chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2017, 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, 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; 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: 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 ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In OCTOBER 2012, the patient's healthcare provider at a physician's office administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. In NOVEMBER 2012, the patient was treated by her healthcare provider at a physician's office 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. Causality assessment considered events to be related to the use of ZOSTAVAX. 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 ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 04-JAN-2008, a healthcare provider at a public healthcare department, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On 24-AUG-2016, the patient was treated by an optometrist (O.D.) at an eye clinic for shingles. The patient was diagnosed with shingles and or other zoster-related injuries (Not further specified) 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 (not further specified); 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: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, concerning a female patient of unknown age. Information about the patient's concurrent conditions, medical history or concomitant medication was unknown by reporter. On an unspecified date in December 2018 (reported as within the last week), the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unspecified date in December 2018, the patient went to an unspecified urgent care, because of pain and redness at the injection site and was diagnosed with cellulitis (injection site cellulitis). It was unknown whether or not the patient received any treatment for the cellulitis, if any laboratory diagnostics or studies were performed and if the patient recovered from injection site cellulitis at the reporting time. The causal relationship between PNEUMOVAX 23 and injection site cellulitis was not reported. Upon internal review, injection site cellulitis was determined to be medically significant.
Sex: F
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 female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2014, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with 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: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Biopsy skin abnormal, Rash, Skin discolouration, Vasculitis
Clinical narrative: This case was reported by a consumer and described the occurrence of vasculitis legs in a 65-year-old female patient who received FLULAVAL QUADRIVALENT 2015-2016 season (batch number 7754S, expiry date 1st June 2016) for prophylaxis. Co-suspect products included FLULAVAL QUADRIVALENT 2016-2017 season (batch number A3AD2, expiry date 1st May 2017) for prophylaxis. On 16th October 2015, the patient received the 2nd dose of FLULAVAL QUADRIVALENT 2015-2016 season (intramuscular) .5 ml. On 15th September 2016, the patient received the 3rd dose of FLULAVAL QUADRIVALENT 2016-2017 season (intramuscular) .5 ml. In October 2015, 6 days after receiving FLULAVAL QUADRIVALENT 2015-2016 season and FLULAVAL QUADRIVALENT 2016-2017 season and not applicable after receiving FLULAVAL QUADRIVALENT 2016-2017 season, the patient experienced vasculitis, rash, skin discoloration and joint pain. In September 2016, the patient experienced vasculitis, rash, skin discoloration and joint pain. On an unknown date, the outcome of the vasculitis, rash, skin discoloration, joint pain, vasculitis, rash, skin discoloration and joint pain were unknown. It was unknown if the reporter considered the vasculitis, rash, skin discoloration and joint pain to be related to FLULAVAL QUADRIVALENT 2015-2016 season. It was unknown if the reporter considered the vasculitis, rash, skin discoloration and joint pain to be related to FLULAVAL QUADRIVALENT 2016-2017 season. Additional details were provided as follows: The age at vaccination was not reported. On 16th October 2015 01:12, the patient received 2nd dose of FLULAVAL QUADRIVALENT 2015-2016 season and on 15th September 2016 10:12, the patient received 3rd dose of FLULAVAL QUADRIVALENT 2016-2017 season. In 2015, 2016, and 2017, the patient had the flu vaccine, 6 days after each dose, the patient experienced vasculitis. The patient experienced a severe rash on legs and trunk which lasted about a month, with some residual discoloration on legs and also experienced joint pain. Follow up information received from physician on 19th November 2018: The reporter's contact details were updated. The patient's demographic details were updated. On 10th September 2017, the patient received FLUZONE HIGH DOSE solution 0.5ml (intramuscularly), In September 2017, 6 days after vaccination the patient experienced lower extremity vasculitis. The patient has had 3 episodes of lower extremity vasculitis biopsy was done by dermatology showed IgA vasculitis. On an unknown date, the outcome of the vasculitis, rash, skin discoloration, joint pain, vasculitis, rash, skin discoloration and joint pain were unknown. It was unknown if the reporter considered the vasculitis, rash, skin discoloration and joint pain to be related to FLUZONE HIGH DOSE solution. The VAERS details were updated. The patient gave authorization to contact their physician. Lab Comments: On an unknown date, biopsy done by dermatology showed as IgA vasculitis. Sender's Comments: US2018GSK007391: Previous VAERS submission in paper format.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever 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, unknown after receiving SHINGRIX, the patient experienced fever, nausea, weakness, injection site pain and injection site erythema. On an unknown date, the outcome of the fever, nausea, weakness, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the fever, nausea, weakness, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient experienced a fever (body temperature 101.4 degree F), nausea, weakness, and extremely painful and red arm at injection site for 4 days post shot. The patient asked how long would this last, should she contact her doctor and would the second injection cause these symptoms. If so, patient was not sure she would get it.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 82-year-old male patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX. On 15th October 2018, 17 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient experienced constant pain in his right arm, which was described as a dull aching pain. The patient stated, when the arm was not in use the pain was 1 to 2, but in use it was 5 to 6. The patient related his pain to the vaccine. Till the time of reporting, the patient had not informed or spoken with his physician about the pain.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 60-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included osteoporosis. Concomitant products included PROLIA. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced nausea. On an unknown date, the outcome of the nausea was recovered/resolved. It was unknown if the reporter considered the nausea to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but could be 59 or 60 years. The patient planned to follow up with her physician on an unknown date. The reporter did not consented to follow up. Limited information was provided. The patient wanted to remain anonymous, and did not want to answer any further questions.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of Guillain Barre syndrome in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced Guillain Barre syndrome (serious criteria hospitalization, GSK medically significant and life threatening). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The physician heard second hand information about that, the patient who was in hospital dying from Guillain Barre Syndrome secondary to SHINGRIX vaccination. The reported physician was not treated this patient and did not have any additional information regarding the patient. The physician requested specific information on this patient. The reporter asked for someone from GSK to follow-up with him regarding this specific patient.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise, Mobility decreased, 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 adult female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received when the patient was 60 years old). On 29th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, tiredness, sickness, influenza-like symptoms and mobility decreased. On an unknown date, the outcome of the pain in arm, tiredness, sickness, influenza-like symptoms and mobility decreased were recovered/resolved. It was unknown if the reporter considered the pain in arm, tiredness, sickness, influenza-like symptoms and mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The patient claimed that the SHINGRIX shot was the worst shot she had received in her life. The patient claimed that she experienced arm pain and she could not lift her arm above her head. The patient was tired and felt sick with flu symptoms and she could not do anything for a day or two but it took a full week to resolve. The reporter did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Incomplete course of vaccination, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 6th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced chills, fever and tremor. On an unknown date, the patient experienced injection site muscle pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site muscle pain, chills, fever and tremor were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the injection site muscle pain, chills, fever and tremor to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of SHINGRIX. The patient received 1st dose of SHINGRIX on the left arm. After receiving SHINGRIX, the patient experienced that the muscle at the injection site and 2 to 3 inches out was very sore for two weeks. After that, it took months before the site felt normal again. Within 36 hours after receiving 1st dose, the patient also experienced worst chills, could not stop shaking, and felt like he had a fever of 106 degrees. The patient never checked the temperature because he felt so bad. The chills resolved within 30 minutes. The patient was overdue for receiving the second dose of the SHINGRIX vaccine. Till the time of reporting, the patient did not receive the second dose of SHINGRIX, which led to incomplete course of vaccination. The patient consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 6th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced chills, fever and tremor. On an unknown date, the patient experienced injection site muscle pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site muscle pain, chills, fever and tremor were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the injection site muscle pain, chills, fever and tremor to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of SHINGRIX. The patient received 1st dose of SHINGRIX on the left arm. After receiving SHINGRIX, the patient experienced that the muscle at the injection site and 2 to 3 inches out was very sore for two weeks. After that, it took months before the site felt normal again. Within 36 hours after receiving 1st dose, the patient also experienced worst chills, could not stop shaking, and felt like he had a fever of 106 degrees. The patient never checked the temperature because he felt so bad. The chills resolved within 30 minutes. The patient was overdue for receiving the second dose of the SHINGRIX vaccine. Till the time of reporting, the patient did not receive the second dose of SHINGRIX, which led to incomplete course of vaccination. The patient consented to follow up.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Dizziness, Feeling cold, Feeling hot
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 87-year-old female patient who received SHINGRIX for prophylaxis. On 20th November 2018, the patient received the 1st dose of SHINGRIX. On 20th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced pain in spine, pain localized, low back pain, nausea, influenza-like symptoms, loss of energy, musculoskeletal disorder, dizziness, feeling hot and feeling cold. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pain in spine, pain localized, low back pain, nausea, influenza-like symptoms, loss of energy, musculoskeletal disorder, dizziness, feeling hot and feeling cold were unknown. It was unknown if the reporter considered the pain in arm, pain in spine, pain localized, low back pain, nausea, influenza-like symptoms, loss of energy, musculoskeletal disorder, dizziness, feeling hot and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain and tenderness in arm. Less than a month after receiving SHINGRIX, the patient experienced spine pain, waist pain, lower back pain, nausea, flu-like symptoms, lack of pep, trouble with legs, dizziness, feeling hot and feeling cold. This case has been linked with case US2018223390 (reporter's son), reported by same reporter.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Musculoskeletal disorder, Nausea, Pain, 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 87-year-old female patient who received SHINGRIX for prophylaxis. On 20th November 2018, the patient received the 1st dose of SHINGRIX. On 20th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced pain in spine, pain localized, low back pain, nausea, influenza-like symptoms, loss of energy, musculoskeletal disorder, dizziness, feeling hot and feeling cold. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pain in spine, pain localized, low back pain, nausea, influenza-like symptoms, loss of energy, musculoskeletal disorder, dizziness, feeling hot and feeling cold were unknown. It was unknown if the reporter considered the pain in arm, pain in spine, pain localized, low back pain, nausea, influenza-like symptoms, loss of energy, musculoskeletal disorder, dizziness, feeling hot and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain and tenderness in arm. Less than a month after receiving SHINGRIX, the patient experienced spine pain, waist pain, lower back pain, nausea, flu-like symptoms, lack of pep, trouble with legs, dizziness, feeling hot and feeling cold. This case has been linked with case US2018223390 (reporter's son), reported by same reporter.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal pain, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 87-year-old female patient who received SHINGRIX for prophylaxis. On 20th November 2018, the patient received the 1st dose of SHINGRIX. On 20th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced pain in spine, pain localized, low back pain, nausea, influenza-like symptoms, loss of energy, musculoskeletal disorder, dizziness, feeling hot and feeling cold. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pain in spine, pain localized, low back pain, nausea, influenza-like symptoms, loss of energy, musculoskeletal disorder, dizziness, feeling hot and feeling cold were unknown. It was unknown if the reporter considered the pain in arm, pain in spine, pain localized, low back pain, nausea, influenza-like symptoms, loss of energy, musculoskeletal disorder, dizziness, feeling hot and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain and tenderness in arm. Less than a month after receiving SHINGRIX, the patient experienced spine pain, waist pain, lower back pain, nausea, flu-like symptoms, lack of pep, trouble with legs, dizziness, feeling hot and feeling cold. This case has been linked with case US2018223390 (reporter's son), reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
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. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The patient experienced flu-like symptoms, which lasted a day or two. This case has been linked with the case US2018223387, reported by the same reporter.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Rheumatoid arthritis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rheumatoid arthritis flare up in a 52-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date unknown) for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On 7th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th December 2018, several hours after receiving SHINGRIX, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant). On an unknown date, the outcome of the rheumatoid arthritis flare up was recovering/resolving. It was unknown if the reporter considered the rheumatoid arthritis flare up to be related to SHINGRIX. Additional details were provided as follows: At 2:50 pm, the patient received SHINGRIX vaccine. The reporter was not certain about the lot number because it was difficult to read the paperwork. The pharmacist reported that one of their patients told them on the day before reporting that she had an rheumatoid arthritis flare up the same night she received a dose of SHINGRIX. The patient felt better.
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Atrial fibrillation, Cardiac ablation, Cough, Heart rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of whooping cough in a 60-year-old male patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On 1st January 2015, unknown after receiving dTpa vaccine, the patient experienced whooping cough (serious criteria hospitalization and GSK medically significant), cough (serious criteria hospitalization) and atrial fibrillation (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced loss of energy (serious criteria hospitalization), heart rate increased (serious criteria hospitalization) and activities of daily living impaired. On an unknown date, the outcome of the whooping cough, cough, atrial fibrillation, loss of energy, heart rate increased and activities of daily living impaired were unknown. It was unknown if the reporter considered the whooping cough, cough, atrial fibrillation, loss of energy, heart rate increased and activities of daily living impaired to be related to dTpa vaccine. Additional details were provided as follows: The age at the vaccination was not reported. In 2013, the patient received whooping cough booster probably. In December 2014, the patient was on cruise for a vacation. On 1st January 2015, the patient was home from the cruise and started coughing violently. The patient saw his health care professional as soon as he could after New Year's and was sent to the hospital for atrial fibrillation. The patient was hospitalized several times until getting an ablation on 1st April 2015. The patient coughed the entire time, but his providers were all concerned with his atrial fibrillation and did not think anything of it. After the ablation, his health care professional finally referred him to a tropical and infectious diseases specialist and the patient was diagnosed with whooping cough. After the ablation the coughing improved some, but he continued to had regular coughing episodes. The patient was hospitalized a couple more times because of a fast heart rate until he had a second ablation on 1st April 2016. Prior to the 2nd ablation the patient did not have any energy and could not do things like walk the dog. After the 2nd ablation, as soon as the patient woke up he knew it had worked because he could not feel his heart beating for the first time since 2014. The two ablations both occurred on 1st April one year apart (2015 and 2016). The coughing continued until spring of 2017. The reporter thought the whooping cough caused him to go into atrial fibrillation. The patient had recovered from whooping cough and atrial fibrillation and was physically active again. Emergency room visit was required. The reporter consented to follow up. Lab Comments: On an unknown date, the heart rate was measured.
Sex: M
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Pertussis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of whooping cough in a 60-year-old male patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On 1st January 2015, unknown after receiving dTpa vaccine, the patient experienced whooping cough (serious criteria hospitalization and GSK medically significant), cough (serious criteria hospitalization) and atrial fibrillation (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced loss of energy (serious criteria hospitalization), heart rate increased (serious criteria hospitalization) and activities of daily living impaired. On an unknown date, the outcome of the whooping cough, cough, atrial fibrillation, loss of energy, heart rate increased and activities of daily living impaired were unknown. It was unknown if the reporter considered the whooping cough, cough, atrial fibrillation, loss of energy, heart rate increased and activities of daily living impaired to be related to dTpa vaccine. Additional details were provided as follows: The age at the vaccination was not reported. In 2013, the patient received whooping cough booster probably. In December 2014, the patient was on cruise for a vacation. On 1st January 2015, the patient was home from the cruise and started coughing violently. The patient saw his health care professional as soon as he could after New Year's and was sent to the hospital for atrial fibrillation. The patient was hospitalized several times until getting an ablation on 1st April 2015. The patient coughed the entire time, but his providers were all concerned with his atrial fibrillation and did not think anything of it. After the ablation, his health care professional finally referred him to a tropical and infectious diseases specialist and the patient was diagnosed with whooping cough. After the ablation the coughing improved some, but he continued to had regular coughing episodes. The patient was hospitalized a couple more times because of a fast heart rate until he had a second ablation on 1st April 2016. Prior to the 2nd ablation the patient did not have any energy and could not do things like walk the dog. After the 2nd ablation, as soon as the patient woke up he knew it had worked because he could not feel his heart beating for the first time since 2014. The two ablations both occurred on 1st April one year apart (2015 and 2016). The coughing continued until spring of 2017. The reporter thought the whooping cough caused him to go into atrial fibrillation. The patient had recovered from whooping cough and atrial fibrillation and was physically active again. Emergency room visit was required. The reporter consented to follow up. Lab Comments: On an unknown date, the heart rate was measured.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Took SHINGRIX #1 Injection on 09/30/2018. Broke out with shingles 10/7/2018 on Left ant neck and face. Also, across ABD bilat.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
Clinical narrative: 73yr old patient presented to PCP on 9/20/18. Patient ordered and administered influenza vaccine-high dose (Trivalent) IM in patient's right deltoid by CMA. CMA noted "shot tolerated, no reaction".  On 12/1/18, patient contacted provider complaining of right arm pain since flu shot administration on 9/20. Endorsed immediate pain, especially with movement, unable to lift right arm or perform upper body exercises. Patient seen by provider on 12/14 for follow up. Patient denied numbness or weakness. Patient endorsed resting arm and using heat for pain. Unknown of other treatments attempted. No prior issues with vaccines noted, but history of rotator cuff surgery on left shoulder. MD requested patient come in for follow up visit. Patient presented on 12/14 for evaluation. MD ordered rest, continued heat, MRI and PT ordered. Patient instructed to use aspercreme or topical lidocaine OTC as needed.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Erythema, Fatigue, Headache
Clinical narrative: Red, hot, itches, upper arm is solid, painful to the touch, pain at shot location, muscle pain, feeling tired or weak, headache, fever, belly pain. Lasted all night but was gone in the morning except for the redness, hotness and solid feel to the upper arm, still sensitive to touch.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site pain, Myalgia, Pain in extremity, Pruritus
Clinical narrative: Red, hot, itches, upper arm is solid, painful to the touch, pain at shot location, muscle pain, feeling tired or weak, headache, fever, belly pain. Lasted all night but was gone in the morning except for the redness, hotness and solid feel to the upper arm, still sensitive to touch.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Red, hot, itches, upper arm is solid, painful to the touch, pain at shot location, muscle pain, feeling tired or weak, headache, fever, belly pain. Lasted all night but was gone in the morning except for the redness, hotness and solid feel to the upper arm, still sensitive to touch.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Dysstasia, Electromyogram abnormal, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Employee faxed in injury report on 12/13/18 to document an adverse reaction that occurred from a flu shot she received through the wellness fair on 11/5/18. The employee reports she started to experience a bilateral numbness and tingling in her feet about 3-4 days after getting her flu shot (the weekend of 11/09/18-11/11/18). She waited about a week to see if the symptoms would go away but they progressively worsened so she went to her PCP who did lab work. Those labs came back negative and she was placed on meds for neuropathy. The symptoms progressed further to numbness in both legs, both arms and abdomen to the point where the employee had difficulty standing up She went to ER for care and the provider there directed her to follow up with a neurologist. The employee looked up a neurologist through her insurance who ordered an EMG.  This results of this test per the employee's report was that she was diagnosed with Guillian Barre.  She was then admitted to the hospital on 12/13/18 for treatment with IVIG until her discharge date of 12/17/18. EE continues to have numbness in her lower extremities.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test normal, Neuropathy peripheral, Paraesthesia
Clinical narrative: Employee faxed in injury report on 12/13/18 to document an adverse reaction that occurred from a flu shot she received through the wellness fair on 11/5/18. The employee reports she started to experience a bilateral numbness and tingling in her feet about 3-4 days after getting her flu shot (the weekend of 11/09/18-11/11/18). She waited about a week to see if the symptoms would go away but they progressively worsened so she went to her PCP who did lab work. Those labs came back negative and she was placed on meds for neuropathy. The symptoms progressed further to numbness in both legs, both arms and abdomen to the point where the employee had difficulty standing up She went to ER for care and the provider there directed her to follow up with a neurologist. The employee looked up a neurologist through her insurance who ordered an EMG.  This results of this test per the employee's report was that she was diagnosed with Guillian Barre.  She was then admitted to the hospital on 12/13/18 for treatment with IVIG until her discharge date of 12/17/18. EE continues to have numbness in her lower extremities.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Hyperhidrosis, Loss of consciousness, Syncope, Tinnitus
Clinical narrative: Student received vaccine at school located flu clinic. About 1/2 hour later, nurse called to classroom for fainting student. When she arrived he reported experiencing bad stomachache, rushing in ears, then loss of consciousness. Already awake and alert upon nurse arrival. Student was diaphretic. BP 90/64. Took by wheelchair to health 104/68. Stayed in health room for 1 hour and 15 min, color and energy came back. Monitored briefly and returned to class.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient described that she developed cellulitis three days after receiving SHINGRIX dose 2. She reported that she had to go to urgent care to obtain antibiotics to cure the infection.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, HPV9, RV1
Symptoms: Pyrexia, Vomiting, Wrong product administered
Clinical narrative: Patient was accidentally given GARDASIL 9 instead of PCV 13. She did experience a "low grade fever," and vomiting x1 on the afternoon of the vaccination. Her symptoms self resolved without treatment.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Rash, Rash papular
Clinical narrative: Patient presented to office 12/17/18 with 1 day h/o rash. No fever. +/- painful/tender. On exam had TNTC papulovesicles arranged in clusters and distributed along dermatome from mid abdomen extending around on left side/flank and stopping at spine.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Bursitis, Injected limb mobility decreased, Injection site discomfort, Injection site reaction, Pain in extremity
Clinical narrative: 10/28/18 Attacked by German Shepard while on a walk. Dog bit my left upper arm. I went to local hospital to emergency department to have bite evaluated. Wound cleaned and bandaged. No rabies globulin given, no sutures. TDAP was given in right upper extremity, since last tetanus shot was 2010. Nurse gave shot too high. Started having discomfort in right upper arm evening of 10/28. Started having severe pain in right upper extremity 10/31. By 11/7/18 I had colleague (orthopedic surgeon) evaluate pain and he said tetanus shot was given too high and caused severe bursitis. Very limited use of right upper extremity due to severe pain. 11/20/18 went to have shoulder evaluated in an official capacity by orthopedic surgeon. He documents: "DOI right shoulder 10/28/18- received Tetanus shot in ER in shoulder. Her left shoulder may have some mild pre-existing rotator cuff pathology based on history but this is clearly been aggravated by the tetanus injection." As of 12/13/18 Right upper extremity has become more of a chronic pain vs. initial acute pain and not improving. Physical therapy ordered and started on 12/17/18. Physical therapist said it will take 3-4 months, on average, to return to normal. The plan is to do daily exercises and to meet with PT on a weekly basis to hopefully progress exercises. Continue to have limited use of right upper extremity due to pain. Physical therapist confirmed that wrongly placed injection caused bursitis and now rotator cuff area injuries.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: 10/28/18 Attacked by German Shepard while on a walk. Dog bit my left upper arm. I went to local hospital to emergency department to have bite evaluated. Wound cleaned and bandaged. No rabies globulin given, no sutures. TDAP was given in right upper extremity, since last tetanus shot was 2010. Nurse gave shot too high. Started having discomfort in right upper arm evening of 10/28. Started having severe pain in right upper extremity 10/31. By 11/7/18 I had colleague (orthopedic surgeon) evaluate pain and he said tetanus shot was given too high and caused severe bursitis. Very limited use of right upper extremity due to severe pain. 11/20/18 went to have shoulder evaluated in an official capacity by orthopedic surgeon. He documents: "DOI right shoulder 10/28/18- received Tetanus shot in ER in shoulder. Her left shoulder may have some mild pre-existing rotator cuff pathology based on history but this is clearly been aggravated by the tetanus injection." As of 12/13/18 Right upper extremity has become more of a chronic pain vs. initial acute pain and not improving. Physical therapy ordered and started on 12/17/18. Physical therapist said it will take 3-4 months, on average, to return to normal. The plan is to do daily exercises and to meet with PT on a weekly basis to hopefully progress exercises. Continue to have limited use of right upper extremity due to pain. Physical therapist confirmed that wrongly placed injection caused bursitis and now rotator cuff area injuries.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, Immunisation, No adverse event
Clinical narrative: Patient was given an expired Vaccination. The PROQUAD Ex Date was 11/08/18 and was given the vaccination 11/21/18. NO reactions. He was given a second dose on 12/18/18 as the Vx was considered not effective by Health Department.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Erythema, Fatigue, Headache, Influenza like illness
Clinical narrative: Soreness at site of injection-outside of left arm. Redness, soreness and swollen inner arm, near lymph glands. Extreme fatigue, flu like symptoms. Headache. Weakness. These symptoms lasted about 36 hours. Redness, soreness and swollen inner arm remained same for 4 days. Soreness continued on inner arm total of 6 days. Headache waxed and waned  for 6 days. Tylenol and Imitrix 50 mg needed to control headache pain.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness at site of injection-outside of left arm. Redness, soreness and swollen inner arm, near lymph glands. Extreme fatigue, flu like symptoms. Headache. Weakness. These symptoms lasted about 36 hours. Redness, soreness and swollen inner arm remained same for 4 days. Soreness continued on inner arm total of 6 days. Headache waxed and waned  for 6 days. Tylenol and Imitrix 50 mg needed to control headache pain.
Age: 2.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is only 2 years old and vaccine is indicated for age 4 years and older, no adverse side effects noted at time of or after administration.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Warm, Hot, Swollen arm. Patient applied ice pack and took BENADRYL.
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: Conjunctivitis, Ear infection, Inappropriate schedule of product administration
Clinical narrative: Patient was seen for a flu shot on 11.13.18 she was then seen again on 11.28.18 for her 9 month wellness appointment at which time the doctor ordered her 2nd Flu shot (booster). On 12.4.18 she was seen for a sick visit and diagnosed with an ear infection and pink eye. Her last dose of medication was 12.14.18 and by that afternoon I had a 2:45 appointment scheduled. It was at this time she was diagnosed with a left ear infection. On 12.18.18 was supposed to be her booster to the flu shot which was canceled due to the error in giving it at her 9 month appointment.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Pt reports blurred vision after receiving vaccine. Not certain on time it began. Currently treating using OTC Wetting drops which provides temporary relief. She will consider contacting her optometrist in a week if no improvement.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient still has sore and pain at injection site since administration date (9/13/2018).
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Soft tissue injury
Clinical narrative: Pain at time of injection that was unusual for flu vaccines she has had in the past. Site soreness that progressed to limited movement of her right arm. Saw a Dr and is now going through physical therapy to get range of motion back. Told she had soft tissue injury.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: RED, SWOLLEN, WARM ARM EXTENDING FROM ABOUT 4 INCHES AND AROUND TOP OF ARM. APPLIED CREAM. TOOK A FEW DAYS TO SUBSIDE.