chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 kids in her neighborhood have died after getting the Pfizer BioNtech Covid vaccine; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer reporting same event under the same suspect product for 6 patients. This is one of 6 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253281 same reporter/SD/AE, different patient;US-PFIZER INC-202101253281 same reporter,same vaccine, same adverse event, different patient; Reported Cause(s) of Death: unknown cause of death
arrhythmia; lightheadedness; brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 11:00 (Lot number: ER8729) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "SVT's" (unspecified if ongoing), notes: prior history of SVT's that had resolved. There were no concomitant medications. Past drug history included: Tetracycline, reaction(s): "Known allergies: tetracycline". Vaccination history included: Bnt162b2 (dose 1, lot number: ER20013, administration time: 11:00 AM, vaccine location: Left arm), administration date: 19Mar2021, when the patient was 62 years old, for COVID-19 immunization, reaction(s): "tachycardia". The following information was reported: ARRHYTHMIA (medically significant) with onset 09Apr2021, outcome "recovering", described as "arrhythmia"; DIZZINESS (non-serious) with onset 09Apr2021, outcome "recovering", described as "lightheadedness"; FEELING ABNORMAL (non-serious) with onset 09Apr2021, outcome "recovering", described as "brain fog". Therapeutic measures were taken as a result of arrhythmia, dizziness, feeling abnormal included: homeopathic and naturopathic cardiac support. Clinical course: After second dose arrhythmia, lightheadedness and brain fog, beginning within minutes of vaccine and continuing for months. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No other medications in two weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200238190 Same reporter/SD/patient, Different AE/dose
Patient presented to the ED on 4/10/21. She presented to the ED on 4/12/21 and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.
Patient called pharmacy about 3 weeks after receiving the vaccine stating that her arm was "still feeling like the vaccine was being pushed in". She stated that her arm was not sore, but feeling weak. I asked her to follow up with her md.
urticaria starting on face & extremities-spread to trunk-lasted 10min then faded-starting w/trunk of body then extremities & face
Coordination abnormal; Demyelination; Paraesthesia; Information was received from a healthcare professional via the health authority Regulatory Authority (RA) (AU-TGA-0000587844) on 25-FEB-2022.  This spontaneous report was received from a other health professional regarding a 44-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.     On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (dose, frequency, route, indication, anatomical location, lot # and expiration date were not provided).    On 05-JUN-2021, the patient started therapy with tozinameran(COMIRNATY), lot # ET3045 (dose, frequency, route, indication, anatomical location and expiration date were not provided).      On 22-JUN-2021, the patient experienced paraesthesia. On 24-JUN-2021, the patient presented with numbness/tingling face and hands. The patient was reviewed by general practitioner (GP) then at clinical exam no cause found, bloods ordered, no cause found. Duration symptoms 2/7 then. Presented again to the same GP-as symptoms persisted. He advised that it was likely modafinil side effect. Patient requested a brain magnetic resonance imaging (MRI).   On 06-JUL-2021, the patient was seen by reporter, symptoms persistent but would migrate to different parts of face and hands. Vaccine history given to reporter --had received Pfizer vaccine. On same visit, she had completed her final quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) vaccine. Patient was advised to get the MRI done.  On 16-JUL-2021, the patient reported symptoms slowly resolving but new symptom of incoordination now (coordination abnormal). Safety net done, discussed case with on call neurology consultant and advised to report vaccine adverse effects as MRI brain confirms demyelination of brain and spinal cord. By the time of report, the patient was recovering from the paraesthesia (also stop date reported as 17-JUL-2021) but she was not recovered from the demyelination. The outcome of coordination abnormal was unknown. The action taken with tozinameran(COMIRNATY) regarding the events was dose not changed.  The agency considered the events as serious and considered coordination abnormal, paraesthesia and demyelination to be possibly related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL).
Patient was nervous due to his shellfish allergy and was apprehensive. He went to get a glass of water after he was vaccinated and when he sat down, missed his chair and had a syncope episode. Taken back by EMS to secluded area, vitals and glucose checked. Glucose was normal, BP reported as low and EMS decided he should be transported.  EMS provided fluids, monitored at ER, BP came back to normal and he was released.
Shingles again, shynrix shots 2 years ago/SUSPECTED VACINATION FAILURE; Shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 16-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got shingles again after having Shingrix shots 2 years ago. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
covid 19 vaccination moderna  2/26 and 3/26/21. Pt presenting with unusual neurological symptoms on 6/1/21.. Wife video recorded his ataxia on her phone to show neurology on follow up. His feeling of spinning which only occurs when lying still and resolves with movement of his head and sitting up is unusual.  Physical therapy notes no ataxia however pt reports they did not test tandem walking or standing on one leg which he is unable to do and was recorded by wife on her phone. atypical presentation of vertigo. Only occurs when lying completely still in bed, does not worsen with head movement and resolves with sitting up. Lifelong non smoker/non drinker. Labs all normal.  No vomiting, nystagmus, recent illness or uri, no sinusitis/mastoiditis on mri brain. No acute abnl of mri brain or cta head or neck. No recent medication changes. Pt consistently in sinus rhythm. No fever. No past hx of covid 19. Case reviewed with neurology. Recommending trial of meclizine and PT. Out pt follow up with neurology for further work up if persists. MRI cervical spine will need to be done as out pt.  Tsh, b 12, folate normal.
I had chronic sore throat.  I ignored it but it never seemed to go away.  Then I started to have trouble feeling things while swallowing like a lump in my throat.  The symptoms kind of built up after this.
5cm x 2 cm warm, red papule (R) thigh with 3 small (approx .25cm) surrounding red papules.
Information has been received from a physician concerning a 74 year old male with hypertension, dyslipidaemia and penicillin allergy and a history of chickenpox who on 13-NOV-2008 was vaccinated with 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # 658859/0411X) into the left upper arm.  Concomitant therapy included QUINAPRIL, FENOFIBRATE, SIMVASTATIN (manufacturer unknown), aspirin and OTC MVI supplement.  On 17-NOV-2008, 5 days after being vaccinated, the patient experienced shingles in the right eye.  It was also reported that herpes ZOSTER  distributed on the right scalp and in the right eye and the rash type included popular and vesicular.  The systemic symptoms included scalp tenderness, tingling, redness and vesicular/popular lesions.  On an unspecified date the patient also experienced general malaise.  There was no recent exposure to chickenpox  or shingles.  The patient reported pain of 6-7 on a scale of 1 to 10.  Subsequently, the patient recovered on an unspecified date.  The patient sought unspecified medical attention.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  Additional information has been requested.
a dose administered from an expired Moderna COVID 19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose administered from an expired Moderna COVID 19 vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-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) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose administered from an expired Moderna COVID 19 vaccine). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (a dose administered from an expired Moderna COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Reportedly, the vial was punctured for more than 12 hours and was administered to one patient on 14Jul2021. The vial was punctured at 11:56am on 13Jul2021. The expired dose was administered at 6:54pm on14Jul2021.   Treatment information was not provided.
She developed a rash around injection site. Area is flat and red. It was limited to within 2 inches around the injection site.  The entire area appeared swollen.  Then, she went to the doctor on Friday, 7/22/16.  The doctor prescribed doxycycline for the rash. When she came to the pharmacy Friday, the reaction had not worsened or improved.
I received a Pneumococcal Conjugate 13 shot. I area around the site is still tender with a hard area in the center. There is also a hot red area about 3 inches in diameter around the injection site. I am also experiencing chills and a headache.
Cough; Headache; Body aches; Arm pain; Chills; This case was reported by a consumer and described the occurrence of cough in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced cough, headache, general body pain, pain in arm and chills. On an unknown date, the outcome of the cough was recovering/resolving and the outcome of the headache, general body pain, pain in arm and chills were unknown.   It was unknown if the reporter considered the cough, headache, general body pain, pain in arm and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient received Shingrix and had headache, body aches, arm pain and chills. The patient had various reactions after Shingrix vaccination, not including a cough. However, 1-2 days after those side effects improved the patient began coughing.
This spontaneous report as received from a healthcare worker refers to a 13 month old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Erythema 5cm in diameter around site of DPT injection, warm to touch. Early cellulitis. Keflex 250 mg BID x 5 days.
BODY ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male 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 was not reported, administered on 19-MAR-2021 for prophylactic vaccination.  Batch no. is not reported. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced body aches. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced headache. On 19-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) Unknown. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, chills and body aches was not reported. This report was non-serious.
Lost part of the use of her left hand / Has limited use of her left hand; Immediate pain / down arm / that settled in thumb and index fingers and is persisting; Immediate / tingling down arm / that settled in thumb and index fingers and is persisting; This case was reported by a consumer via other manufacturer and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd February 2020, the patient received Shingrix. On 22nd February 2020, immediately after receiving Shingrix, the patient experienced pain in arm and tingling of extremity. On an unknown date, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was unknown and the outcome of the pain in arm and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm and tingling of extremity to be related to Shingrix.  Additional details were provided as follows:  The reporter was patient's husband. The age at vaccination was not reported.  The patient received Shingrix vaccine in left deltoid and she felt immediate pain and tingling down her left arm that settled into her thumb and index finger and was persisting to this day and less than a year after receiving Shingrix, she had limited use of her left hand because of the pain and tingling. The reporter consent to follow up. For tolerance of flu vaccine refer case US2021AMR082961.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR082961:Same reporter
Hives; Itchy; Full body rashes; Missed 2nd dose, recommended interval; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy), URTICARIA (Hives), PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose, recommended interval) and RASH (Full body rashes) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose, recommended interval). On 09-Apr-2021, the patient experienced PRURITUS (Itchy) and RASH (Full body rashes). On 27-Apr-2021, the patient experienced URTICARIA (Hives). At the time of the report, PRURITUS (Itchy), URTICARIA (Hives), PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose, recommended interval) and RASH (Full body rashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. The patient was treated with antibiotics and prednisone.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient developed a painful rash accompanied by persistent pain. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from shingles. As a direct and proximate result of the ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Dizziness,  also states elevated heart that may be associated with dizziness and also chest pressure.
Needed an ultrasound of heart. I started having Premature ventricular contractions (PVCs)
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 21-SEP-2017, the patient was vaccinated with a properly stored expired dose of RECOMBIVAX HB lot # M007763 (expiration date: 15-SEP-2017), intramuscularly (frequency was not reported) for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Employee called office approx 1130am, and stated that when she came home from work she vomited X2, and had mild rash on face and abdomen.  Denies any other symptoms.  Denies acute distress.  Sent to Medical Center for evaluation.  Seen by Dr.  Unknown if this is a Hepatitis B reaction per Dr.  Employee stated that she had the vaccine previously on her immunization questionnaire.  Hepatitis B surface antibody was negative.
On about August 1, 2022 I developed a sore throat, all over body aches, some congestion and a low grade fever which progressed over the day.  Most of the UR symptoms were similar to allergy symptoms.  The symptoms worsened over  the next few days with body aches that impaired ADLs, some dizziness and nausea.  It took approximately 7 days for the symptoms to abate, although the congestion and productive cough lingered for another 7-10 days.
Patient received prevnar vaccine on 10/20/23 and after administration it was discovered that the vaccine had an expiration date of 9/30/23
headache; chills; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), MYALGIA (body ache) and PYREXIA (fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (headache), CHILLS (chills), MYALGIA (body ache) and PYREXIA (fever). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, HEADACHE (headache), CHILLS (chills), MYALGIA (body ache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient took vaccine at 12:45 PM on 02-FEB-2021 and started feeling adverse events after 10 PM.
same day and the 2 days following Left arm/shoulder/side of neck had major joint pain, headaches, tiredness, sensitivity to light, brain fog, and felt extremely anxious to the point where my heart was racing and i was shakey. As of today (4/12/2021) I am still feeling extremely anxious (as if my anxiety medicine is not working at all) and have headaches and trouble focusing or remembering things, making it very difficult to work. Also having trouble sleeping because of the anxious feeling.