chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effects reported.; first dose of GARDASIL 9 on an unspecified date in March 2018, second dose of GARDASIL 9 on July 30 2018, third dose of GARDASIL 9 on April 23 2020; This initial spontaneous report has been received from a registered nurse referring to a 17 years old female patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On an unknown date in March 2018, when she was 15 years old, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, route and dose details were unknown) for prophylaxis. On 30-JUL-2018, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: N021732, expiration date: 01-FEB-2020; route and dose details were unknown). On 23-APR-2020, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: R001262, expiration date: 10-NOV-2020; route and dose details were unknown) (inappropriate schedule of product administration). No additional adverse effects reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: N021732; expirationdate: 01-FEB-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Chills, uncontrollable shaking, chattering, temp 101.7 Temp decreased after taking tylenol 100mg Other symptoms lasted 12 hours
On my first dose of Moderna, I had a horrific and almost unbearable headache a few hours after my dose. I had to ice my head. I also committed and had stomach pain, nausea, and need to use the toilet for #2.  I was in terrible pain.  The first lot # was: 003B21A.  I filed a report for my first dose with the incorrect lot number.  On the second dose, which was on 4/20, I experienced slight nausea on the first day and a cough. The following morning I had severe chills, headache, weakness, and dizziness. I took my temperature in the afternoon and had a 102 fever. I was in bed from 6 pm, and 7 am the following day. I had a terrible headache all through the night and morning. I sweated between 4 am- 6 am. I was weak and still had a headache this morning. My fever is gone, and so is my headache now.  I can still use the rest.
This spontaneous report as receive from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 26-SEP-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Patient was given the incorrect pfizer bivalent 12+ vaccine while being 11 years old.  Mop and PCP were informed.
Feeling low; Dizzy; Weak; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling low), DIZZINESS (Dizzy) and ASTHENIA (Weak) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 642620A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced FEELING ABNORMAL (Feeling low), DIZZINESS (Dizzy) and ASTHENIA (Weak). On 09-Sep-2021, FEELING ABNORMAL (Feeling low), DIZZINESS (Dizzy) and ASTHENIA (Weak) had resolved.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
First my shoulder/arm was very swollen and sore.  Then later that evening the area became very red fingering out toward my chest.  The pain was so bad I could not move my arm.  The next day the physician I work for wanted to prescibe an oral antibiotic for me but because of a previous cdiff complication, I could not take one.  He prescribed Bactroban.  This is now 10-24-13 and the area is better but still tender to the touch and aches.
improperly stored vaccine was administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.   On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S035354 has been verified to be a valid lot number, expiration date was reported as 04-NOV-2021, but upon internal validation, it was established as 05-NOV-2021, 1 injection for prophylaxis (exact doses, dose #, route of administration and anatomical location were not reported). The temperature excursion was above 9 Celsius degrees (13.4 Celsius degrees) for 2 hours and 9 minutes. There were no previous excursions reported. The digital data logger was involved.
This spontaneous prospective pregnancy report refers to a 20 year old female patient. Patient's concomitant medications were not reported. The patient's medical history included allergy to codeine. On an unknown date in December 2017, the patient was vaccinated with VARIVAX (dose, frequency, lot number and expiry date not reported), intramuscularly (product use issue) reconstituted with sterile diluent (MERCK) for prophylaxis. The patient was determined to be pregnant on 23-FEB-2018 via urine human chorionic gonadotropin (HCG) test. Nurse reported that gestation age was determined to be 13 weeks and 6 days. Last menstrual period (LMP) was estimated as 18-NOV-2017 and estimated date of delivery (EDD) was 25-AUG-2018. The pregnancy outcome was unknown. No adverse effects were reported. No further information was provided. Product quality complaint was not present.
tingling in hands Narrative: patient developed tingling in both hands during observation period after covid vaccine given.
6 hours after 2nd shot ran 202 degree fever, had head ache, muscle aches, chills, sweats, and fatigue for well over 48 hours.
little soreness; flu like symptoms; This spontaneous case was reported by a physician and describes the occurrence of PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication reported included unknown drug for blood pressure.  It was reported that patient has never been diagnosed/tested positive for COVID-19.  No treatment information was provided.   This case was linked to MOD-2022-540074, MOD-2022-540079, MOD-2022-540072 (Patient Link).   Reporter did not allow further contact
No adverse effects; administered improperly stored doses of VARIVAX; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 31-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R035223, expiration date 04-DEC-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of -11.4 degrees Celsius (C) for 9 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA001214: US-009507513-1906USA001816:
Information has been received from a public health nurse concerning a 7 year old male patient who was vaccinated with a second dose of MMR II. The nurse reported that the patient may have mumps. Additional information has been requested.
Pt received ZOSTAVAX vaccine 2 hours after developed rash on both arms & a headache. Resolved w/i 1 day. No problems now.
Gave shot to patient in the left arm and there was immediate swelling and a bump about the size of a nickel formed that was hard. Patient also bled quite a bit. Advised patient to remain sitting down for a few minutes and he immediately became lightheaded. Patient thought he was going to pass out but after sitting for a while and drinking water he was ok. Patient was monitored for about 20 minutes and was told to call pharmacy if he felt that anything was wrong with him.
Flu shot received on 10/29/2002- painful initially and pain in left upper arm persisting. Sharp pain present especially with reaching or extension of left arm.
First dose (February 25):  "Covid Arm" (left arm) and reactive arthritis (wrist) starting a few days after injection - duration was approx. one week Second dose (March 25, 2021): approx. one week after injection - reactive arthritis (left hand) and constant headache, lasting approx. 2 weeks.  Also, developed vertigo and was markedly light-headed/dizzy.  One episode syncope (emergency room, but had no adverse consequences).  The dizziness lasted at least 2 months.  Subsequently, starting approx. late May, developed tinnitus.  This contined and I am still experiencing it.  I have scheduled an appointment with an ENT doctor to rule out/in a role for general hearing loss in the ear ringing.  Answer to #21 is an estimate
Chills; fatigue; This is a spontaneous report from a non-contactable consumer. A 30-year-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:30 (Batch/Lot Number: EL3247) as 2nd dose single for covid-19 immunization. Age at vaccination was 30-year-old. The patient's medical history and medications was not reported. No Known allergies. No other medical history. Covid was not tested prior vaccination and post vaccination. Historical vaccine of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 14Jan2021 (Batch/Lot Number: EL3247) as 1st DOSE SINGLE for covid-19 immunization. The patient experienced chills and fatigue on 05Feb2021. The patient did not had any treatment. The outcome of events chills and fatigue was recovering.   No follow-up attempts are possible. No further information is expected.
54-year-old female inadvertently received Fluzone HD, no AE; 54-year-old female inadvertently received Fluzone HD, no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 54 years old female patient received 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ283AB, Exp. Date 29-May-2020 via intramuscular route in the right deltoid on 01-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) 0.5 mL dose in left deltoid for Immunisation.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.  At the time of report, no adverse event was reported.  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.
Initial soreness at injection site. Approximately 18 hours after injection, nausea, chills, severe headache. No fever. Chills and nausea decreased in severity throughout the next 12 hours but body aches and severe headache persisted. Nothing taken to treat symptoms (no ibuprofen or acetaminophen) In conclusion: initial reaction began 18 hours after injection and lasted approximately 12 hours.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received SHINGRIX (batch number D294J, expiry date March 2019) for prophylaxis. On 4th October 2018, the patient received the 2nd dose of SHINGRIX. On 4th October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX vaccine in right deltoid. His arm was little sore. The patient expected it would feel better within a day or 2. The physician contact details were provided.
Localized 5" x 4" (approx) swollen and red left arm with some topical itching. States no systemic itching per mom, Resolved.
Fever of 100 to 102; lower back pain; headache; muscle pain; dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Nov2021 15:30 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Gilbert's syndrome" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, single administered via Intramuscular route in right arm), administration date: 12May2021, when the patient was 34 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, single administered via Intramuscular route in left arm), administration date: 19Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 15:30, outcome "unknown", described as "dose number 3"; PYREXIA (non-serious) with onset 25Nov2021, outcome "recovered with sequelae", described as "Fever of 100 to 102"; BACK PAIN (non-serious) with onset 25Nov2021, outcome "recovered with sequelae", described as "lower back pain"; HEADACHE (non-serious) with onset 25Nov2021, outcome "recovered with sequelae", described as "headache"; MYALGIA (non-serious) with onset 25Nov2021, outcome "recovered with sequelae", described as "muscle pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, back pain, headache, myalgia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 1:09 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 1:09 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 28-JAN-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported by the reporter.  Patient received booster dose on 28 Jan 2022 at 01:09:56 pm Patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Treatment medications were not reported by the reporter.
slightly later than 6 months after the first one; Neck pain; Shoulder pain; Arm pain; Ear pain; Welts on skin; Irritation on neck; Irritation on neck with 3 bumps; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (received 1st dose 6 months ago).   On 15th June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 19th June 2020, 4 days after receiving Shingrix, the patient experienced neck pain, shoulder pain, pain in arm, ear pain, welts, skin irritation and papular rash. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the neck pain, shoulder pain, pain in arm, ear pain and welts were recovering/resolving and the outcome of the skin irritation was not recovered/not resolved and the outcome of the papular rash and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the neck pain, shoulder pain, pain in arm, ear pain, welts, skin irritation and papular rash to be related to Shingrix.  Additional details were reported as follows: The case was reported by the wife of the patient. The patient received Shingrix slightly later than 6 months after the first one which led to drug dose administration interval too long. On 19th June 2020, the patient experienced neck, shoulder, arm and ear pain, welts on his skin and irritation on his neck with three bumps in a line. Advised reporter to have patient follow up with his health care professional. Reporter did not consent to follow-up.
arm became swollen and red, it's also warm; arm became swollen and red, it's also warm; arm became swollen and red, it's also warm; arm was really sore to the extent it hurt; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm became swollen and red, it's also warm), VACCINATION SITE WARMTH (arm became swollen and red, it's also warm), VACCINATION SITE ERYTHEMA (arm became swollen and red, it's also warm) and VACCINATION SITE PAIN (arm was really sore to the extent it hurt) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (arm was really sore to the extent it hurt). On 20-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm became swollen and red, it's also warm). On an unknown date, the patient experienced PERIPHERAL SWELLING (arm became swollen and red, it's also warm) and VACCINATION SITE WARMTH (arm became swollen and red, it's also warm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 19-Apr-2021, VACCINATION SITE PAIN (arm was really sore to the extent it hurt) had resolved. At the time of the report, PERIPHERAL SWELLING (arm became swollen and red, it's also warm), VACCINATION SITE WARMTH (arm became swollen and red, it's also warm) and VACCINATION SITE ERYTHEMA (arm became swollen and red, it's also warm) outcome was unknown.            No concomitant medication details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received and contains No New inforrmation; 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.