chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 33 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Eosinophilic esophagitis" (unspecified if ongoing); "allergies: Wheat and dairy" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28May2022, outcome "not recovered" and all described as "Treatment of COVID-19/Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, Covid-19. Clinical Course: Tested positive for COVID-19 after taking Paxlovid and recovering. Tested positive on 29May, 10 days after completing Paxlovid. Patient received Multivitamin- other medication in 2 weeks after vaccination. Anti-viral details: product-COVID 19 Treatment from 14May2022 to 19May2022. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FH8027 was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8027, fill lot FH4340, and the bulk formulated drug product FH4348. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are needed. No further information is expected.
Left ear pain for 3 days (12/13, 12/14, 12/15 of 2021). It went away by itself.
Resident received RSV and COVID 2023-2024 vaccine on 10/25/2023. Began baclofen 10mg three times daily at that time as well. Resident could not assist with transfers on 10/27/2023 and complained of nausea and weakness, appeared lethargic. Seemed to improve after 2 or 3 days. PT/INR checked on 11/6/2023 and showed >8. Resident's normal is between 1.5 and 2 and had been in this range for several months. PT/INR checked again on 11/7/2023 and was > 10 after holding coumadin. Resident became lethargic on 11/5/2023 and lost appetite. Continued w/difficulty transferring. On 11/7/2023, became pale and clammy with hot skin, afebrile. Sent to ER and admitted to hospital.
pt recv vax & lab eval revealed IgG ELISA of 0.48 which indicated that pt failed to seroconvert;
Rt leg erythema & tenderness-4" x 6" won't walk; t103 w/APAP;
In addition to the sore arm, tiredness, muscle pain, headache, shivering, stomach pain & nausea, I developed a rash on my chest, neck,abdomen, thighs, and inside of my arms.  The rash did not itch, but it was warm to the touch. [I did not have a fever]. It started in the afternoon of 8/23/20 and was pretty much gone by Tues, 8/25/20, late morning.
since received the Moderna vaccine,asthma has improved; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (since received the Moderna vaccine,asthma has improved) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (since received the Moderna vaccine,asthma has improved) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (since received the Moderna vaccine,asthma has improved) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported. No treatment information was provided by the reporter.
Dizziness/nausea; Hx of low BP. BP 92/62; HR 71, RR 18 T 97.2 -- > later BP 108/76. When patient was in line to schedule second dose, pt was observed bending down to fall on her knees. Pt reported feeling dizzy and nauseous. Pt was taken to observation area for assessment.
Patient called -said her arm (PNEUMOVAX arm) was very sore, could not lift her arm and had a red rash. She took BENADRYL 50mg for 3-4 days and problem resolved - When I talked to her on 10/20 she was doing much better.
Rash is warm to touch; Raised red rash around injection site; Swollen armpit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen armpit), VACCINATION SITE WARMTH (Rash is warm to touch) and RASH ERYTHEMATOUS (Raised red rash around injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen armpit). On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Rash is warm to touch) and RASH ERYTHEMATOUS (Raised red rash around injection site). At the time of the report, PERIPHERAL SWELLING (Swollen armpit), VACCINATION SITE WARMTH (Rash is warm to touch) and RASH ERYTHEMATOUS (Raised red rash around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe increase in tinnitus, asymmetric hearing loss, diagnosed with Meniere's disease.
First dose / 2 years ago / has not yet received the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago, on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The pharmacist reported this case on behalf of the physician (MD). The age at vaccination was not applicable. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist did not have any patient demographics to provide, as the physician (MD) did not provide patient's demographics. The reporter did not consent to follow-up.
Shortly after getting second dose of Covid-19 Vaccine, I started experiencing some dizziness, then started  experiencing ringing in the ears. This has worsened and developed into dizziness and Tinnitus.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies Penicillin" (unspecified if ongoing), notes: Verbatim:known allergies Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Start date of treatment for COVID-19 was 20Jun2022. Stop date of treatment for COVID-19 was 25Jun2022. The patient previously received a COVID-19 Vaccine. The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment.
panic attack; dizziness / dizzy; I could not drive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PANIC ATTACK (hospitalization) with onset 02Apr2021, outcome "recovered with sequelae", described as "panic attack"; DIZZINESS (hospitalization) with onset 02Apr2021, outcome "recovered with sequelae", described as "dizziness / dizzy"; IMPAIRED DRIVING ABILITY (hospitalization) with onset 02Apr2021, outcome "recovered with sequelae", described as "I could not drive". The patient was hospitalized for panic attack, dizziness, impaired driving ability (hospitalization duration: 1 day(s)). The events "panic attack", "dizziness / dizzy" and "i could not drive" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Nasal Swab. Therapeutic measures were taken as a result of panic attack, dizziness, impaired driving ability. Clinical course: The patient had no other vaccine in four weeks, no other medication in two weeks. Day after the patient received vaccine, he experienced his first panic attack of my life. He then started to experience horrible dizziness. He went on to have several more what he now know they're panic attacks. He was hospitalized and so dizzy that he could not drive. The patient went to the doctor countless times, tried countless medication and finally decided it was an adverse effect of the vaccine. This had been going on for almost a year. The panic attacks had stopped and dizziness had slowed, but still experience it daily. It had ruined the last year of his life. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient had no covid prior vaccination. The patient had covid tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient received his first covid vaccine 4/7/2021 which was pfizer. He returned to receive his second vaccine on 4/28/2021 and was given the wrong vaccine. He was given Moderna
Approx. 5 min after injection, patient reports tingling, numbness to right hand with pain in right arm when attempting to straighten elbow. V/s 11/64. SS 20; Hand grasp weaker on right than on left. nail bed pink, blanching b/c skin warm; improving with ice applied to injection site no redness, no swelling hand grasp improving within minutes of applying cold packs; able to move arm and straighten elbow.
Pt exp t102 ax, diarrhea continuing to 28JUN, no problems w/previous immun, taking APAP;
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine that underwent a temperature excursion in the Freezer), POOR QUALITY PRODUCT ADMINISTERED (patients received vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     Concomitant medications were not reported.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. No adverse event reported. Treatment medications were not reported.
Narrative:  pt died 9/28; prior to receiving the 2nd dose of COVID vaccine; became COVID positive shortly after receiving his first dose.
Patient states she noticed a rash about 2 hours after first dose of Pfizer was administered.
Weird feeling in head tightness in chest radiating to my her back severe pain going up legs, arms and a feeling like lightning had struck entire body unable to stand
pt recvd vax & devel breathing difficulties including hyperventilation, h/a & neck pain; In ER pt exhibited tetany in both hands & rigor tx'd w/Epi & DPH; hospitalized w/t39.5C; dx viremia;
bilious emesis, bowel obstruction/strictures, abd distension beginning evening p/1st dose of  rotashield;surgery 12/24/98-colostomy;2nd dose given 3/8/99;4/27/99 noted flecks of blood in stool;6/4/99 scope ulceration & polyps
Breakthrough case admission after 4 vaccines Pfizer 2/22/21 Lot# EN6200;  Pfizer 3/16/21 Lot# EN6207;  Pfizer 10/25/21 Lot# FE3590;  Pfizer 4/6/22 Lot# FJ9943
Myalgia, Fever, Chills Narrative: Fever,chills and fatigue, and Headache
GARDASIL 9 was used in a 46 years old male patient; misuse adverse event / she had a prescription for the patient; No additional AEs; This spontaneous report was received from a doctor of pharmacy and refers to a 46-years-old male patient. There was no information regarding his medical history, current conditions nor concomitant therapies provided.  On an unspecified date, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration, anatomical location, lot # and expiration date were not provided). The second dose was administered at 1 month and the third dose was administered at 6 months from the first vaccination (details not provided). The pharmacist was not sure what the indication was as the vaccination schedule was not the normal 0, 2 and 6 month series. The reporter stated a colleague informed her she had a prescription for the patient (event was also reported as misuse) (product prescribing issue). No adverse events (AEs) were reported.
Body aches specifically in legs; Cough; Exhausted; Body aches specifically in legs; Headache; Feel like cannot get out of bed.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 11:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 18Apr2021 at 11:00, the patient experienced exhausted, cough, body aches specifically in her legs, headache, and felt like she could not get out of bed. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of reported event which included treatment with OTC pain relievers. The clinical outcomes of event exhausted, cough, body aches specifically in legs, headache, and felt like could not get out of bed were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient has a crater like area in his arm where the shot was given.  MRI is negative.  Concerned about muscle atrophy, no real weakness noted
Pain / at injection site; Redness / at injection site; Swelling at injection site; Shivers; Nausea; Itching; Not administered in his deltoid / below the deltoid instead; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose in September 2020, refer case US2020AMR233628).   On 21st November 2020, the patient received the 2nd dose of Shingrix .5 ml. On 21st November 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 22nd November 2020, the patient experienced injection site pain, injection site erythema, injection site swelling, shivering, nausea and pruritus. Rechallenge with Shingrix was positive. On 23rd November 2020, the outcome of the shivering and nausea were recovered/resolved. On 24th November 2020, the outcome of the injection site pain and pruritus were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling and vaccine administered at inappropriate site were unknown.   The reporter considered the injection site pain, injection site erythema, injection site swelling, shivering, nausea and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and next day experienced pain, redness and swelling at the injection site and reported shivers and nausea which resolved. The patient experiencing itching for 2 days and the vaccine was not administered in his deltoid and was administered below the deltoid instead, which led to vaccine administered at inappropriate site. The reporter followed up with CDC guidelines and did not consent to follow up. The reporter declined to provide HCP information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR233628:Same reporter. 1st dose
19JAN93 pt recvd vax following day fever, malaise, coryza, lasted 2 days; 8MAR93 #2 dose Engerix-B w/in hrs, shoulder & back pain; on 2nd day onset of arthralgia in wrist & ankles & malaise; treated w/NSAIDS, resolved over 2 wks;
The employee/patient was receiving a flu vaccine for the first time. Afterwards, the nurse had the employee wait in a chair for 15 minutes to monitor for any S/S of allergy since this was her first time receiving the vaccine. Approximately 8 minutes after the vaccine, the employee stated her throat felt funny. About 30 seconds later she states her throat felt like it had a lump that was getting larger and felt like her airway was being constricted suddenly. No hives, itching, or tongue swelling noted. EpiPen was administered and employee was transported to the hospital per protocol after Epi administration.
Significant arm pain that has persisted since immunization, weakness and pain. Patient has tried oral corticosteroids, considering cortisone injection.
09/16/2023 left arm pain and itching from injection site to fingers, still with mild pain and itching at injection site only today 09/21/2023; 09/17/2023 severe fibromyalgia flare, lasted through 09/20/2023. I had not had a severe flare in well over a year.
Mother was not able to hold child due to back pain. Patient sat down in a chair by herself, holding the side of opening of the chair and holding mom's hand. Mother, stated patient would be able to sit by herself, patient agreed. Patient received Kinrix im and MMR sub was administered on left arm. Patient was repositioning to left side for administartion of varicella when she suddenly got of her chair start running and saying she needed to go to rest room. She was running to look for rest room. Mother guided her to the rest room in lobby. Mother was waiting when she noticed she was becoming loose and mother carried her in her arms. She entered immunization room and stated patient fainted. She was pale but warm to touch, semi responsive, head brought to her knees. Instantly she said she was ok. Varicella deferred until one month. Mother believes syncope might be stress related. This is the second time she fainted. First time fainted episode, 7/8/19  was after the ambulance had to take her grandfather to emergency room. Patient had medical evaluation 0n 7/8/19 at emergency room and a week later with private physician and all exams were negative. Mother was informed that she may have been got scared. 8/6/19 brother and patient didnot have any breakfast.  10.45 patient dismissed, alert, talkative and good color. Follow up with mother 8/7/19 mother in store. grandmother stated patient is doing fine. 7/7 and 7/9 telephone call to mother, child is doing fine.
Parent believes the child has chicken pox. Got vaccine, has red spots, no blisters or open. Slight temp.
Immediately tasted a metallic taste in my mouth. Within 12 hours experienced body pains (not aches...true pain) just like I had with Covid at Christmas.  We are now almost a week later and the body pains have only gotten worse.  Tylenol and Motrin have not helped.  I don?t have a primary care doctor or insurance so I can?t follow up with a doctor, but I feel terrible.
Fainted after injection. Hit Lt side of head on table. No c/o headache. Hydrated and observed x 20". 1040 AM T 99.5 / T. 99.8 1052 AM T 99.6 @ 1105.
Chest pain; Headache; This is a spontaneous report from a contactable consumer (patient mother). A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0180) via an unspecified route of administration on 28Jun2021 (at the age of 16-year-old) as single dose for covid-19 immunization. Medical history included seasonal allergy (with runny nose, he took seasonal allergic medicine Benadryl 25mg on Sunday morning, one day before of vaccination). Concomitant medications included diphenhydramine hydrochloride (BENADRYL) taken for seasonal allergy from an unknown date. On 29Jun2021, the patient experienced chest pain and headache. It was reported that on Monday, he was okay but on Tuesday, he says he started having a headache. The treatment for the events was not reported. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Vaccination at 0639 0650  erythematous rash across neck & upper chest - observation extended to 30 min denied: SOB, lightheadedness throat tightness or scratchiness 0655  25mg Benadryl liquid given  VS BP 130/90 HR 100, O2 Sat 100%  0705 VS BP 130/92 HR 88 O2 Sat 100% 710 returned to work feeling well
At about 1PM started to feel rundown. A few hours later had a fever of 100.4. Also developed a mild headache. Had mild nausea. Slept for the rest of the day and into the night. Only took a Tylenol for the fever and headache. The next day (Tuesday April 27, 2021) had no fever but felt very run down. Still somewhat nauseaous and was afraid to eat.. Still had a mild headache. Wednesday started to feel a lot better. Thursday still somewhat rundown but ate for the first time. Just toast. By Friday feeling almost normal again.
Information has been received from a consumer regarding a female who was vaccinated with a dose of Recombivax HB (manufacturer unknown). Subsequently the patient developed hepatitis B. It was unknown whether medical attention was sought. The outcome was unknown at the time of this report. There was no product quality complaint. Additional information is not expected.