chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After second dose on 16Mar2021, patient underwent lab tests and procedures which included Nasal Swab/Covid 19 test: positive; i received the 2nd covid 19 vaccination on 16Mar2021. I tested positive for covid 19 on 06Apr2021.; This is a spontaneous report from a contactable consumer (patient). A 50-Year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6203), via unspecified route of administration in left arm on 16Mar2021 at 03:15 (at the age of 50-years-old) as a single dose and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via unspecified route of administration in left arm on 23FEB2021 at 03:00 (at the age of 50-year-old) as a single dose, both the doses for COVID-19 immunisation. The patient did not have any known allergies. The patient did not receive any medication within two weeks of vaccination. The patient medical history and concomitant medication were not reported. The patient did not receive any vaccine within four weeks prior to the vaccine. After second dose on 16Mar2021, patient underwent lab tests and procedures which included Nasal Swab/Covid 19 test: positive on 06Apr2021. The patient did not receive any treatment for the events. The outcome of the event vaccination failure was unknown while for another event was recovering. On 27Apr2021, the investigation results was received from Group.  The product is BNT162B2, Batch numbers for 1st and 2nd dose: EN6203, EL3247.  Description of Complaint: I received the 2nd covid 19 vaccination on 16Mar2021. I tested positive for Covid 19 on 06Apr2021.  Special or Common Cause: Common Cause Root Cause is always present to some degree in the process. Special Cause Root Cause is something different happening at a certain time or place in the process. Conclusion: The complaint for an adverse event requested by safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to the reported finished goods lot EL3247, fill lot EL3230, and the bulk formulated drug product lot EL3223. A complaint sample or photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed.  The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency  Follow-up (27Apr2021): New information received from the Group, included: product quality complaint investigation summary and conclusion.  No follow-up attempts are needed. No further information is expected
swelling at the site of injection; Red spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the site of injection) and ERYTHEMA (Red spot) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 038C71A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 30-Aug-1987.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the site of injection) and ERYTHEMA (Red spot). At the time of the report, VACCINATION SITE SWELLING (swelling at the site of injection) and ERYTHEMA (Red spot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-100383 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Initial Additional-1 : VAERS, AE details, outcome, Dose 2 details, past med history
Information has been received from a physician concerning a 13 year old patient who on 03-JUL-2007 was vaccinated with a dose of ZOSTAVAX instead of VARIVAX. It was reported that it was not a product confusion but a medical error. No problems reported. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the physician who stated that the patient was fine and had no fever and no rash at the injection site. They had the patient on close watch but there were no ill effects. No further information is expected. 03/25/2010 Additional information has been received from the physician who stated that there wer eno adverse effects noted. No further information is expected.
Information has been received from a physician concerning a 39 month old female patient who on 14-FEB-2008 was vaccinated with the first dose of MMR II (route, site and lot number not reported). On 08-DEC-2009 the patient experienced mumps (although the date diagnosed was reported as 03-JAN-2010). The patient was afebrile and had parotitis, cough productive and coryza green. The patient was exposed to mumps, two kids had mumps in same household. On 03-JAN-2010, the patient had a blood work performed (results not provided). The outcome for mumps was not reported. Follow up information has been received from the physician concerning the 38 month old (also reported as 13 year old) male patient who on 25-NOV-2009 experienced mumps(date diagnosed was reported as 27-NOV-2009). The patient was afebrile and developed left parotitis. The patient experienced swelling under her left ear. At the time of the report, the outcome of the patient was unknown. No further information is available.
5 days after KINRIX vaccine developed full body myoclonic jerks while asleep lasting for 2 nights. Jerks occurred frequently throughout the night but asymptomatic during day time. Resolved without any sequelae.
Nasal congestion; Chest congestion; Sore throat; Hoarseness; Weakness in both legs; Feeling listless; Queasy stomach; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal congestion), CHEST DISCOMFORT (Chest congestion), OROPHARYNGEAL PAIN (Sore throat), DYSPHONIA (Hoarseness) and MUSCULAR WEAKNESS (Weakness in both legs) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included PREDNISONE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BUSPIRONE, METOPROLOL, ZOLPIDEM and FEXOFENADINE for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced NASAL CONGESTION (Nasal congestion), CHEST DISCOMFORT (Chest congestion), OROPHARYNGEAL PAIN (Sore throat), DYSPHONIA (Hoarseness), MUSCULAR WEAKNESS (Weakness in both legs), FATIGUE (Feeling listless) and NAUSEA (Queasy stomach). At the time of the report, NASAL CONGESTION (Nasal congestion), CHEST DISCOMFORT (Chest congestion), OROPHARYNGEAL PAIN (Sore throat), DYSPHONIA (Hoarseness), MUSCULAR WEAKNESS (Weakness in both legs), FATIGUE (Feeling listless) and NAUSEA (Queasy stomach) 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.
4 inch red raised local reaction on arm just below injection site. Started 2 days after injection. itches moderate/severe. Used topical steroid. still there today 6 days after shot
localized hives between the elbows and shoulder, in the arm where he received the vaccine; This is a spontaneous report received from contactable reporter(s) (Physician).  A 17-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), in Dec2021 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma; "elevated eosinophils" (unspecified if ongoing); "hypersensitivity to chinchilla dust" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset Dec2021, outcome "unknown", described as "localized hives between the elbows and shoulder, in the arm where he received the vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: At that time, patient had localized hives between the elbows and shoulder, in the arm where he received the vaccine. Reporter had stated that it wasn't redness, it was true hives. Caller states that she understands the contraindication when it is anaphylaxis. This was not anaphylaxis, it was localized hives. Caller states it was tough because she could not give clinical guidance.  Clarified that the caller was made aware of this event today, 1Jul2022. Caller received call from agency today, stating that reporter had contacted them, requesting Filed Medical request. Caller received the message at 9:02am, today, 1Jul2022 and called the reporter back at 3:00pm. Event Details: Localized hives between the elbows and shoulder, in the arm where he received the vaccine: Clarified this occurred Dec2021. Reporter was calling now about this now because it was time for the patient's second dose. Unknown which arm this occurred in. Seriousness Criteria: Caller didn't ask that and reporter knew for sure that it was not anaphylaxis, which would be serious. Caller asks if Pfizer will follow up with reporter. Caller advised that Pfizer may contact reporter for in need of further information.  Follow-up attempts are completed. No further information is expected.
Diarrhea started about 530 am on 2/2. Chills at 930sm and body aches with fatigue. Fever 103 at 330pm 2/3 severe headache at 930am plus low grade temp 100.1.
48 HOURS POST INJECTION SYMPTOMS STARTED: FEVER, COUGH, STIFF NECK, HEADACHE, LETHARGIC (PROBABLY FEVER-DOESN'T HAVE THEMOMETER)  BED BOUND 4 DAYS AND LOST TRACK OF 2 DAYS.
Formed painful, erosive, Oral Lichen Planus lesions in my mouth. Can't eat without severe, burning pain. Can't talk. Can't open my mouth completely without ripping apart these lesions.
allergic reaction in a 17 years old male patient after receiving a dose from Trumenba; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 17-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction in a 17 years old male patient after receiving a dose from Trumenba". Follow-up attempts are not needed. No further information is expected.
LAST GARDASIL VACCINE WAS GIVEN BEFORE THE DATE IT WAS DUE.
Sore arm after 3 days Sudden dizziness that did not go away with normal treatment like water, food, rest, and ice pack on neck; one week later. Nurse acknowledges site injection is inflamed and injection hole has a pimple.  Blood sugar normal, Blood pressure elevated due to dizziness. Doctor said to take Tylenol, rest, and use a cold pack on site. Advised if it gets worse go to the ER. Doctor refused to type up an order for my work stating I had a bad reaction.   From the time of the dizziness to when I got to medical facility and was seen was 7 hours. Stayed dizzy until the next day when I was lethargic and fatigued for 3 days after.
Arm just got a little swollen; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8736), via an unspecified route of administration in arm left on 21May2021 (at the age of 48-year-old) as single dose for COVID-19 immunisation. The family medical history relevant to AE(s) included cholesterol, high blood pressure and diabetes, really high on his dads' side of the family. The patient's medical history (including any illness at time of vaccination) included ongoing high blood pressure, he had high blood pressure for years, ongoing high cholesterol, he was diagnosed with high cholesterol about 2, maybe 3 years ago and pneumonia, the patient had pneumonia shots and never had any problems. The patient's concomitant medications included lisinopril, 12.5 mg, once daily, for blood pressure and atorvastatin, 40 mg, once daily, for cholesterol. Historical vaccine included Flu shots (FLU VACCINE VII), via an unspecified route of administration on an unspecified date as dose number unknown, single for an unspecified indication (the patient had flu shots). Prior vaccinations (within 4 weeks) were reported as none. The AE(s) following prior vaccinations were reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. It was reported that, the caller was a consumer called in regard to the Pfizer COVID-19 vaccine. Stated that, he had been seeing his doctor for about 3 weeks now and his doctor did not know what to do, so he advised the caller to contact Pfizer. The caller stated that, he got his first dose of the COVID-19 vaccine back on 21May2021 and then 3 weeks later, he came in on 11Jun2021 and got the number two shot. Stated that, the caller was unable to provide the NDC number or expiry date of the COVID-19 vaccine. Stated that, when the patient got the first shot, his arm just got a little swollen on 22May2021, but it was not red. Stated that, his arm did not show any signs of infection or anything, so it was just swollen and after a couple days everything was fine. The AE require a visit to emergency room was reported as no and physician office was reported as yes. The reporter seriousness for the event was reported as unspecified. The outcome of the event was recovered on an unspecified date in May2021.  No follow-up attempts are needed. No further information is expected.
Moderna killed my father in law; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Moderna killed my father in law) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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. Death occurred on 27-Aug-2021 The patient died on 27-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-695787.; Reporter's Comments: This spontaneous case concerns a male patient of unspecified age, with no medical history reported, who experienced the fatal, unexpected serious (death and medically significant) event of Death that occurred on unspecified day in context to a dose of mRNA-1273 vaccine. The event was reported as Moderna  killed my father-in-law. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695787:Mother's case; Reported Cause(s) of Death: Unknown cause of death
Immediately following vax, the pt did not walk, he could move his foot, but would not move his leg, he would not put any weight on his leg. Possibly some numbness was experienced. At approximately 36 hours post vax, the pt began testing his leg and within 48 hours walked with slight limp.
Approximately 12 hours after immunizations, pt woke with "skin crawling" headache and fatigue.  Later in day, developed rash on left leg.  Next day, headache, stiff neck with tingling, weakness, nearly fainted.  Saw MD that day.  MD gave pt 1.5mg Betamethasone and 2mg Decadron.
This non-serious initial spontaneous case, was received on 19-Sep-2017 from Other Health Professional and concerns a 51-years-old male patient. The patient's current condition included: Diabetes, hypercholesterolemia and CAD (coronary artery disease). The patient's concomitant medications included Atorvastatin, GEODON, Tiagabine, Clonazepam, NOVOLOG mix, VICTOZA, Metformin, Ziprasidone, Glipizide, Venlafaxine, Carbamazepine, Vitamin D and Metoprolol succinate for unknown indication. It was reported that MDV (multiple dose vials) (open and unopened) affected by Hurricane, reached unknown temperature (possibly 86F) for more than 24 hours, but exact number of hours without power was not known. On 10-Sep-2017, power went out till 12-Sep-2017. On 18-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195124 (as reported), expiry date: Apr-2018, route of administration, anatomical location: not reported). It was reported that vaccine administered following temperature exposure more than 46F. The outcome of the events was not reported. The reporter assessed the report as non-serious.
Onset of fever to 102, hives under bilat axilla, pain and redness at injection site, perceived wheezing and dry mouth with nausea. Patient went to ER and was given fluids, mom denies patient receiving any meds. Pt advised by Dr to take BENADRYL 25 mg po q6h for 2-3 days.
HISTORY OF PRESENT ILLNESS Patient is a 47 y.o. male  with past medical history significant for morbid obesity, hypertension, type 2 diabetes, peripheral neuropathy, peripheral venous insufficiency, history of DVT and pulmonary embolism (5/2019) who presented with acute worsening of right great toe pain, swelling and tenderness. He states that he has had pain and mild swelling in his right great toe since he fractured it in 06/2021. On Monday 10/11 he noticed worsening pain and swelling and yesterday 10/12 he noticed redness on his great toe and foot. This morning 10/13 his great toe opened and began to have serosanguinous drainage which prompted him to present to the ED. He does states that he has had  pain and mild swelling in his right great toe since he fractured it in 06/2021. On Monday 10/11 he noticed worsening pain and swelling and yesterday 10/12 he noticed redness on his great toe and foot. This morning 10/13 his great toe opened and began to have serosanguinous drainage which prompted him to present to the ED. He does states that he has had chills and increased fatigue over the last few days. Notably, he was diagnosed with COVID 09/25/2021 and has had dyspnea on exertion, fatigue and dry cough since. He also endorses right sided chest wall pain that is reproducible with palpation. He denies SOB, abdominal pain, nausea, vomiting, or diarrhea. He does not use tobacco, alcohol (since starting Wellbutrin several months ago) or illicit substance.      In the Emergency Department, he was tachycardic and tachypneic. There were concerns regarding necrotizing fasciitis or osteomyelitis so he was started on vancomycin and zosyn for broad spectrum coverage.  Orthopedic surgery was consulted in the emergency department. They believe this is a subcutaneous abscess with surrounding cellulitis and made a small incision for abscess drainage.  At this time they do not recommend surgical debridement but recommend close follow up and IV antibiotics. He was subsequently transferred to the clinic for management of acute cellulitis.
Patient presented to the hospital on 12/6/21 with symptoms ongoing for several days (unclear which exact date symptoms started). The patient was experiencing fever of up to 102.8 in the hospital with shortness of breath, cough, and body aches. She tested positive for COVID on 12/6/2021 and has been on 6L of Oxygen.
Pt presents following syncopal episode 5 minutes post vaccination of 1 dose Janssen vaccine to left deltoid. Pt was helped to the ground by her fiance and regained consciousness immediately. She had no head injury or other trauma. On immediate evaluation she is conscious but slow to answer questions. She denies medical problems, medications, or any Hx of allergies. She states that this has never happened in the past. The Pt complains of dizziness and generalized weakness. Pt denies swelling of the face, throat tightness, difficulty swallowing, itching of the skin, SOB, CP, nausea or vomiting.   Following repeat vital signs that showed improved BP of 126/58, pulse 61, and O2 98% the Pt refused medical transport and signed out AMA with EMS. Pt was driven home by her fiance.
feeling faint, weakness, low blood pressure, rash, body aches, headaches, chills, fever, swollen lymph nodes.
fever; Chills; Body aches; Bad headache; Muscle pain; This is a spontaneous report from contactable consumer (Patient) reporting herself.  A female patient of an unspecified age received second dose of BNT162B2 (Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 30Jun2021 at 14:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced a bad reaction experiencing which included fever, chills, body aches, muscle pain and a bad headache. During the call she stated that she should take Advil because she was in "much pain" more than she can get used to just to get by. Patient wanted to know if the side effects that she was presenting could be due to the Pfizer´s COVID-19 vaccine or due to something else. Caller disconnected during holding time and was unreachable at call back number provided. Therapeutic measures were taken due to the events. The outcome of the event s was unknown.  Information on the lot/batch number has been requested.
rt anterior thigh 5 cm area red, no edema noted-pt laughing cheerful; mom states pt woke up crying-mom took pt to clinic; cold compresses q hr & cont APAP recommended;
Starting about half an hour after the vaccine I started experiencing what I thought was a migraine; dizzyness, lightheaded, headache, tired. Over the rest of that day it continued to get worse and my arm started to hurt. I started feeling nauseous, shortness of breath, and pressure in my chest. As I had mild flu- like symptoms with the first 2 shots in the series I didn?t worry to much and went to bed. The next morning I had all the same symptoms as well as pain in my chest, I could feel my heart beating fast, and a fever around 100. I tried to continue my day as normal but by around 5 o?clock it felt like someone was squeezing my heart and it hurt to move or breath. At that point I started checking my temp every few hours and it stayed around 101-103. Not much changed for the rest of that night. On the 16th I started to feel a little better. My fever dropped back to 99-100 and it was a little less painful to breath. From then over the next 3-5 days I improved to the point were I was mostly normal. For about a week after that point I would still get tired very easily and I would get light headed easily. On dec 31 I went to the ER with similar symptoms (shortness of breath, pain in chest) but as of a few days after that I have felt fine.