chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is spontaneous report from a contactable consumer (patient). A 64 years old patient of unspecified gender received PREVNAR 13, via an unspecified route of administration in the arm on 05Oct2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. On 06Oct2018 in the morning the patient experienced feeling hot with pain on arm and from night the patient had fever, throw up and pain all over body was like a truck run he/she over, the pain is the arm was like have an operation, the patient was not able to move it. The outcome of fever was recovering, for the other events was unknown.
Spoke with shots line. No adverse reactions noted per shots line representative (nurse). 0.5 of TB was given instead of 0.5 of Td (child).
Meniere's disease; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient aged 61 years received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Viagra, start date: 2015, reaction(s): "problem with Viagra", notes: in 2015 he had a problem with Viagra. The following information was reported: MENIERE'S DISEASE (medically significant) with onset Mar2021, outcome "unknown", described as "Meniere's disease". The patient underwent the following laboratory tests and procedures: audiogram: (2021) significant hearing loss in the right ear, notes: diagnosed with Meniere's disease.  Clinical course: Caller states in Mar2021, the patient started experiencing a loss of hearing in the right ear. Caller states the patient saw a otolaryngologist where an audiogram saw significant hearing loss in the right ear which has persisted and the patient was diagnosed with Meniere's disease, a disease in the inner ear.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal relation, the association between the event of Meniere's disease and the suspect product of BNT162B2 cannot be completely ruled out. 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.
Rash- burning tingling under skin, neck, rt. forearm, under arm.  Rest of body tingling.
Headache, chest tightness, c/o slight pruritus left shoulder & neck discomfort. Nausea, 4 hours - vomited/diarrhea. Headache 90 min after vaccine. Given BENADRYL, FIORICET, PEPCID, Prednisone.
pt recv vax 2JUN97 & 9JUN97 pt felt rundown & devel a rash on neck that was vesicular & sl itchy & stingy;
He/she felt he/she was going to die; heart Palpitation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Manufacturer unknown), for COVID-19 immunization; Bnt162b2 (Dose 2, Manufacturer unknown), for Covid-19 immunization. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "He/she felt he/she was going to die"; PALPITATIONS (non-serious), outcome "unknown", described as "heart Palpitation". The patient was having heart Palpitation. He/she felt he/she was going to die. He/she called 911 already. They did not have any ambulance. He/she was really dying.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
FROM DAY OF INJECTION UNTIL NOW LEFT SHOULDER DOWN TO FINGERS CONTINUES TO FEEL SORE. ARM FEELS LIKE I SLEPT ON IT AND PERSISTS, TIGHTNESS AND A LITTLE NUMBING AT TIMES.
No additional AEs; MMR and VARIVAX vaccines were administered via IM route vs SC route on/11/22/2022.; This spontaneous report was received from a pharmacist and refers to a 25-year-old male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 22-NOV-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered intramuscularly instead of subcutaneously (Incorrect route of product administration), 0.5 milliliter, once, both administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided). No additional adverse events (no adverse event) were reported.
At time of event I am an otherwise healthy 31 year old female, 32 weeks pregnant with an estimated delivery date of 03/26/2021. Side effects following the second dose started around 0100/0200 hours on 02/02/2021.  I was cared for by my husband at home.  I took Tylenol  and used ice packs to reduce my fever which reached a high of 101.4 degrees. body aches,  chills, shaking and nausea persisted till roughly 0800.  right arm soreness and general fatigue  continued till mid day on 02/04/2021.
Pt recvd 1st dose of Engerix-B 31OCT91 & 31OCT91 pt exp hives over entire body; pt discontinued & pt was treated w/DPH;
This spontaneous report as received from other health professional (Medical Assistant) refers to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates since January 2016 (Onset approximated to 2016), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K021444 with an expiry date 17-SEP-2016, lot # L029631 with an expiry date 14-AUG-2017) (doses and frequencies unspecified) intramuscularly. No adverse effects were reported. It was reported that vaccines were not discontinued. This is one of the several reports received from the same reporter.  Additional information has been requested.
Patient recieved Johnson & Johnson on 6/8/2021. Developed muscle aches with facial swelling on 6/11/2021. Came to urgent care on 6/28/2021. Evaluated by doctor . Sent home in stable condition.
Rash on palms of hands 01-2004, rash on face 04-2004-rash on face left scars like scar from smallpox vaccine received 03-04-03. Rash on hands biopsy report-granuloma annulare.
12/14/11 Pt called office. Received flu shot on 12/11/11. Pt woke up on 12/14/11 with full body rash. Pt denied SOB. Denies fever. BENADRYL prn. Pt declined to schedule appt.
Had COVID March 17, 2020 and was put on medication, Brovana, Budesonide, Wixela, for lungs. After shot arm is very sore, body aches, 99.9 temp. When he work up next day,  pulse was 130.  Stayed in bed that day until lunch. Then head started getting hot. Pulse was 130 still.  At 5:00pm pulse was 146 laying down. Went to hospital because of dizziness, ER. Fever 103.  Will see a cardiologist next.
3 days after the vaccine I had 3-4 days of breast pain that made it difficult to even sleep.  That subsided, then I had persistent itching at the injection site.  That subsided but now have large, hard red patch the size of a tangerine at the injection sight that is slightly itchy and tender.  Have been experiencing slight nausea on and off, mostly in the mornings. Six days after injection I was feeling light-headed, dizzy and like I was just going to faint or fade away.  Still have those symptoms on and off, but they are not as strong.
A single bloody/mucousy stool 2 days after Rotateq #1.  Otherwise healthy breast fed infant.  No symptoms of GI illness.  No fever, diarrhea, vomiting, abd pain/fussiness.
fatigue; little swollen in appearance; little swollen in appearance; Arm Soreness that is tolerable; A spontaneous report was received from a consumer concerning a 80-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm soreness that is tolerable, arm soreness became worse day by day, a little swollen in appearance, fatigue.  The patient's medical history was not provided. Concomitant medications reported were Losartan for hypertension, Amlodipine for hypertension, Atorvastatin for cholesterol for drug use for unknown indication.  On 27 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the event(s) arm soreness that is tolerable. On 12 Feb 2021, the patient experienced the event(s) arm soreness became worse day by day, a little swollen in appearance. On an unknown date, the patient experienced the event(s) fatigue.  Treatment details included Took Tylenol and Advil, Cool pad.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm soreness that is tolerable, arm soreness became worse day by day, a little swollen in appearance, fatigue was unknown.
I had a stroke on April 15th. The day after the vaccine, I had a bad headache and chills.
This spontaneous report was received from a pharmacist refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On 01-DEC-2016, the patient was vaccinated with improperly stored ZOSTAVAX (dose: 0.65 ml, once, lot # M033910, expiry date: 17-OCT-2017) via subcutaneous route, for prophylaxis. Pharmacist reported that at the time of the vaccine administration, she was unaware of the excursion until 1 hour later. She mentioned that the vaccine was exposed at less than 0C but not more than 0C, for 4 hours. There were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Patient developed rash 2-3 days after receiving vaccines. Rash was initially 2-3 raised, red spots which appeared on the legs but had spread to chest, extremities and neck by 6/8/01. Father reported on 6/12/01 that rash was beginning to look like blisters and some were rupturing and scabbing over. On examination of 6/13/01, patient was diagnosed with rule out varicella and impetigo. The left lower leg, chest and arms showed red papules. The patient received varicella vaccine on 2/15/01 and had no known exposure to chicken pox.
Approximately 1 week after vaccine injection, I have developed redness, swelling, calor, itchiness, tenderness, and slight soreness with movement just below original injection site.
This spontaneous report as received from a healthcare worker refers to an approximately 59 years old patient (gender unknown). On an unknown date in 2014, the patient was vaccinated with an expired ZOSTAVAX, vial, lot # J000432, expiry date 10-APR-2014, dose (unknown), and route of administration (unknown), for unknown indication. No concomitant medications were reported. No adverse effects have been observed or reported. No product quality complaint was involved. The outcome of events was unknown. No additional information was provided. Additional information has been requested.
Possible cellulitis; slight redness in left upper within 24 hours; severe redness and swelling and warmth of entire upper left arm and half of lower arm; severe redness and swelling and warmth of entire upper left arm and half of lower arm; Some pain; This is a spontaneous report from a contactable Physician.   A 94-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140) on 30Dec2020  at 12.00 pm at single dose Intramuscular on left arm for COVID-19 immunization. Relevant medical history included COVID 19 infection, on 19Jul2020, post COVID left femoral DVT oral anticoagulation, Alzheimer dementia, Osteoarthritis, Spinal Stenosis, Gait Dysfunction and Constipation. Known allergies included acetazolamide, penicillin and sulfa. Concomitant medications included apixban (ELIQUIS ) 5 mg twice a day, colecalciferol (VIT D3) 1000u once a day. On 31Dec2020 at 12:00 pm patient experienced slight redness in left upper within 24 hours. The patient also experienced possible cellulitis, severe redness and swelling and warmth of entire upper left arm and half of lower arm. Some pain. No fever. It was also informed that patient underwent nasal Swab test for Coronavirus (Abbott BinaxNOW) on 05Jan2021 and on 07Jan2021 and resulted negative, for both. Treatment received for cellulitis included Cefuroxime. Outcome for the event possible cellulitis was unknown. Outcome of other reported events was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to temporal association. However patient old age and other underlying conditions cannot be excluded for a contributory role  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 described developing ongoing soreness in her left arm that lasted approx 6 months that went down to her hand. Subsequently developed a shakiness /tremble in the left hand that developed appro Feb 2018.
Initial medication error report received on 10-OCT-2013 from a nurse. A 12 year old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE (lot number, route and site of vaccination was not reported) on an unspecified date. Nurse stated reported that FLUZONE was administered to 12 years old patient. List of documents held by sender: none.
Patient experienced generalized hives and swollen lips and mouth. Patient went to the doctor's office on 04/10/12 and was treated with prednisone and an intramuscular injection of DEPO-MEDROL. The symptoms lasted for a couple of days after treatment. Patient recovered.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Nov2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 28Mar2022 as dose 3, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Positive, notes: Tested positive; (08Jul2022) Negative, notes: tested negative home test; (11Jul2022) Positive, notes: tested positive on home test.  Additional information: adverse event: Tested positive 01Jul2022 completed 5 days Paxlovid on 8Jul2022 tested negative home test. No longer with symptoms. On 11Jul2022 symptoms returned and tested positive on home test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
injection site soreness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 24KZ7, expiry date 15th May 2022) for prophylaxis.   Concurrent medical conditions included fractured hip (on crutches).   On 5th January 2020, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated the patient had a lot of things going on with broken hip and on crutches. The patient received Shingrix in right deltoid. The patient was still experiencing injection site soreness.
Pt received her Pfizer vaccine and in less than 15 minutes she developed red and itching hives on her arms. 1ml of Injectable Dyphenhydramine was given and she was monitored for 15 more minutes. She was re-evaluated by a fellow RN on the team and the hives on her arms disappeared and she stated she felt much better.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients received unspecified doses of improperly stored VARIVAX (lot# L039092, expiry date 06-NOV-2017; lot# K009756, expiry date 09-JUL-2016; dose, route and dose number in immunization series were unspecified). Excursion details: Temperature/Time frame: 12F/3 hours. There was a previous temperature excursion: 22F/60 minutes. This report was not because of a "data logger". No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
5 x 8 cm erythema, slightly warm area to upper left arm after immunization injection to deltoid area. Prescribed Duricef 250/5 4cc BID for 10 days.
patient  was inadvertently given 2 shots today by 2 different groups during the same clinic visit. One of our interns was covering rooms and was checking for the consent form and there wasn?t one so the nurse told her to go ahead in the room and administer the vaccine that she knew it was good and would grab the form. Moments later another one of our team members was handed the paperwork/consent form by someone else and went in the patient?s room and administered the shot for the 2nd time to the patient. The patient had rolled over on her side, so the 2nd team member did not see the bandaid from the previous injection and administered another shot. I am completing the VAERS form right now. We also will coach our team members about importance of having form in hand before administration.
Noticed to be red. Not as active, stiff neck. 4 x 6 cm red area, slightly warm below bruise with shot. Treated with ibuprofen, Benadryl, cool compresses. Allergic reaction to vaccine.
My husband received the shot on the 22nd. He died in his sleep on the 24th. He was complaining how the second shot really was giving him a lot of trouble, but nothing that would indicate life-threatening symptoms
6-7cm redness and edema over left deltoid. 2-3cm erythematous macules on left tricep.
At the time I was a member of a Health plan. I left the health plan in 2001 and had Lyme desease vacinine administered by the Health Plan in the two prior years (3 shots a month apart in first year a booster in the following year). By May of 2002 a series of misc aches and pains would come and go and I would get sudden extreme attacks of tiredness, and a deteriation in my balance. It took months to convince my new Doctor to test me for Lyme desease (positive) and he only reluctantly agreed to treat me after I requested a second opinion. I have been taking DOXYCYCLINE for 3 weeks. The pills resulted in a sudden lessening of the symptoms which has been followed by a slower improvement. At present pains are mostly restricted to joints (hands, knees and hips). I still get tired to a unusual amount compared to my pre innoculation life. Dr says she is unaware of the proper treatment program for people who have had the vacine and now test positive for Lyme desease and exhibit the sypmtoms of Lyme desease. Currently she has said to take the DOXYCYCLINE pills twice a day for a period of 60 days. Up to this catastrophy I have been extremely healthy all my life.  I am worried that the treatment may be stopped to soon and that I now may have permanent damage to my system. The 60 day follow up states extreme tiredness and random pains have disappeared. All joint ache which they did not do before. In particularly fingers, hips and elbow. Took two motnhs of Doxycycline starting 9/6/02 (100mg tablets twice a day).
Pt. states that after receiving the 3rd Booster of Moderna 10/26/2021, started experiencing symptoms 10/27/2021 of chills and fatigue lasting 24hrs. No noted Primary visit/communications. Symptoms have subsided.
Blood pressure high; Hot Face; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure high) and HOT FLUSH (Hot Face) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 immunisation.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPERTENSION (Blood pressure high) and HOT FLUSH (Hot Face). At the time of the report, HYPERTENSION (Blood pressure high) and HOT FLUSH (Hot Face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L006390, expiry date 25-AUG-2016, albumin status HSA and lot # L040414, expiry date 13-APR-2017, albumin status rHA; dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion (14.7F for 2 hours and 15 minutes). There were no previous temperature excursions. This is one of several reports from the same reporter. Additional information has been requested.
Started to run fever around 6:00 p.m. with chills.  Tempt.  ranged from 100.3 to 102 during the night and into today.  Nausea, fever, chills, body aches all over all day today plus no energy to get out of the bed.
Left eye swelling, redness and discomfort followed by shortness of breath 10 minutes after injection. Pt was treated with an epinephrine injection and Benadryl.