chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Dose number 1: Pfizer / BioNTech; Dose number 2: Pfizer / BioNTech; Dose number 3: Pfizer / BioNTech; Dose number 4: Moderna; Dose number 5: Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3302), in left arm, on 01Apr2021 as dose 2, single (Lot number: ER8730), in left arm and on 10Oct2021 as dose 3 (booster), single (Lot number: FF8893), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Apr2022 as dose 4 (booster), single (Lot number: 056A32A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Bee stings" (unspecified if ongoing), notes: Bee stings; "glaucoma" (unspecified if ongoing); "LDL" (unspecified if ongoing), notes: hi LDL. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Apr2022, outcome "unknown", described as "Dose number 1: Pfizer / BioNTech; Dose number 2: Pfizer / BioNTech; Dose number 3: Pfizer / BioNTech; Dose number 4: Moderna; Dose number 5: Pfizer / BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2023) Reinfected with Covid, notes: Reinfected with Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
The patient started crying and moving after I started the injection. The mother reported some local swelling the next day that was more than what she expected.
HEART IS BEATING FASTER THAN NORMAL; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 152.5 pounds, and height was 66 inches. The patient's concurrent conditions included: hypothyroidism, anxiety, ragweed allergy, morphine allergy, non alcoholic, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 15:05 for prophylactic vaccination. Concomitant medications included lorazepam for anxiety. On 13-AUG-2021, the patient experienced heart is beating faster than normal. On 13-AUG-2021, the patient experienced nausea. On 13-AUG-2021, the patient experienced tiredness. Laboratory data included: Heart rate (NR: not provided) 80 to 90 {beats}/min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart is beating faster than normal, nausea, and tiredness. This report was non-serious.
Runny nose; Sore throat; Body ache; This is a spontaneous report from a contactable consumer. This consumer (patients mother) reported that a 16-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, ER8732) at single dose via an unknown route on 12Apr2021 morning for Covid-19 immunization. She had a runny nose and sore throat before she got the vaccine on 12Apr2021 morning and was figured it was allergy but then the reporter was wondering if she was actually had Covid before she got the vaccine. Concomitant drug was not provided. Patient was very well might just feel badly because of the vaccine. She had a runny nose, sore throat and body ache. The reporter realized she just had a vaccine in the past 24 hours so patient not gotten a test.  Outcome of the events was unknown.   Reporter seriousness was unspecified.    No follow-up attempts are needed: information about lot/batch number cannot be obtained.
P/receiving an inject of Influenza virus vax, pt devel transverse myelitis; Pt has improved;
they have had Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (they have had Covid) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (they have had Covid). At the time of the report, COVID-19 (they have had Covid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  Patient confirmed that they had the first two and one booster dose and all were moderna.  No treatment medication reported by reporter.    Reporter did not allow further contact
cannot have an erection/penis cannot get hard/cannot perform his abilities; cannot have sex; very embarrassed/never had this before; worried; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (cannot have an erection/penis cannot get hard/cannot perform his abilities) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ERECTILE DYSFUNCTION (cannot have an erection/penis cannot get hard/cannot perform his abilities) (seriousness criterion medically significant), SEXUAL DYSFUNCTION (cannot have sex), EMOTIONAL DISTRESS (very embarrassed/never had this before) and ANXIETY (worried). At the time of the report, ERECTILE DYSFUNCTION (cannot have an erection/penis cannot get hard/cannot perform his abilities), SEXUAL DYSFUNCTION (cannot have sex), EMOTIONAL DISTRESS (very embarrassed/never had this before) and ANXIETY (worried) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Treatment information was not provided.  Patient states he doesn't drink beer; he doesn't smoke; he doesn't know why this is happening.  Company Comment: This case concerns a 53- year-old, male subject with no medical history reported, who experienced the unexpected events of erectile dysfunction, sexual dysfunction, emotional distress and anxiety. It is not clear if the events occurred before or after receiving the vaccine. The rechallenge is not applicable in this case. The reporter's assessment is not provided.The benefit-risk relationship of the vaccine is not affected by this report; Sender's Comments: This case concerns a 53- year-old, male subject with no medical history reported, who experienced the unexpected events of erectile dysfunction, sexual dysfunction, emotional distress and anxiety. It is not clear if the events occurred before or after receiving the vaccine. The rechallenge is not applicable in this case. The reporter's assessment is not provided.The benefit-risk relationship of the vaccine is not affected by this report
Patient presented to emergency department with shortness of breath on 10/13/2021. He had been diagnosed with COVID-19 on 10/7/2021. He was previously admitted to hospital from 9/8/2021 to 9/13/2021 with neutropenic fever, community acquired pneumonia, and pleural effusion. He was diagnosed with non-hodgkin lymphoma and was undergoing treatment at time of presentation.  He was admitted for further management of COVID-19 infection. Patient continued to deteriorate during his admission and was eventually put on comfort measures only. Patient expired on 10/23/2021.
Beginning 12/11 morning after administration, on awaking: fatigue, muscle aches, chills, fever (99.9), headache.
sore arm; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 31Aug2021 as dose 3 (booster), single (Lot number: FA6780) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Arrhythmia" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL oral taken for arrhythmia (ongoing); MELOXICAM oral taken for arthritis. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT NUMBER: EN6207, Anatomical Location: Arm left, Route of Administration: Intramuscular), administration date: 05Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "sore arm", "Fatigue"; BNT162b2 (DOSE 2, SINGLE, LOT NUMBER: EW0161, Anatomical Location: Arm left, Route of Administration: Intramuscular), administration date: 15Apr2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "sore arm", "Fatigue".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown".  Additional information: Vaccination Facility Type at Pharmacy or drug store. The patient had no adverse events associated with any of her vaccine. Just sore arm plus fatigue for one day. No specific relevant test for thromboembolic events with thrombocytopenia.
44 year old patient reported receipt of AVA #1 and third typhoid booster 8/13/07. Less than one minute later, c/o sudden onset metallic taste in his mouth. Within 2 minutes he c/o neck, oral mucosal, lip, tongue and facial itching, flushing, dizziness (if move too fast he'll fall over) and he felt his mouth-throat begin to tingle and swell. He denied any respiratory distress or dysphagia or chest pain. He worked as an RN at a medical clinic and sought treatment with the attending physician assistant. He was given subcutaneous epinephrine, IV Solumedrol, benadryl and Zantac. He was released on Benadryl, Zantac, and 5 days Prednisone 40 mg. He has changed the Benadryl to Allegra due to sedative properties and hangover effects. The next day (8/14/07) he complained of reoccurring facial swelling and redness with palmar redness and pruritis (due for allegra). He again denied any respiratory reactions, tongue swelling/tingling, problems swallowing, or palpitations/chest pain. His PCP increased Allegra to BID.    As of this interview 8/15/07, he stated the Allegra holds symptoms for approximately 6-7 hours then the itching sensation increases with facial tightness and rash begins. His wife advised redness and fine sandpaper like rash (as if sunburned) begining to all unclothed areas but not to his torso (she is an ER RN also). All symptoms resolve after antihistamines taken.
Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the arm right on 11Apr2021 at 12:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the arm right on 14Mar2021 at 12:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the day after second vaccination, the patient experienced diarrhea. The patient was currently on her third day of diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was not recovered at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
plexus neuritis; pain radiated; pain moved to toes and ankle of the right leg; numbness in whole arm; nerve pain; Ankle froze up during walk; shoulder frozen; Painful in the joints, not just the injection site; arm sore; pinky and ring finger numbness; arm tingly; A spontaneous report was received from a consumer concerning a 45-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not included. Products known to have been used by the patient included unspecified multivitamins.  On 22 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 22 Jan 2021, within hours of the mRNA-1273 vaccine being given, the patient noted that the arm was tingly, really sore, pinky and ring finger numbness and frozen shoulder. She noted it was painful in her joints and not just near the injection site.   On Monday, 25 Jan 2021, she sought medical attention at a clinic where they suggested the vaccine may have been administered too high into the shoulder. By Thursday of that week the pain did not clear up and she reported taking 4 ibuprofen every 4 hours for pain. The patient later saw an orthopedist who diagnosed her with plexus neuritis and recommended that the next shot to go into the glutes.   The following week, She reported that the pain radiated to her toes and ankles of the right leg. While the range of motion in her shoulder returned, she still had numbness and nerve issues in her whole arm and into the fingers as well as toes.   On 14 Feb 2021, while out for a walk, the patient felt her ankle freezing up which she described as "a cramp in her nerves, shooting pain through them. Treatment for the events included ibuprofen.   Action taken with mRNA-1273 is not applicable  The outcome of the events, tingly arm, arm sore, pinky and ring finer numbness, shoulder frozen, pain in joints, not just near injection site, Plexus neuritis, pain radiated, pain moved to toes and ankle of right leg, numbness in whole arm, ankle froze up during walk and nerve pain, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Patient felt faint and fell onto floor, hit head, and mouth. Felt burning sensation across upper chest.
Initial report was received from a health care professional on 20 January 2012. A 57-year-old female patient had received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur Inc., lot number U4147CA on 28 October 2011. On 29 October 2011, the patient's eyes were swelled and irritated, her face broke out in a red rash and had some minor peeling of the skin. Illness at the time of vaccination was reported as none. The patient had no pre-existing medical conditions. It was unknown if the patient took any concomitant medications, had any other vaccinations within four weeks of FLUZONE or had any adverse events following prior vaccinations. No further information was available at time of the report. The patient's outcome was not reported. Documents held by sender: none.
10:05A - received vaccines shortly after got nauseated, warm. Dizzy - laid in supine position. Ice to back of neck. BP (L) arm sitting 104/60 pulse 60 slightly thready. Skin warm & dry palms sweaty/clammy. After 15-20 min c/o trouble getting breath, tongue feeling funny, general feeling "feeling funny", unable to describe. Mid chest became red in color - lacy looking at this time. Client c/o again of not being able to get breath, speech somewhat slurry & thick sounding - E vehicle called. B/P 106/68 Pulse continues to be slightly thready but 60-60 in number. Feeder were evaluated. Skin dry, palms of hands sweaty. Rash after approx 5 min decreased in intensity. Continues to c/o of feeling weird, but unable to describe feelings. Throughout this event client continued to have "spasms of legs, arms & lips - denied being cold. Transported by E-vehicle to hospital. 9-4-09 9AM TC to parent. Patient is tired, but has been taking BENADRYL. No rash at this time. Eating & drinking. Slept most of yesterday. Taking ibuprofen also for c/o HA & sore arm.
The patient is covered from head to toe with hives, temperature 99-101. The patient acts fine.
Lips felt numb; Tongue itching; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 22Sep2021 12:30 (at the age of 58-year-old) as dose 1, single for COVID-19 immunisation.  Medical history included vitiligo and unspecified known allergies. There were no concomitant medications. On 22Sep2021 at 12:30 the patient experienced lips felt numb and tongue itching. It was reported that tongue started itching immediately and lips felt numb like when your gums are numbed by the dentist and it affects your lips. The events were treated with Benadryl given by nurse. The events were resolving.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient came back next day with slightly swollen left arm. She states she is having pain that radiates from her shoulder all the way down to her elbow. Hasn't tried anything for pain yet. Advised patient to contact her PCP and go to ER is symptoms worsen.
Patient stated she started to notice some pain in her left shoulder at some time after her shot.  She did not seem to attribute pain to the shot as she was not able to pinpoint a start date, she made a best guess.  She said she thought pain would go away, but it has not resolved with heat or ibuprofen, which is all she has tried to this point.  She has lost range of motion in left shoulder as well.
This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 23 years old female patient with gastrooesophageal reflux disease. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with the first, second and third dose of GARDASIL (Lot# unspecified) intramuscularly on 12-NOV-2007, 21-JAN-2011 and 05-SEP-2012. No other co-suspects were reported. Concomitant medications included: ZANTAC. The patient became pregnant with an LMP of 01-AUG-2012 and an EDD of 09-MAY-13 before receiving the third dose of vaccine. The pregnancy was discovered via home pregnancy test on 08-SEP-2012. The patient was exposed to GARDASIL during trimester 1. The patient is still pregnant. The patient had sought medical attention via seeing the nurse practitioner. Additional information has been requested.
chest pain 24 hours after receiving vaccine that lasted for 1-2 days. mild in duration. Seen by PMD and had ECG which showed a possible arrhythmia. Referred to ER for evaluation. In ER, repeat ECG was normal and initial ECG felt not to be abnormal. BNP and troponin were negative. Discharged from ED. Followup with pediatric cardiology 1 month later showed decreased LV function by echo.
Immediate sore arm.  Several hours later body aches and pains and general malaise.  Next morning more severe muscle and joint aches followed by a fever of 100.2 later in the afternoon.  Felt like the flu.  Itchy arm near vaccination site. Following day (9/2) no fever and milder body aches.  Less fatigue.  Arm red and swollen and itchy. Today (9/3) red arm, no itch and mild tiredness.
Chest discomfort for 3 weeks after first shot; This is a spontaneous report from a contactable physician. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 15Apr2021 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced chest discomfort for 3 weeks after first shot. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event chest discomfort was recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician who reported to a company representative concerning a 65 year old female who received her first dose pneumococcal 23v polysaccharide vaccine (lot not provided) on an unknown date in approximately 2000. On Oct 31 2005 the patient was vaccinated with her second dose of pneumococcal 23v polysaccharide vaccine (650327/0792P). The same day the patients left arm became red and swollen. The patient was seen by the physician on Nov 1 2005 in his office and was diagnosed with an allergic reaction that was considered to be an other medical event (OMIC). The physician prescribed fexofenadine hydrochloride (Allergra), ice and elevation. Subsequently, on an unknown date the patient recovered from the allergic reaction without complication. Additional information has been requested.
Developed a severe migraine, nausea, fatigue within the next day of vaccine being administered, then on day 7 I developed a huge rash in the injection site (right arm). Everything subsided after 2 weeks. The rash within 5 days went away.
on 03May2021 a patient / received an expired Boostrix / expired on 09Marc2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2774D, expiry date 9th March 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd May 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 3rd May 2021, unknown after receiving Boostrix and Boostrix 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 was provided follows:  On 3rd May 2021, the  patient received Boostrix  which was expired on 9th March 2021. The reporter consented to follow up.
Redness, swelling, fever at site for 6 days; next day, all of above plus body fever aches, 2nd-6th day - lesions, swelling, redness, and pain in 2 inch diameter around injection site.