chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 53 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated with M-M-R II (lot, expiry date, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown date of 2018 (also reported as this week), the patient experienced titre negative. The outcome and causality assessment were not provided by the reporter. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1811USA002393: US-009507513-1811USA002393.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: This spontaneous report was received from a nurse refers to a 57 year old female patient. The patient had none pertinent medical history and concomitant medication. The patient's had penicillin allergy. On 02-NOV-2018, the patient was vaccinated with PNEUMOVAX 23 injection, lot # R012501 (expiry date: 08-JAN-2020), in the left arm for vaccination (route and dosage details were not reported). On an unknown date in November 2018, the patient experienced "swelling and redness at the injection site that ran all the way down to the left hand" (erythema, peripheral swelling, vaccination site erythema, vaccination site swelling). The patient's condition was improving but the injection site was warm to the touch" (vaccination site warmth). The patient was seen by physician. None lab diagnostics/studies performed. No product quality complaint (PQC) was involved. The outcome of erythema, peripheral swelling, vaccination site erythema, vaccination site swelling was reported as recovering. The outcome of vaccination site warmth was not recovered. The reporter did not provide any causality assessment.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 74 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated with M-M-R II (lot, expiry date, dose, frequency and route of administration were not reported) for prophylaxis. On an unknown date of 2018 (also reported as this week), the patient experienced titre negative. The outcome and causality assessment were not provided by the reporter. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1811USA001650.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Headache, Nasal congestion, Throat tightness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of taste peculiar in a 51-year-old female patient who received FLULAVAL QUADRIVALENT (2018-2019 season) for prophylaxis. On 18th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season .5 ml. On 18th October 2018, 2 hrs after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced taste peculiar, throat tightness, nasal congestion and headache. On 18th October 2018, the outcome of the taste peculiar, throat tightness and nasal congestion were recovered/resolved. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the taste peculiar, throat tightness, nasal congestion and headache to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received Flu shot in the left arm. The patient reported that after dose she had strange taste in mouth, head felt all stopped up and her throat began to feel tight. The patient stated at the of reporting she had a headache. The contact details of the physician was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received SHINGRIX. On 20th October 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema. On 21st October 2018, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient noticed a bright red spot at the injection site about the size of a quarter. On 21th October 2018, 2 days after receiving SHINGRIX the patient's red spot was 2.5 to 3 inches in diameter, bright red, was tender and slightly swollen. The red spot was not painful unless the patient touches it.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 79-year-old male patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 1st dose of SHINGRIX. On 20th October 2018, 1 days after receiving SHINGRIX, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved. It was unknown if the reporter considered the dizziness to be related to SHINGRIX. Additional details were provided as follows: This case was not reported previously to anyone. The patient experienced dizziness and continued to have the issue. He had not notified his physician yet.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site pain, Injection site pruritus, Injection site swelling, Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number 5R3J5, expiry date 30th June 2019) for prophylaxis.  On 28th August 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). On 31st August 2018, 3 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site swelling, injection site itching, fever, feeling unwell, injection site discoloration and injection site pain. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the injection site swelling, injection site itching, fever, feeling unwell, injection site discoloration and injection site pain were not recovered/not resolved. The reporter considered the injection site swelling, injection site itching, fever, feeling unwell, injection site discoloration and injection site pain to be possibly related to FLUARIX QUADRIVALENT  2018-2019 season. Additional details were provided as follows: This case was reported by a certified medical assistant (CMA). The patient received a dose of FLUARIX QUADRIVALENT 2018-2019 season vaccine in the left arm. Beginning 3 days after receiving the vaccine, the patient began to experience swelling, pain, itching, and discoloration at the injection site. The patient additionally felt sick and was feverish. As treatment, the patient was prescribed an antibiotic, and the reported events remained ongoing at the time of the report.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season (batch number 5R3J5, expiry date 30th June 2019) for prophylaxis.  On 28th August 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). On 31st August 2018, 3 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site swelling, injection site itching, fever, feeling unwell, injection site discoloration and injection site pain. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the injection site swelling, injection site itching, fever, feeling unwell, injection site discoloration and injection site pain were not recovered/not resolved. The reporter considered the injection site swelling, injection site itching, fever, feeling unwell, injection site discoloration and injection site pain to be possibly related to FLUARIX QUADRIVALENT  2018-2019 season. Additional details were provided as follows: This case was reported by a certified medical assistant (CMA). The patient received a dose of FLUARIX QUADRIVALENT 2018-2019 season vaccine in the left arm. Beginning 3 days after receiving the vaccine, the patient began to experience swelling, pain, itching, and discoloration at the injection site. The patient additionally felt sick and was feverish. As treatment, the patient was prescribed an antibiotic, and the reported events remained ongoing at the time of the report.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash pustular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pustule in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced pustule, blister and rash. On an unknown date, the outcome of the pustule, blister and rash were unknown. It was unknown if the reporter considered the pustule, blister and rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient got SHINGRIX last Wednesday from the reporting date and 2 or 3 days later he developed pustules on his chest and HCP also described it as blisters or bumps on his chest.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 16th October 2018, the patient received SHINGRIX (intramuscular). On 17th October 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced flu like symptoms beginning the day after receipt of the vaccine and the symptoms lasted for a day or 2 then resolved. This is 1 of the 5 cases reported by same reporter.
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pyrexia, Viral infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of viral infection in a 12-month-old male patient who received FLUARIX TETRA 2018-2019 season (batch number AA73L, expiry date unknown) for prophylaxis. On an unknown date, the patient received FLUARIX TETRA 2018-2019 season (intramuscular). On 15th October 2018, 3 days after receiving FLUARIX TETRA 2018-2019 season, the patient experienced viral infection, cold symptoms, fever and sore throat. On an unknown date, the outcome of the viral infection, cold symptoms, fever and sore throat were unknown. It was unknown if the reporter considered the viral infection, cold symptoms, fever and sore throat to be related to FLUARIX TETRA 2018-2019 season. Additional information was reported as follows: The case was reported by the patient's mother. The age at vaccination was not reported. The patient was vaccinated with a Flu vaccine and became ill 3 to 4 days later. The patient experienced viral infection, fever, sore throat and cold symptoms. The patient was seen at the emergency room and was released. The reported batch number AA731 was not found in the sales database, so it was corrected and replaced with the correct one AA73L.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash vesicular, Skin lesion
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a female patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. On 17th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 2 days after receiving SHINGRIX, the patient experienced vesicular rash, skin lesion and erythema of extremities. On an unknown date, the outcome of the vesicular rash, skin lesion and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the vesicular rash, skin lesion and erythema of extremities 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 shingle-like lesions on arm distal to injection site. 2 to 3 days after receiving SHINGRIX, the patient noticed redness and lesions appeared. The patient's condition was stable at the reporting date with all symptoms resolved without any treatment. No further details were reported regarding the event. The healthcare professional had declined permission for further contact by safety.
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of chills in a male patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced chills, general body pain and fever. On an unknown date, the outcome of the chills, general body pain and fever were unknown. It was unknown if the reporter considered the chills, general body pain and fever to be related to FLUARIX QUADRIVELENT 2018-2019 season. Additional information was reported as follows: The age at vaccination was not reported. The patient had to miss a day at work due to the reported side effects.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, 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 55-year-old male patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 19th October 2018, the patient experienced injection site pain, injection site induration and injection site erythema. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the injection site induration and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site induration, injection site erythema and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on left arm. One day after receiving SHINGRIX, the patient developed pain, redness and hardness at the injection site. The patient stated that, the redness and hardness had resolved, however the pain had not gone away and it was limiting his range of motion in his left arm. The patient had denied permission to contact their physician.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 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: In the end of May 2018, the patient received SHINGRIX. The following day after the injection, the patient experienced a lot of pain in her upper arm that lasted a couple of weeks. About a couple of weeks after the injection, the patient did not know for sure, she started having pain when raising her arm and she still had it. The patient provided contact details of physician who was her husband and a retired physician.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of papular rash in a 71-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Vitamin D3 Liquid for an unknown indication and Nature Thyroid for an unknown indication. On 25th September 2018, the patient received the 1st dose of SHINGRIX. In 2018, the patient started Vitamin D3 Liquid at an unknown dose and frequency and Nature Thyroid at an unknown dose and frequency. In September 2018, 2 days after receiving SHINGRIX, the patient experienced papular rash and itchy rash. On an unknown date, the outcome of the papular rash was not recovered/not resolved and the outcome of the itchy rash was recovered/resolved. It was unknown if the reporter considered the papular rash and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient was a retired physician. The patient reported that, he experienced a papular rash on his forehead. It was itchy but not red. The itching lasted 4 to 5 days before resolving. There were still some traces of the rash present. The patient was not sure if SHINGRIX was the cause because he started the two concomitant medications a couple of days prior to getting the vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Periorbital swelling, Skin burning sensation, Swelling of eyelid
Clinical narrative: This case was reported by a consumer and described the occurrence of periorbital swelling in a patient who received SHINGRIX for prophylaxis. On 22nd October 2018, the patient received the 2nd dose of SHINGRIX. On 22nd October 2018, less than a day after receiving SHINGRIX, the patient experienced periorbital swelling and burning sensation skin. On an unknown date, the outcome of the periorbital swelling and burning sensation skin were unknown. It was unknown if the reporter considered the periorbital swelling and burning sensation skin to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 8:45 am, the patient received SHINGRIX. The patient noticed in the Tuesday morning for sure or perhaps Monday morning, about the puffiness under eyes and also when the patient touched it, it felt burnt.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Eye irritation, Injection site pain, Ocular hyperaemia, Swelling of eyelid
Clinical narrative: This case was reported by a consumer and described the occurrence of periorbital swelling in a patient who received SHINGRIX for prophylaxis. On 22nd October 2018, the patient received the 2nd dose of SHINGRIX. On 22nd October 2018, less than a day after receiving SHINGRIX, the patient experienced periorbital swelling and burning sensation skin. On an unknown date, the outcome of the periorbital swelling and burning sensation skin were unknown. It was unknown if the reporter considered the periorbital swelling and burning sensation skin to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 8:45 am, the patient received SHINGRIX. The patient noticed in the Tuesday morning for sure or perhaps Monday morning, about the puffiness under eyes and also when the patient touched it, it felt burnt.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of stiffness in a 75-year-old patient who received SHINGRIX for prophylaxis. On 24th October 2018, the patient received the 2nd dose of SHINGRIX. On 26th October 2018, 2 days after receiving SHINGRIX, the patient experienced stiffness and general body pain. On an unknown date, the outcome of the stiffness and general body pain were unknown. It was unknown if the reporter considered the stiffness and general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient had the extremely stiff and whole body was just aches and pains that, the patient just sat all day and did absolutely nothing. This case has been linked to the case US2018GSK196601.
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Paraesthesia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of palpitation in a 58-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 an hour after receiving SHINGRIX, the patient experienced palpitation and tingling. On an unknown date, the outcome of the palpitation and tingling were recovered/resolved. It was unknown if the reporter considered the palpitation and tingling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had heart palpitations and tingling to face within hour of receiving dose.  The symptoms resolved within an hour and patient did not seek medical attention. The reporter wanted to know if the patient should get the 2nd dose but would call Medical Information for advice and more data. Medical Information number was provided.
Sex: M
Vaccine: DTP
Symptoms: Pertussis
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of whooping cough in a 9-month-old male patient who received DTP (A or W not known) for prophylaxis. On an unknown date, the patient received the 1st dose of DTP (A or W not known). On an unknown date, 14 days after receiving DTP (A or W not known), the patient experienced whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the whooping cough was unknown. It was unknown if the reporter considered the whooping cough to be related to DTP (A or W not known). Additional information received as follows: The age at vaccination was not reported. The case was reported by the patient's father. The patient had whooping cough exactly 14 days (the incubation period) after his First DPT shot (Diphtheria, Pertussis which was whooping cough, and Tetanus). The patient contracted Whooping Cough from that shot. The patient did not have any of the most dangerous reactions because the patient's father took him to the physician at the first sign, but it was scary at the reporting time. The first 48 hours were terrible. The patient did not get another vaccine. For the patient until he started school and then he was afraid. He was all right but even so vaccinations make the patient's father nervous.
Sex: F
Vaccine: FLUX
Symptoms: Heart rate decreased, Heart rate increased, Hypersensitivity, Malaise
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of ventricular tachycardia in a 65-year-old female patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. Concurrent medical conditions included migraine. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On 11th August 2018, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced ventricular tachycardia (serious criteria GSK medically significant), heart attack (serious criteria GSK medically significant), near death experience (serious criteria GSK medically significant), asystole (serious criteria GSK medically significant) and allergy. On an unknown date, the outcome of the ventricular tachycardia, heart attack, near death experience, asystole and allergy were unknown. It was unknown if the reporter considered the ventricular tachycardia, heart attack, near death experience, asystole and allergy to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not reported. The patient felt allergic to the flu shot and was felt the vaccine killed her due to which the patient felt freaking sick. The patient wanted to know what's added in the serum of the vaccine and what was injected in her body and wished to know what was added in the vaccine. The reporter reported she nearly died on 11th August 2018. The reporter reported the hospital gave her 4 double doses of 4 different medication which caused her flat lined and reported that particular medication caused her have a heart attack. The reporter reported that her roommate watched her flat line. She felt every electrical bolt run though her body to get her heart stabilize too. The patient heart rate went from 60's to flatline to 28 to 211 beats a minute. The patient was told to have ventricular tachycardia. Lab Comments: The patient heart rate went from 60's to flatline to 28 to 211 beats a minute.
Sex: M
Vaccine: DTP
Symptoms: Death
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of death in a 18-month-old male patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis. On an unknown date, the patient received DTP (A or W not known) at an unknown dose. On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to DTP (A or W not known). Additional information was reported as follows: This case was reported by a consumer via Interactive Digital Media. The age at vaccination was not reported. It was stated that the Dtap vaccine killed the patient, the patient was only 18 months old.; Reported Cause(s) of Death: Unknown cause of death.
Sex: F
Vaccine: TDAP
Symptoms: Cough, Fall, Loss of consciousness
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a female patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, less than a year after receiving dTpa vaccine, the patient experienced passed out (serious criteria GSK medically significant) and cough. On an unknown date, the outcome of the passed out and cough were recovered/resolved. It was unknown if the reporter considered the passed out and cough to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she experienced very scary coughing episodes and that went on for weeks. The patient was passed out from coughing 3 to 4 times, she took out a fan and side table with 1 of coughing episodes. The patient reported that her niece was trying to get pregnant and the patient had her TDap months before the time of reporting.
Age: 18.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Renal failure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 18-year-old male patient who received BOOSTRIX (batch number K5F5R, expiry date 30th April 2021) for prophylaxis. Co-suspect products included PNEUMOVAX 23 for prophylaxis. On 24th October 2018, the patient received BOOSTRIX and PNEUMOVAX 23. On 27th October 2018, 3 days after receiving BOOSTRIX, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant) and renal failure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the cellulitis and renal failure were unknown. It was unknown if the reporter considered the cellulitis and renal failure to be related to BOOSTRIX. Additional details were provided as follows: The case was reported by the office manager. The patient received BOOSTRIX and PNEUMOVAX in the same arm on the same day. The patient developed cellulitis and was hospitalized that day and while in hospital developed renal failure. The patient remained in the hospital. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Irritability, Nasal pruritus, Pruritus, Rash, Skin tightness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash, pruritus, nasal itching, irritability and skin tightness. The patient was treated with prednisone and ATARAX. On an unknown date, the outcome of the rash, pruritus, nasal itching, irritability and skin tightness were unknown. It was unknown if the reporter considered the rash, pruritus, nasal itching, irritability and skin tightness to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she had been experienced skin tightness, rash, irritability, and intense itching of the midriff, scalp and nose. The patient reported that she was taking prednisone and ATARAX to treat at the reporting date. The patient refused to provide physician information and did not wanted to provide any further details.
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to SHINGRIX. Additional details were reported as follows: The reporter told to the field representative that the patient was hospitalized and was diagnosed with guillian barre syndrome after receiving SHINGRIX vaccine. The patient discharged and was currently undergoing physical therapy. Hospitalization dates and vaccination dates were unknown. No additional details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist did not have patient or vaccine information at the time of reporting. The patient experienced herpes zoster between 1st and 2nd dose of SHINGRIX. The pharmacist gave consent to follow up.
Age: 80.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Cellulitis, Injection site erythema, Local reaction, Rash erythematous, Vaccination site reaction
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported similar events for two patients. This is the 2nd of 2 reports. An 80 years old male patient received PREVENAR 13; (lot W51924, expiry date Jul2020; NDC number 0005-1971-02) on 01Oct2018, at single dose, for immunization. Medical history included ongoing arthritis pain, high blood pressure, ongoing erectile dysfunction and ongoing pain. Concomitant medications included oral ELIQUIS from 2017 and ongoing, 5 mg tablet, twice a day, oral flecainide from 2017 and ongoing, 100 mg tablet, twice a day, nasal fluticasone from 2017 and ongoing, 50 mcg nasal, 2 spray each nostril daily, oral gabapentin from 2017 and ongoing, 600 mg tablet, twice a day, lidocaine 5% ointment twice a day, from 02Oct2018 and ongoing, for arthritis pain, oral lorazepam from 28Sep2018 and ongoing, 0.5 mg tablet, 1 time/day at bedtime, oral hydrochlorothiazide, losartan potassium from 2017 and ongoing, 100/25 mg tablet, once a day, oral VIAGRA from 2017 and ongoing, 100 mg, as needed (up to every other day, only took 4 a month), for erectile dysfunction, oral tramadol from Sep2018 and ongoing, 50 mg tablet, 3x/day, for pain. On 06Oct2018, the patient had a delayed reaction and experienced arm turned red, hot and swollen with little red bumps on arm. The reaction was local where the vaccine was given, though it did spread down his arm from 07Oct2018 until 08Oct2018. The patient went to the Doctor. Treatment for the reaction included sulfamethoxazole-trimethoprim from 08Oct2018 at 800-160 mg tablet, one tablet twice a day for 7 days by mouth. The doctor prescribed this medication for cellulitis (no further clarification was provided about this statement). The events delayed reaction, arm turned red, hot and swollen started getting better on 08Oct2018 and were resolving at the time of report. Little red bumps on arm outcome was unknown. The reporting pharmacist added that she had a box of 10 vaccines and she only administered 3 of the vaccines. Two out of the three patients had delayed reactions where their arm turned red, hot, swollen with little red bumps/dots throughout the arm at the same spot that the vaccine was given. The reporter considered the events arm turned red, hot, and swollen with little red bumps on arm serious as medically significant. The reporter considered all the events related to the vaccination. Sender's Comments: Based on the information currently available, a contributory role of PREVENAR 13 towards the occurrence of "vaccination site swelling/erythema/warmth and red bumps" cannot be fully excluded considering the known adverse event profile of PREVENAR 13. Linked Report(s): US-PFIZER INC-2018421081 same reporter/drug, similar events, different patient.
Age: 80.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported similar events for two patients. This is the 2nd of 2 reports. An 80 years old male patient received PREVENAR 13; (lot W51924, expiry date Jul2020; NDC number 0005-1971-02) on 01Oct2018, at single dose, for immunization. Medical history included ongoing arthritis pain, high blood pressure, ongoing erectile dysfunction and ongoing pain. Concomitant medications included oral ELIQUIS from 2017 and ongoing, 5 mg tablet, twice a day, oral flecainide from 2017 and ongoing, 100 mg tablet, twice a day, nasal fluticasone from 2017 and ongoing, 50 mcg nasal, 2 spray each nostril daily, oral gabapentin from 2017 and ongoing, 600 mg tablet, twice a day, lidocaine 5% ointment twice a day, from 02Oct2018 and ongoing, for arthritis pain, oral lorazepam from 28Sep2018 and ongoing, 0.5 mg tablet, 1 time/day at bedtime, oral hydrochlorothiazide, losartan potassium from 2017 and ongoing, 100/25 mg tablet, once a day, oral VIAGRA from 2017 and ongoing, 100 mg, as needed (up to every other day, only took 4 a month), for erectile dysfunction, oral tramadol from Sep2018 and ongoing, 50 mg tablet, 3x/day, for pain. On 06Oct2018, the patient had a delayed reaction and experienced arm turned red, hot and swollen with little red bumps on arm. The reaction was local where the vaccine was given, though it did spread down his arm from 07Oct2018 until 08Oct2018. The patient went to the Doctor. Treatment for the reaction included sulfamethoxazole-trimethoprim from 08Oct2018 at 800-160 mg tablet, one tablet twice a day for 7 days by mouth. The doctor prescribed this medication for cellulitis (no further clarification was provided about this statement). The events delayed reaction, arm turned red, hot and swollen started getting better on 08Oct2018 and were resolving at the time of report. Little red bumps on arm outcome was unknown. The reporting pharmacist added that she had a box of 10 vaccines and she only administered 3 of the vaccines. Two out of the three patients had delayed reactions where their arm turned red, hot, swollen with little red bumps/dots throughout the arm at the same spot that the vaccine was given. The reporter considered the events arm turned red, hot, and swollen with little red bumps on arm serious as medically significant. The reporter considered all the events related to the vaccination. Sender's Comments: Based on the information currently available, a contributory role of PREVENAR 13 towards the occurrence of "vaccination site swelling/erythema/warmth and red bumps" cannot be fully excluded considering the known adverse event profile of PREVENAR 13. Linked Report(s): US-PFIZER INC-2018421081 same reporter/drug, similar events, different patient.
Age: 80.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported similar events for two patients. This is the 2nd of 2 reports. An 80 years old male patient received PREVENAR 13; (lot W51924, expiry date Jul2020; NDC number 0005-1971-02) on 01Oct2018, at single dose, for immunization. Medical history included ongoing arthritis pain, high blood pressure, ongoing erectile dysfunction and ongoing pain. Concomitant medications included oral ELIQUIS from 2017 and ongoing, 5 mg tablet, twice a day, oral flecainide from 2017 and ongoing, 100 mg tablet, twice a day, nasal fluticasone from 2017 and ongoing, 50 mcg nasal, 2 spray each nostril daily, oral gabapentin from 2017 and ongoing, 600 mg tablet, twice a day, lidocaine 5% ointment twice a day, from 02Oct2018 and ongoing, for arthritis pain, oral lorazepam from 28Sep2018 and ongoing, 0.5 mg tablet, 1 time/day at bedtime, oral hydrochlorothiazide, losartan potassium from 2017 and ongoing, 100/25 mg tablet, once a day, oral VIAGRA from 2017 and ongoing, 100 mg, as needed (up to every other day, only took 4 a month), for erectile dysfunction, oral tramadol from Sep2018 and ongoing, 50 mg tablet, 3x/day, for pain. On 06Oct2018, the patient had a delayed reaction and experienced arm turned red, hot and swollen with little red bumps on arm. The reaction was local where the vaccine was given, though it did spread down his arm from 07Oct2018 until 08Oct2018. The patient went to the Doctor. Treatment for the reaction included sulfamethoxazole-trimethoprim from 08Oct2018 at 800-160 mg tablet, one tablet twice a day for 7 days by mouth. The doctor prescribed this medication for cellulitis (no further clarification was provided about this statement). The events delayed reaction, arm turned red, hot and swollen started getting better on 08Oct2018 and were resolving at the time of report. Little red bumps on arm outcome was unknown. The reporting pharmacist added that she had a box of 10 vaccines and she only administered 3 of the vaccines. Two out of the three patients had delayed reactions where their arm turned red, hot, swollen with little red bumps/dots throughout the arm at the same spot that the vaccine was given. The reporter considered the events arm turned red, hot, and swollen with little red bumps on arm serious as medically significant. The reporter considered all the events related to the vaccination. Sender's Comments: Based on the information currently available, a contributory role of PREVENAR 13 towards the occurrence of "vaccination site swelling/erythema/warmth and red bumps" cannot be fully excluded considering the known adverse event profile of PREVENAR 13. Linked Report(s): US-PFIZER INC-2018421081 same reporter/drug, similar events, different patient.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient who experienced chills, fever and joint pain, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI977AB, expiry date: 09-Mar-2019 via unknown route in the left arm. On 26-Sep-2018, the patient developed a non-serious chills, fever and joint pain (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included No lab data. Final diagnosis was joint pain, fever and chills. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events. Additional information downloaded from database (level 2B) was received from nurse on 30-Oct-2018. Patient's demographics, lot no, therapy date and event onset date were updated in field and narrative and case became valid. List of documents held by sender: none.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 22 months old male patient who received 0.5 ml vaccine FLUZONE QUADRIVALENT lot U6260BA, expiry date:30-Jun-2019 via intramuscular route in the left thigh on 29-Oct-2018 at 04:45. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to overdose. It was reported that a 22-month old male patient was given FLUZONE QIV 0.5 ml, not 2 of the 0.25 ml in error. No bad effect, symptoms or adverse event reported and no known treatment. 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.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old female patient who received two combined 0.25 mL doses of FLUZONE QUADRIVALENT (lot number, expiry date, dose in series and route was not reported) in right thigh on 24-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to Wrong technique in product usage process. No reaction was reported. 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.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves 14 patients who was inadvertently vaccinated with a dose of expired FLUZONE QUADRIVALENT (Batch number: OI044621A, expiration date: 30-Jun-2018, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used (nurse inadvertently gave 14 adult patients expired Flu vaccine). It was unknown whether patient experienced any adverse event following 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: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 29-years female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number: UI995AA, expiration date: 01-APR-2019, dose: 0.5, route: Intramuscular and site of administration was in right deltoid) on a 22-Aug-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration and overdose. It was reported the FLUZONE HIGH DOSE was given to 29-year female employee. It was unknown if 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 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.