chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Fatigue, Somnolence
Clinical narrative: Tired, sleepy, weakness, off work 2 days. Very hard to wake up.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Amnesia, Confusional state, Delirium, Feeling abnormal, Hyperhidrosis
Clinical narrative: Tired, sleepy, weakness, off work 2 days. Very hard to wake up.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Incoherent, Loss of consciousness, Malaise, Speech disorder
Clinical narrative: Tired, sleepy, weakness, off work 2 days. Very hard to wake up.
Age: 93.0
Sex: F
Vaccine: FLUA3
Symptoms: Chest pain
Clinical narrative: Chest pains.
Age: 14.0
Sex: U
Vaccine: FLU4
Symptoms: Abdominal discomfort, Cough, Dyspnoea, Fatigue, Immediate post-injection reaction
Clinical narrative: Patient lost consciousness immediately after injection. Patient regained consciousness, very pale-stated very tired, stomach upset. Seemed as if short of breath. He described felt as if bug bite on his throat and cough. Called 911. Patient was checked out and released with father. Patient stated he started to feel better after 911 was called. He states he didn't eat much that day.
Age: 14.0
Sex: U
Vaccine: FLU4
Symptoms: Loss of consciousness, Pallor, Throat irritation
Clinical narrative: Patient lost consciousness immediately after injection. Patient regained consciousness, very pale-stated very tired, stomach upset. Seemed as if short of breath. He described felt as if bug bite on his throat and cough. Called 911. Patient was checked out and released with father. Patient stated he started to feel better after 911 was called. He states he didn't eat much that day.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Patient said she had a red, sore arm and didn't feel well. She put ice on it and took fever reducers. Was sore for 10 days.
Age: 85.0
Sex: F
Vaccine: FLUA3
Symptoms: Back pain, Chest discomfort, Flushing, Immediate post-injection reaction
Clinical narrative: Patient began to flush immediately. Complained of tightness in the chest and pain in her back. Clinic nurse and pharmacist observed and monitored pulse and breathing. 911 was called and patient was transported to the ER.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient presented with a very red swollen arm, it was hot to the touch. Patient put ice on the spot and took antipyretics.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: The evening after receiving the immunization, her arm was very sore and she could not lift it above her shoulder. The next day there was a large hive looking lump that looked like "a 2nd muscle on my arm". The bump was not at the site of immunization.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Hypoaesthesia, Pruritus
Clinical narrative: After receiving shot, pt reports she was itchy and had a stomach ache. The following morning she noticed her right hand, foot, and butt cheek were numb.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever, very sore arm up through neck, red line on arm.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: IMZ site red, puffy and 2-3 in across. Not hot, or painful.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On an unspecified date in 2012, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date in 2012, the patient contracted a persistent strain of herpes zoster. On or about 24-SEP-2012, the patient was treated for a persistent and severe vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Back pain, Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Patient presented to ED for evaluation of chest pain which started 3/20/18. Sent for cardiac MRI which was consistent with myopericarditis likely related to recent small pox vaccination. Vaccination site currently scabbing. No evidence of infarction on cardiac MRI. Chest pain resolved with several doses of NSAIDs. Patient discharged with instructions to have repeat limited ECHO in 4-6 weeks.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Face and mouth X-ray, Myocarditis, Nuclear magnetic resonance imaging heart, Pericarditis, Scan with contrast
Clinical narrative: Patient presented to ED for evaluation of chest pain which started 3/20/18. Sent for cardiac MRI which was consistent with myopericarditis likely related to recent small pox vaccination. Vaccination site currently scabbing. No evidence of infarction on cardiac MRI. Chest pain resolved with several doses of NSAIDs. Patient discharged with instructions to have repeat limited ECHO in 4-6 weeks.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin, Vaccination complication
Clinical narrative: Patient presented to ED for evaluation of chest pain which started 3/20/18. Sent for cardiac MRI which was consistent with myopericarditis likely related to recent small pox vaccination. Vaccination site currently scabbing. No evidence of infarction on cardiac MRI. Chest pain resolved with several doses of NSAIDs. Patient discharged with instructions to have repeat limited ECHO in 4-6 weeks.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Echocardiogram, Myocarditis, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging heart
Clinical narrative: Patient presented to ED for evaluation of chest pain which started 3/20/18. Sent for cardiac MRI which was consistent with myopericarditis likely related to recent small pox vaccination. Vaccination site currently scabbing. No evidence of infarction on cardiac MRI. Chest pain resolved with several doses of NSAIDs. Patient discharged with instructions to have repeat limited ECHO in 4-6 weeks.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Vaccination site scab
Clinical narrative: Patient presented to ED for evaluation of chest pain which started 3/20/18. Sent for cardiac MRI which was consistent with myopericarditis likely related to recent small pox vaccination. Vaccination site currently scabbing. No evidence of infarction on cardiac MRI. Chest pain resolved with several doses of NSAIDs. Patient discharged with instructions to have repeat limited ECHO in 4-6 weeks.
Age: 21.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Respiratory tract congestion, Tongue pruritus
Clinical narrative: My tongue itched within the first 5 minutes and within the first 10 minutes my throat became very tight and it felt like there was an obstruction I was breathing and swallowing around. I also became very faint feeling and dizzy. It was harder to breathe like my throat was congested.
Age: 21.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Allergy test positive, Dizziness, Dyspnoea, Hypersensitivity, Throat tightness
Clinical narrative: My tongue itched within the first 5 minutes and within the first 10 minutes my throat became very tight and it felt like there was an obstruction I was breathing and swallowing around. I also became very faint feeling and dizzy. It was harder to breathe like my throat was congested.
Age: 21.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Tongue pruritus
Clinical narrative: My tongue itched within the first 5 minutes and within the first 10 minutes my throat became very tight and it felt like there was an obstruction I was breathing and swallowing around. I also became very faint feeling and dizzy. It was harder to breathe like my throat was congested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Contusion, Fatigue, Pain, Pruritus
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 16th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, rash zosteriform, blister, injection site bruising, rash and papule. The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the injection site pain, rash zosteriform and rash were recovered/resolved and the outcome of the blister, injection site bruising and papule were unknown.  It was unknown if the reporter considered the injection site pain, rash zosteriform, blister, injection site bruising, rash and papule to be related to SHINGRIX. Additional information was received as follows: The healthcare professional reported that the patient experienced bruised and achy feeling at the injection site. No timeline was reported for this. Three days after receipt of the first dose of SHINGRIX, the patient noticed a rash on her left hand which later appeared on her right knee and on the right side of her abdomen. She saw her doctor who noted 2 small papule blisters on the patient's face. The physician noted that the rash resembled a zoster rash. The vaccine was not administered at the reporter's facility and no further administration details were available. The patient was treated with antihistamines and the rash had resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash maculo-papular, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 16th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, rash zosteriform, blister, injection site bruising, rash and papule. The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the injection site pain, rash zosteriform and rash were recovered/resolved and the outcome of the blister, injection site bruising and papule were unknown.  It was unknown if the reporter considered the injection site pain, rash zosteriform, blister, injection site bruising, rash and papule to be related to SHINGRIX. Additional information was received as follows: The healthcare professional reported that the patient experienced bruised and achy feeling at the injection site. No timeline was reported for this. Three days after receipt of the first dose of SHINGRIX, the patient noticed a rash on her left hand which later appeared on her right knee and on the right side of her abdomen. She saw her doctor who noted 2 small papule blisters on the patient's face. The physician noted that the rash resembled a zoster rash. The vaccine was not administered at the reporter's facility and no further administration details were available. The patient was treated with antihistamines and the rash had resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site bruising, Injection site pain, Injection site papule, Injection site rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 16th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, rash zosteriform, blister, injection site bruising, rash and papule. The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the injection site pain, rash zosteriform and rash were recovered/resolved and the outcome of the blister, injection site bruising and papule were unknown.  It was unknown if the reporter considered the injection site pain, rash zosteriform, blister, injection site bruising, rash and papule to be related to SHINGRIX. Additional information was received as follows: The healthcare professional reported that the patient experienced bruised and achy feeling at the injection site. No timeline was reported for this. Three days after receipt of the first dose of SHINGRIX, the patient noticed a rash on her left hand which later appeared on her right knee and on the right side of her abdomen. She saw her doctor who noted 2 small papule blisters on the patient's face. The physician noted that the rash resembled a zoster rash. The vaccine was not administered at the reporter's facility and no further administration details were available. The patient was treated with antihistamines and the rash had resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 16th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, rash zosteriform, blister, injection site bruising, rash and papule. The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the injection site pain, rash zosteriform and rash were recovered/resolved and the outcome of the blister, injection site bruising and papule were unknown.  It was unknown if the reporter considered the injection site pain, rash zosteriform, blister, injection site bruising, rash and papule to be related to SHINGRIX. Additional information was received as follows: The healthcare professional reported that the patient experienced bruised and achy feeling at the injection site. No timeline was reported for this. Three days after receipt of the first dose of SHINGRIX, the patient noticed a rash on her left hand which later appeared on her right knee and on the right side of her abdomen. She saw her doctor who noted 2 small papule blisters on the patient's face. The physician noted that the rash resembled a zoster rash. The vaccine was not administered at the reporter's facility and no further administration details were available. The patient was treated with antihistamines and the rash had resolved.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV9, HEPA, HPV4, MNQ
Symptoms: Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness, Seizure, Tinnitus
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patients of an unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On unknown dates, unspecified patients were inadvertently administered doses of the following vaccines, that had been improperly stored (product storage error): VARIVAX lot # N022977, expiration date 23-AUG-2019 (dose and route were not provided) and PROQUAD lot # R006747, expiration date 03-SEP-2019 (dose and route were not provided) both vaccines for prophylaxis. The vaccines were exposed to a temperature of 7.3°C for 50 minutes. There was no previous temperature excursion. It was reported that digital data logger was involved. The vaccines were reconstituted with properly stored diluent. No adverse effect was reported. No product quality complaint (PQC) was involved. Upon receipt of follow-up information on 11-OCT-2018, it was determined that this case is now valid because patient identifiers was reported. The patient did not have any illness at the time of vaccination. On 31-AUG-2018, the physician went in to give patient MENACTRA, GARDASIL and hepatitis A virus vaccine (unspecified). It was reported that temperature excursion did not occur as a result of a reading from a Digital Data Logger. The patient was nervous at first that his mom was on his left side. On the same date, the patient was vaccinated with GARDASIL in right deltoid (strength, dose, route of administration was not reported) (lot# N024812, expiry date not reported) for prophylaxis; and second dose of hepatitis A virus vaccine (unspecified) in right deltoid (lot# 3tg52, expiry date not reported) separately. On 31-AUG-2018, (also reported "as soon as") the hepatitis A virus vaccine (unspecified) was removed, the patient started to seize on the physician. The patient's mother had him in her arms and laid him down. After the patient was laid down the physician grabbed the needles, so he would not get stuck again from seizing. When the physician entered the room, he noticed that the patient was still seizing for a few seconds (seizure) and stopped. He came to his conscious but had ringing in his ears (tinnitus) and couldn't hear (hypoacusis). The patient also urinated on himself. The patient was sent to emergency room (ER) as per the physician. No prescription drug treatment for the experienced required. On 31-AUG-2018, the patient recovered from seizure. The outcome of the event, tinnitus and hypoacusis was unknown. The causality assessment was not reported. The adverse event was not reported previously. Upon internal review, the event seizure was determined to be medically significant.; Sender's Comments: US-009507513-1810USA007703:
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV9, HEPA, HPV4, MNQ
Symptoms: Tremor, Urinary incontinence
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patients of an unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On unknown dates, unspecified patients were inadvertently administered doses of the following vaccines, that had been improperly stored (product storage error): VARIVAX lot # N022977, expiration date 23-AUG-2019 (dose and route were not provided) and PROQUAD lot # R006747, expiration date 03-SEP-2019 (dose and route were not provided) both vaccines for prophylaxis. The vaccines were exposed to a temperature of 7.3°C for 50 minutes. There was no previous temperature excursion. It was reported that digital data logger was involved. The vaccines were reconstituted with properly stored diluent. No adverse effect was reported. No product quality complaint (PQC) was involved. Upon receipt of follow-up information on 11-OCT-2018, it was determined that this case is now valid because patient identifiers was reported. The patient did not have any illness at the time of vaccination. On 31-AUG-2018, the physician went in to give patient MENACTRA, GARDASIL and hepatitis A virus vaccine (unspecified). It was reported that temperature excursion did not occur as a result of a reading from a Digital Data Logger. The patient was nervous at first that his mom was on his left side. On the same date, the patient was vaccinated with GARDASIL in right deltoid (strength, dose, route of administration was not reported) (lot# N024812, expiry date not reported) for prophylaxis; and second dose of hepatitis A virus vaccine (unspecified) in right deltoid (lot# 3tg52, expiry date not reported) separately. On 31-AUG-2018, (also reported "as soon as") the hepatitis A virus vaccine (unspecified) was removed, the patient started to seize on the physician. The patient's mother had him in her arms and laid him down. After the patient was laid down the physician grabbed the needles, so he would not get stuck again from seizing. When the physician entered the room, he noticed that the patient was still seizing for a few seconds (seizure) and stopped. He came to his conscious but had ringing in his ears (tinnitus) and couldn't hear (hypoacusis). The patient also urinated on himself. The patient was sent to emergency room (ER) as per the physician. No prescription drug treatment for the experienced required. On 31-AUG-2018, the patient recovered from seizure. The outcome of the event, tinnitus and hypoacusis was unknown. The causality assessment was not reported. The adverse event was not reported previously. Upon internal review, the event seizure was determined to be medically significant.; Sender's Comments: US-009507513-1810USA007703:
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV9, HEPA, HPV4, MNQ
Symptoms: Eye movement disorder, Hypoacusis, Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patients of an unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On unknown dates, unspecified patients were inadvertently administered doses of the following vaccines, that had been improperly stored (product storage error): VARIVAX lot # N022977, expiration date 23-AUG-2019 (dose and route were not provided) and PROQUAD lot # R006747, expiration date 03-SEP-2019 (dose and route were not provided) both vaccines for prophylaxis. The vaccines were exposed to a temperature of 7.3°C for 50 minutes. There was no previous temperature excursion. It was reported that digital data logger was involved. The vaccines were reconstituted with properly stored diluent. No adverse effect was reported. No product quality complaint (PQC) was involved. Upon receipt of follow-up information on 11-OCT-2018, it was determined that this case is now valid because patient identifiers was reported. The patient did not have any illness at the time of vaccination. On 31-AUG-2018, the physician went in to give patient MENACTRA, GARDASIL and hepatitis A virus vaccine (unspecified). It was reported that temperature excursion did not occur as a result of a reading from a Digital Data Logger. The patient was nervous at first that his mom was on his left side. On the same date, the patient was vaccinated with GARDASIL in right deltoid (strength, dose, route of administration was not reported) (lot# N024812, expiry date not reported) for prophylaxis; and second dose of hepatitis A virus vaccine (unspecified) in right deltoid (lot# 3tg52, expiry date not reported) separately. On 31-AUG-2018, (also reported "as soon as") the hepatitis A virus vaccine (unspecified) was removed, the patient started to seize on the physician. The patient's mother had him in her arms and laid him down. After the patient was laid down the physician grabbed the needles, so he would not get stuck again from seizing. When the physician entered the room, he noticed that the patient was still seizing for a few seconds (seizure) and stopped. He came to his conscious but had ringing in his ears (tinnitus) and couldn't hear (hypoacusis). The patient also urinated on himself. The patient was sent to emergency room (ER) as per the physician. No prescription drug treatment for the experienced required. On 31-AUG-2018, the patient recovered from seizure. The outcome of the event, tinnitus and hypoacusis was unknown. The causality assessment was not reported. The adverse event was not reported previously. Upon internal review, the event seizure was determined to be medically significant.; Sender's Comments: US-009507513-1810USA007703:
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV9, HEPA, HPV4, MNQ
Symptoms: Seizure, Tinnitus, Tremor, Urinary incontinence
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patients of an unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On unknown dates, unspecified patients were inadvertently administered doses of the following vaccines, that had been improperly stored (product storage error): VARIVAX lot # N022977, expiration date 23-AUG-2019 (dose and route were not provided) and PROQUAD lot # R006747, expiration date 03-SEP-2019 (dose and route were not provided) both vaccines for prophylaxis. The vaccines were exposed to a temperature of 7.3°C for 50 minutes. There was no previous temperature excursion. It was reported that digital data logger was involved. The vaccines were reconstituted with properly stored diluent. No adverse effect was reported. No product quality complaint (PQC) was involved. Upon receipt of follow-up information on 11-OCT-2018, it was determined that this case is now valid because patient identifiers was reported. The patient did not have any illness at the time of vaccination. On 31-AUG-2018, the physician went in to give patient MENACTRA, GARDASIL and hepatitis A virus vaccine (unspecified). It was reported that temperature excursion did not occur as a result of a reading from a Digital Data Logger. The patient was nervous at first that his mom was on his left side. On the same date, the patient was vaccinated with GARDASIL in right deltoid (strength, dose, route of administration was not reported) (lot# N024812, expiry date not reported) for prophylaxis; and second dose of hepatitis A virus vaccine (unspecified) in right deltoid (lot# 3tg52, expiry date not reported) separately. On 31-AUG-2018, (also reported "as soon as") the hepatitis A virus vaccine (unspecified) was removed, the patient started to seize on the physician. The patient's mother had him in her arms and laid him down. After the patient was laid down the physician grabbed the needles, so he would not get stuck again from seizing. When the physician entered the room, he noticed that the patient was still seizing for a few seconds (seizure) and stopped. He came to his conscious but had ringing in his ears (tinnitus) and couldn't hear (hypoacusis). The patient also urinated on himself. The patient was sent to emergency room (ER) as per the physician. No prescription drug treatment for the experienced required. On 31-AUG-2018, the patient recovered from seizure. The outcome of the event, tinnitus and hypoacusis was unknown. The causality assessment was not reported. The adverse event was not reported previously. Upon internal review, the event seizure was determined to be medically significant.; Sender's Comments: US-009507513-1810USA007703:
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV9, HEPA, HPV4, MNQ
Symptoms: Hypoacusis, Loss of consciousness, Nervousness, Product storage error, Seizure
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patients of an unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On unknown dates, unspecified patients were inadvertently administered doses of the following vaccines, that had been improperly stored (product storage error): VARIVAX lot # N022977, expiration date 23-AUG-2019 (dose and route were not provided) and PROQUAD lot # R006747, expiration date 03-SEP-2019 (dose and route were not provided) both vaccines for prophylaxis. The vaccines were exposed to a temperature of 7.3°C for 50 minutes. There was no previous temperature excursion. It was reported that digital data logger was involved. The vaccines were reconstituted with properly stored diluent. No adverse effect was reported. No product quality complaint (PQC) was involved. Upon receipt of follow-up information on 11-OCT-2018, it was determined that this case is now valid because patient identifiers was reported. The patient did not have any illness at the time of vaccination. On 31-AUG-2018, the physician went in to give patient MENACTRA, GARDASIL and hepatitis A virus vaccine (unspecified). It was reported that temperature excursion did not occur as a result of a reading from a Digital Data Logger. The patient was nervous at first that his mom was on his left side. On the same date, the patient was vaccinated with GARDASIL in right deltoid (strength, dose, route of administration was not reported) (lot# N024812, expiry date not reported) for prophylaxis; and second dose of hepatitis A virus vaccine (unspecified) in right deltoid (lot# 3tg52, expiry date not reported) separately. On 31-AUG-2018, (also reported "as soon as") the hepatitis A virus vaccine (unspecified) was removed, the patient started to seize on the physician. The patient's mother had him in her arms and laid him down. After the patient was laid down the physician grabbed the needles, so he would not get stuck again from seizing. When the physician entered the room, he noticed that the patient was still seizing for a few seconds (seizure) and stopped. He came to his conscious but had ringing in his ears (tinnitus) and couldn't hear (hypoacusis). The patient also urinated on himself. The patient was sent to emergency room (ER) as per the physician. No prescription drug treatment for the experienced required. On 31-AUG-2018, the patient recovered from seizure. The outcome of the event, tinnitus and hypoacusis was unknown. The causality assessment was not reported. The adverse event was not reported previously. Upon internal review, the event seizure was determined to be medically significant.; Sender's Comments: US-009507513-1810USA007703:
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV9, HEPA, HPV4, MNQ
Symptoms: Tinnitus, Urinary incontinence
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patients of an unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On unknown dates, unspecified patients were inadvertently administered doses of the following vaccines, that had been improperly stored (product storage error): VARIVAX lot # N022977, expiration date 23-AUG-2019 (dose and route were not provided) and PROQUAD lot # R006747, expiration date 03-SEP-2019 (dose and route were not provided) both vaccines for prophylaxis. The vaccines were exposed to a temperature of 7.3°C for 50 minutes. There was no previous temperature excursion. It was reported that digital data logger was involved. The vaccines were reconstituted with properly stored diluent. No adverse effect was reported. No product quality complaint (PQC) was involved. Upon receipt of follow-up information on 11-OCT-2018, it was determined that this case is now valid because patient identifiers was reported. The patient did not have any illness at the time of vaccination. On 31-AUG-2018, the physician went in to give patient MENACTRA, GARDASIL and hepatitis A virus vaccine (unspecified). It was reported that temperature excursion did not occur as a result of a reading from a Digital Data Logger. The patient was nervous at first that his mom was on his left side. On the same date, the patient was vaccinated with GARDASIL in right deltoid (strength, dose, route of administration was not reported) (lot# N024812, expiry date not reported) for prophylaxis; and second dose of hepatitis A virus vaccine (unspecified) in right deltoid (lot# 3tg52, expiry date not reported) separately. On 31-AUG-2018, (also reported "as soon as") the hepatitis A virus vaccine (unspecified) was removed, the patient started to seize on the physician. The patient's mother had him in her arms and laid him down. After the patient was laid down the physician grabbed the needles, so he would not get stuck again from seizing. When the physician entered the room, he noticed that the patient was still seizing for a few seconds (seizure) and stopped. He came to his conscious but had ringing in his ears (tinnitus) and couldn't hear (hypoacusis). The patient also urinated on himself. The patient was sent to emergency room (ER) as per the physician. No prescription drug treatment for the experienced required. On 31-AUG-2018, the patient recovered from seizure. The outcome of the event, tinnitus and hypoacusis was unknown. The causality assessment was not reported. The adverse event was not reported previously. Upon internal review, the event seizure was determined to be medically significant.; Sender's Comments: US-009507513-1810USA007703:
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Chills, Erythema, Headache, Pain, Papilloma viral infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX (batch number 4FS5N, expiry date 31st March 2021) for prophylaxis. Co-suspect products included VALTREX unknown for shingles. Concomitant products included gabapentin and fluconazole. On 19th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd September 2018, the patient started VALTREX at an unknown dose and frequency. On 22nd September 2018, 3 days after receiving SHINGRIX and not applicable after starting VALTREX, the patient experienced shingles and prescription drug used from another patient. (Dechallenge was unknown). Rechallenge with VALTREX was unknown. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the prescription drug used from another patient was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The following Saturday after vaccination, the patient noted shingles, appearing on her back near her bra strap and migrating toward the bottom of her right breast. The patient was not seen by a physician. The patient reported that she took her fiancé's VALTREX to help with symptoms, which led to use of another patient's medication. The patient reported that she reported the case to VAERS.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Rash, Stress
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX (batch number 4FS5N, expiry date 31st March 2021) for prophylaxis. Co-suspect products included VALTREX unknown for shingles. Concomitant products included gabapentin and fluconazole. On 19th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd September 2018, the patient started VALTREX at an unknown dose and frequency. On 22nd September 2018, 3 days after receiving SHINGRIX and not applicable after starting VALTREX, the patient experienced shingles and prescription drug used from another patient. (Dechallenge was unknown). Rechallenge with VALTREX was unknown. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the prescription drug used from another patient was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The following Saturday after vaccination, the patient noted shingles, appearing on her back near her bra strap and migrating toward the bottom of her right breast. The patient was not seen by a physician. The patient reported that she took her fiancé's VALTREX to help with symptoms, which led to use of another patient's medication. The patient reported that she reported the case to VAERS.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX (batch number 4FS5N, expiry date 31st March 2021) for prophylaxis. Co-suspect products included VALTREX unknown for shingles. Concomitant products included gabapentin and fluconazole. On 19th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd September 2018, the patient started VALTREX at an unknown dose and frequency. On 22nd September 2018, 3 days after receiving SHINGRIX and not applicable after starting VALTREX, the patient experienced shingles and prescription drug used from another patient. (Dechallenge was unknown). Rechallenge with VALTREX was unknown. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the prescription drug used from another patient was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The following Saturday after vaccination, the patient noted shingles, appearing on her back near her bra strap and migrating toward the bottom of her right breast. The patient was not seen by a physician. The patient reported that she took her fiancé's VALTREX to help with symptoms, which led to use of another patient's medication. The patient reported that she reported the case to VAERS.
Age: 61.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Cellulitis, Injection site erythema, Rash macular
Clinical narrative: Based on additional information received on 08-Oct-2018, this case became valid from non-valid case. Initial information received on 05-Oct-2018 regarding an unsolicited non-valid non-serious case received from an other health professional. This case is linked to cases 2018SA279808 and 2018SA279814 and 2018SA285737 (same reporter). This case involves a 61-year-old male patient who experienced 8 cm kidney shape blotchy red area on the lateral area of the left arm 1-2 inches below the injection site, while he received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1805 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious 8 cm kidney shape blotchy red area on the lateral area of the left arm 1-2 inches below the injection site (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included no lab test reported). Final diagnosis was 8 cm kidney shape blotchy red area on the lateral area of the left arm 1-2 inches below the injection site. It was reported that the patient refused treatment both times. The patient outcome is reported as unknown. Follow up information received from an other healthcare professional on 08-Oct-2018. Patient details, case validity and new event updated. List of documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Based on additional information received on 08-Oct-2018, this case became valid from non-valid case. Initial information received on 05-Oct-2018 regarding an unsolicited non-valid non-serious case received from an other health professional. This case is linked to cases 2018SA279808 and 2018SA279814 and 2018SA285737 (same reporter). This case involves a 61-year-old male patient who experienced 8 cm kidney shape blotchy red area on the lateral area of the left arm 1-2 inches below the injection site, while he received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1805 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious 8 cm kidney shape blotchy red area on the lateral area of the left arm 1-2 inches below the injection site (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included no lab test reported). Final diagnosis was 8 cm kidney shape blotchy red area on the lateral area of the left arm 1-2 inches below the injection site. It was reported that the patient refused treatment both times. The patient outcome is reported as unknown. Follow up information received from an other healthcare professional on 08-Oct-2018. Patient details, case validity and new event updated. List of documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Injection site erythema, Injection site pain, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (For 1st dose of SHINGRIX refer case US2018GSK187033). On 21st September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 24th September 2018, 3 days after receiving SHINGRIX, the patient experienced fatigue. On 8th October 2018, the patient experienced shingles. On an unknown date, the patient experienced injection site pain and itchy rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the fatigue and injection site pain were recovered/resolved and the outcome of the itchy rash was unknown. It was unknown if the reporter considered the shingles, fatigue, injection site pain and itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient got his 2nd dose of SHINGRIX on 21st September 2018 and the 1st dose about 3 months prior. After both doses he had soreness at the injection site and fatigue for several days. The fatigue peaked, both times, about 3 days after the vaccination. After the 2nd dose, after the fatigue had peaked, he noticed that he got a rash. The rash continued to get worse, was itchy and showed up on several parts of his body less than a month after receiving SHINGRIX. The patient saw his doctor at the time of reporting, 8th October 2018, and was diagnosed with shingles and given a prescription for valacyclovir. This case was linked with case US2018GSK187033 , reported by same reporter and having same patient.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Injection site pain, Rash pruritic, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (For 1st dose of SHINGRIX refer case US2018GSK187033). On 21st September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 24th September 2018, 3 days after receiving SHINGRIX, the patient experienced fatigue. On 8th October 2018, the patient experienced shingles. On an unknown date, the patient experienced injection site pain and itchy rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the fatigue and injection site pain were recovered/resolved and the outcome of the itchy rash was unknown. It was unknown if the reporter considered the shingles, fatigue, injection site pain and itchy rash to be related to SHINGRIX. Additional details were reported as follows: The patient got his 2nd dose of SHINGRIX on 21st September 2018 and the 1st dose about 3 months prior. After both doses he had soreness at the injection site and fatigue for several days. The fatigue peaked, both times, about 3 days after the vaccination. After the 2nd dose, after the fatigue had peaked, he noticed that he got a rash. The rash continued to get worse, was itchy and showed up on several parts of his body less than a month after receiving SHINGRIX. The patient saw his doctor at the time of reporting, 8th October 2018, and was diagnosed with shingles and given a prescription for valacyclovir. This case was linked with case US2018GSK187033 , reported by same reporter and having same patient.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chest pain, Chills, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72 year old male patient with reaction to ethanol and no drug allergies. The patient had no pertinent medical history. On 11-OCT-2018, the patient received a dose of PNEUMOVAX 23 lot # R006466, expiring on 24-OCT-2019, for immunisation (dose, route and site of administration were not reported). The patient's concomitant medications included blood pressure and thyroid medications. On 11-OCT-2018, the patient's arm where the vaccine was administered became swollen (peripheral swelling), red (erythema), and warm to the touch (skin warm). The patient also experienced chills and pain that radiated to his chest. The pharmacist also reported that when the patient blinked his eyes, objects seemed to be vibrating (visual impairment). The patient went to see the pharmacist for medical attention. Not lab diagnostic test were performed. No treatment was given for the events. On 12-OCT-2018, the pain still persisted, but the eye symptoms had subsided. At the time of the report, the patient had not recovered from skin warm, erythema, peripheral swelling, and chills. The reporter did not assess the causal relationship between therapy with PNEUMOVAX 23 and the events.
Age: 72.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain, Visual impairment
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72 year old male patient with reaction to ethanol and no drug allergies. The patient had no pertinent medical history. On 11-OCT-2018, the patient received a dose of PNEUMOVAX 23 lot # R006466, expiring on 24-OCT-2019, for immunisation (dose, route and site of administration were not reported). The patient's concomitant medications included blood pressure and thyroid medications. On 11-OCT-2018, the patient's arm where the vaccine was administered became swollen (peripheral swelling), red (erythema), and warm to the touch (skin warm). The patient also experienced chills and pain that radiated to his chest. The pharmacist also reported that when the patient blinked his eyes, objects seemed to be vibrating (visual impairment). The patient went to see the pharmacist for medical attention. Not lab diagnostic test were performed. No treatment was given for the events. On 12-OCT-2018, the pain still persisted, but the eye symptoms had subsided. At the time of the report, the patient had not recovered from skin warm, erythema, peripheral swelling, and chills. The reporter did not assess the causal relationship between therapy with PNEUMOVAX 23 and the events.