chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: injection site soreness; tiredness; nausea; headache; fever; myalgia; general malaise; blisters on her abdomen, upper arm, legs, thighs; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site pain, tiredness, nausea, headache, fever, myalgia, general malaise and blister. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the tiredness, nausea, headache, fever, myalgia, general malaise and blister were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, nausea, headache, fever, myalgia, general malaise and blister to be related to Shingrix.  Additional details were provided as follows: The patient received dose of the Shingrix vaccine and had injection site soreness tiredness, nausea, headache, fever,myalgia, general malaise, which resolved in a few days. About 3 weeks after the first injection patient had blisters on her abdomen, upper arm, legs, thighs, which took about a month to subside. The follow up consent was granted.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: injection site soreness; tiredness; nausea; headache; fever; myalgia; general malaise; blisters on her abdomen, upper arm, legs, thighs; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site pain, tiredness, nausea, headache, fever, myalgia, general malaise and blister. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the tiredness, nausea, headache, fever, myalgia, general malaise and blister were recovered/resolved.   It was unknown if the reporter considered the injection site pain, tiredness, nausea, headache, fever, myalgia, general malaise and blister to be related to Shingrix.  Additional details were provided as follows: The patient received dose of the Shingrix vaccine and had injection site soreness tiredness, nausea, headache, fever,myalgia, general malaise, which resolved in a few days. About 3 weeks after the first injection patient had blisters on her abdomen, upper arm, legs, thighs, which took about a month to subside. The follow up consent was granted.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Feeling abnormal, Nausea
Clinical narrative: threw up twice last night; hasnt been feeling well; He has not been eating or drinking; diarrhea; dizziness; nausea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received Shingrix (intramuscular). On 5th January 2020, 2 days after receiving Shingrix, the patient experienced vomiting, feeling abnormal and appetite lost. In January 2020, the patient experienced diarrhea, dizziness and nausea. On an unknown date, the outcome of the diarrhea was recovered/resolved and the outcome of the dizziness and nausea were not recovered/not resolved and the outcome of the vomiting, feeling abnormal and appetite lost were unknown.   It was unknown if the reporter considered the diarrhea, dizziness, nausea, vomiting, feeling abnormal and appetite lost to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and started experiencing diarrhea, dizziness and nausea. He has continued to feel like that through the weekend. The patient was still feeling dizzy and nauseous. The patient threw up twice last night and he has never thrown up before in his life. The patient has not been eating or drinking since he had not been feeling well.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: threw up twice last night; hasnt been feeling well; He has not been eating or drinking; diarrhea; dizziness; nausea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received Shingrix (intramuscular). On 5th January 2020, 2 days after receiving Shingrix, the patient experienced vomiting, feeling abnormal and appetite lost. In January 2020, the patient experienced diarrhea, dizziness and nausea. On an unknown date, the outcome of the diarrhea was recovered/resolved and the outcome of the dizziness and nausea were not recovered/not resolved and the outcome of the vomiting, feeling abnormal and appetite lost were unknown.   It was unknown if the reporter considered the diarrhea, dizziness, nausea, vomiting, feeling abnormal and appetite lost to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and started experiencing diarrhea, dizziness and nausea. He has continued to feel like that through the weekend. The patient was still feeling dizzy and nauseous. The patient threw up twice last night and he has never thrown up before in his life. The patient has not been eating or drinking since he had not been feeling well.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: The rash is on her face; Shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2019, the patient received the 1st dose of Shingrix. On 4th November 2019, 34 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced shingles and rash on her face. The patient was treated with Valtrex and the rash has improved, but it was still ongoing at the time of reporting.  The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: felt a stinging sensation inside the node; the injection site after receiving both the first and second dose of the Shingrix vaccine was sore; Chills; Fever of 101.4; lymph node under her left arm, in the arm pit, was swollen; This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced chills, fever, axillary lymph nodes enlarged, lymph node pain and injection site pain. On an unknown date, the outcome of the chills, fever and axillary lymph nodes enlarged were recovered/resolved and the outcome of the lymph node pain and injection site pain were unknown.   It was unknown if the reporter considered the chills, fever, axillary lymph nodes enlarged, lymph node pain and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and developed chills, a fever of 101.4, and the lymph node under her left arm, in the arm pit, was swollen.  She described that she felt a stinging sensation inside the node. She had to prop her arm up most of the night because of the lymph node.  The lymph node swelling lasted for 2 to 3 days.  The fever resolved within 8 hours and the chills were gone after 36 hours. She indicated that the injection site after receiving Shingrix vaccine was sore. The reporter consented to follow up. The reporter gave permission for her physician to be contact. For tolerance to 2nd dose, refer case US2020AMR003032.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: felt a stinging sensation inside the node; the injection site after receiving both the first and second dose of the Shingrix vaccine was sore; Chills; Fever of 101.4; lymph node under her left arm, in the arm pit, was swollen; This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced chills, fever, axillary lymph nodes enlarged, lymph node pain and injection site pain. On an unknown date, the outcome of the chills, fever and axillary lymph nodes enlarged were recovered/resolved and the outcome of the lymph node pain and injection site pain were unknown.   It was unknown if the reporter considered the chills, fever, axillary lymph nodes enlarged, lymph node pain and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and developed chills, a fever of 101.4, and the lymph node under her left arm, in the arm pit, was swollen.  She described that she felt a stinging sensation inside the node. She had to prop her arm up most of the night because of the lymph node.  The lymph node swelling lasted for 2 to 3 days.  The fever resolved within 8 hours and the chills were gone after 36 hours. She indicated that the injection site after receiving Shingrix vaccine was sore. The reporter consented to follow up. The reporter gave permission for her physician to be contact. For tolerance to 2nd dose, refer case US2020AMR003032.
Sex: F
Vaccine: VARZOS
Symptoms: Osteoporosis
Clinical narrative: Osteoporosis after receiving  1st dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of osteoporosis in a elderly female patient who received Herpes zoster (Shingrix) (batch number 9AB33, expiry date 6th December 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced osteoporosis. The patient was treated with denosumab (Prolia). On an unknown date, the outcome of the osteoporosis was unknown.   It was unknown if the reporter considered the osteoporosis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was reported. The patient started taking Prolia for osteoporosis after receiving the first dose of Shingrix. The reporter consented to follow up. This case has been linked to the case US2020002529, reported by same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Fatigue, Glossodynia, Headache
Clinical narrative: sore throat; sensitive tongue; burning tongue; sinus inflammation; chills; fever; red blotchy; itching; whole arm hurt; fatigue; body aches/soreness; headache; nausea; not sleeping good; uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st January 2020, the patient received the 1st dose of Shingrix. On 1st January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fatigue and general body pain. On 2nd January 2020, the patient experienced injection site erythema and injection site itching. On 3rd January 2020, the patient experienced sinusitis, chills and fever. On 4th January 2020, the patient experienced sore throat, sensitive tongue and burning tongue. In January 2020, the patient experienced headache, nausea, poor sleep and discomfort. The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, fatigue, general body pain, injection site erythema, injection site itching, headache, sensitive tongue, burning tongue, sinusitis, chills, fever, nausea, poor sleep and discomfort were unknown and the outcome of the sore throat was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fatigue, general body pain, injection site erythema, injection site itching, headache, sore throat, sensitive tongue, burning tongue, sinusitis, chills, fever, nausea, poor sleep and discomfort to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had whole arm hurt, she was fatigued and had body aches. The next day of reporting she had splotchy redness and itching at the site. She had a headache that started on the left side and moved to the right side and it has not gone away with help of Advil or Tylenol. She had a sore throat that started on the left side and moved to the right side and still sore. She notes her tongue was sensitive and burning, but worse when she eats. She has inflamed sinus, chills, and a fever of 101 that finally broke. She has nausea, she was not sleeping good because she was uncomfortable. She was referred to her physician.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Nausea, Oropharyngeal pain, Pain
Clinical narrative: sore throat; sensitive tongue; burning tongue; sinus inflammation; chills; fever; red blotchy; itching; whole arm hurt; fatigue; body aches/soreness; headache; nausea; not sleeping good; uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st January 2020, the patient received the 1st dose of Shingrix. On 1st January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fatigue and general body pain. On 2nd January 2020, the patient experienced injection site erythema and injection site itching. On 3rd January 2020, the patient experienced sinusitis, chills and fever. On 4th January 2020, the patient experienced sore throat, sensitive tongue and burning tongue. In January 2020, the patient experienced headache, nausea, poor sleep and discomfort. The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, fatigue, general body pain, injection site erythema, injection site itching, headache, sensitive tongue, burning tongue, sinusitis, chills, fever, nausea, poor sleep and discomfort were unknown and the outcome of the sore throat was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fatigue, general body pain, injection site erythema, injection site itching, headache, sore throat, sensitive tongue, burning tongue, sinusitis, chills, fever, nausea, poor sleep and discomfort to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had whole arm hurt, she was fatigued and had body aches. The next day of reporting she had splotchy redness and itching at the site. She had a headache that started on the left side and moved to the right side and it has not gone away with help of Advil or Tylenol. She had a sore throat that started on the left side and moved to the right side and still sore. She notes her tongue was sensitive and burning, but worse when she eats. She has inflamed sinus, chills, and a fever of 101 that finally broke. She has nausea, she was not sleeping good because she was uncomfortable. She was referred to her physician.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Poor quality sleep, Pyrexia, Sinusitis, Tongue discomfort
Clinical narrative: sore throat; sensitive tongue; burning tongue; sinus inflammation; chills; fever; red blotchy; itching; whole arm hurt; fatigue; body aches/soreness; headache; nausea; not sleeping good; uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st January 2020, the patient received the 1st dose of Shingrix. On 1st January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fatigue and general body pain. On 2nd January 2020, the patient experienced injection site erythema and injection site itching. On 3rd January 2020, the patient experienced sinusitis, chills and fever. On 4th January 2020, the patient experienced sore throat, sensitive tongue and burning tongue. In January 2020, the patient experienced headache, nausea, poor sleep and discomfort. The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, fatigue, general body pain, injection site erythema, injection site itching, headache, sensitive tongue, burning tongue, sinusitis, chills, fever, nausea, poor sleep and discomfort were unknown and the outcome of the sore throat was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, fatigue, general body pain, injection site erythema, injection site itching, headache, sore throat, sensitive tongue, burning tongue, sinusitis, chills, fever, nausea, poor sleep and discomfort to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had whole arm hurt, she was fatigued and had body aches. The next day of reporting she had splotchy redness and itching at the site. She had a headache that started on the left side and moved to the right side and it has not gone away with help of Advil or Tylenol. She had a sore throat that started on the left side and moved to the right side and still sore. She notes her tongue was sensitive and burning, but worse when she eats. She has inflamed sinus, chills, and a fever of 101 that finally broke. She has nausea, she was not sleeping good because she was uncomfortable. She was referred to her physician.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Influenza like illness, Injected limb mobility decreased
Clinical narrative: pain at injection site; Can't lift arm above shoulder; flu like symptoms; fever; chills; muscle aches; dizziness; felt tired; Slept for 24 hours straight; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, influenza-like symptoms, fever, chills, muscle pain, dizziness, tiredness and sleepiness. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, influenza-like symptoms, fever, chills, muscle pain, dizziness, tiredness and sleepiness were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, influenza-like symptoms, fever, chills, muscle pain, dizziness, tiredness and sleepiness to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination, the patient had pain at injection site, can't lift her arm above her shoulder, flu like symptoms, fever, chills, muscle aches, dizziness, felt tired, and slept for 24 hours straight. Till the time of reporting, the issues were improving. The reporter did not consent to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia, Somnolence
Clinical narrative: pain at injection site; Can't lift arm above shoulder; flu like symptoms; fever; chills; muscle aches; dizziness; felt tired; Slept for 24 hours straight; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, influenza-like symptoms, fever, chills, muscle pain, dizziness, tiredness and sleepiness. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, influenza-like symptoms, fever, chills, muscle pain, dizziness, tiredness and sleepiness were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, influenza-like symptoms, fever, chills, muscle pain, dizziness, tiredness and sleepiness to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination, the patient had pain at injection site, can't lift her arm above her shoulder, flu like symptoms, fever, chills, muscle aches, dizziness, felt tired, and slept for 24 hours straight. Till the time of reporting, the issues were improving. The reporter did not consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test positive
Clinical narrative: Tested positive for IgG; Tested positive for IgM; This case was reported by a physician via call center representative and described the occurrence of igg in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, between 1 and 2 months after receiving Shingrix, the patient experienced igg and igm. On an unknown date, the outcome of the igg and igm were unknown.   It was unknown if the reporter considered the igg and igm to be related to Shingrix.  Additional case details were reported as follows: The patient tested positive for both IgG and IgM approximately one to two months post receipt of Shingrix doses. The reporter did not have lot or expiry date for either dose of shingrix as it was given at a pharmacy.      Lab Comments: lab test performed on unknown date
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Headache, Injection site warmth, Pain
Clinical narrative: red 2 inch diameter area; soreness/body aches; hot at the site; low grade fever; headache; joint pain; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced erythema, pain, injection site warmth, low grade fever, headache and joint pain. On an unknown date, the outcome of the erythema, pain, injection site warmth, low grade fever, headache and joint pain were recovered/resolved.   It was unknown if the reporter considered the erythema, pain, injection site warmth, low grade fever, headache and joint pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had erythema, pain, injection site warmth, low grade fever, headache and joint pain. The was coming up on her second dose and scared to experience the side effects again.    The patient stated the above noted side effects lasted for a day but did resolve.   She had a red 2 inch diameter area with soreness that was hot at the site.     She has not notified her physician because the issues resolved. The reporter consented to follow up. This case linked with US2020003266, reported by same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: red 2 inch diameter area; soreness/body aches; hot at the site; low grade fever; headache; joint pain; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced erythema, pain, injection site warmth, low grade fever, headache and joint pain. On an unknown date, the outcome of the erythema, pain, injection site warmth, low grade fever, headache and joint pain were recovered/resolved.   It was unknown if the reporter considered the erythema, pain, injection site warmth, low grade fever, headache and joint pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had erythema, pain, injection site warmth, low grade fever, headache and joint pain. The was coming up on her second dose and scared to experience the side effects again.    The patient stated the above noted side effects lasted for a day but did resolve.   She had a red 2 inch diameter area with soreness that was hot at the site.     She has not notified her physician because the issues resolved. The reporter consented to follow up. This case linked with US2020003266, reported by same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Myalgia
Clinical narrative: muscle soreness; Felt warm all the time; This case was reported by a other health professional via call center representative and described the occurrence of muscle soreness in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 3LL4P, expiry date 19th October 2021) and (batch number KH3CZ, expiry date 5th December 2021) for prophylaxis.   On 25th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced muscle soreness and feeling of warmth. On an unknown date, the outcome of the muscle soreness and feeling of warmth were unknown.   It was unknown if the reporter considered the muscle soreness and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The patient that after receiving the first dose of Shingrinx and experienced muscle soreness and felt warm all the time.  The patient was asking about when the patient should receive the second dose. The reporter consented to follow up.  The batch number for Shingrinx was reported as 3LLP , but it was changed to 3LL4P as per sales data sheet. The batch number for Shingrinx adjuvant was reported as 4H3C2, but it was changed to KH3CZ as per sales data sheet.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Left shoulder has been sore; Can't raise arm over head; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number L9F99, expiry date 10th October 2022) for prophylaxis.   On 28th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shoulder pain and mobility decreased. On an unknown date, the outcome of the shoulder pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix and since then her left shoulder had been sore and she could not raise her arm over her head. This event was ongoing at the time of report. The reporter did not consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itchy bumps behind the knee and in the chest / Could have been a rash; This case was reported by a physician via call center representative and described the occurrence of itchy rash in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 45N34, expiry date 21st January 2022) and (batch number 4RR52, expiry date 7th December 2021) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was recovered/resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced itchy bumps behind the knee and in the chest.  The bumps were resolved in 2 days.  The reporter provided the batch numbers and expiration dates of the adjuvant and lyophilized component.  The reporter mentioned about bumps it could have been a rash. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itching all over body/Itching on hands; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced generalized pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized pruritus was unknown.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced itching all over her body, most predominant on her hands, and without signs of rash or hives.    The caller reported that her physician advised her to use Benadryl and that it has not really helped. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: lengthy fatigue/tiredness; This case was reported by a physician via call center representative and described the occurrence of fatigue in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional case details were reported as follows: This case reported by the patient's husband. The patient received Shingrix and had tiredness following the injection. The patient asked how often lengthy fatigue occured. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Issues going on; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th November 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than 2 months after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's wife reported that the patient had issues going on after receiving 2nd dose of Shingrix. Consent to follow up was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: had side effects following administration; This case was reported by a pharmacist via call center representative and described the occurrence of adverse drug reaction in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that they had lots of friends who received Shingrix and some had no side effects and others had side effects following administration. No additional information was available. The case has been linked to the case US2020005553 and US2020005549 reported by same reporter.
Age: 10.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, VARCEL
Symptoms: Crying, Electrocardiogram T wave abnormal, Headache, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: 10 yr old female with history of traumatic brain injury 3 years prior, with residual cognitive delay. Presented for catch-up vaccinations to enter school. No current complaints. Patient was well before, during, and immediately after vaccination. About 30 minutes after vaccination, patient was standing and had syncopal event. She hit the back of her head on the pavement, although the father's story was not clear as to whether she hit with full force or if he partially caught her before her head hit. Pt was unconscious for about 1 min, during which time she had some shaking of her arms and legs. The event was not witnessed by medical personnel. The father carried her back into the clinic. She was awake and crying. She had never had a reaction after a vaccine before and was scared. She was given two juices boxes and 8 oz water, then calmed. She had not had anything to eat or drink since the night prior. All vitals were normal, as was her exam (including her head; there were no signs of trauma). She complained of a mild bifrontal headache. After about 30 minutes of reclining, she sat up and was asymptomatic. She left the clinic but returned about 30 min later with her father. He stated that she had vomited twice, non-bloody, non-bilious. She had not eaten anything and only had sips of water. Her vitals were again normal. She complained of a bifrontal headache again. She was given 12.5 mL acetaminophen by her father and the pediatrician had her lay down. She fell asleep for about 15 minutes, then awoke and vomited twice (clear fluids). At that time, the decision was made to send her to the ER by ambulance. EMS arrived about 10 minutes later. She was no longer complaining of nausea or headache. In the ER, she was examined and observed for 2 hours without any further vomiting or headache. An EKG showed possible right ventricular hypertrophy and non-specific t wave changes. Cardiology reviewed the EKG and suggested that she could be discharged home with an outpatient cardiology appointment scheduled.
Age: 10.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, VARCEL
Symptoms: Nausea, Syncope, Tremor, Vomiting
Clinical narrative: 10 yr old female with history of traumatic brain injury 3 years prior, with residual cognitive delay. Presented for catch-up vaccinations to enter school. No current complaints. Patient was well before, during, and immediately after vaccination. About 30 minutes after vaccination, patient was standing and had syncopal event. She hit the back of her head on the pavement, although the father's story was not clear as to whether she hit with full force or if he partially caught her before her head hit. Pt was unconscious for about 1 min, during which time she had some shaking of her arms and legs. The event was not witnessed by medical personnel. The father carried her back into the clinic. She was awake and crying. She had never had a reaction after a vaccine before and was scared. She was given two juices boxes and 8 oz water, then calmed. She had not had anything to eat or drink since the night prior. All vitals were normal, as was her exam (including her head; there were no signs of trauma). She complained of a mild bifrontal headache. After about 30 minutes of reclining, she sat up and was asymptomatic. She left the clinic but returned about 30 min later with her father. He stated that she had vomited twice, non-bloody, non-bilious. She had not eaten anything and only had sips of water. Her vitals were again normal. She complained of a bifrontal headache again. She was given 12.5 mL acetaminophen by her father and the pediatrician had her lay down. She fell asleep for about 15 minutes, then awoke and vomited twice (clear fluids). At that time, the decision was made to send her to the ER by ambulance. EMS arrived about 10 minutes later. She was no longer complaining of nausea or headache. In the ER, she was examined and observed for 2 hours without any further vomiting or headache. An EKG showed possible right ventricular hypertrophy and non-specific t wave changes. Cardiology reviewed the EKG and suggested that she could be discharged home with an outpatient cardiology appointment scheduled.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Chills, Decreased appetite, Headache
Clinical narrative: High Fever, headache , body aches, shivering, extreme arm pain , loss of appetite, general malaise. Two weeks after the vaccine, swollen lymph nodes above the clavicle lasting two months thus far.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: High Fever, headache , body aches, shivering, extreme arm pain , loss of appetite, general malaise. Two weeks after the vaccine, swollen lymph nodes above the clavicle lasting two months thus far.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Patient states that since he received the flu shot he has had on & off shoulder pain until Thanksgiving. He went to the ER and is now receiving physical therapy at Hospital. Patient is paying out of pocket.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Bone cyst, Cartilage injury, Exostosis, Magnetic resonance imaging abnormal
Clinical narrative: bicipital  groove.  The tendon appears intact.          Bursa  and soft tissues:  There is  minimal fluid in the subacromial         subdeltoid  bursa.           IMPRESSION:         1.  Full-thickness  rotator cuff  tear at the myotendinous   junction of         the supraspinatus.  3 to  4 mm of  tendon retraction at  the site of tear.         AP  diameter 5 to 6 mm.          2.  Severe  degenerative change  of the AC  joint.          3.  Labral  tear involving  the inferior  and posterior  labrum.      Consultation with Orthopedic Surgeon,  Discussed  results of MRI   Starting Physical Therapy  to return mobility and strengthen Shoulder.   Ordered Guided Cortisone injection
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Mobility decreased, Osteoarthritis, Rotator cuff syndrome, Tendon disorder
Clinical narrative: bicipital  groove.  The tendon appears intact.          Bursa  and soft tissues:  There is  minimal fluid in the subacromial         subdeltoid  bursa.           IMPRESSION:         1.  Full-thickness  rotator cuff  tear at the myotendinous   junction of         the supraspinatus.  3 to  4 mm of  tendon retraction at  the site of tear.         AP  diameter 5 to 6 mm.          2.  Severe  degenerative change  of the AC  joint.          3.  Labral  tear involving  the inferior  and posterior  labrum.      Consultation with Orthopedic Surgeon,  Discussed  results of MRI   Starting Physical Therapy  to return mobility and strengthen Shoulder.   Ordered Guided Cortisone injection
Age: 0.08
Sex: F
Vaccine: HIBV
Symptoms: Asthenia, Dyspnoea, Eye disorder, Infantile spitting up, Respiratory arrest
Clinical narrative: Vaccine at 0928 with Mom calling at 1230 same day  with report of not breathing , thin line of spit, big eyes, and flailing.  Pt is adopted and Mom contacted Birth Mom and she stated that breathing difficulty with Hep B in the hospital that required suctioning and immediate care.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Seizure
Clinical narrative: first time seizure with no fever
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered, Injection site rash
Clinical narrative: For above - unsure of which MenB was given - this office was not the office that gave injection.  Adverse reaction: pt developed a rash at the site of injection ~4 days after vaccination. On a side note, pt had previously been vaccinated with meninA (combined vaccine) when she was 16 and again about a month prior to receiving the MenB (so got an extra shot of MenA).
Age: 72.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt stated having no pain at time of injection or immediately following.  She developed radiating arm soreness in November that first radiated down the arm and now up to the arm.  Has been to the doctor and they are unsure of cause. There is no lump, swelling, or redness and MD has attributed it to the shingles vaccine for now
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Pt states left thumb, 1st and 2nd finger are numb upon awaking the day after receiving the vaccine.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: pt said her arm was swollen and red with a tingling pain- she went to her doctors office and got a shot of steroid. Her arm is still swollen at this time.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Redness, warms, confluent swelling from site in left deltoid extending all the way to neck  and upper chest causing neck stiffness starting approx. 12 hours after vaccine and lasting 72 hours before improving.  Given ibuprofen and Benadryl.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm, Swelling
Clinical narrative: Redness, warms, confluent swelling from site in left deltoid extending all the way to neck  and upper chest causing neck stiffness starting approx. 12 hours after vaccine and lasting 72 hours before improving.  Given ibuprofen and Benadryl.
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: pneumonia; Information has been received regarding a case in litigation concerning a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not provided.  On 18-APR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) as routine health maintenance and prevention of shingles (vaccine schedule, route of administration, site of administration, lot number and expiration date were not provided).  On an unknown date (reported as "shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine"), the patient suffered pneumonia requiring multiples hospitalizations (on unspecified dates). As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). Patient 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), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, 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 the Company conduct, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the time of the report, the patient had not recovered from pneumonia.  The causality assessment between zoster vaccine live (ZOSTAVAX) and pneumonia was considered as related.  Upon internal review, pneumonia was considered as medically significant and disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia (PHN).; painful and debilitating outbreak of shingles; Information has been received from a lawyer regarding a case in litigation and referred to a male patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not provided. On 09-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) as routine health maintenance and the prevention of shingles (strength, dose, route of administration, site of administration, lot number and expiration date were not provided). On an unknown day in February 2016 (also reported as "shortly after receiving the Company's zoster vaccine live (ZOSTAVAX) vaccine"), the patient suffered a painful and debilitating outbreak of shingles (herpes zoster) which became reoccurring and resulted in the diagnosis of postherpetic neuralgia (on an unspecified date). These conditions also resulted in hospitalization and extensive medical care. As a result of the patient's injuries, his wife, suffered loss of services and society and asserts a loss of consortium claim. As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered severe injuries and life-long disabilities not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, 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 the Company's conduct, the patient and his wife have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the time of the report, the patient had not recovered from postherpetic neuralgia and herpes zoster. The causal relationship between zoster vaccine live (ZOSTAVAX) and pneumonia was reported as related.  Postherpetic neuralgia and herpes zoster were reported to be disabling events.