chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has been diagnosed with Celiac disease on 02May2022; This spontaneous case was reported by a patient and describes the occurrence of COELIAC DISEASE (Patient has been diagnosed with Celiac disease on 02May2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease (she takes levothyroxine and had this history even before the 1st dose of Moderna vaccine.). Concomitant products included LEVOTHYROXINE for Hashimoto's disease.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2022, the patient experienced COELIAC DISEASE (Patient has been diagnosed with Celiac disease on 02May2022) (seriousness criterion medically significant). At the time of the report, COELIAC DISEASE (Patient has been diagnosed with Celiac disease on 02May2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2022, Biopsy: celiac disease (abnormal) On 02May2022 patient was diagnosed with celiac disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's height was 5'6. Concomitant medication were given as Supplements. Patient stated that she wanted to get the 2nd booster dose on the day of reporting. No treatment medication was received.  Company Comment: This spontaneous case concerns a 68-year-old female patient with relevant medical history of Hashimoto's disease, who was diagnosed with unexpected serious (medically significant) event of Celiac disease. The event occurred 5 months 10 days after the 3rd dose of the mRNA-1273 (Spikevax). Concomitant products included levothyroxine for Hashimoto's disease. Medical history of Hashimoto's disease is known to have association with other autoimmune disorders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old female patient with relevant medical history of Hashimoto's disease, who was diagnosed with unexpected serious (medically significant) event of Celiac disease. The event occurred 5 months 10 days after the 3rd dose of the mRNA-1273 (Spikevax). Concomitant products included levothyroxine for Hashimoto's disease. Medical history of Hashimoto's disease is known to have association with other autoimmune disorders. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient received 1st dose of her Shingrix vaccine. She was putting info in her phone for the next shot and after about a minute, noticed that she had her head leaning against the wall in her seat. Went out to help her and as she said she wasn't feeling well and was having what she called a "vaso vagal reaction" and was feeling very dizzy and like she was going to throw up. She wanted to lie down on the ground so helped her to the ground. Had already had a technician call 911. Once they arrived they helped her stand up and did take her on a stretcher.
Extreme soreness and pain in my shoulders, collar bone and back of head. Comes and goes all of the time since the vaccine with no prior strain or exercise to cause it. Deep soreness and burning in those specific areas only that sometimes cause migraine.
Mother states that post receiving vaccines, pt's attitude changed - she became quiet, withdrawn, shut down, stopped saying "mamas", wouldn't smile. Became more of a baby in the last month post vacc in 3/2013.
COULD NOT RETURN TO SLEEP; FEET WERE FEELING HOT; This spontaneous report received from a patient concerned a 75 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included patient had no known allergies. patient was taking anti-allergen and was taking another medication for going to the bathroom, possibly causing pimples.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 at 12:30-12:45 PM EST to Left Deltoid in arm for prophylactic vaccination. Concomitant medications included allopurinol, amlodipine, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, ergocalciferol, and pravastatin. On 07-APR-2021, the subject experienced hot feeling in feet. On 08-APR-2021, the subject experienced difficulty sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot feeling in feet, and the outcome of difficulty sleeping was not reported. This report was non-serious.
She has been suffering with the hot flashes; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (she got Moderna for the second booster shot, Dose 4 (Booster), Single), administration date: 11May2022, for Covid-19 immunization, reaction(s): "hot flashes"; Covid-19 vaccine (Primary Immunization series completed; unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 Booster), for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 17Oct2022, outcome "unknown"; HOT FLUSH (non-serious), outcome "unknown", described as "She has been suffering with the hot flashes".  Additional information: She has hot flashes 24/7 since the middle of Jun2022, after she received the second booster. She got Moderna for the second booster shot on 11May2022, and she started with the hot flashes since Jun2022. On 17Oct2022 she received a third booster with a Pfizer COVID 19 vaccine, but she has been suffering with the hot flashes since Jun2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Called to assist child post flu shot, child observed falling to the floor & stating "can't move legs." C/O "throat hurts". Diaphoretic, pale. RR 22 HR WNL BP 100/72. A&O x3. EMS called.
Rheumatoid arthritis flare up; Burning leg; Foot/leg cramps; Swelling of legs; Lower extremities weakness of; Generalized aching; Headache; fever; fatigue; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BURNING SENSATION (Burning leg), MUSCLE SPASMS (Foot/leg cramps), PERIPHERAL SWELLING (Swelling of legs) and MUSCULAR WEAKNESS (Lower extremities weakness of) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.   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. In April 2021, the patient experienced BURNING SENSATION (Burning leg), MUSCLE SPASMS (Foot/leg cramps), PERIPHERAL SWELLING (Swelling of legs), MUSCULAR WEAKNESS (Lower extremities weakness of), PAIN (Generalized aching), HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (Chills). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BURNING SENSATION (Burning leg), MUSCULAR WEAKNESS (Lower extremities weakness of), PAIN (Generalized aching), HEADACHE (Headache), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (Chills) outcome was unknown and MUSCLE SPASMS (Foot/leg cramps) and PERIPHERAL SWELLING (Swelling of legs) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.  Company Comment  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.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events; Sender'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.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.
Blood clot.  Right leg.  Treatment Lovenox injections and Pradaxa blood thinner medication.  Time on Pradaxa to be determined on resolution of blood clot.
Severe injection site pain; fever of 101.5 for 24 hours; severe chills; body aches; migraine; This is a spontaneous report from a contactable consumer reporting for herself. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 11Feb2021 at 14:00 (at the age of 47 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unspecified date for COVID-19 IMMUNIZATION. Relevant medical history included Epstein Barr. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included "Fiornel" and ibuprofen (ADVIL).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date, the patient experienced severe injection site pain, fever of 101.5 for 24 hours, severe chills, body aches and migraine. The patient received treatment for these events which included ibuprofen (ADVIL), acetaminophen, (TYLENOL) and "fiornel". The outcome of the events severe injection site pain, fever of 101.5 for 24 hours, severe chills, body aches and migraine was unknown. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Hospitalization: 3/3/2023 - 3/6/2023 (3 days) Presentation to the ED: possible autoimmune encephalitis  COVID + date: 03/04/2023 Treatment: remdesivir Discharge to: SNF 046B21A 4/13/2021 003C21A 5/11/2021 028K21A 1/2/2022
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 08-DEC-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, dose:0.5  milliliter, lot # T001213, expiration date: 12-JAN-2022, intramuscular instead of subcutaneous route for prophylaxis (dose number unspecified) (Incorrect route of product administration). No additional adverse reported. No product quality complaint was reported.
Information has been received from a physician concerning her 2 year old son who was vaccinated with the first dose of varicella virus vaccine live on an unspecified date.  On 12/19/1996, the patient developed shingles.  No additional information was available at the time of this report.  It was reported that the patient's older brother later developed chickenpox. associated WAS0412USA02230.  Additional information has been requested.
SEVERE BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced severe body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe body aches was not reported. This report was non-serious.
Patient reported hard lump that had grown from golf-ball size to size of baseball from 01/25-01/26. Said it was not painful until 01/26. Pt went to an.
High pitched incident screaming for 2hrs started 4 hrs after injection. Tylenol given.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 10-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject's medical history included allergic rhinitis and allergy to amoxicillin. Concurrent vaccination included VARIVAX (non-gsk); Merck given on 19 May 2010. On 19 May 2010 at 16:20 the subject received 2nd dose of HAVRIX (.5 ml, unknown route, right arm). On 20 May 2010, 1 day after vaccination with HAVRIX, the subject experienced injection site redness, injection site swollen and injection site pustule. The subject was treated with ice. At the time of reporting the events were unresolved. The events were reported to the healthcare professional by the school nurse. Follow-up information was received on 03 June 2010. It was reported that the reactions were just local with onset 20 May 2010. The events resolved by 24 May 2010. It was noted that the area around the injection site was bumpy. Treatment included BENADRYL Cream and ice packs. The 1st HAVRIX injection was given on 03 July 2008.
woke up Tuesday am with 102F (orally), generalized body aches, fatigue, headache and diarrhea
Vaccine was given on 2/13/08. The next a.m. (2/14/08) injection site was itching, red, and swollen. An approximate 4cm whelp at injection site noted, with swelling to left upper arm. 2/15 mother reports area remains swollen and itching at injection site. 2/17 symptoms improving and subsiding. Advised parent to see physician. Treated at home with cold compress, Benadryl and ibuprofen.
Woke up feeling weak and tired; Woke up feeling weak and tired; Lost consciousness/passed out for several minutes; This is a spontaneous report from a non-contactable consumer (patient).   A 26 years-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0173) in the left arm, at single dose, on 04May2021, at 08:45 AM, for COVID-19 immunisation. COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, was not the patient diagnosed with COVID-19. Relevant medical history and concomitant medications were unknown. It was reported that the patient received the first dose of vaccine in left arm, then 5 minutes later, on 04May2021, lost consciousness/passed out for several minutes. Woke up feeling weak and tired on an unspecified date. Emergency Room Visit /department or urgent care required. Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the events was unknown at time of this report.   No follow-up attempts possible. No further information expected.
Severe head ache & severe vertigo started 8 days after vaccine. Patient had never experienced vertigo prior to this. Vertigo lasted for 4 days   Severe ear pain on left side started 11 days after vaccine. Ear pain improved then returned and still remains along with head ache. Body aches and chills were also present 11 days after vaccine. Ear pain is extreme and not a symptom patient has experienced before.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: NORETHINDRONE [NORETHISTERONE], start date: 26Apr2021. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19.It was reported that If vaccine received: Yes.Other medication in 2weeks: Yes. Patient started Paxlovid as treatment for COVID 19 on 02May2022 and stopped on 07May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dizziness, Headache, paresthesia in LLE where shot was given Narrative:  Patient had hx of anaphylactic rxn to oral penicillin. After shot he  felt dizzy, was placed in lying position, vital signs stable, 2L oxy mask applied.  Patient stable once sitting but O2 sats around 92% RA, reported baseline 97%
Patient reports developing hives the next day starting on her thighs then spreading to other areas including feet arms and torso. Reported them as itchy and uncomfortable. 10 days later still has some minor spots but otherwise almost completely resolved.
Injection given 10/6/20- left deltoid- 20 minutes after injection left hand started to tingle and left arm weak. Today, 10/7/20, left hand still tingling and injection site warm to the touch.
fever of 101 and lasted 2 days, aches and pains, headache, felt like she had a case of the flu with fibromyalgia in a flare, pain level was 15, muscle spasms in back and legs
PT DEVELOPED CHILLS AT 9:15 PM ON 4/7/2021, 4/8/2021 3:17 AM, PT DEVELOPED FEVER 102, SEVERE DRY COUGH, FELT LIKE CHEST WAS SQUEEZING, BREATHING ISSUES, CHILLS, URINARY URGENCY WITH LEAKAGE EVERY 10 MINUTES  AND SEVERE HEADACHE, WORSE SHE EVER HAD.  AROUND 7:15 PM ON 4/8/2021 COUGH PERSISTED BUT ALL OTHER SYMPTOMS RESOLVED.  PT STILL HAS A DRY COUGH OFF AND ON AS OF 4/14/2021.
Pt recvd flu vax & 2 to 3 hrs later devel a 20mm area of induration which became edematous; Erythematous papules (which MD stated looked like shingles) devel in supraclavicular area, w/a few vesicles on the lt arm & a few macules rt leg;
Swollen/sore tonsils; Swollen/sore tonsils; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 28Apr2021 at 14:30 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 20:45, the patient experienced swollen/sore tonsils. No therapeutic measures were taken for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen/sore tonsils were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
AREA OF REDNESS/INDURATION AROUND THE SITE WHERE GIVEN KINRIX (RT THIGH) OF 2 CM DIAMETER.  GIVEN KEFLEX AND MOTRIN.
I had the flu shot the same day as the Covid vaccine. At the sight of the shot, I had swelling and soreness that lasted a couple of days. Then a few days later I had a fever and aching in my muscles and my stomach was a bit upset. This low-grade fever escalated to a 106 fever. It took about 5 days to get it down to a normal fever, but I could not shake off this fever of 101 for weeks. I was aching all over and did not have an appetite. I was bed ridden, a lot of coughing and phlegm. Eventually the doctor did tests and confirmed I had double pneumonia. My hands and feet were really cold, but I felt hot. They prescribed me medication to bring down the fever and over the counter medication to help with the phlegm. This went on I would say around 5 yo 6 weeks before I started the path to recovery.
The shot was received at Drug Store. State registry says shot given 10/1, but patient reports she received on 10/2/18. Report from ED: 71-year-old female states had a flu shot yesterday and felt slightly off after that last night started having chills and this morning she was coming down to have breakfast fell lightheaded nauseous diaphoretic and then had a syncopal episode. Husband took blood pressure at home and it was in the 70s. No associated chest pressure tightness or heaviness. She states she is feeling better now.
reconstituted with a sterile diluent instead of the supplied AS01b diluent; reconstituted with a sterile diluent instead of the supplied AS01b diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis.   In AUG-2023, the patient received Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with a sterile diluent instead of the supplied AS01b diluent) and inappropriate dose of vaccine administered (Verbatim: reconstituted with a sterile diluent instead of the supplied AS01b diluent).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 25-AUG-2023 Clinical Operations Manager reports that a nurse administered a dose of Shingrix that was reconstituted with a sterile diluent instead of the supplied AS01b diluent, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.   They were not sure which patient it was that received this dose, they have it narrowed down to 4 patients.   The dose was given sometime between 05Aug2023 to 22Aug2023. At the time of reporting, no repeat doses have been administered. The reporter consented to follow up. This case has been linked to the case US2023AMR116984, US2023AMR116985 and US2023AMR116986 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR116984:same reporter US-GSK-US2023AMR116985:same reporter US-GSK-US2023AMR116986:same reporter
Localized induration and erythema treated empirically with clinda for 1 days with resolution of rash. Place size was 3 cm of firmness.
Right arm: Very painful at the injection site (pain felt deep within the arm) and very sore to lift up  Left arm: Pain radiates from the inside of the elbow to the fingertips