chrisvoncsefalvay/vaers-outcomes huggingface dataset:
38 hours after vaccination I woke in the middle of the night with extreme abdominal pain, dizziness, and severe diarrhea.  This continued for 2 hours.  I lost 6 pounds.  After continuing with some diarrhea all day on February 12th, I began having bloody mucous chunks as my stool.  I was advised by my doctor to go to the ER.  I was diagnosed with colitis in the ER and was admitted for several days for treatment due to the severe blood coming out.  CT scan showed severe inflammation, and stool sample showed blood and lactoferrin marker high.  I was given many antibiotics and fluids and was released home on February 14th, 2021.  I am still receiving treatment with oral antibiotics, and appointments with my physician.  I had to be absent from work for over 7 days.
Deafness in the right ear; Ear ringing; Numbness on the ears; A spontaneous report  was received from a 33-year-old male consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness in ears/hypoesthesia, ears ringing /tinnitus, and deafness in right ear/deafness unilateral.  The patient has no known medical history. No relevant concomitant medications were taken during vaccination.    On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) for prophylaxis of COVID-19 infection. The patient did not experience any adverse events after the first dose.  On 13 Mar 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot/batch: 001B21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, 45 minutes after the second dose, the patient experienced ringing in ears and 2 hours later numbness in ears. Approximately 3 hours after vaccination, the patient experienced deafness in his right ear, which was considered as medically significant event. The event deafness persisted, and the patient went to emergency room for consultation.   The patient was treated with prednisone for the events.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events ringing in ears and numbness in ears were considered as unknown. The outcome of the event deafness in his right ear was considered as not recovered.; Reporter'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.
Pt developed nasal congestion and cough, yesterday received his flu shot, felt warm at bedtime, dropped off at daycare this am, mother was called that child had a slight nose bleed, this afternoon and then they also noted fever with cough and eye dc, mother was told to have child pickup and evaluated in order to return to daycare. Hx of eczema and has used an MDI in the past, neg rash, vomiting, diarrhea, signs of pain, or drooling. No medications given for fever prior to arrival to ED. Pt reported to ED at 1820 with fever, cough, transcient epistaxis, and eye dc, all onset in the afternoon while at daycare, hx of wheezing related to URI, fever 103 responded to Motrin, CXR neg pna, did note faint exp wheezing, neg OM, active epistaxis, or rashes, supportive care for fever with URI and RAD.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with allergy to sulfa. The patient did not have any medical history. On 11-AUG-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) (0.5 ml dose, intramuscular in the left arm). There were no concomitant therapies. On 11-AUG-2014, in the evening, the patient experienced swelling of the left arm. The swelling was now down to the left forearm. The patient sought medical attention, and the patient was treated himself with TYLENOL and cold compress. The pharmacist stated she did not know if that was the first dose of PNEUMOVAX 23. There were no laboratory diagnostic studies. The outcome of swelling of the left arm was reported as not recovered. Additional information is not expected, since the reporter does not want to be contacted.
BODY ACHE; MILD STOMACH UPSET; CHILLS; LOW GRADE FEVER; HEADACHE; 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: Unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced mild stomach upset. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced low grade fever. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, chills, headache, body ache and mild stomach upset was not reported. This report was non-serious.
Tinnitus, sudden onset in both ears.  no gradual onset, I woke up 2 weeks later and I had severe ringing in both ears.   Condition is still present and is chronic.
Information has been received from a Registered Nurse concerning a female patient who on 04-AUG-2009 was vaccinated with a dose of GARDASIL (lot # not reported). On the same day on 04-AUG-2009 she received a dose of VAQTA (lot not reported) (manufacturer unknown). Concomitant therapy include DTAP and MENACTRA administered on 04-AUG-2009. On 04-AUG-2009 after received the vaccine the patient fainted. The nurse reported that the patient was able to leave the office. At the time on the report on 10-AUG-2009 the patient had recovered. Additional information has been requested.
Headache, Arthralgia, Fever, NauseaVomiting, FATIGUE, CHILLS, PAIN/SWELL INJ SITE Narrative:
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) exposed to 24 Fahrenheit (F) for 3.5 hours. The outcome of unspecified patients received VARIVAX (Merck) exposed to maximum of 24 F for 3.5 hours was unknown. This case is linked to case # 1405USA000225 (same reporter link). Additional information has been requested.
Patient felt a sharper pain during the injection than ever experienced before during a vaccination. Pain stared immediately, accompanied by soreness and reduced motion in the shoulder. Did not seek medical attention and used TYLENOL to treat the symptoms. Symptoms lasted for 60 days.
8 days after receiving second vaccination, experienced delayed side effects of headache, disturbed sleep, low-grade fever, chills and vomiting.  This mirrors exactly the symptoms I experienced 12 hours after being vaccinated, except for the addition of vomiting.
GBS; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information received via Medical record on 27 May 2021: On 25 Jun 2020, the patient received Shingrix (unknown). On 02 Jul 2020, the patient experienced guillain barre syndrome. On an unknown date, the outcome of the guillain barre syndrome was unknown.
When dose was administered, needle detached from the syringe.  This led to some vaccine on the patient's arm and an improper amount of vaccine administered.
Hives on upper torso; Severe itching; Bumps; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on upper torso), PRURITUS (Severe itching) and SWELLING (Bumps) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced URTICARIA (Hives on upper torso), PRURITUS (Severe itching) and SWELLING (Bumps). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives on upper torso), PRURITUS (Severe itching) and SWELLING (Bumps) outcome was unknown. Visited ER  due to the event. Event took 5 days to go away and came back after 5 days.  Was given Med dose pack and Acetaminophen.  After returning again to ER, he was given steroid and stronger acetaminophen.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. Other relevant treatment included Med dose pack,Steroid.
Hives began on arms about 8 hrs after receiving Hep A vaccine. Hives spread to chest, abdomen, neck & back. No respiratory issues. TX with BENADRYL.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-OCT-2015 12:47, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 6.5 and 1.2 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Information was received from a pharmacy student on 02/05/2001 regarding an unidentified pt who received Tetanus Toxoid adsorbed, Purogenated 30 years ago. The pt developed an allergic reaction reported to be encephalopathy. No further information was available at the date of this report. This event is considered to be medically important. Follow-up info received from the reporter on 02/20/2001 indicated that the pt was a male and that he recovered.
Rash, welts on both arms, 50mg IM Benadryl at 10:46 am. Lungs clear no oral swelling.
This spontaneous report as received from a physician refers to a 70 years old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# was 662856/1559X, expiration date was 28-APR-2010) (dose and frequency were unknown) subcutaneous. On 03-JUL-2014 the patient experienced shingles and post herpetic neuralgia (PHN). The patient seek medical attention via an office visit. The outcome of shingles and PHN was reported as recovering/resolving. Additional information has been requested.
Body aches and pains (started at 8PM), shaking chills and really cold(1:30 AM), nauseous (1:30 AM), fever 100.5 (8:45AM and throughout the day). The next day, some coughs cause my head hurts, aches and pains, low grade fever. Treatment:aspirin and benadryl. Doing better than the day before.
p/vax pt c/o diffuse myalgias & arthralgias, most prominent in the low back & thighs;pt had chills, no know fever, no rash, nausea, vomiting;
vaccine actually administered at Rite Aid Pharmacy. I experienced extreme headache for 3 days, all over body ache,chills, very fatigued, slept most of 2 days. Today I feel great, no symptoms at all.
High dose flu given instead of regular flu vaccine, vaccine container bins had been switched/swapped from their original locations.
General covid  symptoms. Very tired, loss of appetite,  muscular aches especially hip area,  inflammation at injection site, mild  nausea
contracted COVID/I tested positive for COVID/Sick; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (contracted COVID/I tested positive for COVID/Sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID/I tested positive for COVID/Sick). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (contracted COVID/I tested positive for COVID/Sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Concomitant products were not reported.  It was reported that patient had two vaccines with unspecified vaccine and booster with moderna.  Company comment: This spontaneous case concerns female patient (of an unknown age and gender), with no medical history reported, who received a booster dose of mRNA-1273 vaccine (reported as third dose of patient´s COVID  19 vaccination schedule) and experienced the non  serious unexpected AESI of COVID-19. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The patient received treatment with Paxlovid (Nirmatrelvir, Ritonavir). No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns female patient (of an unknown age and gender), with no medical history reported, who received a booster dose of mRNA-1273 vaccine (reported as third dose of patient´s COVID  19 vaccination schedule) and experienced the non  serious unexpected AESI of COVID-19. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The patient received treatment with Paxlovid (Nirmatrelvir, Ritonavir). No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.
feeling like having the flue; a very disgusting metallic taste on their mouth which makes it difficult for them  to eat anything; disgusting metallic taste on their mouth, makes it difficult for them  to eat anything, and has cause them to loose weight; slight cough; pain in their legs, and on every bone on their body; chills; headaches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling like having the flue), DYSGEUSIA (a very disgusting metallic taste on their mouth which makes it difficult for them  to eat anything), WEIGHT DECREASED (disgusting metallic taste on their mouth, makes it difficult for them  to eat anything, and has cause them to loose weight), COUGH (slight cough) and PAIN (pain in their legs, and on every bone on their body) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eye operation NOS (Eye surgery).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (feeling like having the flue), DYSGEUSIA (a very disgusting metallic taste on their mouth which makes it difficult for them  to eat anything), WEIGHT DECREASED (disgusting metallic taste on their mouth, makes it difficult for them  to eat anything, and has cause them to loose weight), COUGH (slight cough), PAIN (pain in their legs, and on every bone on their body), CHILLS (chills), HEADACHE (headaches) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of 2 dosage form every four hours. At the time of the report, INFLUENZA LIKE ILLNESS (feeling like having the flue), COUGH (slight cough), PAIN (pain in their legs, and on every bone on their body), CHILLS (chills) and HEADACHE (headaches) had resolved and DYSGEUSIA (a very disgusting metallic taste on their mouth which makes it difficult for them  to eat anything), WEIGHT DECREASED (disgusting metallic taste on their mouth, makes it difficult for them  to eat anything, and has cause them to loose weight) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was concomitantly taking eye drops medication, cholesterol and triglycerol medication.  The patient treated nausea with an unknown medication.
I developed dermatographia with no clear allergic trigger.  Symptoms include itchy hives and red patches of skin from anything scratching my skin.  Symptoms improve but are not resolved with antihistamines and steroids.  I?ve never had anything like this before and it was sudden onset.
Swelling, tenderness and stiffness at the injection site; Swelling, tenderness and stiffness at the injection site; Swelling, tenderness and stiffness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247), via an unspecified route of administration in the left arm on 04Feb2021 at 11:00 AM at the age of 52 years old at a single dose for COVID-19 Immunization at workplace clinic. The patient medical history was none. Allergies to medications, food, or other products was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive other medications within 2 weeks of vaccination. On 04Feb2021 at 15:00, the patient experienced swelling, tenderness and stiffness at the injection site, developed approximately 4-5 hours after injection. Stiffness disappeared overnight; swelling and tenderness increased overnight (now 21 hours post injection). Area was very tender, didn't affect ability to execute job function. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the event stiffness on an unspecified date in Feb2021 and recovering from other events.  No follow-up attempts are possible. No further information is expected.
Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 24Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Feb2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "very mild high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 01Jan2019.   The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results; (unspecified date) very positive Covid antigen test; (unspecified date) Still positive antigen test; (19May2022) Negative antigen; (20May2022) Negative; (21May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient took Paxlovid for covid-19 treatment from 08May2022 to 13May2022. Took five day Paxlovid course, symptoms improved, negative antigen test days 6, 7 and 8. Stuffy nose returned day 12, awoke day 13 to congestion, cough and brain fog, retested, very positive Covid antigen test. Cough progressed and worsened day 14. Still positive antigen test, congestion and cough today, day 16. Patient had no known allergies  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache, Fever, sweats, chills, decreased appetite, decreased concentration   Narrative:  Fever 102, severe headache, sweats, chills, decreased appetite, decreased concentration; tx tylenol;  resolved.
Severe pain in hips and lower back; Severe pain in hips and lower back; 99.5 Degree Fever; Minor soreness in arm; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP, who reported for herself.  A 60-years-old non-pregnant female received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was CV19/FF8839) via an unspecified route of administration, administered in Arm Right on 11Oct2021 (at 08:30) (age at time of vaccination was 60-years-old) as a DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The relevant medical history included Asthma, known allergies to PENICILLIN, SULFA DRUGS, QUININE, GLUTEN, other medical history included allergies and Hormone replacement therapy from an unspecified date. Concomitant medications included INFLUENZA VACCINE administered in Arm Right on 04Oct2021 as a DOSE 1, SINGLE, FLONASE (FLUTICASONE PROPIONATE) and PROBIOTICS taken for an unspecified indication. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. Previously, the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was CV19/EM9809) via an unspecified route of administration, administered in Left Arm on 24Feb2021 (at 08:15) (age at time of vaccination was 59-years-old) as a DOSE 2, SINGLE for COVID-19 immunization. Also, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was CV19/EL9265) via an unspecified route of administration, administered in Left Arm on 03Feb2021 (at 08:00) (age at time of vaccination was 59-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. On 11Oct2021 (at 20:00), the patient experienced Severe pain in hips and lower back, 99.5 Degree Fever and Minor soreness in arm. The patient received ADVIL, 600mg as a treatment medication for the adverse events. The patient underwent lab tests and medical procedures on 11Oct2021 which included Body temperature which showed result as 99.5 Degree Fever. The clinical outcome of events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Perniosis-like changes on all ten toes; "blue/purple" toes; appeared two weeks after the second shot of the Moderna Covid vaccine.  Improved at f/u on 6/25/2021 but still persistent.  We're treating with oral amlodipine 5mg po QD + protective measures (keep feet/toes warm/dry with woolen socks, etc.) + clobetasol oint.
Patient was to receive Pfizer primary series dose 2; but was inadvertently given the Pfizer bivalent dose instead. Provider onsite was notified and  Patient was notified of error.  Pt was monitored and remained stable with no s/sxs of side effects.