chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 45 seconds after shots given patient collapsed and lost consciousness for about 15 seconds. Regained consciousness and was alert and oriented. Stated that he was light headed and nauseous. Patient had labs and EKG completed and will Follow up with PCM.
Hospitalized for weakness, dyspnea, nausea and vomiting in the setting of COVID 19.
I was fine until 5 days after vaccine when I started with a deep cough. I have not traveled or been around anyone that I know is positive. I have always worn a mask and good hand washing. We did not gather for the holidays. I did my antibody testing the week I was to get the vaccine to make sure I didn't have any. I was Negative so went and got the vaccine.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 30-JUN-2016, the patient was vaccinated with a dose of GARDASIL lot # K016966 and expiration date of 10-MAY-2017, for prophylaxis (dose and route of administration were not reported). On 06-FEB-2017, the patient was vaccinated with a dose of GARDASIL 9 lot # M009378 and expiration date of 23-APR-2018, for prophylaxis (dose and route of administration were not reported). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA003341: US-009507513-1802USA013791.
It was reported in a published article that an approximately 15 month old patient who was enrolled in a phase IIIb, open-label, randomized, multicenter study, received one 0.5ml dose of MMR II SQ into the left deltoid concomitantly with one 0.5ml dose of VARIVAX, SQ into the right deltoid. The patient received two 0.5 ml doses of HAVRIX, IM into one of the anterolateral thighs administered per study protocol. The investigators report that of the 31 serious adverse events (SAE) reported in this study, there was one SAE for which the investigator determined that a causal relationship to the study vaccines could not be confirmed or excluded. This was a subject for which the investigator reported an SAE of autism. This subject was not withdrawn from the study. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
developed Shingles after the Pfizer Covid vaccine.; This is a spontaneous report from a contactable consumer. This case is for one of reporter's two friends.   A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: Unknown) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. Medical history, concomitant conditions and past drug history of the patient were not reported. On an unspecified date, after vaccination, patient developed shingles. Reporter stated that she thought that shingles wasn't related to the vaccine, until a coworker, was at a game, and another parent, who was sitting next to this coworker, brought up the fact that two friends of that parent developed shingles after the Pfizer Covid vaccine. Outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021576866 same reporter/drug/event, different patient;-PFIZER INC-2021576816 same reporter/drug/event, different patient
Fully vaccinated, no booster with COVID infection breakthrough, and inpatient hospital stay recent bacterial infection, multiple comorbidities such as diabetes mellitus, end-stage renal disease, and morbid obesity,
immunocompromised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  An 88-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot number: unknown), for COVID-19 immunisation; Bnt162b2 (Dose 2, single, Batch/Lot number: unknown), for COVID-19 immunisation; Bnt162b2 (Dose 3 (booster), single, Batch/Lot number: unknown), for COVID-19 immunisation; Bnt162b2 (Dose 4 (booster), single, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised".Clinical course: It was reported that patient was immunocompromised, taken two shots primary series and three booster doses from Pfizer she would like to know if they should get another booster shot. It was further mentioned that patient was immunocompromised and took Pfizer COVID-19 vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200126655 same reporter/drug/event, different patient.;
hearing loss; tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss) in a male 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant) and TINNITUS (tinnitus). At the time of the report, DEAFNESS (hearing loss) and TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported by patient.  The patient was reporting own side effects. Patient also reported that he saw that people were reporting tinnitus and hearing loss as a side effect of Moderna. It was becoming more and more frequent. patient found that CDC literature stated this could be a potentially severe side effect. Patient stated these have been reported over the last 6-7 months.  Company Comment: This case concerns a male patient of unknown age with no relevant medical history, who experienced the unexpected event of Deafness. The event occurred approximately 6 days on an unknown date after receiving an unknown dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as there's no information available about the dose number. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a male patient of unknown age with no relevant medical history, who experienced the unexpected event of Deafness. The event occurred approximately 6 days on an unknown date after receiving an unknown dose number of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as there's no information available about the dose number. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Information has been received from a physician concerning a 57 year old female hospitalized patient who while hospitalized was vaccinated with PNEUMOVAX (lot # not provided). Subsequently the patient experienced redness and swelling at the injection site which extended her stay at the hospital. The patient was discharged after couple days and was readmitted for 1 or 2 days for pneumonia. The patient had sought unspecified medical attention. At the time of report, the patient's redness and swelling at the injection site and pneumonia persisted. Additional information has been requested.
The pt received immunization without incident. The next evening mother noticed the leg was swollen "twice its size." Child did not complain of pain but it was hot and red. On Thursday mom took child to the doctor. The doctor gave the child Benadryl prescription but mother states she didn't give it to the pt. Mother states by Friday-Saturday, leg was back to normal. Mother gave Motrin during this time.
Dx with autoimmune disease first time in my life with Multiple Sclerosis post second shot became symptomatic for MS hospitalized had work up post 2nd injection.; This is a spontaneous report from a contactable nurse (patient). A 43-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jan2021 (Lot Number: Ek9231) in Deltoid as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on 22Dec2020 20:00 (lot number: Ek5730) in right arm for covid-19 immunisation. The patient experienced Dx with autoimmune disease first time in her life with Multiple Sclerosis post second shot became symptomatic for MS hospitalized had work up post 2nd injection on 17Jan2021. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient hospitalized for 28 days and received treatment. The patient had COVID tested post vaccination (Nasal swab) with unknown results. The outcome was unknown.; Sender's Comments: Based on the temporal relationship, the association between the event multiple sclerosis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 73 years old male patient with chronic lymphocytic leukaemia. He received two courses of antibiotics in the year before enrollment. There was no therapy prior to ibrutinib.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 11. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 1. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Sender's Comments:  US-009507513-2103USA003406:
All adverse effects have lasted for six (6) plus days post-injection unless otherwise indicated: injection site arm sore, fatigue, sleepiness, joint pain, diarrhea, bad nightmares for four (4) nights and bad dreams (unusual for me) for two plus nights after (I had nightmares after the first covid shot, too), minor dizziness for three days, chills, depression.
Patient was scheduled to receive Pneumovax 20 vaccine and Pneumovax 13 administered instead. Incorrect vaccine grabbed by administering provider and administered prior to entering NDC into system. No adverse effect noted but incorrect vaccine administered.
Extreme pain around hip, lower left front torso first night; subsequently, very sore left leg front of thigh ever since and unable to sleep.
Arm pain and sleepiness day of vaccine, then next day chest pain and SOB.  Went to ED--chest CT clear and labs WNL  Chest pain and SOB still lingering for multiple days.  Denies hx of covid infection.  Says ED did not swab for active Covid 19 infection.
Chills all night, fever of 100.3 the next morning at 8 am. Extreme headache, stomach pain and nausea, very sore arm at injection site, but not swollen.
Stated pt had pain > 7 days after vaccine given no visible injury can be observed on skin surface but it is swollen a bit and felt hard to the touch. Pt said movement to that arm (left) was irritated.
1 week after receiving vaccination the patient developed generalized myalgia, sore throat, and fatigue. On 12/17/21 he developed headache and fought with his parents. They did not speak or see each other for the majority of the day on 12/18/21. On 12/19/21, They found him with a right sided facial droop, nonverbal and unable to follow commands. He was also agitated and unable to follow commands. He was hospitalized for concerns of stroke vs CNS infection.
pt felt light headed in tent after vaccine, was assisted to ground and legs elevated. pt stated he has a hx of anxiety after soys and blood work pt stated he felt better after gatorade and snacks. was evaluated by onsite md and medical staff. pt was observed 30 mins and released in care of family.
pt recv vax & reported 2 days later noted red spots, hives, itching, rash, no fever, knots on head;refused to see MD;
Initial headache, myalgia and chills day after vaccine.  6 days p vaccine felt off balance, vertigo, N/V and unable to walk without falling. Admitted to hospital for 3 days from 3/15/21 to 3/17/21, MRI brain and CSF and labs negative
Patient started with pain in her left shoulder and swelling in the left upper arm at the vaccinations site.  Then in to her left hip. This has resolved but she now has pain and discomfort in her left knee.
Patient was seen today and was given a 6months-4years Bivalent that was not diluted correctly. was diluted with .2 instead of 2.2ML  so dose was over concentrated
she has red dots all over; it started itching on her arms; she had a rash on her chest / arm / ankles; the injection site it started itching; the injection site it started getting red going down the arm; during the night she had a sinus headache; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (during the night she had a sinus headache), ERYTHEMA (she has red dots all over), PRURITUS (it started itching on her arms), RASH (she had a rash on her chest / arm / ankles) and MYALGIA (a sore arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     "No medical history was provided by the reporter.".  Concomitant products included RABEPRAZOLE SODIUM (ACIPHEX) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced MYALGIA (a sore arm). On 01-Sep-2021, the patient experienced SINUS HEADACHE (during the night she had a sinus headache), VACCINATION SITE PRURITUS (the injection site it started itching) and VACCINATION SITE ERYTHEMA (the injection site it started getting red going down the arm). On 02-Sep-2021, the patient experienced ERYTHEMA (she has red dots all over), PRURITUS (it started itching on her arms) and RASH (she had a rash on her chest / arm / ankles). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, SINUS HEADACHE (during the night she had a sinus headache), ERYTHEMA (she has red dots all over), PRURITUS (it started itching on her arms), RASH (she had a rash on her chest / arm / ankles), MYALGIA (a sore arm), VACCINATION SITE PRURITUS (the injection site it started itching) and VACCINATION SITE ERYTHEMA (the injection site it started getting red going down the arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
sore arm; severe headache; This is a spontaneous report from a contactable physician (self-Reported). A 65-years-old non pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot number: EL9262) via an unspecified route of administration in Arm Left on 25Jan2021 09:30 as single dose for covid-19 immunisation. Medical history included atrial tachycardia and asthmatic bronchitis. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore arm and severe headache. The outcome of the event was unknown.
This spontaneous report received from a patient via a company representative 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 (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced woke up shaking like it was having a seizure, sick, could not sleep, woke up shaking, soreness, and headache. The action taken with covid-19 vaccine was not applicable. The outcome of the sick, could not sleep, woke up shaking, woke up shaking like it was having a seizure, soreness and headache was not reported. This report was non-serious.  Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX (subcutaneously, lot # L040422, expiration date 15-OCT-2017; dose was not reported). No adverse effects were reported. Additional information has been requested.
Had redness site of Varivax 2 1/2 " diam-& heat Body ahces, nausea
Arm still red at injection site.; Arm still Sensitive at injection site; Hives all over body; Pain at injection site, painful; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 21-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included cetirizine hydrochloride (Zyrtec).   On 20th December 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. In December 2022, 1 hr after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site hypersensitivity and hives. In December 2022, the outcome of the injection site pain and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site hypersensitivity and hives were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site hypersensitivity and hives to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Feb-2023 Reporter's comment:  The patient received Boostrix on left arm.  The patient stated that within minutes experienced pain and swelling in arm that lasted for 3 days.  After one hour of administration, the patient experienced injection site was swollen and painful, hives appear all over body.  The swollen injection site was resolve but hives were still present. Within hours of receiving the vaccine, the patient experienced hives all over body that still have not gone away and was taking Zyrtec twice a day.  The patient also mentioned left arm was still red and sensitive at the injection site.  The medical disclaimer and medical information phone number provided referred to healthcare professional. The reporter consented to follow up. Additional supportive information: From the narrative it was not clear if patient experienced time to onset for pain and swelling in arm was within a minute or 1 hr. Conservatively 1 hour was captured in the case as per follow up.
3NOV94 fever 100.0 oral; swollen glands under chin; rested; lab test showed neg for neuro
I having Hives and a lot of itching all over my body. I checked my blood pressure during the event and it was elevated to 190/100. I have never had Hives or this intense itching (which last for several hours).  I'm losing my ability to hold my urine - I never had this issue before July 3, 2021). My eyes are watery and my nose always seem wet. -  I never had this issue before July 3, 2021).
Patients  received doses 4 week after expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients  received doses 4 week after expiration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients  received doses 4 week after expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients  received doses 4 week after expiration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment information was provided
swelling, redness @ inj site;whole body aches, pt has chills, hot & cold flashes & arm itches;
I had sinus congestion, I thought I was getting a bad cold. I the congestion felt the same as when I had, had COVID-19 before, I used a home COVID-19 test that came back positive. I called my doctor's office, spoke to NP, discussed the positive test and my symptoms. I was prescribed Paxlovid, within two hours of taking the medication I started feeling better.