chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Faeces discoloured
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of greenish stool in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced greenish stool. On an unknown date, the outcome of the greenish stool was unknown. It was unknown if the reporter considered the greenish stool to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After getting the 2nd shot of SHINGRIX, the patient's bowel moment was green. The patient received the shot of SHINGRIX on Thursday and on Sunday bowel moment was green. The patient was asking should they worry. The patient was stating that none of GSK information stated that this might happen.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 27th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced nausea and shivering. On an unknown date, the outcome of the nausea and shivering were unknown. It was unknown if the reporter considered the nausea and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient had a dose of SHINGRIX vaccine last Tuesday before the date of reporting, and she was still feeling nausea and shivering at the time of reporting the patient took something for the nausea and bundled up, so it was a little better. The patient just want to ask if this was still within the timeline for adverse side effects.
Sex: M
Vaccine: DTP
Symptoms: Brain injury
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of brain damage in a male patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. On an unknown date, the patient received DTP (A or W not known) at an unknown dose. On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced brain damage (serious criteria GSK medically significant). On an unknown date, the outcome of the brain damage was unknown. It was unknown if the reporter considered the brain damage to be related to DTP (A or W not known). Additional details were provided as follows: This case was received via social media post contents by the patient's aunt. The patient's family had no issues in the past with the shot. The age at vaccination was not reported. The reporter stated that the patient was severely mentally brain damaged from the DPT vaccine. This case was linked with case US2018GSK219958, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Fall, Fatigue, Rib fracture
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fatigue in a adult patient who received SHINGRIX prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced extreme fatigue, as a result fell and broke multiple ribs.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 53-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (experienced after receiving 1st dose on 19th September 2018, refer case US2018175499). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th December 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, joint pain, general body pain and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, fever, joint pain, general body pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the chills, fever, joint pain, general body pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: A day before the date of reporting at 2 pm, the patient received SHINGRIX on the left arm. On the day of reporting, the patient woke up with chills, fever, joint ache, body ache and flu like symptoms. The reporter had given consent to contact her physician. No further details were provided.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 53-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (experienced after receiving 1st dose on 19th September 2018, refer case US2018175499). On 3rd December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th December 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fever, joint pain, general body pain and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, fever, joint pain, general body pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the chills, fever, joint pain, general body pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: A day before the date of reporting at 2 pm, the patient received SHINGRIX on the left arm. On the day of reporting, the patient woke up with chills, fever, joint ache, body ache and flu like symptoms. The reporter had given consent to contact her physician. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovered/resolved. It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 63 or 64 years. In 2018, the patient received SHINGRIX and experienced some tenderness in deltoid muscle in the arm where she received the SHINGRIX which lasted approximately a week. The patient could not remember which arm it was. The patient did not consent to follow up as she never saw her doctor. For tolerance to the 2nd dose of SHINGRIX refer case US2018217458, reported for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 67-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had two shot series of SHINGRIX earlier this year (in 2018). At the time of reporting, the patient's doctor told her that she had Shingles. The patient's understanding was that in her age group SHINGRIX had 97.2 percent efficacy. She wanted to know was there common attributes of the 2.8 percent of people who still get Shingles. The patient asked if she should repeat the vaccines after her Shingles clears up. This case was considered as suspected vaccination failure as confirmed laboratory test and time to onset (TTO) was not provided.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Bone pain, Burning sensation, Feeling abnormal, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 20th April 2019) for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced nausea, headache, scab and pain in thumb. On 18th October 2018, the patient experienced injection site pain, bone pain, neck pain, feeling abnormal and pain. On 21st October 2018, the patient experienced rash, blister and burning sensation. On an unknown date, the outcome of the injection site pain, neck pain, scab, feeling abnormal and pain were not recovered/not resolved and the outcome of the bone pain, rash, blister, burning sensation, nausea, headache and pain in thumb were recovered/resolved. It was unknown if the reporter considered the injection site pain, bone pain, neck pain, rash, blister, burning sensation, nausea, headache, scab, pain in thumb, feeling abnormal and pain to be related to SHINGRIX. Additional details were provided as follows: The patient had no history of getting shingles. The patient was told by her physician to call GSK because the company needed her details. The patient did not know if her physicians reported the side effects to GSK. The patient had her dose of SHINGRIX in her left deltoid and on the same day of the SHINGRIX injection she experienced pain in her left deltoid. The pain radiated to her bones and to that left side of her neck. She said the whole area and around where she received the injection was in pain. It was like a dull achy feeling. Three days later the vaccination, the patient on her left forearm she had an angry looking spot, that started spreading on her arm where she got the injection. She started getting blisters, pain, hot burning feeling that she described as hot lava going down her arm and neck area on that side where she got the vaccine. The patient also experienced nausea and headache. Her blisters were gone at the time of reporting but the area still looked scabby. She could still see the marks where she had the blisters and the pain was still on her left arm and left side of her neck. She mentioned that even her left thumb was in pain. Even two days ago, she had pain on her thumb and had nausea from the pain. The patient had visited her physicians three times about these symptoms. The reporter consented to be followed up. The patient had provided the details of her physicians.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 20th April 2019) for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced nausea, headache, scab and pain in thumb. On 18th October 2018, the patient experienced injection site pain, bone pain, neck pain, feeling abnormal and pain. On 21st October 2018, the patient experienced rash, blister and burning sensation. On an unknown date, the outcome of the injection site pain, neck pain, scab, feeling abnormal and pain were not recovered/not resolved and the outcome of the bone pain, rash, blister, burning sensation, nausea, headache and pain in thumb were recovered/resolved. It was unknown if the reporter considered the injection site pain, bone pain, neck pain, rash, blister, burning sensation, nausea, headache, scab, pain in thumb, feeling abnormal and pain to be related to SHINGRIX. Additional details were provided as follows: The patient had no history of getting shingles. The patient was told by her physician to call GSK because the company needed her details. The patient did not know if her physicians reported the side effects to GSK. The patient had her dose of SHINGRIX in her left deltoid and on the same day of the SHINGRIX injection she experienced pain in her left deltoid. The pain radiated to her bones and to that left side of her neck. She said the whole area and around where she received the injection was in pain. It was like a dull achy feeling. Three days later the vaccination, the patient on her left forearm she had an angry looking spot, that started spreading on her arm where she got the injection. She started getting blisters, pain, hot burning feeling that she described as hot lava going down her arm and neck area on that side where she got the vaccine. The patient also experienced nausea and headache. Her blisters were gone at the time of reporting but the area still looked scabby. She could still see the marks where she had the blisters and the pain was still on her left arm and left side of her neck. She mentioned that even her left thumb was in pain. Even two days ago, she had pain on her thumb and had nausea from the pain. The patient had visited her physicians three times about these symptoms. The reporter consented to be followed up. The patient had provided the details of her physicians.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Scab
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 20th April 2019) for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced nausea, headache, scab and pain in thumb. On 18th October 2018, the patient experienced injection site pain, bone pain, neck pain, feeling abnormal and pain. On 21st October 2018, the patient experienced rash, blister and burning sensation. On an unknown date, the outcome of the injection site pain, neck pain, scab, feeling abnormal and pain were not recovered/not resolved and the outcome of the bone pain, rash, blister, burning sensation, nausea, headache and pain in thumb were recovered/resolved. It was unknown if the reporter considered the injection site pain, bone pain, neck pain, rash, blister, burning sensation, nausea, headache, scab, pain in thumb, feeling abnormal and pain to be related to SHINGRIX. Additional details were provided as follows: The patient had no history of getting shingles. The patient was told by her physician to call GSK because the company needed her details. The patient did not know if her physicians reported the side effects to GSK. The patient had her dose of SHINGRIX in her left deltoid and on the same day of the SHINGRIX injection she experienced pain in her left deltoid. The pain radiated to her bones and to that left side of her neck. She said the whole area and around where she received the injection was in pain. It was like a dull achy feeling. Three days later the vaccination, the patient on her left forearm she had an angry looking spot, that started spreading on her arm where she got the injection. She started getting blisters, pain, hot burning feeling that she described as hot lava going down her arm and neck area on that side where she got the vaccine. The patient also experienced nausea and headache. Her blisters were gone at the time of reporting but the area still looked scabby. She could still see the marks where she had the blisters and the pain was still on her left arm and left side of her neck. She mentioned that even her left thumb was in pain. Even two days ago, she had pain on her thumb and had nausea from the pain. The patient had visited her physicians three times about these symptoms. The reporter consented to be followed up. The patient had provided the details of her physicians.
Sex: M
Vaccine: VARZOS
Symptoms: Blister infected, Pruritus, Rash pustular, Rash vesicular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of blistery rash in a adult male patient who received SHINGRIX for prophylaxis. In 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 10 days after receiving SHINGRIX, the patient experienced blistery rash, pruritus and blister infected. The patient was treated with hydrocortisone. On an unknown date, the outcome of the blistery rash and pruritus were not recovered/not resolved and the outcome of the blister infected was unknown. It was unknown if the reporter considered the blistery rash, pruritus and blister infected to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had no history of herpes simplex. The healthcare professional stated that the patient developed a blistering rash on the left side of mouth following SHINGRIX which was not completely resolved over the past 2 months and it was still ongoing. The event started out as being itchy. The patient thought it was just a pimple but then clear liquid and puss came from the blister area. The healthcare professional was unable to provide the lot number and expiry date of the product used at the time of reporting. The patient used Hydrocortisone cream on rash. The patient had improved, but not resolved fully. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a male 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 injection site muscle pain, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site muscle pain, injection site erythema and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site muscle pain, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX 2 months before the date of reporting and afterwards they had a 3 by 3 area at injection site that turned pink, had muscle pain at the injection site and also reported having itching at the injection site. All these symptoms lasted about 1 week and then went away.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site rash, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of malaise in a 64-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (received 1st dose in 2018, refer case US2018GSK221320). 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 malaise, lightheadedness, injection site erythema and injection site rash. On an unknown date, the outcome of the malaise, lightheadedness, injection site erythema and injection site rash were recovered/resolved. It was unknown if the reporter considered the malaise, lightheadedness, injection site erythema and injection site rash to be related to SHINGRIX. Additional details were provided as follows: In 2018, the patient received SHINGRIX and experienced redness and a rash at the injections site that lasted 3 to 4 days. The patient also felt malaise and lightheaded for a few days. The patient did not consent to follow up as she never saw her doctor.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a female patient who received SHINGRIX for prophylaxis. On 30th November 2018, the patient received SHINGRIX. On 30th November 2018, immediately after receiving SHINGRIX, the patient experienced injection site hemorrhage and inappropriate route of vaccination. On an unknown date, the patient experienced wrong injection technique. On an unknown date, the outcome of the injection site hemorrhage, wrong injection technique and inappropriate route of vaccination were unknown. It was unknown if the reporter considered the injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the day of reporting, the patient received SHINGRIX and blood squirted out at the injection site all over the patient and on the pharmacist's clothes. The pharmacist reported that he must have hit a blood vessel while administering SHINGRIX and was questioning how much of the vaccine did the patient received into her deltoid muscle since he hit a blood vessel during administration, which led to Injection site hemorrhage, wrong injection technique and inappropriate route of vaccination. The pharmacist did not consent to follow-up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd August 2018, 1 days after receiving SHINGRIX, the patient experienced fever, malaise, chills and injection site pain. On an unknown date, the outcome of the fever, malaise, chills and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, malaise, chills and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient reported that his wife planned to follow up with her physician on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, 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 pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's friend who was a GlaxoSmithKline employee. The age at vaccination was not reported but, it could be 65 or 66 years. The patient received SHINGRIX in the left deltoid. The patient experienced soreness, redness and warm to touch from the injection site at the deltoid to her elbow. The patient planned to follow-up with her physician on an unknown date. The reporter provided limited information.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, 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 70-year-old male patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On 21st August 2018, the patient experienced headache, tiredness and general body pain. On an unknown date, the outcome of the pain in arm, headache, tiredness and general body pain were recovered/resolved. It was unknown if the reporter considered the pain in arm, headache, tiredness and general body pain to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right arm. The patient experienced pain in the right arm following the injection. The patient stated that the day after he received SHINGRIX, he experienced tiredness, achiness all over and had a headache. The patient stated that these symptoms lasted for approximately 2 days. Emergency room visit was required. The contact details of the physician were provided. The reporter gave consent to follow up. For tolerance to next dose, refer case US2018GSK222617.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Peripheral swelling, Swelling face, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 21-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. On 24th September 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 27th September 2018, 3 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced hives, facial swelling, hand swelling and ankle swelling. The patient was treated with prednisone and DEPO-MEDROL. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the facial swelling, hand swelling and ankle swelling were recovered/resolved. It was unknown if the reporter considered the hives, facial swelling, hand swelling and ankle swelling to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The patient had never had a side effect to a vaccine before. The patient had a dose of FLULAVAL QUADRIVALENT and three days later she broke out with hives. The patient had been to several physicians so far and had taken Prednisone. The hives resolve while she was on Prednisone, but they came back worse afterwards. The patient now had swelling of her face and hands and down to her ankles. The patient took DEPO-MEDROL and it lasted for 2 weeks. It did appear that an adverse event was reported during the call. The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 20th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st June 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, injection site lump, headache, fever, chills, dizziness, malaise, fatigue and migraine headache. On an unknown date, the outcome of the pain in arm, swelling arm, injection site lump, headache, fever, chills, dizziness, malaise, fatigue and migraine headache were recovered/resolved. It was unknown if the reporter considered the pain in arm, swelling arm, injection site lump, headache, fever, chills, dizziness, malaise, fatigue and migraine headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 55 or 56 years. The patient received SHINGRIX in the left arm. The next day, the patient experienced soreness in the arm, swelling of the arm, lumps at the injection site, headache, migraine headache, fever, chills, dizziness, malaise, fatigue, exhaustion. The symptoms lasted for about 2 weeks and then resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Migraine, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 20th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st June 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, injection site lump, headache, fever, chills, dizziness, malaise, fatigue and migraine headache. On an unknown date, the outcome of the pain in arm, swelling arm, injection site lump, headache, fever, chills, dizziness, malaise, fatigue and migraine headache were recovered/resolved. It was unknown if the reporter considered the pain in arm, swelling arm, injection site lump, headache, fever, chills, dizziness, malaise, fatigue and migraine headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 55 or 56 years. The patient received SHINGRIX in the left arm. The next day, the patient experienced soreness in the arm, swelling of the arm, lumps at the injection site, headache, migraine headache, fever, chills, dizziness, malaise, fatigue, exhaustion. The symptoms lasted for about 2 weeks and then resolved.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of red rash in a 43-year-old female patient who received SHINGRIX for prophylaxis. On 20th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th September 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced red rash and itchy rash. On an unknown date, the outcome of the red rash and itchy rash were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the red rash and itchy rash to be related to SHINGRIX. Additional details were reported as follows: The 43 years old patient received SHINGRIX on the left deltoid, which led to inappropriate age at vaccine administration. The patient had rash soon afterwards but the patient could not remember if it was on the same day or later. The rash was small, red and itchy. The events were went away after a few days. The contact details of the physician was provided. The reporter had given consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of rash (received on an unknown date prior to the SHINGRIX vaccination). In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced feeling unwell, slight temperature, chills and pain. On an unknown date, the outcome of the feeling unwell, slight temperature, chills and pain were recovered/resolved. It was unknown if the reporter considered the feeling unwell, slight temperature, chills and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but it could be 66 or 67 years old. The patient thought, he received SHINGRIX on 23rd July 2018 but it was not positive. In July 2018, within 24 hours after vaccination, the patient started feeling ill and she did not feel right. The call center representative asked the patient to describe her symptoms. The patient felt like she had a low-grade temperature, chilled feeling and achy. The all symptoms were resolved within 4 days. The reporter did not want to provide her physician's contact information. The reporter did not given consent to follow-up.
Sex: U
Vaccine: FLU4
Symptoms: Adverse event
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse event in a patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number GD47F, expiry date unknown) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The webform was received which contained a potential adverse event. The healthcare professional reported verbatim, he works with an allergist who asked him to contact to see if you have had any reports of adverse reactions to the FLULAVAL QUADRIVALENT vaccine.
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Urticaria
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a sales representative. A 66-year-old female patient received PREVNAR 13, lot number and expiration date were not reported, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced welt at injection site after pneumococcal 13-valent conjugated vaccine administration on an unspecified date. The outcome of the event was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse (patient) via Pfizer sales representative. A patient of unspecified age and gender started to receive PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, nausea.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Gianotti-Crosti syndrome, Rash
Clinical narrative: Rash onset 2 weeks after vaccine - Gianotti-Crosti suspected diagnosis.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test normal, Chest pain, Computerised tomogram head normal, Dizziness, Echocardiogram normal
Clinical narrative: The morning after: chest pain, palpitations, high resting heart rate, high blood pressure, dizziness. Continuing through present: extreme fatigue with any exertion, elevated resting heart rate, blood pressure, difficulty regulating body temperature, extreme dizziness, chest pain, palpitations. Treatment: anti-inflammatories, prednisone, pain medication.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Fatigue, Heart rate increased, Hypertension, Inflammatory marker test
Clinical narrative: The morning after: chest pain, palpitations, high resting heart rate, high blood pressure, dizziness. Continuing through present: extreme fatigue with any exertion, elevated resting heart rate, blood pressure, difficulty regulating body temperature, extreme dizziness, chest pain, palpitations. Treatment: anti-inflammatories, prednisone, pain medication.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Palpitations, Stress echocardiogram normal, Temperature regulation disorder, Thyroid function test normal
Clinical narrative: The morning after: chest pain, palpitations, high resting heart rate, high blood pressure, dizziness. Continuing through present: extreme fatigue with any exertion, elevated resting heart rate, blood pressure, difficulty regulating body temperature, extreme dizziness, chest pain, palpitations. Treatment: anti-inflammatories, prednisone, pain medication.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Constipation, Exposure during pregnancy, Gastrointestinal inflammation, Gastrointestinal pain
Clinical narrative: Mother's reaction - constipation, hot flashes, intestinal cramping, increased blood pressure. Pregnancy history prior to vaccine - absolutely typical, nothing out of the ordinary. Pregnancy after vaccine - high blood pressure resulting in pre-eclampsia diagnosis at 37 weeks 2 days. Estimated date of delivery was 1/15/2018, baby was born 12/2017 as a result of blood pressure levels of 177/140 + even while on a magnesium sulfate drip. Birth weight was 5 pounds 12 ounces. Family history for birth weight average was 9+ pounds. Additional believed vaccine injury to the infant . . . compromised and unstable immune system resulting in autoimmune flare ups displayed as eczema. Amplified when baby began eating eggs at 8 months of age. Eczema directly correlated with consumption of egg by myself (mother) or the baby directly. Since the guidance of our healthcare provider that has seen this in the past, the elimination of egg from both my diet and my baby's diet has 100% cleared the skin reaction and her intestines have settled in inflammation resulting in more regular and typical bowel habits from the baby.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Hot flush, Pre-eclampsia
Clinical narrative: Mother's reaction - constipation, hot flashes, intestinal cramping, increased blood pressure. Pregnancy history prior to vaccine - absolutely typical, nothing out of the ordinary. Pregnancy after vaccine - high blood pressure resulting in pre-eclampsia diagnosis at 37 weeks 2 days. Estimated date of delivery was 1/15/2018, baby was born 12/2017 as a result of blood pressure levels of 177/140 + even while on a magnesium sulfate drip. Birth weight was 5 pounds 12 ounces. Family history for birth weight average was 9+ pounds. Additional believed vaccine injury to the infant . . . compromised and unstable immune system resulting in autoimmune flare ups displayed as eczema. Amplified when baby began eating eggs at 8 months of age. Eczema directly correlated with consumption of egg by myself (mother) or the baby directly. Since the guidance of our healthcare provider that has seen this in the past, the elimination of egg from both my diet and my baby's diet has 100% cleared the skin reaction and her intestines have settled in inflammation resulting in more regular and typical bowel habits from the baby.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Severe pain in injection site, fever, chills, body aches.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Hand-foot-and-mouth disease, Oral mucosal eruption, Rash
Clinical narrative: Pt has received FLUZONE HIGH DOSE from Health Dept 10/21/15, 10/13/16, 10/12/17, and 9/26/18. Each year she gets a rash on her mouth, hands and feet within 1 month of receiving vaccine. This resolves on its own and has been diagnosed as hand foot and mouth disease based on clinical symptoms.
Age: 12.0
Sex: F
Vaccine: FLU4, HEP, TDAP, VARCEL
Symptoms: Cold sweat, Pallor, Presyncope, Skin warm
Clinical narrative: After patient received all four vaccines, pt had vasovagal episode which lasted less than 20 seconds. Skin was pale, clammy and warm to touch. Patient was treated with cool pack behind neck, legs elevated. Once patient was aware of surroundings, patient was given water/food and monitored by RN before being discharged.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning about a 67-year-old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unspecified date in August 2018, the patient was vaccinated with PNEUMOVAX 23 as prophylaxis (strength, dose, frequency, route of administration, site of administration, lot number, thimerosal status and expiration date were not reported). On 26-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 (thimerosal free) (Lot number: R016640, expiration date: 28-JAN-2020) as prophylaxis (strength, dose, frequency, route of administration and site of administration were not reported) (inappropriate schedule of vaccine administered). On 28-NOV-2018, the patient called to the reporter, after going to see her unspecified primary care physician, and reported that she experienced swelling and redness at injection site and flu-like symptoms. Her physician prescribed to the patient prednisone (unspecified) on that day. On 03-DEC-2018, the reporter spoke to the patient and she stated that she was feeling "all better" and recovered. The primary care physician told the patient that those adverse reactions were because the doses of PNEUMOVAX 23 were not properly spaced. The reporter's causality assessment between swelling and redness at injection site and flu-like symptoms and PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-NOV-2013, a pharmacist administered the ZOSTAVAX (lot# and route not provided) vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related conditions. On or about 19-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber, who was also the female patient of unknown age, reporting on herself. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On unknown dates, the patient was vaccinated with dose 1 and dose 2 of VAQTA 0.5 ml Injection, (strength, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. The patient reported, she believed that she received the wrong dose VAQTA, due to it was documented that she received two doses of the adolescent 0.5 ml. The patient wanted to confirm the lot numbers of the doses she received of VAQTA mentioning that the dosage might have just been documented incorrectly as opposed to actually receiving the wrong dose. No adverse reactions were reported.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd August 2018, 1 days after receiving SHINGRIX, the patient experienced fever, malaise, headache and injection site pain. On an unknown date, the outcome of the fever, malaise, headache and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, malaise, headache and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The patient planned to follow-up with his physician on an unknown date.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Condition aggravated, Immune system disorder, Lip exfoliation, Oral herpes
Clinical narrative: I received the flu shot at my place of employment and it has left my immune system super sensitive. I have Steven Johnson Immunocomplex disease and the reaction mimicked my post hospitalization recovery. My lips peeled massively and completely. I also have HPV1 and it caused a breakout all over my lips. I've had rashes. I've had midnight fevers/chills, I have NEVER had this type of reaction before and I am refusing to take anymore from now on. When I was initially post hospitalized we (my PCP) and I worried about this happening but given my hyper-sensitive immune system the concern is more long term clearly. Disclosure: I am a nurse and did not see my PCP. I monitored myself.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rash, Stevens-Johnson syndrome
Clinical narrative: I received the flu shot at my place of employment and it has left my immune system super sensitive. I have Steven Johnson Immunocomplex disease and the reaction mimicked my post hospitalization recovery. My lips peeled massively and completely. I also have HPV1 and it caused a breakout all over my lips. I've had rashes. I've had midnight fevers/chills, I have NEVER had this type of reaction before and I am refusing to take anymore from now on. When I was initially post hospitalized we (my PCP) and I worried about this happening but given my hyper-sensitive immune system the concern is more long term clearly. Disclosure: I am a nurse and did not see my PCP. I monitored myself.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Middle insomnia
Clinical narrative: A sharp muscle ache in bicep from shoulder to elbow that began a few days after vaccine administration following a short period of normal muscle soreness at injection site. Pain has been consistent without any improvement for 4 months. Pain is strong enough to wake her up at night and prevent her from reaching upwards.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Feeling abnormal, Influenza like illness, Myalgia
Clinical narrative: Cough, chills, nausea, muscle aches, feels absolutely terrible, feels like flu.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Cough, chills, nausea, muscle aches, feels absolutely terrible, feels like flu.