chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pulse raised to 100; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse raised to 100), PYREXIA (fever) and FATIGUE (fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L21B, 026D21A, 030A21A and 038K20A) for COVID-19 vaccination.     Patient never had COVID-19 positive diagnosis or test and no allergy including medications, food and other products. It was reported patient was concerned because he had an open heart surgery.  Previously administered products included for Product used for unknown indication: Flu shot (Flu shot 1 month ago). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Type 2 diabetes mellitus (Since 4 years ago and no recent change in status such as improvement or worsening), Blood pressure high (Since 30 years ago and no recent change in status such as improvement or worsening) and Heart disease, unspecified (Since 30 years ago and no recent change in status such as improvement or worsening). Concomitant products included METFORMIN and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Diabetes, HYDROCHLOROTHIAZIDE for Diuretic therapy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced HEART RATE INCREASED (pulse raised to 100), PYREXIA (fever) and FATIGUE (fatigue). On 05-Apr-2022, PYREXIA (fever) and FATIGUE (fatigue) had resolved. At the time of the report, HEART RATE INCREASED (pulse raised to 100) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2022, Heart rate: 100 (High) Pulse raised to 100 for 4 days.         Normal pulse of the patient was between 60 and 65. Other relevant concomitant medication included Beta blockers. Patient took 1st booster shot on 26Oct2021, and 2nd booster dose on 31Mar2022.  After 2nd booster dose, pulse raised also to 100 for 4 days, and currently then coming down and improving, but still not in the normal range and  patient did not experience a similar event in the past and the adverse event did not cause him to seek medical care including office visit, Urgent care, ER and hospitalized.  No treatment given for his symptoms.   This case was linked to MOD-2022-535597, MOD-2022-535621, MOD-2022-535624 (Patient Link).
On 10-3-07 resident received pneumonia and flu vaccine through the same injection. No adverse reaction.
This spontaneous report was received from a medical assistant concerning a 31 year old female patient. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 23-MAY-2018, the patient was vaccinated with a dose of PROQUAD lot # N020010, expiry date: 13-JAN-2019, for prophylaxis (strength, dose, route, dosage schedule and anatomical location were not provided). No adverse effects reported.
I had very bad sore throat, I was really sleepy. I was sleeping all the time. My joints and muscles ached. My nurse practitioner started me on Paxlovid. After 10 days my oxygen saturation dropped into the 80s. My pulmonologist put me on home oxygen, and I have been on that for 2 months. My doctor said I have long post covid.
A report was received from a health care professional on 10/23/03 concerning approximately 10 pediatric vaccinees less than 4 years old of unknown sex, who were inadvertently administered Fluvirin vaccine between 10/8/03 and approximately 10/22/03. Between 10/8/03 and approximately 10/22/03, approximately 10 pediatric vaccinees less than 4 years old were inadvertently administered Fluvirin vaccine. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 12/9/03: A follow up report was received from a health care professional indicating that a 8 month old male vaccinee inadvertently received Fluvirin on 10/22/03. On 10/22/03 the male vaccinee inadvertently received 0.25ml Fluvirin. At the time of reporting the vaccinee did not exhibit any adverse symptoms. No follow up pending. All information received.
Pt experienced itching at bedtime on 10/9/07 at the site of injection. Upon waking in the morning on 10/10/07, arm was sore and swollen; spoke w/ pt on 10/12/07. Symptoms had improved.
I had the normal reactions fatigue, fever, and body aches within 8 hours of the vaccine. However on 4/12/21 I woke up feeling extremely itchy. I broke out in hives  and whelps on the front of my neck and chest. It spread across my jaw as well by the end of the day. I was extremely hot and my skin felt like it was on fire. My head was extremely itchy. I took a Benadryl which did help the hives/whelps to clear a little after two doses bower I am still extremely itchy. I can?t stop itching. It?s everywhere to. Legs, arms, back head, shoulders...just everywhere, but no more hives. It is very frustrating.  This doesn?t appear to be reported as a side effect and I?m very concerned.
Extreme fatigue, joint pain, painful injection site, headache, inability to work or function.  Worse on 2nd dose.
She received her first dose of the Pfizer COVID-19 vaccine on 1/7/2021 with the second dose administered on 1/28/2021.  She reports that following the second immunization she developed a large red area on the left arm which has since resolved but since less than 1 week after the immunization she has had pain in the left upper arm as well as decreased strength.  Pain and decreased strength have not worsened since onset.  Pain occurs with movement.
anaphylaxis for mangoes and sunflower seeds. Post vaccine: patient was in personal vehicle for one hour post vaccine. No symptoms were originally reported within vaccine site post 15 minutes of vaccine administration. Patient called husband to report symptoms of itchiness. RN and RN assessed her in vehicle. Patient reported symptoms of itchiness to hands and neck with redness. Denies shortness of breath, throat tightness or dizziness. No swelling or or shortness of breath assessed. VS: blood pressure 133/83, pulse 69, oxygen 99% and temp 98.6. Per patient, takes antihistamines at home for allergies. Patient requested benadryl. Benadryl 50 mg given at 1602 as per standing orders. No difficulty swallowing. Patient denied emergency services and further monitoring and stated would be going home with spouse who was at side. Witness  RN. Patient instructed to call 911 if symptoms progress or develops difficulty breathing. No signs of distress noted upon leaving. Medical director was notified at 1620 of intervention and gave no further orders.
Swelling (L) upper arm into axilla redness, warmth & itching. Local ice, ibuprofen & BENADRYL as needed itching.
This case is a cluster of three patients who experienced adverse reactions following administration to DAPTACEL, lot number C4006AA. The other two patients were captured in cases 2012-03354 and 2012-03355. Initial report was received from a health care professional on 23 March 2012. A female patient (age and date of birth unknown) had received a dose four intramuscular injection in the leg of DAPTACEL, lot number C4006AA on an unknown date and an unspecified amount of time later had a "bad reaction" at the injection site. Medical history, concomitant medications, illness at the time of vaccination and any other vaccinations within four weeks of DAPTACEL were not reported. The patient's outcome was unknown. Documents held by sender: None.
Child received 2nd Hepatitis A at 12:00 then went to restaurant for lunch and had classic generalized tonic- clonic seizure at 12:40PM wile waiting for a table.  CT scan, CBC with Differential, Chem 7 all normal.
her arm was sore; her arm had like a black; her arm had like a black and blue to it on the injection site; she saw on her arm a 3-4 inch red spot; that was spread out and it was warm to touch; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On an unspecified date the patient experienced her arm was sore, her arm had like a black, her arm had like a black and blue to it on the injection site, she saw on her arm a 3-4 inch red spot, that was spread out and it was warm to touch. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Increased heart rate, tingling in head & arms, lightheaded, slight rash on upper torso, swollen lymph node.
Episodes of flashing lights in my eyes.  Initially thought to be related to age related vitreous liquifying and detaching.   However length of time since onset and no noticeable changes in my eyes, thoughts turned to ocular migraines.  Several tests were run to rule out other factors.  It wasn't until I reviewed episodes on my calendar to make a summary document that I noticed that the onset was 11 days after my first episode.  I thought "curious."  When I mentioned this to Doctor, he also responded "curious."   Episodes are still occurring, less frequently.  I am just curious if there might be a connection.   All are 2021 dates - 1/28, 2/1, 2/16. 2/19. 2/28,3/8,5/22, 6/2, 6/28, 6/30, 7/2, 7/4, 7/7, 7/13, 7/19. 7/22, 8/11, 8/16 (twice). 8/18, 8/23, 8/28 (twice), 9/1 (twice), 9/30, 10/17, 10/25
Client went to Urgent Care on 4/16 complaining of excessive fatigue, excessive sleeping, unsteadiness and fatigues easily when mobile. He was having trouble getting up and down the stairs. States he had a runny nose and congestion and started taking Mucinex since approximately 4/6. He had some chills on 4/15.  When he wakes up in the morning he still feels tired and could go back to sleep. After his initial assessment he was admitted to hospital for treatment and further evaluation.
With first vaccine, I had post menopausal spotting, which turned into flooding after my booster.  I also had pulmonary emboli after the booster. Had 2 internal exams, 2 D&C's for the post menopausal bleeding. I was in the ER overnight for the pulmonary emboli and was put on Xarelto, blood thinner.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment information was reported. It was stated that the date of refrigeration was 19 Aug 2021.   This case was linked to MOD-2021-363779 (Patient Link).
Tingling in my face (right and left side, forehead) and tightness in my jaw within 20 minutes of receiving vaccine. Visited urgent care 3 hours later after speaking with a nurse on the vaccine clinic hotline. Was given Benadryl and fluids. Sent home after 1 hour with improved symptoms. Symptoms resolved by next day.
Moderna COVID-19 Vaccine EUA. Symptoms started about 34 hours after vaccine. Fever lasted for 16 hours. Had severe chills and shivering overnight for nights 2 through four. Severe body aches, especially headache, neck ache and back ache plus muscle ache lasted 4 days.  Headache and fatigue lasted an additional 4 days for a total of 8 days of symptoms after vaccine.
blisters on my hands; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLISTER (non-serious), outcome "unknown", described as "blisters on my hands".  Additional Information: It was reported that the patient was concerned for having blisters on the hands from the COVID shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored MMR II (lot number reported as L029266 and expiration date 04-AUG-2017, lot number L003856 and expiration date 05-FEB-2017, dose and route of administration were not reported). Concomitant therapy was not reported. The vaccine was exposed to a temperature of 0.6 Celsius degrees for 12 hours and 28 minutes total cumulative time. There was no previous temperature excursion. It was stated that it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
allergies increased; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergies increased) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Anosmia, Ageusia and Allergy. Concomitant products included ALBUTEROL SULFATE and FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced HYPERSENSITIVITY (allergies increased). At the time of the report, HYPERSENSITIVITY (allergies increased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were inhalers.   This case was linked to MOD-2021-226696 (Patient Link).
Rash; This is a spontaneous report from contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 24Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included implantable defibrillator pacemaker replaced (15Mar2021). Concomitant medications were not reported. It was reported that the patient received the first dose of Pfizer vaccine on 24Feb2021, had her defibrillator pacemaker replaced on 15Mar2021 and developed post-surgical rash three days later (18Mar2021). The patient was supposed to receive the second dose on 24Mar2021. The reporter stated that the event was not related to the vaccine. The outcome of the event was not recovered with treatment received.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported event of Rash is assessed as unrelated to vaccine, As the rash was seen after surgery and the narrative clearly explains to having post surgical rash.
This spontaneous report was received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant therapy were not reported. Between 10-AUG-2016 and 26-AUG-2016, the patients were vaccinated with improperly stored M-M-R II, lot # M004063, expiry date 25-JAN-2018, subcutaneously, 12 doses. No adverse effects were reported. The outcome of the events was unknown. Therapy with M-M-R II was continued. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Facial swelling. left side face slightly numb and left side chest wall and left arm tight and sore, lip swelling. No shortness of breath. Symptons within 2 hours of administration of FLU vaccine. Employee took Benadryl.
Patient reports feeling chest pain starting Wednesday morning, which progressed down the side and back. He also reports pain in the stomach. He reported this to us on Saturday 12-19-20.  We told him to seek medical attention since he was having chest pain.
No additional AE reported; patient was accidently administered an expired dose of VAQTA; This spontaneous report was received from an other health professional and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 20-APR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, dose reported as once, lot #T040581, expiration date: 28-MAR-2022 (exact dose, site and route of administration were not provided) for prophylaxis (Expired product administered). No further information was provided (No adverse event).
Received a flu shot on Tuesday, October 18th.  Around 1 or 2 that afternoon she had a severe allergic reaction.  She had a heavy chest and couldn't breath, her eyes were red and glazed over with discharge, her mouth also broke out with hives.  She went to urgent care and they gave her Benedryl, a breathing treatment and Prednisone.  Yesterday she felt a lot better.  But around 11 AM today, it started to happen again, but she had neglected to take her meds because she had felt better the day before and went back to work.  She isn't allergic to eggs, so she thinks she may be allergic to the preservatives in the flu shot.  She just wanted to make sure we were aware of her incident with the vaccine so we could document her response.  She doesn't have information on the shot itself but provided the clinic and their phone number so we could contact them, get the info and then file a report. Short of breath, swollen glands, itchy throat, irritated red eyes, hives in moth, lips swollen, treated with IV Benadryl.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 01May2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21May2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 08May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Covid rebound - tested positive after testing negative; Positive, notes: Covid rebound - tested positive after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
shortness of breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. A 75-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: TK9893) at the age of 75 years, in left arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3(BOOSTER), SINGLE, 3rd dose administered on 30Sep2021 with lot 20145BA), administration date: 30Sep2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, 2nd dose administered on 22Mar2021 with lot EN6208), administration date: 22Mar2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, first dose administered 01Mar2022 with lot EN6203), administration date: 01Mar2021, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset Apr2022, outcome "not recovered", described as "shortness of breath". The event "shortness of breath" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient received his second Pfizer booster shot on 04Apr2022. Within the next week he began symptoms of shortness of breath. This feeling continues as of this Date, 04Jun2022. He had seen his cardiologist and had undergone several tests to see if heart related. The results seem to be not heart related. He believed that the cause of shortness of breath was due to the booster shot and also noted he had seen reports of young people getting myocarditis due to the vaccine and have shortness of breath accompanied by the myocarditis. He also stated that the shortness of breath was ongoing and was somewhat better but had been acting up more frequently in the last couple of days maybe the last 4 to 5 days. He further stated that after he saw the cardiologist and had the shortness of breath, they started giving him tests and had a heart catheterization the day after he saw the cardiologist and had that right away; he did not know the date but it was within a few days and was on the 14th or 18th of Apr2022 and also had a cat scan to see if he had a blood clot in his lung causing the shortness of breath and it was negative; states the echocardiogram seemed to be ok as well.
Swelling and redness along bicep on arm given only. There was pain along with the redness.  It has gone away except for some slight bruising.
25 min after injection and said she had itching all over her body started at the injection site then spread throughout her body. She was sent to an NP for evaluation. They advised her to take a BENADRYL and see if that resolved. She came back at 1700 to let us know she was somewhat better but would go home and take an additional BENADRYL. Recommended she contact her primary if symptoms persist or go to UC.
Day 8 after first dose of Moderna Covid vaccine; injection site became swollen, red, itchy, sore and the red area is hard to the touch
Red/warm area of injection 7 x 8 cm. provider treating as cellulitis with Keflex.