chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy kidney, Dysstasia, Fluid retention, Gait disturbance, Influenza
Clinical narrative: Information has been received via a phone call from the mother of a 12 year old female patient (125 pounds, 64 inches tall) with an allergy to tacrolimus and nonsteroidal anti-inflammatory drugs (NSAIDS). The patient had no medical history. Concomitant medication: prednisone, LASIX and ZANTAC. On 23-JUL-2010, the patient received the first dose (and only dose) of GARDASIL vaccine, intramuscular, for the prevention of HPV (lot# and expiration date not provided). Within a month from that time (August 2010) the patient was seen in the emergency room for 20 extra pounds of fluid in her body and was diagnosed with nephrotic syndrome. The patient had two kidney biopsies performed (results not provided). The patient received an unspecified treatment for the nephrotic syndrome. The patient has been under the care of a nephrologist ever since then. The patient has trouble standing and walking due to fluid in her lower extremities. The mother of the patient could not locate the lot# and expiration date of the vaccine but will call back with that information. It was also reported that the patient has been hospitalized up to five days for the flu. The patient was not pregnant at the time of the call; but was noted to have given birth in February of 2019. The patient's present status was reported to be not recovered. The mother of the patient inquired about compensation for the patient's medical expenses. The reporter considered nephrotic syndrome (trouble standing and walking due to fluid in her lower extremities) and flu to be disabling. The reporter considered nephrotic syndrome (trouble standing and walking due to fluid in her lower extremities) and flu to be life threatening. Upon internal review nephrotic syndrome was considered medically significant. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nephrotic syndrome, Oedema peripheral, Weight increased
Clinical narrative: Information has been received via a phone call from the mother of a 12 year old female patient (125 pounds, 64 inches tall) with an allergy to tacrolimus and nonsteroidal anti-inflammatory drugs (NSAIDS). The patient had no medical history. Concomitant medication: prednisone, LASIX and ZANTAC. On 23-JUL-2010, the patient received the first dose (and only dose) of GARDASIL vaccine, intramuscular, for the prevention of HPV (lot# and expiration date not provided). Within a month from that time (August 2010) the patient was seen in the emergency room for 20 extra pounds of fluid in her body and was diagnosed with nephrotic syndrome. The patient had two kidney biopsies performed (results not provided). The patient received an unspecified treatment for the nephrotic syndrome. The patient has been under the care of a nephrologist ever since then. The patient has trouble standing and walking due to fluid in her lower extremities. The mother of the patient could not locate the lot# and expiration date of the vaccine but will call back with that information. It was also reported that the patient has been hospitalized up to five days for the flu. The patient was not pregnant at the time of the call; but was noted to have given birth in February of 2019. The patient's present status was reported to be not recovered. The mother of the patient inquired about compensation for the patient's medical expenses. The reporter considered nephrotic syndrome (trouble standing and walking due to fluid in her lower extremities) and flu to be disabling. The reporter considered nephrotic syndrome (trouble standing and walking due to fluid in her lower extremities) and flu to be life threatening. Upon internal review nephrotic syndrome was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of enlargement of lymph nodes in a female patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown. It was unknown if the reporter considered the enlargement of lymph nodes to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that last year she was vaccinated with flu vaccine (manufacturer unspecified) and her lymph nodes swelled up like a golf ball. No other adverse event information was reported. Most information fields were marked as refused to answer as the caller declined to provide any additional information.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Hyperaesthesia, Inflammation, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of back pain in a 54-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included pain in cervical spine (about a week previous to the SHINGRIX vaccination). On 3rd March 2019, the patient received SHINGRIX. On 6th March 2019, 3 days after receiving SHINGRIX, the patient experienced back pain, inflammation, interscapular pain and hyperesthesia. On an unknown date, the outcome of the back pain, inflammation, interscapular pain and hyperesthesia were unknown. It was unknown if the reporter considered the back pain, inflammation, interscapular pain and hyperesthesia to be related to SHINGRIX. Additional details were reported as follows: The patient reported that about 3 days later receiving SHINGRIX, he experienced pain and soreness between his shoulder blades. The patient reported that he was in pain below his rib cage in his back and he was sensitive on the front side. The patient also had some inflammation on the same front side. The patient had an epidural with a steroid to alleviate pain in his cervical spine. The patient wanted to discuss his side effects as he was having concern about this.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in an unspecified number of the patients who received PEDIARIX for prophylaxis. On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, unknown after receiving PEDIARIX, 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 PEDIARIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The doctor stated that in previous experience with PEDIARIX he had experienced the many patients who developed fever and some patients would present to emergency room. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect dose administered, Injection site pain, Product preparation issue
Clinical narrative: This case was reported by a consumer via call center representative 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, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. The patient had first dose of SHINGRIX in 2018. The patient did not recall them preparing dose in any special way which led to inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. The patient's arm was sore at the site of injection. This case has been linked to case US2019AMR033855, reported by the same reporter for the same patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Middle insomnia, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative 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, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. The patient had first dose of SHINGRIX in 2018. The patient did not recall them preparing dose in any special way which led to inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. The patient's arm was sore at the site of injection. This case has been linked to case US2019AMR033855, reported by the same reporter for the same patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Somnolence
Clinical narrative: This case was reported by a consumer via call center representative 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, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. The patient had first dose of SHINGRIX in 2018. The patient did not recall them preparing dose in any special way which led to inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. The patient's arm was sore at the site of injection. This case has been linked to case US2019AMR033855, reported by the same reporter for the same patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect dose administered, Injection site pain, Product preparation issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever 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 US2019GSK044638). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever, shivering, muscle pain, exhaustion, sleepiness and nocturnal awakening. On an unknown date, the outcome of the fever, shivering, muscle pain, exhaustion, sleepiness and nocturnal awakening were unknown. It was unknown if the reporter considered the fever, shivering, muscle pain, exhaustion, sleepiness and nocturnal awakening to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. The patient had 2nd dose of SHINGRIX at different pharmacy. The pharmacist explained him that she had to prepare dose or mix it. The patient had shivering during the middle of the night, utter exhaustion, muscle ache and fever. The patient spent entire day in bed sleeping, the thought of moving seemed overwhelming. Lab Comments: On an unknown date the patient performed body temperature test.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Middle insomnia, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever 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 US2019GSK044638). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever, shivering, muscle pain, exhaustion, sleepiness and nocturnal awakening. On an unknown date, the outcome of the fever, shivering, muscle pain, exhaustion, sleepiness and nocturnal awakening were unknown. It was unknown if the reporter considered the fever, shivering, muscle pain, exhaustion, sleepiness and nocturnal awakening to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. The patient had 2nd dose of SHINGRIX at different pharmacy. The pharmacist explained him that she had to prepare dose or mix it. The patient had shivering during the middle of the night, utter exhaustion, muscle ache and fever. The patient spent entire day in bed sleeping, the thought of moving seemed overwhelming. Lab Comments: On an unknown date the patient performed body temperature test.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever 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 US2019GSK044638). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever, shivering, muscle pain, exhaustion, sleepiness and nocturnal awakening. On an unknown date, the outcome of the fever, shivering, muscle pain, exhaustion, sleepiness and nocturnal awakening were unknown. It was unknown if the reporter considered the fever, shivering, muscle pain, exhaustion, sleepiness and nocturnal awakening to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. The patient had 2nd dose of SHINGRIX at different pharmacy. The pharmacist explained him that she had to prepare dose or mix it. The patient had shivering during the middle of the night, utter exhaustion, muscle ache and fever. The patient spent entire day in bed sleeping, the thought of moving seemed overwhelming. Lab Comments: On an unknown date the patient performed body temperature test.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 2nd 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 erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of SHINGRIX and had developed a large area of redness around the injection site. The reporter did not have the lot or expiry date Info was received via web chat.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product supply issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and product supply issue. On an unknown date, the outcome of the injection site pain and product supply issue were unknown. 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. The patient received SHIGRIX in the unknown deltoid. The healthcare professional asked that, was there any information for the Gluteus alternate injection site or any studies done on the Gluteus site. The patient had a reaction to the 1st dose of SHINGRIX and did not want the 2nd dose on the deltoid region. The healthcare professional asked that, how to proceed when the patients were missing 2nd dose due to SHINGRIX availability. The healthcare professional unable to provide the patient information.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Dry throat, Erythema, Feeling hot
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX (batch number N9CA2, expiry date 2nd July 2021) for prophylaxis. The patient's past medical history included thyroidectomy (about 30 years before the reporting date). Previously administered products included SHINGRIX with an associated reaction of adverse event (1st dose received on an unknown date, refer case US2019GSK043645). On 21st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 21st February 2019, less than a day after receiving SHINGRIX, the patient experienced dizziness. On 22nd February 2019, the patient experienced influenza-like symptoms, fever, flushing, general body pain, sore throat, dry throat, stomach virus, stomach pain, cold, sleepiness, erythema of extremities, extremities hot feeling of and sickness. On an unknown date, the outcome of the influenza-like symptoms, fever, flushing, general body pain, dry throat, stomach virus, stomach pain, cold, sleepiness, extremities hot feeling of, dizziness and sickness were recovered/resolved and the outcome of the sore throat was not recovered/not resolved and the outcome of the erythema of extremities was recovering/resolving. It was unknown if the reporter considered the influenza-like symptoms, fever, flushing, general body pain, sore throat, dry throat, stomach virus, stomach pain, cold, sleepiness, erythema of extremities, extremities hot feeling of, dizziness and sickness to be related to SHINGRIX. Additional details were reported as follows: The reporter was the patient. The patient received SHINGRIX vaccine on the left arm. The next day of the vaccination at night, the patient experienced flu like symptoms, fever, flushing, body ache, sore throat, dry throat, stomach virus, stomach pain, cold, sleepiness and red hot area on the arm about 6 inches long and wide. The patient reported that she was sick for 7 days after receiving SHINGRIX vaccine. The patient stated as redness left the arm was started feeling better. The patient's symptoms were lasted for about 6 days. The patient was on the phone with the gentleman for 47 minutes discussing what the situation was with this shot and telling him there experienced with SHINGRIX vaccine. The patient was under the impression that at the end of the phone call that he would reach the reimbursement center and the patient would be able to talk to them. The reporter consented to follow up. No further details were provided. This case has been linked to case US2019041406 and US2019GSK043646, reported by same reporter for the patient's husband.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Gastroenteritis viral, Influenza like illness, Malaise, Nasopharyngitis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX (batch number N9CA2, expiry date 2nd July 2021) for prophylaxis. The patient's past medical history included thyroidectomy (about 30 years before the reporting date). Previously administered products included SHINGRIX with an associated reaction of adverse event (1st dose received on an unknown date, refer case US2019GSK043645). On 21st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 21st February 2019, less than a day after receiving SHINGRIX, the patient experienced dizziness. On 22nd February 2019, the patient experienced influenza-like symptoms, fever, flushing, general body pain, sore throat, dry throat, stomach virus, stomach pain, cold, sleepiness, erythema of extremities, extremities hot feeling of and sickness. On an unknown date, the outcome of the influenza-like symptoms, fever, flushing, general body pain, dry throat, stomach virus, stomach pain, cold, sleepiness, extremities hot feeling of, dizziness and sickness were recovered/resolved and the outcome of the sore throat was not recovered/not resolved and the outcome of the erythema of extremities was recovering/resolving. It was unknown if the reporter considered the influenza-like symptoms, fever, flushing, general body pain, sore throat, dry throat, stomach virus, stomach pain, cold, sleepiness, erythema of extremities, extremities hot feeling of, dizziness and sickness to be related to SHINGRIX. Additional details were reported as follows: The reporter was the patient. The patient received SHINGRIX vaccine on the left arm. The next day of the vaccination at night, the patient experienced flu like symptoms, fever, flushing, body ache, sore throat, dry throat, stomach virus, stomach pain, cold, sleepiness and red hot area on the arm about 6 inches long and wide. The patient reported that she was sick for 7 days after receiving SHINGRIX vaccine. The patient stated as redness left the arm was started feeling better. The patient's symptoms were lasted for about 6 days. The patient was on the phone with the gentleman for 47 minutes discussing what the situation was with this shot and telling him there experienced with SHINGRIX vaccine. The patient was under the impression that at the end of the phone call that he would reach the reimbursement center and the patient would be able to talk to them. The reporter consented to follow up. No further details were provided. This case has been linked to case US2019041406 and US2019GSK043646, reported by same reporter for the patient's husband.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX (batch number N9CA2, expiry date 2nd July 2021) for prophylaxis. The patient's past medical history included thyroidectomy (about 30 years before the reporting date). Previously administered products included SHINGRIX with an associated reaction of adverse event (1st dose received on an unknown date, refer case US2019GSK043645). On 21st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 21st February 2019, less than a day after receiving SHINGRIX, the patient experienced dizziness. On 22nd February 2019, the patient experienced influenza-like symptoms, fever, flushing, general body pain, sore throat, dry throat, stomach virus, stomach pain, cold, sleepiness, erythema of extremities, extremities hot feeling of and sickness. On an unknown date, the outcome of the influenza-like symptoms, fever, flushing, general body pain, dry throat, stomach virus, stomach pain, cold, sleepiness, extremities hot feeling of, dizziness and sickness were recovered/resolved and the outcome of the sore throat was not recovered/not resolved and the outcome of the erythema of extremities was recovering/resolving. It was unknown if the reporter considered the influenza-like symptoms, fever, flushing, general body pain, sore throat, dry throat, stomach virus, stomach pain, cold, sleepiness, erythema of extremities, extremities hot feeling of, dizziness and sickness to be related to SHINGRIX. Additional details were reported as follows: The reporter was the patient. The patient received SHINGRIX vaccine on the left arm. The next day of the vaccination at night, the patient experienced flu like symptoms, fever, flushing, body ache, sore throat, dry throat, stomach virus, stomach pain, cold, sleepiness and red hot area on the arm about 6 inches long and wide. The patient reported that she was sick for 7 days after receiving SHINGRIX vaccine. The patient stated as redness left the arm was started feeling better. The patient's symptoms were lasted for about 6 days. The patient was on the phone with the gentleman for 47 minutes discussing what the situation was with this shot and telling him there experienced with SHINGRIX vaccine. The patient was under the impression that at the end of the phone call that he would reach the reimbursement center and the patient would be able to talk to them. The reporter consented to follow up. No further details were provided. This case has been linked to case US2019041406 and US2019GSK043646, reported by same reporter for the patient's husband.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Metrorrhagia
Clinical narrative: This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of fetal demise in a 37-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. In November 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received FLULAVAL QUADRIVALENT 2018-2019 season at week 7 of the pregnancy and during the first trimester of pregnancy. In November 2018, 2 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced muscle stiffness. On an unknown date, the patient experienced fetal demise (serious criteria hospitalization and GSK medically significant), spotting menstrual (serious criteria hospitalization) and vaccine exposure during pregnancy. FLULAVAL QUADRIVALENT 2018-2019 season was continued with no change. On an unknown date, the outcome of the fetal demise, spotting menstrual, muscle stiffness and vaccine exposure during pregnancy were unknown. The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present. It was unknown if the reporter considered the fetal demise, spotting menstrual and muscle stiffness to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received vaccine on left deltoid. The patient was 7 weeks and 2 days pregnant when she had her first ultrasound. The fetus had a normal heartbeat. After receiving FLULAVAL QUADRIVALENT 2018-2019 season, she had menstrual spotting during the 10th week of pregnancy and the fetus had no heartbeat at the end of the 11th week. She was diagnosed with fetal demise retrospectively during the 8th week of pregnancy.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Ultrasound antenatal screen normal
Clinical narrative: This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of fetal demise in a 37-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season for prophylaxis. In November 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received FLULAVAL QUADRIVALENT 2018-2019 season at week 7 of the pregnancy and during the first trimester of pregnancy. In November 2018, 2 days after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced muscle stiffness. On an unknown date, the patient experienced fetal demise (serious criteria hospitalization and GSK medically significant), spotting menstrual (serious criteria hospitalization) and vaccine exposure during pregnancy. FLULAVAL QUADRIVALENT 2018-2019 season was continued with no change. On an unknown date, the outcome of the fetal demise, spotting menstrual, muscle stiffness and vaccine exposure during pregnancy were unknown. The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present. It was unknown if the reporter considered the fetal demise, spotting menstrual and muscle stiffness to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received vaccine on left deltoid. The patient was 7 weeks and 2 days pregnant when she had her first ultrasound. The fetus had a normal heartbeat. After receiving FLULAVAL QUADRIVALENT 2018-2019 season, she had menstrual spotting during the 10th week of pregnancy and the fetus had no heartbeat at the end of the 11th week. She was diagnosed with fetal demise retrospectively during the 8th week of pregnancy.
Sex: U
Vaccine: PNC13
Symptoms: Skin swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date (reporter a few years ago) at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that after the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) was administered, the patient's skin was raised, it looked like 3D. The outcome of the event was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Drug hypersensitivity, Heart rate increased
Clinical narrative: This is a spontaneous report from a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs).  A contactable Pharmacist reported for a patient of unknown age and gender who received PREVNAR 13, at single dose on unknown date for immunization and Epinephrine. Relevant medical history and concomitant medication were not reported. The patient had an allergy at some point to something he got at the dental office that had epinephrine in it. It was not an anaphylactic reaction, it was more of a side effect. He had a fast heart beat from the epinephrine which is expected. The caller was just concerned of the polysorbate in the PREVNAR 13. Pfizer is a marketing authorization holder of Epinephrine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Epinephrine has submitted the same report to the regulatory authorities. No follow up attempts are possible. No further information is expected.; Sender's Comments: Current information is limited for fully meaningful assessment;  Considering a plausible drug-event temporal association and the consistency of the event with the known safety profile of the suspect product, a reasonable possibility that allergy is related to PREVENAR 13 administration might not be fully excluded. Fast hear beat is attributable to epinephrine being a treatment for allergy.
Sex: U
Vaccine: PPV
Symptoms: Therapy non-responder
Clinical narrative: This spontaneous report was received from a physician, via Pfizer and refers to a 59-years-old patient of an unknown gender. The patient's concurrent condition included immunodeficiency. There was no information about the patient's concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (exact dose, lot#, expiration date or route of administration not provided). On an unknown date, the patient had no response for 20 of the 23 antibodies of PNEUMOVAX 23. The outcome of the event was unknown.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Infection, Neck pain, Swelling
Clinical narrative: Patient called about 3pm and stated there was a hardness, swelling, and pain radiating to the neck. She was advised to see the doctor in the morning. When asked in the AM the following day, she stated the swelling decreased and the hardness dissipated. Per patient, the physician believed there was an infection and prescribed a steroid and an antibiotic.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Muscle Pain, Generalized, Headache, Mild, Slight Fever.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, chills, achiness all over. Mild soreness at injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Flushing, Headache, Injection site pain, Myalgia
Clinical narrative: Muscle pain at injection site bad enough to warrant ice pack all night. Next day, headache and muscle aches (mostly alleviated by TYLENOL). Also flushing of the face. With Dose #1, I also experienced redness about the face and neck, and some itching.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Muscle pain at injection site bad enough to warrant ice pack all night. Next day, headache and muscle aches (mostly alleviated by TYLENOL). Also flushing of the face. With Dose #1, I also experienced redness about the face and neck, and some itching.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Impaired work ability, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: The right shoulder and arm pain so much and has tingling sensation at the same time. It interferes with my ability to work to make my living.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Injection site pain, Pain
Clinical narrative: Pain at injection site (night of), total body aches/upset stomach/pain at injection site~12 hours after inj. continuing to next day.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Headache, Injection site rash, Injection site swelling, Lymph node pain
Clinical narrative: I have a rash and swelling at the injection site 48 hours after injections. I have body pains in the joints, lymph nodes, and muscles starting 30 hours after the injection. I have a headache since yesterday at 5 pm. I have taken 2 ibuprofen tables twice last night to help with pain.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: I have a rash and swelling at the injection site 48 hours after injections. I have body pains in the joints, lymph nodes, and muscles starting 30 hours after the injection. I have a headache since yesterday at 5 pm. I have taken 2 ibuprofen tables twice last night to help with pain.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR
Symptoms: Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, Vomiting
Clinical narrative: Fever overnoc of 105.8 measured at home by parents. Emesis. Required trip to ER.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR
Symptoms: Abnormal behaviour, Agitation, Body temperature increased, Cough, Crying
Clinical narrative: Fever overnoc of 105.8 measured at home by parents. Emesis. Required trip to ER.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR
Symptoms: Feeling abnormal, High-pitched crying, Influenza virus test negative, Malaise, Poor quality sleep
Clinical narrative: Fever overnoc of 105.8 measured at home by parents. Emesis. Required trip to ER.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR
Symptoms: Respiratory syncytial virus test negative, Retching, Screaming, Skin warm, Vomiting
Clinical narrative: Fever overnoc of 105.8 measured at home by parents. Emesis. Required trip to ER.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Acquired diaphragmatic eventration, Dyspnoea, Nerve injury
Clinical narrative: Shortness of breath, followed by ER visit, had pulm f/u which reports "I suspect elevated right hemidiaphragm is due to zoster vaccine; the temporal association is very tight and there are no other obvious causes of phrenic nerve injury in this patient." - staff physician pulmonary medicine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: RASH surrounding vaccinated and slightpain upon tough, it does not itch just is red and bumpy.
Sex: U
Vaccine: HPV9, MMR
Symptoms: Product storage error
Clinical narrative: This Non-Valid spontaneous report as received from a registered nurse regarding an unknown number of patients (gender and age were not provided). The patients' pertinent medical history or concurrent conditions were not provided. On an unknown date, the patients might have received improperly stored vaccines of GARDASIL 9, lot # M041990 and expiration date on 28-JUN-2019) (route, anatomical location, dosage were not provided); and doses of M-M-R II, lot # N026828 and expiration date on 27-SEP-2019) (route, anatomical location, dosage were not provided); both therapies administered as prophylaxis. The doses were storage at 11.8 grades centigrade, for one hour and 45 minutes. The report was identified via "data logger". No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of enlargement of lymph nodes in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on 26th May 2018, refer case US2019GSK045360). On 30th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced enlargement of lymph nodes. The patient was treated with medication unknown (Ice Pack (Nos)) and naproxen (Aleve). On an unknown date, the outcome of the enlargement of lymph nodes was unknown. It was unknown if the reporter considered the enlargement of lymph nodes to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. The patient received the 2nd dose of SHINGRIX on the left arm and she experienced swollen lymph node in armpit of vaccinated arm. The reporter declined consent for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 26th May 2018, the patient received the 1st 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: Age at vaccination was not reported. It was reported that the patient was feverish after recevining SHINGRIX dose. The reporter declined consent for follow up. For tolerance to next dose, refer case US2019GSK040791.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shoulder replacement. Previously administered products included SHINGRIX (1st dose received in June 2018). On 28th February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were unknown. It was unknown if the reporter considered the erythema and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was delayed in getting her second dose due to receiving a total shoulder replacement on her right shoulder and the lack of availability. The patient experienced redness and soreness. The patient reported this information to her doctor. The caller granted permission for GlaxoSmithKline to contact her healthcare professional.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Asthenia, Dizziness, Feeling abnormal, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shoulder replacement. Previously administered products included SHINGRIX (1st dose received in June 2018). On 28th February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were unknown. It was unknown if the reporter considered the erythema and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was delayed in getting her second dose due to receiving a total shoulder replacement on her right shoulder and the lack of availability. The patient experienced redness and soreness. The patient reported this information to her doctor. The caller granted permission for GlaxoSmithKline to contact her healthcare professional.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site induration, Injection site pain, Musculoskeletal stiffness, Neck pain, Wrong technique in product usage process
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shoulder replacement. Previously administered products included SHINGRIX (1st dose received in June 2018). On 28th February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were unknown. It was unknown if the reporter considered the erythema and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was delayed in getting her second dose due to receiving a total shoulder replacement on her right shoulder and the lack of availability. The patient experienced redness and soreness. The patient reported this information to her doctor. The caller granted permission for GlaxoSmithKline to contact her healthcare professional.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shoulder replacement. Previously administered products included Tylenol and Aleve. On 28th February 2019, the patient received the 2nd dose of SHINGRIX. On 28th February 2019, 5 hrs after receiving SHINGRIX, the patient experienced injection site pain, injection site induration, neck pain, stiff neck, headache, dizziness, weakness and feeling anxious. On an unknown date, the patient experienced wrong injection technique. On an unknown date, the outcome of the injection site pain, injection site induration, neck pain, stiff neck, headache, dizziness, weakness, feeling anxious and wrong injection technique were unknown. It was unknown if the reporter considered the injection site pain, injection site induration, neck pain, stiff neck, headache, dizziness, weakness and feeling anxious to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller who was a retired registered nurse reported that the patient received SHINGRIX on left deltoid arm around 1pm. The patient began to had symptoms at around 6 pm that evening consisting of pain at injection site, hardness at injection site the size of a fity cent piece, pain radiating up the left side of her neck with stiffness, headache, dizziness, weakness, felt off center and anxious, dizzy. The patient was taken Tylenol and Aleve for her right shoulder replacement she recently had done and feels the medication may have masked even more symptoms. The patient biggest concern was the vaccine was given with a subcutaneous needle instead of an intramuscular needle, which led to wrong injection technique. The patient also concerned about the efficacy of the second vaccine. She had her second dose at the pharmacy that was listed below. She was also concerned that the same pharmacist was given the vaccine to many others with the incorrect needle. She did contact another pharmacist there and told him what had occurred. She was seeing her surgeon today for a post-op visit for her shoulder replacement and will have him look at her injection site. This case has been linked to US2019GSK046595, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Asthenia, Dizziness, Feeling abnormal, Headache
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shoulder replacement. Previously administered products included Tylenol and Aleve. On 28th February 2019, the patient received the 2nd dose of SHINGRIX. On 28th February 2019, 5 hrs after receiving SHINGRIX, the patient experienced injection site pain, injection site induration, neck pain, stiff neck, headache, dizziness, weakness and feeling anxious. On an unknown date, the patient experienced wrong injection technique. On an unknown date, the outcome of the injection site pain, injection site induration, neck pain, stiff neck, headache, dizziness, weakness, feeling anxious and wrong injection technique were unknown. It was unknown if the reporter considered the injection site pain, injection site induration, neck pain, stiff neck, headache, dizziness, weakness and feeling anxious to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller who was a retired registered nurse reported that the patient received SHINGRIX on left deltoid arm around 1pm. The patient began to had symptoms at around 6 pm that evening consisting of pain at injection site, hardness at injection site the size of a fity cent piece, pain radiating up the left side of her neck with stiffness, headache, dizziness, weakness, felt off center and anxious, dizzy. The patient was taken Tylenol and Aleve for her right shoulder replacement she recently had done and feels the medication may have masked even more symptoms. The patient biggest concern was the vaccine was given with a subcutaneous needle instead of an intramuscular needle, which led to wrong injection technique. The patient also concerned about the efficacy of the second vaccine. She had her second dose at the pharmacy that was listed below. She was also concerned that the same pharmacist was given the vaccine to many others with the incorrect needle. She did contact another pharmacist there and told him what had occurred. She was seeing her surgeon today for a post-op visit for her shoulder replacement and will have him look at her injection site. This case has been linked to US2019GSK046595, reported by the same reporter.