chrisvoncsefalvay/vaers-outcomes huggingface dataset:
overall weakness; AE kept him up all night; chills/shivers; body aches; Pain from the injection site seemed to exacerbate these adverse events and symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (overall weakness), SLEEP DEFICIT (AE kept him up all night), CHILLS (chills/shivers), MYALGIA (body aches) and INJECTION SITE PAIN (Pain from the injection site seemed to exacerbate these adverse events and symptoms) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A219A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced SLEEP DEFICIT (AE kept him up all night), CHILLS (chills/shivers), MYALGIA (body aches) and INJECTION SITE PAIN (Pain from the injection site seemed to exacerbate these adverse events and symptoms). On 19-Mar-2021, the patient experienced ASTHENIA (overall weakness). On 19-Mar-2021, SLEEP DEFICIT (AE kept him up all night), CHILLS (chills/shivers), MYALGIA (body aches) and INJECTION SITE PAIN (Pain from the injection site seemed to exacerbate these adverse events and symptoms) had resolved. At the time of the report, ASTHENIA (overall weakness) had not resolved.            No concomitant and treatment medication information was reported.   This case was linked to MOD-2021-023235 (Patient Link).
This case was reported by a healthcare professional and described the occurrence of erythema in an 18-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 11 October 2010 the subject received 1st dose of FLULAVAL (.1 ml, intradermally, left arm). On 11 October 2010, immediately after vaccination with FLULAVAL, the subject experienced "a little red, nothing else" and wrong vaccine administered. The healthcare professional reported that FLULAVAL 0.1ml was administered intradermally by mistake, she had intended to give the subject a TB test. At the time of reporting the outcome of the erythema was unspecified. Follow-up information was received via the reporter on 09 December 2010. It was reported that FLULAVAL had been administered inadvertently and via the incorrect route (intradermally). The wrong vaccine was grabbed from the refrigerator by accident. The subject experienced erythema which began on 12 October 2010 and ended on 15 October 2010. The event was not considered to be serious.
Persistent dry cough started 1 hour after vaccine dose on 2/24/2021 Wednesday at 10am. The cough symptoms  resolved on 2/26/2021 Friday morning at 11 am after I took 50mg of Benadryl. The Cough stopped an hour after taking 1 single benadaryl dose.    All over body neck and face rash. Not itchy. Rash started on Friday 2/26/2021 at 4am. Took Benadryl 50mg on 2/26/2021 at 10 am. Rash resolved 8 hours after taking Benadryl.
Woke up with extreme nausea in middle of the night (2:30 AM) and passed out/fainted in the restroom. Unsure of how long episode lasted.; Woke up with extreme nausea in middle of the night (2:30 AM) and passed out/fainted in the restroom. Unsure of how long episode lasted.; Woke up with extreme nausea in middle of the night (2:30 AM) and passed out/fainted in the restroom. Unsure of how long episode lasted.; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 24Apr2021 at 09:00 (Batch/Lot Number: EW0164) at 27-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. Medical history included Ehler-Danlos Syndrome, migraine, gastroparesis, and fibromyalgia; all from an unknown date and unknown if ongoing. Concomitant medications included colecalciferol (VITAMIN D); gabapentin (MANUFACTURER UNKNOWN); promethazine (MANUFACTURER UNKNOWN); ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS); all taken for an unspecified indication, start and stop date were not reported; received within two weeks of the suspect vaccine.. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization (Lot number: RE8732; Anatomical Location: Arm Left; Dose Number: 1) on 03Apr2021 at 27-years-old. On 25Apr2021 at 02:30, the patient experienced: woke up with extreme nausea in middle of the night (2:30 am) and passed out/fainted in the restroom. Unsure of how long episode lasted. (medically significant); with no treatment taken. The clinical outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Rash; Feeling very out of it; Metal taste in the mouth; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feeling very out of it"; DYSGEUSIA (non-serious), outcome "unknown", described as "Metal taste in the mouth".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information was received from a registered nurse concerning a patient who was vaccinated with GARDASIL. The patient was vaccinated with the first dose of GARDASIL on 05JUN2012, vaccinated with the second dose of GARDASIL on 02AUG2012 and was vaccinated with the third dose of GARDASIL. No adverse event reported. Additional information not expected.
45 minutes after vaccine, facial numbness, extreme itchiness on face. 48 hours later intense fatigue, aching, nausea, headache. Symptoms subsided, but then one week after shot, intense back of leg pain (strong cramp-like) on both legs (from buttocks to ankles). Taking ibuprofen/tylenol with no effect.
Td administered IM left deltoid muscle on 07/30/2002. Client c/o pain to left shoulder on movement,radiating distally LUE, Also c/o swelling & itching at injection site.
Over the course of several days, symptoms worsened. Started with tingling in extremities, then uncomfortable feeling in abdomen (like a balloon was pushing up), then difficulty chewing, swallowing, inability to eat, felt like "a grapefruit" was in her neck, wrapping around it from the back. All sensations were like nothing she had felt before.
Severe pain, swelling, lump, redness at the injection site, weakness in left arm. joint pain, arthritis, muscle spasms, headaches, fatigue, nausea, vomiting, loss of appetite, dizziness, difficulty breathing, wheezing, anxiety.
26 Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment drug were reported.
Patient woke up with large hives on various parts of her body.  Some spots would go away and others would appear on different areas.
PSORIASIS FLARE-UP; This spontaneous report received from a patient via a company representative concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriasis. 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 prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ustekinumab for psoriasis. On 15-SEP-2021, the patient experienced psoriasis flare-up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of psoriasis flare-up was not reported. This report was non-serious.
1FEB97 t98.2 c/o post nasal drip, moist non-productive cough;inc temp 3FEB97, robitussin ordered 1FEB97; given other med 3FEB97 & again 18FEB97 x 7 days;no cult ordered;
I woke up with a rash on chest tingling and burning.  On Friday I had a Telehealth appt was diagnosed with Shingles.
Swelling at injection site; Redness at injection site; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), MYALGIA (Body aches) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 infection on 08-Sep-2020. Concurrent medical conditions included Hypertension since August 2010, Hypothyroidism since June 2007, GERD since July 2002 and Hyperlipidemia since April 2012. Concomitant products included ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) for GERD, ATENOLOL for Hypertension, LEVOTHYROXINE SODIUM (LEVOXYL) for Hypothyroidism.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). On 30-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). On 30-Jan-2021, MYALGIA (Body aches) and CHILLS (Chills) had resolved. On 10-Feb-2021, VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2020, SARS-CoV-2 test: positive (Positive) Positive.         Treatment medication information is not provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Added second dose information, outcome of the event, medical history and concomitant medications dosage information.
Patient was vaccinated with a dose of improperly stored GARDASIL 9; No adverse effects reported; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot #R032766, expiration date on for prophylaxis (strength, dose and frequency were not reported). The temperature of storage and time frame of the excursion were above 47°F (92.3° F) for 13 hours 11 minutes and above 47°F (73°F) for 9 hours. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-US-009507513-1907USA007468: US-US-009507513-1907USA007439: US-US-009507513-1907USA005368: US-US-009507513-1907USA010550: US-US-009507513-1907USA010551: US-US-009507513-1907USA010552: US-US-009507513-1907USA010553: US-US-009507513-1907USA010554: US-US-009507513-1907USA010555: US-US-009507513-1907USA010556: US-US-009507513-1907USA010557: US-US-009507513-1907USA010557:
Colds and Flu; Colds and Flu; Fatigue following COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Colds and Flu), NASOPHARYNGITIS (Colds and Flu) and FATIGUE (Fatigue following COVID vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Psoriatic arthritis.    Concurrent medical conditions included Ulcerative colitis and Psoriatic 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. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue following COVID vaccine). On an unknown date, the patient experienced INFLUENZA (Colds and Flu) and NASOPHARYNGITIS (Colds and Flu). At the time of the report, INFLUENZA (Colds and Flu), NASOPHARYNGITIS (Colds and Flu) and FATIGUE (Fatigue following COVID vaccine) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  On an unknown date patient experienced colds and flu. In 2021, patient experienced fatigue after COVID vaccine.  Reporters causality of event fatigue after COVID vaccine with Humira was no reasonable possibility  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
I tested + (Positive) for COVID-19 on 03Jan2023; I tested + (Positive) for COVID-19 on 03Jan2023; Dose 1 and Dose 2: Moderna/ Dose 3 and Dose 4: BNT162B2/ Dose 5: BNT162B2, BNT162B2 OMI BA.4-5; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: EW0187), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: FL3198), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jan2021 at 15:30 as dose 1, single (Lot number: 037K20A), in left arm and on 11Feb2021 at 15:30 as dose 2, single (Lot number: 042L20A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "environmental allergies (dust mites, pollen)" (unspecified if ongoing); "environmental allergies (dust mites, pollen)" (unspecified if ongoing); "environmental allergies (dust mites, pollen)" (unspecified if ongoing); "PCN" (unspecified if ongoing), notes: known allergies: PCN. Concomitant medication included: FLONASE [FLUTICASONE PROPIONATE], start date: 01Jun2018, stop date: 03Jan2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2021, outcome "unknown", described as "Dose 1 and Dose 2: Moderna/ Dose 3 and Dose 4: BNT162B2/ Dose 5: BNT162B2, BNT162B2 OMI BA.4-5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2023, outcome "unknown" and all described as "I tested + (Positive) for COVID-19 on 03Jan2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient reported, "I tested + for COVID-19 on 03Jan2023, isolated, started Paxlovid the evening of 04Jan2023 and completed my last dose on the morning of 09Jan2023."; Sender's Comments: A causal relationship to the suspect drug cannot be excluded for the reported events interchange of vaccine products, COVID-19 and drug ineffective. This case will be reassessed upon receipt of additional information.
The person who received the vaccine, my grandmother, began experiencing side effects the day after the "COVID-19 booster" was administered. These side effects include: "flu-like" symptoms. Then she began experiencing "autoimmune" symptoms that resemble Toxic Epidermal Necrolysis. Her skin developed PAINFUL blisters that popped and her skin was raw, bleeding, oozing, and began to fall off of her own body. She eventually died from this. Her day and time of death was 11-3-2021 at 10:25pm.  Her death was one week after the COVID booster was administered.
MONOVALENT DOSE GIVEN INSTEAD OF BIVALENT BOOSTER DOSE THAT WAS NEEDED
Patient states her hand/arm was swollen as of 11/13/21. She used heat and ice, then on 11/15/21 there was decreased swelling. By 11/16/21, the day of reporting to the pharmacy, it was still a "little swollen". Patient also reported a sore, burning throat, upset stomach and vomiting, headache, and sweating.
Husband called to report his wife was suffering from hives all across her stomach that occurred in the past 2 days (that they appeared after her flu vaccine) and that she overall just didn't feel good.  Explained to husband that with her allergies she was unable to take the recommendation of antihistamines so therefore needed to contact her pcp on call or go to the hospital.
4 cm induration - none erythema, no exudate, no lymph nodes.
Triggered an auto-immune response, had a strong fever, GI problems after the first shot escalated dramatically after the second shot; Triggered an auto-immune response, had a strong fever, GI problems after the first shot escalated dramatically after the second shot; Triggered an auto-immune response, had a strong fever, GI problems after the first shot escalated dramatically after the second shot; Triggered an auto-immune response, had a strong fever, GI problems after the first shot escalated dramatically after the second shot; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 38-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (at the age of 38-year-old) for COVID-19 immunization and experienced triggered an auto-immune response, had a strong fever, GI problems after the first shot. It was reported that triggered an auto-immune response, had a strong fever, GI problems after the first shot experienced on 15May2021 escalated dramatically after the second shot. Patient was hospitalized on an unspecified date for 1 day and was treated with colonoscopy and prescription anti-inflammatories. The events required physician office visit. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 16Jul2021. Outcome of events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 75th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
01/20/21- achy fevers  ibuprofen- developed chills - temp 100.3, 01/21/21- fever 103- horrible headaches, went to hospital- tackycardia, low BP, lactic acid increases, met criteria for sepsis admitted. 01/23/21- discharged from hospital, arm of injection sweling, lymph nodes swollen,
Chills; Headache; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, headache and muscle pain. On an unknown date, the outcome of the chills, headache and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the chills, headache and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient after receiving the 2nd dose of Shingrix experienced chills, headache and muscle aches. The patient asked how long do the side effects last
Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported No treatment information was provided.; Sender's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of tested positive for COVID and the product use is assessed as unlikely,