chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Tenderness at injection site started a few hours after injection, on 16-FEB-2020. Body aches started in the evening of the day the vaccine was administered (16-FEB-2020). On 17-FEB-2020, experienced fever to 101.5 degrees F, chills, headache, tooth pain. I took 400mg of ibuprofen immediately after receiving the vaccination on 16-FEB-2020 and again on this same date at 10:30 PM. I took the same dose of ibuprofen again on 17-FEB-2020 at 10:30 AM Fever to 101.5 degrees F, chills, resolved on 17-FEB-2020. Body aches, headache, are resolving/improved as of 17-FEB-2020. Tooth pain not resolved Tenderness at injection site not resolved
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Toothache
Clinical narrative: Tenderness at injection site started a few hours after injection, on 16-FEB-2020. Body aches started in the evening of the day the vaccine was administered (16-FEB-2020). On 17-FEB-2020, experienced fever to 101.5 degrees F, chills, headache, tooth pain. I took 400mg of ibuprofen immediately after receiving the vaccination on 16-FEB-2020 and again on this same date at 10:30 PM. I took the same dose of ibuprofen again on 17-FEB-2020 at 10:30 AM Fever to 101.5 degrees F, chills, resolved on 17-FEB-2020. Body aches, headache, are resolving/improved as of 17-FEB-2020. Tooth pain not resolved Tenderness at injection site not resolved
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Patient informed the pharmacy that he developed chicken pox as a result of the shingles vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Musculoskeletal disorder
Clinical narrative: Patient reported day of vaccination was unable to have any range of motion in arm for 3 weeks after.  Has improved but still unable to fully use arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Headache, Pain in extremity
Clinical narrative: Sore arm, headache, upset stomach 14 hours after injection. Loss of appetite and upset stomach for 48-60 hours.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Mobility decreased, Pain, Swelling
Clinical narrative: SWELLING, REDNESS, HEAT, PAIN, COULD NOT LIFT ARM FOR 3 DAYS. PATIENT HAD STILL NOT RECOVERED BY DAY 7.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Joint range of motion decreased, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: ON 2/5 PATIENT COMPLAIN TO PHARMACY ABOUT ARM.  FIRST 2-3 DAYS, COULD NOT LIFT ARM.  PATIENT STAYED UP ALL NIGHTS AND IN PAIN.  IMPROVED SLIGHTLY DAILY.  STILL AS OF 2/5, PAIN IN SHOULDER.  RANGE OF MOTION WAS LIMITED.  HE DISCUSSED WITH MD AND MD STATED THESE THINGS HAPPEN.  HE WAS TOLD BY MYSELF, PHARMACIST TO PUT ICE ON IT AND TAKE IBUPROFEN. PATIENT WILL NOT USE IBUPROFEN.  HE DOESNT WANT STOMACH ISSUE.  i REITERATED, AND HE STILL REFUSED.  ON 2/11/2020, CALLED HIM AT HOME.  HE STATED HE WAS IMPROVING, STARTING WEIGHT BEARING  EXERCISES AND WAS IMPROVING.  STILL NOT FULL RANGE OF MOTION/  CALLED PATIENT AT HOME AGAIN ON 2/17/2020.  STILL IMPROVING,  RANGE OF MOTION IS COMING BACK.  HE STILL NOT 100% ..  HE DID PLAY GOLF.  ICING, AND STILL NOT TAKING IBUPROFEN.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Bed rest, Chills
Clinical narrative: fever 101 degrees, headache, severe joint pain and body aches, nasua, stomach pain, shivering, weakness and tired, sore and swollen at injection site unable to perform daily functions for approximately 48 hours, lesser symptoms lingered for 72 hours no treatment just complete bed rest for 36 hours
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: fever 101 degrees, headache, severe joint pain and body aches, nasua, stomach pain, shivering, weakness and tired, sore and swollen at injection site unable to perform daily functions for approximately 48 hours, lesser symptoms lingered for 72 hours no treatment just complete bed rest for 36 hours
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: fever 101 degrees, headache, severe joint pain and body aches, nasua, stomach pain, shivering, weakness and tired, sore and swollen at injection site unable to perform daily functions for approximately 48 hours, lesser symptoms lingered for 72 hours no treatment just complete bed rest for 36 hours
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Bed rest, Dizziness
Clinical narrative: fever 101 degrees, headache, severe joint pain and body aches, nasua, stomach pain, weakness and tired, dizziness, sore arm at injection site unable to perform daily functions for 36 hours, lesser symptoms lingered for 48 hours no treatment complete bed rest for 18 hours
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Loss of personal independence in daily activities, Nausea
Clinical narrative: fever 101 degrees, headache, severe joint pain and body aches, nasua, stomach pain, weakness and tired, dizziness, sore arm at injection site unable to perform daily functions for 36 hours, lesser symptoms lingered for 48 hours no treatment complete bed rest for 18 hours
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: fever 101 degrees, headache, severe joint pain and body aches, nasua, stomach pain, weakness and tired, dizziness, sore arm at injection site unable to perform daily functions for 36 hours, lesser symptoms lingered for 48 hours no treatment complete bed rest for 18 hours
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: patient called the pharmacy manager complain about extremely nausea, joints pain, diarrhea, headache , pain and low rate fever 100.9 F.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: patient called the pharmacy manager complain about extremely nausea, joints pain, diarrhea, headache , pain and low rate fever 100.9 F.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Dehydration, Diarrhoea, Feeling abnormal, Headache
Clinical narrative: patient called the pharmacy manager complain about extremely nausea, joints pain, diarrhea, headache , pain and low rate fever 100.9 F.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: patient called the pharmacy manager complain about extremely nausea, joints pain, diarrhea, headache , pain and low rate fever 100.9 F.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED ABOUT 10-15 MINUTES AFTER VACCINE ADMINISTRATION.
Age: 102.0
Sex: F
Vaccine: PPV
Symptoms: Atrial fibrillation, Chest X-ray, Electrocardiogram abnormal, Erythema, Hypoxia
Clinical narrative: Vaccine 3:13pm, pain redness and some swelling started about 4:30pm (same day). On 2/14/2020 Redness and swelling worsened and she went to primary doctor. An EKG was done & was told she was in A-Fib (no history & not on any anticoagulations). Worsened even more on 2/15/20 & came to ER. (Swelling in entire left arm). Also has this nodularity in the right base. Found-slightly hypoxic & right lower lobe infiltrate & treated with right sided pneumonia. Treatment - methylprednisolone, Azithromycin and Ceftriaxone. Outcome: patient treated for Pneumonia and swelling. Patient improving
Age: 102.0
Sex: F
Vaccine: PPV
Symptoms: Lung infiltration, Pain, Peripheral swelling, Pneumonia, Pulmonary mass
Clinical narrative: Vaccine 3:13pm, pain redness and some swelling started about 4:30pm (same day). On 2/14/2020 Redness and swelling worsened and she went to primary doctor. An EKG was done & was told she was in A-Fib (no history & not on any anticoagulations). Worsened even more on 2/15/20 & came to ER. (Swelling in entire left arm). Also has this nodularity in the right base. Found-slightly hypoxic & right lower lobe infiltrate & treated with right sided pneumonia. Treatment - methylprednisolone, Azithromycin and Ceftriaxone. Outcome: patient treated for Pneumonia and swelling. Patient improving
Age: 102.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Ultrasound scan
Clinical narrative: Vaccine 3:13pm, pain redness and some swelling started about 4:30pm (same day). On 2/14/2020 Redness and swelling worsened and she went to primary doctor. An EKG was done & was told she was in A-Fib (no history & not on any anticoagulations). Worsened even more on 2/15/20 & came to ER. (Swelling in entire left arm). Also has this nodularity in the right base. Found-slightly hypoxic & right lower lobe infiltrate & treated with right sided pneumonia. Treatment - methylprednisolone, Azithromycin and Ceftriaxone. Outcome: patient treated for Pneumonia and swelling. Patient improving
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: (Lt) arm swelling + Redness
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Blood test normal, Magnetic resonance imaging brain normal
Clinical narrative: loss of taste the next day; This case was reported by a consumer via call center representative and described the occurrence of taste loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received the 1st dose of Shingrix. On 9th October 2019, 1 days after receiving Shingrix, the patient experienced taste loss. On an unknown date, the outcome of the taste loss was not recovered/not resolved.   It was unknown if the reporter considered the taste loss to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination experienced loss of taste.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia
Clinical narrative: loss of taste the next day; This case was reported by a consumer via call center representative and described the occurrence of taste loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received the 1st dose of Shingrix. On 9th October 2019, 1 days after receiving Shingrix, the patient experienced taste loss. On an unknown date, the outcome of the taste loss was not recovered/not resolved.   It was unknown if the reporter considered the taste loss to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination experienced loss of taste.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Genital rash, Rash, Swollen tongue
Clinical narrative: Received vaccine at Pharmacy at 2:24 p.m. Went directly home - 50.miles. at about 3pm started with very itchy hives. By time we were home the tongue was swelling rapidly. Called Pharmacy advised to take 2 Benadryl & go imm. to Dr. Clinic sent me to ER. had adrenaline shot in deep muscle & IV with steroid, antibiotics & more Benadryl. Home about 7. on Benadryl for about 8 days.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Swollen tongue, Urticaria
Clinical narrative: Received vaccine at Pharmacy at 2:24 p.m. Went directly home - 50.miles. at about 3pm started with very itchy hives. By time we were home the tongue was swelling rapidly. Called Pharmacy advised to take 2 Benadryl & go imm. to Dr. Clinic sent me to ER. had adrenaline shot in deep muscle & IV with steroid, antibiotics & more Benadryl. Home about 7. on Benadryl for about 8 days.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Chills, Injection site pain, Neuralgia, Pyrexia
Clinical narrative: I had the expected minor muscle ache and run down feeling the first 24-36 hours after getting the vaccination.  The big issues started about 72 hours post vaccination.  Both legs began to ache severely in the front thigh area such that I could not sit down for more than about 15 minutes at a time without getting up to walk around to alleviate the aching.  That night I was unable to sleep due to the aching unless I took Motrin at the maximum daily dosage (2 tablets every 6 hours).  The next day I was unable to go to work due to the pain.  After two more days, I was able to return to work as the aching seemed to be easing.  However, I then got back nerve pain which felt like hot prickling in my lower back and a bit on one side of my back.  It felt like a sunburn but there was no burn on the skin.  This took about 7-10 days to subside completely.  I contacted the vaccine manufacturer who urged me to see my doctor but I didn't feel that he would be able to help as the source of this sure seemed related to the vaccination.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Impaired work ability, Insomnia, Myalgia, Neuralgia
Clinical narrative: I had the expected minor muscle ache and run down feeling the first 24-36 hours after getting the vaccination.  The big issues started about 72 hours post vaccination.  Both legs began to ache severely in the front thigh area such that I could not sit down for more than about 15 minutes at a time without getting up to walk around to alleviate the aching.  That night I was unable to sleep due to the aching unless I took Motrin at the maximum daily dosage (2 tablets every 6 hours).  The next day I was unable to go to work due to the pain.  After two more days, I was able to return to work as the aching seemed to be easing.  However, I then got back nerve pain which felt like hot prickling in my lower back and a bit on one side of my back.  It felt like a sunburn but there was no burn on the skin.  This took about 7-10 days to subside completely.  I contacted the vaccine manufacturer who urged me to see my doctor but I didn't feel that he would be able to help as the source of this sure seemed related to the vaccination.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pain of skin
Clinical narrative: I had the expected minor muscle ache and run down feeling the first 24-36 hours after getting the vaccination.  The big issues started about 72 hours post vaccination.  Both legs began to ache severely in the front thigh area such that I could not sit down for more than about 15 minutes at a time without getting up to walk around to alleviate the aching.  That night I was unable to sleep due to the aching unless I took Motrin at the maximum daily dosage (2 tablets every 6 hours).  The next day I was unable to go to work due to the pain.  After two more days, I was able to return to work as the aching seemed to be easing.  However, I then got back nerve pain which felt like hot prickling in my lower back and a bit on one side of my back.  It felt like a sunburn but there was no burn on the skin.  This took about 7-10 days to subside completely.  I contacted the vaccine manufacturer who urged me to see my doctor but I didn't feel that he would be able to help as the source of this sure seemed related to the vaccination.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: none
Age: 63.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; Concern of a potential stroke; This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 2K9T2, expiry date 9th April 2022) for prophylaxis.   On 19th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 5th February 2020, 17 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant) and stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy and stroke were unknown.   It was unknown if the reporter considered the bell's palsy and stroke to be related to Shingrix.  Additional information was provided as follows: The patient was taken to the emergency room with concern of a potential stroke and was told she had Bell's palsy. The patient was not hospitalized. The reporter did not have health care professional's information.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident, Facial paralysis
Clinical narrative: Bell's Palsy; Concern of a potential stroke; This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 2K9T2, expiry date 9th April 2022) for prophylaxis.   On 19th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 5th February 2020, 17 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant) and stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy and stroke were unknown.   It was unknown if the reporter considered the bell's palsy and stroke to be related to Shingrix.  Additional information was provided as follows: The patient was taken to the emergency room with concern of a potential stroke and was told she had Bell's palsy. The patient was not hospitalized. The reporter did not have health care professional's information.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Huge hot red itchy rash persistent for over 4 days. Growing in size. Spreading down and up arm.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Computerised tomogram head normal, Eye pain, Headache, Hyperhidrosis
Clinical narrative: Initial reaction started 3-5 hrs. after administration with swollen, red, warm injection site, headache, neck pain, muscle aches all over, fever less than 100.  Down in bed for approximately 30 hrs. then resolved.  On 2/7/2020,  approximately 7pm, started with chills and fever up to 102.4, severe headache, neck pain, nerve pain down legs, eyes hurt with movement, excessive sweating.  Test for influenza in emergency dept. on 2/8/2020 was negative.  Feeling even worse by 2/12/2020, spent most of day in emergency room.  LP, CT of head, and labs done.  All testing was negative.  Over following two days small area of shingles type rash appeared in same area of previous shingles episode years ago.  Primary care physician
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza virus test negative, Injection site erythema, Injection site swelling, Injection site warmth, Laboratory test normal
Clinical narrative: Initial reaction started 3-5 hrs. after administration with swollen, red, warm injection site, headache, neck pain, muscle aches all over, fever less than 100.  Down in bed for approximately 30 hrs. then resolved.  On 2/7/2020,  approximately 7pm, started with chills and fever up to 102.4, severe headache, neck pain, nerve pain down legs, eyes hurt with movement, excessive sweating.  Test for influenza in emergency dept. on 2/8/2020 was negative.  Feeling even worse by 2/12/2020, spent most of day in emergency room.  LP, CT of head, and labs done.  All testing was negative.  Over following two days small area of shingles type rash appeared in same area of previous shingles episode years ago.  Primary care physician
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lumbar puncture, Myalgia, Neck pain, Neuralgia, Pyrexia
Clinical narrative: Initial reaction started 3-5 hrs. after administration with swollen, red, warm injection site, headache, neck pain, muscle aches all over, fever less than 100.  Down in bed for approximately 30 hrs. then resolved.  On 2/7/2020,  approximately 7pm, started with chills and fever up to 102.4, severe headache, neck pain, nerve pain down legs, eyes hurt with movement, excessive sweating.  Test for influenza in emergency dept. on 2/8/2020 was negative.  Feeling even worse by 2/12/2020, spent most of day in emergency room.  LP, CT of head, and labs done.  All testing was negative.  Over following two days small area of shingles type rash appeared in same area of previous shingles episode years ago.  Primary care physician
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, White blood cell count normal
Clinical narrative: Initial reaction started 3-5 hrs. after administration with swollen, red, warm injection site, headache, neck pain, muscle aches all over, fever less than 100.  Down in bed for approximately 30 hrs. then resolved.  On 2/7/2020,  approximately 7pm, started with chills and fever up to 102.4, severe headache, neck pain, nerve pain down legs, eyes hurt with movement, excessive sweating.  Test for influenza in emergency dept. on 2/8/2020 was negative.  Feeling even worse by 2/12/2020, spent most of day in emergency room.  LP, CT of head, and labs done.  All testing was negative.  Over following two days small area of shingles type rash appeared in same area of previous shingles episode years ago.  Primary care physician
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Computerised tomogram normal, Condition aggravated, Dehydration, Diplopia
Clinical narrative: Initial reaction started 3-5 hrs. after administration with swollen, red, warm injection site, headache, neck pain, muscle aches all over, fever less than 100.  Down in bed for approximately 30 hrs. then resolved.  On 2/7/2020,  approximately 7pm, started with chills and fever up to 102.4, severe headache, neck pain, nerve pain down legs, eyes hurt with movement, excessive sweating.  Test for influenza in emergency dept. on 2/8/2020 was negative.  Feeling even worse by 2/12/2020, spent most of day in emergency room.  LP, CT of head, and labs done.  All testing was negative.  Over following two days small area of shingles type rash appeared in same area of previous shingles episode years ago.  Primary care physician
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye pain, Feeling hot, Headache, Hyperhidrosis, Influenza virus test negative
Clinical narrative: Initial reaction started 3-5 hrs. after administration with swollen, red, warm injection site, headache, neck pain, muscle aches all over, fever less than 100.  Down in bed for approximately 30 hrs. then resolved.  On 2/7/2020,  approximately 7pm, started with chills and fever up to 102.4, severe headache, neck pain, nerve pain down legs, eyes hurt with movement, excessive sweating.  Test for influenza in emergency dept. on 2/8/2020 was negative.  Feeling even worse by 2/12/2020, spent most of day in emergency room.  LP, CT of head, and labs done.  All testing was negative.  Over following two days small area of shingles type rash appeared in same area of previous shingles episode years ago.  Primary care physician
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Lumbar puncture normal, Malaise, Musculoskeletal pain, Neck pain
Clinical narrative: Initial reaction started 3-5 hrs. after administration with swollen, red, warm injection site, headache, neck pain, muscle aches all over, fever less than 100.  Down in bed for approximately 30 hrs. then resolved.  On 2/7/2020,  approximately 7pm, started with chills and fever up to 102.4, severe headache, neck pain, nerve pain down legs, eyes hurt with movement, excessive sweating.  Test for influenza in emergency dept. on 2/8/2020 was negative.  Feeling even worse by 2/12/2020, spent most of day in emergency room.  LP, CT of head, and labs done.  All testing was negative.  Over following two days small area of shingles type rash appeared in same area of previous shingles episode years ago.  Primary care physician
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Peripheral swelling, Pyrexia, Sensitive skin, Spinal pain
Clinical narrative: Initial reaction started 3-5 hrs. after administration with swollen, red, warm injection site, headache, neck pain, muscle aches all over, fever less than 100.  Down in bed for approximately 30 hrs. then resolved.  On 2/7/2020,  approximately 7pm, started with chills and fever up to 102.4, severe headache, neck pain, nerve pain down legs, eyes hurt with movement, excessive sweating.  Test for influenza in emergency dept. on 2/8/2020 was negative.  Feeling even worse by 2/12/2020, spent most of day in emergency room.  LP, CT of head, and labs done.  All testing was negative.  Over following two days small area of shingles type rash appeared in same area of previous shingles episode years ago.  Primary care physician
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: After 2 weeks rash developed at injection site, 5 months later still fighting it on 2 thirds of body
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Inappropriate schedule of product administration, Injection site hypoaesthesia
Clinical narrative: In a previous PAP test, something was detected, but it went away; numbness in the injection site area; feeling dizzy; received her first dose of GARDASIL 9 about 10 years ago and just gave herself her second dose today; This spontaneous report was received from a 33 year old female pharmacist reporting on herself. There were no concurrent conditions, medical history or concomitant therapies reported  On an unspecified date in 2010 (reported as about 10 years ago) the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular (Lot # N035957 with expiration date on 10-OCT-2020). On 11-FEB-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(inappropriate schedule of product administration). Following administration of the second dose, she reported some numbness in the injection site area, and feeling dizzy, which resolved after 5 minutes. No treatment was received. It was also reported that in a previous PAP test from an unspecified date, something was detected (Smear cervix abnormal), but it went away.    The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles/herpes zoster; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 07-JAN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a severe painful rash across the right side of her back and arm. The patient was diagnosed with shingles/herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences 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 patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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 patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles/herpes zoster was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event shingles/herpes zoster to be disability.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; 19 years old patient received a pediatric dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a 19-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 21-JAN-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # S023499, expiration date 24-AUG-2020 (route of administration was not reported), for prophylaxis. The patient received pediatric dose of hepatitis a vaccine, inactivated (VAQTA). No known adverse effects reported. The outcome of the event was unknown.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Incomplete course of vaccination, Pain, Pyrexia
Clinical narrative: body aches; Incomplete course of vaccination; Fatigue; Fever; This case was reported by a physician via call center representative and described the occurrence of fatigue in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 7447A, expiry date 25th April 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue, fever, general body pain and incomplete course of vaccination. On an unknown date, the outcome of the fatigue and fever were recovered/resolved and the outcome of the general body pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the fatigue, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that after vaccination the patient had fever and fatigue for 7 to 10 days. The health care professional asked how to proceed with the second shot. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete cours eof vaccination. The health care professional stated that the patient received the first dose in the facility where she works. The health care professional  was calling to ask if the patient should receive the second dose taking into account the adverse reactions developed, but did not realize the late dose issue until the first line agent mentioned her the recommended schedule for Shingrix. The reporter consented to follow up. The VAERS details were not provided. This case 1 of 3 linked cases, reported by same reporter.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Discomfort, Erythema, Rash, Rash pruritic
Clinical narrative: I broke out in a very painful, itchy rash that would burn if I touched it. My entire stomach and torso were covered and tomorrow marks 2 weeks since the shot and I still have it. My skin feels scaly and irritated and absolutely nothing I have put on it helps to alleviate the discomfort or the red appearance.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Skin exfoliation, Skin irritation
Clinical narrative: I broke out in a very painful, itchy rash that would burn if I touched it. My entire stomach and torso were covered and tomorrow marks 2 weeks since the shot and I still have it. My skin feels scaly and irritated and absolutely nothing I have put on it helps to alleviate the discomfort or the red appearance.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Dry mouth, Dysgeusia, Fatigue
Clinical narrative: Soreness at injection point radiating to elbow,.  Fatique, dry cough, dry mouth, hot and cold chills, metal taste in mouth.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Injection site pain, Pain
Clinical narrative: Soreness at injection point radiating to elbow,.  Fatique, dry cough, dry mouth, hot and cold chills, metal taste in mouth.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administered a dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 27-JAN-2020 the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, lot # S024364, expiration date 06-AUG-2021 (exact dose, frequency and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion between -14 to -10 Celsius degrees (-12.6 Celsius degrees) for 9 hours an 53 minutes. There was previous temperature excursion between -14 to -10 Celsius degrees (-13.00 Celsius degrees) for 14 hours and 22 minutes. Data logger was involved. No additional adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA001483: US-009507513-2002USA001459: US-009507513-2002USA001358: US-009507513-2002USA001517: US-009507513-2002USA001486:
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: Sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on an unknown date and experienced flu like symptoms).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient was sick after vaccination. For tolerance to 1st dose, refer case US2020025207.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Fainting/seizure like activity,
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: Pt states when woke up next morning after vaccine had ringing and tingling in both ears.  She was seen at an urgent care diagnosis was possible allergic reaction after receiving MMR vaccine
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: WRONG VACCINE ADMINISTERED
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Breast pain, Fatigue, Injection site erythema, Injection site swelling, Lymph node pain
Clinical narrative: 1 Feb, 2020.  Shingrix vaccination. Swelling of approx. 2 x 2 inches at injection site within 24 hours. Around 2 to 3 days post vaccination there was a red area, approx. 0.75" h x 2" wide at the bottom of the deltoid muscle (below injection site). Approx. 2 to 5 days post vaccination, mild immune response discomfort of feeling tired, slightly feverish (temp. not taken), general aching. Deltoid stayed swollen for approx. a week.  10 Feb, 2020  - Day 9 I awoke in the middle of the night with very sharp pain along exterior of left breast (side of vaccination). At first I thought it was muscular - pectoralis major muscle, but there had been no event to cause a strained muscle. The area of pain appears to be the axilla lymph nodes extending into the breast. Noted was generalized swelling in the left axilla region. There was no sign of injury (other than the vaccination) that I believe attributed to symptoms experienced.  14 Feb, 2020 - Annual mammogram with normal results  18 Feb, 2020 - The swelling under the armpit has decreased. There is still some residual pain along the lymph node pathway radiating from the axilla and breast. Pain has been gradually decreasing though.  I thought I would report this in the event the adjuvant has been causing lymph node responses in others.
Age: 58.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Mammogram normal, Middle insomnia, Oedema peripheral, Pain, Pyrexia
Clinical narrative: 1 Feb, 2020.  Shingrix vaccination. Swelling of approx. 2 x 2 inches at injection site within 24 hours. Around 2 to 3 days post vaccination there was a red area, approx. 0.75" h x 2" wide at the bottom of the deltoid muscle (below injection site). Approx. 2 to 5 days post vaccination, mild immune response discomfort of feeling tired, slightly feverish (temp. not taken), general aching. Deltoid stayed swollen for approx. a week.  10 Feb, 2020  - Day 9 I awoke in the middle of the night with very sharp pain along exterior of left breast (side of vaccination). At first I thought it was muscular - pectoralis major muscle, but there had been no event to cause a strained muscle. The area of pain appears to be the axilla lymph nodes extending into the breast. Noted was generalized swelling in the left axilla region. There was no sign of injury (other than the vaccination) that I believe attributed to symptoms experienced.  14 Feb, 2020 - Annual mammogram with normal results  18 Feb, 2020 - The swelling under the armpit has decreased. There is still some residual pain along the lymph node pathway radiating from the axilla and breast. Pain has been gradually decreasing though.  I thought I would report this in the event the adjuvant has been causing lymph node responses in others.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Chills, Fatigue, Injection site pain
Clinical narrative: 6-9 hours from administration: Patient reports severe nausea, fatigue, abdominal pain ("it feels like someone took a baseball bat to me a hand's width above my belly button"), joint pain, shivering, and fever (avg temp 96.7, 12 hour peak following administration 100.3).  13 hours following administration: patient reports finally falling asleep 16 hours following administration: pain at injection sight ("it may have hurt all along, but I was distracted by how bad the rest of me was feeling") Symptoms have started to improve ~24 hours following administration of recombinant zoster vaccine.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: 6-9 hours from administration: Patient reports severe nausea, fatigue, abdominal pain ("it feels like someone took a baseball bat to me a hand's width above my belly button"), joint pain, shivering, and fever (avg temp 96.7, 12 hour peak following administration 100.3).  13 hours following administration: patient reports finally falling asleep 16 hours following administration: pain at injection sight ("it may have hurt all along, but I was distracted by how bad the rest of me was feeling") Symptoms have started to improve ~24 hours following administration of recombinant zoster vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: SEVERE PAIN AND PER PT SHE WAS DIAGNOSED WITH SHINGLES OVER THE PHONE. BLISTERS ON NOSE
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Nausea, Peripheral swelling
Clinical narrative: I had severe nausea, headache, chills and fever for 24 hours.  The fever and chills lasted two more days.  I have a welt on my left arm, from shoulder to almost down to the elbow, swollen, red and itchy x 4 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: I had severe nausea, headache, chills and fever for 24 hours.  The fever and chills lasted two more days.  I have a welt on my left arm, from shoulder to almost down to the elbow, swollen, red and itchy x 4 days.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: no adverse event
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Poor quality sleep, Pyrexia, Rash
Clinical narrative: Systemic rash and fever. fussy and not sleeping well.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: a one year old patient was administered a dose of PROQUAD and VARIVAX on the same day in error; a one year old patient was administered a dose of PROQUAD and VARIVAX on the same day in error; the patient was supposed to be administered a dose of MMR II and VARIVAX; This spontaneous report was received from a medical assistant and refers to a 1-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-JAN-2020, the patient was erroneously vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) injection, lot # R030802 with expiration date 22-APR-2020 (exact dose, route and site of administration were not reported) and with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S025610 with expiration date 18-AUG-2021 (exact dose, route and site of administration were not reported), both for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (strength, dose, frequency, route and site of administration, lot # and expiration date were not reported) for prophylaxis. The patient was supposed to be administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (exact dose, route and site of administration, lot # and expiration date were not reported).
Age: 1.0
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: Extra dose administered
Clinical narrative: patient inadvertently received doses of both VARIVAX and PROQUAD; patient inadvertently received doses of both VARIVAX and PROQUAD; patient inadvertently received doses of both VARIVAX and PROQUAD; This spontaneous report as received from an office manager refers to a 12-month-old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-FEB-2020 the patient received doses of both varicella virus vaccine live (oka/merck)(VARIVAX)  and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Suspect therapy included: included sterile diluent(STERILE DILUENT).
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Seizure, Speech disorder
Clinical narrative: seizure; speech became limited; had a high fever; This spontaneous report was received from a patient's mother and refers to a 5-year-old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies.  On an unspecified date in 2015, the patient received the first dose (reported as vaccinated once) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (reported as MMR) subcutaneously (site of administration, lot # and expiration date were not provided) reconstituted with a sterile diluent (STERILE DILUENT) subcutaneously (dose, frequency, lot # and expiration date were not provided), both for prophylaxis (reported as measles, mumps and rubella). On an unspecified date in 2015 (reported as 7 days after receiving the vaccine), the patient experienced a seizure. Additionally, on an unspecified date in 2015, the patient's speech became limited and she had a high fever. The patient received ibuprofen (MOTRIN) as a treatment. There were no lab diagnostics performed. The patient sought medical attention and was seen by a pediatrician. The patient was not hospitalized and recovered from the events on an unspecified date in 2015.   The causality assessment between the events and the suspected therapies was not provided.   Upon internal review the event of seizure was considered to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose ofVAQTA; This spontaneous report was received from a liscenced practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-FEB-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # S010727, expiration date 26-JUL-2020 (dose, route and vaccination site were not reported),  for prophylaxis.         Temperature above 9°C 21.4C Time frame 41 hours 19 minutes Previous temperature excursion? No Was call because of a data logger Yes
Age: 1.0
Sex: M
Vaccine: DTAP, FLUX, HEPA, MMR, VARCEL
Symptoms: Electroencephalogram normal, Eye movement disorder, Injection site bruising, Petechiae, Product administered to patient of inappropriate age
Clinical narrative: Had multiple eye rolling upward episodes that appeared to be seizures; Indurated; Large bruise at site of injection; Petechiae; Rash on arms, legs, and trunk; Patient under 4 years of age received Influenza; Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2015US047488).   This spontaneous report was received from an other healthcare professional and refers to a 1-year-old male patient. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   On 08-DEC-2014, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown), 1 dosage form (exact date, route of administration, anatomical location, lot # and expiration date were not reported). On the same day the patient also received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), 1 dosage form (exact date, route of administration, anatomical location, lot # and expiration date were not reported), varicella virus vaccine live (oka/merck)(manufacturer unknown), 1 dosage form (exact date, route of administration, anatomical location, lot # and expiration date were not reported), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid; 1 dosage form (exact date, route of administration, anatomical location, lot # and expiration date were not reported) and unspecified influenza virus vaccine, 1 dosage form (DF) (exact date, route of administration, anatomical location, lot # and expiration date were not reported). The reporter informed, that the influenza vaccine should not be administered to the patient under 4 years of age (drug use in unapproved population). All the vaccines were administered for immunization.   On 24-DEC-2014, the patient experienced multiple episodes of eye rolling upward that appeared to be seizures, petechiae, vaccination site induration (reported as indurated) and had a large bruise at the injection site and rash on his arms, legs and trunk. Additionally, the reporter informed that on an unknown date the patient had electroencephalogram (EEG) with the result reported as normal. The outcome of the events was unknown.  The relatedness between the event of multiple eye rolling upward episodes that appeared to be seizures and unspecified influenza virus vaccine was reported as suspected. The relatedness between the events of vaccination site induration, large bruise at site of injection, drug use in unapproved population, petechiae, rash and unspecified influenza virus vaccine were reported as not assessable. The causality assessment between the events and the other suspect therapies was not provided by the reporter.   The Agency considered all the events to be medically significant.