chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist regarding a 48 year old female patient. Concurrent condition included dialysis since on an unknown date (some time). The patient drug reactions or allergies included sulfa allergy. On 15-JAN-2016 (reported as today), the patient was inadvertently vaccinated with PNEUMOVAX 23 (lot #: L029306, expiry date: 26-MAR-2017) (dose# not specified) 0.5 ml, once, intravenously (incorrect route of drug administration) during an outpatient dialysis treatment for unspecified reason. On an unknown date in January 2016 (reported as unspecified time after receiving PNEUMOVAX 23), the patient experienced unspecified allergic reaction and was administered an unspecified dose of BENADRYL (manufacturer unspecified). On 15-JAN-2016 (reported as the same day ("about an hour" after receiving the dose of PNEUMOVAX 23)) she also got nauseous and was administered an unspecified dose of ZOFRAN (manufacturer unspecified). Patient had sought medical attention by taking treatment with unspecified doses of BENADRYL and ZOFRAN for the adverse event. The pharmacist reported that the patient was "fine" after receiving the unspecified doses of BENADRYL and ZOFRAN. There was no Product Quality Complaint (PQC) filed. The reporter did not provide the causality between the events allergic reaction and nauseous and suspect therapy PNEUMOVAX 23. Additional information has been requested.
Patient was 12 years old and received the Moderna vaccine. Shot should have been Pfizer #2 in series.
Diarrhea; Pain everywhere in her body; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and MYALGIA (Pain everywhere in her body) in a 42-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and MYALGIA (Pain everywhere in her body) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) and MYALGIA (Pain everywhere in her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.  Company comment: This case concerns a 42 year-old female patient with no reported medical history who experienced the unexpected serious events of diarrhea and myalgia.The events occurred on an unknown date relative to the first dose of mRNA-1273. The rechallenge was unknown as the dates of the vaccine administration and of the events are not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. The events' seriousness is assessed as per Regulatory Authority report.   This case was linked to MOD-2021-350957 (Patient Link).; Sender's Comments: This case concerns a 42 year-old female patient with no reported medical history who experienced the unexpected serious events of diarrhea and myalgia.The events occurred on an unknown date relative to the first dose of mRNA-1273. The rechallenge was unknown as the dates of the vaccine administration and of the events are not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. The events' seriousness is assessed as per Regulatory Authority report.
a lot of inflammation on the left side: into my breast, into my knee, hip; inflammation on the left side: into my breast, into my knee, hip; inflammation on the left side: into my breast, into my knee, hip; teeth chattered for 4 hours; high fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of JOINT SWELLING (inflammation on the left side: into my breast, into my knee, hip) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SL20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced JOINT SWELLING (inflammation on the left side: into my breast, into my knee, hip). At the time of the report, JOINT SWELLING (inflammation on the left side: into my breast, into my knee, hip) 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.   No concomitant medications were provided No treatment information provided
possible swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (possible swollen lymph nodes) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (possible swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (possible swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Delayed rash around injection site at 8 days after injection - hard, warm to touch, itchy, erythematous. Treated with ice compress and nightly diphenhydramine for 5 days.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 04-DEC-2012, the patient was vaccinated with the first dose of VAQTA (dose, lot number, expiration date and route of administration were not reported). The patient was vaccinated with the second dose of VAQTA (dose, lot number, expiration date and route of administration were not reported), slightly before schedule on 13-MAY-2013. There was no adverse effects reported. Additional information has been requested.
Lymphedema of the left arm. Swelling and tenderness in the underarm area of the left arm.
Sore arm a few hours after injection but very mild on first day. Day 2 arm soreness was worse and throbbed at times and was slightly warm to touch with mild swelling but relieved with ibuprofren. Day 3 arm sore but just barely noticeable.  Soreness gone on day 4.  No treatment needed other than the ibuprofren.
At 10 pm I started to experience some moderate body aches. By 1 am, I was in so much pain I could not sleep and started to develop a fever. I drank a ton of fluids, used OTC treatments (Ibuprofen and Motrin) but nothing alleviated the pain. By 10 am I had a sustained fever over 100 degrees. I was in so much pain I was crying in bed. By 3 pm my fever reached 102 degrees. I had to go to the emergency room for IV drip and medication because I couldn't drink enough water to stay hydrated. Once given IV, my temperature plummeted. When the medication they administered wore off, my body started experiencing mild to moderate pains again. Body aches and soreness all over- my muscles feel like they are being squeezed from the inside. I am still feeling a lot of fatigue and pain but it is random and comes and goes along with "hot flashes".
Three weeks later severe inflammatory responses in kidneys, lower back and bladder. 4 weeks later urinating blood. 5 weeks later white spots all over tonsils,  high fever and fatigue, streptococcus test was negative.  5 weeks after vaccination to present neurological damage to arms, especially right arm and right elbow tendons.
They did not mixed the HIB portion and only received the dtap-ipv with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received on 29-Oct-2021 from a consumer.  This case involved a 4 month old male patient who did not mix the hib portion and only received the dtap-ipv with no reported adverse event (product preparation error), while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) (lot number and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event they did not mix the hib portion and only received the dtap-ipv with no reported adverse event (product preparation error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  No relevant laboratory data was provided.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  The reporter did not report causality of events with suspects.
This spontaneous report as received from a healthcare worker refers to two patients of unknown age. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # M004885 and expiry date 23-OCT-2017). No adverse events were reported. No product quality complaint involved. Additional information has been requested.
Fatigue; Hasn't gotten the second vaccine yet; Chills; Sweating; This case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In December 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chills and sweating. On an unknown date, the patient experienced fatigue and incomplete course of vaccination. On an unknown date, the outcome of the chills, sweating and fatigue were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the chills, sweating and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for 2nd dose of Shingrix. The patient received 1st dose of Shingrix intramuscularly into right arm and experienced chills and sweating that started about 10 to 12 hours after the vaccine and lasted about 15 minutes.  The patient also experienced fatigue that started about 12 hours later and lasted for about half a day. The patient received his first vaccine at his local pharmacy and didn't have anymore information in regards to the vaccine lot number or expiration date. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient was asking about needing to restart the Shingrix vaccine series if they were past the 2-6 month time frame.  The reporter did not consent to follow-up.
Urticaria all over the body, no respiratory distress, Benadryl PO after 48 hrs received Orapred for 3 days.
Pt vacc'd w/FLU experienced flashing lights in both eyes for 15 min. When eyes cleared, sneezed several times & soft palate became tender, itchy & edematous. Subsided to mild sore throat & flu like sx, w/ fullness in head lasting longest.
hard; hot reaction; itchy; swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (hot reaction), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M2077) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (hot reaction), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (hot reaction), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Extreme pressure on chest, worse on lying down. Angiogram and EKG slightly abnormal. Troponin elevated. MRI suggest no evidence of heart attack, but possible pericarditis
fast heart beat  (in the 90s) started around 10:30 pm  day of vaccine.  I tried to rest and go to bed but heart rate never went down, I woke up in the middle of the night (around 2:45am) due to loud heart beat, checked my heart rate by smart watch and it was in the 120s consistently.  I could not go back to bed, fast heart rate continues to the morning.  I called doctor office around 8am to schedule appointment.  Conversation with office staff and heart rate was 134 at one time.   Came in doctor's office at 2pm, EKG was performed, md stated you have fast heart rate.  Rx given for Propranolol 10mg 1 tablet three times daily.  Heart rate went down to  normal after total of 3 doses.
Tongue started swelling with slurred speech, also not feeling well and itching.  6 days later, tongue is still swelling
migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fall" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed (Manufacturer Unknown)), for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious), outcome "unknown".  Additional information: The patient was not sure where this should go, but patient had migraine aura several times over the week or two after the latest covid booster. The patient rarely had that (once or twice in a number of years) and after a few days patient thought back and realized it may have been related to the booster. At first patient thought it may have been related to a fall patient would had a few weeks before, but later patient thought it was much closer to the booster. In any case, patient thought someone keeping track of reactions, side effects, might need to know.  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.
Arm at injection site swelled up. Turn red and blue. Painful for 5 days. Developed hives for 5 days.
Developed alopecia/a lot of hair loss; This spontaneous case was reported by a health care professional and describes the occurrence of ALOPECIA (Developed alopecia/a lot of hair loss) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Diabetes. Concomitant products included METFORMIN and GLIPIZIDE for Diabetes, INFLIXIMAB (REMICADE) and METHOTREXATE for Rheumatoid arthritis.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ALOPECIA (Developed alopecia/a lot of hair loss). At the time of the report, ALOPECIA (Developed alopecia/a lot of hair loss) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that a month after the second dose he began notice a lot of hair loss. Patient  reported the only difference was he had the Moderna vaccine 5-6 months ago. Patient reported not taking any medication as treatment.
On the evening of the vaccination I started experiencing migraine symptoms. I experienced blind spots in my vision. The following morning I awoke with flu-like symptoms (upset stomach, dizziness, sneezing, aches and extreme fatigue).   Now, the morning following the day after the vaccination, I have fatigue and mild cold symptoms (itchy, running nose, sneezing)
Fever of 104 for 24 hours, severe infection of arm at injection site was traveling down entire arm.
during the patient 15minute post vaccination time, he began to experience a numbness feeling in his arm. After 30 minutes it subsided, and the patient went home.
Pt. reportedly awakened the day following the booster with fever of 101.  Also reported generalized muscle pain.  By afternoon , temp had risen to 104, Oxygen sats dropped to low to mid 80's and reportedly demonstrated a decreased LOC.  Emergency was called and patient was taken to Hospital.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Monoclonal B-Cell Lymphocytosis" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 31Aug2022; VALSARTAN, start date: 30Nov2022; CRESTOR, start date: 01Jun2021; METFORMIN, start date: 03Nov2019. Past drug history included: Compzine, reaction(s): "Known allergies:Compzine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (14Dec2022) Negative; (15Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Product for COVID 19 Treatment was noted as Paxlovid. Treatment start date was 07Dec2022 and treatment stop date was 11Dec2022. Indication was noted as treatment of COVID-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
Next day after shot I had chest pains (Heart area). Went to the ER maybe a week later and had blood drawn and an EKG. Everything checked out ok. I was still having chest pains and almost passed out about a week after that. Went to ER by way of rescue squad. Had blood taken and an EKG. Again everything seemed to be ok. I was referred to a cardiologist and had an Echo Cardiagram. I was told everything was ok.  Not long after that I started getting underarm and rib pain. I was concerned about my lymph nodes so I went to see a rheumatologist. I had an extensive blood panel done and everything seemed to check out. I then started to smell burning cigarettes every day. I researched this and I made an appointment to see an ENT. He put a scope up my nose and he said everything looked good. That smell lasted for more than a month. While still experiencing underarm and rib pain I started to have pain in my chest, stomach, and back also. I started to see blood in my stool. I made an appointment with a gastroenterologist. I scheduled a colonoscopy and an eddoscopy. I was diagnosed with ulcerative colitis. I also started experiencing tingling hands and feet. I scheduled an appointment with a neurologist. I had an EMG and was diagnosed with neuropathy. I had none of this before the shot. I still experience pain in my ribs, back, chest and stomach on a daily basis. I have tingling in my hands and feet. The bottoms of my feet hurt when I walk.
Large area of erythema with a slight hemorrhagic appearance, encompassing almost entire L thigh
24 hours after receiving Comvax and DTaP in her left thigh, Prevnar in her right thigh, and MMR in her right arm; noticed redness and swelling in her left thigh. She was brought to the Health Dept on 04/20/01. A nurse assessed and had 4 x 3 1/2 inch area of redness, slightly swollen, slightly warm to touch on left thigh. No prior treatment other than 3 doses of Tylenol. Advised to apply cold compresses, give Tylenol see PMD if desires. Called on 04/23/01, the mother stated redness and swelling all gone. They did not see the PMD. Applied compresses and gave Tylenol.
Wife stated patient was febrile, tingling in arms, and difficulty breathing. Patient is currently in emergency room.
Within 15 minutes after 2nd COVID-19 mRNA vaccination (Pfizer) today, patient reported itching of left forearm (vaccine administered in left deltoid), which then also started in right arm and upper back. Slight redness noted on left forearm where patient had been scratching but no visible hives or rash. Patient denied any difficulty breathing, shortness of breath, throat tightness or itching. Diphenhydramine 25mg PO x1 dose administered. A few minutes after diphenhydramine administration, patient reported that her eyes had become itchy. 20 minutes  after diphenhydramine dose, patient denied any worsening of symptoms, reported lessened itching and opted to leave clinic.