chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Inflammation, Injection site pain, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local swelling, injection site pain and inflammation. On an unknown date, the outcome of the local swelling, injection site pain and inflammation were recovered/resolved.  It was unknown if the reporter considered the local swelling, injection site pain and inflammation to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 62 or 63 years. The healthcare professional reported that, the patient had come in for her 2nd dose of SHINGRIX and reported, local swelling, inflammation, and pain in response to the 1st dose that had since resolved. The healthcare professional could not provide batch number and expiry date as the dose was given at a different practice site.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th September 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, injection site pain and chills. On 11th September 2018, the outcome of the influenza-like symptoms, general body pain, injection site pain and chills were recovered/resolved.  It was unknown if the reporter considered the influenza-like symptoms, general body pain, injection site pain and chills to be related to SHINGRIX. Additional details were reported as follows: The patient woke up dizzy, and was very ill on Tuesday and Wednesday. She reported that it felt like a train was going through her head, and that her head was pounding and the headache was severe. She also reported that she basically had flu-like symptoms, which included nausea, body aches, and a high fever. She was bedridden on Tuesday and Wednesday of that week, but stated that she was back to normal, but her arm at the injection site was still sore. The reporter suggested that she follow up with her healthcare professional. The patient had denied permission to contact their physician. This case has been linked with US2018167339, reported by same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th September 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, injection site pain and chills. On 11th September 2018, the outcome of the influenza-like symptoms, general body pain, injection site pain and chills were recovered/resolved.  It was unknown if the reporter considered the influenza-like symptoms, general body pain, injection site pain and chills to be related to SHINGRIX. Additional details were reported as follows: The patient woke up dizzy, and was very ill on Tuesday and Wednesday. She reported that it felt like a train was going through her head, and that her head was pounding and the headache was severe. She also reported that she basically had flu-like symptoms, which included nausea, body aches, and a high fever. She was bedridden on Tuesday and Wednesday of that week, but stated that she was back to normal, but her arm at the injection site was still sore. The reporter suggested that she follow up with her healthcare professional. The patient had denied permission to contact their physician. This case has been linked with US2018167339, reported by same reporter.
Sex: U
Vaccine: PNC13, VARZOS
Symptoms: Arthralgia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of joint pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. Co-suspect products included PREVENAR 13 for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose and PREVENAR 13 at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced joint pain. On an unknown date, the outcome of the joint pain was unknown. It was unknown if the reporter considered the joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per the vaccine indication. The pharmacist reported that on unspecified dates, multiple unspecified patients were administered PREVENAR 13 (manufacturer unknown by reporter) and SHINGRIX (manufacturer unknown by reporter) and an unspecified amount of time later experienced Joint pain. No clarifying information were provided. No additional details were provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox and shingles. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient received SHINGRIX vaccination 48 hours before the reporting date. Other than a very slight soreness at the injection site the patient had no side effects. All of the readings the patient had seen that most people have some nasty side effects. The patient asked that she was just lucky or her immune system was wonky. This case had been linked with case US2018GSK169316, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox and shingles. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient received SHINGRIX vaccination 48 hours before the reporting date. Other than a very slight soreness at the injection site the patient had no side effects. All of the readings the patient had seen that most people have some nasty side effects. The patient asked that she was just lucky or her immune system was wonky. This case had been linked with case US2018GSK169316, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in an unspecified number of adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The all of the readings the reporter have been seen that most people had some nasty side effects after receiving Shingrix. This case has been linked with case US2018GSK164847, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in an unspecified number of adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The all of the readings the reporter have been seen that most people had some nasty side effects after receiving Shingrix. This case has been linked with case US2018GSK164847, reported by same reporter.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, 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 BEXSERO. Additional details were received as follows: The age at vaccination was not reported. The reporter stated that her daughter experienced a sore arm from longer than one week but it eventually go away. This case has been linked with case US2018GSK164861, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were unknown. It was unknown if the reporter considered the injection site pain and pain in arm to be related to BEXSERO. Additional details were received as follows: The age at vaccination was not applicable. The reporter reported that the patients experienced pain at the injection site and a sore arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Feeling abnormal, Malaise, Pain, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 28th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than 4 months after receiving SHINGRIX, the patient experienced sickness, pain, decreased appetite, sleepiness and feels awful. On an unknown date, the outcome of the sickness was unknown and the outcome of the pain, decreased appetite, sleepiness and feels awful were recovered/resolved. It was unknown if the reporter considered the sickness, pain, decreased appetite, sleepiness and feels awful to be related to SHINGRIX. Additional details were provided as follows: The case was previously reported to the doctor. The caller called to report that the patient was sick after receiving the SHINGRIX. The patient stated that for 4 days after she feeling horrible. She also mentioned that, the symptoms that she had, were worse than the flu. The patient suffered from aches, pains, loss of appetite and she also slept a lot and she did make her doctor aware of her symptoms. The patient stated that she did not want to take the 2nd dose of the vaccine. The patient's husband also experienced symptoms after receiving the vaccine for tolerance see case US2018164425. The caller gave permission to contact the pharmacy where she received the vaccine. The patient gave permission to be contacted to her physician.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day 6 hrs after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. 30 hours following dose of SHINGRIX, the patient experienced a skin rash on her stomach and sides. The reporter wanted to know was this a common side effect or one that warrants medical attention and should prompt her to reconsider the second dose. The GlaxoSmithKline information does not seem to reference skin rash in any context, only hives or allergic reaction.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacist via other and described the occurrence of injection site reaction in a 58-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient experienced injection site reaction (unspecified). The batch number of the vaccine, and vaccination date were unknown. The course of vaccination was not discontinued. It was unknown if the patient was hospitalized or the healthcare provider considered the event to be life threatening. There was no seriousness criteria involved for the event including persistent or significant disability/incapacity, death, surgical or medical intervention and conginetal anomaly.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of general body pain in a 17-year-old female patient who received BEXSERO (batch number ABX711AA, expiry date 31st December 2019) for prophylaxis. On 10th September 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. In September 2018, less than a week after receiving BEXSERO, the patient experienced general body pain, malaise and fever. On an unknown date, the outcome of the general body pain, malaise and fever were unknown. It was unknown if the reporter considered the general body pain, malaise and fever to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in left deltoid. The reporter was a registered nurse reporting an adverse event on behalf of the patient. The patient's body temperature was 101 degree fahrenheit. The reporter stated that the patient's mother was planning to take the patient to the visit her physician on the day of reporting. This case was linked with the case US2018GSK165851, reported by the same reporter.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Hyperhidrosis, Hypotension, Muscle spasms
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of low blood pressure in a 18-year-old female patient who received BEXSERO (batch number 168401, expiry date February 2019) for prophylaxis. On 7th September 2018, the patient received the 2nd dose of BEXSERO. On 7th September 2018, less than a day after receiving BEXSERO, the patient experienced low blood pressure, chills, fever, weakness, sweating and muscle cramp. On an unknown date, the outcome of the low blood pressure, chills, fever, weakness, sweating and muscle cramp were unknown.  The reporter considered the low blood pressure, chills, fever, weakness, sweating and muscle cramp to be related to BEXSERO. Additional details were reported as follows: The vaccine given at 11 am, and the patient was brought back 4 hours later with a fever of 103 degrees  fahrenheit , slightly low blood pressure. The provider believes it was related to the vaccine. The reporter agree to follow up from GlaxoSmithKline.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of low blood pressure in a 18-year-old female patient who received BEXSERO (batch number 168401, expiry date February 2019) for prophylaxis. On 7th September 2018, the patient received the 2nd dose of BEXSERO. On 7th September 2018, less than a day after receiving BEXSERO, the patient experienced low blood pressure, chills, fever, weakness, sweating and muscle cramp. On an unknown date, the outcome of the low blood pressure, chills, fever, weakness, sweating and muscle cramp were unknown.  The reporter considered the low blood pressure, chills, fever, weakness, sweating and muscle cramp to be related to BEXSERO. Additional details were reported as follows: The vaccine given at 11 am, and the patient was brought back 4 hours later with a fever of 103 degrees  fahrenheit , slightly low blood pressure. The provider believes it was related to the vaccine. The reporter agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, between 1 and 2 months after receiving SHINGRIX, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown. It was unknown if the reporter considered the injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. A week before the reporting date, the patient started getting an itching sensation at the location of the shot. The patient asked if this was normal and if the patient should take any action. The patient was waiting for response.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, between 1 and 2 months after receiving SHINGRIX, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown. It was unknown if the reporter considered the injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. A week before the reporting date, the patient started getting an itching sensation at the location of the shot. The patient asked if this was normal and if the patient should take any action. The patient was waiting for response.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Pyrexia, Urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of hives in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced hives, chills, fever and diarrhea. In September 2018, the outcome of the hives, chills, fever and diarrhea were recovered/resolved. It was unknown if the reporter considered the hives, chills, fever and diarrhea to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on Thursday. The patient had hives, rigorous chills, fever and diarrhea. The patient went to the emergency room. It was stated that, by Monday the patient was okay. The reporter agreed for follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Hypoaesthesia, Pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a 17-year-old male patient who received BEXSERO (batch number 16E601, expiry date unknown) for prophylaxis. Concomitant products included BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced fever, numbness, weakness and pain. On an unknown date, the outcome of the fever, numbness, weakness and pain were unknown. It was unknown if the reporter considered the fever, numbness, weakness and pain to be related to BEXSERO. Additional information was received as follows: This case was reported by the physician assistant. The patient received BEXSERO on the left arm which was one month apart from the 1st dose vaccination. On 11th September 2018, the patient called clinic after hours of vaccination. The patient spiked a fever and the provider had instructed him to go to emergency room (ER). The reporter agreed for follow up contact.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a female patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th September 2018, 31 days after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that one of the viruses thought to bring on Bell's was the Herpes Zoster Virus. She was just wondering if this could be a side effect of the vaccine. She had done some research on Bells and the vaccine and had not found anything conclusive either way. She was inquiring about any information that could clarify this issue.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included fish oil. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. On 3rd July 2018, 1 days after receiving SHINGRIX, the patient experienced headache and light headedness. On an unknown date, the outcome of the headache and light headedness were recovered/resolved. It was unknown if the reporter considered the headache and light headedness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. The patient received SHINGRIX in the left arm. The events lasted for 24 hours. The contact details of the physician was provided. For tolerance to next dose, refer case US2018164489.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 66-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hepatitis C (previously diagnosed) and neuropathy (in 2015). Previously administered products included Unspecified medication with an associated reaction of paraesthesia (in 2015, three years ago, she was diagnosed with neuropathy from a neurologist within eight hours after receiving another medication and she experienced needles and pins but the side effects resolved). Concurrent medical conditions included drug hypersensitivity (according to her rheumatologist). In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a month after receiving SHINGRIX, the patient experienced influenza like illness. On an unknown date, the outcome of the influenza like illness was recovered/resolved. It was unknown if the reporter considered the influenza like illness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination could be 65 or 66 years. The patient had 3 glucose tests in the past 3 years that came back in the normal range. Three years before the reporting date, she was diagnosed with neuropathy from a neurologist within eight hours after receiving another medication and she experienced needles and pins but the side effects resolved. After receiving 1st dose of SHINGRIX, the patient felt like she had the flu and she was in bed for one week. The patient claimed that she was very thin and active. The patient refused to answer any questions regarding her experience. The patient had denied permission to contact their physician. For tolerance to next dose, refer case US2018164372.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGNRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient was reporter's pharmacist. The age at vaccination was not reported. The age group adult was not reported, but captured as Adult as per the vaccine indication. The reporter stated that that her pharmacist, who had a SHINGRIX dose and felt sick. No specific details were shared at time of report. The reporter did not wish to answer questions for a safety report. This case has been linked with case US2018164345, reported by the reporter for herself.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received and experienced chills refer linked case US2018164482). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's age group was taken based on the product indication as no other patient details were provided. The healthcare professional stated that the patient experienced more severe fever and chills with dose 2 of SHINGRIX. The healthcare professional heard this information about a patient's experience from a healthcare professional outside of her facility. The healthcare professional did not had any patient information or vaccine information regarding this adverse event. The healthcare professional heard it second hand, and had no access to the patient or the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose, refer case US2018164471). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and fever. On an unknown date, the outcome of the influenza-like symptoms and fever were unknown. It was unknown if the reporter considered the influenza-like symptoms and fever to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Hypersensitivity, Urticaria
Clinical narrative: This case was reported by a other health professional and described the occurrence of swallowing difficult in a 35-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4ZY53, expiry date unknown) for prophylaxis. On 14th September 2018, the patient received FLUARIX QUADRIVALENT. On 14th September 2018, less than an hour after receiving FLUARIX QUADRIVALENT, the patient experienced swallowing difficult (serious criteria life threatening and other as per reporter), allergic reaction (serious criteria life threatening and other: as per reporter) and hives (serious criteria life threatening and other: as per reporter). FLUARIX QUADRIVALENT was discontinued. On an unknown date, the outcome of the swallowing difficult, allergic reaction and hives were recovering/resolving. The reporter considered the swallowing difficult, allergic reaction and hives to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received the vaccine and within 15 minutes she had the difficulty swallowing and skin reaction. She was brought to the emergency room. The patient was treated there for an allergic reaction and subsequently discharged. The events were not associated with other seriousness criteria like hospitalization, death, disability and congenital anomaly.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 82-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (Refer case US2018GSK165025). On 7th September 2018, the patient received the 2nd dose of Shingrix. On 7th September 2018, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On 9th September 2018, the patient experienced malaise, nausea, myalgia, chills, sweating and fever. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved and the outcome of the injection site swelling, malaise, nausea, myalgia, chills, sweating and fever were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, malaise, nausea, myalgia, chills, sweating and fever to be related to Shingrix. Additional details were provided as follows: The patient experienced pain at injection site, redness, swelling. The patient used ice externally. On 8th September 2018, the pain and redness remain at injection site. On 9th September 2018, 2 days after vaccination, the patient experienced malaise, nausea, myalgia in extremities, chills, sweating, fever with body temperature of 101.4 degree F. Swelling and redness at injection site was continued and remained unrelieved with topical ice.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 82-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (Refer case US2018GSK165025). On 7th September 2018, the patient received the 2nd dose of Shingrix. On 7th September 2018, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On 9th September 2018, the patient experienced malaise, nausea, myalgia, chills, sweating and fever. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved and the outcome of the injection site swelling, malaise, nausea, myalgia, chills, sweating and fever were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, malaise, nausea, myalgia, chills, sweating and fever to be related to Shingrix. Additional details were provided as follows: The patient experienced pain at injection site, redness, swelling. The patient used ice externally. On 8th September 2018, the pain and redness remain at injection site. On 9th September 2018, 2 days after vaccination, the patient experienced malaise, nausea, myalgia in extremities, chills, sweating, fever with body temperature of 101.4 degree F. Swelling and redness at injection site was continued and remained unrelieved with topical ice.
Sex: M
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 male patient who received Shingrix for prophylaxis. On an unknown date, the patient received 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 received as follows: The age at vaccination was not reported. The reporter mentioned in a very casual statement that she knew a patient that experienced a sore arm for couple days and recovered. When the reporter was asked for detailed information, reporter did not want to provide information without the consent of people involved. This case is one of four cases, reported by the same reporter.
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 extremity in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in extremity. On an unknown date, the outcome of the pain in extremity was recovered/resolved. It was unknown if the reporter considered the pain in extremity to be related to Shingrix. Additional details were received as follows: The age at vaccination was not reported. The reporter mentioned in a very casual statement that she knew a patient that experienced a sore arm for couple of days and recovered. When the reporter asked for detailed information, reporter did not want to provide information without the consent of people involved. This is one of four cases reported by the same reporter.
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 female patient who received Shingrix for prophylaxis. On an unknown date, the patient received 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 received as follows: The age at vaccination was not reported. The reporter mentioned in a very casual statement that she knew a patient that experienced a sore arm for couple of days and recovered. When the reporter asked for detailed information, reporter did not want to provide information without the consent of people involved. This is one of four cases reported by the same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: 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 80-year-old female patient who received Shingrix for prophylaxis. On 19th May 2018, the patient received the 1st dose of Shingrix (intramuscular). On 20th May 2018, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left arm and on the next day the patient experienced a little redness, swelling and soreness at injection site (left arm). The patient was unsure how long these symptoms lasted. For the tolerance of 2nd dose, refer linked to the case US2018164488, reported by the same reporter for the same patient.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient got shingles rash a month after administration of vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site reaction, Local reaction
Clinical narrative: Patient seen through our urgent care facility today for local reaction to left thigh. Examined by Nurse Practitioner. Oval shaped, pink in color approx. 6 cm in size, localized. Erythema. Area improving per patient's mother, patient afebrile at time of visit.
Age: 73.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Nausea, Pain, Pruritus
Clinical narrative: Pt called in to cancel appt today due to the fact that she had aches all over nausea, skin itches, and pain in chest at one point.
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Condition aggravated, Differential white blood cell count, Dizziness, Dysstasia, Electrocardiogram normal
Clinical narrative: The day of the vaccinations and for several days following, I experienced body aches (muscular not joint pain), which was as expected. The morning following the injections for SHINGRIX and FLUCELVAX (09/10/18), I experienced tingling and numbness at all extremities, followed by vertigo and fainting. Brief loss of consciousness only, and was able to call 911 to request EMT response. I was barely able to remain conscious and experienced profound weakness in my limbs (e.g., difficulty raising arms, could not stand), my head felt numb, and then my throat began to close in the ambulance. The EMTs administered BENADRYL by mouth, which alleviated the swelling. This is what made me think of allergic response rather than a medical issue like stroke, cardiac or panic attack. Vital signs remained within normal levels, EKG test was normal, and I was able to stand on my own after approximately 6 hours. On 09/15/18, the area surrounding the SHINGRIX injection site became very red in color and hot to the touch approximately 2 inches in diameter (I have pictures of this), but this resolved after 36 hours without further spread. All body aches ceased by 09/15/18. I continue to experience some lightheadedness and will have a recommended follow up with a neurologist on 10/9/18. In addition, I noticed that previously existing tinnitus was markedly more pronounced (i.e., louder in volume and higher in pitch) for at least 48 hours after the event. Additional comment: I actually work at Agency and am very supportive of vaccines, and I have participated in vaccine trials without incident. This was an unexpected and severe reaction (possibly to SHINGRIX?), and I hope by filing this report that I can learn more about what may have occurred so that I can recover fully. At this time and out of caution, I do not plan to receive the second dose of SHINGRIX as a result of this experience. I have had both chicken pox and shingles in the past, and made this clear to the Pharmacy clinician to ensure no known issues with this new vaccine.
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Full blood count, Hypoaesthesia, Incomplete course of vaccination, Injection site erythema, Injection site warmth
Clinical narrative: The day of the vaccinations and for several days following, I experienced body aches (muscular not joint pain), which was as expected. The morning following the injections for SHINGRIX and FLUCELVAX (09/10/18), I experienced tingling and numbness at all extremities, followed by vertigo and fainting. Brief loss of consciousness only, and was able to call 911 to request EMT response. I was barely able to remain conscious and experienced profound weakness in my limbs (e.g., difficulty raising arms, could not stand), my head felt numb, and then my throat began to close in the ambulance. The EMTs administered BENADRYL by mouth, which alleviated the swelling. This is what made me think of allergic response rather than a medical issue like stroke, cardiac or panic attack. Vital signs remained within normal levels, EKG test was normal, and I was able to stand on my own after approximately 6 hours. On 09/15/18, the area surrounding the SHINGRIX injection site became very red in color and hot to the touch approximately 2 inches in diameter (I have pictures of this), but this resolved after 36 hours without further spread. All body aches ceased by 09/15/18. I continue to experience some lightheadedness and will have a recommended follow up with a neurologist on 10/9/18. In addition, I noticed that previously existing tinnitus was markedly more pronounced (i.e., louder in volume and higher in pitch) for at least 48 hours after the event. Additional comment: I actually work at Agency and am very supportive of vaccines, and I have participated in vaccine trials without incident. This was an unexpected and severe reaction (possibly to SHINGRIX?), and I hope by filing this report that I can learn more about what may have occurred so that I can recover fully. At this time and out of caution, I do not plan to receive the second dose of SHINGRIX as a result of this experience. I have had both chicken pox and shingles in the past, and made this clear to the Pharmacy clinician to ensure no known issues with this new vaccine.
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Loss of consciousness, Metabolic function test, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: The day of the vaccinations and for several days following, I experienced body aches (muscular not joint pain), which was as expected. The morning following the injections for SHINGRIX and FLUCELVAX (09/10/18), I experienced tingling and numbness at all extremities, followed by vertigo and fainting. Brief loss of consciousness only, and was able to call 911 to request EMT response. I was barely able to remain conscious and experienced profound weakness in my limbs (e.g., difficulty raising arms, could not stand), my head felt numb, and then my throat began to close in the ambulance. The EMTs administered BENADRYL by mouth, which alleviated the swelling. This is what made me think of allergic response rather than a medical issue like stroke, cardiac or panic attack. Vital signs remained within normal levels, EKG test was normal, and I was able to stand on my own after approximately 6 hours. On 09/15/18, the area surrounding the SHINGRIX injection site became very red in color and hot to the touch approximately 2 inches in diameter (I have pictures of this), but this resolved after 36 hours without further spread. All body aches ceased by 09/15/18. I continue to experience some lightheadedness and will have a recommended follow up with a neurologist on 10/9/18. In addition, I noticed that previously existing tinnitus was markedly more pronounced (i.e., louder in volume and higher in pitch) for at least 48 hours after the event. Additional comment: I actually work at Agency and am very supportive of vaccines, and I have participated in vaccine trials without incident. This was an unexpected and severe reaction (possibly to SHINGRIX?), and I hope by filing this report that I can learn more about what may have occurred so that I can recover fully. At this time and out of caution, I do not plan to receive the second dose of SHINGRIX as a result of this experience. I have had both chicken pox and shingles in the past, and made this clear to the Pharmacy clinician to ensure no known issues with this new vaccine.
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Paraesthesia, Swelling, Syncope, Throat tightness, Tinnitus
Clinical narrative: The day of the vaccinations and for several days following, I experienced body aches (muscular not joint pain), which was as expected. The morning following the injections for SHINGRIX and FLUCELVAX (09/10/18), I experienced tingling and numbness at all extremities, followed by vertigo and fainting. Brief loss of consciousness only, and was able to call 911 to request EMT response. I was barely able to remain conscious and experienced profound weakness in my limbs (e.g., difficulty raising arms, could not stand), my head felt numb, and then my throat began to close in the ambulance. The EMTs administered BENADRYL by mouth, which alleviated the swelling. This is what made me think of allergic response rather than a medical issue like stroke, cardiac or panic attack. Vital signs remained within normal levels, EKG test was normal, and I was able to stand on my own after approximately 6 hours. On 09/15/18, the area surrounding the SHINGRIX injection site became very red in color and hot to the touch approximately 2 inches in diameter (I have pictures of this), but this resolved after 36 hours without further spread. All body aches ceased by 09/15/18. I continue to experience some lightheadedness and will have a recommended follow up with a neurologist on 10/9/18. In addition, I noticed that previously existing tinnitus was markedly more pronounced (i.e., louder in volume and higher in pitch) for at least 48 hours after the event. Additional comment: I actually work at Agency and am very supportive of vaccines, and I have participated in vaccine trials without incident. This was an unexpected and severe reaction (possibly to SHINGRIX?), and I hope by filing this report that I can learn more about what may have occurred so that I can recover fully. At this time and out of caution, I do not plan to receive the second dose of SHINGRIX as a result of this experience. I have had both chicken pox and shingles in the past, and made this clear to the Pharmacy clinician to ensure no known issues with this new vaccine.