chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Tremor
Clinical narrative: This case was reported by a physician and described the occurrence of injection site reaction in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site reaction and tremor limb. On an unknown date, the outcome of the injection site reaction and tremor limb were unknown. It was unknown if the reporter considered the injection site reaction and tremor limb to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced tremor in the arm of injection (in addition to local injection site reactions). The tremor was, lasting less than three days, and then resolving fully. This case was linked with case US2018GSK089601, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of chills in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were unknown. It was unknown if the reporter considered the chills and fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced not just an injection site. This was 1 of 3 cases reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had erythema at area of injection and swelling. One week later patient denies any pain or itching. Patient uses cool pack as needed.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling and redness to (R) deltoid. Ice, ZYRTEC.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: No adverse event
Clinical narrative: Pt waited for 15 mins, no relations vis given.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis
Clinical narrative: Patient received shot on 10/22/17. Patient stated symptoms (frozen shoulder) began a month later. Patient visited doctor's office and orthopedic surgeon and received treatments with NSAIDs, etc. No surgery needed. Patient report incident to pharmacy on 05/22/18 so VAERS filled out.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of fever in a 54-year-old female patient who received SHINGRIX. On 9th May 2018 12:05, the patient received the 1st dose of SHINGRIX. On 10th May 2018, 1 days after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. The reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: At 12:05, the patient received SHINGRIX. A day after receiving the SHINGRIX vaccine, the patient experienced fever (body temperature: 101.8 degrees F). The reporter gave permission to contact their healthcare provider.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient received vaccine at pharmacy, comes in different pharmacy reporting redness about 3-4 radius in size, a bit warm, a bit swollen.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a elderly female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced erythema, induration and pain. On an unknown date, the outcome of the erythema, induration and pain were not recovered/not resolved. It was unknown if the reporter considered the erythema, induration and pain to be related to SHINGRIX. Additional details were reported as follows: In 2018, the patient received SHINGRIX 1 and half weeks before the day of reporting. She still had an induration that was red and painful/achy. The mark was approximately 7x8 mm or cm in size (the reporter wrote down meters but this was presumed to be accidental). The reporter asked to let her know (for both possible sizes of the reaction site) how long it might take to resolve. Also, she asked if there should be a greater delay before administering the second dose. The reporter was asked about the best time frame to wait from after resolution of mark to second dose. The reporter asked if a reaction was experienced after the first vaccination, how likely it was to occur with the second dose and if it was typically worse, the same, or reduced in severity. She further asked if a reaction occurred, how bad should the redness, pain, induration be before it is recommended to not administer the second dose. The healthcare provider heard that reactions were more likely with the elderly and would like more details as to why they occur more frequently. This seemed counter to what the provider expected as the immune system was less active as you age and, therefore, most people had lessened responses and reactions to vaccines. The healthcare provider stated that she could be contacted by phone, email or live chat.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Lot NX952 Exp 3/6/20. Loss of mobility from lift arm. Pain and ache upper arm across shoulder and into neck. Range of motion issues affect my work and it has been a month now with no change. Referral to P.T. 4/20/18-Vaccination date at Pharmacy. 4/27/18-Spoke to pharmacist about pain, aching, and loss of mobility in left arm. Obtained VAERS form online. She had to send in a form also, she said. 5/4/18-Finally got appt. with my PCP, Dr. She ordered X-rays and Lab work for me, done that afternoon. I had to cancel vacation planned for June 2nd due to my arm pain and impaired mobility issues. Luckily I took out travel protection insurance. I'm getting physical therapy appointment tomorrow. I hope they can do something to alleviate the pain and get my range of motion back to normal.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Myalgia, Pain, Pain in extremity
Clinical narrative: Lot NX952 Exp 3/6/20. Loss of mobility from lift arm. Pain and ache upper arm across shoulder and into neck. Range of motion issues affect my work and it has been a month now with no change. Referral to P.T. 4/20/18-Vaccination date at Pharmacy. 4/27/18-Spoke to pharmacist about pain, aching, and loss of mobility in left arm. Obtained VAERS form online. She had to send in a form also, she said. 5/4/18-Finally got appt. with my PCP, Dr. She ordered X-rays and Lab work for me, done that afternoon. I had to cancel vacation planned for June 2nd due to my arm pain and impaired mobility issues. Luckily I took out travel protection insurance. I'm getting physical therapy appointment tomorrow. I hope they can do something to alleviate the pain and get my range of motion back to normal.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood creatine phosphokinase, C-reactive protein, Differential white blood cell count, Full blood count, Impaired work ability
Clinical narrative: Lot NX952 Exp 3/6/20. Loss of mobility from lift arm. Pain and ache upper arm across shoulder and into neck. Range of motion issues affect my work and it has been a month now with no change. Referral to P.T. 4/20/18-Vaccination date at Pharmacy. 4/27/18-Spoke to pharmacist about pain, aching, and loss of mobility in left arm. Obtained VAERS form online. She had to send in a form also, she said. 5/4/18-Finally got appt. with my PCP, Dr. She ordered X-rays and Lab work for me, done that afternoon. I had to cancel vacation planned for June 2nd due to my arm pain and impaired mobility issues. Luckily I took out travel protection insurance. I'm getting physical therapy appointment tomorrow. I hope they can do something to alleviate the pain and get my range of motion back to normal.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Lot NX952 Exp 3/6/20. Loss of mobility from lift arm. Pain and ache upper arm across shoulder and into neck. Range of motion issues affect my work and it has been a month now with no change. Referral to P.T. 4/20/18-Vaccination date at Pharmacy. 4/27/18-Spoke to pharmacist about pain, aching, and loss of mobility in left arm. Obtained VAERS form online. She had to send in a form also, she said. 5/4/18-Finally got appt. with my PCP, Dr. She ordered X-rays and Lab work for me, done that afternoon. I had to cancel vacation planned for June 2nd due to my arm pain and impaired mobility issues. Luckily I took out travel protection insurance. I'm getting physical therapy appointment tomorrow. I hope they can do something to alleviate the pain and get my range of motion back to normal.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Red blood cell sedimentation rate, X-ray limb
Clinical narrative: Lot NX952 Exp 3/6/20. Loss of mobility from lift arm. Pain and ache upper arm across shoulder and into neck. Range of motion issues affect my work and it has been a month now with no change. Referral to P.T. 4/20/18-Vaccination date at Pharmacy. 4/27/18-Spoke to pharmacist about pain, aching, and loss of mobility in left arm. Obtained VAERS form online. She had to send in a form also, she said. 5/4/18-Finally got appt. with my PCP, Dr. She ordered X-rays and Lab work for me, done that afternoon. I had to cancel vacation planned for June 2nd due to my arm pain and impaired mobility issues. Luckily I took out travel protection insurance. I'm getting physical therapy appointment tomorrow. I hope they can do something to alleviate the pain and get my range of motion back to normal.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Biopsy, Erythema, Facial pain, Herpes zoster, Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 72-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th May 2018, 4 days after receiving SHINGRIX, the patient experienced rash. On 9th May 2018, the patient experienced shingles. On an unknown date, the outcome of the rash and shingles were not recovered/not resolved. It was unknown if the reporter considered the rash and shingles to be related to SHINGRIX. Additional details were reported as follows: The case was reported by a Registered Pharmacist. The patient received SHINGRIX on left deltoid. The patient was seen by her dermatologist. The batch number reported 9A539 for SHINGRIX did not match to the sales data and was changed to 9AS39.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 72-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th May 2018, 4 days after receiving SHINGRIX, the patient experienced rash. On 9th May 2018, the patient experienced shingles. On an unknown date, the outcome of the rash and shingles were not recovered/not resolved. It was unknown if the reporter considered the rash and shingles to be related to SHINGRIX. Additional details were reported as follows: The case was reported by a Registered Pharmacist. The patient received SHINGRIX on left deltoid. The patient was seen by her dermatologist. The batch number reported 9A539 for SHINGRIX did not match to the sales data and was changed to 9AS39.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 72-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th May 2018, 4 days after receiving SHINGRIX, the patient experienced rash. On 9th May 2018, the patient experienced shingles. On an unknown date, the outcome of the rash and shingles were not recovered/not resolved. It was unknown if the reporter considered the rash and shingles to be related to SHINGRIX. Additional details were reported as follows: The case was reported by a Registered Pharmacist. The patient received SHINGRIX on left deltoid. The patient was seen by her dermatologist. The batch number reported 9A539 for SHINGRIX did not match to the sales data and was changed to 9AS39.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 72-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th May 2018, 4 days after receiving SHINGRIX, the patient experienced rash. On 9th May 2018, the patient experienced shingles. On an unknown date, the outcome of the rash and shingles were not recovered/not resolved. It was unknown if the reporter considered the rash and shingles to be related to SHINGRIX. Additional details were reported as follows: The case was reported by a Registered Pharmacist. The patient received SHINGRIX on left deltoid. The patient was seen by her dermatologist. The batch number reported 9A539 for SHINGRIX did not match to the sales data and was changed to 9AS39.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Facial pain, Herpes zoster, Hyperaesthesia, Irritability, Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 72-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th May 2018, 4 days after receiving SHINGRIX, the patient experienced rash. On 9th May 2018, the patient experienced shingles. On an unknown date, the outcome of the rash and shingles were not recovered/not resolved. It was unknown if the reporter considered the rash and shingles to be related to SHINGRIX. Additional details were reported as follows: The case was reported by a Registered Pharmacist. The patient received SHINGRIX on left deltoid. The patient was seen by her dermatologist. The batch number reported 9A539 for SHINGRIX did not match to the sales data and was changed to 9AS39.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Heart rate increased, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: This case was reported by a consumer via out of hour service and described the occurrence of fever in a 61-year-old male patient who received SHINGRIX. Concomitant products included Atorvastatin, Aspirin, Vitamin D3, CIALIS, Lisinopril and fluoxetine. On 12th May 2018 16:45, the patient received SHINGRIX. On 12th May 2018 23:00, 6 hrs 15 min after receiving SHINGRIX, the patient experienced fever, generalized urticarial rash, erythematous rash and itchy rash. On 13th May 2018, the patient experienced generalized rash and inflammation. The patient was treated with ibuprofen and prednisone. On an unknown date, the outcome of the fever, generalized urticarial rash, erythematous rash, itchy rash, generalized rash and inflammation were unknown. The reporter considered the fever, generalized urticarial rash, erythematous rash, itchy rash and generalized rash to be related to SHINGRIX. It was unknown if the reporter considered the inflammation to be related to SHINGRIX. It was unknown if the reporter considered the inflammation to be related to SHINGRIX. Additional information were provided as follows: This case was reported by a patient's wife, who stated that the patient experienced low grade fever and hives on the wrist and back of the legs after vaccination with SHINGRIX in right arm. On the same night, the patient was broke out with red, itchy, hives like rash on his left wrist and back of his left calf and ankle, began running low-grade fever with slightly elevated heart rate. On 13th May 2018, reporter took the patient at around 2:00 to 2:30 to visit doctor. The physician saw the patient documented vitals and confirmed elevated blood pressure and pulse, low-grade fever and rash. After seeing the patient, the physician gave some topical cream. The physician said this reaction was due to vaccine. The adverse events had been progressed. Before the date of reporting, in the evening the patient broke out in same rash all over the body and everywhere. The patient had hives all over the body on areas of legs, belly, arms, chest, buttocks, and neck. The reporter stated that the patient had been went to the doctor twice since then. On 14th May 2018, the patient had an appointment with his health care provider and had been prescribed with prednisone to help with his symptoms. At the time of reporting, the patient presented with peppered on the hives rash. The patient's neck was inflamed extremely with red rash. No further details were provided by the caller.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a consumer via out of hour service and described the occurrence of fever in a 61-year-old male patient who received SHINGRIX. Concomitant products included Atorvastatin, Aspirin, Vitamin D3, CIALIS, Lisinopril and fluoxetine. On 12th May 2018 16:45, the patient received SHINGRIX. On 12th May 2018 23:00, 6 hrs 15 min after receiving SHINGRIX, the patient experienced fever, generalized urticarial rash, erythematous rash and itchy rash. On 13th May 2018, the patient experienced generalized rash and inflammation. The patient was treated with ibuprofen and prednisone. On an unknown date, the outcome of the fever, generalized urticarial rash, erythematous rash, itchy rash, generalized rash and inflammation were unknown. The reporter considered the fever, generalized urticarial rash, erythematous rash, itchy rash and generalized rash to be related to SHINGRIX. It was unknown if the reporter considered the inflammation to be related to SHINGRIX. It was unknown if the reporter considered the inflammation to be related to SHINGRIX. Additional information were provided as follows: This case was reported by a patient's wife, who stated that the patient experienced low grade fever and hives on the wrist and back of the legs after vaccination with SHINGRIX in right arm. On the same night, the patient was broke out with red, itchy, hives like rash on his left wrist and back of his left calf and ankle, began running low-grade fever with slightly elevated heart rate. On 13th May 2018, reporter took the patient at around 2:00 to 2:30 to visit doctor. The physician saw the patient documented vitals and confirmed elevated blood pressure and pulse, low-grade fever and rash. After seeing the patient, the physician gave some topical cream. The physician said this reaction was due to vaccine. The adverse events had been progressed. Before the date of reporting, in the evening the patient broke out in same rash all over the body and everywhere. The patient had hives all over the body on areas of legs, belly, arms, chest, buttocks, and neck. The reporter stated that the patient had been went to the doctor twice since then. On 14th May 2018, the patient had an appointment with his health care provider and had been prescribed with prednisone to help with his symptoms. At the time of reporting, the patient presented with peppered on the hives rash. The patient's neck was inflamed extremely with red rash. No further details were provided by the caller.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure increased, Heart rate increased, Inflammation, Pyrexia, Rash erythematous
Clinical narrative: This case was reported by a consumer via out of hour service and described the occurrence of fever in a 61-year-old male patient who received SHINGRIX. Concomitant products included Atorvastatin, Aspirin, Vitamin D3, CIALIS, Lisinopril and fluoxetine. On 12th May 2018 16:45, the patient received SHINGRIX. On 12th May 2018 23:00, 6 hrs 15 min after receiving SHINGRIX, the patient experienced fever, generalized urticarial rash, erythematous rash and itchy rash. On 13th May 2018, the patient experienced generalized rash and inflammation. The patient was treated with ibuprofen and prednisone. On an unknown date, the outcome of the fever, generalized urticarial rash, erythematous rash, itchy rash, generalized rash and inflammation were unknown. The reporter considered the fever, generalized urticarial rash, erythematous rash, itchy rash and generalized rash to be related to SHINGRIX. It was unknown if the reporter considered the inflammation to be related to SHINGRIX. It was unknown if the reporter considered the inflammation to be related to SHINGRIX. Additional information were provided as follows: This case was reported by a patient's wife, who stated that the patient experienced low grade fever and hives on the wrist and back of the legs after vaccination with SHINGRIX in right arm. On the same night, the patient was broke out with red, itchy, hives like rash on his left wrist and back of his left calf and ankle, began running low-grade fever with slightly elevated heart rate. On 13th May 2018, reporter took the patient at around 2:00 to 2:30 to visit doctor. The physician saw the patient documented vitals and confirmed elevated blood pressure and pulse, low-grade fever and rash. After seeing the patient, the physician gave some topical cream. The physician said this reaction was due to vaccine. The adverse events had been progressed. Before the date of reporting, in the evening the patient broke out in same rash all over the body and everywhere. The patient had hives all over the body on areas of legs, belly, arms, chest, buttocks, and neck. The reporter stated that the patient had been went to the doctor twice since then. On 14th May 2018, the patient had an appointment with his health care provider and had been prescribed with prednisone to help with his symptoms. At the time of reporting, the patient presented with peppered on the hives rash. The patient's neck was inflamed extremely with red rash. No further details were provided by the caller.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: This case was reported by a consumer via out of hour service and described the occurrence of fever in a 61-year-old male patient who received SHINGRIX. Concomitant products included Atorvastatin, Aspirin, Vitamin D3, CIALIS, Lisinopril and fluoxetine. On 12th May 2018 16:45, the patient received SHINGRIX. On 12th May 2018 23:00, 6 hrs 15 min after receiving SHINGRIX, the patient experienced fever, generalized urticarial rash, erythematous rash and itchy rash. On 13th May 2018, the patient experienced generalized rash and inflammation. The patient was treated with ibuprofen and prednisone. On an unknown date, the outcome of the fever, generalized urticarial rash, erythematous rash, itchy rash, generalized rash and inflammation were unknown. The reporter considered the fever, generalized urticarial rash, erythematous rash, itchy rash and generalized rash to be related to SHINGRIX. It was unknown if the reporter considered the inflammation to be related to SHINGRIX. It was unknown if the reporter considered the inflammation to be related to SHINGRIX. Additional information were provided as follows: This case was reported by a patient's wife, who stated that the patient experienced low grade fever and hives on the wrist and back of the legs after vaccination with SHINGRIX in right arm. On the same night, the patient was broke out with red, itchy, hives like rash on his left wrist and back of his left calf and ankle, began running low-grade fever with slightly elevated heart rate. On 13th May 2018, reporter took the patient at around 2:00 to 2:30 to visit doctor. The physician saw the patient documented vitals and confirmed elevated blood pressure and pulse, low-grade fever and rash. After seeing the patient, the physician gave some topical cream. The physician said this reaction was due to vaccine. The adverse events had been progressed. Before the date of reporting, in the evening the patient broke out in same rash all over the body and everywhere. The patient had hives all over the body on areas of legs, belly, arms, chest, buttocks, and neck. The reporter stated that the patient had been went to the doctor twice since then. On 14th May 2018, the patient had an appointment with his health care provider and had been prescribed with prednisone to help with his symptoms. At the time of reporting, the patient presented with peppered on the hives rash. The patient's neck was inflamed extremely with red rash. No further details were provided by the caller.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 63-year-old male patient who received SHINGRIX. On 9th May 2018, the patient received the 1st dose of SHINGRIX. On 9th May 2018, 3 hrs after receiving SHINGRIX, the patient experienced localized erythema, chills and fever. On an unknown date, the outcome of the localized erythema was recovering/resolving and the outcome of the chills and fever were recovered/resolved. The reporter considered the localized erythema, chills and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient did not have lot or expiry date of SHINGRIX. The patient called to report that they experienced redness of the whole deltoid, fever and chills after they received SHINGRIX. The redness on deltoid was still present but diminishing. The fever and chill lasted for a few days and was gone at the time of reporting. The patient stated they did report to the FDA as well.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Erythema, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 63-year-old male patient who received SHINGRIX. On 9th May 2018, the patient received the 1st dose of SHINGRIX. On 9th May 2018, 3 hrs after receiving SHINGRIX, the patient experienced localized erythema, chills and fever. On an unknown date, the outcome of the localized erythema was recovering/resolving and the outcome of the chills and fever were recovered/resolved. The reporter considered the localized erythema, chills and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient did not have lot or expiry date of SHINGRIX. The patient called to report that they experienced redness of the whole deltoid, fever and chills after they received SHINGRIX. The redness on deltoid was still present but diminishing. The fever and chill lasted for a few days and was gone at the time of reporting. The patient stated they did report to the FDA as well.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Fatigue, Immediate post-injection reaction, Injection site erythema, Injection site hyperaesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 63-year-old male patient who received SHINGRIX. On 9th May 2018, the patient received the 1st dose of SHINGRIX. On 9th May 2018, 3 hrs after receiving SHINGRIX, the patient experienced localized erythema, chills and fever. On an unknown date, the outcome of the localized erythema was recovering/resolving and the outcome of the chills and fever were recovered/resolved. The reporter considered the localized erythema, chills and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient did not have lot or expiry date of SHINGRIX. The patient called to report that they experienced redness of the whole deltoid, fever and chills after they received SHINGRIX. The redness on deltoid was still present but diminishing. The fever and chill lasted for a few days and was gone at the time of reporting. The patient stated they did report to the FDA as well.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 63-year-old male patient who received SHINGRIX. On 9th May 2018, the patient received the 1st dose of SHINGRIX. On 9th May 2018, 3 hrs after receiving SHINGRIX, the patient experienced localized erythema, chills and fever. On an unknown date, the outcome of the localized erythema was recovering/resolving and the outcome of the chills and fever were recovered/resolved. The reporter considered the localized erythema, chills and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient did not have lot or expiry date of SHINGRIX. The patient called to report that they experienced redness of the whole deltoid, fever and chills after they received SHINGRIX. The redness on deltoid was still present but diminishing. The fever and chill lasted for a few days and was gone at the time of reporting. The patient stated they did report to the FDA as well.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: I had the SHINGRIX vaccine on May 16, 2018. I am a 55 year old female. The next day I had headache, upset stomach, weak legs, 101 fever, and a very swollen arm at the site of the injection. I was better the next day except for the swollen arm which lasted 3 days.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Headache, Injection site swelling, Muscular weakness, Peripheral swelling
Clinical narrative: I had the SHINGRIX vaccine on May 16, 2018. I am a 55 year old female. The next day I had headache, upset stomach, weak legs, 101 fever, and a very swollen arm at the site of the injection. I was better the next day except for the swollen arm which lasted 3 days.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: I had the SHINGRIX vaccine on May 16, 2018. I am a 55 year old female. The next day I had headache, upset stomach, weak legs, 101 fever, and a very swollen arm at the site of the injection. I was better the next day except for the swollen arm which lasted 3 days.
Age: 24.0
Sex: M
Vaccine: JEV1
Symptoms: Nausea, Vomiting
Clinical narrative: PT received the JEV the afternoon prior. PT returned to the immunizations clinic about 24 hours later stating nausea and vomiting that started the next morning when he woke up. PT stated he was unable to keep food down but was able to hydrate. PT stated he will wait 24 hours prior to seeing a physician unless symptoms become worse.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: The adverse reaction is NOT a health or efficacy issue. I am merely reporting that this injection has proved -- for both doses -- to be quite painful. The pain does not begin upon injection, but perhaps an hour or two later. For the first dose (maybe 9-10 weeks ago) the pain lasted a few days. (I have had just about every sort of vaccination available, and I've never previously experienced such discomfort.)The pain is sufficiently intense that it is impossible to sleep on my left side. It is sufficient as to make me feel like I've contracted a cold (i.e., aches and pains being a symptom of fever -- but without a fever in this case). Lifting my left arm is painful. When I mentioned to the pharmacist the pain I experienced after the first injection, she suggested moving the arm around. I did that quite a bit this time, but with no obvious effect. Re: Item 20. I recovered from the pain of the first dose within a week. I just got the second dose today, so the pain from that is still bothersome.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal discomfort, Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: Fatigue, stomach upset began in hour one, headache began by early afternoon (hour 3), fever began by late afternoon (hour 6), vomiting began in early morning (hour 16).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Discomfort, Headache, Lymph node pain, Myalgia
Clinical narrative: Sore lymph nodes in left armpit, sore muscles like with influenza. 99.1 temp, headache, woke me up from discomfort.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Moderate arm soreness, chills, fever (101 F), upset stomach, fatigue.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Headache, Myalgia, Pain, Peripheral swelling
Clinical narrative: Moderate arm soreness, chills, fever (101 F), upset stomach, fatigue.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Moderate arm soreness, chills, fever (101 F), upset stomach, fatigue.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Headache, Influenza like illness, Injection site erythema, Injection site warmth
Clinical narrative: Moderate arm soreness, chills, fever (101 F), upset stomach, fatigue.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Moderate arm soreness, chills, fever (101 F), upset stomach, fatigue.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Information has been received from an office manager via a company representative referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unspecified day in April 2018, reported as "sometime last week", the patient was vaccinated with GARDASIL 9, by intramuscular route (1 DF; strength, anatomical location, lot number and expiration date were not provided) for prophylaxis. After receiving GARDASIL 9, the patient experienced a fainting episode (syncope). The outcome of syncope was unknown. The causality assessment between therapy with GARDASIL 9 and the event was not reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was reported. Follow up information has been received from the physician on 02-MAY-2018, referring to a 15 year old male patient. The patient had no concomitant medications, no illness at time of vaccination, no pre-existing physician-diagnosed allergies, birth defects or medical conditions. The patient had no adverse event following a prior vaccination. No vaccinations within 4 weeks prior to 02-APR-2018 was given to the patient. On 02-APR-2018, the patient was vaccinated with the first dose of GARDASIL 9 (lot# reported as N02292, expiration date were not reported) in the left arm. On the same day, the patient experienced fainting spell which was recovered on an unknown date in 2018. No treatment was given to the patient.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 07-MAY-2018, the patient was vaccinated with and incorrect stored dose of PROQUAD (lot # N023967 with expiration date on 28-FEB-2019) (strength and route were not reported) for prophylaxis, however no adverse effects reported. Other suspect therapies included sterile diluent. It was reported that the vaccines were exposed to temperature of -3.9 centigrade grades range for a time frame of 1 hour. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: This spontaneous report was received from a nurse and refers to a 26 year old female patient. The patient had no concomitant medications or pertinent medical history. The patient was allergic to cranberries. On 30-APR-2018, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly into right deltoid (lot # N026812, expiration date: 22-JUN-2020, dose and frequency were not provided) for HPV prevention. On 30-APR-2018, the patient experienced burning/tingling in the palm of her right hand. The patient sought medical attention. Nurse practitioner wanted to know if the patient could be administered a second dose of GARDASIL 9 after experiencing burning and tingling in the palm of her hand. The outcome of burning/tingling in the palm of her right hand was reported as recovered/resolved. The patient sought medical attention. The causal relationship between the events and suspected vaccine was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report, was received from a physician, concerning a female patient or unknown age. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 14-MAY-2018, the 28 weeks pregnant patient was inadvertently vaccinated with a dose GARDASIL 9 1 dose, for prophylaxis (strength, frequency, route of administration, lot number and expiration date were not reported). The patient's last menstrual period was calculated to be 30-OCT-2017. The estimated date of delivery was calculated as 06-AUG-2018.
Sex: U
Vaccine: HPV9, UNK
Symptoms: Rash
Clinical narrative: This spontaneous report has been received from a nurse referring to a "15-17 years old" patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date in March 2018, the patient was vaccinated with GARDASIL 9, by intramuscular route (strength, dose, anatomical location, lot number and expiration date were not provided) for prophylaxis. On the same date, the patient also received "other unknown vaccines". Shortly after, the patient developed a rash on her arm, which lasted two months. The outcome of rash was unknown. The causality assessment between therapy with GARDASIL 9 and the event was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On 18-MAY-2018, it was reported that the patient inadvertently received an expired dose of sterile diluent (MERCK) lot # L025374 and expiry date 27-MAR-2018 (strength, dose, route and frequency were not reported) it was used to reconstitute MMR II lot # R002930 and expiry date 31-JAN-2019, also reported as 30-JAN-2019 (strength, dose, route and frequency were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint was filed.
Sex: F
Vaccine: HPV9
Symptoms: Abnormal sensation in eye, Exposure via eye contact
Clinical narrative: This spontaneous report was received from a medical assistant regarding herself, a female patient of unknown age. The patient had no concomitant medications, medical history, concurrent conditions and no drug reactions/allergies. On 21-MAY-2018, the medical assistant was drawing up a dose of GARDASIL 9, (lot # N025428 with an expiration date in 19-JUN-2020), for prophylaxis, that was supposed to be administered to a patient, and an unknown amount splashed into her eye, and since then, "her eye felt funny" (abnormal sensation in eye), the reporter was not able to clarify further. Moreover, it was also reported that the patient sough medical attention via telephone call, but no treatment was prescribed for the patient. At the time of reporting, the outcome of abnormal sensation in eye was reported as not recovered. The causal relationship between GARDASIL 9 and the abnormal sensation in eye was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age. There was no information about the patients' concurrent conditions, allergies or drug reactions, medical history or concomitant medications. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020, for prophylaxis (dose and route of administration were not reported). The administered doses of the vaccine experienced temperatures of excursion at or above 32 Fahrenheit degrees (°F) up to 35°F (32.72°F), for 19 hours and 45 minutes. There was no adverse effects reported. There was not previous temperature excursion. This report was called because of a data logger. No product quality complaint was involved.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Information was received from a consumer referring to an approximately 19 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions, and allergies were not reported. On 17-MAY-2018 at 08:00 AM, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (route of administration, lot number, and expiration date were not reported). On 18-MAY-2018 (one day post injection), the patient experienced itchiness, pain, and some redness at injection site; the outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a 15 year old patient. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On an unspecified date in May 2014 (also reported as "4 years ago on an unspecified date"), the patient was vaccinated with a dose of GARDASIL (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 21-MAY-2018, the patient was vaccinated with a dose of GARDASIL 9 lot # N019104 with expiration date: 03-FEB-2020 (strength, dose, route and anatomical location were not reported) for prophylaxis. No adverse effects. No further information provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. The reporter stated that on 21-MAY-2018, the patient was vaccinated with a dose of the patient was vaccinated with PROQUAD for prophylaxis (strength, dosage, frequency and route were no provided), lot# reported as M025185, which expired on 18-MAY-2018. No adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 18 year old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 21-MAY-2018, the patient was vaccinated with VAQTA lot # N005605 with expiration date of 08-APR-2018, intramuscularly in the right deltoid for prophylaxis (dose was not reported). No adverse effects reported.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician, and refers to a 20 year old female patient. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 16-MAR-2017, the patient was vaccinated with the first dose of GARDASIL 9, subsequently on 15-MAY-2017, the patient received the second dose of GARDASIL 9. Since 16-JAN-2018, 10 months 1 day after onset of therapy the patient experienced Inappropriate schedule of vaccine administered, as she presented to the reporter's office to received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (Lot # N025428, Exp: 19-JUN-2020) on 22-MAY-2018. No adverse effect reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: Had significant arm pain and low grade fever/chills for two to three days after vaccine. On day 4 developed warm, almost circumferential rash about 1-2 inches below the site of the injection (see picture) that lasted for an additional 2-3 days, treated with BENADRYL. Macular, confluent rash, no pain, had warmth, no axillary lymphadenopathy. Fully resolved by day 7 after injection. I have never had either the degree of pain at injection site on the rash with any other vaccine prior to this.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Had significant arm pain and low grade fever/chills for two to three days after vaccine. On day 4 developed warm, almost circumferential rash about 1-2 inches below the site of the injection (see picture) that lasted for an additional 2-3 days, treated with BENADRYL. Macular, confluent rash, no pain, had warmth, no axillary lymphadenopathy. Fully resolved by day 7 after injection. I have never had either the degree of pain at injection site on the rash with any other vaccine prior to this.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Severe shakes, fever, nausea, headache; took ibuprofen to bring down the fever - which worked. Headache lasted several days. Sore and tired. Don't think I'll get the second shot.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Severe shakes, fever, nausea, headache; took ibuprofen to bring down the fever - which worked. Headache lasted several days. Sore and tired. Don't think I'll get the second shot.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Burning sensation, Feeling abnormal, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Pt received the vaccine on 1/2/18 and then started with pain on 1/21/18. It was described as a burning in the center of her low back and spread anteriorly around her right side. The pain or discomfort progressed to a tingling feeling sparing the buttock but continuing down the back of her right leg and this numbness had worsened over the subsequent 4-5 days. No headaches, fevers, known trauma, walking normally, not feeling good but not feeling weak. No recent trauma. Pt received a lumbosacral xray that was negative and was subsequently referred to Ortho, Physical Therapy and Rheumatology. Sx have continued and are being followed by specialists.