chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient experienced no symptoms; on 7/27/2020 a patient was administered an improperly stored dose of PROQUAD; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.    On 27-JUL-2020, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live  (PROQUAD) injection, lot # T001187, expiration date: 11-JUL-2021, albumin status has been verified as recombinant human albumin (rHA), subcutaneously for prophylaxis (strength, dose, frequency were not reported); which was reconstituted with properly stored sterile diluent, lot # S038697, expiration date: 10-AUG-2022. Administered dose of vaccine experienced the temperature excursion of 28.4 degrees Fahrenheit (F) for 6 hours and 38 minutes. Data logger was involved. There was no previous excursion reported. No adverse symptoms were reported.
8hrs after imm received pt had episode of seizure like activity, arched back, extremities flex, apnea, 5-6x 1 mid x imm. To ER hospital x 3 days observation. Temp on adm 100.5 (R). No s/s seizure since 1st episode.
Hearing loss/total deafness in one ear, and partial deafness in the other; rash around both ankles; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 55-year-old female patient received tofacitinib citrate (XELJANZ XR), oral since 19Feb2019 (ongoing) (Batch/Lot number: unknown) at 11 mg daily; COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVAIR; FLUTICASONE; ALBUTEROL SULFATE; PREDNISONE; HYDROCODONE/ACETAMINOPHEN. Past drug history included: Covid-19 vaccine - manufacturer unknown for COVID-19 immunization, notes: Manufacturer Unknown, Dose 1; Covid-19 vaccine - manufacturer unknown for COVID-19 immunization, notes: Manufacturer Unknown, Dose 2. The following information was reported: DEAFNESS (medically significant), outcome "recovered", described as "Hearing loss/total deafness in one ear, and partial deafness in the other"; RASH (non-serious), outcome "unknown", described as "rash around both ankles". The event "hearing loss/total deafness in one ear, and partial deafness in the other" was evaluated at the emergency room visit. The action taken for tofacitinib citrate was dosage not changed. Therapeutic measures were taken as a result of deafness.  Clinical course: Patient Withheld stopped her Xeljanz XR for 5 days per md instructions to get her Covid-19 booster shot. A week later she developed a rash around both ankles, then a few days after that developed total deafness in one ear, and partial deafness in the other and went to the emergency room. was given prednisone and after 1 day hearing went back to normal.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Sender's Comments: based on the available information the causality between the suspect product and the reported adverse events and the suspect vaccine / BNT162B2 /XEliJANZ cannot be ruled out
COVID-19; Plaque psoriasis break out that looked like pimples/bad psoriasis flare; Lump on head; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (Lump on head), COVID-19 (COVID-19) and PSORIASIS (Plaque psoriasis break out that looked like pimples/bad psoriasis flare) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.  No Medical History information was reported.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced SKIN MASS (Lump on head) and PSORIASIS (Plaque psoriasis break out that looked like pimples/bad psoriasis flare). In July 2021, the patient experienced COVID-19 (COVID-19). In 2021, SKIN MASS (Lump on head) and PSORIASIS (Plaque psoriasis break out that looked like pimples/bad psoriasis flare) had resolved. In August 2021, COVID-19 (COVID-19) had resolved.     No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Got sick; Missed his second series; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) and PRODUCT DOSE OMISSION ISSUE (Missed his second series) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ILLNESS (Got sick) and PRODUCT DOSE OMISSION ISSUE (Missed his second series). At the time of the report, ILLNESS (Got sick) and PRODUCT DOSE OMISSION ISSUE (Missed his second series) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information was not provided by the reporter.
3/12/2021 Patient got her first Covid vaccination on March 4.  She was told by her rheumatologist to stop taking methotrexate for 14 days after she had the vaccine.  Yesterday afternoon the patient began experiencing left groin pain.  It progressively got worse.  During the evening it was 10 out of 10 in severity.  Patient took 100 mg of prednisone and also went ahead and took her methotrexate but got no pain relief from this. She localizes the pain to her left groin region.  She said the exact same thing happened 5 years ago right before she was diagnosed with rheumatoid arthritis.  The pain was localized to the same exact area. Over the course of her admission, the patient improved after the methotrexate and the prednisone she took the today prior to arrival, and also started on as needed Percocet.
Water blister formed 1 1/2 inches from injection site. Soreness, numb. Patient called 11/14/14 to report.
Information has been received from a physician concerning an approximately 9 month old male who was vaccinated PO with the first, second and third 2.0 ml doses of Rotateq (no lot number was provided).  Subsequently, "the patient went to and got the rotavirus".  The patient sought unspecified medical attention.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Follow-up information from the reporting physician indicated that an 8 month old (also reported as approximately 9 months old) male with no pre-existing medical conditions or allergies who on 13-APR-2007, 04-JUN-2007 and 09-AUG-2007 was vaccinated PO with his first, second and third doses of ROTATEQ (lot# "07680"). There was no illness the time of vaccination. Concomitant vaccinations administered on 13-APR-2007 included the first IM dose of COMVAX (lot# 655549/1415F), the first SC dose of IPOL (lot# 41032) and the first IM dose of DAPTACEL (lot# C2570). On 18-OCT-2007 the patient experienced gastroenteritis rotavirus while visiting confirmed by labs (results unavailable) as per parents. The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested.
pt recvd vax 20JAN95 9AM & 150PM parent called clinic pt had difficulty breathing & coloring red-blue; referred to ER-parent chose to call paramedics-BP dec referred to ER; parents refused & took pt to pvt MD; pt crying loudly;t102;sore leg
9/28/21 9:a.m. till 2:00 p.m. - Rapid heart rate at 100 bpm (normal for me is 72 bpm) I felt like I was going to die. Heart rate was so high my blood pressure machine couldn't register my blood pressure or heart rate. 9/28/21 all day - Weak, difficult to walk 9/28/21 all day - Very tired 9/28/21 8 p.m. Short of breath Called my doctor in the morning when my heart was racing.  The nurse told me to rest and drink lots of fluids explaining this was a common reaction to the Covid vaccine.   9/29/21 8:00 a.m. feeling better, almost normal  but a bit tired.
myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: elevated (High) elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Reportedly patient visited hospital for chest pain.  Symptoms begun few days after receiving the product. Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram.  Company Comment: This is a literature report of myocarditis in an adult male.  Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author.   Author conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-245527, MOD-2021-284014, MOD-2021-284015, MOD-2021-284013, MOD-2021-284013 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated for a regulatory authority so Incorrect E2B Company Number was removed. Hence new reports generated with correct E2B Number. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of myocarditis in an adult male.  Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author.
Started with a runny nose; progressed during the night to include cough, headache, malaise and fatigue. Tylenol severe cold liquid helped, however I was sick for 4 days!
Information has been received from a physician concerning a female described as healthy and who has no known drug reactions or allergies who "about five years ago", in approximately 2000, was vaccinated with two doses of varicella virus vaccine live. Subsequently, "an IgG antibody test done four years was negative". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Flu; right deltoid-arm felt like it weighed 40-50 pounds more than it should; right deltoid (arm)- mostly painful; sick; Bedridden; migraines; is tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in right deltoid for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1st, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2nd, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3rd, Manufacturer unknown), for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "Flu"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "right deltoid-arm felt like it weighed 40-50 pounds more than it should"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "right deltoid (arm)- mostly painful"; ILLNESS (non-serious), outcome "unknown", described as "sick"; BEDRIDDEN (non-serious), outcome "unknown"; MIGRAINE (non-serious), outcome "unknown", described as "migraines"; FATIGUE (non-serious), outcome "unknown", described as "is tired". Additional Information: Patient stated that he was reporting side effects for the Pfizer Covid 19 Bivalent. Is for his fourth shot. Thinks its the usual side effects. Mentioned that his arm felt like it weighed 40-50 pounds more than it should. Clarified his arm as his right deltoid. Mentioned that his arm was not swelling at the time so he did not call the doctor where he got the Pfizer Covid 19 Bivalent from. Later stated that he had 48 hours of minor swelling of his arm that was mostly painful but not actual painful swelling. Later clarified there was swelling but that it was more painful than swollen. Thinks that he got mostly Covid symptoms. Has not had Covid before. Has never met anyone that got the shot that did not have that symptom of the arm. Later clarified that everyone got this same shot, Pfizer Covid 19 Biavalent and the Moderna and got this symptom of the arm felt like it weighs 40-50 pounds. Has no further details to provide. Stated that if he would have known then he would have brought a list of those people. Declined to complete reports. Stated that he has the flu and is so sick that he is bedridden. Has been bedridden going on his third day. Commented that this is why people don't get the shot it makes them sick. Mentioned that he had migraines and is tired.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient has all over body rash.  No difficulty breathing no swollen lips.. just all over body itchy rash. I advised patient to call his doctor to report this and advised patient to take Benadryl to relieve the rash.
Pt's mother, called this RN at 12:15pm and stated that daughter's left arm from shoulder to elbow is red and swollen and "Hot to touch" Instructed her to take child to ER.  Pt uninsured.
Adverse Event: 17 year-old female vaccinated with Moderna Vaccine on 5/13/2021 Treatment: None indicated Outcomes: No untoward effects reported by Client or Mother. Mother requested that her daughter receive 2nd dose of Moderna.  On-call provider called and approved.
Mouth swelling; hives in mouth and lips; Body aches; joint pain; chills; This is a spontaneous report from a  (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK4176), via an unspecified route of administration in left arm on 14Jan2021 11:45 at first single dose for COVID-19 immunization. Medical history included covid-19 (covid prior vaccination), known allergies: Penicillin, sulfa drugs. There were no concomitant medications in two weeks. No other vaccine in four weeks. The patient experienced body aches, joint pain and chills began about 16 hours after receiving vaccine (15Jan2021). Mouth swelling and hives in mouth and lips began 4 days after (18Jan2021 10:00 AM). AE resulted in doctor or other healthcare professional office/clinic visit. AE treatment included: prescribed steroids. Covid was not tested post vaccination. Outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Symptoms experienced immediately after "I have the flu": weakness, could barely walk, fever, lethargy, chills, nausea, pain.
Bell's Palsy on the right side of the face; A spontaneous report was received from an consumer who was also a 70 years old, female patient who experienced Bell's Palsy on the right side of the face (facial paresis).    The medical history of patient's family included Half-brother with Bell's Palsy since an unknown date. Concomitant product use was not provided by the reporter.   On 03 Mar 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 05 Mar 2021, the patient experienced the event facial paresis. Symptoms included: she could not blink her right eye, could not move right side of mouth and droopy right side of face.  Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event, was not reported; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt reports itching L upper arm am of 3/25/10 development of rash extending down arm. Rx - taper prednisone/ATARAX prn itching. Exam - erthema/induration L deltoid expanding down arm and across anterior ( L ) trunk, ( + ) lymphandenopathy ( L ) LLE.
Erythema annulare centrifugum rash - confirmed by biopsy. Spread over a period of weeks. Resolved with clobetasol ointment
Two weeks to the date after each injection, the lymph nodes deep in my left armpit swelled. I considered this to be normal and did not seek medical care.   However, several weeks after my second injection, my left armpit started swelling again, this time much worse. It was so painful, tender and swollen, I could not normally hold my left arm by my side. Advil provided little relief. I wasn't otherwise ill, didn't have a fever and didn't have any open wounds. Thankfully, I had a doctors appointment already scheduled with Dr.  She was concerned and referred me to get an ultrasound of the area. The ultrasound came back abnormal, and I was told to follow-up with another ultrasound in 4-6 weeks. I will be getting that ultrasound this Friday, July 16. As of now, the node deep in my armpit is still swollen and tender. The radiologist has suggested a biopsy if this ultrasound comes back abnormal. I have no other symptoms.
Pt devel rash on arms & legs 2 wks p/MMR vax; Had no arthralgia or myalgia;
After the vaccines lost temperature they were administered; A spontaneous report was received from a nurse concerning a 67-year-old, White, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # 027L20A.  There were no reported AEs associated with this case of out of specification product use.
covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Itching across chest from left to right arm (within 10-15 minutes of vaccine) moved down right arm, around ankles, up the back of neck on the right all within about 20 minutes.  Dizziness, inner ear itchiness, stabbing in right front chest to the back, hands ice cold and very pale all over within 30 minutes.  No hives anywhere.  Liquid Benadryl, double dose administered about 15 minutes in, held in mouth for about 20 seconds before swallowing.  Of course panic set in, focused on slow, deep breaths, outer ear itchiness and neck all around my neck.  Called ambulance while pharmacist observed me on the floor laying down.  Ambulance assessed BP was high, oxygen was 100%, started feeling better, dizziness stopped and itching almost gone, within an hour of Benadryl dose.  Family member drove me home.  Released from ambulance, not taken to ER or Urgent care.