chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Grip strength decreased, Muscular weakness, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a nurse referring to a 42 years old female patient. The patient's concurrent condition included Crohn's disease. There was no known drug allergy (NKDA) of the patient. The patient's concomitant medications included amitriptyline hydrochloride, REMICADE, multivitamin, ascorbic acid, VITAMIN C AND D, ZOFRAN, pantoprazole and mercaptopurine. On 23-JAN-2019, the patient was administered a dose of PNEUMOVAX 23 (lot # R007722 with expiration date 10-MAR-2020; strength and dose detail were not reported) intramuscularly for prophylaxis. On 25-JAN-2019 (reported as a couple days later), the patient developed some pain/weakness in her arm/hand (same limb as injection was administered). It was reported that these symptoms quickly worsened with severe shooting pain down her entire arm into her hand. The patient had significant weakness in the arm with trouble gripping things and her entire arm was swollen. It was reported that the pain was alleviated by ALEVE. It was reported that the symptoms resolved within 3 days. It was reported no redness nor bruising. The outcome of the events was reported as recovered. The causality between PNEUMOVAX 23 and the events was not provided.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous information was received from a medical assistant and unspecified reporter on 04-SEP-2018 and 19-FEB-2019 respectively, and it was recognized as a non-valid because report did not obtain any patient identify. Upon receipt of follow up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from a medical assistant during a telephone call on 20-FEB-2019, concerning a 4 weeks patient of unknown gender. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was not provided. On 04-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # was reported as R012001, which was invalid, expiration date: 06-NOV-2020; dosing details not reported) orally for prophylaxis (inappropriate age at vaccine administration). No adverse effect was reported. The temperature excursion was from 47 degree Fahrenheit to 77 degree Fahrenheit with a time frame of 30 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. This is one of two reports received from same reporter. Sender's Comments: US-009507513-1809USA001773.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 7-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown date, the patient was vaccinated with unspecified dose/doses of PROQUAD (dose, route of administration, lot# and expiry date not reported). On 08-JUN-2017, the patient was vaccinated with booster dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 0.5 milliliter injection (route of administration, lot#, expiry date and albumin status not reported). On 01-MAR-2019, the patient developed shingles on the left tricep. The patient saw physician on unknown date and treatment with acyclovir was started. The outcome of event was unknown. The causality assessment was not provided.
Sex: U
Vaccine: HIBV, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from the vaccine coordinator who reported about multiple unspecified patients. There was no information about the patients' concurrent conditions, medical history, drug reactions, allergies or concomitant medication. On 11-JAN-2019, 14-JAN-2019, 28-JAN-2019, 08-FEB-2019 and on 07-MAR-2019 the patients were vaccinated with improperly stored doses of M-M-R II (lot # N009172 and expiration date 20-MAR-2019) for prophylaxis (strength, dosage schedule, and route of administration were not reported) and on multiple unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # N013868 and expiration date 04-MAY-2019) and (lot # N025894 and expiration date 19-SEP-2019) for prophylaxis (strength, dosage schedule, and route of administration were not reported); ROTATEQ orally (lot number R012957 and expiration date 11-JUN-2019) for prophylaxis (strength and dosage schedule were not reported); and with LIQUID PEDVAXHIB (lot # R005114 and expiration date 26-NOV-2020) for prophylaxis (strength, dosage schedule, and route of administration were not reported). No adverse effects were reported. The vaccines LIQUID PEDVAXHIB and ROTATEQ were exposed to 11.63 degree Celsius for 5 hours and 31 minutes on an unknown date; M-M-R II (lot # N025894 and expiration date 19-SEP-2019) was exposed to 11.63 degree Celsius for 5 hours and 1 minute and (lot # N009172 and expiration date 20-MAR-2019) (lot # N013868 and expiration date 04-MAY-2019) were exposed to 11.63 degree Celsius for 5 hours and 54 minutes on an unknown date. The vaccines did not have a previous temperature excursion and the call was done due to a data logger. However, it was also reported, that from 19-APR-2018 to 15-OCT-2018, M-M-R II (lot # N009172 and expiration date 20-MAR-2019) experienced 22 excursions. The lowest temperature excursion for M-M-R II (lot # N009172 and expiration date 20-MAR-2019) was 8.45 degree Celsius (on 30-MAY-2018) and the highest was 13.01 degree Celsius (on 11-OCT-2018).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ 2 milliliter, once, orally, lot # R021216, expiration date 25-APR-2020 (reported as "25-MAY-2020) for prophylaxis. The vaccine was exposed to a highest temperature above 47°F (50°F) for 2 hours. There was a previous temperature excursion, where the lowest temperature was below 36°F/2°C (33.4°F) for 12 hours, and the highest temperature was above 47°F/9°C (50°F) for 12 hours. It was reported that digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1903USA006849.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ 2 milliliter, once, orally, lot # R021216, expiration date 25-APR-2020 (reported as "25-MAY-2020) for prophylaxis. The vaccine was exposed to a highest temperature above 47°F (50°F) for 2 hours. There was a previous temperature excursion, where the lowest temperature was below 36°F/2°C (33.4°F) for 12 hours, and the highest temperature was above 47°F/9°C (50°F) for 12 hours. It was reported that digital data logger was involved. No adverse effects were reported.This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1903USA006841.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from the clinical research coordinator referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ lot number R002805 and expiration date 23-SEP-2019, or lot number R016790 and expiration date 20-APR-2020, for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 8.2 degrees Celsius for 6 minutes. Previous temperature excursion of 11.5  degrees Celsius for 37 minutes There was no adverse effect reported. Sender's Comments: US-009507513-1903USA008125.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies. On 06-MAR-2019, the patient received an improperly stored dose of VARIVAX with lot number N023961 and expiration date on 01-SEP-2019, (strength, dose, dose number, anatomical injection site and route of administration were not reported) for prophylaxis. The sterile diluent used for reconstitution of the vaccine was properly stored. It was reported that on an unknown date, the vaccines were exposed to a temperature excursion on 15 F (Fahrenheit) degrees to 46 F degrees (21 F degrees) for 2 hours and 15 minutes. There was a previous temperature excursion reported of 15 F degrees to 46 F degrees for a time frame of 3 hours and 30 minutes. The call was placed because of a Digital Data logger report. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a the clinical research coordinator referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ lot number R002805 and expiration date 23-SEP-2019, or lot number R016790 and expiration date 20-APR-2020, for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 8.2 degrees Celsius for 6 minutes. Previous temperature excursion of 11.5 degrees Celsius for 37 minutes There was no adverse effect reported. Sender's Comments: US-009507513-1903USA007501.
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a adult male patient who received for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, he experienced sore arm and limit in mobility of the arm. The reporter was agree to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Influenza, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of flu syndrome in a 51-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included splenectomy (had no spleen due to Immune thrombocytopenic purpura). Concurrent medical conditions included immune thrombocytopenic purpura. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced flu syndrome, pain, fever and weakness. On an unknown date, the outcome of the flu syndrome, pain, fever and weakness were unknown. It was unknown if the reporter considered the flu syndrome, pain, fever and weakness to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the nurse for her brother. The age at vaccination was not reported, but the patient was 51 years old at the time of reporting. The patient experienced significant reaction which described as a flu syndrome with horrible aching, fever, and staying in the bed. The case has been linked with cases US2019AMR045682 and US2019GSK049611 reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a female patient who received SHINGRIX for prophylaxis. On 11th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced muscle soreness. On 12th March 2019, the patient experienced tiredness, weakness and headache. On an unknown date, the outcome of the muscle soreness, tiredness, weakness and headache were unknown. It was unknown if the reporter considered the muscle soreness, tiredness, weakness and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX and experienced shoulder muscle soreness last night from the reporting date, but that was expected. On the reporting date, the patient really tired, just worn out and feeling a little weak and had headache. The patient asked, how long the symptoms might last. The patient refused to give her date of birth and physician's (MD) contact details.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Eye disorder, Fatigue, 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 86-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date). On 9th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain, discomfort, tiredness and eye disorder. On an unknown date, the outcome of the injection site pain, discomfort, tiredness and eye disorder were unknown. It was unknown if the reporter considered the injection site pain, discomfort, tiredness and eye disorder to be related to SHINGRIX. Additional details were provided as follows: The patient got the 2nd shingles vaccine, and experienced some discomfort. There was a significant pain in the arm where the doctor injected the vaccine, the patient's left eye seems to be pulling and feels sensitive. The patient was very tired. She was a bit concerned as this did not happen the first time.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Influenza, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of flu syndrome in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patients experienced flu syndrome, pain, fever and weakness. On an unknown date, the outcome of the flu syndrome, pain, fever and weakness were unknown. It was unknown if the reporter considered the flu syndrome, pain, fever and weakness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. It was reported that across the 5 practices that the reporter oversees, that they had administered 1540 doses through January. 10 to 15 patients had significant reactions, but only 2 to 3 opted out of receiving the second dose of SHINGRIX. These patients experienced flu syndrome which she described as horrible aching, fever, and stood in the bed. The reporter received these reports from her offices so she could not have any additional details. This case has been linked with US2019AMR044915 and US2019AMR045682 reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vision decreased in a male patient who received SHINGRIX (batch number 7X743, expiry date 22nd May 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vision decreased. On an unknown date, the outcome of the vision decreased was unknown. It was unknown if the reporter considered the vision decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called in to inquire if any information on vision changes with SHINGRIX. The patient experienced decline in vision after receiving 1st dose of SHINGRIX. The health care professional could not provide the patient information.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness, 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 60-year-old female patient who received SHINGRIX for prophylaxis. On 8th March 2019, the patient received the 1st dose of SHINGRIX. On 8th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 9th March 2019, the patient experienced tiredness, loss of energy, chills, general body pain, influenza-like symptoms and fever. On 10th March 2019, the patient experienced sleepiness. On 11th March 2019, the outcome of the influenza-like symptoms was recovered/resolved. In March 2019, the outcome of the injection site pain, tiredness, loss of energy, chills, general body pain, fever and sleepiness were recovered/resolved. It was unknown if the reporter considered the injection site pain, tiredness, loss of energy, chills, general body pain, influenza-like symptoms, fever and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient stated that after vaccination, later that evening, around 7 pm, she started to experience a sore arm around the injection site. Starting the next morning (9th March 2019), the sore arm continued and around 2 pm. The patient started to feel really tired and drained, like she was coming down with the flu. She then started to experience chills, body aches, and temperature of 100.4 that went as high as 101 degrees Fahrenheit before she went to bed. On Sunday (10th March 2019), the patient woke up feeling a bit better but needed a nap at 12:30 pm and slept until 4 pm. This was the longest nap she had ever taken. The patient felt fine on the day of reporting. The reporter provided the consent for follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 8th March 2019, the patient received the 1st dose of SHINGRIX. On 8th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 9th March 2019, the patient experienced tiredness, loss of energy, chills, general body pain, influenza-like symptoms and fever. On 10th March 2019, the patient experienced sleepiness. On 11th March 2019, the outcome of the influenza-like symptoms was recovered/resolved. In March 2019, the outcome of the injection site pain, tiredness, loss of energy, chills, general body pain, fever and sleepiness were recovered/resolved. It was unknown if the reporter considered the injection site pain, tiredness, loss of energy, chills, general body pain, influenza-like symptoms, fever and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient stated that after vaccination, later that evening, around 7 pm, she started to experience a sore arm around the injection site. Starting the next morning (9th March 2019), the sore arm continued and around 2 pm. The patient started to feel really tired and drained, like she was coming down with the flu. She then started to experience chills, body aches, and temperature of 100.4 that went as high as 101 degrees Fahrenheit before she went to bed. On Sunday (10th March 2019), the patient woke up feeling a bit better but needed a nap at 12:30 pm and slept until 4 pm. This was the longest nap she had ever taken. The patient felt fine on the day of reporting. The reporter provided the consent for follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed Shingles after receiving SHINGRIX. The pharmacist said that the patient did not receive vaccine at his facility, and did not have other details at time of initial report.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 22nd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd January 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 23rd January 2019, the patient experienced influenza-like symptoms, light headedness and fever. On an unknown date, the outcome of the influenza-like symptoms, light headedness and fever were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, light headedness, fever and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on right arm. On 23rd January 2019, 1 day after vaccination the patient experienced flu-like symptoms, lightheaded, fever, and injection site arm pain after SHINGRIX. At the time of this report, the arm pain at injection site was described as arm soreness. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm and activities of daily living impaired. On an unknown date, the outcome of the pain in arm and activities of daily living impaired were unknown. It was unknown if the reporter considered the pain in arm and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm soreness after receiving the dose of SHINGRIX making it difficult to drive. No other details were provided. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Myosclerosis, Oral herpes
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle induration in a 70-year-old female patient who received SHINGRIX for prophylaxis.  On 25th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th August 2018, less than a day after receiving SHINGRIX, the patient experienced muscle induration (serious criteria GSK medically significant), fever blister and injected limb mobility decreased. On an unknown date, the outcome of the muscle induration and injected limb mobility decreased were recovered/resolved and the outcome of the fever blister was not recovered/not resolved. It was unknown if the reporter considered the muscle induration, fever blister and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine in left arm. In the evening on the day of vaccination, the patient experienced fever blisters that was still unresolved. The patient claimed that, she currently had one blister under the skin on her lip but not as many as she did initially. She had the outbreak of blisters on her upper and lower lips and ever since, she had fever blisters on her bottom lip. She also reported that the muscle of her left arm got hard and she lost range of motion in her left arm where she had the injection. The muscle issues resolved after six weeks and the range of motion concerns resolved after 2 to 3 months. The patient had not receive the second shot yet because of the side effects she had experienced. The reporter consented to follow up.
Sex: F
Vaccine: HEP, HEPA
Symptoms: Vision blurred, Vitreous detachment
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of vitreous detachment in a adult female patient who received HAVRIX (batch number 5SR75, expiry date unknown) for prophylaxis. Co-suspect products included ENGERIX B (batch number 7N5M5, expiry date unknown) for prophylaxis. On an unknown date, the patient received HAVRIX and ENGERIX B. On an unknown date, unknown after receiving HAVRIX and less than a year after receiving ENGERIX B, the patient experienced vitreous detachment (serious criteria GSK medically significant) and blurred vision. On an unknown date, the outcome of the vitreous detachment and blurred vision were unknown. It was unknown if the reporter considered the vitreous detachment and blurred vision to be related to HAVRIX and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, the patient experienced blurred vison and vitreous detachment after receiving HAVRIX and ENGERIX B. The reported batch number 55r75 for HAVRIX was updated to 5SR75 as per sales data sheet The reported batch number 7ngm5 for ENGERIX B was updated to 7N5M5 as per sales data sheet.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Abdominal pain, Computerised tomogram normal, Constipation, Decreased appetite
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of neuropathy in a 78-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included ovariohysterectomy. Concomitant products included MEDICATION UNKNOWN (OSTEOPOROSIS INJECTION (NOS)). On 20th March 2018, the patient received the 1st dose of SHINGRIX. On 20th March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, fatigue and feeling unwell. On 2nd April 2018, the patient experienced neuropathy (serious criteria GSK medically significant), abdominal cramp, constipation, appetite absent, food aversion and weight loss. On an unknown date, the patient experienced bowel dysfunction and abdominal distension. The patient was treated with DULCOLAX. On 24th March 2018, the outcome of the pain in arm and swelling arm were recovered/resolved. On an unknown date, the outcome of the neuropathy, fatigue, feeling unwell, abdominal cramp, constipation, appetite absent, food aversion, weight loss, bowel dysfunction and abdominal distension were unknown. It was unknown if the reporter considered the neuropathy, pain in arm, swelling arm, fatigue, feeling unwell, abdominal cramp, constipation, appetite absent, food aversion, weight loss, bowel dysfunction and abdominal distension to be related to SHINGRIX. Additional details were provided as follows: The patient was a clinical pharmacologist or investigator, reported that she had her first dose of SHINGRIX in March of last year. The day of the patient had a painful and swollen arm for the next 4 days and felt fatigue and just feeling of illness. On Easter Sunday the patient stated that, she ate raw lamb and then the day after she boarded a plane and experienced cramping, constipation, could not eat, aversion to food, the patient lost 14 pounds. The patient had to take DULCOLAX to help with bowel movements as a treatment. The patient stated, within 3 to 4 weeks she had no bowel function. The patient had a distended abdomen. The patient headed back to the stated for GI (gastrointestinal) consult. The patient had a negative CT (computerized tomography) scan, no blockage, but was anorexic and still (on the day of reporting) no appetite. The patient was told it was an idiopathic disorder but she declined to believe that. The patient consulted with a physician, she decided to place herself on a prokinetic drug and started Resolol 2 mg daily. The patient reported that, the Resolol helped with the bowel function symptoms of activity, but she started to see a decline of effectiveness and may have to increase the dose. The patient hoped to see some reversal of the of the bowel function, but did not believe that would be the case. The patient has diagnosed herself with neuropathy of the Colon. The reporter consented to follow up. Lab Comments: The lab test was performed on an unknown date.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Food aversion, Functional gastrointestinal disorder, Malaise, Neuropathy peripheral
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of neuropathy in a 78-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included ovariohysterectomy. Concomitant products included MEDICATION UNKNOWN (OSTEOPOROSIS INJECTION (NOS)). On 20th March 2018, the patient received the 1st dose of SHINGRIX. On 20th March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, fatigue and feeling unwell. On 2nd April 2018, the patient experienced neuropathy (serious criteria GSK medically significant), abdominal cramp, constipation, appetite absent, food aversion and weight loss. On an unknown date, the patient experienced bowel dysfunction and abdominal distension. The patient was treated with DULCOLAX. On 24th March 2018, the outcome of the pain in arm and swelling arm were recovered/resolved. On an unknown date, the outcome of the neuropathy, fatigue, feeling unwell, abdominal cramp, constipation, appetite absent, food aversion, weight loss, bowel dysfunction and abdominal distension were unknown. It was unknown if the reporter considered the neuropathy, pain in arm, swelling arm, fatigue, feeling unwell, abdominal cramp, constipation, appetite absent, food aversion, weight loss, bowel dysfunction and abdominal distension to be related to SHINGRIX. Additional details were provided as follows: The patient was a clinical pharmacologist or investigator, reported that she had her first dose of SHINGRIX in March of last year. The day of the patient had a painful and swollen arm for the next 4 days and felt fatigue and just feeling of illness. On Easter Sunday the patient stated that, she ate raw lamb and then the day after she boarded a plane and experienced cramping, constipation, could not eat, aversion to food, the patient lost 14 pounds. The patient had to take DULCOLAX to help with bowel movements as a treatment. The patient stated, within 3 to 4 weeks she had no bowel function. The patient had a distended abdomen. The patient headed back to the stated for GI (gastrointestinal) consult. The patient had a negative CT (computerized tomography) scan, no blockage, but was anorexic and still (on the day of reporting) no appetite. The patient was told it was an idiopathic disorder but she declined to believe that. The patient consulted with a physician, she decided to place herself on a prokinetic drug and started Resolol 2 mg daily. The patient reported that, the Resolol helped with the bowel function symptoms of activity, but she started to see a decline of effectiveness and may have to increase the dose. The patient hoped to see some reversal of the of the bowel function, but did not believe that would be the case. The patient has diagnosed herself with neuropathy of the Colon. The reporter consented to follow up. Lab Comments: The lab test was performed on an unknown date.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Weight decreased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of neuropathy in a 78-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included ovariohysterectomy. Concomitant products included MEDICATION UNKNOWN (OSTEOPOROSIS INJECTION (NOS)). On 20th March 2018, the patient received the 1st dose of SHINGRIX. On 20th March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, swelling arm, fatigue and feeling unwell. On 2nd April 2018, the patient experienced neuropathy (serious criteria GSK medically significant), abdominal cramp, constipation, appetite absent, food aversion and weight loss. On an unknown date, the patient experienced bowel dysfunction and abdominal distension. The patient was treated with DULCOLAX. On 24th March 2018, the outcome of the pain in arm and swelling arm were recovered/resolved. On an unknown date, the outcome of the neuropathy, fatigue, feeling unwell, abdominal cramp, constipation, appetite absent, food aversion, weight loss, bowel dysfunction and abdominal distension were unknown. It was unknown if the reporter considered the neuropathy, pain in arm, swelling arm, fatigue, feeling unwell, abdominal cramp, constipation, appetite absent, food aversion, weight loss, bowel dysfunction and abdominal distension to be related to SHINGRIX. Additional details were provided as follows: The patient was a clinical pharmacologist or investigator, reported that she had her first dose of SHINGRIX in March of last year. The day of the patient had a painful and swollen arm for the next 4 days and felt fatigue and just feeling of illness. On Easter Sunday the patient stated that, she ate raw lamb and then the day after she boarded a plane and experienced cramping, constipation, could not eat, aversion to food, the patient lost 14 pounds. The patient had to take DULCOLAX to help with bowel movements as a treatment. The patient stated, within 3 to 4 weeks she had no bowel function. The patient had a distended abdomen. The patient headed back to the stated for GI (gastrointestinal) consult. The patient had a negative CT (computerized tomography) scan, no blockage, but was anorexic and still (on the day of reporting) no appetite. The patient was told it was an idiopathic disorder but she declined to believe that. The patient consulted with a physician, she decided to place herself on a prokinetic drug and started Resolol 2 mg daily. The patient reported that, the Resolol helped with the bowel function symptoms of activity, but she started to see a decline of effectiveness and may have to increase the dose. The patient hoped to see some reversal of the of the bowel function, but did not believe that would be the case. The patient has diagnosed herself with neuropathy of the Colon. The reporter consented to follow up. Lab Comments: The lab test was performed on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site cellulitis in a 65-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site cellulitis. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the injection site cellulitis was unknown. It was unknown if the reporter considered the injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the reporter on behalf of the patient. The age at vaccination was not reported, but the patient was 65 years old at the time of reporting. The patient experienced cellulitis at the injection site and had to receive antibiotics. Patient went to the emergency room for the reaction. It was reported that the patient called her to report the event but she has not physically seen the patient. No additional details were available. This is one of the three cases reported by the same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Malaise
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of unwell in a 70-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced unwell and injection site cellulitis. On an unknown date, the outcome of the unwell and injection site cellulitis were unknown. It was unknown if the reporter considered the unwell and injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the reporter on behalf of the patient. The age at vaccination was not reported, but the patient was 70 years old at the time of reporting. The patient was very ill after and also developed a localized reaction at the injection site (suspected cellulitis). The reporter stated that the patient called her to report the event but she had not physically seen the patient. No additional details were available. This is one of the three cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of general malaise in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patients experienced general malaise. On an unknown date, the outcome of the general malaise was recovered/resolved. It was unknown if the reporter considered the general malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that she had many reports of general malaise for 1-2 days after receiving initial dose of SHINGRIX.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events. Patient received second influenza vaccine by accident.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling cold, Headache, Nausea
Clinical narrative: I had all the listed side effects, fever, chills, headache, exhaustion, nausea AND terrible joint pain in my right hand where, although I have arthritis it is always painfree. I took ibuprofen and stayed in bed for 2 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I had all the listed side effects, fever, chills, headache, exhaustion, nausea AND terrible joint pain in my right hand where, although I have arthritis it is always painfree. I took ibuprofen and stayed in bed for 2 days.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Noticed a hard lump/knot on left arm at the injection site. Used warm and cold compresses alternated.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Aggression, Attention deficit/hyperactivity disorder, Cough, Emotional distress, Hypersensitivity
Clinical narrative: Started to run a very high fever by the next morning and was lethargic, very cranky which lasted around 8 days. Within the next several days she developed a runny nose, coughing, and would randomly run fever of 100-102. Over the next several weeks personality started to change. She would throw fits and have meltdowns that were inconsolable (PANDAS type behavior/become fixated on one thing). She started to show signs of ADHD and just could not sit still. She developed allergy type symptoms. All of this lasted for 3 years (until I reversed it).
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Irritability, Lethargy, Personality change, Pyrexia, Rhinorrhoea
Clinical narrative: Started to run a very high fever by the next morning and was lethargic, very cranky which lasted around 8 days. Within the next several days she developed a runny nose, coughing, and would randomly run fever of 100-102. Over the next several weeks personality started to change. She would throw fits and have meltdowns that were inconsolable (PANDAS type behavior/become fixated on one thing). She started to show signs of ADHD and just could not sit still. She developed allergy type symptoms. All of this lasted for 3 years (until I reversed it).
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Hypersensitivity, Productive cough, Respiratory tract congestion, Retching, Secretion discharge
Clinical narrative: Got MMR today and since then has been vomiting phlegm and mucus since then, started to get congested, about 1 hr later and then emesis started about 3 hrs after vaccine, no rash. Probably allergic Rx to vaccine vs coincidence new viral at same time seems unlike. Gave BENADRYL here. Made him more alert and a little better, but still with dry heaves. Told mom if not tolerating fluids in next few hrs, will need to go to ER. No distress and SAT 97%. Also suggested going to allergist in the future.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Got MMR today and since then has been vomiting phlegm and mucus since then, started to get congested, about 1 hr later and then emesis started about 3 hrs after vaccine, no rash. Probably allergic Rx to vaccine vs coincidence new viral at same time seems unlike. Gave BENADRYL here. Made him more alert and a little better, but still with dry heaves. Told mom if not tolerating fluids in next few hrs, will need to go to ER. No distress and SAT 97%. Also suggested going to allergist in the future.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Mobility decreased, Ovarian cyst, Seizure like phenomena, Syncope
Clinical narrative: Severe stomach pain, Fainting episodes, Seizure like activity, Mobility loss from time to time, Ovarian cysts.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Joint range of motion decreased, Pain, Product administered at inappropriate site
Clinical narrative: Vaccination was adminsitered high, near the top of the shoulder, not in the thickest part of the deltoid. Patient came back to pharmacy next morning stating inability to sleep the night prior due to pain. He tried taking ibubprofen and found some relief, but still in pain and with limited range of motion. Primary care provider Dr aware of incident and asking patient to be seen for evaluation.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Skin infection
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 07-JUL-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX, the patient suffered shingles rash around left eye, upper back, neck and chest areas. The patient was diagnosed with herpes zoster, dermal infection, and herpes zoster with keratitis in his left eye. The herpes zoster infection has resulted in continued care and treatment since the onset of his injuries till present day. As a direct and proximate result the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to the ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Herpes zoster, dermal infection  and herpes zoster with keratitis in his left eye were considered disabling. Upon internal review, herpes zoster with keratitis in his left eye was determined to be medically significant. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Nodule, Rash erythematous, Swelling, Ultrasound scan normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 82-year-old male patient who received SHINGRIX for prophylaxis. On 19th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 7 days after receiving SHINGRIX, the patient experienced local swelling, red rash and adverse reaction. On an unknown date, the outcome of the local swelling and red rash were recovered/resolved and the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the local swelling, red rash and adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st shot of SHINGRIX series intramuscularly in the left deltoid but had a reaction. A week later, he got a knot on the right inside of shin lower leg about half the size of a tennis ball. Knot stayed for 3 days then it went away. About a week later it turned into a red rash on inside of the same leg from knee to ankle, both of these events resolved completely. 1 to 2 weeks later, he developed a knot on the outer side of the same leg. He had an ultrasound done which ruled out a blood clot. This outer knot was mostly resolved because if you rub real hard you feel something on the outside right leg. Lab Comments: On unknown date the ultrasound ruled out a blood clot.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 27th February 2019, the patient received SHINGRIX (intramuscular). On 9th March 2019, 10 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient. The patient got SHINGRIX and she developed a rash around her eyes, on both sides of her face. It looks like mosquito bites, but it was not itching or burning. The patient gave consent to follow up, she had given permission to contact her primary care physician (PCP) and provided contact details for the same.