chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mom has mild cognitive impairment.  She is well above average for a 93 year old. I live with her and she is highly functioning.    The day of her vaccine, she seemed very tired. The next day, she was exhausted. She had a hard time doing her normal activities. No fever. It was much more challenging for her to walk. She just couldn't get moving. It seemed to stay the same. I noticed she was having a harder time doing everything. Suddenly, her comprehension seemed to change. Within a week, she went from mild cognitive deficits to full blown cognitive impairment: not knowing how to take her pills, how to wash hands, how to use her watch/fitness tracker, to not removing her bottle cap to drink water, to having a hard time communicating. I called the Pharmacist where she had the vaccine, and they told me that this was not uncommon after the vaccine. They had been getting lots of similar calls. They haven't given out any second shots yet, and were not looking forward to it after everything they've been hearing.  This is very frightening.!!!! Our Mom cannot be left alone now.  How long will this last????!!!!
Face is now red; Face is now swollen; Face is now itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Face is now red), SWELLING FACE (Face is now swollen) and PRURITUS (Face is now itchy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), OMEPRAZOLE and GABAPENTIN for an unknown indication.   On 31-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 31-Mar-2021, the patient experienced ERYTHEMA (Face is now red), SWELLING FACE (Face is now swollen) and PRURITUS (Face is now itchy). At the time of the report, ERYTHEMA (Face is now red), SWELLING FACE (Face is now swollen) and PRURITUS (Face is now itchy) outcome was unknown. Not Provided          No treatment information was provided.
08feb90 pt vax hepta B. approx. 3hrs after vax pt devel. swollen tongue. flushing and shortness of breath.  pt was combative, lost consciousness and had seizure.  pt hospitalized for 6 days treated w/ benadryl. pt recovered.
Patient was administered 0.2 ml of undiluted Pfizer (5-11 years old) vaccine on 2/25/22. Upon follow up on 2/26/22 patient was doing well and she had no symptoms.
2 days after receiving vaccine - pain  above kidneys on right side back continuing for 5 days, then  next day stabbing pain starting above  right kidney in back and shooting up to base of right shoulder,  then  next day stabbing paid on right side starting at the waist and shooting up ribs, then next day rash appeared on back and right side continuing to front to belly button.  Turned out to be  severe case of shingles.   I had the shingles vaccine several years earlier.
Fluzone High Dose was administered to 3 patients after too long in transit, no AE; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 69 years old female was administered with a 05. ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ307AB, expiry date: 29-Jun-2020, via intramuscular route in the left arm) after too long in transit on 11-Nov-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  At the time of reporting the patient had no adverse event.  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.
Vaccine administered after expiration/beyond use date had passed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after expiration/beyond use date had passed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after expiration/beyond use date had passed). On 01-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after expiration/beyond use date had passed) had resolved. Not Provided      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.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-077583 (E2B Linked Report).; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 031B21A)  with no associated AEs. US-MODERNATX, INC.-MOD-2021-077583:Crosslinked (MOD21-076287)
Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; Vaccine administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 3:58 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 3:38 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 31.61.   No concomitant medications were reported.  On 19-April-2021, The vaccine was moved to fridge. On 29-April-2021, Product moved to clinic and temperature excursion reported as 33 degrees fahrenheit at 10:00 AM. Beyond use date for the vial was reported as 19-May-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Moderately itchy; Red rash all over neck, elbows on both arms, the back of left wrist, the upper part of abdomen, and lower right part of back.; Rash was also over the injection site on right arm; Rash did feel warmer than the surrounding skin; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 06Apr2021 at 12:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and asthma. The patient received unspecified concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 16Mar2021 at 16:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 08:00, the patient experienced red rash all over her neck, when she had looked in the mirror further the rash was also over the injection site on her right arm. At that time, the rash was not itchy or painful but did feel warmer than the surrounding skin. Throughout the day, the rash developed on other parts of her body, including the insides of her elbows on both arms, the back of her left wrist, the upper part of her abdomen and the lower right part of her back. On 09Apr2021, the rash had continued to spread to more of her abdomen and upper back and it was moderately itchy. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with oral antihistamines (fexofenadine, loratidine, and diphenhydramine) and topical cortisone cream. The clinical outcome of the events red rash all over neck, elbows on both arms, the back of left wrist, abdomen, back and over the injection site on right arm, warmer than the surrounding skin and moderately itchy was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Red, swollen, warm, splotches developed at injection site.  Approximately 7 days after injection.
had 2 shots 7 months apart; This case was reported by a contact via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date ).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 25-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient received 2 shingles vaccination 7 months apart. Additional supportive information: The patient received 2nd dose of Shingles vaccine later than the recommended interval, which led to lengthening of vaccine schedule. The follow-up could not be possible as no contact details were available.
Info was rec'd from an allergist concerning a pt who was vaccinated with a dose of hepatitis B vaccine recombinant (yeast). The reporter did not know whether it was  hepatitis B vaccine recombinant (yeast) (MSD) or hepatitis B vaccine recombinant (yeast) (Engerix-B). Subsequently the pt developed a large, local site reaction, reported to be enough to be seen at the ER for evaluation. There was no further information, since the pt was not vaccinated by the reporter nor at his facility. It was noted that the child was vaccinated by a pediatrician at another facility. Additional info has been requested.
Injection on Tuesday at 1:00 pm.  --Sleepiness/tiredness approximately 2 hours after injection which continued for the rest of the day. I went to bed around 9:00PM.  --Moderate fatigue on Wednesday and Thursday. --Sore left arm at injection site, started approximately 4 hours after injection and continued for around three days total. Quite intense initially and also the next morning, but it eased later in the day on Wednesday and was mild on Thursday.   --Chills and shivering, starting at 1:00 AM on Wednesday, which lasted approximately 5 hours. I did not sleep again after the chills started. --Fever ranging from 99.7F to 100.9F for at least eight hours. I didn't take my temperature until 6:00 AM on Wednesday, so it may have started earlier. I took 200mg of ibuprofen at 2:00 PM on Wednesday and the fever started reducing within the hour and my temperature was normal by 4:00PM.  --Headache started around 4:00 AM on Wednesday and became more intense later in the morning. Ibuprofen at 2PM helped a lot and I took a second dose of 200mg around 7:00 PM on Wednesday.  Another 200mg ibuprofen around 10:00 PM at bedtime. I had a mild headache on Thursday and took 200mg of ibuprofen around 3:00 PM.  --Nausea, a brief, intense episode around 6:00 AM on Wednesday, which eased quickly. I did not vomit, but the feeling was very intense. This episode was accompanied by light-headedness and strong  flushing and sweating. Within ten minutes, I felt much better.  --Indigestion, mild. Lasting through the day on Wednesday. Mostly a feeling of mild tension or cramps around my lower abdomen.  --Body aches, mild, and mostly in my neck and back. Starting around 3:00 AM on Wednesday and continuing through the day on Wednesday. Stiff neck and a little tender around the glands, like with a normal cold.   On Friday, I felt good again. All symptoms gone.   I stayed home all day Wednesday and did not go to work because I felt awful. I slept a lot and rested and kept very quiet. On Thursday, I felt well enough to go to work, but was very tired and had little energy. I rested at home the rest of the day on Thursday and had a nap in the afternoon.  I felt a lot better by Thursday evening.    NB: For my first Moderna COVID vaccine dose, I had no notable side effects. A sore arm around the injection site was all.
Breakthrough case admission after 3 vaccines Pfizer 2/3/21 Lot# El9261;  Pfizer 2/24/21 Lot# EL9267;  Pfizer 11/2/21 Lot# FF8028
Muscle aches, fatigue, loss of energy, stamina, and endurance; temporary numbness in both hands; extended numbness and tingling in left hand diagnosed as a carpal tunnel response due to swelling in the left hand and lower arm; headache, mild fever.
This spontaneous case was reported by a consumer and describes the occurrence of RASH MORBILLIFORM (dark, rash, which looked like measles on both inner thighs and both lower legs) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0028L20a) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, METHYLPHENIDATE HYDROCHLORIDE (RITALIN) and CELECOXIB (CELEBREX) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced RASH MORBILLIFORM (dark, rash, which looked like measles on both inner thighs and both lower legs). At the time of the report, RASH MORBILLIFORM (dark, rash, which looked like measles on both inner thighs and both lower legs) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; Reporter's Comments: Based on the 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.
Patient was vaccinated a week earlier.  No adverse effect noted. Parent notified at 5pm, and concerns noted.
Chills, body ache, cough, headache, fatigue starting on 9/17/21.  6 year old daughter tested positive for COVID on 9/17/21
Accidental administration to 17 year old.  Birthdate had been omitted from the consent form and when collected later the mistake became apparent.
little bump/big, thick plaque-kind pieces on her skin; redness; nausea; so fatigued; felt horrible, could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt horrible, could not get out of bed), CYST (little bump/big, thick plaque-kind pieces on her skin), ERYTHEMA (redness), NAUSEA (nausea) and FATIGUE (so fatigued) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001BZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced FEELING ABNORMAL (felt horrible, could not get out of bed), NAUSEA (nausea) and FATIGUE (so fatigued). On 15-Apr-2021, the patient experienced CYST (little bump/big, thick plaque-kind pieces on her skin) and ERYTHEMA (redness). At the time of the report, FEELING ABNORMAL (felt horrible, could not get out of bed), CYST (little bump/big, thick plaque-kind pieces on her skin), ERYTHEMA (redness), NAUSEA (nausea) and FATIGUE (so fatigued) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.  Patient did not have any side effects after the first dose.
Temperature excursion with our Moderna Covid-19 vaccine; No adverse event; Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) and NO ADVERSE EVENT (No adverse event) in a 62-year-old 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. 045H22A) for COVID-19 prophylaxis.     It was unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 14-Feb-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 14-Feb-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with our Moderna Covid-19 vaccine) and POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion with our Moderna Covid-19 vaccine, both monovalent and bivalent, doses were administered post excursion.).    No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master Case
"since her shot, she has developed a large swollen hard circle. Last night I drew a border around the redness - but the firmness is larger than the redness border drawn. It is warm to the touch. She complains of it itching and feeling uncomfortable. She does not have any systemic symptoms."  Mother of patient guessing the redness is approx 1.5-2 inches and describes it as feeling like a "hematoma under the redness"
Sore arm was initial side effect. Chills, body aches, headache, shivering began about 12 hours later. Better by morning.
Sudden death. Autopsy reports body unharmed, asymptomatic, and healthy, other than being dead.
Advises fever of 104, hives on face and legs. Took Tylenol 2 tab every 6 hours. S/s started the day after receiving pneumococcal vaccine. On 11/22 advises no fever x2 days and hives resolving.
patient received COVID-19 vaccine on 18Dec2020 and had a positive pregnancy test on 28Dec2020; patient received COVID-19 vaccine on 18Dec2020 and had a positive pregnancy test on 28Dec2020; patient received COVID-19 vaccine on 18Dec2020 and had a positive pregnancy test on 28Dec2020; fetal cystic hygroma; This is a spontaneous report from contactable consumers (one of them is patient herself) communicated to a Pfizer sales representative. A 32-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, first dose on 18Dec2020 (first dose given pre/peri conception), second dose on an unspecified date in 2021 (second dose given around 4 weeks gestation); both at single dose for COVID-19 immunization. This is my daughter and grandchild. The patient's medical history and concomitant medications were not reported. The patient received COVID-19 vaccine on 18Dec2020 and had a positive pregnancy test on 28Dec2020. The conception date was reported as 01Dec2020. The patient underwent lab test and procedures which included urine pregnancy test: Positive on 28Dec2020. Upon follow-up on 03Mar2021, it was reported that, miscarriage at 13 weeks gestation due to fetal cystic hygroma on 04Mar2021 05:30. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (03Mar2021): New information received from a contactable consumer communicated to a Pfizer sales representative includes: New reporter (consumer), gestational period (13 weeks), suspect drug details (second dosage regimen), new event (fetal cystic hygroma) added.  No follow-up attempts are needed. No further information is expected.