chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with fatigue and aching in the morning following the vaccination. Approximately 24 hours after the vaccination I had developed a fever that reached as high as 103F. By the next morning (a little over 36 hours later) I still had a fever of 100F but am feeling progressively better.
Blood pressure and heart rate changes, nausea, dizziness, fainting, fatigue, brain fog, pens and needles sensation in legs and hands, muscle and joint pain.  She has received PT and OT along with recommended life style changes of body brushing, increased fluid intake, compression garment wearing, eating small meals 6 times a day, resting more frequently , taking prevacid, and avoiding standing too quickly.  These events have taken place over the last 11 months. She has been diagnosed with Amplified Pain Syndrome and Orthostatic Intolerance by Rheumatology and Cardiology Departments.
Dizziness, Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills, Fatigue, Injection site pain, Rigors, Swelling at injection site Narrative:   Other Relevant History:
Chest pain. Stabbing and burning sensation simultaneously over heart  occurred 5 separate times over 10 minutes, created a soreness/tenderness in muscle over heart that lasted for additional 12 hours.
Patient describes developing a red, itching, burning rash at site of injection. The rash has increased in size over a day's time. Two days after, she describes it to be 3 inches wide by 10 in long.
Expired vaccine given. No treatment. No need for revaccination. As per call to Merck these are supported through 6 months after the date of expiration. Potency remains unchanged.
3/11 - enlarge painful lymph nodes axilla neck 3/12 - some OHS sent home 3/17 - enlarge painful lymph nodes axilla cervical.  Breast with yellow drainage.
Pt was admitted on 8/6 for generalized weakness with physical decondition and inability to ambulate. She also had bilateral lower extremity chronic venous stasis dermatitis with resolving BLE cellulitis. Pt was tested on 8/10 for COVID prior to placement for low intensity rehab and tested positive. Pt is asymptomatic.
Fever; Very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore arm) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Very sore arm). On 19-Apr-2021, the patient experienced PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Very sore arm) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. Treatment included Tylenol.
This spontaneous report was received from the registered nurse regarding a 2 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 11-DEC-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Fever,  (felt like she was freezing then burning up) headache, bodyache.
24-36 hrs after shot stomach distress, gas, bloating, cramps, diarrhea, constipation. Went to dr. Pain in stomach continued to get worse and lasted until Monday 9/24/18.
COULD NOT WALK FOR 6 DAYS; This spontaneous report received from a patient via a company representative 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced could not walk for 6 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not walk for 6 days. This report was non-serious. This case, involving the same patient is linked to 20221258571.
About 15 minutes after the patient received her 3rd dose (booster) of covid 19 Phizer vaccine, the patient vomited and her hands started to shake. The patient was in another room being observed by the patient care techs of the facility when this occurred. This was a memory care facility for the mentally ill. I did not witness the occurrence first hand. We sat the patient down where she relaxed and notified the medical physician on staff who would come to evaluate her. There was no signs of difficulty breathing or allergic reaction. Patient seemed tired when I left where she was being observed by the facility staff until the physician arrived.  Side note: she was administered the vaccine shortly after eating lunch.
Administered a vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 58-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 58 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   This report refers to a case of product storage error for mRNA-1273, lot # 025J20-2A.  There were no reported AEs associated with this case of product storage error.
High fever, chills, upper neuralgia nerve/muscle pain lasted for a few days. Pt has fibromyalgia and osteoarthritis and ME. Pain started in arm and radiated throughout body. 11/14/14 first day back to normal.
This spontaneous report ass received from a pharmacist via field representative refers to a 60 year old patient. Approximately on an unknown date in November-2013 (reported as one and half month ago) the patient was vaccinated with ZOSTAVAX. Lot no. # and expiry date of vaccine were not provided. No other concomitant medications were reported. On an unknown date the patient experienced unspecified allergic reaction and rashes that were quarter size. No product quality complaints (PQC) were involved. The outcome of unspecified allergic reaction and rashes that were quarter size was unknown. The causality for unspecified allergic reaction and rashes that were quarter size was not provided. This case is linked to 1312USA011096 via same reporter link. Additional information has been requested.
Client presented to clinic for second dose of Moderna COVID-19 vaccine. Administered 0.25 ml booster dose instead of 0.5 ml full dose. After administration error was identified and while client was still in clinic she was notified of the error. After consulting nurse manager, a second 0.25 ml dose of Moderna COVID-19 vaccine was administered.
Drug ineffective; COVID-19; Pfizer / BioNTech Dose Number: 3 Moderna Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EN5318), in right arm, on 19Feb2021 as dose 2, single (Lot number: EL9264), in right arm and on 24Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Apr2022 as dose 4 (booster), single (Lot number: 065K21A), in right arm and on 06Oct2022 as dose 5 (booster), single (Lot number: B050D22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3, start date: 06Sep2022; VITAMIN C [ASCORBIC ACID], start date: 06Sep2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Apr2022, outcome "unknown", described as "Pfizer / BioNTech Dose Number: 3 Moderna Dose Number: 4"; VACCINATION FAILURE (medically significant), outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid (Lot number: 2692131) as treatment of COVID-19 from 29Nov2022 to 04Dec2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
2nd shot On  JUL 2021  and Booster dose On 29 NOV 2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd shot On  JUL 2021  and Booster dose On 29 NOV 2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included White blood cell count low since July 2021.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd shot On  JUL 2021  and Booster dose On 29 NOV 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd shot On  JUL 2021  and Booster dose On 29 NOV 2021) outcome was unknown.            No concomitant medications were reported. Patient received Evusheld shot on 16-FEB-2022. No treatment medications were reported.   This case was linked to MOD-2021-291017 (Patient Link).
9/26/21: RUNNY  AND STUFFY NOSE, COUGH, HEADACHE
Patient developed a rash near left arm pit on 10/29/17 patient was to dermatologist Dr. patient was then diagnosed with shingles.
1 wk after Flu vaccine administration pt developed hiccups, gen weakness then became Febrile. AMS. Worsening of weakness. Admit to Hosp on 10/23/14. Same event last year after Flu shot.
Severe headache, aches, pains, dizziness, nausea, weakness, swollen eyes, very very sore everywhere. Still having symptoms, but not as bad today.
Received an accidental third dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Received an accidental third dose of the Moderna COVID-19 vaccine) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 024M20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ziprasidone) and Schizophrenia. Concomitant products included DOCUSATE from 15-Mar-2021 to an unknown date for Constipation, HALOPERIDOL from 15-Mar-2021 to an unknown date and CLOZAPINE from 15-Mar-2021 to an unknown date for Psychosis.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received an accidental third dose of the Moderna COVID-19 vaccine). On 17-Mar-2021, EXTRA DOSE ADMINISTERED (Received an accidental third dose of the Moderna COVID-19 vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was  inadvertently administered 3rd dose of Moderna COVID vaccine and had  no ill effects. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up information was received and  patient demographics, current illness, allergy, concomitant medication , the start date, frequency, route of administration and indication for use of concomitant medications were updated.; Sender's Comments: This report refers to a case of Extra Dose Administered for mRNA-1273 (Lot number: 024M20A) with no associated AEs.
Pt came into pharmacy on 2/21/19 and said she has been having adverse reactions, rash all over her body since she got the shingles shot. She says it is still there even though it's gotten much better. She says she got cortisone from MD for rash but didn't tell MD that the rash was from the shot.
Vaccine 11/11/14 approximately 3 pm. Swollen legs/feet, thigh pain, dizziness, and a strong cold feeling started 11/12/14 at night and resolved by morning of 11/13/14.
At the shot area it became red. The red area was getting bigger going down my arm, it was hot and it hurt. Went to walk in. The Dr gave me Cephalexin, 500 mg 4 times a day per 10 days.
Client came by the pharmacy on 9/12/12 PM and showed a big bruise on his right arm. The bruise is about the size of a fist and located below the flu vaccine injection site. Bruising also on LA but not as big as RA's bruise.
2hr p/vax pt vomited, became pale & had a low grade fever;brought to MD office, vomited again & went to ER for re-hydration;pt spent noc in hosp;no vomiting & tolerated morning breakfast;pt sent home w/ f/u in a week;
This case was reported by a consumer and described the occurrence of stridor in a female subject of unspecified age who was vaccainted with influenza virus vaccine (Fluarix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Fluarix. On 10/31/06, at an unspecified time after vaccination with Fluarix, the subject experienced stridor, respiratory distress and vocal cord paralysis. Her physician performed a tracheostomy. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the event were unk.
This was probably unrelated to the vaccine, but just in case.... I experiences extreme lightheadedness the morning of 6/24 while walking my dog. I tried to stand up twice to walk towards my apartment and immediately felt lightheaded and vision began to darken/get fuzzy. No nausea or headache. EMS was called about 5 minutes into the event and it was found that my blood pressure dropped when standing. Blood sugar was normal. Received 1L fluids and felt fine afterward. Fatigued a couple hours later.
This spontaneous report from a Pfizer sales representative who reported on behalf of a contactable physician for a patient. A patient of an unspecified age, ethnicity and gender started to receive TRUMENBA. The start date, dose and frequency were not provided. Medical history, concomitant drugs and laboratory test were not provided. Pfizer sales representative reported on behalf of the doctor the adverse event severe pain at the injection site and arm pain for TRUMENMA. Pfizer sales representative mentioned that she did not have ant details of the patient, she only knew that there was pain at the injection site for 3 days and then the patient took Naproxen. Pfizer sales representative mentioned that the patient was not suffering from the pain as of 29Jul2015 after taking Naproxen, and it was only for 3 days; patient had it no more and the patient was fine. The action taken was not provided. The events outcome was recovered. Causality was not provided. Follow-up (06SEP2015): Follow-up attempts complete. No further information expected.
Arm soreness immediately, 12 hours later low grade temp 99.9F, severe headache, neck/back/shoulder aches
This spontaneous report as received from 74 year old female patient with high blood pressure and none drug reactions or allergies. The patient's medical history included atrial fibrillation. On an unknown date the patient was vaccinated with ZOSTAVAX therapy route reported as: injection (dose, units, route of administration, anatomical location, lot number were not reported). Concomitant therapies included MULTAQ. The reporter stated that she had experienced shingles twice after receiving ZOSTAVAX. The first outbreak was on 02-MAR-2014 and the second outbreak was in October 2014 (exact date not reported). The patient was treated with an unspecified medications and both times she experienced a shingles. On an unknown date CAT (computerized tomography) scan and blood test were performed (results and units not reported). The patient sought medical attention via visiting an unspecified office on an unspecified date. The outcome of events was reported as not recovered. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Patient experienced hives with elevated rash, which did not break the skin or result in pain but were very itchy.  Patient also lost some use of voice for several hours and could only speak in a raspy tone at low distorted volume, but did not experience difficulty breathing.  Patient's symptoms resolved, they did not seek treatment.
Left arm red, edematous to the size of 9 x .9 cm. Red area measures to the size of "baseball". Warm to touch. Temp 97.4.
BODY ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 32 year old male. 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 not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 07:30 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced body ache. On 06-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 to 102 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body ache, and fever. This report was non-serious.
VACCINATION FOR FLUAD GIVEN. ADMINISTRATOR DID NOT REALIZE HE WAS NOT 65 YEARS OLF.
a little nausea; severe body aches for about 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (a little nausea) and MYALGIA (severe body aches for about 6 hours) in an elderly 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (a little nausea) and MYALGIA (severe body aches for about 6 hours). At the time of the report, NAUSEA (a little nausea) outcome was unknown and MYALGIA (severe body aches for about 6 hours) had resolved.            No concomitant medication and treatment information was reported.
Info has been received from a health professional concerning a 5 year old male, with no medical history and no allergies, who on 11/20/00 was vaccinated with a SC, 1st dose in the left side of varicella virus vaccine live. There was no illness at the time of vaccination. It was reported that the pt had a two day history of a rash that began on 3/22/05. The rash was described as scattered chickenpox lesions with about 20 on the pt's forehead and face. The pt was afebrile. Oral Benadryl was given as treatment. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. Follow-up info from a health professional indicated that the pt's mother noted the rash on her body and she was afebrile. It was reported that the pt was seen in the office and 10 chickenpox lesions were noted on her face. Subsequently, the pt recovered. Additional info is not expected.
Patient received Pfizer vaccine after the vial had passed it's recommended use date. Passed the 30 day deadline while in the refrigerator.
Patient's reported that he had blurry vision about one hour post vaccination and eye pain.  The blurry vision subsided but still had slight pain/pressure in his eyes.
2/13/22 patient presented to ER with worsening Covid-19 symptoms. Patient initially diagnosed with Covid-19 on 2/7/2022. Per pulmonology MD patient dx with Covid pneumonia. Initial SpO2 54% upon arrival and placed on 6L O2 NC. Patient completed chemotherapy 11/2/2021. Unable to get much history due to hard of hearing and quick oxygen desaturation off BIPAP.
DUE TO ERROR AT INTAKE PATIENT RECEIVED 3RD DOSE OF COVID (MODERNA) VACCINE.
p/ pt recv vax in 8/96 pt in 7/98 devel a shingles-like rash distributed in a linear fashion. pt exposed to wild-type varicella in approx 7/98;pt also devel rash that blistered then scabbed over;pt had itching but no pain;
Pt immunized on 09/13/2005. Per ER report fevers stated 09/14/2005. On 09/15/2005 appeared to have febrile seizure lasting about 3 mins witnessed by grandmother in bathroom.
This spontaneous report as received from a licensed practical nurse refers to a 24 days old patient who on 21-JUN-2012, was vaccinated with a 2 ml dose of ROTATEQ (lot number not reported). No adverse effects were reported. Additional information has been requested.
Pt. states that after receiving the 3rd dose of Moderna 12/06/2021, started experiencing symptoms 12/07/2021 of pain in the injection arm (arm), itchiness, redness and swelling at the injection site. Headache continuing with shortness of breath. No noted Primary visit/communications.
Swelling size of soft ball, redness some, site warm and very sore to touch pt states hurts when moves.