chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchiness; Diagnosed with UTI; Tingly; Chills; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer sponsored program. A 79-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration and unspecified date as an single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Due for the 2nd shot tomorrow. Patient diagnosed with urinary tract infection, itchiness after the 1st dose, little sore on the first day, little itchy and tingly all over with some chills. Patient second Pfizer COVID vaccine tomorrow on 09Feb2021. She is just diagnosed with a light case of UTI with a temperature of 97F and no fever. Cephalexin given as a treatment for UTI. The patient underwent lab tests and procedures which included body temperature was 97 Fahrenheit. On an unspecified date, the events were resolved and outcome of the event UTI was unknown.  Information about batch/lot number has been requested.
Patient has history of polychondritis w recent flare of recalcitrant scleritis and painful lesions toes thought to be vasculitis and likely related to underlying polychondritis diagnosis; was under treatment for same w prednisone, humira.  4 days after 2nd COVID vaccination Pfizer patient began to report shortness of breath;  After Sx persisted was referred to cardiology and found to be in atrial fib; she received cardioverson and placed on eliquis and symptoms have resolved
This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received an unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP7533), at the age of 46, via an unspecified route of administration, left arm, on Apr 6, 2021, at 18:15, single dose, for COVID-19 immunisation. The patient has not reported any other health issues. The patient has no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On Apr 10, 2021, patient's left arm ached too much from last 3 days. He could not carry even a pound. Since the vaccination, patient has not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the left arm ached too much from last 3 days not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 10-JUN-2010, patient received improperly stored VARIVAX dose 2, from lot # 665413/1128Y expiry date: 07-AUG-2011. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that the vaccine was not thawed. The nurse practitioner reported that there was insufficient date to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
STARTING TWO HOURS AFTER VACCINE, PATIENT REPORTS FAIRLY CONSTANT LEFT SIDED HEADACHE. NOT INTERFERING WITH ACTIVITIES OF DAILY LIVING BUT UNCOMFORTABLE SO SOUGHT MEDICAL ATTENTION AT PRIMARY CARE CLINIC 12 DAYS LATER. WE ARE STARTING WITH OVER THE COUNTER PAIN MEDICATIONS AND WILL CLOSELY FOLLOW TO DETERMINE NEED FOR IMAGING IF SYMPTOMS ADVANCE.
About one month after vaccination (second dose) patient experienced increased shortness of breath.  Patient followed up with cardiologist and they conducted a stress test and a heart monitor.  Heart monitor reported atrial fibrillation resulting in change of medication.  Patient still experiencing shortness of breath.
Fatigue, Muscle pain, Fever and chills, Stomach pain, Nausea. Normal for Shingrix and resolved by rest in about 10 hours. Severe back pain has so far lasted, including Sunday, 4 days, but getting better every day. Probably should resolve itself in another 1-2 days. Treated with heating pad and limiting movement as much as possible. Sunday, movement was nearly impossible due to pain levels.
Pt. states that after receiving the 3rd Booster of Moderna 11/29/2021, started experiencing symptoms that evening of (left) arm pain, fatigue, muscle aches, and headache. Still currently experiencing symptoms. No noted Primary visit/communications.
INJECTION 2 GIVEN APPROX 1 INCH BELOW 1 INJECTION RT THIGH INSTANT SWELLING REDNESS RAISED. HIB INJECTION.
Pt described a horrible allergic reaction with severe pain and swelling. Pt reported pain radiating down the arm and up the arm into the breast. Pt 1 week later still reports swelling and a "knot" at the vaccine site.
septic right knee; A spontaneous  VAERS report was received from a reporter ( healthcare professional)  concerning a 76 year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious event septic right knee (PT-Arthritis bacterial).  The patient's medical history was not provided. The patient received first dose of vaccine (Lot number:039K20A) on 30-Dec-2021. The relevant concomitant medications were also not provided.  On 26-Jan-2021 , prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 019K20A) through intramuscular route of administration in the right arm for prophylaxis of COVID-19 infection.  On 17-Feb-2021, the patient experienced septic right knee and was admitted to the hospital and treatment was provided ( treatment details are not provided).   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event was not provided.; Reporter's Comments: This is a case of a 73-year-old male subject with limited hx and experienced septic right knee 23 days after receiving second dose of vaccine. Very limited information regarding these events have been provided at this time. However, based on the onset date and cause of infection due to bacterial organism, the event is unlikely related to the vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 11May2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 25Jun2021 as dose 3 , single (Batch/Lot number: unknown), on 31Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 29Jun2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Aug2022) Positive. The patient received Paxlovid from 06Aug2022 to 11Aug2022 for COVID 19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 84 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral taken for hypertension, start date: 01Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 including oral paxlovid (Lot number: 69530) from 10Jun2022. Investigation results received from product quality group on 14Jun2022, Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot FF2590 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FF2590, fill lot FF2559, and the bulk formulated drug product lot FE5320. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Follow-up attempts are completed. No further information is expected.
No additional AE; inadvertent administration of GARDASIL 9 to a patient on 08/29/2023 after experiencing a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient´s medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not provided.   On 29-AUG-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (0.5ml/once, lot#: W026152, expiration date: 29-JAN-2025; strength was not provided) for prophylaxis. The vaccine administered inadvertently experienced a temperature excursion before at -0.4C for 6 hours 5 minutes (product storage error). The vaccine also experienced previous temperature excursion at 0.5C for 32 minutes and 1 C for 2 hours 1 minutes. No additional adverse events (AE) were reported (no adverse event).   This case was received from the same reporter with 2309USA002781, 2309USA002616, and 2309USA002803.
Patient received Moderna bivalent booster doses that had undergone a temperature excursion; Patient received Moderna bivalent booster doses that had undergone a temperature excursion; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion).    This case included information of 6th patient out of 77 reported patients.  No concomitant product reported by reporter.  77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Screaming, crying, unable to sleep, restless, could not settle. Continued all night and through the next day. Now over 48 hours and still unable to settle for periods longer than 2 hours.
5 days after Dose 1 and again 6 days after Dose 2 I had severe cold sore/Herpes flare ups. Oddly it was at the base of my nostril in both instances as well as my lower lip after Dose 1; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8727) via an unspecified route of administration on 22Mar2021 16:00 (at the age of 47-year-old, non-pregnant) as dose 1, single for COVID-19 immunization at Public Health Clinic/Administration facility. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not received any other vaccine in four weeks and other medications in two weeks. Patient had no COVID prior to the vaccination and was not tested COVID post vaccination. On 27Mar2021 12:00, 5 days after dose 1 and again 6 days after dose 2, I had severe cold sore/herpes flare ups. oddly it was at the base of my nostril in both instances as well as my lower lip after dose 1. Patient never had one in her nose and in general it was rare for her to had a flare up. She thought it had been 2 years and typically if she had one it was over a year before she got another. This was odd to had 2 flare ups this month, both days after the vaccine. Both more severe than ever and a new location at the base of her nostril also. Patient did not received treatment for the events. The outcome of the event was recovering.  No follow up attempts were possible. No further information was expected.
greater than 35 days between Moderna Covid-19 vaccinations; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between Moderna Covid-19 vaccinations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between Moderna Covid-19 vaccinations). On 17-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between Moderna Covid-19 vaccinations) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported. No other Adverse Reactions or side effects are reported.
Caller is a nurse calling to report a temperature excursion involving PROQUAD and VARlCELLA.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 11-DEC-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter, as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided, lot number T021302 which has been verified to be valid, expiration date reported and validate as 19-DEC-2021), on an unknown date, the patient received varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). Both vaccines experienced a temperature excursion on 2 separate dates of -5 degrees Celsius (C) for 10 hours, and with a time frame of 20 hours, as recorded by a data logger. There was no additional previous temperature excursion reported.
Pt requested the filing of a VAERS to report the onset of her chronic viral syndrome and multiple gynecological problems since the receipt of the adenovirus vaccine types 4&7 in 1981. Continues to have ongoing issues. Unsure of exact onset date.
Pt complained of immediate onset of rash on face.  Nurse examined pt and observed hives on face, neck chest, and lf arm. Lungs were clear. No signs of swelling of difficulty breathing. PHN administered Diphenhydramine 25mg Pt monitored 40 minutes. Reaction did not progress. Redness on neck and chest began to improve.
FEVER, REDNESS SWELLING, PAIN. CLINDAMYCIN 300MG EVERY 6 HOURS FOR 10 DAYS.
Difficult breathing, varying in severity; it is sometimes very bad. I had to go to the ER last week, and they gave me an inhaler. Also, tightness in the chest. This has been ongoing for ten days
Information has been received from a registered nurse concerning a 67 year old female with asthma, cholesterol high, type 2 diabetes mellitus, arthritis and PENICILLIN allergy and a history of pneumonia who on 24-NOV-2008 was vaccinated with the second dose of PNEUMOVAX, IM (lot# 662662/0979X).  The date of the first vaccination was unknown.  Concomitant therapy included influenza virus vaccine (manufacturer unknown) administered in opposite arm and other unspecified medications.  On 24-NOV-2008 the patient experienced a local reaction including redness, swelling, and warmth to touch.  On 25-NOV-2008 the patient was seen in office and prescribed BENADRYL and IBUPROFEN.  Follow up information has been received from the registered nurse who reported that on 24-NOV-2008, the patient received the first dose of PNEUMOVAX, IM (lot# 662662/0979X) (initially reported as the second dose by the same reporter).  The patient's erythema and swelling at injection site was 4-5cm in diameter.  The patient was treated with ice and "NSAID" (nonsteroidal anti-inflammatory drug).  Subsequently, the patient recovered.  Additional information is not expected.
Mom reports that child developed rash over entire body & c/o burning up. Child's temp was 102 degrees. Mom brought child back to H.D. RN looked at rash after hosp. ER visit. Child still has rash over entire body but he states much improved. RN obtained hosp ER record. See attached. Allergic reaction. Had immunizations yesterday at Health Department. Anterior & posterior trunk and upper ext. 97% O2 sat. DEPO-MEDROL 80mg IM. VISTARIL 50mg IM. Hydroxyzine 25mg PO q 6 hours PRN itching. RTC in AM or earlier if symptoms persist.
Initial information and follow up has been received from a health professional concerning a 16 year old female with metabolic syndrome, reflux nephropathy and Gitelman's syndrome who on 17-MAR-2008 was vaccinated with her first dose of Gardasil (lot# 655327/1287U).  Concomitant therapy included K-LOR, Mg oxide, DYRENIUM, CEFTIN and ORTHO TRI-CYCLEN LO.  On 17-MAR-2008 the patient experienced soreness in her injection arm.  On 21-MAR-2008 the patient's upper arm became swollen and on 22-MAR-2008 the swelling spread to her fingertips.  The patient was seen in the ER and is recovering on an unspecified date.  Additional information has been requested.
sneezing in my nose, it's running now; runny nose; slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2: unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster): unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster): unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (Booster): unknown manufacturer), for COVID-19 immunization.  The following information was reported: HEADACHE (non-serious) with onset 26Sep2023, outcome "unknown", described as "slight headache"; RHINORRHOEA (non-serious) with onset 28Sep2023, outcome "not recovered", described as "runny nose"; SNEEZING (non-serious) with onset 28Sep2023, outcome "not recovered", described as "sneezing in my nose, it's running now".  Additional information: The reporter called in because she had her COVID shot last Tuesday and she's sneezing and slight headache wondering if it's a reaction to the vaccine. Caller confirmed inquiry above. Caller confirmed that she received the Pfizer COVID vaccine and this was her shot number 6. Caller added "If she took a COVID test would she test positive if she had the vaccine recently." Caller would like to know if she will have a positive COVID-19 test result if she just recently received the vaccine. Upon providing response, Caller stated "she doesn't feel bad except that she was sneezing in her nose, it's running now." Consumer stated, "Right. she had a headache that day, but she has had the runny nose and sneezing really developed yesterday and today. When asked vaccination card handy with her consumer stated, she do not, they did not give her one. She can get her vaccination card, want her last one, she has had 5. They didn't give her a vaccination card, you want the last number that she has.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Following vaccination, the patient experienced epilepsy.  The mother of the patient felt the epilepsy was related to the 2nd dose of MMR vaccine..
Staff at facility reported that client never had a vaccine before. Staff reported that this was confirmed by family. After client receive the dose, it was brought to our attention that the client already had 2doses of moderna.
12MAR91 started cold- afebrile; 13MAR91 lt leg & knee swollen, red, warm, painful to ER-Xray neg; 15MAR91 MD rash blotchy on lt leg & knee & moves to arms & back & legs; WBC inc admitted 5 days; dx bacterial blood infect;