chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 51 year old female patient. On 05-NOV-2013 the patient was vaccinated with ZOSTAVAX lot # J010447, exp. date: 22-APR-2014, single dose, subcutaneous (site, strength not reported). On 05-NOV-2013 the patient experienced a lump, about two inches wide and was sore, after receiving ZOSTAVAX. The patient only called pharmacist, no treatment was given for adverse event. The outcome of events was not reported. The relatedness between ZOSTAVAX and events was not reported. Additional information has been requested.
Patient presented signs of dizziness and weakness and trouble talking about 4 or 5 minutes after received vaccine. The pharmacist applied a cold compress to patient's neck and called 911.  Patient showed signs of improvement but stated she was diabetic and had not eaten all day.  The pharmacist gave her a Coke which improved her symptoms.  She was much better by the time EMS arrived. They checked her blood sugar which was normal but blood pressure was elevated. Patient stated that was not normal and was advised to follow up with her physician to monitor blood pressure in the future.
Fever (102.6F), chills, nausea, headache, whole body muscle ache, joint ache, and fatigue: treated with acetaminophen, symptoms dissipated in 24 hours Cold sore (herpes simplex): no treatment administered, symptom start on day 3 of vaccine administration (48 hours post injection). Symptom is still ongoing at the time of reporting (58 hours post injection)
left arm pain and skin rash, bodyaches, fever 101.5 F, tongue numbness, tongue and throat swelling, mild shortness of breath.  Treated with oral prednisone QD for 5 days and PO benadryl daily Symptoms appeared within 12 hours of receiving the shot, i.e. on 10/1 (but not within the first 4-6 hours), intensified after 24 hours (on 10/2) and resolved after starting on oral prednisone (by 10/4).
Complete Facial Edema - entire face, eyes, lips, Complete.  Lasting approx 10 days.  Occured after March 13, 2021 for approx 5 months, starting in March approx 4x, continuing for next 5 months about 2-3x per month.  Extensive allergy tests administered.  Saw 2 allergists,, 3 dermatologist and only diagnosis was probability from Covid vaccine.  Per allergist took allergy pills daily & facial creams including prescription and yet no relief.
Itchy rash (Moderna arm/ Covid arm) on vaccinated arm 1 week post vaccination.
Evening after shot,left arm swollen from shoulder to wrist, warm to touch, exctremely red.
Can?t catch my breath- dizziness- vertigo-shaking-sweating-loss of Appetite-heart arrhythmias- vision issues- foul taste in mouth- foul smelling sweat - nausea - diarrhea-  Feeling like I?m going to pass out - muscle aches and spasms  Overall weakness
7cm are of erytema, warmth, mild itching around injection site at left deltoid 48 hours after injection.
I95.9 HYPOTENSION 3/22/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/22/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Narrative:  Patient received 2-dose Moderna COVID-19 vaccine series at facility 1/25/21 and 2/19/21. Patient received third Moderna COVID-19 vaccine dose at facility 9/8/21. Review of state vaccine registry (after administration of third dose) showed patient received 2 doses of Pfizer COVID-19 vaccine at an outside pharmacy (5/3/21 and 5/21/21) and 1 dose of Janssen COVID-19 vaccine at a different outside pharmacy (5/4/21). Unknown if this was intended by patient and if patient experienced any adverse reactions to vaccines.
very painful; spread down to elbow; itching at the injection site; red at the injection site; couldn't get out of bed; very bad reaction; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (couldn't get out of bed), ADVERSE EVENT (very bad reaction), PAIN (very painful), ERYTHEMA (spread down to elbow) and INJECTION SITE PRURITUS (itching at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 05-Mar-2021, the patient experienced MALAISE (couldn't get out of bed) and ADVERSE EVENT (very bad reaction). On an unknown date, the patient experienced PAIN (very painful), ERYTHEMA (spread down to elbow), INJECTION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, MALAISE (couldn't get out of bed) and ADVERSE EVENT (very bad reaction) had resolved. At the time of the report, PAIN (very painful), ERYTHEMA (spread down to elbow), INJECTION SITE PRURITUS (itching at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) outcome was unknown.            Reporter did not allow further contact
Initial report received from a healthcare professional on 19 September 2012. Two patients of unspecified demographics, whose concomitant medications and medical history was not reported, has received second dose of FLUZONE HD vaccine (Lot number: UH489AC or UH457AA, route, anatomical site of vaccination were not reported) on unspecified date last year. The two patient's had unspecified reactions and refused to go for next dose of FLUZONE HIGH DOSE. It was reported that no more description was available. The outcome of the events and corrective treatment was not reported. List of documents held by the sender none.
Administered Vaxelis to an 11-year-old patient; This non-serious spontaneous safety report, with GPV Case Number: 2023SA204243, was received by partner, on 26-JUN-2023 and forwarded to company on 05-JUL-2023 from other health professional.  The causal relationship between Vaxelis and the reported event "Administered Vaxelis to an 11-year-old patient" was assessed as not applicable due to the nature of the event.  Further information is expected.  FOLLOW UP INFORMATION WAS RECEIVED ON 20-JUL-2023, directly sent to company by a certified medical assistant.  The causal relationship between Vaxelis and the reported event "Administered Vaxelis to an 11-year-old patient" was assessed as not applicable due to the nature of the event.  The date of first dose of Vaxelis was provided on 21-Jun-23, batch number# U7535AA and route as intramuscular.  Medical history of autism spectrum disorder and generalized anxiety disorder was provided.  The reason for the event administered Vaxelis to an 11-year old was provided as wrong vaccine was given.  No further information is expected.
1st shot on 22APR2021 and  got his 2nd shot on 1JUN2021, / Got 2nd shot after more than 35 days of interval; Pain; Sick for one day; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st shot on 22APR2021 and  got his 2nd shot on 1JUN2021, / Got 2nd shot after more than 35 days of interval), PAIN (Pain) and ILLNESS (Sick for one day) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st shot on 22APR2021 and  got his 2nd shot on 1JUN2021, / Got 2nd shot after more than 35 days of interval), PAIN (Pain) and ILLNESS (Sick for one day). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st shot on 22APR2021 and  got his 2nd shot on 1JUN2021, / Got 2nd shot after more than 35 days of interval), PAIN (Pain) and ILLNESS (Sick for one day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt stated she felt hot, flushed rash and itching to arms, chest, torso, and face. Also a headache to left side of head only. No respiratory distress.
wrong dose of Pfizer vaccine given (0.5ml instead of 0.3ml). Phone call to parent at 3pm. Text sent this morning to parent-only complaint is a sore arm.
Information has been received from an educator concerning a 7th to 9th grade female student, who "within the last 12 months" was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL. The patient may have been vaccinated in combination with other vaccines that was needed to go back into middle school. "Within the last 12 months", when vaccinated, the patient fully fainted. Subsequently, the patient had recovered at the time of vaccination. The reporter did not know if the patient experienced the adverse event with their 1st, 2nd or 3rd dose. The patient sought unspecified medical attention. This is one of several cases from the same source. Additional information has been requested.
Delayed hives reaction 9 days following injection; hives cover entire body with itchy blitches
small bruise at the vaccination site; developed into a red spot; hot to the touch; small bruise at the vaccination site; developed into a red spot; hot to the touch; small bruise at the vaccination site; developed into a red spot; hot to the touch; I got nervous; something wrong with me; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program.  A female patient of an unspecified age received a BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 13May2021 as dose number unknown, single for COVID-19 immunisation. The medical history and concomitant medication was not reported. On an unknown date the patient experienced small bruise at the vaccination site; developed into a red spot; hot to the touch and she got nervous. She told that she got the vaccine 2 weeks ago the COVID vaccine she felt a small bruise at the vaccination site, small bruise then after a while she noticed she it developed into a red spot, she said it was hot to the touch. . she just noticed that she wanted to go for shower and got nervous and thought something wrong with her. The outcome of the event was unknown.   Information on the lot/batch number has been requested.  Follow-up (26Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts had been completed and no further information is expected.
The next day after receiving the vaccine I started to get chills. I developed mouth sores all over my tongue, and soft palate. I also had blisters that were all over my lips. I went to see my Doctor on 4/16/22 they prescribed me acyclovir and oral topical lidocaine to help treat the blisters and sores. The sores lasted for about a week.
Vomiting, headache, body aches, general weakness, fatigue, increased heart rate, chills, redness/swelling at injection site.
On October 4th after the 2nd shot, my daughter experienced a sever allergy attack from possibly chocolate. She has never had an allergy before. It  happened again on October 8th. We have now restricted her from having chocolate and we scheduled a doctors appointment for Friday to discuss with our pediatrician.
pt recvd 3 doses of Engerix-B as routine vax; MAY92 not titers detected;
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 6:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 6:55 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19-Nov-2021, when the Moderna COVID 19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer or refrigerator, otherwise it was maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported.   This case was linked to MOD-2021-402935 (Patient Link).
Arm swelling, lymph node swelling on the side of the injection site, headaches, fatigue, aching joints
This case was reported by a pharmacist via call center representative and described the occurrence of agitation in a 77-year-old male patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020). The patient's past medical history included dementia. Concomitant products included citalopram. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced agitation and behavior abnormal. On an unknown date, the outcome of the agitation and behavior abnormal were recovering/resolving. It was unknown if the reporter considered the agitation and behavior abnormal to be related to SHINGRIX. Additional details were provided as follows: The patient's wife called to the pharmacy and reported to healthcare professional (HCP) that, the patient experienced increased agitation and his behavior being different for the 24 hours following administration. The patient became more agitated than normal. The patient was up and down all night out of bed, to the bathroom. They spoke with his primary care physician who told him to discontinue the citalopram that he recently started. The primary case physician taught, this might have been the cause. The reporter was unsure if this was vaccine or citalopram related, or both. The reporter was unsure the level of cognitive function the patient had at baseline. The common adverse events were discussed with the reporter and stated that gastrointestinal (GI) complaints might had caused him to get up repeatedly. However no such complaints were verbally stated.
VIAL PUNCTURED ON 19-AUG-2021 AT 4:35 PM AND ADMINISTERED ON 20-AUG-2021 AT 2:30 PM; This spontaneous report received from a pharmacist concerned a 33 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 20-AUG-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 20-AUG-2021, the patient experienced vial punctured on 19-aug-2021 at 4:35 pm and administered on 20-aug-2021 at 2:30 pm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vial punctured on 19-aug-2021 at 4:35 pm and administered on 20-aug-2021 at 2:30 pm was not reported. This report was non-serious.
delayed reaction itchy left arm; delayed reaction warmth; delayed reaction red area, area is 3 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (delayed reaction itchy left arm), VACCINATION SITE WARMTH (delayed reaction warmth) and VACCINATION SITE ERYTHEMA (delayed reaction red area, area is 3 inches in diameter) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (delayed reaction itchy left arm), VACCINATION SITE WARMTH (delayed reaction warmth) and VACCINATION SITE ERYTHEMA (delayed reaction red area, area is 3 inches in diameter). At the time of the report, VACCINATION SITE PRURITUS (delayed reaction itchy left arm), VACCINATION SITE WARMTH (delayed reaction warmth) and VACCINATION SITE ERYTHEMA (delayed reaction red area, area is 3 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not reported.
received the first dose of Shingrix in 2018/never received a second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018 on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The case was reported by the patient himself. Till the time of reporting patient did not receive the 2nd dose of Shingrix vaccination, which led to incomplete course of vaccination. The reporter did not consent to follow up. No Lot or Expiration date was known for 1st dose. Limited information was provided and declined to provide address and did not give permission to be contacted (by phone or mail). The reporter declined to provide HCP information.
Broke out in a rash three days later on my ankles then spread to my upper leg and torso.
Erythematous, swollen, tender, warm, and itchy localized reaction 10 cm diameter around injection site, began within 12 hours of injection.
Began feeling light headed the evening of the vaccine, overnight developed shaking chills, fever of 104 with headache. Took ibuprofen which brought temperature down to 99. Still (on day 2) having some sweats & nausea.
I had a headache and body aches starting at 2 pm the day following my second vaccine. That subsided within 24 hours. 3 days post vaccine I woke up with a headache, low grade fever, and a rash on my face, chest and inner arms. I have had a headache every day since February 10th. I have extreme fatigue, regardless of how much sleep I get. The rash has reappeared several times.
After completing prescribed 15 minute observation period, patient ambulated self to her vehicle, at which time she reported feeling dizzy and "jittery" inside. EMS staff took note of the event and applied heart monitor and BP cuff. Pt HR varying high 90s to 120s. HR decreased with calm breathing and reassurance. HR elevated with stress and upset. Patient observed for another 30 minutes. Patient calm and stable at time of report.
Hives; Warm at the injection site; Itchy at the injection site; Red circle at the injection site, with the shape of a pear; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site, with the shape of a pear) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced URTICARIA (Hives), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site, with the shape of a pear). At the time of the report, URTICARIA (Hives), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Red circle at the injection site, with the shape of a pear) outcome was unknown.            concomitant medication include diabetes medication. no treatment medication reported.   This case was linked to MOD-2021-035951 (Patient Link).
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.
Bleeding gums for hours, pain in his side that seems similar to a kidney stone, headache, lethargy.