chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CHILLS; WEAKNESS; NAUSEA; FELT LIKE HAD A FEVER/FEVER; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no known allergies. the patient had no drug abuse or illicit drug usage. 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 12-APR-2021 16:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced felt like had a fever/fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, chills, nausea, and felt like had a fever/fever. This report was non-serious.
Pt stated left upper arm became itchy on Friday, June 21, 2019. When the pt lifted up sleeve there was a red rash and a few hives. The patient states taking oral Benadryl  but getting no relief. Patient states the redness has spread so pt was instructed to be seen at a local urgent care. Pt verbalized understanding.
Received vaccine Wed 4/16/08 2:30 pm.  Developed rash on arms & back in PM 4/17/08.  Also had difficulty breathing.  "I almost passed out".  Seen in ER.  Given a shot of Benadryl & told to use oral Benadryl til rash goes away.
Patient developed a 5 x 3 cm area of redness, warmth and tenderness.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and unknown gender. Concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On an unspecified dates the patients were vaccinated with exposed to 44F doses of (Oka/Merck) VARIVAX lot # K016129, expiration date 23-SEP-2016 (dose, dose number, route and anatomical location were unspecified). Concomitant therapies were not reported. No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Fever, lasting two days, peaking at 102.3 (oral); along with chills, also lasting two days; followed by elevated temperature, lasting one day, peaking at 99.9 (oral).
At night fatigue then  I woke up puking  and diarrhea at the same time. It was about 30 minutes of nausea then 15 minutes of diarrhea and puking and then nothing else I felt completely fine after. I contacted the non emergency health care number to confirm that I was fine and got the ok but wanted to document the events so that more will be aware at potential first dose symptoms.
RED, SWOLLEN ARM. TIGHTNESS OF SKIN, HOT TO TOUCH, PAINFUL. LOCATION WAS FROM SITE TO 6 INCHES BELOW ON THE ARM AND ALONG THE OUTER AND INNER ASPECT CIRCUMFERENTIALLY.
pt recv vax & 3 days later devel an irritating, itching rash, 3 to 4 cm in diameter; the rash was composed of tiny fluid-filled bumps, on mid-back; condition resolved spontaneously; No further details were provided;
cold; difficulty breathing; aching; hot flash; Diarrhoea; throwing up; nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), DYSPNOEA (difficulty breathing), PAIN (aching), HOT FLUSH (hot flash) and DIARRHOEA (Diarrhoea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), DYSPNOEA (difficulty breathing), PAIN (aching), HOT FLUSH (hot flash), DIARRHOEA (Diarrhoea), VOMITING (throwing up), NAUSEA (nausea) and HEADACHE (Headache). At the time of the report, NASOPHARYNGITIS (cold), DYSPNOEA (difficulty breathing), PAIN (aching), HOT FLUSH (hot flash), DIARRHOEA (Diarrhoea), VOMITING (throwing up), NAUSEA (nausea) and HEADACHE (Headache) had resolved.            No concomitant medications reported.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-056313 (Patient Link).
very cranky, refusing to move leg or walk, also febrile; sl tenderness, swelling inject site rt thigh-cries w/any movement of leg; Ibuprofen;
This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patient was vaccinated with first and second dose of M-M-R II (unknown albumin status) for prophylaxis (doses, anatomical location, lot# and expiration date were not reported; route of administration reported as vaccination). On an unknown date, the patient experienced mumps. The outcome of mumps was unknown. The relatedness between the event of M-M-R II was not reported. Additional information has been requested.
Breakthrough case of COVID - SX onset 05/05/2022, Tested positive with PCR test 05/06/2022, She started with losing her voice, sore throat, fever upwards of 102, fatigue, cough, runny nose, achiness, headache, which lasted 48-72 hours with a lingering cough and sore throat. These SX lingered for about 3-5 days.
Blood Clots in lungs, Xarelto taken 20 days, blood in stool, discontinued meds. after tests med. resumed 9/2/21.
Pt to the ED with c/o altered mental status 6/4. COVID+ 6/4, pt A&O x 1- to person, answers appropriately to questions regarding her needs and on room air. Pt not on antibiotics and not requiring supplemental oxygen. 6/7 not on oxygen, mentation has improved. 6/8 pt doing well, did receive mAB and is stable. 6/9 on RA O2, tolerating well; Bebtelovimab provided.  6/9 VSS and discharged.
43 yo developed exanthem with onset 12 days after vaccine receipt; seen in ER day 14 (IHB contacted by CDC): Initially papular with appearance consistent with nonviral pustulosis, day 15 progressed to significant vesicular lesions on erythematous base, discrete lesions coalescing then progressed to impetiginous honey crusted, more vesicular lesions, with several larger bullous lesions and erythematous patches. Appearance was not consistent with nonviral pustulosis, benign acral papulovesicular eruption, Autoinoculation or generalized vaccinia. Sites included both axilla, adjacent to inoculation site, low back and R abdomen across belt line and hip. Differential diagnosis includes atypical form of erythema multiforme minor (no mucosal lesions), id reaction (auto-and eczematization) or some other Immune-mediated dermatoses related to his recent vaccination. Reviewed with derm and treated as Immune mediated dermatosis with secondary infection with doxycycline, ibuprofen and cetirizine: improvement at day 17, but still significant dermatitis. Treated then with prednisone 40 x5 days. Now on day 26, most lesions fully resolved except mild residual to his back. Symptoms: Rash, oth nonspecific skin eruption.
FULL 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced full body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of full body aches was not reported. This report was non-serious.
Patient tested positive on 13Jun2023; tested positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EL9261), in left arm, on 01Mar2021 as dose 2, single (Lot number: EN6202), in left arm, on 01Nov2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 30Mar2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "hyperlipidimia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 13Jun2023 at 22:00, outcome "recovering", described as "Patient tested positive on 13Jun2023"; COVID-19 (medically significant) with onset 13Jun2023 at 22:00, outcome "recovering", described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2023) positive, notes: tested positive; (17Jun2023) Negative, notes: Testing Negative; (18Jun2023) Negative, notes: Testing Negative; (19Jun2023) Negative, notes: Testing Negative; (20Jun2023) Negative, notes: Testing Negative; (21Jun2023) Negative, notes: Testing Negative; (22Jun2023) Negative, notes: Testing Negative; (23Jun2023) Negative, notes: Testing Negative; (23Jun2023) positive, notes: at 22:00 test positive again; (01Jul2023) negative, notes: test negative; (03Jul2023) positive, notes: test positive again; (05Jul2023) negative, notes: test negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.; Sender's Comments: Based on the available information, reported events 'vaccination failure' and 'COVID-19' were likely related to the suspect product due to an established temporal association.
This spontaneous report as received from a pharmacist refers to a 65 years old female patient with fibromyalgia, and no known drug allergies with medical history of sciatica pain always on the right side and shingles (October 2011) with lesions on right buttocks that lasted two to three months (approximately in January 2012). On 03-AUG-2012, the patient was vaccinated subcutaneously with, 0.65 ml ZOSTAVAX (lot 0562AE exp: 20-MAR-2013). Concomitant medications included oxycodone and CYMBALTA. The pharmacist reported that a patient that was vaccinated with ZOSTAVAX on 03-AUG-2012, told him that on approximately on 05-AUG-2012 (2 or 3 days after getting vaccinated with ZOSTAVAX she had a low grade fever that lasted 24 hours (approximately on 06-AUG-2012), in addition, client developed generalized muscle pain (approximately in August 2012) that lasted for 30 days but at the time of the report was a deeper stabbing pain, the deep muscle pain runs across the right side of the buttocks and the pain radiates down her right leg, the patient did not reported any lesions. Pharmacist stated that the patient would have a follow up doctor appointment scheduled the first week of next month. This is already mentioned in the report. At that time of the report the patient was treated with a unspecified antiviral treatment and recovered. The outcome of the fever was reported as lasted 24 hours (recovered also reported by the pharmacist as not recovered). At the time of the report the outcome of the patient for generalized muscle pain and the deep muscle pain runs across the right side of the buttocks and the pain radiates down her right leg was reported as not recovered by the pharmacist. The pharmacist confirmed that the patient did not had any shingles or lesion outbreak. The relatedness for adverse events was unknown for ZOSTAVAX. Additional information has been requested.
On the morning of June 15, maybe evening of Tuesday the 14th, I noticed that I started getting a sore throat. I spent a weekend with people who later tested positive for COVID. So I had quarantined myself in the basement. Got a sore throat. The next day, Wednesday, got aches ? body aches, headache. I was tired. No fever. No vomiting or diarrhea. First positive test was the morning of the 15th. I was negative Monday and Tuesday 13 and 14. Had an online appointment with a doctor later that afternoon and got the PAXLOVID prescription. Couldn't get that until the next day so I started PAXLOVID the next day the evening of June 16. Did the 5 day twice a day course. Standard dose. PAXLOVID gives a metallic taste in the mouth, but no other side effects that I particularly noted. In the process of recovery (on Day 6 of isolation).
joint and muscle pain; joint and muscle pain; had elevated AST, ALT and absolute neutrophils; had elevated AST, ALT and absolute neutrophils; had elevated AST, ALT and absolute neutrophils; This is a spontaneous report from a contactable other Health Care Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 28Jan2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.On an unspecified date the patient experienced joint and muscle pain, had elevated ast, alt and absolute neutrophils, had elevated ast, alt and absolute neutrophils. The patient underwent lab tests and procedures which included alanine aminotransferase: elevated on 17Feb2021, aspartate aminotransferase: elevated on 17Feb2021, blood test: elevated ast, alt and absolute neutrophils on 17Feb2021 she had blood work done and had elevated AST, ALT and absolute neutrophils , neutrophil count: elevated on 17Feb2021.The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged prostate" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: TAMSULOSIN; LATANOPROST; DORZOLAMIDE. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: ER8732, Anatomical location: Left Arm), administration date: 30Mar2021, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EN1699, Anatomical location: Left Arm), administration date: 03Mar2021, for Covid-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization) with onset 23Sep2022 at 15:30, outcome "recovered with sequelae", described as "Stroke". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 2 day(s)). The event "stroke" required emergency room visit. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical course included: AE treatment: Stroke treatment & clot buster.
I woke up the next day after receiving the vaccine with my arm swollen and hurting, my throat hurt a little and I was very tired. I called and had a telehealth visit with my primary care physician. He advised me to rest, not to overexert myself so that my arm would heal up. I am feeling much better.
Numb face within 20 min of 2nd injection lasted two hours; swelling of finger joints, not able to bend a couple fingers for about 6 hours day after 2nd injection; not able to bend a couple fingers for about 6 hours day after 2nd injection; chills; severe muscle aches; headache in eyes and head; headache in eyes and head; This is a spontaneous report from a contactable consumer. This 65-year-old female consumer (patient) reported. A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 10:45 (at the age of 65-years-old) as a single dose for covid-19 immunization; methocarbamol (METHOCARBAMOL), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown (750) for an unspecified indication; losartan (LOSARTAN), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 50 mg for an unspecified indication. Medical history included hypertension, asthma, drug hypersensitivity, milk allergy. Concomitant medications in two weeks included hydrocodone. The patient previously took percodan [acetylsalicylic acid;oxycodone hydrochloride] and experienced drug hypersensitivity, ultram [paracetamol;tramadol hydrochloride] and experienced drug hypersensitivity. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration administered in Arm Left on 25Mar2021 10:45 (at the age of 65-years-old) as a single dose for covid-19 immunization. The patient had allergies with percodan penicillin ultram, milk. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Apr2021 11:15, the patient experienced numb face within 20 min of 2nd injection lasted two hours, swelling of finger joints, not able to bend a couple fingers for about 6 hours day after 2nd injection, chills and severe muscle aches, headache in eyes and head. The patient received treatment with anti-inflammatory. Outcome of the event was recovering, at the time of this report. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Mild jerks for 45 min.; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en6207), via an unspecified route of administration in the left arm on 21Mar2021 12:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no other vaccines in four weeks. There were no other medications in two weeks. The patient was not pregnant. There were no concomitant medications. The patient experienced mild jerks for 45 min. on an unspecified date in Mar2021 (also reported as 05Mar2021; pending clarification). The event resulted in emergency room/department or urgent care, hospitalization. The patient was hospitalized for mild jerks for 45 min. for 5 days. Treatment was received. The patient had not had COVID prior vaccination.  The patient was not COVID tested post vaccination. The outcome of the event was recovered with sequel on an unspecified date.   The event mild jerks for 45 min. occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.
Case number PHEH2015US021475, is an initial spontaneous report from a pharmacist received on 21 Oct 2015. This report refers to an 8-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUCELVAX, (batch number: 173989) intramuscularly on 20 Oct 2015. No adverse event was reported.
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, lot number, expiration date were not reported) that were stored improperly. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse events reported at this time.  Reporting because the patient was administered a 1.0ml dose of Moderna COVID19 vaccine. patient received a double dose of vaccine.
Local swelling of right upper arm over deltoid, warm to touch, patient without fevers, also complains of itching.
2 days after the vaccine the side effects were swelling, rash, headache, numbness in face and legs, chills after approximately 5 days had numbness in face and swelling and yesterday I had symptoms appear like shortness of breath, throat sensation, chest and stomach bloating
mom states on 16NOV93 knot came on rt leg w/in 2 hrs p/vax given; rt leg became red & ran elevated temp x 1 wk;
EE HAD COVID-19 PFIZER VACCINE  Dose 1 date: 12/23/2020      Dose 2 date: 01/13/2021. TESTED POSITIVE TO COVID 8/30/21