chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Vaccination site pain; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037KZ0A) for COVID-19 vaccination.     The patient's past medical history included Cyst ovary from April 2020 to September 2020, Appendicitis in January 2015, General physical condition abnormal in 2012, Weight gain in 2012, Diabetes since 2016, Fatty liver, Elevated liver enzymes in 2017, Psoriasis in 2016, Shingles from November 2020 to December 2020 and Alcohol use (Abstain from alcohol). Concurrent medical conditions included Drug allergy (Sulfa drug allergy associated with manifestations of itching and burning skin.). Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease, METHOTREXATE for Psoriasis, LIDOCAINE and DOXYCYCLINE for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and METFORMIN at an unspecified dose and frequency. On 03-Jan-2021, FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2012, Weight: inconclusive (Inconclusive) Inconclusive. In January 2015, Abdominal X-ray: inconclusive (Inconclusive) Inconclusive. In January 2015, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. In 2016, Glycosylated haemoglobin: inconclusive (Inconclusive) Inconclusive. On 13-Nov-2020, Ultrasound liver: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment for the event included TYLENOL, METFORMIN and BYDUREON BCISE.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.   This case was linked to MOD-2021-047583 (Patient Link).
Within just a few hours of receiving the first Pfizer vaccine in my right arm, I began to get tingling and numbness in my pinky and ring fingers. By the following day, the numbness, tingling, pins/needles (paresthesias) had migrated to my left hand and foot, then proceeded to march up my arm and leg. By the third day after vaccination, I was also experiencing paresthesias around my face, mouth, and jaw. The sensations have waxed and waned and are still present nearly three weeks after getting the vaccine. The sensations are extremely uncomfortable and migrate throughout the day. I am also experiencing sensations of muscular weakness.
PATIENTS CARD WAS FILLED OUT INCORRECTLY INITIALLY. FOR THE FIRST DOSE THE PATIENT RECEIVED MODERNA BUT THE CARD WAS FILLED OUT AS IF THE PATIENT RECEIVED PFIZER FOR THEIR 1ST DOSE WITH INFORMATION TO RETURN IN 21 DAYS TO GET PFIZER. WHEN THE PATIENT RETURNED FOR 2ND DOSE THE PATIENT WAS GIVEN PFIZER SINCE THE CARD WAS WRITTEN AS IF THE PATIENT RECEIVED PFIZER FOR THEIR FIRST SHOT. AFTER THE PATIENT BROUGHT IT TO OUR ATTENTION, RECORDS WAS CHECKED AND SYSTEM SAYS PATIENT RECEIVED MODERNA. THE PATIENT IS OKAY AND THE DOSE WAS NOT REPEATED AS RECOMMENDED BY THE CDC.
I did not have a reaction to the vaccine. On 08/10/2022 I began feeling symptoms that was unique and I tested for COVID-19 with a home test which was negative. My primary symptom was I sensed smells that where not there (exhaust fumes) and continues to this day. I've been to the dentist to see if I had any dental issues that would cause this symptom a everything was within normal range. I had CT scan and was within normal range. My doctor determined that I have long COVID-19 but I have never tested positive for COVID-19. My doctor has tried me on a different prescription to see if that will help with my symptoms. For a few days we tried albuterol inhaler, we tried ipratropium nasal spray, one week course of antibiotic doxycycline (deep sinus infection), nasal rinse with a steroid budesonide. I have had cold symptoms the last five days and have not tested positive for COVID-19.
She had increase in pain in elbows, wrists and hands after each dose/States she has bilateral knee pain and they feel hot; She had increase in pain in elbows, wrists and hands after each dose.; She had increase in pain in elbows, wrists and hands after each dose/States she has bilateral knee pain and they feel hot; This is a spontaneous report from a contactable other health care professional and consumer. A 24-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number& Expiry date not reported) via unspecified route of administration on unspecified date in Jun2021 (at age of 24-year-old) as dose 2, single for COVID-19 Immunisation. Patient medical history includes rheumatoid arthritis, Blood pressure readings went high in Nov2020 (her blood pressure readings went high in the 180 over102-104 range). Concomitant medications include tofacitinib citrate (XELJANZ) taken for rheumatoid arthritis from 2019 and ongoing. Patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number& Expiry date not reported) via unspecified route of administration (at age of 24-year-old) on unspecified date in May2021 and experienced pain in elbows, wrists and hands after each dose. Patient reports when she was off Xeljanz for 10 days following each covid vaccine in May2021 and Jun2021. She had increase in pain in elbows, wrists and hands after each dose following second dose she was on short course of prednisone due to this once back on Xeljanz, it took 2-2.5 weeks for her to feel less pain and back to normal and MD was aware. Patient underwent lab test and procedures include blood pressure reports in Nov2020 her blood pressure readings went high in the 180 over102-104 range, her MD put her on medication and her readings are now 145/77 on unspecified date. Patient states MD believes it was from Xeljanz. Patient now states she has bilateral knee pain, and they feel hot, she reports she ices them and puts on biofreeze and registered nurse encouraged to update MD. patient agreed. The Outcome of all events was unknown.  Information on the lot/batch number has been requested.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021906599
Patient developed hives over her body.  Took Benadryl for about 3 days and recovered.  No respiratory issues.
The patient was given two vaccinations in bilateral upper arms. The patient was warned about possible fainting from shot. Immediately after giving the shots the patient got up from his chair to watch his girlfriend receive her shots.  Then the patient fainted and fell to the ground hitting his far head. EMS was called Immediately, and the patient was revived. After EMS evaluated him,  which showed a slow heart rate, low and the patient was diaphoretic. The patient refused transport to the hospital. He went home with family members that were present with a lump on the head.
This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in an elderly patient of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received unspecified dose of Flulaval (.5 ml, unknown).  Two days after vaccination with Flulaval, the subject experienced swelling of the arm, redness, soreness and warm to touch.  At the time of reporting the outcome of the events were unspecified.
headache; extreme fatigue/exhausted in bed/cannot get out of bed; blood pressure is up; diarrhea.; This is a spontaneous report from two contactable consumers (patient and patient's wife).  A 73-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E13302) at Left arm, via an unspecified route of administration on 15Jan2021 16:00 at single dose for covid-19 immunisation.  Medical history included high blood pressure but usually under control. Patient did not have covid prior vaccination. The patient's concomitant medications were not reported. The patient experienced headache and extreme fatigue, blood pressure is up on 24Jan2021 17:00, diarrhea on 24Jan2021. No treatment for the events headache and extreme fatigue, blood pressure is up. Patient did not have covid tested post vaccination. The patient was having COVID-like symptoms, including fatigue and diarrhea. He was having full blown symptoms like Covid. He was exhausted in bed, had a headache and it was unsure if he had a temperature. He cannot get out of bed and had diarrhea. His blood pressure was high yesterday. All night long that he had a headache and that was up and down. He had a tendency to have diarrhea and he known when its worst than normal and it was worst than normal. The outcome of events was not recovered. Diarrhea was worsened.
Patient was administered original Pfizer Covid-19 vaccine instead of bivalent Pfizer  Covid-19 vaccine
Myalgia, Fever & NauseaVomiting Narrative:  Other Relevant History:
Received H1Ni on 11/10/09, on that same day pt. states she had "bad HA" and BP high 200/100. She had been controlled up to that point with BP 9/16/09 of 120/56. She was seen in our office 11/13/09 -  still had c/o HA - "but better" - BP 164/78. Being tx'd and monitored.
50 mm X 80 mm reddened, hot to touch and indurated area. Prescribed Dicloxacillin.
Fever; terrible headache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) and HEADACHE (terrible headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and HEADACHE (terrible headache). At the time of the report, PYREXIA (Fever) and HEADACHE (terrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
positive test result on 03May2022 at 8pm rapid test; positive test result on 03May2022 at 8pm rapid test; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 85-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), on 21Oct2021 as dose 3 (booster),  single (Batch/Lot number: unknown) and on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 02May2022, outcome "unknown", described as "fever"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03May2022 at 20:00, outcome "unknown" and all described as "positive test result on 03May2022 at 8pm rapid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The arm became sore in the afternoon Friday. Chills started Friday evening. During the night, body aches and nausea started. Saturday morning all the symptoms continued. Fatigue started along with headache. Patient slept all day and took medication for nausea. Vomitting X1. Sunday continued with back headache and hot flashes. Returned to work Monday with a little fatigue and sore arm, hot flashes.
Called by home heath nurse to say, pt developed a rash. Pt was seen in occupational medicine. Treatment given and ambulance called to transfer to hospital. Put on oxygen and getting IV prednisone.
High Fever, Chills, sore throat, dizziness. treatment: alternate tylenol 650mg with Ibuprophin 400mg.
Headaches congestion - sweezing. Rt. arm muscle spasm. Painful contracture of rt upper arm.
Pt was feeling like she couldn't swallow and that her throat was closing. Provider was informed and 0.5 mL of benadryl was given to pt.
headache; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9267; Expiration Date: May2021, NDC number was unknown), via an unspecified route of administration, administered in left arm on 09Feb2021 at 11:00 hours as dose 2, single (at the age of 54-years-old) for COVID-19 immunisation. Patient had no medical and family medical history. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262; Expiration Date: May2021 and NDC number was unknown), via an unspecified route of administration, administered in left arm on 21Jan2021 at 13:00 hours as dose 1, single (at the age of 54-years-old) for COVID-19 immunisation. There were no concomitant medications received by the patient. Patient had no prior vaccinations (within 4 weeks). On 10Feb2021, when patient woke up, he experienced headache and wants to take Tylenol and asked if he can take pain killer. Patient stated that it is little better now. Patient had no physician or emergency room visit and no relevant tests were performed. The outcome of the event was recovering.   Follow-up attempts completed. No further information expected.
Dizziness, Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Fatigue Narrative:
severe allergic reaction; 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 HYPERSENSITIVITY (severe allergic reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction). At the time of the report, HYPERSENSITIVITY (severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  Treatment medication was not provided
pt devel a deep constant severe pain in lt deltoid, site of vax 6 inches in diameter for two full days; rxn started 1 1/2wk p/vax;no redness or induration noted;tissue not sore to touch;
PATIENT WAITED THE 15 MINUTES FOR OBSERVATION AND LEFT AFTER THE RECOMMENDED TIME POST VACCINATION. AFTER LEAVING, PATIENT SAID THROAT STARTED CLOSING AND A BIG BUMP PRESENTED IN THE BACK OF HER THROAT. SHE TOOK BENADRYL IMMEDIATELY AND EMS WAS CALLED. SHE WAS FURTHER REFERRED TO AN URGENT CARE FACILITY AND WAS TREATED THERE.
This spontaneous report was received from a doctor of pharmacy and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On 21-AUG-2018, the patient was vaccinated with M-M-R II (dose was not reported, lot number N025891 and expiration date 19-SEP-2019) for prophylaxis by intramuscular route instead of subcutaneous route. No adverse event was reported.
Breakthrough COVID-19 case with unknown symptom status. Death 7/26/2021. From Vital Records COD = ACUTE HYPOXIC RESPIRATORY FAILURE, COVID 19 INFECTION. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: OBESITY UNKNOWN BUT SIGNIFICANT CARDIAC HISTORY.  place of death: HOSPITAL-INPATIENT, HEALTH SYSTEM; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occ/ind: CERTIFIED NURSE ASSISTANT, NURSE ASSISTANT
Information has been received via a literature article regarding a case in litigation concerning a male who in November 2004, was vaccinated with a dose of MMRII (dose, route and lot number not reported).  The family asserted the patient experienced childhood disintegrative disorder, which is on the "spectrum" of autism disorders.  During the week of his vaccination, in November 2004, the patient experienced abrupt loss of speech skills.  In approximately February 2005, the patient began injuring himself prompting his mother to buy a helmet for him in March.  He also experienced a gradual decline in appetite.  Upon internal review, childhood disintegrative disorder, which is on the "spectrum" of autism disorders was determined to be an other important medical event.  No further information is available.
After the second one i did have a mild flare up after holding it for a week; This is a spontaneous report from a contactable other hcp. A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date at 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Pregnancy details were unknown at the time of vaccination. The patient medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ). The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on unspecified date at single dose for covid-19 immunization. Patient stated that occasionally she gets mild flare ups. Patient MD was aware. Patient had to stop Xeljanz for a week for each covid injection. After the second dose she did have a mild flare up. Treatment included Aleve otc (Over the Counter) which relieved her mild flare ups. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Pfizer COVID-19 Vaccine was administered to the patient after the beyond use date. No adverse events reported by patient.
Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: The box had 5 vials of the adjuvant missing.  The sales representative asked what happened to the vials.  The response that was given was that they were administered to 5 patients. No further information was gathered by sales representative such as lot number, patient's initials, patient's genders, or route of administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient administered vaccine adjuvant suspension component (liquid) without active antigen (powder) component which led to inappropriate preparation of medication and inappropriate doseof vaccine administered. This case is 1 out of 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100445:Same reporter US-GLAXOSMITHKLINE-US2022AMR100447:Same reporter US-GLAXOSMITHKLINE-US2022099857:Same reporter US-GLAXOSMITHKLINE-US2022AMR100452:Same reporter US-GLAXOSMITHKLINE-US2022101093:duplicate/retained case
Site of injection is swollen and red hot and hurts to the tough. It is also itchy and very firm and red. It?s very noticeable and is approximately 2?3 inches in diameter. It still has not gone away after 48 hours
Patient fainted after 5 minutes of being vaccinated. Patient began to lean to the right and was immediately assisted by 2 pharmacists. Patient was laid down and monitored by pharmacists. Patient lost consciousness for less than a minute. Patient was alert and oriented to person, place, and time. Patient's blood pressure was assessed by paramedics with a reading of low to normal.  Patient was observed for an additional 20 minutes.
Patient was given varicella 4-16-18 and MMR and pneumococcal 13 during well child visit. Mother called this morning 4/19/18 stating patient started with fever and rash this AM 4/19/18.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that the vaccine was stored in refrigerator on 5-Nov-2021, there was no temperature excursion and the patient did not experience any adverse event.  No treatment medications were provided.
Day 1&2 Headache and injection site pain  Day 7 itchy red raised spot (1"diameter) at injection site
Left arm very red hot to touch and swollen. Client states she is running fever and has general malise.  Started on 08/07/07 day after shot and has gotten progressively worse.  Reddedned area extends from 2 inches below shoulder to 4 inches above elbow.  Advised MD ASAP
died 2 weeks after getting the vaccine; This is a spontaneous report from a contactable consumer. A female patient in her 30s received bnt162b2 (COMIRNATY), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. She died 2 weeks after getting the vaccine. Unknown if autopsy was done. Outcome of the event was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101353646 Same reporter/ drug/ event for different patients; Reported Cause(s) of Death: died 2 weeks after getting the vaccine