chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Joint range of motion decreased, Pain
Clinical narrative: According to the pt she was seen by a neurologist as a result of the pain she was experiencing post-vaccination. The neurologist concluded that the pain, restricted range of motion and loss of strength is a result of the vaccine administration.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product supply issue, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-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 fever and chills. On an unknown date, the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the fever and chills to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient for himself. The age at vaccination was not provided but it could be 63 or 64 years. Few months before the date of reporting, the patient received Shingrix. After receiving Shingrix, the patient experienced fever and chills for 24 hours. This case has been linked with case US2018192668, reported by same reporter for same patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-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 fever and chills. On an unknown date, the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the fever and chills to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient for himself. The age at vaccination was not provided but it could be 63 or 64 years. Few months before the date of reporting, the patient received Shingrix. After receiving Shingrix, the patient experienced fever and chills for 24 hours. This case has been linked with case US2018192668, reported by same reporter for same patient.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Cough, Dry throat, Malaise, Oropharyngeal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sore throat in a 63-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number Y79A5, expiry date 30th June 2019) for prophylaxis. On 17th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 17th October 2018, 10 min after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced sore throat, feeling unwell and cough. On an unknown date, the outcome of the sore throat, feeling unwell and cough were not recovered/not resolved. It was unknown if the reporter considered the sore throat, feeling unwell and cough to be related to FLULAVAL QUADRIVALENT2018-2019 season. Additional details were reported as follows: The patient received FLULAVAL QUADRIVALENT 2018-2019 season in right deltoid. The pharmacist reporting an adverse event on behalf of the patient. The patient presented with sore throat, intermittent cough, and was not feeling well. The patient did not receive the vaccine at the pharmacy but received it at one of the health clinics associated with the pharmacy or same health system.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Cough, Malaise, Oropharyngeal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of sore throat in a 63-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number Y79A5, expiry date 30th June 2019) for prophylaxis. On 17th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 17th October 2018, 10 min after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced sore throat, feeling unwell and cough. On an unknown date, the outcome of the sore throat, feeling unwell and cough were not recovered/not resolved. It was unknown if the reporter considered the sore throat, feeling unwell and cough to be related to FLULAVAL QUADRIVALENT2018-2019 season. Additional details were reported as follows: The patient received FLULAVAL QUADRIVALENT 2018-2019 season in right deltoid. The pharmacist reporting an adverse event on behalf of the patient. The patient presented with sore throat, intermittent cough, and was not feeling well. The patient did not receive the vaccine at the pharmacy but received it at one of the health clinics associated with the pharmacy or same health system.
Age: 44.0
Sex: F
Vaccine: HEP, MMRV, MMRV
Symptoms: Cellulitis, Clostridium difficile infection, Erythema, Induration, Malaise
Clinical narrative: Cellulitis.
Age: 44.0
Sex: F
Vaccine: HEP, MMRV, MMRV
Symptoms: Product administered at inappropriate site, Scar, Skin warm, Ultrasound scan, Wrong product administered
Clinical narrative: Cellulitis.
Age: 44.0
Sex: F
Vaccine: HEP, MMRV, MMRV
Symptoms: Cellulitis, Ultrasound scan
Clinical narrative: Cellulitis.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Pt. came by pharmacy 3 days after vaccination to show her right arm to pharmacist. The arm was red and appeared swollen on upper area of arm, also there was an area the size of a quarter that looked like it had blistered and popped. The blister location was really low on arm well below injection site, but still inside the red swollen area of the upper arm. The pt had stated the doctor thought it was caused by pneumonia shot and placed pt on course of antibiotics. The pt. continues to post pictures of her arm on social media. The redness seems to have reduced greatly, but the blistered area looks to be deeper in the tissue and dark in color. Pt. is still currently on antibiotics.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pruritus
Clinical narrative: Pt. came by pharmacy 3 days after vaccination to show her right arm to pharmacist. The arm was red and appeared swollen on upper area of arm, also there was an area the size of a quarter that looked like it had blistered and popped. The blister location was really low on arm well below injection site, but still inside the red swollen area of the upper arm. The pt had stated the doctor thought it was caused by pneumonia shot and placed pt on course of antibiotics. The pt. continues to post pictures of her arm on social media. The redness seems to have reduced greatly, but the blistered area looks to be deeper in the tissue and dark in color. Pt. is still currently on antibiotics.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Pt. came by pharmacy 3 days after vaccination to show her right arm to pharmacist. The arm was red and appeared swollen on upper area of arm, also there was an area the size of a quarter that looked like it had blistered and popped. The blister location was really low on arm well below injection site, but still inside the red swollen area of the upper arm. The pt had stated the doctor thought it was caused by pneumonia shot and placed pt on course of antibiotics. The pt. continues to post pictures of her arm on social media. The redness seems to have reduced greatly, but the blistered area looks to be deeper in the tissue and dark in color. Pt. is still currently on antibiotics.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Fatigue, Hyperaesthesia, Influenza like illness
Clinical narrative: About 12 hours after injection, had flu-like symptoms: "bone" pain, skin sensitivity, chills, fatigue. I was pretty sick!  After24 hours, symptoms subsided except fatigue, which took 2-3 more days to go away.  This was the second injection in  2-injection series. Second injection was about 9 weeks after first injection. First injection was uneventful. FWIW, had non-eventful flu vaccination about two weeks earlier.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Decreased appetite, Dysphonia, Eye irritation, Headache
Clinical narrative: Muscle ache, headache, burning eyes sensitive to light, decreased appetite. Chills. Eventually hoarse voice over period of five days.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Photophobia
Clinical narrative: Muscle ache, headache, burning eyes sensitive to light, decreased appetite. Chills. Eventually hoarse voice over period of five days.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Rash on upper thighs, fever off and on.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Erythema, Fatigue, Headache, Influenza like illness
Clinical narrative: Swelling /sore/arm stiffness at injection site - 10/29-11/1/2018; General fatigue/flu-like aches/ headache ; bed-ridden for 6 hr - 10/30/2018; Left arm redness/tenderness/excessively warm to touch/heat/pain- 10/31-11/1/2018.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Swelling /sore/arm stiffness at injection site - 10/29-11/1/2018; General fatigue/flu-like aches/ headache ; bed-ridden for 6 hr - 10/30/2018; Left arm redness/tenderness/excessively warm to touch/heat/pain- 10/31-11/1/2018.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Tenderness
Clinical narrative: Swelling /sore/arm stiffness at injection site - 10/29-11/1/2018; General fatigue/flu-like aches/ headache ; bed-ridden for 6 hr - 10/30/2018; Left arm redness/tenderness/excessively warm to touch/heat/pain- 10/31-11/1/2018.
Sex: U
Vaccine: HEPA, MMR, PPV, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to multiple, unspecified patients of unknown ages and genders. Information of concurrent condition, pertinent medical history, concomitant medication and drug reactions/allergies were not provided. From June 2018 to October 2018, multiple, unspecified patients received improperly stored doses of VAQTA (dose, frequency, route were unknown; therapy type: digital data logger; lot number N030287 with expiration date 22-JAN-2019; lot number N020951 with expiration date 15-OCT-2018); PNEUMOVAX 23 (dose, frequency, route were unknown; therapy type: digital data logger; lot number R002085 with expiration date 26-OCT-2019; lot number N030847 with expiration date 09-JUN-2018); ROTATEQ (dose, frequency, route were unknown; therapy type: digital data logger; lot number N004815 with expiration date 07-OCT-2019); M-M-R II (dose, frequency, route were unknown; therapy type: digital data logger; lot number N024698 with expiration date 08-SEP-2019; lot number N025889  with expiration date 18-APR-2019; lot number M045394 with expiration date 14-NOV-2018) and VARIVAX (dose, frequency, route were unknown; therapy type: digital data logger; lot number N035937 with expiration date 18-DEC-2019; lot number N030410 with expiration date 30-OCT-2019; lot number N019127 with expiration date 22-JUN-2019; lot number N017698 with expiration date 09-JUN-2019) with sterile diluent (MERCK) for prophylaxis. VAQTA, PNEUMOVAX 23, M-M-R II and ROTATEQ were exposed to temperature excursion of 9 degree centigrade to 25 degree centigrade for 1 hour and 30 minutes. VARIVAX were exposed to temperature excursion of -14 degree centigrade to -10 degree centigrade for 1 hour and 30 minutes. There was no previous temperature excursion. At the time of reporting, ROTATEQ was expired but they were not expired when administered to an unspecified patient. The sterile diluent (manufacturer unknown) used to reconstitute M-M-R II and VARIVAX was properly stored. No adverse effects were reported. This case was determined to be non-valid as no patient identifier.
Sex: M
Vaccine: PPV
Symptoms: Guillain-Barre syndrome, Plasmapheresis
Clinical narrative: This spontaneous report has been received from a pharmacy technician via a company representative, concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were unknown by reporter. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced Guillain-Barre syndrome and it was not known if the patient sought for medical attention or if laboratory diagnostics-studies were performed for the event. The reporter stated that the patient received plasmapheresis on an unknown date, due to Guillain-Barre syndrome. The outcome of Guillain-Barre syndrome was unknown. The causal relationship between the therapy and the adverse event was not assessed. Upon internal review, the adverse event of Guillain-Barre syndrome was determined to be medically significant.
Sex: U
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash in a patient who received Flu trivalent vaccine for prophylaxis. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Flu trivalent vaccine. Additional details were provided as follows: The age at vaccination was not reported. About 10 to 15 years ago, 1 to 2 patients experienced rash after receiving flu vaccine. The healthcare professional (HCP) reported that they used to pre-treat patients with BENADRYL who had reactions (rash) to flu vaccines (unknown brand). They would give 1 dose of BENADRYL an hour beforehand and ask patients to take one more dose 4 hours later, they usually do fine and they did not have any reaction again with the same sort of rash thing. Currently they have flu vaccine with no egg protein and no preservatives so they no longer have to do this. No details regarding patients or flu vaccine brand were provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 65-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. On 30th August 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd September 2018, 3 days after receiving SHINGRIX, the patient experienced rash, skin warm, swelling arm and erythema of extremities. On an unknown date, the patient experienced headache, fatigue and fever. On an unknown date, the outcome of the rash, skin warm, swelling arm, erythema of extremities and fever were recovered/resolved and the outcome of the headache and fatigue were unknown. It was unknown if the reporter considered the rash, skin warm, headache, swelling arm, fatigue, erythema of extremities and fever to be related to SHINGRIX. Additional details were reported as follows: The patient presented with swelling, hot, and red in left arm around the third day after receiving the SHINGRIX vaccination. The patient reported that there was a line of red dots on the swollen area, but this was determined to be a rash. The also experienced fatigue and headache. This case is linked with case US2018188581, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 65-year-old female patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. On 30th August 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd September 2018, 3 days after receiving SHINGRIX, the patient experienced rash, skin warm, swelling arm and erythema of extremities. On an unknown date, the patient experienced headache, fatigue and fever. On an unknown date, the outcome of the rash, skin warm, swelling arm, erythema of extremities and fever were recovered/resolved and the outcome of the headache and fatigue were unknown. It was unknown if the reporter considered the rash, skin warm, headache, swelling arm, fatigue, erythema of extremities and fever to be related to SHINGRIX. Additional details were reported as follows: The patient presented with swelling, hot, and red in left arm around the third day after receiving the SHINGRIX vaccination. The patient reported that there was a line of red dots on the swollen area, but this was determined to be a rash. The also experienced fatigue and headache. This case is linked with case US2018188581, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adult female 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, immediately after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. 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 but the patient was 50 years or older. In 2018, the patient had one dose of SHINGRIX two to three months before the reporting date and immediately she started to have pain in the arm that was injected and it had been painful ever since. The patient did not plan to get a second dose of SHINGRIX.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site pustule, Injection site swelling, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pustule in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 15th May 2018 09:00, the patient received SHINGRIX. On 15th May 2018 17:00, 8 hrs after receiving SHINGRIX, the patient experienced injection site pustule, shivering, general body pain, injection site swelling, fever and injection site burning. On 16th May 2018, the outcome of the shivering, general body pain, injection site swelling, fever and injection site burning were recovered/resolved. On an unknown date, the outcome of the injection site pustule was recovered/resolved. It was unknown if the reporter considered the injection site pustule, shivering, general body pain, injection site swelling, fever and injection site burning to be related to SHINGRIX. Additional details were provided as follows: By 5 or 6 pm on the day of vaccination, the patient experienced pimples all around the injection site, burning at the injection site, shivering, chills, swelling at the injection site, low grade fever and body ache. The symptoms were lasted throughout the night. All her symptoms went away within the next day except the pimples at the injection site, they lasted 3 or 4 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pustule in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 15th May 2018 09:00, the patient received SHINGRIX. On 15th May 2018 17:00, 8 hrs after receiving SHINGRIX, the patient experienced injection site pustule, shivering, general body pain, injection site swelling, fever and injection site burning. On 16th May 2018, the outcome of the shivering, general body pain, injection site swelling, fever and injection site burning were recovered/resolved. On an unknown date, the outcome of the injection site pustule was recovered/resolved. It was unknown if the reporter considered the injection site pustule, shivering, general body pain, injection site swelling, fever and injection site burning to be related to SHINGRIX. Additional details were provided as follows: By 5 or 6 pm on the day of vaccination, the patient experienced pimples all around the injection site, burning at the injection site, shivering, chills, swelling at the injection site, low grade fever and body ache. The symptoms were lasted throughout the night. All her symptoms went away within the next day except the pimples at the injection site, they lasted 3 or 4 days.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, muscle pain and chills. On an unknown date, the outcome of the fever, muscle pain and chills were recovered/resolved. It was unknown if the reporter considered the fever, muscle pain and chills to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient experienced all the symptoms for 3 days. The patient had denied permission to contact their physician. The reporter refused to provide date of birth. This case was linked with case US2018190184 (wife's case), reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On 13th October 2018, the patient received SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and fever. In October 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm and fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had a fever for a couple of days but her arm was still sore five days after administration.    The reporter refused to provide additional information until he enters the adverse event into his system. The reporter was transferred to Medical Information for additional assistance.
Sex: F
Vaccine: FLUX
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 adult female patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine (intramuscular). On an unknown date, less than a day after receiving Flu vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received flu vaccine on an unknown arm but she could not recall the name of the vaccine and experienced pain in arm at the injection site which lasted for a few days and then resolved. No additional details were available. The patient denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of decreased white cell count in a adult male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 6 days after receiving SHINGRIX, the patient experienced decreased white cell count. On an unknown date, the outcome of the decreased white cell count was unknown. It was unknown if the reporter considered the decreased white cell count to be related to SHINGRIX. Additional details were provided a follows: The age at the vaccination was not reported, however the patient was in the 50 to 60 age range. The patient received a dose of SHINGRIX 3 weeks ago. Six days later the patient had a routine well visit with his physician and normal blood work was drawn. The reporter stated his white blood cells (WBC) was half of what it was normal, providing a 3.2 value. The reporter believed this was a result of the SHINGRIX vaccine. The reporter noted he had a follow up appointment in a month with his physician to test again. The patient felt fine and no other events otherwise.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site pain, Oral herpes, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced cold sores, pruritus and blister. On 17th July 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, cold sores, pruritus and blister were recovered/resolved. It was unknown if the reporter considered the injection site pain, cold sores, pruritus and blister to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The next day post vaccination, the patient experienced pain and soreness at the injection site which lasted for a couple of days. Within a week of vaccination, the patient developed blisters and itching on her buttock area, along with cold sore on lip, this lasted for about 7 to 10 days. The patient gave permission to contact her physician and provided the address details for the same. No further details were provided.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received FLUARIX QUADRIVALENT (batch number 92XR5, expiry date 30th June 2019) for prophylaxis. On 17th October 2018, the patient received the 2nd dose of FLUARIX QUADRIVALENT (subcutaneous) .5 ml. On 17th October 2018, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema, pain, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, pain and injection site swelling were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site erythema, pain and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT in the right arm subcutaneously, which led to incorrect route of vaccination. The patient presented with redness at injection site, swelling at injection site and right side of body hurt.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse via out of hour services and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. Concomitant products included INFLUENZA VACCINE (INFLUENZA SHOT). On 17th October 2018, the patient received SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that she administered the SHINGRIX vaccine to a patient 5 days before the time of reporting and the patient came back the day before the time of reporting with shingles on his arm. The patient also had a high dose flu shot one week earlier than the SHINGRIX vaccine. Attempted to call the healthcare professional to gain additional details and the voicemail box was full.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin erosion, Sunburn
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy scalp in a 75-year-old female patient who received SHINGRIX (batch number EY93J, expiry date unknown) for prophylaxis. On 22nd October 2018, the patient received the 1st dose of SHINGRIX. On 23rd October 2018, 1 days after receiving SHINGRIX, the patient experienced itchy scalp, sunburn and raw skin. On an unknown date, the outcome of the itchy scalp, sunburn and raw skin were not recovered/not resolved. It was unknown if the reporter considered the itchy scalp, sunburn and raw skin to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on Left arm at 12:07 PM. The patient received the Shingrix vaccine two days ago from the date of reporting. The patient called the pharmacy and reported that the following day she had a raw, itchy scalp and it feels like a sun burn on her head. The patient had not washed her hair and the symptoms had not resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. The patient's past medical history included shingles (reoccurring). 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 shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that a patient received their initial dose of SHINGRIX and developed shingles thereafter. No further details were reported regarding the event.
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cancer in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In September 2018, unknown after receiving SHINGRIX, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown. It was unknown if the reporter considered the cancer to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The reporter stated via online chat that the patient was diagnosed with cancer in September 2018. The patient had already received one dose of SHINGRIX, but the timing was unknown. No other information was provided. The chatter stated that question was urgent and that the patient was waiting at the time of reporting. The reporter stated that the timing was unknown, but if the patient was diagnosed in September it was likely that the patient received the first dose before being diagnosed.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of shingles in a 53-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported, but the patient was 53 years old at the reporting time. The patient never had shingles until the 1st dose of SHINGRIX. The shingles was mild and on the patient's forehead and face. The second dose of SHINGRIX which was scheduled on 1st November 2018. Since the patient had an outbreak at the time of reporting, she asked if she could keep the 2nd dose scheduled if the adverse event had not cleared up by then and if not did she have to start over with the first dose again. The patient reported that her physician did not leave her with much confidence in his knowledge of the vaccine.
Sex: U
Vaccine: FLU4
Symptoms: Blood pressure increased, Dyspnoea, Headache, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shortness of breath in a patient who received FLULAVAL QUADRIVALENT (2018-2019 season) (batch number Y79A5, expiry date unknown) for prophylaxis. On 19th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season .5 ml. On 19th October 2018, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced shortness of breath, increased blood pressure, hives and headache. On an unknown date, the outcome of the shortness of breath, increased blood pressure, hives and headache were unknown. It was unknown if the reporter considered the shortness of breath, increased blood pressure, hives and headache to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional information received as follows: The age at vaccination was not reported. The pharmacist stated that the patient experienced some side effects like shortness of breath, headache, elevated blood pressure and hives. The patient was sent to the emergency room. This is 1 of the 12 linked cases, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Blood pressure increased, Dyspnoea, Headache, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shortness of breath in a patient who received FLULAVAL QUADRIVALENT (2018-2019 season) (batch number Y79A5, expiry date unknown) for prophylaxis. On 19th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season .5 ml. On 19th October 2018, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced shortness of breath, increased blood pressure, hives and headache. On an unknown date, the outcome of the shortness of breath, increased blood pressure, hives and headache were unknown. It was unknown if the reporter considered the shortness of breath, increased blood pressure, hives and headache to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional information received as follows: The age at vaccination was not reported. The pharmacist stated that the patient experienced some side effects like shortness of breath, headache, elevated blood pressure and hives. This is 1 of the 12 linked cases, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Blood pressure increased, Dyspnoea, Headache, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shortness of breath in a patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number Y79A5, expiry date unknown) for prophylaxis. On 19th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season .5 ml. On 19th October 2018, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced shortness of breath, increased blood pressure, hives and headache. On an unknown date, the outcome of the shortness of breath, increased blood pressure, hives and headache were unknown. It was unknown if the reporter considered the shortness of breath, increased blood pressure, hives and headache to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional information received as follows: The age at vaccination was not reported. The pharmacist stated that the patient experienced some side effects like shortness of breath, headache, elevated blood pressure and hives. This is 1 of the 12 linked cases, reported by the same reporter.
Sex: U
Vaccine: TD, TDAP
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received from a nurse on 01-Aug-2018. In this case unknown quantity of vaccines ADACEL and ADULT TENIVAC (lot number not reported via unknown route in unknown administration site for both the vaccines) were improperly stored and were administered to 5 unknown number of patients. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was as potential medication error due to product storage error. It was not confirmed whether the patients 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 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: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult patient (age and gender not reported), who was vaccinated with a dose of vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were not reported. It was a case of actual medication error due to incorrect product storage. It was unknown if any adverse event occurred or not following the vaccination. 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. Documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Immune system disorder, Lymphadenopathy
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 59 years old male patient who developed some difficulty with his immune response and lymphadenopathy, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route. On an unknown date, the patient developed a non-serious the patient develops some difficulty with his immune response following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious lymphadenopathy following the administration of INFLUENZA QUADRIVAL A-B VACCINE. In the past the patient has taken the FLUZONE INTRADERMAL as the alternative to the Quadrivalent IM, but it not available this year. No lab data reported. Final diagnosis was lymphadenopathy and the patient develops some difficulty with his immune response. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for the patient develops some difficulty with his immune response and as Unknown for lymphadenopathy.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 years old female patient who experienced redness at injection site and swelling at injection site, while she received vaccine FLUZONE QUADRIVALENT. Patient had been ill with a cold and sinus infection prior to flu vaccine for 5 weeks. On 05-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the left deltoid. The patient developed a non-serious redness at injection site same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient developed a non-serious swelling at injection site same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient also had cough, low grade fever and vomiting on an unknown date following vaccination. (Other relevant tests included no lab test). Final diagnosis was swelling at injection site and redness at injection site. The doctor told to give her BENADRYL. The patient outcome is reported as recovered for redness at injection site and as recovered for swelling at injection site. Outcome of other events were not recovered.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient who experienced administered the vaccine to a patient SQ instead of IM, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via subcutaneous route. It was a case of actual medication error due to vaccine administered at inappropriate site. The patient outcome is reported as Not Applicable for administered the vaccine to a patient SQ instead of IM. 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.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse. This case is linked to cases 2018SA284725, 2018SA284730, 2018SA284726, 2018SA284727, 2018SA284723, 2018SA284722, 2018SA284728, 2018SA284732, 2018SA284733 and 2018SA284734. (Same reporter). This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and expiry date not reported) via intramuscular route in the left deltoid on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No information about any adverse event reported. 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: M
Vaccine: DTAP
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an adult male patient (age was not reported) who was vaccinated with a 0.5 ml dose of DAPTACEL (lot: C5206AA; expiry date: 05-May-2019) via subcutaneous route in the left forearm instead of ADULT TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and Inappropriate route of vaccination. It was also a case of Inappropriate age at vaccine administration. It was unknown whether patient had adverse event related to vaccination. 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. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 76 years old female patient who developed red/pink circle was bigger, and it was about 3.5 to 4 inches long and 2 to 2.5 inches across/no pain but this time it did swell up, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Notes: The patient received the flu shot last year and underneath where she received the injection there was a red or pink circle. She said that it was the size of a 50 cent piece and it was 1.5 inches thick and then went away. On 14-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported in the left arm. On an unknown date, the patient developed a non-serious the red/pink circle was bigger, and it was about 3.5 to 4 inches long and 2 to 2.5 inches across/no pain but this time it did swell up following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No lab data reported. Final diagnosis was the red/pink circle was bigger, and it was about 3.5 to 4 inches long and 2 to 2.5 inches across/no pain but this time it did swell up. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered/Resolved on an unknown date for the red/pink circle was bigger, and it was about 3.5 to 4 inches long and 2 to 2.5 inches across/no pain but this time it did swell up.