chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Johnson and Johnson Dose Number: 1, Moderna Dose Number: 2, Pfizer / BioNTech Dose Number: 3;  Language reporting type  Report about covid treatment: Yes  Reporter type: Patient Gender: Male  Patient occupation: None of the above If vaccine received: Yes Other medication in 2weeks: No  Anti viral details: Product: COVID 19 Treatment  Covid vaccine details : vaccine brand: Pfizer / BioNTech, vaccine brand unknown: False, vaccine administration date: 08Sep2022, vaccine lot unknown: True, vaccine lot unknown reason: Other, vaccine lot unknown reason other: It was the bivalent vaccine, I don't know more specific information., vaccine dose number: 3, vaccine dose number unknown: False, vaccine location: Left arm,  vaccine brand: Other, vaccine brand other: Moderna, vaccine brand unknown: False, vaccine lot unknown: True, vaccine lot unknown reason: Not available/provided to reporter at the time of report completion, vaccine dose number: 2, vaccine dose number unknown: False,  vaccine brand: Other, vaccine brand other: Johnson and johnson,  vaccine brand unknown: False, vaccine lot unknown: True, vaccine lot unknown reason: Not available/provided to reporter at the time of report completion, vaccine dose number: 1, vaccine dose number unknown: False  Adverse event: Symptoms and positive test result 6 days after completing medication and a negative test result.  Adverse event  Adverse event start date: 27Feb2023 Ae resulted in: [None of the above] If patient recovered: Not recovered If treatment ae: No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Johnson and Johnson Dose Number: 1, Moderna Dose Number: 2, Pfizer / BioNTech Dose Number: 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: negative test result; Positive, notes: positive test result 6 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt has no adverse events  pt recieved two diffirent manufacturers of the Covid-19  vaccines, both are MRna vaccines   the Pzifer vaccine (2 doses at Dialysis) and the Moderna Vaccine (2 doses at the nursing home where she 's staying.
Lymph nodes in underarm of injection site swelled andbecame very sore; Lymph nodes in underarm of injection site swelled andbecame very sore; The soreness hasradiated to the outer edge of mybreast.; am having trouble sleepingon that side (my usual positioning).; Chills; Low-grade fever; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 13:45(at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included inflammatory bowel disease, allergy to PCN, sulfa and latex. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and omeprazole (PRILOSEC); all for unknown indication and start date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 as a single dose for COVID-19 immunisation and also experienced drug allergy from cefaclor (CECLOR), albuterol (MANUFACTURER UNKNOWN) and ciprofloxacin lactate (CIPRO). 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 patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 13:45, patient experienced chills, low-grade fever that started 24hours after vaccination and abated within few hours. More significant beginning about 30 hours post injection, on 08Apr2021 at 19:45, patient lymph nodes in underarm of injection site swelled and became very sore and it hurt when she put her arm down. The soreness radiated to the outer edge of her breast and had trouble sleeping on that side (her usual positioning). Patient stated that she did not believe medical intervention was necessary, but she wanted to report the event. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event chills and low-grade fever were recovered on 08Apr2021. The clinical outcome of lymph nodes in underarm of injection site swelled and became very sore, soreness radiated to the outer edge of her breast and had trouble sleeping on that side were recovering at the time of this report.  No follow up attempts needed; no further information can be expected
Patient returned today to clinic - Had vaccine adm 5/28/19. Sought Tx 5/29/19 at urgent care for arm pain and received rx for ATB. Today for exam area red, swollen and painful to touch - Localized reaction
Weakness; Disorientation; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and DISORIENTATION (Disorientation) 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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced ASTHENIA (Weakness) and DISORIENTATION (Disorientation). At the time of the report, ASTHENIA (Weakness) and DISORIENTATION (Disorientation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
40 chickenpox lesions, few on legs;mostly on trunk, inc extremities & face;afeb;not acting sick;
Patient received the vaccination after a temperature excursion; Patient received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported. On an unknown date, the patient received 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the vaccination after a temperature excursion).    No concomitant medication was reported.  No treatment medication was reported. The facility had a temperature excursion in the freezer. RA was not recording the temperatures and needed a viability letter from Moderna about further steps to be done.  The vial was stored in the freezer nad the vaccine was still frozen. The vial size was 2.5 ml or 5.5 ml.
I experienced tiredness, fatigue, headache, muscle ache at injection site in left arm, muscle pain throughout body, joint pain throughout body, sore throat, mild cough, and nausea.
Arm and injection site sore for one day and fever for one day.  Neither bad enough to take medicine to mitigate.
Approximately 5-10 minutes after vaccine administration patient fell in the waiting area of the pharmacy while pushing shopping cart away from area.  She was with her husband who was having difficulty ambulating so we are unsure if she lost her footing (she does have history of falls) or if she had episode of syncope. Bystanders said it looked like she just fell straight back, possibly shopping cart moved faster than she was moving her feet. When I got to her she was laying on her back on the floor - her eyes were slightly rolled back in her head, her mouth was open and it was almost like she was choking. After watching her she was breathing but she could not respond to my questions. We called 911 and within a few minutes she came around and was able to answer questions. She didn't have any memory of falling but said she might have felt a little lightheaded right before falling.
This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic hepatitis B virus (HBV) infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decreased perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observational study. Patients: 4446 infants born to 3253 HBV-positive mothers between 1997 and 2010. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, minimal risk factors for HBV transmission, and transmission rates. Tests for HBsAG (HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 infants with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAG-positive as of January 2012 (Table 4). All these 25 patients had hepatitis B immune globulin (H-BIG) and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patients had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received their third dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. A copy of the published article is attached as further documentation of the patient's experience. This is one of 25 reports from the same source. Additional information has been requested.
No other symptoms or AE reported; Caller is an office manager who reports four doses of VARIVAX were given following temperature excursion. No other symptoms or other AE reported. No other AE/no PQC.         ?    Names of vaccines involved (including lot/exp) VARIVAX, lot U022732 e; This spontaneous report was received from an office manager on 29-MAR-2022, concerning a patient of unknown age and gender.There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. In March 2022, the patient was vaccinated with an improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U022732, expiration date: 20-JUL-2023 for prophylaxis (dose and route of administration were not reported) (Product storage error).  The administered dose of the vaccine experienced a temperature excursion of 7.4 Fahrenheit for 10 minutes and 5.4 Fahrenheit for 5 minutes, on 25-MAR-2022. Previous excursion was not reported. The cumulative time frame was reported as 15 minutes. It was unspecified if the data was recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved.
PATIENT DESCRIBED DEVELOPED FEVER RAPIDLY THE DAY AFTER, NOW 02/20/2018 PATIENT DESCRIBED IT HAS IMPROVED. PATIENT AFTER 6 DAYS DEVELOP LIKE A CHICKEN POX RASH AROUND THE AREA OF INJECTION. PATIENT DESCRIBED A LOT IF ITCHING SOME PAIN AND WARMING SENSATION.
feeling lazier; the arm was sore, not quite as bad after the second dose; fever; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (feeling lazier), PAIN IN EXTREMITY (the arm was sore, not quite as bad after the second dose) and PYREXIA (fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced LAZINESS (feeling lazier), PAIN IN EXTREMITY (the arm was sore, not quite as bad after the second dose) and PYREXIA (fever). At the time of the report, LAZINESS (feeling lazier), PAIN IN EXTREMITY (the arm was sore, not quite as bad after the second dose) and PYREXIA (fever) outcome was unknown.            Concomitant medications include: Thyroid medication and Cholesterol medication Concurrent medical condition includes: Cholesterol disorder  No treatment medications were reported.   This case was linked to MOD-2021-363314, MOD-2021-363179 (Patient Link).
Patient received his COVID, then his flu vaccine.  He waited 15 minutes then returned to his office.  A little while later he returned to the clinic (in his place of employment) and stated he had neck pain in the middle of his lower neck and numbness of the left corner of his mouth.  His neck pain resolved within 5 minutes, the numbness persisted.  Denied SOB, throat tightness, itching, and other symptoms.  Watched for approximately 20 minutes.  Numbness began to resolve.  Given follow-up instructions to call 911 if symptoms worsened and to call his physician to schedule an appointment within the next 24 hours.  Verbalized understanding.
pt recvd vax; devel redness, edema, and induration at the injection site;
Patient was given second dose 14 days early. She indicated on her form that she hasn't had any vaccine in past 28 days but her card showed it had only been 14 days.
It was reported that a 43 year old female patient received a Fluzone SV '01-'02 vaccination on 11/13/01 administered in her right deltoid. The next day, patient developed generalized edema. Weight increased  11 pounds. Patient was given Lassix with Potassium 20mg PO for 5 days. Patient left for Florida next day so no follow up.
Fatigue and malaise.  Then on 4/6/21 experienced intense skin sensitivity/pain (especially on back) and chills, followed by a papule type rash on elbows, hands, fingers, back, and at the gluteal fold. Rash on fingers and back were also itchy.  The rash had subsequently resolved, but it returned again accompanied by skin sensitivity/pain on my back  along with nausea and lightheadedness on 4/29/21. It has not resolved as of this day.
PRESENTS TO HD 4/26/AA @ 4:30 PM WITH 13 CM X 10 CM RED, RAISED AREA. HOT TO TOUCH. HAS BEEN TO URGENT CARE PRIOR TO SEEING US @ HEALTH DEPARTMENT. SAW DR. WHO TOLD HER IT WAS A LOCAL REACTION AND TO GO TO ER IF WORSENS. PUBLIC HEALTH NURSE ENCOURAGED TO APPLY WARM COMPRESSES AND TO TAKE MOTRIN FOR PAIN RELEIF.  VERBALIZED UNDERSTANDING. MARGINS MARKED WITH PEN.
Allergic reaction; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an allergic reaction. On an unspecified date, the patient was hospitalized due to an unknown reason. The patient was inquiring if the company can help with hospital bills. Outcome of the event allergic reaction was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swelling, redness, itchiness started 2 days after injection. Pt seen 4/13/10 Rx triamcinolone cream.
Pt reported on 4/8/03 that she experienced one episode of chest pain occurring between 7-9 days post vaccination. Pt described sudden onset of a painful jolt in her chest "like grabbing an electric fence" followed by several hours of soreness and aching.  Pt has also had "nagging" headaches daily from day of post vaccination which are not severe.
Lost sense of taste; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant, female patient of unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route on 09Apr2021 at 09:45 as single dose for COVID-19 immunisation. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. The medical history and concomitant therapy were not reported. It was unknown if the patient received any other medication within 2 weeks of COVID vaccination. It was unknown if the patient received other vaccination within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) on an unknown date as single dose for COVID-19 immunisation. Since the vaccination, it was unknown if the patient was tested for COVID-19. On 09Apr2021, Friday night, the patient had lost sense of taste. The taste returned on 10Apr2021, Saturday, with some foods but not others - intermittent. It was better on Sunday. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event of lost sense of taste was recovered on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
Patient received the vaccine with no issue.  Immediately after the vaccine was administered and the muscle was massaged, the patient passed out.  She regained consciousness at no more than 5-10 seconds after symptoms presented.  However, as a result of her passing out, she fell forward from the chair she was seated in and hit her head on the concrete floor.
- He received TPA at 2330 on 4/23. Subsequently transferred to Medical Center ICU for further care. Hospital suspect that this may be seizure related.  Aspirin was discontinued and the patient was initiated on Eliquis 5 mg p.o. twice daily. Recommend Eliquis for right ICA occlusion with fetal PCA for 6 weeks.  Repeat CT of the head and neck in 6 weeks to determine continuation of anticoagulation in the neuro clinic at that time. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Red eyes; Watery eyes; A spontaneous report was received from a consumer concerning a 70-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red eyes and watery eyes.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, approximately seven days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced red eyes and watery eyes. The patient checked to ER (emergency room). Treatment for the event included olopatadine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events red eyes and watery eyes was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
she had complained of pruritus, swelling of the lower extremities, generalized body ache, and feeling feverish
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with an expired dose of ZOSTAVAX (route and lot # not reported). No adverse effect was reported. Additional information has been requested.
administered Shingrix reconstituted with an Unapproved Diluent; administered Shingrix reconstituted with an Unapproved Diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number B3F47, expiry date 10th April 2023) for prophylaxis.   On 25th February 2022, the patient received Shingrix. On 25th February 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Nurse administered Shingrix to the patient, which was reconstituted with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  Healthcare professional realized this error on the date of reporting. The reporter consented to follow up.
mom states child has gen rash, sleep & can't awaken;mom told to bring child to hlth dept;pt initially appeared lethargic but soon awoke & responsive;fine red rash on face, neck, arms & body;tissue under eyes red & swollen;dx allerg rxn
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 16-FEB-2011 the patient was vaccinated with the first dose of GARDASIL (lot# unspecified). Late on 29-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (lot# unspecified). Early on 24-OCT-2013 the patient was vaccinated with the third dose of GARDASIL (lot# unspecified). No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Pediarix (Dtap Hep B Polio), Prevnar (pneumococcal) vaccines given in error.