chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Folic acid increased; ABNORMAL LIVER CELLS; Liver function test abnormal; Ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), LIVER FUNCTION TEST ABNORMAL (Liver function test abnormal), BLOOD FOLATE INCREASED (Folic acid increased) and HEPATIC FUNCTION ABNORMAL (ABNORMAL LIVER CELLS) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    Concomitant products included PREDNISONE for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and METHOTREXATE (Oral) at an unspecified dose. In April 2021, the patient experienced PAIN (Ache). In December 2021, the patient experienced LIVER FUNCTION TEST ABNORMAL (Liver function test abnormal) and HEPATIC FUNCTION ABNORMAL (ABNORMAL LIVER CELLS). On an unknown date, the patient experienced BLOOD FOLATE INCREASED (Folic acid increased). At the time of the report, PAIN (Ache), LIVER FUNCTION TEST ABNORMAL (Liver function test abnormal) and HEPATIC FUNCTION ABNORMAL (ABNORMAL LIVER CELLS) had resolved and BLOOD FOLATE INCREASED (Folic acid increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood folate: folic acid increased. On an unknown date, Liver function test: Abnormal.         It was unknown if the patient was enrolled in COVID-19 vaccine trials.  The reporter's causality for the event(s) of ABNORMAL LIVER CELLS, INCREASED PAIN, FOLIC ACID WAS INCREASED and FEVER was not provided. The reporter's causality for the event(s) of ACHE with RINVOQ(UPADACITINIB) was a reasonable possibility.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.    This case was linked to MOD-2021-620820, MOD-2022-623622 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Patient information updated. Event added.
This spontaneous report was received from a medical assistant referring to a female patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. In 1999, the patient was vaccinated with PEDVAXHIB (dose, route of administration and lot number were not reported) for prophylaxis. Other suspect therapies included (unspecified), DTaP (manufacturer not reported) and poliovirus vaccine inactivated (unspecified) (manufacturer not reported). The medical assistant reported that the patient received a "vaccine combination, DTaP, Polio and some kind of HIB back in 1999 where the combination caused hives". The outcome of hives was resolved/recovered. Causality assessment was not provided by the reporter. No further information was provided. Additional information has been requested.
Patient received vaccine at around 11am.  After waiting around for a few minutes he stated he was light headed.  I went over to observe and gave patient some water.  He was starting to sweat and turned very pale.  1 minute later he passed out.  I brought him to the floor from his chair and he  starting shaking and 'seizing" for about 10-15 seconds.  We used pressure on his chest to try to "snap" him out of it.  After about 15 seconds of "seizing,not breathing normally and his left arm completely locked up" he came to and did not know where he was for about 2-3 minutes.  After about that time he started to realize where he was and recognized his wife who was assisting.  EMS was called and arrived shortly,  He was lucid and knew where he was and started to feel normal again.  EMS checked his vitals and they were normal.  Patient refused to go to hospital and EMS released him to his wife.  I checked on patient 4 hours later and he had no ill effects and stated he felt just like he did before receiving the vaccination.
pt had a positive COVID test on 1/5/2022; admitted to Hospital; limited medical records sent from hospital; pt was DNR, comfort measures only; inpatient hospice where he passed away
Rolling rashes all over the body (including head, shoulders, torso, legs, hands & feet) began to form 6 days following booster shot. Rashes would last 20-30 minutes and begin to appear in other areas. Cordisone was applied and anti-histamine was taken, but rashes continued for another week. Went to Immediate Care and was prescribed Famotidine and Prednisone.
COVID-arm; redness grew bigger; looks blotchy; bump on her arm; itchy; This spontaneous case was reported by a consumer and describes the occurrence of MASS EXCISION (bump on her arm), PRURITUS (itchy), HYPERSENSITIVITY (COVID-arm), ERYTHEMA (redness grew bigger) and RASH MACULAR (looks blotchy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MASS EXCISION (bump on her arm) and PRURITUS (itchy). On 14-Mar-2021, the patient experienced HYPERSENSITIVITY (COVID-arm), ERYTHEMA (redness grew bigger) and RASH MACULAR (looks blotchy). At the time of the report, MASS EXCISION (bump on her arm), PRURITUS (itchy), HYPERSENSITIVITY (COVID-arm), ERYTHEMA (redness grew bigger) and RASH MACULAR (looks blotchy) outcome was unknown.        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.   Birth control pills were included as concomitant medications
pt recv vax 1PM & 3AM woke w/feeling of throat closing w/severe shooting pains going up neck & down rt arm;flu like sx started;unusual effect was sharp pain in neck & arm;had chills & lost voice 3 days;entire process took 10 days;
Pt. describes "knot" in shoulder w/swelling, redness, fever, chills and a rash on the trunk. He self-treated with diphenhydramine then saw a Dr. on 10-23-16 who administered a steroid injection.
Lymph nodes under the right arm are swollen; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes under the right arm are swollen), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes under the right arm are swollen), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. At the time of the report, LYMPHADENOPATHY (Lymph nodes under the right arm are swollen), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Heart rate: increased (High) fast heart beat that persisted for a couple days.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       concomitant medications  were not reported   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: event was updated (Heart beat increase), withdrawn the 2nd dose
After about 45 minutes, I got very, very sick to my stomach. I was vomiting profusely. That didn't really stop at all. Anything that I put in my mouth, I would immediately vomit it up. I couldn't keep anything down. That lasted for two weeks. I also have a heart murmur - the vaccine made it worse- I couldn't breathe or go to sleep. I couldn't catch my breath - that started at 6 or 7. I had taken a Xanax - but I couldn't keep anything down - even that. So I tried to keep myself calm. My heart was palpitating the entire two weeks after I had it. I lost about 14 pounds. I could only pee once a twice a day - about day 14 - I was threatened to being taken to ER if I couldn't keep fluids down. I called my doctor and had a telephone appt. High fever - 103 - for a week and a half. It would go down to about 100.2 but then it would rise back up to 103 the first week. I was still running fevers the second week but that week was 101 was the highest. My period: I've never had children but my period has been completely off. I started my period the day after the vaccine - heavy clotting and I just had had my period two weeks before. It was the worst period that I have ever had - it went up to 17 days. I started eating baby food around 17 days. I started drinking broth and eating baby food at about day 15 after vaccine -something really really light that I didn't have to chew. I'm still having symptoms with food now. I have not been able to keep anything really solid  - it just sits in my throat (the food doesn't get to my stomach) and then it comes out like it's been sitting in a tube. I have had really bad skin reaction on my back. I have never had any back acne or anything weird. About four or five days after vaccine, it felt like sparklers were being lit on my back. I have red sores all over my back.  I am having issues controlling my arms and hands. I can't hold the spatulas when I cook. When I go to grab things they fly out of my hands. I have never had that issue before. I started noticing those things about week 2 - about right when I started to eat. At first, I thought I was just weak and that I just couldn't control it because I hadn't eaten. But it's still happening. I have had constant headaches. The day after the vaccine, I had about six or seven days in a row of Optical migraines. I haven't had anymore or those but I'm still having headaches. Within about five days after I started slowly sipping the broth and eating baby food, I was starting to be able to be a little strength.
I developed severe waves of nausea, hives, vertigo, tinnitus and the rash would cover my entire body burning and tingling for several hours at a time. I also developed skin allergies to metal, sunlight, physical activity, and others. This condition has continued since I received the vaccination.
Information has been received from a physician concerning a 15 year old female patient, who on an unspecified date, was vaccinated with ZOSTAVAX (Oka/Merck).  The physician reported that the patient received ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck0 (MSD).  The outcome is unknown.  Follow-up information from her physician indicated that she was a 15 year old female patient, with no known drug reactions/allergies, who on 19-DEC-2008 at 18:30, the patient was accidentally vaccinated with the first dose of ZOSTAVAX (Oka/Merck) (Lot # 659760/0159X), subcutaneously, instead of VARIVAX (Oka/Merck).  Concomitant therapy included the first dose of GARDASIL (Lot # 661530/0575X), intramuscularly, the first dose of MENACTRA (Lot # U2733AA), intramuscularly and the first dose of ENGERIX B (Lot # AHBUB5E2AA), intramuscularly.  There were no illnesses at the time of vaccination.   Additional information has been requested.
The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported.On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.) had resolved. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were provided.No treatment medications were provided.
Pt recvd vax 4FEB93 & 21FEV93 had swelling, stiffness & pain in both wrists & knee & a rash from neck to ankles; swelling, pain, & stiffness progressed to ankles, hips, shoulder & digits; pt went to MD took blood for RA factor, Sed rate;
Patient did nothing but cry and sleep for 2 weeks after receiving initial (2 month old) vaccines - DTaP, HepB, Hib, IPV, Prevnar. He did not want to be touched or moved. He has since received DT seperately without incident.
a PCR positive case of COVID; a PCR positive case of COVID; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CIDP" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 04Dec2019; IVIGLOB-EX, start date: 01Sep2014, stop date: 26Apr2022.  The following information was reported: VACCINATION FAILURE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "recovered" (Apr2022) and all described as "a PCR positive case of COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (Apr2022) Positive; SARS-CoV-2 test: (Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination Failure and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Vaccine injected into shoulder joint; A spontaneous report was received from a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine was injected into shoulder joint.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 30 Dec 2020, during vaccine administration, the vaccine was injected into the patient's shoulder joint instead of the muscle. Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, vaccine injected into shoulder joint, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273.  There were no reported adverse events associated with this case.
Varicella Information has been received from a physician and a school nurse concerning an 10 year old male who on 08-JAN-1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was also noted that the patient was vaccinated with a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl-Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 15-DEC-1995 and 24-JUN-2000. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005 the child developed a mild case of break through varicella with less than 50 lesion. Unspecified medical attention was sought. The outcome was recovered. A product quality complain was not involved. No additional information is expected.
No ADR, timing ERROR, 2nd dose given 45 days after 1st one  Narrative: No ADR, timing ERROR, 2nd dose  given 45 days after 1st one
pt recv vax 26AUG96 & devel swelling @ site;extended to below elbow to chest w/erythema warmth & pain;cellulitis;needed IV ATB surgery consulted;did not need drainage;sent home on ATB; swelling dec but not back to nl;
severe weakness in arms and legs, called MD, saw MD on 10/8., LAbs drawn, sent to another MD on 10/10 11/9/09: Rheumatology consult received for date of service 11/2/09.  DX:  Polyarticular synovitis, elevated ESR, elevated CRP.  Assessment:  Presents in wheelchair with c/o pain after flu shot.  Having difficulty performing ADL's.  Occasional blurry vision, shakes and tremors secondary to pain.  Bilateral shoulders with positive impingement sign, negative drop sign.  Bilateral hands with MCP and PIP synovitis, unable to make fists bilaterally.  Bilateral knees with synovitis. Bilateral knee arthrocentesis performed with Depo Medrol and Lidocaine injected. Placed on prednisone taper.  No evidence of GBS.  To RTC in one week.      11/25/09 Hosp. records received for date 10/30/09 to 9/3/09. Operative report from date 9/1. DX: left hip osteoarthritis. Surgery: left total hip arthroplastying .  ER visit on 10/30/09 w/ c/o weakness,  hurting all over, swelling left hand and foot, poor appetite. Pt states started after receiving the flu shot x3-4wks ago. Assessment: (+)weakness, (+)leg swelling, (+)tremors focal weakness,(+)hand edematous, abnormal muscle tone. DX: musculo-skeletal pain, tremors, generalized weakness.
This spontaneous case, initially received from a pharmacist on 18-Oct-2018, concerns a 33-year-old, adult male patient. The patient's current condition included autism (reported as medical history). The patient's concomitant medication included ZOLOFT. On 17-Oct-2018, the patient (under age of 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 250788 and expiry date: 30-Apr-2019] (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse event was reported after the vaccination. The reporter assessed this case as non-serious. Non-significant follow-up received from the pharmacist on 13-Nov-2018: The reporter confirmed that autism was ongoing at the time of vaccination and no adverse events were noted after the vaccination. No changes were made in the narrative.
day of- fever, fatigue 2 weeks after and continued to present: swelling of lymph nodes in right axillary. Same reaction after dose 2 completed, lasted 6months. - 1 week after lasting 1 month:  SOB worse on exacerbation, no relief with rescue inhaler.
RASH ON RIGHT LOWER ARM AND RASH SPOTS ALL OVER SKIN; ITCHINESS; This spontaneous report received from a patient 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 not reported, batch number: Unk) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 11-MAR-2021, the subject experienced rash on right lower arm and rash spots all over skin. On 11-MAR-2021, the subject experienced itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on right lower arm and rash spots all over skin and itchiness was not reported. This report was non-serious.
Muscle spasms; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating) and MUSCLE SPASMS (Muscle spasms) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included CHOLESTEROL for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 29-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced MUSCLE SPASMS (Muscle spasms). At the time of the report, HYPERHIDROSIS (Sweating) had resolved and MUSCLE SPASMS (Muscle spasms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was treated with Muscle Relaxant.  No Treatment Drug information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Severe muscle spasms and all over body pain. Fever 103 for over 24hrs.
Information has been received from a physician and a medical assistant concerning a 14 year old female with a history of asthma and recurrent otitis media; penicillin, KEFLEX, and sulfa drug allergies, who on 13-OCT-2008 was vaccinated with a first dose of GARDASIL (lot # 655205/1426P), intramuscularly.  Concomitant therapy included medroxyprogesterone acetate DEPO-PROVERA.  On October 2008 the patient experienced dizziness.  She experienced the dizziness mainly in the in the morning but the dizziness is progressively getting worse and occurs during the day also.  Laboratory diagnostics studies performed included a CBC, a complete metabolic panel and a TSH on 03-Dec-2008.  The patient sought medial attention through an office visit.  The patient had not recovered.  Additional information has been requested.
11Sep90 pt vax; 16Sep90 devel temp of 103F.  Tx w/ APAP.  FEver subsided.
Patient received vaccine and was waiting by clinic for the 15 minute wait time. During the first 10 minutes, Patient started to feel dizzy. Brought patient into exam room to have him lay down. Checked oxygen status and it was WNL. Gave patient some water and patient started to feel better.  Mom was at bedside with patient and stated the patient has anxiety and this has happened before with some vaccines/illnesses. Patient was able to walk out of the clinic and no longer felt dizzy.
Patient is complaining of continued soreness at injection site. Soreness has been noted for 2 weeks post injection. Claims that it is difficult to raise her arm. The area is not swollen or warm to the touch. Claims that this is the first time this has occured following an immunization.
Information has been received from an attorney indicating that on an 11/16/98 a pt was vaccinated with a dose of hep B virus vaccine. It was also reported that, on 11/16/98, the pt was vaccinated with a dose of hep B virus vaccine and Hib conj vaccine (622469/1015H). Subsequently the pt experienced death. The cause of death was not reported. Additional info will be provided as it becomes available.
COVID (+) WITH SYMPTOMS SORE THROAT AND NASAL CONGESTION Narrative:
Reported "entire body feels heavy, foggy, slow thinking, decision-making, chest tightness, left frontal headache"