chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart Attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 total. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart Attack) (seriousness criteria death and medically significant). The reported cause of death was Heart attack. It is unknown if an autopsy was performed.            Concomitant drug details not provided. The patient received mRNA-1273 (Moderna COVID-19 Vaccine) after receiving COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE). On an unspecified date, following vaccination with mRNA-1273, the patient had a heart attack. On the next day (after vaccination) the patient died due to heart attack. No treatment information was provided.  Company Comment -  This case concerns a 49 year old patient of unknown gender with no relevant medical history, who experienced the serious unexpected event of myocardial infarction. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. The outcome was fatal , with death occurring 1 day after receiving a dose of mRNA-1273 vaccine. The reported cause of death was heart attack. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 49 year old patient of unknown gender with no relevant medical history, who experienced the serious unexpected event of myocardial infarction. The event occurred on an unknown date after a dose of mRNA-1273 vaccine. The outcome was fatal , with death occurring 1 day after receiving a dose of mRNA-1273 vaccine. The reported cause of death was heart attack. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Heart Attack
She reports developing having sharp, shooting pain down arm, bone pain, and fever the next day after she received her vaccination. She reports fever has resolved and her symptoms of leg and arm pain are easing but still present.
1:00 pm numbness and tingling extending from elbow to 4th & 5th fingers on left (injected side) arm, mostly resolving within 15 minutes but lingering somewhat on 9/27/2012 9:00 pm extremely cold hands, shivering, fatigue 10:00 pm shivering underneath heavy blankets, mild fever 12:00 am chills ended, mild fever continues 3:00 am headache, mild nasal congestion 9/26 all day: headache, fatigue, inflammation around eyes.  Stayed home from work and remained in bed most of the day. 9/27 Mild nausea in the a.m. but no longer fatigued.  Returned to work.
1 of 2 pts who exp an inject site react which consisted of a red & swollen arm; poss cellulitis; @ the time of this report, ATB had not been prescribed; pt recovered;
Pt recvd Pneumovax 23 on 10MAR91; It was noted that the vax had an expiration date of 08FEB91;
Within 10-15 mins flushing, tingling feeling, light headed, rapid heart rate, tightness in chest. Given juice, also ate cracker after first VS taken: BP 180/90 2nd VS: BP 164/100 HR 104 3rd VS: BP 154/96 HR 102 4th VS: BP 154/92 HR 98  5TH VS around 17:17: BP 178/98 HR 82, BP 102-. Sent home with husband.
This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Reaction to COVID-19 Vaccine) and HYPERSENSITIVITY (General body allergy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 21-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg,1 in 2 wk, Solution for injection in pre-filled pen. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2022, the patient experienced IMMUNISATION REACTION (Reaction to COVID-19 Vaccine) and HYPERSENSITIVITY (General body allergy). In 2022, IMMUNISATION REACTION (Reaction to COVID-19 Vaccine) and HYPERSENSITIVITY (General body allergy) had resolved.            No concomitant medications were reported.  The reporter's causality for the events of reaction to COVID-19 vaccine and general body allergy with HUMIRA 40MG/0.4ML(ADALIMUMAB) was reported as no reasonable possibility. Reporter did not have the lot number information, because the packaging was discarded. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medications were reported.
pt recv vax JUL98 & reportedly in 2wk pt c/o of urticaria & hives;
Rash outbreak on tailbone, much worse than previous outbreaks which were considered minor per patient.
Pt reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia. Pt consented to receiving second dose after education with RN, physician  @1535: BP 202/102, HR 91, O2 100%, Temp 36;.8C; @1540 BP 185/106, HR 98, O2 100%, Temp 36.8C @1545 BP 179/94, HR 90, O2 100% @1557 BP 199/113, HR 88, O2 100%, Temp 36.2C Pt received no medications in ED.
Chills for 15 hours Muscle aches for 5 days (still have it) Headache for 5 days (still have it) Nausea for 3 days Diarrhea for 5 days (still have it) Felt very tired for 3 days
Our patient describes a "normal" vaccine experience for the first couple of days following being vaccinated. He described being really tired the day after, and felt better on day 2. The third day to the 10 day he reports he suffered with headaches, body aches, and shoulder pain, It was severe enough he missed work. On day 11 he reported feeling much better.
10 minutes after getting my shot I was lightheaded and dizzy, I felt flushed, a paramedic noticed and gave me water and watched me. They made me stay about 15 more minutes.  About 3 to 4 hour after I had a sharp jolt of pain in my left calf it felt like an electric shock or a bad sting. (I checked there were no insects near me nor did I have a mark on my leg) It happened about a dozen more time over the next 24-36 hours. They became less painful as time went on. It was mostly in my left leg but sometimes in my right thigh. Also about the same start time of my other symptoms I felt tingling sensation in my left arm and fingers. They tingling persists today, it comes and goes and is now also in my right hand.  I am scheduled to get my second shot on June 1st but am hesatant
platelets had dopped down to nothing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Jul2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Jan2021, stop date: Jan2021. The patient's concomitant medications were not reported. Past drug history included: Regeneron treatment  for COVID-19. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, Unknown manufacturer), administration date: Jan2021, for COVID-19 immunization. The following information was reported: PLATELET COUNT DECREASED (hospitalization, medically significant), outcome "unknown", described as "platelets had dopped down to nothing". The event "platelets had dopped down to nothing" required physician office visit. The patient underwent the following laboratory tests and procedures: Platelet count: dopped down to nothing. Therapeutic measures were taken as a result of platelet count decreased. Clinical information: Reporter stated that he and his wife both got covid 19 virus in Jan2021 and had the regeneron treatment right after that. They were vaccinated in Jul2021 and in Aug2021 he had a check up, fine looked great, then got booster 12Jan2022, another appt 2nd week of Feb2022 and platelets had dopped down to nothing. He has been in hospital 1-3 times a week since going into almost a year starting in Feb2022 for dealing with this. He was put on 2nd oral medication because 1st did not work, just had a check up yesterday and platelets down to a 1, obviously new oral med hasn't worked. Patient asked if there were any steps or what they have to do about this other than what his oncologist or hematologist has suggested.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300004954 same reporter/patient, different vaccine dose and event;
Customer received her vaccine and whole in observation she started to have heart palpitations.  As per customer she was sitting and started feeling the palpitations and got the attention of one of the employees.  EMS and staff nurse responded.  Blood pressure taken 173/86, HR 88, O2Sat 96, Resp. even, skin warm and dry
He got his vaccine, he started to feel very achy all over, muscle and joints, sleepy, took some Tylenol and went to bed.   He went to bed early, and when he woke up this morning it was more of chills and also starting to run fever.  He may have been having fever over the night.  He got up every couple of hours drinking water and going to the bathroom.  He is not wanting to move around and just sore all over.  He was having to put on extra clothing to try and stay warm with his apartment at 72 he felt cold.  He took a nap and just got up again and is now sweating, does not feel like he has a fever, temp is back to normal.  He has been taking Tylenol for his symptoms, about 4 doses of 1000 mg at a time.   He also does not have much of an appetite.    He thinks he has experienced this in the past with other vaccines, possibly COVID ones, and has called his doctor for and told him to push fluids and take Tylenol.
Information has been received from a physician concerning a patient who on approximately 08-Mar-2007 was vaccinated with Zostavax. On approximately 10-MAR-2007, 2 days after getting the Zostavax, the patient experienced a "wheel red mark". This is one of two reports from the same source. Additional information has been requested.
Pfizer dose was not diluted received 0.3 mL dose from vial without dilution.
This spontaneous report was received from a 61 year old female patient, reporting on herself. The patient's current condition included sulfa drug allergy, arthritis, on and off acid reflux and osteoporosis. The patient did not have any concomitant medications ongoing. On 28-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 1 dose for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On an unspecified date in 2018 (reported as "no long after receiving the PNEUMOVAX 23), the patient developed swelling, redness and muscle pain at the injection site. Approximately on 07-MAR-2018 (reported as about a week after receiving the vaccine) the patient recovered from swelling and redness. Approximately on 24-APR-2018 (reported as about two weeks ago),  the patient recovered from muscle pain.  Further, the patient informed that starting on 06-MAY-2018, she developed a red spot around the injection site, that was red, warm to the touch and painful and was starting to expand in size. The patient received an unspecified treatment. At the time of reporting, the patient had not recovered from red spot around the injection site, that was red, warm to the touch and painful and was starting to expand in size. The causal relationship between the vaccination with PNEUMOVAX 23 and the events was not provided by the reporter.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Additional Details: place in supine position on the floor with feet elevated. VS- @ 1839; BP 130/70, HR 40, RR 18, SPO2 95% RA; reassessment- VS- BP 122/78, HR 42, RR 18, SPO2 92% RA. Never loss consciousness but became very groogy. orange juice given, returned to baseline in < 15 minutes, sent home with mom as driver.
Patient was mistakenly administered MMRV (ProQuad), indicated for ages <12, and varicella (Varivax) on same visit. In accordance with vaccine manufacture's health team, patient is eligible to receive second dose of MMR II after 28 days, which would count as the second dose in the series. Called patient's parents/guardian at listed phone number to discuss, but was only able to leave voicemail with callback number. At this time awaiting response.
I developed a severe head ache about 8 hours after the injections. After about 12 hours (the next day) I developed a rash that started around the top of my left bicep and expanded to cover my entire bicep region over the course of the day.  The rash is not in the region of the injection which was given in the deltoid muscle. The rash is warmer than surrounding skin and is tender to the touch and the bicep area aches.  Also, I was extremely fatigued the day following the injections, so much so that I could not stay awake and had to take a nap.  The injection was on Monday afternoon. It is now Thursday morning and I still have the rash. The headache and fatigue are now gone.
After 30 minutes, My heart rate would rise to 150-160 frequently for 3 days. It started my menstrual cycle back that had been gone for 2 years and restarted menopause.; After 30 minutes, My heart rate would rise to 150-160 frequently for 3 days. It started my menstrual cycle back that had been gone for 2 years and restarted menopause.; After 30 minutes, My heart rate would rise to 150-160 frequently for 3 days. It started my menstrual cycle back that had been gone for 2 years and restarted menopause.; This is a spontaneous report from a contactable nurse. A 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 (age at vaccination 52-years-old) (Batch/Lot Number: ER8729) as dose 1, single for covid-19 immunisation. Medical history included hyperthyroidism, meniere's disease, cardiac disorder and covid-19. Concomitant medication included levothyroxine sodium, hydrochlorothiazide, triamterene (DYAZIDE), magnesium and potassium. Patient had COVID prior to vaccination. Patient was tested for COVID-19 post vaccination. Patient did not receive any vaccines in 4 weeks. On 08Apr2021 10:00, after 30 minutes heart rate would rise to 150-160 frequently for 3 days. It started her menstrual cycle back that had been gone for 2 years and restarted menopause. The patient underwent lab tests and procedures which included heart rate rise to 150-160 on 08Apr2021. On an unspecified date in Jun2021, patient was tested for sars-cov-2 with nasal swab and showed negative results. Patient did not receive any treatment for events. At the time of this report, the outcome of event was recovering.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  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
weakness and dyspnea causing hospitalization and ultimately death.  Patient was a DNR/DNI.
Pt c/o severe headache and nausea x 3 days prior to Tdap IM - prescribed Hydrocodone with APAP 800 mg and used excedrin.
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever, chills, swelling and fatigue. On an unknown date, the outcome of the fever, chills, swelling and fatigue were unknown. It was unknown if the reporter considered the fever, chills, swelling and fatigue to be related to SHINGRIX. Additional details were received as follows: The reporter spoke about some of the side effects. The reporter stated that he had fever, chills, swelling and fatigue for example he had experienced, within 14 hours of vaccination. This was all of the information that the reporter knew.
Allergic reaction with a red rash, swelling of the lips ears and tongue, and shortness of breathe.
1st dose around 2018-2019, 2nd not yet; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date around 2018 to 2019).   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: 28-DEC-2022 Reporter's Comments: A nurse practitioner reported that a patient wanted to receive a 2nd dose of Shingrix vaccine. The health care professional (HCP) wanted to remain anonymous, also did not want to give out information on the patient or the situation in general.  The HCP dropped the called before getting transferred to another specialist. 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.
According to  my log, 20 minutes after I administered the vaccine to her and her son who was accompanying her,  she stopped me in the hall while I was returning  to the pharmacy from another injection.  She told me that her neck felt swollen (she was rubbing the area of the lymph nodes)  but that she was swallowing fine.  She didn't appear an any distress, no breathing difficulty, splotching or rashes, but we decided that she should see one of the nurses on site.  I told her to get her BP in the case something was happening there.  She left to go to the nurse.  The rest was relayed to me that she saw the nurse and then proceeded to the hospital where she subsequently broke out in a rash and received an epi pen.
Received first Janssen vaccine 11/05/21 around 9:45 am, then Saturday 11/06/21 around 10:00 am woke up with itching and urticaria (hives) on legs, arms, and face. Given benadryl and tylenol for headache which after a few hours the hives went away and did not come back.
High fever, body aches, rapid heart rate, and chest pains still occurring the following day.
acute demyelinating neuropathy; Inflammatory neuritis; symmetrical paralysis; Guillain Barre syndrome; Pain in neck; Pain in shoulder; Pain in arm; Weakness in legs; This case was reported by a consumer and described the occurrence of guillain barre syndrome in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number UNK, expiry date unknown) for prophylaxis.   The initial information was received on 10 December 2020 via medical records (case now medically confirmed). The patient had shingle vaccination on 17 August 2020. Admission date was 29 August 2020 and discharge date was 08 September 2020. Admission diagnoses was Weakness of both legs for proximal weakness involving bilateral thigh and shoulder muscles associated with back pain and sharp thigh pain. He developed the weakness over a period of two days; it started with thighs and then involved shoulder muscles. Back pain and thigh pain preceded the weakness by about one week. Electromyography showed electrophysiologic evidence of mild acute demyelinating neuropathy. magnetic resonance imaging of spine showed mild surface enhancement along anterior conus and cauda equina most suggestive of inflammatory neuritis. Given these findings and ascending symmetrical paralysis, Guillain-Barre Syndrome most likely diagnosis. The patient was treated with Intravenous Immunoglobulin IG for 5 days. His upper extremity strength gradually improved each day and was now near baseline. During hospitalization, his lower extremity strength initially worsened over several days, then stabilized and began to slowly improve.
I had late menstruation after every COVID-19 shot in the series and also after my booster shot. I track my cycle and it was 1 week late after my first dose; 1 week late after my second dose and now 2 weeks late after my booster. There is no chance that I am pregnant. I have had consistent regular periods since I was 10 years old.
2 hours after the vaccine patient has sharp pain on outside of right half on/off. Continues to experience side effects today. Same side effects in husband who had vaccine the day prior.
For about 4 days after I received this vaccination (my second dose) I experienced extreme weakness, shaking joints, nausea, swollen lymph nodes, body aches, and a fever reaching up to 103 degrees. Looking back I wish I would have gone into urgent care or something but I didn't think they could do much for me and it eventually subsided so I felt as if I had a bad cold that lingered for weeks. As of now, I am still experiencing body aches, fatigue, and my lymph nodes are still swollen specifically in my neck (they can sometimes be seen pulsing).
Missed the window for 2nd shot; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose in January 2021) and Covid 19 vaccine (received 1st dose in April 2021).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter suggested to wait on the second shingles dose until, the patient's second COVID dose, which led to social problem.
Pt. given vaccine at 0800 and observed for 30 minutes. Pt. left without s/s of rxn. Pt. returned to vaccine clinic 0910 c/o of submandibular tightness, denied soa or difficulty breathing. Vitals reviewed and WNL. Pt. reports hx of anxiety and allergy to sulfa(n/v). Pt. kept in observation for 20 minutes after arrival with no change until the 20 minute mark when the pt. reported chest discomfort and tingling in L hand. Pt. transferred  to  ER. Patient given Duoneb and discharged from ER and instructed to follow up with primary care provider within 2 to 3 days.