chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pericarditis; Myocarditis; Heart attack; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 49-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 1, 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: MYOCARDIAL INFARCTION (medically significant) with onset May2022, outcome "unknown", described as "Heart attack"; MYOCARDITIS (medically significant) with onset May2022, outcome "unknown"; PERICARDITIS (medically significant) with onset May2022, outcome "unknown". The events "pericarditis", "myocarditis" and "heart attack" required emergency room visit. The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: Unknown results. Therapeutic measures were taken as a result of pericarditis, myocarditis, myocardial infarction.  Clinical course: In May2022, patient experienced Pericarditis and Myocarditis. After received first BioNTech Covid vaccine and 8-12 hours later developed chest pain. Patient felt like heart attack and went to ER. Patient had heart cath and cardiologist for follow up. Sign and symptoms were resolved at this time. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, a causal association between the reported events and BNT162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Patient complained that her left arm got red and swelling after she got the 3rd dose of Pfizer. Today is Wednesday and her arm is still not better. I counseled her to use ice compression, and take benadryl and I will follow up next 1-2 days. If it gets worse, I advise her to go to ER
pt reported malaise, fever 102, weakness, bad cough, lassitude; went to ER had been recovering from bronchitis (3wk hx)
pt devel itching & rash (like mosquito bites) lt arm @ site of flu vax inj w/in hrs of administration;
Appendicitis, hurt for 2 weeks, had ct scan, had surgery 9/25/21
pt recv vax & exp febrile episode & irritability; MD did not feel that vax was the cause of sx; MD stated that the pt did not suffer from any reportable adverse rxn;
she has seasonal allergies; Runny nose; Sneezing; This is a spontaneous report from a contactable consumer (general public) reported for herself. A adult female patient on an unknown age (>65 age) received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: not reported, expiry date: not reported), via an unknown route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included pollen allergy and cancer (also stated had cancer last year); both were from an unknown date and unknown if ongoing. Concomitant medication was not reported. The patient received flu shot (clarification of full product name/brand name/Lot/NDC/Expiry: Not provided, caller unwilling to complete the report) back in Nov as historical vaccine. On an unknown date, allergies, but not a cold or fever or the flu, runny nose, sneezing, asked if it is ok to get the next Pfizer covid shot next week. Received first dose. Due to receive second dose next week, indicates she has seasonal allergies and stated that she did not had any allergies and HCP does not know. Also stated had cancer last year. It was also informed that she was to have her next Pfizer Covid shot next week. Due to the season and pollen and she has history of allergies this time of year. Usually has a runny nose from the allergies, but not a cold or fever. This was normal for her this time of year because of the oak trees. Had flu shot back in Nov, long before Pfizer Covid shot. Wants to know if it's okay for her to get the next shot next Tuesday. Has had runny nose and sneezing when she has allergies and mentions again this is normal, she does not have a cold or fever or the flu but is it okay for her to get the next shot next week, Tuesday. Mentions she is over 65 years old. Attempts made to slow and clarify details. No further details provided. The outcome of the events was unknown.  Declines to provide her address or email address. Declines report and wants answer to question. No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 52 years old female patient who experienced worsening hives on her neck, chest, face, hairline and down her back/a very sensitive sunburn, painful just from contact with clothing, red raised hives and pain at the injection site, while she received vaccine FLUBLOK QIV. The patient's past vaccination(s) included FLUBLOK several times in the past and did not experience hives just injection site pain. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing food allergy (egg allergy). The patient had no concomitant medications reported. On 02-Nov-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1814 in the left arm. On an unknown date, the patient developed a non-serious had worsening hives on her neck, chest, face, hairline and down her back/a very sensitive sunburn, painful just from contact with clothing, red raised hives and pain at the injection site, following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The patient denies shortness of breath and facial/tongue swelling. (Other relevant tests included No lab data reported.) Final diagnosis was pain at the injection site and had worsening hives on her neck, chest, face, hairline and down her back/a very sensitive sunburn, painful just from contact with clothing, red raised hives. The patient was treated with BENADRYL. The patient outcome is reported as Unknown for pain at the injection site and as Unknown for had worsening hives on her neck, chest, face, hairline and down her back/a very sensitive sunburn, painful just from contact with clothing.
Pt received pneumonia and flu vaccine on 10/27. Later that night she started having soreness in arm and large red spots appeared on right arm almost in a band around arm, redness on chest. The next morning she had high fever and chest pain. She came back to clinic on 10/29 and told us of symptoms and she also had a swollen knot on chest midsternum. She was sent to medical provider for treatment. Tried to call pt and left message.
Fever, headache, body ache, fatigue, loss of appetite, nausea, loss of sense of taste, sneezing, congestion, runny nose, coughing
Extremely ill; sweating; vaccination site pain; fever; chills; headache; body ache; extremely fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely ill), HYPERHIDROSIS (sweating), VACCINATION SITE PAIN (vaccination site pain), PYREXIA (fever) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cystitis interstitial since 1993, Hypertension since 2019, Arthritis since 2007, Chronic back pain since May 2003 and Chronic fatigue syndrome since 1985. Concomitant products included HYDROXYZINE from 2004 to an unknown date for Cystitis interstitial, PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Extremely ill), HYPERHIDROSIS (sweating), VACCINATION SITE PAIN (vaccination site pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and FATIGUE (extremely fatigue). At the time of the report, ILLNESS (Extremely ill), HYPERHIDROSIS (sweating), VACCINATION SITE PAIN (vaccination site pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body ache) and FATIGUE (extremely fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97 (High) Typically about 97 degree celsius.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. It was reported that patient had many RX sensitivities, but not allergies that are life threatening. Patient race is white.   This case was linked to MOD-2021-374847, MOD-2021-368330.
I record the shot at 3pm on Wed. I felt fine all Wed. night. I woke up Thursday morning feeling a little fatigue and arm soreness. By noon on Thursday I started getting a headache and chills. I went home and took ibuprofen and felt better by evening. On Friday, I was feeling better. Late Friday night my stomach started to hurt. From midnight to 6am (now Saturday morning) I was in the bathroom vomiting and diarrhea. I stayed in bed all day Saturday with fever and chills and couldn?t eat anything. It?s not Sunday and my stomach is still feeling gurgly but I haven?t had any vomiting or diarrhea since.  It?s now Sunday and I currently have fatigue and a headache, I could just be dehydrated now from all the vomiting and diarrhea.
Slight redness, swelling (quarter size) right thigh. Warm compresses, Tylenol/Motrin.
This spontaneous report was received from a medical assistant concerning a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 26-NOV-2018, the patient was administered with improperly stored VAQTA (lot # R018935, expiry date: 05-SEP-2019) for prophylaxis. Dosing details were unknown for the vaccine. No adverse effect reported. The temperature excursion occurred between 0 degree Celsius to 1 degree Celsius (0.5 degree Celsius multiple) for a time frame of 13 hours and 18 minutes. There were no previous temperature excursions occurred. Data logger was involved. No product quality complaint was involved. This is one of the two reports received from the same reporter (cross linked case reference: 812USA006429).
I had the normal shoulder pain for a couple days. Then day 6 developed extreme malaise with nausea.  I kept saying it felt like my whole body was floppy and melting into the couch, and I couldn?t motivate to stand or do anything for 24 hours.  Then myalgias and nausea continued for 2 days.  Around the same time as the malaise, I developed a palpable indurated area under the vaccine site.  Then day 8 my entire shoulder swelled up with overlying red leathery skin and axillary pain but no adenopathy.  Day 10, back to normal except for some residual red pruritic skin extending down my arm.
Immediate swelling at site where DTaP given. Benadryl tsp PO in the first few minutes.
sort of laryngitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunisation; Bnt162b2 (Dose: 2), for COVID-19 immunisation; Bnt162b2 (Dose: 3), for COVID-19 immunisation; Bnt162b2 (Dose: 4), for COVID-19 immunisation. The following information was reported: LARYNGITIS (non-serious) with onset 11Sep2022, outcome "unknown", described as "sort of laryngitis". The event "sort of laryngitis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: the patient without any recent medical history, received the fifth dose of Pfizer/ BioNTech booster against the omicron variant on 09Sep2022, at a facility. Two days after, the patient noticed develop a "sort of laryngitis." None of the previous doses resulted in this type or any type of reaction. After three Covid tests to make sure it was not COVID she went to see the doctor who told her that other patients were having "similar reactions" after the last booster against the omicron variant. 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.
Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 18Jan2021 17:15 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and asthma, both from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 at 01:15 PM (lot number: EL1284) in the left arm for COVID-19 immunization given when the patient was 53 years old. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She had known allergies which were not specified. She was not pregnant. The patient experienced chest tightness, wheezing, throat swelling, tongue tingling and lip numbness, all on 18Jan2021 at 05:45 PM with outcome of recovering. The events resulted to Emergency room/department or urgent care. Treatment received for all events included DECADRON and Benadryl script for Epipen. The patient had no covid prior vaccination. She was tested for covid post vaccination through nasal swab on 20Jan2021 with pending result.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of chest tightness, wheezing, throat swelling, tongue tingling and lip numbness  due to temporal relationship.  However,  the chest tightness, wheezing may possibly be associated with the patient's history of asthma. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray and pulmonary function tests, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Arthralgias neuritis symptoms.  Short of breath, tachycardia, mild aches, generalized.  Administered 09/15/2003.
I did not have an adverse reaction to the vaccine. I was having a difficult breathing and I had difficulty getting up off the floor. In 11/2021, I was hospitalized for blood clots in my right leg that traveled up to my chest.  I was hospitalized for 5 days. In 03/2023, I had fluid around my lungs.
Mom reports <50 chicken pox like spots. Fever for 1 day. Resolved 3/30/03.
Reduced mobility in left shoulder, muscles on left side of body chronically sore, left hand, leg and foot tremors, rash on back.
I have noticed increased soreness at the site of the injection and my left shoulder is red, swollen and sore as if I am having an allergic reaction to the vaccine. I have also had moderate to severe headaches and fatigue. I do not have a fever and my daily temperature has been ~97.0.
3/28/11 0300 - bilateral inflammation, swelling, and pain of knees, ankles 3/28/11 330pm - swelling, inflammation joint tenderness bilateral hands, wrists, fingers, elbows, upper arms, shoulders; 3/28/11 and 3/29/11 - unable to ambulate for first 48 hours; 3/28/11 0900 - seen by Dr, labs drawn; rx for Ibuprofen 800 mg Q 4 hr 3/29/11- seen by Dr. reviewed lab tests 3/30/11 -> rx for TYLENOL #3; methylprednisolone. Faint pink rash chest, arms, hands 4/1/11 pain, rash swelling subsiding. Off work until 4/4/11.
1435: Patient stated he was feeling dizzy and tingly  1437: Blood pressure 142/92 Pulse 86 O2 stat 96% 1440: Patient stated he was feeling tingly in the arms and hands and his legs had fallen asleep  1451: Blood pressure 150/98 pulse 92 1455: Stated he had difficulty breathing  1459: Patient laid supine, chest pain  1512: EMS arrived, EKG done and no cardiac emergency found  1520: Reevaluated patient, chest pain reduced, vision back to normal, dizziness present, tingly reduced  1523: Patient refused hospital transport via ambulance
Debilitating dizziness with nausea/vomiting; Debilitating dizziness with nausea/vomiting; Debilitating dizziness with nausea/vomiting; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 18Apr2021 at 10:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, environmental asthma, hypothyroid, allergy to penicillin (PCN) and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN), insulin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 28Mar2021 at 09:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation and took codeine (MANUFACTURER UNKNOWN), morphine (MANUFACTURER UNKNOWN), metronidazole (FLAGYL) and gentamicin (GENTAMYCIN); all on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 04:45,  about 18 hours after vaccination, the patient experienced debilitating dizziness with nausea/vomiting. This lasted 8 hours on 19Apr2021 and has lasted over 6 hours on 20Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event debilitating dizziness with nausea/vomiting was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
No adverse events occurred. The patient was administered a Pfizer Pediatric Covid vaccine that was stored in the refrigerator for 10 days beyond what is approved by the manufactuer.
Within 3 days after receiving the vaccine nothing had happened. On the 4th day I started having a bruise on my lips, gums, and on the sides of my mouth were blisters. My tonsils were all open, and my joints was painful. I had soreness and swelling under my right armpit. On the right side of my lower back and ribs I had pain. It felt as if someone was punching me. The pain in that are bothers me still. Those symptoms lasted for about 2 weeks, and then I was fine. About 3 weeks later after that, the symptoms from my back came back. Then I had got sick with a cough, and my mouth was dry. I had blisters on my tongue and lips. I took a covid test and it was negative. My joints was painful again. 2 weeks later from that I was ok again. Then 2 or 3 weeks after that I had got sick again with a fever, and I was coughing all the time for 4 days. The same symptoms as before came back. I was out of work for 2 weeks. I did another covid test and it was negative again. I went to the doctor for my back and kidney. I was also losing my vision so I went to the eye doctor. I went to a foot doctor because from the heel on my right foot all the way up to my hip was painful. I was seeing a chiropractic doctor for almost 2 months because of the pain on my spine, back, and ribs. I still have have pain on my joint, back, and shoulders. My joints are painful all the time. When I go to work they bother me a lot. I keep going to doctors and explain the symptoms that I am having, but they don't have an answer for me. They just say that covid is new.  My lower back on right side is still hurting all the time. I also did have some prostate issues.
Patient felt light-headed, said she lost some sense of hearing, stomach was upset. Her blood pressure was 88/60, HR read irregular when measured manually. When EMTs arrived at 10:40 A.M., her BP was around 117/89, HR 91.
Headache; fever ranging from 99 - 101; Shortness of breath; Fatigue; Body ache; Nausea; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 04Mar2021 at 15:15 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP), obesity, type 2 diabetes, asthma and COVID-19 in Mar2020 and Apr2020. It was reported that the patient was on unspecified concomitant medications. The patient had no known allergies. The patient did not receive any other vaccines within four weeks, prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 05Mar2021 at 02:30, the patient experienced, headache, fever ranging from 99 - 101, shortness of breath, fatigue, body aches, nausea, vomiting, and diarrhea. The symptoms lasted for about forty hours after they began. The events resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures taken included tylenol (MANUFACTURER UNKNOWN) for fever and ondansetron (MANUFACTURER UNKNOWN) for nausea. The clinical outcome of the events headache, fever, shortness of breath, fatigue, body ache, nausea, vomiting and diarrhea were resolved on 07Mar2021.   No follow-up attempts are needed. No further information is expected.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-MAY-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
NO ADVERSE EVENT NOTICE RECEIVED ON DATE OF VACCINE.   RECEIVED NOTICE FROM CORONOER THAT THIS PATIENT EXPIRED  2/28/2021.  COLLECTED URINE, BLOOD, AND TOXICOLOGY SCREEN.  NOT SENT TO HOSPITAL.  SENT TO FUNERAL HOME