chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Headache, Initial insomnia, Injected limb mobility decreased, Injection site pain, Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th July 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site rash and injection site erythema. On 26th July 2018, the patient experienced injection site swelling and injected limb mobility decreased. On 26th July 2018, the outcome of the fever was recovered/resolved. On 29th July 2018, the outcome of the chills, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced chills, low fever, tired, headache, loss of taste bud, trouble sleeping, pain and redness at injection site. On 26th July 2018, the patient's fever was gone and her headache was less severe. The injection site was swollen and the pain in the arm increased. She could not even lift her arm. The redness at injection site turned into a rash around the injection site in size of 4 centimeters in diameter. On 28th July 2018, the rash was only present underneath the injection site and it was 6 centimeters in diameter. By 29th July 2018, the patient recovered from all her symptoms. The patient was referred to her health care provider. The reporter did not consent to be followed up.  No further details were provided.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Limb discomfort, Neck pain, Pain in extremity, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th July 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site rash and injection site erythema. On 26th July 2018, the patient experienced injection site swelling and injected limb mobility decreased. On 26th July 2018, the outcome of the fever was recovered/resolved. On 29th July 2018, the outcome of the chills, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced chills, low fever, tired, headache, loss of taste bud, trouble sleeping, pain and redness at injection site. On 26th July 2018, the patient's fever was gone and her headache was less severe. The injection site was swollen and the pain in the arm increased. She could not even lift her arm. The redness at injection site turned into a rash around the injection site in size of 4 centimeters in diameter. On 28th July 2018, the rash was only present underneath the injection site and it was 6 centimeters in diameter. By 29th July 2018, the patient recovered from all her symptoms. The patient was referred to her health care provider. The reporter did not consent to be followed up.  No further details were provided.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th July 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site rash and injection site erythema. On 26th July 2018, the patient experienced injection site swelling and injected limb mobility decreased. On 26th July 2018, the outcome of the fever was recovered/resolved. On 29th July 2018, the outcome of the chills, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced chills, low fever, tired, headache, loss of taste bud, trouble sleeping, pain and redness at injection site. On 26th July 2018, the patient's fever was gone and her headache was less severe. The injection site was swollen and the pain in the arm increased. She could not even lift her arm. The redness at injection site turned into a rash around the injection site in size of 4 centimeters in diameter. On 28th July 2018, the rash was only present underneath the injection site and it was 6 centimeters in diameter. By 29th July 2018, the patient recovered from all her symptoms. The patient was referred to her health care provider. The reporter did not consent to be followed up.  No further details were provided.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Rash, Thirst
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th July 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site rash and injection site erythema. On 26th July 2018, the patient experienced injection site swelling and injected limb mobility decreased. On 26th July 2018, the outcome of the fever was recovered/resolved. On 29th July 2018, the outcome of the chills, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced chills, low fever, tired, headache, loss of taste bud, trouble sleeping, pain and redness at injection site. On 26th July 2018, the patient's fever was gone and her headache was less severe. The injection site was swollen and the pain in the arm increased. She could not even lift her arm. The redness at injection site turned into a rash around the injection site in size of 4 centimeters in diameter. On 28th July 2018, the rash was only present underneath the injection site and it was 6 centimeters in diameter. By 29th July 2018, the patient recovered from all her symptoms. The patient was referred to her health care provider. The reporter did not consent to be followed up.  No further details were provided.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Injection site pain, Neck pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th July 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site rash and injection site erythema. On 26th July 2018, the patient experienced injection site swelling and injected limb mobility decreased. On 26th July 2018, the outcome of the fever was recovered/resolved. On 29th July 2018, the outcome of the chills, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced chills, low fever, tired, headache, loss of taste bud, trouble sleeping, pain and redness at injection site. On 26th July 2018, the patient's fever was gone and her headache was less severe. The injection site was swollen and the pain in the arm increased. She could not even lift her arm. The redness at injection site turned into a rash around the injection site in size of 4 centimeters in diameter. On 28th July 2018, the rash was only present underneath the injection site and it was 6 centimeters in diameter. By 29th July 2018, the patient recovered from all her symptoms. The patient was referred to her health care provider. The reporter did not consent to be followed up.  No further details were provided.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Ageusia, Chills, Fatigue, Headache, Injected limb mobility decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th July 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site rash and injection site erythema. On 26th July 2018, the patient experienced injection site swelling and injected limb mobility decreased. On 26th July 2018, the outcome of the fever was recovered/resolved. On 29th July 2018, the outcome of the chills, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced chills, low fever, tired, headache, loss of taste bud, trouble sleeping, pain and redness at injection site. On 26th July 2018, the patient's fever was gone and her headache was less severe. The injection site was swollen and the pain in the arm increased. She could not even lift her arm. The redness at injection site turned into a rash around the injection site in size of 4 centimeters in diameter. On 28th July 2018, the rash was only present underneath the injection site and it was 6 centimeters in diameter. By 29th July 2018, the patient recovered from all her symptoms. The patient was referred to her health care provider. The reporter did not consent to be followed up.  No further details were provided.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Insomnia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th July 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site rash and injection site erythema. On 26th July 2018, the patient experienced injection site swelling and injected limb mobility decreased. On 26th July 2018, the outcome of the fever was recovered/resolved. On 29th July 2018, the outcome of the chills, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced chills, low fever, tired, headache, loss of taste bud, trouble sleeping, pain and redness at injection site. On 26th July 2018, the patient's fever was gone and her headache was less severe. The injection site was swollen and the pain in the arm increased. She could not even lift her arm. The redness at injection site turned into a rash around the injection site in size of 4 centimeters in diameter. On 28th July 2018, the rash was only present underneath the injection site and it was 6 centimeters in diameter. By 29th July 2018, the patient recovered from all her symptoms. The patient was referred to her health care provider. The reporter did not consent to be followed up.  No further details were provided.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 24th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th July 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site rash and injection site erythema. On 26th July 2018, the patient experienced injection site swelling and injected limb mobility decreased. On 26th July 2018, the outcome of the fever was recovered/resolved. On 29th July 2018, the outcome of the chills, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the chills, fever, tiredness, headache, taste loss, pain in arm, difficulty sleeping, injection site swelling, injection site rash, injection site erythema and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced chills, low fever, tired, headache, loss of taste bud, trouble sleeping, pain and redness at injection site. On 26th July 2018, the patient's fever was gone and her headache was less severe. The injection site was swollen and the pain in the arm increased. She could not even lift her arm. The redness at injection site turned into a rash around the injection site in size of 4 centimeters in diameter. On 28th July 2018, the rash was only present underneath the injection site and it was 6 centimeters in diameter. By 29th July 2018, the patient recovered from all her symptoms. The patient was referred to her health care provider. The reporter did not consent to be followed up.  No further details were provided.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Arm began to ache several days after injection. Saw internist who prescribed VOLTAREN 100 mg to be taken for 1 week. My arm did not respond. She suggested I see a neurologist.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm began to ache several days after injection. Saw internist who prescribed VOLTAREN 100 mg to be taken for 1 week. My arm did not respond. She suggested I see a neurologist.
Age: 1.25
Sex: F
Vaccine: FLU4, HIBV, PNC13, FLUX, HEPA, MMR
Symptoms: Autopsy, Drug screen, Resuscitation, Unresponsive to stimuli
Clinical narrative: Death.
Age: 1.25
Sex: F
Vaccine: FLU4, HIBV, PNC13, FLUX, HEPA, MMR
Symptoms: Death
Clinical narrative: Death.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Feeling hot, Headache, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of red face in a 64-year-old female patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX (1st dose received on 20th August 2018, having batch number YE9YL and expiry date 6th December 2021). On 1st December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th December 2018, 3 days after receiving SHINGRIX, the patient experienced red face, tingling and skin warm. On an unknown date, the patient experienced headache and tiredness. The patient was treated with VALTREX. On an unknown date, the outcome of the red face, tingling, skin warm, headache and tiredness were unknown. It was unknown if the reporter considered the red face, tingling, skin warm, headache and tiredness to be related to SHINGRIX. Additional details were reported as follows: In December 2018, less than a week after receiving SHINGRIX, the patient began to experience a normal reaction, which was clarified as a headache and feeling tired. In beginning, the patient experienced warmth, redness and tingling on one side of her face. This was further described as the symptoms she had experienced when she had Shingles in the past. As treatment, the patient used VALTREX, which she was instructed to use for shingles in the past. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Headache, Paraesthesia, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of red face in a 64-year-old female patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX (1st dose received on 20th August 2018, having batch number YE9YL and expiry date 6th December 2021). On 1st December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th December 2018, 3 days after receiving SHINGRIX, the patient experienced red face, tingling and skin warm. On an unknown date, the patient experienced headache and tiredness. The patient was treated with VALTREX. On an unknown date, the outcome of the red face, tingling, skin warm, headache and tiredness were unknown. It was unknown if the reporter considered the red face, tingling, skin warm, headache and tiredness to be related to SHINGRIX. Additional details were reported as follows: In December 2018, less than a week after receiving SHINGRIX, the patient began to experience a normal reaction, which was clarified as a headache and feeling tired. In beginning, the patient experienced warmth, redness and tingling on one side of her face. This was further described as the symptoms she had experienced when she had Shingles in the past. As treatment, the patient used VALTREX, which she was instructed to use for shingles in the past. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Influenza like illness
Clinical narrative: After 5 days, experienced chills/fevers, tremors, muscle weakness, lack of appetite and flu-like symptoms, weight loss of 20 lbs. Initial lab work obtained indicated increased WBC. Immunosuppression therapy (Methotrexate on hold). Symptoms continuing into the 7 week without relief. Multiple of tests ordered to rule out other possible reasons for the change in health.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Chest X-ray, Chills, Decreased appetite, Differential white blood cell count, Full blood count
Clinical narrative: After 5 days, experienced chills/fevers, tremors, muscle weakness, lack of appetite and flu-like symptoms, weight loss of 20 lbs. Initial lab work obtained indicated increased WBC. Immunosuppression therapy (Methotrexate on hold). Symptoms continuing into the 7 week without relief. Multiple of tests ordered to rule out other possible reasons for the change in health.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Immunosuppressant drug therapy, Influenza like illness, Laboratory test, Muscular weakness, Prostatic specific antigen
Clinical narrative: After 5 days, experienced chills/fevers, tremors, muscle weakness, lack of appetite and flu-like symptoms, weight loss of 20 lbs. Initial lab work obtained indicated increased WBC. Immunosuppression therapy (Methotrexate on hold). Symptoms continuing into the 7 week without relief. Multiple of tests ordered to rule out other possible reasons for the change in health.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Pyrexia, Tremor, Urine analysis, Weight decreased, White blood cell count increased
Clinical narrative: After 5 days, experienced chills/fevers, tremors, muscle weakness, lack of appetite and flu-like symptoms, weight loss of 20 lbs. Initial lab work obtained indicated increased WBC. Immunosuppression therapy (Methotrexate on hold). Symptoms continuing into the 7 week without relief. Multiple of tests ordered to rule out other possible reasons for the change in health.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Pain in extremity, Rash
Clinical narrative: Rash, arm and shoulder were sore.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Musculoskeletal pain, Pain in extremity, Rash
Clinical narrative: Rash, arm and shoulder were sore.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician, and the 59 year old female patient, referring to herself. The patient's medical history included; past drug reaction/allergy to ibuprofen. Concurrent conditions included; gastrooesophageal reflux disease (GERD), high blood pressure, high cholesterol and osteoporosis. Concomitant therapies included; amlodipine, ZETIA, ZOLOFT, gabapentin and ZOCOR. On 06-DEC-2012, the patient was vaccinated with ZOSTAVAX to prevent shingles (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On the same date, the patient experienced a big bump where the shot was administered. The patient also reported, that her physician during consultation told her, that the swelling would go down, and was told to treat the swelling with ice. The patient also reported, that the swelling did not go down and had a hard bump like a callus in that area that was about 3 inches around, described by the physician as a swollen painful mass at the injection site. In 2013 or 2014 (no specific date was given), the patient still got the shingles (vaccination failure). On unknown date, the patient had a blood work test, however results were not provided. The outcome of vaccination failure, vaccination site pain, vaccination site swelling and vaccination site mass was not recovered. The outcome of the herpes zoster was not provided. At the time of the report, the causal relationship between the aforementioned events and ZOSTAVAX was not reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: This spontaneous report was received from a physician, and the 59 year old female patient, referring to herself. The patient's medical history included; past drug reaction/allergy to ibuprofen. Concurrent conditions included; gastrooesophageal reflux disease (GERD), high blood pressure, high cholesterol and osteoporosis. Concomitant therapies included; amlodipine, ZETIA, ZOLOFT, gabapentin and ZOCOR. On 06-DEC-2012, the patient was vaccinated with ZOSTAVAX to prevent shingles (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On the same date, the patient experienced a big bump where the shot was administered. The patient also reported, that her physician during consultation told her, that the swelling would go down, and was told to treat the swelling with ice. The patient also reported, that the swelling did not go down and had a hard bump like a callus in that area that was about 3 inches around, described by the physician as a swollen painful mass at the injection site. In 2013 or 2014 (no specific date was given), the patient still got the shingles (vaccination failure). On unknown date, the patient had a blood work test, however results were not provided. The outcome of vaccination failure, vaccination site pain, vaccination site swelling and vaccination site mass was not recovered. The outcome of the herpes zoster was not provided. At the time of the report, the causal relationship between the aforementioned events and ZOSTAVAX was not reported.
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 2010, a healthcare provider at a medical group 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 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 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: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Influenza like illness, Injection site discolouration, Injection site pain, Lacrimation increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th September 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and injection site discoloration. On 12th September 2018, the patient experienced influenza-like symptoms, pain and watering eyes. On 12th September 2018, the outcome of the injection site pain was recovered/resolved. On 13th September 2018, the outcome of the influenza-like symptoms, pain and watering eyes were recovered/resolved. On an unknown date, the outcome of the injection site discoloration was recovered/resolved. It was unknown if the reporter considered the injection site pain, influenza-like symptoms, pain, watering eyes and injection site discoloration to be related to SHINGRIX. Additional details were received as follows: As the patient received SHINGRIX vaccine, the vaccine hurted as it was being injected. By early evening the injection site on left arm was sore to the touch.   Later in the evening, the patient had fist size black and blue area as well as continued soreness at the injection site. On the next day, she felt fine early in the day. That afternoon, the patient was felt like she was getting the flu. The patient felt a little achy and her eyes were watery. By the next day these symptoms were resolved. It took almost two weeks for the black and blue area to resolve. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. The reporter was unable to obtain additional information. For to tolerance, refer case US2018GSK226117.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th September 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and injection site discoloration. On 12th September 2018, the patient experienced influenza-like symptoms, pain and watering eyes. On 12th September 2018, the outcome of the injection site pain was recovered/resolved. On 13th September 2018, the outcome of the influenza-like symptoms, pain and watering eyes were recovered/resolved. On an unknown date, the outcome of the injection site discoloration was recovered/resolved. It was unknown if the reporter considered the injection site pain, influenza-like symptoms, pain, watering eyes and injection site discoloration to be related to SHINGRIX. Additional details were received as follows: As the patient received SHINGRIX vaccine, the vaccine hurted as it was being injected. By early evening the injection site on left arm was sore to the touch.   Later in the evening, the patient had fist size black and blue area as well as continued soreness at the injection site. On the next day, she felt fine early in the day. That afternoon, the patient was felt like she was getting the flu. The patient felt a little achy and her eyes were watery. By the next day these symptoms were resolved. It took almost two weeks for the black and blue area to resolve. The reporter consented to follow up. The reporter gave permission for her physician to be contacted. The reporter was unable to obtain additional information. For to tolerance, refer case US2018GSK226117.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Muscle strain, Musculoskeletal stiffness, Myalgia
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of muscle pain in a male patient who received SHINGRIX for prophylaxis. On 2nd March 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain, stiffness, joint pain and pulled muscle. On an unknown date, the outcome of the muscle pain, stiffness, joint pain and pulled muscle were unknown. It was unknown if the reporter considered the muscle pain, stiffness, joint pain and pulled muscle to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced, extreme lower body stiffness including muscle pain, joint pain, and feeling as though he had pulled every muscle in his legs. By June 2018, the symptoms had progressed to his upper body. No additional adverse event information was available.
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Rash
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing in a female patient who received (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced difficulty breathing and rash. On an unknown date, the outcome of the difficulty breathing and rash were unknown. It was unknown if the reporter considered the difficulty breathing and rash to be related to dTpa vaccine. Additional details were reported as follows: This case was reported by a consumer via Media. The age at vaccination was not reported. The patient was given a DPT shot after a car crash. The patient was told it was a tetanus shot. The patient broke out in a horrible rash on her chest and experienced breathing problems. The patient stated, that stuff was poison.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 13th May 2018, refer case US2018219508). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 3rd December 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. On 4th December 2018, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain and drug dose administration interval too long were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient received the SHINGRIX on the left arm. On the day of reporting, the patient woke up with pain and soreness at the injection site. The patient received the 2nd dose of SHINGRIX late, which led to lengthening of the vaccination schedule. No further details were provided. The reporter did not give consent to follow-up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Headache, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site warmth (1st dose received on 28th June 2018, refer case US2018219446). On 28th November 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 28th November 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site warmth, injection site erythema, intramuscular formulation administered by other route and vaccine administered at inappropriate site. On 3rd December 2018, the patient experienced injection site itching. On an unknown date, the patient experienced fever, nausea and headache. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fever, nausea, injection site itching and headache were recovered/resolved and the outcome of the injection site warmth and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site warmth, fever, nausea, injection site itching, injection site erythema and headache to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX subcutaneously in the back of his right arm, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site. The patient began feeling warmth at the injection site, two hours after receiving the vaccine but this started to spread. The patient noticed that from the injection site down to almost his elbow began to swell and it stretched the shirt he was wearing and there was redness and swelling in a tear drop shape. The patient felt that he had a fever, headache, and he was nauseous. On 2nd December 2018, the patient notes that the symptoms were worst on Sunday. The patient reported that yesterday, on 3rd December 2018, 5 days after vaccination patient began to experience itching at the injection site, there was heat at the injection site, and it was still red. The other symptoms had resolved. The reporter consented to follow up. The reporter gave permission for his physician to be contacted. Unable to obtain additional information. The caller hung up because he could not get an answer as to whether he would need to get another vaccination since the second one was administered subcutaneously.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site warmth (1st dose received on 28th June 2018, refer case US2018219446). On 28th November 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 28th November 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site warmth, injection site erythema, intramuscular formulation administered by other route and vaccine administered at inappropriate site. On 3rd December 2018, the patient experienced injection site itching. On an unknown date, the patient experienced fever, nausea and headache. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fever, nausea, injection site itching and headache were recovered/resolved and the outcome of the injection site warmth and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site warmth, fever, nausea, injection site itching, injection site erythema and headache to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX subcutaneously in the back of his right arm, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site. The patient began feeling warmth at the injection site, two hours after receiving the vaccine but this started to spread. The patient noticed that from the injection site down to almost his elbow began to swell and it stretched the shirt he was wearing and there was redness and swelling in a tear drop shape. The patient felt that he had a fever, headache, and he was nauseous. On 2nd December 2018, the patient notes that the symptoms were worst on Sunday. The patient reported that yesterday, on 3rd December 2018, 5 days after vaccination patient began to experience itching at the injection site, there was heat at the injection site, and it was still red. The other symptoms had resolved. The reporter consented to follow up. The reporter gave permission for his physician to be contacted. Unable to obtain additional information. The caller hung up because he could not get an answer as to whether he would need to get another vaccination since the second one was administered subcutaneously.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (Refer case US2018219418). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd December 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. In December 2018, the patient experienced chills, headache and pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, chills, headache and pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, chills, headache and pain to be related to SHINGRIX. Additional details were received as follows: During SHINGRIX vaccination, the vaccine hurt as it was being injected. Three hours later, the patient's arm felt sore at the injection site, even while lifting her arm. There was no bruising. On 4th December 2018, at 4 am, the patient started having bad chills, feeling achy, and having a headache. Till the time of reporting, all symptoms were unresolved. The reporter consented to follow up. The reporter gave permission for physician to be contacted. The reporter unable to obtain additional information.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of teeth chattering in a 59-year-old male 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 day after receiving SHINGRIX, the patient experienced teeth chattering. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the teeth chattering was recovered/resolved. It was unknown if the reporter considered the teeth chattering to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient began to experience extreme shivering around 1:00 AM after receiving the SHINGRIX vaccine approximately 2 months before the date of reporting. The patient's teeth were chattering too. The patient took Tylenol and the symptoms resolved the next day. The patient was not with the reporter at the time of the reporting. The reporter was unable to obtain additional information. The reporter did not consent to follow-up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th June 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site warmth. On an unknown date, the patient experienced injection site nodule and injection site pain. On an unknown date, the outcome of the injection site warmth, injection site nodule and injection site pain were recovered/resolved.  It was unknown if the reporter considered the injection site warmth, injection site nodule and injection site pain to be related to SHINGRIX. Additional details were reported as follows: Two hours after receiving the SHINGRIX vaccine, the reporter began to experience a little warmth at the injection site.   A painful nodule then developed at the injection site. He was not able to lay on the arm. This lasted for two weeks. The reporter consented to follow up. The reporter gave permission for his physician to be contacted. Unable to obtain additional information. For tolerance after 2nd dose refer case US2018GSK225475.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Insomnia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX for prophylaxis. The patient's past medical history included prostate cancer, neck surgery and wrist surgery. In November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, shivering and tremor. The patient was treated with TYLENOL. In November 2018, the outcome of the shivering and tremor were recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain, shivering and tremor to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; the patient could be 85 or 86 years old. The patient stated that, he received SHINGRIX vaccine on left arm approximately 3 weeks before the date of reporting. The evening of getting the vaccine he experienced pain in the area of the injection site and upper arm to the shoulder. It was the most intense pain due to which he was not able to sleep. The afternoon of the second day he took TYLENOL and he took 2 doses of TYLENOL again on the third day. The pain lasted for total of 3 days. The first night he also experienced shivering and shaking that lasted all night and he recovered by morning. Once in a while the patient gets a surge of intense pain that goes through the area of injection site which goes away quickly. The reporter gave consent to follow up. The contact of physician was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 13th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient stated that he experienced pain and soreness at the injection site which lasted for 1 day. No further details were provided. The reporter did not give consent to follow-up. For tolerance to 2nd dose, refer case US2018GSK223652.