chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got sick; Initial information was received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (Patient).  This case involves patient [age and gender unspecified] who got sick (illness), while patient received INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site.   On an unknown date, the patient got sick (illness) (non-serious) about a week after following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
Informaiton was received from a mother concerning her 7 year old son who in 1999 was vaccinated with Varicella.  The mother reported that in MAR 2005 her son developed a Varicella rash with pustules shout 100 in number with more occuring.  It was unknown if medical attention was sought.  At the time of this report, the patient's varicella persisted.  No furhter information is available. This is in follow-up to report (s) previously submitted on 5/16/2005. Information has been received from a mother concerning her 7-year-old son who in 1999 was vaccinated with a dose of VARIVAX (Merck). The mother reported that in March 2005, her son developed a varicella rash with pustules about 100 in number with more occuring. It was unknown if medical attention was sought. At the time of this report, the patient's varicella rash persisted. No further information is available.
My calves are hurting and burning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My calves are hurting and burning) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (My calves are hurting and burning). At the time of the report, PAIN IN EXTREMITY (My calves are hurting and burning) had resolved.
Severe itching from head to toe, dermatographia, started 10 days from Moderna Booster
This spontaneous report was received from a vaccine coordinator referring to an unspecified number of patients whose on an unknown dates were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, (lot # L030868, expiry date 09-JUN-2018). The vaccine was stored in refrigerator at a temperature of 47°F to 77°F (48 °F) for current excursion, but data not available for prior excursions. The time frame was 45 minutes. No previous temperature excursions were reported. No datalogger reported. No adverse effects reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of five cases from the same reporter source, (linked to MARRS # 1704USA012566 and 1704USA013567 to 1704USA013569). Additional information is not expected as no information to obtain follow up was provided.; Sender's Comments:  US-009507513-1704USA012566: US-009507513-1704USA013567: US-009507513-1704USA013568: US-009507513-1704USA013569:
Sore shoulder starting 3 weeks after vaccine given, when raising arm (i.e. to put on a shirt or jacket) and resolves shortly after lowering arm
No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 13-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 01-JUL-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA012231: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA002267: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012221: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA012223:
patient received an extra Ipol the same day she received a Pentacel/no AE; Initial information received on 29-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 5 years old female patient who received vaccines a dose of IPV (VERO) [IPOL] even after receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] on same day.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 16-Dec-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. On 16-Dec-2019, the patient received a 0.5 ml single dose of suspect IPV (VERO) lot P1F491M via unknown route in the left deltoid.  It was of actual medication error due to extra dose administered.  It was reported that no adverse event was experienced by te patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 08Mar2021 at 17:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included human immunodeficiency virus syndrome (HIV). The patient had no known allergies. 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 vaccination. Concomitant medications included paracetamol (ACETAMINOPHEN), emtricitabine/tenofovir alafenamide fumarate/bictegravir sodium (BIKTARVY), bupropion (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN); all started from unknown dates for unspecified indications and were unknown if ongoing. On 08Mar2021 at 21:30, the patient experienced sore arm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event sore arm was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
sore arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 16Jan2021 (Batch/Lot number: unknown) as dose 1, single and administration date 06Feb2021 (Batch/Lot number: unknown) as dose 2, 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), outcome "unknown", described as "sore arms". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was seen at ED 12/19/2015 for rash post vaccination.  He previously had a similar reaction to same vaccines but not as severe.  Patient was prescribed prednisone and sent home.  Patient followed up at ED 12/20/2015 for continued rash, given IM Decadron in ED, sent home with prescription for Benadryl and Tylenol and advised to continue Prednisone.  Patient seen today in clinic 12/21/2015 for follow-up.  Patient with worsening rash despite treatment with medications.  Patient was send to another ED for further evaluation and treatment.
Was being monitored for 15 minutes. About 7 minutes after vaccine a fine rash started on left arm, spread to chest and other arms. Mild itchiness. No shortness of breath, no lip swelling, no tingling.  Self medicated with 50mg Benadryl.  I called her 1-9-21 at 9:50am. No rash, no itchiness. No issues at this time. Instructed she may want to pre-medicate or at least bring with her for her 2nd dose.
problems to sleep; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INITIAL INSOMNIA (problems to sleep), PAIN (Body aches) and CHILLS (Chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No medical history information was provided by the reporter.  Concurrent medical conditions included Diabetes.   On 09-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, the patient experienced INITIAL INSOMNIA (problems to sleep), PAIN (Body aches) and CHILLS (Chills). At the time of the report, INITIAL INSOMNIA (problems to sleep), PAIN (Body aches) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment medication were not provided.
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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. 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) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. From 23Jun2022 to 28Jun2022, the patient received nirmatrelvir; ritonavir (PAXLOVID) for treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received a dose of Moderna after leading pharmacist to believe that she was 18. No adverse events were observed.
Fever, chills, tired, dizziness, sore armpit, nauseous, sore arm, and rash on arm.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient) received  (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: ER8731), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE. The following information was reported: VERTIGO (non-serious) with onset 25Apr2021, outcome "recovered", described as "Vertigo. First vaccine was a sever case 11 days later". The event "vertigo. first vaccine was a sever case 11 days later" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo.  Follow-up attempts are completed. No further information is expected.
injection site is painful; injection site is hot; injection site is red, redness; injection site is swollen, swelling; injection site is hard, hard to touch; didn't shake vigorousl,  no white appearance achieved; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th January 2023, less than a day after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site swelling, injection site induration and wrong technique in product usage process. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema, injection site swelling and injection site induration were not recovered/not resolved and the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, injection site swelling and injection site induration to be related to Kinrix and Kinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: The mother was calling on behalf of her son who was the consumer.  The reporter stated that patient received a dose of Kinrix yesterday at the pediatricians office.  The reporter stated thate the nurse did not shake the prefilled syringe vigorously to obtain a homogeneous, turbid, white suspension prior to administration.  The reporter identified themselves as a pharmacist and the parent of the affected patient. The reporter gave details about the institution at which the dose was given and the symptoms presented. The patients arm at the injection site was hard, swollen, red, painful, and hot. The reporter also disclosed information about the patient but did not have specific information about the vaccine. The reporter consent to follow up. Additional Supportive Information: The nurse did not shake the prefilled syringe vigorously to obtain a homogeneous, turbid, white suspension, which led to wrong technique in drug usage process. The case US2023006931 is identified as duplicate of case US2023006929. All future correspondence would be added in case US2023006929, which stands as case of record for this patient and the case US2023006931 would be deleted. Note: The event onset date was captured as 16th Jan 2023 and outcome kept as not recovered based upon initial source document as all events were reported at the injection site.
Patient did not receive second Moderna Covid-19 vaccine greater than 35 days.; Palpitation; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second Moderna Covid-19 vaccine greater than 35 days.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol, Palpitations (for 4 years, 2-3 times per year) and White blood cell count low.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PALPITATIONS (Palpitation). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive second Moderna Covid-19 vaccine greater than 35 days.). At the time of the report, PALPITATIONS (Palpitation) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second Moderna Covid-19 vaccine greater than 35 days.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-124288, US-MODERNATX, INC.-MOD-2021-124831 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up information was received on 12 May 2021 wherein reporter contact details were updated and event was added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-124831: US-MODERNATX, INC.-MOD-2021-124288:
Lymph nodes under right arm are swollen and painful; Lymph nodes under right arm are swollen and painful; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 at 12:00 as DOSE 2 (Age at vaccination: 70 Years), SINGLE for covid-19 immunisation. Medical history included myocardial infarction from 2009 (Heart Attach 12 years ago-healthy now). No allergies to medications, food, or other products. Concomitant medications included atorvastatin (ATORVASTATIN), lisinopril (LISINOPRIL), metoprolol (METOPROLOL) and Entebia. The patient received dose 1 of bnt162b2 on 27JAN2021 at 12:00 PM for covid-19 immunisation (lot_number: EN6201, vaccine location: Left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced lymph nodes under right arm are swollen and painful on 18Feb2021 at 08:00. No treatment was received for the adverse events. Outcome of the events was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
covid vaccine breakthrough case    dose 1 Moderna 2/8/21 007M20A dose 2 Moderna 3/8/21 010A21A
The next morning, post vax, pt noted "small, red bumps on left arm near vaccine site". Called clinic on 7/25/00 and was seen. (+) Koplik's spot on right buccal. Vesicular lesions X 6 or 7, no fever.
Blood Clots; Pulmonary Embolisms; DVT (Deep vein thrombosis); This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ENG207), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:00 (at the age of 47years) as single dose for Covid-19 immunization. The patient received the dose 1 of BNT162B2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 08:30 (Batch/Lot Number: ENG203) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included essential tremor, insulin resistance, and anxiety; all from an unknown date and unknown if ongoing. Concomitant medications included propranolol, metformin, bupropion, and citalopram; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood clots, pulmonary embolisms, and a DVT (deep vein thrombosis) on 04Apr2021 (11:00AM). The patient was hospitalized due to the events for 4 days. The patient was treated with Heparin and Eliquis. The patient was tested for Covid-19 post vaccination via Nasal Swab on 03Apr2021 with Negative result. The outcome of events was recovering. The adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).
Varicella like rash on face, neck maculopapular, no vesicles found.
injection area still sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection area still sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M0A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection area still sore). At the time of the report, VACCINATION SITE PAIN (injection area still sore) had not resolved.            Patient stated it is fluctuated pain, worse pain at night in bed.  Concomitant medications were not reported.  Treatment information was not reported.   This case was linked to MOD-2021-123621 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up information received contain no new information.
pt recv vax 12AUG96 & 4wk p/exposure to brother who had chickenpox pt on 8JUL97 devel approx 20-30 lesions;
On 11/19/09, patient received H1N1 nasal spray vaccine. After administration, it was noted she is pregnant, EDC 5/16/10. She and her mother were advised of the wrong vaccine given; CDC contacted and her obstetrician notified. 11/23/2009 OB-GYN records indicate pregnant patient  EDC 5/16/10 exposed to vaccine, no sx noted at present