chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADACEL was administered after exposed to 82.62 F for 15 minutes with no reported adverse event; ADACEL was administered after exposed to 82.62 F for 15 minutes with no reported adverse event; Initial information received on 15-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 months old female patient to whom DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] was administered after exposed to 82.62 F for 15 minutes.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Aug-2021, the patient received 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6964AA, Exp date: 19-FEB-2023) via unknown route in unknown administration site for prophylactic vaccination.  On 31-AUG-2021 the patient reported a non-serious event of ADACEL was administered after exposed to 82.62 F for 15 minutes with no reported adverse event (product storage error) (poor quality product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  IPOL was administered to 4 patients after excursion (Inquiry 01148676).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error; Sender's Comments:  01148676:
COVID-19; COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 08Sep2022 at 21:00 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years 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), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 with nirmatrelvir/ ritonavir (PAXLOVID) from 17Oct2022 to 21Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
7 days post vaccination redness, swelling, itching, heat at injection site.   Reaction is 9 1/2 in x 5 1/4 inches in diameter.   Duration of reaction unknown as it's still present 5 days later.  Swelling is going down, but still red and itchy.   Have applied hydrocortisone cream topically to area and the first couple of days took advil to reduce inflammation.
Unknown sx onset. Tested positive on 11/23/22. Treatment includes admission, PT/OT.
ACUTE CORONARY SYNDROME, UNSPECIFIED 11/20/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a registered nurse concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patient was vaccinated with his first dose of GARDASIL 9, (lot number #L001312, expiration date 24-FEB-2017, dose and route not reported) and then, on 11-AUG-2015, received his second dose of GARDASIL 4) (lot no., dose, route and anatomical location of administration were not reported) (interchange of vaccine products). No adverse effect reported. Additional information has been requested.
No additional AE details; Professional in charge of vaccine storage calling for valuation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. Professional provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report has been received from a healthcare business professional, concerning an identified patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 05-SEP-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) Lot# W011278   experienced a temperature excursion above 46 Fahrenheit (F) (62.8F); no other temperature excursions. If a digital data logger was involved was not reported (product storage error).   Consequently, on 06-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally as prophylaxis (lot number W011278 confirmed to be valid, expiration date reported and stablished as 01-NOV-2023) (strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA002722:Case number: 02242132 US-009507513-2209USA003021:Case number: 02242077 US-009507513-2209USA002510:Case number: 02242136 US-009507513-2209USA002566:Case number: 02242139 US-009507513-2209USA002779:Case number: 02242131 US-009507513-2209USA002481:Case number: 02242135 US-009507513-2209USA002745:Case number: 02242092 US-009507513-2209USA002570:Case number: 02242096 US-009507513-2209USA002722:Case number: 02242097 US-009507513-2209USA002574:Case number: 02242099 US-009507513-2209USA002469:Case number: 02242101 US-009507513-2209USA002573:Case number: 02242103 US-009507513-2209USA002606:Case number: 02242106 US-009507513-2209USA002532:Case number: 02242109
Initial report received on 01 November 2013 from a health care professional. A 57 year old female patient, medical history and concomitant medications were not reported, received a dose of FLUZINE (lot # UH900AD) intramuscular at left deltoid on 24-OCT-2103. It was reported that a patient had localized reaction shortly after (24-OCT-2013) vaccination with FLUZONE. Event was resolved. List of documents held by sender:  none.
Blood pressure started increasing on 4-26-21.  It steadily rose over a 2 day period to 226 / 125 -- I sought medical help at 197/115.  Finally, I was given lotenopil by IV and it came down to 150 over 100 within 4 hours at ER.
Chills; Muscle pain; Joint pain; Pain near or surrounding injection site; This is a spontaneous report from a non-contactable healthcare professional. A non-pregnant 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left arm, on 19Jan2021 at 13:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a workplace clinic facility. On an unspecified date, the patient experienced chills, muscle pain, joint pain, and pain near or surrounding injection site. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.   No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Due to reconstitution error patient was given less than half of required dosage. Awaiting further guidance from regarding third dose for an immunocompromised patient.
Persistent symptoms lasting 17 days so far. Extreme mental fog. Swelling of lymph nodes. Pressure in head. Diarrhea. Fatigue. Tingling and numbness in left arm and leg. Recurrent fever. Chills. Pressure in head. Symptoms have not subsided - please help.  Headache on injection day.
received expired TYPHIM VI vaccinations with no reported adverse event;Initial information received on 08-Oct-2021 regarding an unsolicited valid non-serious case received from a physician and consumer non health care professional via Medical Information number: 00665242.   This case involves a 4 years old male patient who who was administered an expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.    On 30-Sep-2021, the patient received a 0.5 ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination . It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.   It was reported "Doctor states that neither of these patients experienced any adverse events and that he was calling to find out if Sanofi had any safety or efficacy data related to expired products. Doctor also asked if the patients should be re-vaccinated. See case number 00805095 for information related to the first patient".   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I was approximately 5 weeks pregnant and had a miscarriage after I got the first Covid vaccine.
8:00am. Sunday, april 11th woke up with extremely sore neck on the right side. It became visibly swollen over the day and unable to turn my head without extreme pain. The lymph node in the area is extremely tender and warm to the touch. Around 5:30 a rash started occuring on the neck where it is swollen.  All of this is occuring on the opposite side of where the injection was given.  No other side effects have been noticed through out the days after the injection until today.
Within 5 minutes of getting the shot, I got a weird metallic/salty-saline taste in my mouth that lasted until Saturday/Sunday.  Also gradually within an hour, my left side of my mouth (cheek, bottom lip, gums) went completelt numb. That last until Saturday then it became tingly like for the next few days after that. I was able to use facial muscles, I just literally had no feeling.    My heart started to have palpitations and I am pretty sure it went into AFib until Friday.  I also felt like I had vertigo for the first 24 hours. I could not keep balance like I was very intoxicated.  With my endometriosis, it did also cause a d Flare up in my back pelvic area like my endo has returned to my "cal de sac" area. That lasted a few days too.
Headache; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Tinnitus,  sinus congestion, "fullness in head & ears", headache, fatigue; all presented upon awakening Sunday 7/1 (11:30)
I have numbness in my three little fingers on both hands from the second day of the vaccine.  More prevalent in the left hand where I got the vaccine. Also the left hand freezes up when I am hold the phone. At work if I am at the phone and writing with my right hand the left is freezing numb.  Bother hand also free when I am sleeping.  I thought it would go away but it has not. I got vaccinated on 3/25. I am a bit worried now. I called the doctor's office and hope I can see them this week.
After 10 minutes, throat began to become numb/tingly/itchy. Then at 20 minutes, I started to have difficulty swallowing. I told the medical provider who was there in the observation room. My vitals were stable. They sent me to the ER to be watched and observed for 6 hours. my throat's numb/itchiness/tingling went away, but remained difficult to swallow until the next morning. My vitals stayed stable.
Patient with signs/symptoms immediately post injection of Pneumococcal. Redness at injection site, then pain in arm, slight BP increase, followed by a lightheaded feeling, itching in right arm, then nausea and vomiting. MD notified, patient placed on gurney, PIV started, and patient given hydroxyzine IM, famotidine IV, and hydration of Normal Saline for 3 hours. Signs/symptoms abated with only soreness around injection site upon patient release from clinic.
Local reaction left deltoid site of Pneumovax injection, administered along with Influenza vaccination on 3/23, started 3/25 symptoms resolved by 3/28.
six days post vax the pt developed approximately 30 varicella like lesions. One week post onset the pt recovered.
Fever (102 F) chills, nausea, body aches. Injection site swollen, red, sore, and hot.
Right arm has chicken pox type blotches sprinkled over arm area.  Left arm has some.  Are below belly also has a few; Right arm has chicken pox type blotches sprinkled over arm area.  Left arm has some.  Are below belly also has a few; A bit itchy; Watery bumps noticed; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Oct2021 (Lot number: EW0179) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Parkinson's" (ongoing), notes: Verbatim: Parkinson's; "Sleep disorder" (ongoing). Concomitant medication(s) included: AMLODIPINE (ongoing); ATORVASTATIN (ongoing); CARBIDOPA LEVODOPA taken for parkinson's disease (ongoing); CLONAZEPAM taken for sleep disorder (ongoing); LOSARTAN (ongoing). Vaccination history included: Bnt162b2 (Lot/Batch number: EL3248, Route of administration: Intramuscular, Anatomical location: Right arm, Dose no: 1), administration date: 22Jan2021, when the patient was 75 years old, for Covid-19 immunization; Bnt162b2 (Lot/Batch number: EM9810, Route of administration: Intramuscular, Anatomical location: Right arm, Dose no: 2), administration date: 12Feb2021, when the patient was 75 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Oct2021, outcome "unknown", described as "Booster"; VARICELLA (non-serious), RASH MACULAR (non-serious) all with onset 12Oct2021, outcome "not recovered" and all described as "Right arm has chicken pox type blotches sprinkled over arm area. Left arm has some. Are below belly also has a few"; PRURITUS (non-serious) with onset 12Oct2021, outcome "not recovered", described as "A bit itchy"; BLISTER (non-serious) with onset 11Oct2021, outcome "recovered" (2021), described as "Watery bumps noticed". Therapeutic measures were not taken as a result of varicella, rash macular, pruritus, blister. Additional information: Specific relevant test for thromboembolic events with thrombocytopenia was not done. Patient did not have covid prior vaccination and patient was not tested positive for covid after vaccination. Patient was not received any other vaccine in four weeks. They appeared late as one day before report (reported as yesterday) with more appearing on the day of the report (reported as today). shot on Friday, 08Oct202, breakout today, the 13Oct2021.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a pharmacist via a field representative refers to a 40 year old female patient. No information about medical history, concurrent conditions was reported. On 28-OCT-2014 the patient was vaccinated with ZOSTAVAX (lot#, dose, route not reported). No concomitant medications were reported. The pharmacist reported to the representative that the patient had requested to receive ZOSTAVAX because she has experienced shingles prior to receiving ZOSTAVAX. The representative states that the patient has not experienced shingles since she received ZOSTAVAX. No adverse experience was reported. There was no product quality complaint. Additional information has been requested.
Patient reported getting COVID after completion of 2 shots of Pfizer Covid vaccine; Patient reported getting COVID after completion of 2 shots of Pfizer Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 "Patient reported getting COVID after completion of 2 shots of Pfizer Covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Covid test type post vaccination=Unknown. It was unknown if therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
(2/26/2021) Went to ER after having nausea and fever for a few days. Was given a few tests (COVID-19, Flu, Blood panel, CT scan) all was normal. Was given Zofran and saline IV. After a few days on the following Wednesday (3/3/2021) went to a different ER and was given a full testing including, Spinal tap, Basic Metabolic panel, Liver, UA conditional, Hemogram platelet diff and C reactive protein. All returned normal except C reactive showing inflammation, but no infection was present in spinal fluid. Zofran, Advil and Tylenol were given for treatment. Issues lasted up to 3/8/2021 and was able to return to work. Follow up with Dr. and labs showed all clear but seemed to be viral infection. I felt I had recovered at this point.
48hr p/vax took long nap (3hr vs 1hr) awakened by mom, found to be bright red, dec responsive;tried to feed unsuccessfully;took temp turned white, limp, cyanotic lips, ? apnea;to ER pt w/T100.4 R feeling OK @2hr;mom reported dec activity
2nd dose of covid19 vaccine administered on 1/25/21 AM.  First dose was about 12/28/2021.  Patient had a change in condition noted same day PM, which included worsening mental status with increased confusion such as disorientation and decreased functional status, as well as opening of pressure ulcer on coccyx.  Patient became lethargic.  Patient condition worsened over the next few days.  Patient decreased oral intakes, including medications.  Care and comfort measures were in place.  Patient expired on 2/4/2021.
Lightheaded; Nausea; Hot flush; Fatigue; Chills; This is a spontaneous report received from a contactable pharmacist. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8270) via an intramuscular route of administration in the left arm the 23Mar2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported and there were no known allergies. The concomitant medications were unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 23Mar2021 at 12:00, the patient experienced lightheaded, nausea, hot flush, fatigue and chills. The patient did not receive any treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the lightheaded, nausea, hot flush, fatigue and chills was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected
Redness, warmth, swelling of arm around vaccine administration site.  Fever 104F, myalgias.
Doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) 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) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient received vaccine form vial which had 20 minutes temperature excursion in the freezer.  No concomitant medications were reported.  No treatment information were reported.
Fever and redness, swelling, pain at injection site. Fever x 1 day.
Site of injection is red and itchy. Taking BENADRYL and applying hydrocortisone cream. And will go to the doctor if doesn't improve or gets worse.
Diarrhea; Her arm hurt really bad; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-JUN-2023, the patient received the 1st dose of Shingrix (right arm). On 09-JUN-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Her arm hurt really bad). On an unknown date, the patient experienced diarrhea (Verbatim: Diarrhea).  The outcome of the pain in arm was resolved (duration 3 days) and the outcome of the diarrhea was not resolved.   It was unknown if the reporter considered the pain in arm and diarrhea to be related to Shingrix.     It was unknown if the company considered the pain in arm and diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-AUG-2023 The patient was self-reported this case. The reporter reported that she received Shingrix vaccine and on same day she experienced arm hurt really bad for 3 days. The patient experienced diarrhea before receiving 2nd dose of Shingrix vaccine. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR122939: