chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ITCHING THAT GOES UP AND DOWN THE INJECTION SITE; LOOKED LIKE A LITTLE CUT AND RED AROUND INJECTION (LIKE SOMEBODY TOOK A SHARP BLADE TO IT); THE MUSCLE ON THE LEFT ARM HURT THAT SOMETIMES GOES DOWN THE ARM A LITTLE OR GOES UP NEAR SHOULDER; VERY TIRED AND FATIGUE; BURNING THAT GOES UP AND DOWN THE INJECTION SITE; This spontaneous report received from a patient concerned an 85 year old male. The patient's height, and weight were not reported. The patient's past medical history included: open heart surgery, pace maker, and covid-19 infection, and concurrent conditions included: non-smoker, alcohol use, penicillin allergy, and hard of hearing, and other pre-existing medical conditions included: The patient is taking medications for blood pressure, cholesterol, no illicit drug use. The patient experienced itching, shortness of breath, swelling of throat and welts when treated with sulfamethoxazole/trimethoprim, and warfarin sodium.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. Concomitant medications included lansoprazole for gastroesophageal reflux disease, and acetylsalicylic acid.  On 11-AUG-2021, the patient experienced itching that goes up and down the injection site. On 11-AUG-2021, the patient experienced looked like a little cut and red around injection (like somebody took a sharp blade to it). On 11-AUG-2021, the patient experienced the muscle on the left arm hurt that sometimes goes down the arm a little or goes up near shoulder. On 11-AUG-2021, the patient experienced very tired and fatigue. On 11-AUG-2021, the patient experienced burning that goes up and down the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from looked like a little cut and red around injection (like somebody took a sharp blade to it), itching that goes up and down the injection site, the muscle on the left arm hurt that sometimes goes down the arm a little or goes up near shoulder, very tired and fatigue, and burning that goes up and down the injection site. This report was non-serious.
Left arm sore evening after vaccination. Ran a low grade temp 100.3. Next day soreness, redness, and swelling spreading. Warm to touch.
Pt started having muscle pain in left leg  on 3/18/2021 went to hospital on 3/19/2021 had doppler done and confirmed blood clot in left leg. Pt has been started on Eliquis. Currently out of hospital and at home.
Adverse events are not related to the vaccine, though rather I contracted COVID. On 10/08/21, I started to feel a tension headache/migraine at the base of my skull, light headedness, pain emanating from above my nose towards my temples, runny noise, ticklish throat, and fatigue. On 10/11/21, I had diminished sense of smell and taste. On 10/12/21, I tested positive to COVID. By 10/18/21, other than the diminished sense of smell and taste, my health has resumed to what it was previously.
SHORTNESS OF BREATH; PERICARDITIS; This 60-year-old, female subject was participating in study and experienced shortness of breath and pericarditis.  The subject's medical history, as provided by the investigator, included anxiety, restless leg syndrome, seasonal allergies, and post-menopausal. Concomitant medications reported included fluoxetine, ropinirole, and cetirizine hydrochloride.  The subject previously experienced the SAE shortness of breath while participating in this study.  Prior to event onset, the subject received intramuscular mRNA-1273 (Dose 3, booster) for SARS-CoV-2 vaccination on 27 Oct 2021, approximately 10 months before onset of the event.   On 26 Aug 2022, the subject experienced shortness of breath and pericarditis and was admitted to the hospital. She had a pericardial window procedure and was treated, however, treatment information was not provided.  On 30 Aug 2022, the subject was discharged from the hospital for the event of shortness of breath.  On 05 Sep 2022, the subject was discharged from the hospital for the event of pericarditis.   The subject received all scheduled doses of study drug prior to the event of shortness of breath; therefore, action taken with study drug in response to the event was not applicable.   No action was taken with the study drug in response to pericarditis.  The events, shortness of breath and pericarditis, were reported as resolved on 05 Sep 2022.  The investigator assessed the event, shortness of breath, as not related to study drug and not applicable to study procedure.  The investigator assessed the event, pericarditis, as not applicable to study drug and not applicable to study procedure.  Follow-up received on 29 Sep 2022 included updated event outcome, end date, and hospitalization discharge date.   Follow-up received on 03 Oct 2022 and 05 Oct 2022 included additional event of pericarditis, updated causality of the study drug, and event end date of the event shortness of breath.   Company Comment: This case concerns a 60-year-old female subject with a medical history of anxiety, restless legs syndrome, seasonal allergies, and post-menopause, who experienced the unlisted event of shortness of breath, and the listed event of pericarditis. The events occurred approximately 2 years 18 days after the first dose of mRNA-1273 and 10 months after third (booster) dose. The events, shortness of breath and pericarditis, were reported as resolved. The event shortness of breath was considered not related to agreement with the investigator. The event might be explained by concurrent event of pericarditis. The investigator assessed the event pericarditis, as not applicable to study drug and not applicable to study procedure. The sponsor considers the event as not related due to long latency. Additional information was requested.
Patient's husband said patient passed out and had a seizure around 30 minutes after vaccine.  When I arrived at patient she was sitting up conscious.  Ambulance arrived and she was turned over to their care.
Low Blood Sugar; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOGLYCAEMIA (Low Blood Sugar) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, ALFUZOSIN, FUROSEMIDE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) and FLUTICASONE for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPOGLYCAEMIA (Low Blood Sugar). At the time of the report, HYPOGLYCAEMIA (Low Blood Sugar) outcome was unknown.        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 medication included K-Tab (10 mg), Trelegy, an Insulin Pump, and vrious Vitamins.  Treatment medication not reported.; 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.
right facial numbness and swelling-unsure if this is related to vaccine but reporting to be safe
Next day, patient after booster dose, mom reports patient became lethargic, had fever 102.0 and began vomiting. Fever was present upon rising, vomiting started 2 hours after taking seizure medication Oxcarbazepine. Fever lasted one day. Lethargy and vomiting persisted, worse after taking seizure medications for 3 full days. On day 4, mom only gave 1/2 dose of typical seizure meds and the patient did not have the lethargy and vomiting again. Mom suspects the Pfizer vaccine enhanced the blood level of her seizure meds. She has been on these seizures meds for 3 years with no problems.
13Nov90 pt vax w/ hepta B; devel non-raised, erythematous, pruritic rash on lower arms + around mouth.sx persisted.
Requested flu shot be given in hip due to previous problem last year after giving flu shot in arm had swollen axillary lymph nodes and very sore arm. Day after receiving flu shot in hip notice golf ball size knot in groin, back and leg pain. Saw MD who ordered urinalysis which was negative. Health department was notified. No reaction of this sort had been reported. Symptoms subsided and were gone within 2 weeks. Advised to confer with MD before receiving anymore flu shots.
I received my Covid 19 vaccine on 10/10/2022. 12/09/2022 I was feeling fatigue, occasional sneezing and cough with elevated blood pressure. I took a Covid test and was positive for Covid-19. I was prescribed blood pressure medicine for two weeks. Symptoms lasted.
Starting at 6pm on the same day of vaccination, I started to feel chills / body aches. Body aches worsened & fever onset around 7pm. Took extra strength Tylenol at 6:45pm, took daily indomethacin nighttime dose (50mg) at 9pm, and took Tylenol again at 12:10am as fever worsened. At 12:00, body aches were severe and fever was 104.4. At 12:45am (35 min after taking 3 extra strength Tylenol), fever was down to 103.9. Fever did not lessen until around 2am, when fever dropped to 100.5. By 9am on 4/16, fever was fully gone - experienced night sweats that soaked through clothing, sheets, and mattress protector. Nausea and headache mild on 4/16 into 4/17.
Information has been received from a physician concerning a either 15 or 16 year old female who was vaccinated with a dose of GARDASIL (lot number not available) on an unspecified date. Immediately following injection, the patient experienced faint. Subsequently, the patient recovered on an unspecified date. The patient sought unspecified medical attention. Additional information has been requested.
Broke out in severe hives two days after the shot. It lasted several days and I was put on steriods for treatment.
circular raised lesion, red, warm, no pain no streaks 5 x 6 cm
pretty sick from the last vaccine; felt bad; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (pretty sick from the last vaccine) and FEELING ABNORMAL (felt bad) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 095A21A and 089A21A) 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 24-Apr-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 ILLNESS (pretty sick from the last vaccine) and FEELING ABNORMAL (felt bad). At the time of the report, ILLNESS (pretty sick from the last vaccine) and FEELING ABNORMAL (felt bad) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-370441 (Patient Link).
Just before noon on 02/10/21, I noticed a rash on my chest. Nothing significant. I am prone to rashes and have a history of uticaria so didn't think anything of it. At 6:00pm that evening, I went to take a shower and saw that I had a large rash on my shoulders and upper back. Solid red, not splotchy. It looked like I was wearing a cape. Neither rash itched. I took a Benadryl, no change. The morning of 02/11/21, the rash was still there; it spread a bit on my chest and was not behind my right ear, also. Still no itching, no oozing, not raised or flaking. Prior to the rash, after the second vaccine dose, I had a 100.5 fever, chills, body aches, headache, and nausea. For the rash, I was prescribed triamcinolone 0.1% cream twice daily. By 02/14/21, the rash was virtually gone.
Pt had sudden onset abdominal pain necessitating visit to emergency room.  He was diagnosed with gallbladder attack.  He did not have previous history of gallbladder disease but US imaging did show thickened gallbladder.   He was treated with zofran, morphine and IV fluids and discharged home.  2 days later  he had diarrhea x 24 hours (day 4 after shot)
Third dose administerd of 0.30 ml instead of 0.25 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of OVERDOSE (Third dose administerd of 0.30 ml instead of 0.25 ml) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FH8020, 006B21A and 023M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .3 milliliter. On 12-Dec-2021, the patient experienced OVERDOSE (Third dose administerd of 0.30 ml instead of 0.25 ml). At the time of the report, OVERDOSE (Third dose administerd of 0.30 ml instead of 0.25 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2022-592899 (Patient Link).
Area app size of a half dollar of my arm was swollen, red, hot, itchy. Was given Cleocin to counteract reaction which I was allergic to (allergic reaction was severe inflammation) and within 6 weeks I got severe rheumatoid arthritis because of this!
Redness, itchiness at injection site 5 days post vaccination. Continues through today (2/16/21) but improving
I had a rash show up an hour after I got the vaccine. I have now had it for 2 weeks. I've been given 2 steroid shots in 10 days, prescription steroid cream, benadryl, and they now have me on Vistril.
Periods of dizziness and "blacking out." After EEG results we know now these are absence seizures. She also has debilitating chronic joint pain.
No adverse event - reporting Covid vaccine error.  Patient received Moderna vaccine for the first 2 doses.  Came to facility requesting a booster shot.  Patient indicated she had previously received Pfizer vaccine, but did not have her records.  Staff did not check the NC State Vaccine system to verify previous records prior to administration of the booster shot.  When recording the booster in the state system, nurse noticed that the patient had previously received Moderna.  Patient was monitored, but there were no adverse effects.  Patient instructed to call clinic with any problems.
Fatigue, severe diarrhea, nausea, abdominal/pelvic pain, headache
The evening following my vaccination I started heavily menstrating lasting 6 full days. Prior to this vaccine I have not experienced a period for 8 months as I have an IUD. I have experienced a monthly period every month since the vaccination.
tingling in fingers of both hands, more so with thumb and pointer finger.  started right after the injection.  lasted about 3 hours.  after that, temperature sensation altered in both hands.  anything that touched my hands felt hotter than it actually was.
This spontaneous report as received from an office administrative staff member refers to a 44 years old female patient with no medical history and no known drug reactions/allergies. The patient was vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX 23 on 08-OCT-2012. Lot # H0123972 (in validation), exp. date 09-MAR-2014. No other co-suspects were reported. Concomitant medications included hydrocodone, metformin, lisinopril, ARMOUR THYROID TABLETS, methotrexate and cyclosporine. On 08-OCT-2012, the patient's arm became very hard around the injection site, as well as very warm, and hot to the touch after receiving PNEUMOVAX 23. The patient was also unable to lift her arm above her head. The patient sought medical attention. No laboratory tests were performed. Treatment included KEFLEX. At the time of reporting the patient was recovering. Additional information has been requested.
Severe achy, severe headache, nausea, dizziness  lasting 4 days
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 66-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 19-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805537 was crossed linked to original cases 201804863 due to same reporter.
After the first dose I had no side effects but after the second dose I had various reactions: - about thirty minutes after the shot I developed a strange sensation on the left temporal area of my head extending to behind my eye. This went away after a few hours but when it started I thought of Bell's Palsy.  - Later my arm got extremely sore at the site of the injection it still hurts and in a large area of the arm 5 days later - Painful area below the left armpit and in an area about 3 inches in diameter (area of the lymph node). Still have pain although less after 4 days.
feels warm; itching; arm  is red; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feels warm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (arm  is red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FEELING HOT (feels warm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (arm  is red). At the time of the report, FEELING HOT (feels warm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (arm  is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information reported.
No additional adverse event reported; A nurse called to report that a expired VAQTA was administered to a patient on 27-OCT-2020; This spontaneous report was received from a licensed practical nurse concerning a 27-year-old male patient. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not provided.  On 27-OCT-2020, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) 1 dosage form (location and route of administration were not provided) lot number S030588 and expiration date 20-OCT-2020 for prophylaxis. No adverse events were reported.  Lot No. S030588 has been verified to be a valid lot number for Hepatitis A Vaccine, Inactivated (VAQTA), expiration date reported as 21-OCT-2020, but upon internal validation established as 20-OCT-2020.
tested + to covid between doses; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested + to covid between doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested + to covid between doses). At the time of the report, SARS-COV-2 TEST POSITIVE (tested + to covid between doses) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Client received the Pfizer 12 & up dose of vaccine instead of the 5-11 year old dose.
No additional AE; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 27-SEP2022, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #U012004, expiration date: 15-OCT-2022, administered for prophylaxis (strength and route of administration were not provided) reported also as hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W007371, expiration date: 13-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided). Administered dose of vaccine was stored in a temperature 34.5 F for 1 hour 7 minutes. Previous temperature excursion was 66.7F for 13 hours 52 minutes 0 seconds (product storage error). No additional adverse event was reported (no adverse event).  This is one of several reports received from the same reports. ; Sender's Comments:  US-009507513-2210USA005936:MSD US-009507513-2210USA005917:MSD US-009507513-2210USA005916:MSD US-009507513-2210USA005942:MSD US-009507513-2210USA005929:MSD US-009507513-2210USA005937:MSD US-009507513-2210USA005979:MSD US-009507513-2210USA005994:MSD US-009507513-2210USA005996:MSD US-009507513-2210USA006007:MSD
PATIENT PRESENTED WITH A GENERALIZED "RASH", SWELLING IN THE LEFT AXILLA, FEVER, HEADACHE
Tingling and pain in the neck with 1st and 2nd vaccine doses with ongoing neck pain and occipital headaches
TONGE FEELING THICK 25 MG BENADRYL ORAL GIVEN DECREASED SYMPTOMS
1148-c/o lightheadedness & dizziness, given 25mg diphenhydramine PO 1151-BP 130/90, P 69 O2 99% RR 24 1155-BP 132/87 P 70 O2 99 RR 16, states symptom resolved  1200-no complaints 1210-D/c to home
A lot of itchiness all over their body; Itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (A lot of itchiness all over their body) and VACCINATION SITE PRURITUS (Itchiness at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.   Concurrent medical conditions included Acid reflux (esophageal) and Irritable bowel syndrome.  On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site). On 08-Mar-2021, the patient experienced PRURITUS (A lot of itchiness all over their body). On 08-Mar-2021, VACCINATION SITE PRURITUS (Itchiness at injection site) had resolved. At the time of the report, PRURITUS (A lot of itchiness all over their body) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  The concomitant medications included acid reflux medication, antidepressant medication, irritable bowel syndrome medication, and probiotic used for an unknown indications.
Brief seizure following administration of vaccines. Information from medical records state limp, dusky, sinusitis, vasovagal episode. msv
Patient received the covid booster (bivalent) Moderna  on 9/19/22 ,  then his blood pressure went up on 9/20/22 .  Patient saw MD,   MD increased the  dose of Losartan and will follow up in in 2 weeks.
Soon after the injection of H1N1-patient felt faint, vom, h.a., crying, had to lay down for 10-15 mins before leaving.