chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after initial, expected, deltoid aching pain which lasted for a few days, very mild achiness has persisted.  at approximately 1.5 weeks (17d), I noticed actual weakness when I attempted to lift weights (5#) above my shoulders.  isolated to the left arm, which was the injection site.  Exercising now, daily, with very slow response and increased aching.   despite history of intermittent radiculopathy, there had been no weakness prior to the vaccine. Is this a reported vaccine AE?
Received 2nd Pfizer COVID vaccine in right arm on 3/26/2021.  One month/30 days later/ on 4/26, patient awoke with a right arm rash - warm and red - similar to known "COVID VACCINE ARM" What was different is that she had a large blister in the middle of the large area of redness, pain and warmth. She was seen 4/26/2021 and Cephalexin was started. Follow up 2 days later - pt had improvement of the redness, but a new blisters were forming around the first blister.  I will see her again in follow up in 5 days.  She states she did not apply anything to the right arm after getting the vaccine.
The Moderna vaccine cause an adverse reaction. My heart and blood pressure went up  heart rate 153 blood pressure 156 I was hospitalized for 5 days.
Client attended by onsite EMS.  Client concerned about dizziness after receiving COVID-19 vaccine.  Decided to have bp taken. Pulse/heart rate 107, O2 96%, stated had anxiety.
Patient was feeling lightheaded and dizzy after receiving vaccne, she was taken to the medical observation area, BP  was 138/89, pulse ox 97 and hear rate 63, patient was monitored for a brief period of time and her follow up vital signs were 138/84 HR 67 and pulse oc 97 on room air. patient was release from observation and was taken to the exit via wheelchair
No adverse event; A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml) 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 WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721461 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721461:
Redness, swelling at left upper arm x 1 day itching noted initially. Treatment- compression and antihistimine.
EXCESSIVE URINATION; VOMITING; INCREASED HEART RATE; CHILLS; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight was 134 pounds, and height was 176.78 centimeters. The patient's concurrent conditions included supraventricular tachycardia, high cholesterol, thinning bones, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no no allergies/no history of drug abuse/no past history of similar event/no adverse event after any previous vaccinations/ no history of allergy to vaccine, drug or food/ no history of hospitalization in last 30 days, with cause/no family history of any disease (relevant to vaccination) or allergy. the patient was not pregnant at the time of event. the patient was not currently breastfeeding.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered to the left deltoid, on 07-MAR-2021 16:30 for prophylactic vaccination. The batch number was not provided and has been requested. Concomitant medications included fish oil for heart health, pravastatin for high cholesterol, metoprolol succinate for supraventricular tachycardia, and calcium carbonate/colecalciferol for thinning bones. On 07-MAR-2021, the subject experienced excessive urination. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced increased heart rate. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excessive urination, vomiting, increased heart rate, nausea, and fatigue on 08-MAR-2021, and chills on 07-MAR-2021. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment is not required as per standard procedure as the case is non serious
Trulicity was given but had been doubled as of 5/25/21 and started taking it as of 6/8/2021. This slowed digestion to a near stop. Kidney pain, lack of appetite, constipation, blood in urine. Doctor stopped higher dose and treatment reduced as of 6/19/2021. Dehydration was found at checkup and two bags of saline solution was administered.
Elevated heart rate at rest (125bpm) 24 hours after 2nd dose.; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient (pregnant: unknown) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 22Jan2021 13:45 at single dose in right arm for COVID-19 immunization. The patient's medical history was none, no known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 on 07Jan2021 11:45 in right arm for COVID-19 immunization. Facility type vaccine at Hospital. No other vaccine in four weeks. No other medications in two weeks. On 23Jan2021 13:00, the patient experienced elevated heart rate at rest (125bpm) 24 hours after 2nd dose. No treatment received for the event. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt entered study of HIB safety; Pt recvd 1st vax 09JAN91; On 08FEB91 pt devel OM, & URI; On 14FEB91 pt devel rash & URI cont; 16FEB91 fever; 22FEB91 walk was noted to be unsteady; 26FEB91 refused to walk; Erythematous mac rash, GBS synd;
tired; little fever; chills; This is a spontaneous report from Pfizer-sponsored program via a contactable consumer. A 40-years-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that the patient was tired for the first Pfizer vaccine for a day or day and a half and got up and was fine and felt a little fever and chills. The outcome of the event tired was resolved, while the outcome of other events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Rash started on trunk on 6/3/18, spread to face, neck and arms. Afebrile. Rash is itchy.
Metallic taste in mouth on the way home from pharmacy.  Next day eye running tingling in mouth. Next day tingling in mouth worse. Next day hospital speech slurred, mouth drooped eye not closing.
gotten deathly ill; Initial information received on 29-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media. This case involves a patient (unknown demographics) who got deathly (illness) while the patient received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date (for last two years), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date not reported) via an unknown route at an unknown administration site (for both doses) for prophylactic vaccination.  On an unknown date, the patient got deathly ill (illness) both the times 2 hours following the administration of INFLUENZA VACCINE. The patient did not take any shots afterwards.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on the batch number for this case.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a 33-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Information has been received from a consumer, concerning her friend, a 79 year old male with prostate cancer and no known drug allergies who on 4-SEP-2008 was vaccinated with ZOSTER (therapy route, site unknown) and then around 26-SEP-2008 the patient had tingling down the back of the leg and then a rash developed on his left groin. The patient did not see his regular physician, but he saw a neurologist who diagnosed the patient with the shingles. Concomitant therapy included triptorelin pamoate  (TRELSTAR injection), "CATHADEX". At the time of report, the patient was not recovered. Additional information has been requested.
This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had itching around neck and shoulders and upper back within an hour of immunizations. Gave patient topical Benadryl spray and an Aveeno Bath Soap.
This case was reported by a consumer via pharmacist and lawyer and described the occurrence of unspecified adverse effect of drug or medicament in a female subject of unspecified age who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On an unspecified date, the subject received an unspecified dose of FLUARIX QUADRIVALENT (unknown route and injection site). At an unspecified time after vaccination with FLUARIX QUADRIVALENT, the subject experienced an unspecified adverse effect. At the time of reporting, the outcome of the event was unspecified.
after first vaccination about midnight, I rolled on to right arm and it hurt really bad, next day I took Acetaminophen and I noticed my lip was swollen, it went down 5 hours and yesterday 1/21/2021 flu symptoms started. Experienced fatigue, weird body ached and pains in strange locations pain in top left top of foot, left hip, back and chills and fever 101.9 and cheeks were flushed. woke up this morning  and all aches and pains were gone.
Gave BV Pfizer on 4/21/23, should have been given 5/25/23, two months after MV on 3/25/23.
feeling a bit under the weather; feeling wiped out; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling a bit under the weather) and FATIGUE (feeling wiped out) in a 74-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced FEELING ABNORMAL (feeling a bit under the weather) and FATIGUE (feeling wiped out). In December 2022, FATIGUE (feeling wiped out) had resolved. At the time of the report, FEELING ABNORMAL (feeling a bit under the weather) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: His temperature is 96.8.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Patient explained that he was super fit and had done sports all his life. People won't believe him when he told them he was 74. It was reported that the patient felt wiped out for first few days after the bivalent booster dose.   No treatment drug information was provided.   This case was linked to MOD-2022-691929 (Patient Link).
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:42 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 63.63.  Concomitant products were not provided.  For Lot no : 031A21A on 20-Mar-2021, excursion time was 9 AM and 10 AM and temperature was 34 and 37 respectively, total doses given for the day was 184, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Mar-2021 and was moved to clinic on  20-Mar-2021. 19 vials was sent to clinic. Vaccine BUD date was 08-Apr-2021.  For Lot no : 031A21A  vial was stored on cooler 1 , on 03-Mar-2021, Excursion duration At 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM : 35, 2 PM : 36, 3 PM: 36, 4 PM: 36.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
inappropriate schedule of vaccine; Shivering; fever; numbness and tingling in left nostril; numbness and tingling in left nostril; This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number C7B9P, expiry date 27th February 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shivering, fever, intranasal numbness, tingling and incomplete course of vaccination. On an unknown date, the outcome of the shivering, fever, intranasal numbness and tingling were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shivering, fever, intranasal numbness and tingling to be related to Shingrix.  Additional details were provided as follows: The reporter stated that after receiving 1st dose of Shingrix in the right deltoid, the patient experienced shivering, fever and numbness and tingling in left nostril for 2 weeks. The reporter stated that the patient had delayed getting 2nd dose for fear of having side effects again, which led to incomplete course of vaccination. The batch number reported for Shingrix(C789P) did not exist and was updated to C7B9P, as per sales database. This case has been linked with case US2019140583, reported by the same reporter.
Mother refer patient started with erythematous itchy wheals on face, trunk, and extremities since 11/19/21 morning. No breathing difficulties. No history of prior allergies. At hospital, patient received Benadryl, Solu-medrol, Loratadine, Atarax, Budesonide nebulization. Patient recovered in 3 days and was discharged.
She started itching on 2/18/21 and bumps started on her legs, itching. It then spread to her knees, legs, side, arm and her back. It came and then it went away, then it came back again twice that day.  Each day it would come and go and would leave hives on her body. She took Benadryl and then started having ankle issues, and then a ball formed on the bottom of both feet, which lasted for several hours and went away. She went to the hospital yesterday 2/23/21 and broke out into hives again and then went to the hospital as her PCP did not have an opening. They told her that they had had some report of people breaking out with hives, and told her to not to get hot, keep the house on a cool temperature. He prescribed Prednisone and Pepcid and to continue with the Benadryl and suggested to not to take the 2nd shot. She called the help desk to see if it was okay to take the Prednisone and answered her questions and told her there was no indication that she could not take it. The symptoms still come and go with the hives and itching.
Scleritis/episcleritis several days post second injection with recurrence 3 times total since. Each episode has been less severe.
History of Present Illness     Patient is a 64-year-old male tested positive for COVID-19.  He came into the ER with diarrhea for 3 days.  He has 2 roommates who are also sick.  1 is vaccinated 1 is not.  The patient is fully vaccinated.  Denies any chest pain or shortness of breath.  Denies any nausea vomiting.  Denies any fevers or chills.  Denies any dizziness lightheadedness.  He is a nonsmoker.  He is complaining of weakness, tiredness, and fatigue.  No other active complaints at this time.
After Pfizer biontech COVID-19 vaccine EUA, lymphadenopathy. Underarm of left arm noticeably swollen and tender/sore and is still swollen and sore as of today , 2 weeks later
Dizziness, Headache, Myalgia, Fever, Diarrhea, NauseaVomiting,  4 days fever chills n, d  Narrative:  Other Relevant History:
I developed hives and rashes randomly on my body. Sometimes it looks like paintbrush stokes on my skin. Both types are extremely itchy.; I developed hives and rashes randomly on my body. Sometimes it looks like paintbrush stokes on my skin. Both types are extremely itchy.; I developed hives and rashes randomly on my body. Sometimes it looks like paintbrush stokes on my skin. Both types are extremely itchy.; Rashes; Paintbrush stokes of redness on his skin; The initial case was missing the following minimum criteria [Unidentifiable reporter]. Upon receipt of follow-up information on [27Apr2021], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer or other non-health care professional (patient) via Pfizer-sponsored program Corporate (Pfizer).  A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number-unknown (not specified clearly) via an unspecified route of administration in left arm on 08Feb2021 (at the age of 59 years-old) as dose 2, single for COVID-19 immunization at hospital. The patient medical history was not reported. The patient had no known allergies. The concomitant medications included other medications taken within two weeks was simvastatin (ZOCOR) taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch no: not reported/Lot number- EL1283) via an unspecified route of administration in right arm (reported as right) on 11Jan2021 08:00 am (at the age of 59 years-old) as dose 1, single for COVID-19 immunization. No other vaccine taken within four weeks. Patient had not tested for covid prior vaccination and tested for covid post vaccination. It was reported that a week after his second dose on 17Feb2021, the patient had developed hives and rashes randomly on his body. Sometimes it looks like paintbrush strokes of redness on his skin, these hives/rashes are very itchy. Reported adverse events resulted in Doctor or other healthcare professional office/clinic visit. Both his allergist and dermatologist told him that it was his body reaction to the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test results negative for covid-19 on 13Feb2021 for type of other and on an unspecified date tested for Allergy test with normal results (everything was fine). No treatment received for adverse events. The outcome of all events was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot been obtained. No further information is expected.
L leg L2 dermatome vesiculopapular rash, low grade fever, pain 8/10/06 seen 8/14/06 placed on Acyclovir. 8/2206 resolving rash, its nl now.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VAQTA (Lot # N002921, expiration date 08-APR-2018, dose and route were unknown) for prophylaxis. The temperature excursion was at 47.2 Fahrenheit for 45 minutes. Previous temperature excursion was at 47.8 Fahrenheit for 1 hour and 16 minutes. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA003659: US-009507513-1708USA001211: US-009507513-1708USA003658: