chrisvoncsefalvay/vaers-outcomes huggingface dataset:
funny feeling; fell asleep could not get up from the sofa.; ittle bit of nausea; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (funny feeling), SOMNOLENCE (fell asleep could not get up from the sofa.) and NAUSEA (ittle bit of nausea) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012HZ113) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and NAUSEA (ittle bit of nausea). On an unknown date, the patient experienced FEELING ABNORMAL (funny feeling) and SOMNOLENCE (fell asleep could not get up from the sofa.). The patient was treated with ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) for Nausea, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (funny feeling), SOMNOLENCE (fell asleep could not get up from the sofa.) and NAUSEA (ittle bit of nausea) outcome was unknown.            No concomitant medication was provided.
Patient left office after getting 4 vaccines. She was standing at window to make another appt. She asked for water then had a syncopal episode with ? of seizure activity. Very pale, weakness. Pt laid in waiting room. Pulse 56, BP 116/38. Was given apple juice & crackers. She had only eaten chocolate and water for breakfast. Moved to exam room. She was monitored for about 30 minutes. Rechecked by MD then left feeling fine.
Numb Hands, discolored, cold; Irregular Heart Rhythm; Can not sleep; Headache; High Blood Pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numb Hands, discolored, cold), BLOOD PRESSURE INCREASED (High Blood Pressure), HEART RATE ABNORMAL (Irregular Heart Rhythm), INSOMNIA (Can not sleep) and HEADACHE (Headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M2oA) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (High Blood Pressure). On 11-Mar-2021, the patient experienced HYPOAESTHESIA (Numb Hands, discolored, cold), HEART RATE ABNORMAL (Irregular Heart Rhythm), INSOMNIA (Can not sleep) and HEADACHE (Headache). At the time of the report, HYPOAESTHESIA (Numb Hands, discolored, cold), BLOOD PRESSURE INCREASED (High Blood Pressure), HEART RATE ABNORMAL (Irregular Heart Rhythm), INSOMNIA (Can not sleep) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included Baby Aspirin.
sore, stiff shoulder; sore, stiff shoulder; chills; fever; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient (also reported as 50 months) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) as a first dose, single on 16Mar2021 at 11:00 Am in the right arm for COVID-19 immunization at a workplace clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Medical history was not reported. Concomitant medication includes atorvastatin (LIPITOR) and lisinopril within 2 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021 23:00, the patient experienced sore, stiff shoulder and 12 hours after vaccine fever and chills lasting 6 hours. No treatment received for the adverse event. Outcome of the events fever and chills was reported as recovered on 17-MAR-2021 05:00, outcome of events sore, stiff shoulder was recovered on an unspecified in Mar2021.   No follow-up attempts are possible; no further information is expected.
Broke up all over body / Has at this moment one in her eye, arm and one on her back; nausea; felt bummed; Feverish; weak; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received the 1st dose of Shingrix. On 8th October 2019, less than a day after receiving Shingrix, the patient experienced nausea, emotional distress, fever, weakness and blister. On an unknown date, the outcome of the nausea and weakness were recovered/resolved and the outcome of the emotional distress and fever were resolved with sequelae and the outcome of the blister was recovering/resolving.   It was unknown if the reporter considered the nausea, emotional distress, fever, weakness and blister to be related to Shingrix.  Additional details were provided as follows: The patient stated that after vaccination had nausea, felt bummed, feverish, weak. The patient also broke up all over her body and that has not gone away. The patient usually gets one single red pop that turns into a water blister and then it goes away. At the time of reporting patient had one in her eye, arm and one on her back. The patient said it was not a lot of them but they show up randomly at different places since she got the vaccine. The patient consented to follow up.
pain right arm , at injection site.  large, warm,  circular erythematous lesion slightly raised, moderate erythema. tender to touch and unable to raise arm. tx: advised warm compresses 4 times a day, hot water shower massage once a day.  expect to ressolve within a weeks time.  dx cellulitis of deltoid region
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  The vaccine was administered after 7 days of first puncture.  The Moderna vaccine was used as though it had preservative, just like flu multi-dose vials.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains no significant information.
This spontaneous report was received from a medical assistant refers to an unspecified patients of unknown age. On an unknown date from 28-JUL-2016 to 03-OCT-2016, the patients were vaccinated with improperly stored VAQTA for 66 hours, previous excursion 10 centigrade for 10 hours, Time 0.89 centigrade. No adverse effects were reported. This is one of the several cases reported from the same reporter. Additional information has been requested.
Patient states night of receiving vaccination and night after that he was hallucinating and shaking. Patient states he did not have a fever. Recommended patient visit urgent care or emergency department
Sudden onset: dizziness, lightheaded, sweating, shortness of breath, chest pain, shaking. Acute symptoms lasted about one hour. After that I felt extreme fatigue and slept a lot for the next 4 days.
INTENSE MENSTRUATION WITH BLOOD CLOTS; A LOT OF HEADACHES; BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-SEP-2021, the patient experienced body aches. On 10-SEP-2021, the patient experienced a lot of headaches. On 11-SEP-2021, the patient experienced intense menstruation with blood clots. The action taken with covid-19 vaccine was not applicable. The outcome of the a lot of headaches, body aches and intense menstruation with blood clots was not reported. This report was non-serious.
Patient started to complain of itching on the back and right arm. I checked her and noticed she has hives developing on the back and on right arm below the vaccine site.  Benadryl 10 ml PO was ordered. Patient received it and symptoms resolved around 30 min after.  Before leaving the clinic, patient was stable, itching resolved, only mild erythema below vaccine site on right arm. Rash on the back completely disappeared.
Client vaccinated for Covid with Pfizer vaccines on May 26 and June 19, 2021.  Symptoms started on 12/12/2021 - chills, fever 101.2 x 2 days, sore throat.  Probable source is school.
No adverse event; first dose of the Moderna covid19 vaccine on 1March2021 the lot number 025A21a, second dose 8Apr2021 with lot number 038A21A; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna covid19 vaccine on 1March2021 the lot number 025A21a, second dose 8Apr2021 with lot number 038A21A) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 025A21a) for COVID-19 prophylaxis.     Patient had no allergy to food and other products It was unknown if the patient ever had COVID-19 test or diagnosis.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna covid19 vaccine on 1March2021 the lot number 025A21a, second dose 8Apr2021 with lot number 038A21A). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna covid19 vaccine on 1March2021 the lot number 025A21a, second dose 8Apr2021 with lot number 038A21A) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of the Moderna covid19 vaccine on 1March2021 the lot number 025A21a, second dose 8Apr2021 with lot number 038A21A).    No concomitant medications were reported. No treatment medications were reported. It was reported patient has not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine   This case was linked to MOD-2022-633828 (Patient Link).
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date between 15-JUN-2017 and 06-JUL-2017, the patients received unspecified doses of PNEUMOVAX 23 (lot# N005096, expiration date: 22-OCT-2018 and lot# N004564, expiration date: 22-OCT-2018) (dose, frequency and route of administration were unspecified) for prophylaxis, in immunization series that were improperly stored. No adverse events were reported. It was stated that the vaccines were exposed to a temperature of 1 Celsius degree for a time frame of 65 hours and 5 minutes. There were no previous temperature excursions and a digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA003300: US-009507513-1707USA003301: US-009507513-1707USA003302: US-009507513-1707USA003303: US-009507513-1707USA003298: US-009507513-1707USA003299.
chills; nausea; joint pain; diarrhea; dizziness several times; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DIZZINESS (dizziness several times), MYALGIA (body aches), CHILLS (chills) and NAUSEA (nausea) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke since 1999 and Shoulder replacement (had shoulder replacement 4 years ago). Concurrent medical conditions included COVID-19 since 29-Dec-2020, Pneumonia since 29-Dec-2020, Arthritis and COPD. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), Metropolol, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (PROAIR BRONQUIAL), BUDESONIDE, Nebulizer, ARFORMOTEROL TARTRATE (BROVANA) and Vitamin D once a week for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (dizziness several times), MYALGIA (body aches), NAUSEA (nausea) and ARTHRALGIA (joint pain). On 30-Mar-2021, the patient experienced CHILLS (chills). At the time of the report, DIARRHOEA (diarrhea), DIZZINESS (dizziness several times), MYALGIA (body aches), CHILLS (chills), NAUSEA (nausea) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive she went to Emergency room with a bad cough was tested positive for Covid19, she remained in the hospital for 6 more days, and was released on 17JAN2021..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       she had a heart test done,gall bladder surgery,she had an infusion on the 31DEC2020.
CHICKENPOX LESIONS APPEARED A FEW DAYS AFTER VARICELLA VACCINE WAS GIVEN.  PT DID NOT PRESENT TO MEDICAL UNTIL LESIONS HAD RESOLVED.
Significant, life threatening drop of platelets in ITP patient despite months of stability on Promacta.     Covid Shot on 1/6/21. Platelets dropped to 11, 000,  on 1/13/21. Bruising noted. Doubled her dose of Promacta to 50 mg as per Dr.  1/19 - platelets down to 5,000.  Increased dose of Promacta to 75mg.  1/21 platelets trending up to 24,000.   Will continue on 75 MG on Promacta as per doctors orders but this has caused liver function issues and liver sickness at these high doses in 2021.
After 1 hour of light housework she walked approximately 200 yards to her daughter?s house to retrieve her dog. She bent over a couple times to pick up the dog then she became dizzy and passed out and fell to the ground.  This has never happened before taking this shot.
Patient was given half of the vaccine. The powder vile (MenA) was diluted with Sterile Water vs the diluent provided in the box.  nurse on call contacted and advise received from RN. No patient harm noted. But patient does need to be revaccinated with no timeframe between the two shots required. Patient and parent contacted and explained situation. Parent verbalized understanding and scheduled to return to the clinic to have vaccine given again per recommendation of helpdesk on call RN. Patient is stable with no concerns at this time.
Patient started experiencing signs and symptoms of an anaphylactic reaction and received an Epi-Pen.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 14-JUL-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) (dose strength, route unspecified) lot # L006388, expiration date 25-AUG-2016. No symptoms reported. The outcome of events reported is unknown. No product quality complaint was involved. This case is linked to the case 1507USA007770 via same reporter link. Additional information has been requested.
pt recvd vax 21MAR95 & approx 4 hrs later, fainter for approx 3-4mins;pt was disoriented & was sleeping more than usual throughout day;seen by MD exam results unk;22MAR pt fainted again @ 15 sec;very pale, disoriented & sleepy
Patient vaccinated x2 (8/13/21, 4/12/22) Patient admitted to hospital (9/26/22) and tested COVID+ (10/12/22)
Client reported erythema from vaccine site up her neck as well as feeling of flush and tingling around mouth 20 minutes following the vaccine. She took 25 mg of Benadryl and symptoms resolved within 30 minutes.
Headache, Arthralgia,  Fatigue, chills, injection site pain and swelling.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Patient reports burning/shooting pain in left upper arm radiating down to hand. Associated with some numbness. It is aggravated by driving/grasping/gripping. Some relief with Ibuprofen but has not improved signficantly over past 2 months.
Pt developed urticaria - extensive coverage of body/extr's /face - within 24 hrs of vaccine.
On 10/3/08 mother called RE: VARIVAX immunization had local swelling, redness, itchiness "hard" but has gone down and improved. Mother wished note to be made of medicines
Patient was given a Prevnar 13 vaccination on 6/28/21 that expired on 5/31/21. This Medical Assistant called the Department of Health and was advised that the vaccine was invalid and patient needed to be revaccinated.   Patient was informed and came back to the office to receive Prevnar 13 that expires in 3/31/23.
Received HPV #2 7/21/09. This vaccine expired on 6/29/09. Parents contacted. Pt will receive an additional HPV vaccine 4 months after she receives her HPV# 3 to insure efficiency.
pt recvd vax; 3" hives at site, then progressed to gen hives;most resolved by 22aug94;
This spontaneous report as received from a pharmacist refers to a 77 year old female patient without drug allergies. On 02-JAN-2014 the patient was vaccinated with 0.5ml PNEUMOVAX23 (lot# H013399, expiration date 07-MAR-2014) injections, subcutaneous in the right arm. There was no concomitant therapy. On 03-JAN-2014 or 01-JAN-2014, approximately one to two days post vaccination with PNEUMOVAX23, patient developed itching, hives and hoarseness. The patient informed their unspecified physician of the adverse reactions by calling and the physician suggested that the patient use Benadryl and inform the pharmacist. The pharmacist reported that the patient was "doing better"; however, it was unspecified if the patient was completely recovered. Additional information has been requested.
itching bad, red, enlarged, sore @ site of inj;never did this before, going up arm-took 2 DPH;
Received 7/31/09- R. arm hives that spread to back and around down legs. Sat and Sunday felt nauseous and feverish. No documented fever. Monday fine rash on face and chest. And still some achiness.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Known allergies were reported as no. It was reported that the patient received Paxlovid from 08Jun2022 to 12Jun2022 as COVID-19 treatment. The patient had Diarrhea, metallic taste in mouth about an hour after taking the pills (Paxlovid), lasting several hours.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe body aches, with the pain especially concentrated in the joints (knees, neck, back, and shoulders). Very tired and fatigued, slept for almost 24 hours straight. Fever for about 8 hours with sweating. Weak and dizzy. Vaccine was administered in the right deltoid. Glands swollen under the right shoulder in the armpit; it hurt to lift the right arm or move the right arm. I treated this by sleeping, drinking fluids, staying in bed for 48 hours, applying ice to sore and stiff joints and eventually taking 650mg of Tylenol. I considered going to the emergency room or an urgent care center but was too exhausted and confused to make a trip to the emergency room or urgent care center, and I was concerned about the financial burden of going to see a doctor at the ER or urgent care. I have to have the final dose of the Rabavert vaccine on 7/15/2016 and I am afraid of having the same reaction.
Case number PHHY2011US29939 is an initial spontaneous report received from a nurse on 04 Apr 2011 with a follow up received from a nurse on 26 Apr 2011. This report refers to an 11 year old female patient. She was given only the CYW-135 liquid component of MENVEO vaccine (batch number 090901) intramuscularly) on 30 Mar 2011. NO other adverse reaction was reported. It was reported that the immunization would be repeated in two years. Follow up received on 26 Apr 2011: Updated information about patient demographics, batch number and dosage of the vaccine was provided.
Nausea, vomiting, fever(100 degrees), muscle & joint aches, stiff joints
Pt to ED 7/25 with cc of bilateral leg swelling x2 week and trouble walking. Pt COVID+ 7/25, a&o x4, non-ambulatory. 7/26 Patient is A&Ox4, 3 liters of O2. 7/26 Pt underwent procedure on infected necrotic right gluteal ulcer. 7/27 2L nasal cannula maintained, will start remdesivir and Decadron for COVID. 7/28 Pt oriented x4, denies any pain or sob, 3L nasal cannula maintained, no distress noted. 7/29 pt denies pain, mild SOB with exertion. 7/30 Pt remains A&Ox4, but experiencing generalized weakness. 7/31 pt is A&Ox4, but remains generally weak. 8/1-2 pt is A&Ox4, showing no s/s of distress, no SOB. 8/3 pt is A&O x 4, on bedrest, with no signs of distress noted. 8/4 Patient is A&ox4, vss. 8/5 pt discharged.
Rash & itchy x 24 hrs. Denied SOB but increase of phlegm. BENADRYL 2-25 mg tabs at 1700 PM & 8 hrs later 25mg at 0100 AM.
apparent SIDS, child found dead in crib, baby had nasal congestion for 2 days prior to death