chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hashimoto thyroid disease; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004202.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization. The following information was reported: AUTOIMMUNE THYROIDITIS (non-serious), outcome "unknown", described as "Hashimoto thyroid disease". The patient underwent the following laboratory tests and procedures: Test: Hashimoto thyroid disease, notes: He did a test that confirmed Hashimoto thyroid disease.  Additional information: On 11Nov2022, it was reported that a patient started treatment on an unspecified date in 2021 with Pfizer BioNTech COVID-19 Vaccine at dose 1 and dose 2 for COVID-19 immunisation. The patient stated that after taking her second Pfizer shot she started having some really strange side effects, her arms were burning. She told her doctor and he did a test that confirmed Hashimoto thyroid disease.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient mother).   A female patient of an unspecified age received BNT162b2 (Pfizer BioNTech Vaccine, Solution for injection, Lot No, Expiry Date, NDC number, UPC number was not reported), via an unspecified route of administration on 29Mar2021 as 2nddose, single for covid-19 immunisation. Historical Vaccine was a female patient of an unspecified age received BNT162b2 (Pfizer BioNTech Vaccine, Solution for injection, Lot No, Expiry Date, NDC number, UPC number was not reported), via an unspecified route of administration on unspecified date as 1stdose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced fever, headache on Mar2021.Reason for no lot number of Pfizer BioNTech Vaccine other reporter stated that don't have it. Expiry Date of Pfizer BioNTech Vaccine was unknown. Reporter stated about mother. She has received the Pfizer BioNTech Vaccine, she received the second dose of vaccine yesterday. She has nothing remarkable, she has like a fever, headache and she wanted to take a Tylenol, but the packet said that it didn't give any information whether she can take Tylenol or not, they just gave this number. Is there anything preventing someone who can otherwise take Tylenol from taking a Tylenol in 24-48 hours after the vaccine and got it yesterday at 4:30 PM and has a fever and a headache. She just wants to know if she can take the Tylenol. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. .
Initial unsolicited report received from a medical assistant on 13 January 2017. This case is linked with 2017SA007210, 2017SA007211(same reporter,same vaccine, same event). This case involves a 18-months-old female patient who was vaccinated with doses of DAPTACEL (batch number: C5117AA, expiry date: 19 January 2019, dose and dose in series were not reported) and HEPATITIS A VACCINE (HEP A) (batch number: M032492 UNK, expiry date, dose and dose in series were not reported) both via intramuscularly in thigh on 09 January 2017. Patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination. Concomitant medications were not reported. On 10 January 2017, one day of following the vaccination, the patient had developed a knot at the injection site. The patient was seen by physician. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
pt states 15 minutes after she got the covid vax she could taste the medicine in her mouth.  She became very flushed.  The medicine taste disappeared after 2 days and the flushing went away after 4 days.  About a week later she developed chest pressure that felt abnormal.  She went to the ER w/ Gastro problems and had them do an  EKG and labs for the  chest pressure she was having.  These test came back normal.  After 2nd dose on 9/7/2021 LOT # 088621A she had arm pain with some fever, diarhea, chills, weakness and flu like symptoms that lasted about 4 days.  She was still weak so went for another EKG and more lab work that was normal.
Primary physician responsible for pt's care:; pt had a positive COVID test when came to the hospital on 4/2/22; started Remdesivir and steroids; ABX for a UTI; in hospital 4/2 - 4/26/22; pt's condition continued to decline with increase in O2 requirements; pt admitted for hospice care and pt passed away in the hospital
MILD HEADACHE/FELT LIKE A SINUS HEADACHE; FELT TIREDNESS; NAUSEA ON AND OFF; This spontaneous report received from a patient concerned a 49 year old. 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced mild headache/felt like a sinus headache. On 13-APR-2021, the subject experienced felt tiredness. On 13-APR-2021, the subject experienced on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild headache/felt like a sinus headache, felt tiredness, and nausea on and off. This report was non-serious.
LEFT ARM STARTED TO HURT, AND IT WAS REALLY PAINFUL AND WENT TO THE HOSPITAL 4/3/17. PATIENT WAS GIVEN NORCO FOR A WEEK. THEN PATIENT'S PAIN RETURNED AND WENT TO  HOSPITAL 4/8/2017 2:30 PM.
died from Hpv vaccine; HPV 16 11 18 (first vial tested and turned out to be positive); PQC present: Yes/sent me at the first vial so i tested and it turned out to be positive altogether 16 vials; This spontaneous report was received from a consumer via social media referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, anatomical location, lot# and expiry date not reported) for prophylaxis. On an unknown date, the patient died from quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). It was reported that, the first vial was sent to the reporter by the local paediatrician. The reporter tested the vial and was turned to be positive with strains HPV 16, 11, 18 (Human papilloma virus test positive and product quality issue). Cause of death was unknown and it was unknown whether autopsy was performed. The outcome of papilloma viral infection and product quality issue was unknown. The reporter considered the event of death as related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). Causality assessment for human papilloma virus test positive and product quality issue was not reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA012460:same reporter US-009507513-0807USA02497:same reporter; Reported Cause(s) of Death: unknown cause of death
Administration error, Patient received pfizer 12 years plus formulation. Patient is 10 years old. This occurred at a Pop Up clinic. Parent contacted. Per mom's request, patient's pediatrician was contacted as well to report. Mother reports patient is doing well, with no ADRs.
I tested positive for COVID-19 and had a scratchy throat, running nose, and cough. I saw a doctor on a cruise and he prescribed me Paxlovid. My symptoms lasted 3 to 4 days.
Rash with hives over entire body. Fever 7 days after MMR #1.
Dizziness; Diarrhea; Vomiting; Prevented to move head, get out of bed; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of dizziness (On an unknown date in 2020, received 1st dose, case US2022182824 and experienced diarrhea, vomiting and mobility decreased). Concurrent medical conditions included asthma.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 6 days after receiving Shingrix, the patient experienced dizziness, diarrhea, vomiting and mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the dizziness, diarrhea, vomiting and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the dizziness, diarrhea, vomiting and mobility decreased to be related to Shingrix.     Linked case(s) involving the same patient:  US2022182824   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: On an unknown date in 2020, the patient received his first and second Shingrix doses six months apart. About 6 days after each dose of Shingrix the patient experienced dizziness, diarrhea and vomiting (adverse events recovered). The dizziness prevented him from moving his head or getting out of bed for 3 or 4 days. The dizziness gradually improved then resolved after 7 to 14 days. The vomiting and diarrhea lasted for 3 or 4 days. The patient had nothing else to report. The patient did not want to be contacted. Declined to provide his mailing address. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022182824:Same reporter
PALM SIZED RASH AROUND INJECTION SITE WITHOUT ITCHING, WARMTH, NOR PAIN.. CURRENTLY UNRESOLVED
6 PM. Cold Chills/Shakes. 9:30 - 10 pm skin burning (hands/feet), sore joints (couldn't walk). Pt took some BENADRYL at 3 am, symptoms eased up around 6 am. Sore and general feeling of malaise until Monday am.
Ache and pain have settled to hips and buttocks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6200) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Flu shot", start date: Sep2020 (unspecified if ongoing), notes: Anatomical location: Left arm, Number: 1, Age at immunization if date not available: 70+; "Prostate" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE taken for prostate examination (ongoing); ROSUVASTATIN taken for blood cholesterol (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Lot no: EL9266, Anatomical location: Left arm, Expiry date: 31May2021), administration date: 16Feb2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "Joint pain", "Muscle pain". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Ache and pain have settled to hips and buttocks". Therapeutic measures were not taken as a result of pain.  Additional information: Now, a month after 2 shot, ache and pain have settled to hips and buttocks. Patient stated, it was painful to move. Patient had to give up his daily walking exercise due to pain in thighs and buttocks, but he was resorting to calisthenics in the meantime. Appreciate an earliest help response The AE did not require to visit emergency room and physician office. The family medical history relevant to AE taking Finasteride and Rosuvastatin Rx daily for Prostate and cholesterol. There was not any other product that were taken together with those indicated above.   No follow-up attempts are possible. No further information is expected.
Witnessed pt. pass out. (1/19) mom called 1/25 with c/o dizziness since receiving vaccine.
NO ADVERSE EVENT TO REPORT. REPORTING DUE TO VACCINE GIVEN AFTER THE EXPIRATION DATE OF 09/30/2022 PER THE PFIZER RECALL STATING THEY HAD REPORTED THE WRONG ACTUAL EXPIRATION OF THE VACCINE.
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 37 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The pt received injections of LYMErix in early April 1999 and on 5/21/99 "according to the client." On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "back pain and generalized joint pains." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a neurologist, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
11-15-10 - Urgent care decreased strength hands & feet 11-16-10 ER -> neuro admit to hospital re weakness spreading to lower extremities. 2 wks prior had URIs. Pt stated he had been playing football but head CT was normal. Guillain Barre - 11/24 hospital discharge 11/26 ER - blood patch myelin sheath damage in extremities.
I was given two shots,one in each arm.That night I could not lie on either side becouse of the pain in my sholders.I thought it was becouse they were sore from the shots but the pain has remained every day and night since.Most of the time I cant raise my arms higher than my sholders and cannot sleep on my sides.I am writing becouse I saw something on TV about joint pain after having the flu shot.
Headache, dizziness, nausea, loss of appetite, muscle weakness. At entry to hospital, after numerous testing, was advised heart attach took place. Dehydrated.
frozen arm/shoulder; This case was reported by a pharmacist and described the occurrence of frozen shoulder in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 2 days after receiving Shingrix, the patient experienced frozen shoulder. On an unknown date, the outcome of the frozen shoulder was recovered/resolved.   It was unknown if the reporter considered the frozen shoulder to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. In August 2020, the patient received 1st dose of Shingrix in the left deltoid. On an unknown date, 2 days after the vaccination, the patient developed frozen arm and shoulder which lasted for 2 months and resolved spontaneously without treatment. The reporter consented to follow up.
Erythema multiforme and swelling, increased warmth, and decreased range of motion of left arm. Ceftriaxone mg once, azithromycin mg other.
Most, if not all/ contents spilled/unknown quantity went into the patient's arm; This case was reported by a nurse via sales rep and described the occurrence of accidental underdose in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th July 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 5th July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose 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 details were provided as follows: The age at vaccination was not reported. The nurse was administering a dose of Bexsero to a patient in deltoid muscle and the needle apparently was not connected properly to the syringe. As per the nurse, most, if not all of the syringe contents spilled onto the exam table and an unknown quantity went into the patient's arm, which led to accidental underdose. The nurse believed that none of the vaccine went into the arm but she did inject the needle into the deltoid muscle as planned.
Parent stated that patient needed the vaccinations to be in school, she did not disclose that he had them before.  When charting after they were given, it was discovered that the patient was given these last year.  The patient had NO adverse effects in the exam room. The parent was called and a message left for her to return our call.
Soreness in arm with injection site started shortly after shot.  6+ hours later, both arms were extremely sore, though the non-injection arm may have been sore from having arm suspended for 4-5 hours of driving in one day.   Only soreness in injection arm remained the next day.  Moderate/noticeable fatigue lasted until second day after vaccination, when soreness and fatigue were barely noticeable.
Heart chest pain; Diagnosed within 4 days with Myocarditis Hospitalized; This is a spontaneous report received from a non-contactable consumer (patient). A 17-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at arm right on 02May2021 at 12:00 AM at age of 17-year-old at single dose for COVID-19 immunization. Medical history included known allergies to Sulfa. Patient also had known allergies to amoxicillin. Other medical history was none. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient didn't receive any other medications within 2 weeks of vaccination. Concomitant medication was none. Patient experienced heart chest pain on 06May2021 at 07:00 AM, and was diagnosed within 4 days with Myocarditis and hospitalized. The events resulted in emergency room/department or urgent care visit and hospitalization. Patient was hospitalized for  6 days. Patient performed echocardiogram and MRI, both with unknown results. Patient received antibiotics and steroids as treatment for the events. Outcome of the events was recovering. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
This case was reported by a physician via sales rep and described the occurrence of vaginal mucosal blistering in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included immunocompromised and rheumatoid arthritis (RA). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced vaginal mucosal blistering and shingles. On an unknown date, the outcome of the vaginal mucosal blistering and shingles were not reported. It was unknown if the reporter considered the vaginal mucosal blistering and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced vesicles around vaginal area 1 week of 1st dose. The patient experienced shingles after an unspecified period of time from the 1st dose of SHINGRIX. The reporter agreed to follow up.
Vomiting, lightheadedness, and brief syncopal episode two days after receipt of 2nd dose of Moderna COVID-19 vaccine -chills, fatigue, loss of consciousness, lightheadedness, nausea, vomiting   Patient went to ED
Patient had a syncopal episode while walking through the office. She regained consciousness after about 5 seconds at which time she complained of a rapid heart rate prior to the syncope. She was able to walk herself to the waiting room where she was observed for 15minutes. After 15minutes, she reported feeling well and was A+O x 3.
Felt moderately crappy, rested a lot in bed, checked my pulse and was in a fib for a few hours or more. I have not experienced a fib since sometime in 2020. This event lasted for a couple of hours or more. I didn?t think to check my pulse because there was no chest pain or other symptoms.
Information has been received from a RN concerning a 79 year old female with Tylenol, Floxin and tetanus toxoid allergy who on 04-NOV-2004 was vaccinated with a third dose of Pneumovax 23, IM in the left deltoid. On 04-NOV-2004 the pt developed "increased left arm red, hot hard, sore 6x8 cm lasting 1.5 days." Subsequently, the pt recovered on 07-NOV-2004. It was noted that the pt at 74 years of age experienced "swelling, hot" following vaccination with tetanus toxoid. Additional information has been requested.
1/5/21 Within 10 min, started hot flash, right side of face was numb but was not paying attention and went to visit his wife and mother in hospital and came back to the clinic.  Noted right facial swelling, right leg felt off, no blurred vison, no difficulty with swallowing. Staff walked to the ED. Gave Benadryl IM given, Steroid IM given. Discharged from ED about 1400
Patient received Covid19 vaccine booster (BioNTECH Bivalent) at 1352H today. At 1403 pt c/o being "Itchy and sweaty and feeling warm"  Patient denied SOB and no chest pain, administered o2 via mask at 10 lpm, administered normal saline 0.9% and Diphenhyramine 50mg IVP also given at 1407 per allergic reaction protocol. Patient was monitored closely and condition improved approximately at 1416 post intervention. No other allergy protocol medicine given after diphenhydramine. Patient stayed, observed for any changes in status for next 45 mins.   Patient was discharge with No new c/o voiced,AAOX3, standing b/p of 121/62 and pulse 77 Reg. Stable.
did not go back for the second dose patient has not received another dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th July 2019, batch number:9X374 and expiry date: 10th October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not go back for the second dose patient has not received another dose).The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The patient did not go back for the second dose of Shingrix. At the time of reporting, the patient had not received another dose. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix , which led to incomplete course of vaccination.
Headache, Myalgia, Rash, NauseaVomiting, Fatigue, Flu-like Symptoms Narrative:
Patient came in for 2nd COVID-19 dose. Per nurse she offered Pfizer since it was what he was given as a 1st dose. He refused Pfizer stating he came in to start a new series. He wanted Novavax. He stated it was okay, it should be given. Nurse administered vaccine stating "I felt pressured" due to the patient's credentials. Nurse was reminded of off-label request protocol and of chain of command for difficult situations. Her temp agency was also contacted.