chrisvoncsefalvay/vaers-outcomes huggingface dataset:
possible heart attack; High pain in left arm; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular, administered in left arm on 08Feb2021 13:00 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation.  Medical history included atrial fibrillation from 2010 to an unknown date, hypertension from 1971 to an unknown date, both knees replace from May2011 to an unknown date, left shoulder replaced from Nov2011 to an unknown date, left eye cataract removal from Jun2013 to an unknown date, right eye cataract removal from Oct2013 to an unknown date, L4 & L5 disc repair from Aug2014 to an unknown date, Gall bladder removed from Sep2014 to an unknown date, Right shoulder, Kidney disorder, cramps, Virus fighter, Heart disorder, eye disorder, General Health, Blood thinner, R. shoulder pain, sleep disorder, constipation, Clear vessels. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's concomitant medications were not reported. The patient experienced possible heart attack on 08Feb2021 with outcome of not recovered, high pain in left arm on 08Feb2021 with outcome of not recovered. High pain in left arm-possible heart attack on 08Feb2021. Reported it was not caused by shot, but result is possible pitched nerve- X-ray and CT scan Being done. AE required Scheduled X-Ray and then CT scan on neck. Treatment included the event did require the initiation of new medication/other treatment/procedure. Seriousness criteria reported as not serious. COVID-19 testing had not been conducted.; Sender's Comments: A contributory role of the vaccine BNT162B2 to the event possible heart attack cannot be fully excluded based on the temporal relationship. Patient's advanced age, underlying hypertension, atrial fibrillation, kidney disorder and other comorbidities provide alternate explanation for the event. Case will be  reassessed if additional information is received.   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.,Linked Report(s) : US-PFIZER INC-2021277193 same patient, same product (second dose), similar events.
Flu-like symptoms after 1st dose; sick; Severe diarrhea since 1st dose; Very weak after 1st dose; Injection site itchy more than a week after 1st dose; Injection site red more than a week after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st dose), ILLNESS (sick), DIARRHOEA (Severe diarrhea since 1st dose), ASTHENIA (Very weak after 1st dose) and VACCINATION SITE PRURITUS (Injection site itchy more than a week after 1st dose) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021821a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st dose), ILLNESS (sick), DIARRHOEA (Severe diarrhea since 1st dose), ASTHENIA (Very weak after 1st dose), VACCINATION SITE PRURITUS (Injection site itchy more than a week after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red more than a week after the 1st dose). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st dose), ILLNESS (sick), DIARRHOEA (Severe diarrhea since 1st dose), ASTHENIA (Very weak after 1st dose), VACCINATION SITE PRURITUS (Injection site itchy more than a week after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red more than a week after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication provided by reporter. No concomitant medication provided by reporter.
Rash started 2/13/2020 on right arm got wose 2/14/20 - went to hospital was given on clindamycin - saw pt on 2/18/20 swelling subsided still red a little bit Called patient on 2/17/2020 @ 9AM as soon as I received the message & as soon as the pharmacy opened. She accused me that I didn't wear gloves. I explained to her that I did wear gloves & that is the protocol, & I cleaned her skin w/ 2 alcohol swaps. & I went to explain to her that pneumonia is related with redness & as I explained to her during the shot that of she received this redness to apply ice on it & sometimes it resolved 5 day. According to site of manufacture. PPSV23 is associated w/ injection site soreness/ tenderness/ swelling/ induration/ erythema contacted the manufacture to send info to pt as well on 2/17/20 w call 2/18/20 to follow up. Pt came in on 2/18/20 w/ her parents, the rash has subsided, area still a little red & 0 swolleness. I gave all the paper/documentation requested by pt VARS & VAERS form & explained to the pt the risk of pneumonia PPSV23 Rxn. Will speak w/manufacturer to send pt more info about vaccine  (rash swolleness Rxn.
Within a couple hours of getting vaccine, patients eyes became swollen and purple and he developed a rash on his right leg. Mom reports eyes remain purple, this Am but swelling has reduced, rash stayed the same. Small red dots on right leg only.
12/16/22 presents to ED for "chest pain". PMHx of "CAD s/p CABG, bradycardia s/p PPM, HTN, dyslipidemia, hypertrophic cardiomyopathy, CVA, and rheumatoid arthritis"
This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 30th May 2018, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fever, rash, chills and influenza-like symptoms. On an unknown date, the outcome of the fever, rash, chills and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever, rash, chills and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. After receiving SHINGRIX, the patient sustained a fever, rash, chills and flu like symptoms. The patient did not seek any medical.
Knee injury; Back injury; Unable to get his second vaccine on time due to medical issues; Came back on 01-Jun-2021 to get second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of JOINT INJURY (Knee injury), BACK INJURY (Back injury), INTENTIONAL PRODUCT USE ISSUE (Unable to get his second vaccine on time due to medical issues) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Came back on 01-Jun-2021 to get second dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Came back on 01-Jun-2021 to get second dose). On an unknown date, the patient experienced JOINT INJURY (Knee injury), BACK INJURY (Back injury) and INTENTIONAL PRODUCT USE ISSUE (Unable to get his second vaccine on time due to medical issues). On 01-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Came back on 01-Jun-2021 to get second dose) had resolved. At the time of the report, JOINT INJURY (Knee injury) and BACK INJURY (Back injury) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Unable to get his second vaccine on time due to medical issues) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.
Local reaction at site - swelling, heat, muscle pain, red rash  Chills Fatigue Nausea
Less than 2 min after injection pt. was clammy and pale. O2 given at 2LPM via N/C. EMS called. Cold pack applied to back of neck and Gatorade given per pts request. Pt stated that she has a fear of needles and this has happened in the past when she gets an injection. EMS arrived, pt refused to go, pt states she "felt fine". Pt's normal pallor returned, pt left without further complication. V/S 110/64; P-74; R-18; O2-98% on RA; Glucose 107.
Accelerated dosing, did not receive 4th dose; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included TWINRIX (received accelerated dosing for Twinrix back in 2011).   On an unknown date, the patient did not receive the 4th dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment:  The reporter reported that the patient started the accelerated dosing for Twinrix vaccine in 2011 but did not received the 4th dose of Twinrix vaccine. The reporter stated that the vaccine administration facility was the same as primary reporter. The reporter declined to provide patient initials and date of birth. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 4th dose, which led to incomplete course of vaccination.
Pt recvd series of 3 hep B vax & was a non-responder.
No complaint of systemic symptoms. Pt states the injection felt 'different'. The site of injection bruised and became sore. By the evening she had pain and decreased range of motion of her shoulder.  Pt reported adverse to the pharmacy on 10/15/12, stating continued pain and loss of motion. Advised patient to contact physician. Pt had visit with someone at her PCP office and patient was told she is having an adverse reaction.  As of 10/26/12 patient is still in pain and experiencing decreased range of motion.
During the night I experienced flu-like symptoms (alternating chills and sweat, muscle pain, nausea and dizziness). I woke feeling nauseated around 3:45 a.m. and went to the bathroom. I was overcome with sweats and dizziness on the way there and took a break to lie down on the floor for a few minutes. Then I got up and made it to the toilet to urinate. While sitting there, darkness crept in on my vision and I experienced ringing in my ears. I knew I was about to faint and called for my husband. By the time he arrived in the bathroom, I was unconscious. He said that I was completely rigid and my eyes had rolled to the side of my head but were open. He called 911, managed to wake me, and drove me to the emergency room. I felt sweaty and dizzy when I woke and my husband said my sentences were not completely coherent.
pt recv 2 doses of MMR & exp negative titers;no furthers details were provided;
Information has been received from a Registered Nurse concerning a patient who was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The patient developed a measles like rash after receiving the vaccine. No other information was reported. Additional information is not expected.
Information has been received from a health professional concerning a female patient with a penicillin allergy and no significant medical history who on 1/21/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On 1/22/02 patient reported she developed a fever of 101 and a 5-6 cm raised red spot at the injection site. On 1/24/02, she called the physician's office and reported that her temperature was 98 degrees. The patient recovered from the fever and the outcome of the raised red spot at the injection site was unknown. Unspecified medical attention was sought. Additional information has been requested. A 15-day follow up report received 08/05/2003 adds: Info has been received from a woman at a family practice office concerning a 57 year old female pt with a penicillin allergy and no significant medical history who on 01/21/2002 was vaccinated in the right deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot #637487/1071K). There was no illness at the time of vaccination. On 01/22/2002 pt reported she developed a fever of 101 and a 5-6 cm raised red spot at the injection site. On 01/24/2002, she called the physician's office and retported that her temperature was 98 degrees. Follow-up info indicated that the pt experienced a fever and sore arm. The pt recovered from the fever and the outcome of the raised red spot at the injection site and sore arm were unknown. Unspecified medical attention was sought. Additional info has been requested.
Information has been received from a physician and the consumer a 48 year old female who on 01-MAY-2006 was vaccinated with Vaqta (lot # 646789/0753N) 1ml, injection. Concomitant therapy included typhoid vaccine (unspecified) administered on 01-MAY-2006. The consumer reported that on approximately 03-MAY-2006, "2 or 3 days after the shot". she developed diarrhea, liver enzyme elevation, and a fever of 102.7. Blood work and stool samples were being performed. At the time of reporting, the patient was recovering. Additional information was received from the physician. He reported that the patient received typhoid vaccine on 01-MAY-2006. He was unsure at this time if the patient even received hepatitis A virus vaccine inactivated on 01-MAY-2006. At the time of reporting, the patient had elevated total serum alkaline phosphatase and elevated transaminase of 140. The patient had low grade hepatitis which is most likely unrelated to vaccine. Additional information has been requested.
Second dose of the vaccine made her want to sleep; tenderness in her left arm for the first two doses; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Feb2021 12:15 (Lot number: EM9810) at the age of 75 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; VITAMIN B12 [VITAMIN B12 NOS]; CALCIUM; CINNAMON. Vaccination history included: Bnt162b2 (Dose number=1, Lot number=EL3302 , Anatomical location=Left arm, Route: Intramuscular, Time: 12:15), administration date: 02Feb2021, when the patient was 75 years old, for Covid-19 immunization. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "Second dose of the vaccine made her want to sleep"; TENDERNESS (non-serious), outcome "unknown", described as "tenderness in her left arm for the first two doses". No follow-up attempts are possible. No further information is expected.
Evening after receiving vaccine (starting at approximately 7 PM, had slight headache, felt lightheaded and more tired than usual; 2nd day felt fine during day, then by approximately 8 PM felt more tired than usual; but had trouble sleeping; seemed to have rapid heartbeat; and slight chills. Third day (today); fine during day, but as of approximately 7:30 PM quite tired again, and slight chills again. Sore arm at vaccination site, but not more than what I usually experience with a flu shot.
SICK; she has bronchitis and a sinus infection; she has bronchitis and a sinus infection; she is not feeling well; This is a spontaneous report from a contactable consumer or other non hcp.    A 74-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  It was reported that, 74-year-old caller mentioned she received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 6April 012. She explained she is scheduled to receive the second dose tomorrow, but she is "sick". She specified she has no fever and has either a "sinus infection" or "bronchitis". She asked if she should get the second dose as scheduled. Patient received the first dose of the vaccine on 06Apr2021 and is scheduled to get her second dose tomorrow, 27Apr2021 but is not feeling well and likened her symptoms to that of bronchitis. She mentioned that the vaccination card she has expires on 30Jul2021 so she would like to know if it would be okay to receive the second dose a week later than the scheduled appointment of three weeks. The outcome of the events was unknown on an unspecified date.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
received 3rd dose; patient confirmed verbally it was his first dose, but upon review of records, patient already had 2 doses
03/22/2022 I came down with COVID-19 symptoms like a scratchy throat. And the home test came back negative. On the 23rd I got a PCR test that came back positive. Symptoms included nasal congestion, sore throat, slight fever for one day, coughing, fatigue. These symptoms lasted for about 5 days time and after I was still fatigued. I came down with brain fog and was not able to make decisions and the first few days. I am still being affected by brain fog.
I broke out in hives on both arms, took Benadryl , hives were gone in a couple of hours.  The hives appeared at 3 PM on day of vaccination.    Ran a temperature, highest was 103 took a Tylenol got temperature down to 99 in a few hours.  Had chills, nausea, aches and a headache, all of these symptoms happened on  03/11.  Was also extremely tired and soreness in arm of injection.  Felt much better on 3/12 but still somewhat tired and sore muscles.
Nosebleeds began 2/21. Presented to Community Hospital on 3/9/21 with nose bleeds, spontaneous bleeding from mouth, and severe dyspnea. Had bone marrow biopsy done 3/10, then transferred to Community Hospital for further management. Diagnosed with aplastic anemia on 3/12 and discharged with a plan for follow-up. Readmitted to Community Hospital for treatment with ATGAM and cyclosporine.  Completed course of ATGAM 3/16.  Has yet to be discharged as of 3/23.
Rash and hives break out.  It started on my arms and spread to my chest, side, back, upper buttocks, and thighs.  It started in the evening the night after I got my 2nd shot.  I had a headache, probably had a fever (didn't check my temp) and was achey all night long.  That first night into the following morning, the rash got worse and was super itchy.  It was worse that next night (Tuesday night into Wed morning).  I got Benadryl Wed morning and took it that day and Thursday night, which helped reduce the rash.  I didn't take it Friday as I felt 100% but the rash came back Friday night.  I went to urgent care that Sat and got prescribed some Prednizone for 5 days.   Took that for the following week and it helped as well.  By the next Wednesday, I was 100% and the rash had gone away.
Patient was transported to Medical Center via EMS with seizue activity.  Diagnosed with febrile seizures, pneumonia and ear infection.
No adverse effects were reported; patients received one separate dose each of the improperly stored PROQUDA; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug allergies/reactions was not provided.  There were three separate patients received one separate dose each of the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number reported as R022566 and expiration date 04-FEB-2020, subcutaneously for prophylaxis) (product storage error). The three separate doses of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were administered on 22-FEB-2019, 19-MAR-2019 and 15-APR-2019. It was unknown as to which patient which dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) on which day. It was unspecified if the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored properly. No adverse effects were reported. No product quality complaint (PQC) was involved.  The other two patients were captured in case# 1906USA000042 and 1906USA000043.; Sender's Comments:  US-009507513-1906USA000042: US-009507513-1906USA000043:
Pt developed redness of about 3 1/2 inches in length and 2 inches wide.  Site was hard, hot to touch, and also very painful.
Gave flu shot in deltoid, IM Patient said arm hurt the next day and got progressively worse to the point he could not lift it. He saw family doctor and received steroid shot. Arm is still hurting.
1st vaccine looked brown in color.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT COLOUR ISSUE (1st vaccine looked brown in color.) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PRODUCT COLOUR ISSUE (1st vaccine looked brown in color.). At the time of the report, PRODUCT COLOUR ISSUE (1st vaccine looked brown in color.) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medication was reported.   This case was linked to MOD-2021-081240 (Patient Link).
This spontaneous report was received from physician via Pfizer regarding a 12 months old infant of unknown gender. Information on pertinent medical history and concomitant medications were not reported. On an unknown date, the patient received VARIVAX, lot# R021504 with expiry date of 26-JUL-2020, for prophylaxis (dosage schedule was not reported). It was reported that the patient had received his varicella and hepatitis vaccines. He had received two of those (Extra dose administered and Inappropriate schedule of product administration). Varicella or varivax.
Child had generalized non-febrile seizure 5-1/2 days after getting MENACTRA and ADACEL vaccine. No etiolology found for seizure.
severe head, neck, and shoulder pain. and fever. Reports could not sleep or move due to pain.
Has erythematous papules around location of vaccination site and severe 10/10 pain in movement of extremity where vaccination was performed.
VACCINE GIVEN IN OFFICE 10/18/22, GRANDMA CALLED TO REPORT PT. HAD A SEIZURE ON 10/19/22