chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was given expired Covid vaccine by the pharmacy. Vaccine expired on 6/30/22. I received vaccine on 7/23/22
Unexplained hoarseness at 7:00 am 02/06/2021 and cough at 0:700 pm on 02/06/2021. Fall (first time ever), followed vomiting, and choking at 2:00 pm 02/07/2021. Ambulance called recorded vitals 97.5 Temp 102/70 BP, 98 HR at 2:51 pm at home and 146/90 BP 102 HR at 3:09 pm enroute to hospital; pt pointed to hip pain and answered questions in native language Polish (although pt spoke English). Pt delivered alert and kicking blankets off legs inside emergency room. Emergency room staff failed to communicate with pt. Pt was discovered unresponsive 20 minutes later when staff arrived to take admission vitals. Pt passed 02/07/2021 in ER. No causeof death given by ER doctor to family.
COVID - Bivalent booster received 2 days ago at 1900. Yesterday walked to lunch, sitting for at least 5 minutes around 1240, and noticed his heart was beating fast, felt tired. (But maybe had started earlier and just didn't notice with being busy at school). After lunch had to walk across school and noticed heartbeat was faster and felt more tired. Faster heart rate continued through the school day, calmed some by bedtime. Began monitoring with watch, HR 100-120, variable rate recorded. This morning, similar symptoms, resting all day and HR still 100s. Redness and swelling at injection site. +HA yesterday.
Severe headache - lasting for 24 hours starting at 3:30pm Nausea - lasting for 2 hours starting at 3:30pm on 3/10/2021 Chills - lasting for 4 hours starting around 7pm on 3/10/2021 Low-grade fever - lasting for 4 hours starting around 7pm on 3/10/2020 Soreness - effecting entire body and lasting for 24 hours starting at 3:30pm on 3/10/2020
patient was administered with an expired dose of Typhim Vi vaccine with no adverse event; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of unknown demographics who received an expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (lot N1K901, Expiry date- 24-Oct-2019) via unknown route in unknown administration site on 28-Oct-2019.  Medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient came to our pharmacy on 8/19/21 at 4:15pm. She filled out our required , where she reported that she had not received any previous Covid vaccine. Since she reported this, we did not check. We gave her a new completed Vaccination Record Card and gave her her Moderna vaccine. After giving the vaccine, I told the patient she needed to wait the required 15 minutes in the waiting area. I then went to put her information, and noticed that she received a Pfizer vaccine on 3/22/21 at . I then asked the patient about this, asked her if she did get a vaccine there on that date and she told me that she did not get that vaccine there on that date. She stated that "if I did, I couldn't remember." The patient then asked if she should get the second Moderna vaccine. We told her that we would have to report this incident in VAERS, and call Pfizer to see what the required action should be. We verified her phone number and told her that we would give her a call once we had an answer; she verbalized understanding and thanked us before leaving. Seeing the previous Pfizer dose and that the patient's address was somewhere else, we wanted to investigate further. We had our medical staff nurses check the  and found that patient received another Pfizer vaccine (the same day she received the Pfizer vaccine aLso received a third Pfizer vaccine on 4/13/21 in. So the Moderna vaccine she received from us was her 4th total Covid vaccine.
Precipitating depression after HPV #2 (Seen and was Rx'd by psychiatrists).
I was diagnosed with Tendinosis on November 5, 2021. I experienced pain in left ankle, unable to walk, can't flex foot, can't walk, I was taking ADVIL, TYLENOL, for my symptoms.
Patient started experiencing dizziness fogginess in her brain and "out of it" for a full 24 hours starting about 6 hours.
Pt recv vax on 12/18/98; on 12/20/98 pt exp tonic-clonic seizure, fever (102)
Swelling and redness at injection site - has improved. Swelling of lips and tongue - not till 11/14/14.
producing diarrhea; Producing vomits; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (producing diarrhea) and VOMITING (Producing vomits) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (producing diarrhea) and VOMITING (Producing vomits). At the time of the report, DIARRHOEA (producing diarrhea) and VOMITING (Producing vomits) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment of the events were not reported.
Patient fainted after about 5 minutes after administration.  We called 911 and patient was laid flat and monitored until emergency services responded.   Vitals were checked and found to be normal.  Blood pressure, heart rate, O2 sats and blood glucose were all within normal limits.  Patient was released home with mother.
Pt c/o of being nauseated ~10 minutes after 1st dose of vaccine. Pt instructed to prop feet up. He was pale, hot, and diaphoretic. Vitals reviewed and WNL. Pt provided water and snack and cold water bottle placed on neck. Pt reports still feeling "weird" but a little better and still c/o light headedness. Vitals continually monitored. Responding physician requested a pediatrician be notified. Pt also started reporting feeling shaky. Pediatrician arrived and evaluated pt. Blood sugar reviewed and WNL. Pt reports feeling okay to go home. Pt dc' d home with grandma and given ED precautions.
sneezing; severe runny nose; This is a spontaneous report from a non-contactable consumer. A 68-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 26Feb2021 10:00 (Batch/Lot Number: EN6202) as dose 2, single (at the age of 68 years) for covid-19 immunisation. Medical history included known allergies: Sulfa from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient has not had Covid-19 prior to vaccination and was not tested for Covid post vaccination. The patient received the first dose of BNT162B2 (lot: EM9810), via unspecified route of administration in the left arm on 05Feb2021 at 08:30AM as dose 1, single (at the age of 68 years) for Covid-19 immunisation. The patient experienced sneezing and severe runny nose on 02Mar2021 08:30. The patient did not received treatment for the events. The outcome of the events was not recovered. The patient has not had vaccine in 4 weeks or other medications in two weeks.  No follow-up attempts are possible. No further information is expected. Information about the batch/lot number already obtained.
Patient presented to clinic on 4/24/09 c/o right arm pain extending to neck and fever. Upon examination, right arm edema from shoulder to elbow. Right arm circumference 1/2 inch larger than the left. Pt is right handed. Temp. 98.3 degrees F.
Information has been received from a medical assistant concerning a 78 year old retired, white male patient with no known drug allergies, relevant medical history or illnesses at time of vaccination who on 12/12/2002 at 08:00 was vaccinated IM in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644218/1027M).  Concomitant therapy was unspecified.  On 12/14/2002 the patient developed swelling and redness at the injection site 24-48 hours after vaccination.  The patient developed some swelling in the left upper arm down to mid forearm 48 hours after injection.  It was noted that the patient was afebrile with no fash or hives.  Subsequently, the patient recovered.  The reporter expressed concern with the lot.  The medical assistant reported on another male patient (WAES # 0212USA01466).  The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  No further information is requested.
This is a spontaneous report from a contactable physician. A 63-year-old female patient received PREVNAR 13, via an unspecified route of administration at single dose on 10Jan2016 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient admitted with B symptoms, fever of unknown origin (FUO), and elevated liver function test (LFTs)  that required hospitalization. On an unspecified date, the patient also experienced a new rash following that vaccination and red, raised plaques of her skin involving both the upper and lower extremities. Differential dignosis included erythema nodosum and discoid lupus. It was reported that on an unspecified date CRP was 19.4. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: onset date of the events. This case will be reassessed when additional information becomes available. 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.
Started menstrual period the next morning when not due for two weeks and periods have never been irregular; This is a spontaneous report from a non-contactable nurse, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 23Mar2021 at 10:45 (age at vaccination was 35-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Patient had no known drug allergy. Concomitant medications included montelukast (MANUFACTURER UNKNOWN), erenumab (AIMOVIG), spironolactone (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC) for unspecified indications from unspecified dates received within 2 weeks of vaccination. The patient did not have any known allergies to food, medications, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, the next morning after receiving vaccine, patient started with her menstrual period when not due for two weeks and reported that periods had never been irregular. No therapeutic measures were taken for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of menstruation irregular was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient described localized pain, redness, heat, swelling, general discomfort in both arms from the injections.  There we no signs of rash, hives, or trouble breathing.  Symptoms lasted for roughly 2-3 days, and then went away, and the patient was fine.
This spontaneous report as received from a registered nurse refers to 4 years old patient of unknown gender. On 10-APR-2014 the patient was vaccinated with M-M-R II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 was exposed at an unsupported temperature excursion (temperature range: 45F, time frame: 24h). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I have the Shingles virus with facial outbreak along with fatigue, headache and prior nausea.
given a dose /nonviable after a temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 18-year-old male patient who received HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th June 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 11th June 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 case details were reported as follows: The patient was given a dose of Havrix that was deemed nonviable after a temperature excursion, which led to incorrect storage of drug.  No symptoms reported. The reporter consented to follow up. This case was 1st of 6 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142818:Same reporter US-GLAXOSMITHKLINE-US2021142817:Same reporter US-GLAXOSMITHKLINE-US2021142816:Same reporter US-GLAXOSMITHKLINE-US2021142815:Same reporter US-GLAXOSMITHKLINE-US2021142813:Same reporter
She got shingles after getting Shingrix/Suspected vaccination failure; She got shingles after getting Shingrix; This case was reported by a nurse via sales rep and described the occurrence of Suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown 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 details were provided as follows: The age at vaccination was not reported. The patient got Shingles after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting. The reporter consented to follow up.
Chronic spontaneous urticaria. Constant itching and hives with dermatographia. I went to Urgent care 1/11 and they gave me 80 mg solu-medrol which offered some minor relief but by 10 pm the hives were back. I am currently taking 20 mg Zyrtec and 25mg Pepcid AC twice daily with Benadryl 50 mg as needed through the day and am on prednisone 30 mg start step down dose for 10 days.
Irregular menses including heaving bleeding, clotting and cycle irregularity (2x per month) persisted through November 2021, with continued cycle irregularity but did not include heavy bleeding and clotting between November 2021 and February 2022 until booster was received. After Pfizer booster was received 2/4/2022 at Medical Center clotting and heavy bleeding returned and cycle irregularity became more frequent than 2x per month.
sore arm for short period of time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for short period of time) in a 71-year-old male patient 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 PAIN IN EXTREMITY (sore arm for short period of time). At the time of the report, PAIN IN EXTREMITY (sore arm for short period of time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.  It was reported that patient experienced same kind of sore arm with any other vaccine.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 07-JUL-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
After leaving clinic patient returned with lacy rash on bilateral hands that extended up forearms? no rash at injection sits? patient described the rash as itchy, but denies any other symptoms? denies any SOB or itchy throat? O2 sat is 100% with clear lung sounds
pain and swelling at site, burning red area, pain up into ear and down into elbow, swelling continued for 10 days, without getting better, patient came to pharmacy, recommended antihistamine tablet and cortisone cream, followed up next day swelling was slightly better
Headache; pain; site pain; Dry cough; Sneezing; This is a spontaneous report (letter response) received from a contactable consumer. This 60-years-old female consumer reported.  A 60-years-old female patient received second dose of BNT162B2 (BNT162B2, Pfizer-BioNTech COVID-19 Vaccine, Solution of injection, Lot Number: EN6208), via intramuscular, administered in left arm on 31Mar2021 at 11:30 (at the age of 60-year-old) as 2nddose, single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (Lot number: EN9899) on 23Dec2020 at 10:00 via intramuscular, administered in arm left for COVID-19 immunisation and tested positive for Covid (drug ineffective), symptoms similar to flu, Loss of taste, Loss of smell, Body ache, On 28Dec2020 she went to hospital to get neurocloral infusion. Medical history included, seasonal allergy and concomitant medications included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); metoprolol (METOPROLOL); atorvastatin (ATORVASTATIN). On an unspecified date, the patient experienced headache, pain, site pain, dry cough, sneezing. The patient still had dry cough. The patient did not require medical intervention. The patient was visited the emergency department. The patient was not hospitalized. The patient was not admitted to an Intensive Care. There is no information about organ involvement. On 27Dec2020, the patient underwent lab tests and procedures which included covid-19: positive. Patient was treated with Advil also took Vit D, Vit C, Zinc Nuletomy for sneezing and dry cough. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The outcome of the event dry cough was not resolved and other events was unknown.  No follow-up attempts are needed. No further information is expected.
It's not too late to get my second shot 4 years later; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-Apr-2022 Reporter's comment: This case was reported via interactive digital media. The patient reported that it was not too late to get his/her second shot of Shingrix 4 years later. Additional Supportive Information:  Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Second shot in series received 3/19/21.   When undergoing routine colonoscopy on 4/28/21, I was found to be in atrial fibrillation.  This was not present in prior EKGs or in my primary care checkup in January 2021.  Following up with cardiologist, taking Eliquis, submitted 2 weeks of cardiac monitoring  and will undergo cardioversion if indicated.
strange feeling on tongue; hives; Rash on legs; Rash on opposite arm; Rash on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (strange feeling on tongue), RASH (Rash on opposite arm), RASH (Rash on legs), VACCINATION SITE RASH (Rash on injection arm) and URTICARIA (hives) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash on opposite arm).   On 27-Jan-2021, the patient experienced RASH (Rash on legs). On an unknown date, the patient experienced PARAESTHESIA ORAL (strange feeling on tongue), VACCINATION SITE RASH (Rash on injection arm) and URTICARIA (hives).   On 28-Jan-2021, RASH (Rash on opposite arm) had resolved.   On 31-Jan-2021, RASH (Rash on legs) had resolved. At the time of the report, PARAESTHESIA ORAL (strange feeling on tongue) and URTICARIA (hives) outcome was unknown and VACCINATION SITE RASH (Rash on injection arm) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.