chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.  Date the vial was initially stored in the refrigerator - 07-Oct-2021
TOP BACK ON NECK SORE; FELT LIKE A FEVER/WARM; TENSION HEADACHE; LITTLE ACHES AT INJECTION SITE; This spontaneous report received from a patient concerned a 35 year old female. 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: 206A21A and expiry: 21-SEP-2021) dose was not reported, administered on 18-AUG-2021 16:30 for prophylactic vaccination. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced little aches at injection site. On 19-AUG-2021, the patient experienced top back on neck sore. On 19-AUG-2021, the patient experienced felt like a fever/warm. On 19-AUG-2021, the patient experienced tension headache. Laboratory data included: Body temperature (NR: not provided) 98.3 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little aches at injection site, tension headache, top back on neck sore, and felt like a fever/warm. This report was non-serious.
20 minutes after vaccination, lips and tongue started to tingle and tongue swelled. Administered epi-pen and symptoms resolved. No residual effects.
Asthma flare requiring rescue inhaler, fever 102.6 after 30 hours
Morning after vaccination given patient started feeling nausea, headache, low blood pressure, sleepyness, dizzyness.
Received 2nd Moderna Covid vaccine at 10:45 am at work on January 25, 2021. Started feeling tired and had a slight cough developing by 2 pm without fever. Kept working until 4:30. Went to bed at approximately 8 pm feeling very tired and achy . Woke up at 1 am with fever of 103°F tympanic, heaviness in chest, chills, cough, headache, stiff neck, arthragia, nausea and dizziness. Oxygen Saturation was 98%.  Put cool rag on head and fell back to sleep.  Within an hour, woke up and temperature was up to 103.9. Took 400 mg of Advil approximately 2:45 am. At 4:23 am, temperature was 104.0 Took another 200 mg Advil and sent text to my boss, about this.
Death  05/24/2021 Causes of death listed on death certificate: 1) COVID  2) ATRIAL FIB  3) CKD 3  4) Hypertension
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On 06-MAY-2016, the patient was inadvertently vaccinated with an expired dose of VAQTA with lot # L018498 Expiration date: 28-APR-2016 (dose and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
pt had unusual high pitched cry off/on for 2 days;pt was taken to ER for eval;pt fine;pt also had low grade inc temp;
pt recvd vax & devel hives on arms; in am; pt woke up w/ eyes almost swollen shut; hands were swollen & pt had rash;
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Still running a fever today, it's not that high) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included METHOTREXATE for an unknown indication. On 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced PYREXIA (Still running a fever today, it's not that high). At the time of the report, PYREXIA (Still running a fever today, it's not that high) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Body temperature: high (High) high (104.4 degree F temp.). No treatment history was reported.
Received HPV vaccine at age 32 years on 5-14-2007 and 7-17-2007. No adverse event.
5 deaths, from that vaccine was reported; This is a spontaneous report from a contactable consumer received from a Pfizer-sponsored program. This is the 3rd of 5 reports. A patient of an unspecified age and gender  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, Consumer stated that 5 deaths, from that vaccine was reported and over 50% of people reported a debilitating disease, or cannot function, and have thousands of dollars in medical bills. The outcome of event was fatal. Autopsy was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100913512 Same reporter/drug/AE, different patient; Reported Cause(s) of Death: 5 deaths, from that vaccine was reported
I would like to report that on 6 Jan 03 I took an anthrax vaccination.   I had the common burning sensation at the site and a knot later that day.  The site was red and angry looking.  My wife is an RN and she said it looked horrible. By Monday night I felt like I had a mild case of the flu.   I felt the same way on Tuesday all day.  On Wednesday morning I felt better but by mid-morning I felt horrible again.   I felt as if I were in a daze.  I decided to drive myself home which was a mistake because I should not have been driving and ended up in a wreck.   I totaled my car and damaged another car.  I felt like I was in a daze until the weekend.  I still have the knot though it is not as large as it was.  I have put off reporting this but at the insisitence of my wife I report it now.
Information has been received from a physician concerning a male pt who in September 1997 was vaccinated with varicella virus vaccine live.  On 03/11/04 the pt's mother called the MD's office stating that her son had chickenpox. The pt sought unspecified medical attention. There was no product quality complaint involved. It was also reported that four other pt's developed chickenpox after being vaccinated with varicella virus vaccine live (WAES # 0403USA01664, 0403USA01645, 0403USA01646, 0403USA01647).  Additional information has been requested.
pt went to the ER stating having hives, difficulty breathing, and swollen lips. ER gave pt benadryl. pt will be taking benadryl for couple of days and as of 11.5 pt is feeling much better. ER md and pt are not sure if this was due to the flu shot
Stomach is still hard and swollen; Stomach hurt so bad he could barely walk; Sweating profusely; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach hurt so bad he could barely walk), HYPERHIDROSIS (Sweating profusely) and ABDOMINAL DISTENSION (Stomach is still hard and swollen) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurt so bad he could barely walk) and HYPERHIDROSIS (Sweating profusely). On an unknown date, the patient experienced ABDOMINAL DISTENSION (Stomach is still hard and swollen). At the time of the report, ABDOMINAL PAIN UPPER (Stomach hurt so bad he could barely walk) and ABDOMINAL DISTENSION (Stomach is still hard and swollen) outcome was unknown and HYPERHIDROSIS (Sweating profusely) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment included Milk of Magnesia and 2 Dulcolax gummies.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 9:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:07 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Feb-2021 at 9:12 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 36.94 for dose administered on 27-FEB-2021 and Age of patient was reported as 37.02 for administered on 27-MAR-2021  No concomitant and treatment medications were reported.  Batch number 014M20A, underwent temperature excursion with temperature 33,35,34 degrees Fahrenheit from 09:00 AM To 05:00 PM. This vial was moved to fridge on 24-FEB-2021 and beyond use date for the vial was reported as 26-MAR-2021. Product moved to clinic on 27-FEB-2021.  Batch number 019B21A, underwent temperature excursion with temperature 35 degrees Fahrenheit from 09:00 AM To 10:00 AM. This vial was moved to fridge on 23-MAR-2021 and beyond use date for the vial was reported as 22-APR-2021. Product moved to clinic on 27-MAR-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.
Painful swelling on collarbone; developed painful swelling on collarbone; This spontaneous case was reported by a consumer and describes the occurrence of BONE SWELLING (Painful swelling on collarbone) and BONE PAIN (developed painful swelling on collarbone) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 30-Oct-2021, the patient experienced BONE SWELLING (Painful swelling on collarbone) and BONE PAIN (developed painful swelling on collarbone). At the time of the report, BONE SWELLING (Painful swelling on collarbone) and BONE PAIN (developed painful swelling on collarbone) had not resolved.            No concomitant medication reported. No treatment medication reported.  Patient developed painful swelling on collarbone which was still there (left side - same side as the injected arm).   Patient was wondering if this could be a blood clot. It was confirmed all three doses were Moderna COVID-19 vaccine
I have reported to VSafe any symptoms immediately following injection and for the week following the event. However, on 3/5, I woke up with a migraine that progressed throughout the day. I had chills, nausea, muscle pain and red splotches on my forehead (right side) and could do nothing but sleep by the afternoon. I thought it odd as these are symptoms that have been reported immediately following vaccine but I got these 10 days after vaccine. Second dose had less early symptoms with mainly pain at injection site until 3/5. OK 3/6/21.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 02-FEB-2015, the patient was vaccinated with GARDASIL (lot number: K007264 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Arm became red swollen and hot reaction was localized to the vaccine area on the left arm she said she had not had anything like it to her other vaccines as they were all moderna
Patient came in stating his arm hurts after the flu shot.  He stated it did not hurt initially but started possibly 3-4 days after the shot.  He states there is some additional pain in his back, but is not sure if that started before or after the vaccination.  He states that he normally takes Aleve for pain, but it does not seem to be helping much.
Patient experienced redness, swelling, heat, and hardness in the left deltoid after receiving both Tdap and Gardasil 9 on 3/23/23. Both injection were given in the left arm and he had Menveo given in the right arm. The next day, mom reports the symptoms were worsening and took the patient to the ER. While there they did an ultrasound of his arm which showed a very small mass and cellulitis. He was prescribed Clindamycin 75mg/5mL, take 20mL three times daily for 10 days. He followed up at our clinic on 3/27/23 and the symptoms were improving.
Developed several bumps on left forearm. Then 3 days later developed bumps on both buttocks cheeks. As a couple weeks went on developed bumps in the palm of the hand. Went to the determatogist & was diagnosed with Guttate psoriasis.; This is a spontaneous report from a contactable consumer. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 09Feb2021 at 10:45 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication included unspecified high blood pressure medication (CHL). The patient previously took ampicillin (MANUFACTURER UNKNOWN) on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021, the patient developed several bumps on the left forearm. Then 3 days later developed bumps on both buttocks, cheeks. As a couple weeks went on, the patient developed bumps in the palm of the hand. The patient went to the dermatologist and was diagnosed with guttate psoriasis. Given a corticosteroid (cream) which, to her made it worse. Finally clearing up as of 10Apr2021. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with corticosteroids (cream). The clinical outcome of the event developed several bumps on the left forearm then, 3 days later developed bumps on both buttocks, cheeks, as a couple weeks went on, developed bumps in the palm of the hand, went to the dermatologist and was diagnosed with guttate psoriasis was resolving at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No aditional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 13-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S003872 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
3/23/2021 @ Vaccination drive through- pt received 1st dose Moderna vaccine in L deltoid. Approx. 5 minutes after vaccination @ 11:00 am, pt reported R side chest pain increasing suddenly on pain scale 5-10. EMS  personnel onsite Assessed pt VS 153/90  HR 66. R-16 in AM pt's pain subsided. Refused to be transported to hospital. Pt continued to be observed during the next hour. No c/o chest pain upon leaving vaccination site
Broken capillaries on the underside of left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 (Batch/Lot Number: ER2613 expiry date was not reported) via intramuscular route of administration at arm left on 23Mar2021 09:00 (at the age of 30-years-old) as a single dose for covid-19 immunisation. The patients medical history included thyroid cancer from an unknown date, thyroidectomy was done in 2016 on an unspecified date and Thyroid was removed, other relevant medical history including but not limited to these conditions: diagnosed allergies(Unspecified), compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Thyroid cancer in 2016. Concomitant medications included levothyroxine dosage text - 100mcg daily taken for hormone replacement therapy from 2016 to an unspecified stop date. She wanted to know if she was having a normal side effect. On 25-MAR-2021 21:00 the patient experienced broken capillaries on the underside of her left arm. It was not at injection site, but on the underside. There was maybe a dozen of broken capillaries in spots like a tiger stripe. The patient did not had any other vaccinations within four weeks prior to this. The outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a multiple unspecified patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unknown dates, the patient were vaccinated with an improperly stored dose of VARIVAX, lot numbers M020899 with expiration date 27-APR-2018 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were previously exposed to temperature excursion of 15 Fahrenheit (F) to 46 Fahrenheit (F) during 6 hours in November 16 (year unspecified) additionally, the vaccine was exposed to temperature excursion (unspecified dates) of 15 Fahrenheit (F) to 46 Fahrenheit (F) during 12 hours; however, no patient was vaccinated with the last temperature excursion reported.  The call was because "data logger". No adverse effects were noted. This is one of two reports from the same source Additional information has been requested. Sender's Comments:  US-009507513-1703USA004386.
This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a 57-year-old, adult, male patient. On 16-Oct-2018, temperature excursion of the vaccine occurred. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805018) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
pt rec'd grey cap pfizer vaccine after being stored in freezer for 22days- replacement dose rec'd on 6/3/22
Dizziness; Migraine; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MIGRAINE (Migraine) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), MIGRAINE (Migraine) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), MIGRAINE (Migraine) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.  No treatment medication provided.