chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fainted; weak; tired; itching; trouble breathing; face swelling; unstable vital signs; This is a spontaneous report from a contactable consumer. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 05Apr2021 10:00 as single dose for covid-19 immunisation. Medical history included hypothyroidism, high cholesterol, allergies to penicillin and shell seafood.  here were no concomitant medications.  The patient previously took Percocet [oxycodone hydrochloride;paracetamol] and experienced allergies. The patient experienced fainted, weak, tired, itching, trouble breathing, face swelling and unstable vital signs on 05Apr2021 21:30. The patient was hospitalized. It was unknown if the patient received any treatment. The outcome of the events was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
This is a 57-year-old female with history of epilepsy on lacosamide who just  received her second dose of the Pfizer coronavirus vaccine and she noted onset of  double vision, nausea, light sensitivity, headache that is throbbing in nature.  This is gradual in onset. She reports these symptoms are similar prior to her  seizures. Her last seizure was March when she had coronavirus. She denies any  history of migraines. She otherwise denies any chest pain or dyspnea. No urinary  or bowel complaints otherwise.
Infant developed fever, vomiting and rash 10/30/02 am. He was hospitalized 11/01-11/04/02. Dx. pneumonia.
Child's grandfather was with child;  child had a seizure, shaking allover with a blank stare on face at 1:30 pm on 1/31/2005.  Child's father was home, took child to ER.  Mother was called and was present at hospital.  Blood work was done.  Motrin was given to child. Temperature was 102 degrees F. orally.  Child was released from ER at 5pm that afternoon.  No further seizures.
Patient reports that several hours after receiving her flu shot her right arm at the injection site was sore and had a burning sensation. She took TYLENOL and applied ice. She saw a chiropractor when the pain didn't go away and he massaged it. She continued to have pain in her arm but not as severe. Taking ibuprofen.
COVID infection; COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 41-year-old female patient (not pregnant) received BNT162b2 (Pfizer), on 22Feb2021 at 09:30AM as dose 1, single (Lot number: EL3247), in right arm, on 15Mar2021 at 09:30AM as dose 2, single (Lot number: EL3247), in right arm and on 05Nov2021 at 11:45AM as dose 3 (booster), single (Lot number: FH8030) at the age of 40 years, in right arm, all intramuscular for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Apr2022, outcome "recovered" (2022) and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: Nasal Swab: (19Feb2021) Negative; (15Mar2021) Negative; (29Dec2021) Negative; (19Apr2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient had no Covid prior vaccination. The patient had Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
PAIN IN THE RIGHT FOOT AND STARTED TO GO UPWARD TO THE CALF AND THIGH
Patient was vaccinated prior to trip. Approx 3-4 weeks later, upon return from trip developed pins/needle sensation which progressed to thighs; weakness of legs; unable to ambulate and presented to our facility.
shingles once in between the first and 2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles once before first dose).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.  It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient had shingles 4 times, once in between the 1st and 2nd shot of the vaccine. The follow-up would not possible as no contact details were available. For second dose refer linked case US2021AMR176140, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR176140:Same reporter
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Patient received treatment for COVID-19, Route of administration: Oral.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Psoriasis developed on my forehead, ears, and hair line.  Was worse during the winter.  Used a combination of Pimecrolimis cream and heavy moisturizers. I have not had psoriasis before but I am treated for eczema and atopic dermatitis.
Pt was admitted to the hospital on 09/15/2021 Pt collapsed and presented with upper Respiratory symptons (cough , Nasal drainage.pt tested positive for covid -19 on 09/14/2021. Tx with atorvascatine, apinapherine,and Diphenhydramine. pt still admitted.
This spontaneous report was received from a registered nurse concerning an unknown number of patient of unknown age and gender that were vaccinated with a dose of PNEUMOVAX 23 (dose, dose number, lot number, expiration date and route were not reported), that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of eight (8) reports from tje same reporter. Additional information has been requested.
Information has been received from a 73 year old frail female "resident" who on 02-Nov-2005 was vaccinated in the shoulder joint instead of intramuscular with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P) . On 02-Nov-2005 the patient developed pseudo sepsis arthritis. The patient had material removed from her should by a scope procedure. There was right shoulder swelling, pain, abduction and disability. The patient underwent a "joint tap" which had a white cell count greater than 100,000. The patient was reported as recovering. Pseudo sepsis arthritis was considered to be disabling and other important medical event (OMIC) by the patient. There was no product complaint involved. Additional information has been requested.
positive for covid; positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (non-serious), DRUG INEFFECTIVE (non-serious), outcome "unknown" and all described as "positive for covid". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient chief complaint was rash, that was persistent. She did mention that she had an outbreak of shingles 10 yrs ago.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Vaccine 3/10/2021. Vac. 3/112021. Severe Flu symptoms 3/152021 for both of us. Sinus inflamed, severe and constant headaches, fever & chills, body aches, ear-tooth-jaw severe pain. Tested at pharmacy for Antigen 3/31/21 & 4/1/21 for Covid -Negative results.  We have been sick for a month. Severe pain in ear, teeth, head remain. No chest congestion.  Improving slowly.  It may be vaccine, cold, or flu.
05/10/2021 presents w/ SOB; "Roughly 10 days ago started to not feel well. Went on vacation 5/2 and states she could not do anything because of how sick she felt. Had fever, chills, fatigued, sinus pressure, congestion, headache, nauseous, overtime developed a cough, sob and diarrhea"; PMH HTN, CKD, CLL.; Pt. passed away on 05/19/2021; D/C Dx. "Acute hypoxemic respiratory failure".
Pt presented to MPX site for 2nd dose of Jynneos vaccine.  At 2:55 PM, patient received intradermal injection in his left arm by RN Lot #FDP00015 exp 12/14/2022.  Per Immunization Registry the patient's first dose was on 09/20/2022 (Lot #FDP00014). After waiting 15 minutes in the observation area,  patient reported to registration that he felt dizzy. Registration alerted PHN Lead and PHN Co-Lead. At 3:15 PM, patient is assisted to sit in gravity chair and was handed a bottle of water. Patient states he has Mal de Debarquement, and  frequently feels dizzy. Patient states that his first dose went well, and the dizziness is due to his diagnosis. A first set of vital signs  is taken at 3:18PM: BP: 104/62, O2: 96%, R: 18, and HR: 71bpm. Patient stated that his baseline is normally around 135/80. Patient was encouraged to drink more water at 3:23 PM. At 3:25 PM, a second set of vitals were taken, and BP: 112/70, HR: 65 bpm,R: 17, and O2: 95%. Patient is reclined on the gravity chair and his feet are elevated. Patient finishes water bottle and is handed an additional water bottle by staff. Patient reports at this time that he is not dizzy. Patient stated to PHN that he drove to the site. PHN verbalized that we will need to make sure he is safe to drive, and we want to ensure he is not dizzy before he leaves the site. PHN takes another set of vital signs at 3:29PM: BP: 108/74, R: 17, O2: 97%, and HR 50bpm. Patient stated that his HR is usually in the 50s. Patient denies dizziness, and states he feels he can drive. Patient asked to wait to ensure his safety. At 3:45PM, orthostatic vitals were performed and were negative. Patient denies dizziness laying down, sitting up, and standing up. A last set of vitals were taken at this time: BP : 124/72, HR: 70 bpm, R: 18 and O2: 97%. PHN and other PHN walked with patient to his car. Patient safety ambulated to car and  left site in stable condition.
Patient with 3 Moderna COVID vaccinations admitted after fall with positive COVID test.  Provider d/c note below:  "74 YO female with history of coronary artery disease, hypertension, diabetes presented with complaints of generalized weakness leading to ground level fall.  Found to be COVID 19 positive. She was subsequently admitted for evaluation of weakness in setting of COVID-19 infection.   During her stay, she received fluid resuscitation with her home diuretic held.  She was found to have orthostatic hypotension and acute hyponatremia as well.  She remained well despite having COVID-19 infection.  On day of discharge, patient was in stable condition without complaints.  She was seen by therapist who recommended home with therapy but the patient declined.  She was discharged home in stable condition.  Strict return precautions given.  She was advised to continue to hold home diuretics and to follow-up with primary care physician in a week.   Issues Requiring Follow Up:  Fall, weakness, orthostatic hypotension:  Home Lasix held.  Follow-up with primary care physician Acute COVID-19 infection:  Follow-up with primary care physician"
experiencing gastrointestinal issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  A male patient received BNT162b2 (BNT162B2), in Apr2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "experiencing gastrointestinal issues".  Additional Information: The patient had the covid shots thru this manufacturer and so did her husband in Apr2020. They both started experiencing gastrointestinal issues and at times severe issues. Never had these issues prior. Could this be an alternate side effect of covid shots and booster shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a physician via a field employee concerning an 11 year old female. Medical history and concomitant medications were unknown. On an unspecified date, the female received her first dose of GARDASIL 9. The physician mentioned that the female fainted after the first vaccination. The outcome of the event was not provided. Additional information has been requested.
Patient looses control of it's left side, falls on it's left side and hits their head. Take to the Hospital and is now connected to a mechanical ventilator.
had an active case of Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) (batch number K2397, expiry date unknown) for prophylaxis.   On 1st November 2019, the patient received the 1st dose of Shingrix. In January 2020, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and had an active case of Shingles a couple of days before the day of reporting. The reporter called to inquired how to proceed with 2nd dose of Shingrix. The reporter did not consent to follow up.
The patient called the pharmacy 12-5-16. He stated he is having numbness and tingling in his right arm after receiving a vaccine on 11/29/16. I left a message with his primary care MD and spoke with staff at the ordering physician's office. Staff recommended pt go to ER. I let pt know that.
Pt returned 2 hrs p/inject w/rash on both arms & buttocks given Epinephrine & Decadron given IM, PO DPH begun;
12/30/2014 10:37:32 AM > seen for WCC/shots yesterday - mom states that he woke up with temp of 101 (axillary with degree added); Motrin was given and went back to sleep. Hasn't had any diarrhea so far today - states that stooled 2 good stools and several small traces throughout the day.  Presented to office on 12/31/2014 reporting temp up to 104.5 (axillary with degree added) and runny nose x 2 days - clear in color.  Noted to have Tonsillitis; started on Amoxicillin.
This case was reported by a pharmacist via call center representative and described the occurrence of erythropapular rash in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced erythropapular rash, fever, chills and incomplete course of vaccination. On an unknown date, the outcome of the erythropapular rash and incomplete course of vaccination were unknown and the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the erythropapular rash, fever and chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporting pharmacist was the concerned patient.   The patient reported that a day later, she had red bumps appear on different body areas, fever, and chills. Events resolved after 5 days. Till the time of reporting, the patient did not receive the 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The reporter did not give consent to follow up.
Pt first dose of COVID19 vaccine was Moderna Lot # 020B21A on 03/31/2021.  Second dose given was Pfizer Lot #ER8733 on 05/01/2021.  Pt had no reaction to receiving the Pfizer as a second dose.
Approximately one week after I got my second pfizer covid shot, I heard a loud high pitched whine that seemed to come from inside my head.  It lasted about 1-2 minutes then went away.  Since then, this same whine has happened about 1 time every week to teo weeks.  Still only for about a minute at a time.
fever (no actual measuring); chills; headache; body ache; soreness at injection site and pain in arm; soreness at injection site and pain in arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 37-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0170), dose 2 via an unspecified route of administration, administered in left arm on 18Apr2021 11:00 (at the age of 37-year-old) as dose 2, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included ongoing eye stye and chalazion where the patient was under treatment with antibiotics (oral, ointment and eye drops). Concomitant medications included cefalexin and doxycycline calcium taken for stye (eye disorder). Patient previously took first dose of BNT162B2 (lot number: ER8733, vaccine location: Left arm) on 28Mar2021 at 10:30 AM for covid-19 immunisation and experienced soreness at injection site and pain in arm. On 18Apr2021 at 13:00 the patient experienced soreness at injection site and pain in arm after 2 hours post vaccination. It was also reported that the patient also experienced fever (no actual measuring), chills, headache and body ache 12 hours after second dose. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The patient underwent lab tests and procedures which included body temperature resulting 98.7 f on 19Apr2021. Patient received treatment post onset of the events. The treating medications was Tylenol. Outcome of headache was recovered on an unspecified date in 2021, body ache was not recovered and all the other events was recovering.   No follow-up attempts are possible. No further information is expected.
Flu symptoms beginning the evening of the 2nd injection worsening the second day and ringing in ears began. Third day (April 17th) fever broke, aches were minimal but right arm pit very sore and ears ringing. As of today, 4/19/21, still experiencing ear ringing and my right armpit is still really sore.
got a rash on the other forearm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 27-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: Unknown), via unspecified route of administration on 13Apr2021, (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 13Apr2021, at night (as reported) the patient experienced rash on the other forearm, the patient also wanted to know if rash and COVID-19 Immunization are related to each other. Also, patient asks if it was okay to get the second dose after this symptom. The outcome of the event was reported as unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
No adverse event; 20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-May-2023, the patient experienced UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (20 patients who were over 65 years old. They were given today 25May2023 0.25 ml instead of 0.5 ml).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about patient 2nd out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-726464 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726464:Elderly Patient - 1
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); both single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had fatigue (very tired after both doses of Pfizer COVID-19 vaccine), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Chest pain in heart area (aching/tightening feeling) lasting for about 5-10 minutes and did not lessen with movement. Radiated down left shoulder. Intermittent for about 12 hours. Happened a total of about 4 times. 1x shooting pain through jaw lasting about 2 seconds.
Patient said her arm was red and swollen for 2-3 days. She iced it and took BENADRYL.