chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning the 16 year old daughter of his receptionist, with polycystic kidney who in August 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). In August 2007, on an unspecified date, after receiving GARDASIL vaccine (yeast) by injection, the patient experienced "passing out." She received her second dose of GARDASIL vaccine (yeast) on an unreported date in October 2007. Her hormonal contraceptives were discontinued in November 2007. The patient was not given the third dose of GARDASIL vaccine (yeast). She sought unspecified medical attention and had a stress test and an electroencephalogram (EEG) performed, no results were provided. At the time of reporting the patient was still experiencing "passing out." Additional information has been requested.
Started with swelling behind right ear, red and sore, Tues. has progressed up into the scalp and in front of ear, red, swollen and painful.  This, Wed. is all the way to the eye, down side of throat.  Hurts, sore, red and very swollen.  Have a few aches elswhere in hips.  On Mon. had an extreme hard chill that lasted over 10  mins.  Really scary.
Felt warm with a temperature of 99 degrees Fahrenheit; Itchiness; Sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt warm with a temperature of 99 degrees Fahrenheit), PRURITUS (Itchiness) and VACCINATION SITE PAIN (Sore injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Ovarian cyst, Allergy to antibiotic (Cefuroxime antibiotic), Allergy to antibiotic (Tetracycline), Sulfonamide allergy and Allergy to antibiotic (Bactrim).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Felt warm with a temperature of 99 degrees Fahrenheit), PRURITUS (Itchiness) and VACCINATION SITE PAIN (Sore injection site). At the time of the report, FEELING HOT (Felt warm with a temperature of 99 degrees Fahrenheit) and PRURITUS (Itchiness) outcome was unknown and VACCINATION SITE PAIN (Sore injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (Inconclusive) felt warm with a temperature of 99 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included a pill daily for ovarian cyst.  No treatment information was provided.
Abscess left thigh: drained on 11/1/04. Culture and MRSA. Bactroban/ hot socks. Follow up: 11/3/04 much improved.
This spontaneous report as received from a medical assistant refers to a 13 year old patient of an unknown gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 17-AUG-2016, the patient was inadvertently vaccinated with a dose of PROQUAD, (Lot #, expiration date and dose were not reported) via subcutaneous and also with a dose of VARIVAX (Lot #, expiration date and dose were not reported) via subcutaneous. Patient's concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
a week after vaccine, started to get a rash on the arm that receive the vaccine. rash is located 2 inches below site of injection, was initially lumpy and warm but has subsided
mouth swolled up; Like some allergic reaction thing; Some type of reaction on the plate; Did not get the second one/ doctor told her not to take the second dose; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (mouth swolled up), HYPERSENSITIVITY (Like some allergic reaction thing), PAIN IN EXTREMITY (Pain in the arm), ADVERSE REACTION (Some type of reaction on the plate) and PRODUCT DOSE OMISSION ISSUE (Did not get the second one/ doctor told her not to take the second dose) 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm). On an unknown date, the patient experienced MOUTH SWELLING (mouth swolled up), HYPERSENSITIVITY (Like some allergic reaction thing), ADVERSE REACTION (Some type of reaction on the plate) and PRODUCT DOSE OMISSION ISSUE (Did not get the second one/ doctor told her not to take the second dose). On 17-Feb-2021, PAIN IN EXTREMITY (Pain in the arm) had resolved. At the time of the report, MOUTH SWELLING (mouth swolled up), HYPERSENSITIVITY (Like some allergic reaction thing), ADVERSE REACTION (Some type of reaction on the plate) and PRODUCT DOSE OMISSION ISSUE (Did not get the second one/ doctor told her not to take the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was not allergic to anything before.  Treatment medication include antibiotics.  Patient stated that she did not think that the events were related to the vaccine because she took antibiotics and it cleared up.    Reporter did not allow further contact
Initial information was received from a health care professional on 24 FEB 2014. A 61-year-old female patient had medical history of seizure disorder and with an immune condition whose concomitant medication were not reported received, a dose of FLUZONE ID vaccine, intradermally on 31 JAN 2014 (dose, site not reported batch number: UT4725BA). It was reported that on 06 Feb 2014 patient had experienced feeling of heavy limbs, slept for 20 hours, tiredness and difficulty breathing. Laboratory investigations were not reported. Patient had received corrective treatment of Tamiflu (route, site, dose and batch number not reported). At the time of report, outcome of event was not recovered. List of documents held by sender: none.  Follow up information received from a health care professional on 10 June 2014. The patient received FLUZONE ID in the left deltoid. The patient had medical history of Epstein-Barr and autoimmune problem trigger neuromuscular response. The patient experienced reactions took about one week. The laboratory investigations were done.
Overall body weakness lasting 36 hours, chills lasting 4 hours, tremors lasting 2 hours, vomiting lasting 2 hours, brain fog lasting 36 hours, night sweats lasting 2 days, low grade fever
Respiratory failure due to COVID-19.  Dexamethasone, Remdesivir, O2, albuterol, dextromethorphan and tylenol for discomfort.   Sent from another medical facility due to no beds available.
Fever, chills and body ache started on 3rd day after 1st shot then continued for five days in a row (fever 99-102). Fatigue and cough got worse with each day and continued for another 7 days. Cough and fatigue continue, (to a lesser degree).  I'm VERY apprehensive about getting the second shot this Saturday, April 24.
Fever, chills, body ache that night and a few days later. Now I am lethargic and tired all the time.
Took Vivotif on days 1, 2,3 , and 5; Spontaneous report received on 12DEC2019.  A physician reported that a female consumer "took Vivotif on days 1, 2, 3, and 5" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis. The consumer took Vivotif on days 1, 2, 3, and 5, which was not according to the schedule. It was reported that she would be travelling to country on 29DEC2019. Action taken with Vivotif was not applicable. Outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif on days 1, 2, 3, and 5 (Inappropriate schedule of vaccine administered). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer took Vivotif on days 1, 2, 3, and 5 (Inappropriate schedule of vaccine administered). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
nausea rt p/vax;rash all over body in AM; will take DPH po
From initial information received on 05/23/2005 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 40 year old female patient received a dose of Tetanus Toxoid, lot number U1298AA, administered intra-muscularly in the left deltoid on 05/09/2005.  Seven days later, on 05/16/2005, the patient developed nausea and vomiting.  She also reported that her skin hurts all over.  The patient reported the events to the physician's office on 05/23/2005 and at that time she had not recovered from the events.
A non-serious spontaneous report of administration of expired dose was received from a health professional concerning a 46-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 11-Dec-2011. On 12-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Influenza virus vaccine (FLUVIRIN) 2008-2009 formula expiration 6/30/2009 given instead of 2009-2010 formula. Vaccinated with influenza virus vaccine (FLUZONE) 2009-2010 formula after error discovered.
Pt severely lethargic, limp, pale, shallow respirations following vax; Taken to ER-t101.5;
dose 3 (booster), single; HIV; heart condition; Chronic obstructive pulmonary disease (COPD); heart condition and Chronic obstructive pulmonary disease (COPD); visually impaired; This is a spontaneous report received from a contactable reporter (consumer) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 75 year-old male patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "heart condition" and "Chronic obstructive pulmonary disease (COPD)", both unspecified if ongoing. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose and 2nd dose), for COVID-19 immunization, reactions: "HIV", "heart condition", "Chronic obstructive pulmonary disease (COPD)", "disease recurrence" and "visually impaired". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "dose 3 (booster), single "; HIV INFECTION (medically significant), outcome "unknown", described as "HIV"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "Chronic obstructive pulmonary disease (COPD)"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "heart condition and Chronic obstructive pulmonary disease (COPD)"; and VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "visually impaired". The patient mentioned that he has a heart condition and Chronic obstructive pulmonary disease (COPD) now. He already had his first and second dose of the vaccine and already had his Booster Shot. He was asking if he can get an antibody test to assess the effectiveness of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) booster dose 4 months after vaccination and if there are currently any ongoing investigation for a 4th dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) for people that are immunocompromised.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101837932 same reporter/patient/vaccine, similar events and different dose
Continuous pain in left shoulder also lymph nodes was swollen under the left arm for three days..felt under the weather for seven days.
fainted; hit their heads; This spontaneous report was received from a registered nurse via a company representative referring to a 11 or 12 years old female patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     In September 2018, the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, route, lot # and expiration date were not reported) for prophylaxis.  In September 2018(reported as after receiving the dose of the vaccine), the patient fainted in the office and hit her head. On an unknown date, the patient required medical attention from an unspecified hospital. It was unknown if the patient was admitted to the hospital. The patient was still in the doctor's office. The outcome of the events was recovered on an unknown date. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, fainted was determined to be medically significant.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA010534:
The tips of all my fingers on both hands, except my thumbs, are real white on top, like they don't have any circulation. As I move them around, it seems like the blood starts circulating again; The pain at the injection site was more severe than the others; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (The tips of all my fingers on both hands, except my thumbs, are real white on top, like they don't have any circulation. As I move them around, it seems like the blood starts circulating again) and VACCINATION SITE PAIN (The pain at the injection site was more severe than the others) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 026A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (oesophageal).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, the patient experienced SKIN DISCOLOURATION (The tips of all my fingers on both hands, except my thumbs, are real white on top, like they don't have any circulation. As I move them around, it seems like the blood starts circulating again) and VACCINATION SITE PAIN (The pain at the injection site was more severe than the others). The patient was treated with PARACETAMOL (TYLENOL) for Injection site pain, at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (The tips of all my fingers on both hands, except my thumbs, are real white on top, like they don't have any circulation. As I move them around, it seems like the blood starts circulating again) and VACCINATION SITE PAIN (The pain at the injection site was more severe than the others) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-333396 (Patient Link).
vertigo when in a reclined position (greater than 90 degrees) Minimal or disappears if on feet.  Am able then to do normal tasks
torn retina; sore arm; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (Mfr. Control No. :21K-163-4064125-00) from a contactable male consumer (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. On unknown dates, the patient experienced torn retina and sore arm. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The action taken in response to the events for adalimumab was unknown. The outcome of events was recovering.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of torn retina and sore arm with HUMIRA (ADALIMUMAB) was no reasonable possibility.  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN): The reporter's causality for the events of torn retina and sore arm with vaccine was not reported.  No follow-up attempts are needed; information about lot/batch no. can not be obtained. No further information is expected.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Retinal tear and pain in extremity 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.
At approximately 12 P.M. on 6/11/21, a mental fog resulting in foggy thinking, forgetful, unable to focus, strange space-y feeling in head, and decreased ability to hear began. This resulted in being unable do to normal daily activities. The fog was still present the evening of 6/12/21, but appeared to be receding. On 6/13/21, the fog continued to reduce and I was nearly able to function normally. As of the afternoon of 6/14/21, the mental fog was completely gone and I was back to normal function.
This report as received from a health professional via company representative refers to 3 unspecified patients of unknown age and gender. The reporter stated that in two clinic locations, an expired M-M-R II was administered to unspecified patients (dose, route of administration, Lot# and expiration date were not reported) on unspecified dates. At one clinic location this occurred once, at second clinic location this occurred twice. No adverse effects were noted. The reporter went to write in her e-mail to company representative that she had previously reported one of these events herself. However, no additional information identifying this report was provided. Additional information has been requested.
left arm pit developed a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (left arm pit developed a rash) in a patient of an unknown age and gender 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 RASH (left arm pit developed a rash). At the time of the report, RASH (left arm pit developed a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
Itchy throat, red eyes after 30 minutes. EMS on site gave IV Benadryl, epi pen shot and took to ER for monitoring. Vitals were good so he was discharged.
Developed swelling, redness on right arm up to posterior aspect of arm (vascular 1 deltoid), slightly indurated 2 days after the shot.  Treated for Benadryl and Ghabcin.
Approximately two days after receiving the vaccine, she had nausea and some vomiting. Three days afterwards, she is coughing.; Approximately two days after receiving the vaccine, she had nausea and some vomiting. Three days afterwards, she is coughing.; Approximately two days after receiving the vaccine, she had nausea and some vomiting. Three days afterwards, she is coughing.; This is a spontaneous report from a contactable consumer.  An 89-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021 at 15:00 at single dose in left arm for COVID-19 immunisation at the age of 89-year-old. Medical history included dementia, breast cancer, high blood pressure, high cholesterol, depression, thyroid disease, Allergy. Approximately two days after receiving the vaccine, she had nausea and some vomiting. Three days afterwards, she was coughing. The patient did not receive any treatment for the events. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 at 16:45 as dose 4 (booster), single at the age of 51 years for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Drug allergy". Vaccination history included: Covid-19 (PRIMARY IMMUNISATION SERIES COMPLETED, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were not taken as a result of drug ineffective, Covid-19. Additional Information: Antiviral COVID 19 Treatment Paxlovid  Pfizer with start date: 07Jun2022 and stop date: 11Jun2022 Lot number: GA1529. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Growing lump under arm pit Pain in extremities ( finger tips, Achilles, neck and ear)
After my second dose I felt light headed, tired, then later had full body aches and pains, fever of 101 degrees,  soreness in arm. Similar to having the flu
Left Supraclavicular lymph node, approximately 1 cm, mobile, non tender noted by patient 5 days after vaccination
Allergic reaction at injection site left arm. Itching and swelling. Pain also was experienced by patient. Allergic reaction related to PREVNAR 13.
I95.9 HYPOTENSION 3/20/2023 BILAT CAROTID ARTERY STENOSIS
received his first dose and he tested positive; received his first dose and he tested positive; pneumonia; This is a spontaneous report from a contactable consumer (patient's child). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included cancer. The patient's concomitant medications were not reported. The patient received his first dose and he tested positive after on an unspecified date. He actually developed pneumonia on an unspecified date which could kill him as stated by the reporter. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021244030 Same reporter/drug/event, different patient.;US-PFIZER INC-2021252441 Same reporter/drug/event, different patient.