chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients got doses after the 30-day beyond use date; Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 15NOV2022 and first dose was administered on 16DEC2022).    This case contains information of 10th patient out of 14 patients as described by the reporter.  No concomitant medication was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.   It was reported that the pharmacist had received the vaccine order on 15-Nov-2022 and accidently put the expiration date as 10 weeks instead of 30 days. 14 patients got the vaccine beyond use date and the reporter was enquired the patients need to be re-vaccinated.   Reportedly, vial size included 2.5mL and date the vial was initially stored in the refrigerator on 15-Nov-2022 and the dates vaccine were administered on 16-Dec-2022, 28-Dec-2022, 4-Jan-2023, 7-Jan-2023, 9-Jan-2023, 11-Jan-2023, 13-Jan-2023, and 18-Jan-2023 and the vial did not undergone any temperature excursions.   Treatment medication was not provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-706920 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-706920: MASTER CASE
12 hrs after immunizations, patient started with generalized hives, mild eye lid edema. Reaction involuted after 3 doses of BENADRYL. No resp. distress. No other antigen identified.
This spontaneous case reported by a consumer, describes the occurrence of tinnitus in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced tinnitus. At the time of the report, tinnitus outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
area lt @ inj site red approx 2 1/2" circle sl swollen;
10 min after injection: Headache frontal lobe, physically weak, dizzy. slight nausea, 4 hours after Muscle pain at site of injection
The face felt hot, felt tiredness, chills, pain and redness of the face.  Benadryl was taken.
Pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 33-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included In vitro fertilisation. Previously administered products included for an unreported indication: ALCOHOL (5 drinks/ week socially.) from 22-Dec-2008 to 01-Sep-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 25-Aug-2020 to 17-May-2021, ACETYLSALICYLIC ACID (BABY ASPIRIN), PROGESTERONE from 13-Sep-2020 to 07-Nov-2020, ESTRADIOL (ESTROGEN) from 24-Aug-2020 to an unknown date, ESTRADIOL (ESTROGEN) from 04-Sep-2020 to an unknown date and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) from 08-Dec-2020 to an unknown date for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 05-Jun-2021. On 24-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 24-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2020, Pregnancy test: Positive. On 19-Oct-2020, Ultrasound foetal: normal. On 24-Oct-2020, Ultrasound foetal: normal. On 25-Nov-2020, Prenatal screening test: normal. On 25-Nov-2020, Ultrasound foetal: normal. On 20-Jan-2021, Ultrasound foetal: normal.     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.   Patient had a positive pregnancy test on 22 Sep 2020. Her last menstrual period was 1 Aug 2020 and estimated date of conception was 12 Sep 2020.Patient had a missed pregnancy on 12 Oct 2019.  Patient's medical history include unexplained infertility , unsuccessful medicated / monitored aids followed by successful IVF.  Family history include down syndrome for the father's sister.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Patient demography , medical history , lab data and concomitant medications information were updated.
Received MMR 1/10/03, LA, SC. Returned to clinic on 1/21/03 with complaint of pain in back of both ears and neck. Temperature was 101F. On 1/23/03, complained of rash on face, back and chest that was itchy. She had swelling behind ears with bumps. TX: Benadryl 25mg prn itch.
MALAISE; TIREDNESS; NAUSEA; BOWEL MOVEMENT IRREGULARITY IN TEXTURE; CHILLS; INTENSE HEADACHE; FELT REALLY BAD; 3 OR 4 BOWEL MOVEMENTS EACH OF DAY; SOFTER TEXTURE THAN NORMAL STOOL; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced 3 or 4 bowel movements each of day. On APR-2021, the subject experienced softer texture than normal stool. On 08-APR-2021, the subject experienced felt really bad. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced intense headache. On 09-APR-2021, the subject experienced bowel movement irregularity in texture. On 11-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced malaise. On 12-APR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and intense headache on 09-APR-2021, and had not recovered from bowel movement irregularity in texture, nausea, malaise, tiredness, felt really bad, 3 or 4 bowel movements each of day, and softer texture than normal stool. This report was non-serious.
Feeling sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling sick). At the time of the report, MALAISE (Feeling sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information was reported.
Arm became mobile again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Jan2021 09:45 (Lot number: EL3249, Expiration Date: May2021) at the age of 84 years as dose 1, single and administered in arm right, administration date 12Feb2021 09:00 (Lot number: EL9266, Expiration Date: May2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Poliomyelitis" (unspecified if ongoing), notes: Verbatim: Polio, Had polio at 9 years old. Due to having polio, she only has 30% of kidney access. When she had polio, it took out one kidney so she only has a partial kidney left; "damaged her right arm" (unspecified if ongoing), notes: She had damaged her right arm in lifting heavy objects during November and December. She could not raise that arm above her head and she was afraid she damaged her rotator cuff. She was upset about that. The patient took concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 22Jan2021, outcome "unknown", described as "Arm became mobile again".  Additional information: When she went to get the first shot in Jan, the physician asked which arm did she want it in and she decided to get it in her right arm because she could hardly move it anyway. Within 24 hours of getting the vaccine, her arm was mobile again and she has had no problems since. Whether she had damaged muscles and the vaccine relaxed the muscles or what, she has no way of knowing, but the doctor's and three nurses said she should report this good thing to Pfizer. She's 84 years old and she had polio when she was 9. She was really upset about her shoulder because she couldn't even lift her arm to brush her hair, it was that bad. She was very happy with her COVID shot.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513 1806USA009054: US-009507513-1806USA009056.
Shingles outbreak 17 days after 2nd dose.  Never  had shingles before.  Did have the old single dose shingles vaccine ago
This spontaneous report as received from a nurse refers to an approximately 2 months old male infant. On 06-AUG-2014 the patient was vaccinated with first dose RECOMBIVAX HB (lot number and expiry date unknown) (dosing regimen and route unknown). No concomitant medications were reported. On 06-AUG-2014 the patient was vaccinated with first dose of RECOMBIVAX HB and on 02-OCT-2014 received the second dose and on 05-DEC-2014 the patient received the third dose of RECOMBIVAX HB (inappropriate schedule of drug administration). No adverse events were reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. There was no product quality issue reported. Additional information has been requested.
48hr p/vax pt lt deltoid presented w/moderate swelling, erythemic, warm & induration;unable to lift lt arm above head;no fever, playful;
initially w/in 48hr of vax pt had diarrhea approx 4x;nausea x2 then rt hip stiff & w/spasms to lt hip, down lt leg;diff moving lt leg;tightness in both shoulders between shoulder blades;
SEIZURES- GRAND MAL, FEVER 104.1, UNABLE TO SPEAK OR OPEN EYES FOR 36 HOURS, BREATHING 38 BREATHS PER MIN, BLOOD PRESSURE SPIKING, BREATHING THRU STOMACH NOT LUNGS, HEART RATE FINE, ENDED UP HAVING BACK FRACTURE FROM SEIZURE.
Sweating, nausea, dizzy, foot itching, trouble swallowing  30 days later mouth sores developed. Oral cyst's had to be surgically removed. Now have permanent scar tissue and damage to gums and lip and nerves in face. Also still have some cysts that have not gone away but are too deep to be removed per the oral surgeon
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a 69-year-old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no information on medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On 02-JUN-2021, the patient had a negative antibody test (coded as suspected immunological vaccine failure). Laboratory data included: SARS-CoV-2 ELISA test (NR: not provided) as negative. The test was an IgG Elisa-Spike. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210626695 -Covid-19 vaccine ad26.cov2.s- suspected immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Spiked a high Fever of 105 in the morning and was taken to emergency-placed on IV and took blood to check for viral infection-given tylenol to reduce fever and sent home with temp at 101. Advised us to keep eye on patient and bring him in if fever spikes again.
Patient received the vaccine but was not planning on it. Patient complained of fevers the following morning. Patient also had a Shingrix vaccine on the same day.
Local pain at site(R Shoulder), developed several hours later, then fever and fatigue present the next day with loss of appetite.  This continued into day 2 post vac at which time developed rash over injection site had nausea and vomited one time.  At this time (day 3 post vac) seems better with non-tender erythema over injection site.  Now affebrile and otherwise asymptomatic.
Patient was to wait in vaccine area for 30 minutes after injection. No adverse reaction developed. Pt was then called 7 days and 14 days later to assess reaction. Pt stated he was fine and developed no reaction or adverse events.
Elevated Prostate-Specific Antigen (PSA) levels; Soreness in the arm and a little bit of tiredness, nothing to complain about; Soreness in the arm and a little bit of tiredness, nothing to complain about; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm and a little bit of tiredness, nothing to complain about), PROSTATIC SPECIFIC ANTIGEN INCREASED (Elevated Prostate-Specific Antigen (PSA) levels) and FATIGUE (Soreness in the arm and a little bit of tiredness, nothing to complain about) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis and Multiple sclerosis. Concomitant products included OFATUMUMAB (KESIMPTA) for Multiple sclerosis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm and a little bit of tiredness, nothing to complain about) and FATIGUE (Soreness in the arm and a little bit of tiredness, nothing to complain about). On 31-Mar-2021, the patient experienced PROSTATIC SPECIFIC ANTIGEN INCREASED (Elevated Prostate-Specific Antigen (PSA) levels). On 11-Feb-2021, PAIN IN EXTREMITY (Soreness in the arm and a little bit of tiredness, nothing to complain about) and FATIGUE (Soreness in the arm and a little bit of tiredness, nothing to complain about) had resolved. At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (Elevated Prostate-Specific Antigen (PSA) levels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2020, Prostatic specific antigen: 4.790 ng/mL (Inconclusive) Ultra-sensitive PSA test results: 4.790 ng/mL. On 31-Mar-2021, Prostatic specific antigen: 7.040 ng/mL (High) elevated 7.040 ng/mL.
Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a clinic. On an unknown date, the patient was treated by a healthcare provider at a clinic for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 02-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ "2ml, 10 unit dose tube" and lot number K009752 with expiration date of 15-APR-2016, orally, which was stored at the lowest recorded temperature of 33 (0.555555556 Celsius degrees) for 72 hours and at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 24 hours. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient is fully vaccinated. Admitted with SOB, fall, hypoxia, COVID-19 and AFib with RVR. Treatment: IV Solu-Medrol, Breo inhaler daily, steroids, Eliquis B.I.D., Patient is on remdesivir. Hypokalemia, electrolyte replacement protocol. AKI (acute kidney injury). metoprolol and Eliquis. She medically improved throughout her stay and she was deemed stable for discharge.
Moderate dizziness. Made my herpes on the back of my leg breakout with sores. Floaters in my left eye.
had a doctor call in a prescription for Menactra and the patient is 70 years old, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 70 years old patient who was prescribed with vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was prescribed with vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported. The patient has not received Menactra yet. Patient who will be taking Solaris.  It was a case of medication error due to product prescribing error. It was reported that patient is 70 years old, and will therefore be receiving Menactra off label.   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