chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pharmacy technician administered 3rd COVID-19 vaccine dose on 02/15/21 at long-term care facility in under supervision of Pharmacist. Pharmacist received consent form from facility staff indicating patient needed a 2nd dose of COVID-19 vaccine. Patient's vaccination record card indicated first dose was administered 01/25/21.  Patient was informed prior to vaccination that he would be receiving 2nd dose; however patient may not have memory of being vaccinated. Upon data entry,  pharmacist discovered patient received Pfizer COVID-19 vaccine on 01/04/21, 01/25/21 and 02/15/21.  Patient's nurse was alerted via telephone call about the event. No adverse event has been reported. Facility will monitor.
LOW FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. 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, the subject experienced low fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low fever, and headache. This report was non-serious.
swelling began at the injection site/Caller got pretty good swelling right where the injection site is; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Medical Information Team. The reporter is the patient.  A 73 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 02Mar2021 at 14:00 (Lot number: EL3247) at the age of 73 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (first dose, Lot: FL3302), for COVID-19 Immunisation, reaction: "No adverse effect".  The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 02Mar2021, outcome "not recovered", described as "swelling began at the injection site/Caller got pretty good swelling right where the injection site is".   No follow-up attempts are possible. No further information is expected.
The patient was administered the Pfizer vaccine after the Beyond Use Date of 5/10/2022.   The patient had no other adverse events.
This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 25-year-old female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine, Hepatitis B vaccine and ENGERIX B pediatric (batch number 392RL, expiry date 21st August 2017). Concomitant products included ENGERIX B adult and ENGERIX B adult. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine and the 3rd dose of ENGERIX B pediatric .5 ml. On an unknown date, an unknown time after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine and not applicable after receiving ENGERIX B pediatric, the patient experienced therapy non-responder, underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the therapy non-responder, underdose and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: The patient had reportedly been vaccinated before (unsure of which Hepatitis vaccine they used for the first series), but did not have adequate titers leading the patient to be a therapy non-responder. Therefore, the patient started 2nd series with ENGERIX B adult and received a pediatric dose of ENGERIX B as her 3rd dose in the series (this was really 6th hepatitis B vaccination). This led to an underdose and an inappropriate age at vaccine administration.
A 4 months old patient received Havrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received HAV (Havrix pediatric) (batch number 4ZY9H, expiry date 28th April 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29 Apr 2022 Reporter's comment: A health care professional reported that the patient was administered with a havrix dose. The reporter consented to follow up. Additional supportive information: The 4 months old patient received havrix which led to inappropriate age at vaccine administration.
After receiving HPV patient started to not feel well and had a vasovagal episode. Patient did lose consciousness. Was out for about 10 seconds. The treating physical was pulled out of the room he was currently in to access the situation.
Received Moderna Covid 19 Vaccine EUA Approximately 8 hours after receiving the vaccine I developed a cold sore (not unusual when I have had influenza shots in the past). Approximately 36 hours later, late at night, I developed pruritus on my left arm (near elbow, same are as injection).  I examined it in the morning and there were small lesions as well as a circular "bulls eye" lesion, similar to when I was told I had contracted Cox Pox when doing surgery on farm workers at Hospital, 10 years ago.  Acyclovir helped relieve the puriritis.  At this time (60 hours after vaccination and 18 hours after pruritus and lesion developed) the condition has not progressed and has slightly improved.
sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th August 2021, the patient received Shingles vaccine. In August 2021, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The patient had received 'booster' for Shingles two days ago and feeling sick right now, it's a good thing to get vaccine. The reporter probably would have had an extreme case if he/she actually gotten through it. The follow up would not be possible as no contact details were available.
80 Yo pt  received ZOSTAVAX vaccine 4/29/08 in left deltoid (Merck Lot #0204/X Exp -6/19/09) One day later noticed trouble getting into his truck and lifting things. His neurological presentation was one of acute onset of bilateral global upper and lower extremity weakness. IVIG was given x 5 days along with acyclovir with significant improvement. Guillain-Barre syndrome. Globulin Immune dose: Units: Freq: Route - ACYCLOVIR Dose: Units: Freq: Route
15 MINS AFTER RECEIVING VACCINE PATIENT REPORTED HAVING THROAT TINGLING/SWELLING. WAS GIVEN BENEDRYL 50MG INJECTION, SYMPTOM RESOLVED APPROXIMATELY ONE HOUR LATER.
pt says three weeks after taking 1st covid dose she developed 4 little dots on her back and then found 3 on her stomach.  This became a rash on the left side of her stomach and back.  On 4/20/21 the went to Urgent Care. She was diagnosed w/ Shingles.  She was prescribed Valtrex and prednisone. She FU w PCP and DX was confirmed and instructed to wait an extra 2 weeks to take 2nd dose.   Her symptoms had cleared up at this time so she scheduled her 2nd dose on 5/10/21. (Moderna Covid vax in right arm, Lot # 022C21A)  Three weeks after getting 2nd dose she developed a rash on the right side of her body on her scalp and going down her neck.   On 6/3/2021 she went to ER where she was diagnosed w/ Shingles and was prescribed Valtrex and Prednisone.  She FU w/ PCP on 6/4/2021 that confirmed her DX of Shingles and feels like it was vax related. Pt still has the rash and taking her medicine.
The morning after the immunization, developed erythema and induration of the skin overlying the left deltoid. Seen 9/22, DX'd with arthus reaction, given loratadine PO by myself at my office.
Receive vaccine 9/11 by next day began having pain, swelling, redness, hot to the touch, by 9/15 at urgent care, arm red from above site of admin. to below elbow. Diagnosis: cellulitis as a result of shot. Sentinel node dissection in left arm - why shots only in right arm. Cephalexin 250 mg 4 cap bid x 10 days, all symptoms except pain began resolving approximately 10 days after beginning Abx. 3 mo after vaccine and still in lots of pain. Pain 11 out of 10 middle arm but radiates to shoulder and lower arm w/certain daily movements.
Rash/ rash on back around belt; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that a patient developed a rash on back around belt line after receiving Shingrix. The reporter did not consent to follow-up. No patient data given other than the healthcare professional (HCP) was a relative.
Vaccine administered on 9/28/06 to right ant thigh vastus lateralus, temp, began on 9/29/06 rash appeared body on 10/02/06 per mother very itchy and progressed over next day 10/03/06 seen.
1st day p/vax pt woke up throwing up, couldn't eat & feverish 99.5;couldn't walk on or near leg;blood shot eyes & pain in shoulder;2nd day fever 101.1, extreme redness & pain @ inj site;
A couple days after the shot my taste and smell was altered and since then I have not been able to taste and what I can taste only tastes like nickels
Moderna COVID-19 Vaccine EUA  Chills, Rigors , Severe Headache , Extreme fatigue Began at 7:00pm 12/31/2020, , Chills  , Rigors  resolved  at midnight , Headaches and fatigue continued till 1/2/2021
After receiving the flu vaccine 10-24-16 AM, site of injection (upper right arm) became red, irritated w/itchy rash by the PM. After 3 day returned to facility to show and report the adverse reaction. (No tx)-red, irritated itchy rash did not clear up until after 2 weeks. After 2 weeks I began to experience numbness and tingling and warm feeling surrounding the site of injection area reported adverse reaction to Dr. during an appt on Nov. 9th, 2016. (No tx). Continue w/intensity of numbness and tingling w/increase burning pain Feb. 1, 2017. URI.
Indurated abey on deltoid 2" in diameter, tender to the touch, mild erythema.
Patient received Zostavax shot which resulted in an allergic reaction.  Site of administration was swollen, red, warm to touch within 3-4 hours after receiving.  Patient received Benadryl po, cream & cold ice patch the relieved swelling.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient had no history of drug allergies/reactions. The patient's concurrent conditions and medical history were none. The patient was vaccinated with first dose of PNEUMOVAX 23 in February 2015 (unknown lot #). On 30-OCT-2015, the patient was vaccinated with second dose of PNEUMOVAX 23 lot # K009105 and expiry date of 21-JAN-2015 intramuscularly. On 31-OCT-2015, following the administration of the second dose of PNEUMOVAX 23, the patient experienced a fever, body aches, chills, redness, and swelling that localized at the injection site. No lab diagnostic procedures were performed. The patient sought medical attention and called primary care physician. The outcome of fever, body aches, chills was resolving as it was reported that the patient's fever, body aches, and chills have gotten better. The outcome of redness, and swelling that localized at the injection site was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: Er8734), in left arm, on 23Apr2021 as dose 2, single (Lot number: Er8735), in left arm and on 28Oct2021 as dose 3 (booster), single (Lot number: 3lo308d) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (Jun2022) 102, notes: 102 fever began on Day 11 of covid onset or 4 days after last paxlovid dose. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Blurred vision, BP 158/64 (pulse 73), O2 sat 97%.
NAUSEA, HEAVINESS IN TONGUE. GIVEN MECLIZINE FELT BETTER AFTER.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Macrobid (The patient was taking Macrobid as a prevention and developed Cough/ Raspy voice.). Past adverse reactions to the above products included Cough with Macrobid. On 30-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. No concomitant medicine was reported. No treatment medicine was reported. This case was linked to MOD-2022-679102 (Patient Link).
Headache, Myalgia, Arthralgia, Fever, inus issues, & back pain Narrative:  Other Relevant History:
Severe  Raynauds episodes in both hands began within a week or two after the second vaccine dose.. After the second dose of the vaccine I started having severe episodes of Raynaud?s after minor cold exposure such as when cutting a pepper after taking it out of the fridge or going grocery shopping.  Many fingertips go completely numb. In September 2021 I also developed a tendon friction rub requiring a cortisone injection and I still have pain and constant discomfort in my right hand and wrist. The Raynauds has gotten so severe with even minor cool exposure (such as going to the park with my kids in 60 degree weather). It completely changed how I live my life and I avoid so many activities for fear that I will lose circulation on my hands and occasionally feet.
Patient had an allergic reaction  unknown cause . Onsite EMS was called vitals were taken BP 158/86  100% O2 room air HR 56. Patient refused evaluation/care. Left aginst medical advice.
This spontaneous report received from a patient concerned a white and not Hispanic or Latino female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid condition, and Graves' disease. The patient has no known allergies. The patient received the flu shot before and never had a reaction before after receiving those several times. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced faint, upset stomach, felt like passing, flu like feeling, chest pain/heart, bad reaction, fever, vomiting and missed work, and was hospitalized on 10-APR-2021. The patient was hospitalized for two days. On an unspecified date, the patient missed work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from faint, upset stomach, felt like passing, flu like feeling, chest pain/heart, bad reaction, fever and vomiting and the outcome of missed work was not reported. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0: 20220150535-: Covid-19 Vaccine Ad26.Cov2.S -Faint, upset stomach, felt like passing, flu like feeling, chest pain/heart, bad reaction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0: 20220150535- COVID-19 VACCINE AD26.COV2.S- fever and vomiting. This event(s) is labeled per RSI and is therefore considered potentially related.
Pt indicated that prior to Engerix-B pt became Hepatitis surface antibody neg; p/1 dose of Engerix-B became Hepatitis surface antigen pos;
This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced a lingering side effect. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered.
Information has been received from a physician concerning a 26 year old female who on 08-OCT-2007 was vaccinated with her first dose of Gardasil (lot # 653736/0689F). Concomitant therapy included Yasmin. The patient received her second dose of Gardasil (lot # 653736/0689F) on 08-DEC-2006 and her third dose (lot # 653736/0014U) on 03-APR-2007. The patient experienced insomnia after each dose was given. No lab diagnostics were performed. Subsequently she recovered. No further information is available.
Shortness of breath; swelling in the body; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autismo" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSPNOEA (life threatening) with onset 22Nov2021 12:00, outcome "recovered with sequelae", described as "Shortness of breath"; SWELLING (life threatening) with onset 22Nov2021 12:00, outcome "recovered with sequelae", described as "swelling in the body"; DIZZINESS (life threatening) with onset 22Nov2021 12:00, outcome "recovered with sequelae", described as "dizziness". The events "shortness of breath", "swelling in the body" and "dizziness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dyspnoea, swelling, dizziness.  Clinical information: Patient did not receive other vaccine in four weeks. Ae resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). Patient received treatment with Oxygen, benadryl, provid, prednisone. Patient had no covid prior vaccination and was not covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Right Femoral DVT; Superficial Great Saphenous Vein Symptoms; This is a spontaneous report from a contactable physician. A 71-year-old male patient received bnt162b2 (Pfizer COVID 19 vaccine), dose 2 intramuscular on 10Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received sulfasalazine and experienced allergies. Received 1st dose of bnt162b2 (Pfizer COVID 19 vaccine) intramuscular on 12Feb2021 for COVID-19 immunisation. There were no concomitant medications. The patient experienced right femoral DVT (deep vein thrombosis) and superficial great saphenous vein symptoms on 14Mar2021, 4 days after #2 vaccination, with outcome of not recovered. Therapeutic measure taken as a result of events: Xarelto. Events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed of COVID prior vaccination and has not been tested for COVID post vaccination.  Information on the lot/ batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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.
Patient was seen for travel consultation and immunization. Patient was given TYPHIM on the upper left arm. Then was given ADACEL on the lower left arm, separated by 1 inch from TYPHIM injection site. Patient fainted after ADACEL shot. Patient kept going in and out of consciousness for about a minute. Patient regained consciousness within a minute but was sweating. 911 call was made for patient, but patient refused service. Patient was given sugary drink and asked to stay put for further monitoring. Patient stated being dizzy at which point asked to contact family member/friend to pick her up. Patient returned to original state and was able to leave site without further action. Patient returned to site for TWINRIX and was asked to lay down for an injection. Patient did not have a reaction to TWINRIX.
I woke up with vertigo, dizziness, and nausea. My neurologist told me to take MOTRIN. I tried to move my face and eyes, which seemed to help with the spinning and nausea. My condition has improved but my balance is still off but the dizziness and spinning are improved.
Case number PHEH2011US01199 is an initial spontaneous report received from a physician on 10 Aug 2011. This report refers to a 12 years old female patient. She was vaccinated with MENVEO (batch number: M10053) intramuscularly at a dose of 0.5 ml on 01 Aug 2011. On 03 Aug 2011 she developed a red rash on her neck and ears. Outcome of the event was unknown.