chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Verify fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Verify fatigue) in a 54-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Verify fatigue). At the time of the report, FATIGUE (Verify fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Alanine aminotransferase (6-29): 93 (High) 93. On 25-Mar-2021, Albumin globulin ratio (1.0-2.5): 1.6 (normal) 1.6. On 25-Mar-2021, Aspartate aminotransferase (10-35): 54 (High) 54. On 25-Mar-2021, Blood albumin (3.6-5.1): 4.6 (normal) 4.6. On 25-Mar-2021, Blood alkaline phosphatase (37-163): 189 (High) 189. On 25-Mar-2021, Blood bilirubin (0.2-1.2): 0.3 (normal) 0.3. On 25-Mar-2021, Blood calcium (8.6-10.4): 9.5 (normal) 9.5. On 25-Mar-2021, Blood chloride (98-110): 102 (Low) 102. On 25-Mar-2021, Blood creatine phosphokinase (29-143): 39 (normal) 39. On 25-Mar-2021, Blood creatinine (0.50-1.05): 0.82 (normal) 0.82. On 25-Mar-2021, Blood glucose (65-99): 82 (normal) 82. On 25-Mar-2021, Blood potassium (3.5-5.3): 5.0 (normal) 5.0. On 25-Mar-2021, Blood sodium (135-146): 139 (normal) 139. On 25-Mar-2021, Blood urea increased (7-25): 19 (normal) 19. On 25-Mar-2021, Blood urea nitrogen/creatinine ratio (6-22): inconclusive (Inconclusive) inconclusive. On 25-Mar-2021, Carbon dioxide (20-32): 27 (Low) 27. On 25-Mar-2021, Gamma-glutamyltransferase (3-7.0): 267 (High) 267. On 25-Mar-2021, Globulin (1.9-3.7): 2.8 (normal) 2.8. On 25-Mar-2021, Glomerular filtration rate (60-Unknown): 81 (normal) >OR+60 ML/Min 1.73m2. On 25-Mar-2021, Hepatitis A antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B core antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis B surface antigen: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Hepatitis C antibody: non reactive (Negative) Non reactive and non reactive (Negative) Non reactive. On 25-Mar-2021, Protein total (6.1-8.1 g/dL): 7.4 g/dL (Low) 7.4. On 25-Mar-2021, SARS-CoV-2 antibody test (<1.00-Unknown Index of reactivity): 6.40 Index of reactivity (High) 6.40. On 25-Mar-2021, White blood cell count: tnp thousand per microlitre (Inconclusive) TNP.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided No treatment medication details were provided.
Greater than 35 days since first dose; Mild headache; Sore arm; Inadvertently administered dose to a teenager; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Mild headache), MYALGIA (Sore arm), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager) and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced HEADACHE (Mild headache), MYALGIA (Sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose). On 29-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertently administered dose to a teenager) had resolved. On 30-Jul-2021, HEADACHE (Mild headache) and MYALGIA (Sore arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since first dose) had resolved.        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.   No concomitant medication information were provided. No treatment information were provided
Pt recv vax on unspecified date; pt exp localized rx on unspecified date.
A physician reported the occurrence of arthritis in an adult male of unspecified age who was vaccinated with Lyme disease vaccine recombinant OspA for prophylaxis. The subject's medical history, concurrent condition, and concurrent medications were unknown. On an unspecified date following his third LYMErix injection, the subject developed arthritis characterized by "non-specific and specific" arthralgias. As of 9/12/02, the outcome of the event was unknown. The adverse event "arthritis" does not meet serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/000 letter.
Starting at 0215 on 01/29/21 I was woken up abruptly with Severe joint pain, body aches, fever, at 101.8, nausea and vomiting, chills, headache, fatigue. These severe symptoms lasted until around 2300 on 1/29/21. Mild body aches and headache continue through 1/30/21.
weakness in right leg Narrative: 75 yo male with PMH: COPD, cervicalgia, depression, s/p TKA, HLP, hypothyroid and HTN called triage line on 3/3/2021 to report that he felt dizzy and had weakness in his legs x 2 weeks after he had his second dose of covid19 vaccine on 2/17/2021. Pt said he took nothing for it, symptoms self-resolved. Pt had his first dose of covid19 vaccine on 1/27/2021. Both vaccines were administered without complication. Pt did not report any ADR with the first dose.
Mom reported that pt woke up on Sunday feeling fatigued, achy, h/a.  No fever. Those symptoms improved but then a swollen area developed under armpit/axilla about the size of a golfball, not red or warm.
Extreme body aches, stiff neck, sore neck to even lightly touch, headache also sore to touch head, chills/sweats back and forth.
Pt was administered a full dose (0.5mL) of influenza vaccine and a dose of Menactra.
This is a spontaneous report from a contactable Physician communicated to a Pfizer sales representative. This physician reported similar events for 4 patients, this is the third of 4 reports. A 19 years old male patient of an unspecified ethnicity received on 19Sep2017 the second dose of TRUMENBA (lot# S26985), intramuscular at single dose, in the deltoid and influenza vaccine (FLU SHOT), via an unspecified route of administration both for immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of meningococcal group b rlp2086 for immunisation. The patient underwent tuberculin test on unspecified date. On 19Sep2017 the patient experienced fever of 102 F and chills after receiving vaccine. Mother of patient called the office later the evening after the patient got the vaccine to report the events. The doctor asked that the patient get Ibuprofen. The office followed up three days later and the patient was fine. The patient recovered on unspecified date in Sep2017. Sender's Comments: Linked Report(s): US-PFIZER INC-2017421689 same reporter/product, different patient/event.
patient received KINRIX as part of 4y.o. physical, in (L) deltoid 4/3/09 at approximately 9:AM; went to school after appt, picked up from school at 5PM; mom noted redness and swelling at injection site at 6PM; received BENADRYL at bedtime x 2 nights, TYLENOL Drn, site pain fill to touch but didn't limit activities, (L) arm swollen to elbow by AM of 4/5 but significantly improved by AM 4/6; now less swollen, less red
The mother of the child stated that the onset of the symptoms started at least 24 hours after the vaccinaion. The child developed flat, pink spots that do not itch (per the child) on her face, and arms. The mother stated that the child had a fever, but she never took her temperature. The injection site was red, swollen, and warm to the touch. Upon visual inspection by the nurses here at the County Health Department, no spots were found on the child's chest or back.
Subsequent to receiving vax, the pt developed a fever of 102 degrees. The reporter indicated that 2 pts experienced fever; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
I had heavy, sudden onset uterine bleeding two weeks after my first dose that lasted for three intense days and then stopped as abruptly as it began. It was not consistent with my expected period cycle. I received the 2nd dose Pfizer covid dose three weeks after the first. Since that first dose, my periods have been irregular - at first coming very close together, then farther apart, and very heavy.
pt recvd vax;started shaking all over & was acting like he was in a daze & not responding well;mom took pt to to er; md said it was fever & red ear;atb given T 100.3 at er;to PMD next am who felt rxn to MMR;
Cutaneous hyperesthesia at about 12 hours post injection. Started with lower body and at about 14 hours, was entire body. It was most noticeable in lower extremity, face, abdomen, and scalp.
? 1st dose Pfizer was on 05/01/21, 2nd on 05/24/21. Patient was 15yrs old at the time of their doses but turned 16 on 06/02/21.   No adverse effects to report, just age at the time of first dose.
vax given 1130AM;pt had hard crying beginning 3hr p/shot lasted 12hr not a high pitched cry;limping w/lt leg
This spontaneous case reported by a consumer, describes the occurrence of rash (rash on stomach about the size of a palm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunisation. No medical history reported. On Mar 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 16, 2021, patient experienced rash (rash on stomach about the size of a palm). At the time of the report, rash (rash on stomach about the size of a palm): not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant product use and treatment information not provided.
This spontaneous report was received from a pharmacist refers to a 71 year old male patient enrolled in a patient support program ZOSTAVAX pharmacy competitive qual exploration. The patient has current condition of cholesterol, high blood pressure and diabetes. On an unknown date in NOV-2014, the patient was vaccinated with ZOSTAVAX (lot # not reported). On an unknown date in 2014 (10 days after the vaccination) the patient developed herpes zoster. The outcome of the event was reported as recovered/resolved. The reporter considered the event to be not related to ZOSTAVAX. Additional information has been requested.
Ascending paresthesias, loss of distal reflexes, gait unsteadiness, progressed over 3 weeks. Diagnosis of Guillain-Barre Syndrome.
A consumer report has been received. The report concerns a 7 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 08-Nov-2012. The patient experienced fever which started on 08-Nov-2012. At the time of reporting, the event of fever was ongoing. The report was considered to be non-serious.
1/18/22 pt had a positive COVID test ordered by a local HCF; per death certificate, the manner of death was natural, the cause of death was COVID 19; the pt died at his residence
red rash; shoulder became swollen; sick; This case was reported by a other health professional via call center representative and described the occurrence of red rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced red rash, swollen joints and sickness. On an unknown date, the outcome of the red rash, swollen joints and sickness were recovered/resolved.   It was unknown if the reporter considered the red rash, swollen joints and sickness to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was reported. The patient received 1st dose of shingrix and same shoulder became swollen, developed rash and became sick. The reporter mentioned that, the events resolved within 2 weeks. No further information provided. The reporter consented to follow up.
12 hrs. after receiving injection I started having body aches, fever, and excruciating headache.  Headache lasted about 12 hrs.  But fever and body aches lasted for 2 days.
My side affects from first dose is really bad.; 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 ADVERSE EVENT (My side affects from first dose is really bad.) 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 ADVERSE EVENT (My side affects from first dose is really bad.). At the time of the report, ADVERSE EVENT (My side affects from first dose is really bad.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
feeling of swelling in tongue and lower lip. Scratchy feeling also in same areas. Started about 25 minutes after shot on drive home. Took allegra and it went away in 30-60 minutes. Tongue was sore the next day.  I also suffered a mild anxiety attack at the same time. Treatment for that was meditation and cessation of throat swelling symptoms.  Lastly, I also had a severe flare up of my fibromyalgia symptoms in my forearms starting 3 days after the injection. I don't know if this was a primary effect from the vaccine, or secondary from the additional nociceptive input from the joint and muscle pain I was experiencing in my forearms. I increased my lyrica to compensate. Two weeks out from the shot I'm almost back to baseline.
Low grade temperature 99.4. Shivers until I literally shook so hard I could not stand up, ache for about 36 hours.
The patient received her COVID vaccine on March 17, 2021 at a local clinic. She developed bruises within days after the shot.  She pursued care and diagnosis and reporting with the vaccine administrator, but finally had to see PCP.  After multiple visits, the patient was sent to Hospital.  She was diagnosed with AML (hospitalized 5 days: April 6-10) and started chemotherapy (outpatient on April 19).  She returned to hospital on April 25 in distress and diagnosed with COVID.  The patient was put on a ventilator with pressor support on May 1 and passed away on May 10, 2021.
tested positive; tested positive; coughing; wheezing; feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6198) and on 05Oct2021 as dose 2, single (Lot number: FF8839) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Covid-19", start date: Nov2020 (unspecified if ongoing); "Acid Reflux" (unspecified if ongoing); "Herpes on her skin" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; LOSARTAN taken for hypertension; OMEPRAZOLE taken for gastrooesophageal reflux disease; VALACYCLOVIR [VALACICLOVIR] taken for herpes virus infection. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive"; COUGH (non-serious), outcome "unknown", described as "coughing"; WHEEZING (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "feeling tired". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: fine; SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, cough, wheezing, fatigue. Clinical courses: She is currently having her 2nd round of COVID, the current one she thought that it was started on Tuesday and she tested positive on Wednesday and she did say that it was a milder case with some coughing, wheezing, feeling tired and she was put on Paxlovid and it is her fourth day today (08Aug2022). Also she mentioned that 2 days after testing positive, she tested she used a home test and she tested negative and she did ask if Paxlovid would have any effect on test. And also she mentioned when she tested positive she went to a heath care facility. The patient was very active, healthy, thin and did not look like and act like 81. The patient was just less than 5 feet 4 like little more that 4'11, under 5 feet like 4 feet 11 and a half she was half inch lee than 5 feet. She did take other medication quite a few. She did take two high blood pressure medicines. Losartan in the morning and amlodipine in the night time and she had been checking her pressure because she knew she read that it could affect pressure but it has been fine. Omeprazole for acid reflux and other one she did take Valacyclovir every day, she had a very very light case of herpes that she had had for 30 years that is on her skin and she was cutting down with that because she had not had any break out for over 2 years that was the strange thing where she had this but she did not had a for very long time and she had not had a  break out for two years so she was cutting down she did not take every day now (Further not clarified). Treatment, consumer stated, No, the coughing she was actually just drinking some tea, lots of water and using lozenges.
The patient had negative titers to rubella; This spontaneous report was received from a pharmacist and refers to a 47-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history.  It was reported that the patient might or might not have been administered 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (unknown lots and expiration dates) on two separate dates when he was a child. On an unknown date, (reported as couple of years ago) the patient attended to his doctor's office and the doctor drew a bloodwork which showed that the patient had negative titers to rubella and was encouraged to get revaccinated, however, the patient did not at that time.  On 05-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # R028523, expiration date on 04-OCT-2020, subcutaneously (strength, dose, frequency, route of administration, and anatomical location were not reported) to protect against measles, mumps and rubella (prophylaxis).  The relatedness between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
pt recvd vax 945AM 14FEB95 & @1130AM mom called stated pt was shivering & shaking, t101 R; brought pt back to clinic; pt limp & pale; HR 180; R48; called MD & ambulance; sent to hosp adm; t105; dx allerg react to pertussis vax;
I have had chronic migraines since age 15. They have been well controlled with my medications and I was only having 1-2 weekly.  On September 21, 2021 I received the Jansen vaccine. I had concerns about being vaccinated from the beginning and my concerns were valid, I now have the exact problem that I was concerned about.  I had a severe migraine for 17 days.  Since then I have had moderate to severe headaches and/or migraines every day except 2.  This has significantly affected my health and life as I have had to miss multiple events, have called in to work and am unable to complete daily activities because of the significant pain from the migraines. Because of someone else's beliefs I had to be vaccinated, now I have to suffer for who knows how long.
Pt developed redness, swelling and pain at site of varicella vaccine same day.  Morning after vaccines given pt had headache, fever and vomiting and later developed runny/stuffy nose and cough.  Mother took patient to Urgent Care and told Staph infection and started on Bactrim DS.  Follow up dx 4 days later with me, vaccine administering provider:  No redness, mild swelling and mild pain at Var injection site, pt with cold symptoms and not yet fully recovered as of 4/7/08.  It is my professional opinion that this was not a Staph infection but a combination of a new onset upper respiratory infection and localized reaction to Var vaccine.
Very tired; Dose interval of 2 weeks/ doses were 2 weeks apart; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval of 2 weeks/ doses were 2 weeks apart) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic fatigue syndrome and Fibromyalgia. Concomitant products included NAPROXEN, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), ZOLPIDEM TARTRATE (AMBIEN) and SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval of 2 weeks/ doses were 2 weeks apart). In May 2021, the patient experienced FATIGUE (Very tired). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose interval of 2 weeks/ doses were 2 weeks apart) had resolved. At the time of the report, FATIGUE (Very tired) had not resolved.            No treatment information was provided.   This case was linked to MOD-2021-399093 (Patient Link).
About 15 minutes after the shot my tongue was swelling and my throat. I was taken to the ER where they gave me an IV of Prednisone, Benadryl and after 2 hours I was discharged home.   I have not received the second dose of the vaccine .
After the vaccine I was sick more frequently. I had sinus issues and allergies issues more then I would throughout the year. Now I have been diagnosed with COVID. Throughout the whole year of 2021 after getting the vaccine I did not feel good.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium, Additional Details: Patient fainted 1 min after receiving vaccine, then started seizing in chair was moved to ground with legs up. Was checked to make sure breathing was occuring, after 3 min patient was back to normal. when woke up felt dizzy asked what year and where they were and answered correctly. Ambulancewas called pt denied being taken to hospital. bp low
Pt states that her top part of her left arm is swollen and toward the front part of her arm/ arm pit area and red and very sore to touch.
Rash on both arms and neck leaving permanent scarring and skin discoloration that is ongoing, joint pain and swelling significantly impacting mobility - used steroids to relieve symptoms, red spots on hands/fingers/feet that are on going