chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Drug administered to patient of inappropriate age, Herpes zoster, Inappropriate schedule of drug administration, Vaccination failure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 48-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. On 19th June 2018, the patient received the 2nd dose of SHINGRIX. On 27th April 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On 19th June 2018, the patient experienced drug dose administration interval too short and inappropriate age at vaccine administration. On 1st August 2018, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were recovering/resolving and the outcome of the inappropriate age at vaccine administration, drug dose administration interval too short and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional information was reported as follows: The case was reported by certified medical assistant. At age of 48 years, the patient received 2 doses of SHINGRIX, which led to inappropriate age at vaccine administration. The patient received 2nd dose of SHINGRIX earlier than recommended schedule, which led to shortening of vaccination schedule. A 1st dose was given at a pharmacy, not at HCP (healthcare professional) office reporting so they had no information on lot number or expiry date of first dose. A Second dose was given at reporting HCP office.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Injection site erythema, Injection site pain, Ultrasound Doppler
Clinical narrative: Patient developed redness and pain at injection site. Was treated in ER
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema
Clinical narrative: This spontaneous report was received from a 52-year old male pharmacist, who refers to himself. The patient's pertinent medical history included community acquired pneumonia from sinus infection at the age of 13 years old. The patient's drug reactions and allergies included allergy to FLUARIX QUADRIVALENT, sulfamethoxazole (+) trimethoprim (BACTRIM DS) and hydrocodone. The patient's concomitant therapies included montelukast sodium (SINGULAIR), walsartan, sertraline hydrochloride (ZOLOFT), bupropion hydrochloride (WELLBUTRIN), atorvastatin, indomethacin, fluticasone propionate (+) salmeterol xinafoate (ADVAIR) and daily aspirin. On 05-JUL-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly (dose, lot # and expiration date were not provided) due to history of community acquired pneumonia at age 13. On 06-JUL-2018, the patient's temperature rose to 103.1 degrees Fahrenheit and he had a sizable red reaction an injection site. The patient went to see general practitioner and was prescribed cephalexon. On approximately 13-JUL-2018 (reported as a week later), the patient went to allergist who suggested that the patient might have had an allergic reaction to inactive ingredients as he also received SHINGRIX in approximately 2017 (reported as past year), and had no adverse reactions. The outcome of the events was reported as recovered on an unknown date in July 2018. The relatedness between the events and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 31-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N031939, expiration date 13-NOV-2019 (exact dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (lot# N030173, expiration date 02-JUL-2020). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -9 to 8 degrees Celsius for 9 hours and 45 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: MMR
Symptoms: Exposure to communicable disease, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a physician who is also the female patient of unknown age. The patient's medical history, concurrent conditions and drug reactions/allergies. Her concomitant therapies included sterile diluent. On unspecified dates, the patient was vaccinated with the first two doses of M-M-R II as prophylaxis. On an unknown date, she reported that she was later exposed to measles when she cared for two patients from outside the country who had confirmed cases of measles, however, she did not developed measles. On an unknown date, due to exposure concerns she was required to be re-vaccinated with a third dose of M-M-R II. On an unknown date, she was required to have titers drawn which resulted negative for immunity to measles, mumps and rubella. As a result, the patient's facility required her to be re-vaccinated with a fourth dose of M-M-R II. On an unknown date she had titers measured again whiche resulted negative once more. On an unknown date, she received a fifth dose of M-M-R II (Dose, route, lot # and expiration date were not reported for any of the doses given), and this time her titers were drawn again which were positive for immunity to measles, mumps and ruibella. The outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was reported as recovered on an unknow  date. The reporter did not provide the causality between the events and M-M-R II. This is one of two reports received from the same reporter.; Sender's Comments: 1808USA011297:
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, Injection site urticaria
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 18 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 10-AUG-2018, the patient was vaccinated with a properly stored but expired VARIVAX, lot number M030183, subcutaneously for prophylaxis (expiration date was reported as 15-JUN-2018). The patient developed a welt at the injection site on an unspecified date in August 2018. She did not seek medical attention, no laboratories were performed to her. She did not receive any treatment for the event. At the time of the report, the patient was recovering from the welt at the injection site. The pharmacist did not assess the causal relationship between the event and vaccination with VARIVAX. Lot number M030183 is an invalid lot number for varicella virus vaccine live (oka/merck).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 14-AUG-2018, the patient was vaccinated with a properly stored but expired M-M-R II lot # M034387, expiration date 19-JUL-2018, for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Death, Malaise
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a elderly male patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date in 2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were not provided) for prophylaxis. At the same time, the patient received also a dose of influenza virus vaccine (unspecified) (reported as "Flu vaccine") (dose, route, lot # and expiration date were not provided) for an unknown indication. The pharmacist stated that, on an unknown date in 2017 (reported as "next day"), the elderly patient got sick and was hospitalized. The pharmacist reported that, shortly after that, the patient passed away on an unknown date in 2017. The cause of date was not reported. It was unknown if autopsy was done. The outcome of malaise was not reported. The causality between the events and PNEUMOVAX 23 was not reported. Reported Cause(s) of Death: Pharmacist reported the "elderly man passed away shortly after".
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 2 year old patient of an unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unspecified date in August of 2017, the patient was vaccinated with VARIVAX)(dose, frequency, route, lot# and expiration date were not provided) and M-M-R II (dose, frequency, route, lot# and expiration date were not provided), both for prophylaxis. On 21-AUG-2018, the patient was vaccinated with a second dose of VARIVAX (dose, frequency and route were not provided)  lot # R002507 expiration date 25-JAN-2020; and M-M-R II (dose, frequency and route were not provided)  lot #  N014482 expiration date 10-MAY-2020. No adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Adverse drug reaction, Ill-defined disorder, Influenza, Surgery, Visual impairment
Clinical narrative: This spontaneous report was received from a currently 79 female patient, concerning herself. The patient's historical drugs included an unspecified flu vaccine to which she was allergic. Concomitant drugs included about 14 unspecified medications. No information was provided regarding the patient's historical conditions. On an unknown date, the patient was vaccinated with pneumococcal  vaccine, polyvalent (manufacturer unknown) for prophylaxis (route of administration, lot number and expiration date were not provided). On unknown date, the patient started therapy with sitagliptin phosphate (JANUVIA) 100 mg tablets, once daily per via oral, (lot number an expiration date were not provided). In August 2016 (reported as "two years ago"), the patient was hospitalized due to an illness that she developed after receiving the  pneumococcal  vaccine, polyvalent (manufacturer unknown). On an unspecified date, the patient had side effects to sitagliptin phosphate (JANUVIA), even though it was effective for helping control her blood sugar. On an unknown date, the patient had a unspecified surgery, also since an unspecified date, the patient "does not see very well". On an unknown date, the patient experienced a flu. Therapy with sitagliptin phosphate (JANUVIA) was continued. At the time of the report, the patient still had the flu. The outcome of the remaining events was not provided. The patient considered the side effects to be related to therapy with sitagliptin phosphate (JANUVIA). The causal relationship between the remaining events and therapy with sitagliptin phosphate (JANUVIA) was not provided. The relationship between the events and therapy with the pneumococcal vaccine, polyvalent (manufacturer unknown) was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 24-JUN-2016, the patient was treated by a physician/MD at a clinic for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2012, the patient was treated by a physician/MD for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a direct and proximate result of these malfunctions, 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, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient (unknown gender and age). No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated by a physician at a healthcare facility/office with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 15-AUG-2016, the patient was treated by a physician at a healthcare facility/office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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, and pain and suffering, and other damages.  Causality assessment was related. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated by a physician at a healthcare facility/office with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated by a physician at a healthcare facility/office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster.  As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated at a healthcare facility/office with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2014, the patient was treated at the medical center/hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included ZOSTAVAX with an associated reaction of herpes zoster (received ZOSTAVAX previously on an unknown date and had shingles 5 times since receiving ZOSTAVAX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in January or February 2018. About 12 hours after receiving the vaccine, she experienced flu-like symptoms that lasted for 2 to 3 days. This case has been linked with US2018151143 and US2018151144, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of herpes zoster (received ZOSTAVAX previously on an unknown date and had shingles 5 times since receiving ZOSTAVAX). 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 fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however it could be 71 or 72 years. In 2018, the patient received her second dose of SHINGRIX and developed a fever of over 100 degrees F. This case has been linked with US2018151138 and US2018151144, reported by same reporter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Colitis ulcerative, Colonoscopy abnormal, Diarrhoea, Haematochezia, Mucous stools
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ulcerative colitis in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 10 days after receiving SHINGRIX, the patient experienced ulcerative colitis (serious criteria GSK medically significant), blood in stool (serious criteria GSK medically significant), mucus stools and diarrhea. On an unknown date, the outcome of the ulcerative colitis was unknown and the outcome of the blood in stool, mucus stools and diarrhea were recovered/resolved. It was unknown if the reporter considered the ulcerative colitis, blood in stool, mucus stools and diarrhea to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to doctor. The patient received the vaccine on left arm. The patient stated that he had a colonoscopy on 9th May 2018 and he was diagnosed with ulcerative colitis. The patient was prescribed medication for the ulcerative colitis and the symptoms had resolved. The patient stated that any follow up could be sent to him and he could forward the information to his physician. The patient did not provide health care professional information during the call. For tolerability of 2nd dose, refer case US2018GSK153596.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a male patient who received Shingrix for prophylaxis. On 6th May 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced diarrhea, chills and influenza-like symptoms. On an unknown date, the outcome of the diarrhea, chills and influenza-like symptoms were unknown. It was unknown if the reporter considered the diarrhea, chills and influenza-like symptoms to be related to Shingrix. Additional details reported as follows: The age at vaccination was not reported. The reporter's husband received vaccination and experienced shivers. This case has been linked with US2018151935, reported by same reporter for herself (patient's wife).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Crying, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Shingrix for prophylaxis. On 21st August 2018, the patient received the 2nd dose of Shingrix. In August 2018, 11 hrs 30 min after receiving Shingrix, the patient experienced generalized aching, nausea, fever, sleep disturbance, chills, pain in hip and crying. On 21st August 2018, the patient experienced injection site pain, headache and stiff neck. On an unknown date, the outcome of the injection site pain, headache, generalized aching, nausea, fever, stiff neck, chills, pain in hip and crying were not recovered/not resolved and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the injection site pain, headache, generalized aching, nausea, fever, sleep disturbance, stiff neck, chills, pain in hip and crying to be related to Shingrix. Additional details were provided as follows: At 13:30, the patient received Shingrix in left arm. The patient reported feeling extreme pain when the injection was given. She said the medication hurt going in and her arm continued to hurt after that. At 8:00 pm, that night, 6 hours and 30 minutes after vaccination she felt stiffness in her neck and a headache. On 22nd August 2018, she woke up at 1:00 am morning with extreme arm pain, chills, pain in her hips, feeling achy all over, nauseous and a low grade fever. The arm pain was described as so extreme that when she moved it, it made her cry. The chills made her teeth chatter. She was not able to sleep the rest of the night. The contact details of the physician were provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pyrexia, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Shingrix for prophylaxis. On 21st August 2018, the patient received the 2nd dose of Shingrix. In August 2018, 11 hrs 30 min after receiving Shingrix, the patient experienced generalized aching, nausea, fever, sleep disturbance, chills, pain in hip and crying. On 21st August 2018, the patient experienced injection site pain, headache and stiff neck. On an unknown date, the outcome of the injection site pain, headache, generalized aching, nausea, fever, stiff neck, chills, pain in hip and crying were not recovered/not resolved and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the injection site pain, headache, generalized aching, nausea, fever, sleep disturbance, stiff neck, chills, pain in hip and crying to be related to Shingrix. Additional details were provided as follows: At 13:30, the patient received Shingrix in left arm. The patient reported feeling extreme pain when the injection was given. She said the medication hurt going in and her arm continued to hurt after that. At 8:00 pm, that night, 6 hours and 30 minutes after vaccination she felt stiffness in her neck and a headache. On 22nd August 2018, she woke up at 1:00 am morning with extreme arm pain, chills, pain in her hips, feeling achy all over, nauseous and a low grade fever. The arm pain was described as so extreme that when she moved it, it made her cry. The chills made her teeth chatter. She was not able to sleep the rest of the night. The contact details of the physician were provided.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Shingrix for prophylaxis. On 25th May 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th July 2018, 51 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The patient broke out with shingles. At the reporting time, the patient's pharmacy had her 2nd dose in stock and she was questioning if she could get the 2nd dose during an outbreak of shingles. The patient did not provide name of her doctor as she was given the vaccination at the urgent care. She said she could find out whom so the follow up letter might be sent to her.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a non-health professional via sales rep and described the occurrence of injection site pain in a male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced local injection site pain that lasted for 2 days. This case has been linked with case US2018GSK155277, reported by same reporter for same patient for 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Microscopic polyangiitis, Vasculitis
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of vasculitis aggravated in a adult patient who received Shingrix for prophylaxis. Concurrent medical conditions included vasculitis and microscopic polyangiitis. On 6th August 2018, the patient received the 1st dose of Shingrix. In August 2018, less than a month after receiving Shingrix, the patient experienced vasculitis aggravated, microscopic polyangiitis and condition aggravated. On an unknown date, the outcome of the vasculitis aggravated, microscopic polyangiitis and condition aggravated were unknown. It was unknown if the reporter considered the vasculitis aggravated, microscopic polyangiitis and condition aggravated to be related to Shingrix. Additional details were provided as follows: The patient's past medical history was not reported. The patient's concomitant condition was not reported. The age at vaccination was not reported. The patient experienced flare Microscopic polyangiitis (MPA) vasculitis. No further information was reported.
Sex: M
Vaccine: MEN
Symptoms: Biopsy skin abnormal, Pityriasis lichenoides et varioliformis acuta, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Meningococcal B vaccine for prophylaxis. On 3rd August 2018, the patient received the 2nd dose of Meningococcal B vaccine. On 5th August 2018, 2 days after receiving Meningococcal B vaccine, the patient experienced rash and pityriasis lichenoides et varioliformis acuta. On an unknown date, the outcome of the rash and pityriasis lichenoides et varioliformis acuta were unknown. The reporter considered the rash and pityriasis lichenoides et varioliformis acuta to be related to Meningococcal B vaccine. Additional information was reported as follows: The age at vaccination was not reported. The reporter was the patient's grandfather. After vaccination with his decongestant Meningitis B vaccination. On Sunday, the patient came out in a rash. The Pediatrician could not identify it on 8th August 2018. The patient was taken to a Dermatologist who was attached to a hospital on the 14th August 2018. After carrying out a biopsy the patient was diagnosed with pityriasis lichenoides et varioliformis acuta (PLEVA). The reporter stated he was alarmed about the seriousness of this condition and asked to be advised. It had been determined the vaccine caused this. The reporter stated the patient had a significant problem on his hands. The reporter asked to advice, since they had tracked back to the vaccinated meningitis injection. Lab Comments: Lab test was done on an unknown date.
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Chest discomfort, Dyspnoea
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shortness of breath in a adult male patient who received Shingrix (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shortness of breath, chest tightness and anxiety. On an unknown date, the outcome of the shortness of breath, chest tightness and anxiety were unknown.  The reporter considered the shortness of breath, chest tightness and anxiety to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced  shortness of breath day after admininstration of Shingrix, chest tightness, could not get a full breathe of air, and anxiety all attributed to Shingrix. The nurse agreed to be contacted for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Rash pustular
Clinical narrative: This case was reported by a nurse and described the occurrence of influenza-like symptoms 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, several days after receiving Shingrix, the patient experienced influenza-like symptoms and shingles. On an unknown date, the outcome of the influenza-like symptoms and shingles were unknown. The reporter considered the influenza-like symptoms and shingles to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The physician (patient) had received Shingrix and a couple of days later felt like he had flu like symptoms and also had two pox like bumps appeared on his face. The patient felt Shingrix might have caused a mild case of shingles, he would like to be able to talk with someone about his experience. The physician and patient (for tolerance see case US2018GSK152330) had similar experiences they felt it was caused by Shingrix. The reporter agreed to be contacted for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was recovered/resolved. It was unknown if the reporter considered the erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported for the patients. The age group was not reported, but was selected as adult as per vaccine indication. The reporter had siblings (unknown number) that also experienced redness. This case has been linked with the case US2018148549, reported by reporter for herself.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of colitis ulcerative (mucous in stool, bloody stool and diarrhea after receiving 1st dose, refer case US2018151930). On 20th August 2018, the patient received the 2nd dose of Shingrix (intramuscular). On 20th August 2018, 30 min after receiving Shingrix, the patient experienced injection site pain and injection site swelling. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix. Additional details were provided as follows: The patient received the 2nd dose of Shingrix in right arm. The patient stated that any follow up could be sent to him and he could forward the information to his physician. The patient did not provide health care professional information during the call.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a non-health professional via sales rep and described the occurrence of injection site pain in a male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (for tolerance of 1st dose refer case US2018GSK148189). 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 injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced local injection site pain that lasted for 2 days.
Sex: M
Vaccine: HPVX, MENB
Symptoms: Injection site pain
Clinical narrative: A 17-year-old male patient received the first dose of TRUMENBA via an unspecified route of administration on an unspecified date at 0.5 ml single for immunization. The patient medical history was not reported. Concomitant medication included HPV vaccine. The patient received meningococcal group b rlp2086 and HPV vaccine in the same arm. The patient experienced burning and pain at the injection site on an unspecified date. The outcome of event was unknown. The patient experienced burning and pain at the injection site on an unspecified date. The outcome of event was unknown. Amendment: This follow-up report is being submitted to updated information on concomitant vaccine for a correct electronic transmission to health authorities.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A female patient in her late 60's received PREVNAR 13 (lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain and swelling at the injection site. The pain persisted and was tender over 2 months after injection was received. The outcome of the pain at injection site was not recovered while outcome of the swelling at injection site was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: 8 hours after recieving vaccines, patient experienced chills and could not get warm. Experienced hives, swelling, redness, and heat at site of injections. Spoke with patient two days after receiving vaccines and said she had taking loratidine and used hydrocortisone cream; told her to take BENADRYL instead of the loratadine. Biggest issue at that time was still the swelling, heat, and pain at site of injection. Called her the next day and it had gotten better with use of BENADRYL but was still experiencing symptoms.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth
Clinical narrative: 8 hours after recieving vaccines, patient experienced chills and could not get warm. Experienced hives, swelling, redness, and heat at site of injections. Spoke with patient two days after receiving vaccines and said she had taking loratidine and used hydrocortisone cream; told her to take BENADRYL instead of the loratadine. Biggest issue at that time was still the swelling, heat, and pain at site of injection. Called her the next day and it had gotten better with use of BENADRYL but was still experiencing symptoms.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Cough, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Patient initially experienced muscle soreness and then developed itchiness in the arm injection was given. This progressed into hives, sore throat, cough, and headache.  He also complains of chest tightness.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient initially experienced muscle soreness and then developed itchiness in the arm injection was given. This progressed into hives, sore throat, cough, and headache.  He also complains of chest tightness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Paresthesias in armpit upon injection in upper arm. Headache and nausea within hours of injection  Night pain with body aches, 3:00 am first 2 nights then to a lesser degree for 4 add'l nights. Fatigue for 4 days. Upper arm pain with redness,swelling and itching lasted 5 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: Paresthesias in armpit upon injection in upper arm. Headache and nausea within hours of injection  Night pain with body aches, 3:00 am first 2 nights then to a lesser degree for 4 add'l nights. Fatigue for 4 days. Upper arm pain with redness,swelling and itching lasted 5 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypersomnia, Injection site induration, Injection site pain
Clinical narrative: Chills all day the day after my vaccine, slept approx. 16-18 hrs the following day, injection site was sore and firm for 3 days after.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Anger, Anxiety, Crying, Disorientation, Dizziness
Clinical narrative: Approximately, 5 min after pt. receiving the vaccines- while mother was talking to me and pt. was standing in the hallway, with syncopal episode. Pt. his head on scale, and was pale- lasted about 20-30 sec. Pt. was supported in Trendelenburg postion. As she started to come around for 5-6 sec-- passed out again. This time lasted about 2 min. Pt. had a seizure- stiffening of upper extremities. Was pale, but no cyanosis. + enuresis. When pt. came to, was very disoriented, and had no recollection of event. Pt. became very upset and anxious- crying. As pt. was observed- tolerated some water and licking of lollipop. Started to complain of headache and dizziness. Sent over to ER for evaluation. In ER- pt. had lab.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Electrocardiogram normal, Enuresis, Full blood count normal, Head injury, Headache
Clinical narrative: Approximately, 5 min after pt. receiving the vaccines- while mother was talking to me and pt. was standing in the hallway, with syncopal episode. Pt. his head on scale, and was pale- lasted about 20-30 sec. Pt. was supported in Trendelenburg postion. As she started to come around for 5-6 sec-- passed out again. This time lasted about 2 min. Pt. had a seizure- stiffening of upper extremities. Was pale, but no cyanosis. + enuresis. When pt. came to, was very disoriented, and had no recollection of event. Pt. became very upset and anxious- crying. As pt. was observed- tolerated some water and licking of lollipop. Started to complain of headache and dizziness. Sent over to ER for evaluation. In ER- pt. had lab.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Metabolic function test normal, Musculoskeletal stiffness, Pallor, Seizure
Clinical narrative: Approximately, 5 min after pt. receiving the vaccines- while mother was talking to me and pt. was standing in the hallway, with syncopal episode. Pt. his head on scale, and was pale- lasted about 20-30 sec. Pt. was supported in Trendelenburg postion. As she started to come around for 5-6 sec-- passed out again. This time lasted about 2 min. Pt. had a seizure- stiffening of upper extremities. Was pale, but no cyanosis. + enuresis. When pt. came to, was very disoriented, and had no recollection of event. Pt. became very upset and anxious- crying. As pt. was observed- tolerated some water and licking of lollipop. Started to complain of headache and dizziness. Sent over to ER for evaluation. In ER- pt. had lab.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Approximately, 5 min after pt. receiving the vaccines- while mother was talking to me and pt. was standing in the hallway, with syncopal episode. Pt. his head on scale, and was pale- lasted about 20-30 sec. Pt. was supported in Trendelenburg postion. As she started to come around for 5-6 sec-- passed out again. This time lasted about 2 min. Pt. had a seizure- stiffening of upper extremities. Was pale, but no cyanosis. + enuresis. When pt. came to, was very disoriented, and had no recollection of event. Pt. became very upset and anxious- crying. As pt. was observed- tolerated some water and licking of lollipop. Started to complain of headache and dizziness. Sent over to ER for evaluation. In ER- pt. had lab.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Poor quality sleep, Pruritus, Pyrexia
Clinical narrative: Started to feel tired, muscle aches and fatigue. Around 1 PM and took 2 TYLENOL.  I left my office at around 2:45 PM to go home and rest and continued to feel tired and muscle aches, as well as itchy (arms, back, legs). Took 2 more TYLENOL around 6 PM. Woke up around 11:30-12:00 and felt feverish. Started to shake and took my temperature, which was 100.1 around 12:30 AM. I took 2 more TYLENOL around 1:00 AM and it took about an hour before the shaking stopped and I fell back to sleep around 3:00 AM. Restless sleep, but woke up around 7:00 AM - fever of 99.8 and feeling muscle aches and tired. My concern is the SHAKING last evening and that this could happen again during the night. The fever was 100.1 but the shaking was a bit scary.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Started to feel tired, muscle aches and fatigue. Around 1 PM and took 2 TYLENOL.  I left my office at around 2:45 PM to go home and rest and continued to feel tired and muscle aches, as well as itchy (arms, back, legs). Took 2 more TYLENOL around 6 PM. Woke up around 11:30-12:00 and felt feverish. Started to shake and took my temperature, which was 100.1 around 12:30 AM. I took 2 more TYLENOL around 1:00 AM and it took about an hour before the shaking stopped and I fell back to sleep around 3:00 AM. Restless sleep, but woke up around 7:00 AM - fever of 99.8 and feeling muscle aches and tired. My concern is the SHAKING last evening and that this could happen again during the night. The fever was 100.1 but the shaking was a bit scary.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Large, very painful red swelling at injection site, chills, fatigue, joint pain, headache.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Large, very painful red swelling at injection site, chills, fatigue, joint pain, headache.
Age: 42.0
Sex: F
Vaccine: FLUR3
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: Nausea, lightheadedness, left arm ache. previous reaction (unknown) to a Tdap 8/7/14 and a local site reaction to Td 12/29/10.