chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of both VARIVAX lot # N017700, expiry date 09-JUN-2019 or lot # N023960, expiry date: 01-SEP-2019 and M-M-R II lot # N009800, expiry date: 24-MAR-2018, lot # N013280, expiry date: 28-APR-2019 or lot # N034411, expiry date: 04-DEC-2019 for prophylaxis (strength, dose, frequency, route and anatomical location were not provided). It was unknown which of the lots of VARIVAX and M-M-R II were administered to the patient. Also, the nurse reported that sterile diluent(MERCK) used for reconstitution of vaccines was properly stored. No adverse effects reported. The temperature excursion and time frame for VARIVAX was between -14 degree C to -10 degree C (-9.9 degree C) for a time frame of 3 hours and 57 minutes and for M-M-R II was between 9 degree C to 25 degree C (13.4 degree C) for a time frame of 2 hours and 36 minutes. No previous temperature excursion was reported. Data logger was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004192: US-009507513-1808USA004220: US-009507513-1808USA004217: US-009507513-1808USA004218: US-009507513-1808USA004219.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of both Oka/Merck VARIVAX lot # N017700, expiry date 09-JUN-2019 or lot # N023960, expiry date: 01-SEP-2019 and M-M-R II lot # N009800, expiry date: 24-MAR-2018, lot # N013280, expiry date: 28-APR-2019 or lot # N034411, expiry date: 04-DEC-2019 for prophylaxis (strength, dose, frequency, route and anatomical location were not provided) (product storage error). It was unknown which of the lots of Oka/Merck VARIVAX and M-M-R II were administered to the patient. Also, the nurse reported that MERCK STERILE DILUENT used for reconstitution of vaccines was properly stored. No adverse effects reported. The temperature excursion and time frame for Oka/Merck VARIVAX was between -14°C to -10°C (-9.9°C) for a time frame of 3 hours and 57 minutes and for M-M-R II was between 9°C to 25°C (13.4°C) for a time frame of 2 hours and 36 minutes. No previous temperature excursion was reported. Data logger was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004219: US-009507513-1808USA004218: US-009507513-1808USA004216: US-009507513-1808USA004220: US-009507513-1808USA004192.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of both VARIVAX lot # N017700, expiry date 09-JUN-2019 or lot # N023960, expiry date: 01-SEP-2019 and M-M-R II lot # N009800, expiry date: 24-MAR-2018, lot # N013280, expiry date: 28-APR-2019 or lot # N034411, expiry date: 04-DEC-2019 for prophylaxis (strength, dose, frequency, route and anatomical location were not provided). It was unknown which of the lots of VARIVAX and M-M-R II were administered to the patient. Also, the nurse reported that sterile diluent(MERCK) used for reconstitution of vaccines was properly stored. No adverse effects reported. The temperature excursion and time frame for VARIVAX was between -14 degree C to -10 degree C (-9.9 degree C) for a time frame of 3 hours and 57 minutes and for M-M-R II was between 9 degree C to 25 degree C (13.4 degree C) for a time frame of 2 hours and 36 minutes. No previous temperature excursion was reported. Data logger was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004216: US-009507513-1808USA004217: US-009507513-1808USA004219: US-009507513-1808USA004220: US-009507513-1808USA004192.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N009800, expiry date: 24-MAR-2018, lot # N013280, expiry date: 28-APR-2019 or lot # N034411, expiry date: 04-DEC-2019 for prophylaxis (strength, dose, frequency, route and anatomical location were not provided). It was unknown which of the lots of M-M-R II were administered to the patient. Also, the nurse reported that sterile diluent (MERCK) used for reconstitution of vaccines was properly stored. No adverse effects reported. The temperature excursion and time frame for M-M-R II was between 9°C to 25°C (13.4°C) for a time frame of 2 hours and 36 minutes. No previous temperature excursion was reported. Data logger was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004216: US-009507513-1808USA004217: US-009507513-1808USA004218: US-009507513-1808USA004220: US-009507513-1808USA004192.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of general body pain in a 53-year-old female 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 general body pain, chills and nausea. On an unknown date, the outcome of the general body pain, chills and nausea were unknown. It was unknown if the reporter considered the general body pain, chills and nausea to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The medical assistant reported that, after receiving a dose of SHINGRIX the patient experienced nausea, chills and body aches. The caller did not have any additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Insomnia, Limb discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Concomitant products included Tetanus NVS (Tetanus vaccine). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, insomnia, chills, muscle pain, joint pain and pressure in limbs. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the insomnia, chills, muscle pain and joint pain were not recovered/not resolved and the outcome of the pressure in limbs was unknown. It was unknown if the reporter considered the injection site pain, insomnia, chills, muscle pain, joint pain and pressure in limbs to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received tetanus shot as concomitant vaccine a week and a half before the SHINGRIX shot. 5 weeks ago from the date of reporting, the patient received SHINGRIX. The patient experienced pain at injection site when injected. Two to three days following the injection, the patient experienced what she described as muscle joint pain in legs from the waist down. Less than a week after receiving SHINGRIX, the patient also had chills every now and then. The patient experienced muscle pain which felt like pressure in her lower legs and she had not slept well because of it. The patient declined the request by the reporter to provide additional information as she had to get to work.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Concomitant products included Tetanus NVS (Tetanus vaccine). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, insomnia, chills, muscle pain, joint pain and pressure in limbs. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the insomnia, chills, muscle pain and joint pain were not recovered/not resolved and the outcome of the pressure in limbs was unknown. It was unknown if the reporter considered the injection site pain, insomnia, chills, muscle pain, joint pain and pressure in limbs to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received tetanus shot as concomitant vaccine a week and a half before the SHINGRIX shot. 5 weeks ago from the date of reporting, the patient received SHINGRIX. The patient experienced pain at injection site when injected. Two to three days following the injection, the patient experienced what she described as muscle joint pain in legs from the waist down. Less than a week after receiving SHINGRIX, the patient also had chills every now and then. The patient experienced muscle pain which felt like pressure in her lower legs and she had not slept well because of it. The patient declined the request by the reporter to provide additional information as she had to get to work.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 29th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 30th April 2018, 1 days after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, flu-like aching, rash and pain in arm. On an unknown date, the outcome of the swelling arm, erythema of extremities, flu-like aching, rash and pain in arm were recovered/resolved. It was unknown if the reporter considered the swelling arm, erythema of extremities, flu-like aching, rash and pain in arm to be related to SHINGRIX. Additional information was received as follows: The healthcare professional reported that the patient experienced a severe rash, redness, swelling, and soreness on the upper arm. The rash was only on one side. The patient also experienced flu-like body aches. All symptoms were lasted for a week and have resolved. The healthcare professional did not have information of the vaccine lot number and expiry date administered. The patient thought that she received the vaccine on 29th April 2018, but was not sure if it was the exact date. For dose and route of administration, she stated it was the normal dose and route.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 68-year-old female patient who received SHINGRIX (batch number 95LX9 ?, expiry date February 2019) for prophylaxis. On 1st August 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 3rd August 2018, 2 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced rash on her stomach. The batch number reported was not available as per sales data sheet, clarification was raised however no reply was received.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fluid retention, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. Concomitant products included Atorvastatin and Levothyroxine. On 30th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th July 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fluid retention, injection site erythema, injection site swelling, fever and headache. On an unknown date, the outcome of the chills, fluid retention, injection site erythema, injection site swelling, fever and headache were not recovered/not resolved. It was unknown if the reporter considered the chills, fluid retention, injection site erythema, injection site swelling, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The registered pharmacist reported that, she spoke to the patient on the phone, and the patient had not been seen by the pharmacy or her physician.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. Concomitant products included Atorvastatin and Levothyroxine. On 30th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th July 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fluid retention, injection site erythema, injection site swelling, fever and headache. On an unknown date, the outcome of the chills, fluid retention, injection site erythema, injection site swelling, fever and headache were not recovered/not resolved. It was unknown if the reporter considered the chills, fluid retention, injection site erythema, injection site swelling, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The registered pharmacist reported that, she spoke to the patient on the phone, and the patient had not been seen by the pharmacy or her physician.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Herpes zoster, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX (batch number Y24KE, expiry date unknown) for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX (1st dose received with batch number XC534). 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, shingles and paresthesia. On an unknown date, the outcome of the fever and shingles were recovered/resolved and the outcome of the paresthesia was unknown. The reporter considered the fever, shingles and paresthesia to be possibly related to SHINGRIX. Additional details were provided as follows: The expiration dates were unknown. The patient experienced a sensation of reactivation of shingles. The healthcare professional further clarified that the reported reactivation of the shingles as, a stabbing sensation in her left side and back kidney area, where she previously had shingles. The reported symptoms resolved after a couple of days following administration. This case has been linked to US2018140187, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Limb discomfort
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site discomfort in a adult 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 injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown. It was unknown if the reporter considered the injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was a retired nurse and mentioned that her friend had the SHINGRIX injection and then experienced arm discomfort (at the injection site). No further information was collected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received SHINGRIX (batch number AKJSBDKAJS ?, expiry date 31st March 2019) for prophylaxis. Previously administered products included BCG vaccine with an associated reaction of no adverse event, cholera vaccine with an associated reaction of no adverse event, tuberculosis vaccine with an associated reaction of no adverse event, typhoid vaccine with an associated reaction of no adverse event, smallpox vaccine with an associated reaction of no adverse event and Flu vaccine with an associated reaction of no adverse event (high dose). Concurrent medical conditions included neck injury, penicillin allergy and sulfonamide allergy. On 28th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site warmth, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had lots of vaccinations in the past with no reaction. She was not allergic to latex and she sleeps on right side. The patient received SHINGRIX in the left deltoid. Lot numbers were collected but appeared to be invalid. The patient had not reported the events to her physician. The patient experienced swelling at the injection site, pain at injection site, heat or hot at injection site, almost no redness at injection site of the left deltoid. These events did not restrict her activities in any way and resolved after about 3 days. For tolerance to next dose, refer case US2018GSK144786. The reported batch number AKJSBDKAJS for SHINGRIX does not exist in sales database. Clarification is requested for the same.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Lethargy, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 2nd August 2018 02:00, the patient received the 2nd dose of SHINGRIX. On 2nd August 2018, less than a day after receiving SHINGRIX, the patient experienced fever. In August 2018, the patient experienced headache, lethargy, tiredness and influenza-like symptoms. On an unknown date, the outcome of the fever, headache, lethargy, tiredness and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever, headache, lethargy, tiredness and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was patient's husband, he reported that the patient might have started having a fever overnight, but she had one at the time of reporting which was 101 degrees. He said she was having the same side effects you might have like flu like symptoms.
Sex: U
Vaccine: RV1
Symptoms: Oral administration complication, Regurgitation, Underdose
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of regurgitation of medication in a infant patient who received ROTARIX for prophylaxis. On an unknown date, the patient received the 2nd dose of ROTARIX (oral). On an unknown date, 15 min after receiving ROTARIX, the patient experienced regurgitation of medication and accidental underdose. On an unknown date, the outcome of the regurgitation of medication and accidental underdose were unknown. It was unknown if the reporter considered the regurgitation of medication to be related to ROTARIX. Additional information was received as follows: The age at vaccination was not reported. The patient regurgitated 15 to 20 minutes after administering the ROTARIX vaccine, which led to accidental underdose.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Influenza, Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included flu vaccine with an associated reaction of pyrexia (For tolerance to the flu vaccine received 3 years ago, refer case US2018GSK146090). Concomitant products included SHINGRIX. On 16th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 9 days after receiving SHINGRIX, the patient experienced hives and pruritus. On 17th July 2018, the patient experienced headache, feeling cold, influenza-like symptoms, pain in arm and chills. On an unknown date, the patient experienced red blotches and injection site erythema. The patient was treated with BENADRYL. On 18th July 2018, the outcome of the headache, feeling cold, influenza-like symptoms and chills were recovered/resolved. On an unknown date, the outcome of the pain in arm, red blotches and injection site erythema were recovered/resolved and the outcome of the hives and pruritus were recovering/resolving. It was unknown if the reporter considered the headache, feeling cold, influenza-like symptoms, pain in arm, hives, pruritus, chills, red blotches and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received the first dose of SHINGRIX two months ago. At 12:00 pm, the patient received SHINGRIX in the left arm. The next day after receiving the vaccination, the patient woke up with a bad headache, sore arm, chills, freezing and flu-like symptoms. Less than a month after receiving vaccination, the patient also had red splotches extending from the injection site under her armpit up to her shoulder. The headache, chills, freezing and flu-like symptoms resolved by the next day. The sore arm and splotchiness resolved within a few more days. About seven days after the headache, chills, freezing, and flu-like symptoms resolved, the patient broke out in hives that itched. The patient had total of seven hives which were resolving. The patient was taking BENADRYL orally and using BENADRYL topical cream to treat them. The patient had denied permission to contact their physician. Unable to obtain additional information.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity, Pruritus, Rash macular, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included flu vaccine with an associated reaction of pyrexia (For tolerance to the flu vaccine received 3 years ago, refer case US2018GSK146090). Concomitant products included SHINGRIX. On 16th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 9 days after receiving SHINGRIX, the patient experienced hives and pruritus. On 17th July 2018, the patient experienced headache, feeling cold, influenza-like symptoms, pain in arm and chills. On an unknown date, the patient experienced red blotches and injection site erythema. The patient was treated with BENADRYL. On 18th July 2018, the outcome of the headache, feeling cold, influenza-like symptoms and chills were recovered/resolved. On an unknown date, the outcome of the pain in arm, red blotches and injection site erythema were recovered/resolved and the outcome of the hives and pruritus were recovering/resolving. It was unknown if the reporter considered the headache, feeling cold, influenza-like symptoms, pain in arm, hives, pruritus, chills, red blotches and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received the first dose of SHINGRIX two months ago. At 12:00 pm, the patient received SHINGRIX in the left arm. The next day after receiving the vaccination, the patient woke up with a bad headache, sore arm, chills, freezing and flu-like symptoms. Less than a month after receiving vaccination, the patient also had red splotches extending from the injection site under her armpit up to her shoulder. The headache, chills, freezing and flu-like symptoms resolved by the next day. The sore arm and splotchiness resolved within a few more days. About seven days after the headache, chills, freezing, and flu-like symptoms resolved, the patient broke out in hives that itched. The patient had total of seven hives which were resolving. The patient was taking BENADRYL orally and using BENADRYL topical cream to treat them. The patient had denied permission to contact their physician. Unable to obtain additional information.
Sex: U
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a patient who received BEXSERO for prophylaxis. On 3rd August 2018, the patient received BEXSERO. On an unknown date, 10 days after receiving BEXSERO, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that he received this report late in the day on Friday, 3rd August 2018. The reporter noted that patient received BEXSERO and on day 10 after administration experienced a swollen arm.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching, injection site tenderness and injection site warmth. The patient was treated with BENADRYL and ibuprofen. On an unknown date, the outcome of the injection site erythema, injection site itching, injection site tenderness and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching, injection site tenderness and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to a physician. The patient received SHINGRIX vaccine in the right arm. The patient experienced the events at the site of her injection about a day or two after receiving the vaccine. The patient continued to have the issues still at the time reporting. The patient notified this to her physician, who told her to contact GlaxoSmithKline (GSK), as he had not given the product and he was not familiar with it. The pharmacist recommended BENADRYL and Ibuprofen. The patient asked, if that was also a recommendation from GSK. The GSK provided medical disclaimer but provided information on side effects and duration from prescribing information. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX (batch number T1501326 ?, expiry date unknown) for prophylaxis. Previously administered products included BCG vaccine, Tuberculosis vaccine, cholera vaccine, typhoid vaccine, smallpox vaccine, Flu vaccine (high dose) and SHINGRIX (1st dose, refer case US2018140211). Concurrent medical conditions included neck injury, penicillin allergy and sulfonamide allergy. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, erythema of extremities, tiredness and sleep disorder. On 2nd August 2018, the patient experienced generalized rash and measles-like rash. On an unknown date, the outcome of the pain in arm, swelling arm, erythema of extremities, tiredness, sleep disorder and generalized rash were not recovered/not resolved and the outcome of the measles-like rash was unknown. It was unknown if the reporter considered the pain in arm, swelling arm, erythema of extremities, tiredness, sleep disorder, generalized rash and measles-like rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had lots of vaccinations in the past with no reaction. She was not allergic to latex and she sleeps on right side. The patient received SHINGRIX in the left deltoid. The patient felt that the shot was given a little higher in the left deltoid on her 1st shot compared to her 2nd shot. On Wednesday morning, she woke up with pain in the upper left arm which did not restrict her movement. She said the arm was still swollen and a little red in the shape of a square at the injection site. She felt tired and napping on 1st August 2018, 2nd August 2018 and on the day of reporting. She reported that this was abnormal for her as she usually did not feel tired and did not normally nap. The nap on 2nd August 2018 was a 4 hours nap. She said she was too tired to take a shower and stayed in her pajamas all day on 2nd August 2018. Around 7:30 or 8 pm on Thursday 2nd August 2018, the patient noticed a rash on her body that looked like measles. It covered her entire back, trunk, neck under her chin, under both arms, below belly button down to pubic hair, under the breasts. The rash did not itch. It was flat, not raised and not flaking. She said if she closed her eyes and felt where the rash was vs. where it was not she could not feel a difference. She did not make dietary changes and no detergent changes. She reported that the rash was still present on day of reporting and in all the same places but was not quite as bright red as on 2nd August 2018. The patient had denied permission to contact her physician. The reported batch number T1501326 ? for SHINGRIX does not exist in sales database. Clarification is requested for the same.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash erythematous, Rash generalised, Rash morbilliform
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX (batch number T1501326 ?, expiry date unknown) for prophylaxis. Previously administered products included BCG vaccine, Tuberculosis vaccine, cholera vaccine, typhoid vaccine, smallpox vaccine, Flu vaccine (high dose) and SHINGRIX (1st dose, refer case US2018140211). Concurrent medical conditions included neck injury, penicillin allergy and sulfonamide allergy. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, erythema of extremities, tiredness and sleep disorder. On 2nd August 2018, the patient experienced generalized rash and measles-like rash. On an unknown date, the outcome of the pain in arm, swelling arm, erythema of extremities, tiredness, sleep disorder and generalized rash were not recovered/not resolved and the outcome of the measles-like rash was unknown. It was unknown if the reporter considered the pain in arm, swelling arm, erythema of extremities, tiredness, sleep disorder, generalized rash and measles-like rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had lots of vaccinations in the past with no reaction. She was not allergic to latex and she sleeps on right side. The patient received SHINGRIX in the left deltoid. The patient felt that the shot was given a little higher in the left deltoid on her 1st shot compared to her 2nd shot. On Wednesday morning, she woke up with pain in the upper left arm which did not restrict her movement. She said the arm was still swollen and a little red in the shape of a square at the injection site. She felt tired and napping on 1st August 2018, 2nd August 2018 and on the day of reporting. She reported that this was abnormal for her as she usually did not feel tired and did not normally nap. The nap on 2nd August 2018 was a 4 hours nap. She said she was too tired to take a shower and stayed in her pajamas all day on 2nd August 2018. Around 7:30 or 8 pm on Thursday 2nd August 2018, the patient noticed a rash on her body that looked like measles. It covered her entire back, trunk, neck under her chin, under both arms, below belly button down to pubic hair, under the breasts. The rash did not itch. It was flat, not raised and not flaking. She said if she closed her eyes and felt where the rash was vs. where it was not she could not feel a difference. She did not make dietary changes and no detergent changes. She reported that the rash was still present on day of reporting and in all the same places but was not quite as bright red as on 2nd August 2018. The patient had denied permission to contact her physician. The reported batch number T1501326 ? for SHINGRIX does not exist in sales database. Clarification is requested for the same.
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX (batch number T1501326 ?, expiry date unknown) for prophylaxis. Previously administered products included BCG vaccine, Tuberculosis vaccine, cholera vaccine, typhoid vaccine, smallpox vaccine, Flu vaccine (high dose) and SHINGRIX (1st dose, refer case US2018140211). Concurrent medical conditions included neck injury, penicillin allergy and sulfonamide allergy. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, erythema of extremities, tiredness and sleep disorder. On 2nd August 2018, the patient experienced generalized rash and measles-like rash. On an unknown date, the outcome of the pain in arm, swelling arm, erythema of extremities, tiredness, sleep disorder and generalized rash were not recovered/not resolved and the outcome of the measles-like rash was unknown. It was unknown if the reporter considered the pain in arm, swelling arm, erythema of extremities, tiredness, sleep disorder, generalized rash and measles-like rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had lots of vaccinations in the past with no reaction. She was not allergic to latex and she sleeps on right side. The patient received SHINGRIX in the left deltoid. The patient felt that the shot was given a little higher in the left deltoid on her 1st shot compared to her 2nd shot. On Wednesday morning, she woke up with pain in the upper left arm which did not restrict her movement. She said the arm was still swollen and a little red in the shape of a square at the injection site. She felt tired and napping on 1st August 2018, 2nd August 2018 and on the day of reporting. She reported that this was abnormal for her as she usually did not feel tired and did not normally nap. The nap on 2nd August 2018 was a 4 hours nap. She said she was too tired to take a shower and stayed in her pajamas all day on 2nd August 2018. Around 7:30 or 8 pm on Thursday 2nd August 2018, the patient noticed a rash on her body that looked like measles. It covered her entire back, trunk, neck under her chin, under both arms, below belly button down to pubic hair, under the breasts. The rash did not itch. It was flat, not raised and not flaking. She said if she closed her eyes and felt where the rash was vs. where it was not she could not feel a difference. She did not make dietary changes and no detergent changes. She reported that the rash was still present on day of reporting and in all the same places but was not quite as bright red as on 2nd August 2018. The patient had denied permission to contact her physician. The reported batch number T1501326 ? for SHINGRIX does not exist in sales database. Clarification is requested for the same.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 20th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The caller was unable to provide the batch number and expiry date but could provide NDC number. The stated that after 1st dose of SHINGRIX the patient experienced arm hurting which resolved within 48 hours of injection. The permission was given to contact pharmacy and primary health care pharmacy. No further information was provided. This case has been linked with case US2018140216 reported by the same reporter for the same patient (case for 2nd dose).
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date. For tolerance refer: US2018139561). 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 adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had more mild reactions, after receiving the 2nd dose in the series approximately three months later the 1st dose, no specific events or event description was provided. Limited information was reported, the reporter did not wish to complete the safety report and hence a follow up was discouraged. The reporter also stated that, she did not complain about the SHINGRIX and was very happy with her experience with the SHINGRIX vaccine.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site discolouration, Injection site mass, Muscular weakness, Neck pain, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 18-year-old male patient who received BEXSERO for prophylaxis. Concomitant products included BEXSERO. On 17th July 2018, the patient received the 2nd dose of BEXSERO. On 17th July 2018, less than a day after receiving BEXSERO, the patient experienced injection site lump and injection site discoloration. On 19th July 2018, the patient experienced neck pain. On 3rd August 2018, the patient experienced coldness of lower extremities, lower extremities weakness of and tingling of extremity. The patient was treated with ibuprofen and Warm Compresses. On an unknown date, the outcome of the neck pain, coldness of lower extremities and lower extremities weakness of were not recovered/not resolved and the outcome of the injection site lump was recovered/resolved and the outcome of the injection site discoloration and tingling of extremity were unknown. It was unknown if the reporter considered the neck pain, coldness of lower extremities, lower extremities weakness of, injection site lump, injection site discoloration and tingling of extremity to be related to BEXSERO. Additional details were provided as follows: The reporter was the patient's mother. The patient received BEXSERO in the right arm and that afternoon the injection site looked splotchy and there was a lump the size of a grapefruit. On 19th July 2018, 2 days after vaccination the patient experienced neck pain in the back at the hairline above the spine. The neck pain was worse in the morning. The doctor recommended warm compresses and ibuprofen for the neck pain. It did not resolve and was worse the following day. A day before the reporting date, the doctor examined the area ruled out the cause as muscle related. On the reporting date, 17 days after vaccination the patient's left leg felt weak and cold from the shin down to the foot. She described it as feeling colder than the right leg and slightly tingly. The patient had denied permission to contact their physician. This case has been linked with US2018140221, reported for same patient for 1st dose.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Peripheral coldness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 18-year-old male patient who received BEXSERO for prophylaxis. Concomitant products included BEXSERO. On 17th July 2018, the patient received the 2nd dose of BEXSERO. On 17th July 2018, less than a day after receiving BEXSERO, the patient experienced injection site lump and injection site discoloration. On 19th July 2018, the patient experienced neck pain. On 3rd August 2018, the patient experienced coldness of lower extremities, lower extremities weakness of and tingling of extremity. The patient was treated with ibuprofen and Warm Compresses. On an unknown date, the outcome of the neck pain, coldness of lower extremities and lower extremities weakness of were not recovered/not resolved and the outcome of the injection site lump was recovered/resolved and the outcome of the injection site discoloration and tingling of extremity were unknown. It was unknown if the reporter considered the neck pain, coldness of lower extremities, lower extremities weakness of, injection site lump, injection site discoloration and tingling of extremity to be related to BEXSERO. Additional details were provided as follows: The reporter was the patient's mother. The patient received BEXSERO in the right arm and that afternoon the injection site looked splotchy and there was a lump the size of a grapefruit. On 19th July 2018, 2 days after vaccination the patient experienced neck pain in the back at the hairline above the spine. The neck pain was worse in the morning. The doctor recommended warm compresses and ibuprofen for the neck pain. It did not resolve and was worse the following day. A day before the reporting date, the doctor examined the area ruled out the cause as muscle related. On the reporting date, 17 days after vaccination the patient's left leg felt weak and cold from the shin down to the foot. She described it as feeling colder than the right leg and slightly tingly. The patient had denied permission to contact their physician. This case has been linked with US2018140221, reported for same patient for 1st dose.
Sex: U
Vaccine: RAB
Symptoms: Accidental exposure to product, Injury associated with device
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of needle stick/puncture in a healthcare professional who administered RABAVERT for prophylaxis. On 25th July 2018, the patient received RABAVERT. On 25th July 2018, immediately after receiving RABAVERT, the patient experienced needle stick/puncture. On an unknown date, the outcome of the needle stick/puncture was unknown. Additional information was received as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that while administering the vaccine the healthcare professional stuck themselves with the needle. The healthcare professional did not receive any of the vaccine and was not exposed to the vaccine, but was stuck with the needle. This case has been linked to the case US2018140145, reported by the same reporter.
Age: 26.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient experienced numbness and tingling in both hands and feet 1 day post vaccination. Symptoms lasted one week. No treatment. Patient reports no longer having the numbness and tingling in hands and feet.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Myalgia, Pain, Pyrexia, Rash erythematous
Clinical narrative: 8 hrs. post vaccination, fever, chills and severe generalized muscle aches. Sx lasted about 16 hrs. (until next am). Little relief with TYLENOL. Sx returned in afternoon of second day but not as severe. About 36 hrs. after vaccination, noticed a flat red rash (no hives or anaphylactic sx). Rash seemed to start under breasts and armpits and on neck. Spread down chest to abdomen and groin. On third day, rash had spread down both arms. No further fever or aches after 2nd day. No pain or redness at injection site today.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash erythematous, Rash macular
Clinical narrative: 8 hrs. post vaccination, fever, chills and severe generalized muscle aches. Sx lasted about 16 hrs. (until next am). Little relief with TYLENOL. Sx returned in afternoon of second day but not as severe. About 36 hrs. after vaccination, noticed a flat red rash (no hives or anaphylactic sx). Rash seemed to start under breasts and armpits and on neck. Spread down chest to abdomen and groin. On third day, rash had spread down both arms. No further fever or aches after 2nd day. No pain or redness at injection site today.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Bedridden, Fatigue, Hypersomnia, Injection site erythema
Clinical narrative: Patient reported redness, heat, and swelling from left shoulder to elbow. Also has joint pain in elbows and knees that has now somewhat subsided. Redness started about 6 hours after the injections and is still visible. Patient stated he was very fatigued the day after immunization and was bed ridden that day, slept from mid afternoon until the next morning. Recommended that patient see his primary physician if no improvement or symptoms worsen. Patient has previously recieved influenza vaccine with no reaction, spouse reports that he had some adverse reaction to PREVNAR 13 given in 2017, patient does not remember any adverse reaction.