chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient received a dose of Fluzone Quadrivalent that was invalid, which had shipped on 24-sep-2020 and received on 28-sep-2020 / No AE; a patient received a dose of Fluzone Quadrivalent that was invalid, which had shipped on 24-sep-2020 and received on 28-sep-2020 / No AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a six-months-old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot number: UT7058MA, expiry date: 30-JUN-2021) via an unknown route in the left thigh that was invalid, which had shipped on 24-sep-2020 and received on 28-sep-2020 for prophylactic vaccination (product storage error and product distribution issue).  The patient medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HIB VACCINE, ROTAVIRUS VACCINE, DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  At the time of report, no adverse event was reported.  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.
Information has been received from a pharmacist concerning a 65 year old female who on 13-NOV-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTER (Oka/Merck) (Lot # 663194/1415X).  The patient experienced a rash on her arm after receiving ZOSTER (Oka/Merck).  The rash was described as a red line extending down her arm.  The patient's symptom was recovering.  The patient spoke to the pharmacist.  Additional information has been requested.
Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received 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-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 65th out of 100 patients.  No concomitant medication was provided by reporter.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11 Jan 2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.   This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:Master case
p/vax pt devel persistent fever ranging from 99.8 to 100.2;medical attention was sought;pt was evaluated for a temp, sore throat & abd discomfort;dx w/viral synd;
This spontaneous case reported by a consumer, describes the occurrence of severe chest pain (like a heart attack), gastrointestinal inflammation (inflammation of his gastrointestinal region noted) and esophagitis (inflammation of his esophageal region noted) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 022M20A and 042L20A) for COVID-19 immunization. Concurrent medical conditions included seasonal allergy, pollen allergy and allergy to animals (cat). On Jan 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 23, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 23, 2021, patient experienced severe chest pain (like a heart attack) and gastrointestinal inflammation (inflammation of his gastrointestinal region noted). Feb 23, 2021, patient experienced esophagitis (inflammation of his esophageal region noted). At the time of the report, severe chest pain (like a heart attack), gastrointestinal inflammation (inflammation of his gastrointestinal region noted) and esophagitis (inflammation of his esophageal region noted) outcome: unknown. No concomitant medications provided. Treatment: Patient prescribed acupuncture, antacids and gabapentin but he is not taking.
night sweats; body ache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats) and MYALGIA (body ache) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS] for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced NIGHT SWEATS (night sweats) and MYALGIA (body ache). At the time of the report, NIGHT SWEATS (night sweats) had resolved and MYALGIA (body ache) outcome was unknown. Not Provided          No treatment information was reported. Patient experienced night sweats after both the doses which lasted a day and felt fine later.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant FU - 2nd dose information added and event night sweats outcome updated
body aches; slept all day; 2nd shot-28Mar had chills; slight fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 01, Lot: EL9266), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 27Mar2021, outcome "recovered" (29Mar2021), described as "2nd shot-28Mar had chills"; PYREXIA (non-serious) with onset 27Mar2021, outcome "recovered" (29Mar2021), described as "slight fever"; PAIN (non-serious), outcome "recovered" (29Mar2021), described as "body aches"; SOMNOLENCE (non-serious) with onset 27Mar2021, outcome "recovered" (29Mar2021), described as "slept all day". Therapeutic measures were not taken as a result of chills, pyrexia, pain, somnolence.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large raised red circle in area of injection site, as well as smaller rash/hive marks appearing on other limbs, that appeared 9 days after injection. Also consistent nausea, and severe headache that covers whole right side of head, as well as severe pressure behind right eye. Also sudden fatigue and muscle aches. Red circle is warm and painful to touch.
Narrative:  Patient contacted phone center 7/29/21 for temp, cough, runny nose, sore throat, fatigue, congestion, muscle aches, diarrhea, headache, low pulse ox (onset 7/25/21). Symptoms began after attending county fair 7/23/21. Positive COVID-19 test 7/29/21. Received monoclonal antibody therapy (7/31/21 - outside facility). Transferred to hospital from outside ED for continued care for sepsis with acute hypoxic respiratory failure due to COVID-19 pneumonia. Started remdesivir and dexamethasone 7/31. Had AKI and hyponatremia on admit that improved with fluids. He was titrated to room air by 8/3 and able to ambulate without assistance. Discharged to home 8/4 stable and much improved from admission.
Day of shot (Tuesday) had chills, then fever spiked to 104.1º. Wednesday temperature fluctuated between 101º and 104º with chills off and on and no appetite. Thursday temperature stayed about 1º above normal all day, but my appetite came back in the afternoon. Had the runs that evening and night - a lot of water came out. Friday temperature back to normal and no runs. Treatment was to take Tylenol, turn up heat, get under extra blankets and sleep/rest as much as possible. Only drank water and grapefruit juice, and only ate clementines (didn't want to eat anything else until Thursday afternoon).
got the flu; Initial information received on 11-Dec-2022 regarding an unsolicited valid Social media non-serious case from a consumer/non-health care professional.  This case involves an unknown age and unknown gender patient who got the flu after receiving vaccine Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, frequency, dose, lot number, expiry date: not reported) via unknown route in unknown administration site for flu vaccination (Influenza immunization).  On an unknown date the patient got the flu (influenza) (latency: unknown) following the administration of influenza vaccine.  It was reported "as took the flu shot in October and I still got the flu been a week and it been horrible think I might be getting over it".  It is unknown if there were lab data/results available.  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the event.  The outcome was Unknown.
This spontaneous report as received from a consumer (patient's grandmother) refers to an infant female patient. The patient's pertinent medical history and drug allergies were none. On an unknown date, the patient was vaccinated with first dose of ROTATEQ. On an unknown date, after the first dose the patient experienced a mild case of diarrhea. Concomitant medications were none. On 10-MAR-2015 the patient received second dose of ROTATEQ (lot # K016278 and expiry date: 21-APR-2016). On 11-MAR-2015 (reported as next day), the patient became ill with the following symptoms, severe diarrhea, dehydration and developed a raw fire engine red bottom to the point that her skin was peeling on her buttocks. The patient sought medical attention and was treated in the emergency room with Pedialyte and other unspecified treatment. The action taken with ROTATEQ was reported as waiting to recover before completing the series. The outcome of the events was reported as recovering/resolving. The relatedness of the events with ROTATEQ was not reported. Additional information has been requested.
pt recv vax 25AUG98 & was not up to date of vax this being #4;pt mom returned 27AUG98 w/pt rt arm red, blotchy & warm about 3" in diameter around inj site (upper arm deltoid area);mom said had hives on legs & was itchy;
TC from mom: 7SEP94 as described by mom: pt recvd vax 1SEP94 & on 3SEP site became inflammed & there was some swelling; sm red bump noted @ site; mom called peditrician-pt was not seen by MD; pt had wheal @ site & c/o itching @ site;
have Hair Loss / hair falling out; Itchy scalp bumps; Not feeling well /  did not feel well; Itchy scalp bumps; This case was reported by a consumer via call center representative and described the occurrence of hair loss in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Revlimid. Concurrent medical conditions included multiple myeloma and amyloidosis.   On 3rd March 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th March 2020, 14 days after receiving Shingrix, the patient experienced hair loss, papular rash, malaise and pruritus. On an unknown date, the outcome of the hair loss and malaise were resolved with sequelae and the outcome of the papular rash and pruritus were recovering/resolving.   The reporter considered the hair loss, papular rash, malaise and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient reported adverse reaction she believed to Shingrix injection and wanted to know if these were common for individuals receiving Shingrix. The patient's hairs were falling out when she brushed it, itchy bumps on scalp, and not feeling well.  The reporter consented to follow up.
I experienced extreme heart racing & shortness of breath for about half an hour after which symptoms subsided a bit. When they did not disappear by 9PM I went to urgent care and they diagnosed me with Atrial Fibrillation and had a rescue squad take me to Hospital a. They gave me drugs to lower my heart rate and when it didn't convert by the morning they gave me a cardiovert treatment and restored the regular rhythm of my heart.
Imz was given with daughter present.  Pt left as normal, other daughter returned the next day to ask what she could do for her mother.  Stated her mother was unable to move  her arm and having tingling.  After much discussion with pt, it changed to "pt can move her arm, but it's painful and has some tingling".  She has tried 1 ibuprofen 4 times.  She really wanted another recommendation and something to try topically.  I recommended if it continues, to definitely see the dr.  Pt took home menthol topical to see if that alleviated any discomfort and was encouraged to use ice as well. I followed up with the phone # on file the following day.  The daughter that was present at the time of imz stated that she was still having some tingling in her hand, but she hadn't spoken with mother yet that day.  She was supposed to have the pt call me back that day.  Still have not gotten to speak directly with the pt, therefore was hesitant how to report this due to some inconsistencies.
This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a 63-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020) for prophylaxis. On 5th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site rash, injection site erythema and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced light reddish rash and itching at injection site which lasted for 1 week.
Henoch-schonlein purpura palpable purpura on lower extremities, vasculitis on face. The hospital discharge summary states pharyngitis.
"mild cold, flu type feeling"; Redness is spreading; area of the size of her palm that is hard; feels tired; area of the size of her palm that is very red; arm became very sore; "mild cold, flu type feeling"; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS ("mild cold, flu type feeling"), INFLUENZA LIKE ILLNESS ("mild cold, flu type feeling"), ERYTHEMA (Redness is spreading), VACCINATION SITE INDURATION (area of the size of her palm that is hard) and FATIGUE (feels tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus-like syndrome, Osteoarthritis, High cholesterol, Fibromyalgia and Drug allergy (codeine). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), DULOXETINE HYDROCHLORIDE (CYMBALTA), METOPROLOL SUCCINATE (TOPROL) and HYDROCHLOROTHIAZIDE for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced NASOPHARYNGITIS ("mild cold, flu type feeling"). On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS ("mild cold, flu type feeling"), ERYTHEMA (Redness is spreading), VACCINATION SITE INDURATION (area of the size of her palm that is hard), FATIGUE (feels tired), VACCINATION SITE ERYTHEMA (area of the size of her palm that is very red) and VACCINATION SITE PAIN (arm became very sore). At the time of the report, NASOPHARYNGITIS ("mild cold, flu type feeling"), INFLUENZA LIKE ILLNESS ("mild cold, flu type feeling"), ERYTHEMA (Redness is spreading), VACCINATION SITE INDURATION (area of the size of her palm that is hard), FATIGUE (feels tired), VACCINATION SITE ERYTHEMA (area of the size of her palm that is very red) and VACCINATION SITE PAIN (arm became very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: follow up received and contain no new information
A month after getting the shots I started experiencing heart palpitations, heart racing rapidly and shortness of breath around January 9 or 10th of 2022. The shortness of breath had been ongoing before due to lingering effects from covid that I got in January of 2021 but now the heart was racing and palpitating. Saw my family doctor January 11th. She discovered on the stethoscope pvc's were happening and sent me to a cardiologist immediately. Saw Dr. and had a heart monitor for a week, ectocardiogram and stress test. I have pvc's randomly due to the covid shots was the probable cause. I still have the problem currently at random times.
This spontaneous report was received from a medical assistant concerning an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 injection, lot number M044717, expiration date 19-JUL-2019) for prophylaxis. The temperature of excursion with GARDASIL 9 was 47 to 77 Fahrenheit degrees during 1 hour and 38 minutes. No previous of temperature excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA009380.
Patient developed gross hematuria with signs of symptoms of UTI, stones after 1st and 2nd doses of Rabies. Urinalysis revealed no bacteria, WBC in each instance. After 2nd dose patient also developed tender lymphadenopathy in the superclavicular area; most likely lower aspect of anterior cervical chain. From acknowledgement letter: The reaction she had was to the Rabies vaccine, not Hep A or Menomune.
First dose of Moderna vaccine was administered at 1:45 pm. Patient was observed for 30 minute post vaccination due to previous anaphylactic response. At 2:40 PM patient returned to vaccination area to report a "lump" in throat and feels as though her bottom lip has been bitten. Patient received 25mg of Benedryl.  Vitals were assessed and within normal limits. Bottom lip red in color with no swelling present. At 2:55 PM vitals assessed and WNL. Patient reports she feels the same as she did upon initial assessment. Vitals assessed and WNL at 3:10 PM, 3:30 pm and 3:50 PM. 3:10 PM patient reports that the lump in throat is dissipating. By 3:30 PM assessment "lump" in throat is gone and patient is still feeling as though her bottom lip has been "bitten." Patient was discharged at 3:50 PM and advised to follow up with physicians office.
On 12/5/2022, patient presented to the emergency department from home with complaint of weakness and fatigue. He was hypoxic and required oxygen; his COVID-19 NAA test was positive. Patient was admitted to the hospital for further treatment. He was in stable condition until 12/7/2022 when his respiratory status began declining. His condition continued to decline and required more oxygen and then BiPAP. Patient became dyspneic and hypotensive and was transferred to the ICU. A family meeting was held as patient's respiratory and circulatory status was deteriorating. Family decided to transition to comfort care only. Patient died at 15:21 on 12/8/2022.  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.