chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 patients received dose past viability time; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients received dose past viability time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for an unknown indication.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients received dose past viability time). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (4 patients received dose past viability time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Red fine rash appeared on face immediately after shot was given and fine rash appeared on thigh approx. three minutes after shot was given. On 09/19/2018 contact client fifteen minutes after she left the Health Center, client was driving and I ask how are you feeling?, Client replied "I feel fine." Also contact client one hour and thirty minutes later, and I ask had she seek medical attention and she replied "no"! Recommended to seek medical attention to have blood work drawn to see if she is allergy to any of the component in the vaccine.
101.7 fever for two days (in bed-malaise).  Red rash around Pneumococcal vaccine injection site.  Mild headaches for about 10 days.
7 of 8 adult pts vaxed from the same lot# but from 3 different vials exp varying degrees of flu-like sxs (chills, fever, nausea, vomiting, sweating, aching); 2 of the 7 pts had fevers 102-103 documented viral outbreak in area also
Patient was in back seat of car, noted by grandfather to be makin"gurgling"noise, eyes rolled up into head, unable to respond, shaking - called 911, taken to ER, unable to recall events until paramedics were talking to him, arrival in ER, numerous labs,MRI, EEG reportedly WNL, Tox screens negative.
Gave PREVNAR on 12-1-15. Patient says it was sore, but on 12-8-15 started having more soreness and redness in injection area.
This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX lot # N022980 (dose, frequency and route of administration were not provided) for prophylaxis which was reconstituted with a properly stored dose of sterile diluent (manufacturer unknown). The vaccine was stored at a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 48 hours and, 15 degree Fahrenheit to 46 degree Fahrenheit for 9 hours with no previous temperature excursion. Digital Data logger was involved.
fever, fatigue, jittery day 1-day 3,  Day 4-7 developed measles-like (morbilliform) rash from hip to hip on lower abdomen, traveling up up below breast. New spots appeared daily.
The patient received Moderna Covid-19 vaccine from a vial that had been punctured on 15 JUN 2022 and dose administered on 16 JUN 2022 more than 12 hours later; patient also recieved Moderna Covid-19 vaccine from a vial that had been at room temperature for 27 hours and 36 minutes.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine from a vial that had been punctured on 15 JUN 2022 and dose administered on 16 JUN 2022 more than 12 hours later) and PRODUCT STORAGE ERROR (patient also recieved Moderna Covid-19 vaccine from a vial that had been at room temperature for 27 hours and 36 minutes.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A and 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Dec-2021 at 3:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine from a vial that had been punctured on 15 JUN 2022 and dose administered on 16 JUN 2022 more than 12 hours later) and PRODUCT STORAGE ERROR (patient also recieved Moderna Covid-19 vaccine from a vial that had been at room temperature for 27 hours and 36 minutes.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine from a vial that had been punctured on 15 JUN 2022 and dose administered on 16 JUN 2022 more than 12 hours later) and PRODUCT STORAGE ERROR (patient also recieved Moderna Covid-19 vaccine from a vial that had been at room temperature for 27 hours and 36 minutes.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  It was reported that the patient received Moderna Covid-19 vaccine from a vial that had been punctured on 15 Jun 2022 and dose administered on 16 Jun 2022 more than 12 hours later. The patient also received Moderna Covid-19 vaccine from a vial that had been at room temperature for 27 hours and 36 minutes.  Treatment medication was not provided by the reporter.
Patient started to have red arm, swelling , and started feeling hot to touch.  Patient was instructed to take Benadryl and an nsiad as package package instructions.
Systemic: loss of balance and fell on the floor -Mild, Additional Details: patient is reporting that after her 15 minute observation, patient fell on the floor. Two nurses checked up on her and ensured she is feeling well, no body injury or harm was reported.
Bexsero administered as 2nd dose of Trumenba.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number J52PN, expiry date 31-MAR-2024) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 15-SEP-2023, the patient received Bexsero. On an unknown date, the patient received TRUMENBA. On 15-SEP-2023, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: Bexsero administered as 2nd dose of Trumenba.).  The outcome of the interchange of vaccine products was unknown.   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: 18-Sep-2023 The pharmacist called to inform that a patient received a dose of Bexsero, but such patient had already received a dose of Trumenba which led to interchange of vaccine products. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
cardiomyopathy; This is a literature report for the following literature source(s):   A 28-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: CARDIOMYOPATHY (medically significant) with onset 2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy heart: no inflammatory infiltrates or granulomas; Brain natriuretic peptide: 1,399; Catheterisation cardiac: no significant CAD; PCWP 20; PAP 43/26 (33 mmHg); mild pHTN; C-reactive protein: < 0.5; Echocardiogram: severe 4 chamber dilatation; LVEF 15-20%, notes: elevated LVEDP; Red blood cell sedimentation rate: 12; Troponin: 0.03. Therapeutic measures were taken as a result of cardiomyopathy.; Sender's Comments: Based on the available information in the case, an association between the reported events CARDIOMYOPATHY  and The suspected drug cannot be ruled out.  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.
I have a golf ball-size rash on my injection site. Sore and painful to the touch. Started today. I will track the size if it continues to grow.
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 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Other medical history: Hypothyroidism; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM, start date: 01Jan2021; LEVOTHYROXINE, start date: 01Jan2003. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
consumer reports: pt exp extreme pain radiating from shoulder to hand in the same arm which inject was given; pain began 2 days p/vax; 29DEC f/u states GBS confirmed by neurologist; EMG, LP w/elevated protein; ont disability
After receiving a higher dose of flu vaccine plus whooping cough vaccine I broke out with Shingles within a week. Dr. prescribed antiviral med. As of Nov 26, 2012 I still have symptoms.
Muscle soreness 3-26-15. Redness/itching 3-28-15. Bruising at site 3-28-15. Redness spread with swelling over upper arm saw Dr. 4-1-15 prescribed antibiotics 7 days.
felling awful in general; severe nausea; she is not sure  if she has a fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felling awful in general), NAUSEA (severe nausea) and PYREXIA (she is not sure  if she has a fever) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson vaccine and Johnson vaccine. Past adverse reactions to the above products included No adverse event with Johnson vaccine and Johnson vaccine. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felling awful in general), NAUSEA (severe nausea) and PYREXIA (she is not sure  if she has a fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felling awful in general), NAUSEA (severe nausea) and PYREXIA (she is not sure  if she has a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Rebound case, tested positive for Covid; Rebound case, tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team and product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EZ3247), on 11Feb2021 as dose 2, single (Batch/Lot number: unknown), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 26Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 70 years, in left arm for covid-19 immunisation; atorvastatin (ATORVASTATIN), (Lot number: 312269) at 10 mg daily (10 mg, daily [10mg per day]). The patient's relevant medical history included: "Underlying kidney conditions" (unspecified if ongoing); "Treated for kidney stones" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "Very low folic acid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder; ASPIRINE taken for prophylaxis; FOLIC ACID GENERIC taken for folate deficiency. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Aug2022, outcome "unknown" and all described as "Rebound case, tested positive for Covid". The patient underwent the following laboratory tests and procedures: Blood creatinine: (unspecified date) Stable, notes: He was stable with his BUN and Creatinine level; Blood urea: (unspecified date) Stable, notes: He was stable with his BUN and Creatinine level; Echocardiogram: (unspecified date) Showed leaky heart valve, notes: Did Echocardiogram about 3 weeks ago that showed leaky heart valve, nothing significant; Renal function test: (unspecified date) Unknown results, notes: Kidney functions has been monitored; SARS-CoV-2 test: (06Aug2022) Negative; (09Aug2022) Positive; Urine analysis: (unspecified date) Unknown results, notes: Also did 24 hour urine sample.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Upon data entry into the state registry, it was noted that I had given Tdap instead of the 3rd dose of DTaP. I reviewed the ACIP statement and found that because this was the third dose, it could not be counted as valid. The parents were notified of this incidence and will return in 4 weeks for the replacement dose of DTaP. Parents have been bringing the child in for one vaccine at a time so child is behind on schedule for age.
?Moderna COVID-19 Vaccine EUA? 1/15:  received dose 1 left arm 1/15 pm - 1/17 pm:  soreness/tenderness upper left arm 1/17 pm - 1/22 am :  no issues 1/22 pm:  some soreness returned to upper left arm , itching begins along with some redness to upper left arm 1/23 - 1/27:  increased and spreading redness contained to upper arm, continued itching, no soreness
supected Vaccination failure; Internal shingles no rash but severe pain; severe pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 07-JUN-2022 Reporter's comment: This case was reported by a patient's friend via interactive digital media. The patient got both her shingles shots and still got internal shingles. The patient had no rash but severe pain. The vaccination did not work for her. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Approximately 24 hours after vaccination Pt developed relatively acute onset of chills, myalgias, arthralgias (wost in knees and ankles) which resolved within 24 hours.  Pt also developed injection site pain, induration and erythema.  Pt states that redness was greater than 4cm and induration was 150mm.  No treatment used by Pt.  When Pt was seen he had no limitations in ROM no LAD noted.  Pt was instructed to use Ibuprofen and cold packs.  Pt returned with marked reduction in induration and erythema.  Doing well at this time.
PATIENT REPORTED STRONG FLU LIKE SYMTOPS THAT STARTED THE DAY AFTER VACCINATIONS MAINLY COMPLAINING ABOUT PAIN IN MUSCLE AND JOINTS AND NAUSEA.
Case number PHEH2016US025914, is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to a 90-year-old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with one single dose of FLUVIRIN (lot number: 1618521) at a dose of 1 ml. No adverse event was reported following this medication error (accidental overdose).
day after and days after right side of mouth was in serious pain, thought she had a real bad toothache that just kept throbbing, she couldn't bite down on anything for 3 days. It became isolated to the right side of face. called the dr and he said to treat it with ibuprofen and tylenol and if pain continue he want he to come in the office.
pt recv vax 6NOV95 & exp h/a 4hr post vax;h/a was successfully treated w/APAP & the pt was able to remain @ work the rest of the day
Both vaccines were given in the right arm, the entire upper right arm became severely bruised and painful.
muscle twitching; Insomnia; rapid heartbeat; Short of breath; Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (muscle twitching), INSOMNIA (Insomnia), HEART RATE INCREASED (rapid heartbeat), DYSPNOEA (Short of breath) and ANXIETY (Anxiety) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced MUSCLE TWITCHING (muscle twitching), INSOMNIA (Insomnia), HEART RATE INCREASED (rapid heartbeat), DYSPNOEA (Short of breath) and ANXIETY (Anxiety). At the time of the report, MUSCLE TWITCHING (muscle twitching), INSOMNIA (Insomnia), HEART RATE INCREASED (rapid heartbeat), DYSPNOEA (Short of breath) and ANXIETY (Anxiety) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment details included that the patient was prescribed with sleeping and anxiety medication.
I am reported my break through COVID Case. Woke up and my voice was sore and I had chills and a headache. My voice was hoarse. Since the rest of my group tested positive, I called my doctor and prescribed me some meds. I tested positive from home test. I was told to take it easy. As of today I am doing better and I am recovered.
accidentally administration of extra dose with no reported adverse event; Initial information was received  on 27-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 12 months old female patient who involved in accidentally administration of extra dose of poliomyelitis vaccine (inactivated) [ipol] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for prophylactic vaccination (Immunisation); pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for prophylactic vaccination (Immunisation); and 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 prophylactic vaccination (Immunisation);  On an unknown date, the patient received accidentally extra 0.5 ml total dose of suspect poliomyelitis vaccine (inactivated) Suspension for injection (lot number: V1V891M, expiration date: 01-Jun-2023, strength, administration site: Unknown) via intramuscular route for prophylactic vaccination (immunization) with no reported adverse event (extra dose administered) (latency: same day)  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event accidentally administration of extra dose with no reported adverse event.  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 the 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.
received booster dose in less than 6 months after their primary series; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received booster dose in less than 6 months after their primary series) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 035C21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received booster dose in less than 6 months after their primary series). On 06-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received booster dose in less than 6 months after their primary series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
2 weeks after injection site still red in a circle and arm below has large circle and feels hot to the touch. Arm was sore for 2 days after injection but now again 2 weeks later and worse.
Shot given on 10-4. 10-5 felt achy, fever that night started vomiting. 10-6 felt hot looked in mirror red rash on neck on truck was spreading. My throat got numb went to hospital