chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Rheumatoid arthritis flare up; This is a solicited report based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-4031079-00). A non-contactable consumer (patient herself) reported for a 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (Batch/Lot number was not reported) as dose 1, single and on an unspecified date (Batch/Lot number was not reported) as dose 2, single; both intramuscular for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneously from an unspecified date (Batch/Lot number was not reported), at unspecified dose and frequency for moderate to severe rheumatoid arthritis. The patient's medical history included moderate to severe rheumatoid arthritis. Concomitant medications were not reported. The reporter was reporting non-serious rheumatoid arthritis flare up and headache with adalimumab (HUMIRA). On an unknown date, the patient experienced headache. In Jul2021, the patient experienced rheumatoid arthritis flare up. Pfizer BioNTech Covid-19 Vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date she received first and second dose of COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the events for adalimumab was unknown. Outcome of rheumatoid arthritis flare up was recovered in 2021 while headache was recovered on an unspecified date.   Causality for adalimumab (HUMIRA): The reporter's causality for the event(s) of rheumatoid arthritis flare up and headache with adalimumab (HUMIRA) was a reasonable possibility.   The reporter's assessment of the causal relationship of the event with the suspect product (BNT162B2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the reported information, obscure temporal relationship and possible contributory effects from concomitant use of adalimumab which can manifest events of  Rheumatoid arthritis flare up and headache,a causal association with suspect drug bnt162b2 was assessed as unrelated.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.
Case number PHEH2014US021662 is an initial spontaneous report received from a medical assistant on 24 Oct 2014. This report refers to a 26 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1413601) multi-dose vial (MDV) intramuscularly in the deltoid on 23 Oct 2014. It was reported that on the same day evening, she experienced redness and hotness and her arm was swollen. The event outcome was reported as unknown. The seriousness and causality were not reported. Following an internal review of the data received on 24 Oct 2014, it was identified that the event verbatim "redness and hotness" were erroneously coded as erythema and skin warm and hence the events were recoded using local vaccination site terms.
I never had any types of warts.  After the gardasil injections, I got a filiform wart on my eyebrow that had to be removed because it affected my visual field.
Developed bruising starting from the elbow, same arm, large area, with progression over the next two days. seen 6 days later with evolution of the bruise and no new bruising noted. no cp, no sob, no ha, no fever, no other skin findings.
Shortly after vaccine was given, the patient fainted with jerking seizure like movements, body rigidty with feet turned inward and shaking. After coming too she said that prior to fainting she saw flashes of colored lights in her eyes-colors of pink and blue.  She came too and appeared fine, but scared and shaky. That night and for 2 days she ran low grade fever, was very lethargic and complained of headache.  It has been four days and she still doesn't seem her normal energetic self, and she seems to have complaints of a headache daily.
10 minutes after shot administered in left arm upper bicep. Anaphylactic Reaction:  sore throat went to very sore strep throat feeling, throat felt like closing, difficult breathing 15 minutes: coughing asthma began. Blood sugar felt it was dropping ( 20 min prior had breakfast sandwich before shot). Right arm hand tremors began, week in legs even when sitting  sever headache.  Asked staff get a Benadryl- call 911. Took 25 mg tab benedryl 5 min prior to EMT arrived.  Same time another woman started difficulty breathing and staff at facility asked if Emt could look at her too. Emt called another ambulance to scene as strap into gurney. Way to ER gave me liquid steroid. ER given epi, nebulizer breathing treatment  Abuterol help breathing, pepicid too.  Discharge after 3:30 pm. 40 mg prednisone ( 2 tabs a day for 4 days) and instructed Benedryl 4-6 hours. Use epi pen if throat and sever sore throat comes back- return to er.
Information has been received from a physician concerning a patient with liver disease (unspecified) who was vaccinated IM with a dose of 0.5 ml PNEUMOVAX 23 in the left or right deltoid "within the last 2 months."  The physician reported that the patient experienced a severe injection site reaction which impaired the use of the injection site arm (could not lift for 3 to 4 days).  The patient sought medical attention and contacted the physician.  At the time of the report, the patient recovered.  The reporting physician considered injection site reaction and impaired use of injection site arm, (could not lift) to be disabling.  This is one of several reports received from the same source.  Additional information has been requested.
got a very mild case of Covid19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (got a very mild case of Covid19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2022, the patient experienced COVID-19 (got a very mild case of Covid19). At the time of the report, COVID-19 (got a very mild case of Covid19) outcome was unknown.      No concomitant medication information was provided. Patient had received first dose of Moderna in January and second dose in July. Patient received the first two Moderna vaccines 6 months apart way back in 2021. Six months later patient took a Moderna booster in December2021. Patient not had another shot since then. Someone visited patient and patient got a very mild case of COVID-19 on 06-Sep-2022. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-675041, US-MODERNATX, INC.-MOD-2022-675042 (E2B Linked Report). This case was linked to MOD-2022-675038 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675041:MOD-2022-675040 (Patient 1 male booster dose case) US-MODERNATX, INC.-MOD-2022-675042:(Patient 1 male booster dose case)
Had shots about 4:15pm 10/31/07.  Had difficulty sleeping that night due to arm pain.  11/1-got up about 8am.  R delt very sore, felt hard when pushed arm.  Did some household chores, got a shower about 1:30pm.  When stepped out right delt-inner area slightly pink & very tender to touch.  At 2:30pm was seen by Dr. at clinic where I work.  He called it "a large local hypersensitivity", told me to take Benadryl as directed, continue my Allegra & to use ibuprofen 600 mg Q 6 hrs.  On 11/2 at about 2pm Dr. re-evaluated my right upper arm. The pink area had increased to nearly wrapping the diameter of my arm, was warm to touch & still very painful in spite of doing as previously directed.  At this point the area was traced around, I was advised to continue with Benadryl & ibuprofen.  However he gave me a script for Keflex 500 mg once TID x10 days, told me if pink area continued over ink lines on 11/3 I was to start ATB.  I actually started Keflex about 6pm 11/2.  When I got home that night, the pink area had already moved beyond the pen lines in several directions, moving towards shoulder & elbow joints as well as completely wrapping around upper arm.
Excruciating pain traveling ip and down right arm.  No formal treatment so far other than CBD Muscle & Joint to manage pain.  I've been waiting for the pain to go as has been stated in my places.
06/01/2022 I had a headache and swelling in my arm. 6/2/2022 I had chills, headache and swelling in my arm. 6/3/2022 I had an earache and my right eye was twitching. I had paralysis on my right side. I went to Urgent Care and was told my symptoms were signs of a stroke. My face was drooping, and my eye was bulging. I went to the ER. No tests were performed. The doctor said it was Bell's Palsy. I was prescribed Prednisone and Acyclovir. I was told my blood pressure was up and I needed to monitor. I was also told to see my PCP for follow-up.
Left thigh red swollen, hot to touch x 1 day, no fever, Lump where injection given
Information has been received from a third party claims administrator for a pharmacy concerning a female patient. On an unspecified date the patient was vaccinated with ZOSTAVAX (lot # J010447, exp. date 22APR2014). On 27NOV2013 the patient experienced an adverse reaction. The outcome of adverse reaction is unknown. Additional information has been requested.
6 days after injection, tinnitus and extreme dizzyness followed by needle like sensations to both beet, esp big toe continuing to april 2 when both knees became very swollen and painful.  Unable to get up from sitting position without assistance..  Tests negative for gout or rheumatoid symptoms.  xrays negative except for swelling.  Neurologist suggested an autoimmune response.  Rheumatologist suggested Polymyalgia Rheumatica and started steroids.  After 30 days symptoms improved but returned two weeks after steroids finished.  Back on steroids.  Dizzyness has persisted throughout.
administrated with engerix-b batch recall; administrated with engerix-b batch recall; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 7th December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were 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: 18-APR-2022 Reporter's comments: No patient's identifiers were provided.  The patient was administrated with Engerix B batch recall for October.  The reporter had been on maternity leave and had just found out about it. No vaccination date was provided. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The nurse reported that a patient was administered with Engerix B batch recall, which led to recalled drug administered and drug dispensing error. The vaccine administration facility was the same as primary reporter. This case is one of the eight cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR068021:Same reporter US-GLAXOSMITHKLINE-US2022AMR068022:Same reporter US-GLAXOSMITHKLINE-US2022AMR068023:Same reporter US-GLAXOSMITHKLINE-US2022AMR068024:Same reporter US-GLAXOSMITHKLINE-US2022AMR068025:Same reporter US-GLAXOSMITHKLINE-US2022AMR068026:Same reporter US-GLAXOSMITHKLINE-US2022AMR068027:Same reporter
positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive for Covid-19) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive for Covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (positive for Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Reaction started 40min after injection.  It started with tingling above the lips and then numbness on the whole face + redness on face and neck per coworker, then collapsed trying to go to the bathroom to look at the redness, then had generalized weakness for about 45 minutes (couldn't move at all or open mouth and eyes). I was finally able to open my eyes 1 hour after it started. Got discharged 2 hours after symptoms resolution.  No medication was needed, symptoms gradually faded away.
Awakened by itchy, red hives at about 4am or 5am every morning since administration of the vaccine.  Most of the hives are on the torso, more severe on the front and some on the back.  A few have been on my arms.  After going back to sleep, the hives are gone when get up for the day.  No hives during the day.  Then awakened by hives again at 4am or 5am.  Prior to receiving the one-dose Janseen COVID-19 vaccine,  had only experienced hives three times in my life, several years apart.  Now it has occurred early every morning seven times in a row and expect it will happen again, since the ones this morning were worse than the previous few times.
toes tingling, feet burn pain in legs...tired...no fever.. pain in hands and itch...
Rash all over body. Developed 3 weeks post-injection. Rash is red, raised, and itchy.   Took extra allergy pill, Benadryl, and applied hydrocortisone cream. Treatment helped a little with itchiness.
Patient given Pfizer vaccine. Twenty minutes later she developed single hive to left neck. No other symptoms. Hx of allergies. Vitals and exam normal. She was given oral diphenhydramine x1. She waited an additional 30 min and then was accompanied home by her significant other.
I had 104-105° temperature for 3.5 days after getting my 2nd shot; Also had a terrible headache; was extremely fatigued with body aches and chills; was extremely fatigued with body aches and chills; was extremely fatigued with body aches and chills; Also extremely elevated blood pressure and pulse; Also extremely elevated blood pressure and pulse; This is spontaneous report from a non-contactable consumer (patient). A 35-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 30Apr2021 12:30 (age at the time of vaccination 35-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 vaccine, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. On 30Apr2021 19:00, the patient experienced I had 104-105 degree temperature for 3.5 days after getting my 2nd shot, Also had a terrible headache, was extremely fatigued with body aches and chills, Also extremely elevated blood pressure and pulse. On an unspecified date, the patient underwent lab tests and procedures which included Blood pressure measurement: extremely elevated; Body temperature: 104-105 degree, I had 104105 degree temperature for 3.5 days after getting my 2nd shot; and Heart rate: extremely elevated. Patient received ibuprofen and Tylenol as pain and fever reducers as a treatment for adverse events. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
severely ill.; fever; pain; received 2 Engerix-B vaccines and experience allergic reaction to binders.; suffered greatly; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced sickness (serious criteria hospitalization), fever (serious criteria hospitalization), pain (serious criteria hospitalization), allergic reaction and emotional suffering. On an unknown date, the outcome of the sickness, fever, pain, allergic reaction and emotional suffering were recovered/resolved.   It was unknown if the reporter considered the sickness, fever, pain, allergic reaction and emotional suffering to be related to Engerix B.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist was looking for binders in Engerix B vaccine because the patient was allergic to binders from the vaccine. The 5 years prior to the report, the patient received the 1st dose of Engerix B vaccine and experienced allergic reaction to binders. The patient was severely ill, had fever and pain that went about 2 to 3 months. The patient was hospitalized and went to the Emergency room (ER) and suffered greatly. The physician fount out that the patient might be allergic to ingredients in the Engerix B. They were trying to find out what in the Engerix B and the patient might be allergic to and they were guessing aluminum hydroxide. The reporter did not have the details about lot numbers, dates or patient information at the moment of the call. The reporter consented to follow up via fax. For further tolerance of 2nd odse, refer case US2021073794, reporter for same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073794:same reporter, same patient, same vaccine, different dose-2nd dose
Patient has a history of syncope after vaccinations (last occurred with a vaccination 10 years ago) but did not state this prior to  receiving his first COVID-19 vaccine. About 1 minute after sitting down in the observation area, he fell to the ground and briefly lost consciousness. Multiple staff members came immediately to assess, rolled him over, and he immediately came to and was alert and oriented. He was taken to a medical area and laid down on a cot. He had unremarkable vitals and was breathing normally. He initially endorsed feeling lightheaded, but denied any other symptoms. He was given crackers and water given that he had not had much to eat or drink before the vaccination. He had a normal neurological exam. He was noted to have a superficial abrasion above and below the left eye (lower forehead and upper cheek), and a small Bandaid was  placed on the forehead. Fire rescue on site called EMS, who assessed him. There were no immediate concerns and he refused transportation to a hospital for further assessment.  After 1 hour had passed, the patient confirmed that he was feeling normal and he was allowed to leave. He was able to walk out of the facility of his own volition and did not have further symptoms when standing. His wife verified that she would drive him home. Prior to leaving, he was given strict instructions of reasons to seek immediate medical care should he have any new or worsening symptoms. The patient indicated understanding. Communication was performed via a Language Line medical interpreter.
Hives (itchy red spots on the skin), itching, nasal congestion (known as rhinitis), rash, scratchy throat, watery or itchy eyes, swelling of the face, eyes, or tongue, weakness, wheezing, difficulty breathing.
10 days after receiving the SPV, the patient noticed a generalized outbreak of small, red papules located over arms, torso, face, neck and legs. He complains of pruritus and general fatigue, headache, mild nausea. He denies fever, chills, myalgias, shortness of breath, chest pain, visual changes. The lesions have just started to form vesicles. All lesions involved with the generalized rash are of the same stage. No treatment has been given. The primary vaccine site is well into the pustule stage.
Chest pain and RUQ pain. Chest pain resolved as on 12/23/2021. RUQ pain persists. Delayed second dose by 1 month to allow improvement of symptoms.
10/26 O.V. for generalized, erythematous, and itchy rash. Pt. had received flu shot 10/25. No local reaction at site.