chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain on arm; pain on his arm and difficulty moving it; Chills; Headaches; Fatigue; Swelling on his armpit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on arm), LIMB DISCOMFORT (pain on his arm and difficulty moving it), SWELLING (Swelling on his armpit), CHILLS (Chills) and HEADACHE (Headaches) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A2PA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Cholesterol.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced SWELLING (Swelling on his armpit). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain on arm), LIMB DISCOMFORT (pain on his arm and difficulty moving it), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain on arm), LIMB DISCOMFORT (pain on his arm and difficulty moving it), SWELLING (Swelling on his armpit), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent medical conditions included Diabetes and Cholesterol.
fever & petechiae on 17FEB96;fever d/t strep throat infect;adm to hosp for eval;on 17FEB had pancytopenia full work-up w/dx evan's synd;tx w/IV steroids,plasmaphoresis,vincristine & Danazole which returned hematologic profile to nl
Patient received vaccine around 6:50-6:55, patient was instructed to remain seated in waiting area for monitoring. Patient's significant other noticed patient was acting strange and began questioning if she was okay. Patient was having trouble breathing  and indicated she needed help. The significant other called over to the pharmacy staff to help. Patient was pale and had collapsed out of the chair forward. Pharmacy staff attended to patient, she was unresponsive and had urinated herself. Patient had a lot of trouble breathing, was wheezing for breath and unresponsive. Emergencies services were called and immunization emergency kit was retrieved. Patient was given an Epipen Autoinjector 0.3 mg into left leg. Patient began recovering and started reacting to epinephrine. Eventually coming to patient was monitored until emergency services arrived at which point she was taken to the hospital for further monitoring due to Epipen usage.
Case number PHEH2014US022262, is an initial spontaneous report from a nurse received on 05 Nov 2014. This report refers to a 33-year-old female patient. Historical conditions were not reported. No concomitant medications was reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 04 Nov 2014. On 04 Nov 2014, she experienced dizziness, nausea, pain on the left side of face and felt heat spreading over neck and shoulders. The final outcome of the events was unknown. Seriousness and causality was not reported.
swollen lips.  received Kybella lip filler October 14th. lips today were swollen and tender.
so breathless he cannot take off his coat.; feels very fatigue.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (so breathless he cannot take off his coat.) and FATIGUE (feels very fatigue.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A, 002A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included RUXOLITINIB for Cancer, PHENYTOIN (DILANTIN [PHENYTOIN]), PHENOBARBITAL SODIUM (PHENOBARBITAL [PHENOBARBITAL SODIUM]), LEVOTHYROXINE SODIUM (SYNTHROID), SPIRONOLACTONE and TORSEMIDE for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced DYSPNOEA (so breathless he cannot take off his coat.) and FATIGUE (feels very fatigue.). At the time of the report, DYSPNOEA (so breathless he cannot take off his coat.) and FATIGUE (feels very fatigue.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2021, Oxygen saturation: 93-96 (abnormal) abnormal.         weight was reported as 200. No treatment medications were reported.
Narrative:  Patient presented to the ED via EMS on 12/29/2021 with a chief complaint of vomiting x 24 hours. He reported testing positive for COVID on a home test. Symptoms began about 12/26/2021. EMS reported normal blood glucose and atrial fibrillation with HR sustaining in 120s. On arrival to our ED, Patient was saturating 86% on room air He was febrile (T 99.8) and tachycardic (HR 127). Labs in ED revealed leukopenia (WBC 2.80), thrombocytopenia (PLT 92), mild DKA (Glu 222mg/dL, bicarb 20.8mmol/L, AG 14.9, beta-hydroxybutyrate 0.5mmol/L), hyponatremia (Na 131mmol/L), hypochloremia (Cl 95.3mmol/L), elevated CRP (19.49), elevated d-dimer (0.5), elevated ferritin (714.4), and negative lactate. ABG on 2LPM via nasal cannula revealed hypoxic respiratory failure (pH 7.46, pCO2 34, pO2 62). COVID test was POSITIVE. CXR revealed multifocal peripheral patchy airspace opacities. Blood cultures were obtained. Patient was given LR x 1L, acetaminophen 1000mg IV x 1, and ondansetron 4mg IVP x 2. He was admitted to ICU for further care. Update of present Illness: 1/3/2022 - Remdesivir and dexamethasone were initiated. Levofloxacin was initiated for empiric CAP coverage. BIPAP was placed on 12/30/2021. FiO2 requirements have increased to 100%. Patient is BIPAP dependent this AM. 1/4/2022 - Remdesivir and levofloxacin completed. Dexamethasone continued. Patient remains BIPAP dependent this AM. Dexmedetomidine initiated for agitation with improvement in symptoms.  1/5/2022 - Patient desaturates with the removal of BIPAP.  Transition to comfort care is being considered. 1/6/2022 - Patient was transitioned to comfort care. Morphine IVP initiated. BIPAP removed. Patient progressed to asystole at 1240.
Man called office 3/16/06 and states child has generalized rash all over body
Pt was given a dose of Pfizer 5-11 formulation that had was past expiration after vial was open. (The vial was open and ambient for 24 hours and was used once before it was noticed.
Feverish on 5/29/09, raised, itchy, painful x 2d seen in the office 5/29/09: T: 98.2. Exam: dry papules upper forearms, back, trunk, scattered = 6 = blisters at base. Imp: Varicella Keratosis Pilanis. 6/1/09: No new lesions, activity level WNL, papules decreased in size. Pt was seen in own office on 5/29/09 but symptoms rash started 2 days prior (5/29/09) her appt time on 5/29/09 was 16:05
coughs a lot; can't sleep; short of breath; Anxiety; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughs a lot), INSOMNIA (can't sleep), DYSPNOEA (short of breath), ANXIETY (Anxiety) and FATIGUE (Exhaustion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (coughs a lot), INSOMNIA (can't sleep), DYSPNOEA (short of breath), ANXIETY (Anxiety) and FATIGUE (Exhaustion). At the time of the report, COUGH (coughs a lot) and INSOMNIA (can't sleep) had not resolved and DYSPNOEA (short of breath), ANXIETY (Anxiety) and FATIGUE (Exhaustion) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.  It was reported that the patient felt exhaustion, like he was short of breath and since 3 days ago he had felt again like that, like he would choke and patient does not had any history of previous heart conditions or myocarditis/pericarditis.
About 5 minutes after vaccination, pt reported feeling weak and hot/sweaty. He denied feeling itchy, dry mouth, or difficulty swallowing. Pharmacist gave pt a cold orange juice and he sat on the floor with his head between his knees with a fan blowing on him for about 10 minutes. He continued to deny feeling itchy or having swallowing difficulty. After about 10 minutes he said he was feeling better and left.
bleed as much as he did; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient wanted to know if he was supposed to bleed as much as he did on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.
I had fever, body aches, Chills and night sweats. The fever lasted longer than the original series. I had a fever for 2 days. The body aches in my lower back were concerning. I?ve had night sweats for now 3 nights.
Pt recv vax on 2/20/99; on 2/23/99 pt exp cellulitis of rt arm
4-23-original symptoms were feeling very loopy like I had been given pain meds.  lasted for about 2 hours.  then mild headache.  4-24 other symptoms didn't begin until late afternoon the next day.  low grade fever (99.9), chills, body aches, vomiting, headache.  4-25-very lethargic and tired into the entire next day.  4-26 -back to feeling completely normal
local rxn: induration, erythema, warmth, swelling @ inj site of lt arm;
Received Hepatitis A, Menactra, Varivax, and Gardasil. Received Hepatitis A, Menactra, and Varivax first, and was fine.  The nurse went to get a different needle for the Gardasil vaccine and was gone for 3-4 minutes. She returned and gave the shot. Within a few seconds, patient complained that her throat felt "like someone had [her] in a headlock". She also complained of pins and needles sensation on her face. She had short, quick breaths but did not initially have shaking or numbness of the hands.  We had her lay down and put some ice behind her neck. We also had her blow into a paper bag. She still complained of the pins and needles sensation on her face. We also gave her some Gatorade. 10 minutes later she felt better but was then having shakineess and numbness of extremities. No headache, no vision changes, no syncope. Blood pressure was fine. 20 minutes later the pins and needles sensation was gone, she felt better, and went home. This same patient did have a reaction to a pertussis vaccine (Tetramune) in October 1994, but otherwise has not reacted to vaccines and has had all of them.
stayed in bed; driving headache; felt like throat had something in it; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (stayed in bed), HEADACHE (driving headache), OROPHARYNGEAL DISCOMFORT (felt like throat had something in it) and PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FISH OIL and RIVAROXABAN (XARELTO) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (stayed in bed), HEADACHE (driving headache), OROPHARYNGEAL DISCOMFORT (felt like throat had something in it) and PAIN IN EXTREMITY (sore arm). At the time of the report, ASTHENIA (stayed in bed), HEADACHE (driving headache), OROPHARYNGEAL DISCOMFORT (felt like throat had something in it) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I went into my car and got really dizzy. I got nausea and been coughing a lot ever since. I could test it in my mouth.
Patient came in on 8/29/2021 for his second dose of Moderna.  Pateint is required to fill out a questionaire before the immunization.  On the questionaire the patient mentioned that he experienced his heart racing/chest pain.  I asked further questions.  Patient said he experienced this with the first shot of Moderna for  a day or 2 after the first dose.  I explained to him that these symptoms can match Myocarditis associated with the vaccine.  I told the patient about the side effects of Myocarditis and said to be on the safe side to call his PCP  on Monday 9/29/21 and get checked out on a precautionary basis due to the similar side effects even though it happened a month ago.  2nd dose is on hold for now, waiting to see if he is cleared by his doctor.  Patient agreed.
My daughter came home from daycare and went to sleep at 6:30 p.m. on February 13, 2013.  She woke early a.m. on February 14, 2013 with a low fever (99.8).  She came home from daycare that day (Feb. 14) and again went to sleep really early (7:00 p.m.).  She woke early a.m. on February 15, 2013, with a fever of 102.5.  By 2:30 p.m. on February 15, 2013, her fever was 103.3.  By 3:30 p.m., she had a rash.  By 9:30 p.m., her hands and feet were swollen & blue and she was unable to stand, walk or use her hands and her rash was worse.  ED trip & bloodwork revealed elevated SED Rate of 34.  Was seen in ED on Friday, February 15, 2013; seen again in ED at Saturday, February 16, 2013; admitted via direct admit to Medical Center on Sunday, February 17, 2013 & released on February 18, 2013.  Seen by pediatrician on Feb. 19 & Feb. 21 & Feb. 25.  On February 25, 2013 she was sent for direct admit at another hospital for IVIG infusion and additional treatment of Kawasaki disease.
Initial report received from a healthcare professional on 17 July 2013. A 33-year-old female patient had received an intramuscular dose of ADACEL vaccine; lot number U4667AA (anatomical site of administration was not reported) on 17 July 2013. The patient was pregnant at the time of vaccination. Last menstrual period date was 30 November 2012. The estimated date of delivery was reported as 06 September 2013. The patient's health during pregnancy, specific risk factors (e.g.: alcohol, tobacco or recreational drugs), medical history, concomitant medications and treatment for infertility were not reported. At the time of the report, the patient had not experienced any adverse events. At the time of this report, the outcome was unknown. Documents held by sender: none.
chills; fever 102; headache; stomach; fatigue; arm pain; immediatly felf dizzy; nausea after shot; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, in right arm on 23Feb2021 (at the age of 46-years-old) as dose 2, single for COVID-19 immunization. Medical history included covid-19 from 03Jan2021 to 24Jan2021. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (at the age of 45-years-old) as dose 1, single for COVID-19 immunization after which the patient experienced chills, fever, headache, stomach discomfort, fatigue and arm pain. The patient experienced chills, fever 102, headache, stomach discomfort, fatigue, arm pain on an unspecified date and dizzy and nausea after shot on 23Feb2021. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Day after receiving vaccine my daughter with no known medical conditions presented with gross hematuria. Cultures and labs confirmed no bacteria, UTI or any other infection. After x-rays, labs and ultrasounds there was no confirmed cause. Since this event she now sees a nephrologist who cannot identify a diagnosis and is suspicious of IgA Nephropathy with no explained cause and no family history. All labs show microscopic blood in urine and protein ever since. She had an additional dose on 10/156/2002 and the following day presented once again with significant gross hematuria.
Low grade fever of 101, chills, body aches on the first and second day. Today is day 3 and at this time, 10:30 am, I am feeling better, only a sore spot at injection site. I have been taking Advil for the symptoms and I think it has helped.
sore arm; Arm has a huge lump; Arm is red; Arm is warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Arm is warm to the touch), VACCINATION SITE PAIN (sore arm), INJECTION SITE SWELLING (Arm has a huge lump) and INJECTION SITE ERYTHEMA (Arm is red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced INJECTION SITE WARMTH (Arm is warm to the touch), INJECTION SITE SWELLING (Arm has a huge lump) and INJECTION SITE ERYTHEMA (Arm is red). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, INJECTION SITE WARMTH (Arm is warm to the touch), INJECTION SITE SWELLING (Arm has a huge lump) and INJECTION SITE ERYTHEMA (Arm is red) had not resolved and VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
syncopal episode; This spontaneous report was received from a physician  via company representative referring to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose description, lot #, expiry date, anatomical location and route of administration were not provided) for prophylaxis, and subsequently, she experienced a syncopal episode. The subject sought medical attention and received epinephrine following the vaccination. It was reported that she recovered and was fine.   The causal relationship between syncopal episode and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.  Upon internal review, the event syncopal episode was determined to be medically significant.
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 90 years old and in the facility receiving palliative care for high risk myelodysplastic syndrome and CKD. He was transferred from hospice to the ED for aspiration pneumonia on 1/24/21. By 2/2/21 he was unresponsive and died with respiratory failure and hypoxia from bilateral pneumonia on 2/3/21
This case was reported by a other health professional via other manufacturer and described the occurrence of drug allergy in a male patient who received Hepatitis B vaccine. The patient's past medical history included depression, hypercholesterolemia, hypertension, atherosclerosis and peripheral vascular disease. Concurrent medical conditions included iodine allergy and penicillin allergy. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown. It was unknown if the reporter considered the drug allergy to be related to Hepatitis B vaccine. Additional details were provided as follow: This case was received from Pfizer. It was reported in the medical history of the patient that he had a drug allergy to Hepatitis B vaccine.
Estimated due date 6/9/22. Received COVID booster 9 days before beginning of miscarriage.  Reporting just in case it could be related. Miscarriage began at 7 weeks.
This case was reported by a other health professional via sales rep and described the occurrence of erythematous rash in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was recovered/resolved. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a red rash after receiving SHINGRIX. It was less than 100 mm in size and resolved within 3 days. The reporter had a picture of the rash. No additional information was available.
Temp 101 5-5 with stomache, headache, low energy and appetite. 5-7 presented with left arm rash at injection site 4x3 cm. 5-7 (+) bullae (L) ankle and starting on (R)-Resolving rash.
not immunocompromised and went to get a booster because of her age and condition; very ill; felt like she was coming down with the flu; weak; tired/fatigued; had nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (very ill), INFLUENZA (felt like she was coming down with the flu), ASTHENIA (weak), FATIGUE (tired/fatigued) and NAUSEA (had nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced PRODUCT USE ISSUE (not immunocompromised and went to get a booster because of her age and condition). In September 2021, the patient experienced ILLNESS (very ill), INFLUENZA (felt like she was coming down with the flu), ASTHENIA (weak), FATIGUE (tired/fatigued) and NAUSEA (had nausea). On 02-Sep-2021, PRODUCT USE ISSUE (not immunocompromised and went to get a booster because of her age and condition) had resolved. At the time of the report, ILLNESS (very ill), INFLUENZA (felt like she was coming down with the flu), ASTHENIA (weak), FATIGUE (tired/fatigued) and NAUSEA (had nausea) outcome was unknown.            No concomitant medications were reported No treatment medications were reported.
Moderna COVID-19 Vaccine EUA Had same side effects (all listed for Moderna vaccine) as the first dose of vaccine.  Went to bed feeling blah and with heavy chills.  Awoke several times. Got out of bed around 4am, fever 101.5, pounding headache, mild nausea, body aches, injection site pain. Headache was stronger all day long than for first dose, pounding! Vomited once around 4pm after trying to eat sips of smoothie. Feeling some better when went to bed and fever down to 99.6.   Slept pretty well, awoke still with less of a headache, that resolved by noon. Felt fine since.