chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.   No Medical History information was reported.  On 15-Apr-2021 at 10:06 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:06 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The age of patient was provided as 60.35  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  Vial was stored in cooler 1, on 15-Apr-2021, temperature excursion at 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was 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.  Treatment medications were not reported.
loss of hearing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEAFNESS (loss of hearing) 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 DEAFNESS (loss of hearing) (seriousness criterion medically significant). At the time of the report, DEAFNESS (loss of hearing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.
1.5 cm painful mass at injection site (R) deltoid developed after he received injection. Shoulder X-ray negative, CBC, LMP, LDH normal. Pt. noticed reaction about one month after receiving injection.
Pt c/o headache, dizziness, dry mouth, and extreme thirst.  Pt unable to walk in straight line. VS BP142/94, P88, R18. Feet elevated.  @220pm, VS  BP180/100, P88, R20, still c/o thirst.  911 called.  Ambulance crew reported Pulse ox 99%, blood sugar 122.  Transported to hospital @245pm for evaluation.
Sore arm; Underdose; exposure via skin contact; exposure via skin contact; the patient twitched severely; This case was reported by a pharmacist via call center representative and described the occurrence of twitching in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date 11th September 2021) for prophylaxis.   On 9th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th May 2019, immediately after receiving Shingrix, the patient experienced twitching, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On 10th May 2019, the patient experienced pain in arm. On an unknown date, the outcome of the twitching, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the twitching and pain in arm to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that while he was administering the Shingrix to the patient into the right deltoid and after the needle was in, the patient twitched severely and most of the dose went down his arm, probably half of it. However, the pharmacist gave the remaining 0.1 ml that was in the syringe, which led to an underdose, exposure via skin contact and inadvertent exposure to vaccine. The patient complained of a very sore arm on the day of reporting.
Lt upper arm developed blisters, redness, swelling & pain on Saturday 10/9/10 after flu vaccine on 10/8/10. Also had bad headache Friday, Saturday and Sunday & Monday. Blisters disappeared Saturday night. Headache disappeared Tuesday am.
Within 15 minutes of shot, the left side of my face went numb.  This remained for several hours and caused numbing, left eye tearing, left ear tenderness, numbness inside left cheek.  Within 1 day, severe sciatic pain on my left side developed and has not gone away since that day.  In addition, left knee pain has persisted since that (did not have pain prior to that day).
Death  5/31/2021 Causes of death listed on death certificate: 1) atherosclerotic heart disease  Other: recent Cove at 19, pneumonia, peripheral vascular disease, hypertension, dementia, extensive squamous cell carcinoma of skin of scalp, protein calorie malnutrition
By 11:00 PM of the day I received the vaccine, following rapid heartbeats and feeling like painful gas was moving up and down my arms, I fell into a deep sleep. I saw myself shot from a cannon, I floated away from a light then suddenly I was shot back to the light, and started feeling extremely hot. I lay on bathroom floor until about 4:30 AM. I couldn't talk. My wife wanted to call 911 but I motioned "no". By 8:00 AM my wife called the doctor but the call was not returned. I called the next day.
Extreme fatigue after the first shot on the same day.  Extreme fatigue on the day after the second dose.
Patient felt tingling tongue, top lip felt tingly,  Observed for 1 hr pulse ox 95-97%. BP 124/84. HR 65-85. Felt well and okay to leave.
Chills, cough, SOB w/exertion Loss of taste and smell Fatigue  COVID Antibody Infusion
It was so painful; I can't even move my arms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: It was so painful) and mobility decreased (Verbatim: I can't even move my arms). The outcome of the pain and mobility decreased were resolved (duration 1 week).   It was unknown if the reporter considered the pain and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the pain and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shot but it was so painful.  The patient can't even move her/his arms and lasted for a week. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
It started with chest pain, rashes, vomiting blood, bowl movements of blood, fatigue, and headaches. I also had hair loss, issue with and memory loss. It effected my period cycles. I also have been diagnosed with cancer. I have had lots of test. I have blood work, showed that my compound levels were high and my protein level was high.
Headache, chills, fever (102.4), joint pain, fatigue, slight lethargy, lasting 24 hours.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 13-AUG-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-JUN-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles and other post-herpetic nervous system involvement. The patient has been prescribed capsaicin cream for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Parents state about one hour after the vaccination, patient developed stiff hands, wide open eyes, behavioral changes, and side pain. He knew who his parents were but he couldn't remember his teacher's name. This lasted about 20-30 mins and sx resolved without treatment.
Case number PHEH2013US021726 is an initial spontaneous report from the health care professional received on 16 OCT 2013 with a follow up information received from a health care professional on 17 JAN 2014. This report refers to a 17-years-old female patient. Her medical history was not reported. Her concomitant vaccinations included Varicella virus vaccine (other manufacturer, batch number H006539) tetanus, diphtheria, acellular pertussis (other manufacturer,batch   number: 44325AB) and human papilloma virus vaccine (other manufacturer, batch number 1495AA) all the vaccines administered intramuscularly at a dose of 0.5 ml on 23 SEP 2013. She was accidentally vaccinated with only Men CYW liquid component of MENVEO (batch number A13013) intramuscularly in the right deltoid on 23 SEP 2013 and she did not receive MenA lyophilized conjugate. It was reported that she did not experience any adverse event after the mal-administration. She was re-vaccinated with MENVEO (batch number: not reported) on 23 OCT 2013 without any incident. No other information was available.   Follow up information received from a health care professional on 17 JAN 2014. Patient demographics (initials, date of birth, age, gender, height and weight), concomitant vaccinations, suspect vaccine batch number, vaccination date and site of vaccination and re-vaccination information updated.
bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath; low platelets; bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath; did not get the 2nd dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath), PRODUCT DOSE OMISSION ISSUE (did not get the 2nd dose of the vaccine), PLATELET COUNT DECREASED (low platelets) and VACCINATION SITE SWELLING (bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fibroids and Hysterectomy. Concurrent medical conditions included Liver disorder.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get the 2nd dose of the vaccine). On an unknown date, the patient experienced VACCINATION SITE BRUISING (bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath), PLATELET COUNT DECREASED (low platelets) and VACCINATION SITE SWELLING (bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath). On 16-Aug-2021, PRODUCT DOSE OMISSION ISSUE (did not get the 2nd dose of the vaccine) had resolved. At the time of the report, VACCINATION SITE BRUISING (bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath), PLATELET COUNT DECREASED (low platelets) and VACCINATION SITE SWELLING (bruise at the injection site and this began to grow bigger;  3x3 inches swollen underneath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 38,000 (Low) 38,000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  The reporter reported that the primary care doctor thought it was clot and advised the patient to take aspirin but patient did not take as she was suffering from unspecified liver disease.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded- However chronic liver disease could be a confounder. Further information has been requested.
Palpitations; Tachycardia; Increased heart rate; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 2, single (Lot number: EL3247), in left deltoid for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "Increased heart rate"; PALPITATIONS (non-serious) with onset 2021, outcome "unknown"; TACHYCARDIA (non-serious) with onset 2021, outcome "unknown". The events "palpitations", "tachycardia" and "increased heart rate" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The action taken for BNT162b2 was unknown. Therapeutic measures were not taken as a result of palpitations, tachycardia, heart rate increased.  No follow-up attempts are needed. No further information is expected.
heart pounding/ pounding heartbeat/ heart was palpitating; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (age reported as over 65; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 23Jan2021 (Lot number: EN6198) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PALPITATIONS (non-serious) with onset 23Jan2021, outcome "recovered" (2021), described as "heart pounding/ pounding heartbeat/ heart was palpitating". Additional information: The event was reported to occur 10 or 11 hours after vaccination at night.  No follow-up attempts are possible. No further information is expected.
I now have Bell's Palsy on the left side of my face.  The numbness and loss of taste started 3 days after the vaccine, then I had an achiness behind my left ear the 4th and 5th day after the vaccine. Then I woke up with the paralysis of the left side of my face.  I went to the dr's that morning.
Patient reported itchy throat, dizziness, tongue feeling weird and blurry vision shortly after administration of vaccine. Patient was administered 50 mg of diphenhydramine and laid on the floor for 45 minutes. Blood pressure and pulse were monitored. After 45 minutes of little to no improvement, EMS was notified. She was taken to the ER, observed and discharged.
Information has been received from a licensed practical nurse concerning a 12 year old female with no pertinent medical history who on 23-JUL-2007 was vaccinated intramuscularly with Gardasil and the patient received less than a full dose. There was no concomitant medication. The nurse reported that the needle was not fully attached to the syringe and some of the Gardasil leaked out at the syringe hub. The nurse reported that this was due to misuse not a product quality issue. On 23-JUL-2007 the patient developed a burning sensation after the vaccination that quickly resolved. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to reports previously submitted on 8/14/2007. Initial and follow-up information has been received from a liscensed practical nurse concerning a 12 year old female with no pertinent medical history who on 23-JUL-2007 was vaccinated intramusculary with a dose of GARDASIL (lot# 657622/0388U). There was no concomitant medication. Subsequently the patient received less than a full dose. The nurse reported that the needle was not fully attached to the syringe and some of the GARDASIL leaked out at the syringe hub. The nurse reported that this was due to misuse not a product quality issue. On 23-JUL-2007 the GARDASIL was reported. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient was recovered. Additional information has been requested.
Pt received COVID 19 (Moderna) vaccine series on Dose 1: 3/18/21 & dose 2: 4/16/21. Pt is currently 8 weeks pregnant with expected delivery date of Nov 24, 2021. Pulmonary embolism diagnosed 4/20/21 treated with enoxaparin.
12-23-20  LEFT SIDE OF FAVE DECREASED SENSATION/NUMBNESS AND LEFT ARM. RESOLVED THE FOLLOWING DAY WITH NO DEFICITS 1-7-21 15 DAYS AFTER RECEIVING THE VACCINE LEFT ARM BECAME MORE RED, SWOLLEN, HOT AND ITCHY
scheduled to get her 2nd vaccine tomorrow, 07May2021; a little Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a little Soreness in arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled to get her 2nd vaccine tomorrow, 07May2021) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (a little Soreness in arm). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled to get her 2nd vaccine tomorrow, 07May2021). On 06-Mar-2021, VACCINATION SITE PAIN (a little Soreness in arm) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (scheduled to get her 2nd vaccine tomorrow, 07May2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional event was updated.
Pt recvd vax & 5 mins later became dizzy; The dizziness resolved; pt then devel redness & pain @ the inject site;
Patients states that she began having right arm pain - 3 to 4 hours after receiving the vaccine on 10/6/10. Complains of right shoulder, arm & elbow pain. States pain was severe for the 1st 3 days - has improved some but still has pain. Patient taking TYLENOL, tried applying heat & ice with mild relief.
rashes; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included hypothyroid, Rashes. It was reported that she had hypothyroid before so sometimes she has immune system problems and will have rashes. She says she will take Zyrtec and the rashes will go away. She says 10 years ago was the first time that happened and she had to take Zyrtec every day to make the rashes go away. The patient Concomitant medications were not reported. It was reported that She said she had some side effects of rashes. She said after the vaccine she was ok then that night, after 10 hours, she started to have rashes all over her body. She said this time after the shot on the first time she got rashes the night she got the shot and they went away. She said then after maybe 5 days she had a very stressful day, drank more tea, and the rashes were coming back. She said she took a Zyrtec immediately and the rashes went away. She said now she doesn't have rashes but she doesn't know if she should get the second shot. She says she is scheduled this week for her second shot. She said right now she just called hospital and talked about the rashes. She said that lady at the hospital told her some people might have an allergic reaction to the vaccine which cause rashes; because they are allergic to the vaccine and stated that she also has the rashes from the immune system.Therapeutic measures were taken as a result of events.The outcome of rashes was resolved on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.