chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received expired dose of vaccine; The vial was initially stored in the refrigerator on 06-Jul-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Jul-2022 ) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Jul-2022 ) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Jul-2022 ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Jul-2022 ).    No concomitant medications were reported.  Monovalent vials of Moderna COVID-19 vaccine in the freezer moved to the refrigerator on 06-Jul-2022 and Beyond use date was 05-Aug-2022. 12 Adult patients received Expired Monovalent dose of Moderna COVID-19 vaccine 19-Sep-2022 until 09-Nov-2022. 9 Boosters were 3rd dose and 3 second doses. No previous excursion was there.  The vial was initially stored in the refrigerator on 06-Jul-2022. 6 Patients received on 19-Sep-2022, 2 Patients 04-Oct-2022, 1 Patients on 06-Oct-2022, 1 Patient on 09-Nov-2022.   The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 5th of 12th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-720531 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720531:
About an hour after pt received Hep-B shot, she became lethargic and non-responsive at home. She also developed a rash on her back and chest. With EMS, pt awoke. Admitted to the hospital with orders for Solu-Medrol IVP. Attending physician at the hospital wrote that apparently because of the confusion and the misunderstanding, the pt had a 4th shot that she did not need. She did well initially and went home. Then she started to feel dizzy and became very confused. She cannot remember anything else from that point. Her memory is back basically from ER when she started to feel better. The pt admits to some sore throat 2 days earlier which resolved completely. In the hospital she complained of a mild headache. On discharge she will be given Tylenol with Codeine for headache.
Information has been received from a pharmacist referring to 4 newborns (numbered 92, 93, 94 and 95). Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7 F. On 04-JUL-2015, there was a low temperature of 30.2F. On 13-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration ate of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
back hurt; dizziness; hasn't been able to eat much; no energy - just slow; every bone and every muscle and joint ached; kidneys hurt - cannot get comfortable; so weak - couldn't keep head up; could barely get out of bed; even eyelids hurt; headache; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (kidneys hurt - cannot get comfortable), ASTHENIA (so weak - couldn't keep head up; could barely get out of bed), EYELID PAIN (even eyelids hurt), MUSCULOSKELETAL PAIN (every bone and every muscle and joint ached) and BACK PAIN (back hurt) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, CALCITRIOL, APIXABAN (ELIQUIS), FUROSEMIDE, LOSARTAN, METOPROLOL, Mutlaq and SPIRONOLACTONE for an unknown indication, CALCIUM and COLECALCIFEROL (VITAMIN D 3).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA (so weak - couldn't keep head up; could barely get out of bed), EYELID PAIN (even eyelids hurt) and HEADACHE (headache). On 22-Jan-2021, the patient experienced RENAL PAIN (kidneys hurt - cannot get comfortable) and MUSCULOSKELETAL PAIN (every bone and every muscle and joint ached). On 26-Jan-2021, the patient experienced BACK PAIN (back hurt), DIZZINESS (dizziness), DECREASED APPETITE (hasn't been able to eat much) and FATIGUE (no energy - just slow). At the time of the report, RENAL PAIN (kidneys hurt - cannot get comfortable), ASTHENIA (so weak - couldn't keep head up; could barely get out of bed), EYELID PAIN (even eyelids hurt), MUSCULOSKELETAL PAIN (every bone and every muscle and joint ached), BACK PAIN (back hurt), DIZZINESS (dizziness), DECREASED APPETITE (hasn't been able to eat much), HEADACHE (headache) and FATIGUE (no energy - just slow) outcome was unknown.        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.   Very limited information regarding these events has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
No adverse event; HBP calling regarding a medical information request. Caller stated that a female patient was administered pediatric doses of VAQTA and RECOMBIVAX HB instead of the adult doses by a newly trained medical assistant.; HBP calling regarding a medical information request. Caller stated that a female patient was administered pediatric doses of VAQTA and RECOMBIVAX HB instead of the adult doses by a newly trained medical assistant.; This spontaneous report was received from an office manager and referred to an adult female patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-AUG-2023, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, strength: 25/0.5 (units not reported), valid lot #1966107, expiration date: 06-FEB-2024 (dose, frequency, strength, and route of administration were not provided); and the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, valid lot #W038864, expiration date: 16-JUL-2025, (strength, and route of administration were not provided), both of them administered for prophylaxis. It was reported that the patient received pediatric doses of the vaccines instead of the adult doses (Product administered to patient of inappropriate age) (Wrong product administered) by a newly trained medical assistant. No symptoms were reported. No additional information was reported.
Minutes after receiving the Lyme vaccination in their right arm, the patient felt tinging in their left arm. within in a few hours, it was red and swollen. The pain spread around their body effecting their knees, shoulders, ankles, back, hand and the other (right) elbow. at the time of this report, their right hand is constantly swollen. they have also experienced from time to time; blurred vision, "horrible" hot flashes, constant fatigue, memory lapses and rashes.
weird pain on side of her body near her ribs; pain is localized near armpit and side of breast; pain in both of her arms; radiating; hurts when you touch it; body is more swollen in general; gained a bit of weight; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (weird pain on side of her body near her ribs), BREAST PAIN (pain is localized near armpit and side of breast), PAIN IN EXTREMITY (pain in both of her arms), PAIN (radiating) and PAIN (hurts when you touch it) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A030A21A012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (weird pain on side of her body near her ribs), BREAST PAIN (pain is localized near armpit and side of breast), PAIN IN EXTREMITY (pain in both of her arms), PAIN (radiating), PAIN (hurts when you touch it), SWELLING (body is more swollen in general) and WEIGHT INCREASED (gained a bit of weight). At the time of the report, MUSCULOSKELETAL CHEST PAIN (weird pain on side of her body near her ribs), BREAST PAIN (pain is localized near armpit and side of breast), PAIN IN EXTREMITY (pain in both of her arms), PAIN (radiating), PAIN (hurts when you touch it), SWELLING (body is more swollen in general) and WEIGHT INCREASED (gained a bit of weight) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Had chicken pox as child, doctor getting shingles shot to prevent from happening. Well of Sept. 20, 2016, started out with headache and Friday 23, face and top of right side head covered. Went into right eye, swollen, matted.
Left upper arm -blanching faint pink macular rash 10x 11 cm extending to medial arm
Pt recvd 3 doses of Engerix-B 23MAR91 8MAY91 & 30SEP91 & it was deterined that pt was a non-converter; a booster dose & subsequent titer check is planned;
This is a spontaneous case, initially received from other health care professional (nurse) on 28-Sep-2018, concerns a 61-year-old adult, female patient. The patient's medical history and concomitant medications were unknown. Since 27-Sep-2018, 09:00 am to 28-Sep-18, 09:00 am, the one dose of open multi-dose vial (MDV) of vaccine was left out of the refrigerator and room temperature was 20-degree Celsius (explicitly coded as incorrect product storage). On 28-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch no: 252234, expiry date: 30-Jun-2019 and anatomical location: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The nurse inquired that, whether she should revaccinate the patient again, since previous dose of the vaccine had been exposed to temperature excursion. The reporter assessed this case as non-serious.
fine after the shot, went home and developed headache, general feeling of achiness and fatigue which worsened over the next four days.  Was really too sick to do anything.  Headache was the worst symptom which got worse as the days went on.  After recovering initially, the headache came back off and on with no particular association with anything else, although I have no way of knowing if it was vaccine related.  Headache became so bad on Friday July 30 that I suspected possible breakthrough covid, although a test the next day (the three day test) was negative.  At that point saw an ENT who was not sure of the cause of the headache and treated for sinus infection.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right 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: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. The patient has no known allergies.. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Five days after, symptoms returned with positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment from 15Feb2023 to 20Feb2023. 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. The patient had not recovered from the events.
inflamed mouth; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (inflamed mouth) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced STOMATITIS (inflamed mouth). At the time of the report, STOMATITIS (inflamed mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-377057 (Patient Link).
Patient developed several clustered pustules near his armpit (several inches away from injection site). They were red and drained fluid for a few days before scabbing over. He reported a swollen lymph node in his armpit that was painful.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age who on an unknown dates, were vaccinated with an unspecified number of doses of PROQUAD (Merck) (doses, routes and lot numbers not reported) that were exposed to a first excursion of -12C for 15 hours on 17-FEB-2014 and then an additional excursion of -12C for 19.5 hours beginning on 01-MAR-2014 which were supported as long as the overall average temperature remained between -50C and -15C. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Suspected vaccination failure; shingles; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In March 2021, the patient received the 2nd dose of Shingles vaccine. In February 2021, the patient received the 1st dose of Shingles vaccine. In October 2021, between 6 and 8 months after receiving Shingles vaccine and between 7 and 9 months after receiving 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 was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. For the last week before the date of reporting, the patient had been suffering with the shingles and the patient had very painful shingle for the last 5 days. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles was not provided.
Information has been received from a 25 year old female consumer concerning herself who was not pregnant. The patient's medical history, concurrent condition and concomitant therapy were not provided. The patient reported that she missed doses of GARDASIL. In approximately 2013 (reported as some time "2 to 3 year ago"), the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date and dose not reported), intramuscularly. Then 9 months later in February 2014, the patient administered the second dose (intramuscular, lot# and dose not reported) (inappropriate schedule of vaccine administration), and she had not received her third dose of vaccine a year and half later. No adverse effect was reported. Additional information has been requested.
40 hours after the second vaccine, I woke up and felt drained and exhausted with no energy. No other symptoms. I took a 4 hour nap and when I woke from the nap I felt perfectly fine and full of energy.
Patient became lightheaded and knees buckled as he walked across the room.  Patient was caught by staff and patient's father and laid onto the exam table.  His legs were elevated and a cool, wet cloth laid across his forehead.  Overhead was used to page a physician who came and assessed the situation.  Patient did not fall onto the floor or hit his head.  After 5 minutes patient was feeling much better so his head was elevated.  After another 5 minutes he walked to the chair.  His blood pressure and pulse were then taken and were as follows:  BP 188/72 and P 78. After a total of 15 minutes patient was feeling much better and left the room.  No follow up is needed.
postmenopausal bleeding, muscle spasms of the left forehead, tingling/numbness of right hand at prior viral rash
injection site pain and swelling beginning the evening of injection, Next morning could not raise hand up because of pain and weakness and the evening post injection reported swollen area over biceps that is red and enlarged. Also reported fatigue.  2 days post injection - Very tired, weak, skin over biceps uniformly very red, area more swollen than day before. Dizzy and lightheaded. Continued fatigue and reported shortness of breath. Patient reports almost going to the ED.  3 days post injection - Symptoms resolving - SOB gone, redness of skin almost gone. Continued to report fatigue  4 days post injection - continued to report fatigue
Shortly after receiving the vaccine, complained of fever and constitutional symptoms which progressed to complaints of muscle weakness, pain & fatigue over the ensuing months.  After evaluation by specialists including neurology and rheumatology, and extensive diagnostic testing, the rheumatologist felt that this could be sarcoid arthritis triggered by the flu vaccination.
Pain on a line from spine to breast bone with blistered thickened erythematous skin.
Information has been received from a physician concerning a now four year old male with no known medical history who at the age of 15 months was vaccinated with MMR II (631643/0919J). There were no concomitant medications. In approximately September 1999, the pt developed a rash and a fever (body temp measurement of 102 deg F). The pt sought unspecified medical attention. Additional info has been requested.
Hives with no relief; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives with no relief) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives with no relief). At the time of the report, URTICARIA (Hives with no relief) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter Patient has been to several doctors with no relief
Breakthrough case admission after 2 vaccines Moderna 8/17/21 lot# 006D21A;  Moderna 5/2/22 lot# 059M21A
Patient asked how to report a missed abortion (miscarriage) after the second dose of the Moderna vaccine since she was told by doctors to report it.  Patient had a positive pregnancy test on 3/14/21 after receiving the second dose of Moderna on 3/11/21 but did not know prior to receiving the second dose.   Patient stated that it was determined she was 6 weeks pregnant 6 days after the second shot. On 4/1/2021 patient had abdominal pain and bleeding so went to the emergency room and an ultrasound was performed.  It was determined that the missed abortion occurred when the baby was at 6 weeks.  After several doctor visits, the patient was advised to report this and that is why this was brought to our attention.  She simply asked how to report this and then I asked her some questions and gathered information.  She was okay and sounded fine.
This spontaneous report was received from a doctor of pharmacy concerning an approximately 76 year old female patient with no pertinent medical history and with no drug reactions or allergies. On 02-OCT-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J001697 and 08-MAY-2014 respectively), subcutaneously. There were no concomitant medications. On 02-OCT-2013, the patient experienced breaking out, red and itching on her arm and abdomen after receiving ZOSTAVAX. The patient sought medical attention (called pharmacist). The patient was treated with BENADRYL. No lab tests were performed. The outcome of breaking out, red and itching on her arm and abdomen was unknown. The relatedness for breaking out, red and itching on her arm and abdomen was unknown for ZOSTAVAX. Additional information has been requested.
Pt described somewhat raised rash about the size of the palm of ones hand that felt warm to the touch.
pt was crying & would not calm down-had given APAP-pt would not stop crying x 5-10 mins @ most x 2-3 hrs; MD was called & nurse told mom to dilute milk that it could be gas; MD advised mom to get immunized w/o pertussis;
transient episode of blurred vision lasting 10min the evening of vax;noticiable h/a afterwards;
Information has been received from a 53 year old female registered nurse with cystitis interstitial and a history of gastrooesophageal reflux disease and allergy to CIPRO who on 19-FEB-2002 was vaccinated IM with the first 1 ml dose of VAQTA. On 12-SEP-2002 the patient was vaccinated IM with the second 1 ml dose of VAQTA. No lot number reported. Concomitant therapy included PREVACID and ELMIRON. The patient had negative hepatitis A antibody testing on an unspecified date "recently", in approximately 2010. Unspecified medical attention was sought. The outcome of the patient was not reported. No further information is available.
Moderna. Injection 2.  Fever. Cough. Gagging. Muscle aches. Chills. Confusion. Fatigue. Weakness.  Soreness at injection site. Symptoms still persisting  6 days later.
Patient complained of anxiety, feeling cold and clammy, and being lightheaded. Patient was laid supine, Vital signs monitored, reassurance, fluids, and snack. Patient left for home following an extended period of observation.