chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(Felt like she had a cold) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Arm was swollen, hot, red, itchy), DRY THROAT (dry throat), PAIN IN EXTREMITY (Arm was really sore/both arms got really large, swollen, and hurt), BLISTER (Her arm just got huge, they were blister-looking), NASOPHARYNGITIS (Felt like she had a cold), VACCINATION SITE PRURITUS (Arm was swollen, hot, red, itchy), VACCINATION SITE ERYTHEMA (Arm was swollen, hot, red, itchy), VACCINATION SITE SWELLING (Arm was swollen, hot, red, itchy/both arms got really large, swollen), FATIGUE ("tired, doesn't want to expand energy, general tiredness") and MYALGIA ("bones achy, feel washed out"). The patient was treated with PARACETAMOL (TYLENOL) at a dose of every 6 hours for 3 doses. At the time of the report, VACCINATION SITE WARMTH (Arm was swollen, hot, red, itchy), DRY THROAT (dry throat), PAIN IN EXTREMITY (Arm was really sore/both arms got really large, swollen, and hurt), BLISTER (Her arm just got huge, they were blister-looking), NASOPHARYNGITIS (Felt like she had a cold), VACCINATION SITE PRURITUS (Arm was swollen, hot, red, itchy), VACCINATION SITE ERYTHEMA (Arm was swollen, hot, red, itchy), VACCINATION SITE SWELLING (Arm was swollen, hot, red, itchy/both arms got really large, swollen), FATIGUE ("tired, doesn't want to expand energy, general tiredness") and MYALGIA ("bones achy, feel washed out") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. In second follow up patient stated that checked vital signs and pulse oximeter level and her oxygen has been normal.   This case was linked to MOD-2021-031020 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up received on 12 Jul 2021. The event verbatim, anatomical location and narrative was updated. An additional event nasopharyngitis was also added. On 19-Jul-2021: Follow-up information received on 19 Jul 2021 contains significant information. added medical history COPD, added events myalgia, fatigue, nasopharyngitis, dry throat.
Blood in the stool; Hives all over her legs/Hives spread to arms and lips; Chills; Body aches; Fever 100F; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in the stool) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever 100F). On 31-Aug-2021, the patient experienced HAEMATOCHEZIA (Blood in the stool) (seriousness criterion medically significant) and URTICARIA (Hives all over her legs/Hives spread to arms and lips). On 30-Aug-2021, PYREXIA (Fever 100F) had resolved. At the time of the report, HAEMATOCHEZIA (Blood in the stool), URTICARIA (Hives all over her legs/Hives spread to arms and lips), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, Body temperature: 100 (High) 100F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient experienced fever, chills and body aches.On 31 Aug 2021,in the morning she noticed hives all over her legs but there were no itching and in the evening the hives were also on her arms and lips.No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
NO ADVERSE AFFECT EXPERIENCED BY PATIENT.  TD ADMINISTERED TO PATIENT ON THE 23JUN21.  EXPIRED ON THE 06JUN21.  ADVISED BY PHARMACY OFFICER THAT VACCINE IS NOT VALID AND MEMBER WILL HAVE TO RECIEVE A NON EXPIRED DOSE.
defer second dose of vaccine; contracted COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (contracted COVID-19) and OFF LABEL USE (defer second dose of vaccine) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 14-Feb-2021, the patient experienced COVID-19 (contracted COVID-19). On an unknown date, the patient experienced OFF LABEL USE (defer second dose of vaccine). At the time of the report, COVID-19 (contracted COVID-19) and OFF LABEL USE (defer second dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received monoclonal antibodies infusion approximately 17-Feb-2021 or 18-Feb-2021. No concomitant medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Email from reporter: no idea what this is regarding.
Day of injection I felt alright, some arm soreness as the day went on and ended with a touch of dizziness. Day after injection, I woke up with fever chills, shivering, couldn't get warm. But around 2 in the afternoon it subsided and I was feeling a bit better. Day 2 after injection, in the shower, I noticed my lymph nodes on my armpits were a bit swollen and tender to the touch.
This spontaneous case, initially received (combinedly processed with follow-up received on 11-Oct-2018) from other non-health professional (consumer) on 05-Oct-2018, concerning a 14-month-old, male infant patient. The patient had no medical history and concomitant medications. On 04-Oct-2018, the patient (under 4 years age) administered FLUCELVAX QIVc [dose: 0.5 ml, batch number, 252657, expiry date: 31-May-2019, route of administration, anatomical location: not reported]. On the same day, after vaccination, the patient was uncomfortable overnight, crying and the injection site was swollen. No treatment was received. At the time of this report, the outcome of the events (discomfort, crying and injection site swelling) was not reported. The reporter assessed the case as non-serious.
Anaphylactic Shock; rapid heart rate; injection site redness; injection site soreness; body ache; troble swallowing; diarrhea; A Spontaneous report was received from a consumer concerning a 40- year-old , female patient, who received Moderna's COVID-19 vaccine (mRNA)and experienced Anaphylatic shock, diarrhea, injection site soreness and redness.  The patient's medical history was not provided and allergies included allergic to latex. No concomitant medication was reported.  On 21 Jan 2021, approximately 25 minutes prior to the onset of events, the patient received their first  of two planned dose of mRNA-1273(lot number-012L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, prior to receiving mRNA-1273, after 25 minutes the patient experienced anaphylactic shock and the symptoms during shock include rapid heart rate, trouble swallowing and passing out. The patient was rushed to hospital and was intervened with Epinephrine and Benadryl.  The action taken with mRNA-1273 in response to the events was unknown.  The events anaphylactic shock, body ache , diarrhea, injection site soreness and redness are not resolved.; Reporter's Comments: This report concerns a 40--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273) (Lot #012L20A) and experienced anaphylactic shock, diarrhea, injection site soreness and redness. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Saturday morning my daughter did not feel well. I had been anticipating this because of her vaccine she got the few days prior. She got more and more upset, and I realized she had a fever. When I checked it, it was 104 F. I put a cool wet cloth on her forehead, and gave her a dose of TYLENOL. I wasn't too worried about her fever being so high because she was willing to drink fluids, and she was responding normal. I held her on the couch after giving her TYLENOL, and she fell asleep. I checked her temperature every 15 minutes or so as she slept in my arms. Her fever went down to 101. She was sleeping when she started whining/crying. She opened her eyes then her eyes rolled back and she went completely limp. I sat her up immediately trying to get her to respond. She woke up immediately and started vomiting. She continued to vomit throughout the day with a fever of about 100. She was responsive the rest of the day, and drinking fluids so I did not take her to urgent care.
Deep muscle pain and joint pain on hips, knees and ankles. No joint pain above the waist. No pain in a sitting or standing position. the pain happens at night when lying down often followed by cramping and "charlie horse"  symptoms. This has lessened somewhat after 2 weeks, but it does still happens. Really considering declining the second vaccine as that is reported to be much more likely to have side effects.
This spontaneous report was received from an administrator reporting on multiple patients of unknown age or gender. No information regarding the patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (doses, lot numbers or expiration dates were not reported), for prophylaxis. The temperature excursion ranged from 0 to 1 degree Celsius and lasted for 57 hours 25 minutes. It occurred once on an unspecified date and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA004567: US-009507513-1706USA002610:
death NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) Pulmonary emboli (CMS/HCC) Acute kidney failure, unspecified Thrombocytopenia, unspecified
Medial surface (L) arm midway between elbow and shoulder has non raised light red area about 25 cent (quarter) sized. Tender to touch, smooth. Also 1 inch reddened line just below on same surface, not connected. Fatigue, headache.
Hospitalization: 12/1/2022 - 12/3/2022 (2 days) Presentation to the ED: dizziness post fall and head injury x 3 weeks ago.  COVID + date: 12/1/22 Treatment: no treatment specific to COVID.  Discharge to: home.   031L02A 2/11/2021 Moderna  027A21A 3/11/2021 Moderna
Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 030M20A, 037C21A and 005M21A) for COVID-19 vaccination.     Concurrent medical conditions included Exposure to poison ivy (Poison ivy), Latex allergy and Adhesive tape allergy. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and TRAZODONE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (Covid-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: (Negative) Negative.  The patient was ready to get new booster. The patient got COVID-19 for her daughter, son-in-law and granddaughter who came from a trip.  The height was 152.4 cm 95 feet).  The patient had no history relating to mentioned AE and both acute and chronic illness.   This case was linked to MOD-2022-660892, MOD-2022-660889 (Patient Link).
slightly sore arm/slight arm soreness/sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (slightly sore arm/slight arm soreness/sore left arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L21A, 041B21A, 016M20A and 041620A) for COVID-19 prophylaxis.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (slightly sore arm/slight arm soreness/sore left arm). At the time of the report, VACCINATION SITE PAIN (slightly sore arm/slight arm soreness/sore left arm) outcome was unknown.            The patient experienced slightly sore arm/slight arm soreness/sore left arm after 1st dose (16/Jan/2021), 2nd dose (13/Feb/2021), first booster (19/Aug/2021) and second booster (27/Apr/2022).  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662126 (E2B Linked Report). This case was linked to MOD-2022-661802 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662126:Same reporter
Cancer; This spontaneous case was reported by a non-health professional and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. An autopsy was not performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NEOPLASM MALIGNANT (Cancer) to be related.    It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The suspect product dosage text was reported as unknown. No concomitant medication was reported. It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine was poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors were part of it along with Moderna. No treatment medication was reported.  This case contains information about patient 25th out of 25 patients.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the Fatal serious (due to medically significant) unexpected, event of Neoplasm malignant, which occurred after the mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The patient died on an unknown date, and it is unknown whether an autopsy was performed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:Master case; Reported Cause(s) of Death: Cancer
C/O pain.  In am 30 March 2012 site examined and induration noticed  4.2 X 2.8.
some oral issues; she got a golf ball size on her arm; she got a golf ball size on her arm with itching; redness somewhat there and it's going down; back of her tongue is now white with patches; 3rd shot felt a little different on the arm.; fatigue; pain in her joints; brain fog; papules on her mouth; This is a spontaneous report from a contactable other HCP (Patient). A 75-year-old immunocompromised female patient received bnt162b2 (BNT162B2 formulation; Solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included immunocompromised, chronic lyme and Low Antibodies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported and other products was not provided. Historical vaccine included first dose and second dose of bnt162b2 on an unknown date for covid-19 immunisation. It was reported that the patient antibodies were very low and her doctor was very concerned and told her to get the third dose as soon as she could as she was at high risk. The patient experienced some oral issues, she got a golf ball size on her arm with itching and redness somewhat there and it's going down, back of her tongue was now white with patches, 3rd shot felt a little different on the arm, fatigue, pain in her joints, brain fog and papules on her mouth on an unknown date. The patient got the third dose because the vaccine didn't give her the immunity as her doctor expected. The patient wanted to know if oral issues have been reported to see if the side effect she experienced was just a coincidence because she's also on a lot of different things and have a lot of other issues. The patient stated that her mouth isn't irritated. The patient glad that there were no major issues that popped up with the Comirnaty vaccine. The patient asked as anyone had oral issues with the 3rd shot, she didn't have it with the first 2 or was there a study saying people having this. The patient battling chronic Lyme (medical history) and was on a regime and was on natural things at the moment. The patient had different reaction than she did with the first 2 dose. The patient stated, she had fatigue and pain in her joints already so it's hard to tell if it's one thing or something else. Patient stated her mouth was something different and she had some irritation due to a change of one thing. States she needs to go to the dentist or if she was having problems not to go today. The patient stated its confusing right now. The outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Initial and follow-up information has been received from a physician concerning a 5 year old female with a history of febrile seizure at 6 months of age and no allergies who on 30-JUL-2007 at 11:00 was vaccinated in the left arm with a 0.5ml subcutaneous dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Lot # 655414/1470F).  There was no concomitant medication.  There was no illness at the time of vaccination.  On 13-AUG-2007 the patient had a generalized seizure while in daycare.  The seizure happened about two weeks after the child was vaccinated with MMR II.  The seizure included rolling of the eyes and body jerking and lasted for about 1.5 minutes.  The patient developed a fever of 101.6 degrees Fahrenheit the following day, on 14-AUG-2007 (also reported as the patient had no fever).  Unspecified medical attention was sought.  On 15-AUG-2007 the patient fully recovered.  There was no product quality complaint involved.  No further information was provided.  Upon internal review, the event of seizure was determined to be an other important medical event.  Additional information is not expected.