chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Chills, Headache, Herpes virus infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpetiform lesion in a 71-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes simplex type i (Herpes type 1 since 1970's for at least 30 to 40 years). Concomitant products included acyclovir. On 25th March 2019 10:30, the patient received the 1st dose of SHINGRIX. In March 2019, 16 hrs 30 min after receiving SHINGRIX, the patient experienced herpetiform lesion, muscle pain, shivering, headache, mass, burning sensation and blister. On an unknown date, the outcome of the herpetiform lesion was unknown and the outcome of the muscle pain, shivering and headache were recovered/resolved and the outcome of the mass, burning sensation and blister were not recovered/not resolved. It was unknown if the reporter considered the herpetiform lesion, muscle pain, shivering, headache, mass, burning sensation and blister to be related to SHINGRIX. Additional details were provided as follows: The patient usually take Acyclovir. On Monday, the patient received a dose of SHINGRIX. On 26th March 2019 at 03:00 AM, in the next morning after vaccination, the patient experienced muscle aches, chills, shivering, and headache. On 28th March 2019, at around 06:00 AM in the morning, 2 days, 19 hours and 30 minutes after vaccination, the patient noted that a lump or blister, underneath the patient's right side under the chin.  The patient also reported that, the site of the lump was burning. The patient noticed that, the patient had a recurrence of herpes lesions. At the time of reporting, the symptoms were improved except for the lump under the chin and the burning. The patient should not took Acyclovir after getting SHINGRIX, since the patient read. The reporter did not consent to follow-up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Mass, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpetiform lesion in a 71-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included herpes simplex type i (Herpes type 1 since 1970's for at least 30 to 40 years). Concomitant products included acyclovir. On 25th March 2019 10:30, the patient received the 1st dose of SHINGRIX. In March 2019, 16 hrs 30 min after receiving SHINGRIX, the patient experienced herpetiform lesion, muscle pain, shivering, headache, mass, burning sensation and blister. On an unknown date, the outcome of the herpetiform lesion was unknown and the outcome of the muscle pain, shivering and headache were recovered/resolved and the outcome of the mass, burning sensation and blister were not recovered/not resolved. It was unknown if the reporter considered the herpetiform lesion, muscle pain, shivering, headache, mass, burning sensation and blister to be related to SHINGRIX. Additional details were provided as follows: The patient usually take Acyclovir. On Monday, the patient received a dose of SHINGRIX. On 26th March 2019 at 03:00 AM, in the next morning after vaccination, the patient experienced muscle aches, chills, shivering, and headache. On 28th March 2019, at around 06:00 AM in the morning, 2 days, 19 hours and 30 minutes after vaccination, the patient noted that a lump or blister, underneath the patient's right side under the chin.  The patient also reported that, the site of the lump was burning. The patient noticed that, the patient had a recurrence of herpes lesions. At the time of reporting, the symptoms were improved except for the lump under the chin and the burning. The patient should not took Acyclovir after getting SHINGRIX, since the patient read. The reporter did not consent to follow-up.
Age: 60.0
Sex: F
Vaccine: MNQ, VARZOS
Symptoms: Chills, Feeling cold
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shivering in a 60-year-old female patient who received SHINGRIX (batch number H7JY4, expiry date 1st July 2021) for prophylaxis. Co-suspect products included MENACTRA for prophylaxis.  On 13th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) and MENACTRA. In March 2019, less than a month after receiving SHINGRIX, the patient experienced shivering and cold. On an unknown date, the outcome of the shivering and cold were recovered/resolved. It was unknown if the reporter considered the shivering and cold to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that patient was administered MENACTRA on the same day but in a differed arm, SHINGRIX first dose administered in the right arm deltoid. Patient experienced chills down to the bone for about a week. Shivering and cold for several days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 8th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th January 2019, 1 days after receiving SHINGRIX, the patient experienced general body pain, fatigue, chills, fever and influenza-like symptoms. On 11th January 2019, the outcome of the general body pain, chills, fever and influenza-like symptoms were recovered/resolved. On 12th January 2019, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the general body pain, fatigue, chills, fever and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left deltoid and experienced flu-like symptoms which included fever of 101 degree F, chills, body aches. These symptoms started the next day after receiving the vaccine and lasted for approximately two days. The patient said she felt fatigued for one additional day after the other symptoms had resolved. The reporter gave permission for her physician to be contacted. The reporter unable to obtain additional information. For tolerance of 2nd dose refer linked case US2019GSK061316.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date and the patient had no problems from the dose). On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 25th March 2019, 3 hrs after receiving SHINGRIX, the patient experienced fatigue, muscle pain, chills, fever and tremor. On 27th March 2019, the outcome of the fatigue, muscle pain, chills, fever and tremor were recovered/resolved. The reporter considered the fatigue, muscle pain, chills, fever and tremor to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX vaccine on Monday around midday. By 3 pm, the patient began to feel extremely fatigued and experienced muscle aches. These progressively got worse into the evening, when chills and fever started. The chills were so bad she was shaking. The patient had a fever over 100 for the entire next day. By Wednesday morning from the day of reporting, the patient was feeling better. The patient did not gave the consent for follow up. Lab Comments: On March 2019, the patient had fever over 100.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm, fever, malaise and pain. On an unknown date, the outcome of the pain in arm, fever, malaise and pain were unknown. It was unknown if the reporter considered the pain in arm, fever, malaise and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated his wife's arm was a little more sore than his after SHINGRIX, and she was achy, feverish, and had malaise the day after, but nothing exceptional. Declined to complete full safety report. No further information provided. This case has been linked with US2019056560, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in a 61-year-old female patient who received SHINGRIX (batch number D9474, expiry date 10th September 2021) for prophylaxis. On 26th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th February 2019, 1 days after receiving SHINGRIX, the patient experienced injection site redness, injection site pain and injection site lump. On an unknown date, the outcome of the injection site redness, injection site pain and injection site lump were not recovered/not resolved. It was unknown if the reporter considered the injection site redness, injection site pain and injection site lump to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The pharmacist reported that the next morning after vaccination, the patient experienced redness at and around the injection site about 1 inch in diameter, along with soreness and a knot underneath the injection site. The patient did have the side effects at the time of reporting. No further details were provided.
Sex: U
Vaccine: TDAP
Symptoms: Hypersensitivity
Clinical narrative: Boostrix allergic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. On an unknown date, unknown after receiving Boostrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Boostrix.  Additional details were reported as follows: The pharmacist reported that the patient had an allergic reaction to a previous tetanus vaccine from an unknown manufacturer. The pharmacist had no information on the vaccine or the patient at the time of reporting. At the time of this report, it was unknown if the suspect vaccine was Boostrix or not.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 27th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th March 2019, 12 hrs after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, headache, fatigue, shivering, weakness, upset stomach and flu-like symptoms. On an unknown date, the outcome of the injection site pain, muscle pain, headache, shivering, weakness and flu-like symptoms were recovered/resolved and the outcome of the fatigue and upset stomach were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, muscle pain, headache, fatigue, shivering, weakness, upset stomach and flu-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The case was reported by the patient for himself. The patient stated that by 12 hours after the dose his arm was really sore where he got the injection, he had bad muscle pain, headache, fatigue, shivering, weakness and upset stomach, he felt like he had the flu. On the day of reporting, he was mostly feeling better but his stomach was a little upset and he had a little fatigue, but the rest of the symptoms had resolved. The upset stomach was the worst part for him. The reporter consented to follow up. This case has been linked with case US2019057159, reported for patient's twin sister.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 27th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th March 2019, 12 hrs after receiving SHINGRIX, the patient experienced injection site pain, muscle pain, headache, fatigue, shivering, weakness, upset stomach and flu-like symptoms. On an unknown date, the outcome of the injection site pain, muscle pain, headache, shivering, weakness and flu-like symptoms were recovered/resolved and the outcome of the fatigue and upset stomach were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, muscle pain, headache, fatigue, shivering, weakness, upset stomach and flu-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The case was reported by the patient for himself. The patient stated that by 12 hours after the dose his arm was really sore where he got the injection, he had bad muscle pain, headache, fatigue, shivering, weakness and upset stomach, he felt like he had the flu. On the day of reporting, he was mostly feeling better but his stomach was a little upset and he had a little fatigue, but the rest of the symptoms had resolved. The upset stomach was the worst part for him. The reporter consented to follow up. This case has been linked with case US2019057159, reported for patient's twin sister.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 27th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The case was reported by the patient for his twin sister. The reporter stated that the patient complained about a sore arm after the injection. The reporter did not consent to follow up. This case has been linked with case US2019057158, reported for patient's twin brother.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal blistering, Tongue blistering
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of throat blister in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 11th March 2019, the patient received the 1st dose of SHINGRIX. On 12th March 2019, 1 days after receiving SHINGRIX, the patient experienced throat blister (serious criteria GSK medically significant) and tongue blistering. On an unknown date, the outcome of the throat blister and tongue blistering were not recovered/not resolved. It was unknown if the reporter considered the throat blister and tongue blistering to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm and next day, she woke up with blisters on the back of the tongue that had progressed down her throat. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Dysstasia, Flushing, Gait inability, Headache
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of thirst in a 73-year-old female patient who received SHINGRIX (batch number JN25B, expiry date 11th September 2021) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) and Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). In March 2019, less than a day after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced thirst, lower extremities weakness of, difficulty in standing, unable to walk, cold hands, sweating, headache, dizziness and flushing. On an unknown date, the outcome of the thirst, lower extremities weakness of, difficulty in standing, unable to walk, cold hands, sweating, headache and flushing were recovered/resolved and the outcome of the dizziness was unknown. It was unknown if the reporter considered the thirst, lower extremities weakness of, difficulty in standing, unable to walk, cold hands, sweating, headache, dizziness and flushing to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional case details were reported as follows: The patient received her first dose of SHINGRIX yesterday, along with an influenza vaccine. The patient woke in the middle of the night to get water because she was thirsty. She found that she had weakness in her legs, and was unable to stand or walk, her hands were cold, her body was sweaty, she had headache and dizziness and was flushed. The patient contacted the health care professional office around 8:30 in the morning of day of reporting and was already starting to feel better. It was reported that patient required emergency room visit. As per sales data sheet reported batch number was changed from JN258 to JN25B.
Age: 73.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Hyperhidrosis, Muscular weakness, Peripheral coldness, Thirst
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of thirst in a 73-year-old female patient who received SHINGRIX (batch number JN25B, expiry date 11th September 2021) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 28th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) and Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). In March 2019, less than a day after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced thirst, lower extremities weakness of, difficulty in standing, unable to walk, cold hands, sweating, headache, dizziness and flushing. On an unknown date, the outcome of the thirst, lower extremities weakness of, difficulty in standing, unable to walk, cold hands, sweating, headache and flushing were recovered/resolved and the outcome of the dizziness was unknown. It was unknown if the reporter considered the thirst, lower extremities weakness of, difficulty in standing, unable to walk, cold hands, sweating, headache, dizziness and flushing to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional case details were reported as follows: The patient received her first dose of SHINGRIX yesterday, along with an influenza vaccine. The patient woke in the middle of the night to get water because she was thirsty. She found that she had weakness in her legs, and was unable to stand or walk, her hands were cold, her body was sweaty, she had headache and dizziness and was flushed. The patient contacted the health care professional office around 8:30 in the morning of day of reporting and was already starting to feel better. It was reported that patient required emergency room visit. As per sales data sheet reported batch number was changed from JN258 to JN25B.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) 0.5 ml. On 29th March 2019, 4 days after receiving SHINGRIX, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient's husband reported the case. The age at vaccination was not reported but it could be 74 years or 75 years. On Monday 25th March 2019, the patient and her spouse had their 1st SHINGRIX shot. The patient received SHINGRIX in right deltoid. On the day of reporting, the patient woke up with dizziness. Her spouse encouraged to report the adverse event to her physician. The patient did not consent to follow-up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in March 2018). On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced headache, tiredness, injection site erythema and injection site swelling. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the headache, tiredness, injection site erythema and injection site swelling were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the headache, tiredness, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The case number US2019058160 was identified as duplicate of US2019GSK057807. US2019GSK057807 was deleted and all the future correspondence will be added in the present case (US2019058160) which stands as case of record for this patient. The age at vaccination was not reported. After 1st dose it was time for patient to get the 2nd one 2 to 6 month later, patient was unable to find it available anywhere till finally 1 year later. The patient asked had it been too long (1 year), since 1st one, & still need a 2nd one, or was this 2nd one that we just got, going to be just fine even though it had been a year since the 1st one. The patient experienced tiredness, headache, redness, and swelling at the injection site. The symptoms from dose 2 began the next day and had resolved. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in March 2018). On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced headache, tiredness, injection site erythema and injection site swelling. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the headache, tiredness, injection site erythema and injection site swelling were recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the headache, tiredness, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The case number US2019058160 was identified as duplicate of US2019GSK057807. US2019GSK057807 was deleted and all the future correspondence will be added in the present case (US2019058160) which stands as case of record for this patient. The age at vaccination was not reported. After 1st dose it was time for patient to get the 2nd one 2 to 6 month later, patient was unable to find it available anywhere till finally 1 year later. The patient asked had it been too long (1 year), since 1st one, & still need a 2nd one, or was this 2nd one that we just got, going to be just fine even though it had been a year since the 1st one. The patient experienced tiredness, headache, redness, and swelling at the injection site. The symptoms from dose 2 began the next day and had resolved. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Inappropriate schedule of product administration, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 63-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in March 2018). On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced tiredness. On an unknown date, the patient experienced product supply issue. On 27th March 2019, the outcome of the tiredness was recovered/resolved. On an unknown date, the outcome of the product supply issue was unknown. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's wife. After receiving 1st dose of SHINGRIX, the patient was unable to find the 2nd dose available 2 to 6 months later. The patient found 2nd dose of SHINGRIX 1 year later from 1st dose. The patient was confirming that if it was fine to receive 2nd dose too long after 1st dose. After receiving 2nd dose of SHINGRIX, the patient experienced tiredness the next day and the event resolved after 1 day. The reporter consented to follow up. This case has been linked with case US2019GSK057807 and US2019058160, reported by for patient's wife.
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Feeling hot, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a adult male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis and SHINGRIX for prophylaxis. Previously administered products included Flu vaccine (with no reactions). On 17th September 2018, the patient received the 1st dose of SHINGRIX and the 1st dose of Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 18th September 2018, 1 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season and not applicable after receiving SHINGRIX, the patient experienced feeling hot and feelings of weakness. On an unknown date, the patient experienced drug dose administration interval too long. On 20th September 2018, the outcome of the feeling hot and feelings of weakness were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the feeling hot and feelings of weakness to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The patient received both a SHINGRIX and flu shot on the day of his physical. The day after the vaccinations, he felt weak and feverish but these symptoms resolved within a couple of days. Since the patient never had a reaction to a flu vaccine, he was attributing these reactions to SHINGRIX. The purpose of the patient's call was for guidance on getting the 2nd dose at the time of reporting that it had been over six months since getting the 1st dose, which led to lengthening of vaccination schedule.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Head discomfort, Pain, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 20th March 2019, the patient received SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced erythema, pain in arm, fever, pain and sleep deprivation. On 27th March 2019, the patient experienced raised rash, tingling, skin discoloration and head pressure. On an unknown date, the outcome of the erythema and pain in arm were recovered/resolved and the outcome of the fever, pain and sleep deprivation were not recovered/not resolved and the outcome of the raised rash, tingling, skin discoloration and head pressure were unknown. It was unknown if the reporter considered the erythema, pain in arm, fever, pain, sleep deprivation, raised rash, tingling, skin discoloration and head pressure to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that, she got SHINGRIX a week ago before the date of reporting. The patient's arm was sore and had a red area 1 by 2 inches that lasted for a few days. She also has been feeling feverish and achy and when she woke up in the morning it did not feel like she has slept. At the day of reporting morning she woke up with 4 spots on her forehead which are darker in color than her skin and might be a little raised. She could feel pressure or tingling in the area of the spots. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Skin discolouration, Sleep deficit
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 20th March 2019, the patient received SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced erythema, pain in arm, fever, pain and sleep deprivation. On 27th March 2019, the patient experienced raised rash, tingling, skin discoloration and head pressure. On an unknown date, the outcome of the erythema and pain in arm were recovered/resolved and the outcome of the fever, pain and sleep deprivation were not recovered/not resolved and the outcome of the raised rash, tingling, skin discoloration and head pressure were unknown. It was unknown if the reporter considered the erythema, pain in arm, fever, pain, sleep deprivation, raised rash, tingling, skin discoloration and head pressure to be related to SHINGRIX. Additional details were provided as follows: The reporter reported that, she got SHINGRIX a week ago before the date of reporting. The patient's arm was sore and had a red area 1 by 2 inches that lasted for a few days. She also has been feeling feverish and achy and when she woke up in the morning it did not feel like she has slept. At the day of reporting morning she woke up with 4 spots on her forehead which are darker in color than her skin and might be a little raised. She could feel pressure or tingling in the area of the spots. The reporter consented to follow up.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Injection painful when given, felt as if the needle hit a nerve. Left upper arm/bicep area red, painful, warm to touch; swollen for a few days to a week, then pain in the bicep area and in the humerus for weeks - achy/throbbing.
Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Gait inability, Pain in extremity
Clinical narrative: Left foot in extreme pain. Could not walk on it for two days. Got red did not swell
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: Crying, Electrocardiogram, Pyrexia, Regressive behaviour
Clinical narrative: After her vaccines, she never stopped crying. She cried for DAYS following vaccines. After 4-5 days passed, she woke up a different baby. She had no eye control. No neck control and no hand movement. She had a very high fever (higher than ?normal? after vaccines) her original pedi said it was normal. After a few ?normal? appointments, i decided to have a second opinion with Dr and he immediately noticed her regression and reffered us to a neurologist and put her in therapy. There was nothing normal about my 5 month old scoring at a 2 month old gross development. She had no issues prior to the appointment on September 14th 2018.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rotavirus test positive
Clinical narrative: Child positive for Rotavirus 4/2/19.  She received RotaTeq vaccine on 7/30/18, 11/1/18, and 12/4/18.  Just wanted to make report due to child receiving full vaccine series and then positive for Rotavirus on 4/2/19.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: MMR and Varicella were combined in one injection. MMR reconstituted with one 0.5ml vial of Sterile dilutent. Added to Varicella vial to reconstitute and given as one injection. No reported adverse events from family reported as of 4/8/2019.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: MMR and Varicella were combined in one injection. MMR reconstituted with one 0.5ml vial of Sterile Dilutent. Added to Varicella vial to reconstitute and given as one injection. No adverse reactions noted by family as of 04/08/2019.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Headache, Hot flush, Hyperhidrosis
Clinical narrative: FRIDAY, APRIL 5, 2019, 7am, Received second SHINGRIX vaccination in right deltoid. Took BENADRYL, ibuprofen, and TYLENOL. 11am - Hot flashes, Sweats. 12pm - Muscle aches everywhere, but increased on right upper arm, right side of neck. Continue BENADRYL, ibuprofen, and TYLENOL. 7p - Skin on chest and arms feels like sunburn. Chills/uncontrollable shivering. Increased temp. Muscle aches everywhere, but increased on right upper arm, right side of neck, bilat shins. Mild headache. Unquenchable thirst. Injection site swelling and tenderness. Continue BENADRYL, ibuprofen, and TYLENOL. Had to leave restaurant due to above symptoms. 3am - Swelling, warm to touch, and tenderness from injection site on right deltoid, right shoulder, to up the right side of my neck to my ear Injection site tenderness. Chills/uncontrollable shivering and temp continues. Continue BENADRYL, ibuprofen, and TYLENOL. SATURDAY, APRIL 6, 2019, 730am - Swelling, warm to touch, and tenderness from injection site on right deltoid, right shoulder, to up the right side of my neck to my ear Injection site tenderness. Chills/shivering have subsided. Continue BENADRYL, ibuprofen, and TYLENOL. 12p - Sweats. Neck swelling has gone down Swelling, warm to touch, and tenderness continues on right deltoid and right shoulder. Continue Ibuprofen and TYLENOL. 6p - Sweats have discontinued. Swelling, warm to touch, and tenders continues on right deltoid. SUNDAY, APRIL 7, 2019, 6am - No swelling in right upper arm, Tenderness at injection site only. 6pm - All symptoms have subsided.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Myalgia, Pain of skin
Clinical narrative: FRIDAY, APRIL 5, 2019, 7am, Received second SHINGRIX vaccination in right deltoid. Took BENADRYL, ibuprofen, and TYLENOL. 11am - Hot flashes, Sweats. 12pm - Muscle aches everywhere, but increased on right upper arm, right side of neck. Continue BENADRYL, ibuprofen, and TYLENOL. 7p - Skin on chest and arms feels like sunburn. Chills/uncontrollable shivering. Increased temp. Muscle aches everywhere, but increased on right upper arm, right side of neck, bilat shins. Mild headache. Unquenchable thirst. Injection site swelling and tenderness. Continue BENADRYL, ibuprofen, and TYLENOL. Had to leave restaurant due to above symptoms. 3am - Swelling, warm to touch, and tenderness from injection site on right deltoid, right shoulder, to up the right side of my neck to my ear Injection site tenderness. Chills/uncontrollable shivering and temp continues. Continue BENADRYL, ibuprofen, and TYLENOL. SATURDAY, APRIL 6, 2019, 730am - Swelling, warm to touch, and tenderness from injection site on right deltoid, right shoulder, to up the right side of my neck to my ear Injection site tenderness. Chills/shivering have subsided. Continue BENADRYL, ibuprofen, and TYLENOL. 12p - Sweats. Neck swelling has gone down Swelling, warm to touch, and tenderness continues on right deltoid and right shoulder. Continue Ibuprofen and TYLENOL. 6p - Sweats have discontinued. Swelling, warm to touch, and tenders continues on right deltoid. SUNDAY, APRIL 7, 2019, 6am - No swelling in right upper arm, Tenderness at injection site only. 6pm - All symptoms have subsided.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling, Tenderness, Thirst
Clinical narrative: FRIDAY, APRIL 5, 2019, 7am, Received second SHINGRIX vaccination in right deltoid. Took BENADRYL, ibuprofen, and TYLENOL. 11am - Hot flashes, Sweats. 12pm - Muscle aches everywhere, but increased on right upper arm, right side of neck. Continue BENADRYL, ibuprofen, and TYLENOL. 7p - Skin on chest and arms feels like sunburn. Chills/uncontrollable shivering. Increased temp. Muscle aches everywhere, but increased on right upper arm, right side of neck, bilat shins. Mild headache. Unquenchable thirst. Injection site swelling and tenderness. Continue BENADRYL, ibuprofen, and TYLENOL. Had to leave restaurant due to above symptoms. 3am - Swelling, warm to touch, and tenderness from injection site on right deltoid, right shoulder, to up the right side of my neck to my ear Injection site tenderness. Chills/uncontrollable shivering and temp continues. Continue BENADRYL, ibuprofen, and TYLENOL. SATURDAY, APRIL 6, 2019, 730am - Swelling, warm to touch, and tenderness from injection site on right deltoid, right shoulder, to up the right side of my neck to my ear Injection site tenderness. Chills/shivering have subsided. Continue BENADRYL, ibuprofen, and TYLENOL. 12p - Sweats. Neck swelling has gone down Swelling, warm to touch, and tenderness continues on right deltoid and right shoulder. Continue Ibuprofen and TYLENOL. 6p - Sweats have discontinued. Swelling, warm to touch, and tenders continues on right deltoid. SUNDAY, APRIL 7, 2019, 6am - No swelling in right upper arm, Tenderness at injection site only. 6pm - All symptoms have subsided.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: I received the vaccine at 2:30 in the afternoon. At around 5:30 pm, I experienced soreness in my arm at site of injection and down my arm. At about 10:00 pm. I started having flu like symptoms - aching, headache, chills. The symptoms got worse as time went on - developed a 102 temperature, severe headache and pain in my neck, vomiting and nausea. I went back to my physicians office at 9:00 am the next morning (04/03/2019). They gave me an injection for the nausea. I went home and slept the remainder of the day only being able to drink small amounts of fluid. On 04/04/2019 I felt better, but still stayed in bed all day with fatigue and overall not feeling well. All symptoms were gone by 04/05/2019.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Nausea, Neck pain, Vomiting
Clinical narrative: I received the vaccine at 2:30 in the afternoon. At around 5:30 pm, I experienced soreness in my arm at site of injection and down my arm. At about 10:00 pm. I started having flu like symptoms - aching, headache, chills. The symptoms got worse as time went on - developed a 102 temperature, severe headache and pain in my neck, vomiting and nausea. I went back to my physicians office at 9:00 am the next morning (04/03/2019). They gave me an injection for the nausea. I went home and slept the remainder of the day only being able to drink small amounts of fluid. On 04/04/2019 I felt better, but still stayed in bed all day with fatigue and overall not feeling well. All symptoms were gone by 04/05/2019.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Mother returned with child to clinic on 4/05/2019 at 1:30 pm.  Childs right upper arm swollen and war to touch.  No tenderness, no pain. Mother denies child had any fever, irritability, nor loss of appetite.  Mother states she gave oral Benadryl to child to help with swelling but did not see any improvement.  Recommended mother to start cold compresses multiple times a day to help with swelling. Compresses were not previously as recommended during visit. Contacted mother via telephone on 4/08/19 at 9:08 am; she reports that child is "doing better" and the swelling is gone.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Foreign travel, Urticaria
Clinical narrative: Patient had a Td on 3/13/19.  Came to the clinic on 4/8/19 am to report she had a reaction after vaccination.  Stated she had hives on her lower back starting on 3/14/19.  The hives got progressively worse over the next several days.  She went to an urgent care clinic sometime the following week (not sure of the date).  The hives were from the waist up, and coming and going.  She was given a prescription medication.  She denies being exposed to any new detergents or other products.  She did go out of the country from 3/30/19-4/4/19.  She is still experiencing hives today.  Instructed her to contact her primary care MD.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction reported; The patient received one dose of VAQTA on 04-APR-2019 that expired on 02-APR-2019; This spontaneous report was received from office manager refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 04-APR-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # R006471, expiry date: 02-APR-2019) 1 dosage form via intramuscular route for prophylaxis (expired product administered). The product had no previous temperature excursions. No adverse reaction reported (no adverse event). No additional information provided. No product quality complaint (PQC) was involved. The outcome of expired product administered, and no adverse event was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain, influenza-like symptoms, fever and feeling bad. On an unknown date, the outcome of the pain, influenza-like symptoms, fever and feeling bad were unknown. It was unknown if the reporter considered the pain, influenza-like symptoms, fever and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The age group of the patient was not reported, but it was taken as an adult, as per vaccine indication. The patient experience adverse event after receiving 2 doses of SHINGRIX vaccine. Till the time of reporting, the reporter decline to report and would update safety via correspondence. The Vaccine Administration Facility is the same as Primary Reporter. No additional details were provided. This case was 1 of 3 cases, reported by same reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic, Rash pustular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of itchy rash in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 18th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a month after receiving SHINGRIX, the patient experienced pustule, shingles and painful rash. On 25th March 2019, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash, pustule, shingles and painful rash were not recovered/not resolved. It was unknown if the reporter considered the itchy rash, pustule, shingles and painful rash to be related to SHINGRIX. Additional details were reported as follows: Three to four days before the date of reporting, a rash appeared on the patient's back that was itchy and then presented on his front. The rash on his front had raised pustules filled vessels that were painful. The reporter thought the rash on the patient's front might be shingles.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: Patient experienced profuse rash and possible hives on the injected arm, trunk, groin, flank, and legs in addition to soreness at the injection site starting within 3 days of vaccination and continuing for the past month. The rash is still unresolved but has gotten better.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Patient experienced profuse rash and possible hives on the injected arm, trunk, groin, flank, and legs in addition to soreness at the injection site starting within 3 days of vaccination and continuing for the past month. The rash is still unresolved but has gotten better.
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: unable to lift his arm; excruciating pain; This spontaneous report was received from a 67-year-old male patient. The patient's concurrent conditions included high blood pressure, unspecified urinary condition and allergy to sulfa drugs. Concomitant medications included unspecified blood pressure medication and unspecified urinary medication  On 01-APR-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscularly, in deltoid muscle for pneumonia prevention (dose, lot # and expiration date were not reported). On the same day, hours after getting pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) administered, the patient was unable to lift his arm and experienced excruciating pain. No treatment was given for the events, no lab diagnostics were performed. The patient did not seek medical attention.  At the time of the report, the patient did not recover from the events. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects; 12 month old patient received PROQUAD and VARIVAX on 30-MAR-2019; This spontaneous report was received from a medical assistant regarding a 12-month-old patient of unknow gender. The patient's concurrent conditions, historical conditions and past drugs were unknown. Concomitant therapy included sterile diluent. On 30-MAR-2019 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Albumin status: recombinant Human albumin (rHA)) (strength, dose, frequency were not provided) (lot # R007684 and expiration date 11-SEP-2019) subcutaneously (defaulted route) for prophylaxis and on the same day, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency were not provided, lot # R010466, expiration date 10-APR-2020) subcutaneously (defaulted route) for prophylaxis (inappropriate schedule of product administration). No adverse effects (no adverse event) were reported. No product quality complaint involved.