chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 100.6 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100.6 F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 12-Feb-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 100.6 F). At the time of the report, PYREXIA (Fever of 100.6 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: abnormal (High) 100.6 degrees Fahrenheit.         Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
high-pitched continous crying which started almost immed p/vax  & lasting more than 4 hrs; APAP given;
6NOV95 given flu vax @ MD's office;7NOV95 sever aching of every bone of body, muscular soreness of lt deltoid area;9NOV95 mod diarrhea;
severe headache; shootingpain; slight pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Apr2021 at 14:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic severe asthma treated with mepolizumab (NUCALA) injection monthly and allergic to penicillin (PCN). Concomitant medications included mepolizumab (NUCALA) for asthma from an unknown date. The patient had known allergies to past drugs NSAIDs (non-steroid anti-inflammatory drugs), cyproheptadine hydrochloride (CYPRO) and zithromax (Z-PAK). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 04Apr2021 at 19:00, the patient experienced sudden severe headache, shooting pain and slight pain at injection site. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of severe headache, shooting pain and injection site pain was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Slightly elevated erythematous area. Pins and needle feeling when the area is touched. Slightly warm to the touch.
headache; felling sick; runny nose; cough; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felling sick), RHINORRHOEA (runny nose), COUGH (cough) and HEADACHE (headache) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MALAISE (felling sick), RHINORRHOEA (runny nose) and COUGH (cough). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, MALAISE (felling sick), RHINORRHOEA (runny nose), COUGH (cough) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
hives starting 4 days p/vax; treated w/Pred & Ataraxl
Systemic: Fainting / Unresponsive-Medium, Additional Details: passed out, ems and mother called. no injury. said that she reacts to all shots this way
I am a FDA employee and received the 2010-2011 seasonal flu vaccine (influenza A/H1N1, A/H3N2, B) shot at the Health Unit at the FDA. After receiving the flu shot, I experienced a low grade fever (99.4F according to home use thermometer) and body aches that lasted for approximately 2 days. I took ibuprofen to relieve symptoms. Other than that, the symptoms resolved on their own. I did not seek medical attention as such side effects were noted as possible in the vaccination information sheet I was provided.
About 5-7 mins after injection patient standing walked out to where parent was waiting. Felt queasy & dizzy - fainted. Landed on tailbone. Had patient lie down with cool compress on head. Stated felt nauseated & hot. Feeling better 25 min after incident.
Patient stated she has a rash and problems with her eyes. She said she doesn't feel well.
p/vax lt thigh is red, warm & swollen w/an induration;205inches width x 3 inch length;painful to touch;area started to get swelled next day p/shot given;mom states using a cool compress & APAP;
This spontaneous prospective pregnancy report was received from a nurse regarding his wife, a female patient of unknown age. No concurrent conditions or medical history were provided. On approximately 26-JAN-2016 (reported as "about 2 weeks ago"), the patient was vaccinated with a dose of M-M-R II injection (lot# and expiry date, strength, dose, route and site of administration were unspecified). No concomitant medications were reported. On an unknown date in 2016, the patient experienced pain at the injection site and some lightheadedness following the administration of the vaccine but these symptoms went away within a couple of hours. The patient sought medical attention, she was seen by her unspecified physician on 08-FEB-2016, for an unspecified reason, where she was given an unspecified pregnancy test which resulted in a positive response. The patient became pregnant with unspecified last menstrual period (LMP) and estimated date of delivery (EDD), however, the nurse reported that the patient was due to start menstruation cycle on 01-FEB-2016 but did not and therefore might be a little over of a month pregnant. The pregnancy outcome was outcome pending and fetal outcome was unknown. The outcome of an unspecified adverse event was unknown. The outcome of injection site pain and dizziness was reported as recovered in 2016. The relatedness between the events and M-M-R II was not provided. Additional information has been requested.
pt recv vax 17OCT96 & 19OCT96 pt exp swelling, pain, & redness in the rt deltoid;
Strong headache that lasted through the day; slight fever; had chills; Dizziness; lack of appetite; aching all over body, especially the spine; aching all over body, especially the spine; Arm where shot was received was very sore and painul to move; This is a spontaneous report from a contactable consumer. This 23-year-old male consumer reported for himself.  A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0181), dose 3 via an unspecified route of administration, administered in left arm on 11Oct2021 as DOSE 3, (BOOSTER) SINGLE for COVID-19 immunization; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), via an unspecified route of administration, administered in right arm on 11Oct2021 (Batch/Lot Number: UT7347JA), as single dose for an unspecified indication (both at the age of 23-years-old). The patient's medical history was not reported. There were no concomitant medications. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EK9231), dose 1 via an unspecified route of administration, administered in left arm on 26Dec2020, as DOSE 1, SINGLE; and bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EL3247) dose 2, via an unspecified route of administration, administered in left arm on 19Jan2021, as DOSE 2, SINGLE (both at the age of 22-years-old) and both for COVID-19 immunization. The patient had no other vaccine within four weeks, and no other medications in two weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. On 12Oct2021, the patient experienced strong headache that lasted through the day until pain meds taken in the mid-afternoon. On 12Oct2021, the patient ran a slight fever and had chills, experienced dizziness, lack of appetite, aching all over body, especially the spine. The arm where shot was received was very sore and painful to move. The adverse event did not result in emergency room visit or physician office visit. The patient underwent lab tests and procedures which included slight fever: slight on 12Oct2021. Therapeutic measures were taken as a result of strong headache that lasted through the day (headache). Treatment was not provided for other adverse events. The action taken in response to the events for influenza vaccine was not applicable. The clinical outcome of the events was recovered on an unspecified date in Oct2021.  Follow-Up: Follow-up attempts are completed. No further information is expected.
Pneumonia due to COVID-19 virus Sepsis   Shortness of Breath ? Weakness - Generalized ? Dizziness
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 28-JUN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX injection, lot # M024698 with expiration date of 27-JUN-2017, reconstituted with sterile diluent (manufacturer unknown). This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA008061.
Developed lower back pain, sciatica and skin sensitivity in right hip and leg approximately 10 days after second dose.  Managed pain with OTC medications, stretching and massage over ensuing week as symptoms worsened.  Approximately nine days following onset of symptoms, began developing blisters in patches on lower right leg.  Visited urgent care and confirmed shingles, which is now being treated with valacylovir and predinsone.  Symptoms are abating.  This is my third bout with shingles as an adult.  There is no confirmed linkage to my COVID vaccinations but I thought I should report this as a possible vaccine reaction given the close proximity of shingles onset to my last COVID shot.
Information has been received from a physician concerning a female patient who on 19-MAR-2007 was vaccinated with a dose of Gardasil. After receiving the injection the patient developed a rash that extended from head  to toe. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Redness, swelling size of golf ball 1 hour after vaccine per mother of patient. Mother informed to keep close eye on breathing issues and to use OTC Motrin/Benadryl along with ice packs and massaging the area.
No further AE details; HCP called to report an expired dose of PROQUAD was administered to Multiple patients.; Date of excursion: 3/2/2023/Date of administration: 6/14/2023; This spontaneous report was received from a pharmacist and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-JUN-2023, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHa)(PROQUAD) injection, 1 dose, lot #W034210, expiration date: 24-APR-2024 (also reported as 02-JUN-2023), administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered ). On 02-MAR-2023, this vaccine underwent temperature excursion of 70 Fahrenheit (F) for 9 minutes (Product storage error). No additional adverse event were reported.; Sender's Comments:  US-009507513-2306USA007844:
Vertigo, nausea, altered vision within minutes of receiving vaccine.  Observed in clinic for 1 hour.  Symptoms resolved.  Returned to work.  Vaccine received around 1150 am - patient had not had anything to eat that morning.
This spontaneous report was received from a licensed vocational nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported), lot# L014415 with expiration date 25-JUL-2017 or lot# L016428 with expiration date 30-JUL-2017). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
I had high blood pressure from Tues 3/30 to Sat April 3 it ranged from 155/123 pulse 83 to to 153/97. From the 4th forward it has gone to normal range of 113/84 & 140/88. Will continue to monitor to get back and stay in normal range and not pre hypertension and stage 1 hypertension range.
Diffuse migrating urticaria that started about 11 days post Moderna Booster.  It is still present now 3 days later and is minimally responsive to oral antihistamines
Patient states that her mother started noticing red, blotchy areas on the right side of her face. Patient states that her face, upper lip and bilateral upper extremities started itching, she also started having  a tingling sensation to her fingers and red, blotchy areas to her hands.  Patient started having symptoms 45min after immunization. Patient was given Benadryl 25mg, her symptoms improved and she went back home.
Developed acute cellulitis on face about 18 after injection. Had slightly inflamed pore on jaw on day of injection. When woke up bottom of jaw was hot, swollen and inflamed.
29 year old female Patient received the vaccine and had no reactions during observation period of 15 minutes. She checked out and left the clinic at 10:00 am. She began to develop pink rash spots to the right arm with one quarter size raised inflamed rash to the brachial area. Patient returned to the vaccination clinic to report symptoms at 10:45 am. She denies any respiratory distress. Manager assessed patient. Benadryl was offered and patient agreed to take a 50 mg of oral  Benadryl capsule at 11 am. Patient refused to be observed further stating she had to go pick up her child and felt less itching prior to leaving. Advised her to drive with caution due to risk of drowsiness from taking Benadryl. She verbalized understanding and stated she lived close by that she would be fine.
This case was reported by a healthcare professional via sales representative and described the occurrence of influenza type a in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date in November 2010 the subject received a dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced influenza type a and vaccination failure. The sales representative stated a subject was vaccinated with FLUARIX in November 2010, came into the office and tested positive for influenza (tested for type A). This case was assessed as medically serious by GSK. At the time of reporting the outcome of the influenza type a and vaccination failure was unspecified. This is the second of three cases the sales representative reported that tested positive for influenza (two subjects tested for type A and one subject tested for type B). Please see cases A0914702A and A0914709A.
It was around 5:00-6:00 PM when I started to feel very lightheaded all the time and had bad muscle aches. It got to the point where if I did anything but lay down, I would feel lightheaded and off balance. The worst happened at 3:00 AM on 4/10/2021 (the day after) when I got up to use the bathroom. I was washing my hands afterwards and nearly passed out. I couldn't hear, I couldn't see, and it was a bit difficult to breath. Luckily I knew what all of this meant and I sat down and took deep breaths until I felt fine again.
Headache, body, muscle and joint pain. Severe rash on stomach.  Arm where injection site was, quivering .  Fatique for 26 hours straight sleep
1 1/2 weeks post vax, the pt developed upper extremity arthralgias/ synovitis in metacarpophalangeal joint, proximal interphalangeal joint, also had arthralgias synovitis in knees.
she has a sinus infection and it has gone into her chest; had such a terrible reaction; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (she has a sinus infection and it has gone into her chest) and IMMUNISATION REACTION (had such a terrible reaction) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (she has a sinus infection and it has gone into her chest) and IMMUNISATION REACTION (had such a terrible reaction). At the time of the report, SINUSITIS (she has a sinus infection and it has gone into her chest) and IMMUNISATION REACTION (had such a terrible reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Patient had such a terrible reaction and doctor advised her not to get the second one.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Erythema/induration 6x10cm at site of injection. Associated with 5x3cm erythematous, swollen node in the left groin. Treated with Orapred and Benadryl.
patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received a dose of a vial after 12 hours of initial puncture) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received a dose of a vial after 12 hours of initial puncture). On 17-Aug-2021, EXPIRED PRODUCT ADMINISTERED (patients received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and treatment medications were reported. Vial punctured 01-Jun-2021 Vial stored in refrigerator once punctured, in freezer prior to puncture (Vial was being used past the recommended 12 hour post puncture time).   This case was linked to MOD-2021-418964 (Patient Link).
Since Feb 2021, shortly after receiving COVID-19 Pfizer vaccine, she has had  waxing and waning nausea, vomiting, diarrhea, abd pain, swelling of her lips,  nasal bridge, peri-orbital area, feet, along with scattered uritcaria across her  entire body. She also notes general hair loss, weight loss associated with  decreased appetite and frequent GI losses. Diarrhea- no mucous or blood by  description No trouble breathing or swallowing with facial edema Denies cough, dyspnea Not much joint pain. Pain in feet when legs are swollen.  Urticaria - persists for many days, some fade, some stay slightly  hyperpigemented, always present somewhere ED visits in June and July. Walk-in eval July.  Treatment with antihistamines - no improvement Was found to have H pyolori which explains GI symptoms and was started on triple therapy; however, urticaria, angio and other edema still present
Pt called 10/21/08, states received Flu vaccine at 10:12 AM (Never had one before), approx. 2 1/2 hr after received, developed a cough, throat felt tight, HA, chills and vomited. Lasted several hrs no intervention.  Much better today. Stayed hm from work 10/21/08 - but still some residual
The patient was seen at outpatient on April 26, 2021, for agitation, incoherent and disorganized speech, inappropriate attire for weather (i.e. one shoe and shorts in 40 degree weather). His condition improved somewhat with Ativan injectable and Haloperidol oral. He was then taken to ER.    There is no previous history of agitation/psychosis or mental health disorder on record. A nurse noted disorganized/pressured speech on 4-16-2021 during a community event but was not medically related.
Elevated temp began 5MAR92, cont to 104 on 6MAR92; 6MAR92 began itching, welts all over body w/some wheezing; pt was given Pediaprofen 5MAR-6MAR; On 6MAR 3PM took pt to MD for tx & was given med;
nose bleed; Atrial Fibrillation; hypertension; This is spontaneous report from a contactable consumer or other non HCP. The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 19Jul2021, this case now contains all required information to be considered valid.   A 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1283, Expiration date: unknown), via unspecified route of administration in the right Arm, on 28Jan2021 at 12:00 PM, (at the age of 84-year-old) as dose 1, single for COVID-19 Immunisation. Medical history included blood too thin to coagulate. Concomitant medications included warfarin taken for Blood too thin to coagulate start and stop date was not reported, acetylsalicylic acid (ASPIRIN 81) taken for unspecified indication start and stop date was not reported. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3302), via unspecified route of administration in the left shoulder, on 19Mar2021 at 11:00 AM, as dose 2, single for COVID-19 Immunisation.  On 10Feb2021 at 07:15 PM, the patient experienced nosebleed. On an unknown date, the patient experienced hypertension and atrial Fibrillation. The patient visited 3 times to emergency room for bleeding and received two transfusions to stop bleeding and kept in hospital until 19Feb2021. On an unknown date, the patient transferred to ENT physician. It was reported that he was hospitalized and couldn't make it to appointment for second dose on 26Feb2021. Prior vaccinations within 4 weeks were none. The patient was visiting her primary care physician and cardiologist regularly. The outcome of the events were not recovered.    Information about lot/batch number has been requested.  Follow-up (19Jul2021): The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (19Jul2021), this case now contains all required information to be considered valid. new information added which included suspect product detail, event detail, Patient age at time of vaccination, patient medical history was updated.  Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.
Approximately 2 weeks after vaccination developed a red, itchy rash on left side of neck with mild swelling.