chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:03 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient's age was reported as 35.84.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 03-Apr-2021, At excursion time 09:00 AM temperature was 34, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were moved to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Patient began to feel short of breath, fatigue, with distal numbness/tingling to feet about 1 week after being vaccinated.
This spontaneous report as received from a other health professional refers to a 12 month old patient. On 25-JUL-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date 25-JUN-2014) 0.5 ml, subcutaneously , which was expired. This is one of several reports received from the same source. Additional information has been requested.
Chills; Fatigue; Full body ache; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 17:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. It was unknown whether the patient was pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Mar2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Apr2021 at 09:00 the patient experienced chills, fatigue and full body ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events chills, fatigue and full body ache were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
since after the two doses , i had very frequent mild to moderate flu like symptoms, almost like every other week, it really bothers me
This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 40 year old female. The patient's height, and weight were not reported. The patient's past medical history included: fatigue, and concurrent conditions included: drug allergy (Not reported), and sleep apnea, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. Patient had other lifelong issues which causes her to normally deal with excessive daytime sleepiness. The patient was previously treated with modafinil, methylphenidate hydrochloride, and amfetamine aspartate/amfetamine sulfate/dexamphetamine saccharate/dexamphetamine sulfate for fatigue. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medication included duloxetine hydrochloride. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2). The patient received non-company suspect drug included: Paxlovid (form of admin, route of admin, and batch number were not reported), dose, administered on 14-AUG-2022 for covid-19 treatment. Last dose of administration was 19-AUG-2022. On 15-AUG-2022, patient had insomnia due to Paxlovid (dose number in series 2) and was not getting sleepy and now that patient was on it and could only get herself to fall asleep if patient took a NyQuil to knock herself out. The patient could easily let 24 hours go by without feeling tired at all. The patient had noticed to be more mentally alert and sensitive (bothered by) sensations like a clothing tag or stray hay or blade of grass poking or brushing against patient. Paxlovid was far more effective than those were at keeping me awake and alert painlessly. But it was too effective at it. The patient did not need to sleep at night for good health and really could not because of the Paxlovid. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable and with Paxlovid drug was discontinued. The patient had not recovered from insomnia, and the outcome of suspected covid-19 infection was not reported. This report was non-serious. Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Client was inadvertently given Moderna vaccine dose prior to turning 18 years old. Parents received vaccine at the same time as client. No adverse reaction reported. Error was discovered when client returned to clinic without parents for 2nd dose. Did not administer 2nd dose. Instructed to return after Moderna is approved by FDA for teenagers.
1. R arm pain (severe)-couldn't lift arm or pull up clothes 2. Fever x 36 hours max: 101.0F 3. Chills 4. Rash generalized-did take zyrtec and benadryl for itching 5. Headache 6. Nausea 7. Fatigue 8. Body aches 9. Slept off and on for 2 days
Patient experienced shortness of breath and bilateral extremity numbness and tingling since receipt of recent COVID vaccination.
Got vacination during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vacination during pregnancy) in a 40-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included Prenatal Multivitamins, ESCITALOPRAM OXALATE (LEXAPRO), SERTRALINE HYDROCHLORIDE (ZOLOFT) and ACETYLSALICYLIC ACID (BABY ASPIRIN).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Sep-2020 and the estimated date of delivery was 29-May-2021. On 02-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vacination during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 02-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got vacination during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2020, Pregnancy test positive: positive (Positive) Positive. On 11-Jan-2021, Ultrasound abdomen: normal normal (normal) normal. On 01-Feb-2021, Full blood count: normal microgram (normal) normal. On 01-Feb-2021, Metabolic function test: normal (normal) normal. On 01-Feb-2021, Urine analysis: normal normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This is a case of product exposure during pregnancy with no associated adverse events for this 40-year-old female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this 40-year-old female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
Patient woke with pain, erythema, and swelling at vaccine site. Maximal diameter of erythema approximately 10 cm.
vaccine past its expiration date administered to 11 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications are not provided.  On 04-Oct-2021, the vial was initially stored in the refrigerator. On 29-Oct-2021, 1 first dose given, 1 third dose given to an immunocompromised patient and 1 booster dose given for a total of 3 patients. On 29-Oct-2021, 1 first dose given, 5 third doses given to immunocompromised patients, total of 6 patients. On 30-Oct-2021, 1 first dose given. 1 third full dose to an immunocompromised patient given.   Treatment information does not provided.   This case was linked to MOD-2021-371236 (Patient Link).
Breakthrough case of Covid-19 infection after Covid-19 vaccination.; Breakthrough case of Covid-19 infection after Covid-19 vaccination.; This is a spontaneous report from a contactable physician. A 66-year-old male patient received second dose of bnt162b2 (BNT162B2), intramuscular on 02Mar2021 (Lot number was not reported) as single dose, first dose intramuscular on 03Feb2021 (Lot number was not reported) as single dose for covid-19 immunisation, age at vaccination 66-year-old. Medical history and concomitant medications were not reported. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 13Aug2021 patient experienced covid-19 infection after covid-19 vaccination (reported as breakthrough case of Covid-19 infection after Covid-19 vaccination). Event resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. Since the vaccination, the patient has been tested for COVID-19. The patient underwent laboratory tests and procedures which included Polymerase chain reaction (PCR) Nasal Swab positive on 15Aug2021. Patient had not recovered from the event, at the time of the report.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available.
Massive Right sided Stroke on young  healthy patient in her 30s. Cleared of underlying factors that would cause a stroke.
10 cm x 10 cm rash on (R) deltoid. Erythematous bilateral check rash. Nausea. SOB.
tingling around mouth and palpitations  Sx resolved spontaneously within 5 minutes of onset
tighness in chest, wheezing, dry non productive cough, nasal congestion, fevers.
The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 08-Mar-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 08-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 08-Mar-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 08-Mar-2022) in an 81-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 08-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 08-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 08-Mar-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 08-Mar-2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that number of doses/vials: HCP reported 84 doses total administered to 82 patients total (2 of the patients received 2 doses from the same lot; their 1st and 2nd primary series dose from the same affected lot). Total number of vials not reported. The vial was initially stored in the refrigerator on 11-Jan-2022. Administration of vaccine from 16-Feb-2022 range through 11-May-2022 The vial did not undergo any temperature excursions. No treatment medication was reported.
On day nine (3/28/2021) 10 PM post vaccination, I started vomiting profusely that lasted approximately one hour. On day 10  (3/29/2021) post vaccination, I had diarrhea from 9 AM till 8 PM. On day 11 (3/30/2021) and day12  (3/31/2021) Post vaccination, I had severe body aches, joint aches, headache and severe fatigue. I slept most of days 11 and 12 post vaccination. Approximately 11 PM on day 12 postvaccination I felt perfectly fine once again.
01/08/21 reported around 3:30pm sick to stomach, 01/09/21 04:00am noted redness to right arm at injection site.
Patient noted a itchy and inflamed area, warm to the touch, around the site of the vaccine administration. The patient reported the area continued to expand despite a trial of naproxen sodium 220 mg and diphenhydramine 25 mg.  Patient sought out medical help and provider prescribed a Medrol dose pack on 1/28/2021.
The pt was diagnosed with Kawasaki disease within 2 weeks of the varicella vaccine. 60 day follow-up states the pt still has an aneurysm. Some have disappeared but not the one leading into her heart. The follow-up indicates that,"the pt's problem is Kawakaki's disease complicated by mild coronary artery aneurysm. She is being treated with a second course of IVIg and high dose aspirin."
GIVEN VACCINE OUTSIDE OF TEMPERATURE EXCURSION; VACCINES DRAWN FROM A VIAL AND LEFT OUT IN ROOM TEMPERATURE FOR A MAXIMUM OF 3 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced given vaccine outside of temperature excursion. On 01-JUN-2021, the subject experienced vaccines drawn from a vial and left out in room temperature for a maximum of 3 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the given vaccine outside of temperature excursion and vaccines drawn from a vial and left out in room temperature for a maximum of 3 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210633324.
Within approximately 12 hours post vaccination, I experienced extreme fatigue, significant body/muscle aching, low grade fever, nausea, significant back pain and general weakness and I described it as feeling like a truck hit me.  These symptoms lasted for approximately 72 hours, with slow resolution.  I noticed that when I started to feel better, it felt like a fog had been lifted.
Information has been received from a RN concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed breakthrough varicella. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Patient complains of rash on arm and slightly on upper body. Says she is experiencing a great amount of pain in her arm and says she had to sleep on that side of her body last night so it hurt more. Says she is experiencing chills. Onset the afternoon/evening after receiving the shot, and seems to have worsened overnight.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 3:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). On 27-Oct-2021 at 3:26 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  No treatment medication was provided.
Pt was in on 2/24/03 and given DTaP IM R thigh, IPV SQ L thigh upper and MMR SQ L thigh lower. ON 2/25/03 mother called on call nurse after office closed and was told to give Benadryl and to be seen on 2/26/03. Pt came in on 2/26/03 had erythema and heat in a 10.5 c 8cm R upper outer thigh with central puncture.
Patient came in complaining that her arm looked red and swollen to her, she also stated that it felt warm to touch. She stated that she had received 2 vaccines on 9/10/2018. The FLUZONE HD and PNEUMOVAX 23 into Left arm. Advised patient to go see a provider at urgent care. Patient later on the day advised me she had went, and was provided KEFLEX 500 mg 1 TID with 21 caps. Patient will follow up with primary care provider.
Woke with severe body aches, joint pain, chills and fever of 101.4, nauseated. Alternated 400mg of ibuprofen and 650mg of tylenol every 2 hours-symptoms lasted for 30 hours, did not get below 101 despite fever reducing meds for 30 hours.
Information has been received from a nurse concerning a 22 month old male who on 24-MAR-2009 was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot#, route and site of administration not reported). On approximately 24-JUN-2009 ("3 months after the first vaccination") the patient developed a case of viral out break of chickenpox. The patient also had fever and random type like rash all over his body. On 11-AUG-2009 the patient was seen at the physician's office. On an unspecified date, the patient was completely recovered. Additional information has been requested.
1/12/22 pt to ED with SOB, diarrhea; found to be positive for COVID; 1/16/22 pt suffered a cardiac arrest, coded, post code he was stable without vasopressors; on ventilator; the following day, pt suffered another cardiac arrest, coded with ROSC achieved; the next day pt passed away in the hospital
fever of 101F; whole body aches, neck, legs feet; sore throat; Immense headache; This is a spontaneous report from a contactable consumer or other non hcp.  An 18-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EW0168; Expiration Date: Aug2021), dose 2 via an unspecified route of administration on 02May2021 as dose 2, single dose for an covid 19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, The patient experienced fever of 101F, whole body aches, neck, legs feet / sore throat Immense headache with outcome of unknown.The patient underwent lab tests and procedures which included pyrexia: 101 Fahrenheit on 03May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.