chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of syncope in a 18-year-old male patient who received BEXSERO (batch number ABX766AA, expiry date July 2020) for prophylaxis. Co-suspect products included MENVEO for prophylaxis. The patient's past medical history included syncope (similar episode occurred on 7th April 2014) and sickness. On 19th November 2018, the patient received the 1st dose of BEXSERO .5 ml and MENVEO. On 19th November 2018, immediately after receiving BEXSERO and MENVEO, the patient experienced syncope (serious criteria GSK medically significant), dizziness, pallor, blood pressure decreased and pulse weak. The patient was treated with nutritional supplement nos (Pediasure) and citric acid + glucose + potassium phosphate monobasic + sodium chloride + sodium citrate + sucrose (Gatorade). On an unknown date, the outcome of the syncope was recovered/resolved and the outcome of the dizziness, pallor, blood pressure decreased and pulse weak were unknown. It was unknown if the reporter considered the syncope, dizziness, pallor, blood pressure decreased and pulse weak to be related to BEXSERO and MENVEO. Additional details were reported as follows: According to the physician, the patient visited to a physician because the patient was sick but no vaccine was administered at this visit. The patient received BEXSERO on the left arm. On 19th November 2018, the patient received MENVEO on the right arm. Almost immediately (like within 2 minutes) after vaccination, the patient experienced dizzy, face and lips were pale. The patient was lie down and this was all had in the office. The physician took pulses and noted they were weak but blood pressure was 110/70. So, the patient was observed and syncope resolved without further issue or medical intervention. On 19th November 2018 around 3:40 PM, the patient visited to a physician. The physician informed that, the patient had not anything to eat all day but drunk only Gatorade. The patient was left office at 4:40 pm with instructions from physician to eat something. On 20th December 2018, the patient received 2nd dose of BEXSERO without any incident. The reporter agreed upon follow up from GlaxoSmithKline.
Sex: U
Vaccine: FLU4
Symptoms: Joint range of motion decreased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of joint range of motion decreased in a patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number Y279A, expiry date 30th June 2019) and (batch number 92XR5, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced joint range of motion decreased. On an unknown date, the outcome of the joint range of motion decreased was unknown. It was unknown if the reporter considered the joint range of motion decreased to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The physician reported that they had 8 patients who experienced limited range of motion in their arm after receiving the FLUARIX vaccine. The could not identify the patients who received the FLUARIX. They stated that 8 patients out of 1400 patients developed limited range of motion after receiving the FLUARIX vaccine. The reporter did not have specific patient information. The reporter stated that the patients required follow up treatment.  The healthcare professional (HCP) did not give specifics on what that treatment involved. The reporter consented to follow up. This is 1 of 8 cases reported by the same reporter. There are 2 batch numbers provided for FLUARIX QUADRIVALENT 2018-2019 season, but it is not sure which is the correct batch number.
Sex: U
Vaccine: FLU4
Symptoms: Joint range of motion decreased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of joint range of motion decreased in a patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number Y279A, expiry date 30th June 2019) and (batch number 92XR5, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced joint range of motion decreased. On an unknown date, the outcome of the joint range of motion decreased was unknown. It was unknown if the reporter considered the joint range of motion decreased to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were received as follows: The age at vaccination was not reported. The physician reported that they had 8 patients who experienced limited range of motion in their arm after receiving the FLUARIX vaccine. The could not identify the patients who received the FLUARIX. They stated that 8 patients out of 1400 patients developed limited range of motion after receiving the FLUARIX vaccine. The reporter did not have specific patient information. The reporter stated that the patients required follow up treatment.  The healthcare professional (HCP) did not give specifics on what that treatment involved. The reporter consented to follow up. This is 1 of 8 cases reported by the same reporter. There are 2 batch numbers provided for FLUARIX QUADRIVALENT 2018-2019 season, but it is not sure which is the correct batch number.
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Screaming
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling of legs in a 37-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis.  Previously administered products included Dtap with an associated reaction of induration (1st dose received at 3 month of age, other events were skin warm and erythema. refer case US2018228793.) and Dtap with an associated reaction of induration (2nd dose received on unknown date, other events skin warm and erythema, refer case US2018GSK232635). On an unknown date, the patient received the 3rd dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced swelling of legs, leg pain, fever and screaming. On an unknown date, the outcome of the swelling of legs, leg pain, fever and screaming were recovered/resolved. It was unknown if the reporter considered the swelling of legs, leg pain, fever and screaming to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. After the third shot, the entire leg swelled up and was sore and she had a fever. The baby screamed for hours. It took 10 days to resolved. The reporter reached out through the whooping cough website and was instructed to call the agency. The reason for reporter call was to advocate for vaccines not to report an adverse event (AE). She had 3 kids and at the advice of the physician, she did not vaccinate the other two because of the reactions her first child experienced but now she wishes she had vaccinated them as well because the other 2 kids had bad cases of whooping cough but the first child (the patient in this report) never had it.
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Mass, Skin warm, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of induration in a 37-year-old female patient who received DTaP vaccine for prophylaxis. Previously administered products included Dtap with an associated reaction of induration (1st dose received at 3 month of age, other events were skin warm and erythema. Refer case US2018228793.). On an unknown date, the patient received the 2nd dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced induration, mass, skin warm and redness of legs. Rechallenge with DTaP vaccine was positive. On an unknown date, the outcome of the induration, mass, skin warm and redness of legs were recovered/resolved. It was unknown if the reporter considered the induration, mass, skin warm and redness of legs to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. On unknown date, the same three reactions presented with the second shot but the knot was bigger. The size of half a baseball. The reporter could not provide dimensions. The events were resolved after a week. The reporter reached out through the whooping cough website and was instructed to call the agency. The reason for reporter call was to advocate for vaccines not to report an adverse event (AE). The reporter had 3 kids and at the advice of the physician, she did not vaccinate the other two because of the reactions her first child experienced but now she wishes she had vaccinated them as well because the other 2 kids had bad cases of whooping cough but the first child (the patient in this report) never had it. For tolerance to further doses, refer cases US2018GSK232634 (3th dose).
Sex: F
Vaccine: TDAP
Symptoms: Brachial plexus injury, Cerebral disorder, Complex regional pain syndrome, Deformity, General physical health deterioration
Clinical narrative: This case was reported by a nurse via interactive digital media and described the occurrence of paralysis in a 60-year-old female patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced paralysis (serious criteria disability and GSK medically significant), disfigurement, brachial plexus injury, muscle spasm, myofascial pain syndrome, stiff neck, complex regional pain syndrome, pain, general physical health deterioration, immune system disorder and brain disorder nos. On an unknown date, the outcome of the paralysis, disfigurement, brachial plexus injury, muscle spasm, myofascial pain syndrome, stiff neck, complex regional pain syndrome and pain were not recovered/not resolved and the outcome of the general physical health deterioration, immune system disorder and brain disorder Nos were unknown. It was unknown if the reporter considered the paralysis, disfigurement, brachial plexus injury, muscle spasm, myofascial pain syndrome, stiff neck, complex regional pain syndrome, pain, general physical health deterioration, immune system disorder and brain disorder Nos to be related to dTpa vaccine. Additional details were receive as follows: In 2007, the patient received Tdap vaccine, which as per the reporter was the beginning of the end of the her life. The patient suffered and remained suffering and was struggling from having a severe adverse side effects from the Tdap vaccine that left her disfigured, permanently and totally disabled, paralyzed on her left upper extremity with the paralysis spreading to the right side, which was progressive and no cure, severe brachial plexus injury, myofascial pain, constant and continuous right trapezius muscle spasm. At times, the patient could not turn her head side to side or look up or down and complex regional pain syndrome. The patient was in pain every single second of the day. CRPS, made the patient feel as if being burned alive. The patient was on medications, but it just took the edge off for a very short time. The pain never went. The patient was devastated that she lost her dream job as a critical care NICU RN. The patient loved the job, preemies and peers. At the time of reporting, she required help even to be able to take care of herself, all because of the mandated vaccine. The patient's right thumb and the body was slowly deteriorating and became completely paralyzed. The patient stated that those who fear a side effect had never seen this illness in action. As per her, the vaccine destroyed her immune system, as well as, part of the brain and body.
Sex: F
Vaccine: TDAP
Symptoms: Immune system disorder, Muscle spasms, Musculoskeletal stiffness, Myofascial pain syndrome, Pain
Clinical narrative: This case was reported by a nurse via interactive digital media and described the occurrence of paralysis in a 60-year-old female patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced paralysis (serious criteria disability and GSK medically significant), disfigurement, brachial plexus injury, muscle spasm, myofascial pain syndrome, stiff neck, complex regional pain syndrome, pain, general physical health deterioration, immune system disorder and brain disorder nos. On an unknown date, the outcome of the paralysis, disfigurement, brachial plexus injury, muscle spasm, myofascial pain syndrome, stiff neck, complex regional pain syndrome and pain were not recovered/not resolved and the outcome of the general physical health deterioration, immune system disorder and brain disorder Nos were unknown. It was unknown if the reporter considered the paralysis, disfigurement, brachial plexus injury, muscle spasm, myofascial pain syndrome, stiff neck, complex regional pain syndrome, pain, general physical health deterioration, immune system disorder and brain disorder Nos to be related to dTpa vaccine. Additional details were receive as follows: In 2007, the patient received Tdap vaccine, which as per the reporter was the beginning of the end of the her life. The patient suffered and remained suffering and was struggling from having a severe adverse side effects from the Tdap vaccine that left her disfigured, permanently and totally disabled, paralyzed on her left upper extremity with the paralysis spreading to the right side, which was progressive and no cure, severe brachial plexus injury, myofascial pain, constant and continuous right trapezius muscle spasm. At times, the patient could not turn her head side to side or look up or down and complex regional pain syndrome. The patient was in pain every single second of the day. CRPS, made the patient feel as if being burned alive. The patient was on medications, but it just took the edge off for a very short time. The pain never went. The patient was devastated that she lost her dream job as a critical care NICU RN. The patient loved the job, preemies and peers. At the time of reporting, she required help even to be able to take care of herself, all because of the mandated vaccine. The patient's right thumb and the body was slowly deteriorating and became completely paralyzed. The patient stated that those who fear a side effect had never seen this illness in action. As per her, the vaccine destroyed her immune system, as well as, part of the brain and body.
Sex: F
Vaccine: TDAP
Symptoms: Paralysis
Clinical narrative: This case was reported by a nurse via interactive digital media and described the occurrence of paralysis in a 60-year-old female patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced paralysis (serious criteria disability and GSK medically significant), disfigurement, brachial plexus injury, muscle spasm, myofascial pain syndrome, stiff neck, complex regional pain syndrome, pain, general physical health deterioration, immune system disorder and brain disorder nos. On an unknown date, the outcome of the paralysis, disfigurement, brachial plexus injury, muscle spasm, myofascial pain syndrome, stiff neck, complex regional pain syndrome and pain were not recovered/not resolved and the outcome of the general physical health deterioration, immune system disorder and brain disorder Nos were unknown. It was unknown if the reporter considered the paralysis, disfigurement, brachial plexus injury, muscle spasm, myofascial pain syndrome, stiff neck, complex regional pain syndrome, pain, general physical health deterioration, immune system disorder and brain disorder Nos to be related to dTpa vaccine. Additional details were receive as follows: In 2007, the patient received Tdap vaccine, which as per the reporter was the beginning of the end of the her life. The patient suffered and remained suffering and was struggling from having a severe adverse side effects from the Tdap vaccine that left her disfigured, permanently and totally disabled, paralyzed on her left upper extremity with the paralysis spreading to the right side, which was progressive and no cure, severe brachial plexus injury, myofascial pain, constant and continuous right trapezius muscle spasm. At times, the patient could not turn her head side to side or look up or down and complex regional pain syndrome. The patient was in pain every single second of the day. CRPS, made the patient feel as if being burned alive. The patient was on medications, but it just took the edge off for a very short time. The pain never went. The patient was devastated that she lost her dream job as a critical care NICU RN. The patient loved the job, preemies and peers. At the time of reporting, she required help even to be able to take care of herself, all because of the mandated vaccine. The patient's right thumb and the body was slowly deteriorating and became completely paralyzed. The patient stated that those who fear a side effect had never seen this illness in action. As per her, the vaccine destroyed her immune system, as well as, part of the brain and body.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth and stiffness. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth and stiffness were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth and stiffness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received her 1st dose in her left arm. The injection site was sore, hot, swollen, tight and red. The reporter consented to follow up. For tolerance after 2nd dose of SHINGRIX, refer case US2018230523.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth and stiffness. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth and stiffness were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth and stiffness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received her 1st dose in her left arm. The injection site was sore, hot, swollen, tight and red. The reporter consented to follow up. For tolerance after 2nd dose of SHINGRIX, refer case US2018230523.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Musculoskeletal stiffness, Pain, Poor quality sleep, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth and stiffness. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth and stiffness were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth and stiffness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received her 1st dose in her left arm. The injection site was sore, hot, swollen, tight and red. The reporter consented to follow up. For tolerance after 2nd dose of SHINGRIX, refer case US2018230523.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth and stiffness. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth and stiffness were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth and stiffness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received her 1st dose in her left arm. The injection site was sore, hot, swollen, tight and red. The reporter consented to follow up. For tolerance after 2nd dose of SHINGRIX, refer case US2018230523.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose, refer the case US2018GSK233039). Concurrent medical conditions included arthritic pains. On 19th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 19th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site reaction, general body pain, stiffness and poor sleep. On 20th December 2018, the patient experienced fever, appetite absent and chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site reaction, general body pain, fever, appetite absent, chills and stiffness were not recovered/not resolved and the outcome of the poor sleep was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site reaction, general body pain, fever, appetite absent, chills, stiffness and poor sleep to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose in left arm. he experienced all the same injections site reactions after 1st dose. She did not sleep well last night due to be achy all over. She thought it might be due to her being arthritic and having torn rotator cuffs but she woke up feeling feverish, chilled, achy and has no appetite. The reporter gave consent to follow up. This case has been linked with case US2018GSK233039, reported by the same reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Decreased appetite, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose, refer the case US2018GSK233039). Concurrent medical conditions included arthritic pains. On 19th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 19th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site reaction, general body pain, stiffness and poor sleep. On 20th December 2018, the patient experienced fever, appetite absent and chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site reaction, general body pain, fever, appetite absent, chills and stiffness were not recovered/not resolved and the outcome of the poor sleep was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site reaction, general body pain, fever, appetite absent, chills, stiffness and poor sleep to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose in left arm. he experienced all the same injections site reactions after 1st dose. She did not sleep well last night due to be achy all over. She thought it might be due to her being arthritic and having torn rotator cuffs but she woke up feeling feverish, chilled, achy and has no appetite. The reporter gave consent to follow up. This case has been linked with case US2018GSK233039, reported by the same reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Musculoskeletal stiffness, Pain, Poor quality sleep, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose, refer the case US2018GSK233039). Concurrent medical conditions included arthritic pains. On 19th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 19th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site reaction, general body pain, stiffness and poor sleep. On 20th December 2018, the patient experienced fever, appetite absent and chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site reaction, general body pain, fever, appetite absent, chills and stiffness were not recovered/not resolved and the outcome of the poor sleep was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site reaction, general body pain, fever, appetite absent, chills, stiffness and poor sleep to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose in left arm. he experienced all the same injections site reactions after 1st dose. She did not sleep well last night due to be achy all over. She thought it might be due to her being arthritic and having torn rotator cuffs but she woke up feeling feverish, chilled, achy and has no appetite. The reporter gave consent to follow up. This case has been linked with case US2018GSK233039, reported by the same reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose, refer the case US2018GSK233039). Concurrent medical conditions included arthritic pains. On 19th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 19th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site reaction, general body pain, stiffness and poor sleep. On 20th December 2018, the patient experienced fever, appetite absent and chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site reaction, general body pain, fever, appetite absent, chills and stiffness were not recovered/not resolved and the outcome of the poor sleep was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth, injection site reaction, general body pain, fever, appetite absent, chills, stiffness and poor sleep to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose in left arm. he experienced all the same injections site reactions after 1st dose. She did not sleep well last night due to be achy all over. She thought it might be due to her being arthritic and having torn rotator cuffs but she woke up feeling feverish, chilled, achy and has no appetite. The reporter gave consent to follow up. This case has been linked with case US2018GSK233039, reported by the same reporter.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a adolescent female patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO with an associated reaction of injection site pain (For tolerance of 1st dose refer case US2018GSK230218). On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. Rechallenge with BEXSERO was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age of vaccination was not reported. The patient experienced injection site pain which persisted for approximately one week. This case has been linked to the cases US2018GSK164861, US2018GSK164860 and US2018GSK091195.
Age: 72.0
Sex: F
Vaccine: VARZOS, 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 72-year-old female patient who received SHINGRIX for prophylaxis. On 17th November 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. 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: In 2018, the patient experienced arm pain. The reporter did not consent to follow-up. This case has been linked with case US2018230492 (husband's case), reported by the same reporter and for tolerance to next dose, refer case US2018230489.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Disorientation, Gait disturbance, Hyperhidrosis, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 17th November 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. 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: In 2018, the patient experienced arm pain. The reporter did not consent to follow-up. This case has been linked with case US2018230492 (husband's case), reported by the same reporter and for tolerance to next dose, refer case US2018230489.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of walking difficulty in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 17th October 2018, refer case US2018GSK233125). On 18th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th December 2018, less than a day after receiving SHINGRIX, the patient experienced walking difficulty, balance difficulty, drenching sweats and fever. On 19th December 2018, the patient experienced disorientation. On an unknown date, the outcome of the walking difficulty, balance difficulty and disorientation were not recovered/not resolved and the outcome of the drenching sweats and fever were unknown. It was unknown if the reporter considered the walking difficulty, balance difficulty, drenching sweats, disorientation and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. Later that day, the patient experienced difficulty walking due to losing her balance, felt feverish, went to bed for a day and woke up drenched in sweat and was feeling disoriented at the reporting time. At the time of reporting, the patient felt better but had not fully recovered yet. The reporter did not consent to follow-up. This case has been linked with case US2018230492 (husband's case), reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Disorientation, Gait disturbance, Hyperhidrosis, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of walking difficulty in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 17th October 2018, refer case US2018GSK233125). On 18th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th December 2018, less than a day after receiving SHINGRIX, the patient experienced walking difficulty, balance difficulty, drenching sweats and fever. On 19th December 2018, the patient experienced disorientation. On an unknown date, the outcome of the walking difficulty, balance difficulty and disorientation were not recovered/not resolved and the outcome of the drenching sweats and fever were unknown. It was unknown if the reporter considered the walking difficulty, balance difficulty, drenching sweats, disorientation and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. Later that day, the patient experienced difficulty walking due to losing her balance, felt feverish, went to bed for a day and woke up drenched in sweat and was feeling disoriented at the reporting time. At the time of reporting, the patient felt better but had not fully recovered yet. The reporter did not consent to follow-up. This case has been linked with case US2018230492 (husband's case), reported by the same reporter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Musculoskeletal pain, Neck pain, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 62-year-old male patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, 18 days after receiving SHINGRIX, the patient experienced neck pain, shoulder pain and skin blotches. On 25th November 2018, the patient experienced shingles. On an unknown date, the outcome of the shingles and neck pain were not recovered/not resolved and the outcome of the shoulder pain and skin blotches were unknown. It was unknown if the reporter considered the shingles, neck pain, shoulder pain and skin blotches to be related to SHINGRIX. Additional details were received as follows: Approximately 20 days before the date of reporting, the patient received SHINGRIX on the left arm. About 18 days later, the patient started to experience pain on the right side of neck and rear of neck which went towards the base of the shoulders. The patient rated the pain as number 3 to 4 on a scale of 1 through 10. He also experienced pink blotchy patches on the back of the right shoulder and little bit on the front shoulder. On 25th November 2018, the patient contacted his physician over the weekend, the physician told him that it was a mild case of Shingles. The patient was started on antiviral medication. The patient was referred to physician. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Hypertension
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hypertensive episode in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced hypertensive episode. On an unknown date, the outcome of the hypertensive episode was unknown. It was unknown if the reporter considered the hypertensive episode to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional (HCP) did not have batch number or expiry date of SHINGRIX that was given. The HCP reported that a patient had hypertensive episodes after dose of SHINGRIX. The reporter did consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 14th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 17th December 2018, the patient experienced shivering and cold. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the shivering and cold were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, shivering and cold to be related to SHINGRIX. Additional details were provided as follows: On Friday, the patient received SHINGRIX on the left arm and experienced soreness at the injection site on Friday, Saturday, and a little bit on Sunday. On Monday night, three days after receiving SHINGRIX, the patient began to experience shivering and cold. The patient did not consent to follow-up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 80-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included back disorder. Concomitant products included tramadol. On 17th December 2018, the patient received the 2nd dose of SHINGRIX. On 17th December 2018, less than a day after receiving SHINGRIX, the patient experienced headache, muscle pain, weakness and tiredness. On an unknown date, the outcome of the headache, muscle pain, weakness and tiredness were recovering/resolving. It was unknown if the reporter considered the headache, muscle pain, weakness and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX around noon, on the right arm. Later on the same day, the patient experienced the events. The symptoms started to subside at the time of reporting. The patient did not provide consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Influenza like illness, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (Received on an unknown date). On 17th December 2018, the patient received the 1st dose of SHINGRIX. On 17th December 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell, feels awful, influenza like illness, headache and numbness in hand. On an unknown date, the outcome of the pain in arm, feeling unwell and feels awful were not recovered/not resolved and the outcome of the influenza like illness, headache and numbness in hand were unknown. It was unknown if the reporter considered the pain in arm, feeling unwell, feels awful, influenza like illness, headache and numbness in hand to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm at afternoon 2:00- 2:30 hours and by the evening she started feeling awful. It was felt like she had flu and arm became very painful. She did not have fever but did have a headache. Her wrist and hand felt little numb. Batch number was not provided. The reporter denied permission for follow up.
Age: 68.0
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 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (Received on an unknown date). On 17th December 2018, the patient received the 1st dose of SHINGRIX. On 17th December 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell, feels awful, influenza like illness, headache and numbness in hand. On an unknown date, the outcome of the pain in arm, feeling unwell and feels awful were not recovered/not resolved and the outcome of the influenza like illness, headache and numbness in hand were unknown. It was unknown if the reporter considered the pain in arm, feeling unwell, feels awful, influenza like illness, headache and numbness in hand to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm at afternoon 2:00- 2:30 hours and by the evening she started feeling awful. It was felt like she had flu and arm became very painful. She did not have fever but did have a headache. Her wrist and hand felt little numb. Batch number was not provided. The reporter denied permission for follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Extensive swelling of vaccinated limb, Herpes zoster, Incomplete course of vaccination, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 76-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 30th June 2018, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles and chest pain. On an unknown date, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and incomplete course of vaccination. The patient was treated with VALTREX. In July 2018, the outcome of the shingles and chest pain were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, shingles and chest pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of SHINGRIX. The patient received the 1st dose of SHINGRIX vaccine on left arm. The next day she experienced a red spot at the injection site in size of 1 inch and which increased to 4 to 5 inches in size, along with swelling and heating at the injection site which spread down to the arm. This lasted for about a week and she recovered. On 30th June 2018, the patient experienced a mild case of shingles and pain around the chest above the left breast area. On 3rd July 2018, the patient visited her doctor. She was prescribed generic of VALTREX. The patient recovered in a week. Till the date of this report, the patient had not received the 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The reporter had consented to follow up and had provided physician's contact details.