chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm and site pain only.; Arm and site pain only.; My blood pressure is up from pre shot range. 118-128/ 80-86. Now 130-164/ 90-102; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208, expiration date not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 (at the age of 62 years) as dose 2, single for covid-19 immunization. Medical history included coronary artery disease, contact dermatitis, both on unknown if ongoing, and ongoing hypertension, all from an unknown date. Patient had known allergies to Penicillin, tylox and lotrel. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200, expiration date not reported) via unspecified route of administration, administered in left arm on 26Feb2021 (at the age of 62 years) as dose 1, single for covid-19 immunization and experienced arm pain. Patient did not take other vaccine in four weeks. Concomitant medication included amlodipine besilate, benazepril hydrochloride; and rosuvastatin, both taken for an unspecified indication, start and stop date were not reported. On an unknow date, the patient experienced arm and site pain only. Patient blood pressure was up from pre shot range 118-128/ 80-86, now 130-164/ 90-102. Patient did not had covid prior to vaccination and had not been tested for covid since the vaccination. Events resulted in doctor or other healthcare professional office/ clinic visit. Treatment taken for events was unknown. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
A few hours after I came home from getting the vaccine, I started feeling a little bit spaced out. A little off. Then a little while after that,  I started getting a ring in my ear, then a slight pain in my chest. I didn't get to sleep until 4am this morning, mostly because of the ringing in my ear and the anxiety of what I could see was a reaction of what I was having. The ringing in my ear has subsided about 90% and is still noticeable in both ears. (I did not go to the ER due to a snow storm)
Started with a headache, nausea, body aches, chills which was expected.   Ever since I have noticed a difference in my skin, I randomly have rashes, itching, if I get a scratch my skin swells
mom states 2hr p/vax pt exp a blister, swollen, reddened, painful area on rt thigh, states 12h later pt had a gen rash & called MD & was treated w/DPH;
fever, nausea, fatigue, muscle and joint pain, chills resolved after about 36 hours
Allergy; Initial information received on 25-Jun-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves patient of unknown age and gender who experienced allergy, while he/she received vaccine TETANUS TOXOID.  At the time of the event, the patient had ongoing Drugs hypersensitivity with Phenytoin, Tetanus toxoid, Chlorhexidine topical, Talwin, Tegretol, Depakote, Vistaril, IV contrast and Oxycodone., peach allergy and peanuts allergy.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious allergy (hypersensitivity) (Unknown latency) following the administration of TETANUS TOXOID.  No laboratory data not reported.  Final diagnosis was hypersensitivity.   It was not reported if the patient received a corrective treatment.  The outcome was Unknown for the event hypersensitivity.  There will be n information on the batch number for this case.
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 12:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 90.53 years.  Concomitant products were not provided.  On 02-Feb-2021, the vaccines were moved to fridge and on 05-Feb-2021, three vials were moved to clinic. Proposed beyond use date for these three vials was 03-Mar-2021.  On 09-Feb-2021, the vaccines were moved to fridge and on 12-Feb-2021, three vials were moved to clinic. Proposed beyond use date for these three vials was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 Fahrenheit.  On the date of administration, at 10:00 A.M. and at 11:00 A.M, the temperature recorded was 35 Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Arm swelled to 3x normal, red from elbow to shoulder, skin peeling - took to ED. IV steroid, IV BENADRYL, CT scan.
I am getting the rash and hives; Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 (Lot number: ER8729) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), administration date: Apr2021, when the patient was 39 years old, for covid-19 immunisation, reaction(s): "RASH", "URTICARIA". The following information was reported: URTICARIA (non-serious) with onset 2021, outcome "not recovered", described as "I am getting the rash and hives"; RASH (non-serious) with onset 2021, outcome "unknown", described as "Rash". The event "i am getting the rash and hives" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria. No follow-up attempts are possible. No further information is expected.  Follow-up attempts are completed. No further information is expected.
I felt like I was coming down with the flu, and it lasted 5 straight days after the day I received the vaccine. I experienced extreme fatigue, body aches and fever. I received the vaccine on Saturday, and the symptoms started on Sunday morning. I missed 3 days of work plus 1 day that was a holiday.
small peripheral right lower lobe pulmonary embolism; anaphylaxis; whole body rash and erythema; whole body rash and erythema; This is a spontaneous report received from a contactable physician. A 57-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 01Mar2021 (at the age of 57-year-old) as single dose for COVID-19 immunization. Medical history included joint pain and ongoing 45-packs per year smoker. The patient did not have any allergies to medications, food, or other products. Concomitant medications included salbutamol (ALBUTEROL), hydroxyzine (manufacturer unknown) and diclofenac sodium (manufacturer unknown). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The physician reported, "patient had anaphylaxis and whole-body rash and erythema on separate hospitalization (I was not involved for this but reviewed photos and this was reportedly attributed to the vaccine; I'm uncertain if that event was reported). On hospitalization, the patient was with small peripheral right lower lobe pulmonary embolism on a CT PE (CT scan for Pulmonary Embolus). Patient is an active smoker. No other obvious cause." As a result of the adverse events (unspecified), the patient was hospitalized for one day. The start date of the events was on 29Mar2021. The patient was treated with apixaban (for pulmonary embolism). The clinical outcome of "anaphylaxis and whole-body rash and erythema" and "small peripheral right lower lobe pulmonary embolism" was resolving.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events pulmonary embolism, anaphylactic reaction and associated generalized rash and generalized erythema. 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 developed little ulcer on different part of my body with clear liquid then make scab (Black) and disappeared. Another appeared some time. I have more than 2 on the body.
she had the Covid shot, which she didnt ask for, but they gave it to her; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (she had the Covid shot, which she didnt ask for, but they gave it to her) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included PALBOCICLIB (IBRANCE) for Cancer.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (she had the Covid shot, which she didnt ask for, but they gave it to her). At the time of the report, WRONG PRODUCT ADMINISTERED (she had the Covid shot, which she didnt ask for, but they gave it to her) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided.   This case was linked to MOD-2021-121489 (Patient Link).
HURTS TO WALK; BOTH FEET HURT; BOTH HANDS HURT; BOTH ANKLES HURT; BUMP UNDER AND BEHIND LEFT EAR/BUMP ON NECK HURT WHEN TOUCHED; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: autism. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211021A, and expiry: UNKNOWN) dose was not reported, administered on 27-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-DEC-2021, the patient experienced bump under and behind left ear/bump on neck hurt when touched. On 27-DEC-2021, Laboratory data included: Blood test (NR: not provided) Unknown. On 30-DEC-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Unknown. On 01-JAN-2022, the patient experienced hurts to walk, both feet hurt, both hands hurt, and both ankles hurt.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump under and behind left ear/bump on neck hurt when touched, and the outcome of both feet hurt, both hands hurt, hurts to walk and both ankles hurt was not reported. This report was non-serious.
This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. On 31-OCT-2013 the patient was vaccinated with VARIVAX, subcutaneous. Dose, dose number, lot number and frequency were not reported. Later the day (31-OCT-2013), the results of the patient's antibody titer were received by the physician assistant. The patient was already positive for varicella immunity according to the titer results. (The titer was drawn "a few days earlier: on an unspecified date.) No known adverse effects. Additional information is not expected.
really bad arm pain; hurts like crazy; hardly lift her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really bad arm pain), PAIN (hurts like crazy) and PAIN IN EXTREMITY (hardly lift her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-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 PAIN IN EXTREMITY (really bad arm pain), PAIN (hurts like crazy) and PAIN IN EXTREMITY (hardly lift her arm). At the time of the report, PAIN IN EXTREMITY (really bad arm pain), PAIN (hurts like crazy) and PAIN IN EXTREMITY (hardly lift her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
only Diluent diluent DTap/IPV of the Pentacel was received instead of Reconstituting with the HIB Powder, no AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with case 2019SA266039 (same reporter).   This case involves a 6 months old male patient received a dose of DTap/IPV from DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] instead of Reconstituting with the HIB Powder on 13-Sep-2019 via intramuscular route in right thigh while receiving his third dose of the series. The reported Lot numbers were for a Vial DTap/IPV (Lot: U6469AB, Expiration Date: 11-Oct-2020), Pentacel Box (Lot UJ134AAA, Expiration Date: 11-Oct-2020) and HIB Vial (Lot: UJ134AA, Expiration Date: 11-Oct-2020).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); HEPATITIS B VACCINE (HEPATITIS B VACCINE) and INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) for Immunisation on 13-Sep-2019.  It was an actual medication error due to inappropriate reconstitution technique.  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.  List of documents held by sender: none.
two days after vaccine, started getting like large red spots mostly on both legs.  Very similar to a mosquito bite with a little white spot at the top. The itch very severe.
administered 3 doses of this expired vaccine on 20MAY2022 to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 3 doses of this expired vaccine on 20MAY2022 to patients) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 028K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 3 doses of this expired vaccine on 20MAY2022 to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 3 doses of this expired vaccine on 20MAY2022 to patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The vial was initially stored in the refrigerator on 09-May-2022. HCP stated that they had Moderna at the facility which showed as expired on 17-May-2022 upon entering into the expiration look up tool on Moderna's website. It was reported that the vial did not undergo any temperature excursions. None of the patients have reported any adverse reactions to the expired dose. No treatment drug was reported.
Information has been received from a physician referring to his 63 year old wife with mild hypertension and allergic to cats. On an unknown date in approximately February 2015 (reported as "about a month ago") the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (lot number, expiration date unknown), 0.65 ml, intramuscularly in the triceps area of her left arm (subcutaneous injection formulation administered by other route). The reporter was not certain how much time passed after the vaccination, when the patient developed "what looked like a cellulitis" which lasted "about a week". No lab diagnostic studies were performed. The patient did not seek any medical attention for the "cellulitis", and she used an occasional ice pack on the effected area as needed. The "cellulitis" resolved within two weeks on an unspecified date approximately in 2015 and the patient was fully recovered. The causality between ZOSTAVAX and the event was unknown. Additional information has been requested.
pt recv vax 23MAY95 & 2 days later devel clear mucous in nose, stuffiness not relieved by saline nose drops or steam inhaler;30MAY seen by MD poss allergy given med;pt unable to suck bottle or breast;unresponsive  to deep painful stimuli
2nd dose 21 days after 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 21 days after 1st dose) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1414b) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1 and Lot number FT 9142.) on 01-Jul-2022. Past adverse reactions to the above products included No adverse event with Pfizer.    On 22-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 21 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 21 days after 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Patient received first dose of Pfizer and second dose of Moderna vaccines within 21 days timeline. No treatment medication was provided.
approx 18-20 hrs p/receiving Recombivax pt devel a severe h/a which lasted for 8 hrs; no relief w/APAP was noted; nausea began 5 hrs p/h/a, vomited x 1 then relief to all sx;
got covid; who have received vaccine and then got covid; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced got covid and drug ineffective and who have received vaccine and then got covid on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: got covid on unspecified date. The clinical outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Continuous pain at injection site and start of unbearable pain in left shoulder blade on the same side as the injection site.
Soon after vaccine, pt exhibited symptoms of pain, abdominal stress off and on, especially aggravated by food consumption. His weight gain slowed and he seemed slightly less content.
Received vaccine at age 17 years, 3 months below the age of 18. No untoward effects.
Fever 105, left thigh red, swollen, hot (spreading from side of thigh around to front). In ER 9/27/05 PM. Rx for antibiotic given. T 100.2 9/28/05 - Erythema spreading; sent to ER. Information from medical records states cellulitis, allergic reaction. msv
Breakthrough case admission after 2 vaccines Pfizer 4/7/21 lot# Ew0150;  Pfizer 4/28/21 Lot# Ew0162
Initial unsolicited report received from a consumer on 23 October 2015. This case involves a 14-year-old male patient who was vaccinated with a intramuscular [dose in series were not reported] dose of FLUZONE QIV (batch number UI464AA, and expiry date 30 June 2016) in left deltoid on 13 October 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was amoxicillin allergy. The patient concomitant medications were not reported. On 15 October 2015, two days following the vaccination, the patient experienced nausea, vomiting, chills and high fever which later diagnosed as pneumonia and gastrointestinal (GI) virus diagnosed during the emergency room visit. On 16 October 2015, patient went to doctor with fever 104 Fahrenheit and with diagnosis of gastrointestinal (GI) bug. Lab data included on 19 October 2015, patient had flu test which showed B strain positive (test unknown). Corrective treatment was not reported. The outcome of event was not recovered. Upon internal review, the company decided to consider the event serious because of important medical event nausea, vomiting, chills, high fever and pneumonia. List of documents held by sender: none.