chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upon waking 5.22.21 around 6:30 PM, experienced headache, fatigue, stomach pain, and nausea. On attempt to rise from bed and travel to bathroom many feet away, experienced increasing dizziness. Nausea increased with dizziness, knelt to toilet - brief improvement in dizziness at that time. Stood and stepped into walk-in shower, dizziness disrupted my ability to perceive what I was seeing - everything appeared to be violent motion so I couldn't discern what was immediately in front of me, also extreme nausea. My balance was completely compromised such that I couldn't determine where I was placing my feet. I found a wall with my hand, and stumbled back to the bed. This entire process took about 10 minutes. I found my bed and vision cleared after lying prone for 30 seconds.  I was able to use my phone then to call a family member to help; I was prone for one hour and twenty minutes - fatigued, nauseated, dizzy - while awaiting assistance. I was fatigued and dizzy but recovered after about 6 hours of sleep, hydration, and light eating without medical intervention.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 12/23/20pfizer,Lot#EK9231 2nd dose: 01/12/20,Pfizer,Lot# EL3248 Diagnosed covid positive:07/21/21 Symptoms started:07/21/21 Exposure:Home exposure Symptoms:Fever, cough, SOB, muscle aches,ABD pain,chills, nausea,diarrhea.
red blotchy rash on bilateral arms that started shortly after 30 minutes post injection.   Immediately took 50mg Benadryl at symptom onset and repeated does 4 hours later.
Positive COVID test Narrative:  Patient received 1st dose of COVID vaccine on 2/16/2021. COVID test completed on 3/8/2021 as routine screening prior to dental procedure. Patient denies all symptoms of COVID-19 infection, including fever and cough, since positive test. Patient still intending to receive second dose of vaccine, however second dose will be delayed as patient will still be under quarantine when he was originally scheduled to receive his second dose.
3/12 ED female that has chronic respiratory failure at baseline and uses walker in assisted living had her second vaccine dose on 3/11 and within 24 hours had body aches and fevers.  Patient admitted for IVF and observation by the next day patient reported feeling much better.  No other acute process identified and symptoms felt most likely to the "reactogenic vaccine" patient got for COVID-19.  Patient seen by PT, tolerated PO without symptoms and discharged to home.
she's having a hard time hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Booster (2nd), DOSE 4), administration date: Nov2022, for COVID-19 immunization; Bnt162b2 (Booster (1st), DOSE 3), administration date: Aug2022, for COVID-19 immunization; Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "she's having a hard time hearing".  Additional information: Patient had all the Pfizer vaccinations and boosters in 2022. She would like to know if she needs to take the new booster. She had no side effects with the vaccines. Caller mentioned that she started to take Pfizer vaccines because she is up in years and she's healthy. She has no lasting effects at all from Pfizer vaccines. They are wonderful and happy to take them. She also had 2 boosters in November and Aug2022. She said that they are telling people to go for a 3rd vaccine booster because more stuff was added for the diseases. She is wondering if she needs to go for a new 4th booster. She has not had any booster since 2022. She had one in February. She mentioned that she is worried because half of 2023 has gone and she needs to know if boosters are ready.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251590 same patient, different vaccine dose/event;
Round, red, hard swollen area @ vaccine injection site; warm to the touch; mildly itchy
Round red itchy 2.5 inch spot around injection site and swelling at injection site.
1st shot in Dec 2020, 2nd until Feb 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th December 2020, batch number KG52X, expiry date 28th November 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. 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 patient had received his 1st shot of Shingrix and did not come back to get 2nd dose until the date of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
A spontaneous report was received from a pharmacist concerning a 44-year-old female patient who received COVID-19 vaccine and was administered with 0.3 ml of the vaccine. The patient's medical history was not provided. No concomitant medications were reported. On an undisclosed date, prior to the onset of the events, the patient received their first of two planned doses (Lot number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. While the vaccine was administered, the patient received less than the 0.5 ml dose of the Covid-19 vaccine because the syringe was set to 0.3 ml instead of 0.5 ml. No treatment information was provided. Action taken in response to the events was not provided. The event, administered with 0.3 ml of the vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of accidental under dose.  There were no reported adverse events associated with this case.
It was caused from the Vx/ suspected vaccination failure; It is rare, it; 19 MO received Shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 19-month-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure, shingles and inappropriate age at vaccine administration were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 24-Feb-2023 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that no, the patient had her vaccination and her pediatrician said that it was rare but it was caused from the vaccination. Additional supportive information: The patient received Shingles vaccine at an inappropriate age, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Based upon the pediatrician statement causality was captured as yes.
Patient start sweating on his head, face and hands and a 30 seconds brief loss of consciousness.
Sick; weak; burning sensation all over the body; tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), BURNING SENSATION (burning sensation all over the body), FATIGUE (tired) and ILLNESS (Sick) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced ASTHENIA (weak), BURNING SENSATION (burning sensation all over the body) and FATIGUE (tired). On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ASTHENIA (weak), BURNING SENSATION (burning sensation all over the body), FATIGUE (tired) and ILLNESS (Sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Day of Vaccine 102 fever followed by 100 for 4 days.  On Sunday 3/4 severe hives eyes swollen shut. The hives returned 2 hours post Benadryl on 7 occasions through the next day. Saw allergist on Monday after seeing ped. on Sunday. Allergist believed it was a vaccine reaction. Zyrtec resolved symptoms.
erectile dysfunction; A spontaneous report was received from a consumer reporting on himself, a male of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced erectile dysfunction.  The patient's medical history was not provided. Concomitant medication use was not provided.   On 13Jan 2021, the patient received an unknown dose number of two planned doses of mRNA-1273 ([LOT number, route and location unknown]) for prophylaxis of COVID-19 infection.   On an unspecified date, the patient experienced erectile dysfunction.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the erectile dysfunction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 04-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had two temperature excursions: 16 and 64 hours respectively. The lowest recorded temperatures were 33 (0.555555556 Celsius) and 34 (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
PT with right arm circumferential edema and erythema with deperolent swelling into wrist and hand. Seen in ER 02/08/04. Started on Benadryl and Motrin. Symptoms improved but not 100% resolved as of 02/09/04 @ 09:00.  Pt consulted to Allergy clinic.
Vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The patient had no adverse events.   This case was linked to MOD-2021-395985 (Patient Link).
vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated; Vaccine administered beyond use date or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired) and PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date or expired) and PRODUCT STORAGE ERROR (vaccines are kept frozen in fridge about1-3 days/tend to store 1 to 3 bottles in fridge to thaw out/they would have been in fridge for about week if no one comes to be vaccinated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
After injection of For the Moderna Vaccine, I waited for 30 mins. During the 30 mins, I had one episode of dizziness, then it resolved. My wife drove us home, and I rested for about 2-3 hours, felt fine, and logged in for work during the zoom meeting; I notice my left foot began feeling numb. Then it experienced prickles and pinpricks in the seat of my pants area. Then I felt occasional hard pinpricks randomly over my face, near the eyes' orbital regions ( but the eye activity resolved). I went to bed. I got up in the morning, noticed left foot numbness was more pronounced, accompanied by muscle fasciculations above left knee. I went to work and and experience random pinpricks in my fingers, wrist, and lower leg. It Then began to move to the right leg. Then I experiment morse code like buzzing in the left foot. Skin felt itchy, especially on lower legs. I decided to go to hospital, where I was examined, prescribed prednisone, and released. Mild weakness noted on left calf. Today, the PN-like symptoms started to travel up the legs and began having pinpricks in the abdomen. I notified my PCP an was placed on the schedule to be seen tomorrow at 12pm. Neurology was notified and was placed on the schedule for next Friday.
4x5cm area of erythema at injection site. Treated with Augmentin, Claritan syrup. 07/01/02 site healed.
This spontaneous report was received from a medical assistant regarding unspecified multiple patients with unknown demographics. Information on pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date, unspecified multiple patients were administered improperly stored PNEUMOVAX 23 (lot# L014458 with expiry date: 11-FEB-2017) on multiple unspecified dates. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Tingling/burning tongue, feeling of swelling in lips, about 30 to 40 minutes after injection I waited 15 minutes at hospital, felt fine.   On drive home, the tip of my tongue started to feel tingley.  Then lips.  Instinct told me to use my inhaler (on hand for seasonal use). It helped me to clear my throat, but I did not feel like my throat was closing   Lips subsided within 1.5 to 2 hours.   Tongue finally subsided fully after about 5 hours, but I still feel a slight feeling today, as if I drank too hot of coffee.
C/o left arm pain, redness, swelling surrounding injection site. ROM intact. Ice applied, VSS, no numbness or tingling. Steady gait. Denies weak/dizzy, parents called to pickup student. Recommended pediatrician be notified.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR. Provider d/c note: "97yo with CAD and Diabetes Mellitus presents with generalized weakness and fever. He has been feeling weak for the past week. He was seen in the ER 3/10/23 and tested neg for covid then. He is now positive. No cough, cp or sob. Tolerating diet but appetite down. He currently denies any problems while lying down. His daughter is in room with him. Pt lives with wife and his son and normally very independent. No dementia or cognitive impairment   Pt was started on covid-pathway including remdesivir, decadron.  His energy/appetite improved. Walk test was without any significant hypoxia and he was discharged to Assisted Living".
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 11-JUL-2014 the patient was vaccinated with an expired MMR II (Lot # reported as H012132, Expiration date reported as 25-JUL-2014 (dose and route were unknown). It was reported that this information was supported. No adverse events reported. Additional information has been requested.
Red, oval patch; itchy patch on her left shoulder blade; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-JUN-2023, the patient received the 1st dose of Shingrix (left deltoid). On 16-JUN-2023, 3 days after receiving Shingrix, the patient experienced localized erythema (Verbatim: Red, oval patch) and localized itching (Verbatim: itchy patch on her left shoulder blade). The outcome of the localized erythema and localized itching were not resolved.   It was unknown if the reporter considered the localized erythema and localized itching to be related to Shingrix.   It was unknown if the company considered the localized erythema and localized itching to be related to Shingrix.   Additional Information: GSK Receipt Date:20-JUN-2023 The reporter called to gather informatoin on a suspected adverse event following administration of Shingrix. The patient was complaining of a red, oval, itchy patch on her left shoulder blade, which appeared approximately 4-5 days after her Shingrix shot on the same side of the body.
diagnosed me Pericarditis/ a fever around 38-39 C (101 F)/ a mild chest pain/with a strong chest pain that I couldn't sleep at night at all; I couldn't sleep at night at all; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 18-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 27May2021 13:15 (Batch/Lot Number: EW0167) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 18 years old.  Medical history reported as none. There were no concomitant medications. No known allergies. Historical vaccine included first dose of  BNT162B2 (Product=COVID 19, lot number=EW0179; vaccine location=Right arm) on 06May2021 at 04:15 PM.  The patient experienced diagnosed me pericarditis (medically significant) on 30May2021 with outcome of recovering, a fever around 38-39 c (101 f) on 28May2021 01:00 AM with outcome of recovering, a mild chest pain/with a strong chest pain that i couldn't sleep at night at all on 28May2021 01:00AM  with outcome of recovering, i couldn't sleep at night at all on 29May2021 with outcome of recovering.  The patient underwent lab tests which included body temperature: 101 fahrenheit (38-39 C) on 28May2021 and 29May2021, sars-cov-2 test: negative on 29May2021 (Nasal Swab).  Additional information: "12 hours after 2nd shot I had a fever around 38-39 C (101 F) and a mild chest pain. 24 hours after that I still had the same fever, but with a strong chest pain that I couldn't sleep at night at all. Next day I went to the emergency room and they diagnosed me Pericarditis. I've never had any health problem before, especially heart problem." The events result in: Emergency room/department or urgent care. Treatment received for events included: Colchicine 0.6 mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on Lot/Batch number was available. Additional information has been requested.
Mother reported "welt at site of injection given 10 days ago". Noticed welt when getting up this AM.
Patient was given 0.25mcg Moderna Bivalent Booster which is half dose, was to be given 0.5mcg. Patient was given wrong dosage.
On Jan 14th had sinus congestion wouldn't go away. I had a really strange taste in my mouth, had body aches like when you have the flu. I had brain fog that stayed until yesterday. My vision was not clear. I had no fever, no migraines, and a headache that was treated with two TYLENOL. Everything else was okay functioning. I went in to clinic and they treated it as it was a sinus bug. I then said I wanted a COVID test and it came out to be positive. Follow-up on Wednesday Jan 26th with my PCP virtually, my doctor said everything should be fine and not to worry. Due to my weakened immune system I am dealing with bronchitis; my doctor thinks it may be due to the residual of COVID. I take albuterol for SOB.
Narrative:  80yo male patient who was receiving home health through facility community care patient died on 1/14/2022. Cause and location of death unknown. had received covid vaccines on dose #1 at facility on 1/15/21 and dose #2 at HD on 2/26/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration. See patient's facility problem list below: PROBLEM LAST MOD PROVIDER Hypothyroidism (SCT 40930008) (ICD-10-CM E03.9) 07/14/2021 Edema (SCT 267038008) ICD-10-CM R60.9) 04/12/2021 Urinary incontinence (SCT 165232002) (ICD-10-CM 06/09/2020 R32.) Polyneuropathy (SCT 42345000) (ICD-10CM G62.9) 12/13/2019 Spinal stenosis of lumbar region (SCT 18347007) 09/25/2019 (ICD-10-CM M48.062) Benign prostatic hypertrophy with outflow 06/17/2018 obstruction (SCT 236646007) (ICD-10-CM N40.1) Diabetes mellitus (SCT 73211009) (ICD-10-CM 05/18/2017 E11.9) Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.5) 05/18/2017 History of malignant neoplasm of prostate (SCT 05/18/2017 428262008) (ICD-10-CM Z85.46) Allergic rhinitis (SCT 61582004) (ICD-10-CM 05/18/2017 J30.89)