chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Erection wise it is more often than usual; Erection increased, more than it used to do/Caller states it is not a bad side effect.; Caller stated that instead of getting a booster dose he got a full dose, he stated that the booster is; This spontaneous case was reported by a consumer and describes the occurrence of ERECTION INCREASED (Erection wise it is more often than usual), THERAPEUTIC RESPONSE UNEXPECTED (Erection increased, more than it used to do/Caller states it is not a bad side effect.) and ACCIDENTAL OVERDOSE (Caller stated that instead of getting a booster dose he got a full dose, he stated that the booster is) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Oligospermia in 2017.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Caller stated that instead of getting a booster dose he got a full dose, he stated that the booster is). On an unknown date, the patient experienced ERECTION INCREASED (Erection wise it is more often than usual) and THERAPEUTIC RESPONSE UNEXPECTED (Erection increased, more than it used to do/Caller states it is not a bad side effect.). On 17-Aug-2021, ACCIDENTAL OVERDOSE (Caller stated that instead of getting a booster dose he got a full dose, he stated that the booster is) had resolved. At the time of the report, ERECTION INCREASED (Erection wise it is more often than usual) and THERAPEUTIC RESPONSE UNEXPECTED (Erection increased, more than it used to do/Caller states it is not a bad side effect.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2017, Sperm concentration: low (Low) Low. On an unknown date, Semen analysis: high (High) High semen volume. On an unknown date, Sperm concentration: sky high (High) Sky high.         Symptoms: It was reported that the patient had a medical condition with low sperm count since 2017, and he would not be able to conceive a baby, he stated that it was due to bad eating and drinking habits, after third dose of vaccination he experienced high volume in his sperm count as well as semen volume than any other average men at his age, he did nothing on his diet, he was not sure if vaccine had anything to do with this, he stated it was not a bad side effect. He reported that he received a full dose of booster shot instead of half dose.  No concomitant medications were reported  No treatment medications were reported
Tested positive for Covid virus, after being fully vaccinated.; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 37 patients. This report is for 36th patient of 37 patients. This consumer reported for a 72-year-old male patient that:  A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318, Expiration date was not reported), dose 2 via an unspecified route of administration on 06Feb2021 as dose 2, single for covid-19 immunisation. Medical history included renal cancer from an unknown date and ongoing. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EJ1686, On 16Jan2021 for covid-19 immunization. The patient experienced tested positive for covid virus, after being fully vaccinated on 12Aug2021. Agent reports that Caller states 15% of breakthrough cases are from one Pfizer Covid 19 Lot number: EN5318.which was concerning. Covid positive is defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. Description of complaint: Caller reporting on the Pfizer Covid 19 vaccine. Caller reports 37 breakthrough cases, for fully vaccinated patients testing positive for Covid.  Some identifying details provided. Product strength and count size dispensed: not applicable. Additional lot numbers: not applicable. Is a sample of the product available to be returned, if requested (Y/N): No, Packaging sealed and intact: unknown. The patient underwent lab tests and procedures which included body mass index was 29.8, NAAT Covid test was positive on 12Aug2021. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Chills, headache, fever, joint pain, muscle pain, zero energy, lack of appetite.
Pfizer Biv - About 4 hours after injection, I had a 100 degree fever, discomfort across chest including right shoulder (injection arm). The worst thing that happened (and I have never had a reaction to a Covid shot before except for a tender injection site) is intense, knife-stabbing pains (brought tears to my eyes) in my lymph nodes on the right side of my neck under my chin. I survived almost 24 hours of this pain by pressing hard a hot heating pad to my neck. I did not sleep until the next day when the pain eased up. If after 24 hours it didn't stop, I was going to call my doctor.  The only reaction I ever had to an injection was the first Shringix shot. The pain was so severe in that arm for a couple of days that I refused to get the second one. I couldn't move or touch my arm the whole time.
itchy rash at the injection site; red rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash at the injection site) and VACCINATION SITE ERYTHEMA (red rash at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced RASH PRURITIC (itchy rash at the injection site) and VACCINATION SITE ERYTHEMA (red rash at the injection site). In February 2021, RASH PRURITIC (itchy rash at the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red rash at the injection site) outcome was unknown. Not Provided          No concomitant and treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Outcome, duration and stop date of the event 'itchy rash at the injection site' was updated. Action taken was corrected.
Pt recvd 1st dose of Hep B vax & exp muscular aches & pains, t102, rashes, abn liver function tests, & elevated antinuclear antibody & serum sickness;
Myalgia, Arthralgia, fatigue Narrative: reports Roughly 18 hours after my vaccine I became EXTREMELY fatigued, this lasted 8 hours and then resolved
Aching body everywhere, arm hurting from shot, increasing fever, headache, chills, sweats.
Hives and patches of red, swollen, itchy skin on both upper arms, stomach/lower chest/both upper and lower back. Started a few hours after the shot and progressively got worse during the day peaking the morning of day 2. Extremely uncomfortable but felt fine otherwise. Day 3 my symptoms are still here but have gone down a lot, nearly gone.
Pt states (L) arm pain increased after 2 days - her (L) thumb became tingly & numb & arm difficult to move in last 2 days. On 12/7/11 Pt woke up & was unable to move neck, denies fever or rash, advised to go to ER. ER advised hot pack & 800 mg of Ibuprofen. 12-9-11 Pt states tingling & pain in arm gone - slight stiffness in neck, feels much better.
Started with pain in my arms then led to chest pains on the upper left region of my chest.  Pain was extensive for about 48hours and still persist but only mildly.
Within 5 of the shot I collapsed in the car, blood pressure and heart rate dropped so low that the medics on site chose to call an ambulance and transport me to hospital for further tests. My blood sugar test was normal, but my blood pressure remained low. I was given a saline drip at the hospital.
This spontaneous report was received from a registered nurse refers to a 13 month old patient. The patient's medical history and concurrent conditions were not reported. On 29-JUL-2015, the patient was vaccinated with an imporperly stored VARIVAX (Merck) (lot # L001335, exiry date 13-JAN-2017). Concomitant medications were not reported. The outcome was unknown. This is one of the several reports received from the same reporter. Additonal information has been requested.
Very tired after 1st dose; Chills after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired after 1st dose) and CHILLS (Chills after 1st dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 FATIGUE (Very tired after 1st dose) and CHILLS (Chills after 1st dose). At the time of the report, FATIGUE (Very tired after 1st dose) and CHILLS (Chills after 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported.  Treatment information not reported. It was reported patient got second dose on 17-May-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-148126, US-MODERNATX, INC.-MOD-2021-148165 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: NNI.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148126:Mother 1st dose case US-MODERNATX, INC.-MOD-2021-148165:Mother 2nd dose case
Janssen COVID-19 vaccine EUA. Technician administered Janssen Covid-19 vaccine and upon removal of needle patient began to tense up and slide down chair. He began to shake and sweat. Technician asked patient if he was okay and his wife responded "no, he is passing out." The technician then went to get the pharmacist. The patient passed out for 5-10 seconds and then began coming back to. Patient was provided with ice packs and cold water. Pharmacist had the patient lie down with feet elevated until patient felt well enough to stand back up. He was comfortable to leave and divulged that he takes midodrine daily for his vagovasal syncope and has a history of passing out every time he is injected with a vaccine or has a blood draw.
4hr p/vax pt exp fussy/irritable spell x 1 1/2hr then 8hr p/vax floppy & unresponsive;
I had the injection in the left arm Tuesday morning, had the expected arm soreness starting by tuesday afternoon. Wednesday evening I broke out in hives on my right cheek, then starting getting burning/searing pain shooting down my right arm into my hand that has not resolved. I am still getting arm pain on and off daily and it wakes me up at night sometimes. Today I started getting muscle twitching also in the right bicep and tricep muscles on and off.
No AE; Expired Gardasil 9 Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 21-SEP-2021, the patient was vaccinated with a expired dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1614897, expiration date 20-SE-2021; 0.5 milliliter for prophylaxis (strength, vaccination scheme, and administration route were not provided) (expired product administered). No adverse events or product quality complains were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1614897; expirationdate: 20-SEP-2021; deviceage and unit: 0; operatorofdevice: Nurse; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
FATIGUE; INJECTION SITE PAIN (LEFT SIDE); MUSCLE ACHES; HARD TIME MOVING HAND; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyoid, pollen allergy, and zofan allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 23/JUN/2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced hard time moving hand. On 12-APR-2021, the subject experienced injection site pain (left side). On 12-APR-2021, the subject experienced muscle aches. On 13-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain (left side), muscle aches, and fatigue, and the outcome of hard time moving hand was not reported. This report was non-serious.
Small rash looked like several bug bites in somewhat a circle.  Itched and red.  Another spot appeared next day.  After a few days, not getting better and leisons starting to hurt, went to dr and diagnosed as shingles.  Put on Presisone pack and Valtrex for 7 days.  Seven days have passed and the leisons are drying up but have not yet disappeared.
Minor site pain and lump after 4hrs; Minor site pain and lump after 4hrs; This is a spontaneous report from a contactable consumer (patient himself). A 68-year old male patient receive his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on the right arm on 21Feb2021 at 01:45 PM (at the age of 68-year old) at single dose for COVID-19 immunization at Hospital. relevant medical history included osteoarthritis and syncope (have pacemaker). Concomitant medications included atorvastatin. omeprazole and ergocalciferol (VIT D). On 21Feb2021 at 06:00PM the patient experienced minor site pain and lump. They disappeared after 24 hours (outcome recovered).  Information on the lot/batch number has been requested.
A few times since getting vaccine # 2,  I experienced a muscle spasm/wave with sudden onset, over my upper body, travelling up my arms to my shoulders. This time today, I was just standing at my kitchen sink not doing anything, and I felt it start. My arms felt like they could not move, and the spasm was felt uniformly in both upper arms, more on the outer areas, then lodged in both shoulders. My hands felt weak and there was a slight tremor in my right hand. It feels like it lasts for a minute or 90 seconds.   This has occurred 2-3 times. Is this unusual?  First vaccine was 1/20, and 2nd was 2/17.
Patient with complaints of tickling feeling over body, and feeling a little warm. She stated her head felt heavy, then she remembered people talking around her. Patient hit the floor, and hit right side of head, no notable injury.  Patient denies blurred vision, dizziness, nor nausea and vomiting, but states has a slight headache. Patient remained oriented during evaluation period, and was accompanied by her coworker. She stated that she consumed a protein shake this morning before coming to the event.  Patient stated she also had a headache last night  and consumed two Ibuprofen tablets before bed.12:48 pm  vitals- B/P 120/74, HR 54 R 20.  At 1:05pm, patient stated she felt better, and denies nausea, blurred or double vision, vomiting, but remains with slight headache .  This nurse advised that her friend drive home, and patient agreed. Patient transported to car per wheelchair.
Child began having a "staring off seizure". Parent called 911. Child began convulsing and was taken to hospital. Seizure continued on and off for over 1.5 hours. Three medications given before seizing stopped. CT scan and EEG done - everything normal. No sign that seizure was caused by anything else. Shot assumed.
Patient presented with tightness in chest.   HR 70  sinus rhythm BP 171/81 and then 171/89 She refused transport to hospital.
Patient above requested inactivated influenza immunization. Completed VAR, reported not sick today, no allergies, no reaction to previous vaccinations. Developed several hives (3) 30 min. after injection. Felt warm, itching local at hives, redness. No SOB. Pulse 88. Hives on (R) wrist, (L) wrist, (R) upper chest observed for 30 minutes, no change. Suggested to take BENADRYL 25-50mg and repeat 25-50mg q 4-6 hours, patient to evaluate response to dose.
Lump in left deltoid since receiving HPV on 8/30/18 only painful if area is palpated.
Urticaria on chest, eyelid puffiness, upper lip puffiness, no wheeze, tachypnea or desaturation, Rx= Benadryl.
no adverse event; one dose of VARIVAX was given following a temperature excursion; This spontaneous report has been received from an office vaccine coordinator, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medication was not provided.  On 31-MAY-2022, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U039948 with expiration date: 16-DEC-2023, single dose, strength and route were unknown) for prophylaxis (product storage error) and sterile diluent (indication, dose, frequency, strength, route, lot number and expiration date were unknown), both following a temperature excursion. No other adverse event/no product quality complaints (PQC).  Administered dose of varicella virus vaccine live (oka/merck)(VARIVAX) experienced the temperature excursion below 18.7 Fahrenheit degrees (F) for 3 hours 15 minutes 0 seconds. No previous temperature excursions reported.
The night of the vaccination the patient experienced injection site pain and a fever of 101 F. She also experienced rash on different sites on her body. She was seen at clinic on 10/29/2018 and received a prescription to treat the rash.
A physician reported that his 64 year old wife received an injection of Pnu-Imune 23 on 01/24/01. The reporter indicated that this was a booster dose with a previous dose given 5 years ago. Subsequently, she developed a "severe" reaction described as dizziness, head pressure, nausea, and back ache. The patient recovered in 5 minutes. Follow-up info received from the physician on 05/30/01, indicated that the patient also experienced pain of her upper posterior thighs along with the previous reported events within 60 seconds of vaccine administration. All symptoms resolved within 5 minutes with no sequelae.
Headache, Fever, LEFT ARM TINGLING, SWOLLEN, LIMITED RANGE OF MOTION Narrative:
SWEATS, FEVER, BODY ACHES, MENSTRUAL BLEEDING, JOINT PAIN.
Pt reports developing a rash on her right arm that is the size of her palm. The rash is burning and the pt iced it with some relief.  Pt took ibuprofen but it did not help. The pt also reports feeling tired/fatigued. Advised pt to take some Benadryl and visit urgent care if no improvement or worsening of symptoms
Left arm upper outer muscle became extremely sore. in some positions, can't lift my left arm above shoulder level without pain. Some positions don't hurt. Example: CAn't reach out car window to get mail out of mailbox with left arm.  Saw doctor. Was given steroids without any effect. Had EMG that was normal on 01/05/2022. Currently, pain is less, but still present.
pt cried for 12 hrs following administration of DTP vax; (continous, uncontrollable);
Initial flare-up of rheumatoid arthritis in proximal left phalanges, on going.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The nurse reported that an improperly stored VARIVAX (Merck) was administered (0.5 ml, subcutaneously, lot#, expiration date unknown) on an unspecified date. The nurse states that the vaccine reached a temperature of 39.2F for 6 hours. She also stated that there was a "possibility" that VARIVAX (Merck) reached up to 59.4F but she was unsure at the time of report. She reported that she would find out if VARIVAX (Merck) did reach to 59.4F and give the national service center a call back. There was no adverse effect reported. No further information was provided. This report is linked with MARRS# 1405USA001152 and with MARRS# 1405USA002848 via same reporter. Additional information has been requested.
itching  of the skin in the neck area. Lightheaded. Ambulated with staff to the medical area. Given water and Benadryl 50 mg po. Rested lying down for 15 minutes, felt much better and declined to receive further medical care. Husband with her and driving her home.
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 POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (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 29-Oct-2021 at 1:38 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021 at 1:38 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, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (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 medication information was provided. No treatment medication information was provided. Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for one month. The vial was in frozen state at the time of the excursion. The vials moved from freezer to refrigerator on  29-Oct-2021 . The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or 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 excursion issues had happened.   This case was linked to MOD-2021-402935 (Patient Link).
Pt devel SOB w/o audible wheezing & some dizziness & vomiting a few hrs p/MMR;
Received vaccine at 3:40pm. Tiredness started around 7pm. Fever started at 11pm and lasted until morning. Terrible body aches, unable to sleep. Painful. Fever broke around 5am but then returned around 1pm. Finally broke fever around 4pm. Body aches lasted the rest of the day. Overall weakness and tiredness for a week.