chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stools have been weird looking and smelly, like yeast; stools have been weird looking and smelly, like yeast; coffee (which is what has been tasting weird), tasted so gross; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 37-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3302, Expiry date: unknown), at 37 years of age via an unspecified route of administration on Left arm on 01Feb2021 at single dose for COVID-19 immunisation. Medical history was none. Concomitant medication included multivitamin (unspecified) and estradiol (ESTROGEN) as a supplement within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (Lot number: EJ1685, Expiry date: unknown) on 07Jan2021 at 09:30 AM on left arm for COVID-19 immunisation and experienced Exactly two weeks after the first vaccine I started smelling cigarette smoke and a sweet garlicky smell. Things tasted a little funny, but I mostly noticed it with coffee. Patient also had known allergies to clindamycin and Sulfa. The patient stated that, things tasted a little funny, but I mostly noticed it with coffee. I didn't think about the COVID shot, I just thought maybe I had a cold. Then exactly two weeks after the second, my coffee (which is what has been tasting weird), tasted so gross I had to throw it out in Feb2021. That's when I put it all together that it is probably from the vaccine. Then the more I research that sweet garlic is actually yeast I am smelling. Then I realized since all this has started by in Feb2021 stools have been weird looking and smelly, like yeast and sure enough I googled it and it looks similar. My co-worker is having a yeast infection also, but it is only in her mouth. The patient received treatment for the events with diflucan 150mg a 20-week cycle. The reporter considered the events as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed as non-serious by the reporter. The outcome of the events was reported as not recovered.; Sender's Comments: Based on temporal relationship, the causality between the suspect 'BNT162B2' and the reported 'stools have been weird looking and smelly, like yeast' cannot be completely 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.
HIVES, ITCHING /SWELLS/RASHES EVERY WHERE/ 90%//
This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for an unknown indication.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2021, the patient experienced SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Dec-2021 to 23-Dec-2021 due to SEIZURE. The patient was treated with LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Adverse event, at an unspecified dose and frequency and VALPROATE SEMISODIUM (DEPAKOTE) for Adverse event, at a dose of 1 dosage form twice a day. At the time of the report, SEIZURE (Seizure) outcome was unknown.            No concomitant medication reported. Exactly a month after receiving the booster dose of the Moderna COVID 19 vaccine, she had a seizure (23 Dec 2021). The seizure was at home and she had to be taken with an ambulance to the hospital. She was in the hospital for one day, with husband called the ambulance at about 3:30 am and she was back home by 6:30 pm. Initially she was not taking any medication, but she was later prescribed Keppra. She had a bad reaction to Keppra and was switched to Depakote 500 mg twice a day. She has an appointment with her doctor tomorrow. She has never had seizure or nothing before in her entire life.  Company comment: This spontaneous case concerns a 58-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant and hospitalization) event of Seizure (AESI) after mRNA- 1273 vaccine. The event occurred approximately 1 month after the booster dose of mRNA- 1273 vaccine. The patient was hospitalized for one day. Treatment with Levetiracetam was prescribed and then switched to Valproate. Very limited information is available regarding diagnostic work-up and potential triggers of the event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-433967, MOD-2021-433968 (Patient Link). Sender's Comments: This spontaneous case concerns a 58-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant and hospitalization) event of Seizure (AESI) after mRNA- 1273 vaccine. The event occurred approximately 1 month after the booster dose of mRNA- 1273 vaccine. The patient was hospitalized for one day. Treatment with Levetiracetam was prescribed and then switched to Valproate. Very limited information is available regarding diagnostic work-up and potential triggers of the event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
This spontaneous report was received from a registered nurse refers to unspecified patients of unknown age and gender. On 23-JUN-2015 the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, lot and route not provided). No adverse effects reported. Additional information is not expected.
bruising in legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising in legs and feet) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruising in legs and feet). At the time of the report, CONTUSION (bruising in legs and feet) outcome was unknown.        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.   One of the nieces had an adverse event and also had an acute case of ITP when she as a teenager struggling with Chronic Fatigue syndrome. Concomitant medications were not reported.  No treatment information was provided by the reporter. 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.
Even though I received the vaccine on 1/21/2021, I noticed a slight knot on my shoulder on 1/31/2021. There is no pain but I do feel it. I only felt slight  discomfort after the shot but nothing noticeable. I put some ointment and ice on it and it has went down some. I am scheduled for my 2nd does on 2/18/2021.
Patient reported that her whole arm was red, swollen and hot the day after vaccination. The following day she saw her doctor & was given a steroid shot, antibiotic & antihistamine.
Patient could not breathe, was very stiff, sweating, salivating from the mouth, his eyes were rolling in the back of his head, he was incoherent and he could not sit up on his own.  I administered an Epi-pen injection and called an ambulance.  He was taken to the hospital.
Information has been received from a healthcare worker referring to a 62 year old male patient. No relevant medical history or concurrent conditions were reported. On 27-AUG-2015 the patient was vaccinated with improperly stored PNEUMOVAX23 (lot # K009876, expiration date 19-MAR-2016; dose and route not reported) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
her tongue is slippery or something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date 06May2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 07May2021, outcome "unknown", described as "her tongue is slippery or something".  Additional Information: The patient received the first dose of the Pfizer COVID-19 vaccine. Unfortunately, about an hour ago, she was spraying Lysol spray in her son's room to eliminate odors and as she was spraying, she opened her mouth to call for her son and in that moment, the Lysol that she was putting into the air entered into her mouth. The caller explains she could feel the flavor of the Lysol on her mouth. After that, her tongue is slippery or something. She cannot describe it in this language, she can only describe it in her own language, she doesn't know. She clarifies it just feels weird. Her question for Pfizer is if the substances from the Lysol spray effect the vaccine? She mentions she read through the Lysol bottle, like the application and warnings, and everything she read is in regards to if something happens to the skin or eyes. Since she accidentally put some Lysol in her mouth, it doesn't say anything about if a little drip is swallowed/gets into your mouth. It only says something about the skin, nothing for swallowing. Caller doesn't had her vaccine record card with her. She mentions she received the first dose at Hospital. She knows that her second vaccine is scheduled for 27May2021. She states she only had a question in regards to the Lysol affecting the vaccine, nothing else is wrong  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortness of breath; Joint pain; Headache; electric shock like headache with little tingling in her head; Swelling of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of the arm), DYSPNOEA (Shortness of breath), PARAESTHESIA (electric shock like headache with little tingling in her head), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    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 PERIPHERAL SWELLING (Swelling of the arm), PARAESTHESIA (electric shock like headache with little tingling in her head) and HEADACHE (Headache). On 03-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Swelling of the arm), DYSPNOEA (Shortness of breath), PARAESTHESIA (electric shock like headache with little tingling in her head), ARTHRALGIA (Joint pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not reported by the reporter.
administered an expired Bexsero; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB38AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 23rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   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: 23-AUG-2022 Reporter's Comments: The physician reported that they administered an expired Bexsero dose to a patient.  The reporter called to enquire what to do. The reporter consented to follow-up.  Additional Supportive Information:On the day of reporting, the patient received an expired dose of Bexsero, which led to expired vaccine used.
Sore swollen and hot at site of injection. Vomiting fever chills shivering. Over all feeling of sick
Fever of 102, chills, headache, body aches, dizziness, sneezing, runny nose
Information has been received from a female patient who after receiving the first dose of GARDASIL in her left arm the left side of her body feels numb and tingling including her stomach. No further adverse event information provided. Consumer stated she was going into her physician and would call back with additional information. Additional information has been requested.
Sore arm; Sleepy and went to sleep around 7:00PM but then he was fine; This is a spontaneous report from a contactable consumer (reporter's sister) via medical information team. A contactable consumer reported similar events for 3 patients. This is 2 of 3 reports. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201, Expiration date: Unknown), via an unspecified route of administration in right arm on 26Mar2021 (at the age of 63-years-old) as dose 1, single, and second dose via an unspecified route of administration on 14Apr2021 (at the age of 63-years-old) (Batch/Lot Number: ER8737) as dose 2, single for covid-19 immunisation. Additional vaccines administered on same date of the Pfizer suspect was none. No prior vaccinations were performed within 4 weeks. The weight of the patient was between 135 and 138 lbs. Medical history included ongoing disabled (He's disabled, and he was in the military. He's had to learn to walk again). The patient's concomitant medications were not reported. On an unspecified date of 2021, the patient experienced sore arm and sleepy and went to sleep around 7:00pm but then he was fine. The events did not result in emergency room or physician office. The reporter was asking how long it will be before the third dose or booster shot comes out? Response: As part of Pfizer's and BioNTech's continued efforts to stay ahead of the virus causing COVID-19 and circulating mutations, the companies provided an update on booster dosing on 09Jul2021. Please note that the use of a 3rd or booster dose was not recommended or authorized and Pfizer does not suggest the use of the vaccine in any manner other than as described in the (if US) authorized EUA Prescribing Information authorized product monograph. Initial data from the ongoing study of booster doses demonstrated a consistent tolerability profile and high neutralization titers against the wild-type virus (the naturally occurring non-mutated virus) and the Beta variant. It is thought that the effects seen against the Beta variant may also be seen in the Delta variant. We are doing studies to confirm this. We expect to publish the data soon in a peer-reviewed journal and submit to regulatory authorities like the FDA in the coming weeks. Note to frontline: This FAQ should only be used if an HCP or non-HCP specifically asks about the Pfizer statement on booster doses. The patient has the mind of a young person. She reported her brother would not get the flu vaccine. He won't get any vaccination, but he was watching TV and wanted to get the Covid 19 vaccination. The outcome of the events was recovered on an unspecified date of 2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100962856 same reporter/product/event, different patient
Exactly 2 week after receiving the second Covid-19 vaccine shot I woke up in the morning with a serious balance issue.  I felt like I was on a rocking boat.  This was a constant feeling, with some days worse than others, but balance was off for two weeks.  I also experienced slight "fogginess", which is still an issue.  I have never experienced any type of balance in my entire life.  This was most concerning.  After doing some intensive research, I found an article that some that recieved the vaccine did have some vestibular issues, balance/dizziness.  Which makes me think that my episode was vaccine related. I am only reporting this so that you can track a possible non-typical adverse reaction.  I am in no way indicating the vaccine was defective.
Arm sore at the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore at the injection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A. and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm sore at the injection). At the time of the report, VACCINATION SITE PAIN (Arm sore at the injection) outcome was unknown.            Patient took medication to help with symptoms 6 hours later. Patient was taking eye drops for glaucoma taking other medication.  No treatment medication was provided   This case was linked to MOD-2021-367411, MOD-2021-367368 (Patient Link).
I have had a runny nose, cough, muscle aches, very sore throat, a slight headache. I have had no fever. I also experienced fatigue. My doctor prescribed me PAXLOVID, and I am on my third dose today. I am also taking ADVIL. My doctor had me stop taking my cholesterol medication while I am taking PAXLOVID. Also my NORVASC dosage is now cut in half while I am taking PAXLOVID for this 5 days.
The patient did not get her 2nd dose on the due date; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient did not get her 2nd dose on the due date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient did not get her 2nd dose on the due date). On 15-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient did not get her 2nd dose on the due date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Patient complained of feeling warm, and that heart was racing. Stated "I feel funny". Alert and oriented speech clear. HR 42 BP 80/42, type one diabetic BG self  monitor 142. Stat call made. Patient declined to be taken to the ER when offered.
got vaccine at 8:00 am around 1:00 pm started with a bad headache triggered a really bad migraine caused nausea and vomiting, then started with body aches, fatigue , it's been 5 days now still have migraine.
Shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, route and lot # not reported) for long-term prevention of shingles and/or zoster-related conditions.         On an unknown date, "shortly after" receiving zoster vaccine live (ZOSTAVAX), the patient experienced shingles and was treated by a healthcare provider at a medical office. As a direct and proximate result of the use of Zoster Vaccine Live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown.   The event was considered to be related to zoster vaccine live (ZOSTAVAX).
No AE reported; temperature excursion occurred on 6/3-4/2021/ improperly stored temperature excursion/ GARDASIL 9 lot BELOW 2C (-51.0C) for 14 hours; This spontaneous report was received from a physician referring to an 18-year-old patient whose gender was not specified. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, drug reactions, or allergies.  Between 03-JUN-2021 and 04-JUN-2021 (reported as "6/3-4/2021"), a temperature excursion involving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number 1659422, verified as valid for syringe formulation, with an expiration date reported and validated as 04-SEP-2022) occurred. The HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was improperly stored at a temperature below 2 degrees Celsius (-51 degrees Celsius) for 14 hours. There was no previous temperature excursion, and a data logger was not involved. On 09-JUN-2019, the improperly stored vaccine was administered to the patient for prophylaxis (administered dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported) (product storage error). No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1659422; expirationdate: 04-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA008011: US-009507513-2107USA002641: US-009507513-2107USA002967: US-009507513-2107USA003379: