chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Feb-2022; Administered expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Feb-2022) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 007C21A and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired dose of the Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 16-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Vaccine expired on 05 May 2022. It was reported that the reporter had identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 are not in accordance with the EUA.  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. Patient received First booster dose on 16-Feb-2022. Did not reported any adverse reactions.  Treatment information was not provided by the reporter.
Patient not immunocompromised  received a full dose instead the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (Patient not immunocompromised  received a full dose instead the booster dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OVERDOSE (Patient not immunocompromised  received a full dose instead the booster dose). At the time of the report, OVERDOSE (Patient not immunocompromised  received a full dose instead the booster dose) outcome was unknown.            Patient is not immunocompromised, she was advised to receive the full dose by her pharmacist. No concomitant medications were reported. No treatment medications were reported.
REPORTING PHYS INDICATED PT HAD NO IMMUNITY.  HEP PROFILE ON 11-29-89 SHOWED CORE ANTIBODY POSITIVE, REMAINDER OF TEST NEGATIVE.
After his first shot he had intermittent numbness in his contralateral hand. After the second shot he had a raised, red rash in his antecubital region bilaterally.
Sepsis; A spontaneous report was received from a consumer of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sepsis.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received a dose (first or second dose not specified) of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On an unknown date, the patient  was reportedly rushed to the hospital for sepsis (details not provided). Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, sepsis was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment.
got a cold unrelated to COVID; Sick; failed get vaccinated with the second dose it has now been 72 days; This spontaneous case was reported by a health care professional and describes the occurrence of NASOPHARYNGITIS (got a cold unrelated to COVID), ILLNESS (Sick) and PRODUCT DOSE OMISSION ISSUE (failed get vaccinated with the second dose it has now been 72 days) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced NASOPHARYNGITIS (got a cold unrelated to COVID), ILLNESS (Sick) and PRODUCT DOSE OMISSION ISSUE (failed get vaccinated with the second dose it has now been 72 days). At the time of the report, NASOPHARYNGITIS (got a cold unrelated to COVID), ILLNESS (Sick) and PRODUCT DOSE OMISSION ISSUE (failed get vaccinated with the second dose it has now been 72 days) outcome was unknown. Not Provided      The action taken with 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.   No Concomitant medication were reported. Treatment medication was not provided.
soreness on the arm; pain; discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on the arm), PAIN (pain) and DISCOMFORT (discomfort) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN (pain) and DISCOMFORT (discomfort). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness on the arm). At the time of the report, PAIN IN EXTREMITY (soreness on the arm), PAIN (pain) and DISCOMFORT (discomfort) outcome was unknown. Not Provided
I began experiencing pain & lymphedema within 6 hours .  By the next morning 6am my entire left arm and left breast were indurated and very swollen & painful.   By 10 am on Oct 19 th my left leg became weak & would buckle when I walked.
fogginess feeling; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "fogginess feeling".  Additional information: Patient experienced fogginess feeling for several hours after vaccine administration. No significant medical history. Patient experienced this shortly after administration. Symptoms resolved after resting in bed for several hours. Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized w/ ischemic colitis. Vaccination took place 3/10/08. According to physician relationship is "none'.
I started to get itchiness, rash and a bit swollen on the injected area but no pain a week after I got the vaccine shot. To ease the itchiness, I applied Triamcinolone Acetonide cream USP 0.1%. This started last Friday, Jan. 15, 2021 at around 6:00pm.
Pediarix administrated to a 15 year old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 7p2y3, expiry date 8th April 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 13th September 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The patient reported that Pediarix was administered on the same day to a 15 year old patient, which led to inappropriate age at vaccine administration. No further events were reported. Health care professional agreed to be contacted for follow-up.
approximately 6 weeks of GI distress, including nausea, variable stool patterns (diarrhea, constipation), anorexia and weight loss (~20#)
Loss of equilibrium, nausea, blurred vision and chills lasting about 6 hours.
The 2 days after the vaccine I experienced usual post symptoms- malaise and achiness.  5 days after developed nagging chest pain left side that was not relieved with ibuprofen. Also with fatigue. On 10/15/2015 disseminated distinct shingles rash on left chest with distinct severe pain.
Pt stated her left arm was very sore. She said she did not have much strength to lift up her arm. Pt was referred to physical therapy.
No adverse event; adult doses given to 2 children; adult doses given to 2 children; This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (adult doses given to 2 children), INCORRECT DOSE ADMINISTERED (adult doses given to 2 children) and NO ADVERSE EVENT (No adverse event) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On 12-Aug-2022, the patient experienced OVERDOSE (adult doses given to 2 children) and INCORRECT DOSE ADMINISTERED (adult doses given to 2 children). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (adult doses given to 2 children), INCORRECT DOSE ADMINISTERED (adult doses given to 2 children) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OVERDOSE (adult doses given to 2 children) and INCORRECT DOSE ADMINISTERED (adult doses given to 2 children).    No concomitant drug information was provided.  Reporter reported that two patients had received adult dose (100mcg) from a Moderna vial with red cap.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-630766 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-630766:MOD-2022-630766  (Another case by same reporter of 7 years old male)
resistance when withdrawing the medication/"sticky" at the beginning/ could not get the medication to come out/  difficulty to push the plunger; was not able to administer the full dose due to difficulty to push the plunger; get the medication to come out of the barrel of the syringe.; Product consitency issue; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 24-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9335X, expiry date 29th January 2023) for prophylaxis. This case was associated with a product complaint.   In May 2021, the patient received Boostrix. In May 2021, unknown after receiving Boostrix, the patient experienced underdose, syringe issue and product physical consistency issue. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the underdose, syringe issue, product physical consistency issue and pharmaceutical product complaint were unknown.  Additional details were provided as follows:  The age at vaccination was not reported.  The pharmacist was the reporter. The pharmacist reports that he began to administer the vaccine but was not able to administer the full dose due to difficulty to push the plunger which led to syringe issue and pharmaceutical product complaint. The pharmacist stated that he could not get the medication to come out of the barrel of the syringe, which led to syringe issue. The pharmacist reports that he immediately met a lot of resistance when withdrawing the medication and was sticky at the beginning, which led to product physical consistency issue. The pharmacist reports that this complaint occurred over the weekend. The pharmacist does still have the device in question and states he will try to return it without the needle. The pharmacist did not take any pictures of the product. The following PQC questions were asked did the plunger eventually push or was it unusable and replied it was not impossible but too difficult to administer completely, are any blockages visible in the syringe body or barrel and replied no, are any abnormal particles observed in the vaccine and replied no and was luer lok needle used or different kind used and replied luer lock. The reporter consent to follow up.
Pt recvd vax in 1985.On 03OCT90 pt recvd 2nd vax & on 04OCT90 devel a sore throat, coated tongue resembling thrush, fatigue, nausea & burning sensation in mouth. On 11OCT90 pt exp chest pain.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated- wrong vaccine; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated- wrong vaccine) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 06-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated- wrong vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated- wrong vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated- wrong vaccine).    Concomitant product use was not provided by the reporter.  On 25-Mar-2023, patient received 25 microgram dose 1 of Moderna monovalent vaccine (batch number: AS1903B).  The route of administration of suspect Moderna bivalent was reported as BI.  No adverse event was reported. Appropriate vaccine scheduled or given as indicated by the CDC.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Extreme lethargy to the point I couldn't get him to wake up to feed. Hives/rash on chest, neck, face and upper arms, breathing abnormally, kept taking a deep breath and holding it for a very long period of time, inconsistent breaths etc.
BILATERAL TREMOR, PAIN, WEAKNESS, HYPEREFLEXIA IN BOTH LEGS. GAIT AFFECTED. WAS HOSPITALIZED.
I started having ringing/clicking in my left ear the day after my injection. It has continued since that time (about 2 1/2 weeks), but does seem to be gradually improving. I do have intermittent tinnitus, but this has been more severe and more long lasting than my usual bouts.
Nausea & Tired. went to bed. woke up this morning with nausea, temp of 99, feeling weak and tired.  Stated right arm feels numb and weak.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On unknown dates since 13-JUL-2015, the patients were administered with PNEUMOVAX 23 lot # K007826 with expiration date of 03-FEB-2015, (strength, dose and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
January 2020 the 1st dose of Shingrix / she has pulmonary fibrosis; This case was reported by a pharmacist via call center representative and described the occurrence of pulmonary fibrosis in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Cellcept.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pulmonary fibrosis (serious criteria GSK medically significant). On an unknown date, the outcome of the pulmonary fibrosis was unknown.   It was unknown if the reporter considered the pulmonary fibrosis to be related to Shingrix.  Additional case details were reported as follows: After vaccination patient started taking Cellcept to received a transplant because she had pulmonary fibrosis. The reporter consented to follow up.
Dizziness, Myalgia, Arthralgia, Fever, NauseaVomiting, swollen glands under left arm; chills; redness, ithcing and pain at injection site Narrative:
Patient was given children's vaccine dose rather than Adult dose Pfizer. No adverse reaction noted or reported.
Patient arm turned black and blue and spread across arm. Patient felt fine, no fever, just very black and blue.
Patient presented to ER with complaints of chest pain. Treatment was IV saline. This is per staff at Hospital.
Patient experienced nausea and dizziness.  She was monitored for unknown amount of time and unknown disposition, but likely discharged without complication.
Positive for full blown rotavirus; This spontaneous report was received from a nurse prescriber via company representative regarding a 9-month-old male patient. The patient's concurrent condition, medical history, concomitant medication and drug allergies was not reported. On an unknown date the patient was vaccinated with 3 doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (prevention of rotavirus gastroenteritis) via oral route (strength, frequency and lot/batch number were not reported). On an unknown date the patient developed positive for full blown rotavirus. The patient sought medical attention. The outcome of the event was recovered. The causality of the event with respect to rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.
Fever, chills, migraine, woozy, exhaustion, dehydration, loose stools
My mother began to expeience increased heart rate, cotton mouth and SOB at approximately 6PM.  Within an hour she began vomiting, which persisted for 3 hours.  This was followed by diarrhea.  Today, Dec 6th she is experiencing symptoms common following flu vaccine, including sore throat and congestion.  GI symptoms have resolved.
pounding heart; trembling/shaking; This is a spontaneous report received from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 31Mar2021 (at the age of 75 years) (Batch/Lot number unknown, reported as ER87(9 or 3)0) as a single dose for COVID-19 immunization. Medical history included ongoing discoid lupus, ongoing blood pressure high, ongoing spondylosis, ongoing allergies, ongoing diverticulitis, ongoing pre-diabetic, ongoing collapsed mitral valve and in 2019 she became diabetic, but when she went back to her doctor it had gone down so she is now back to pre-diabetes. On prior vaccinations (within 4 weeks), it was reported that the patient had a yearly physical on 03Mar2021, and patient was unsure as to whether or not she received a flu shot at that appointment. AEs following prior vaccinations was reported as nothing other than pains or a slight headache when she gets the flu shot and it really made her feel bad. Reporter thinks she took a Tylenol when she got home on 03Mar2021. Concomitant medication included cyanocobalamin (VITAMIN B12). No additional vaccines administered on same date of the Pfizer suspect. Patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 10Mar2021 13:10 (lot number: EN6207) in the right arm and the glands in the patient's neck were swollen 4 days later, woke up racing and pounding heart on the morning of day 5, and has had that ever since. Patient also experienced having acid problems with gas, tightness in her chest, and little problem with reflux. Patient had been to the ER multiple times and she was told that it was not a side effect of the vaccine. Patient was hospitalized and put on monitor, had tests, etc, and found nothing wrong. After the second vaccination, the patient experienced pounding heart, shaking, and trembling. The event pounding heart was reported as serious with seriousness criteria: caused/prolonged hospitalization. Heart racing and pounding required a visit to the emergency room and physician office. Lab tests included heart monitor: nothing wrong, barium test: only saw a little problem with reflux (after the first dose), taking a lot of blood, EKG, and chest x-ray. Most of these tests occurred while she was in the hospital. After she was discharged and she was still having problems, she went back to her doctor's office to complain of the same things, so they did an EKG in the doctor's office, and it was fine; said she was not having a heart attack. Her doctor also told her that her cholesterol is excellent. Patient is having an upper GI on 10Aug2021 to see if it's coming from her stomach and is having a sleep study on the fifth of next month. Outcome of the events was not recovered.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.