chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin abrasion, Skin exfoliation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (she had chicken pox as a child). Previously administered products included Shingles vaccine (received shingles shot in 2011). On 28th January 2019, the patient received the 1st dose of SHINGRIX. On 1st February 2019, 4 days after receiving SHINGRIX, the patient experienced shingles, skin abrasion, rash, pain and skin peeling. The patient was treated with VALTREX and hydrocodone. On an unknown date, the outcome of the shingles, skin abrasion, rash and pain were not recovered/not resolved and the outcome of the skin peeling was unknown. It was unknown if the reporter considered the shingles, skin abrasion, rash, pain and skin peeling to be related to SHINGRIX. Additional details were provided as follows: The patient experienced chaffing under her arm from the front of her breast bone to the back of her back bone under her bra strap. The chaffing continued both undersides of her arm to her elbow. The worst part was under her arm and she had a rash that was giant in a circle and very painful. When she touches herself, or puts her arm down the skin seems to be adhering to the fold on her arm and it pulls skin off each time. She went to a physician and she was diagnosed with shingles on Monday 4th February 2019. They put her on VALTREX and Hydrocodone and her symptoms are still unresolved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeding disorder, Feeling cold, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX (batch number XL527, expiry date 5th May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose and experienced, refer case US2019GSK032701). On 1st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 2nd February 2019, 1 days after receiving SHINGRIX, the patient experienced fever, headache, nausea and feeling unwell. In February 2019, the patient experienced chills and feelings of weakness. On an unknown date, the patient experienced cold and unable to eat. On 3rd February 2019, the outcome of the fever was recovered/resolved. In February 2019, the outcome of the headache, chills, nausea, cold, unable to eat, feeling unwell and feelings of weakness were recovered/resolved. It was unknown if the reporter considered the fever, headache, chills, nausea, cold, unable to eat, feeling unwell and feelings of weakness to be related to SHINGRIX. Additional details were provided as follows: At 8 PM after receiving the SHINGRIX vaccine, the reporter began to feel cold. By 10:00 PM she began to experience chills. She woke up Saturday morning, 2nd February 2019, and had a fever of 101.5 F add unit, headache, felt nauseous, and felt sick all day. She reports she could not eat anything and only drank liquids. She noted that Saturday night she started feeling better. On Sunday, the fever was gone although she still felt weak. By Monday, 4th February 2019, she was almost fully recovered. She was recovered now. Did not consent to follow-up. This case linked with US2019GSK032701, reported by same reporter for the same patient.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX (batch number XL527, expiry date 5th May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (received 1st dose and experienced, refer case US2019GSK032701). On 1st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 2nd February 2019, 1 days after receiving SHINGRIX, the patient experienced fever, headache, nausea and feeling unwell. In February 2019, the patient experienced chills and feelings of weakness. On an unknown date, the patient experienced cold and unable to eat. On 3rd February 2019, the outcome of the fever was recovered/resolved. In February 2019, the outcome of the headache, chills, nausea, cold, unable to eat, feeling unwell and feelings of weakness were recovered/resolved. It was unknown if the reporter considered the fever, headache, chills, nausea, cold, unable to eat, feeling unwell and feelings of weakness to be related to SHINGRIX. Additional details were provided as follows: At 8 PM after receiving the SHINGRIX vaccine, the reporter began to feel cold. By 10:00 PM she began to experience chills. She woke up Saturday morning, 2nd February 2019, and had a fever of 101.5 F add unit, headache, felt nauseous, and felt sick all day. She reports she could not eat anything and only drank liquids. She noted that Saturday night she started feeling better. On Sunday, the fever was gone although she still felt weak. By Monday, 4th February 2019, she was almost fully recovered. She was recovered now. Did not consent to follow-up. This case linked with US2019GSK032701, reported by same reporter for the same patient.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site urticaria, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site hives in a 59-year-old male patient who received SHINGRIX for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, 3 days after receiving SHINGRIX, the patient experienced injection site hives, injection site itching and hives. The patient was treated with BENADRYL. In January 2019, the outcome of the injection site hives, injection site itching and hives were recovered/resolved. It was unknown if the reporter considered the injection site hives, injection site itching and hives to be related to SHINGRIX. Additional details were provided as follows: The batch number was not reported. The pharmacist stated that the patient received SHINGRIX in the first week of January, she believed that it could be on 6th January 2019, but was not sure of the exact date as she was not in office at the time of reporting. The hives then spread to his body and legs. The patient was given oral BENADRYL and itching and hives resolved after approximately one week.
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Immediate post-injection reaction, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of flushing in a adult female patient who received Zoster vaccine for prophylaxis. On 13th December 2018, the patient received the 1st dose of Zoster vaccine. On 13th December 2018, immediately after receiving Zoster vaccine, the patient experienced flushing. In December 2018, the patient experienced pain in arm. On 13th December 2018, the outcome of the flushing was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the flushing and pain in arm to be related to Zoster vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine on left arm. The patient requested to know if it would be better to get the 2nd dose of vaccine at the time of reporting or wait for 4 more months. The patient experienced arm soreness and flushing. The patient planned to receive the 2nd dose of SHINGRIX.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphasia, Blood pressure increased, Bruxism, Dysarthria, Heart rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 12th February 2019, 20 min after receiving SHINGRIX, the patient experienced ringing in ears, tremor, speech loss, increased blood pressure and heart rate increased. On 14th February 2019, the patient experienced slurred speech, speech disorder and teeth clenching. The patient was treated with lorazepam (Ativan). On an unknown date, the outcome of the ringing in ears, tremor, slurred speech, speech disorder and teeth clenching were not recovered/not resolved and the outcome of the speech loss, increased blood pressure and heart rate increased were recovered/resolved. It was unknown if the reporter considered the ringing in ears, tremor, speech loss, increased blood pressure, heart rate increased, slurred speech, speech disorder and teeth clenching to be related to SHINGRIX. Additional details were reported as follows: The patient's boyfriend got the SHINGRIX on Tuesday pharmacy. The patient started having ringing in his ear, tremors and loss of speech. The tremors were so severe that the pharmacy called EMS (Emergency medical services) at the hospital. The symptoms started about 20 minutes after the injection. The patient was observed for about 4 hours at the hospital and the day of vaccination, his blood pressure and heart rate were extremely elevated. The patient had an injection of Ativan at the hospital and was relieved. The tremors subsided and he was able to speak again. However, the day of reporting he started having the tremors and ringing in his ears. Two days after vaccination, the patient was slurring, had difficulty speaking and his teeth were clenching. Emergency room visit was required. The reporter said that they had a bill of $400 at emergency room. They do not want to go back to emergency room because they cannot afford it.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Speech disorder, Tinnitus, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 12th February 2019, 20 min after receiving SHINGRIX, the patient experienced ringing in ears, tremor, speech loss, increased blood pressure and heart rate increased. On 14th February 2019, the patient experienced slurred speech, speech disorder and teeth clenching. The patient was treated with lorazepam (Ativan). On an unknown date, the outcome of the ringing in ears, tremor, slurred speech, speech disorder and teeth clenching were not recovered/not resolved and the outcome of the speech loss, increased blood pressure and heart rate increased were recovered/resolved. It was unknown if the reporter considered the ringing in ears, tremor, speech loss, increased blood pressure, heart rate increased, slurred speech, speech disorder and teeth clenching to be related to SHINGRIX. Additional details were reported as follows: The patient's boyfriend got the SHINGRIX on Tuesday pharmacy. The patient started having ringing in his ear, tremors and loss of speech. The tremors were so severe that the pharmacy called EMS (Emergency medical services) at the hospital. The symptoms started about 20 minutes after the injection. The patient was observed for about 4 hours at the hospital and the day of vaccination, his blood pressure and heart rate were extremely elevated. The patient had an injection of Ativan at the hospital and was relieved. The tremors subsided and he was able to speak again. However, the day of reporting he started having the tremors and ringing in his ears. Two days after vaccination, the patient was slurring, had difficulty speaking and his teeth were clenching. Emergency room visit was required. The reporter said that they had a bill of $400 at emergency room. They do not want to go back to emergency room because they cannot afford it.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills and pain in arm. On an unknown date, the outcome of the fever, chills and pain in arm were recovered/resolved. It was unknown if the reporter considered the fever, chills and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient's wife. The patient received SHINGRIX on left arm. The patient's arm was hurt after receiving SHINGRIX vaccine. The patient also experienced fever and chills. All symptoms resolved with 2 to 3 days. The reporter did not consent to follow up and could not obtain additional information. This case has been linked with case US2019027669 (wife's case) reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 25th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 26th November 2018, 1 days after receiving SHINGRIX, the patient experienced loss of consciousness (serious criteria GSK medically significant), headache and activities of daily living impaired. On an unknown date, the outcome of the loss of consciousness and activities of daily living impaired were unknown and the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the loss of consciousness, headache and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. She had a bad headache the day after receiving the first SHINGRIX vaccine. She was unable to do anything that whole day - she was knocked out. This case has been linked with case US2019GSK032783, reported by same reporter.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 89-year-old female patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient received SHINGRIX and later reported developed Shingles. She reported that the shingles was resolved at the time of report. The pharmacist read what could be interpreted from a scanned document. No additional details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Rash, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling in a male patient who received SHINGRIX for prophylaxis. On 5th April 2018, the patient received the 2nd dose of SHINGRIX. In February 2018, less than a year after receiving SHINGRIX, the patient experienced tingling, rash, welts and pruritus. The patient was treated with SHINGRIX and BENADRYL. On an unknown date, the outcome of the tingling, rash, welts and pruritus were recovering/resolving. It was unknown if the reporter considered the tingling, rash, welts and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received both doses of the SHINGRIX and after 1st dose the patient experienced some side effects including tingling neck, bumps, spots or welts on her upper arms and back and tremendous itching. The patient had the same side effects and she had a concern that her symptoms from the SHINGRIX. The patient husband took BENADRYL and his symptoms are improving but he still has a slightly itchy feeling. He experienced was only above the waist and it was related to an area that follows a nerve. This case linked with US2019GSK032767, reported by same reporter for the different patient (wife's case).
Age: 33.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Induration, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm: Round, 3x3 inches of redness and pain. On exam, the area is slightly swollen/indurated and very tender to touch, with limited range of motion at the left arm. Symptoms were developing slowly over the 48 hours following the vaccination. Patient reported low grade fever at home. In office V/S: Temp was 99.3F, pulse 117 bpm, BP 136/83 mmHg. Treatment recommendations were localized cold compresses and PO NSIADs. Should symptoms worsen, patient to seek urgent medical attention. Outcomes are pending as of the time of writing this report.
Age: 33.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Left arm: Round, 3x3 inches of redness and pain. On exam, the area is slightly swollen/indurated and very tender to touch, with limited range of motion at the left arm. Symptoms were developing slowly over the 48 hours following the vaccination. Patient reported low grade fever at home. In office V/S: Temp was 99.3F, pulse 117 bpm, BP 136/83 mmHg. Treatment recommendations were localized cold compresses and PO NSIADs. Should symptoms worsen, patient to seek urgent medical attention. Outcomes are pending as of the time of writing this report.
Age: 10.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: THERE WERE NO ADVERSE EVENTS, OUTCOMES OR SIGNS/SYMPTOMS IN OUR FOLLOW UP.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Valacyclovir; Tramadol.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Patient got red inflamed area that extended over time down arm.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No treatment. Error reported to Public Health by another public health department when reviewing file.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pruritus, Rash, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling in a female patient who received SHINGRIX for prophylaxis. On 6th February 2019, the patient received the 2nd dose of SHINGRIX. On 12th February 2019, 6 days after receiving SHINGRIX, the patient experienced tingling, rash, welts and pruritus. On an unknown date, the outcome of the tingling, rash, welts and pruritus were unknown. It was unknown if the reporter considered the tingling, rash, welts and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient experienced some side effects including tingling neck, bumps, spots or welts on her upper arms and back and tremendous itching. This case linked with US2019030628, reported by same reporter for the different patient (husband's case).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Paraesthesia, Pruritus, Rash, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling in a female patient who received SHINGRIX for prophylaxis. On 6th February 2019, the patient received the 2nd dose of SHINGRIX. On 12th February 2019, 6 days after receiving SHINGRIX, the patient experienced tingling, rash, welts and pruritus. On an unknown date, the outcome of the tingling, rash, welts and pruritus were unknown. It was unknown if the reporter considered the tingling, rash, welts and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient experienced some side effects including tingling neck, bumps, spots or welts on her upper arms and back and tremendous itching. This case linked with US2019030628, reported by same reporter for the different patient (husband's case).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling in a female patient who received SHINGRIX for prophylaxis. On 6th February 2019, the patient received the 2nd dose of SHINGRIX. On 12th February 2019, 6 days after receiving SHINGRIX, the patient experienced tingling, rash, welts and pruritus. On an unknown date, the outcome of the tingling, rash, welts and pruritus were unknown. It was unknown if the reporter considered the tingling, rash, welts and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient experienced some side effects including tingling neck, bumps, spots or welts on her upper arms and back and tremendous itching. This case linked with US2019030628, reported by same reporter for the different patient (husband's case).
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: Arthralgia (Joint Pain) - Anti-inflammatory med: Ibuprofen; 600mg every 6 hours. Prednisone; 40mg daily x 5days.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Abdominal pain upper, Blood pressure decreased, Crying, Feeling abnormal, Feeling hot
Clinical narrative: 8:36 AM received vaccine, verbalized painful shot became pale after Hep A vaccine. Waited awhile when felt better and color came back gave HPV 9 - client became pale, c/o being hot then passed out, muscles stiff then awoke startled sat up crying. Verbalized that she did not like how she felt, had severe stomach ache and nausea. Blood pressure decreased 98/43, O2 sat 95-100%, she verbalized feeling like she had a nightmare "someone was after her" when she passed out. She immediately responded to nurse and her mother within 10 seconds. Ice packs applied and client fanned for c/o being hot. Outer shirt removed to make more comfortable. Client's vital signs monitored and told client to take time before leaving clinic. Client laid on exam table, then slowly sat on side of bed before standing and walking around room. Sipped on can of Coke after had spell. Client left clinic in stable condition at 9:42 AM. Blood pressure 110/77, O2 Sat 100%.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Injection site pain, Loss of consciousness, Musculoskeletal stiffness, Nausea, Pallor
Clinical narrative: 8:36 AM received vaccine, verbalized painful shot became pale after Hep A vaccine. Waited awhile when felt better and color came back gave HPV 9 - client became pale, c/o being hot then passed out, muscles stiff then awoke startled sat up crying. Verbalized that she did not like how she felt, had severe stomach ache and nausea. Blood pressure decreased 98/43, O2 sat 95-100%, she verbalized feeling like she had a nightmare "someone was after her" when she passed out. She immediately responded to nurse and her mother within 10 seconds. Ice packs applied and client fanned for c/o being hot. Outer shirt removed to make more comfortable. Client's vital signs monitored and told client to take time before leaving clinic. Client laid on exam table, then slowly sat on side of bed before standing and walking around room. Sipped on can of Coke after had spell. Client left clinic in stable condition at 9:42 AM. Blood pressure 110/77, O2 Sat 100%.
Age: 27.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse concerning to a 27 year old female patient. Patient's concurrent condition, medical history and concomitant medication were not provided. On 12-FEB-2019 the patient was vaccinated with PROQUAD, subcutaneously, for prophylaxis (strength, dose number, lot # and expiration date were not reported) instead of VARIVAX due to human error. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a clinical supervisor referring to a 6 month old patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On 11-FEB-2019, the patient was vaccinated with ROTATEQ dose 1, oral, lot # R021216 and expiration date 25-APR-2020 (dosage schedule, anatomical location were not reported). On the same day, a six months patient was administered 1 dose of ROTATEQ that was reconstituted with dexamethasone. No adverse effects. The outcome of product preparation error, product administered to patient of inappropriate age, and no adverse effects were unknown. The causality between the aforementioned events and ROTATEQ was unknown.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and the administrator for the estate of an approximately 85 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacist at a pharmacy. On an unknown date in 2015, the patient was treated by a healthcare provider at a hospital for the following injuries resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient died on 24-DEC-2017. The cause of the patient's death is unknown. It is unknown if an autopsy was performed. The patient claims damages as a result of: injury to themselves, wrongful death, survivorship action, and economic losses. Upon internal review, death was determined to be medically significant. Additional information has been requested.; Reported Cause(s) of Death: Death.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 29-JUL-2013, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a by a health care provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, and economic losses. The outcome of the shingles is unknown. 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 was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, at approximately 72 years of age, the patient was administered the ZOSTAVAX by a healthcare provider at a county health department. On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. The reporter considered the influenza-like symptoms to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter had stated that after they provided the 1st dose of BEXSERO to the patient, they experienced flu like symptoms. Although, the reporter believed that the event was related to the BEXSERO, the reporter explicitly stressed that GlaxoSmithKline (GSK) not follow up and contact them as they did not want to deal with the paper work and information related to the incident. The reporter did not agree to follow up. This case was linked with US2019GSK030180, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Monoplegia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of monoplegia in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, 1 day after receiving BEXSERO, the patient experienced monoplegia (serious criteria GSK medically significant). On an unknown date, the outcome of the monoplegia was unknown. The reporter considered the monoplegia to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient was not able to move their leg the following day after receiving their 1st dose of BEXSERO. Although, the reporter believed that the event was related to the BEXSERO, the reporter explicitly stressed that GlaxoSmithKline (GSK) not to follow up and contact them as they did not want to deal with the paper work and information related to the incident. This case was linked with US2019GSK030162, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in January 2016). On 26th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injected limb mobility decreased, influenza-like symptoms, chills and fever. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, chills and fever were not recovered/not resolved and the outcome of the injected limb mobility decreased was recovered/resolved. It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, influenza-like symptoms, chills and fever to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in the left arm. The patient had SHINGRIX vaccine which hurt very bad. The patient could not lift her arm for approximately 4 to 5 days due to the arm pain. That night after receiving the SHINGRIX vaccine, several hours after vaccination the patient developed flu-like symptoms, including chills and fever. She was sick for two days and the symptoms resolved. The reporter consented to follow up. For tolerance, refer case US2019027669 for 2nd dose. This case has been linked to US2019027673 (husband's case), reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 23rd November 2018, the patient received the 1st dose of SHINGRIX. In February 2019, 1 hr after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The pain in arm resolved within 2-3 days. The reporter did not consent to follow-up. This case linked with US2019026015, reported by same reporter for the same patient.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated, Heart rate increased, Heart rate irregular, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation aggravated in a 90-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included atrial fibrillation (lasted one day and then resolve). In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced atrial fibrillation aggravated (serious criteria GSK medically significant), pain in arm, heart rate increased and heartbeats irregular. On an unknown date, the outcome of the atrial fibrillation aggravated, pain in arm, heart rate increased and heartbeats irregular were recovered/resolved. It was unknown if the reporter considered the atrial fibrillation aggravated, pain in arm, heart rate increased and heartbeats irregular to be related to SHINGRIX. Additional details were provided as follows: After vaccination, the patient experienced atrial fibrillation was worse for a few days which was included a rapid heart rate and an irregular heartbeat. The patient did not have to be seen by a physician. The reporter did not consent to follow-up. Lab Comments: On an unknown date, the patient's heart rate was rapid and irregular.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received the 2nd dose of SHINGRIX. On 13th February 2019, 1 days after receiving SHINGRIX, the patient experienced chills, general body pain and feeling unwell. On an unknown date, the outcome of the chills, general body pain and feeling unwell were not recovered/not resolved. It was unknown if the reporter considered the chills, general body pain and feeling unwell to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. At the time of reporting, the patient experienced pain all over her body and generally did not feel well. The patient disconnected the call, so the representative was unable to ask additional questions. The patient did not consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of headache in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 8th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced headache, tingling, shivering and numbness facial. On an unknown date, the outcome of the headache, tingling, shivering and numbness facial were not recovered/not resolved. It was unknown if the reporter considered the headache, tingling, shivering and numbness facial to be related to SHINGRIX. Additional details were received as follows: On 12th February 2019, a day before reporting, the patient came into health care professional's (HCP) office with headache, shivering, tingling and facial numbness. The HCP referred the patient for an MRI (Nuclear magnetic resonance imaging). Emergency visit was required. The HCP was unsure if the symptoms were related to the SHINGRIX vaccine.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Mobility decreased, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 13th February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, myalgia, fatigue, feeling hot, feeling abnormal and mobility decreased. On 14th February 2019, the outcome of the myalgia, fatigue and feeling hot were recovered/resolved. On an unknown date, the outcome of the pain in arm and mobility decreased were recovering/resolving and the outcome of the feeling abnormal was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, myalgia, fatigue, feeling hot, feeling abnormal and mobility decreased to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX vaccine in left arm. The patient experienced a very sore arm which started around 1:00 pm after receiving the vaccine. The patient could barely lift her arm to remove her shirt. That night after receiving the vaccine, she also experienced myalgia, fatigue, and she felt like she had a fever. At the time of reporting, the patient's arm was not as sore compared to vaccination day and she still felt a little "off". The reporter consented to follow up. The reporter gave permission for her physician to be contacted and provided contact details for the same.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 13th February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, myalgia, fatigue, feeling hot, feeling abnormal and mobility decreased. On 14th February 2019, the outcome of the myalgia, fatigue and feeling hot were recovered/resolved. On an unknown date, the outcome of the pain in arm and mobility decreased were recovering/resolving and the outcome of the feeling abnormal was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, myalgia, fatigue, feeling hot, feeling abnormal and mobility decreased to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX vaccine in left arm. The patient experienced a very sore arm which started around 1:00 pm after receiving the vaccine. The patient could barely lift her arm to remove her shirt. That night after receiving the vaccine, she also experienced myalgia, fatigue, and she felt like she had a fever. At the time of reporting, the patient's arm was not as sore compared to vaccination day and she still felt a little "off". The reporter consented to follow up. The reporter gave permission for her physician to be contacted and provided contact details for the same.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Myalgia, Pain, Pruritus, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly female patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 14 days after receiving SHINGRIX, the patient experienced ringing in ears. On an unknown date, the patient experienced muscle pain, erythema, swelling, pruritus and pain. On an unknown date, the outcome of the muscle pain, erythema, swelling, pruritus and pain were recovered/resolved and the outcome of the ringing in ears was not recovered/not resolved. It was unknown if the reporter considered the muscle pain, erythema, swelling, pruritus, pain and ringing in ears to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. Less than a year after vaccination, the patient experienced muscle pain, redness, swelling, itching and soreness. On 29th January 2019, the patient received 2nd dose of SHINGRIX. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly female patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 14 days after receiving SHINGRIX, the patient experienced ringing in ears. On an unknown date, the patient experienced muscle pain, erythema, swelling, pruritus and pain. On an unknown date, the outcome of the muscle pain, erythema, swelling, pruritus and pain were recovered/resolved and the outcome of the ringing in ears was not recovered/not resolved. It was unknown if the reporter considered the muscle pain, erythema, swelling, pruritus, pain and ringing in ears to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. Less than a year after vaccination, the patient experienced muscle pain, redness, swelling, itching and soreness. On 29th January 2019, the patient received 2nd dose of SHINGRIX. The reporter did not consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Erythema, Fatigue, Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in January 2016). Previously administered products included ZOSTAVAX (received in October 2016) and SHINGRIX with an associated reaction of pyrexia (1st dose received on 26th September 2018 (refer case US2019GSK030794). On 18th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th January 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills and sweating. On 9th February 2019, the patient experienced shingles, blister and pruritus. In February 2019, the patient experienced skin red, skin warm, skin irritation and scab. On an unknown date, the patient experienced exhaustion. The patient was treated with acyclovir. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shingles, skin red, exhaustion, skin warm, blister and skin irritation were not recovered/not resolved and the outcome of the influenza-like symptoms, fever, chills, sweating and pruritus were recovered/resolved and the outcome of the scab was unknown. It was unknown if the reporter considered the shingles, influenza-like symptoms, fever, skin red, chills, exhaustion, sweating, skin warm, blister, skin irritation, pruritus and scab to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in the left arm. Less than a day after vaccination with SHINGRIX, at 9:00 pm, the patient experienced flu-like symptoms which included sweating, fever and chills. Less than a month after vaccination, the patient was feeling exhausted after all of the other symptoms resolved but only for an evening. On 9th February 2019 on Sunday, 22 days after vaccination, the shingles blisters started appearing on chest and spread to both sides of neck over the next couple of days. On 10th February 2019 on Monday, the patient was diagnosed with shingles. The patient was prescribed with Acyclovir. The patient reported that, the itching was insane on the first day. At the time of reporting, she had the episodes of itching and then it stopped. Less than a month after vaccination, some of the blisters had scabbed over; some looked like white pustules and the skin around the blister were red, hot and irritated. The reporter consented to follow up. This case was linked with case US2019027673 (husband's case), reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Influenza like illness, Pruritus, Pyrexia, Rash pustular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in January 2016). Previously administered products included ZOSTAVAX (received in October 2016) and SHINGRIX with an associated reaction of pyrexia (1st dose received on 26th September 2018 (refer case US2019GSK030794). On 18th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th January 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills and sweating. On 9th February 2019, the patient experienced shingles, blister and pruritus. In February 2019, the patient experienced skin red, skin warm, skin irritation and scab. On an unknown date, the patient experienced exhaustion. The patient was treated with acyclovir. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shingles, skin red, exhaustion, skin warm, blister and skin irritation were not recovered/not resolved and the outcome of the influenza-like symptoms, fever, chills, sweating and pruritus were recovered/resolved and the outcome of the scab was unknown. It was unknown if the reporter considered the shingles, influenza-like symptoms, fever, skin red, chills, exhaustion, sweating, skin warm, blister, skin irritation, pruritus and scab to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in the left arm. Less than a day after vaccination with SHINGRIX, at 9:00 pm, the patient experienced flu-like symptoms which included sweating, fever and chills. Less than a month after vaccination, the patient was feeling exhausted after all of the other symptoms resolved but only for an evening. On 9th February 2019 on Sunday, 22 days after vaccination, the shingles blisters started appearing on chest and spread to both sides of neck over the next couple of days. On 10th February 2019 on Monday, the patient was diagnosed with shingles. The patient was prescribed with Acyclovir. The patient reported that, the itching was insane on the first day. At the time of reporting, she had the episodes of itching and then it stopped. Less than a month after vaccination, some of the blisters had scabbed over; some looked like white pustules and the skin around the blister were red, hot and irritated. The reporter consented to follow up. This case was linked with case US2019027673 (husband's case), reported by the same reporter.