chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2013, the patient was treated by the patient's healthcare provider at a community hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 26-APR-2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On 14-JUN-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 25-JUN-2007, a healthcare provider at a clinic administered ZOSTAVAX to the patient (dose, route, and lot # not provided).  The patient was inoculated with ZOSTAVAX to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 15-OCT-2013 and in June 2014, the patient was treated by a physician at the same clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with zoster vaccine live (ZOSTAVAX) and suffered serious physical, emotional, and economic damages as a result of the patient's injuries.  As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Condition aggravated
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of arthralgia in a 64-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. Concurrent medical conditions included arthritis. On 15th October 2018, the patient received SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced arthralgia and arthritis aggravated. The patient was treated with MOBIC. On an unknown date, the outcome of the arthralgia and arthritis aggravated were not recovered/not resolved. It was unknown if the reporter considered the arthralgia and arthritis aggravated to be related to SHINGRIX. Additional details were provided as follows: On an unknown date in October 2018, the patient began to experience arthralgia. On the day of reporting, arthralgia remained ongoing and was not improving. The pharmacist additionally described the arthralgia as significant, and stated that the patient was unsure if it was an exacerbation of her preexisting arthritis. As treatment, the patient used MOBIC, which reportedly helped the patient's symptoms.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Injection site erythema, Injection site swelling, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a 78-year-old female patient who received SHINGRIX for prophylaxis. On 30th May 2018 11:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced loss of energy, general body pain, injection site swelling, injection site erythema, sleepiness and influenza-like symptoms. On an unknown date, the outcome of the loss of energy, general body pain, injection site swelling, injection site erythema, sleepiness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the loss of energy, general body pain, injection site swelling, injection site erythema, sleepiness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. Four hours after receiving vaccination, the patient experienced swelling and redness at the injection site. The patient also experienced feel like she did not have energy, she felt like she had the flu, was achy all over, and slept most of the day. All of these symptoms resolved after four days. For tolerability of 2nd dose of SHINGRIX, refer case US2018GSK209484. The patient had denied permission to contact their physician.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a 78-year-old female patient who received SHINGRIX for prophylaxis. On 30th May 2018 11:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced loss of energy, general body pain, injection site swelling, injection site erythema, sleepiness and influenza-like symptoms. On an unknown date, the outcome of the loss of energy, general body pain, injection site swelling, injection site erythema, sleepiness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the loss of energy, general body pain, injection site swelling, injection site erythema, sleepiness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. Four hours after receiving vaccination, the patient experienced swelling and redness at the injection site. The patient also experienced feel like she did not have energy, she felt like she had the flu, was achy all over, and slept most of the day. All of these symptoms resolved after four days. For tolerability of 2nd dose of SHINGRIX, refer case US2018GSK209484. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that a patient experienced an area of redness around the injection site which lasted for three weeks. The patient visited their doctor. The reporter did not have additional information.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain in extremity, Pruritus, Rash erythematous, Rash macular
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of localized itching in a 56-year-old female patient who received SHINGRIX (batch number FZ3ND, expiry date unknown) for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX. On 17th October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 18th October 2018, the patient experienced localized itching. On 19th October 2018, the patient experienced red rash, blister and blotchy rash. On 24th October 2018, the patient experienced skin peeling. The patient was treated with benadryl (nos) (Benadryl). On 23rd October 2018, the outcome of the red rash and blotchy rash were recovered/resolved. On an unknown date, the outcome of the localized itching, blister and pain in arm were recovering/resolving and the outcome of the skin peeling was unknown.  It was unknown if the reporter considered the localized itching, red rash, blister, skin peeling, pain in arm and blotchy rash to be related to SHINGRIX. The reporter was a health department nurse who's colleague experienced the symptoms after vaccination. The patient was vaccinated on Wednesday. On Thursday night, 1 day after vaccination, the patient had itching starting on her feet. On Friday, 2 days after vaccination, the patient had red blotchy rash appeared on feet, arms and hands and was blistered up. The patient took Benadryl those days to deal with symptoms. On Monday, the symptoms had greatly improved. On Tuesday, the rash was completely gone. At the time of reporting the patient also felt like her feet were going to peel. The patient had a rash like this been reported with SHINGRIX. The patient took Benadryl in those days to deal with symptoms. The reporting nurse agreed to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of localized itching in a 56-year-old female patient who received SHINGRIX (batch number FZ3ND, expiry date unknown) for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX. On 17th October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 18th October 2018, the patient experienced localized itching. On 19th October 2018, the patient experienced red rash, blister and blotchy rash. On 24th October 2018, the patient experienced skin peeling. The patient was treated with benadryl (nos) (Benadryl). On 23rd October 2018, the outcome of the red rash and blotchy rash were recovered/resolved. On an unknown date, the outcome of the localized itching, blister and pain in arm were recovering/resolving and the outcome of the skin peeling was unknown.  It was unknown if the reporter considered the localized itching, red rash, blister, skin peeling, pain in arm and blotchy rash to be related to SHINGRIX. The reporter was a health department nurse who's colleague experienced the symptoms after vaccination. The patient was vaccinated on Wednesday. On Thursday night, 1 day after vaccination, the patient had itching starting on her feet. On Friday, 2 days after vaccination, the patient had red blotchy rash appeared on feet, arms and hands and was blistered up. The patient took Benadryl those days to deal with symptoms. On Monday, the symptoms had greatly improved. On Tuesday, the rash was completely gone. At the time of reporting the patient also felt like her feet were going to peel. The patient had a rash like this been reported with SHINGRIX. The patient took Benadryl in those days to deal with symptoms. The reporting nurse agreed to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient was not feeling well for a few days. The reporter did not agree to receive follow up from GlaxoSmithKline.
Sex: F
Vaccine: TDAP
Symptoms: Cough, Malaise
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received DTPa (DTPa vaccine) for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, less than a week after receiving DTPa vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to DTPa vaccine. Additional details were provided as follows: This case was posted by a patient on a facebook page big bad cough. In 2018, the patient was forced to receive Tdap vaccine and had been sick all week.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patients experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not applicable for this report. The age group was not reported, but was captured as adult as per the vaccine indication. The sales representative stated the reporting physician was very vague. The physician stated that she believed that SHINGRIX was responsible for several shingles outbreaks in her patients over the past several months. The physician stated that there had been two or three patients who experienced adverse event that looked like a shingles outbreak shortly after vaccination with SHINGRIX, the time frame for the same was over the past several months. The physician was asked if she was sure that the patients experienced shingles, she stated that the symptoms presented as shingles. No single patient was identified. The physician did not agree to follow up. The case was considered for suspected vaccination failure as the time to onset and the vaccination schedule completed by the patient were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, 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 female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX 2 month before the time the time of reporting and experienced sore arm which had resolved. The reporter did not want to provide additional information. The case has been linked with case US2018203338 for 2nd dose of SHINGRIX.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Hypersomnia, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of asthenia in a 79-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of asthenia (1st dose received on 30th May 2018, refer case US2018193553). On 17th October 2018 16:00, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In October 2018, 4 hrs after receiving SHINGRIX, the patient experienced asthenia, general body pain, injection site swelling, injection site erythema, sleepiness and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the asthenia was not recovered/not resolved and the outcome of the general body pain, injection site swelling, injection site erythema and sleepiness were recovered/resolved and the outcome of the influenza-like symptoms was recovering/resolving. It was unknown if the reporter considered the asthenia, general body pain, injection site swelling, injection site erythema, sleepiness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient recevied SHINGRIX vaccine on left deltoid. Four to six hours after receiving vaccination, the patient experienced swelling and redness at the injection site, felt like she did not have energy, weakness, felt like she had the flu, was achy all over, and slept most of the day. The patient reported that the redness and swelling at the injection site was less after the 2nd dose of SHINGRIX. All of these symptoms had resolved except she was still feeling weak. She did feel that the weakness was resolving. The patient had denied permission to contact their physician.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of asthenia in a 79-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of asthenia (1st dose received on 30th May 2018, refer case US2018193553). On 17th October 2018 16:00, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In October 2018, 4 hrs after receiving SHINGRIX, the patient experienced asthenia, general body pain, injection site swelling, injection site erythema, sleepiness and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the asthenia was not recovered/not resolved and the outcome of the general body pain, injection site swelling, injection site erythema and sleepiness were recovered/resolved and the outcome of the influenza-like symptoms was recovering/resolving. It was unknown if the reporter considered the asthenia, general body pain, injection site swelling, injection site erythema, sleepiness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient recevied SHINGRIX vaccine on left deltoid. Four to six hours after receiving vaccination, the patient experienced swelling and redness at the injection site, felt like she did not have energy, weakness, felt like she had the flu, was achy all over, and slept most of the day. The patient reported that the redness and swelling at the injection site was less after the 2nd dose of SHINGRIX. All of these symptoms had resolved except she was still feeling weak. She did feel that the weakness was resolving. The patient had denied permission to contact their physician.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Induration, Insomnia, Limb discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 1st dose of SHINGRIX. On 6th September 2018, less than a day after receiving SHINGRIX, the patient experienced swelling, erythema and induration. In September 2018, the patient experienced itching. On 17th September 2018, the patient experienced pain in arm, shoulder pain, sleeplessness, chills and limb discomfort. On an unknown date, the patient experienced swelling of fingers. On an unknown date, the outcome of the pain in arm, shoulder pain, swelling, erythema, chills, itching and induration were recovered/resolved and the outcome of the sleeplessness, swelling of fingers and limb discomfort were unknown. It was unknown if the reporter considered the pain in arm, shoulder pain, sleeplessness, swelling, erythema, chills, itching, swelling of fingers, induration and limb discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced some swelling, redness and hardness. Less than a week after receiving SHINGRIX, the patient experienced some itching when the swelling, redness and hardness started to go away in 3 days. Eleven days after receiving SHINGRIX, the patient's two middle fingers on her left had began to had pain that went up to her shoulder and could not sleep for 3 days. Less than a year, the patient's some fingers no her right had to swell which lasted a couple of days for which she could not use her hand. This had improved and the swelling was gone. The patient experienced some pain and chills for 2 months. The reporter saw a nurse practitioner but the patient said the nurse ignored her concerns. The reporter said that she was scheduled to have the 2nd dose on 6th November 2018 and she had reservations on whether she should get it. The patient wanted to know if there was any benefit from getting only one dose reservations on whether she should get it. The reporter consented to follow up. Emergency room visit required.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity, Peripheral swelling, Pruritus, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 1st dose of SHINGRIX. On 6th September 2018, less than a day after receiving SHINGRIX, the patient experienced swelling, erythema and induration. In September 2018, the patient experienced itching. On 17th September 2018, the patient experienced pain in arm, shoulder pain, sleeplessness, chills and limb discomfort. On an unknown date, the patient experienced swelling of fingers. On an unknown date, the outcome of the pain in arm, shoulder pain, swelling, erythema, chills, itching and induration were recovered/resolved and the outcome of the sleeplessness, swelling of fingers and limb discomfort were unknown. It was unknown if the reporter considered the pain in arm, shoulder pain, sleeplessness, swelling, erythema, chills, itching, swelling of fingers, induration and limb discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced some swelling, redness and hardness. Less than a week after receiving SHINGRIX, the patient experienced some itching when the swelling, redness and hardness started to go away in 3 days. Eleven days after receiving SHINGRIX, the patient's two middle fingers on her left had began to had pain that went up to her shoulder and could not sleep for 3 days. Less than a year, the patient's some fingers no her right had to swell which lasted a couple of days for which she could not use her hand. This had improved and the swelling was gone. The patient experienced some pain and chills for 2 months. The reporter saw a nurse practitioner but the patient said the nurse ignored her concerns. The reporter said that she was scheduled to have the 2nd dose on 6th November 2018 and she had reservations on whether she should get it. The patient wanted to know if there was any benefit from getting only one dose reservations on whether she should get it. The reporter consented to follow up. Emergency room visit required.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a male patient who received 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 swelling arm, fever and pain. On an unknown date, the outcome of the swelling arm, fever and pain were unknown. It was unknown if the reporter considered the swelling arm, fever and pain to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The physician reported that the patient experience bad side effects after SHINGRIX. The patient had been seen at the physician's office everyday for 10 days due to a severely swollen arm, fever and pain. The reporter gave consented to follow up. Emergency room visit was required. The contact details of the healthcare professional's assistance were provided for contact or if follow up required. This has been linked to the case US2018199468 reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a male patient who received 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 pain, swelling arm and fever. On an unknown date, the outcome of the pain, swelling arm and fever were unknown. It was unknown if the reporter considered the pain, swelling arm and fever to be related to Shingrix. Additional information received as follows: The age at vaccination was not reported. The physician reported that the patient experienced bad side effects after Shingrix. The patient experienced pain, arm swelling and fever. The reporter gave consented to follow up. The contact details of the health care professional's assistant were reported for if follow up requested. This has been linked to the case US2018199491, reported by the same reporter.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received Shingrix for prophylaxis. Co-suspect products included Shingrix for prophylaxis. In March 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms and product supply issue. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported but could be 65 years or 66 years. In the first week of March 2018, the patient received 1st dose of Shingrix. The patient experienced flu like symptoms which lasted for total of 2 days. The patient reported that it had been more than 6 months from the 1st dose and he was not able to find the second dose anywhere (product supply issue). The reporter did not consent to follow-up. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (sore arm after receiving 2 month before the time of reporting, see case US2018GSK208487). On 6th November 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 6th November 2018, less than a day after receiving Shingrix, the patient experienced pain in arm and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the chills was unknown. It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient received the a dose of Shingrix in the right arm and her arm was still sore at the time of reporting on 7th November 2018 at 12:00 noon. The patient also reported that she had chills during the last night. The reporter did not want to provide additional information.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 58-year-old male patient who received SHINGRIX for prophylaxis. On 4th November 2018, the patient received SHINGRIX. On 4th November 2018, less than a day after receiving SHINGRIX, the patient experienced fever, chills and pain in arm. On 7th November 2018, the patient experienced red rash. On an unknown date, the outcome of the fever, chills and red rash were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the fever, chills, pain in arm and red rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient developed fever, chills, and a lot of soreness in the vaccinated arm the same day he received the SHINGRIX. The patient also developed a red spot that lasted for a day and a red streak about 3 to 4 inches long a little lower than the injection site. The patient given consent to follow up. The pharmacist did not have the vaccine information available. The patient did not receive the vaccine by this reporting pharmacist.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying
Clinical narrative: Child was crying for several hours (approximately 5 hours) straight before falling asleep. Child was his "normal self" per mother when he woke up that day. PCP saw child roughly 1 hour after vaccine administered for a previously scheduled appointment. Mother was told to give child TYLENOL, however, mother did not contact PCP after she contacted the health department to let someone now that child had been crying since vaccines were given that morning.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right arm with redness and swelling began the day patient received vaccines Warm to touch very painful and difficulty raising arm and sent home from school because of pain Doctor reports this at visit: Right upper arm with swelling of deltoid muscle up to shoulder and midway down upper arm with splotchy erythema, tender to palpation and tender as patient moves arm at shoulder.  Treatment plan by physician: Ice area once hourly until bedtime, ibuprofen or TYLENOL for pain, notify clinic for worsening condition.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Right arm with redness and swelling began the day patient received vaccines Warm to touch very painful and difficulty raising arm and sent home from school because of pain Doctor reports this at visit: Right upper arm with swelling of deltoid muscle up to shoulder and midway down upper arm with splotchy erythema, tender to palpation and tender as patient moves arm at shoulder.  Treatment plan by physician: Ice area once hourly until bedtime, ibuprofen or TYLENOL for pain, notify clinic for worsening condition.
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypersensitivity, Rash
Clinical narrative: Patient received the vaccine at pharmacy 11/2/18. Came to office 11/5/18 with rash over back, abdomen and chest. Began taking BENADRYL- was seen in office again 11/12/18 and prescribed prednisone. Provider feels it was likely allergic reaction- patient had history of egg allergy now resolved. Parent requested VAERS be completed.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Unable to lift arm, pain in arm, pain awakes me from sleep (***unsure of type of flu shot, manufacturer, given in workplace via employee health and documentation does not specify details requested above***).
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Pt. states she started to develop hives, onset hotness, and swelling on Lt. deltoid.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Dysphonia, Rash, Rash erythematous, Throat irritation
Clinical narrative: Six hours after vaccine she had rapid onset hoarseness, scratchy throat, erythematous rash on chest, and anxiety.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: Vaccine placement too high, near shoulder joint. Patient experiencing "zing" of pain with certain ROM movements.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient presented with significant swelling 2 days after vaccination administration, approx 4" by 6" and red/warm to touch. Advised by another PHN to apply compress PRN and RTC if swelling worsened or did not resolve.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Soreness, pain in Left upper arm muscle restricting normal motions.
Age: 22.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: Patient called the pharmacy on 11/19/18 and spoke with Associate. The patient complained of ongoing pain in his arm including sharp pains, also with difficulty lifting heavy objects. Patient states he has not see an physician at this point and will follow up within a week.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: Multiple small red and blue-ish dots on both legs. Nowhere else on body per patient's mother.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Feeling abnormal, Headache, Loss of personal independence in daily activities
Clinical narrative: Patient stated she had, joint pain, low fever (~100 degrees F) chills and headache, also presented with a 2 inch band around the arm which was warm and painful. She felt bad for 4 days but only 2 days where it affected her day to day activities. Started the day after the shot.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Patient stated she had, joint pain, low fever (~100 degrees F) chills and headache, also presented with a 2 inch band around the arm which was warm and painful. She felt bad for 4 days but only 2 days where it affected her day to day activities. Started the day after the shot.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Patient fainted after pharmacist gave immunization within the first few minutes of our in store waiting period post immunization. Pharmacist quickly responded lying patient flat and utilizing cold compress. Patient was breathing and responding and 911 was called. Patient was fine and left store with Mother.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: Pt developed hives at the injection site and trailing several inches down the arm and around the bicep.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Formication, Influenza like illness, Injection site pain, Pain
Clinical narrative: After the expected pain at the injection site, I began, about 5 hours later, to feel severe body aches, especially in my head, shoulders and back. By the time I went to bed, I felt as if I had the flu, with body aches and my skin felt "crawly," as if I had a fever, although I did not. The body aches reached their peak throughout the next day, easing up on the third day and I felt back to normal by the end of the 4th day.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Anal incontinence, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Patient had Guillain-Barre syndrome requiring hospitalization and IVIG. Followed up by rehabilitation.  Symptoms started approximately 3 days after immunization with bilateral lower extremity weakness was started on steroids as an outpatient. With one-week patient was noted to have progressive bilateral weakness, numbness and progressed to ascending paralysis with bowel and bladder incontinence.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Urinary incontinence
Clinical narrative: Patient had Guillain-Barre syndrome requiring hospitalization and IVIG. Followed up by rehabilitation.  Symptoms started approximately 3 days after immunization with bilateral lower extremity weakness was started on steroids as an outpatient. With one-week patient was noted to have progressive bilateral weakness, numbness and progressed to ascending paralysis with bowel and bladder incontinence.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site, Swelling
Clinical narrative: Patient stated that she experienced a significant amount of pain during the injection and added that the injection occurred above her deltoid. She continued to experience excruciating pain and some swelling over the next few days and was unable to move her arm the way she is normally able to. She applied ice and that helped with the swelling. Two weeks later she still experiences some pain and she complains of some limitation of range of motion.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Mobility decreased, Pain, Swelling
Clinical narrative: Patient stated that she experienced a significant amount of pain during the injection and added that the injection occurred above her deltoid. She continued to experience excruciating pain and some swelling over the next few days and was unable to move her arm the way she is normally able to. She applied ice and that helped with the swelling. Two weeks later she still experiences some pain and she complains of some limitation of range of motion.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient called 11-19-18 and said she has had a sore arm and difficulty raising it above her head. It is a little better today then it was. She said she has been taking ibuprofen and massaging it. I recommended stretching exercises as well and ask her to have her dr check her out and she said she already had an appointment for tomorrow for another issue and would check with her doctor.
Age: 55.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site bruising, Injection site induration, Injection site pain
Clinical narrative: PATIENT HAS A BRUISE AND A LITTLE HARD SPOT ON BACK OF HER ARM WHERE SHE SAID THE SHOT WAS GIVEN. IT HAS BEEN ALMOST 2 MONTHS SINCE THE VACCINE. SHE ALSO REPORTS A LITTLE BIT OF SORENESS AT THE SITE.
Age: 30.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Bilirubin urine present, Blood creatinine normal, Blood culture negative, Glomerular filtration rate normal, Glucose urine present
Clinical narrative: Pain in the right shoulder, difficult to lift the arm, and fever reported at home of 102 degrees F.
Age: 30.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia, Urine analysis normal, Urine ketone body present
Clinical narrative: Pain in the right shoulder, difficult to lift the arm, and fever reported at home of 102 degrees F.
Age: 30.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Urine phosphorus, White blood cell count increased
Clinical narrative: Pain in the right shoulder, difficult to lift the arm, and fever reported at home of 102 degrees F.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Deafness, Dizziness
Clinical narrative: PATIENT FELT VERY LIGHTHEADED, FELT TEMPORARY LOSS OF HEARING AND FELT CLOSE TO FAINTING.
Age: 51.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received adolescent HAVRIX instead of adult version. Has been notified. No adverse events.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Band neutrophil percentage increased, Blood albumin decreased, Brain natriuretic peptide increased, C-reactive protein increased
Clinical narrative: 4 hours after injection pt complaints of diffuse body aches, pain soreness in joints, myalgia, arthralgia, ED visit  Nov 9 and Nov 16 w hospital admission w Leukocytosis, elevated crp.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Leukocytosis, Myalgia, Neutrophil percentage increased, Pain, Platelet count increased
Clinical narrative: 4 hours after injection pt complaints of diffuse body aches, pain soreness in joints, myalgia, arthralgia, ED visit  Nov 9 and Nov 16 w hospital admission w Leukocytosis, elevated crp.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: 4 hours after injection pt complaints of diffuse body aches, pain soreness in joints, myalgia, arthralgia, ED visit  Nov 9 and Nov 16 w hospital admission w Leukocytosis, elevated crp.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX (lot# and route unknown) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 16-AUG-2010, a health care provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 07-NOV-2014 the patient was treated by the physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 15-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 04-OCT-2016, a healthcare provider at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2016, the patient was treated by the patient's healthcare provider at a medical group immediate care for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.