chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe heart palpitations; crushing back pain; tingling; nausea; headache; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 10:00(at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021, the patient experienced severe heart palpitations, crushing back pain, nausea, headache, tingling, which were persists and worsening. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the events severe heart palpitations, crushing back pain, nausea, headache, tingling, which were persists and worsening was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Well child visit, vaccines given at approx 10:45 am. Pt felt a little lightheaded after 4th shot but didn't say anything. Pt & mother left exam room, walked out to front desk to check out. At approx 11A pt passed out, fell to floor but first, was out a couple of seconds. Kept on floor few minutes then taken to exam room given juice & cookie, vitals stable. Sat in room x15 minutes then released. No dizziness, felt fine, no injury.
immune-mediated thrombotic thrombocytopenic purpura (iTTP); This is a literature report for the following literature source(s).  A 61-year-old male patient received BNT162b2 (BNT162B2), 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: THROMBOTIC THROMBOCYTOPENIC PURPURA (medically significant, life threatening), 5 days after the suspect product(s) administration, outcome "recovered", described as "immune-mediated thrombotic thrombocytopenic purpura (iTTP)". The patient underwent the following laboratory tests and procedures: ADAMTS13 activity assay: less than 3; 97 %, notes: on day 142; ADAMTS13 activity assay: unknown results. Therapeutic measures were taken as a result of thrombotic thrombocytopenic purpura.  Clinical course: Treatment included TPE, with a median of 7.5 (range 217).TPE sessions until sustained normalization of platelet counts (number not reported in three cases). Steroids were administered in 20/21 patients (not reported for one case).While four patients (19%) received no additional treatment, weekly rituximab (RTX) or daily caplacizumab was added in 43% (9/21) and 14% (3/21) of patients, respectively, and 5/21 (24%) patients received both.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a 19 week old female who on 07-AUG-2007 was vaccinated with the second 2ml oral dose of Rotateq (Lot# 656393/0240U).  Concomitant therapy included PEDIARIX and PREVNAR.  On 13-AUG-2007 the patient experienced a fever of 102.3 after vaccination.  Unspecified medical attention was sought.  The recovery status was unknown.  There was no product quality complaint.  Additional information has been requested.
Symptoms: Shivering, freezing cold fingers, headache, dizziness, insomnia, and low blood pressure (90/66).  Treatment: Aspirin for headache, held BP medications in the morning upon consult with the pharmacist
Complaint of severe pain at injection site, unable to lift arm, painful shoulder.  Dr. (Hospitalist) confirmed on 11/01/19 stated her patient is recovering and being discharged today 11/01/19.
Infertility secondary to Primary Ovarian Failure resulting in premature menopause at 27 years old.   Onset of symptoms at 26 when it became difficult to carry a pregnancy. 5 miscarriages as a result of imbalance of hormones and high levels of Follicular Stimulating Hormone (FSH), decreased Anti Mullerian Hormone (AMH) and poor egg quality.
01/07/22 presents to ED for "chest pain". PMHx of "CAD s/p stenting, HTN, HLD"
Approximately 24 hours after vaccine, I woke  feeling  very weak and tired, experienced body aches, headache, clumsiness, foggy thinking, and fevers/chills/sweats?highest measured was 100.9.  All these symptoms resolved approximately 24 hours later as well.  Now,  3 days later, I have skin rash and arm swelling in area of injection.
Expired Heplisav-B dose given to patient; Initial Report Received on 30-May-2019  A pharmacist from the Agency reported that a patient (age, gender, and race not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Relevant medical history was not provided.    Concomitant medications were reported as unknown.    On 30-May-2019, the patient received an expired dose of Heplisav-B (lot #1033384, expiration date: 06-Apr-2019, NDC # unknown). The pharmacist reported that he received the information from another source and that he had no information about the patient or provider. No further information was provided.   At the time of the report, there were no adverse events reported.   The reporter did not provide a seriousness assessment for the event.   Company comment:  The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI. ; Sender's Comments: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.
gave a shot to a patient and then 5 or 6 days the area has been red , redness started that thursday 28 April 2022; redness and swelling and hot to the touch it goes from the injection down to her elbow; redness and swelling and hot to the touch it goes from the injection down to her elbow; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 53-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 20Apr2022 as dose number unknown, single (Lot number: FJ2605, Expiration Date: 31Jul2023) at the age of 53 years. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LANTUS; NOVOLOG. The following information was reported: ERYTHEMA (non-serious) with onset 28Apr2022, outcome "unknown", described as "gave a shot to a patient and then 5 or 6 days the area has been red , redness started that thursday 28 April 2022"; VACCINATION SITE SWELLING (non-serious), FEELING HOT (non-serious) all with onset 28Apr2022, outcome "unknown" and all described as "redness and swelling and hot to the touch it goes from the injection down to her elbow".  Additional information: Concern: Transferring agent Stated, She is stating that a patient, a female patient 53 years old received a shot of Prevnar 20 on 20Apr2022. She has experienced redness that started the day of the vaccination. She said the patient has redness and swelling and its hot to the touch and it goes from the injection site down to her elbow. Her question was how long should it last or should the patient seek medical attention if it last longer than 10 days, which I provided information for but she needs to report the adverse event.  No follow-up attempts are possible. No further information is expected.
She is mildly tachycardic and oxygen saturation is mildly decreased at 95%.
NO REACTION REPORTED BY FAMILY, WRONG DOSE WAS GIVEN TO PATIENT. FLUARIX IS FOR 3 YEARS AND OLDER THIS CHILD IS 2 YEARS OLD AND 8 MONTHS.
Expired vaccine was stored and then administered/Vial refrigirated after expiry; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was placed in refrigerator on 29-Oct-2021 Vial did not undergone to any temperature excursion. No adverse event was reported. No treatment medications were reported.
2 days after I received the 2 vaccinations, I lost range of motion in my shoulder.  It was very painful. I had a difficult time doing every day things like getting dressed and driving. This has lasted several weeks, although it has improved. I am still not pain free and I do not have full range of motion.
This spontaneous report as received from a Registered Nurse refers to a 15 year old female patient with no pertinent medical history or drug reactions/allergies. On 20-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # J009827, expiration date 10-AUG-2014, 0.5 ml, intramuscular in the left arm) for history of hereditary spherocytosis. There was no concomitant medication. On 20-JAN-2014, the patient's left arm swelled up, it was really red, hot to the touch, and pain from the left shoulder to elbow. There was no treatment given for the patient. No lab diagnostics studies performed. The patient sought medical attention via visiting the office. The outcome of the events was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
Pt was here for MCV40. Pt was injected with diluent only. Vaccine was not mixed.
Extreme fatigue, myalgias, arthralgias similar to symptoms post Lyme's disease 3 years ago.  These have been persistent for weeks.
Patient presented to clinic RN in observation room 5 minutes post COVID-19 vaccination. Was visibly diaphoretic while sitting in chair and reporting dizziness/feeling like she "is going to faint." Patient walked with 2 RNs to stretcher.  Patient was alert, then laid down on stretcher and given water. Emergency response team was called and team arrived on unit within 10 minutes. Vitals on arrival include BP: 94/50 HR: 49, spO2: 100%. Patient reports low BP and HR at baseline. Vitals recheck: BP: 100/59, HR: 67, spO2: 100%. Patient reporting feeling "back to normal" after total time of 25 minutes. Denies pain, itching, SOB, difficulty breathing, or dizziness. BG: 109.  Emergency response physician cleared patient. Patient walked with around with clinic RN prior to leaving. Denies any distress. Independently exited clinic.
Covid arm started 6 days after vaccine & swelled and rash in left arm exactly on week later with fatigue.  Still have symptoms at 8th day.
dizziness; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (father) reported that a male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient experienced dizziness 5 days after the second shot on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about batch/ lot number cannot be obtained.
J&J COVID-19 Vaccine EUA  J&J Dose 3/16/21 (1805018) COVID Positive 5/3/21  5/3/21: Presented to ED. 35-year-old female presents the ER with chief complaint of cough.  Patient stated symptoms started 1 week ago.  Fiancee has similar symptoms.  Other associated symptoms include pleuritic chest discomfort, lightheaded upon standing, fever 102, chills, bilateral ear pain, headache, general malaise, bilateral leg pain, and fatigue.  Cough is described as productive producing yellow green phlegm.  No prior history of DVT or PE.  No recent travels or surgeries.  Patient is on Depo.  She has no reports of unilateral leg pain or swelling.  Patient is a diabetic type 2 with blood sugars running in the 170s 2 days ago.  Normal is 100-200.  She takes metformin and glipizide.  She also has a history of anxiety, depression, bipolar, hypothyroidism. Discharged to home with albuterol, doxycycline, prednisone.
Swelling of face / left jaw area; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration in the left arm on 13Apr2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) and esomeprazole magnesium dihydrate (MANUFACTURER UNKNOWN); taken for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 18:30, the patient experienced swelling of face / left jaw area. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event swelling of face / left jaw area was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Induration of thigh with slight raised, patchy urticaria rash.  Entire upper leg swollen 3-4 inch high diameter.  Fever @ home.
beginning approximately 11:45 pm on the day of the vaccine, severe chills such that the whole bed was shaking, couldn?t get warm, fever about 101 F. Woke up at 4:30 am with pulse of 130 and fever of 100.7 F. Chills gone by then. As the morning wore on, funny taste in mouth, stomach isn such that there?s a loss of appetite. Feeling almost inebriated. Fatigue.
pt recv vax 12DEC95 & 26DEC95 pt exp vesicular rash w/dermatome patterns on the rt knee,lt axilla & rt groin;04MAR96 pt exp resp distress & was hospitalized;dx w/gram-neg pneumonia;10MAR96 placed on therapy w/acyclovir;exp fevers;
24 ours after, I developed a red bullseye- softball size - on right arm. Fever and back pain as well. And headache. The bullseye - lasted about 7-10 days. About three days into I went to the  Urgent Care - they gave me a cream to put on it and Benadryl. The red bump was warm to the touch and it was painful. Those helped resolved the bulls eye bump within three days.
Within  30 minutes after the injection,  my face became flush and my heatrate was racing.  I went back into the clinic where I  received the injection and was checked by EMT's.  I was experiencing chest pain and  my  bloodpressure was extremely high (195/125) An EKG was done which showed irregularities and I was given Baby Asprin and Nitrogylicern.  I was then transported by ambulance to  Hospital and kept overnight.  Several Tests were conducted including EKG's, Ultrasound, Nuclear stress test, and Enzyme Test to determine if I had a heart attack.  In the end, all tests were negative and I was released from the hospital the following evening (8:00 pm).    I was extremely fatigued and weak for the next two weeks and eventually recovered.  The chest pain was determined to be a pulled chest muscle wwas exacerbated by the high blood pressure.
Pfizer-BioNTech COVID-19 Vaccine  Approximately 24 hours after injection I felt dyspnea with minimal exertion and at rest while wearing my hospital mask, which I attributed to the cheap quality of the mask.  Breathlessness was relieved after I took it off.  I shoveled snow with no problem over the weekend, and was off work.  Three days later, on 1/3 around 7 pm, I experience the same feeling while wearing the same type of mask, and it was relieve when I took it off.   The following day, 1/4 around 2pm, while wearing a different disposable mask in the grocery store, felt extremely overheated and realized I was having difficulty breathing with minimal exertion.  This time the feeling did not pass when I left the store/removed my mask, and residual effects of not being able to easily take a deep breath stayed with me the entire day.   The feeling was gone in the morning, but did eventually re-occur the next day (tightness in my lungs not allowing for easy deep breaths) on 1/5 near the end of a shift where I had been wearing yet a different type of disposable mask. The symptoms starting around 4:30 pm and lasted throughout the rest of the evening.  At this point I notified employee heath and scheduled a covid test.   The next two days, on 1/6 and 1/7, the same type of dyspnea persisted throughout the day; while at rest, not relieved, and with no other symptoms (no cough, fever, etc.)   Ibuprofen appears to relieve the discomfort, and I have returned to work, however the symptoms are still present if I am not taking Ibuprofen.  Possibly some kind of pleurisy.  My lung sounds are clear.
Patient became nauseous, diaphoretic, dizzy and felt as if she was going to "pass out"
Headache; Chills; Nausea; Vomiting; Body aches; Pain at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 12Mar2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine and COVID-19 antibody test positive. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vita fusion women's vitamins (MANUFACTURER UNKNOWN) and magnesium (MANUFACTURER UNKNOWN) all for unknown indication from an unknown date and unknown if ongoing. On 12Mar2021 at 22:00 the patient experienced headache, chills, nausea, vomiting, body aches and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. On an unknown date, the patient underwent COVID-19 antibody test and the result was positive. The clinical outcome of the event headache, chills, nausea, vomiting, body aches and pain at injection site were resolving at the time of report.   No follow-up attempts are possible. No further information is expected.
Within 15 sec. of completion of vaccination administration pt. (sitting on father's lab for immun.) became rigid and fell back against Dad. Lasted not even 5 sec. Then arms, legs normal, but not talking, lips blue, skin pale, lasted another 5 sec. Then child would respond with nodding of head, took sips of water without problems - started talking within 5 sec. Cool moist cloth applied to neck and arms throughout incident. Pt. back to normal, laughing and talking - walked with Father out of office.
"a lot of fatigue"; "severe joint pain"; "fever"; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE ("a lot of fatigue"), ARTHRALGIA ("severe joint pain") and PYREXIA ("fever") in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included Chronic lymphocytic leukemia (exposed to Agent Orange spray during the war).   On 16-Feb-2021, the patient received second 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) (unknown route) dosage was changed to 2 dosage form. On 15-Mar-2021, the patient experienced FATIGUE ("a lot of fatigue"), ARTHRALGIA ("severe joint pain") and PYREXIA ("fever"). On 22-Mar-2021, FATIGUE ("a lot of fatigue"), ARTHRALGIA ("severe joint pain") and PYREXIA ("fever") had resolved.            no concomitant medications reported. no treatment details reported.
1st dose on 03-Mar-2022, 2nd not received; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd March 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-Nov-2022 Reporter's comment: The patient did not receive the 2nd dose as of yet, which was past the 6 month recommendation.  The reporter mentioned that she will administer, however the patient was not in the office at the time of the call. No reactions were reported. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The details were reported for 1st dose of Shingrix.
This case was reported by a consumer via patient support programs and described the occurrence of injection site warmth in a female patient who received SHINGRIX for prophylaxis. On 5th July 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site warmth, tenderness and band sensation. On an unknown date, the outcome of the injection site warmth, tenderness and band sensation were unknown. It was unknown if the reporter considered the injection site warmth, tenderness and band sensation to be related to SHINGRIX. Additional details were reported as follows. The age at vaccination was not reported. The patient stated that after injection they felt tenderness and a band formed around the arm about 3 inches below the injection site. The band was about 3 inches around and 1 inch wide. The injection site was warm to touch. Till the time of reporting the issue did not resolve.
Red rash around inj site and around arm. Prednisone x 5 days.