chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. A 52-year-old male patient received First dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 27Mar2021 17:00 (at the age of 52-year-old) as dose 1, single for covid-19 immunisation. Medical history and known allergies were reported as no. Concomitant medications included atorvastatin (LIPITOR), amlodipine (NORVASK), omeprazole (PROTONIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included Lipitor, Norvask, Protonix. The patient experienced fever 101 on 28Mar2021 at 12:00. Seriousness of the event was reported as non-serious. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. The patient did not have covid prior to vaccination and has not been tested for Covid-19 post vaccination. The patient did not receive any treatment for the adverse event. The outcome of event was recovered on an unspecified date of 2021. No follow-up attempts are needed. No further information is expected.
pt had sl fever in  the arm 230PM; APAP given for temp 100; 8PM fever rose pt vomited then had seizure; paramedics arrived temp 106.8; pt taken to hosp various test lab all neg; ER MD felt poss virus;
My initial reaction to the vaccine was extreme tingling and falling asleep of my left arm where I had the injection. This occurred for the entire day of June 7th. On June 8th I woke up with slight tingling in my left arm but also with chest pain. A couple of hours after that I had shortness of breath and a tight throat. The tightness in my throat and shortness of breath lasted off and on throughout that day and the chest pain remained the same. The next few days my chest pain still remained with a tingling sensation and a fullness that came and went. That Friday, June 11th I had to use my inhaler as my throat felt very tight and I was having a hard time breathing. My heart immediately started beating so fast and I knew from using my inhaler here and there that I have never had that reaction. I went into urgent care that night and was told I have Costochondrtis.
Pharmacist injected a clean empty syringe into patient's left deltoid. He noticed the error that no vaccine was drawn up after the syringe had been injected. The second syringe was already prefilled with Pfizer vaccine and ready to go but the pharmacist did not grab this prefilled syringe that was drawn up moments before. Patient called addressing the concern with receiving an empty syringe. The same pharmacist explained what had happened and the patient is not experiencing any symptoms at this time.
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. About two years ago in 2013, the patient received a dose of ZOSTAVAX, .65 ml, subcutaneous. On 25-MAR-2015 the patient inadvertently received a second dose of ZOSTAVAX. No adverse effects were reported. Outcome of the event was unknown. Reporting pharmacist considered the event to be not related to ZOSTAVAX. Additional information has been requested.
During administration, unable to completely push entire contents of syringe and dose.  Adminsitering MA had to withdraw the needle and obtain a new sterile needle.  The remainder of the dose was adminstered in the same arm 1 inch apart.
COVID vaccine arm, onset day 8 after first dose. Injection area got swollen, red, hot to the touch. Skin also felt rubbery where red and swollen.  On day of onset of signs and symptoms (8 days post vaccine), also felt significant fatigue and sleepiness. No fever or any other signs/symptoms. Day 9 post vaccine, the redness and swelling were reduced and continue to fade each day.
Expired vaccine administered; Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 03-May-2022); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 03-May-2022)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 03-May-2022)). On 03-May-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 03-May-2022)) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  The vaccine provider removed the vaccine from the fridge, thawed it if needed and administered it on the same day of removal. The expired vaccine was kept it in the fridge and only removed to administer the patients.  No treatment information was provided by the reporter.
pt recv vax 4/6/98 & 4/10/98 pt devel lymphadenopathy that was painful in the lt inguinal area;4/15/98 pt presented to MD office;1wk later there was no change in status;
At 4:15 am, 1/30/2021 (8 hours after received dose 1 of Moderna, I was awakened with a very strong heart beat in my chest, fast and irregular heart rate, I had no arm, back, or jaw pain. Within 40 mins., the pounding heart sensation subsided yet the fast, irregular heart beat continued. I finally fell asleep again  around 5:00 am that morning and awoke at 9:30 am. At that time my pulse rate was still fast and irregular yet not strong.  On Oct. 31 in the morning, my pulse rate was back to normal at 60 bpm and regular.
Patient felt hot once sat down at bleachers, became sweaty and queasy. 15 minutes passed. Patient felt better then stood up and became hot and queasy again.
injection site pain; This is a spontaneous report from a contactable consumer (patient himself).  This 72-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3248 with Expiration Date Apr2021), via an unknown route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history was provided. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140 with Expiration Date Mar2021) administered on 22Dec2020 at 10:58 and developed lymph nodes swollen, sore throat, loss appetite, achy, tired and feel like sleeping all day. No relevant concomitant medications were provided. After second dose he developed injection site pain. He took ibuprofen (MOTRIN) 500. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020511614 same patient/reporter/drug, different dose (first dose)
Initial and follow up information has been received from a 60 year old male physician concerning himself, who in September 2002 and 16-SEP-2003 at 09:00 was vaccinated intramuscularly with the first and second doses of PNEUMOVAX (second dose lot # 644218/1027M). On 16-SEP-2003 the patient experienced an inappropriate schedule of the vaccine. On approximately 16-SEP-2003 the patient experienced Guillain barre syndrome. He complained of dragging his feet and became unable to walk. He could urinate at first but had difficulty 12 hours later. He then had paralysis up to the bottom of his ribs. Then function began to return over the next four weeks, moving down to his feet. There were no relevant diagnostic tests performed. He only missed 2 days of work but had trouble walking x 1 month, then he was "ok". Subsequently, (reported as 15-OCT-2008) the patient recovered from Guillain-Barre syndrome. No product quality complaint was involved. The reporting physician considered Guillain-Barre syndrome to be disabling. Additional information has been requested.
Pt was given her first dose of the Moderna Covid-19 vaccine on 1/4/2021 at the health center. She then called us at the county health dept several times requesting the vaccine because she is a healthcare professional. She came to the health dept on 1/7/2021 and received another dose of the  Moderna Covid-19 vaccine, without disclosing to us that she had received a dose 3 days earlier. . Making it a total of 2 doses only 3 days apart. Pt was contacted after it was realize and she stated that she did this because she did not think she actually received her first dose because she did not feel it. She has not reported any adverse effects .
Headache and injection site pain day 1-3, Body ache, fever, chills, sweats, diarrhea, vomiting's, and gas day 3-5.
This spontaneous report as received from a Registered Nurse refers to a 15 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-APR-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L020015 expiration date: 16-AUG-2017 (dose, site and route of administration were unknown), more than 2 months after her first dose which was GARDASIL (dose, site and route of administration, lot and expiration date were unknown) vaccinated on an unknown date in 2015 (date unspecified). There was no adverse events reported. No product quality issue was involved. Additional information has been requested.
Swelling, redness and pain at injection site. Parameters of inflammation marked to monitor for worsening.  Still monitoring have not had to seek medical attention yet.
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date the subject received 3rd dose of hepatitis B vaccine at 20 mcg in an unknown deltoid to complete the three dose series.  An unspecified amount of time after completion of the hepatitis B vaccine series, the subject was tested and noted to have decreased response to vaccination.  At the time of reporting the event was unresolved.  Follow-up information received via the reporter on 21 May 2007 indicated that the reaction that the subject experienced was determined to be due to another unspecified condition that the subject has and not related to hepatitis B vaccine.  No further information will be reported.
On Feb 9 got the vaccination, on February 20, my throat started to shut down could not sallow, drawling,  got small ulcer in my tongue, bleeding, went to urgent care, got tested for covid-19, sent to emergency room, were I was admitted, again tested multiple times for COVID, scan of the head, chest, antibiotics by IV and morphine for the pain , sent home February 23, 2021
Moderna was accidentally given to a 17  year-old patient. No reactions experienced after receiving the vaccine.
What are some side effect of the 2nd dos of modern vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (What are some side effect of the 2nd dos of modern vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (What are some side effect of the 2nd dos of modern vaccine). At the time of the report, VACCINATION COMPLICATION (What are some side effect of the 2nd dos of modern vaccine) outcome was unknown.            No concomitant and treatment information were available.
Red, raised area 8cm, blisters on thighs, left worse than right. Triple antibiotic ointment - change dressings - keep covered.
Received Tdap (IM/RDT), VZV (s/c/RTR) without incident or complaint.  A few seconds later, was given Hep B (IM/LDT and MCV4 (IM/LDT); a few seconds after last IM, client had what appeared to be a small seizure, lasting approximately 5 seconds.  Client was supported in a chair by mother & nurse and remained safe during the seizure. Client began to cry upon opening eyes, and was tearful about 5 min.  BP 140/100, P 100 immediately after and 130/90 after 10 min.  Client given juice and observed about 10 more min., then was encouraged to follow up with primary care provider.
Info has been received from a physician concerning a 12 month old white female twin who on 1/3/01 was vaccinated, SC with the 1st 0.5ml dose of varicella virus vaccine live. Concomitant vaccinations on that same day included the 1st dose of MMRII. There was no illness at the time of vaccination. The physician reported that on approximately 1/10/01, 7-10 days, post vaccination, the pt developed 40 varicella skin lesions without significant systemic illness. Unspecified medical attention was sought, but no lab/diagnostic tests were performed. Subsequently, the pt recovered from the varicella skin lesions. Additional info is not expected.
patient received an incorrect vaccine which was QUADRACEL instead of Pentacel with no adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 months old male patient received an incorrect vaccine which was DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 20-Oct-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE at a dose of 0.5 ml (lot U7526AA, expiry date: 07-Sep-2024) via intramuscular route in the left thigh for immunization.  On 20-Oct-2022 the patient developed a non-serious patient received an incorrect vaccine which was QUADRACEL instead of Pentacel with no adverse event (wrong product administered). Caller reported the patient had not received any previous vaccinations. The patient came in to start his vaccinations, and one of the providers wrote orders for him to receive pentacel among other vaccinations to start the catch-up process. Another provider wrote orders for a different patient to receive quadracel, the orders were inadvertently mixed up and this patient received quadracel in error.   Action taken: Not applicable.  Outcome: Unknown.   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.
Case number PHHY2013US117733 is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (reference number: 487512) on 15 Oct 2013: This report refers to a 24-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with the seasonal Influenza vaccine (manufacturer and batch number unknown) on an unknown date. On an unknown date, after vaccination, she experienced allergic reaction to Influenza vaccine. Seriousness, outcome and causality of the event were not reported.
she wasn't feeling well/it is like getting worse/She is feeling not great; Headache; Her lymph nodes are really swollen and there is pain everywhere; Her lymph nodes are really swollen and there is pain everywhere; This is a spontaneous report from a contactable consumer. A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch no: not reported/lot number: EL3302), dose 2 via an unspecified route of administration on 18Feb2021 as dose 2, single for covid-19 immunization. Medical history included Hashimoto's disease (she got immuno Hashimoto's but nothing that she was suffering from). Concomitant medication included levothyroxine sodium (SYNTHROID). Historical vaccine included as patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch no: not reported/lot number: not reported) via an unspecified route of administration, on an unknown date as dose 1, single for covid-19 immunization. Reporter stated that his wife and he got the second dose of Pfizer Vaccine. He was fine but her wife was going through long reaction. So, she got it on Thursday morning on 18Feb2021 and that night she started just like a slight headache and the Friday 19Feb2021 she wasn't feeling well. Saturday on 20Feb2021, started to feel little better, but still didn't feel well and then on 21Feb2021 it was like getting worse. Patient lymph nodes are really swollen and there was pain everywhere, on an unknown date in Feb2021. She was feeling not great. Therapeutic measures were taken as a result of headache and pain included treatment with Tylenol. Outcome of the events was not recovered.
2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022); No adverse event; 2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)), PRODUCT STORAGE ERROR (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)), PRODUCT STORAGE ERROR (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)) and PRODUCT STORAGE ERROR (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)).    No concomitant drug were reported.   It was reported that 7 Patients have received 8 doses of the Moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date. All patients received primary series doses of the 6m-5y presentation of the Moderna COVID-19 vaccine(lot number AS1414B, expiration date unknown). All patients have not reported any symptoms. No patients have received any additional doses, medications or treatments to the knowledge of the vaccination provider. Vial size was reported as 2.5mL.   On 22-JUL-2022, the vial was initially stored in the refrigerator.   Thaw date was reported as 22-Aug-2022.  The vial was not underwent any temperature excursions.   No treatment drug were reported.
Information has been received from a Certified Medical Assistant concerning a patient who was vaccinated with a dose of PEDVAXHIB (OMPC).  The reporter stated that a mother said her child had been "fussy" after receiving the injection.  Medical attention was sought.  The patient's outcome was unknown.  The physician was not convinced symptoms were related to the vaccine.  Additional information has been requested.
Within 30 hours, my right eye began to burn and get extremely red and eventually became swollen shut. I had temporary paralysis on the right side of my face and all across my forehead. I had tingling around my lips.   I was referred to an ophthalmologist the following Monday after being prescribed antibiotic eye drops, steroids, and a cream.
they had a vial of punctured IPOL that was exposed to temperature beyond 8C with no reported adverse event; the 4 doses of IPOL were administered to 4 patients with no reported adverse event; Initial information was received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 patients of unknown age and gender patient who   had a vial of punctured IPV (VERO) [IPOL] that was exposed to temperature beyond 8c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Reportedly from 26-Jun-2023 to 29-Jun-2023, the patients received a 0.5 ml dose, once of suspect IPV (VERO) (Suspension for injection) (Lot number, expiry date: not reported, Strength; standard via unknown route in unknown administration site for Immunization (poor quality product administered) (Latency: same day).  The information on the batch number was requested.  On an unknown date the patient had a vial of punctured ipol that was exposed to temperature beyond 8c with no reported adverse event (product storage error).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  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.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: pt experienced lighthead, flushing and mild sweating symptoms, had pt lay down on floor and elevate legs, took blood pressure (was 112/80, osat 99 HR 75). pt started feeling better, had drink water and retook blood pressure ( 126/70, osat 99 HR 71), pt called wife who came to pick him up, pt declined calling 911, had nurse practicioner take blood glucose at pt request was (117)