chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COULD NOT WALK FOR 3 DAYS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis.  The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced could not walk for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not walk for 3 days. This report was non-serious.
This spontaneous report was received from an immunization coordinator referring to a female patient of unknown age who on 10-NOV-2014, was inadvertently vaccinated with a dose of PROQUAD (Merck), 0.5 ml, subcutaneously (lot # K004713, expiration date 02-OCT-2015) instead of intended ZOSTAVAX dose. No adverse effects reported. This is one of two reports from the same reporter source (linked report 1411USA004622). Additional information has been requested.
A few hours after shot I felt achy and had joint pain. The following day in the morning I had a nosebleed which is unusual for me.  I had had a blood clot and anemia six months prior to vaccine. I had two episodes of diarrhea. I had the second dose of vaccine and had no symptoms.
The patient presents with 6 day Hx of cold symptoms including dyspnea, loss of sense of taste and smell, headache, cough, rib pain, vomiting, and fevers. Pt was prescribed Azithromycin by her PCP. She had positive test result for COVID-19 infection 4 days ago despite receiving Pfizer brand vaccinations in April of this year.  The onset was 6  days ago.  The course/duration of symptoms is constant.  The character of symptoms is cold symptoms.  Risk factors consist of COVID-19 infection.  Therapy today: prescription medications.
had trouble motivating around the house; I would get up and stagger to left but this could've have had to do with with my ears; I would get up and stagger to left but this could've have had to do with with my ears; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jul-2021. The most recent information was received on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (had trouble motivating around the house), GAIT DISTURBANCE (I would get up and stagger to left but this could've have had to do with with my ears), EAR DISCOMFORT (I would get up and stagger to left but this could've have had to do with with my ears) and ANTIBODY TEST NEGATIVE (antibodies were not enough to have immunity) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 10231M20A and MOD101M201) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer and Yeast infection (yeast infection under breast for which she was given medication for the yeast). Concomitant products included LETROZOLE for Breast cancer, VACCINIUM SPP. (CRANBERRY [VACCINIUM SPP.]) for Urinary tract infection, CALCIUM for an unknown indication, MULTIVITAMINS [VITAMINS NOS].   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LAZINESS (had trouble motivating around the house), GAIT DISTURBANCE (I would get up and stagger to left but this could've have had to do with with my ears), EAR DISCOMFORT (I would get up and stagger to left but this could've have had to do with with my ears) and ANTIBODY TEST NEGATIVE (antibodies were not enough to have immunity). At the time of the report, LAZINESS (had trouble motivating around the house), GAIT DISTURBANCE (I would get up and stagger to left but this could've have had to do with with my ears), EAR DISCOMFORT (I would get up and stagger to left but this could've have had to do with with my ears) and ANTIBODY TEST NEGATIVE (antibodies were not enough to have immunity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, Antibody test: negative (Negative) She checked for antibodies and did not have any antibodies after receiving both the vaccine doses.     Other relevant medication history included medication for yeast infection under breast. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-250041 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant follow up/New event added, causality provided as "She believes the symptoms she had were not really related to the vaccine. After having both doses of the Moderna vaccine"
Fever up to 101.7, fatigue, muscle aches, headache starting around 12 hrs after vaccination lasting approximately 24 hours. No treatment taken.
numbness of the hand; side effects; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness of the hand), ADVERSE REACTION (side effects) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-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 HYPOAESTHESIA (numbness of the hand), ADVERSE REACTION (side effects) and NAUSEA (nausea). At the time of the report, HYPOAESTHESIA (numbness of the hand), ADVERSE REACTION (side effects) and NAUSEA (nausea) outcome was unknown.            No concomitant medication details were provided. No treatment medication details were provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2022 as dose 4 (booster), single (Lot number: Fjs682) at the age of 39 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Jan2021 as dose 1, single (Lot number: 012l20a), in right arm, on 10Feb2021 as dose 2, single (Lot number: 007m20a), in right arm and on 21Aug2021 as dose 3 (booster), single (Lot number: 939901), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Negative, notes: Began testing negative for COVID on 10Jul; (12Jul2022) Negative, notes: On 12Jul new symptoms began but continued to test negative; (14Jul2022) Positive, notes: Tested again and on 14Jul, positive result showed on test within 1min. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Took paxlovid as follows: 2 doses each on 7/6,7,8. 1 dose each on 7/9 (missed 2nd dose) & 7/10 (stopped at this point due to severe diarrhea with blood in stool.  Began testing negative for COVID on 7/10. On 7/12 new symptoms began but continued to test negative- very runny nose, watery eyes, and sinus pressure.  Symptoms worsened over the next two days. Tested again and on 7/14, positive result showed on test within 1min. Device Date : 15Jul2022.; Sender's Comments: subsequent to COVID-19 vaccine roll out.  Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Vaccine vial was not properly reconstituted and patient was ultimately getting only the diluent ( Sodium Chloride 0.9%) administered.. Patient was contacted later same day about incident and was given the diluent properly reconstituted vaccine dose on the next day.  No adverse reactions were reported by patient when they returned to get the satisfactory vaccination dose,
This is a 65y.o. male admitted from home with increasing shortness of breath intractable cough with wheezing fatigue history of being exposed to Covid wife admitted on 122 to hospital with acute Covid symptoms patient thinks he got it from his disorder who comes to visit. Patient has shortness of breath long-standing history of congestive heart failure respiratory failure COPD uses BiPAP CPAP at home morbid obesity atrial fibrillation Coumadin 3 allergies Levaquin and penicillin and adhesive tape patient has not had chest pain but has had progressive shortness of breath with cough dyspnea chills febrility has had aching feeling. Was noted to have a positive test at home and came into the hospital where his Covid positivity was confirmed. Patient at this time states she is coughing somewhat less he is concerned because he had hemoptysis. Patient occasionally drinks he does not smoke family history of diabetes hypertension congestive heart failure. Patient has a history of hypothyroidism lymphedema lower extremity edema allergic rhinitis atrial fibrillation.
8 PM 10/12/12: Patient had a throbbing headache, a temperature of 104.2 degrees F and a small red spot. AM 10/13/12: Temperature 102.4 degrees F, small red spot developed into a large welt on arm of injection. PM 10/13/12: Temperature decreased to 101 degrees F, found large welt became thick, hot to touch and painful. Her arm was very sore. AM 10/14/12: Temperature 99.1 degrees F and large welt remains the same. 10/15/12: No treatment because welt disappeared.
I receive vaccine and the next day I had fever body ache, slight nausea and pain at the injection site. The day after that everything was gone with exception of the pain at the injection site. Then Jan 1 around 6 I had swelling under my arms the injection pain was. I thought it was a mass with fluid 4 in long and 2 inches wide. I waited a couple of days and couldn't get in touch with him until Jan 10. By this time the swelling had gone down, and he said it was my lymph nodes they were measured at 305 centimeters. The doctor ordered blood work and a CT scan on my upper body. I am waiting on the orders to come through.
Left shoulder pain, left arm weakness, left arm numbness tingling. Consistent with brachial plexus neuritis. Physical therapy initiated.
This spontaneous report was received from a licensed practical nurse via company representative and refers to a female patient in her 70's (exact age was unknown). No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown day in approximately 2017, the patient was vaccinated with a one shot of PNEUMOVAX 23 injected subcutaneously (frequency, lot# and expiration date were not reported). On an unknown day in approximately September 2017 (also reported as within the past 5 days), after receiving PNEUMOVAX 23, the patient experienced "increased redness" at injection site. The patient sought medical attention and went to the clinic. As treatment, the patient was given antimicrobial (unspecified) "appropriate for cellulitis". Although, the reporter was not informed whether or not the patient had a confirmed case of cellulitis. The antimicrobial (unspecified) treatment was started after the begging of redness "within the past 5 days". Product quality complaint was not involved. The outcome of cellulitis was unknown. The causality assessment between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant.
REDNESS AND SWELLING ON THE ARM, ALSO SAYS IT FEELS HOT.
Induration, erythema (4x5 1/2cm area) and tender local injection site noted 2 days after injection.
excruciating radiating pain in left arm/ great difficulty moving arm/ swelling on top of shoulder two weeks later I still have a lot of pain in my shoulder joint two tele -health consultations with physician/ 3/01/21 and 3/12/21
There is a red circle around the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (There is a red circle around the shot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for Headache.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (There is a red circle around the shot). At the time of the report, VACCINATION SITE ERYTHEMA (There is a red circle around the shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Pt reports that on the evening after vaccination had ??? febrile seizure, increased temp 103 F and went to ER. NO reaction at 2M/4M.
Moderate right kidney pain and light left kidney pain; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0158) via an unspecified route of administration in the left  arm on 12Apr2021 at 14:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic idiopathic pancreatitis, previous kidney infections right kidney, migraine, sulfonamide (sulfa) allergy and fruit (banana) allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), levonorgestrel (NORTREL 1/35), promethazine (MANUFACTURER UNKNOWN) for an unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: GR8727) via an unspecified route of administration in the left arm on 22Mar2021 at 12:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 10:00, the patient experienced moderate right kidney pain and light left kidney pain. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, moderate right kidney pain and light left kidney pain was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient was awoken in the middle of the night, paralyzed - unable to move anything but my eyelids and in excruciating pain all over my body. Heat in my feet began to move upwards. My heart was racing. When the heat reached my neck, I felt a sensation of tightening and that is the last I remember until morning. My bed, down to the mattress, and bedclothing were soaked from perspiration. I was exhausted. I slept for 24 hours. I felt weak for a few days.
This patient recevied 3rd dose of Rotateq on May 15, 2009. She developed intussusception on May 25, 2009.  7/14/09 Hospital records received DOS 5/25/09 to 5/26/09. Assessment: Intussusception. Patient presented with vomiting and bloody diarrhea. Cough, fussy, abdomen tender to palpation. Air enema with successful reduction. ICD-9 Codes: 560.0
Right leg swelling for INR, Diphendryl 12.5 mg/5 ml, 4 ml, PO, TID, 3 days.
Subsequently post vax, he experienced migratory arthritis which persisted for three weeks. He was treated with prednisone for eight days.
chills; fever/102.2 fever; head and body aches began around midnight; head and body aches began around midnight; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 67-year-old female patient received bnt162b2 (Comirnaty, Solution for injection, Batch/Lot number: EN6202, expiry date: not reported, Age at vaccination: 67-year-old) via an unspecified route of administration in Left arm on 05Mar2021 09:30 AM as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Synthroid, Singulair, Ambien. Historical vaccine included bnt162b2 for COVID-19 immunisation. On 05Mar2021 11:30 PM, patient experienced chills, fever, head and body aches. No other vaccine in four weeks. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. Lab test included Fever: 102.2 on 05Mar2021. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
The morning after the vaccine, I experienced fatigue and nausea. Soon after, I had a headache and fever. Throughout the day and into the next day, the injection site was sore with the skin showing red irritated patches around the area. The second day the fever, headache, nausea and fatigue were gone, but the injection site was still sore with irritated skin surrounding.
16 year old received vaccine; A spontaneous report was received from a nurse concerning a 16 years old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273).  The patient's medical history not provided. The patient's concomitants not provided.  On 26 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (lot #029K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  Treatment was not provided.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the events was resolved on 26 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (XX year old) for mRNA-1273 (lot number 029K20A) with no associated AEs reported.
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced joint pain, general body pain, weakness and activities of daily living impaired. On an unknown date, the outcome of the joint pain, general body pain, weakness and activities of daily living impaired were unknown. It was unknown if the reporter considered the joint pain, general body pain, weakness and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced significant weakness, body pain, joint pain that was significant enough to lose time off work. This case has been linked with US2019GSK032959, reported for same patient.
Information received from the review of scientific literature on 02JUL2018. This is case 1 of 6 (18000138LT, 18000139LT,18000140LT, 18000141LT, 18000142LT, 18000143LT). The article notes an 18-year-old male who presented to the ED with left-sided pleuritic chest pain, diffuse ST elevations with PR depressions on electrocardiogram (ECG) and positive troponin-I elevation of 0.14 ng/mL (normal <0.03 ng/mL). Ten days after vaccination with ACAM2000, AVA (BioThrax), and typhoid vaccine. He was admitted for further evaluation and management of myopericarditis. Transthoracic echocardiogram was normal. Consultation with cardiology confirmed that his presentation was consistent with smallpox vaccination-associated myopericarditis. He was discharged with colchicine, activity restrictions for 3 months and flagged as non-deployable. Three months after diagnosis, the patient developed sharp chest pain while running and was brought to the ED. An ECG was unchanged since prior and troponin was elevated but downtrending. The patient was discharged home, and on follow-up with cardiology his activity restrictions and nondeployable status were extended due to his continued chest pain. The patient's outcome was not reported in the article. Additional information has been requested.
Dose administered >12 hours post puncture & after exposure to room temperature >24 hours; Total amount of time after post puncture the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) almost 70 hours; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture & after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (Total amount of time after post puncture the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) almost 70 hours) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jun-2022 at 9:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022, the patient experienced PRODUCT STORAGE ERROR (Total amount of time after post puncture the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) almost 70 hours). On 27-Jun-2022 at 9:52 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture & after exposure to room temperature >24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture & after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (Total amount of time after post puncture the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) almost 70 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported The vial had been first punctured on Friday & left out at room temperature over the weekend. It was reported that date the vial was initially stored in the refrigerator was 24Jun2022 and on the same day at 12:10pm vial was first punctured. The vial did not  undergo any temperature excursions. No treatment medication was reported.
Flu like symptoms; Headache; pain and aches; A spontaneous report was received from a 77 year old female consumer concerning who was participating in the mRNA-1273 Emergency Use Program and experienced flu like symptoms, headache and myalgia.  The patient's medical history was not provided. Concomitant medications reported included pravastatin.  On 2 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 011620A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 2 Jan 2021, after the administration of vaccine, the patient experienced flu like symptoms, headache, pain and aches. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, flu like symptoms, headache and myalgia were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The events of headache and myalgia are listed in CCDS.