chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Activated partial thromboplastin time normal, Erythema, Full blood count normal, International normalised ratio normal, Metabolic function test normal
Clinical narrative: PCP appointment 9/10 and received the SHINGRIX vaccine for the first time around 2 PM. He was feeling well until 9/11 around 7:30 AM when he developed itching on his palms and soles associated with redness of these areas. Also noted hives on his thighs and trunk. He has a past history of anaphylaxis so checked his blood pressure which was in the 120s systolics and took a BENADRYL. Later that morning he continued to have some itching and noticed his tongue felt "thick".  Felt somewhat similar to a past history of angioedema. He took another BENADRYL and had his blood pressure taken which was in the 90s systolics. Came to ER for evaluation. At ER triage, BP 112/68, pulse 68, RR 18, O2 93%. Received NS x 1 liter, methylprednisolone 125mg IV,  epinephrine 0.3 mg IM, ranitidine 50 mg IV, and diphenhydramine 12.5 mg IV.  After those treatments, he is feeling better with minimal itching and no skin findings. BP after treatment was 106/53. Patient was admitted for observation.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Prothrombin time normal, Pruritus, Tongue disorder, Urticaria, White blood cell count increased
Clinical narrative: PCP appointment 9/10 and received the SHINGRIX vaccine for the first time around 2 PM. He was feeling well until 9/11 around 7:30 AM when he developed itching on his palms and soles associated with redness of these areas. Also noted hives on his thighs and trunk. He has a past history of anaphylaxis so checked his blood pressure which was in the 120s systolics and took a BENADRYL. Later that morning he continued to have some itching and noticed his tongue felt "thick".  Felt somewhat similar to a past history of angioedema. He took another BENADRYL and had his blood pressure taken which was in the 90s systolics. Came to ER for evaluation. At ER triage, BP 112/68, pulse 68, RR 18, O2 93%. Received NS x 1 liter, methylprednisolone 125mg IV,  epinephrine 0.3 mg IM, ranitidine 50 mg IV, and diphenhydramine 12.5 mg IV.  After those treatments, he is feeling better with minimal itching and no skin findings. BP after treatment was 106/53. Patient was admitted for observation.
Age: 4.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction noted. Wrong vaccine administered.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphonia, Headache, Pharyngeal oedema
Clinical narrative: Patient experienced hoarseness and swelling of throat and headache. Gave her 100mg of diphenhydramine and monitored her BP then sent her to the ER.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. On 6th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced arm pain for one month after receiving the injection. No further details regarding the patient's experience were available at the time of report.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pyrexia, Skin warm, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 55-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 31st August 2018, the patient received SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, erythema of extremities, skin warm and welts. The patient was treated with ibuprofen and Acetaminophen. On an unknown date, the outcome of the fever, erythema of extremities, skin warm and welts were unchanged. It was unknown if the reporter considered the fever, erythema of extremities, skin warm and welts to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The healthcare professional who was also the patient reported that she developed a larger than golf-ball sized red, hot to the touch welt on her arm after receiving a dose of SHINGRIX. The patient also reported that she had a consistent fever with max temp of 102 (F) which had been controlled with the administration of ibuprofen and acetaminophen. No further information reported regarding the adverse reaction.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain 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 pain and erythema. On an unknown date, the outcome of the pain and erythema were recovered/resolved. It was unknown if the reporter considered the pain and erythema to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a physician assistant. The age at vaccination was not reported. The patient had mild soreness and erythema. The healthcare professional stated vaccines were administered at two different pharmacies, thus did not have expiry date or lot numbers. For tolerance to 2nd dose refer case US2018GSK163609.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 64-year-old female patient who received SHINGRIX (batch number MY2B2, expiry date 28th February 2021) for prophylaxis. On 31st August 2018, the patient received SHINGRIX. On 31st August 2018, unknown after receiving SHINGRIX, the patient experienced wrong solution used in drug reconstitution and inappropriate preparation of medication. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate preparation of medication were unknown. Additional details were provided as follows: The healthcare professional reconstituted SHINGRIX with sterile water instead of the adjuvant provided with the vaccine and administered it to the patient, which led to wrong solution used in drug reconstitution and inappropriate preparation of medication.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Middle insomnia, Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 86-year-old male patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and shoulder pain. On 4th September 2018, the patient experienced injection site lump. On an unknown date, the outcome of the injection site pain and injection site lump were not recovered/not resolved and the outcome of the shoulder pain was unknown. It was unknown if the reporter considered the injection site pain, shoulder pain and injection site lump to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported that he experienced extreme pain in the site for 3 days after the injection. The pain had decreased but not resolved. He noted the pain was a 4 to 5 during the day but a 8 to 9 at night, often awakening him from sleep. The pain was noted at the injection site and in the shoulder area also. He noted he also felt a lump in his muscle like it was swollen. The size noted was 1 and a inches by 4 to 5 inches, and that he did not notice until the day of reporting. He stated he had notified his physician, who instructed him to not get the 2nd dose of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site mass, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 68-year-old female patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. On 4th September 2018, the patient received the 2nd dose of SHINGRIX. On 4th September 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site hemorrhage. On an unknown date, the outcome of the injection site swelling and injection site hemorrhage were unknown. It was unknown if the reporter considered the injection site swelling and injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a Registered Pharmacist (RPh). The age at vaccination was not reported. The pharmacist administered a dose of SHINGRIX to a patient on right arm and noted when she went to put band aid over injection site, that there was almost like a bubble or swelling around the injection site just smaller than the size of a quarter. On the same day upon transfer the pharmacist additionally stated that the patient bled at the injection site, and that there was a mass like the vaccine just sat in her arm. The reported lot number (P45MA) for SHINGRIX did not exist and was updated to P45M9, according to the sales database.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Anaemia, Burning sensation, Chest pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 83-year-old female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received SHINGRIX. On 27th August 2018, less than a year after receiving SHINGRIX, the patient experienced burning sensation. On 4th September 2018, the patient experienced anemia. On an unknown date, the outcome of the burning sensation and anemia were unknown. It was unknown if the reporter considered the burning sensation and anemia to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and over the last 2 weeks, she had experienced a burning sensation around her face, chest and abdomen. The patient went to the emergency department yesterday on 4th September 2018, less than a year after receiving SHINGRIX, the patient was diagnosed with anemia. The patient had denied permission to contact their physician.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old male patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX. On 5th September 2018, 7 days after receiving SHINGRIX, the patient experienced injection site erythema and erythromacular rash. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the erythromacular rash was unknown. It was unknown if the reporter considered the injection site erythema and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The reporter was wife of the patient. At 16:00 hours, the patient received SHINGRIX on left arm. The patient experienced redness at the injection a week after receiving the injection. It was a red spot above, below and on the sides of the injection site. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Incorrect route of product administration, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 5th September 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 6th September 2018, the patient experienced feeling unwell, injection site erythema, injection site warmth, injection site rash, injection site pain and hypersensation skin. On an unknown date, the outcome of the feeling unwell, injection site erythema, injection site warmth, injection site rash and injection site pain were not recovered/not resolved and the outcome of the hypersensation skin and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the feeling unwell, injection site erythema, injection site warmth, injection site rash, injection site pain and hypersensation skin to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. One of his nurses reported that pharmacist gave SHINGRIX to the patient by subcutaneous route instead of intramuscular route, which led to incorrect route of drug administration. Then at morning of the reporting day, the patient called and went to the office because she was not feeling well, she had a giant rash near the injection site. The injection site was also very painful, red, hot to the touch. It was a sensitive spot.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 5th September 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 6th September 2018, the patient experienced feeling unwell, injection site erythema, injection site warmth, injection site rash, injection site pain and hypersensation skin. On an unknown date, the outcome of the feeling unwell, injection site erythema, injection site warmth, injection site rash and injection site pain were not recovered/not resolved and the outcome of the hypersensation skin and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the feeling unwell, injection site erythema, injection site warmth, injection site rash, injection site pain and hypersensation skin to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. One of his nurses reported that pharmacist gave SHINGRIX to the patient by subcutaneous route instead of intramuscular route, which led to incorrect route of drug administration. Then at morning of the reporting day, the patient called and went to the office because she was not feeling well, she had a giant rash near the injection site. The injection site was also very painful, red, hot to the touch. It was a sensitive spot.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Nasal discomfort, Pharyngeal paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 21st August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a month after receiving SHINGRIX, the patient experienced nasal soreness. On 21st August 2018, the patient experienced pharyngeal paresthesia. On an unknown date, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms and pharyngeal paresthesia were unknown and the outcome of the nasal soreness was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, nasal soreness and pharyngeal paresthesia to be related to SHINGRIX. Additional information was received as follows: The healthcare professional reported that the patient experienced flu-like symptoms, the sore nose which lasted for one week, and tingling in throat which began about one hour after receiving the vaccine. No further details were reported regarding the event.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction 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 per the vaccine indication. The health care professional reported via chat that patient might had an allergic reaction from the SHINGRIX. The health care professional would not provide additional information. The health care professional just wanted a copy of the package insert.
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction, Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. The reporter considered the rash to be unrelated to SHINGRIX. Additional details were reported 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 healthcare professional stated the patient experienced a large local reaction. The healthcare professional was not sure if reaction was due to SHINGRIX. The healthcare professional was not willing to provide patient demographics or any additional information at the time of the call. The healthcare professional stated she had not actually seen the rash.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 15th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The patient reported that her arm was painful for up to 4 days.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter's husband received the SHINGRIX vaccination on left arm approximately one month before the date of reporting. The patient developed shingles on his left shoulder and the back of his head, two weeks after receiving the vaccination. The reporter gave permission for husband's physician to be contacted.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of nausea (1st dose received on 22nd March 2018, for events information refer case US2018120827). On 16th August 2018, the patient received the 2nd dose of SHINGRIX. On 16th August 2018, 6 hrs after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced mild soreness in her left arm at the injection site and it presented 6 hours after receiving the injections and was resolving. She received the vaccine at 3:00 PM and the soreness presented that night. This case has been linked with case US2018120827 reported by the same reporter for the same patient (case of 1st dose).
Sex: M
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of radiating pain in a male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced radiating pain. On an unknown date, the outcome of the radiating pain was recovered/resolved. It was unknown if the reporter considered the radiating pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient had radiated pain after the injection for almost a week.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Loss of personal independence in daily activities, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. Previously administered products included Tdap with an associated reaction of injection site pain (received in 2015, refer case US2018GSK163780). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, fatigue, shivering, malaise and activities of daily living impaired. On an unknown date, the outcome of the influenza-like symptoms and fever were unknown and the outcome of the fatigue, shivering, malaise and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, fatigue, shivering, malaise and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The patient reactions from SHINGRIX 1st dose included fever and flu-like symptoms within 6 hours of the vaccination. The patient also experienced extreme fatigue, shivering, malaise, unable to carry on with regular routine for almost 72 hours. The patient had a Tdap vaccination in 2015, with only symptom being a sore arm at injection site. That was expected by the patient and hoped for with the SHINGRIX. The 2nd dose was scheduled in the reporting month, and might be less of a reaction with the next one.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. Previously administered products included Tdap with an associated reaction of injection site pain (received in 2015, refer case US2018GSK163780). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, fatigue, shivering, malaise and activities of daily living impaired. On an unknown date, the outcome of the influenza-like symptoms and fever were unknown and the outcome of the fatigue, shivering, malaise and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, fatigue, shivering, malaise and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The patient reactions from SHINGRIX 1st dose included fever and flu-like symptoms within 6 hours of the vaccination. The patient also experienced extreme fatigue, shivering, malaise, unable to carry on with regular routine for almost 72 hours. The patient had a Tdap vaccination in 2015, with only symptom being a sore arm at injection site. That was expected by the patient and hoped for with the SHINGRIX. The 2nd dose was scheduled in the reporting month, and might be less of a reaction with the next one.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 84-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, erythema and shivers. On an unknown date, the outcome of the pain, erythema and shivers were unknown. It was unknown if the reporter considered the pain, erythema and shivers to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient had stated side effects red, painful about circumference of a tennis ball, shivers, etc. The patient was reluctant to take the second dose of SHINGRIX, and the patient asked if she did receive it, then what she could expect. The patient was not looking forward to more of the same. The patient said that her husband did not have any problem.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a 70-year-old 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 influenza-like symptoms and pain in arm. On an unknown date, the outcome of the influenza-like symptoms and pain in arm were recovered/resolved. The reporter considered the influenza-like symptoms and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 69 or 70 years old. The patient experienced pain in arm for 3 days and he was able to use without restriction. The patient experienced flu-like symptoms for 24 hours. The reporter thought these events were related to the SHNGRIX. The reporter did not agree to be followed up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX. On 5th September 2018, less than a day after receiving SHINGRIX, the patient experienced chills, sweating, fever and headache. On an unknown date, the outcome of the chills, sweating, fever and headache were unknown. It was unknown if the reporter considered the chills, sweating, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX the day before reporting day and the night before reporting he had chills and woke up sweating with a fever and headache. The patient was inquiring about how long the events would last.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pain, Pruritus, Rash, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (erythema after 1st dose refer case, US2018160765). 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 pain, rash, feeling of warmth, pruritus and swelling. The patient was treated with Antihistamines. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the rash was not reported and the outcome of the feeling of warmth, pruritus and swelling were recovering/resolving. It was unknown if the reporter considered the pain, rash, feeling of warmth, pruritus and swelling to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a physician assistant. The age at vaccination was not reported. The healthcare professional stated both doses of SHINGRIX vaccines were administered at two different pharmacies. The healthcare professional treated the patient with antihistamines and the patient was 80 percent better at the reporting time.
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. In 2015, the patient received Tdap vaccination and experienced a sore arm at injection site. This case has been linked with, US2018GSK161255 reported by same reporter for events after SHINGRIX vaccination.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Night sweats
Clinical narrative: Patient got the vaccines, one in each arm, in the morning of 9/10/18. He presented to the pharmacy on the morning of 9/12/18 to show me that he had redness down his right arm which was the arm he received the PNEUMOVAX 23 in. It was not warm to touch, and the patient said it didn't hurt. He said he had a little soreness right at the injection site. There was no swelling compared to his other arm. He had no redness on the side where he got his flu shot. He also mentioned that he woke up this morning wet from sweat overnight. I counseled the patients on what signs/symptoms to look for that would warrant visiting a doctor.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: Small, pruritic rash bilateral arms and upper thighs.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Patient returned to the pharmacy on 9/12/18 at 9:30am complaining of persisting pain and inflammation in her right arm where she received the PREVNAR vaccine. Feels like the pain is not improving. Explained to the patient that it was not common for her pain to still persist and not improve after 6 days. Notified patient that I would report the incident to my incident report system at pharmacy and our claims department. Also will notify her doctor of the adverse event. Patient stated she wanted to report the event to me so I could be aware of the incident and that she would visit her doctor's office if she doesn't feel better in the next couple of days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Abscess, Peripheral swelling, Scab
Clinical narrative: Patients arm swole and ended up having an abscess. She didn't go to Drs office for this. She has a scab on her elbow. She called her Drs office and they told her to go to urgent care.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Facial paralysis
Clinical narrative: Patient developed bell's palsy on right side of face approximately 2 months after administration of SHINGRIX.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient stated that she had pain in her left shoulder and was unable to move her arm. Patients pain started a few hours after injection. Patient was given tramadol for her pain.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Neck pain, Pain, Vaccination site pain
Clinical narrative: The day of the shot - pain at site of vaccination, traveled from there to the neck, prominent headache, body aches, chills. Symptoms continued for 48 hours, with one episode of vomiting, completely emptying the stomach, overnight after 36 hours.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: The day of the shot - pain at site of vaccination, traveled from there to the neck, prominent headache, body aches, chills. Symptoms continued for 48 hours, with one episode of vomiting, completely emptying the stomach, overnight after 36 hours.
Age: 12.0
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Fall, Syncope
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative refers to a 12-year-old female patient. Her medical history, concomitant drugs, and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (reported as: Tdap) in her right arm (dose, frequency, route of administration, indication, lot# and expiry date were not provided) and meningococcal vaccine (unspecified) (dose, frequency, route of administration, indication, lot# and expiry date were not provided) in her left arm. Subsequently, at the same visit, according to the mother's decision, the patient was vaccinated with her first dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiry date were not provided) in the right arm (at the different location from diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid vaccine) for prophylaxis. A few minutes after receiving GARDASIL 9, the patient fainted and fell out of a chair. She was not hurt. She was observed with no intervention and no treatment, and went home because she seemed to be fine. The current status of the patient at the time of reporting was unknown. The reporter did not provide causality assessment between the event and GARDASIL 9 vaccine.
Age: 0.42
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a non- health care professional. This case involves a 5 months 27 days old male patient who was vaccinated with a 0.25 ml first dose of FLUZONE QUADRIVALENT (lot no UT6259KA and Expiry date 30-Jun-2019) via intramuscular route in the thigh on 31-Aug-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported whether any adverse event occurred following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Pruritus, Rash erythematous, Urticaria
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 76 years old female patient who experienced mild facial edema, a raised red rash, itching and broke out in hives, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Aug-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number UJ000AA, expiry date: 28-Mar-2019, route of administration was not reported) in the right deltoid. On 31-Aug-2018, the patient developed a non-serious raised red rash (rash), itching (pruritus) and broke out in hives (urticaria), one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also reported that the rash and the welts spread to her trunk and to her right leg. On an unknown date, the patient developed a non-serious mild facial edema (face oedema), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Relevant tests were not reported. Final diagnosis was broke out in hives, itching, a raised red rash and mild facial edema. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) every 4-6 hours, HYDROCORTISONE Cream, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and RANITIDINE HYDROCHLORIDE (ZANTAC). The patient was recovering from the events. List of documents held by sender: none.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two months old patient (gender not reported) who was vaccinated with a 0.5 ml first dose of PENTACEL (lot C5461AA and Exp. Date 26-jul-2019) via intramuscular route in the right thigh on an unspecified date. The patients medical history was not reported. Concomitant medications included PREVNAR 13 for Immunization and ROTAVIRUS VACCINE for Immunization. It was an actual medication error due to patient was given the ACTHIB portion of the PENTACEL with either Normal Saline or Hep B was not sure (product preparation error). It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, PNC, RVX
Symptoms: Expired product administered
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA252194, 2018SA252198 and 2018SA252204, same reporter. This case involves patient (age and gender not provided) who was given expired vaccine PENTACEL. The patients past medical history and family history were not provided. Concomitant medications included PREVNAR and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) Lot number, dose, route and site of administration not provided on an unknown date. It was an actual medication error due to expired vaccine used. It was reported that patient was given expired vaccine Pentacel on 05 Jul 2018, which got expired on 30 Jun 2018. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Expired product administered
Clinical narrative: Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to case 2018SA252181 (same reporter). This case involves a patient (patient 2) (age and gender not reported) who received expired vaccine of PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; and ROTAVIRUS VACCINE for Immunisation. On 15-Jul-2018, the patient received 0.5 ml dose of suspect PENTACEL lot C5384AA (expiry date: 30-JUN-2018) in the left leg. It was a case of actual medication error due to expired vaccine used. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, Product preparation error
Clinical narrative: Initial unsolicited report received from a nurse on 05-Sep-2018. This case involves a patient (age and gender not reported) who was vaccinated with a dose of ACT-HIB (Batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong solution used in drug reconstitution and it was reported that the reporter used another diluent besides the 0.4% diluent to reconstitute the ACTHIB. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pruritus
Clinical narrative: Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 68 years old female patient who had bruising and itching, while she received vaccine FLUZONE HD. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 06-Sep-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UI995AB and expiry date: 01-Apr-2019) via intramuscular route in the left arm. On an unknown date, following the vaccination the patient experienced bruising and itching. (Other relevant tests included no lab test.) Final diagnosis was itching and bruising. The patient was treated with TYLENOL and placed with Band Aid as a corrective treatment. The outcome of the event was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Chills, Pyrexia
Clinical narrative: Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves female patient who experienced fever and chills while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route. On an unknown date, the patient developed a non-serious fever and chills after receiving FLUBLOK vaccine following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included No lab data.) Final diagnosis was patient had fever and chills after receiving FLUBLOK vaccine and patient had fever and chills after receiving FLUBLOK vaccine. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for patient had fever and chills after receiving FLUBLOK vaccine. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 51 years old female patient who was given an expired dose of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant Medication was not reported. On 06-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI826AC (exp date: 30-JUN-2018) via intramuscular route in the left deltoid. It was a case of actual medication error due to expired vaccine used. It was not reported if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.