chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no additional adverse events reported; may have been involved in shipping temperatures outside the prescriving information; This spontaneous report was received from a 66-year-old female patient referring to herself. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 25-AUG-2020, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S036495, expiration date was not reported but upon internal review was established as 13-SEP-2021, dose of 0.5 milliliter (formulation, route of administration and anatomical location were not reported) for prophylaxis. It was reported that this vaccine may have been involved in shipping temperatures outside the prescribing information. The patient's clinic called and told her that they do not know what the temperature was or how long it had been at that temperature. She was advised to contact her physician for any direction on healthcare needs. No additional adverse events reported. A data logger was not used to capture the temperature excursion. The reporter had no knowledge of a previous temperature excursion. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Fatigue, body aches, soreness in right arm, soreness in armpit, headache,
Patient was fully Vaccinated with Moderna (6/14/21 & 7/12/21) and was admitted to the hospital with COVID. Patient tested positive 9/2/21 with high flow nasal cannula and SOB. Was finally admitted 9/12/21 and is currently still admitted
CHILLS; FEVER; This spontaneous report received from a consumer concerned a 32 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, Laboratory data included: Temperature elevation (NR: not provided) 99.1. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and chills. This report was non-serious.
Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 09-May-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.  The patient had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1.
Fell asleep shortly after vaccine, difficult to awaken, ashy/pale color, eyes rolled back in sleep, finally awakened 8 hrs. after shots.
About 10 minutes after vaccination, patient began to experience heightened anxiety with no other symptoms.  Evaluated by a paramedic on staff and symptom quickly resolved.
This form keeps changing my date of birth by 1 day.  The day after my Covid shot I had body aches, fever and nausea.  After 24 hours of this I had extreme tiredness for several days and then these symptoms came back with the addition of vomiting and diarrhea.  After this stopped I fealt extremely tired for several days.  Just shy of 2 weeks feeling like crap.  If I could have a do over I never would have taken this shot.
This spontaneous report as received from a health care worker refers to unspecified number of patients with unspecified demographics. On an unknown date, unspecified patients received improperly stored RECOMBIVAX HB injection strength 2.5/0.5 (dose and frequency unspecified) that were exposed to 26.2 F for 5.5 hours. Concomitant therapy was unspecified. No adverse effects were reported. No product quality complaint was involved. The outcome of patients received improperly stored RECOMBIVAX HB injection that were exposed to 26.2 F for 5.5 hours was unknown. No further information was provided. This case is linked with MARRS # 1405USA003793 and MARRS # 1405USA003794 as same reporter cases. Additional information has been requested.
I?m am a 55 year old male, no medications, no allergies, basic aches and pains for said age.  I received the Moderna booster shot on 26 November.  On or around 17 December I was putting Christmas lights up outside.. My arm brushed across a holly bush.  When finished and inside my home the palms of my hand as well as areas on the tops of my hands near fingers began itching?.no rash?.just itchy skin.  Thought maybe a reaction to contacting the holly bush.  No changes in laundry soap or eating habits? since that time, intense itches began to occur all over my body BUT skin looked normal.  Itching occurred on front waistline, thighs, scrotum, feet, etc?I also began to notice something that has never happened?after itching, whether lightly or moderate, streaks began to appear.  The streaks would raise and become itchy and bumps would appear all over the scratched area. After 20 minutes they would subside.  On 22 December my scalp became incredibly itchy.  So much so I would wake up early morning (2,3,4 am) and find myself scratching my scalp.  I would notice that my entire scalp had little bumps after (and during) scratching.  Earlier in this experience around 20 December, I also noticed if my pants contacted my skin - say in a pressurized way if sitting on angles- hive like bumps would appear and would be slightly itchy.  I would scratch and of course red streaks would appear and subside in 20 minutes or so.  I believe the reactions after scratching to be localized antihistamine related so I now take Benadryl if I feel bouts coming on?which is gaurenteed. E theme itching with no appearance of rash or bumps on otherwise normal looking skin until after scratching or pressure on skin.
rash/red spots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Lot number: GG7401, Expiration Date: Jun2025) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBRANCE taken for breast cancer, start date: 10Sep2023 (ongoing); LETROZOLE, start date: 27Aug2023 (ongoing); ELIQUIS, start date: 2019 (ongoing); ATORVASTATIN, start date: 2019 (ongoing); LOSARTAN POTASSIUM, start date: 2021 (ongoing); FUROSEMIDE, start date: 2019 (ongoing); SPIRONOLACTONE, start date: 2019 (ongoing). The following information was reported: RASH MACULAR (non-serious), outcome "recovered", described as "rash/red spots".
Patient presented to ED on 3/12/21. On 3/15/21 he presented to the ED again and was admitted. He also had an ED visit on 3/26/21.
PT describe gradual onset of severe right shoulder pain (injection arm) without evidence of cellulitis or allergic response. Injection given in Right Posterior Aspect of Deltoid.
Injection site swelling; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Fever; Joint pain; Vomiting; Dizziness; Overall fatigue; Ddehydration; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm right on 12Apr2021 at 12:15 hours (at the age of 68-year-old) as a single dose for COVID-19 immunisation. The patient received unspecified medication within two weeks of vaccination. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm right on 24Mar2021 at 12:15 hours (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 14:00 the patient experienced dehydration, injection site swelling, injection site pain, tiredness, headache, muscle pain, chills, fever, joint pain, vomiting, dizziness and overall fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dehydration, injection site swelling, injection site pain, tiredness, headache, muscle pain, chills, fever, joint pain, vomiting, dizziness and overall fatigue was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient states that they experienced redness and a rash on the left arm and know she is not able to move her left arm above her head.
pt started 29MAR99 broke out w/rash on body;ran a fever sat & sunday of 102;father devel chickenpox 22MAR99;child in no distress;obvious lesions of varicella maybe about 30;chickenpox;?vax related;?mild infect;
after the first three doses everything was ok, aside from headache and chills.; after the first three doses everything was ok, aside from headache and chills.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), on 19May2021 as dose 1, single (Lot number: EW0164) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "after the first three doses everything was ok, aside from headache and chills.".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300039544 same product and patient, different dose;US-PFIZER INC-202300039545 same product and patient, different dose;US-PFIZER INC-202300039546 same product and patient, different dose;
it started to give me bad headache; Passed out; My head just Spun; I think I might have messed up my certain position of my neck and I had neck issues; It caused some massive confusion; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiry date not reported, age at the time of vaccination: 63-year-old), via an unspecified route of administration, in Arm Right (shoulder) on 06May2021 13:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number not reported), in Arm right (shoulder) on 15Apr2021(got about noon time, got it about may be earlier at about 10 am) for covid-19 immunization. The patient did have any vaccination since he was a child. On 06May2021, the patient had the shot in noon right above 1 pm and went home laid down and felt kind of like he did the first time only little better. Actually he felt pretty good and came and laid down for 24 hour period, and on 07May2021, he went to do some laundry at 3 pm, just one 'load of sheets' and then came home, and upon coming home in his apartment complex it's kind of, snakes as come in those left and right kind of and let permit from going fast, so, he come home and pulled in and when he pull in he got this nasty feeling like, but he was looking at the rare view and got 4 cars behind him, and they were really tight behind, but he can't move any faster and he was not going to speed up just because, and when he was looking at them, at the rare view and forward, and was doing those 3 things, he probably turned around to see and while doing his head just Spun and got the sick feeling and passed out and his head ended up in the passenger seat and bounced up and he think he might have messed up his certain position of neck and had neck issues, and blow the car and wreck his car and it's in shop right now. And also it caused some massive confusion and he wrecked his car and may have the surgery on neck again because of banging of neck on the seat, it was the bad accident but thank god he didn't hit anybody. That the only good thing about the whole thing, that nobody else got hurt but I got hurt. He also have to go to 2 emergency rooms. When patient was asked about the lot number and other questions, he asked to slow down as his head was hurting as he just can't keep up with the caller and it starting to bother him and started to give bad headache but because his brain was working over time. As a corrective therapy, the patient's doctor has not offered any kind of medication for that occurrence. The outcome of events was unknown.  Information about lot/batch number is requested.
shortness of breath (SOB) with hyperventilation; shortness of breath (SOB) with hyperventilation; Lightheaded; red blotching on face and neck; appeared shaky; This is a spontaneous report from a contactable pharmacist. An adult female patient (pregnant unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 for first dose at single dose (lot number: EL1283) for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded, shortness of breath (SOB) with hyperventilation on 08Jan2021. She was laying on the floor and appeared shaky with red blotching on face and neck on 08Jan2021. Medical response called. Anaphylaxis medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to emergency room (ER). Patient also received Diphenhydramine and Famotidine. The events resulted in emergency room/department or urgent care. It was unknown if covid prior vaccination and if covid tested post vaccination. The outcome of the events was recovered in Jan2021.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162b2 to the 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.
Information has been received from a physician concerning a female (NOS) who was vaccinated on an unknown date intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently the patient fainted. Subsequently, the patient recovered from the syncope. Additional information has been requested.
I woke up at 2AM I could tell that my heart was not feeling right. I took three aspirins and my wife and I drove to the ER of the closest hospital. They found that I was in A-Fib and needed surgery. I was transferred from the local hospital to another one. There I flatlined in the ER waiting to be admitted to my room. Three days after being admitted I had a heart defibrillator and pace maker implanted in my chest. I also contracted COVID-19.
9-30-16 Received FLUZONE HD influenza vaccine. 10-1-16 Redness appeared in an area of 1 inch by 1 1/2 inch that is painful to touch, at the injection site. There is no notable muscle soreness with normal ambulatory.
The flu shot was injected high on the left arm near the shoulder resulting in left shoulder pain and weakness which progressively increased with time. No pain prior to flu shot.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. NO concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly store VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 19-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
with both 1st and 2nd injection pt experienced muscle stiffness, Back pain that limited ROM and throbbing pain at inj site that lasted 2-3 weeks. Initial tx was to treat with KEFLEX x10days and had 10 days doses for injection site infection. The very same sx's occurred with 2nd injection. Pt given KEFLEX x10days, MOTRIN, told to take BENADRYL
This is a spontaneous report from a contactable reporter, who reported on behalf of the physician. A 30-month-old, male patient received a dose of PREVNAR 13 in the morning on 01Jun2011 to prevent pneumonia. There was no relevant medical history and no concomitant medication. Relevant past drug history included PREVNAR. At night on 01Jun2011, the patient started limping. On 02Jun2011, the patient developed redness and swelling on the entire left thigh. Relevant laboratory data were unknown. Therapeutic measures taken in response to the redness and swelling on the entire left thigh were KEFLEX at three times a day and BENADRYL at 6.25 mg as needed. The patient had not recovered from the events at the time of report. Base on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR 13.
having dreams about dead people following the second dose of the Covid-19 vaccine; This is a spontaneous report received from a contactable other healthcare professional (nurse). This nurse reported similar event for two patients. This is the second of two reports.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 from an unspecified date for COVID-19 immunisation. The nurse reported that she was not the only one having nightmares.  Nurse reported that her coworker, the patient, had the PFIZER-BIONTECH COVID-19 VACCINE and said that she had the same problem.  Nurse stated that her coworker reported that she was having dreams about dead people following the second dose of the COVID-19 vaccine. The nurse reported that the patient was better now but that the patient said she thought she was going to die. The outcome of the event was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021677871 same reporter/drug/event, different patient
Inappropriate age at vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient was healthy and not immunocompromised. Patient had not received the second dose. There was no adverse event that had occurred after the first dose.   No concomitant medication were provided  No treatment details were provided
01/05/22 presents to ED for "fall". PMHx of "Parkinson's, Afib, htn"
Pt here for Covid vaccine - first dose.  While waiting, developed reaction. Pt felt chilled, short of breath and racing heart.  Pulse 170's x several minutes, then 160's.   Dr. into evaluate.  25 mg Benadryl given PO - per Dr.'s verbal order.  911 called and arrived in appro x 10-12 minutes. HR remained elevated - decreased over a  15 min period to 140's.     HR 124 as pt was being placed on the stretcher and wheeled out.  O2 sat remained 98+% during entire episode.
Dizziness and headache immediately following the vaccine on 1/23/2021, this resolved in a few hours.  Small, splotchy redness occurred around the injection site 24 hours later but disappeared the next day.     On 1/31/2021 (8 days post vaccine) redness/itchiness/swelling occurred near the injection site (immediately below) and grew in size to approx 3 inches long and 2 inches wide, became warm and raised by the evening of 1/31/2021 and remains this way today 2/1/2021.   Appears like cellulitis but no other symptoms and does not appear to be growing in size as of now.
About one week after vaccine, developed back and hip pain. Adm to hosp for pain 10/5 night. Dx "DJD". Developed leg weakness and atrophy - several falls, urine retention. Re-adm - MRI Spine - DX - diffuse myelopathy. Tx'd with steroids with some improvement. Still with weakness and urinary retn (catheterized). In rehab now.
Large (grapefruit sized) local redness which spread to elbow and chest. Joint soreness. Elbow and shoulder. Fever 101 degrees. did not see phy. Taking Benadryl, Ibuprofen and cold packs (feel better than warm packs).