chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was already fully vaccinated with Covid Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (patient was already fully vaccinated with Covid Vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (patient was already fully vaccinated with Covid Vaccine). On 30-Apr-2021, EXTRA DOSE ADMINISTERED (patient was already fully vaccinated with Covid Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information was not provided by the reporter. Reporter stated patient told the reporter that he was already fully vaccinated with a COVID vaccine (unknown manufacture) prior to receiving the dose on 30-Apr-2021.
Flu Vaccine given on Monday, 10/2/17 early afternoon. On Wednesday (10/4/17) evening at home, began to have mild itching with mild flat red rash on left arm, which rash spread to torso, other arm and upper legs. No SOB, nausea or vomiting. Started Loradtine Thursday, 10/5/17 am, and saw Employee Health 10/5/17 afternoon. Using Benadryl at bedtime.
fever; fatigue; malaise; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on an unknown date, refer case US2019109628 ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, fatigue and malaise. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, fatigue and malaise were recovered/resolved.   It was unknown if the reporter considered the fever, fatigue and malaise to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter stated that the patient was in her 60's. The patient received Shingrix on an unknown arm.  The patient developed fever, fatigue and malaise that lasted approximately 2 to 3 days. The reporter did not provide any additional information.
6:00PM Right Arm Muscle Pain - x2 Tylenol Taken 9:00PM Fever 1:00AM Mild Grade Fever 99 - x2 Tylenol Taken 1:00AM Right Arm Muscle Pain - 8/10 5:00AM Fever  Current Time: 8:25AM - Fever, Right Arm Pain (8/10), Whole Body Fatigue (6/10)
General arthralgia/myalgia, fever up to 103, dizziness, sinus & chest congestion/drainage w/ dry cough, dfficulty focusing, general malaise.
A report has been received from a Pharmacist concerning a child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced EXPIRED FLUMIST GIVEN. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. Clinic administered FLUMIST that had expired one day prior to administration. The report was considered to be non-serious.
Patient received Tdap on 2/10/17, R am. Came in 2/15/17 to be seen. Positive pain, positive warm, no erythema whole arm hurts - injection site appears to be too far anterior of deltoid, swelling noted.
pt became pale, diaphoretic 5 mins p/vax; vital signs normalized w/stimulation;
I began to have generalized body aches and lower back pain. Body aches are a normal reaction for me from the vaccine. By 10/31/15 my body aches were gone but back pain remained and increased in intensity. On 11/02/2015 I could hardly walk or rise from sitting to standing. My pain radiated into anterior thighs as well. I iced my back, took ibuprofen and stay in a jacuzzi got tub on and off for the next few days. The back pain is tolerable at this time but has not fully dissipated. I went through events/activities that I had done that could've harmed my back besides the vaccine but could not recall anything.
This spontaneous case was reported by a consumer and describes the occurrence of LEUKAEMIA (A young man who received the Moderna Covid-19 vaccine and developed Leukemia) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LEUKAEMIA (A young man who received the Moderna Covid-19 vaccine and developed Leukemia) (seriousness criterion medically significant). At the time of the report, LEUKAEMIA (A young man who received the Moderna Covid-19 vaccine and developed Leukemia) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were reported. Company comment: This spontaneous case concerns a male patient with no reported medical history, who experienced the unexpected, serious medically significant event of leukaemia. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The report stated that a young man who received an unspecified dose of mRNA-1273 vaccine, developed leukemia. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a male patient with no reported medical history, who experienced the unexpected, serious medically significant event of leukaemia. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The report stated that a young man who received an unspecified dose of mRNA-1273 vaccine, developed leukemia. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
About a day after vaccination I began experiencing discomfort & difficulty urinating. This has continued to occur through today (18Mar2021). Symptoms appear to be lessening as time goes by.
Patient presented to medical clinic on 30AUG21 for evaluation of vertigo, photophobia, dizziness, vomiting. Patient was evaluated on 31AUG21 via Emergency Department, was later diagnosed with Angiosarcoma and passed away on 07OCT21.
I was double vaccinated had Covid; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (I was double vaccinated had Covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (I was double vaccinated had Covid). At the time of the report, COVID-19 (I was double vaccinated had Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) patient had had Covid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided Patient was received monoclonal antibodies in September 23.  Company comment: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19, on unknown date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The onset latency was unknown as the specific dates of the vaccine and event was not provided.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the non-serious, unexpected AESI event of Covid-19, on unknown date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The onset latency was unknown as the specific dates of the vaccine and event was not provided.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Tongue started itching. Benadryl 25 mg given. Assessed and kept 30 minutes.  Pt states that she felt better and discharged to home.
Soreness on Arm (though not as much as the first shot); This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EW0153, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on unspecified date in Apr2021 (at the age of 30 years old) as first dose, single for COVID-19 immunisation in a Pharmacy or Drug Store. Medical history included anxiety from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination and  did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccine the patient was not diagnosed with COVID-19. The patient has list of other medications received within 2 weeks of vaccination. The patient experienced soreness on arm on Apr2021. The case was considered as non-serious. Since vaccination, the patient has not been tested for COVID-19. Treatment was given in response to the event which included ibuprofen. Outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Hives (red) swelling - Left side by neck. Diarrhea, Itching in chest by hives Reported to Doctor Friday. Doctor instructions are to purchase Benadryl Liquid 25 mg and Benadryl Cream for itching on 10/9/20.
trouble walking; her head felt really hot; her hands felt really cold; her upper arm sore; headache; her temperature was not very high; Sweats; she really did not feel good; chills; aching in her joints; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (Sweats), MALAISE (she really did not feel good), GAIT DISTURBANCE (trouble walking), FEELING HOT (her head felt really hot) and PERIPHERAL COLDNESS (her hands felt really cold) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053022A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Pfizer COVID-19 vaccine (1st dose, lot number: ER8727) on 18-Mar-2021, Pfizer COVID-19 vaccine (2nd dose, lot number: ER8729) on 08-Apr-2021, Pfizer COVID-19 vaccine (1st booster dose and lot number: FU162C) on 16-Mar-2022. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. Concomitant products included LISINOPRIL and METFORMIN for an unknown indication.    On 19-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Oct-2022, the patient experienced HYPERHIDROSIS (Sweats), MALAISE (she really did not feel good), CHILLS (chills) and ARTHRALGIA (aching in her joints). On 20-Oct-2022, the patient experienced GAIT DISTURBANCE (trouble walking), FEELING HOT (her head felt really hot), PERIPHERAL COLDNESS (her hands felt really cold) and HEADACHE (headache). 20-Oct-2022, the patient experienced PAIN IN EXTREMITY (her upper arm sore) and PYREXIA (her temperature was not very high). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweats), MALAISE (she really did not feel good), GAIT DISTURBANCE (trouble walking), FEELING HOT (her head felt really hot), PERIPHERAL COLDNESS (her hands felt really cold), PAIN IN EXTREMITY (her upper arm sore), CHILLS (chills), ARTHRALGIA (aching in her joints), HEADACHE (headache) and PYREXIA (her temperature was not very high) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   The patient had no allergies and no acute and chronic illnesses at the time of vaccination. The patient was not given any other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient had never had COVID + test or diagnosis.  On 19-Oct-2022, the patient received the booster dose of Moderna COVID-19 vaccine, Bivalent. The patient took 5 Baby Aspirins.
Pt here for second pfizer vaccine. RN chose syringe from prefilled syringes filled by another  in clinic, , RN.  This RN cleansed left deltoid with alcohol wipe and inserted needle into left deltoid. At this time noticed that there was no fluid in syringe and plunger was already fully down. Needle was removed and syringe was disposed of in sharps container.  Area cleaned again with alcohol swab and vaccine was administered without difficulty. Team lead, on duty was notified of the situation. Both RN and Team lead spoke to both parents and explained the situation, assuring parents that patient did not receive 2 doses of vaccine today.
Pt was in his usual state of excellent health prior to December 2007. He had completed a physical exam in Sept 2007 and had no physical complaints at that time. Pt received FLUMIST vaccine on 14 Nov 2007. He did not received any other vaccines on that day. He denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the day of vaccine receipt. Sometime in late November or early December 2007, pt noted blurring of his vision. Between December 2007 and the end of January 2008, pt experienced tiredness, increased urination (voiding every 1-2 hours during day), nocturia (voiding every 2-3 hours throughout the night) and increased thirst (drinking up to 2 quarts of orange juice a day). BY mid-January, pt noted numbness and tingling in his fingertips and toes. While in another city on 28 January 2008, pt was seen at a local clinic for dehydration. When he described his symptoms, his blood glucose level was checked and reported to be 432. While at the clinic, he received several liters of IV fluids. (No documentation of this visit visible to VHC). When pt returned to his city on 5 Feb 2008, he sought medical evaluation. By that time, in addition to the above symptoms worsening, he also had lost 30 lbs since late November 2007. When he was evaluated, his blood glucose level was 326 mg/dL, his UA showed trace positive ketones, and his HgbA1c was 11.6 (4.0-6.0). He was diagnosed with Type 2 diabetes. Between February 2008 and July 2009, pt was tried on a number of combinations of oral diabetes medications. Insulin was initiated in July 2009 and pt was recently changed to an insulin pump. Pt has never experienced ketoacidosis. He has lost consciousness several times secondary to severe hypoglycemic episodes. He denies diabetic peripheral neuropathy and diabetic retinopathy. Microalbuminuria was noted on a urine sample in 2008 and pt was subsequently started on an Angiotensin Receptor Blocker.
Approx 2 hours after shot - severe neck stiffness , reduced ROM. Later that day - severe joint pain , all joints. Stiffness , pain in neck is diminishing but remains. Patient states also had fever that night.
Patient is a 85 y.o. male patient of MD with history of Afib, CAD, COPD, HTN and cancer of L kidney presented to Hospital with cough and SOB.     Acute Hypoxemic Respiratory Failure COPD Exacerbation COVID-19 Cough, SOB, fever, chills and congestion x 4 days COVID positive, Flu negative Pt vaccinated and boosted Febrile with T max 101 on admission CXR No acute cardiopulmonary process based on AP image alone SpO2 88 on admission, improved to 98% on 3 L NC; weaned to RA this morning Received 4 days of  Remdisivir and  will continue Decadron as po to complete 10 day course.  Clinically  improving, on room air with O2 saturation 95%, ambulatory in room.  Okay medically for discharge to home today.  Discussed wearing a mask for 5 more days to complete his isolation protocol.     AKI, improving Cr 1.48 on admission improved to 1.24 this AM, baseline 1.16 No IVFs  given due to LE edema and COVID infection   HTN BP 136/72 on admission Lopressor 25 mg at home, restart but hold for SBP<100 or DBP<60 Monitor   Pancytopenia WBC 4.26, Hb 13.4 and Platelets 85 on admission Iron study consistent with iron deficiency B12/Folate wnl Start daily PO iron supplement Follow-up with PCP  A-Fib Currently asymptomatic  Continue home Coumadin, pharmacy to dose while in hospital.  INR 1.9 this morning   Hypothyroidism Pt on Synthroid at home TSH 0.04, T4 wnl Continue home meds.  Follow-up with PCP
Nausea and fatigue morning after injection, resolved by midday. Local arm swelling, pain, warmth at injection site.
chills; slight fever; flu like symptoms; minor headache; slight aching limbs; mild fatigue; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: el3247), via an unspecified route of administration on 15Feb2021 11:45 at a single dose on left arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food or other products. Concomitant medication included fluticasone propionate (FLOVENT). The patient previously received first dose of BNT162B2 on 26Jan2021 for COVID-19 immunization (lot number: el3247, administration time: 11:00 AM, vaccine location: left arm, dose number: 1). The patient did not receive any other vaccine within 4 weeks prior to COVID vaccine. On 15Feb2021 23:00, the patient experienced chills, slight fever, slight aching limbs, minor headache (would describe as flu like symptoms) occurred 10 hours post injection with mild fatigue during course of following day. The events were reported as non-serious. No treatment was received for the adverse events. The patient was recovering from the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
Received HepA, HIB,and Prevnar vaccine at 12 month checkup on 2/27/07-exam done by Dr. Child had no ill symptoms at the time of visit. Parent took child to Hospital that night due to blotchy hive-like reaction-was advised to give Benadryl q4-6h as needed for hives. No new foods or environmental items. HepA was the only vaccine that child had not received before. On 3/1/07, child was seen in our office by Dr. for follow up. Child presented with blanching eryth plaques over face/trunk and extremities,no target lesions per MD documentation. Mother reported mild nasal stuffiness and fever less than 100 for 2 days. Assessment-urticaria-possibly secondary to vaccines vs possible viral illness given recent cold symptoms. Advised to continue Benadryl q6h PRN and to call if ras not better in 2-3 days. On 3/1/07 child sen again in same ER due to worsening of rash- diagnosis the same-Rx given for Orapred for 6 days.
Weakness, swollen lymph node in between collar bone, swelling at injection site, nerve pain in arms.
COULD NOT LIFT HIS ARM OVER HIS HEAD; BODY WAS DETERIORATING; FIDGETY; PAIN AT INJECTION SITE; PAIN WAS WAKING HIM UP; SEVERE MUSCLE SPASMS; NECK PAIN; SHOULDER PAIN/PAIN IN ELBOW; PAIN IN ARM; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid problem, non alcoholic, and smoker. The patient does not have any allergies. The patient does not have medical history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: Unknown) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included levothyroxine sodium for thyroid. On 27-MAY-2021, the subject experienced severe muscle spasms. On 27-MAY-2021, the subject experienced neck pain. On 27-MAY-2021, the subject experienced shoulder pain/pain in elbow. On 27-MAY-2021, the subject experienced pain in arm. On 01-JUN-2021, the subject experienced pain was waking him up. On an unspecified date, the subject experienced fidgety, could not lift his arm over his head, body was deteriorating, and pain at injection site. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain was waking him up, pain at injection site, fidgety, severe muscle spasms, neck pain, shoulder pain/pain in elbow, and pain in arm, and the outcome of could not lift his arm over his head and body was deteriorating was not reported. This report was non-serious.
Fever, shortness of breath, pancytopenia, shock, AKI, Acute Respiratory Failure, abnormal liver function tests thought to be profound immune response to the vaccine booster.  I was hospitalized for five days.
Patient has had two strokes and she believes that the vaccine is the cause. Patient said she was health with no problems before receiving the vaccine.
Ongoing chills, nausea, diarrhea, fatigue and malaise. On the 7th day after the vaccine was administered, the patient also developed injection site erythema, swelling and tenderness; left supraclavicular and left axillary lymphadenopathy  outcome pending