine administered (4mm) in size. Crying for more than three hours at a time on 5/31/05.
MAJOR FATIGUE,BAD HEADACHE, MUSCLE CRAMPS, EVEN UP UNTIL 9-22.  SHE STATES IT TOOK HER 2 & 1/2 WEEKS TO HAVE RELIEF FROM THE 1ST DOSE AS WELL
Patient fainted after immunization. She waited 15 minutes after and was walking to car and fainted. EMS was called and came to evaluate her. No treatment was needed.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # K003407 and expiry date of 06-MAR-2016 and lot # L000453 with expiry date of 06-JAN-2017) subcutaneous. The nurse did not know which lot of VARIVAX (Merck) the patient received. Concomitant medications were not reported. There were no adverse effects. The outcome of the event was unknown. There was no product quality complaint involved. Additional information has been requested.
Hello. I had reactions to both the first and second injection. I was 28 weeks pregnant when I had the first vaccine 1/15/21 and 31 weeks pregnant when I had my second injection 2/5/21. I took Tylenol prior to the first shot and after, with the second shot I did not take Tylenol before the shot because it was not recommended. I did take it after.  My symptoms began around 5 hours after each shot and were moderate (aches, joint pain, fatigue, headache, and nausea). No fever. My symptoms were gone within 24 hours after the first shot. My symptoms lingered for a few days with the second shot, but were mild after the initial 24 hours. I had no known pregnancy complications.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales Representative. A patient of unspecified age, race, ethnicity and gender received PREVNAR 13 at single dose via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness on the injection site on an unspecified date. Outcome was unknown. No follow-up attempts are possible. No further information is expected.
The patient's wife states she asked for the Flu vaccine and not the COVID-19 vaccine.  Pfizer Comirnaty 2023-2024 was administered in error.
Hypersensitivity at the site; Red; Tender; Site was swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity at the site), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PAIN (Tender) and VACCINATION SITE SWELLING (Site was swollen) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Type I diabetes mellitus. Concomitant products included LEVOTHYROXINE, LISINOPRIL and SIMVASTATIN for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitivity at the site), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PAIN (Tender) and VACCINATION SITE SWELLING (Site was swollen). The patient was treated with INSULIN ASPART (NOVOLOG) ongoing since an unknown date for Type I diabetes mellitus, at a dose of 6 unit at bedtime. At the time of the report, HYPERSENSITIVITY (Hypersensitivity at the site), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE PAIN (Tender) and VACCINATION SITE SWELLING (Site was swollen) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 50-250 mg/dl (abnormal) Blood sugars with  wide fluctuations of lows of 50's and highs of 250 mg/dl.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional treatment included ice applied on the vaccination site.   Due to the fluctuations in blood glucose post-COVID-19 vaccination, insulin treatment varied from  the regular dose of 6 units up to 24 units nightly.
"When I was leaving for work on Thursday 1/14 (8 days post vaccine) I noticed my arm was sore and heavy, almost like I got the vaccine all over again. When I got to work, I looked at my arm and it was very swollen, red, warm, firm, and itchy. By Sunday 1/17, I started to see progress with the swelling, warmth and redness.  It is still mildly itchy. Please note, when I got the vaccine on 1/06/21, I had the normal side effects of arm soreness, fatigue, mild muscle aches and a mild headache; all of these symptoms were gone by Friday 1/08/21. I saw [vaccine administrator] and she instructed me to use ice and hydrocortisone cream.  I iced it for 4 days and there was no change until day 4 (Sunday). I also used Aleve during this time as well. I saw my PCP on Monday 1/18 and she told me to continue the current treatment of ice and Alieve and to update her on Wednesday 1/20."
severe pain, stiffness, unable to move, unable to get out of bed without struggle. it lasted for 2 days then improved sunday evening (09/27/20). she is using ibuprofen,muscule relaxant,pain med,messager and it improved
12APR99 mom called states 11APR99 had pimply rash in both groin areas;no elevation in temp, no itching, has a runny nose;instructed on what pox looks like;if rash does not clear up next day or 2 & if has any other sx to call hlth dept;
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-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 02-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 02-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was provided.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: AFTER RECIEVING THEIR 2ND PFIZER COVID VAC DOSE, PT DISCLOSED TO PHARMACIST THAT HE EXPERIENCED CHEST PAIN AFTER HIS FIRST DOSE. PATIENT REPORTED THAT AFTER HIS FIRST DOSE HE WALKED HOME AND EXPERINCED AN ISOLATED INCIDENT OF CHEST PAIN LASTING APPROXIMATELY 30 SECONDS.  RPH ADVISED HIM TO REPORT THE INCIDENT TO HIS PCP AND TO SEEK MEDICAL ATTENTION IN FUTURE CASES OF CHEST PAIN.
Supraclavicular lymph node swelling right side with heat and redness.  Lymph node swelled until 5/4/21 then ruptured.  It drained like an abscess until 5/8/21 when healing began.  Healing is still not complete.
Vaccine was given on 10/10/22 and the vaccine unknowingly expired on 9/30/22.
This is a spontaneous report from a contactable consumer, who reported for herself, via Pfizer-sponsored program Patient Testimonial Recruitment. A female patient of an unspecified age received PREVNAR 13 on an unknown date in 2016 at single dose for immunisation. Patient reported she had pneumonia on and off since 2006. She went for 12 days of tests and was diagnosed with bronchiolitis and being treated, but she would still get pneumonia off and on. She had lingering wheezing and coughing and had a bronchioscope in Jul(year unspecified). Pathology showed no unusual infections. In Jul(year unspecified) she went to Urgent Care because she was having trouble breathing. By midnight she couldn't breathe and was stuck in hospital for 10 days with pneumonia. She was encouraged to follow-up with her doctor. They tried inhalers which never worked. She used the inhaler that was prescribed and got an appointment with a pulmonologist. She had a chest x-ray on an unknown date which showed she still had pneumonia. "The doctor said she really had a lung infection, but he was coding it as pneumonia for insurance purposes". In 2016, she got the pneumococcal 13-val conj vac (dipht crm197 protein) shot and she continued to get pneumonia. Final outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sore arm began on afternoon of shot, the next day was very tired and a headache. Overnight, woke up with vertigo. All symptoms went away within the next 24 hours.
titers were borderline; This spontaneous report was received from a consumer referring to his daughter, a 27-year-old female patient. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in 1996, the patient was vaccinated with her first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, one dose (injection site, route of administration, lot # and expiration date were not provided) for vaccination reconstituted with sterile diluent (MERCK) (exact dose, injection site, route of administration, lot # and expiration date were not provided). She needed vaccination proof for her school and when the blood test was done on an unknown date in August 2020 the titers were borderline. The patient did not seek medical attention. The physician recommended the patient get the dose as a treatment and she received her second dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (exact dose, injection site, route of administration, lot # and expiration date were not provided) reconstituted with sterile diluent (MERCK) (exact dose, injection site, route of administration, lot # and expiration date were not provided) on an unknown date in August 2020. The outcome of the event was unknown.  The relatedness between the event and varicella virus vaccine live (oka/merck) (VARIVAX) and sterile diluent (MERCK) was not reported.
Night of the vaccination woke up with stomach, nausea, body aches which continued to the next morning and were followed by fatigue and headache. Self treated with switching between Motrin and Tylenol. The following day I have much relief, some body aches but not as bad as the day before. Headache, nausea and stomach pain have subsided.
Patient presents to ED with left sided numbness started one hour ago. Pt states she has been having issues with nerve pain since the covid shot- March 16th. Unable to lift left arm and leg. Grip on left more weak. Slurred speech.
UrticariaPruritus & PRURITUS; URTICARIA (2/19/20@14:42); ERYTHEMA; PERIPHERAL EDEMA
I ran a really high Fever yesterday 103.9 F it's back up to 103. F; chills; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 48-years-old female patient (consumer) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), second vaccination dose via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. On an unknown date, patient took first vaccination dose of BNT162B2 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 28Apr2021 after getting second shot on Tuesday, the patient had ran a really high Fever yesterday 103.9 F it's back up to 103. F and chills were observed with the first 1 to 2 days after vaccination. Patient took Acetaminophen 20 minutes ago and is still pretty high 103 F. On an unknown date, the events were resolved shortly. As per the Clinical Trials Experience Table, Fever which is greater than 38.9 degree C to 40.0 degree C, after second vaccination dose, 1.2 % of patient reported the same event. Outcome of events was resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Bladder cancer recurrent; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (NOT PROVIDED). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) at the age of 70 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Route of administration:Intramuscular), administration date: Feb2021, for Covid-19 immunization. The following information was reported: BLADDER CANCER RECURRENT (Serious,medically significant) with onset Oct2021, outcome "unknown", described as "Bladder cancer recurrent". The action taken for adalimumab was unknown. Clinical comment: The patient had event of bladder cancer and scraped it out and it had come back with humira (adalimumab). In Oct2021, the patient experienced bladder cancer and scraped it out and it had come back. Chemo in bladder after procedure was done. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Dec2021, the patient received third dose of BNT162B2 Vaccine. Other relevant history was not reported.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of bladder cancer and scraped it out and it had came back was not provided. abbvie's opinion is that the event of bladder cancer and scraped it out and it had came back is not assessable.  Causality for Humira (Adalimumab), unknown 1) Bladder cancer recurrent (#) (Bladder cancer recurrent (#)) [v.#] Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr(Drug/Vaccine):  Not assessable  Causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran) (Tozinameran),Un-Known, Unknown 1) Bladder cancer recurrent (#) (Bladder cancer recurrent (#)) [v. #] Causality as per reporter (Drug/Vaccine): possible   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event. The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as 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.
Haven't felt well; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose of shingles vaccine received on an unknown date, for tolerance of 1st dose, refer case US2023AMR011206).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.   Linked case(s) involving the same patient : US2023AMR011206   Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had not felt well since got the shingles vaccine. Additional Supportive Information: The follow up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR011206:Same patient
Twitching of my left upper eyelid, if Iclose my eyes or sneeze my uppereyelid spasm and shaking left and right; Twitching of my left upper eyelid, if Iclose my eyes or sneeze my uppereyelid spasm and shaking left and right; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 17:45 (Lot number: ER8729) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Season allergies" (unspecified if ongoing), notes: Verbatim: Season allergies; "Known Allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: wheat, gluten, tree nuts, peanuts, soy" (unspecified if ongoing). Concomitant medication(s) included: TRI LO MARZIA; XYZAL; NASACORT. Past drug history included: Tetracycline, reaction(s): "Known allergies: tetracycline", notes: Verbatim: Known allergies; Zythromax, reaction(s): "Known allergies: Zythromax", notes: Verbatim: Known allergies; Erythromycin, reaction(s): "Known allergies: erythromycin", notes: Verbatim: Known allergies. The following information was reported: MUSCLE TWITCHING (non-serious), BLEPHAROSPASM (non-serious) all with onset 12Apr2021 20:00, outcome "not recovered" and all described as "Twitching of my left upper eyelid, if Iclose my eyes or sneeze my uppereyelid spasm and shaking left and right". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle twitching, blepharospasm.  Additional Information: Patient had no other vaccine in four weeks .Patient had no covid prior vaccination and covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patients were vaccinated concomitantly with ZOSTAVAX VIAL (19400 plaque-forming unit (PFU), dose, route of administration, lot# and expiration date were not reported) and PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patients experienced injection site reactions. The pharmacist noticed that more patients (unspecified number) experienced injection site reactions when ZOSTAVAX and PNEUMOVAX 23 were administered concomitantly than when ZOSTAVAX and PNEUMOVAX 23 were administered 4 weeks apart (captured in MARRS# 1604US005983). The outcome of injection site reactions was not reported. Causality assessment was not provided. This is one of two reports received from the same reporter. Additional information has been requested.
mild covid symptoms; unbearable pain; tendonitis; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN (unbearable pain), TENDONITIS (tendonitis) and SUSPECTED COVID-19 (mild covid symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).   On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Jan-2021, the patient experienced PAIN (unbearable pain) and TENDONITIS (tendonitis). On an unknown date, the patient experienced SUSPECTED COVID-19 (mild covid symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (unbearable pain), TENDONITIS (tendonitis) and SUSPECTED COVID-19 (mild covid symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.
Three, maybe four: 1. Sleep pattern, almost right away, I had a sleep pattern I had not had before. I would sleep maybe ten or fifteen minutes, wake, be awake for a few minutes, then wake again ten or fifteen minutes later. Eventually, a month or so, this went away. 2. Headache, I have headaches since I was maybe three our four, fell down a set of stairs. Usually, when I feel a headache starting, I had maybe a minute or two to take some over-the-counter medication. After the shot, that changed to maybe ten to fifteen seconds, the headache came much faster and with sharp pain. Eventually, a month or so, this went away. 3. Chills, I get cold, shoulders mostly, a lot, after shot, this, even in the Summer, happens more  often and this continues, even into early September 2021. 4. This one is much harder to understand, for me, but the immediate weeks after the shot, I had a really bad attitude. I was mean to at least one person and this is not my usual behavior. This has caused me a lot of grief and I really can only say an expression, such and such (person's name) is a mean drunk. I guess I became somehow mean after the shot. I really have no idea of what happened. This has gone now, but some of the outcome of being mean still persist. Once you are mean to someone, it is hard to repair. I do not believe this would have happened but for the shot.
I didn?t have any immediate reactions, but around March 24th the infection site became really itchy. It?s been itching since. It?s not all the time, but about 1/4 of the time it will itch on and off throughout the day. I don?t have this issue anywhere else and it is at the site of the Covid vaccine injection that I had on March 17th. I do not have any rash or redness. The reaction is not major, but I have read about ?Covid arm? as I was googling why the site may be itching, and what I read is that the itching has happened in the moderna vaccine but none have been reported with the Pfizer vaccine. So I wanted to report this happening to me as I had the Pfizer vaccine. I have not sought any medical attention for it as it is not causing any other issue apart from itching at the moment. It is still ongoing.
Case previously recorded as MA2009-4589. Initial case report received from a physician on 17 NOV 2009. A patient 3-year-old younger was vaccinated with FLUVIRIN 2009/2010 i.m on 13 NOV 2009. No adverse effect was reported. NA09-008308.
DIAGNOSED WITH PNEUMONIA A FEW WEEKS AFTER THE PREVNAR 13 VACCINE.
63 y o male with h/o idiopathic PE (RLL segmental and subsegmental) 3/29/22  (though he had the Johnson J+J covid vaccine in July 2021 and he thinks that it  was related to it, and requested that this be documented, so I have added an ADR  in pharmacy) noting that he had no other risk factors. He quit smoking in 2021  and had been running 1-2 miles regularly prior to the PE>
SOB,heart palpitations.,dizziness,weakness ,difficulty concentrating..sweating,then chills
On 12/22/2020 the day of vaccination in the evening around 6:30pm when I was driving I started having visual disturbances. The next morning 12/23/2020 I woke up with a bloody eye it was my right eye it lasted one day. On the following Monday on 12/28/2020 I was not feeling good I started getting headaches, feeling aching, at night I started getting fevers, congestion,  & fatigue. It went away on 1/1/2020.   Seen doctor on 12/29/2020