chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At the time of vaccination I did not know I was pregnant. I?m not sure if the vaccine had anything to do with what happened, but I would still like to report that on May 8th 2021 I started to miscarry. Any number of reasons could have caused this, the doctors do not know why, but it?s important to know I did get the first dose during the beginning of my pregnancy.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2022-448109 (Patient Link).
Severe Heart palpitations starting two weeks after second dose. Severe fatigue, Joint Pain, Pressure Headaches, & Elevated Heart Rate. Ended up going to emergency room twice for heart attack like symptoms on July 13th and July 19th. Was diagnosed with Pericarditis from my cardiologist July 29th.
Rabavert administered in the gluteal muscle; Case reference number US-BN-2021-002544 is a spontaneous case report initially received from a health care professional via regulatory authority (reference ID: USBAV21-0636) on 17-Dec-2021 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient found a bat in her bedroom, however, no bite wound was found.  On an unspecified date, the patient was vaccinated with RabAvert (inactivated rabies virus vaccine; batch number: not reported) at an unknown dose, in the gluteal muscle via intragluteal route of administration, for post-exposure prophylaxis (explicitly coded as ' Vaccine administered at inappropriate site')  At the time of this report, it was not known whether the patient experienced any adverse event.  Additional information received on 20-Dec-2021: included local BN case ID.  No further information was provided.; Reporter's Comments: The female patient of unspecified age was vaccinated with RabAvert in the gluteal muscle, for post-exposure prophylaxis, which is considered as product administered at inappropriate site. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient's medical history and concomitant medication details were not provided. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.; Sender's Comments: The female patient of unspecified age was vaccinated with RabAvert in the gluteal muscle, for post-exposure prophylaxis, which is considered as product administered at inappropriate site. No associated adverse events have been reported with the reported medication error. The product administered at inappropriate site is considered as listed per convention. The patient's medical history and concomitant medication details were not provided. The product administered at inappropriate site has been considered as not related to the suspect vaccine, but to a human action. This case is considered as non-serious.
Pt. stated that the evening of shot arm was swollen and itchy. I advised her to use BENADRYL cream and call MD -> next day still worse, MD dx cellulitis and gave doxycycline. Pt is recovering I advised to continue antibiotic until gone.
She said she is having problem with, her face feels like numb and all kind of problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 01), for Covid-19 Immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "She said she is having problem with, her face feels like numb and all kind of problems". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had syncopal episode 10 minutes after being vaccinated and fell off the chair from a seated position.  Blood pressure was low and patient was transported to the hospital for evaluation.
Sore arm worse on second day, about 2 weeks after large rash at shot place,then sick for 3 days with flue like symptoms.Extreme fatigue
urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary tract infection) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Prostate infection.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). The patient was treated with CIPROFLOXACIN for UTI, at a dose of 500 mg. At the time of the report, URINARY TRACT INFECTION (urinary tract infection) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication were reported.     Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up contains No new information
Developed full case of Herpes Zoster, 4 yrs after receiving vaccine.  Full rash, painful, burning.
Myalgia, SkinRash, Rash, UrticariaPruritus, Diarrhea &  NauseaVomiting Narrative:  Painful, pustular rash on right temporal and right occipital  areas of scalp. Painful, burning sensation. Suspect possible shingles. Referred to PCP for further evaluation.
after getting the vaccine, about 2 min later, pt stated that he was have syncope and feels like his throat is closing up. we called 911 and checked on patient and measure his blood pressure and was 135/105. after a few min i checked his blood pressure again and it was 135/90.  when ambulance came, they check his Oxygen and blood pressure and all were normal.
anaphalaxis report covid vaccine: pt came to the pharmacy at 145pm on sunday 12/12/21 for a booster shot of pfizer covid 19 (3rd dose). Pt had a history of multiple allergies and when asked at time of administration had a history of anaphalaxis and carried her own epi pens and that she currently worked as an emergency room nurse in city. Vaccine was given and patient was instructed to stay in the store for 30min to be on the safe side. Approximately 10min later she came to pharmacy counter with squeaky voice saying that she was having an anaphalacitc reaction. Pharmacist  had technician call 911 while pt was taken epi pens. Due to pts previous experience she was given an epipen from pharmacy stock to self administor. She stated that she always required 2 epi pens so a second epi pen was given to her a few min later to self administer.  One of our store comangers, who is also a paramedic, came and sat with the patient while pharmacist then drew up diphenhydramine. Ems arrived before diphenhydramine was administered but had me go ahead and give it while they interviewed patient and brought in  a stretcher. During the interview it was overheard that she had been intubated frequently do to an "auto immmune condidtion" and that the last time was 2 weeks prior. Patient was taken to the hospital and no further information about her condition was known at the writting of this report.
Rash-face, upper ext. Vaccines given At 11 am mother called to report rash at 3 pm.
Patient  received a moderna covid vaccine for the first dose of the series on 2/9/22. Patient should have received pfizer instead due to age. Pfizer covid vaccine given 03/09/2022 as second dose of series. department of health, patients parents and patient's PCP made aware of the error. Patient has now completed the covid vaccine series. No unexpected adverse events. Patient reported fatigue, sore arm and feeling run down after having Moderna vaccine. Symptoms lasted a day.
Narrative:  The patient received two doses Pfizer COVID 19 vaccine Jul/Aug 2021. The patient tested positive for COVID 19 on 4 Jan 2022. The patient presented to the ED with leg swelling and shortness of breath. The patient was admitted on 4 Jan 2022 with COVID pneumonia and acute systolic heart failure and treated with oxygen, remdesivir, and dexamethasone. The patient was discharged in stable condition on oxygen on 21 Jan 2022.
This case was reported by a consumer and described the occurrence of multiple sclerosis like symptoms in a 52 year old male subject who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject stated that he had no remarkable medical history and was healthy before receiving hepatitis B vaccine. Concurrent medication included Multivitamins + mineral supplement. On 12/12/01 and 1/16/02, the subject received the first and second doses of Engerix B. The consumer reported that he, "had no problems after receiving the first two doses." On 6/18/02, the subject received the third dose of Engerix B (lot ENG5294C6). On 6/19/02, 1 day after vaccination with the third dose of Engerix B, the subject experienced fatigue, blurred vision, insomnia, depression, and loss of appetite. The subject was seen at a physician's office and was treated with amitryptiline. The subject discontinued amitryptiline after an unspecified period of time and was subsequently treated with tryptophan for several months. The depression and loss of appetite resolved on an unspecified date on or before 8/2/02. At the time of initial reporting, 8/2/05, the subject reported that fatigue is not as severe and that he "still has occasional bouts of blurred vision." The insomnia improved. The subject reported also that, "after the initial symptoms resolved or improved on an unspecified date after 6/19/02 and on or before 8/2/05, he experienced dizziness and peripheral neuropathy primarily in the feet and lower legs. The subject was seen by a neurologist. The subject reported that a, "blood test ruled out diabetes." The subject reported that the physician described his symptoms as multiple sclerosis like and may be due to an auto-immune disorder." At the time of initial reporting, 8/2/05, the multiple sclerosis like and auto-immune symptoms, dizziness and peripheral neuropathy were ongoing. Comment: Multiple sclerosis like symptoms was assessed as medically serious (OMIC).
Body aches, diarrhea, nausea, headache,  sweating, swelling at injection site
Arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm was sore at the injection site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced INJECTION SITE PAIN (Arm was sore at the injection site). At the time of the report, INJECTION SITE PAIN (Arm was sore at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-089345 (E2B Linked Report).; Sender's Comments:  MOD-2021-089345:Wife case
Pt received immunization on afternoon of 2/4, that evening noticed numbness in 4th-5th digits (L) hand w/ weakness, called in to clinic 2/12 and was seen at clinic on 2/12 for s/s of (L) hand numbness, advised rest, ice per provider, expected to resolve spontaneously.
within couple of minutes of getting flu shot: Hot flashes, Dizziness, Vision blacking out for a second while standing up.
SkinRash, ErythemaMultiform, UrticariaPruritus, Arm soreness, swollen w/ solid white raised circle on  1/20/21, Turned red and raised bumps on 1/21/21  Narrative:
pt recv vax 26AUG96 & that evening pt had a 6hr crying spell & was considered inconsolable by mom;fussiness cont 27AUG96;no significant temp or site rxn;
Arm was sore a few days ago again after not being sore for a while; Fever two weeks after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore a few days ago again after not being sore for a while) and PYREXIA (Fever two weeks after the first dose) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore a few days ago again after not being sore for a while) and PYREXIA (Fever two weeks after the first dose). At the time of the report, PAIN IN EXTREMITY (Arm was sore a few days ago again after not being sore for a while) and PYREXIA (Fever two weeks after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
9pm  pressure at site; 1am pain in right arm at injection site; 3/19 7am pain in right scapula radiating up into neck; swelling to right side of neck; pain radiating down to hand with pain in first two knuckles; swelling noted to axillary area; pressure moving to 1st and second rib from shoulder; feeling of fullness in right arm and shoulder; difficulty move arm and hand grasp affected.
Information has been received from a health professional concerning her daughter an 18 year old female who in October 2007, was vaccinated with the first dose of GARDASIL (lot number not reported). There were no pertinent medical history and drug reactions/allergies. Concomitant therapy included RECOMBIVAX HB (unspecified). The healthcare worker reported that her daughter developed "stabbing head pain associated with a twitch" in approximately October 2007 about 2 weeks after she received her first dose of GARDASIL. The patient had been diagnosed with pseudotumor cerebri which limited her physical activity and she was hospitalized. The patient's pseudotumor cerebri persisted. The patient underwent lumbar puncture to relieve fluid pressure. Multiple unspecified blood tests and diagnostic studies were performed with results not report. Pseudotumor cerebri was considered to be disabling, immediately life-threatening and an other important medical event by the healthcare worker. Follow up information was received from a healthcare professional who reported the patient was vaccinated with the first dose of GARDASIL on 28-FEB-2007, the second dose of GARDASIL on 15-OCT-2007, and the third dose of GARDASIL on 01-JUL-2008 (lot numbers not reported). Concomitant vaccine included MENACTRA received on 28-FEB-2007 and VAQTA (unspecified) received on 28-FEB-2007 and 15-OCT-2007 (lot number not reported). At the 28-FEB-2007 office visit, the patient had bronchitis. At the 15-OCT-2007 office visit, there was no mention of any adverse event. On 23-OCT-2007, the patient was seen for hives and ZYRTEC was given. On 30-OCT-2007, the patient complained of pins and needles all over, rash was gone. On 28-NOV-2007, the patient complained of blurred vision, and a neuro consult was directed. In November and December 2007, the patient was admitted to the hospital (no other details available). In November 2008, the patient was admitted for nausea, vomiting and headache (no other details). On 05-JUN-2009, the patient was last seen in their office. Additional information has been requested.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a two months old male patient who was vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT (Batch number: UT6262NA, expiration date: 30-Jun-2019, route: intramuscular and site of administration: left thigh) on 24-Oct-2018. The patients medical history were not reported. No concomitant vaccinations given. It was an actual medication error due to inappropriate age at vaccine administration (FLUZONE QUADRIVALENT was administered to a 2 month old baby/No AE). No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
fainting episode which lasted for approximately 10 seconds after administering menactra vaccine.child claimed she felt dizzy after the last injection. was observed for 30 minutes, left with parents in stable condition.
Client reported feeling faint and fatigued. EMS took vitals and daughter gave client food to eat. Client felt better after 40 minutes. EMS assessed and gave client banana for low blood sugar.
Received vaccine dose #1 on Jan 5, 2021.  Had mild injection site discomfort,  and no systemic symptoms, which resolved in 24 hours and did not impact work, etc. On Jan 14, 2021 noticed mild pruritus at injection  site and noted there was also erythema (approximately  2 inch x 2 inch area ) but  no swelling, no pain, no systemic symptoms and no treatment rendered and no impact on work etc.   Pruritus dissipated over 24-48 hours but erythema persisted for another 5 days until Jan 19th.  No lymphadenopathy was noted at any time and no impact on arm function at any time.  I took pictures so just let me know if you would like me to forward these.
Have gotten worse daily with joint pain and swelling in hands and feet since this vaccine and my lumbar fusion which I was pain free has started pain same time with mri showing no changes but yet pain out of the blue only to get worse and had a RH factor of 21.8 in lab.. was fine until all this started around end of august
Information has been received from a physician referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L008271, expiration date 11-MAR-2017; Lot # K005428, expiration date: 15-APR-2016; lot#: K016131, expiration date 24-SEP-2016, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
High blood pressure; Bad headache; Hallucinations; Temperature went to 104.6F; A spontaneous report (), was received from a consumer (patient), a 41 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced hallucinations, high blood pressure (hypertension), temperature went to 104.6 F (pyrexia), and bad headache (headache).     The patient's medical history included COVID-19 diagnosed in Oct 2020. Concomitant medication was not provided.   On 05 Feb 2021, approximately one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: 030M20A) intramuscularly for the prophylaxis of COVID-19 infection.  On 06 Feb 2021, post vaccination, the patient's body temperature was 104.6 F, and hallucinations. On 09 Feb 2021, the patient woke up with high blood pressure and had a bad headache. Subsequently, the patient went to emergency room on the same day. Treatment medications included acetaminophen and ibuprofen.   Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome for the events, hallucinations, high blood pressure, temperature went to 104.6 F, and bad headache were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Severe pruritic rash involving trunk and extremities, including palms and soles and roof of mouth. started 8 days after vaccination and persistent
Local reaction to PNEUMOVAX (redness & swelling at inj. site - 5 cm).
Information has been received from a nurse practitioner concerning an approximately 2 year old male with asthma, eczema and no known drug allergies who on an unspecified date was vaccinated with VARIVAX (Merck) (lot# not reported). There was no concomitant medication. One week after the vaccination, in 2001 the patient developed varicella rash. The patient was fussy the day before the rash developed. The rash started as small itchy bumps on his legs, chest and arms. The nurse practitioner stated the patient was "not all that sick". No medical attention was sought and no laboratory performed. On an unspecified date the patient recovered. No further information is available.
Patient stated she has rashes all over her body. Denied any new lotions, cream, detergent or foods.
Moderna COVID-19 Vaccine, Dose #2. 6 hours after injection - overwhelming fatigue/sleepiness.  Overnight symptoms included chills, body aches, restless sleep, muscle and joint pain.  Total duration of worst symptoms: 24 hours. Extreme soreness at injection site in arm for 48 hours.
covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Mar2023 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FINASTERIDE, start date: 01Sep2021. Past drug history included: Minocycline, reaction(s): "Known allergies: Minocycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 10Oct2023 to 14Oct2023 as treatment of COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.