chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly 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. 067H22A) for COVID-19 prophylaxis.  It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.  On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml).  This case corresponds to 13th out of 27 patients as described by the reporter.  The age of the patient was reported as over 65 years.  Concomitant medication of the patient was not reported as it was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination or at the time of the adverse event.  It was reported that on 10-May-2023, 27 patients had received 0.25 ml of bivalent booster instead of 0.5 ml. On 11-May-2023, the patients were contacted and on 12-May-2023, 18 patients received additional 0.25 ml. Vaccine body site was reported as deltoid.  The reporter did not report any other adverse reactions.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
Information has been received from a registered nurse concerning an approximately 40 year old male health center employee who was vaccinated with MMR vaccine. Recently, in approximately November 2001, the pt had a negative rubella titer and on 11/16/2001, received a dose of MMR vaccine. Six days later, on 11/22/2001, the pt developed lymphadenopathy at the neck and behind the ears. No rash was noted and the pt was afebrile. The diagnosis from a family physician was mild rubella. The pt was scheduled to see "ENT" during the week of 12/03/2001. On 11/28/2001, the pt developed a fever and arthritic symptoms, which persisted. Follow-up info received from the registered nurse indicated that her office did not administer the pt's vaccine or evaluate the pt after the event. No further info is available.
This spontaneous report was received from a medical assistant referring to unspecified amount of patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally, lot # M042172 and expiration date on 08-JUN-2018, (dose was no provided) for prophylaxis. The doses of ROTATEQ were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010123: US-009507513-1709USA009967.
pt recvd vax on 17JUL92 & on the day of 2nd vax exp lt arm tenderness & muscle aches in arms & leg;
The day following the injection, she developed postmenopausal menstrual bleeding with lasted several days, and has had intermittent bleeding since.
Patient states she woke up @ 7:am on 1/22/2021 with right sided facial weakness and paresthesia.  she went to the Emergency Room and was evaluated and discharged with a diagnosis of Bell's Palsy.
At an unknown time, Iwoke up to use the bathroom.  During that time, I fainted and hit myhead on the floor resulting in a concussion.  I regained consciousness around 3am after being unconscious for an unknown period of time.  I then went to the ER at a Medical Center, where I was admitted.
VO2 max dropped from "high" where it had been for over a year at around 50-51 down to "below average" around 39-40 where it has been since about a week after the first dose of moderna.
Very sore right arm for two days after shot.  Then on day 7 Or 8 started with itching and then developed large red circular area around upper arm which is sore and itchy
Ongoing hospitalization began 8/28/2021  for Pneumonia due to COVID-19 virus, acute respiratory failure with hypoxia: Vapotherm, BiPAP, MDI,  Sarted baricitinib 8/30/2021
Had a fever for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had a fever for 2 days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-19 infection) in March 2020 and Cardiomyopathy. Concomitant products included CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for Inflammation, VITAMIN D NOS for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Had a fever for 2 days). At the time of the report, PYREXIA (Had a fever for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant and treatment included medications to lower blood pressure and heart rate.   This case was linked to MOD-2022-460491 (Patient Link).
ribcage to feel sore, as if it was bruised; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Batch/Lot number: unknown) 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 1), for Covid-19 immunization. The following information was reported: MUSCULOSKELETAL CHEST PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "ribcage to feel sore, as if it was bruised".  Additional information: Caller received the second dose of the Pfizer-BioNTech COVID-19 Vaccine last Tuesday, 06Apr2021. Caller reported that by the following Monday, she experienced her "ribcage to feel sore, as if it was bruised". She said this "came and went for 24 hours".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The nurse inquired around dosing regimen for RECOMBIVAX HB. The pediatric-patient (age unspecified) had first dose of RECOMBIVAX HB on 22-AUG-2013, 2nd dose on 08-JAN-2014 (dose regimen unspecified). The nurse asked when we recommend providing 3rd dose. Additional information has been requested.
Breakthrough COVID-19 case with symptom onset 8/24/2021: Fever, Cough. Hospitalized 8/20/2021. Death 8/27/2021. From Records COD = CARDIORESPIRATORY ARREST, COVID-19 VIRAL PNEUMONIA. Per records, Other Significant Conditions include: None listed. lace of death: HOSPITAL-INPATIENT; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN, occ/ind: COOK, FOOD
This spontaneous report was received from a registered nurse and refers to 3-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-FEB-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (MRK). Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 30 minutes. Digital Data logger was involved. The dose of PROQUAD underwent two separate temperature excursions: the first on 18-APR-2016 (also reported as on 18-APR-2017) and the next on 03-FEB-2017 (also reported as first one). No product quality complaint was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1704USA009837: US-009507513-1704USA010916.
Injection site pain; Tiredness; Headache; Feeling unwell; A little congestion; Some chest pain; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 18Jun2021 at 15:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included hypoglycemia. Concomitant medication included mylan (MANUFACTURER UNKNOWN) (unspecified) from an unknown date for an unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took tetracycline (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 28May2021 at 15:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 19Jun2021 at 20:00, the patient had and was still having some chest pain. It felt like she had just finished a really bad coughing spell and it was achy. It was to the point that yawning or sneezing irritated the pain. The patient also had normal side effects on 20Jun2021, the two days after the second dose - injection site pain, tiredness, headache, feeling unwell, and a little congestion. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, tiredness, headache, feeling unwell, a little congestion and some chest pain was not resolved at the time of the report.
pt recv vax; seen on 12jun w/ erythema & induration at inject site; tx w/ keflex & warm soaks;
Information has been received from a registered pharmacist concerning an unidentified female patient who was vaccinated with a first and second dose of varicella virus vaccine live on 08/24/1999 and 09/24/1999, respectively. The serum varicella zoster virus antibody test was done recently, in approximately August 2000, and the patient does not have detectable antibodies. Unspecified medical attention was sought. Additional information has been requested.
Pt. noticed swollen, hive like, raised area at site of injection, approximately 20 hrs. after injection.
congestion; Fever; headache; weakness; arm pain; armpit pain; This is a spontaneous report from a contactable consumer (patient).  A 45-year-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN5918) via an unspecified route of administration in the Left arm (at the age of 45-year-old) On 18Feb2021 at 10:45 as a single dose for COVID-19 immunisation. The patient medical history included Hypoglycaemia. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient concomitant medication included buspirone hydrochloride (BUSPAR), (sertraline hydrochloride) ZOLOFT, simvastatin (ZOCOR), amitriptyline, clonazepam (KLONOPIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Flonase and experienced allergies and also took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 28Jan2021 at 13:45 in the left arm (at the age of 45-year-old) for COVID-19 immunisation. On 18Feb2021, at 17:00 the patient experienced Fever, headache, weakness, congestion, arm pain, armpit pain. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Information about Lot/batch has been requested.
The patient was admitted to a HCF on 02/24/2022 with end-stage alcoholic cirrhosis, hepatic encephalopathy, AKI on CKD, severe thrombocytopenia, acute anemia, and acute on chronic subdural hematoma.  The patient tested positive for COVID 19 on 2/24/22.  During the hospital course the patient intermittently required vasopressor support, and blood products, and was found not to be a candidate for dialysis.  The patient decided to proceed with DNR code status.  On 3/20/2022 he quickly decompensated, had AMS, and a CT head revealed small areas of subarachnoid hemorrhage.  The family wished to proceed with comfort measures.  The patient expired on 3/20/2022.
At store it is against our policy along with ACIP policy to give COVID vaccine into the thigh, it must be given in the deltoid. Pharmacist gave vaccine in left thigh per patient request.
Information has been received from a pharmacy intern concerning a female who was vaccinated with an unspecified number of doses of GARDASIL. The patient currently had hand and foot warts. The patient sought medical attention. At the report time the patient's hand and foot warts persisted. Additional information has been requested.
Severe fever, debilitating headache and body aces. Lasting 5 days. Ibuprofen, aspirin, Tylenol and heat packs.
lost of color, felt weak, foggy minded, tired, muscle ache, headaches, fatigue, chills, difficulty breathing, coughing and sore throat
Within 2-3 days of flu shot, developed symptoms of diabetic which progressed over 3 weeks to diabetic ketoacidosis.
My brother had a stroke right after the Johnson and Johnson vaccine. He was totally fine now has a blood clot on his brain at 49 years old
Pt phoned this nurse 7/9/21 11:55 am stating that on 7/6/21, 4 hours after vaccination, she experienced loss of vision momentarily and chest tightness. Pt stated the black vision resolved almost immediately but chest tightness lasted 17 hours. Pt stated that she did not seek emergency medical care and that symptoms are fully resolved currently.
Fatigue; lot of aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included Prednisone (the patient had too dealt with yearly bronchitis. Prednisone helped). Concurrent medical conditions included bronchitis. Concomitant products included prednisone.   On 16-SEP-2023, the patient received RSV vaccine. On 17-SEP-2023, 1 days after receiving RSV vaccine, the patient experienced fatigue (Verbatim: Fatigue) and pain (Verbatim: lot of aches).  The outcome of the fatigue and pain were resolved.   It was unknown if the reporter considered the fatigue and pain to be related to RSV vaccine.     It was unknown if the company considered the fatigue and pain to be related to RSV vaccine.   Additional Information: GSK receipt date 20 Sep 2023: This case was reported by a consumer via interactive digital media. The patient reported that he/she had too dealt with yearly bronchitis. Prednisone helped. Got the new Moderna just this past Saturday along with RSV. Fatigue and lot of aches the next day, but ok now.  The patient stated anti vaccers could go their route, but he/she had no sympathy if they did not make it.
Had skin things on and off and said something is going on; Barely sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jun2021 (Lot number: EW0180) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bell's palsy" (ongoing); "Underlying autoimmune disorder" (ongoing), notes: Verbatim: underlying autoimmune disorder; "Morton's neuroma" (ongoing); "Nerve surgery", start date: 2015 (unspecified if ongoing), notes: Verbatim: nerve surgery on her feet back in 2015; "Allergy: Latex" (unspecified if ongoing), notes: States she had an extreme nearly life threatening reaction to latex and adhesives also. There were no concomitant medications. The following information was reported: SKIN DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Had skin things on and off and said something is going on"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Barely sore".  Additional information: The patient reported that when she went in for her first shot of the Pfizer COVID Vaccine she had photos of the type of severe allergy she had on her feet from the adhesive and had bells palsy in the last two years and had skin things on and off and said something was going on. The patient reported that she did not know what was going on but has had this since she was a little kid and the pharmacy said she will be fine and took time to look up information and said for her not to be nervous and she was safe. The patient reported that the first dose of the Pfizer vaccine was great and easy and no problem and was barely sore and like nothing ever happened. The patient did not receive any other vaccinations within four weeks prior to COVID vaccine. The patient family medical history relevant to adverse events were none. Relevant tests were none. The patient had received both doses of the Pfizer COVID-19 vaccine. She received the second dose on 12Jul2021.   No follow-up attempts are possible. No further information is expected.
Diffuse hives about five minutes after vaccine administration. Patient received Benadryl and Zyrtec and was observed for 30 minutes. At that time patient had faint rash with a few isolated hives.
No additional adverse events reported; improperly stored vaccines were potentially administered to unknown patients; This spontaneous report has been received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 26-JAN-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # T033815 with expiration date: 05-OCT-2022, route, strength and dose were unknown) for prophylaxis (Product storage error). No additional adverse events reported.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) experienced the temperature excursion below 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions were reported as 32.9F for 53 hours 16 minutes; 49. 1F for 5 hours 9 minutes; 56.3F for 14 hours 7 minutes.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003321: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003335: US-009507513-2202USA003592:
Vaccine administered 3:10pm, reaction started within 5 minutes. Felt lightheaded and experienced hypertension (209/152), came down to 201/140, and again to 165/100. A pillow was placed under her and her legs/feet were elevated. While in our care, patient was provided and consumed 5 bottles of water and 2 packs of peanut butter crackers (pt is prediabetic and only thing she had consumed all day was a double espresso). She complained of oscillating between hot and cold... when she was cold she was provided a blanket. Patient refused our offer to call EMS. Patient consented to us reaching out to her physician, but they did not answer and patient refused our offer to leave a voicemail for her doctor. Patient left area and went to restroom to evacuate bowels and reported she felt significantly better. Patient stated she did not have a BP cuff at home and was provided both a BP cuff and acetaminophen and was advised to check her BP in a couple of hours. She walked out on her own and was advised to contact her doctor and that we would call her later that evening. When contacted that evening, she reported she was doing well.
vaccine was expired, no temperature excursions occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported on adverse reactions.
Very high fever, shaking chills, muscle aches, began at about 12 hours after the flu vaccine, left exhausted and debilitated the next two days.  Missed two days of work.  Never happened previously
pain & swelling @ site of DTP shot; hives & rash about 10 hrs later; some pain in joints; exam by MD 2 days later & all was nl;
Painful, reddened big toe on left foot within 24 hours of injection. Pain and redness disappeared after 24 hours. Itchy, reddened rash at injection site on left arm which is still present as of 2/15/21.