chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rebound and awful taste in mouth while taking the medication; Rebound and awful taste in mouth while taking the medication; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 16:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Mar2021 as dose 1, single (Lot number: 011A21A), in left arm, on 09Apr2021 as dose 2, single (Lot number: 026B21A), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: 020F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer 5 years prior; "Sulfonamide derivatives/ sulfa antibiotics" (unspecified if ongoing); "Known allergies: penicillins" (unspecified if ongoing). Concomitant medication(s) included: VALACYCLOVIR MYLAN, start date: 25Aug2022, stop date: 21Nov2022; VIT D [VITAMIN D NOS]; ZINC; VIT C. Past drug history included: Tetracyclines & related, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound and awful taste in mouth while taking the medication". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Concomitant medications included Valacyclovir brand was Mylan, Multi vitamin.
This spontaneous case reported by a consumer, describes the occurrence of fatigue (tired) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history provided. Concomitant products included vitamins (NOS) for an unknown indication. On Aug 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 7, 2021, patient experienced fatigue (tired). In August 2021, fatigue (tired): resolved. No treatment information provided. Reportedly,  patient didn't take any medications for the symptoms. She didn't go to the doctor as a result of her symptoms. This case linked to MOD-2021-343037 (patient link).
Patient felt pain s/p vaccine administration then 1 week late had discoloration (hyperpigmentation) of skin in 2 areas, with increased pain and difficulty lying on her L side.
An initial report was received at manufacturer on 3/26/03 from a patient from the USA. Two provisional diagnoses are reported: asthma attack and just co-incidental event according to the Pulmonologist; systemic possible allergic reaction according to the patient's physician. The patient, 31 year old female, developed chest tightness, headache and disorientation, wheezing, and a 50mmx70mm area of redness with pain at injection site the evening after the injection of Fluzone, requiring 2.5 days of hospitalization. The patient received a flu shot in December 2002 with no reactions. The patient's physician feels that she had a systemic possible allergic reaction. Pulmonologist opinion is that the symptoms were an asthma attack and just co-incidental. She received oral and IV steriods, tenalog, breathing treatments, xanax for spasms and Vicoden for pain. Chest tightness, wheezing and shortness of breath continue. Local burning and pain at injection site at time of administration. Outcome not reported.
Face is swollen; Neck is swollen; Tongue is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face is swollen), SWELLING (Neck is swollen) and SWOLLEN TONGUE (Tongue is swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disability.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Face is swollen), SWELLING (Neck is swollen) and SWOLLEN TONGUE (Tongue is swollen). At the time of the report, SWELLING FACE (Face is swollen), SWELLING (Neck is swollen) and SWOLLEN TONGUE (Tongue is swollen) outcome was unknown.            On Dec-2021 Patient experienced her face, neck and tongue is swollen. No concomitant medication details was reported. No treatment medication details was reported.
EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned an 87 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no illness at the time of vaccination. the patient had no past history of similar event. the patient had no adverse event after any previous vaccination. the patient had no history of allergy to vaccine, drug, or food. the patient had no pre-existing acute illness 30 days prior to vaccination. the patient had no history of hospitalization in last 30 days. the patient had no family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine (suspension for injection, intramuscular, and batch number: 1805029 expiry: 25-MAY-2021) .5 ml, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced expired vaccine used. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case is a duplicate of 20210559435. This case, from the same reporter is linked to 20210549259 and 20210557958.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Patient ID was reported as Unknown. Concomitant medications details were not reported by the reporter. It was reported that 60 doses received to several patient from Lot AS7148B. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details were not reported by the reporter.
while sleeping pt had sudden onset of jerking movements of arms, also urinated on self; sz lasted less than 5 minutes; arrival in ER fever 101.6;
Associate received the Moderna vaccine on January 26, 2021 at 7:10 a.m.  Associate woke up around 3:30 a.m. on January 27, 2021 with extreme body aches, fever, chills, nausea. These symptoms continued for 72 hours. Mild symptoms of fatigue and nausea continued for another few days. 5 days total
Pruritic maculopapular erythematous rash (approx 3-4 cm) on left upper thigh where MMRV vaccine was administered. Treated with OTC BENADRYL cream. Seen in the office 8/1/2016 by Dr.
No additional adverse event.; Inadvertent administration of PROQUAD and MMR II to the patient; This spontaneous report has been received from a medical assistant referring to a 13-month-old patient, of unknown gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 08-MAY-2020, the patient started to received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, administered subcutaneously (SC) lot # S029456, and expiration date 19-SEP-2021 (strength, dose, frequency and indication were not reported); and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection SC, lot # S022917, expiration 19-JAN-2021 (strength, dose, frequency and indication were not reported). Both vaccines were inadvertently administered to the patient (inappropriate schedule of product administration) on that date for prophylaxis. In addition, an sterile diluent (MERCK STERILE DILUENT) was also administered (dose, route of administration were not reported, lot number and expiration date were unknown by the reporter). No additional adverse event was reported.
features of course include treatment of covid19 with 5 days of remdesivir and 8 days of dexamethasone. Given she was immunocompromised we obtained compassionate-use authorization to administer regneron, which was given HOD#4. She did well from a respiratory standpoint, and on day of d/c was satting well on 1L NC.
6" area erythema and 1/4" induration, local to injection site, noted by mother.  Written 24 hours of administration.
pt presented to clinic c/o fever, chills & itchy welt like areas; stated areas have dried up originally they had pus top;
Patient was unknowingly give Dose #3 of expired vaccine.  Once this was realized the patient was notified by her provider.
Loss of hearing and tinnitus. Symptoms began within one week of getting first Shingles vaccine. Symptoms of hearing loss and tinnitus are still present on 1/21/2023. Visited ENT to have hearing exam and was diagnosed with bilateral hearing loss and tinnitus. I was only 53 at the time of the injury to my ear drum by this vaccine. I have never had hearing problems in my life until I had the Shingles vaccine.  I subsequently had the second Shingles vaccine on October 7, 2022.  A few days later, the ringing in my ears became worse as well as my hearing loss. It was at this time that I thought it might be from the Shingles vaccine and I visited an ENT for assistance with the hearing loss and ringing.
Patient was given vaccine past the "Do not use after Time"  of 5/12/22 at 11:00pm
feeling headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (feeling headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M20A) for COVID-19 immunisation.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (feeling headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, HEADACHE (feeling headache) outcome was unknown.            No concomitant product use was reported   This case was linked to MOD21-050404 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 04-MAY-2021. Updated reporter information; Sender's Comments:  MOD21-050404:
After four hours developed red ring about vaccine injection site then entire arm became swollen to wrist. Client reports swelling was severe enough she could not raise her arm. 72 hours after inj mild swelling persists in arm and elbow area with c/o joint pain. Benadryl helped a little. Dr advised using Motrin 2 BID and call if symptoms persist. Follow Up: Reaction at Pneumovax site.
Narrative:  Pt is a 92y.o. male who died on 05/04/2021 with h/o DM. Pt received Pfizer Covid-19 vaccination on 01/14/2021. Unlikely Pfrizer Covid-19 caused/contributed to pt death.
she had a stiff neck; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), via an unspecified route of administration on 18Dec2020 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. Patient received the first dose of vaccine on 18Dec2020 and reported that she had a stiff neck for two days. The outcome of the event was recovered on 20Dec2020.  No follow-up attempts are possible. No further information is expected.
Raised red whelps on right arm with itching. Mother rushed patient to ER. Raised red whelps on torso by time they got to ER. Child placed on Benadryl and Prednisone and improved. Went to school next day and whelps improved per mother.
Pfizer vaccine given at 18:41, patient at 19:11 reports numbness to left side of body (upper and lower extremities) dizziness. Patient was taken to exam room 1, vitals were checked BP were in systolic-170, diastolic 85's. Oxygen saturation on room air 97-100. HR-80-95's.   she was given some water. in the room she started to report dizziness, she was told to lay down, and sent to ER for further evaluation due to symptoms not improving. ER was called and report was given. Brother in law, picked up patient and husband and drove her to the Emergency room.
Developed chickenpox-like rash on left forearm. Intense itching for 10 days.
Rash located on upper back, upper R arm, forehead, Less amount on L upper arm. Tiny, papules, slightly erythema.
After 15 min observation time from receiving the 1st dose of COVID19 moderna vaccine at 02:58pm on 8/25/22  pt stated feeling numbness in the mouth, water was given to pt drank w/o difficulty, spoke clearly without problem, A/O to time, place, and name. Pt vitals recorded at 3:07pm read BP-132/78, HR-106, RR-22, O2-98% on RA. pt observed for remaining 15 min vitals recorded again at 3:14pm BP-130/82, HR-104, RR-22, O2-99% on RA, pt stated a history of HTN and DM, stated currently taking medications pt stated BP runs a bit high even with medications, after a few min pt stated feeling better regained sensation of the mouth and last vitals recorded at 3:28pm BP-128/82, HR-98, RR-20, O2 sat-99% RA. pt stated feeling better and ok to drive, ER precautions provided with s/s of allergic reactions to observe, pt verbalized understanding.
large left leg blood clot found on Ultrasound in clinic on 10/21/21
Pt's skin formed a bump at injection site immediately. After injection on 8/4/13 about 1 week ago 11/2/13 that bump which is still there started to hurt. In the last few days pain has subsided some what.
Case number PHEH2015US018940 is a combined initial and follow-up spontaneous report from a pharmacist received on 18 Sep 2015. This report refers to a 63 years old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) in 2014. On 10 Oct 2014 the patient experienced rash on the arm of the injection site. The pharmacist inquired whether the patient be vaccinated again following an adverse event from her vaccination last year. The outcome, seriousness and causality of the event were not reported.
tingling arms and legs, muscle weakness, headache, muscle pain, chills, numbness, shortness of breath, dry cough, rapid heart beat, fatigue, loss of balance
Shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via call center representative 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, less than 2 years 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 and shingles were unknown.   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: 28-Jun-2022 Reporter's Comments: The reporter wanted to know if one gets the two shots last year from the day of reporting and now came down with shingles what to do for the future, if one should get more shots. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
VAGAL RESPONSE 30 MINUTES AFTER INJECTION.  DIZZY, HYPOTENSIVE.
she had arm soreness but on the second day the soreness was gone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left (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. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "got the COVID vaccine in her left arm and she had soreness but on the second day the soreness was gone.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366695 same reporter/drug/similar event, different patients
Pt called stating that he noticed a cough 3 days after getting PNEUMOVAX immunization.
Terrible coughing for over one month. Some minor cold symptoms, but mostly coughing. Barking sounds (a few times in the one-month duration). Given honey and children's cough medicine. Not much relief, but symptoms ended after a little over one month. Patient's mother became ill and was much more severely affected. Mother's persistent cough lasted 3.5 months. Went to doc, chest x-ray revealed no pneumonia, though symptoms were similar. Treatment include NAC, Lobelia, and many cough formulas. Nothing helped. Finally recovered after 3.5 months of terrible coughing, some barking, and severe exhaustion.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, two weeks after vaccination the patient went into a coma and her blood pressure was "dropping a lot." The patient was reported to be a cousin of a patient of the reporting physician and is not a patient of the reporting physician. Information regarding the patient's health care provider was not provided. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Coma and blood pressure dropped were considered to be disabling. Additional information is not expected.
Received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL; Received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL; Significant body aches; This is a spontaneous report from a contactable physician. This physician reported similar events for 15 patients. This is 10th of 15 reports. A patient of unspecified age and gender received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration and date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced significant body aches. The report received as; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL. They reported significant body aches. Outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient
6 hours of 7/10 crampy umbilical abdominal pain starting 10:00am [22 hours after shot administration] with nausea. Improved thereafter. x5 bowel movements, from solid to liquid and diarrhea. Had to call out of work for afternoon, could not work.
Beginning ~24 hours after injection, extreme pain in left neck starting near base of skull and down along muscles on left scapula edge.  Within 48 hours, red blister rash developed along left scapula area. Shingles-like rash, but no blistering or weeping. Saw chiropractor for adjustment (thought it was neck issue), saw massage therapist and acupuncturist for treatment (still thought neck issue. Contacted primary care physician with photos, who prescribed Valacyclovir 1gram tablet for 21 doses (3xday x 7 days). Pain and rash symptoms resolved after taking antiviral medication; pain resolved within 12 hours, and rash resolved within 48 hours.