chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Lymphocytic colitis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Known allergies: demerol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from17Feb2023 to19Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Heart rate is around 100 bpm / increased to 125 bpm; Got very sick  /  like "5 Mack trucks ran over her"; Didn't have any energy; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rate is around 100 bpm / increased to 125 bpm), ILLNESS (Got very sick  /  like "5 Mack trucks ran over her") and ASTHENIA (Didn't have any energy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced TACHYCARDIA (Heart rate is around 100 bpm / increased to 125 bpm), ILLNESS (Got very sick  /  like "5 Mack trucks ran over her") and ASTHENIA (Didn't have any energy). At the time of the report, TACHYCARDIA (Heart rate is around 100 bpm / increased to 125 bpm), ILLNESS (Got very sick  /  like "5 Mack trucks ran over her") and ASTHENIA (Didn't have any energy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Heart rate: 125 (High) Her heart rate was around 100 bpm and had increased to 125 bpm at one point..
Pt developed fever of 103 at suppertime last night. Fever ranged between 102-103 during the night, according to mom. Pt had 30 second seizure at 2 am and at 6:45 am. Mom brought pt to ER with fever of 103. Fever went down to 101 after receiving analgesics. Mom was giving Tylenol but was under dosing for weight. No prior seizure history.
pt recvd vax;30jul95 pt broke out w/ lesions, hundreds of them from head to toe;
This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. In November 2021, the patient received Menveo. In November 2021, unknown after receiving Menveo, 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 the powder portion of the Menveo vaccine by reconstituting with Sterile Water and not the diluent that comes with the vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No other details were available. The reporter consented to follow up.
Received Pfizer booster mid-afternoon Tuesday 1/11/22; that evening, observed slightly bloody urine. Seems to be cleared up now, less than 48 hours later
Information has been received from a healthcare worker (certified medical assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 10-FEB-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a health professional concerning a 25 year old Native Hawaiian female with asthma, a history of hydrocephalus, no drug reactions/allergies and no illness at the time of the vaccination who on 22-APR-2008 was vaccinated with GARDASIL (lot # 659964/1978U) in the right deltoid at 2:30 PM. Concomitant therapy included DEPO-PROVERA. On 22-APR-2008 at 2:33 PM the patient developed itching and rash over the entire body from face to feet. The patient was given 10 CC's of BENADRYL. Additional information is not expected.
Lightheadedness/dizziness within seconds. Sat for about 1 min. Walked out to waiting room, seeing white fogginess, sat down with 1 min blacked out with eyes open, smacked back of head on wall, convulsed with eyes open and ended up on floor sitting up convulsing. Higher heart rate, low blood pressure. Nursed rushed out to monitor him and get his number back to normal. Still pale and lightheaded on way home. Pale-faced for at least 3 hours afterward. Napped at home starting about 1:35 PM.
Patient developed hives (raised red rash) on chest with intense itching reported.  Diphenhydramine 25mg PO taken every 4 hours for approximately 4-5 doses.
tested positive for Covid-19; tested positive for Covid-19; Cough; Sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Lot number: 301308A) at the age of 81 years as dose 3 (booster), single, administration date 16Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 26Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Two heart stents", start date: 12Feb2020 (unspecified if ongoing), notes: Verbatim: two heart stents. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "tested positive for Covid-19"; COUGH (non-serious) with onset 2022, outcome "unknown", described as "Cough"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "unknown", described as "Sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2022) positive. Therapeutic measures were taken as a result of covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
No adverse effects occurred. Janssen was given as pt denied multiple times that he received any COVID-19 vaccines. Pt did wait 15 minutes after administration and no adverse effects.
Medical assistant administered the wrong Moderna vaccine to 7-month-old. Patient received the Moderna batch/lot# AR5186C, which is the 6 years to 11-year-old dose. Patient should have received 6 months to 5-year-old dose.
If he is concerned about receiving an expired vial, suggested him to verify first the expiration of the vial in the vaccination center or place where he will receive the second booster shot.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2) (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: PRODUCT EXPIRATION DATE ISSUE (non-serious), outcome "unknown", described as "If he is concerned about receiving an expired vial, suggested him to verify first the expiration of the vial in the vaccination center or place where he will receive the second booster shot.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was administered with doses of GARDASIL in a series, via intramuscularly route (dose and lot numbers not reported). The first dose was given on 21-OCT-2014, a second dose on 12-MAR-2015 and the third dose too soon on 28-APR-2015 (Inappropriate schedule of drug administration). No adverse effects and no product quality complaint (PQC) reported. No further information provided. Additional information has been requested.
During the post-vaccination waiting period, she fainted twice after receiving the flu and moderna bivalent vaccine. Pt regained consciousness after a few seconds and was able to walk on her own after around 10 minutes. We provided supportive care (water, ice pack). No medication was administered. According to her family, pt experienced this same reaction before with needles. Pt left the pharmacy on her own accord after about 15 minutes.
I am on birth control and am not supposed to have a period. I had vaginal bleeding a few days after receiving the vaccine. It is still occurring over a week later.
MOTHER PRESENTS WITH CHILD TO OBTAIN HIS BOOSTER. MOTHER CLAIMS CHILD HAS RECEIVED PRIMARY SERIES AND IS DUE FOR BOOSTER AT THIS TIME. SHE DID NOT HAVE VACCINE CARD WITH HER FOR VERIFICATION. CHILD COVID VACCINES NOT ENTERED IN DATA BASE. ADMINISTERED BOOSTER AS REQUESTED. WHILE CHILD AND MOTHER IN OBSERVATION AREA, MOTHER DISCOVERS VACCINE CARD IN HER PURSE AND GIVES TO NURSE TO RECORD BOOSTER DOSE. NURSE NOTES THAT SECOND DOSE WAS ADMINISTERED 12/21/2021 AND THAT IT WAS TOO EARLY FOR BOOSTER. CHILD IS NOT IMMUNOCOMPROMISED.
Information was received 13-OCT-2016 via telephone call from a registered nurse who reported that an improperly stored dose of GARDASIL 9 was administered to a 14 year old patient on 10-OCT-2016. (Lot # L036301, expiration date 20-DEC-2017 and Lot # M018810, expiration date 28-MAY-2018). It was not specified which lot # was administered to this patient. No adverse effects reported. This report was due to data logger. This is one of several reports from the same source. Additional information was requested.
Infant presented to emergency room with fever approximately 12 hours after vaccinations.  Admitted and started on empiric antibiotics.  Two days later, lumber puncture attempted with subsequent cardio-respiratory arrests.  4/7/09 Autopsy report states COD as complications of multiple congenital abnormalities & manner of death as natural.  Report also states multiple congenital abnormalities of: normal pressure hydrocephalus; patent foramen ovale; VSD; mildly atretic right dominant coronary artery system.  Also had UTI w/enterococcus faecalis, sepsis & lobar pneumonia.  Tox screen neg.
entire body felt very cold; body pains; voice turned hoarse; itched all over; chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (entire body felt very cold), PAIN (body pains), DYSPHONIA (voice turned hoarse), PRURITUS (itched all over) and CHILLS (chills) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced FEELING COLD (entire body felt very cold), PAIN (body pains), DYSPHONIA (voice turned hoarse), PRURITUS (itched all over), CHILLS (chills) and HEADACHE (bad headache). At the time of the report, FEELING COLD (entire body felt very cold), PAIN (body pains), DYSPHONIA (voice turned hoarse), PRURITUS (itched all over), CHILLS (chills) and HEADACHE (bad headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.
minor rash, acene sized, started roughly a week and half after 1st does of vaccination sometimes a couple appeared throughout the day and sometimes it does not occur, itching
My first menstrual period post-vaccine arrived approximately 14 days early. My periods are normally very regular and this had never happened before, and has never happened since. This only occurred after my initial dose in the series.
flushing, shortness of breath, urticaria. 20 ga Right hand, Duoneb, Benadryl
T99.2.  Full upper L arm erythema, induration + warmth.  12cm x 10cm.  Also pain assoc.
Fever 5 hours after injection lasting 1.5 days, itchy rash on torso, arms, and legs 3.5 days after injection still present after 5 days post injection (treating with over the counter meds)
Sore arm; Mild headache; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Mild headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Mild headache). The patient was treated with ACETAMINOPHEN ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Mild headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was  not reported.    Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No specific follow-up information recorded.
Patient arrived in clinic to receive their second dose of COVID 19  vaccine. Lower than authorized dose administered.  Administered 10 mcg/0.2mL, NDC: to 3 year old child.  Information provided by the CDC & agency relating to the updated COVID 19 vaccination schedules on 04/18/2023 was not clear.  Specificity of vaccine dose & injection volume in disseminated informations from these sources would have improved our understanding. This error was discovered 2 weeks following it's occurence.
Narrative:  Patient came to clinic for eye appointment and stopped at desk to ask for nurse. Nurse went to triage patient and he states he had Moderna COVID 19 injection 2/16 and felt hot and had a low grade fever day two after vaccination. He states day 3 he noticed welts on arms and chest and has itching. Patient states day 4 he had more itching and developed welts to groin, back, arms and chest area. Patient states his daughter is a pharmacist and told him to take a benadryl and he did. Patient states he is today day 5 he is better and denies any welts on body. rISKS AND BENEFITS OF SECOND VACCINE DISCUSSED WITH PATIENT BY PROVIDER.
left sided facial muscle soreness; Arm soreness/by injection in the left arm; This is a spontaneous report from a contactable consumer (patient).  The 30-year-old male patient received BNT162B2(COVID Pfizer vaccine, Batch/lot number: EK9231), via an unspecified route of administration on 31Dec2020 at single dose by injection in the left arm for COVID-19 immunization.  Medical history and concomitant medications were none.  The patient stated that he just got the COVID vaccine an hour ago. Within 20 minutes he developed left sided facial muscle soreness, which was the side he got the vaccine on, and arm soreness, on 31Dec2020. There was no treatment. Outcome of events was not recovered.
The pt experienced a large circle of redness and itching from 3rd dose. A hard lump the size of a dime was experienced from 1st dose.
Immediately following vaccination pt developed 3cm x 5cm and one hive on right knee. Pt improved after 3/4 tsp Dimetapp.
Information has been received from a 65 year old female consumer who on 30-APR-2009 was vaccinated with a dose of ZOSTAVAX (Merck). In March 2010 she got an acute case of shingles. She had tried acupuncture and had been on LYRICA for several months. At the time of report she still had post therapeutic neuralgia. Additional information has been requested.
Headache started 8 hours post vaccine, chills, joint pain, muscle aches, fatigue started 16 hours post vaccine. Lasting approximately 32 hours.
treatment or prevention of recurrent squamous cell carcinoma as the pharmacist received the prescription; no additional AE; This spontaneous report was received from a pharmacist concerning a 54-years old patient of unknown gender. The patient's concurrent condition included recurrent squamous cell carcinoma. Concomitant medications, drug allergies and historical conditions were not reported.   Pharmacist received a prescription for treatment or prevention of recurrent squamous cell carcinoma for a 3 series vaccination with 1st dose followed by second dose at 1 month and a 3rd dose at 6 months (product prescribing issue). Therefore, the pharmacist contacted the physician who stated that they had tried other treatments with the patient and the carcinoma was caused by a strain of human papillomavirus. It was stated that the patient has not yet received the vaccine due to just received the COVID 19 vaccine and they were waiting 14 days. No additional ad verse events reported.  The outcome of the event was unknown.
Received a lower dose (0.4ml) of the Moderna Vaccine; A spontaneous report was received from a nurse, concerning a 57-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) of lower dose (0.4ml).  The patient's medical history was not provided. No concomitant product use was reported.  On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A, expiry date: 25-Feb) intramuscularly for prophylaxis of COVID-19 infection.   On 08 Feb 2021, a health care professional reported that a patient was given 0.4 milliliters of the Moderna COVID-19 vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, received a lower dose (0.4ml) of the Moderna vaccine, was considered resolved on 08 Feb 2021.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273 (Lot number: 007M20A, expiry date: 25-Feb) with no associated AEs.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant medication was not reported. Treatment information was not reported.
Felt Bell?s Palsy effects within four hours of vaccine and officially diagnosed within 24 hours of vaccine. Doctor prescribed prednisone and valacyclovir.  I?m in the second day of Bell?s Palsy treatment with no relief, but I?m wishing soon.
1/17/19 Client called and reported redness/warmth/discomfort below injection site that started on 1/16/19. Instructed to take ibuprofen and ice area for comfort. Instructed we would check on her tomorrow. 1/18/19 Client came in to office for redness, warmth and pain to Rt upper arm below injection sites. Stated she slept a lot on Wed. and Thurs. Area of redness 10 cm vertical by 19.5 cm horizontal around lower to mid upper arm. Client stated it was not as red as previous day but wanted someone to see it. Advised we would recontact next week. 1/22/19 Client contacted via phone. Reported decreased redness but stated area continued to be sore. 1/31/19 Client contacted and reports redness is gone but area remains sore.
Left sided Facial paralysis after flu shot. October 30, 2017 received flu shot afternoon. October 31, 2017 eye and lip muscle spasms in a.m. and subsequent weakening of left facial muscles. Went to urgent care Dr. and started on valacyclovir 1gm TID and prednisone burst (tapered by PCP Dr. on Nov 1). Antivirals started in case it was related to shingles, as I had left posterior head pain, but no skin lesions. Symptoms were very responsive to prednisone- improved within 5 days. November 26, 2017- Recurrence of eye and lip spasms followed by weakening of left facial muscles, with more pronounced left eyelid weakness than on Oct 31, 2017. Nov 27, 2017- Valacyclovir 1gm TID and Prednisone 40mg daily x 5 days- Dr. December 1, 2017- Prednisone 40mg daily x 2, 30 x2, 20 x 2, 10 x 2. December 8, 2017- Valacyclovir 1mg TID x 7 days Dr. May (refill). December 17, 2017- Prednisone 3 days each dose (starting at 40mg)  on hand- didn't use. Dec 29, 2017- MRI brain with and without contrast showing no tumors or explanation for facial paralysis. Symptoms were resolved by this time and no recurrence of symptoms since. (Neurologist).
I got the vaccine but still got shingles / Suspected vaccination failure; I got the vaccine but still got shingles; Miserable; Terrible pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling miserable and pain. On an unknown date, the outcome of the vaccination failure, shingles, feeling miserable and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, feeling miserable and pain to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient got the vaccine but still got shingles, he/she was miserable and had terrible pain. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
Patient fully vaccinated (Moderna) but not boosted, admitted to the hospital with COVID-19 associated hypoxia. Patient was discharged on 12/29/21.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with "three doses" of GARDASIL (Lot# unknown), 0.5mL, IM. The physician reported that the patient was using GARDASIL and on an unspecified date experienced syncope. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested.