chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOT FLUSH (Hot flashes), SLUGGISHNESS (Sluggish), ABDOMINAL DISCOMFORT (Swishy stomach), DIZZINESS (Dizzy) and PAIN IN EXTREMITY (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HOT FLUSH (Hot flashes), SLUGGISHNESS (Sluggish), ABDOMINAL DISCOMFORT (Swishy stomach), DIZZINESS (Dizzy), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain in her right arm) and NAUSEA (Nausea). On 06-Mar-2021, the patient experienced PARAESTHESIA (Tingling in both arms / Tingling in right leg / Tingling in the neck / Tingling in the back). The patient was treated with HYDROXOCOBALAMIN (VITAMIN B12 [HYDROXOCOBALAMIN]) for Symptomatic treatment, at an unspecified dose and frequency and VITAMIN C [ASCORBIC ACID] for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (Hot flashes), SLUGGISHNESS (Sluggish), ABDOMINAL DISCOMFORT (Swishy stomach), DIZZINESS (Dizzy), PAIN IN EXTREMITY (Sore arm), PARAESTHESIA (Tingling in both arms / Tingling in right leg / Tingling in the neck / Tingling in the back), MYALGIA (Muscle pain in her right arm) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood pressure measurement: high (High) High. On 06-Mar-2021, Glycosylated haemoglobin: elevated (High) Elevated.. On 06-Mar-2021, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information also included to take more fluids.
Mother  reported fever symptoms, mild widespread rash that she felt was similar to measles based on Internet research
My father, who at 80 was walking 2 miles a day and had just had a  check up within the month consisting of an MRI, cardiac monitor and lab work which gave him essentially a clean bill of health felt fatigued after his second Moderna shot. 11 days after his second dose he took an afternoon nap  and was found dead by my mother and myself.  We are devastated. The time frame so close to his second moderna shot can not be ignored. We want no one to suffer a loss such as this if the vaccine was a catalyst. Full autopsy is ongoing, no know cause with initial results.
Redness, swelling, itching to L deltoid x 2 days. Tx with OTC BENADRYL, cool compress.
This spontaneous report was received from a Licensed Practical Nurse referring an unknown number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not provided. The Nurse reported that the patients were administered improperly stored doses of VARIVAX (Lot # reported as M012991, Exp date: 14-MAR-2018 and Lot # reported as M005974, Exp. date: 02-FEB-2018) on unknown dates "since last week" (prior to 29-JUL-2016). She also reported that excursion details were not yet available. The report was due to a data logger. No adverse events were reported. There was not a product quality complaint involved. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot number M045401 with expiration date on 14-NOV-2018, for prophylaxis (dose, route of administration and anatomical location were not reported) with a well storage sterile diluent. The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (53.5°F) for 2 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. Sender's Comments: US-009507513-1802USA013807: US-009507513-1802USA013806.
Vaginal bleeding as of mental cycle is about to begin the last 24 hrs; This is a spontaneous report from a contactable Consumer (patient herself). A 38-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Apr2021 at 07:45 am (at the age of 38-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No known allergies were reported. No other vaccine was administered in four weeks. Other medications in two weeks were none. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient reported that, vaginal bleeding as of mental cycle is about to begin the last 24 hrs on 15Apr2021. Treatment was received for the event (unspecified). Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax & 30 mins p/vax exp anaphylaxis, eyes swollen, hives, raspy breathing; pt was seen by MD & treated w/DPH & Susphrine; sx resolved w/in 1 1/2 hrs; poss allerg react;
Patient was potential anaphylaxis from PEG (polyethylene glycol) and Polysorbate 80; Initial information regarding an unsolicited valid serious case was received from the other health professional via Agency (Reference number- 00638599) and transmitted to Sanofi on 13-Jun-2021.  This case involves an 80 year old patient (gender unspecified) who experienced potential anaphylaxis from PEG (polyethylene glycol) and polysorbate 80 (anaphylactic reaction), after patient received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  On an unknown date, in September 2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number, expiry date and other dosing details] for prophylactic vaccination.  On an unknown date, the patient developed a serious potential anaphylaxis from PEG (polyethylene glycol) and Polysorbate 80 (anaphylactic reaction), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  At the time of report, the patient was more than 80 year old and was on-hold for a corona virus disease (COVID) vaccine due to potential anaphylaxis from PEG (polyethylene glycol) and Polysorbate 80 and wanted to know if either of these ingredients is in FLUZONE HIGH-DOSE and additionally, if PEG is an ingredient then wanted to know the molecular weight.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the event outcome was unknown for the anaphylactic reaction.  Information on the batch number was requested.; Sender's Comments: This case involves an 80 year old patient who presented with anaphylactic reaction after the administration of HIGH-DOSE QUADRIVALENT. Time of onset is unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Subject received the second course of GARDASIL vaccine on 3/27/2008.  He experienced pain at the injection site, grade 2 on 3/27/08 through 3/29/08.  Then on 3/29/08, he experienced muscle strain grade 2, while performing his yoga routine in the same muscle that was sore from the injection site.
Numbness on left arm all the way to fingertips, left side of chest, left side of neck, lower left side of face
Received injection 5/1/2018 1700. Awakened next am with extreme pain R deltoid area. By 1600 on 5/2 had chills, shakes and nausea. For the next 2 days I was extremely nauseated, shakes, chills, subjective fevers, only drank 1 glass of water each day. I was dizzy upon sitting or standing and was in bed for these days. On 5/4 I had explosive diarrhea x4 but was able to start sm. amts. fluid. I was able to start solid foods on 5/6. I did report my adverse reaction to Dr. 5/9 and she sent me a reply stating that I had an allergic reaction.
Information was received by a pharmacist regarding a female of unknown age who received GARDASIL9 on approximately 22-FEB-2017 (reported as 3 weeks ago)( lot number, dosage and route of administration was not provided). The patients medical history and concomitant medications are unknown.  On a unspecified date in 2017, "the patient began to experience pain along the back of her muscle". The pharmacist also stated that "the pain was not at the injection site where the GARDASIL 9 was administered".  The patient has not recovered. No treatment was received. No further information was provided. Additional information has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 72-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. On 18-Oct-2018, the patient was administered FLUAD (TIV) which underwent temperature excursion (route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported). At the time of this report, no adverse event was reported. This case 201805449 was crossed linked to the original case 201804863 due to same reporter.
Ringing in my ears and feeling flushed.  Not serious, but friends insisted I report it.   I didn?t go to the Doctor or feel I required any care.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and gender. On an unknown dates the patients were administered unspecified number of doses of GARDASIL that were improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
LEFT ANTERIOR THIGH WITH 5CM RED, INDURATED AREA. INDISITINCITVE BORDER
No adverse event; Patient received a full third dose and 1st booster dose , Patient was not immunocompromised; Patient received a full third dose , Patient was not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received a full third dose , Patient was not immunocompromised), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a full third dose and 1st booster dose , Patient was not immunocompromised) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033R212A, 062E21A, 012A21A and 041L21A) for COVID-19 vaccination.     Family history included Immunocompromised (Patient stated his immunocompromise wife) since an unknown date. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) from 01-Sep-2021 to an unknown date for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 27-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 22-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient received a full third dose , Patient was not immunocompromised). On 27-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a full third dose and 1st booster dose , Patient was not immunocompromised). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Patient received a full third dose , Patient was not immunocompromised), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a full third dose and 1st booster dose , Patient was not immunocompromised) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.         Patient had no Allergies with medications, food and other products.   Patient had no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-026251.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026251:Dose 2
Just after I was given the injection and sat in my vehicle I felt a sharp pain in the back of my right hip. It felt like when I make love and I was about climaxing that sensation that I have is the same sensation but this hurts and it keeps coming back.
Redness and itching at injection site immediately following injection. BENADRYL 50 mg PO given. Prednisone 60 mg PO given for persistent upper body itching.
Patients vaccinated using old vial from 03/10/21; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) 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 drugs were not provided. Treatment drugs were not provided   This case was linked to MOD-2021-208074, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258682, MOD-2021-258689, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258703, MOD-2021-258704, MOD-2021-258706, MOD-2021-207548 (Patient Link).
About 6pm in the evening of the vaccination date, the patient noticed swelling at the elbow on the vaccination arm. The arm continued to swell, it became hard on the outside of the elbow and was bulbous on the inside of the elbow. Redness spread from the tricep down to the wrist. The injection site was not actually showing signs of adverse events. The morning after vaccination the patient woke up with very achy joints all over body. The patient went to the emergency room and was treated with IV antibiotics then sent home with oral KEFLEX 500mg 1 QID. The patient stated pain was never higher than a 1 on pain scale but inflammation was a 10. There were no fevers, nausea, vomiting, diarrhea or upset stomach. Patient was given ibuprofen 600mg tablets for pain/swelling, he only used this for a day then D/C the medication after it was messing up his stomach. After 6 days, the patient is finishing the antibiotic and the swelling as reduced but the redness persists, although getting better.
Lingering headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EL3247) at the age of 37 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FISH OIL. The following information was reported: HEADACHE (non-serious) with onset 15Mar2021 12:00, outcome "recovered" (Mar2021), described as "Lingering headache". Therapeutic measures were not taken as a result of headache.  Additional information: It was reported that The awareness date is 15Mar2021 for adverse event report, which is 4 days after my 1st vaccine. The patient did not receive any other vaccines within 4 weeks, since the vaccination, the patient has been not tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination:tri-lo-sprintec, centrum multivitamin, fish oil.  Prior to vaccination, the patient was not diagnosed with COVID-19. No Allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Patient was administered 0.5 mL of Moderna (conc=100mcg/0.5 mL) instead of booster dose (#3)  of 0.25 mL. Pt. was observed for 30 minutes post administration with no untoward effects. Pt. notified when error was recognized in evening of 12/7/2021. No related symptoms. Checked again on 12/8/2021 - feeling well. No follow up necessary.
The actual injection was very painful, more so than any other I've experienced. Within a few hours,  the injection site was extremely sore.  I at first assumed that it may be a similar reaction to how one feels after a flu-shot (tenderness, etc.) but this pain went well beyond tenderness. My arm was swollen, it clicked on the inside when I moved it and I could not raise it over my head without it taking my breath away.  I called/contacted/visited the doctor several times. He administered steroid shots which helped but the pain returned as soon as the shot wore off. It is now constant. It affects everything that I do. It never goes away.  I wake from it.  I dream about it.
Vaccine OK on Tuesday - Wed a little redness started and got larger with soreness and swelling. Thursday was less, now much better. Has a nickel size ecchymotic area but erythema subsided. Still sore.
Client was here for her first dose of Pfizer, received at 1325 to her RD. At approximately 1343, she c/o feeling flushed and dizzy to the Charge RN, who responded immediately to provide care. RN had the client lie down on the cot and provided her some juice. The client was able to transfer herself and drink the juice without issue. She reported that she?s had similar reactions in the past, that this one was mild, and that her symptoms resolved upon lying down. VS at 1343 were: BP laying 100/60, HR 70, SPO2 100% RA, RR 20. The client had slight diaphoresis, but no pallor. No LOC was noted. The client reported that her baseline BP is ?low?. This writer, RN, also responded at this point. At 1349, the client?s sitting BP was 110/60, HR was 80, SPO2 was 100% on RA, and RR was 18. The client reported that she felt ?back to normal? and that she was ready to leave. This writer provided education on vasovagal reactions and s/s to watch for/when to seek out medical care. The client and her mother verbalized understanding. The client?s mother reported that she would stay with the client and monitor her throughout the day. The client stood without difficulty, walking with a normal gait and appearing to have returned to baseline. The client and her mother exited the facility at 1359 in a private vehicle, to be driver by the mother
was prescribed Valtrex and Zovirax same day which has caused the cold sores to subside; however, I still have issues with mouth ulcers
Shingles on right arm and ribcage; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route of administration in the arm right on an unknown date in Apr2021 at 11:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received medications (unspecified) within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Apr2021, the patient experienced shingles on right arm and ribcage. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles on right arm and ribcage which included treatment with FAMOVIR on an unspecified date. The clinical outcome of the event shingles on right arm and ribcage was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
localized swelling. Also reported vaginal bleeding--in the 3 days after vaccine, decreased by visit
Hospitalized after first dose for Other reason; Patient was hospitalized for quite a while so she could not receive her second dose as per scheduled; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Hospitalized after first dose for Other reason) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).  On 22-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 HOSPITALISATION (Hospitalized after first dose for Other reason) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was hospitalized for quite a while so she could not receive her second dose as per scheduled). At the time of the report, HOSPITALISATION (Hospitalized after first dose for Other reason) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was hospitalized for quite a while so she could not receive her second dose as per scheduled) had resolved.     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.   No concomitant medications reported by investigator. Treatment of the events were not reported. The reason for the hospitalization not reported.  Company comment: Very limited information regarding this event has been provided at this time. No further information is expected at this time.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.
Bruise that about 1 1/2 inch in diameter at the site of flu shot injection.  Round in shape, black and blue in color, at time of report (9/17/2013) according to pt the bruise was fading and wasn't as dark as before. No other symptoms reported. Contacted pt today (9/19/13) and pt reported the bruise is still fading and no other symptoms.
9pm: nauseous, chills, fever, soreness, headache, extreme fatigue 11pm: Took 15ml NyQuil  8AM: took 2 800mg tylonal 9am 3/5/2021: chills subsided All symptoms lasted until 11pm on 3/5/2021 3/6/2021: lymph node on left side swollen and sore, mild headache and mild fatigue and fogginess