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 provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In APRIL 2017, the patient was treated by a 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 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(s) 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 11-FEB-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 27-APR-2017, the patient was treated by a physician at a clinic 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 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: M
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 male patient of unknown age.  No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2012, a healthcare provider 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 2016, 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.
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 provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a healthcare provider (not further specified if it was a pharmacist) at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2013, the patient was treated by a 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 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(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In JANUARY 2011, a healthcare provider at a healthcare facility administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In OCTOBER 2016, the patient was treated by a healthcare provider at a healthcare facility 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 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: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2015, 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 at the physician's office 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.
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. In 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for permanent prevention and protection against shingles and zoster related injuries. In February 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
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. On or about 17-JUL-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) t prevention and protection against shingles and zoster related injuries. On or about 16-MAR-2016 and 20-MAY-2016, the patient was treated by a healthcare provider for herpes zoster and post herpetic neuralgia. 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. {Additional information has been requested. / Additional information is not expected.}
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 19-JAN-2017 and 21-FEB-2017, the patient was treated by healthcare providers at an eye emergency department at a hospital and an eye hospital for shingles and herpes zoster dermatitis, respectively. The patient was diagnosed with shingles and herpes zoster dermatitis and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Headache, Ophthalmic herpes zoster, Pain, Paraesthesia
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. In or around 18-APR-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles. Within one month after receiving the ZOSTAVAX, the patient began experiencing sudden and severe headaches, intermittent shooting pain and tingling in his right eye and sudden horizontal bilateral diplopia. The patient was diagnosed with sixth nerve palsy, zoster opthalmicus, hypertropia of right eye, and diplopia. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, sixth nerve palsy, and zoster opthalmicus were determined medically significant. Sixth nerve palsy, zoster opthalmicus, hypertrophia of right eye, bilateral diplopia, and tingling in his right eye were considered disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Strabismus, VIth nerve paralysis
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. In or around 18-APR-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles. Within one month after receiving the ZOSTAVAX, the patient began experiencing sudden and severe headaches, intermittent shooting pain and tingling in his right eye and sudden horizontal bilateral diplopia. The patient was diagnosed with sixth nerve palsy, zoster opthalmicus, hypertropia of right eye, and diplopia. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, sixth nerve palsy, and zoster opthalmicus were determined medically significant. Sixth nerve palsy, zoster opthalmicus, hypertrophia of right eye, bilateral diplopia, and tingling in his right eye were considered disabling. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 27-year old female patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On an unspecified dates, when the patient was 17 years old, she received 2 doses of GARDASIL (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. Nurse reported the patient did not receive a third dose of GARDASIL. The patient was in the office then and would like to complete the  Human papillomavirus (HPV) series with GARDASIL 9. Nurse reported the patient had not yet received dose of GARDASIL 9. No adverse effects were reported. The outcome of the events was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a female patient who received SHINGRIX for prophylaxis. On 1st January 2019, the patient received SHINGRIX. On 2nd January 2019, 1 days after receiving SHINGRIX, the patient experienced stomach pain and injection site tenderness. On an unknown date, the outcome of the stomach pain and injection site tenderness were not recovered/not resolved. It was unknown if the reporter considered the stomach pain and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: This case was reported via click to chat. The age at vaccination was not reported. The patient experienced stomachache and tender injection site. The patient asked, how long the events would typically last. The patient denied permission to contact their MD.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) and (adjuvant batch number 32PE4, expiry date 23rd January 2021) for prophylaxis. On 16th January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional stated that the patient exceeded the 6 month interval for their 2nd dose of SHINGRIX due to a fever after the 1st dose. Consent to follow up was provided.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shoulder pain in a 54-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, no reaction). On 15th October 2018, the patient received the 2nd dose of SHINGRIX. On 16th October 2018, 1 days after receiving SHINGRIX, the patient experienced shoulder pain, fever and pain in arm. On an unknown date, the outcome of the shoulder pain, fever and pain in arm were unknown. It was unknown if the reporter considered the shoulder pain, fever and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain in his shoulder and arm and a fever the following day of vaccination. The healthcare professional had no lot or expiry date.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 61-year-old female patient who received SHINGRIX (batch number GL2HR, expiry date 22nd May 2021) for prophylaxis. On 27th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th December 2018, 2 days after receiving SHINGRIX, the patient experienced injection site warmth and pain in arm. On an unknown date, the outcome of the injection site warmth and pain in arm were unknown. The reporter considered the injection site warmth and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. The patient called the pharmacist on 31st December 2018 but he felt the adverse events started on 29th December or 30th December 2018. The patient stated there was a hot spot at the injections side with pain and achiness in the arm in which the vaccine was administered. The pharmacist was transferred to Medical Information for information on whether the 2nd dose should be administered.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. 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 was a pharmacist who mentioned that the shot was painful. She had only received the 1st dose and was awaiting the 2nd dose as it was nearing the end of the 6 month period. No additional information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, 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 female patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and muscle soreness. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the muscle soreness was unknown. It was unknown if the reporter considered the pain in arm and muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient still experiencing muscle soreness with activity in her injected arm 6 months after dose 1 of SHINGRIX. The healthcare professional did not have vaccine lot number or expiry information, as the dose was not given at her pharmacy.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Myalgia, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 20th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In December 2018, 3 days after receiving SHINGRIX, the patient experienced itchy rash. On 21st December 2018, the patient experienced muscle pain, injection site erythema and injection site pain. On an unknown date, the outcome of the muscle pain, injection site erythema and injection site pain were recovered/resolved and the outcome of the itchy rash was recovering/resolving. It was unknown if the reporter considered the muscle pain, injection site erythema, injection site pain and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The next day after vaccination, the patient experienced redness and soreness at injection site along with muscle ache which lasted for total of 2 to 3 days. After 3 days post vaccination, the patient noticed  a rash which was 2 inches in diameter on his right wrist. The rash then increased to 6 to 8 inch of area on both arms which started oozing and became itchy. The rash had started to decrease but it was not completely gone. The patient contacted his doctor via phone in regards to the rash that he experienced. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received BOOSTRIX for prophylaxis. The patient's past medical history included ruptured Achilles tendon. On 28th December 2018, the patient received BOOSTRIX (intramuscular). On 29th December 2018, 1 days after receiving BOOSTRIX, the patient experienced pain in arm. The patient was treated with ADVIL. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to BOOSTRIX. Additional details were provided as follows: The patient received a Tdap vaccine that her pharmacy said was manufactured by GSK. Her arm started hurting after getting the vaccine and the pain has continued to get worse. She used to be able to relieve the pain with ADVIL, but at the date of reporting, it only took the edge off. She said that it hurt more than when she tore her Achilles tendon. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: This spontaneous report as received from a neurologist via Pfizer refers to a currently 70 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown date, the patient experienced drug allergies which included fever (pyrexia), chills, headache, site pain(vaccination site pain), joint pain (arthralgia), weakness (asthenia) and  exhaustion (fatigue). The outcome and causality assessment were not provided by the reporter.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from a neurologist via Pfizer refers to a currently 70 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown date, the patient experienced drug allergies which included fever (pyrexia), chills, headache, site pain(vaccination site pain), joint pain (arthralgia), weakness (asthenia) and  exhaustion (fatigue). The outcome and causality assessment were not provided by the reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever for 2-3 days, aches.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Loss of consciousness
Clinical narrative: Pt. received above vaccines, approximately 7 minutes. Later passed out.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt states that after getting her third rabies injection the next day she arm became sore and within a couple of days she had severe pain when moving her arm. Now, 6 weeks past the incident, she cannot lift her arm up to shoulder height and cannot move her left arm without pain.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Asthenia, Blood thyroid stimulating hormone normal, Bursa disorder, Discomfort, Electromyogram abnormal
Clinical narrative: Pt states that after getting her third rabies injection the next day she arm became sore and within a couple of days she had severe pain when moving her arm. Now, 6 weeks past the incident, she cannot lift her arm up to shoulder height and cannot move her left arm without pain.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Haematocrit normal, Haemoglobin normal, Injected limb mobility decreased, Injection site pain, Metabolic function test normal
Clinical narrative: Pt states that after getting her third rabies injection the next day she arm became sore and within a couple of days she had severe pain when moving her arm. Now, 6 weeks past the incident, she cannot lift her arm up to shoulder height and cannot move her left arm without pain.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging abnormal, Pain, Paraesthesia, Peripheral motor neuropathy
Clinical narrative: Pt states that after getting her third rabies injection the next day she arm became sore and within a couple of days she had severe pain when moving her arm. Now, 6 weeks past the incident, she cannot lift her arm up to shoulder height and cannot move her left arm without pain.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Product administered at inappropriate site, Radiculitis brachial, Red blood cell count normal, Rotator cuff syndrome, Urine analysis normal
Clinical narrative: Pt states that after getting her third rabies injection the next day she arm became sore and within a couple of days she had severe pain when moving her arm. Now, 6 weeks past the incident, she cannot lift her arm up to shoulder height and cannot move her left arm without pain.
Age: 35.0
Sex: F
Vaccine: RAB, RAB
Symptoms: White blood cell count increased
Clinical narrative: Pt states that after getting her third rabies injection the next day she arm became sore and within a couple of days she had severe pain when moving her arm. Now, 6 weeks past the incident, she cannot lift her arm up to shoulder height and cannot move her left arm without pain.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Woke at 12:15 am with rectal temp of 101.4. No discomfort at site.
Age: 17.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 flu vaccines within the same month.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash
Clinical narrative: Pt reported general itching and rash like symptoms in the evening of receiving the vaccine. Self treated with Benadryl and otc hydrocortisone. Following morning reaction is much less severe.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling abnormal, Gingival pain, Injection site pain
Clinical narrative: *Severe dizziness for 24 hours beginning 5 hours after the injection, my forehead felt like it was swirling, life disrupting dizziness lasted 3 more days, on day 5 slight dizziness and a spacey feeling, now 13 days later at times I start to veer left or right and focus to walk straight. *Extreme fatique-the day after the injection I stayed in bed all day except to eat, bathroom, or to breakup the bedtime. I stayed in bed due to fatigue and dizziness. *The evening of the shot, 12/27 I had uncontrollable shaking due to fever. I put on all my winter clothes and wore them to bed. The next morning the fever was better. I did not take the temperature because our thermometers don't work. *Gums hurt to chew soft food. *Achey all over for a couple days. Area of shot very sore for 8 days. Still slightly sore.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: *Severe dizziness for 24 hours beginning 5 hours after the injection, my forehead felt like it was swirling, life disrupting dizziness lasted 3 more days, on day 5 slight dizziness and a spacey feeling, now 13 days later at times I start to veer left or right and focus to walk straight. *Extreme fatique-the day after the injection I stayed in bed all day except to eat, bathroom, or to breakup the bedtime. I stayed in bed due to fatigue and dizziness. *The evening of the shot, 12/27 I had uncontrollable shaking due to fever. I put on all my winter clothes and wore them to bed. The next morning the fever was better. I did not take the temperature because our thermometers don't work. *Gums hurt to chew soft food. *Achey all over for a couple days. Area of shot very sore for 8 days. Still slightly sore.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Pyrexia
Clinical narrative: About 7 hours after injection, began to have serious chills. Lasted all night. At 9 am the following day the chills were gone but had a fever of 102.4. Took TYLENOL. Fever came down to about 100 and stayed there the rest of the day in spite of regular does of TYLENOL. No energy and no appetite. About 11 pm fever was 101.2. Took TYLENOL and went to bed. No chills. At 8 am today, no fever or chills. Feel normal.
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 April 2016, a  healthcare provider at a family practice 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 physician at the family practice 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.
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(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2011, a healthcare provider at a medical center/hospital administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider at the medical center/hospital 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 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: 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 provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2007, a pharmacist at a pharmacy 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 at a healthcare facility/ medical 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 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.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pain, Skin warm, Swelling
Clinical narrative: Severe pain, swelling, very hot upper arm, chills.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Inflammation, Injection site irritation, Injection site mass, Injection site reaction, Pain
Clinical narrative: He had heavy inflammation and pain/irritation. A hard lump developed at the injection site that is still there to this day. It constantly causes irritation and scratching on his left thigh.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Scratch, Skin irritation
Clinical narrative: He had heavy inflammation and pain/irritation. A hard lump developed at the injection site that is still there to this day. It constantly causes irritation and scratching on his left thigh.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: PT RECEIVED VACCINE TOO EARLY, NO ADVERSE REACTION NOTED, WILL SCHEDULE FOR ANOTHER INJECTION .
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Biopsy skin abnormal, Pityriasis rosea, Rash morbilliform, Rash pruritic
Clinical narrative: Received flu shot on 11/11, noticed small measle like bumps on 11/12. Measle like bumps spread all over my trunk and arms (not on my face). Have 10 days of prednisone and used creams. It is now 12/8 and still have rash which is now also appearing on my forearms. It still itches.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nasopharyngitis, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient reported having the typical symptoms of a sore arm and cold like symptoms for a couple days but the arm soreness got worse since the time of the vaccination. The patient reports her entire upper arm is red and hot to the touch. That area is reported as being itchy and painful. The patient does not report any systemic symptoms.
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Impaired driving ability, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Pain began upper left arm in late afternoon and got increasing worse as evening wore on. Pain became severe and excruciating into the night. Couldn't put on clothes or drive to emergency because of severe pain.  Didn't know what to do. Never had something like this before. Called doctor's off in morning. Was told by aide to take BENADRYL and use cold pack.
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac failure, Herpes zoster
Clinical narrative: Information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer and an estate administrator concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 15-DEC-2016, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2017, the patient was treated by a healthcare provider at a hospital for heart failure. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Upon internal review, heart failure was considered to be medically significant. Additional information has been requested.