chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of allergic reaction in a 62-year-old female subject who was vaccinated with FLULAVAL. Concurrent medical conditions included abdominal pain and urinary tract infection. Concurrent medications included COUMADIN, LIPITOR, ATENOLOL, XANAX and CIPRO. On 15 October 2008, the subject received a dose of FLULAVAL (.5 ml, intramuscular, right arm). On 15 October 2008, within six to eight hours after vaccination with FLULAVAL, the subject experienced allergic reaction, extensive swelling of vaccinated limb, injection site redness and injection site tenderness.  The subject's bladder symptoms started one week prior to receiving FLULAVAL. The subject came into the physician's office on 15 October 2008 with abdominal pain and a urinary tract infection was diagnosed. There was no fever so the physician gave FLULAVAL while the subject was in the office and prescribed CIPRO for the UTI. The subject had "taken CIPRO previously for UTI with no reaction (thus CIPRO is not suspected)". The physician reported a moderately severe swelling reaction to FLULAVAL, which included redness and tenderness and is thought to be due to an allergic reaction. The physician described the swelling as "impressive". Per the subject, these events began within six to eight hours after the injection. The physician did not examine these events until the next morning, which was greater than 24 hours after the onset. The FLULAVAL injection was given in triceps muscle, "the swelling began one inch above the injection site, and extended eight to nine inches down toward elbow, the width of the swelling is three to four inches in diameter". The physician has not prescribed any treatment such as steroids, because she does not want to interfere with the immune response of FLULAVAL. The physician expects that these events will resolve without treatment. The subject reported that the events are still worsening but the physician stated, "that is to be expected as allergic reactions usually so not peak until 48 hours". The physician is question whether the subject should receive flu vaccines in the future due to these events. The physician has already submitted this report to VAERS. At the time of reporting, the events were worse. The physician considered the events were probably related to vaccination with FLULAVAL.
Client reported of pain in left arm shooting down arm on 6/14/2017. On 6/15/2017 client reported of feeling weak, dizzy, foggy, nauseous, hot and stinging inside of her body but skin is warm to touch.
hives all over body;swelling of arms & hands;arthralgias;seen in ER 4JUN95 & tx w/DPH & APAP w/some resolution then 5JUN95 w/fever & dehydration & huge hives on body w/swelling of lips & mouth;is diabetic & sugar became elevated;fatigue;
This spontaneous report as received from a physician via a company representative refers to a 30-year-old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. In 2017 (reported as "in the past 2 months" and "within the past month or two"), the patient was vaccinated with PNEUMOVAX 23 intramuscular injection, left arm (dose, lot number and expiration date were not provided) for prophylaxis. In 2017, the patient experienced swelling in his left arm at the injection site and a 102 degree fever for an unspecified period of time. The patient received an antibiotic cefuroxime axetil (CEFTIN) (dose, frequency, route of administration, lot number and expiration date were not provided) for an unspecified period of time as a treatment. The outcome of the events was reported as recovering. The relatedness between PNEUMOVAX 23 and the events was not provided.
I had swelling under my left arm in the underarm area, which I assumed was swollen lymph nodes. This swelling and pain lasted more than 48 hours
He reports that approx. 3-4 days after vaccine, he develop a rash to the right side of his face- was on forehead, nose, right lip, and below right cheek.  He did not seek treatment at the time.  Rash eventually faded, was left with no residual symptoms.  Did not affect vision, hearing, or smell.
Slept most of the day; March 3 second dose only reaction was tiredness on March 4; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (March 3 second dose only reaction was tiredness on March 4) and HYPERSOMNIA (Slept most of the day) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Flutter atrial (02/2019 Pacemaker, 09/2019 Av node ablation) in 2017. Concurrent medical conditions included Allergy to antibiotic (Early 1970s -1980s, red rash (reaction to Declostatin,swollen thumb with warm red rash)), Hypersensitivity reaction (hypersensitivity reaction to Flecainide and had Extreme dizziness and irregular heartbeat) in 2019, Hypersensitivity reaction (hypersensitivity reaction to Ilosone) in 1970, Hypersensitivity reaction (hypersensitivity reaction to Vytorin and had legs ached) in 2013 and Type 2 diabetes mellitus since 2018.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (March 3 second dose only reaction was tiredness on March 4). On an unknown date, the patient experienced HYPERSOMNIA (Slept most of the day). At the time of the report, FATIGUE (March 3 second dose only reaction was tiredness on March 4) and HYPERSOMNIA (Slept most of the day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medication was provided by the reporter.   This case was linked to MOD-2021-018614 (Patient Link).
Information has been received from a consumer concerning her daughter who on an unspecified date was vaccinated with the second dose of GARDASIL. The reporter mentioned she believed her daughter had anxiety and depression for a whole week after received the vaccine. At the time of reporting the patient's outcome was unknown. No further information is available.
High fever > 103 - 104, rash around injection site and diffusely fatigue.
skin turned grey; feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (skin turned grey) and FATIGUE (feeling very tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00a21a and 029l020a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced SKIN DISCOLOURATION (skin turned grey) and FATIGUE (feeling very tired). On 25-Feb-2021, SKIN DISCOLOURATION (skin turned grey) had resolved. At the time of the report, FATIGUE (feeling very tired) outcome was unknown.            Concomitant medication of the patient included high blood pressure pill.  The patient did not receive any corrective treatment for the events; her relatives watched her during the night and her skin color was normal by the next day.  Primary physician of the reporter told her to call Moderna as they had never seen something like that before.
FELT ITCHING, NOTICE RED BUMPS ALL OVER ARMS AND LEGS.
itching all over the back, legs, buttocks; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (all over the back, legs, buttocks) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MULTIVITAMINS, CALCIUM, and BIOTIN for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRURITUS (all over the back, legs, buttocks). At the time of the report, PRURITUS (all over the back, legs, buttocks) outcome was unknown. Not Provided.      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 treatment medicine has been reported by reporter.
The second dose of Pfizer vaccine was place in my right arm September 30, October 1st Arm area turned reddish and itchy, and on day 5 I started with pain in my feet ,burning , stinging, burning, and pain in my hands. I called my doctor and he told me that it was Neuropathy, and he sent me to take Generic Neurontin.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single at the age of 45 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing); "sulfa drugs allergy" (unspecified if ongoing); "shrimp allergy" (unspecified if ongoing). No other medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (08Jul2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (Jun2022) remained positive, notes: after 5 day treatment; (Jul2022) negative, notes: 4 days after the recrudescence. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 24Jun2022 to 28Jun2022. Clinical course: Initial COVID symptoms improved while on Paxlovid, but antigen test remained positive after 5 day treatment (test bar became lighter in color). Then the bar began to darken again and patient had recurrence of COVID symptoms on July 4th, 10 days after initial positive test. Symptoms included runny nose and body aches and lasted 3 days. Patient antigen test became negative 4 days after the recrudescence.; Sender's Comments: Based on the available information provided, the causal association between the reported events (Drug ineffective and COVID-19) and BNT162B2, cannot be excluded. Case to be reassessed should a follow-up information becomes available.
Hospitalized (1.10.22);  COVID-19 positive (1.10.22); fully vaccinated. Admission Date: 1/10/2022, Discharge Date: 1/12/2022. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia of both lungs due to infectious organism, unspecified part of lung [J18.9], COVID-19 [U07.1], Pneumonia due to COVID-19 virus [U07.1, J12.82]. HOSPITAL COURSE: Patient is a 71 year old male admitted on 1/10/22 for COVID pneumonia. He was told to go to the ER by his PCP after 6-7 days of worsening symptoms. He presented with chills, fever, fatigue, congestion, cough, shortness of breath, and muscle pain. In the ER he was found to be 88% on room air which improved to 90% on 2 liters of nasal cannula. CRP was elevated at 41.7 on admission and trended down to 21.5. His chest x-ray was consistent with COVID pneumonia. He did receive 1 dose of Rocephin in the ER and 1 dose of dexamethasone 6 mg. Patient was given Albuterol inhaler every 6 hours. Blood glucose was between 200-300 during his stay. He was given Insulin lispro to corrective scale. On his second day of admission (1/11/22) he was weaned off oxygen and was 91% on room air. He was given a second dose of dexamethasone 6 mg and given a one time dose of IV Lasix. Today he feels much improved. He is maintaining >90% on room air, afebrile, and denies significant shortness of breath. He feels comfortable being discharged home today.
Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; Left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient) reported for herself. A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0191), second dose via an unspecified route of administration, administered in left arm on 04Jun2021 at 17:00 (at the age of 52-year-old) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. Medical history included Lyme disease from an unknown date and unknown if ongoing. No known allergies were reported. Concomitant medications included valaciclovir hydrochloride (VALTREX) taken for an unspecified indication, start and stop date were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0183), first dose via an unspecified route of administration, administered in left arm on 15May2021 at 09:15 (at the age of 52-year-old) as dose 1, single for COVID-19 immunisation at pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other vaccines within 2 weeks of COVID vaccine included Valtrex. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced left arm, leg, back went numb tingling for a day intense pain, hives on face, lump in armpit lymph node still there on 05Jun2021 at 03:00. No treatment was received for the events. The outcome of the events was reported as resolving.  Follow-up attempts are completed. No further information is expected.
Patient was given a 2nd bivalent booster when it was not recommended or due- No harm to patient and no adverse reactions
I contracted Covid-19 confirmed with a PCR test the week of 27Oct; I contracted Covid-19 confirmed with a PCR test the week of 27Oct; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Aug2021 15:00 (Lot number: FC3184) at the age of 53 years as dose 3 (booster), single, administered in arm left (Lot number: EN6199) as dose 2 , single and administered in arm left (Lot number: ER8732) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Inflammatory arthritis" (unspecified if ongoing), notes: Other medical history: Inflammatory arthritis. Concomitant medication(s) included: METHOTREXATE; HYDROXYCHLOROQUINE; LEVOXYL; LEUCOVORI. Vaccination history included: Flu (vaccination date: 10Aug2021, lot number: UJ586AA, dose number: 1, vaccine location: left arm), administration date: 10Aug2021. The following information was reported: IMMUNISATION (medically significant) with onset 30Aug2021 15:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Oct2021 12:00, outcome "unknown" and all described as "I contracted Covid-19 confirmed with a PCR test the week of 27Oct". The event "i contracted covid-19 confirmed with a pcr test the week of 27oct" and "i contracted covid-19 confirmed with a pcr test the week of 27oct" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Oct2021) positive, notes: COVID Test type post vaccination: Nasal swab COVID test name: SAR-COV-2, RT-PCR COVID test date: 28Oct2021 test result: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: AE treatment: Regen-COV, OTC cold meds and benzonatate. Adverse event: Patient contracted Covid-19 confirmed with a PCR test the week of October 27th. First symptoms that week.   No follow up attempts are possible. No further information is expected.
She has shortness of breath, DOE, fatigue, chest pressure / burning, cough x months.  She feels that she cannot take full breaths. She feels like she has lost about 1/3 of her lung capacity.    She received a booster dose of the Moderna vaccine 10/29/21 and her symptoms started 14 hours afterwards. She had heart palpitations, chest pain, shortness of breath, could not get a full breath.  She had a mild fever for < 24 hours.  Most of those symptoms resolved but she still has shortness of breath and chest pain.  She has a "booster cough", feels deep lower sternum chest pain / pressure.  She uses an Albuterol inhaler but it does not help much
I have severe muscle pain in my left arm. It first started as throbbing at injection site and progressed to muscle soreness and inflammation of the entire arm. I?m unable to sleep and movement of the arm is extremely painful z
Patient stated she had second Moderna vaccine on 5/7.Next day, mid day she started vomiting, had diarrhea, temp 99.5-99.6, and feels weak, and contiues this morning. RN reviewed increasing hydrqation, but she stated she is unable to keep anything down. RN adviced to call her provider today so he can recommend medication to can take for diarrhea, so she does not become dehydrated. She stated understanding.
5 cm red tenderness over injection site R biceps at day 1 but tender when seen at day 3 - records don't indicate which vaccine was placed in this location.
Pt came to ED with complain of dizziness, nausea and abd cramping at 12:47 PM on Oct 20, but pt reports that abd cramping started before receiving vaccine. Pt reports receiving FLUMIST at 6:00 AM on Oct 20, and later developed nausea and dizziness. Ondansetron and NS 1000ml were given and pt got discharged on the dame day. Pt also complained about vaginal discharge and dysuria for the last 3 days UA revealed slightly elevated WBC count, and subsequently BACTRIM DS was ordered.
first flu immunization lt deltoid 9/19/2009.  C/O of burning sensation through out that day with some redness and itching at site.  Two days later C/O feeling exhausted, muscle aches, chills, nasal congestion.  Sleeping 8 hours per night, but still feeling tired the next day.  SOB with exertion.  No medications
Exactly one week after my first Moderna Covid 19 vaccination the vaccination site is swollen, red, itches, is very warm.  Also have a rash around the vaccination site.
Headache/ pain close to migraine; I also have chills (getting hot and cold at random times); Am really tired as well; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Headache/ pain close to migraine), CHILLS (I also have chills (getting hot and cold at random times)) and FATIGUE (Am really tired as well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Headache/ pain close to migraine), CHILLS (I also have chills (getting hot and cold at random times)) and FATIGUE (Am really tired as well). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, MIGRAINE (Headache/ pain close to migraine), CHILLS (I also have chills (getting hot and cold at random times)) and FATIGUE (Am really tired as well) outcome was unknown. Not Provided          Patient reported that, she had headaches every day since receiving the vaccine and the pain was close to migraine. Patient also had chills (getting hot and cold at random times) and was tired well.  Concomitant medications were not reported.
Fever 100 to 102       Aching Muscles in both shoulders     Felt very cold