chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the day of the vaccination, in 30 minutes my eyes felt heavy. and I felt a warmth throughout my body down into my vagina. Later, in the day, and since I felt tired sometimes.  On Tuesday, September 27, 2021, late afternoon, broke out in hives on my right forearm to right above my elbow. I called by doctor and she asked questions and suggested I take Benadryl or an antihistamine. Later, there was a small hive on my left arm, then another developed on my left arm.  My heart feels different and I feel itchy all over. I will report this to my doctor. I took two Benadryl. The next day I took one benadryl at bedtime.
A 44 year old male pt received preventative maintenance treatment with Oncotice for carcinoma in situ of the bladder since Sept 2003. He presented with fever three times since 9/3/04 and recurring burning, right hip pain since 9/13/04. He also presented with a high cholesterol and high thyroid levels since approx two years ago. The fever resolved without treatment, high cholesterol and high thyroid levels resolved with current medication, the right hip pain was considered unresolved.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: 8727), in left arm, on 25Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 31Dec2021 as dose 3 (booster), single (Lot number: 330308D) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme disease" (unspecified if ongoing); "sudden sensorineural hearing loss due to childhood virus" (unspecified if ongoing), notes: sudden sensorineural hearing loss due to childhood virus. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (02Jul2022) Negative, notes: Tested multiple negative Tests 02Jul-05Jul; (03Jul2022) Negative, notes: Tested multiple negative Tests 02Jul-05Jul; (04Jul2022) Negative, notes: Tested multiple negative Tests 02Jul-05Jul; (05Jul2022) Negative, notes: Tested multiple negative Tests 02Jul-05Jul; (06Jul2022) Positive, notes: positive on 06Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19.   No follow-up attempts are possible. No further information is expected.
Very upset and "is freaking out"; Received Moderna as a second dose after receiving Pfizer as a first; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Very upset and "is freaking out") and INTERCHANGE OF VACCINE PRODUCTS (Received Moderna as a second dose after receiving Pfizer as a first) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (Batch No:30130BA andDose-1) on 17-Sep-2021.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Moderna as a second dose after receiving Pfizer as a first). On an unknown date, the patient experienced FEELING ABNORMAL (Very upset and "is freaking out"). On 15-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (Received Moderna as a second dose after receiving Pfizer as a first) had resolved. At the time of the report, FEELING ABNORMAL (Very upset and "is freaking out") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Breakthrough case admission after 2 vaccines Moderna 3/20/21 lot# 047A21a;  MOderna 4/17/21 lot# 040B21A;
Breakthrough COVID infection in fully vaccinated patient. Positive date 09/24/2021.
This spontaneous report as received from two pharmacists refers to a patient of unknown age and gender. On 29-APR-2014, the patient was vaccinated with a dose of improperly stored ZOSTAVAX, lot # J013451, expiration date 24-JAN-2014 (dose and route not reported) with worst case exposure of 34F for 506 hours, Dates of excursions: 06-MAR-2014 to 29-APR-2014. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician via Pfizer and Merck Biopharma, referring to a 15 years old male patient. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 28-JUN-2018, the patient was vaccinated with a an improperly stored unidentified Merck Human papilloma virus (HPV) vaccine (name, strength, dose, dose number, anatomical injection site, route of administration, lot number and expiration date were not reported) for prophylaxis.; Sender's Comments: US-MMM-WNDKC0ES:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "FMD"(Foot and mouth disease) (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive. COVID rebound. Positive test after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid to treat drug ineffective, covid-19. Treatment start date: 22Jun2022, treatment stop date: 26Jun2022,  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
11OCT95 reports onset of gen red, maculopapular rash over torso et extremities around HS on 10OCT95; fever 101, inc fussiness;mom reports rash has faded some today
The evening of the vaccination, patient had hot flash, near syncope and body tremors, stuttering. One week later, she developed complete body itching, but no rash present.
Erythematous, swollen warm area surrounding injection site. Pain with movement of arm. Swollen arm 8 x 12".
a 82y.o. female with history of CAD hypertension A. fib on Eliquis, asthma, GERD, hyperlipidemia, hypothyroidism, hypertension presented with complaints of diarrhea  On admission vitals were stable.  Labs showed elevated liver function tests ALP of 139 AST 60, ALT of 41.  White count 3.2.  COVID-19 was positive. CT abdomen and pelvis showed SMA artery stenosis .   Patient presented with diarrhea  Stable T11 compression fracture.  C. difficile was ordered however as diarrhea resolved was not sent . Patient needs outpatient follow-up with orthopedic spine   For stable T11 compression fracture. PT OT evaluated recommended home with home health care.  Discussed with patient and husband Were agreeable with the plan.
Genital Herpes flair up, two sores on left labia, itching and tingling..  Previously asymptomatic genital herpes diagnosed via blood test in 2001, became symptomatic 5 days  after 3rd dose of Moderna
Deep achiness all over body, as though suffering a fever. No chills or temperature. Deep  physical fatigue; mentally alert however. Lasted about 24 hours.
Few days later patient's left arm has been more sore and experiencing muscle weakness radiating down to her fingers. It has been going on for over a month now. As her if it was nerve pain but she said it's more muscle pain and soreness.
Daily migraines that caused vomiting. Fatigue and shortness of breath. I was going to the gym to lift weights 2 times a week and going for 2-3 miles walks with my husband every week also. the shots took that away! I also developed a cough that my GP sent me to an ENT doctor, and he said that I had cluster migraines and did not address the cough. At times the cough the cough was so bad that I thought I would die. This went on and I was sent to a Nuru and had MRI done and it was clear, I have had 4 different migraine medicines. Also developed walking phenonium and took 2 rounds of antibiotics and steroids. I still suffer from migraines and a cough. Still have shortness of breath. I wish to get my health back and exercise again with my husband. I owned a fitness club and enjoyed good health before trusting in these shots.
3 days post vax onset neck swelling/achiness w/complete resolution reoccurred approx 15 days p/similar sx w/clinical UTI & delayed institution of tx w/Bactrim DS; SMAC/CBC neg;
This spontaneous report as received from a registered nurse refers to unspecified number of patients. On unknown dates, the patients were vaccinated with GARDASIL (lot #, dose, route not reported), which were exposed to 31.5F during a period of 4.7 days in a physician's office. The reporter stated that the physician's office has twice told her that no vaccines were administered, but then told her that there were, however, she had no specified patient information or dates of administration. No adverse effect was reported at the time of report. This is one of several reports received from the same source. Additional information has been requested.
Body aches all over, neck, back, etc.; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (Body aches all over, neck, back, etc.) 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.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches all over, neck, back, etc.). At the time of the report, MYALGIA (Body aches all over, neck, back, etc.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Sore arm for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm for 2 days".  Additional Information: The report was not related to a study or programme. NDC number and expiry date was not reported. He got his first dose a week ago and it went very well. Stated he only had a sore arm for like 2 days. He was looking forward to his second shot. He thinks that the reporting coming out is wrong.  He says he believes that with the two dose vaccines, the majority of people are only getting one dose; but it is being counted and reported as they got the complete dose. They sent him the appointment for his second dose first, and the appointment for his first dose second. He thinks that a lot of people may have gotten these emails, which look the same but with 2 different dates; and only looked at the most recent one they received.  Therefore, only going to one appointment. States he keeps seeing different television and radio reports for different age groups.  Says he gets the reporting PDF file and some of it is correct; but he thinks some is getting lost in too much data.  He thinks that Pfizer's numbers for the vaccine are being misreported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 0554A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine).    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Vial size was initially stored in refrigerator 07-APR-2023. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738751 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738751:Patient 1
Vasovagal. Legs elevated then proceeded to med bay. VS stable. BP 125/59; 114/60, HR 85; 77, RR 12 x2, SpO2 100% RA x2
Atrial fibrillation.  Went to emergency room was admitted and spent two days in intensive care until it was brought back to normal.  Was prescribed amiodarone and eliquis and episodes subsequent episodes diminished and have not had one since May 13, 2021.
A lot of severe dizziness, chills, fatigue, headache, tingling, swelling in legs, and maybe a fever.
(R) deltoid area has area of redness initially w/ "little fine bumps". Today is just slightly red, not raised, not itchy (it was). Approx 60 mm across in size.
My balance and walking speed became worse after my 1st injection and even worse after 2nd injection. Had to start using a cane in July 2021 after several falls. Lost footing & fell off treadmill on May 10, 2021 and had a concussion. Neurologist was seen in July 2021 and referred for specialized Physical Therapy evaluation. PT recommended using cane anytime I was walking around.
Dev a rash 6d after ZOSTAVAX injection - arm, abd, leg-Rt.
Chills; Fever; Tiredness; Achiness; Sore arm; Her arm became swollen, red at injection site, and very itchy; Her arm became swollen, red at injection site, and very itchy.  It was a knot that was the size of her palm; Her arm became swollen, red at injection site, and very itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Her arm became swollen, red at injection site, and very itchy), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tiredness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 027L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Platelet disorder.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Her arm became swollen, red at injection site, and very itchy), VACCINATION SITE SWELLING (Her arm became swollen, red at injection site, and very itchy.  It was a knot that was the size of her palm) and VACCINATION SITE ERYTHEMA (Her arm became swollen, red at injection site, and very itchy). On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tiredness) and MYALGIA (Achiness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Her arm became swollen, red at injection site, and very itchy), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tiredness), VACCINATION SITE SWELLING (Her arm became swollen, red at injection site, and very itchy.  It was a knot that was the size of her palm), VACCINATION SITE ERYTHEMA (Her arm became swollen, red at injection site, and very itchy) and MYALGIA (Achiness) outcome was unknown.            Concomitant medication include daily chemotherapy pill.  Treatment also include lots of ice.  Patient had the symptoms 24 hours after the third dose and she was in bed for 48 hours and now reporter says that it was going away at the time of reporting.   This case was linked to MOD-2021-294214, MOD-2021-294229 (Patient Link).
allergic reaction; swelling of face; itchiness of face and neck; dizziness; swelling of neck; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (allergic reaction), SWELLING FACE (swelling of face), PRURITUS (itchiness of face and neck), DIZZINESS (dizziness) and SWELLING (swelling of neck) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A or T) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Environmental allergy. Concomitant products included CALCIUM for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), SWELLING FACE (swelling of face), PRURITUS (itchiness of face and neck), DIZZINESS (dizziness) and SWELLING (swelling of neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergic reaction), SWELLING FACE (swelling of face), PRURITUS (itchiness of face and neck), DIZZINESS (dizziness) and SWELLING (swelling of neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included hidroclorotizia, calcium, slow nides, salastin. Patient had chosen to not receive the second shot.
She states that a 4-year-old patient received first dose Moderna Bivalent COVID-19 vaccine on 23JUN2023; Dose may have been administered after 30-day Use By Date; Dose may have been administered after 30-day Use By Date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (She states that a 4-year-old patient received first dose Moderna Bivalent COVID-19 vaccine on 23JUN2023), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Dose may have been administered after 30-day Use By Date), EXPIRED PRODUCT ADMINISTERED (Dose may have been administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 23-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (She states that a 4-year-old patient received first dose Moderna Bivalent COVID-19 vaccine on 23JUN2023), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Dose may have been administered after 30-day Use By Date), EXPIRED PRODUCT ADMINISTERED (Dose may have been administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (She states that a 4-year-old patient received first dose Moderna Bivalent COVID-19 vaccine on 23JUN2023), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Dose may have been administered after 30-day Use By Date), EXPIRED PRODUCT ADMINISTERED (Dose may have been administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (She states that a 4-year-old patient received first dose Moderna Bivalent COVID-19 vaccine on 23JUN2023), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Dose may have been administered after 30-day Use By Date) and EXPIRED PRODUCT ADMINISTERED (Dose may have been administered after 30-day Use By Date).    Concomitant product use was not provided by the reporter.  The patient received first dose Moderna Bivalent COVID-19 vaccine.  Dose may have been administered after 30-day Use By Date.  NDC: 80777-0282-02  Intact Carton, Vial size 0.4ml, Dark Pink Cap.  Date the vial was initially stored in the refrigerator was unknown.   The vial did not undergo any temperature excursions.  Treatment information was not provided.
PT received second injection on 1/13/2021 and had significant side effects following the second vaccine.  24 - 48 hours of low grade fever, severe nausea, headache, fatigue and body aches.
Presented to the ED with shortness of breath and respiratory failure and hypoxia, coughing Was put on BiPAP. Started on decadron, remdesivir, zinc, vitamin D, melatonin, albuterol, pulmicort, and was sedated to put on a ventilator Developed sepsis cefepime and vancomycin. Vasopressors were given. Vancomycin was later stopped because she was MRSA negative Patient not getting better and patient's spouse thought that it was time to give up and stop all agressive treatments Patient transferred to comfort care and died