chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Internuclear ophthalmoplegia, left eye; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 51-year-old male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Batch/Lot number: unknown) at the age of 51 years as dose 2, single for covid-19 immunisation at drug Store. Relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing); "Seafood allergy" (unspecified if ongoing); "Apple' allergy" (unspecified if ongoing), notes: Apple' allergy; "COVID-19" (unspecified if ongoing), notes: diagnosed with COVID-19 prior to vaccination. Concomitant medication(s) included: MONTELUKAST; ATORVASTATIN; LIPITOR; METFORMIN; BREO ELLIPTA; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 19Oct2021, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: OPHTHALMOPLEGIA (hospitalization, disability) with onset 18Nov2021, outcome "not recovered", described as "Internuclear ophthalmoplegia, left eye". The patient was hospitalized for ophthalmoplegia (hospitalization duration: 3 day(s)). The event "internuclear ophthalmoplegia, left eye" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: echocardiogram: unknown; magnetic resonance imaging: unknown; ultrasound scan: unknown. Therapeutic measures were taken as a result of ophthalmoplegia with Stroke workup, aspirin, ophthalmology and neurology evaluation.  Clinical Course: Patient developed Internuclear ophthalmoplegia, left eye, 9 days after the second dose which required 3 days of hospitalization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the event and suspected drug cannot be 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
I got the first Pfizer shot in January and the second in February/It's been 6 months so I plan to go back to get another round of shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "I have glaucoma", start date: 2001 (not ongoing), notes: glaucoma, started on Latanoprost. went back 6 months later and was told that I don't have glaucoma.; "I have PTSD" (unspecified if ongoing), notes: really bad PTSD but I feel like I'm finally in the waking stage; "don't remember things" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dos=2), administration date: Jan2021, for COVID-19 Immunization; Bnt162b2 (dose=2), administration date: Feb2021, for COVID-19 Immunization. The following information was reported: PRODUCT COMPLAINT (non-serious), outcome "unknown", described as "I got the first Pfizer shot in January and the second in February/It's been 6 months so I plan to go back to get another round of shots". The patient got the first Pfizer shot in Jan2021 and the second in Feb2021. (Caller confirmed shots as Pfizer BioNTech covid vaccine). Now they was giving them away for free. It was 6 months so he plan to go back to get another round of shots to see what happens and use himself as a test dummy.  The patient not going to tell them that Ive already gotten the shots. 10 years ago, at the (Privacy) the patient was told he had glaucoma and was started on Latanoprost. The patient was going thru a bottle a month and his medication was always running out.  The patient got it through the (Privacy). The patient called Pfizer and their company told him that they would send him 5 bottles of it if the patient needed it.  The patient went back 6 months later and was told that the patient did not had glaucoma and did need to take.  (Caller confirmed he no longer uses Latanoprost.)  The patient calling because the (Privacy) lies about giving patients their medication and he want this call recorded and sent to doctor so she can help.  Caller stated the patient had PTSD, and did not remember things.  The patient wont remember their name 5 minutes after he hang up.  The patient take heart meds and others take cancer meds. The patient and other patients had to go into (Privacy) to get our medications because the (Privacy) doesnt give us what we need.  The (Privacy) has the highest suicide rate.  The patient had 18 friends, who had committed suicide mostly through overdose. The patient know of college students who buy fentanyl in (Privacy) and sell it on the streets as oxycontin.  The patient 74 years old with really bad PTSD but feel like the patient finally in the waking stage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A Refugee came to this county on 12/7/06.  Client is HIV postive. Was given variclla vaccine on 12/12/06. She had already received a varicella on 7/17/06 without any incident. Client is being carefully watched for any adverse reactions.  Also gave Td. SPU1704AA LA  IM  1 previous dose  Box 13- At this time, client has had no adverse reactions
Hep. B vaccine given in the left arm. MMR vaccine given in the right arm.  Both were vaccines given to a healthcare provider following low titer labs.  No prior vaccine records.  Patient may have had MMR and/or Hep. B series in the past, but records not available.    Patient developed hives on her face and neck about an hour after having the vaccinations. Associated with all over itchiness and chest tightness.  She took some Benadryl with some improvement in symptoms and contacted the office by phone. She was referred to the ER for further evaluation and agreed to seek ER care.
My next period was very light?normally quite heavy. I haven?t had a light one in years. It did seem to return to normal the next cycle, but I was concerned about the effect on younger, developing systems of girls and wanted to report it.
A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction characterized by burning, "severe" pain, swelling and redness. This is 1 of 5 pts from this office who experienced an adverse event with Flu Shield. No further information was available at the date of this report.
This spontaneous report was received from a physician via company representative to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient received one dose of GARDASIL 9 injection (strength, dose, lot number, expiration date, route of administration were not reported). On an unknown date the patient received one dose of GARDASIL 9 injection (strength, dose, lot number, expiration date, route of administration were not reported. On unknown dates, after vaccination the patient developed a skin wart on his hand. The outcome of the event was unknown and no product quality complaint was involved. The relationship between the event and the GARDASIL 9 was unknown. Additional information is not expected as the reporter did not consent a new follow up attempts.
Caller has not received second dose; Hives from neck to feet; Redness on her face; Pain moved to her back which made it hard for; Excruciating pain in wrist; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BACK PAIN (Pain moved to her back which made it hard for), URTICARIA (Hives from neck to feet), ERYTHEMA (Redness on her face) and PRODUCT DOSE OMISSION ISSUE (Caller has not received second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-Mar-2021, the patient experienced ARTHRALGIA (Excruciating pain in wrist). On 12-Mar-2021, the patient experienced BACK PAIN (Pain moved to her back which made it hard for). On 20-Mar-2021, the patient experienced URTICARIA (Hives from neck to feet) and ERYTHEMA (Redness on her face). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller has not received second dose). On 11-Mar-2021, PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Excruciating pain in wrist) had resolved. On 13-Mar-2021, BACK PAIN (Pain moved to her back which made it hard for) had resolved. On 23-Mar-2021, URTICARIA (Hives from neck to feet) and ERYTHEMA (Redness on her face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-278631 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Non-significant followup added: Reporter contact updated On 05-Aug-2021: follow up done contain nni
Arm has a big red rash and is severely swollen. The rash extends all the way to elbow
Found out that the vial that was administered on October 7, 2022 had expiration of September 30, 2022.  Spoke with patient's mother. Explained and apologize for the incident, and inform the need to revaccinate. Patient's mother said the patient has currently no adverse reaction, but worried if there will be long term effects in the future. Told her that this incident will be reported to VAERS for reference.
Difficulty breathing 3:30 AM, 10/9/8. About 24 hrs. better now.
Report received from a Health professional on 04-Dec-2009.  A 36 year old female patient received pre-filled H1N1 (lot 00749611A, exp date 30-Jun-2010) on 25-Nov-2009.  On 03-Dec-2009, the patient presented with neck swelling and neck redness.  The physician examined the patient.  The patient had no shortness of breath, there were no physician orders and the patient will be monitored.  Awaiting further information from the reporter.  The company considered events unlikely to PANVAX administration given the 9 day time interval from vaccination to onset of events.  Information derived from this report does not change the current safety profile of the product.  10-FEB-2010 - The reporter has been contacted twice and no further information expected.
Swelling, inflammation, pain, unable to lift arm - pain at injection site and under armpit toward back.
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M042324 (doses, route of administration, anatomical location and expiration date were not reported). No adverse effects were reported. Administered doses of vaccine underwent a temperature excursion between -1 degree Celsius to -2 degree Celsius which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the physician. Sender's Comments: US-009507513-1703USA014121: US-009507513-1703USA014122: US-009507513-1703USA012983.
"widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; Cardiogenic shock; Anterior myocardial infarction; This is a spontaneous report from a contactable consumer.  An 81-years-old female patient received BNT162B2, dose 2 via an unspecified route of administration, administered in left arm on 06Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included very sensitive to medication effects (usually takes only 1/2 dose with strong efficacy to avoid side effects). Breast cancer survivor (2014 onset, 2019 declared permanent remission) and mild blood pressure treated successfully with medication for about 10 years. Concomitant medications included spironolactone and valsartan, both taken for blood pressure. The patient previously received first dose of BNT162B2 on 16Jan2021 in left arm for COVID-19 immunization. The reporter's mother died 3 weeks and 6 days after having received the second dose of the Pfizer covid vaccine. The cause of death was a "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; the event began about 11:45pm on 04Mar2021. The blockage was confirmed via cardiac cath procedure performed within 2 hours of the onset by Doctor, he removed the clot and placed a stent. However her heart was too damaged and could not recover. Doctor confirmed to us that she did not have excessive or evidence of any prior blockage and not excessive plaque. The blood clot likely came on and caused the cardiac event within roughly an hour, he explained. The patient had no prior symptoms and no comorbidities for blood clotting and was full of life and energy on 05Mar up to when she went to bed that night. She died 06Mar at 4:04 am at hospital. The strat date of the events was reported as 04Mar2021 at 11:45 PM. AE resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient died on 06Mar2021. An autopsy was not performed. The death cause: Triggered by the sudden 100% blockage of the LAD by a blood clot, the cause of death is listed as (A) Cardiogenic shock (B) Anterior myocardial infarction. Treatment was received for the events which included multiple resuscitations and angioplasty surgery. No covid prior vaccination, no covid tested post vaccination. The outcome of the events was fatal.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; "widow maker" type heart attack where the LAD artery
Cellulitis with fever and chill. Patient went to Dr. the next day & was placed on amoxicillin 500mg 1 bid and ibuprofen 800 1 tid.
Patient received 2 doses HIB. Patient  did not require treatment and had no adverse effects.
pt skin w/papular eruptions over body (entire) w/mild erythema; no treatment; rash appeared approx 10 days p/vax
Small, wide spread, itchy bumps similar in appearance and feeling to bug bites began to appear within 2 days after the first Covid-19 Moderna vaccine. At first they were thought to be mosquito bites, however the bumps continues to appear in the following day despite patient staying indoors with no pests identified inside the home. They were then thought to be bedbugs, but no other family members (wife and child) experienced any bites or bumps despite sleeping in the same bed. All other causes have been ruled out - no new medications, stress, exercise, new soaps/detergents, new skin cleansing techniques, nothing at all that can explain this urticaria other than the vaccination.
SIDE EFFECTS INVOLVING SANGUINEOUS CLOTS; This spontaneous report received from a consumer (source: article published) concerned 6 patients. 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, expiry: unknown) dose, start therapy date were not reported, frequency 1 total  administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that the center for disease control and prevention (CDC) and arm of food and drug administration (FDA), the agency responsible for health surveillance, was about to discuss whether the pause in the use of covid-19 vaccine ad26.cov2.s is expected to continue after 6 people developed rare side effects involving sanguineous clots on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects involving sanguineous clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210460381-covid-19 vaccine ad26.cov2.s-side effects involving sanguineous clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Fatigue, weakness, all over body aches, loss of appetite, chills, headache, abdominal pain and nausea, started the morning after the vaccine was taken. Started on naproxen for aches; bedrest for fatigue; did not eat; sipped Gatorade. I am on the day after at this time.
sore throats; Patient stated that he had the flu symptoms; Patient missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throats), INFLUENZA (Patient stated that he had the flu symptoms) and PRODUCT DOSE OMISSION ISSUE (Patient missed second dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throats), INFLUENZA (Patient stated that he had the flu symptoms) and PRODUCT DOSE OMISSION ISSUE (Patient missed second dose). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (XL 3) for Flu symptoms, at an unspecified dose and frequency and NAPROXEN SODIUM, PARACETAMOL (FEBRAX) for Flu symptoms, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throats) had not resolved and INFLUENZA (Patient stated that he had the flu symptoms) and PRODUCT DOSE OMISSION ISSUE (Patient missed second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
DIARRHEA; CRAMPS; THROWING UP; This spontaneous case report (PVX2019-2583) was received from a consumer on 16-Oct-2019. It described female consumer who had "diarrhea" (PT: Diarrhoea), "cramps" (PT: Abdominal pain) and "throwing up" (PT: Vomiting) while receiving oral Vivotif for typhoid fever.  Case report: The consumer reported to be fine after taking her first Vivotif dose. After the second dose, she experienced "real cramps, menstrual like cramps but they were only in her upper body part, under her breast". She reported that she had never experienced these cramps before, nor she had menstrual cramps in the past. She described the cramps as tightness and spasmodic. The cramps came in waves (of time). Last night, the consumer was "violently ill" which she clarified as throwing up twice and had diarrhea at the same time.   Action taken with Vivotif with respect to the events was unknown.  The clinical outcome of the reported events was unknown.  Company's Comment: In this case, it was reported that the consumer female consumer who had "diarrhea", "cramps" and "throwing up" while receiving oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, diarrhea, cramps and throwing up are labelled as per CCDS.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer female consumer who had "diarrhea", "cramps" and "throwing up" while receiving oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, diarrhea, cramps and throwing up are labelled as per CCDS.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Lot number: EW0167), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mildly raised cholesterol" (unspecified if ongoing); "hay fever" (unspecified if ongoing); "coeliac disease" (unspecified if ongoing), notes: Known allergies: coelic disease. Concomitant medication(s) included: LORATADINE, start date: Jan2007, stop date: 28May2022; ATORVASTATIN, start date: Jan2020. The following information was reported: VACCINATION FAILURE (medically significant) with onset 28May2022, outcome "unknown", COVID-19 (medically significant) with onset 28May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28May2022) Positive; (01Jun2022) Positive, notes: Antigen test weakly positive days 5 and 6; (02Jun2022) Positive, notes: Antigen test weakly positive days 5 and 6; (03Jun2022) Negative, notes: Antigen test weakly positive days 5 and 6, negative day 7 (03Jun2022); (04Jun2022) Positive, notes: On day 8 after treatment start (04Jun2022) test was positive again; (06Jun2022) Positive, notes: Antigen test strongly positive on day 10 (within 1 minute). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Paxlovid rebound Symptoms started 27May2022. Paxlovid started on 28May2022 after positive test that day. Symptoms that day were of cough, runny nose, blocked sinuses and sore throat. Briefly had tachycardia of 105 on first day of treatment. Symptoms resolved on day 4. Antigen test weakly positive days 5 and 6, negative day 7 (03Jun2022) On day 8 after treatment start (04Jun2022) test was positive again. Symptoms except tachycardia returned on day 9 but less severe so far. Antigen test strongly positive on day 10 (within 1 minute) product COVID 19 Treatment, brand Paxlovid, treatment start date 28May2022, treatment stop date 01Jun2022, Lot number GA5120.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.