chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old male patient received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 62 years 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: "Diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", COVID-19 (medically significant), 10 days after the suspect product(s) administration, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
Something came out between the axilla and my chest; I try to lower my arm, I can't because the ball is there; I could not sleep because I feel the ball; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Something came out between the axilla and my chest), MOBILITY DECREASED (I try to lower my arm, I can't because the ball is there), INSOMNIA (I could not sleep because I feel the ball) and HEADACHE (Headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, TOPIRAMATE (TOPAMAX) and SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) for an unknown indication.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced SWELLING (Something came out between the axilla and my chest), MOBILITY DECREASED (I try to lower my arm, I can't because the ball is there), INSOMNIA (I could not sleep because I feel the ball) and HEADACHE (Headache). At the time of the report, SWELLING (Something came out between the axilla and my chest), MOBILITY DECREASED (I try to lower my arm, I can't because the ball is there), INSOMNIA (I could not sleep because I feel the ball) and HEADACHE (Headache) outcome was unknown.            Treatment: Patient is taking Ibuprofen 200mg 2 tablets PO every 6 hours   This case was linked to US-MODERNATX, INC.-MOD-2021-114900 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114900:First dose case
My son received all of the two month vaccines exception Hepatitis B. Within two hours he started throwing up, having significantly increased bowel movements, and crying more than usual. On day 3 the crying reached such an alarming level that we took him to the pediatrician, who gave us the choice of TYLENOL or the ER. They advised us it was a reaction to ROTATEQ. Since then he has continued to have significant GI distress that was NOT present prior to the vaccine. He has continued to have increased bowel movements, severe gas, and discomfort/crying.
pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (pneumonia) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  She stated that she had her last vaccine in October and caught pneumonia 4 weeks ago. Patient was not taking prednisone and worried about lacking immunity especially while going out of tow. Patient was recommended to get another vaccine by the provider but as per the pharmacist, due to cdc guidelines, they could not administer another vaccine to patient . Patient had already had both primary series and 3 boosters already. No treatment information was provided.  Company comment: This spontaneous case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Pneumonia, unknown days after receiving a dose of COVID 19 vaccine with mRNA-1273.222 bivalent vaccine. It was reported that the patient had received the primary series and 3 booster doses already with unspecified product. No information on risk factors, detailed clinical course, investigations, treatment of the event and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Great grandmother noted "Slight fever" June 4 &5. On June 6 there was slight swelling under his ears, more swelling there on June 7. The morning of June 9, his neck was swollen, even facial, under eye area was swollen area was like a hard knot. She took child to MD. Dx Mumps.
Information has been received from a physician concerning a 6 year old male who on 5/31/02 was vaccinated with a dose of varicella virus vaccine live. On 9/9/04 the patient was seen by a physician with a rash. On 9/11/04, the patient was diagnosed with breakthrough varicella. There was no product quality complaint involved. The reporter also indicated that another patient (WAES0409USA01523) had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
PATIENT'S MOTHER REFERS RASH IN ARMS, LEGS, BACK AND IN THE BACK OF THE NECK.
pt seen in office yesterday w/ 1 day hx of itchy rash 1wk p/exposure to cousin w/chickenpox;documented presence of 60 repeat chickenpox lesions over chest, abd, abd, extremities;afeb;
Pt diagnosed with varicella on 12/23/2002. Sym: fever, rash on back, groin, chest, temp. 102.6 x 2 days
Shingrix reconstituted with other diluent.; Shingrix reconstituted with other diluent.; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number 4G94Z, expiry date 3rd February 2023) for prophylaxis.   In October 2021, the patient received Shingrix. In October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received powder component of Shingrix reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not want to provide patients demographic data. The reporter consented to follow up. This case was 1 of 8 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232215:Same reporter US-GLAXOSMITHKLINE-US2021AMR232923:Same reporter US-GLAXOSMITHKLINE-US2021AMR232926:Same reporter US-GLAXOSMITHKLINE-US2021AMR232924:Same reporter US-GLAXOSMITHKLINE-US2021AMR232925:Same reporter US-GLAXOSMITHKLINE-US2021AMR232927:Same reporter US-GLAXOSMITHKLINE-US2021AMR232929:Same reporter
phlegm in my throat; causes problem talking until I clear my throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 01:00 (Lot number: EN6198) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "Heart problems" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Cholestrol" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ATENENOL; VENLAFAXINE HYDROCHLORIDE; LORAZEPAM; CLONAZEPAM. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer-BioNTech, Lot number: EN5318, Lot number: False, Administration date: 02Feb2021, Dose number: 1, vaccine location: Left arm), administration date: 02Feb2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: PRODUCTIVE COUGH (non-serious) with onset 23Feb2021, outcome "not recovered", described as "phlegm in my throat"; SPEECH DISORDER (non-serious) with onset 23Feb2021, outcome "not recovered", described as "causes problem talking until I clear my throat". Therapeutic measures were not taken as a result of productive cough, speech disorder.  Additional information: There was no other vaccine in four weeks. Other medications in two weeks included lisinopril, atenenol, venlafaxine, lorazepam, clonazep. Adverse events was Ever since shot have phlegm in my throat that does not come up, but causes problem talking until I clear my throat. Takes 2 or 3 tries to clear the throat, Happens throughout the day and night. If treatment ae was no. There was no COVID prior vaccination. No COVID tested post vaccination. Known allergies was n/a.  No follow-up attempts are possible. No further information is expected.
The patient received second dose of the Moderna vaccine on 04/19/2021. The dose was administered 21 days after the first dose was administered on 03/29/2021. The patient is being monitored for any adverse reactions. As of 04/24/2021, the patent denies any symptoms.
PAXLOVID REBOUND; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: nirmatrelvir/ritonavir ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 09-JUL-2023 to 13-JUL-2023 for covid-19 treatment. No concomitant medications were reported. On an unspecified date, the patient experienced paxlovid rebound. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from paxlovid rebound. This report was non-serious.
Experienced extreme dry mouth immediately after receiving the Moderna Covid vaccine. Symptom relieved by water provided by hospital team observing patients after vaccination. Further relief obtained by consuming cool grapes. Reaction completely resolved within 15-30 minutes. I did not feel that medical attention was needed.
syringe  uncapped, needle attached, stored in fridge then administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 8-Sept-2022 Reproter's comment: The clinical director reported that Pediarix syringe was uncapped and a needle was attached. The dose was stored in the refrigerator overnight for 16 to 18 hours and the dose was then administered to a patient. The reporter did not knew patient's gender, date of birth or initials.  The reporter had nothing else to report. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Pediarix after being stored in the in the refrigerator overnight for 16 to 18 hours, which led to incorrect storage of drug.
Since May 28th, 2021, been having migraine headaches that have continued for three days now.
after having the fever of 102, fainting and throwing up  I had horrible vertigo and nausea. had to go on anti vert and anti nausea meds, now 1 month later, I am still dizzy in the morning, my muscles ache terrible , especially my lower leg muscles , joint pain, and I am so exhausted
Heart pounding; Sick; I dont really feel quiet normal; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Sep2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received the Pfizer vaccine on 21Sep2021, (yesterday) and her/his heart has been pounding since. Patient dont know if that was a normal side effect because he/she dont really feel quiet normal. paient feel sick. Thank you for being so concerned about her/his health because my heart been pounding all day and now he/she got to make another phone call. The outcome of the events was unknown.  Follow-up attempts completed. No further information is expected.
Approximately 4 hours after vaccination, patient began having chills, severe headache, body aches all over, and insomnia.  The side effects lasted for approximately 14 hours then spontaneously resolved.
Developed fever on the evening of 5/13, the following day developed facial and lip swelling which resolved the same evening, then 2 days later developed rash, rash started on face and moved down, the next day the rash covered most of her and she still continued with fevers.
employee received covid vaccine in Lt deltoid. Soon after developed red itchy rash. Given 25 mg Bendadryl orally. C/o feeling dizzy and pins and needles in extremities. Given Benadryl 25mg  and Solumedrol 125mg IVP. Monitored until 2:45 pm. Symptoms subsided and patient was discharged home. Followed up same evening and next day. Patient stated by the next day symptoms were gone.
Bell's palsy on right side of the face. Started with the tongue feeling numb, no sense of taste to part of the tongue, and 2 days later it lead to the right side of face not being able to close eye at same rate as my other eye. During the morning is when it started to feel like I was losing control of my blinking and being able to gargle when brushing teeth. That Monday I went to the ER to get checked, it was 6 months after vaccinated. So then, tests were provided, COVID, MRI, cat scan, blood tests for Lyme, and observation for 9+ hours. I was released after 9 hours in ER. I had a neurologist follow up and over 2.5 weeks, I started to feel my face muscles coming back slowly. Felt 97% after that. There's still some muscle weakness that I only notice 3 months later and some muscle soreness around mid cheek, chin, and when jawning my eye closes.
Pt recvd vax & the next day c/o myalgias in the back, lower extremities, inability to stand; pt was admitted to hosp 14MAY92; neurologic & immune work up was neg; pt was d/c from hosp w/dx bulimia & hypo-osomolality;
COMPLAINED OF ITCHYNESS TO HEAD, NECK AND BACK. TONGUE FELT FUNNY, NUMB LIPS.  BENADRYL 25MG PO GIVEN.  ISSUES RESOLVED.
Healthcare provider states improperly stored vaccine involved in a temperature excursion was administered to a patient. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): PEDVAX HIB; No additional AE reported; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # W006595, expiration date 10-OCT-2024 (strength, dose, route and frequency were not reported) for prophylaxis.        The vaccine was stored at a temperature of 57.49 Fahrenheit degrees (F), during 1 hour and 45 minutes. No additional adverse event or product quality complaint was involved.
Weakness in legs and arms/Knees feel like buckling; Afraid she's going to fall anytime; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in legs and arms/Knees feel like buckling) and FEAR OF FALLING (Afraid she's going to fall anytime) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included VITAMINS NOS for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MUSCULAR WEAKNESS (Weakness in legs and arms/Knees feel like buckling) and FEAR OF FALLING (Afraid she's going to fall anytime). At the time of the report, MUSCULAR WEAKNESS (Weakness in legs and arms/Knees feel like buckling) and FEAR OF FALLING (Afraid she's going to fall anytime) had not resolved.            Concomitant medications includes Blood pressure medications and vitamins. No treatment medications were provided.
After Influenza (Inactivated) shot, the following morning I woke with itchy eyes and have a strange bowel movement with a soft stool. It lasted until midday.
This case was reported by a other health professional via call center representative and described the occurrence of vesicular rash in a 64-year-old female patient who received SHINGRIX (batch number 97H72, expiry date 8th February 2021) for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vesicular rash, injection site pain and injection site rash. The patient was treated with Diphenhydramine and Steroid Injection. On an unknown date, the outcome of the vesicular rash, injection site pain and injection site rash were recovered/resolved. It was unknown if the reporter considered the vesicular rash, injection site pain and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid and reported a painful herpes zoster like rash at the injection site. She was given a steroid injection and diphenhydramine three days after start of symptoms. The symptoms began to resolve the following day. The herpes zoster was not confirmed, as there was no culture done.
Got 2 shots, still came down shingles/Suspected vaccination failure; shingles/Got 2 shots, still came down shingles/suffering through it now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 4-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got his/her 2 shots and still came down shingles. The patient stated that he/she was suffering through them now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Common reactions..red, swollen, hard, and warm to the touch at area surrounding injection site lasting 3-4 days. Day after these symptoms started to go away she developed a red rash that encircled the first reaction.  nurse practioner felt this was an uncommon reaction as well as an other doctor in the practice who looked at her. No treatment.  Symptoms went away after 2 weeks of injection.
Pt had 103.5 fever 1 day following DTaP, HIB, .25 flu vaccines and (possible febrile) seizure.
Syncope. Per ED note, patient has experienced syncope epsoides before Diagnosis:Syncope and collapse, Injury of head, initial encounter Vasovagal episode
Sore arm at injection site, slight swelling and redness, body aches, headache, chills, nausea. This lasted for two days.  The redness near the injection site continues (day 3).
No problems noted except slight soreness at shot site. Next morning I went to aerobics exercise class, 1 hour, as usual, feeling okay. As class began I began ... feeling bad? And fatigued. Got home from class feeling really rotten, and took two-hour nap, followed by another two-hour nap. Feeling much better afterwards. At about 4 pm, I had a mild diarrhea-like attack, although not very severe, which was followed by a second one about two hours later. End of symptoms and feeling just fine today. My lady friend had an identical shot, same place, same time, and except for a bit of swelling at the shot site, had no reactions at all.
About 2 days later, (I usually get shingles at the top of my butt just below the hip) it began to tingle like it usually does and then got a rash breakout. I contacted my doctor and I was prescribed Valtrex which made me horribly ill and went away in about 2 weeks.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. The medical assistant reported that those patients were administered with a doses of RECOMBIVAX HB (doses, routes of administration, indications, lot#, expiry dates unspecified) between 13-OCT-2013 and 13-NOV-2013 that had been improperly stored. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.