chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Metallic taste in the mouth, that has so far lasted two days.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 12:00 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received treatment with hydrocodone bitartarate, paracetamol (VICODIN) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 12:00 as a single dose for COVID-19 immunisation. 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 28Apr2021, the patient experienced metallic taste in the mouth, that has so far lasted two days. The clinical outcome of the event metallic taste in the mouth, that has so far lasted two days was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, Weakness Narrative:
Moderna COVID-19 Vaccine EUA  Circular rash around injection site on left arm.   Rash is spotty red outline of rash is a ring of red.
Possible infection dm. 21 month 1 day old female presents with c/o rash on left thigh where had varicella vaccine 10 days ago.
Drops / dips head to right shoulder, conscious less than 1 sec.  Began occurring within 1/2 -1hr after shots given.  10-15 episodes in a row, then 2-5 sequence.  At 4 days after shots, still 5-8 day.
Felt little tightness in the throat Narrative:  1015 , Cetirizine 10mg po given , She tolerated well. Provided hydration . Symptoms subsided within 30minutes. and she was released at 10.55am. left Stable condition.
"Moderna" Adverse vaccine reaction possible as began 12 hours post second COVID vaccine dose on Friday. A ER note was  generated in a T-Con on a patient who got their 2nd Covid Vaccine and began experiencing chest pain approx. 12 hours post vaccine. Patient did not report to the ER until 28Feb21. It was discussed that he has myocarditis v pericarditis, elevated D-Dimer of 770, swollen lymph nodes, and elevated Troponin. Patient was transferred to Research Medical Center due to no available beds. Patient was referred to a Case Manager and Cardiology. The patient completed a follow up appointment with 509 MDG on 9Mar21 and reported Dull pain that has been affecting sleep. Cardiology reports shows Troponin was elevated to 9.1 decreased to 4.2 and back up again to 13.4. Cardiac revealed late gadolinium enhancement, possibly representing myocarditis and then at discharge possibly myocarditis.
Urticaria; This case was reported by a physician via sales rep and described the occurrence of urticaria in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced urticaria. On an unknown date, the outcome of the urticaria was unknown.   It was unknown if the reporter considered the urticaria to be related to Shingrix.  Additional details were provided as follows:  On 15th April 2019, the patient alerted that, she experienced urticaria. The physician was unsure if the event related to vaccine.
Approx. 02/04/2021 Pfizer Vaccine dose # 1 Started feeling cold all the time soon after which continues. Not feeling well in general which still continues. Very high fever and skin on face turned dark and red on left cheek like sunburned and dried up and then skin started flaking off. Heart rate remained normal which is in upper 50?s and 60?s.  02/25/2021 Pfizer Vaccine dose # 2  02/26/2021  57 BPM Heart Rate BP 155/69  03/01/2021  65 BPM Heart Rate BP 146/70  03/03/2021  59 BPM Heart Rate BP 155/67  03/04/2021  59 BPM Heart Rate BP 151/77  03/06/2021  59 BPM Heart Rate BP 145/68  03/10/2021  54 BPM Heart Rate BP 174/77  03/11/2021  80 BPM Heart Rate BP 151/79  03/12/2021  104 BPM Heart Rate BP 146/102 108 BPM Heart Rate BP 152/118  03/13/2021  114 BPM Heart Rate BP 125/72 Trouble breathing   03/14/2021  131 BPM Heart Rate BP 113/82  03/15/2021  129 BPM Heart Rate BP 155/111  03/26/2021 - 03/27/2021 can?t catch her breath and nearly lost consciousness several times  Still feeling cold all the time and still not feeling well in general.   Heart rate remains dangerously high and in atrial fibrillation
Patient fainted a few minutes after administration, had a few tremor/seizure like movements, extreme sweating and vomitting. 911 was called and patients vitals were checked by EMT. Patient declined transport and had family member pick him up so he didn't have to drive home.
I started to get this body rash and it was very red, very itchy and it would go away & then it would come back in a different area.
Admitted 10/21/09 respiratory arrest and intubation by paramedics. URI x 1 wk prior to this event. Bronchial asthma aggravated by URI, also found to have mediastinal, subq and pericardial emphysemas. No pneumothorax. Extubated 10/23/09. Did well and went home 10/27/09. 11/3/09:  Hospital Records and Discharge Summary received for dates of service 10/21/09 to 10/27/09.  Final DX:   Acute respiratory arrest secondary to asphyxia bronchial asthma exacerbated by acute upper respiratory infection, mediastinal and pericardial emphysema, resolved. Assessment:  Found having respiratory arrest and intubated by paramedics before being brought to the emergency room.  Suffering from a respiratory infection and bronchial asthma before arrest.  White blood cell count elevated on admission.  Admitted to the ICU on ventilator support and extubated two days later.  He did well and was discharged to home on day 6.
Had a fever 3 weeks after her shot for a couple days. And today she has a little cough and running nose. She tested negative for COVID-19.
I started out with a sore throat and it felt like my head was stuffed up. It was like a headache feeling. It wasn't terrible at first but it did worsen over time. I did end up with a really runny nose, mucus, and had a low grade fever for about 4-5 days. Anywhere from 99 to 100.4. I didn't lose my sense of taste and smell, but I did lose my appetite. Food didn't sound good to me at the time. I was tired and coughing. I had a lot of sneezing. I called my doctor and she prescribed PAXLOVID. I did take that for the entire course. The first couple of days I had vomiting and some diarrhea but I did keep taking it. I also took regular TYLENOL and MUCINEX D. I did use some nasal spray as well for the symptoms. I continued to have sinus and head symptoms through to March. Sometime around 03/13 was when I started to feel better. I did see my doctor on 03/08, but we did also talk about the COVID-19 infection. I was prescribed doxycycline due to a possible secondary infection.
While driving my car I suddenly became very dizzy, the lines on the street seemed to be moving and I had to pull over and put my head in my lap.  The rest of the day, I was very tired and my arm was warm and sore.
2 days post injection (October 2022)  unusual spotting a week earlier than scheduled period. Seemingly normal period followed. (November 2022) Delayed period. Believe ovulated on time/normal per at-home urine-based IVD tracking system (trying to conceive).
Itchy rash on abdomen: on arm, spreading on legs; Started to welt on legs; Open sores; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on abdomen: on arm, spreading on legs), URTICARIA (Started to welt on legs) and WOUND (Open sores) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2021. Concurrent medical conditions included Pain and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Pain.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itchy rash on abdomen: on arm, spreading on legs), URTICARIA (Started to welt on legs) and WOUND (Open sores). The patient was treated with NYSTATIN at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Itchy rash on abdomen: on arm, spreading on legs), URTICARIA (Started to welt on legs) and WOUND (Open sores) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         Other concomitant products included blood pressure medication.  Treatment medication included anti itching cream (unspecified).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Additional information included patient initials, treatment and additional events.
Shaking; Migraine; Raised bumpy are on the injection site dime size; felt like passing out; Nausea; Rash like the map of africa; Hives; Warm on the injection site; injection site reactions as redness; Soreness on the left arm, arm is painful and sore; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like passing out), URTICARIA (Hives), TREMOR (Shaking), MIGRAINE (Migraine) and INJECTION SITE MASS (Raised bumpy are on the injection site dime size) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer in 2015 and Breast cancer in 2016. Concurrent medical conditions included Drug allergy (Allergic to Percocet .).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced URTICARIA (Hives), INJECTION SITE WARMTH (Warm on the injection site), INJECTION SITE ERYTHEMA (injection site reactions as redness), MYALGIA (Soreness on the left arm, arm is painful and sore) and RASH (Rash like the map of africa). On 23-Apr-2021, the patient experienced PRESYNCOPE (felt like passing out), TREMOR (Shaking), MIGRAINE (Migraine), INJECTION SITE MASS (Raised bumpy are on the injection site dime size) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (felt like passing out), URTICARIA (Hives), TREMOR (Shaking), MIGRAINE (Migraine), INJECTION SITE MASS (Raised bumpy are on the injection site dime size), INJECTION SITE WARMTH (Warm on the injection site), INJECTION SITE ERYTHEMA (injection site reactions as redness), MYALGIA (Soreness on the left arm, arm is painful and sore), NAUSEA (Nausea) and RASH (Rash like the map of africa) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported. 4 surgeries for Breast Cancer in 2015 and 2016.
No additional AEs were reported; Patient was administered a dose of PROQUAD after it was involved in a temperature excursion; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 15-FEB-2023, the patient was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5 milliliter, subcutaneously, lot # W024980 with expiration date 05-FEB-2024, for prophylaxis) that suffered a temperature excursion. No additional adverse events were reported.  The temperature excursion lasted 3 hours and 50 minutes at a temperature of 34.7°F. No temperature excursion occurred previously.
first dose of pfizer vaccine, 24 hours latter developed high blood pressure and heart beat over 140, went to the urgent care and they send me straight to the Emergency room at the hospital where I spend 12 hours- they had to rule out cardiac and other conditions- they conclyded it was a side effect of the vaccine. They lower my heart rate with morphine and hidration. I have never been a hipertense person.  They send me hoe with pain meds and a follow up visit to a doctor who cant still figure our why the vaccine made my heart rate so high and my blood pressure super high.
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. On an unknown date, these patients were vaccinated with PEDVAXHIB (strength, lot number, expiry date, route and dose were not reported) post supported excursion. No adverse effects were reported. This is one of two reports received from the same reporter (linked to 1502USA000844). Additional information has been requested.
itchy-redness on arms, throat clear, allergic to ASA only= anaphylaxis history, positive NSAIDs, negative dysphagia, negative airway or oropharynx component, admin 50 mg benadryl PO 12:45, admin famotidine 20 mg PO 1300, BP 130/80; HR 98; O2 sat 98% R.A., pharmacist monitored over time, pharmacist gave PO meds for home zyrtec and famotidine
Nausea; Fever; Chills; Body aches; Lethargy; Injection site inflammation and swelling; Injection site inflammation and swelling; This is a spontaneous report from a non-contactable healthcare professional reporting for self. This 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9261) on 20Jan2021 10:00 AM at single dose (vaccine location=left arm) for COVID-19 immunisation.  Medical history was none. No known allergies.  Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=EL0140) on 30Dec2020 07:15 PM at single dose (vaccine location=left arm) for COVID-19 immunisation. The were no other vaccine in four weeks, patient did not have COVID prior vaccination. Patient was not pregnant. The patient experienced nausea, fever, chills, body aches, lethargy, injection site inflammation and swelling on 21Jan2021. No treatment received. Patient did not test COVID post vaccination. The outcome of events was recovered in Jan2021.    No follow-up attempts are possible. No further information is expected.
Initial misuse report received from a healthcare professional on 14 January 2014. This is invalid case as the individual patient identifiers missing. Patient received ACTHIB which was reconstituted with sterile. No adverse event was reported. List of documents held by sender: none.
pt reports a raised itchy mark on her arm at the injection site. Pt is taking cetirizine and ibuprofen to control the swelling and itch
MMR administered right thigh- needle scratch 7/8" @ site. DTaP administered right lateralis with 3x3.5 inch erythematous area.
Shingrix late second dose / received one dose of Shingrix on July 2nd 2018 / never received Shingrix second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 2nd July 2018).   On an unknown date, the patient received 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 details provided were as follows: Age at vaccination was not applicable for this report. The pharmacist was called to report about the patient who received 1st dose of shingrix and was late for the 2nd dose. Till the time of reporting, the patient did not receive the 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter consented to follow-up via phone.
While standing at the check out desk, patient experienced dizziness with fall and loss of conciousness for ~30 seconds.  He was not observed to hit his head and reported no headache or feeling of brusing of his head  Treatment Administered:  Cold Compress and Sips of Water      Treatment Comments:  Patient was taken to the observation area where he was observed for 40 minutes.  He reported resoluation of any dizziness and reported prior vasovagal events from other vaccinations/blood draws.
fever 101, listless, tremors, discoloration of skin & vomiting; pupils dilated && high pitched cry; seen by MD;
pt had dizziness, shaky and nausea and went to local emergency room. pt also had shallow breathing with tremors.
Noticeable worsening of arthritic pain. Decreased joint mobility. Decreased stamina.  Moderate hoarseness and definite change in vocal ability. Swollen vocal cords. Tightness in throat. Vocal fatigue.
Case number PHEH2014US025050, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 62 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 29 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degrees F during the excursion.
No adverse events/outcomes. Reason for this report is due to administering vaccine to an 18 month patient when vaccine is for age range for 4-6 years.
Very sore arm starting A few hours after injection. Then I woke up around 3 AM with arm pain, total body soreness, chills, fever, fatigue, and nausea.
Severe arm pain, exacerbated by movement. Pain 3/10 at rest, 7/10 with movement. Pain so severe that it inhibited sleep.
Dose was administered high up in the arm. Pain present in left should since night/day after vaccine administration. Currently unable to raise arm above shoulder without significant pain. Unable to fully extend and reach for items. Dull pain exists at rest. Treated with ICE, Heat, Advil 400mg with alleviation of pain.
she is experiencing heart pain around the heart; she is experiencing heart pain around the heart and body; This is a spontaneous report from consumer (patient) reported for herself via Pfizer sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 21Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced heart pain around the heart and body after taking the first dose of Covid-19 vaccine last 21Mar2021. She was scheduled to take the 2nd dose on 12Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Feels terrible now; Sinus headache; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient's husband) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date, after the first dose of vaccination, the patient had felt "terrible now"; and had sinus headache. The outcome of the events, 'felt terrible' and 'sinus headache', was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
cannot get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (cannot get out of bed) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced MOBILITY DECREASED. At the time of the report, MOBILITY DECREASED (cannot get out of bed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, Blood pressure measurement normal. On an unknown date, Body temperature normal.         Concomitant medications were not provided. Treatment information was not provided.
At 4pm I spoke a fever and chills- lasted until 2am.  Skin had spots on left arm, left calf and face that felt like a bad sunburn
Around 12:00 am started getting a headache, a while after that started getting chills, then feverish, around 11:00 am woke up and still had all of those side effects. Took 3 Advil and drank a cup of water then slept until 5:30 pm. Once I woke up I still felt sick but I took 5 ibuprofen, ate a bowl of noodles and showered and felt perfectly fine. Around 8:30 pm I noticed a light rash forming around the injection site. Does not hurt or itch as of 7:32 pm April 18th
Heart flutter; Fever; Hurt self in the toilet/broken ribs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FLUTTER (Heart flutter) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Plaque psoriasis. Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) from 01-Mar-2021 to an unknown date for Plaque psoriasis.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced RIB FRACTURE (Hurt self in the toilet/broken ribs). On an unknown date, the patient experienced CARDIAC FLUTTER (Heart flutter) (seriousness criterion medically significant) and PYREXIA (Fever). At the time of the report, CARDIAC FLUTTER (Heart flutter), RIB FRACTURE (Hurt self in the toilet/broken ribs) and PYREXIA (Fever) outcome was unknown.            The patient reported after started Skyrizi, she hurt herself in the toilet. She went to the emergency room on 18-Apr-2021 as she had broken ribs and physician prescribed medication, but she could not recall name. She reported after receiving Moderna vaccine she experienced heart flutter and fever in 2021.  Company comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the pyrexia event.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the pyrexia event.
Fever of 101 noted at 01:00 on the 27th of January. Headache, dizziness, nausea, and loss of appetite also noted. Dizziness still noted on the 28th, all other side effects cleared.