chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vial was initially stored in the refrigerator on 16-MAY-2023 and was administered on 11-JUN-2023; No adverse event; pediatric patient (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-JUN-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric patient (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-JUN-2023), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 16-MAY-2023 and was administered on 11-JUN-2023) and NO ADVERSE EVENT (No adverse event) in a child 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. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric patient (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-JUN-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 16-MAY-2023 and was administered on 11-JUN-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric patient (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-JUN-2023), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 16-MAY-2023 and was administered on 11-JUN-2023) 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 (pediatric patient (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-JUN-2023) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 16-MAY-2023 and was administered on 11-JUN-2023).    No concomitant medication was reported. It was reported that 5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-JUN-2023. No PQC was reported. The expiry date was reported as 09-Jun-2023. Vial size was reported as unknown. Vial did not undergo any temperature excursions. Treatment information was not provided.  This case contains information about patient 2nd out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730079 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730079:Master case patient no. 01
Swelling and hard knot at injection site; itching and painful to the touch; Swelling and hard knot at injection site; itching and painful to the touch; Swelling and hard knot at injection site; itching and painful to the touch; Swelling and hard knot at injection site; itching and painful to the touch; diarrhea; tired all weekend; This is a spontaneous report from a contactable consumer (patient). A 53-years-old nonpregnant female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: EWO151), via an unspecified route of administration, administered in Arm Left on 08Oct2021 16:15 (at the age of 53 years old) as dose 3 (BOOSTER), single for covid-19 immunisation. Medical history included colitis ulcerative. The patient had no known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included mesalazine (APRISO). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received second dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VAC-CINE, Lot number: ER8735) in left arm on 31Mar2021 (at the age of 53 years old) for single dose, received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6208) in left arm on 10Mar2021 (at the age of 53 years old) for covid-19 immunisation. On 08Oct2021 at 20:00, the patient experienced Swelling and hard knot at injection site; itching and painful to the touch, diarrhoea , tired all weekend. No treatment was received for the events. The outcome of the events was recovering  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients medical history and concomitant conditions were not reported. On an unknown date (reported as since 30-OCT-2015), the patients were vaccinated with inappropriately stored doses of VARIVAX (Merck) subcutaneous, lot # L013824 (expiration date 24-APR-2017) (dose, dose number and frequency were not provided). Concomitant medication were not reported. The reporter stated that these unspecified number of doses of VARIVAX (Merck) were stored at 5 degrees Celsius for 24 hours (incorrect product storage). No product quality complaint was reported. This is one of two reports from the same source. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of depression in a 17-year-old female patient who received BEXSERO. In April 2018, the patient received BEXSERO. In April 2018, less than a day after receiving BEXSERO, the patient experienced depression, feeling sad and crying. On an unknown date, the outcome of the depression, feeling sad and crying were unknown. It was unknown if the reporter considered the depression, feeling sad and crying to be related to BEXSERO. Additional details were provided as follows: The patient had no history of depression. The patient experienced sadness, depression, crying. At the time of reporting, the patient was still experiencing depression and sadness. This was the 1 of 3 cases, reported by same reporter.
Now its itching very bad at the injection site; It hurts around the injection site; It is really really warm to touch; Itchy at the injection site; Redness is back again,red circle is getting bigger every day; slight headache; Left arm sore; Red circle around injection site; warm to touch; Bruise around injection site; Hard around injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE WARMTH (It is really really warm to touch), VACCINATION SITE PRURITUS (Now its itching very bad at the injection site), HEADACHE (slight headache) and VACCINATION SITE PAIN (It hurts around the injection site) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid. Concomitant products included VENLAFAXINE and VITAMINS NOS for an unknown indication.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 03-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch). On 11-Jan-2021, the patient experienced HEADACHE (slight headache). On 12-Jan-2021, the patient experienced VACCINATION SITE WARMTH (It is really really warm to touch), VACCINATION SITE PAIN (It hurts around the injection site) and VACCINATION SITE ERYTHEMA (Redness is back again,red circle is getting bigger every day). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Now its itching very bad at the injection site). At the time of the report, VACCINATION SITE WARMTH (warm to touch) had resolved and VACCINATION SITE WARMTH (It is really really warm to touch), VACCINATION SITE PRURITUS (Now its itching very bad at the injection site), HEADACHE (slight headache), VACCINATION SITE PAIN (It hurts around the injection site) and VACCINATION SITE ERYTHEMA (Redness is back again,red circle is getting bigger every day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes cortisol cream and ibuprofen since Tuesday (twice a day since 12jan2021)   Reporter did not allow further contact
This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age and gender. On 14-JAN-2014 the patient was vaccinated with GARDASIL (dose and route not reported, lot # J009098, expiration date 04-DEC-2015). There was no concomitant medication reported. The nurse reported that the patient received the improperly stored, GARDASIL on 14-JAN-2014. No adverse effects reported. This is one of two reports from the same source. Additional information has been requested.
at injection site: red itchy rash, small bumps, hot to touch, hard to touch, stings when scratched, site has increased over past 6days.
her arm above the elbow began to cause pain up to her shoulder, within a few days, from her left elbow to and over her shoulder was painful; her arm above the elbow began to cause pain up to her shoulder, within a few days, from her left elbow to and over her shoulder was painful; her neck was beginning to hurt; This is a spontaneous report from contactable consumer (patient). A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Mar2021 11:00 (Lot Number: ER2613, at the age of 62-year-old) as single dose for covid-19 immunization. Medical history included interstitial lung dis, post-traumatic stress disorder (PTSD). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); clonazepam; hydrochlorothiazide (HYDRODIURIL); paracetamol (TEMPERINE); omeprazole (PRILOSEC). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Mar2021 at 11:00 am (lot number: EN6199, at the age of 62-year-old) as single dose for covid-19 immunization. Day after second vaccine (28Mar2021) her arm above the elbow began to cause pain up to her shoulder, within a few days, from her left elbow to and over her shoulder was painful, it came and went from hurting only a little to hurting to the extent of topical cream and 2 Ibuprofen and 2 Tylenol to ease the pain. Her PM doctor hadn't addressed it, a stay at the hospital in Apr2021, they wouldn't address it either, now her neck was beginning to hurt. No treatment for "neck was beginning to hurt". The patient was not pregnant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (nasal swab) on 10Apr2021. The outcome of the events was not recovered.
Fifteen minutes after vaccination pt c/o lightheadedness; symptoms progressed w moderately severe headache and nausea.  She was hemodynamically stable no signs of any allergic reaction.  There are concerns her V-P shunt is not working properly.  After lying in a recumbent position for 30+ minutes headache worsened.  We elected to transport to  ER, via ambulance so she was recumbent during transport.
Immediately after immunization administered, went across the room to a health screening and had a finger stick for glucose and cholesterol testing. Then had her blood pressure checked at another table. While having blood pressure checked, felt dizzy. Laid on floor inn supine position. B/P in the 90s/60s rang which she sated was normal for her. Monitored for 30 minutes. Felt better and left the flu clinic site.
I had my vaccination on 03/10/2022. On 07/27/2022 I went to the pharmacy and tested COVID-19 positive. I received the results on 07/30/2022. I was provided monoclonal antibodies as a course of treatment. On 08/17/2022 I was still COVID-19 positive. I was prescribed PAXLOVID. I started to have some cardiac events with increase in blood pressure with arrhythmia after testing COVID-19 positive. I did wear a heart monitor for 30 days. I am scheduled for an Echocardiogram on 04/04/2023.
Saturday morning woke up with painful swollen injection site - about the size of 3" x 1". Warm to touch, hard lump, tender to touch. Still there but reduced on Monday.
Felt like throat was swelling, sought treatment, was given Epinephrine and Benadryl.
The dose made her very sick; she had redness and pain at the injection site; she had redness and pain at the injection site; 2-year-old was accidentally given dose of GARDASIL 9; 2-year-old was accidentally given dose of GARDASIL 9; This spontaneous report was received from a physician assistance on behalf a consumer reporting a 2-year-old female patient. There was no information regarding the patient's past medical history, previous drug reactions or allergies, concurrent conditions or concomitant medications.  On approximately 21-SEP-2021 (reported as "6 months ago"), the patient was accidentally vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (accidental exposure to product/product use issue) administered as prophylaxis (dose, dosage regimen, route of administration, anatomical injection site, lot number and expiration date were not reported).  It was reported that the dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) made her very sick (illness) and she experienced injection site reactions such as redness and pain at the injection site (vaccination site erythema/vaccination site pain). It was confirmed that the patient was not hospitalized due to the events and she recovered on an unspecified date.  The event illness was considered as related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), since it was reported that the dose made her very sick. The causality between the events vaccination site erythema and vaccination site pain was not reported.
Patient had never had a flu shot before. The nurse had her sit for 15 min at 2:35 PM with complaints of feeling woozy, upset stomach. BP 148/88.  After giving her a soda and sitting she felt much better.
This spontaneous report as received from a physician (D.O.) via a representative refers to a 60 year old female patient. On 04-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX, one single injection, lot # J011338, expiry date 19-DEC-2104, injection route. On 06-FEB-2014, the patient developed a sore arm with a red rash like patch at the injection site after receiving ZOSTAVAX vaccine. This red rash like patch at the injection site was one inch in size. The patient also experienced headache, nausea and vomiting after receiving the ZOSTAVAX vaccine. The patient saw the physician. The physician administered 80 mg of DEPO-MEDROL (frequency and manufacturer unknown) for treatment of the nausea. At the time of reporting, the patient was recovering from the adverse events. The causality between ZOSTAVAX and adverse events was not provided. Additional information is not expected.
Very achy throughout my body for 12 hours. Achiness began 14 hours after the shot.
Client reported that evening her arm began to swell. She had fever, redness and swelling to her Left deltoid area. She iced it and took BENADRYL. One week later she came for her second TWINRIX and showed this RN her Left arm. She reported the redness and swelling had gone down.  Still warm to touch. Measured 30mm x 30mm. Instructed to continue icing her arm and take TYLENOL or ADVIL. Instructed to report to her PCP.
Nausea, joint pain, persistent abdominal pain, chills, diarrhea, loose stools since the 24 hours post vaccination and has been going on for 5 days
No additional AE/PQC.; the patient was administered an expired dose of VARIVAX; Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 30-AUG-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #u024220, expiration date: 04-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided). No adverse effects were reported.
I had a severe coughing, low-grade fever between 99-99.9, and body aches.
Fever, chills, very sore arm, brain fog, achy, nauseous, back pain, very tired.  Went to bed at 6 pm. Woke up at 6:30 am with all symptoms gone, except a one degree fever, brain fog & tired. Took  500 mg Tylenol at 1 pm on 4-7-21.  Took two naproxen 220 mg each at 9 pm on 4-7-21.  Took Tylenol 500 mg at 9 am 4-8-21.
Shortly after vaccination, the patient started feeling clammy, dizzy, and had cold sweats. She remained seated and we gave her some water. After a few minutes, she started feeling back to normal.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involves a 65 years old male patient who reported that patient sick for 3 days, couldn't get out of bed and had a fever, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medications included PNEUMOVAX. On 24-Oct-2018, the patient received a dose of 0.5 ml suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ0363AB and expiry date: 09-May-2019) (dose in series and route was not reported) in the left deltoid. On an unknown date, the patient developed non-serious sick for 3 days, couldn't get out of bed (malaise) and had a fever (pyrexia), following the vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Relevant tests were not reported. Final diagnosis was sick for 3 days, couldn't get out of bed (malaise) and had a fever. The patient stayed home and did not receive corrective treatment. On an unknown date, the patient was recovered from the events. List of documents held by sender: none.
Red bumps two weeks after receiving each of the Moderna shots; Itchy bumps two weeks after receiving each of the Moderna shots; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH ERYTHEMATOUS (Red bumps two weeks after receiving each of the Moderna shots) and RASH PRURITIC (Itchy bumps two weeks after receiving each of the Moderna shots) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red bumps two weeks after receiving each of the Moderna shots) and RASH PRURITIC (Itchy bumps two weeks after receiving each of the Moderna shots). At the time of the report, RASH ERYTHEMATOUS (Red bumps two weeks after receiving each of the Moderna shots) and RASH PRURITIC (Itchy bumps two weeks after receiving each of the Moderna shots) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-446935 (Patient Link).
Fever and diarrhea following a couple days after the  vaccine Being administered. The day prior to hospital emergency  admission  uncontrollable throwing up extreme side/Stomach/chest pain. Was taken by ambulance to emergency.
felt like he was about to pass out; felt dizzy; felt like his heart was racing; felt like he had a cold; felt like he wanted to sleep; felt nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (felt like he was about to pass out) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Mar-2021 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRESYNCOPE (felt like he was about to pass out) (seriousness criterion medically significant), DIZZINESS (felt dizzy), PALPITATIONS (felt like his heart was racing), NASOPHARYNGITIS (felt like he had a cold), SOMNOLENCE (felt like he wanted to sleep) and NAUSEA (felt nauseous). On 29-Mar-2021, PRESYNCOPE (felt like he was about to pass out), DIZZINESS (felt dizzy), PALPITATIONS (felt like his heart was racing), NASOPHARYNGITIS (felt like he had a cold), SOMNOLENCE (felt like he wanted to sleep) and NAUSEA (felt nauseous) had resolved.        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 drugs were reported.  On 29 Mar 2021, the patient went to emergency room and was monitored for a couple hours, not medical treatment was provided for side effect relief.; Sender's Comments: This case concerns a 34-year-old male with a serious unexpected event of presyncope, palpitations, and nonserious unexpected dizziness, somnolence, palpitations, nasopharyngitis and expected nausea. Event onset Day1 after first dose. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Medium sized rectangular swelling. Hot to touch. Very itchy.  Used ice packs, Benadryl for itching and hydrocortisone
C/O of weakness and left arm numbness.  Skin warm and dry, color good. 9:35 132/75,76,SAO2 100%   9:55, states weakness improving, left arm numbness gone but tingling to face with blurry vision.   121/6,62, SAO@100%  Continues to rest on stretcher.10:20 improved, drank ginger ale and water.   111/73, 67, SAO@100%
This spontaneous report was received from a back office lead and refers to a 35 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, in left deltoid, lot # reported as 042846 (verified to be non valid), expiration date 15-SEP-2017; route was not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Unexpectedly long wait time at clinic; frightening and dehumanizing behavior from nurses and other staff; long drive in extreme heat in the middle of the afternoon. stroke, sunburn, and vomiting/migraine/nausea immediately after getting home.   Extreme acute stress for weeks later.  still waiting to see PCP.
On April 14, 2021 at 2:15 AM, I woke up with severe pain in my lower right calf/ankle. Unable to bear weight on right leg. Reduced to crawling around house on hands and knees. Went to former Primary Care Physician  on 4//14/21, where I was treated for Sciatic Nerve flare up. Returned to Dr on 4/19/21 in severe severe pain. Dr referred me to  hospital where I was again treated for Sciatic related symptoms. Symptoms worsened daily.  On April 28, 2021, I crawled into  Hospital, was admitted. Received injection in spine. Symptoms worsened. Changed Primary Care Physicians to Dr on 4/11/21.
fully vaccinated (moderna, 3/31/21, 4/28/21); onset of symptoms 7/28/21