chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received booster of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (received booster of 0.5 ml) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (received booster of 0.5 ml). On 23-Oct-2021, ACCIDENTAL OVERDOSE (received booster of 0.5 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported.
Severe whole body aches; chills; fever; This is a spontaneous report from a contactable consumer (patient).  This 28 year old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection) from Lot# EL8982, at left arm on 15Jan2021 09:15 AM at SINGLE DOSE for COVID-19 immunization. Medical history included Depression, Anxiety. The patient had COVID prior vaccination (He was a recovered COVID-19 patient that was hospitalized for 8 days in Mar2020 with severe viral pneumonia). Facility where the most recent COVID-19 vaccine was administered was the hospital. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) vilazodone hydrochloride (VIIBRYD) , Clonazepam. Clinical course was reported as follows: Following vaccination, the patient  was great the whole day, then quite abruptly he started to experience Severe whole body aches, chills, and a 101.5 fever. He took NyQuil  and Ibuprofen at the direction of the Nurse Line. He was Still experiencing lingering body aches, the fever broke in the morning.  The patient had not been tested for COVID post vaccination. The outcome of the events was recovering
Caregiver had 2nd dose COVID vaccination. She said she was pregnant and had discussed with her provider.  10 minutes after vaccination she stated she felt dizzy.  Then it escalated to chest pain.  EMS was called and she was transferred to the ED.
Progress Notes     12/22/2020       Subjective Patient is a 46 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   Pt has h/o hypothyroidism on LT4- last lab a few months ago Started feeling lightheaded and warm Doing a temp check   135/94- repeat BP check Pulse between 72-90s on rechecked     Blood sugar was just checked and normal at 76--repeat also normal at 86   She is eating a snack and having some water.    She was given the Pfizer vaccination in the right deltoid muscle.   She said she has a h/o vasovagal episodes with shots, mammograms, etc.    During her 15 minute waiting period after the injection, the patient began to experience dizziness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including rapid progression of symptoms, vomiting, abdominal pain, hypotension, dysrhythmia, chest pain and collapse.        Objective     Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic and atraumatic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are dry.     Pharynx: Oropharynx is clear.  Eyes:     Extraocular Movements: Extraocular movements intact.     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion and neck supple.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Abdomen is flat. Bowel sounds are normal.     Palpations: Abdomen is soft.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time. Mental status is at baseline.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: rest, snack. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.     Discharge time 5:51pm        12/22/2020 5:19 PM
She stated approximately 12 minutes after receiving dose #1 Covid, she told the RN at the facility her tongue was stinging.  The nurse had her go to another area and her symptoms started to change.  Her eyes became red, she had increased mucus forming in her throat, her throat became red and scratchy, and she started coughing because of the increased mucus in her throat. She was given an injection 25 mg of Benadryl and transported to the ER. She was treated with Decadron at the ER, given an epipen to take home. She stated she felt nauseated the next day but had no other symptoms. She followed up with her primary care and the allergy clinic.
On 10/11/17, patient received a flu shot from me. She requested that she get about 1/2 half of the total vaccine in each arm to reduce soreness. The vaccination occurred without any problems and she left probably 10 minutes afterwards. On 10/16/17, the patient called the Pharmacy to tell me that about 1 hour after she left the pharmacy, she developed chest pain and shortness of breath. She went to the emergency Dept at Hospital for treatment where she says she received several doses of epipen and remained under observation until her discharge around 4AM 10/12/17.  She claims she was discharged with prescriptions for Prednisone, Benadryl and Famotidine to take over the next 4 days. They also told not to get any future flu shots in the future. She reported feeling "ok" at the time she called me.
Moderna - left sided severe neck pain starting 1/8/2021 developing into shingles pustules appearing on left temporal and occiptal scalp progressing to left anterior neck.  Started on Valtrex 1g 3x/day plus oral prednisone 20 mg bid for 5 days.  Currently still have scalp tingling/pain.
3 days of Diarrhea, Severe Headache, Dizziness, Nauseous, Very Sore Arm for 5+ Days, Fever, and extreme tiredness. Most of these symptoms lasted about a week. Had second vaccination on April 14 at 10:00 am and experienced symptoms. Those included Headache, Severe Dizziness, Fever, Tiredness. For the past 2 weeks have had Coughing, Dizziness, Sneezing, Phleum discharge in the throat and nose.
Patient received the first injection of Gardasil and at the injection site, extreme scar tissue and it seems like the muscle has huge divot to the bone in it. Patient has been to the doctor and a dermatologist and they are contacting the company that makes the drug.
Swelling at base of neck, mild discomfort reported all on injection side. Also, arm red and swollen at injection site. Patient reported to primary care provider who examined and noted enlarged lymph nodes on injection side. Report back to primary care if does not resolve in 2 weeks time or becomes worse. Symptoms began 24-48 hours after vaccine administration.
Patient stated about 10 minutes after receiving the vaccine she developed a lot of saliva, and also had what appeared to be a small red rash to the upper chest. Patient was looked at by M.D. and ordered Benadryl 25mg po, and XYZAL 5mg po. We then observed her for another 15 min so a total of 30 minutes she seemed to be doing better. Told if worsens to give our office a call or ER if feels like she cant breathe or severe hives. We will follow up with patient later today.
Joint, leg and arm pain. Headache, skin pain, abdominal pain. Saw/spoke to doctor. Told him I thought it was related to Gardasil injection. He did nothing.
Fast Heartbeat - Went to bed at 10:30 pm with chills and slight fever.  Awakened at 2:30 am with higher fever, and could feel rapid heartbeat in my neck.  Timed heart rate was 95 beats per minute. (My usual lying down heart rate is usually closer to 65 beats per minute.)  Threw off blankets and rechecked my heart rate peridocally.  It was down to 85 beats per minute by 3:00 am.  I fell asleep at about 3:15 am and woke up at 7:00 am.  Heart rate at 7:00 am was 76 beats per minute.   Heart rate returned to my normal low 70's by 10:00 am.
had aches/had pains; muscle pain; joint pain; headache; fatigue; started to get sick; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (started to get sick), ABDOMINAL DISCOMFORT (upset stomach), PAIN (had aches/had pains), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), FOLIC ACID, ATORVASTATIN CALCIUM (LIPITOR), CLONAZEPAM (KLONOPIN), CYANOCOBALAMIN (VITAMIN B-12) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ILLNESS (started to get sick), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced PAIN (had aches/had pains). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, ILLNESS (started to get sick), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue) had resolved. At the time of the report, PAIN (had aches/had pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication taken by the patient include Gatorade.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Additional Event and Treatment Details were updated.
52 year male presented to vaccine clinic, scheduled for a Moderna booster. Reconciled past immunization records on multiple databases, pt had received 1st  dose (4/16/21) and 2nd dose (5/13/21) of Moderna. Dates of prior vaccinations were missed during registration and vaccination, indicating too early for 3rd dose. Pt received 0.5cc of Moderna on 10/21/21 @ 10:31, double the recommended volume of 0.25cc for booster as well as less than 6 months from his previous dose. Pt did not have any allergic reaction or adverse event during 15 min monitoring period nor upon leaving.    Moderna Lot #11F21A, exp 1/19/2021
patient experienced redness in the general area where the vaccine was administed- redness that was shaped in as a circle
Information has been received from a physician concerning patients who developed diarrhea after the first dose of oral ROTATEQ. The physician did not state how many patients. No patient specific information was provided. No product quality complaint involved. No further information is expected.
I had arm pain that started about 4 hours after the first dose. I also got a low-grade fever of 99.5 about 6 hours after the vaccine and lasted about 4 hours. I also experienced sluggishness for about 24 hours.
Headaches; Fevers; Chills; Injection site pain; Swelling; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 65-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 65-years), administered in arm right on 02Feb2021 as dose 1, single for COVID-19 immunization. Medical history included diabetes, asthma and high blood pressure from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other medications in two weeks. The vaccination facility type was reported as other. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. On 21Feb2021, the patient experienced headaches, fevers, chills, injection site pain and swelling. The treatment was not received for all the events. The clinical outcome of the events was reported as recovered on unspecified date in Feb2021.   Follow-up attempts completed. No further information expected.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 27-APR-2015 was vaccinated with a dose of GARDASIL (lot # K006960) (dose and route not reported) that was 24 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Arm has a 5-6 inch red rash; Swollen; Feels feverish to the touch; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 09:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient was not allergic to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 11Mar2021 at 13:30 (at the age of 57-years-old), 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 15Apr2021 at 06:00, 6 days after second dose of injection, the patient's arm had a 5-6 inch red rash, swollen and felt feverish to the touch. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events red rash, swollen and felt feverish to the touch were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a female patient who received SHINGRIX for prophylaxis. 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 general body pain and performance status decreased. On an unknown date, the outcome of the general body pain and performance status decreased were recovered/resolved. It was unknown if the reporter considered the general body pain and performance status decreased to be related to SHINGRIX. Additional information was reported as follows: The exact age at vaccination was not provided. However, the patient was over 50 years old. After vaccination with SHINGRIX, the patient experienced systemic pain, inability to function and bone pain for a period of three days. The pharmacist did not have any other information at the time of reporting. The reporting pharmacist had not vaccinated the patient. No address was provided, as the reporting pharmacist she was not working at the time of reporting. This case was linked with case US2018134312 (husband's case), reported by the same reporter.
Rheumatoid arthritis flare up; This is a solicited report based on the information received by Pfizer. A non-contactable 55-year-old female consumer (patient) reported for herself.  Solicited report by a consumer of an adult male with an event of   Non-serious rheumatoid arthritis flares after second pfizer covid shot with rinvoq (upadacitinib). There was no reported medical history. On an unknown date, the patient experienced rheumatoid arthritis flares after second pfizer covid shot. on an unknown date, rheumatoid arthritis flares after   second pfizer covid shot resolved. COVID-19 VACCINE was also considered suspect.  The patient had flares following the second Pfizer Covid shot. He had not stopped  The Rinvoq as directed by the physician.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown    Causality assessment: Causality assessment between the event Rheumatoid arthritis flare up with RINVOQ (upadacitinib) was No reasonable possibility by the reporter, with COVID VACCINE was Not Reported.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  The lot number for BNT162b2 was not provided and will be requested during follow up; Sender's Comments: Based on the available information in the case, the causal association between the event rheumatoid arthritis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Unable to get 2nd vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to get 2nd vaccination) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-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 PRODUCT DOSE OMISSION ISSUE (Unable to get 2nd vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Unable to get 2nd vaccination) had resolved.            The patient was unable to get second dose because the vaccine facility did not schedule the second dose and then never had the Moderna vaccine in stock. No relevant concomitant medications were reported. No treatment information was reported.
Pt recv vax on 11/5/98; 10 min post vax pt exp numb arm, difficulty breathing, fever (100), high blood pressure, hyperventilating; tx=Choramine, supine position, Epinephrine
Noticed a raise, red, warm oval area approximately 3 inches long by 2 inches wide on same site where injection was. This was noticed about 8 days after vaccination. May have been present longer than this but didn't notice until this time. The area does not cause discomfort, just is mildly itchy. No other systemic symptoms. Initially after vaccine had sore arm for about 2 days but do not have that anymore.
had malaise (mild) p/vax 7MAY93 devel mod severe h/a & elevated temp 102-103; 19MAY PM of 23MAY improved 24MAY-25MAY saw local MD; 26MAY awoke @ 530AM w/ h/a;
This spontaneous report as received from a health worker refers to a 32 years old female patient. The patient was vaccinated with GARDASIL (dose, route and lot # not reported) immunization series at another facility "years ago". The patient had just received a letter advising her that one or more of the doses of GARDASIL administered had been stored at improper temperatures. No adverse effect reported. No other co-suspects were reported. No concomitant medications were reported. The physician exists in SR contacts to receive medical information in connection with this case, but was not the treating provider when the GARDASIL was administered. Patient sought medical attention not reported. Additional information has been requested.
Hospitalized 01/11/2022-still currently admitted; COVID-19 positive 01/10/2022; fully vaccinated plus booster  70-year-old man who was vaccinated induced that against COVID-19.  He reports he has not been feeling himself for past 2 weeks.  He reports that he has been having intermittent chest pressure, that comes and goes, it is not precipitated by activity.  He reports that this has been ongoing for the past few weeks.  He reports no chest pain currently.  Patient also reports that he has been having some shortness of breath, cough that is nonproductive of sputum for approximately 2 weeks as well. ASSESSMENT / PLAN:   Troponinemia 2/2 myocardial injury Recently elevated proBNP with DOE - Admit to GMF as inpatient, anticipate >2 midnight hospital stay. - Recently found to have elevated proBNP (11k), scheduled for outpatient TTE. - Trops 376 ? 345, EKG with non-specific ST-T wave changes. - CXR clear and maintaining appropriate SpO2 on baseline RA. - Cardiology contacted from ER ? no need for IV heparin, follow trops, will consult. - Obtain ECHO - Monitor volume status with daily weights and I/O?s.  Monitor telemetry. COVID-19 infection - Symptom onset > 2 weeks. + PCR on 1/10. - Comfortable and saturating normally on baseline RA. - CXR clear without e/o opacities or infiltrates. - Not a candidate for remdesivir or dexamethasone.  - Supportive care, encourage IS/pulm toilet. In regards to COVID-19, symptom onset does appear to be greater than 2 weeks.  He is vaccinated and boosted.  He is on room air.  Chest x-ray without evidence of pneumonia.  Agree he is not currently a candidate for remdesivir dexamethasone but would initiate dexamethasone if he were to develop hypoxemia. 01/14/2022 notes: Acute hypoxic respiratory failure; resolved COVID-19 pneumonia Continue Decadron 6 mg q.day Supplemental oxygen to maintain O2 sats greater than 90% Continue severe respiratory precautions 01/17/2022 notes: Acute hypoxic respiratory failure; resolved currently on room air COVID-19 pneumonia Continue Decadron 6 mg q.day Supplemental oxygen to maintain O2 sats greater than 90% Continue severe respiratory precautions  Dispo:  Transitioned to oral torsemide a nephrology; nephrology anticipating discharge from their perspective 1 2 days; cardiology recommending cardiac MRI tomorrow; still considering whether not to discharge patient on a Life Vest; likely patient will be hospitalized for at least 2-3 more days