chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; sore arm; fatigue; developed shingles; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: En6206) via an unspecified route of administration in the right arm on 13Mar2021 at 12:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included ibuprofen (ADVIL), multi vitamin (MANUFACTURER UNKNOWN), sambucus nigra (ELDERBERRY), sertraline hydrochloride (ZOLOFT) and clarithromycin (CLARITIN), all for unknown indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6200) via an unspecified route of administration in right arm on 20Feb2021 at 12:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 20Mar2021 at 00:00, the patient had experienced headache, sore arm, fatigue and developed shingles 9 days after on an unknown date in Mar2021. The patient underwent lab tests and procedures, which included COVID-19 virus test via nasal swab on 23Mar2021 and the result found to be negative. The patient was treated with Valtrex for the reported events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events headache, sore arm, fatigue and shingles was not resolved at the time of report. No follow-up attempts are needed. No further information expected.
seizure/ massive seizure; light headed; Shoulder popped out; not allowed to drive or work; not allowed to drive or work; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizure/ massive seizure), DIZZINESS (light headed) and JOINT DISLOCATION (Shoulder popped out) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Type 2 diabetes mellitus.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced SEIZURE (seizure/ massive seizure) (seriousness criteria hospitalization, medically significant and life threatening), DIZZINESS (light headed) (seriousness criteria hospitalization and life threatening) and JOINT DISLOCATION (Shoulder popped out) (seriousness criterion hospitalization). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (not allowed to drive or work) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not allowed to drive or work). On 05-May-2021, SEIZURE (seizure/ massive seizure) outcome was unknown. At the time of the report, DIZZINESS (light headed), JOINT DISLOCATION (Shoulder popped out), IMPAIRED DRIVING ABILITY (not allowed to drive or work) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not allowed to drive or work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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 product was not reported. Treatment was not reported. Patient has never had a seizure before and is also a Type 2 diabetic.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-264175 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow-up received on 22-JUL-2021 Contains updated information on patient demographics, updated event seriousness; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Some of the vaccine leaked into syringe cap; Patient did not receive total dose; A spontaneous report was received from a nurse  concerning a 62 years old, female patient who was administrated Moderna's COVID-19 vaccine at under dose and had a device connection issue during vaccination.   The patient's medical history was not provided. No relevant concomitant medications were not reported.  On 19 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  While administrating the vaccine, on 19 Feb 2021, some of the vaccine leaked into syringe cap and patient did not receive total dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, some of the vaccine leaked into syringe cap and patient did not receive total dose was resolved.; Reporter's Comments: This report refers to a case of device connection issue and underdose,  for Moderna's COVID-19  mRNA-1273, vaccine (lot # unknown) with no associated AEs.
Patient  believed she had a infected tooth, but was having pain from injection site up to jaw line.
Patient experienced immediate swelling at the injection site. It was treated with a cold compress for 15 minutes and 50 mg of diphenhydramine. The swelling was resolved when I followed up 5 hours later. The vaccine was administered with a safety needle and monoject syringe.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 18-Oct-2021. On 27-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 27-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided          Concomitant product use was not provided by the reporter.  Treatment information was not provided.
18 month old got Pentacel and Adacel on the same day; 18 month old got Pentacel and Adacel on the same day; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional via phone.  This case is linked to case 2019SA147706 (same reporter).  This case involves a 18 months old male patient who was vaccinated with a 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch number: C5572AA and expiry date: 13-Oct-2019) in the right thigh and 0.5 ml first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number: U6226AA and expiry date: 21-Apr-2020) in the left thigh on 20-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  No other vaccines given.   It was a case of actual medication error due to inappropriate age at vaccine administration and extra dose administered.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.   Documents held by the sender: none.
Pt came up to the EMS table and stated she did not feel well. Pt lost conciousness from a standing position and was caught and lowered to the ground. Pt was unconcious for approx 5 minutes. Pt regained conciousness. Pt was placed in a wheelchair and wheeled to the examination room. Pt was monitored for 30 minutes. Pt states she is feeling better and would like to leave. Pt was walked out to her car. Pt was driven home by her mother. Pt did not require transport.
Severe hives all over body and itchiness; Severe hives all over body and itchiness; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: GN6200), via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 68-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included, known allergies- just environmental (ragweed). There were no concomitant medications. No other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced severe hives all over body and itchiness on 30Mar2021 21:00. The event resulted physician office visit. Treatment included, oral antihistamine and steroid injection. The clinical outcome for the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.
Information has been received from an office manager concerning a female patient who in 2008 was vaccinated with the first dose of GARDASIL (lot # not reported). The reporter stated that she over heard another office staff member stating that the patient received the first dose of GARDASIL and she felt like she "was dying". The patient never called about the experience at the time it happened. The patient didn't sought medical attention. Her outcome was unknown. Additional information has been requested.
Not Apply.  Pt. given Tdap for adolescents and adults instead of the DTaP for ages 7 and under. No adverse event occurred.
Vasovagal syncope while walking after getting out of bed at night. This occurred approximately at the onset of chills/rigors.
Sore throat, fever (101.1), chills, body aches, fatigue Took home rapid test on 7/26/2022 that came back positive, took PCR test at Hospital drive thru facility that came back positive on 7/26/2022 Treated with Paxlovid for 5 days Still tested positive by home rapid test on 5th day of Paxlovid (7/30/2022) Recovered 8/1/2022
fever 104.6-runny nose, cough, bumps all over body;aches, would not walk-wanted to be held;
pt recvd vax FEB92 & immed following vax pt devel localized redness & swelling @ the inject site; following day exp general malaise; lab eval revealed anti-HBs 0.33;
Fever; Shortness of breath; I started throwing up/she is puking; I am totally out of it; I felt like a truck ran me over; Sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 22Jun2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 23Jun2022, outcome "unknown", described as "Fever"; CONFUSIONAL STATE (non-serious) with onset 23Jun2022, outcome "unknown", described as "I am totally out of it"; MALAISE (non-serious) with onset 23Jun2022, outcome "unknown", described as "I felt like a truck ran me over"; VOMITING (non-serious) with onset 23Jun2022, outcome "unknown", described as "I started throwing up/she is puking"; DYSPNOEA (non-serious) with onset 23Jun2022, outcome "unknown", described as "Shortness of breath"; ILLNESS (non-serious) with onset 23Jun2022, outcome "unknown", described as "Sick".  Additional information: It was reported that the caller experienced side effects of the vaccine.
Bright red vaginal bleeding after no cycle for approximately 8-10 yrs. diagnosed post menopausal approximately 6 yrs ago. Bleeding was too heavy for pantyliner. Lasted 2 days. Mild uterine cramping.
Unusual impotence; Extreme night sweats; Elevated heart rate resting rate of 100. My normal is 74 BPM; Shortness of breath; This is a spontaneous report from a contactable other health care professional. A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 02Mar2021 16:00 (at the age of 51-years-old) (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient previously took tylenol and experienced allergies. The patient did not receive other vaccines in four weeks, and other medications in two weeks. On 12Mar2021 16:00, the patient experienced Elevated heart rate resting rate of 100. My normal is 74 BPM. Shortness of breath. Extreme night sweats. Unusual impotence. All started 10 day after injection. The outcome of the events was not recovered.; Sender's Comments: The company does not attribute the unusual impotence (PT: Erectile dysfunction) to BNT162b2, considering the event being an intercurrent disorder.  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.
This spontaneous report was received from a nurse and refers to a unspecified patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with a dose of improperly stored PNEUMOVAX23, lot number reported as M039060 with expiration date 22-MAY-2018, (dose, route and anatomical location were not reported) for prophylaxis. The PNEUMOVAX23 23 vials were exposed to temperatures between 8 Celsius and 25 Celsius during 5 hours and 35 minutes. The vaccine was not exposed to previous temperature excursion. Data logger was filed and no adverse effect was reported. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA008075:
Approximately 3 weeks after immunization I got severe joint pain, knees, ankles, fingers, wrists etc., the pain lasted 4-5 days and lessened in serverity over that time.  I took Advil for the pain.
Body aches/ full body sourness; Soar joints; Swollen stomach; Pain in the stomach; Fatigue; Chills; Fever; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.   A 55-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Dec2021 at 14:00 (Lot number: unknown) at the age of 55 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Clot blood" start date: an unknown date in 2018 (unspecified if ongoing), notes: 4 years prior the patient had a blood clot in small intestine and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medications included: AMLODIPINE; BENAZEP; ALLOPURINOL and 81 MG ASPIRIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical location: right arm; Administration time: 12:00), administration date: 01Apr2021, when the patient was 54 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical location: left arm; Administration time: 12:00), administration date: 23Apr2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 28Dec2021 at 14:00, outcome "unknown", described as "Dose received: 3"; CHILLS (non-serious) with onset 29Dec2021, outcome "not recovered", described as "Chills"; PYREXIA (non-serious) with onset 29Dec2021, outcome "not recovered", described as "Fever"; PAIN (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Body aches/ full body sourness"; ARTHRALGIA (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Soar joints"; ABDOMINAL DISTENSION (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Swollen stomach"; ABDOMINAL PAIN UPPER (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Pain in the stomach"; FATIGUE (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Fatigue". The events "Chills", "Fever", "Body aches/ full body sourness", "Soar joints", "Swollen stomach", "Pain in the stomach" and "Fatigue" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of chills, pyrexia, pain, arthralgia, abdominal distension, abdominal pain upper and fatigue.  Additional information: The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID vaccine. First 2 days the patient had chills, fever. It was reported that 1 "through" 2 weeks later and present the patient had body aches, sour joints, swollen stomach, pain in the stomach, fatigue, full body soreness. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sore at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at the site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M2CA) for COVID-19 vaccination.     The patient's past medical history included Clot blood. Concurrent medical conditions included Diabetes, Ovarian cancer ((20 years ago)) and Glaucoma. Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma, METFORMIN, PRASUGREL HYDROCHLORIDE (EFFIENT), GLIPIZIDE, FENOFIBRATE, LOSARTAN, TRAZODONE, ATORVASTATIN, LINAGLIPTIN (TRADJENTA), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), MECLIZINE [MECLOZINE], ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN C [ASCORBIC ACID], FOLIC ACID, ZINC, CALCIUM and MAGNESIUM for an unknown indication.    On 12-Feb-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 VACCINATION SITE PAIN (Sore at the site). At the time of the report, VACCINATION SITE PAIN (Sore at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's conmeds includes Sulfate.  No treatment medication were provided.  Patient mentioned that her doctor experienced the same thing as she did after receiving Moderna vaccine.  Patient wanted to confirm the dose of the booster because a person at the pharmacy stated that it was the  full dose and she was confused whether it was the full dose or the half dose.  Additionally, patient asked about side effects of the 50 mcg booster dose and if they would the same as the primary series or different.   This case was linked to MOD-2021-400476, MOD-2021-400304 (Patient Link).
Headache, heaviness in head.  I was  able to concentrate and do my work but head felt heavy and cloudy (?) when standing. Was okay when doing work a my desk.  An extreme and unusual fatigue.  Some occasional weakness in legs especially when getting up.  Some interior shaking.  It happened 4-5 times over 10 days. Did not last more that 30 seconds to 1 minute. Had absolutely no symptoms after vaccine.  Symptoms started about 4-5 days after vaccine.
FATIGUE, NAUSEA,  LEFT SIDE MUSCLE PAIN, CHILLS, SORENESS, AND CHEST PAIN.
Case received on 04 October 2011 from a healthcare professional. A female patient, with no medical history reported, had received on an unspecified date her dose of FLUZONE HIGH DOSE (batch number UH468AB, number in series, route and site of administration not reported). No concomitant therapy was reported. On an unspecified date, the patient developed redness and severe arm swelling. No corrective therapy was reported. The final outcome was not reported. Follow-up information was received from a health care professional on 12 January 2012. The reporter claimed the initial report had the wrong patient and vaccine. The correct patient was a 34-year-old (reported as 35) female who received an injection in the left arm of FLUZONE Intradermal, lot number UT4163BA on 29 October 2011 and an unspecified amount of time later experienced a red, swollen raised dime sized area at the injection site "like a TB test". The patient's arm also got hot, red and swollen 24 hours later and the site was the size of a silver dollar. The patient experienced arm pain and shoulder pain. The patient was seen on 29 October 2011 with a large, red, swollen arm and was seen again on 05 January 2012 and the arm was still sore with a dime size and red spot still on the arm. It was very hard for the patient to lift child or lay on that part of the arm. No medical history was reported, no concomitant medications were reported and the patient had no illness at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: none.
patient is now having positive HIV antibody tests; This spontaneous report was received from a pharmacist and refers to female patient of unknown age. No information on patient's medical history, concurrent conditions and concomitant medications was provided.   On 23-SEP-2023, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (injection) (intramuscularly, exact dose, lot #, expiration date and anatomical location were not provided) for prophylaxis.  On unknown day in October 2023 (reported as 'approximately 2 weeks after completing the series'), patient was having positive human immunodeficiency virus (HIV) antibody tests. The patient's HIV antibody tests were positive, but the HIV antigen tests had come back negative. Outcome of the event was unknown.  The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.