chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in hands; He feels blood rushes from waist to feet when he stands too fast; diarrhea worsened for 10 days following booster; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 41 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) at the age of 41 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer (DOSE 1, DOSE 2)), for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset Jan2022, outcome "recovering", described as "diarrhea worsened for 10 days following booster"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in hands"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "He feels blood rushes from waist to feet when he stands too fast". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: patient reported he had COVID booster Jan2022 and diarrhea worsened for 10 days following booster. symptoms have now improved to where they were prior to booster. He feels blood rushes from waist to feet when he stands too fast. this feeling passes in less than 30 seconds - new since start of therapy and has been happening less often lately. MD is not aware and he is advised to update. Patient reported lab work last week (no date) C - reactive protein 23.3/sedimentation rate 34, both elevated has not discussed with MD. Reported since covid booster Jan2022 experienced pain in hands which has gotten worse in last few weeks (no date). Unsure if md aware.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Site became very swollen, red, hot, throbbing.  Swollen lymph node in armpit on same side of injection.  Next day rash was larger (over 5 in. diameter).  By 11/30, rash was covering entire upper arm and shoulder, but center was less hot and throbbing.
the neurologist agreed that the vaccine has attacked nervous system; developed signs of stroke, he can't stand up and walk up straight; feeling unwell and was unable to work for a few days; he had tingling on the left side that moved to his right side; he has difficulty speaking/ word finding/Slurring his speech; tinnitus; nausea; pain in the rear of his neck, between the neck and skull; His symptoms continue to be severe and is unable to work; he cannot coordinate his thoughts and fantasies; dizziness, he felt his head was spinning; He had some kind of palsy where his face was not reacting bilaterally; pressure in his brain; Got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms; This is a spontaneous report from a contactable consumer (patients wife).   A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced the neurologist agreed that the vaccine has attacked nervous system (nervous system disorder) (hospitalization) on an unspecified date with outcome of unknown , developed signs of stroke, he can't stand up and walk up straight (cerebrovascular accident) (medically significant) on an unspecified date with outcome of unknown , feeling unwell and was unable to work for a few days (malaise) (medically significant) on an unspecified date with outcome of unknown , he had tingling on the left side that moved to his right side (paraesthesia) (medically significant) on an unspecified date with outcome of unknown , he has difficulty speaking/ word finding/slurring his speech (dysarthria) (medically significant) on an unspecified date with outcome of unknown , tinnitus (tinnitus) (non-serious) on an unspecified date with outcome of unknown , nausea (nausea) (non-serious) on an unspecified date with outcome of unknown , pain in the rear of his neck, between the neck and skull (neck pain) (non-serious) on an unspecified date with outcome of unknown , his symptoms continue to be severe and is unable to work (loss of personal independence in daily activities) (medically significant) on an unspecified date with outcome of unknown , he cannot coordinate his thoughts and fantasies (coordination abnormal) (medically significant) on an unspecified date with outcome of unknown , dizziness, he felt his head was spinning (dizziness) (medically significant) on an unspecified date with outcome of unknown , he had some kind of palsy where his face was not reacting bilaterally (paralysis) (medically significant) on an unspecified date with outcome of unknown , pressure in his brain (head discomfort) (non-serious) on an unspecified date with outcome of unknown , got really sick 18 hours after it and it lasted for like two days where he was really sick, all sorts of symptoms (illness) (non-serious) on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022).    Concomitant medication information was not provided by the reporter.  Patient received half dose.  Vial was initially stored in the refrigerator on 04-Jun-2022.  Vaccine administered to 346 patients after the 30 day by used involved 35 vials. Vial did not undergone any temperature excursions.  Treatment information was not provided by the reporter.
haven't been able to work; It feels like it's burning up some days and some other days it's not as bad.; it's like swollen; swollen red; inflammation/inflamed; hurts really bad; arm has been acting really bad ever since/where they gave me the shot/hurt every day/pain is central; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (haven't been able to work), BURNING SENSATION (It feels like it's burning up some days and some other days it's not as bad.), SWELLING (it's like swollen), ERYTHEMA (swollen red) and INFLAMMATION (inflammation/inflamed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION SITE PAIN (arm has been acting really bad ever since/where they gave me the shot/hurt every day/pain is central). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (haven't been able to work), BURNING SENSATION (It feels like it's burning up some days and some other days it's not as bad.), SWELLING (it's like swollen), ERYTHEMA (swollen red), INFLAMMATION (inflammation/inflamed) and PAIN IN EXTREMITY (hurts really bad). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (haven't been able to work), BURNING SENSATION (It feels like it's burning up some days and some other days it's not as bad.), SWELLING (it's like swollen), ERYTHEMA (swollen red), INFLAMMATION (inflammation/inflamed), PAIN IN EXTREMITY (hurts really bad) and VACCINATION SITE PAIN (arm has been acting really bad ever since/where they gave me the shot/hurt every day/pain is central) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
No symptomatic side effects reported. No additional AE; MMR-II and VARIVAX were inadvertently administered intramuscularly instead of subcutaneously; This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 22-DEC-2022, the patient was vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (rHA) subcutaneous injection, 0.5 milliliter, (lot number W002787 has been verified to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (rHA), expiration date reported and confirmed as 25-JAN-2024); and with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (lot number W021743 has been verified to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported and confirmed as 10-JUL-2024), inadvertently administered intramuscularly instead of subcutaneously as prophylaxis (Incorrect route of product administration). Other suspect therapies included sterile diluent, solution for injection/infusion (lot number W030217 has been verified to be valid for sterile diluent, expiration date reported and confirmed as 23-MAY-2025) (strength, dose, route of administration, and indication were not provided).  No symptomatic side effects nor additional adverse events (AEs) were reported.
Vasomotor collapse, Placed supine. BP 70/35 P 40; BP 68/34 p 40; BP 90/60 P 55; BP 110/60 P 60 (after 10 minutes of monitoring). Refused further treatment and released.
DEATH; DEMENTIA; GUILLAIN BARRE SYNDROME; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This solicited report received from a consumer via PPSCVM000196: Janssen Account concerned a female of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received 2 doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported, administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with 2 doses of covid-19 vaccine (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced Guillain-Barre syndrome (dose number in series 2).  On an unspecified date, the patient experienced dementia. It was reported as broke through the blood brain barrier and she developed stage 5 dementia in months (dose number in series 2). On an unspecified date, the patient died from an unknown cause of death (dose number in series 2). It was unknown if an autopsy was performed. Reporter stated, "My Aunt died from this after 3 Vax shots. Broke through the blood brain barrier and she developed stage 5 dementia in months." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of dementia, Guillain-Barre syndrome and revaccination with different covid-19 vaccine was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and death, dementia, and revaccination with different covid-19 vaccine was not related, and between covid-19 vaccine ad26.cov2.s, and Guillain-Barre syndrome was related. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20230658538- death, dementia. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered not related. 20230658538-Guillain-Barre syndrome. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
POSITIVE COVID-19 TEST AFTER VACCINATION; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-OCT-2021, the patient experienced positive covid-19 test after vaccination. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive covid-19 test after vaccination was not reported. This report was non-serious. This case is a duplicate of 20211016096.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
~17 hours after receiving my second dose of the Pfizer vaccine I developed chills, body/muscle/joint aches, severe fatigue, and a headache.  This persisted for 4 days.  I took Acetaminophen for the muscle aches.  Five days later (2/15) I continue to have a headache but other symptoms have resolved.  Today (2/15) I am 18w3d pregnant.  On the day of the 2nd dose (2/10), I was 17w5d pregnant.  I haven't had any pregnancy complications prior to either covid vaccine dose and I haven't experienced any pregnancy complications since my 2nd dose.
bad headache; dizzy; weak; tired; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient who is a doctor had a bad headache, was dizzy, weak and tired after receiving the vaccine on an unknown date in Jan2021 with outcome of unknown.   Information about lot/batch number has been requested.
has an infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (has an infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced INFECTION (has an infection). At the time of the report, INFECTION (has an infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient wanted to know for the infection, if she was allowed to take antibiotics after getting the vaccine.
I developed a mild headache, some chills, fatigue, pain at the injection site and bright redness around the injection site and upward - about 4 inches.
Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   This case contains information about patient 02 out of 04 patients. No concomitant medication was provided by reporter. Four adult  patient was impact due to Moderna COVID-19 Vaccine for Illness. Reporter assumed patient  get sick because of the vaccine . Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-737834 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737834:Patient 2
Information was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On 13-JUN-2017, the patient was vaccinated with VARIVAX (lot # M027347 with expiration date 01-JUN-2018; concentration, dose and frequency were unknown) subcutaneously for prophylaxis. The medical assistant reported that the physician ordered varicella zoster vaccine and wanted the patient to receive ZOSTAVAX. Medical assistant reported that no attempt was made to clarify which vaccine the physician wanted patient to receive. No adverse effect was reported. No product quality complaint (PQC) was involved in this case.
Redness, swelling from just above elbow to shoulder. Site was hot to the touch. From injection site to below left ear ached. Lasted approx 3 days for aching, redness, and heat stayed over 10 days.
MISSED TO TAKE LAST DOSE ON DAY SEVEN; This spontaneous case report (PVX2019-2802) was received from a nurse on 13-Nov-2019. It described a 68-year-old female consumer who "missed to take last dose on day seven" (PT: Product dose omission), while being on oral Vivotif for typhoid fever.  Case report: The consumer took three doses of Vivotif on 04-Nov-2019, 06-Nov-2019, and on 08-Nov-2019, respectively. However, she missed to take the fourth dose on 10-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed to take last dose on day seven" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take last dose on day seven" was considered as not applicable.
Patient report pain-redness-swelling which increased 8 hrs. after shot note MD. Upon awakening patients hand was significantly swollen. On call provider was called 11/2/14 and patient was told to elevate, ice and take BENADRYL. Follow up call to patient at 1:03 pm on 11/2/14 patient reports swelling in hand has gone down.
"Pt received Pfizer covid vaccine dose number two at 1020. Felt ""odd"" after vaccine with HA.  She returned to our area with complaints of selling tongue and throat with continued headache and hot feeling. Remained in alcove for monitoring. VS 1117 HR 102, BP 148/84, 100% 1125 HR 85, BP 126/82 99% 1130 HR 75, 124/85, 100% Admistered 25mg of Benadryl at 1119.  Tongue swelling decreased at reassessment at 1135.  Patients spouse was called to pick up and drive home as pt was tired due to Benadryl administration.
Information has been received from a 27 year old female patient with arthritis who on 24-Aug-2009 was vaccinated with a 0.5 ml first dose of GARDASIL. Concomitant therapy included HUMIRA. The patient reported that on 25-Aug-2009 she experienced severe joint pain after getting her first dose of GARDASIL. At the time of this report, the patient had not recovered. No further information is available.
Low grade fever, aches and pains lasting all night and into the late afternoon of the next day, Then...poof, all gone around 5 pm.
Slight Soreness at Site of Injection; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 73-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 24Feb2021 at 10:30 am (age at vaccination was 73 years) as dose 1, single for COVID-19 immunization. The patient's medical history included 2 bowel obstruction surgeries and COVID-19 from an unknown date. Concomitant medications and other medications the patient received within 2 weeks of vaccination included multivitamins [vitamins NOS], ascorbic acid (VIT C), ergocalciferol, retinol (VITAMIN A & D [ERGOCALCIFEROL; RETINOL]) and zinc all taken for an unspecified indication. The patient previously took eritrovis [erythromycin] and experienced allergies to it. The facility where the most recent COVID-19 vaccine was administered was Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 24Feb2021 at 17:00 pm, the patient experienced slight soreness at site of injection. No treatment was received for the adverse event. 2 weeks from dose 1 date there were no side effects to report. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP7534, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 17Mar2021 at 10:15 am (age at vaccination was 73 years) as dose 2, single for COVID-19 immunization. The outcome of the event was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.