chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"eye problem with focusing" for 2 hours; muscle pain; felt "extremely tired"; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT ("eye problem with focusing" for 2 hours), MYALGIA (muscle pain) and FATIGUE (felt "extremely tired") in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes. Concomitant products included METFORMIN, GLIMEPIRIDE, ROPINIROLE, CLONAZEPAM (KLONOPIN) and GABAPENTIN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA (muscle pain) and FATIGUE (felt "extremely tired"). On 20-Mar-2021, the patient experienced VISUAL IMPAIRMENT ("eye problem with focusing" for 2 hours). On 21-Mar-2021, VISUAL IMPAIRMENT ("eye problem with focusing" for 2 hours) and MYALGIA (muscle pain) had resolved. On 22-Mar-2021, FATIGUE (felt "extremely tired") had resolved. Not Provided          The action taken with mRNA-1273 in response to the event was not applicable.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-054493, US-MODERNATX, INC.-MOD-2021-054456, US-MODERNATX, INC.-MOD-2021-056898 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054493:1st dose case  US-MODERNATX, INC.-MOD-2021-054456:2nd dose case US-MODERNATX, INC.-MOD-2021-056898:1st dose case
Doesn't feel well; Feeling funny in the top of her stomach with lots of gases; Nauseated; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (Doesn't feel well), FLATULENCE (Feeling funny in the top of her stomach with lots of gases) and NAUSEA (Nauseated) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, AMLODIPINE, METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), INSULIN GLARGINE (LANTUS), VITAMINS NOS and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 22-Jan-2021, the patient experienced VACCINATION COMPLICATION (Doesn't feel well), FLATULENCE (Feeling funny in the top of her stomach with lots of gases) and NAUSEA (Nauseated). The patient was treated with ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Adverse event, at a dose of UNK dosage form. On 21-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION COMPLICATION (Doesn't feel well), FLATULENCE (Feeling funny in the top of her stomach with lots of gases) and NAUSEA (Nauseated) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 98 % normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medical included glucoride (1mg, twice a day).  The patient received treatment with inhaler (indication unspecified).
After 15 minutes felt light headed and throat started to constrict slightly.  Had an Allegra with me, so took it.  Seemed to subside in about 30 minutes.  Took a benedryl at bedtime.  In morning, seemed ok, though took another benedryl.  Seemed OK on this next day, but before bed, face was puffy, then woke up at 3:50 a.m. Saturday, and throat glands swollen and was having difficulty swallowing.
Vaccine administered beyond Expiration date. However, per Moderna- all vaccines met viability requirements.  Completing VAERS per facility requirements.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 43-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that patient's facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients.  Treatment information was not provided.
Patient presented and was admitted through the ED for complaint of epigastric abdominal pain onset this morning that has since resolved, as well as complaint of shortness of breath, fatigue that is persistent. She had HD  but stopped 10-15 minutes into HD with noted severe bradycardia. Diagnosis on admission - 3rd degree heart block. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine.
Menstrual period delayed by approximately 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Menstrual period delayed by approximately 2 weeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 004F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In September 2021, the patient experienced MENSTRUATION IRREGULAR (Menstrual period delayed by approximately 2 weeks). At the time of the report, MENSTRUATION IRREGULAR (Menstrual period delayed by approximately 2 weeks) outcome was unknown.            Concomitant medication was not provided.  The patient was expecting menstrual period on 23-Aug-2021 but it came 1st week of September approximately 2 weeks delayed).  Treatment information was not provided.
Reports to ED with nausea, vomiting 2 days after 2nd covid vaccine. Admitted to hospital as patient also had recent abdominal surgery. Treated for gastroparesis and discharged home.
After receiving the shot on 5/24, I broke out in red itchy bumps all over my body. It looks as if I had been bitten by a bunch of mosquitoes. I called my doctor and was told to use Benedryl cream. I have these itchy bumps on my legs, knees, arms, back, stomach, and breasts. I'm using the cream and taking Benedryl orally to help get rid of this issue.
@ 2PM on 23NOV92 pt was awakened by lt arm pain in the armpit & lymph node area; was also nauseated & SOB given Toradel IM & APAP;
After 4 days left upper arm started hurting and kept hurting worse. Went to clinic due to pain and received injection. Continues to hurt and returned to clinic and received medication for pain and muscle relaxer. Returned 5/22/21 due to continued pain and was sent to get ultrasound. To follow up with Orthropedic Doctor on May 24,2021.
had the vaccine and he has shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated the patient had the Shingles vaccine and he has shingles in his 70's. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report was received from a 53-year-old female patient. The patient's height, and weight were not reported. The patient had no known allergies and no medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1805029, and expiry: unknown) dose was not reported, 1 total, administered on left deltoid on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced dizziness. On 05-APR-2021, the patient experienced body aches and headache. Her treatment medication included Tylenol (paracetamol) (date unspecified). On 07-APR-2021, the patient recovered from body aches and on 08-APR-2021, she recovered from the headache. On 11-APR-2021, her COVID-19 antigen test was negative, following which a PCR (polymerase chain reaction) test was done. On 13-APR-2021, the PCR test showed a positive result (confirmed covid-19 infection and confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210424819-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I only get around three hours sleep now after vaccine. I don't take caffeine or stimulants. I was always getting about 8-9 hours solid sleep before. Bad dreams. My digestive system is not working correctly. I have loose stools two, three times a day. I am not overweight and eat the same as before. Very sluggish feeling. Headaches.
Varicella rec.'d, 11/10/08, with influenza, Hep A, MMR, IPV vaccinations. G mother reports 9 days later "chicken pox" with high fever" and "fine rash". Resolved without intervention.
Complains of vomiting, severe headache, body aches, body stiffness, abdominal cramping.
Fever, Stomach pain, Dizziness, Fainting, Appendicitis.
I received the booster on 2/4/22 and one week later I began to have menstrual bleeding like crazy. I had not had this type of bleeding for many months. I went to the doctor and my ultrasound was negative and it was probably a side effect from the vaccine. I also began to have heart palpitations. I wore a heart monitor for two weeks. The palpitations have happened ever since dose 2. My heart rate increased according to my smart watch. The palpitations would happen occasionally one after another, but sometimes they were spread apart. I will have an Ultrasound of the heart next week.
pt recvd vax; approx 36 hrs p/ vax, pt was extremely lethargic; unable to rouse; t rectally 99; hosp x 2 days; dx: rxn to pertussis;
fever, body aches, nausea, SOB, cough, fatigued, head congestion
some left arm soreness since receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (some left arm soreness since receiving the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Patient had heart attack 5 weeks prior to dose vaccination) in December 2020.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (some left arm soreness since receiving the vaccine).   At the time of the report, VACCINATION SITE PAIN (some left arm soreness since receiving the vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  It is reported that patient was taking blood thinner post-heart attack condition. No treatment information was provided.; Sender'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.
Increase numbness starting at toes and fingers and spreading up to legs, arms, and radiating through the torso. Face began twitching and taste was impacted.    Diagnosis: Myokymia (face) Paraesthesia Dysgeusia Chronic inflammatory demyelinating polyneuropathy (CIDP)   Treatment: Gabapentin IVIG
THE PATIENT STARTED FEELING WEAK AND FATIGUED, AS WELL AS  HAVING NECK PAIN SEVERAL HOURS AFTER RECEIVING THE MODERNA COVID VACCINE.  THE NEXT MORNING, HE WAS BARELY ABLE TO GET OUT OF BED AND HAD SEVERE BODY ACHES AND FATIGUE, THE NECK PAIN WAS WORSE, HE HAD DEVELOPED A RASH ON HIS EXTREMETIES AND COULDNT SWALLOW OR SPEAK.  HE WAS EVALUATED AND TREATED FOR POSSIBLE MENINGITIS / GUILLAIN-BARRE.  PT WAS HOSPITALIZED FROM 2/26 TO 3/6/2021.  HE WAS DISCHARGED HOME IN STABLE CONDITION .
No concerns noted per chart review at time of vaccine - admitted to hospital at this time with new dx of Guillian Barre Syndrome
This is a spontaneous report from a contactable consumer or other non healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 31Aug2021 08:30 (Batch/Lot Number: EW0167) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea on 2021 with outcome of unknown, he is shaking like a baby with tremor, he is throwing up over everything with vomiting and chills on 2021 with outcome of unknown.  Follow-up (31Aug2021): This is a follow-up spontaneous report form a contactable consumer. This consumer reported for a patient (son) that: The adverse events were updated and wanted to know if he needs the emergency room.
severe Shingrix vaccine reaction / hospitalized for almost three weeks; This case was reported by a consumer via call center representative and described the occurrence of hospitalization in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that she had a complex issue, but it was a severe Shingrix vaccine reaction, patient was hospitalized for almost three weeks. The reporter was wondering what commonalities there might be with the new COVID vaccines. She was guessing other people have this big problem, so that to her it was something that need to figure out, so she don't  have to have her doctor track this down. The reporter consented to follow up.; Reporter's Comments: realize we have a complex issue, but it was a severe Shingrix vaccine reaction, my husband was hospitalized for almost three weeks, (inaudible) I was wondering what commonalities there may be with the new COVID vaccines. I'm guessing other people have this big problem, so that to me is something you guys need to figure out, so I don't have to have my doctor track this down.
Heartbeats irregular/heart rate was all over the place/up to like a 101; This is a spontaneous report from two contactable consumers (patient self and patient's husband). This 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982) on 15Jan2021 15:00 at single dose for COVID-19 immunisation, and received cetirizine hydrochloride (ZYRTEC, lot# 1663312, expiry date: Jan2022) from unspecified date at unknown dose for unknown indication. Medical history included allergic rhinitis, blood cholesterol abnormal. Concomitant medications included atorvastatin for cholesterol, fluticasone propionate (FLONASE) for allergic rhinitis. The patient received her first dose on Friday (15Jan2021), about 3 o' clock in the afternoon. And she was experiencing an irregular heartbeat from yesterday (16Jan2021). Reported that on 16Jan2021 morning, she woke up and heart rate was all over the place. She was in bed and it was up to like a 101 already. She had also taken cetirizine hydrochloride the night before. So, she didn't know if that's the problem also. No treatment received for the event. The action taken for cetirizine hydrochloride was unknown. Outcome of event was not recovered.
Approximately one hour post vax, the pt experienced "some extremity swelling and her hand were cold to the touch and somewhat reddened. The pt sought unspecified medical attention. No further information is available.
It's been more than 36 days since caller got the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It's been more than 36 days since caller got the first dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (It's been more than 36 days since caller got the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It's been more than 36 days since caller got the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
4 days after the vaccine, severe muscle aches, fatigue, and nausea.  Also had gastrointestinal bloating and nausea.   These symptoms were severe for 3-4 days.
sore arm after the 1st shot; Patient got positive for covid after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient got positive for covid after receiving 1st dose) and INJECTION SITE PAIN (sore arm after the 1st shot) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Feb-2021, the patient experienced COVID-19 (Patient got positive for covid after receiving 1st dose). On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm after the 1st shot). The patient was treated with PLASMA at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient got positive for covid after receiving 1st dose) and INJECTION SITE PAIN (sore arm after the 1st shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included heart medication. Event included Sore arm .   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: TCR Document received on 15-JUN-2021 Contains Patient reported AE outcomes added, event was updated Sore arm .
5/1/09 - Vaccine administered - no adverse event during 15 min wait. 5/6/09 -Courtesy call follow-up - Pt reports rash and bumps under right breast and back - using hydrocortisone since 5/2/09. Pharmacist referred pt to her doctor (encouraged appt.). 5/20/09 - Courtesy call follow-up - conf. shingles by physician and was treated per pt.
Day after:  fever, chills, muscle aches, racing heart. Day 6:  severe abdominal cramps,gas, and diarrhea
Fever 105.5 to 106.5 for 48 hrs beginning 5 1/2 hrs per vaccine with no accompaning upper respiratory or gastric symptoms only extreme irritability and lethargy regardless of autipgretics which began to subside after 48 hrs and took 4 1/2 hrs before return to near normalcy. Appears to be but too soon to be certain.
Moderate Left upper mid back pain started less than 24 hours after injection. 7 days after injection pt had fully developed shingles in this area; This is a spontaneous report from a contactable Physician. A 39-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular route of administration on 16Dec2020 17:00 at single dose on left arm for COVID-19 immunization. Medical history was none. Concomitant medication included omeprazole. The patient had no other vaccine in four weeks. The patient experienced moderate Left upper mid back pain started less than 24 hours after injection on 17Dec2020 15:00. 7 days after injection (23Dec2020) the patient had fully developed shingles in this area. Treatment received included Valacyclovir tid (Three times a day) for 7 days. The outcome of the events was not resolved.   Information on the lot/batch number has been requested