chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Back pain, Chills, Hot flush, Injection site pain
Clinical narrative: This spontaneous report was received from a 59 year old male patient, reporting on himself. The patient's concurrent conditions included: "sugar", drug reactions/allergies included penicillin. Concomitant medication included Metformin. On 02-OCT-2018, the patient was vaccinated with PNEUMOVAX 23, route was reported as intramuscular or subcutaneous injection, for immunization for the prevention of pneumococcal disease (dosage information, anatomical site of vaccination and lot number were not informed). Concomitant therapies included Metformin. The patient reported that on 02-OCT-2018, when he got home "I had cold chills and hot flashes." He also reported that when he went to sleep he "sweated all night." Additionally, on 03-OCT-2018 (reported as today), he was experiencing "weakness in legs and hips, swelling and pain at injection site, and pain in back." It was also reported that treatment was not given for the adverse events. Laboratory diagnostics/studies were not performed. The patient sought medical attention calling his doctor. The outcome for all the events was reported as not recovered. The causality assessment between chills, back pain, injection site pain, injection site swelling, asthenia, muscular weakness, night sweats and hot flush and PNEUMOVAX 23)was not provided.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Muscular weakness, Night sweats
Clinical narrative: This spontaneous report was received from a 59 year old male patient, reporting on himself. The patient's concurrent conditions included: "sugar", drug reactions/allergies included penicillin. Concomitant medication included Metformin. On 02-OCT-2018, the patient was vaccinated with PNEUMOVAX 23, route was reported as intramuscular or subcutaneous injection, for immunization for the prevention of pneumococcal disease (dosage information, anatomical site of vaccination and lot number were not informed). Concomitant therapies included Metformin. The patient reported that on 02-OCT-2018, when he got home "I had cold chills and hot flashes." He also reported that when he went to sleep he "sweated all night." Additionally, on 03-OCT-2018 (reported as today), he was experiencing "weakness in legs and hips, swelling and pain at injection site, and pain in back." It was also reported that treatment was not given for the adverse events. Laboratory diagnostics/studies were not performed. The patient sought medical attention calling his doctor. The outcome for all the events was reported as not recovered. The causality assessment between chills, back pain, injection site pain, injection site swelling, asthenia, muscular weakness, night sweats and hot flush and PNEUMOVAX 23)was not provided.
Sex: F
Vaccine: HPVX
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from the patient's mother, a health professional via a company representative, and refers to a 13 year old female patient.  No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL or with a dose of GARDASIL 9 for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported), it could not be confirmed if the product was GARDASIL or GARDASIL 9. It was reported that the patient fainted (syncope) after receiving GARDASIL or GARDASIL 9, on an unknown date. The patient did seek medical attention, but it was unknown if the patient required treatment, no intervention to prevent serious criteria or hospitalization was need. The outcome of syncope was reported as resolved. The causality assessment between syncope and GARDASIL or GARDASIL 9 was not reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a practice manager referring to a patient of unknown age. Information about concomitant medications, concurrent conditions, and medical history was not provided. On 02-AUG-2018, the patient were vaccinated with improperly stored RECOMBIVAX HB (strength, dose, route of administration were unknown; lot # R006746 and expiration date 19-NOV-2020) for prophylaxis. No adverse effects were reported. The reporter reported multiple temperature excursions over the past year and a half found during an audit. The excursion temperature in 08-NOV-2017, 16-NOV-2017; 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 was 47 degree Celsius for max 15 hours. And in 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. Data logger was not involved. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a practice manager referring to a patient of unknown age. Information about concomitant medications, concurrent conditions, and medical history was not provided. On 21-NOV-2017, the patient were vaccinated with improperly stored GARDASIL 9 (strength, dose number, anatomical location, route of administration were unknown; lot # N019923 and expiration date 28-APR-2019) for prophylaxis. No adverse effects were reported. The reporter reported multiple temperature excursions over the past year and a half found during an audit. The excursion temperature in 08-NOV-2017, 16-NOV-2017 was 47 degree Celsius for max 15 hours. Data logger was not involved. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a practice manager referring to a patient of unknown age. Information about concomitant medications, concurrent conditions, and medical history was not provided. On 25-JUN-2018, the patient were vaccinated with improperly stored M-M-R II (strength, dose number, anatomical location, route of administration were unknown; lot # M034856 and expiration date 27-JUL-2018) for prophylaxis. No adverse effects were reported. The reporter reported multiple temperature excursions over the past year and a half found during an audit. The excursion temperature in 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017; 30-JAN-2018, 23-FEB-2018, 18-MAY-2018 was 6 degree Celsius for max 8.75 hours. In 02-MAR-2018 was 7 degree Celsius for max 8.75 hours. In 07-DEC-2017 was 8 degree Celsius for max 15 hours. In Data logger was not involved. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a practice manager referring to a patient of unknown age. Information about concomitant medications, concurrent conditions, and medical history was not provided. On 05-SEP-2018, the patient were vaccinated with improperly stored PROQUAD (strength, dose number, anatomical location, route of administration were unknown; lot # R006216 and expiration date 28-AUG-2019) for prophylaxis. No adverse effects were reported. The reporter reported multiple temperature excursions over the past year and a half found during an audit. The excursion temperature in 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017; 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 5-JUL-2018, 15-AUG-2018 was 6 degree Celsius for max 8.75 hours. In 02-MAR-2018 and 27-AUG-2018 was 7 degree Celsius for max 8.75 hours. In 07-DEC-2017 was 8 degree Celsius for max 15 hours. In Data logger was not involved. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a practice manager referring to a patient of unknown age. Information about concomitant medications, concurrent conditions, and medical history was not provided. On 24-JUL-2018, the patient were vaccinated with improperly stored ROTATEQ (strength, dose number, anatomical location, route of administration were unknown; lot # N028258 and expiration date 30-MAY-2019) for prophylaxis. No adverse effects were reported. The reporter reported multiple temperature excursions over the past year and a half found during an audit. The excursion temperature in 08-NOV-2017, 16-NOV-2017; 23-JAN-2018, 06-JUN-2018, 03-JUL-2018, was 47 degree Celsius for max 15 hours. And in 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. Data logger was not involved. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Herpes zoster, Myalgia, Oral herpes
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Valacyclovir unknown for shingles. The patient's past medical history included shingles (experienced 8 times and most recently in December 2017, January 2018 and February 2018). Previously administered products included ZOSTAVAX (received many years prior to the date of reporting). On 31st August 2018, the patient received SHINGRIX (intramuscular). On an unknown date, the patient started Valacyclovir 500 mg once daily (500 mg daily). On 5th September 2018, 5 days after receiving SHINGRIX and less than a year after starting Valacyclovir, the patient experienced red blotches. On 6th September 2018, the patient experienced pain, swelling, burning sensation, vesicular rash, fever blister and erythema. On an unknown date, the patient experienced muscle pain. The action taken with Valacyclovir was unknown. On an unknown date, the outcome of the muscle pain was recovered/resolved and the outcome of the pain, swelling, burning sensation, vesicular rash, fever blister and erythema were not recovered/not resolved and the outcome of the red blotches was recovering/resolving. It was unknown if the reporter considered the muscle pain, pain, swelling, burning sensation, red blotches, vesicular rash, fever blister and erythema to be related to SHINGRIX and Valacyclovir. Additional information was reported as follows: In early 2018, the patient had experienced shingles 3 times within 6 weeks, for which she had been taking Valacyclovir. After the previous cases of Shingles were resolved the patient took Valacyclovir 500 mg twice daily, but after vaccination with SHINGRIX, the patient was instructed to take 500 mg daily. The patient experienced bad muscle pain after receiving SHINGRIX, which was resolved after 2 days. On the fifth day, the patient noticed three big red blotches which went down her arm from the injection site. On the sixth day, the patient saw a spot which looked like a spot of Shingles on her neck underneath her ear and was red and swollen. A day before the date of reporting, it felt like the patient got a fever blister between her lip and chin where the fever blister was burning, painful. The blotches were fading at the time of report.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash macular, Rash vesicular, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Valacyclovir unknown for shingles. The patient's past medical history included shingles (experienced 8 times and most recently in December 2017, January 2018 and February 2018). Previously administered products included ZOSTAVAX (received many years prior to the date of reporting). On 31st August 2018, the patient received SHINGRIX (intramuscular). On an unknown date, the patient started Valacyclovir 500 mg once daily (500 mg daily). On 5th September 2018, 5 days after receiving SHINGRIX and less than a year after starting Valacyclovir, the patient experienced red blotches. On 6th September 2018, the patient experienced pain, swelling, burning sensation, vesicular rash, fever blister and erythema. On an unknown date, the patient experienced muscle pain. The action taken with Valacyclovir was unknown. On an unknown date, the outcome of the muscle pain was recovered/resolved and the outcome of the pain, swelling, burning sensation, vesicular rash, fever blister and erythema were not recovered/not resolved and the outcome of the red blotches was recovering/resolving. It was unknown if the reporter considered the muscle pain, pain, swelling, burning sensation, red blotches, vesicular rash, fever blister and erythema to be related to SHINGRIX and Valacyclovir. Additional information was reported as follows: In early 2018, the patient had experienced shingles 3 times within 6 weeks, for which she had been taking Valacyclovir. After the previous cases of Shingles were resolved the patient took Valacyclovir 500 mg twice daily, but after vaccination with SHINGRIX, the patient was instructed to take 500 mg daily. The patient experienced bad muscle pain after receiving SHINGRIX, which was resolved after 2 days. On the fifth day, the patient noticed three big red blotches which went down her arm from the injection site. On the sixth day, the patient saw a spot which looked like a spot of Shingles on her neck underneath her ear and was red and swollen. A day before the date of reporting, it felt like the patient got a fever blister between her lip and chin where the fever blister was burning, painful. The blotches were fading at the time of report.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site plaque, Lyme disease
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of lyme disease in a 75-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (refer case US2018GSK177661 for tolrance of 1st dose). On 11th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In September 2018, less than a month after receiving SHINGRIX, the patient experienced lyme disease (serious criteria GSK medically significant), cellulitis (serious criteria GSK medically significant), raised rash and localized erythema. On an unknown date, the outcome of the lyme disease, cellulitis, raised rash and localized erythema were unknown. It was unknown if the reporter considered the lyme disease, cellulitis, raised rash and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however, it could be 74 or 75 years. The patient had developed big red plaque that was 10 to 12 cm in diameter at an inferior location to the injection site which was on the shoulder. The reporter described the area of the red plaque as being in the bicep area. The patient's family care physician was treating for possible lymes disease, but the reporter thought that the reaction might be a general cellulitis or related to the SHINGRIX injection site. The reporter was driving in his car and was not able to provide further details but was fine with follow-up from safety team.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of lyme disease in a 75-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (refer case US2018GSK177661 for tolrance of 1st dose). On 11th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In September 2018, less than a month after receiving SHINGRIX, the patient experienced lyme disease (serious criteria GSK medically significant), cellulitis (serious criteria GSK medically significant), raised rash and localized erythema. On an unknown date, the outcome of the lyme disease, cellulitis, raised rash and localized erythema were unknown. It was unknown if the reporter considered the lyme disease, cellulitis, raised rash and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however, it could be 74 or 75 years. The patient had developed big red plaque that was 10 to 12 cm in diameter at an inferior location to the injection site which was on the shoulder. The reporter described the area of the red plaque as being in the bicep area. The patient's family care physician was treating for possible lymes disease, but the reporter thought that the reaction might be a general cellulitis or related to the SHINGRIX injection site. The reporter was driving in his car and was not able to provide further details but was fine with follow-up from safety team.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 64-year-old male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX .5 ml. In September 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness, injection site swelling, injection site discoloration and cutaneous hypersensitivity. On an unknown date, the outcome of the injection site erythema, injection site tenderness, injection site swelling and injection site discoloration were not recovered/not resolved and the outcome of the cutaneous hypersensitivity was unknown. It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site swelling, injection site discoloration and cutaneous hypersensitivity to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. In September 2018, about 12 days before the date of reporting, the patient was vaccinated with the 1st dose of SHINGRIX. The patient stated that the injection site was very tender and he had used cold and warm compresses on the area and was unable to sleep on it. In September 2018, 11 days after vaccination with SHINGRIX, the patient experienced injection site discoloration and skin hypersensitivity. This case was linked with case US2018173511 (wife case), reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 64-year-old male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX .5 ml. In September 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness, injection site swelling, injection site discoloration and cutaneous hypersensitivity. On an unknown date, the outcome of the injection site erythema, injection site tenderness, injection site swelling and injection site discoloration were not recovered/not resolved and the outcome of the cutaneous hypersensitivity was unknown. It was unknown if the reporter considered the injection site erythema, injection site tenderness, injection site swelling, injection site discoloration and cutaneous hypersensitivity to be related to SHINGRIX. Additional information was reported as follows: The batch number for SHINGRIX was not reported. In September 2018, about 12 days before the date of reporting, the patient was vaccinated with the 1st dose of SHINGRIX. The patient stated that the injection site was very tender and he had used cold and warm compresses on the area and was unable to sleep on it. In September 2018, 11 days after vaccination with SHINGRIX, the patient experienced injection site discoloration and skin hypersensitivity. This case was linked with case US2018173511 (wife case), reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included spinal cord injury. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the general body pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Three months from the date of reporting the patient experienced body aches and pains that lasted for about a week and then resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was unknown. It was unknown if the reporter considered the herpes simplex to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter heard from her pharmacist that the mother of a coworker had received SHINGRIX and developed a herpes lesion on her shoulder. No further details were available. This case has been linked to US2018173523, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 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 day after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms and chills. On an unknown date, the outcome of the fever, influenza-like symptoms and chills were recovered/resolved.  It was unknown if the reporter considered the fever, influenza-like symptoms and chills to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The reporter stated that while the reporter was speaking to the healthcare professional, she also mentioned that she had a male friend who received SHINGRIX who also complained of having fever, chills, flu-like symptoms but these symptoms started on the day of vaccination with SHINGRIX and resolved a few days later. The healthcare professional did not have any additional details.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Vomiting
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of feeling unwell in a 73-year-old female patient who received SHINGRIX for prophylaxis. 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 feeling unwell and vomiting. On an unknown date, the outcome of the feeling unwell and vomiting were unknown. It was unknown if the reporter considered the feeling unwell and vomiting to be related to SHINGRIX. Additional details were provided as follows: The physician reported that they had a patient that received the SHINGRIX vaccine and experienced vomiting and they did not feel well for 48 to 72 hours. No additional details were available.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Borrelia test negative, Chills, Decreased appetite, Fatigue, Lethargy
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of upper respiratory tract infection in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 14th June 2018, the patient received the 1st dose of SHINGRIX. On 15th July 2018, 31 days after receiving SHINGRIX, the patient experienced generalized aching. On 4th September 2018, the patient experienced upper respiratory tract infection. On an unknown date, the patient experienced appetite lost, chills, night sweat, fatigue, fever, sore throat, neck pain, lethargy and myalgia. The patient was treated with amoxicillin trihydrate (Amoxicillin), ceftriaxone sodium (Rocephin), amoxicillin sodium, potassium clavulanate (Augmentin), levofloxacin (Levaquin), prednisone, magic mouthwash (nos) (Magic Mouthwash) and medication unknown (Over Counter Medicines). On an unknown date, the outcome of the upper respiratory tract infection, generalized aching, chills, fatigue, sore throat, neck pain and lethargy were unknown and the outcome of the appetite lost, night sweat, fever and myalgia were not recovered/not resolved. It was unknown if the reporter considered the upper respiratory tract infection, generalized aching, appetite lost, chills, night sweat, fatigue, fever, sore throat, neck pain, lethargy and myalgia to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional was also the patient's wife. The healthcare professional reported that 1 month post the dose of SHINGRIX, the patient began to exhibit a constellation of symptoms including generalized aches for which the patient self-medicated with over-the-counter products. On 4th September 2018 the patient was seen in an urgent care facility where 82 days after vaccination, an upper respiratory infection was suspected. The patient was treated with Amoxicillin, Prednisone and Magic Mouthwash for a sore throat. He had pain on the back of his neck. Two weeks later he returned to urgent care, still complaining of lethargy and a sore throat. He was found to have an elevated WBC.   He received 1 gram of Rocephin and was prescribed Augmentin. Two days later the patient visited his LMD where the Augmentin was discontinued in favor of Levaquin. The laboratory tests for mononucleosis, Streptococcus test, west nile and lyme disease were negative. The course of Levaquin has been completed and the patient was still experiencing myalgia, fever occasionally spiking to 101 degrees F, night sweats and loss of appetite. The helath care professional did not have access to the lot number or expiration date of the SHINGRIX.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Mononucleosis heterophile test negative, Myalgia, Neck pain, Night sweats, Oropharyngeal pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of upper respiratory tract infection in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 14th June 2018, the patient received the 1st dose of SHINGRIX. On 15th July 2018, 31 days after receiving SHINGRIX, the patient experienced generalized aching. On 4th September 2018, the patient experienced upper respiratory tract infection. On an unknown date, the patient experienced appetite lost, chills, night sweat, fatigue, fever, sore throat, neck pain, lethargy and myalgia. The patient was treated with amoxicillin trihydrate (Amoxicillin), ceftriaxone sodium (Rocephin), amoxicillin sodium, potassium clavulanate (Augmentin), levofloxacin (Levaquin), prednisone, magic mouthwash (nos) (Magic Mouthwash) and medication unknown (Over Counter Medicines). On an unknown date, the outcome of the upper respiratory tract infection, generalized aching, chills, fatigue, sore throat, neck pain and lethargy were unknown and the outcome of the appetite lost, night sweat, fever and myalgia were not recovered/not resolved. It was unknown if the reporter considered the upper respiratory tract infection, generalized aching, appetite lost, chills, night sweat, fatigue, fever, sore throat, neck pain, lethargy and myalgia to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional was also the patient's wife. The healthcare professional reported that 1 month post the dose of SHINGRIX, the patient began to exhibit a constellation of symptoms including generalized aches for which the patient self-medicated with over-the-counter products. On 4th September 2018 the patient was seen in an urgent care facility where 82 days after vaccination, an upper respiratory infection was suspected. The patient was treated with Amoxicillin, Prednisone and Magic Mouthwash for a sore throat. He had pain on the back of his neck. Two weeks later he returned to urgent care, still complaining of lethargy and a sore throat. He was found to have an elevated WBC.   He received 1 gram of Rocephin and was prescribed Augmentin. Two days later the patient visited his LMD where the Augmentin was discontinued in favor of Levaquin. The laboratory tests for mononucleosis, Streptococcus test, west nile and lyme disease were negative. The course of Levaquin has been completed and the patient was still experiencing myalgia, fever occasionally spiking to 101 degrees F, night sweats and loss of appetite. The helath care professional did not have access to the lot number or expiration date of the SHINGRIX.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Streptococcus test negative, Upper respiratory tract infection, West Nile virus test negative
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of upper respiratory tract infection in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 14th June 2018, the patient received the 1st dose of SHINGRIX. On 15th July 2018, 31 days after receiving SHINGRIX, the patient experienced generalized aching. On 4th September 2018, the patient experienced upper respiratory tract infection. On an unknown date, the patient experienced appetite lost, chills, night sweat, fatigue, fever, sore throat, neck pain, lethargy and myalgia. The patient was treated with amoxicillin trihydrate (Amoxicillin), ceftriaxone sodium (Rocephin), amoxicillin sodium, potassium clavulanate (Augmentin), levofloxacin (Levaquin), prednisone, magic mouthwash (nos) (Magic Mouthwash) and medication unknown (Over Counter Medicines). On an unknown date, the outcome of the upper respiratory tract infection, generalized aching, chills, fatigue, sore throat, neck pain and lethargy were unknown and the outcome of the appetite lost, night sweat, fever and myalgia were not recovered/not resolved. It was unknown if the reporter considered the upper respiratory tract infection, generalized aching, appetite lost, chills, night sweat, fatigue, fever, sore throat, neck pain, lethargy and myalgia to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional was also the patient's wife. The healthcare professional reported that 1 month post the dose of SHINGRIX, the patient began to exhibit a constellation of symptoms including generalized aches for which the patient self-medicated with over-the-counter products. On 4th September 2018 the patient was seen in an urgent care facility where 82 days after vaccination, an upper respiratory infection was suspected. The patient was treated with Amoxicillin, Prednisone and Magic Mouthwash for a sore throat. He had pain on the back of his neck. Two weeks later he returned to urgent care, still complaining of lethargy and a sore throat. He was found to have an elevated WBC.   He received 1 gram of Rocephin and was prescribed Augmentin. Two days later the patient visited his LMD where the Augmentin was discontinued in favor of Levaquin. The laboratory tests for mononucleosis, Streptococcus test, west nile and lyme disease were negative. The course of Levaquin has been completed and the patient was still experiencing myalgia, fever occasionally spiking to 101 degrees F, night sweats and loss of appetite. The helath care professional did not have access to the lot number or expiration date of the SHINGRIX.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of upper respiratory tract infection in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 14th June 2018, the patient received the 1st dose of SHINGRIX. On 15th July 2018, 31 days after receiving SHINGRIX, the patient experienced generalized aching. On 4th September 2018, the patient experienced upper respiratory tract infection. On an unknown date, the patient experienced appetite lost, chills, night sweat, fatigue, fever, sore throat, neck pain, lethargy and myalgia. The patient was treated with amoxicillin trihydrate (Amoxicillin), ceftriaxone sodium (Rocephin), amoxicillin sodium, potassium clavulanate (Augmentin), levofloxacin (Levaquin), prednisone, magic mouthwash (nos) (Magic Mouthwash) and medication unknown (Over Counter Medicines). On an unknown date, the outcome of the upper respiratory tract infection, generalized aching, chills, fatigue, sore throat, neck pain and lethargy were unknown and the outcome of the appetite lost, night sweat, fever and myalgia were not recovered/not resolved. It was unknown if the reporter considered the upper respiratory tract infection, generalized aching, appetite lost, chills, night sweat, fatigue, fever, sore throat, neck pain, lethargy and myalgia to be related to SHINGRIX. Additional details were reported as follows: The healthcare professional was also the patient's wife. The healthcare professional reported that 1 month post the dose of SHINGRIX, the patient began to exhibit a constellation of symptoms including generalized aches for which the patient self-medicated with over-the-counter products. On 4th September 2018 the patient was seen in an urgent care facility where 82 days after vaccination, an upper respiratory infection was suspected. The patient was treated with Amoxicillin, Prednisone and Magic Mouthwash for a sore throat. He had pain on the back of his neck. Two weeks later he returned to urgent care, still complaining of lethargy and a sore throat. He was found to have an elevated WBC.   He received 1 gram of Rocephin and was prescribed Augmentin. Two days later the patient visited his LMD where the Augmentin was discontinued in favor of Levaquin. The laboratory tests for mononucleosis, Streptococcus test, west nile and lyme disease were negative. The course of Levaquin has been completed and the patient was still experiencing myalgia, fever occasionally spiking to 101 degrees F, night sweats and loss of appetite. The helath care professional did not have access to the lot number or expiration date of the SHINGRIX.
Age: 81.0
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 81-year-old female patient who received SHINGRIX for prophylaxis. On 27th July 2018, the patient received the 1st dose of SHINGRIX. On 28th July 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: This case was reported by the patient for herself. The patient received SHINGRIX in the arm. After receiving SHINGRIX, her arm got quite sore, slightly swollen and quite red. All symptoms happened from the injection site downward but not all the way down to her elbow. The patient saw a primary care physician about this. The events started the day after the injection, they got worse for 2 to 3 days and then started easing up. The patient has denied permission to contact their physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX. On 29th August 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth, injection site pain and sweating. On an unknown date, the outcome of the injection site warmth and sweating were recovered/resolved and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site warmth, injection site pain and sweating to be related to SHINGRIX. Additional details were provided as follows: The patient reported that a day after receiving SHINGRIX, she experienced skin being hot to touch around the injection site, sweating and extreme pain at injection site.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 19-year-old female patient who received BEXSERO for prophylaxis. On 18th September 2018, the patient received the 2nd dose of BEXSERO. In September 2018, 1 day after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site warmth to be related to BEXSERO. Additional details were provided as follows: The vaccine was administered elsewhere, and lot number was not available. The patient had worsening of symptoms ever since receiving 2nd dose of BEXSERO. One to two days after receiving BEXSERO the patient developed injection site redness, swelling, and a raised area about 4x4 inches. The area was also hot.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Decreased appetite, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of decreased appetite in a male patient who received SHINGRIX for prophylaxis. On 21st September 2018, the patient received SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced decreased appetite, abdominal pain and nausea. On an unknown date, the outcome of the decreased appetite, abdominal pain and nausea were unknown. It was unknown if the reporter considered the decreased appetite, abdominal pain and nausea to be related to SHINGRIX. Additional details were reported as follows: The nurse practitioner (NP) said that a patient got a dose of SHINGRIX on Friday before the reporting date at the pharmacy and the patient contacted the NP on the reporting date to make an appointment because the patient was complaining of decreased appetite, nausea and abdominal pain.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients 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 pain, myalgia, headache and fatigue. On an unknown date, the outcome of the injection site pain, myalgia, headache and fatigue were unknown. It was unknown if the reporter considered the injection site pain, myalgia, headache and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not provided. The age group was not reported but it was selected as adult as per vaccine indication. The pharmacist stated that pain at the injection site, fatigue, myalgia and headache was reported by everyone who had gotten the SHINGRIX.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Computerised tomogram normal, Diarrhoea, Injection site bruising, Injection site erythema
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. On 7th 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 erythema, tremor, balance disorder, injection site bruising and diarrhea. On an unknown date, the outcome of the injection site erythema and diarrhea were recovered/resolved and the outcome of the tremor and injection site bruising were not recovered/not resolved and the outcome of the balance disorder was recovering/resolving. It was unknown if the reporter considered the injection site erythema, tremor, balance disorder, injection site bruising and diarrhea to be related to SHINGRIX. Additional details were reported as follows: The reporter was a medical assistant. The patient received SHINGRIX on left deltoid. The patient called on 8th September 2018, complaining about redness that went all the way 5 inches below the injection site, diarrhea, balance issues, tremors. Onset of events was not reported (whether they started the same day of the injection or the day after the injection). The reporter spoke with the patient the day of reporting.  The patient was still having tremors. Her balance was better. The patient said that the diarrhea only lasted one day. The patient said that she went to the emergency room. She had two CT Scans, two lumbar punctures. The physicians can't determine a diagnosis. She had an appointment with a neurologist end of October. The patient said that she had a wellness visit with her physician a couple of days before getting the SHINGRIX vaccine and all lab and physical results came back normal. The reporter provided name and address for the patient. He asked the company to follow up with the patient directly.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Lumbar puncture normal, Tremor
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. On 7th 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 erythema, tremor, balance disorder, injection site bruising and diarrhea. On an unknown date, the outcome of the injection site erythema and diarrhea were recovered/resolved and the outcome of the tremor and injection site bruising were not recovered/not resolved and the outcome of the balance disorder was recovering/resolving. It was unknown if the reporter considered the injection site erythema, tremor, balance disorder, injection site bruising and diarrhea to be related to SHINGRIX. Additional details were reported as follows: The reporter was a medical assistant. The patient received SHINGRIX on left deltoid. The patient called on 8th September 2018, complaining about redness that went all the way 5 inches below the injection site, diarrhea, balance issues, tremors. Onset of events was not reported (whether they started the same day of the injection or the day after the injection). The reporter spoke with the patient the day of reporting.  The patient was still having tremors. Her balance was better. The patient said that the diarrhea only lasted one day. The patient said that she went to the emergency room. She had two CT Scans, two lumbar punctures. The physicians can't determine a diagnosis. She had an appointment with a neurologist end of October. The patient said that she had a wellness visit with her physician a couple of days before getting the SHINGRIX vaccine and all lab and physical results came back normal. The reporter provided name and address for the patient. He asked the company to follow up with the patient directly.
Sex: U
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of palpitation in a 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 palpitation. On an unknown date, the outcome of the palpitation was unknown. It was unknown if the reporter considered the palpitation to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The case was reported by the patient's sister, where she stated that the patient experienced heart palpitations and went to the emergency room after vaccination with the 1st dose of SHINGRIX. This was the only information the reporter was able to provide.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 21st 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 dizziness, nausea, pain in arm and fever. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the dizziness, nausea and fever were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the dizziness, nausea, pain in arm and fever 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. After receiving SHINGRIX, he experienced dizziness, in particular when bending over to pick something up off of the floor, fever and mild nausea without vomiting. He took Aspirin and the fever resolved. The dizziness and nausea resolved within that day. The patient had a sore arm that had not resolvedat the time of reporting.