chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, via another unspecified reporter, and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, previously drug reactions, allergies, concurrent conditions or concomitant medications. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9, intramuscularly for prophylaxis at age 11 (strength, anatomical site, lot number and expiration date were not reported). Then the patient missed his second dose and on an unspecified date, more than 12 months after the first dose, the same patient got a second dose of GARDASIL 9 for prophylaxis intramuscularly (strength, anatomical site, lot number and expiration date were not reported) (Inappropriate schedule of product administration). No adverse effects were reported.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 73 years old male patient. The patient had no concomitant medications, pertinent medical history or drug reactions/allergies. On 24-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in an unspecified arm for prophylaxis (indication reported as doctor recommended) (lot #: R017900, expire date: 26-MAR-2020, dose and strength were not reported). On the same day after the vaccination, the patient developed swelling and itching in the arm where he was vaccinated. And reported the swelling and itching extended from the deltoid down to the bend of the patient's arm. No treatment was given and no lab diagnostics/studies were performed for the events. The patient had sought medical attention by contacting the pharmacist. The outcome of the events were reported as not recovered at the time of this report. The causality assessment was not provided.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 81 year old female patient who had no pertinent medical history. The patient was allergic to codeine and penicillin (unspecified). The patient didn't have any concomitant medication (reported as nothing related, different or new). On 25-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 0.5ml (intramuscular, 0.5ml once, lot # R012632 and expiration date 15-JAN-2020) for prophylaxis (reported as age indication). From 26-OCT-2018, the patient had swelling redness and itching at the injection site. On 29-OCT-2018(at time of the report), the patient had been recovered from the events. No treatment was given for the events. No lab diagnostics/studies were performed. The patient did not seek medical attention. The causality was not reported.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist via a company representative, referring to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included unspecified anti-inflammatory. On an unspecified date in October 2018 (reported as "last week"), the patient was vaccinated with the first dose of PNEUMOVAX 23 0.5 milliliter (anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis. On an unknown date in October 2018 (reported as "a couple days after receiving the vaccine"), the patient experienced an "Injection site type reactions at a location in his arm other that the injection site. The patient experienced redness, swelling and pain 2 to 2/12 inches below his bicep". It was confirmed that no treatment was received due to the events. The outcome of all the aforementioned events was unknown and the causality assessment between these events and the vaccination with PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pruritus, Pruritus generalised
Clinical narrative: Information has been received from a 56 year old female patient, concerning on herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 27-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 (administration route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unspecified date in October 2018, the patient developed itching around the injection site and then became itching all over the body which got red from scratching. It was reported that the patient took one BENADRYL which helped some (however discrepant information was reported as "not recovered). The causality assessment between the aforementioned events and the vaccination with PNEUMOVAX 23 was not provided.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Headache, Palpitations, Vomiting
Clinical narrative: Information has been received from a physician via a company representative referring to a 16 year old female patient. The patient's pertinent medical history and drug reactions/allergies were unknown by reporter. Concomitant medication included TRUMENBA. In approximately September 2018 (reported as 1 month ago), the patient administered the first dose of GARDASIL 9 (dose detail, route, strength, batch/lot # and expiration date were not reported) for prophylaxis. The patient was observed for 30 minutes after the administration of both vaccines. Physician stated the patient left the medical office and drove to an unspecified school. Upon her arrival at the school, the patient developed a headache, heart palpitations and vomited an unspecified number of times. The patient was taken to an unspecified emergency room for unspecified treatment. The outcome of the events of headache, vomiting and heart palpitations was reported as unknown. The causality was not reported.
Sex: M
Vaccine: HEPA
Symptoms: Angioedema, Milk allergy, Nausea, Pain, Swelling face
Clinical narrative: This spontaneous report as received from a 41 year old male patient, concerning himself. The patient's current conditions included allergy to pecans, walnuts, almonds, ragweed, pollen, and grass. The patient's medical history included corneal transplants and his concomitant therapies included an steroid eyedrop called fluorometholone (FML) as treatment for corneal transplants. On an unspecified date in April 2018, the patient was vaccinated with one dose of VAQTA injection (strength, anatomical location, route of administration, lot # and expiration date were not provided) as prevention of hepatitis A. On an unspecified date in 2018 (reported as A few weeks after getting the first dose of VAQTA, the patient started to get minor hives on his back, butt and legs any time after he had dairy products like Milk or Ice cream (Milk allergy, angioedema). The patient stated that that had never happened before getting the first VAQTA vaccine. On an unspecified date in October 2018, the patient received the second dose of VAQTA (strength, anatomical location, route of administration, lot # and expiration date were not provided). On an unspecified date in 2018 (reported as after getting the second dose of VAQTA, the patient started to get a major allergy after eating any dairy products, he would get nauseous and had major hives, he stated that it was very painful, his face would swell up, but not his throat. As treatment, the patient tried BENADRYL, and said that would make it better. At the time of the report, the patient has not recovered from aforementioned adverse events, he had not seek medical attention and no laboratory diagnostics or studies had been performed. The causal relationship between VAQTA and the events was not reported. He also stated that the events were a "major allergy", however, he did not consider the events to be life threatening. Upon internal review, angioedema was considered a medically significant event. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1811USA002196.
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a 41 year old male patient, concerning himself. The patient's current conditions included allergy to pecans, walnuts, almonds, ragweed, pollen, and grass. The patient's medical history included corneal transplants and his concomitant therapies included an steroid eyedrop called fluorometholone (FML) as treatment for corneal transplants. On an unspecified date in April 2018, the patient was vaccinated with one dose of VAQTA injection (strength, anatomical location, route of administration, lot # and expiration date were not provided) as prevention of hepatitis A. On an unspecified date in 2018 (reported as A few weeks after getting the first dose of VAQTA, the patient started to get minor hives on his back, butt and legs any time after he had dairy products like Milk or Ice cream (Milk allergy, angioedema). The patient stated that that had never happened before getting the first VAQTA vaccine. On an unspecified date in October 2018, the patient received the second dose of VAQTA (strength, anatomical location, route of administration, lot # and expiration date were not provided). On an unspecified date in 2018 (reported as after getting the second dose of VAQTA, the patient started to get a major allergy after eating any dairy products, he would get nauseous and had major hives, he stated that it was very painful, his face would swell up, but not his throat. As treatment, the patient tried BENADRYL, and said that would make it better. At the time of the report, the patient has not recovered from aforementioned adverse events, he had not seek medical attention and no laboratory diagnostics or studies had been performed. The causal relationship between VAQTA and the events was not reported. He also stated that the events were a "major allergy", however, he did not consider the events to be life threatening. Upon internal review, angioedema was considered a medically significant event. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1811USA002196.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This case was previously received from a medical assistant considered non-valid as there was no patient identity on 31-MAY-2018. Follow up information has been received from a medical assistant during a phone call on 30-OCT-2018. The phone call was answered by the receptionist and transferred to the medical assistant. This spontaneous report refers to an 8 weeks old female patient. Information of concurrent condition, medical history and concomitant therapy was not provided. On 03-MAY-2018, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, strength and frequency were unknown, lot # N022008, expiry date 18-FEB-2019) orally for prophylaxis. No adverse effects reported. The administered doses of ROTATEQ underwent a temperature excursion between 9 and 25 Celsius degrees for 1 hour. There was no previous temperature excursion. Data Logger was involved. This is one of the four reports received from the same reporter. Sender's Comments: US-009507513-1811USA001370: US-009507513-1811USA001371: US-009507513-1806USA000270.
Age: 0.5
Sex: F
Vaccine: RV5, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This case was previously received from a medical assistant considered non-valid as there was no patient identity on 31-MAY-2018. Follow up information has been received from a medical assistant during a phone call on 30-OCT-2018. The phone call was answered by the receptionist and transferred to the medical assistant. This spontaneous report refers to a 6 months years old female patient. Information of concurrent condition, medical history and concomitant therapy was not provided. On 23-MAY-2018, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, strength and frequency were unknown, lot # N022008, expiry date 18-FEB-2019) orally for prophylaxis. No adverse effects reported. The administered doses of ROTATEQ underwent a temperature excursion between 9 and 25 Celsius degrees for 1 hour. There was no previous temperature excursion. Data Logger was involved. This is one of the four reports received from the same reporter. Sender's Comments: US-009507513-1806USA000270: US-009507513-1811USA001371: US-009507513-1811USA001369.
Age: 0.5
Sex: F
Vaccine: RV5, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This case was previously received from a medical assistant considered non-valid as there was no patient identity on 31-MAY-2018. Follow up information has been received from a medical assistant during a phone call on 30-OCT-2018. The phone call was answered by the receptionist and transferred to the medical assistant. This spontaneous report refers to an 6 months years old female patient. Information of concurrent condition, medical history and concomitant therapy was not provided. On 23-MAY-2018, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, strength and frequency were unknown, lot # N022008, expiry date 18-FEB-2019) orally for prophylaxis. No adverse effects reported. The administered doses of ROTATEQ underwent a temperature excursion between 9 and 25 Celsius degrees for 1 hour. There was no previous temperature excursion. Data Logger was involved. This is one of the four reports received from the same reporter. Sender's Comments: US-009507513-1811USA001370: US-009507513-1806USA000270: US-009507513-1811USA001369.
Sex: U
Vaccine: FLUN3
Symptoms: Multiple allergies
Clinical narrative: A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin. No medical history was reported. No concomitant products were reported. The patient received FLUMIST (intranasal) (batch number NR) once/single administration, via nasal route, during 2015. On an unknown date, the patient experienced has a lot of different allergies. Treatment with FLUMIST (intranasal) was discontinued. The outcome of the event was unknown. The event was considered non-serious.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 18 hrs after receiving SHINGRIX, the patient experienced pruritus, localized erythema and blister. On an unknown date, the outcome of the pruritus, localized erythema and blister were not recovered/not resolved. The reporter considered the pruritus to be related to SHINGRIX. It was unknown if the reporter considered the localized erythema and blister to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband along with the patient herself. At 14:00, the patient received SHINGRIX. On the day of reporting i.e. 19th October 2018, the patient noticed itching behind her neck, blister behind her neck, blister popped and release a fluid. There was redness where the blister was located. This case has been linked with US2018190928 (husband's case), reported by the same reporter. The contact details of the physician were updated.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Neck pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of neck pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received SHINGRIX (intramuscular) .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced neck pain, pain in arm and erythema. On an unknown date, the outcome of the neck pain, pain in arm and erythema were unknown. It was unknown if the reporter considered the neck pain, pain in arm and erythema to be related to SHINGRIX. Additional details were provided as follows: Pharmacist reported that the patient was having a reaction to SHINGRIX. It was travelling up her neck, and then also below her deltoid, away from the injection site more towards her elbow. The reporter thought the reaction involved both pain and redness, though she was not sure the extent of the redness, if it was travelling all the way up the patient's neck, or if it was just occurring around the injection site, or below the injection site. The patient was concerned that the injection was not given in the deltoid.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of buttock pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (8 to 9 years ago) and post herpetic neuralgia (8 to 9 years ago, PHN for about 9 months in left buttock and down back of left leg). On 2nd October 2018, the patient received the 1st dose of SHINGRIX 50 ug. On 4th October 2018, 2 days after receiving SHINGRIX, the patient experienced buttock pain and leg pain. The patient was treated with gabapentin. On an unknown date, the outcome of the buttock pain and leg pain were not recovered/not resolved. It was unknown if the reporter considered the buttock pain and leg pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine, 2 to 3 days later she developed severe pain in her left buttock and down the back of her left leg. The pain was occurring in the same place where she had post herpetic neuralgia 8 to 9 years ago. She was taking extra gabapentin to help with the pain. She described her current pain as like having shingles again.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a year after receiving SHINGRIX, the patient experienced injection site pain, myalgia and injection site erythema. On an unknown date, the outcome of the injection site pain, myalgia and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, myalgia and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient received her dose of SHINGRIX sometime in the middle of August at her primary care office and experienced redness and pain at the injection site and myalgia throughout the body. The patient said the adverse events lasted about 4 days. The patient got 1st dose of SHINGRIX elsewhere so no other information was provided.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Mass, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of mass in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX. On 11th September 2018, 1 days after receiving SHINGRIX, the patient experienced mass and myalgia. On an unknown date, the patient experienced feeling unwell. The patient was treated with TYLENOL and ibuprofen. On an unknown date, the outcome of the mass and myalgia were recovered/resolved and the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the mass, myalgia and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The health care professional reported developing a lump that lasted a week and myalgia that started the day after receiving the dose of the SHINGRIX series. The health care professional stated she felt like she was getting sick. The health care professional was taking TYLENOL and Ibuprofen for the adverse effects. She did not have lot number and expiration date of vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that the patient had a reaction to the SHINGRIX vaccine. The healthcare professional did not say what the reaction was, but it was bad enough that the patient waited a week to get the flu shot. No patient or vaccine information was given.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Inappropriate schedule of product administration, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 82-year-old male patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 20th September 2018, (batch number B57NG, expiry date 16th April 2021)). On 23rd October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced fever, chills, erythema and tremor. On 23rd October 2018, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the fever, chills, erythema, tremor and drug dose administration interval too short were unknown. It was unknown if the reporter considered the fever, chills, erythema and tremor to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had no reaction after the first dose. On 23rd October 2018, the patient received the 2nd dose of SHINGRIX, which led to which led to shortening of the vaccination schedule. After the second dose the patient developed redness, felt feverish and had shaking.
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received FLULAVAL TETRA 2018-2019 season for prophylaxis. On an unknown date, the patient received FLULAVAL TETRA 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL TETRA 2018-2019 season, the patient experienced influenza-like symptoms and injection site stinging. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site stinging was unknown. It was unknown if the reporter considered the influenza-like symptoms and injection site stinging to be related to FLULAVAL TETRA 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms which lasted for 2 to 3 days and stinging at time of injection.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a 52-year-old female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced sickness. On 3rd October 2018, the patient experienced shingles. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the shingles and sickness were unknown and the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the shingles, rash and sickness to be related to SHINGRIX. Additional details were reported as follows: The reporter agreed to follow up from GlaxoSmithKline. The patient received 1st dose at the end of July and till the time of reporting, had not received 2nd dose. The patient got shingles on approximately 3rd October 2018. The location was upper thigh of right leg and rash resolved after 1 week. The case was fairly mild according to the patient. The patient felt very sick within 4 hours of 1st dose and was in bed for the 2 days but was fine after those two days.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event 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, unknown after receiving SHINGRIX, the patient experienced adverse event (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. The reporter stated that the patient had initial shot of SHINGRIX and was convinced that he had the second when he was hospitalized briefly. The reporter stated that there was no indication that the patient had this second shot of SHINGRIX, but this had happened. The reporter asked, what would be the consequences of a third shot of a SHINGRIX.
Sex: F
Vaccine: FLUX
Symptoms: Acute macular outer retinopathy, Visual field defect, Visual impairment, Vitreous floaters
Clinical narrative: This case was reported in a literature article and described the occurrence of acute macular outer retinopathy in a 42-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced acute macular outer retinopathy (serious criteria GSK medically significant), scotoma and floaters. On an unknown date, the outcome of the acute macular outer retinopathy, scotoma and floaters were recovering/resolving. The reporter considered the acute macular outer retinopathy, scotoma and floaters to be possibly related to Influenza vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of acute macular neuroretinopathy (AMN) of right eye in a 42-year-old female who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a female. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient had received unspecified seasonal influenza vaccine (administration route and site unspecified; dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient presented with a 2-week history of black spots and a paracentral scotoma in the right eye. Findings on multimodal imaging were classic for AMN. The findings improved but did not fully resolve 4 weeks after initial presentation with observation alone. Treatment was unknown. The author considered the event of AMN possibly related to unspecified seasonal influenza vaccine. The authors stated, "Although a febrile illness or the use of oral contraceptives is most commonly associated with the development of AMN, it is important for clinicians to also consider influenza vaccination as a possible aetiology". The article corresponding to this case is not available for regulatory submission due to copyright restriction.  Lab Comments: Lab tests were performed on unspecified date. Findings on multimodal imaging were classic for Acute macular neuroretinopathy.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 55-year-old female 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The batch number and expiry date was not obtained from patient. The patient received SHINGRIX on left arm. The patient reported that after receiving SHINGRIX, the patient at the time of reporting had a deep aching pain in her arm.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Limb discomfort
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of redness of legs in a 3-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 4MA57, expiry date 11th June 2019) for prophylaxis. On 27th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. In October 2018, 1 day 12 hrs after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced redness of legs and limb discomfort. On an unknown date, the outcome of the redness of legs was recovering/resolving and the outcome of the limb discomfort was unknown.  It was unknown if the reporter considered the redness of legs and limb discomfort to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT  2018-2019 season on an unknown thigh. Approximately 36 hours after vaccine administration, the patient developed an area of redness which measured approximately 7 inches across the anteriolateral and medial thigh. The patient also experienced some mild discomfort and was possibly favoring the extremity. The area of redness had lessened, but was still visible as of 30th October 2018.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Dyspnoea, Eye swelling, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 31st October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd November 2018, 3 days after receiving SHINGRIX, the patient experienced anaphylaxis (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), lip swelling, eye swelling, facial swelling and difficulty breathing. On an unknown date, the patient experienced injection site swelling, injection site pain, headache and nausea. On an unknown date, the outcome of the anaphylaxis, passed out, lip swelling, eye swelling, facial swelling and difficulty breathing were unknown and the outcome of the injection site swelling, injection site pain, headache and nausea were resolved with sequelae. It was unknown if the reporter considered the anaphylaxis, passed out, injection site swelling, injection site pain, headache, nausea, lip swelling, eye swelling, facial swelling and difficulty breathing to be related to SHINGRIX. Additional details were provided as follows: The patient reported that less than a week after receiving SHINGRIX vaccine the patient experienced swelling and pain at injection site, as well as headache and nausea. The patient reported that those issues resolved. The patient reported that he experienced anaphylaxis on the next Saturday, which included him passing out in the bathroom and being taken by ambulance to the emergency room where he had swelling of lips, eyes and face and had difficulty breathing. The patient reported that he was not admitted to the hospital and was released from the emergency room about 8 hours later to go home. The patient reported that his eyes and face were a little puffy as a result of the anaphylaxis, at the time of reporting. The reporter agreed to be followed up. The reporter had provided contact details of her physician.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Lip swelling, Loss of consciousness, Nausea, Swelling face
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 31st October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd November 2018, 3 days after receiving SHINGRIX, the patient experienced anaphylaxis (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), lip swelling, eye swelling, facial swelling and difficulty breathing. On an unknown date, the patient experienced injection site swelling, injection site pain, headache and nausea. On an unknown date, the outcome of the anaphylaxis, passed out, lip swelling, eye swelling, facial swelling and difficulty breathing were unknown and the outcome of the injection site swelling, injection site pain, headache and nausea were resolved with sequelae. It was unknown if the reporter considered the anaphylaxis, passed out, injection site swelling, injection site pain, headache, nausea, lip swelling, eye swelling, facial swelling and difficulty breathing to be related to SHINGRIX. Additional details were provided as follows: The patient reported that less than a week after receiving SHINGRIX vaccine the patient experienced swelling and pain at injection site, as well as headache and nausea. The patient reported that those issues resolved. The patient reported that he experienced anaphylaxis on the next Saturday, which included him passing out in the bathroom and being taken by ambulance to the emergency room where he had swelling of lips, eyes and face and had difficulty breathing. The patient reported that he was not admitted to the hospital and was released from the emergency room about 8 hours later to go home. The patient reported that his eyes and face were a little puffy as a result of the anaphylaxis, at the time of reporting. The reporter agreed to be followed up. The reporter had provided contact details of her physician.
Sex: F
Vaccine: TDAP
Symptoms: Aphonia, Cough, Malaise, Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), whooping cough (serious criteria GSK medically significant), sickness and loss of voice. The patient was treated with IV Antibiotics (Nos) and Breathing Treatment (Medication Unknown). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the whooping cough, sickness and loss of voice were recovered/resolved. It was unknown if the reporter considered the vaccination failure, whooping cough, sickness and loss of voice to be related to dTpa vaccine. Additional information received as follows: The reporter was responding to a message on social media requesting she called GlaxoSmithKline concerning about whooping cough. The patient said that 15 years before reporting date, she received the DTAP but she did not know the brand. She had a case of whooping cough 6 years before reporting date. The patient was the first documented adult to had whooping cough in her county 6 years before reporting date. She was very sick for over 6 weeks. The patient was treated in the hospital. The patient lost her voice for 3 years from the severe coughing. The patient said that she found vaccine for this evidently was not effective as she found out later. She advised to cover mouth when cough and sneeze, wash hands and kept vaccines current. This would affect her breathing the rest of her life. This was nothing to fool with. This case was considered as a suspected vaccination failure case as the time to onset and the lab test confirmation for whooping cough were unknown. The patient did not consent to follow-up. Due to technical issues, the caller was lost so no additional information was provided. The patient's physician had since retired so she did not provide his name.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received PREVNAR 13, (batch/lot number and expiration date were not reported), via an unspecified route of administration in deltoid on an unspecified date to at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced red, raised, round area about two inches below the PREVNAR 13 injection site on an unspecified date. The patient bled after the PREVNAR 13 injection in the deltoid and a vein or artery may have been hit. The outcome of the events was unknown. The information on the batch/lot number and expiration date has been requested.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 83-year-old female patient received PREVNAR 13, intramuscular on 18Oct2018 at 0.5 ml, single dose in the right arm for immunization/ pneumonia prevention, at a pharmacy/drug store. The patient's medical history and concomitant medications were reported as none. The patient experienced redness, swelling, and itching at injection site on 18Oct2018, a couple hours after receiving the injection. It was also reported that the patient's right arm was still a little sore on an unspecified date. The patient recovered with sequelae from the events, redness, swelling, and itching at injection site on an unknown date and outcome of the event, right arm was still a little sore was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Axillary pain, Blood test, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 66-year-old female patient received PREVNAR 13, (lot number: W33491), at the physician's office, intramuscular on an unspecified date at single dose for immunization/pneumonia. Medical history included vasculitis, Sjogren's syndrome both about 16 years ago, anaemia about 12 years ago and chronic kidney disease about 4 years ago. There were no concomitant medications. The patient stated on 23Sep2018. "Whole upper arm about 6 inches long and 3 inch wide swelled up; got really brick red and my under arm in my armpit swelled up and hurt". The patient underwent lab tests and procedures which included blood work on an unspecified date. The outcome of the events was recovering.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer. A 66-year-old female patient received PREVNAR 13, (lot number: W33491), at the physician's office, intramuscular on an unspecified date at single dose for immunization/pneumonia. Medical history included vasculitis, Sjogren's syndrome both about 16 years ago, anaemia about 12 years ago and chronic kidney disease about 4 years ago. There were no concomitant medications. The patient stated on 23Sep2018. "Whole upper arm about 6 inches long and 3 inch wide swelled up; got really brick red and my under arm in my armpit swelled up and hurt". The patient underwent lab tests and procedures which included blood work on an unspecified date. The outcome of the events was recovering.
Age: 71.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Hypersensitivity, Rash
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A 71-year-old female patient received PREVNAR 13, (lot number and expiration date unknown), via an unspecified route of administration at the left arm on 18Oct2018 at a single dose for immunization. The patient's medical history was not reported. Concomitant medication included influenza vaccine (FLU) administered on the right arm on 18Oct2018 for immunization. The patient had the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on that arm and then on an unspecified date, the rash was from the back of her arm to her elbow and then it started receding. The nurse described it as like an allergic reaction from the base of her elbow up to the top like the back part of her arm. Within two weeks, it was gone and so within 48 hours the rash has gone. The patient did not take any medication for the event. The outcome of the event was recovered. Information on the lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration in the arm at a single dose in Oct2018 for immunization. The patient's medical history was not reported. Concomitant vaccine include influenza vaccine (manufacturer unknown) via an unspecified route of administration in the arm at unknown dose in 01Nov2018 for immunization. It was reported that 9 days after pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccination, the patient was vaccinated with flu shot in the same arm, almost same spot. On an unspecified date, the patient reported pain on the injection site and trouble moving her arm. The outcome of the events was unknown. It was reported that the patient attributed that events to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). Information on the batch number has been requested.
Sex: M
Vaccine: MENB
Symptoms: Headache, Measles, Seizure
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer reporting for himself. A male patient of an unspecified age received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient experienced measles, seizures and headache all on an unspecified date with outcome of unknown.
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Loss of consciousness, Pneumonia
Clinical narrative: This is a spontaneous report from a contactable other HCP via a sales representative. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration in Aug2018 at single dose for immunization. Medical history included Wegener's Granulomatosis. The patient's concomitant medications were not reported. Approximately 48 hours post vaccination (on an unknown date in 2018) the patient became short of breath, passed out and was admitted to hospital with a diagnosis of pneumonia. The patient was recovered and was discharged from hospital on an unknown date in 2018. No follow up attempts are possible. No further information is expected. Information about batch number cannot be obtained. Sender's Comments: Reported diagnose of pneumonia present as short of breath and passing out occurred 2 day post vaccination with PREVENAR 13. As the timeframe between the event and vaccination date is far shorter than 14 days, the event is thus not due to the lack of efficacy with PREVENAR 13 but represents an intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program [Pfizer RXPathways]. A non-contactable consumer reported that a female patient of an unspecified age started to receive PREVNAR 13 (Solution for injection in pre-filled syringe), via an unspecified route of administration from an unspecified date to an unspecified date at an unknown dose and frequency for an unspecified indication. The patient medical history and concomitant medications were not reported. It was reported that patient had allergies with the ingredients. The action taken in response to the event for pneumococcal 13-val conj vac (dipht crm197 protein) was unknown. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Erythema, Pain, Pain in extremity, Pruritus
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a male patient who experienced burning sense from armpit to elbow and sharp burning pain when stretch arm daily for 2 weeks., sizable redness, webbing with itching within a few days, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy were reported. On an unknown date (reported as Sep 4), the patient received a dose of suspect ADACEL lot number not reported via unknown route in unknown administration site. The patient developed a non-serious burning sense from armpit to elbow and sharp burning pain when stretch arm daily for 2 weeks. (pain) (Unknown latency), sizable redness (erythema) (unknown latency), webbing with itching within a few days (pruritus) (Unknown latency) and burning sense from armpit to elbow and sharp burning pain when stretch arm daily for 2 weeks (burning sensation) (Unknown latency) following the administration of ADACEL. (Other relevant tests included No lab data.) Final diagnosis was burning sensation, redness, itching and painful arm. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome was Unknown for all the events. List of documents held by senders: None.
Sex: U
Vaccine: TYP
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age patient who was vaccinated with TYPHIM VI (Lot number: N1K811M) route and site of administration was unknown. It was reported that as nurse was giving the TYPHIM VI vaccine to patient the fluid shot out sideways, before reaching the Luer-Lok adaptor. Fluid was all over the patient during administration while needle was in patient skin (syringe leakage and exposure via skin contact). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any adverse event. Id: 100002708 Batch no: N1K811M, Expiry date: 19-Oct-2019 Sample status: Requested and Awaited. List of documents held by sender: None.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasal congestion, Pain, Pain in extremity, Respiratory tract congestion
Clinical narrative: Sore arm, aching, nasal and chest congestion.