chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022).    No concomitant product use was reported.  Vaccine was stored in refrigerator on 04-Jun-2022.  Patient received half dose.  Vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 81.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Product was stored in refrigerator on 4Jun2022 and administered on 14Jul2022; No adverse event reported; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Product was stored in refrigerator on 4Jun2022 and administered on 14Jul2022) and NO ADVERSE EVENT (No adverse event reported) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was stored in refrigerator on 4Jun2022 and administered on 14Jul2022) and NO ADVERSE EVENT (No adverse event reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Product was stored in refrigerator on 4Jun2022 and administered on 14Jul2022) and NO ADVERSE EVENT (No adverse event reported) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event reported) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Product was stored in refrigerator on 4Jun2022 and administered on 14Jul2022).    No concomitant drug information was provided.  Patient had received half dose of the vaccine.  Vial was initially stored in refrigerator on 04-Jun-2022. The product hadn't undergone any temperature excursion issue.  No treatment drug information was provided.
Age: 81.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product was stored in refrigerator on 4Jun2022 and administered on 14Jul2022; No adverse event reported; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Product was stored in refrigerator on 4Jun2022 and administered on 14Jul2022) and NO ADVERSE EVENT (No adverse event reported) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was stored in refrigerator on 4Jun2022 and administered on 14Jul2022) and NO ADVERSE EVENT (No adverse event reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Product was stored in refrigerator on 4Jun2022 and administered on 14Jul2022) and NO ADVERSE EVENT (No adverse event reported) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event reported) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Product was stored in refrigerator on 4Jun2022 and administered on 14Jul2022).    No concomitant drug information was provided.  Patient had received half dose of the vaccine.  Vial was initially stored in refrigerator on 04-Jun-2022. The product hadn't undergone any temperature excursion issue.  No treatment drug information was provided.
Age: 68.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Product use issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered on 26-JUL-2022).    No concomitant product use was reported.  Reportedly, Patient received half dose. Vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 68.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered on 26-JUL-2022).    No concomitant product use was reported.  Reportedly, Patient received half dose. Vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: COVID positive after vaccination; COVID positive after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN5318), on 16Mar2021 as dose 2, single (Lot number: EN6205), on 18Aug2021 as dose 3 (booster), single (Lot number: FA7484) and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 70 years, in left arm for covid-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID positive after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown, notes: Tested herself for COVID using Binax antigen home tests; positive, notes: received Paxlovid treatment; It was all fine It was all fine, notes: She did travel over seas this past spring and had to have an antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid, 24Jul2022 to 28Jul2022).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID positive after vaccination; COVID positive after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN5318), on 16Mar2021 as dose 2, single (Lot number: EN6205), on 18Aug2021 as dose 3 (booster), single (Lot number: FA7484) and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 70 years, in left arm for covid-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID positive after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown, notes: Tested herself for COVID using Binax antigen home tests; positive, notes: received Paxlovid treatment; It was all fine It was all fine, notes: She did travel over seas this past spring and had to have an antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid, 24Jul2022 to 28Jul2022).
Age: 49.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Bell's palsy
Clinical narrative: pt came in to get moderna booster and same in 1 week later to explain that she had to go to the ER for an episode of bell's palsy. she has since been in to pick up medication for treatment of bells palsy with us.
Age: 49.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Asthenia, Bell's palsy, Hypoaesthesia
Clinical narrative: pt came in to get moderna booster and same in 1 week later to explain that she had to go to the ER for an episode of bell's palsy. she has since been in to pick up medication for treatment of bells palsy with us.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: VACCINE WAS GIVEN PAST THE BEYOND USE DATE.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after the beyond use date.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after he beyond use date.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Arthralgia, Blood pressure increased, Blood test, C-reactive protein increased
Clinical narrative: I took both Covid Vaccines and the Booster. I became VERY ill with each of them and not for just a couple days. No, about a month with each! Then, on day #28 after the Booster, I suddenly became even MORE ill. My jaw hurt SO much when I chewed and it felt like spasms in my mouth with Tonsillitis (My Tonsils are gone). I had Jaw Claudication. I had a sharp pain on the right side of my head (Temporal) and I also had ACUTE Fatigue (Could barely get out of my chair and I am usually SO active and going all the time!) Also, felt "Flu-ish" (General Malaise). I went to my Internal Medicine Doctor. She got me on HIGH-Dose Steroids which did help me but the side effects of the Steroids were HORRIFIC. Then, sent me to a group of Rheumatologists at Clinic. They verified my Temporal Arteritis/Vasculitis (Giant Cell Arteritis) was from the Covid Vaccines. They told me they are indeed seeing an increase in Vasculitis not only from the Vaccines, but also in people who have had Covid. My rotten luck!!! It can make you go instantly blind, or throw blood clots into your brain, your lungs etc, aneurisms..... So, I am still on the Steroids, but have been able to have them drop it a bit lower each month, for the past few months. Prior to this, I did consider myself healthy and have always been an active person. The acute Fatigue is something I am still actively contending with, along with various new joint/muscle pains. My A-1C is elevated and I have gained weight from the Steroids. (I probably eat less too!) Also, have the "Moon Face" from the Steroids. My Pulse and Blood Pressure are elevated which NEVER, EVER did I have before! My Rheumatogist has told me not to have any more boosters at this time. I do really hope many more studies are done SOON, as I believe this is going to be a huge new problem, with so many people getting Covid Vaccines and/or Covid itself!!
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Claudication of jaw muscles, Computerised tomogram, Dysstasia, Echocardiogram
Clinical narrative: I took both Covid Vaccines and the Booster. I became VERY ill with each of them and not for just a couple days. No, about a month with each! Then, on day #28 after the Booster, I suddenly became even MORE ill. My jaw hurt SO much when I chewed and it felt like spasms in my mouth with Tonsillitis (My Tonsils are gone). I had Jaw Claudication. I had a sharp pain on the right side of my head (Temporal) and I also had ACUTE Fatigue (Could barely get out of my chair and I am usually SO active and going all the time!) Also, felt "Flu-ish" (General Malaise). I went to my Internal Medicine Doctor. She got me on HIGH-Dose Steroids which did help me but the side effects of the Steroids were HORRIFIC. Then, sent me to a group of Rheumatologists at Clinic. They verified my Temporal Arteritis/Vasculitis (Giant Cell Arteritis) was from the Covid Vaccines. They told me they are indeed seeing an increase in Vasculitis not only from the Vaccines, but also in people who have had Covid. My rotten luck!!! It can make you go instantly blind, or throw blood clots into your brain, your lungs etc, aneurisms..... So, I am still on the Steroids, but have been able to have them drop it a bit lower each month, for the past few months. Prior to this, I did consider myself healthy and have always been an active person. The acute Fatigue is something I am still actively contending with, along with various new joint/muscle pains. My A-1C is elevated and I have gained weight from the Steroids. (I probably eat less too!) Also, have the "Moon Face" from the Steroids. My Pulse and Blood Pressure are elevated which NEVER, EVER did I have before! My Rheumatogist has told me not to have any more boosters at this time. I do really hope many more studies are done SOON, as I believe this is going to be a huge new problem, with so many people getting Covid Vaccines and/or Covid itself!!
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Giant cell arteritis, Glycosylated haemoglobin increased, Headache, Heart rate increased
Clinical narrative: I took both Covid Vaccines and the Booster. I became VERY ill with each of them and not for just a couple days. No, about a month with each! Then, on day #28 after the Booster, I suddenly became even MORE ill. My jaw hurt SO much when I chewed and it felt like spasms in my mouth with Tonsillitis (My Tonsils are gone). I had Jaw Claudication. I had a sharp pain on the right side of my head (Temporal) and I also had ACUTE Fatigue (Could barely get out of my chair and I am usually SO active and going all the time!) Also, felt "Flu-ish" (General Malaise). I went to my Internal Medicine Doctor. She got me on HIGH-Dose Steroids which did help me but the side effects of the Steroids were HORRIFIC. Then, sent me to a group of Rheumatologists at Clinic. They verified my Temporal Arteritis/Vasculitis (Giant Cell Arteritis) was from the Covid Vaccines. They told me they are indeed seeing an increase in Vasculitis not only from the Vaccines, but also in people who have had Covid. My rotten luck!!! It can make you go instantly blind, or throw blood clots into your brain, your lungs etc, aneurisms..... So, I am still on the Steroids, but have been able to have them drop it a bit lower each month, for the past few months. Prior to this, I did consider myself healthy and have always been an active person. The acute Fatigue is something I am still actively contending with, along with various new joint/muscle pains. My A-1C is elevated and I have gained weight from the Steroids. (I probably eat less too!) Also, have the "Moon Face" from the Steroids. My Pulse and Blood Pressure are elevated which NEVER, EVER did I have before! My Rheumatogist has told me not to have any more boosters at this time. I do really hope many more studies are done SOON, as I believe this is going to be a huge new problem, with so many people getting Covid Vaccines and/or Covid itself!!
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypophagia, Immunisation reaction, Magnetic resonance imaging, Malaise, Mastication disorder
Clinical narrative: I took both Covid Vaccines and the Booster. I became VERY ill with each of them and not for just a couple days. No, about a month with each! Then, on day #28 after the Booster, I suddenly became even MORE ill. My jaw hurt SO much when I chewed and it felt like spasms in my mouth with Tonsillitis (My Tonsils are gone). I had Jaw Claudication. I had a sharp pain on the right side of my head (Temporal) and I also had ACUTE Fatigue (Could barely get out of my chair and I am usually SO active and going all the time!) Also, felt "Flu-ish" (General Malaise). I went to my Internal Medicine Doctor. She got me on HIGH-Dose Steroids which did help me but the side effects of the Steroids were HORRIFIC. Then, sent me to a group of Rheumatologists at Clinic. They verified my Temporal Arteritis/Vasculitis (Giant Cell Arteritis) was from the Covid Vaccines. They told me they are indeed seeing an increase in Vasculitis not only from the Vaccines, but also in people who have had Covid. My rotten luck!!! It can make you go instantly blind, or throw blood clots into your brain, your lungs etc, aneurisms..... So, I am still on the Steroids, but have been able to have them drop it a bit lower each month, for the past few months. Prior to this, I did consider myself healthy and have always been an active person. The acute Fatigue is something I am still actively contending with, along with various new joint/muscle pains. My A-1C is elevated and I have gained weight from the Steroids. (I probably eat less too!) Also, have the "Moon Face" from the Steroids. My Pulse and Blood Pressure are elevated which NEVER, EVER did I have before! My Rheumatogist has told me not to have any more boosters at this time. I do really hope many more studies are done SOON, as I believe this is going to be a huge new problem, with so many people getting Covid Vaccines and/or Covid itself!!
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Pain in jaw, Red blood cell sedimentation rate normal, Vasculitis
Clinical narrative: I took both Covid Vaccines and the Booster. I became VERY ill with each of them and not for just a couple days. No, about a month with each! Then, on day #28 after the Booster, I suddenly became even MORE ill. My jaw hurt SO much when I chewed and it felt like spasms in my mouth with Tonsillitis (My Tonsils are gone). I had Jaw Claudication. I had a sharp pain on the right side of my head (Temporal) and I also had ACUTE Fatigue (Could barely get out of my chair and I am usually SO active and going all the time!) Also, felt "Flu-ish" (General Malaise). I went to my Internal Medicine Doctor. She got me on HIGH-Dose Steroids which did help me but the side effects of the Steroids were HORRIFIC. Then, sent me to a group of Rheumatologists at Clinic. They verified my Temporal Arteritis/Vasculitis (Giant Cell Arteritis) was from the Covid Vaccines. They told me they are indeed seeing an increase in Vasculitis not only from the Vaccines, but also in people who have had Covid. My rotten luck!!! It can make you go instantly blind, or throw blood clots into your brain, your lungs etc, aneurisms..... So, I am still on the Steroids, but have been able to have them drop it a bit lower each month, for the past few months. Prior to this, I did consider myself healthy and have always been an active person. The acute Fatigue is something I am still actively contending with, along with various new joint/muscle pains. My A-1C is elevated and I have gained weight from the Steroids. (I probably eat less too!) Also, have the "Moon Face" from the Steroids. My Pulse and Blood Pressure are elevated which NEVER, EVER did I have before! My Rheumatogist has told me not to have any more boosters at this time. I do really hope many more studies are done SOON, as I believe this is going to be a huge new problem, with so many people getting Covid Vaccines and/or Covid itself!!
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heart rate increased, Mental impairment, Myocarditis
Clinical narrative: Nausea, Headache, Fever. Dizziness, Rapid Heartbeat.  Myocarditis. Lowered Brain Function.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea, Headache, Fever. Dizziness, Rapid Heartbeat.  Myocarditis. Lowered Brain Function.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: It's not safe and affective; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "It's not safe and affective".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: MMR, MMRV, VARCEL
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: the patient wanted to get the "booster" of MMR II and VARIVAX but received PROQUAD on 7/13/2022 instead; a 31 year old patient received PROQUAD instead of MMR II and VARIVAX; patient's recent titer test for MMR and varicella came back "low level"; patient's recent titer test for MMR and varicella came back "low level"; Mumps antibody test negative; patient's recent titer test for MMR and varicella came back "low level"; This spontaneous report has been received from an office manager, regarding a 31-year-old male patient. The patient's concurrent and historical conditions, drug reactions/allergies and concomitant medications were reported as none.   On an unspecified date (in the past), the patient had received varicella virus vaccine live (oka/merck) (VARIVAX) (lot #, expiration date, dose, site and route of administration were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, dose, site and route of administration were not provided) for prophylaxis.  However, the patient's recent titer tests for measles, mumps, and rubella (MMR) and varicella came back "low level" (measles antibody negative, mumps antibody test negative, rubella antibody negative, antibody test negative), so the patient wanted to get the "booster" of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).    But on 13-JUL-2022, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (Oka/Merck) virus vaccine live (PROQUAD) 1 dose, (lot number# U014798, expiration date: 06-NOV-2022) (dose, site, and route of administration were not provided) (product administered to patient of inappropriate age) instead (wrong product administered). No additional adverse events (AEs) were reported. These events were no cancer, overdose, hospitalized or prolonged, life-threatening, significant disability, or intervention to prevent serious criteria. No further information was provided.   The outcome of these events was not reported. The causal relationship between the events and varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported. The causal relationship between the events and measles (+) mumps (+) rubella (+) varicella (Oka/Merck) virus vaccine live (PROQUAD) was not related.
Sex: F
Vaccine: HPV9
Symptoms: Loss of personal independence in daily activities, Malaise, Mobility decreased, Myalgia, Nasopharyngitis
Clinical narrative: the patient experienced "general cold like symptoms" /fever / being sick; The patient experienced myalgia,; This spontaneous report was received from a physician via company representative referring to a non-pregnant female patient of unspecified age. Her medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered intramuscularly (strength, lot #, expiry date and anatomical location were not provided) used as directed to prevent human papilloma virus infection.  On an unknown date, the patient was out of school due to being sick for a week. She experienced myalgia and fever. It was stated that the patient experienced "general cold like symptoms" and was "in bed for a week". At the time of reporting, she was recovered from the events.  The causal relationship between myalgia,cold symptoms and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: the patient experienced "general cold like symptoms" /fever / being sick; The patient experienced myalgia,; This spontaneous report was received from a physician via company representative referring to a non-pregnant female patient of unspecified age. Her medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered intramuscularly (strength, lot #, expiry date and anatomical location were not provided) used as directed to prevent human papilloma virus infection.  On an unknown date, the patient was out of school due to being sick for a week. She experienced myalgia and fever. It was stated that the patient experienced "general cold like symptoms" and was "in bed for a week". At the time of reporting, she was recovered from the events.  The causal relationship between myalgia,cold symptoms and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A improperly stored vaccine (VARIVAX) was administered to a 22 year old, female patient.; No adverse effects reported.; This spontaneous report has been received from a medical assistant concerning to a 22-years-old female.  The patient's medical history, current conditions, previous drug reactions or allergies, were not reported.   On an unknown date, the patient was  vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered subcutaneousl, as prophylaxis (dose, route, anatomical site of administration, and vaccine scheme were not provided, lot number T029533 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported and upon internal validation established as 01-SEP-2022) (product storage error). It was reported that the sterile diluent was used as concomitant therapy to reconstitute the vaccine (lot number and expiration date was not provided) but it was not reported at what temperature it was stored.  The vaccine was stored at a temperature of 19.2 degrees Fahrenheit (F) for a timeframe of 3 hour and 15 minutes. There was no previous temperature excursion. No PQC (product quality complaint) was reported.  No adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Nerve injury
Clinical narrative: nerve damage; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. In on around October 2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered nerve damage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the suspect vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of nerve damage was considered to be not recovered/not resolved. The reporter regarded the event as related to zoster vaccine live (ZOSTAVAX).  The event of nerve damage was considered by the reporter to be disabling.
Sex: F
Vaccine: VARCEL
Symptoms: Viral titre decreased
Clinical narrative: the patient's titers being low; This spontaneous report was received from a pharmacist and refers to a 27-year-old female patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date (reported also as "within 5 years"), the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 ml (route of administration, anatomical location, lot # and expiration date were not reported) and in approximately 2019 (reported as "about 3 years ago"), the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 ml (route of administration, anatomical location, lot # and expiration date were not reported), both for prophylaxis.  On an unknown date, the patient's varicella titers were low. The prescriber indicated that he would like to administer the third dose due to this event, however at the reporting time, the third dose had not been administered. The outcome of the event was unknown.  The causality assessment between the event and the suspect vaccine was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No adverse event; temperature excursion and also reported that the vaccine, VAQTA was administered; This spontaneous report was received from a pharmacist regarding a patient of an unknown age and unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-AUG-2022, a dose of hepatitis a vaccine, inactivated (VAQTA) lot # U033212, expiration date: 07-NOV-2022 (strength, and route of administration were not provided) was administered, following a temperature excursion (product storage error). No additional adverse events had been reported (no adverse event). No additional information was provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs.; HCP called in to report a temperature excursion and also reported that the vaccine, GARDASIL 9 was administered; This spontaneous report was received from a Licensed Practical Nurse regarding a patient of an unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 29-JUL-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1780876, expiration date: 09-NOV-2023, (dosage regimen, strength, route of administration, and anatomical location were not provided) as prophylaxis, which underwent a temperature excursion (Product storage error). No additional adverse events (AEs) were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs.; HCP called in to report a temperature excursion and also reported that the vaccine, GARDASIL 9 was administered.; This spontaneous report was received from a Licensed Practical Nurse regarding a patient of an unspecified age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 29-JUL-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1780876, expiration date: 09-NOV-2023, (dosage regimen, strength, route of administration, and anatomical location were not provided) as prophylaxis, which underwent a temperature excursion (Product storage error). No additional adverse events (AEs) were reported.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 12-month-old female patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided. On 03-AUG-2022, the patient was vaccinated with M-M-R II injection, 0.5 ml, once, lot # T025930 confirmed to be valid with expiration date: 30-JUL-2022 (route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The vaccine did not undergo a temperature excursion. The patient did not experience any adverse reaction.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs reported.; Nurse reports the administration of VARIVAX via intramuscularly versus subcutaneously. No additional AEs reported. No PQCs reported. No further details provided.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 03-AUG-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection 0.5 ml, lot # W011625 confirmed to be valid with expiration date: 06-APR-2024,  intramuscularly instead of subcutaneously (incorrect route of product administration), for prophylaxis. There was no additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; VARIVAX may have accidentally pushed out some of the vaccine prior to administration thus administering less than the full 0.5 mL dose to patient; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 03-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (ml), lot #U024220, expiration date: 04-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided); which had been diluted with sterile diluent, lot #T032311, expiration date: 05-MAY-2023. It was reported that the medical assistant who administered varicella virus vaccine live (oka/merck) (VARIVAX) to the patient might had accidentally pushed out some of the vaccine prior to administration thus administering less than 0.5 ml dose to the patient. The reported stated that the patient might had received 0.3 ml or 0.4 ml (accidental underdose). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional ae reported; PROQUAD was administered after a temperature excursion to multiple patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not provided.  On 04-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, once (lot #W010061 with an expiration date on 20-SEP-2023) administered for prophylaxis (strength, and route of administration were not provided). after a temperature excursion of 5.56°F degrees Fahrenheit with time frame of 9 hours 30 minutes and 0 seconds to multiple patients.  No additional adverse events and no previous temperature excursion were reported. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose last October 2020; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose in October 2020).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-AUG-2022 Reporter's comment: This case was reported by the patient's spouse. The patient had a question about Shingrix two dose series. The patient asked whether he/she could receive the second dose now. It had been greater than six months. Although the patient's primary care physician was recommending to start the series over. The request for consent to follow-up was granted. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: vaccine given without diluent; vaccine given without diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 8-Aug-2022 Reporter comment: The reporter stated that needing to ask about a vaccine administration error and a vaccine was given without the diluent.  The reporter want to know if patient could come back in right away for revaccination. Additional Supportive Information: The vaccine was given without the diluent which leads inappropriate preparation of medication and inappropriate dose of vaccine administered
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: tingling around the bottom lip; tingling around the chin area; This case was reported by a consumer via call center representative and described the occurrence of tingling lips in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced tingling lips and tingling skin. On an unknown date, the outcome of the tingling lips and tingling skin were unknown.   It was unknown if the reporter considered the tingling lips and tingling skin to be related to Shingrix.     Additional Information: GSK Receipt Date: 8-Aug-2022 Reporter's comment: The patient self reported the case. The patient received a dose of Shingrix about 2 months ago and got tingly bottom lip and chin. The reporter wanted to know if the Shingrix vaccine caused it. Follow up was not possible as no contact details were available.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: temperature went up to 60 degrees; This case was reported by a consumer via interactive digital media and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 05-Aug-2022 Reporter's Comments: The case was received from the patient via interactive digital media. The refrigerator door did not seal overnight and the temperature went up to 60 degrees. Follow-up could not be possible as no contact details were available. Additional supportive information: The Boostrix vaccine temperature was exposed upto 60 degrees, which led to incorrect storage of drug.