chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 16-Jul-2022).    No concomitant medication information was provided.  The reporter administered the vaccine to the patient after the 30 day by used.  Patient received half dose.  The vial was initially stored in refrigerator on 04-Jun-2022.  The vial did not undergo any temperature excursions.  No treatment drug details was reported.
Child had intracranial cysts dx'd on 2/14/01. Child received vaccines 3 days before death, which was noted as asphyxia death (facial compression), face down sleeping position in bed with mother. Office felt this should be reported. Death certificate and autopsy reports states cause of death to be positional asphyxia.
patient received two doses of pfizer 12+ (gray cap) in different arms on 4-13-2022. patient waited 20 minutes afterwards. there were no adverse reaction during  that time.
Pt reported swelling in her right arm around the injection site. Area of injection is red, raised and pt is reporting it feels hot to touch. The area of swelling is approximately 5" in circumference. The following morning the pt reported the symptoms expanding to her lymph nodes resulting in swelling on the side of her body and her right breast. She also reported the fever and chills for about 12 hours after the injection but this went away the next day.
Evening of injection - left arm swollen, hard and hot to touch.  Very sore.   Chills, low fever and aches.   Difficult night.  Used Tylenol.  Day after - felt exhausted, aches, medium headache, very sore arm, low fever between 99 and 100 .  By evening realized left arm had a large red splotch about 4 in long and 2 in wide.  Used Tylenol for headache etc.  Following day -  Fever ,aches and headache gone.  Feel fatigued and arm has subsided somewhat, blotch still there  3rd day - feel normal except for still have a  somewhat sore arm, blotch is much paler.  I expect it to go away in another 24 - 48 hours.  This was the second dose.   At first dose my left arm was sore, warm and swollen for 2 - 3 days but no blotch.  Only other reaction was some muscle soreness in the left shoulder to neck area but often experience that with my flu annual shot.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 34-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 27-Apr-2021 at 9:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 9:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 34.57.  No concomitant medications were reported.  Batch number 007C21A administered on 27-Apr-2021 had  temperature 35 at 09:00. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 27-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. 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 Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported
Patient felt dizzy and nauseated few minutes after getting her 1st Pfizer dose. Mother stated her daughter didn?t eat anything since morning. 3 ice packs were used, 2 on her neck and 1 on her head. Two crackers and bottle water was offered. Blood pressure at 10:45am 107/66 Hg/mm. Blood pressure at 10:55 am  126/75 Hg/mm. She states I feel much better and no longer feel dizzy or nauseous.
some people had "reactions"; fever; cold chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (some people had "reactions"), PYREXIA (fever) and CHILLS (cold chills) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (some people had "reactions"), PYREXIA (fever) and CHILLS (cold chills). At the time of the report, ADVERSE DRUG REACTION (some people had "reactions"), PYREXIA (fever) and CHILLS (cold chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Soreness at site, redness and itching lasting (6) six days. Resolved without treatment.
MMR was drawn up and screening not completed. medical assistant placed mixed vaccine in freezer while asking questions so as not to leave at room temp vs placing in fridge. frozen MMR then given to patient, but could not be fully administered as it was frozen. When injection removed, about 1/2 of 0.5mL had been given.  No adverse outcome, patient ok. Given a full dose of MMR on same day per county health department
Vomited in car several times on way home from appt after receiving vaccines.  Had been well prior to appt.
Bilateral TMJ pain starting 3 days after injection. No tooth pain. Pt does have hx of grinding teeth at night prior to vaccine administration but did not complain of the TMJ pain until afterward.
delayed second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (delayed second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (delayed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (delayed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got monoclonal antibodies on 27JUL2021, wants to know if there is any interactions and do still need to wait the 90 days even though it is the second dose? No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
sore arm after receiving a flu shot; Their arm is sore and hard to lift up; felt the injection burning; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case from a consumer (Physicians Assistant).  This case involves a 70 years old female patient who experienced sore arm after receiving a flu shot (pain in extremity), arm is sore and hard to lift up (injected limb mobility decreased) and injection burning as it went in and it has not gone away (vaccination site pain), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ285AB and expiry date: 06-May-2020) via unknown route in unknown administration site.  On an unknown date, the patient experienced sore arm after receiving a flu shot (pain in extremity), felt the injection burning as it went in and it has not gone away (vaccination site pain) and arm is sore and hard to lift up (injected limb mobility decreased) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab data was reported.  Final diagnosis was pain in extremity, injected limb mobility decreased and vaccination site pain.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as not recovered for all events.
Six days after her first vaccine patient became lightheaded. She presented to Hospital where she was found to have bilateral pneumonia with ground glass opacities, AKI and severe hypertension-systolic BP 200. She was admitted and began a steady downhill course intubated 5/5/21. Transferred to another hospital and seen by multiple specialists. On ventilator with kidney  support. Repeated cultures negative for bacterial infection although pressors needed to maintain BP. Kidney biopsy showed vasculitis. Patient died with catastrophic multiorgan failure 5/26/21. Autopsy lists cause of death as pneumonia complicated by antiphospholipid Syndrome.
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported itching and injection site redness. Vital signs within normal ranges except heart rate 102 beats per minute. Patient administered oral diphenhydramine and observed. Symptoms improved and repeat vital signs all within normal ranges. Patient was discharged from vaccine clinic stable with symptom improvement.
Patient was vaccinated in left deltoid on 9/3/15. Patient presents today, Friday (9/4/15), with rash on her right outer hip and slight stomach pain upon awakening. After questioning, she stated that the rash was warm to the touch and had about 5 "pimple-like" bumps that were closer to her inner thigh/groin area. Patient denies fever, difficulty breathing or itch. Patient states she gets the influenza vaccine every year and has never had a reaction. Patient states she takes a Benadryl nightly to help her sleep and took one Thursday night after vaccination.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 13th July 2018, the patient received SHINGRIX. On 14th July 2018, 1 days after receiving SHINGRIX, the patient experienced rash. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the rash was recovering/resolving. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient noticed the rash next day after receiving the SHINGRIX, which was below the injection site. The rash was treated with cortisone cream which made it lighter.
He started having discomfort on the left chest, around the heart area; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (He started having discomfort on the left chest, around the heart area) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A, 042L20A, 065F21A and 045L21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD (10 years ago, Taking Inhalers) and Blood pressure high (diagnosed about 25 years ago under control with HBP medicine.). Concomitant products included CHLORTALIDONE (CHLORTHALIDONE), LISINOPRIL, TERAZOSIN, BISOPROLOL, SPIRONOLACTONE, OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) and CICLESONIDE (ALVESCO) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced CHEST DISCOMFORT (He started having discomfort on the left chest, around the heart area). At the time of the report, CHEST DISCOMFORT (He started having discomfort on the left chest, around the heart area) outcome was unknown.            It was reported that patient started having discomfort on the left chest, around the heart area. Doctor did not find anything. The doctor reduced his blood pressure medications. He stated that his COPD and Blood pressure did not get any better or worst after vaccination.    This case was linked to MOD-2022-660909 (Patient Link).
Pfizer vaccine reconstituted with 0.8 ml vs 1.8 m. of diluent.  Patient received a more concentrated dose. On 6/12 patient was notified of issue.  RN called patient who reported the following, reports feeling well at this time, denies any sxs of anaphylaxis or SE of Pfizer, pt speaking in full sentences.Informed pt we do not expect he will experience any adverse effects but we will still monitor and check in with him, reviewed expected SE of the COVID Pfizer vaccine and how to manage them. Writer reviewed with red flags when needing to seek ED level of care. Patient called again on 6/13 and reports the following: reports feeling well today, no rash at injection site, arm is a little sore but thats it, no other symptoms. Advised wil call tomorrow, pt verbalized understanding. On 6/14 patient contacted and reports,  Patient reports he is feeling well.
I developed stomach issues and originally went to the doctor and they told me to try omeprazole. They did a CT scan that didn't show anything. I was sent to an gastroenterologist, they did an endoscopy and colonoscope and they found more water than usual is how they worded it in regards to what was found. They also did a gastro emptying study and I was diagnosed with gastroparesis.
To Whom It May Concern:  Dear Sir/Ma?am:  Good day. I am emailing to report a possible adverse event/s for the COVID-19 Vaccine(Moderna), that I had last February 18, 2021, at 8:45 am. I was fine the entire day of Thursday, February 18, 2021, until Friday afternoon, but on Friday evening of March 19, I had chest pain, palpitations(reached 130), my lips, legs, and arms trembled, and my b/p reached 188/89. Because of muscle pain localized in the chest, and as I just had the vaccination less than 48 hours earlier, I was compelled to rush to the ER to make sure it was not a heart attack. During the ER Consult, my Potassium Level was low. I feel that we have to look into the causality if the vaccine could also cause hypokalemia. Additionally, I had the same symptoms last Saturday evening(February 20) evening around 8pm. I had to call a friend to stay with me as my b/p reached 193/93. It subsided around midnight:116/72. Last night and today, I still feel mild chest pains.  I am looking forward to hearing from you.  Thank you.  Yours sincerely, P.S.  I sent an email last February 22, 2021, but I did not receive a reply.
Bilateral tinnitus increased in volume.  I have had tinnitus all of my life but it was only audible in a very quiet room.  Now I hear it all of the time, and it is noticeable even in noisy situations.  My tinnitus got louder with the first vaccine but only for about 48 hours.  I am 37 days post-second vaccine and the louder tinnitus seems to be here to stay.  (Also, I am an audiologist so I am well versed in tinnitus.)
Was diagnosed with Halo Nevi; This spontaneous case was reported by a patient and describes the occurrence of MELANOCYTIC NAEVUS (Was diagnosed with Halo Nevi) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 001A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Seasonal allergy (Allergy since patient was a kid.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-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 MELANOCYTIC NAEVUS (Was diagnosed with Halo Nevi). At the time of the report, MELANOCYTIC NAEVUS (Was diagnosed with Halo Nevi) outcome was unknown.            Patient's birth year was provided as 1959.  No concomitant medication were given.  Halo Nevi which patient said was an auto immune disease in which white spots around the moles and skin eats the moles.   No treatment information were given.   This case was linked to MOD-2022-629961 (Patient Link).
Patient returned to vaccination POD after developing tongue swelling within one hour of vaccine administration Patient took her own Benadryl with resolution of symptoms.
Itchy rash  developed around the site of the shot 6 days after receiving the vaccine.   (2/10)   Still present on 2/15.     3-4 inches wide, 5 inches length.
PAID NURSE AT PHARMACY DID NOT DILUTE VACCINE PRIOR TO ADMINISTERING ORANGE CAP PFIZER TO 8 YEAR OLD CHILD. CHILD IS WITHOUT NOTICEABLE SIDE EFFECTS AT TIME OF DISCOVERY.
Pt came to ER with abdominal pain, onset 2 weeks prior. Nausea.
Woke up the next morning with chills, body aches, and low-grade fever. Sick for only 1 day.
Left arm cellulitis developed 24 hours after injection, started under --- and moving to forearm.
Very painful at time of vaccine administration. Woke up in the middle of the night (1am) feeling feverish. I would switch back and forth between being overwhelming hot to having chills. Nauseated, muscle aches all over, headaches, exhaustion, and slight dizziness when standing up.
After receiving the first dose of the Moderna vaccine, I had a very minor, dull headache - pressure behind my eyes and left side of my head.  My body felt fatigued and sore like I had a very intense workout where my muscles were burning from exertion.  These all subsided after about a day and a half.  Exactly 8 days later, my left arm (same injection arm but NOT at the injection site) felt itchy.  When I looked at my arm, there was a huge, oval shaped, red, swollen, hard bump on the front of my shoulder.  The skin also felt very leathery.  I wasn't sure what was going on and it was Friday and my doctor's office had already closed.  I spoke with a pharmacist where our family gets prescriptions and he asked if I had any other types of symptoms.  I did not.  He said had not heard of this type of reaction from the vaccine this many days later and directed me to call my primary care if it didn't clear up in a couple of days.  It did clear up.  First the leathery skin went away the next day, followed by the redness and swelling and then after a couple of days it still felt slightly itchy but visually, the location looked like my normal skin.  I did not contact my doctor because coincidentally, that weekend, I saw an article pop up on my phone about Covid arm and the description was identical to what I experienced.  I will mention it to my doctor when I go in for my second dose but figured I would report it on .
Information has been received from a health professional concerning a 7 year old female pt who on 06/04/1997, was vaccinated with a dose of varicella virus vaccine, live. Subsequently, on  approximately 04/27/2004, the pt developed breakthrough chickenpox with 50-500 lesions. Follow up information indicated that "there was not a single report of adverse reaction following varicella vaccination.  The reporter indicated that 49 other patients developed breakthrough cases of chickenpox (WAES # 0405USA02615, 0405USA00572, 0405USA00573, 0405USA00574, 0405USA00575, 0405USA00576, 0405USA00577, 0405USA00578, 0405USA00579, 0405USA00580, 0405USA00581, 0405USA00582, 0405USA00583, 0405USA00584, 0405USA00585, 0405USA00586, 0405USA00587, 0405USA00588, 0405USA00589, 0405USA00590, 0405USA00591, 0405USA00592, 0405USA00593, 0405USA00594, 0405USA00595, 0405USA00596, 0405USA00597, 0405USA00598, 0405USA00599, 0405USA00600,  0405USA00601,  0405USA00602,  0405USA00603,  0405USA00604,  0405USA00605,  0405USA00606,  0405USA00607,  0405USA00608,  0405USA00609,  0405USA00610, 0405USA00611, 0405USA00612, 0405USA00613, 0405USA00614, 0405USA00615, 0405USA00616, 0405USA00617, 0405USA00618, and  0405USA00619). No additional information is expected.
Information has been received from a consumer concerning unspecified patients who on unspecified dates were vaccinated with doses of RECOMBIVAX HB. The consumer commented: "Was it true you made the hepatitis B shot they caused multiple sclerosis that you made the medicine that helped with sclerosis." At the time of the report, the patients' outcome was unknown. Upon internal review, multiple sclerosis was determined to be an other important medical event. This is one of the several reports received from the same source. No further information is available.
Child experienced a seizure lasting about 2-3 minutes the morning after getting vaccinated. Had a fever of 104 or higher.