chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chronic heart problem; hypothyroidism; thyroid storm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 39 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown Manufacture), for COVID-19 immunization. The following information was reported: CARDIAC DISORDER (hospitalization), outcome "unknown", described as "chronic heart problem"; HYPOTHYROIDISM (medically significant), outcome "unknown", described as "hypothyroidism"; THYROTOXIC CRISIS (medically significant), outcome "unknown", described as "thyroid storm". Clinical course: Caller was a pharmacist calling on behalf of a friend who said upon receiving their second dose of the Pfizer covid vaccine, her and all female members of her family developed thyroid problems (thyroid storm, hypothyroidism,...). Caller stated she forgot to mention that the patient, a 39 year old female had also chronic heart problems currently. She also added ''because she was hospitalised''.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported chronic heart problem, hypothyroidism and thyroid storm were most likely concurrent diseases/conditions, and unlikely causally related to the vaccination with  bnt162b2.   The case will be reassessed should additional information become 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.
I went in for a colonoscopy and everything seemed normal. When I woke up, the first thing that I came to was "We found that you have A-fib" and I had no idea what that was. And I was scared. I was totally out of it and already, our doctor was already on the phone with my husband and made an appointment for the next day. Everything seemed fine before I was put out for the procedure. So I went to the doctor the next day and they did an EKG and everything was fine. I've never had symptoms where my heart rate was too high. I don't remember all the circumstances and they immediately put me on Warfarin 5mg daily to thin out the blood. And it took me almost 2 months to get me into the cardiologist and she set me up on a heart monitor for a month. I had EKGs in the past and everything seemed fine between the time of the coloscopy and before the diagnosis. The only symptom that I had after the vaccine was the fatigue. I submitted the heart monitor and they put me on a medication Metoprolol 25mg for the next year and might be a life-long thing where my episodes were only during at night.  INR to track thickness - every week, then every two weeks - questions on the metoprolol medication that I'll ask at my doctor in the next week.
Influenza vaccine given in right arm. Patient now with swelling and pain into right upper arm, right shoulder, tight chest wall and right axilla. All areas warm to touch. Swelling started 24 hours after vaccine.
itchy first, then redness, swelling and warmth to site. 3 days later had a 3" x3" red mark at injection site.  slight pain at site. Did not seek medical care or self medicate. improvement noted on day 2.
she missed her second Moderna dose scheduled for 8Feb2021 due to her COVID-19; positive COVID-19 diagnosis; cough; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (positive COVID-19 diagnosis), PRODUCT DOSE OMISSION ISSUE (she missed her second Moderna dose scheduled for 8Feb2021 due to her COVID-19), COUGH (cough) and FATIGUE (Fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced COVID-19 (positive COVID-19 diagnosis). On 08-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (she missed her second Moderna dose scheduled for 8Feb2021 due to her COVID-19). On an unknown date, the patient experienced COUGH (cough) and FATIGUE (Fatigue). The patient was treated with AZITHROMYCIN (ZITHROMAX Z-PACK) (oral) for SARS-CoV-2 infection, at a dose of 5 day dosage; METHYLPREDNISOLONE (MEDROL DOSEPAK) (oral) for SARS-CoV-2 infection, at a dose of 5 days dosage; ASCORBIC ACID (VIT C) (oral) for SARS-CoV-2 infection, at a dose of 1 g once a day; ZINC (oral) for SARS-CoV-2 infection, at a dose of 100 mg once a day and MONOCLONAL ANTIBODY 17-1A (intravenous) for SARS-CoV-2 infection, at an unspecified dose and frequency. On 08-Feb-2021, PRODUCT DOSE OMISSION ISSUE (she missed her second Moderna dose scheduled for 8Feb2021 due to her COVID-19) had resolved. At the time of the report, COVID-19 (positive COVID-19 diagnosis), COUGH (cough) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) Nasopharyngeal source.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient did not experience any covid-19 related complications or dysfunctions.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: received  Reporter email address updated. On 27-Jun-2021:  On 28-Jun-2021: Significant follow up- patient medical history, additional symptom and treatment drug updated
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked with 2018SA296383, 2018SA297469, 2018SA297471, 2018SA297472, 2018SA297470 (same reporter). This case involves a 5 years old patient (unknown gender) who received single 0.25 ml of vaccine FLUZONE QUADRIVALENT (Suspension for injection) (lot UT6259JA and expiration date 30-Jun-2019) instead of the 0.5 ml via unknown route in the right unspecified site on an unknown date (reporter Sep-25 - Oct-12) for Immunization. Patient's medical history was not reported. No concomitant therapies was received by patient. It was a case of actual medication error due to vaccine underdose. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
PATEINT GIVEN VACCINE BEFORE DUE DATE OR ACCELERATED DATE. NO SERIOUS MEDICAL EVENT OCCURRED.
Patient fainted. We sat her down. Offered to call an ambulance. gave her some orange juice to drink. We monitored blood pressure and made sure she was not driving home.
TESTED POSITIVE FOR COVID AFTER RECEIVING THE JANSSEN COVID 19 VACCINE; This spontaneous report received from a consumer concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 01-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced tested positive for covid after receiving the janssen covid 19 vaccine. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid after receiving the janssen covid 19 vaccine was not reported. This report was non-serious.
Being miserable; Having total body aches; shaking; Feeling frigid; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-hcp (healthcare professional).  This case is linked to case 2021SA008600 (death case).  This case involves an 85 years old male patient who became miserable (Feeling abnormal, having total body aches (pain), shaking (tremor) and feeling frigid (feeling cold), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccinations included Flu vaccine after which he got sick for 2 to 3 days and had a pneumonia shot a while back and had a reaction (that the provider told him the reaction was due to the immune system working and that he is sensitive to medications that with a dose of morphine he goes crazy).  Medical history, medical treatments, concomitant medication and family history were not provided.   On 15-Oct-2020 at 08:30 am, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiration date were not reported) via intramuscular route in the right arm for prophylactic vaccination.  On 15-Oct-2020, the patient became miserable (feeling abnormal), had total body aches (pain), shaking (tremor) and feeling frigid (feeling cold) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient had to turn his heat up in the house due to the reaction.  The patient taken 2 Advil, 2 PARACETAMOL (TYLENOL), BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE], SLEEP AID [DIPHENHYDRAMINE HYDROCHLORIDE] and kept on a cot.  The patient recovered from all the events on an unknown date.  There will be no information on the batch number for this case.
Shortly after getting the 1st HPV vaccine pt began to feel dizzy and weak. She is still feeling this way at day 9. She has obvious loss of balance and is very dizzy. She also started to develop swelling at the injection site at day 8 which has continued. No redness or evidence of infection present.
Patient received COVID 19 vaccine and was in the waiting room sitting for 15 minutes before he could leave. After about 7 minutes, the patient passed out and fell on the floor. He caught his arm on the chair when falling and it is unknown if he hit his head. He almost immediately regained consciousness and we kept him laying down on the floor until 911 arrived. Patient was still light headed, felt tingly, and was hot (sweating profusely). Patient was taken away by 911 to be locally evaluated.
Patient claimed she shortly felt pain on her left arm where she received the vaccine after she left the pharmacy on 3/28/18. Then, it progressed to trouble lifting arm, significant pain all over the body, including both hands, legs and feet which seriously affected patient's daily life for a long time. Initially, the sole of her feet hurt to a point that she couldn't even stand for over a week. She did not see a doctor or receive any treatment regardless of all these symptoms. Patient just waited out to let it subsided. It's over 3 months out and she said she could lift her arm higher but still not normal and still in pain. Yet, she still refused to consult a doctor for evaluation and very determined that it is caused by the vaccine she received.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (COVID vaccine was administered on 07-Apr-2022 and expiration date was 06-Apr-2022) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination. Concomitant products included AMLODIPINE, ATORVASTATIN, LEVOTHYROXINE SODIUM (EUTHYROX), HYDROCHLOROTHIAZIDE and LISINOPRIL for an unknown indication. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022 at 8:40 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Apr-2022 at 8:40 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (COVID vaccine was administered on 07-Apr-2022 and expiration date was 06-Apr-2022). On 07-Apr-2022 at 8:40 AM, EXPIRED PRODUCT ADMINISTERED (COVID vaccine was administered on 07-Apr-2022 and expiration date was 06-Apr-2022) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient's weight was reported as 196. Reporter stated that patient had no known allergies and it was unknown that the patient had been tested positive or diagnosed with COVID-19, had no acute illness at the time of vaccination and up to one month before and chronic or long standing health conditions information was unknown. It was unknown that the patient experienced similar event in the past and unknown for other potential causes for the event and Patient did not seek medical care for the event. Reporter also stated that no adverse reaction to the vaccine took place after administration. Treatment information was not provided by the reporter. This case was linked to MOD-2022-538544, MOD-2022-538516, MOD-2022-535445 (Patient Link).
Has a painful red rash that is located on his abdomen, left arm and legs. Did have a rash last week and this rash started today 10/11/2019 and redness around injections site.
At noon, the same day I received the vaccine, I had a headache. At 4pm I had a fever. At 5pm I  had chills and was shaking continuously for 48-72 hours. Then I had a headache off and on. 2 weeks after, I had fatigue and was feeling nauseas that lasted for 2 weeks.
Patient is not yet 18 years old, but received a booster dose (dose #3) of Pfizer COViD-19 vaccine. Patient's second dose was in May 2021. No immediate reaction to vaccine. Patient and family were notified of the adverse event and told to monitor and return to clinic for any concerning symptoms.
Client complained of elevated heart rate following administration of vaccine via Apple watch (91 bpm). After an hour, client requested EMS as heart rate had not returned to baseline, no other complaints. Vitals per EMS = 1) HR=85, BP=167/105, 2) HR=82, O2=100%, RR=14, BP=138/95, 3) HR=86, O2=99%, BP=144/96. Ekg = NSR with "long" ST segment. Client was transported via EMS to  ER.
Ringing ears (left ear more noticeable than the right ear); This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration on left arm on 17Mar2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to walnut from an unknown date. The patient was allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. On 20Mar2021 at 13:00 the patient experienced ringing in ears but left ear had more noticeable when compared to right ear. The patient did not receive any treatment for events. The clinical outcome of the event ringing ears (left ear more noticeable than the right ear) was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Three hours (9:00pm) after receiving the shot in Left Deltoid muscle pain started. Getting progressively worse it radiated from neck under Left ear to end of fingers in Left hand  Pain was so extreme that I took 2 - 500mg tylenol at 10:30pm.  Pain evident without even moving.  At 3:30am (2/17) I took 2 - 200mg Ibuprophin.  Unable to sleep.  At 9:30am took 2 - 500mg tylenol.  Called pharmacist explained to him the pain. He said he probably hit a nerve upon injection.  Take tylenol and ice it 20 min on and off.  Today Friday 2/19 I am still in pain even with meds. Not as severe but still have limited motion. Scale of 1-10 with out motion about 2-3, on motion 9-10. Is there anything else I can do?
It started with back pain 2 Days later and then knee joint pain 2 days after that
On September 20, 2022 I experienced a high fever of 102.1 on September 21, my fever went up to 103.5 that would not break I also experienced a concussion with a really bad headache that would not go away and by Friday morning temperature was back to normal.
General fatigue and dull fever for the first two days following. Arm pain in injection site. Day 3 hives started in the pm. They were short-lived. Day 4 hives again...lasted a couple hours. Day 5 heavy lungs and more fatigue. Day 6 hives appeared again. Fatigue got worse and worse from this point forward. By day 9 extreme exhaustion, heavy lungs  and dull fever. I consulted my homeopath who prescribed a remedy which is greatly helping.  Today is day 17 and I?m still not back at work. The exhaustion is gone and lungs feel much better but any exertion the fever returns. Fever has never been high at all just a degree over my normal.
This spontaneous report as received from a nurse refers to a 17 months old female patient. There was no medical history and drug allergies. On 06-MAR-2017 the patient was vaccinated with VARIVAX (lot # M037008, Expiry date : 25-AUG-2018) 0.5 ml, subcutaneously in the right upper thigh for prophylaxis. Concomitant therapies included desonide, probiotics (unspecified), TYLENOL and MOTRIN. On 09-AUG-2017, the patient developed a "significant crusty rash on the left side of her back, her left arm and the left side of her chest". On 15-AUG-2017, the patient saw her unspecified "family doctor" due to the rash. The unspecified "family doctor" prescribed Acyclovir (manufacturer unspecified) as treatment on the same day. The nurse stated the "family doctor" also performed a "varicella/zoster PCR" which came back as "positive for shingles" on 17-AUG-2017. Nurse specifically requested to send samples for testing. On 23-AUG-2017, Varicella Zoster Virus Identification Program (VZVIP) polymerase chain reaction (PCR Results) - VACCINE STRAIN. At the reporting time, the outcome of rash and herpes zoster was reported as recovering/resolving. The reporting physician did not provide the causality assessment for the events.
One week after, April 15, first Pfizer vaccine, I experienced severe vertigo for about 1 week. As of today, am not experiencing the vertigo because I have limited the movement of my head. Still have dizziness and nausea.
This case was reported by a nurse via sales rep and described the occurrence of erythema in a 23-year-old female patient who received BEXSERO (batch number 16E901, expiry date unknown) for prophylaxis. On 16th November 2018, the patient received BEXSERO .5 ml. In November 2018, less than a week after receiving BEXSERO, the patient experienced erythema and swelling. The patient was treated with ibuprofen and Warm Packs (Nos). On an unknown date, the outcome of the erythema and swelling were unknown. It was unknown if the reporter considered the erythema and swelling to be related to BEXSERO. Additional information received as follows: Over the weekend the patient developed redness and swelling that got worsen each day. The reporter asked about giving the second dose of BEXSERO. The reporter stated referred patient's medical information at GlaxoSmithKline. The reporter agreed to follow up from GlaxoSmithKline.
This case was reported by a nurse via sales rep and described the occurrence of cold sweat in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cold sweat and influenza-like symptoms. On an unknown date, the outcome of the cold sweat and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the cold sweat and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but he was in early 50s at the time of reporting. After receiving the SHINGRIX dose the patient had cold sweats and felt like symptoms for about 36 hours. The reporter did not agree to follow up from GSK. For tolerance of 2nd dose refer linked case US2019GSK065585.
Pt was initially admitted to the medical COVID floor where he was initiated on Dexamethasone and Remdesivir therapies. His hypoxemia continued to worsen and he required initiation of noninvasive positive pressure ventilation and was eventually transferred to the ICU on 10/28/2021 for ongoing care and management in the setting of refractory hypoxemia. His ICU course was initially complicated by delirium. His condition continued to worsen and was intubated on 10/30/2021 in the setting of impending respiratory/cardiac arrest. He began to experience increasing  hypotension as well and required initiation of vasopressors. Given the history of heart failure with reduced ejection fraction, cardiologist was consulted and Pt was additionally placed on Dobutamine. He had worsening acidemia despite optimization of ventilator settings and required initiation on renal replacement therapy on 11/02/2021. Unfortunately, he continued to decompensate and on the evening of 11/04/2021, the patient did suffer of a cardiac arrest. Unfortunately Pt did succumb to his critical illness on the evening of 11/04/2021.
Information has been received from a health professional concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient  developed a varicella like rash. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. No additional information regarding this event was available, as the office was unable to identify the patient. No additional information is expected.
Patient awoke at 4:00 AM on October 4th with complaints of sharp, stabbing pain localized to the left side of his chest. No radiation of pain. Pain made worse with movement and deep inspiration. No fevers, cough, SOB, abdominal pain, nausea, vomiting, anosmia, aguesia. Played soccer the day prior.