chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Moderna bivalent booster doses that had undergone a temperature excursion; Patient received Moderna bivalent booster doses that had undergone a temperature excursion; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) 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. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (Product storage error).    Concomitant medication was not reported.  Patient received Moderna bivalent booster doses that had undergone a temperature excursion. The dose were administered before it was known if the vaccine was ok to use after the excursion. Treatment medication was not reported.  This case contains information for the 15th of 77 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
8/10 pain at injection site next morning. The next day, severe weakness in particular to quadriceps muscles. Continues to the date of this report. Attempted relief using cold / heat then TENS. Nothing helps. The issue "feels" permanent. Very debilitating. Until the injection, I had no problem getting off the floor with one or both knees. Now I need to push myself off a table or other item to get enough leverage to stand up.
Blood work from a routine PE done approximately 1 month post covid-19 booster shot, (first shot was 1/29/21 and second given on 2/22/21) showed platelet level of 9,000 on 3/22/21. It was 7,000 on 3/24. Patient went to ER and was admitted on 3/25/21. Recently started Losartan was held for admission due to hematology recommendations as rare side effect of thrombocytopenia and not restarted while at the hospital. Multiple bruises on body noted in different stages of healing. Platelet count was 8,000 on 3/25/21. Platelet antibody tests positive, no platelet clumps on smear, denies HA, chest pain, SOB, n/v or fever. Denies hematochezia and hematemesis, blood in urine or epistaxis. CT scan negative. PT/INR results normal
Patient presented to pharmacy on 9/23/2018 with erythema, inflammation, itching and pain in the area of administration. Cold compress administration was recommended and MD office visit also recommended. Prescriber called on 9/24 and said patient was doing better that area has mild erythema and patient will continue with cold compress treatment. No infection. Prescriber Dr. provided diagnostics of visit.
p/ pt recv vax 2/98 approx 2 mo later pt devel red rash w/approx 30 lesions over his ribs, buttocks, legs.
4 days after receiving Influenza shot, leg became red and developed temperature of 100 degrees. 7 days after receiving shot saw physician. Then had red papules, 1 on each leg which was firm, pale center, surrounding erythema. Given Zyrtec, Benadryl.
pt recvd vax & had fever of 102 which lasted 24 hrs even w/ apap & ibuprophen; screaming constantly;
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/2/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE
At 3:00 PM on 10-19-09, dollar coin-size red "blotches" appeared on the arms. Throughout the evening, night, and day on 10-20-09, the red spots spread to legs, back, belly, and neck. BENADRYL was taken and CORTISONE cream applied with no relief. Red spots described as raised and very itchy. No respiratory compromise. Spoke with patient's grandmother on 10-23-2009. Patient went to Dr. received medication, and is getting better.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 27Nov2021 as dose 3 (booster), single, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2014US022248 is an initial spontaneous report received from health care professional (infection control manager) on 03  NOV 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly in her arm on an unknown date (vaccination date was reported as 2 weeks ago). The patient thought that the vaccine leaked out at the injection site, but the nurse did not think so. The nurse had to put the needle way into the muscle due to her large arm. It was reported that the patient had a bruise due to hitting a blood vessel or something as per reporter. The patient did not  think she was protected. The events outcome was unknown. The seriousness and causality were not reported.
7-21-07 - Pt developed hives all over body and 1" induration at injection site. Pt was taken to ER and treated with Benadryl and Prednisone.
pt had sore arm x 2d then improved;however on approx 20DEC began having deep aching pain in lt arm, worse in AM;does not get better or worse over time;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 08Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (manufacture unknown, dose 1). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". No other medications/products within 2 weeks of starting COVID-19 treatment. Seriousness reported as no. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Anti-viral drug Paxlovid which treatment started on 25Jun2022 and stopped on 29Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received my first vaccine shot on 1/12/21 in my right arm. My right shoulder was more sore than from my annual flu shot but went away after a day. On 2/9/21 I received the second shot in my left shoulder but was not as sore as the right. The soreness however has not gone away and I felt increasing numbness ever since and it is painful every time I lift or rotate my arm.
This spontaneous report as received from a registered nurse refers to a 16 year old patient who on 05-JUN-2013, was vaccinated subcutaneously with the first dose of MMR II (dose and lot number not reported). No adverse effects were reported. Additional information has been requested.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 65 year-old female patient received, on an unspecified date, PREVNAR 13 intramuscularly in deltoid of unknown arm, at 0.5 ml, single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, one day after the injection, the patient experienced cellulitis of deltoid. Clinical outcome of the event was unknown at time of this report.
Abdominal pain, burping, slight nausea, fatigue, somewhat looser bowel movements, bad taste on tongue, began 3 days after first Shingrix vaccination.  Went away after a month and a half.  Recurred day after second Shingrix vaccination.  Recurred June, 2020, ongoging.
Patient present with father at the COVID-19/FLU clinic to receive both COVID-19 and FLU vaccines. Patient received COVID-19 vaccines and was about to receive FLU vaccine and started falling off the chair. Father of patient and staff held patient and prevented patient from falling of the chair. Patient responded to questions on where she was, who her father is, what she is receiving. Patient was immediately laid on the stretcher and vital signs taken. Vital signs x 2 lying down; 14:18 84/47 68 96% RA, 14:21 92/56 81 97% RA. and when sitting at 14:24 98/52 92 97% RA. Father of patient said patient has never had reactions to any vaccines before, has no allergies, and patient said she felt tired. Nurse advised father of patient for patient not to have FLU vaccine today and to always inform future vaccinator of today's incident.
This spontaneous report as received from a pharmacist refers to a 17 year old patient. The patient's pertinent medical history and concurrent conditions were not reported. On 09-APR-2014 the patient was vaccinated with 2 doses of GARDASIL (Dose and route of administration were not reported) in the same office visit at an unspecified physician's office. No adverse effects were reported. The outcome was not reported. Additional information has been requested.
PATIENT REPORTED TO CLINIC ON 5/7/2021 NEEDING ANOTHER HEP B VACCINE.  I ORDERED AND SCANNED THE VACCINE IN SYSTEM BEFORE ADMINISTERING THE DOSE. I ADMINISTERED THE VACCINE AND THEN WENT TO ADMINISTER IT IN SYSTEM. WHEN I DID I COULD NOT GET THE LOT NUMBER TO PULL UP. I THEN LOOKED AT THE VACCINE AND IT EXPIRED ON 04/03/2021. I THEN ALERTED THE ASSISTANT NURSING SUPERVISOR OF THE MISTAKE.  I CALLED THE TIPS LINE AND EMPLOYEE INFORMED ME THAT THE DOSE WOULD NEED TO BE REPEATED. CALLED PT TO INFORM HER AND PT VERBALIZES UNDERSTANDING. ALSO INSTRUCTED TO FILL OUT VAERS REPORT.
Patient was given her 2nd Moderna vaccine 10 days before the recommended time between the 1st and 2nd dose.
Patient arrived for an Evusheld appointment, upon approaching the check in area. he said he was there for his booster. The check - in nurse checked him in without verifying the appointment type. Vaccinator did read the label correctly.   Patient was given a Moderna booster instead of Evusheld injection
Rota vaccine was given to patient in error. Pediatrician was notified and Hematologist/Oncologist was contacted . Signs and Symptoms were addressed with patient's mother.  Child will be monitored for symptoms over the next 2 weeks, instructions given for what to do if symptoms occur; patient to be taken to hospital.
devel lt sided paralysis;would fall to lt side while sitting;lt arm & leg would twitch;had similar episode in ER but w/lt cheek twitching;started on phenytoin;MRI=rt facial abnormality;neuro consult;has ongoing sz disorder
Information has been received form a medical assistant concerning a 55 day old female with a history of acute ocular conjunctivitis who on 06-NOV-2008 was vaccinated with ROTATEQ vaccine. Unspecified medical attention was sought. Subsequently,  on 06-NOV-2008, the patient recovered from vomiting. Additional information has been requested. 03/05/09 This is in follow-up to report(s) previously submitted on 12/12/2008. Information has been received from a medical assistant concerning 55 day old female with a history of acute ocular conjunctivitis who on 06-NOV-2008 was vaccinated with ROTATEQ. The patient vomited 2 minutes after receiving ROTATEQ. Unspecified medical attention was sought. Subsequently, on 06-NOV-2008, the patient recovered from vomiting. Follow up information was received that the patient with illness of acute follicular conjunctivitis at the time of vaccination spit up along with milk 30 seconds after the vaccine ROTATEQ was given. No further information is available.
Psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to Severe Chronic Plaque Psoriasis).   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis). At the time of the report, PSORIASIS (Psoriasis) was resolving.            No concomitant medication was provided by the reporter. It was reported that the covid 19 vaccine might had caused her psoriasis. No treatment medication was provided by the reporter. The reporter's causality for the event of Psoriasis with Skyrizi (Risankizumab)  Solution for Injection Single-Dose Prefilled Syringe with Needle Guard was not Provided.
pt recv vax JUN95&lab eval revealed varicella antibody titer to be 0.11 which was negative;pt also reported son who was also vax failed to seroconvert&was reported as WAES95121394;
Pt recvd vax 24AUG92 & 28AUG92 devel a rash & fever; 11SEP92 had shoulder inflammation & joint pain; 3JAN93 devel a lt swollen knee which was painful; 6JAN93 seen by another MD; testing showed lyme titers & western blot strongly pos; dx lym
pt recvd vax & approx 1 day later devel edema of lt hand; no other sx or manifestations;
11/24/08 - Office visit - Dr. - Shingles on R forehead & scalp - mild - 2 wks.  12/23/08 - Office visit - Dr. - Pink eye 2/20/09 - Office visit - Dr. - Shingles - R back - milder - 1 wk.
1 big whelp that is red, hot to touch on arm/gotten an inflammation; This is a spontaneous report from a contactable pharmacist (patient).  A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730, Expiration Date 31Mar2021), via an unspecified route of administration into left arm on 29Dec2020 16:45 at 0.3 mL, single for preventive as front line healthcare worker.  Medical history included compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, chronic sinusitis (took allergy medication for that).  Family medical history was None. No Relevant test. Concomitant medication included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA-D), levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). No additional vaccines administered on same date of the BNT162B2. The patient experienced 1 big whelp that is red, hot to touch on arm - immediately after, so around 16:45. They were required to stay in clinic for 15 minutes after receiving it, and it was immediately after 16:45 on 29Dec2020. She didn't believe she received it intramuscularly. She believed the needle was a little short to be the 1 inch needle. Now she had a huge red whelp on left arm where she was vaccinated. She was not sure if she need to report it or not. She also wanted to know if there were studies about alternate routes. If it was not given intramuscularly, would she need to receive an additional dose? It was one big whelp. You can see bumps superficially. It was not where the muscle was. She was quite fat on her arm. It is superficial, right on skin. You would usually have to press on skin if it was intramuscular. This you just press on skin lightly, and it was red. She was not able to answer question about serious criteria for both events. With anything, she probably should not have gotten an inflammation. She does not have a lot or expiration or dose for any of those. Right after administration of injection. No emergency room or physician's office required. The outcome of event was not recovered. lot/batch number has been requested.
HPV (Gardasil) due today 07/03/2023, Bexsero and MenQuadfi given to patient instead. Pt. did not receive HPV
This case was reported by a pharmacist via call center representative and described the occurrence of tingling of extremity in a 88-year-old female patient who received SHINGRIX (batch number G45LN, expiry date unknown) for prophylaxis. On 24th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tingling of extremity, numbness in fingers and stiff fingers. On an unknown date, the outcome of the tingling of extremity, numbness in fingers and stiff fingers were not recovered/not resolved. It was unknown if the reporter considered the tingling of extremity, numbness in fingers and stiff fingers to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX on left arm in their pharmacy and since then has experienced tingling down the left arm, left hand ring finger was numb and hard to move. The patient reported that these events were not resolved and the expiration date was not available.
Week after vaccination very bad headaches and ringing in ears  Now is fifty days after vaccination still have headaches every day and buzzing and ringing in ears
Initial information received from a healthcare professional on 18 November 2013. A 6-month-old male patient who had no medical history had received a dose of PENTACEL (batch number: C4485AA) intramuscularly in the right thigh, a dose of PREVENAR (batch number: G63308) intramuscularly in left thigh and ROTATEQ (batch number: J009050) orally on 01 August 2013. The patient had no illness at the time of vaccination. On 01 August 2013, the patient had high pitched inconsolable crying for 2 hours. Lab investigations and treatment medications were not reported. At the time of this report, the patient had recovered. List of documents held by sender: none.
Patient admitted 03/08/2022 after he stopped eating and drinking after having contracted Covid-19 at home.  He was admitted to the hospitalist service and he was in renal failure as well as having an AMS and PNA.  His renal function worsened and he was not responding to therapy, family decided to make him DNR/Comfort care.  Patient expired on 03/11/2022.
Dose 2 mouth ulcers; I have been getting constant sore.As they heal I get new sores; This is a spontaneous report from a contactable other health care professional (patient). A 47-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 14Jul2021 (age at vaccination was 47 years and patient was not pregnant at the time of vaccination) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. The patient's medical history included asthma and known allergies to paper tape. The patient's concomitant medications included fluticasone propionate (PROAIR) and montelukast sodium (SINGULAIR). The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported), via an unspecified route of administration, administered in arm left on 30Jun2021 12:00 PM (age at vaccination was 47 years) as dose 1, single for COVID-19 immunisation and experienced mouth sores, multiple on each side of her mouth, upper and lower, 6-8 at a time on 02Jul2021. They went away. After dose 2, She experienced mouth ulcers in Jul2021. She had been getting constant sore. As they healed, she got new sores. She constantly had 2. Her last dose was 14Jul2021. She was at the end of 2. It seemed though as she thought they were gone a new one started. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no hospitalization prolonged. The patient was not received any treatment for adverse events. Prior to vaccination, she was not diagnosed with COVID-19 and since the vaccination, she had not tested for COVID-19. Outcome of event at the time of last observation was not resolved.  No follow-up attempts were completed. No further information was expected.
Hive developed on neck at 06:00 day after getting HPV and Tdap at 09:43, Hive spread to right shoulder, then upper back then most of back, very itchy, seen  at 10:11 in clinic , Benydrl 25 mg IM, and Famotadine 20 mg po , sent home with Hydroyxzine 25 mg po q  hrs prn  Famotadine 20 mg po BID for next 10 days, Triamicinolone cream 0.1% to be mixed 50-50 with Eucerin cream and apply twice daily as needed
Body aches, muscle pain, fatigue, headache.  Tylenol given.  Symptoms resolved after 24 hours.
an unspecified patient was administered the third dose of ROTATEQ at age 8 and a half months old on an unspecified date.; This spontaneous report was received from a physician referring to an 8 and a half month years old patient of unknown gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.   On an unknown date, the patient was administered the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route, batch/lot# and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration). The physician was in another country . The physician was warm conferenced to Merck.
Child was in a deep sleep when I got her home, could not wake her up for 2 minutes, the outline of her lips was turning blue.  Kept her up for the rest of the day.   For the next five days she would be walking, and her legs would go out from under her like she was a raging alcoholic.  Progressively the falling subsided, and things got back to normal.  Worried that the allergy to the second dose of the mmr will be worse.