chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 14-OCT-2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. Upon information and belief, on or about 14-OCT-2010, a physician recommended and/or administered the ZOSTAVAX to the patient for its intended purpose of long-term prevention of shingles and zoster-related injuries (unclear if administered at a pharmacy or by the physician). The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended. In or about 2013, the patient was treated at an urgent care center for shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from an office manager concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 21-SEP-2018, the patient was vaccinated with improperly stored GARDASIL 9 with lot number R002344 and expiration date on 16-NOV-2020, 0.5 ml once (dose number, route of administration and anatomical location were not provided), for prophylaxis. It was reported that on an unknown date, the vaccine was exposed to a temperature of -0.3 Centigrade degrees for 3 hours. It was unknown if there was previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported.
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative, Therapy non-responder
Clinical narrative: Information has been received from a literature article, referring to a 26-year-old male patient with common variable immunodeficiency (CVID) with an intrinsic microdeletion of chromosome 1q42.1-42.3, where gene for inositol 1,3,4, trisphosphate kinase beta (ITPKB) was localized. ITPKB had an important role in the development, survival and function of B cells. In this subject, the expression of ITPKB mRNA as well as ITKPB protein was significantly reduced. The sequencing of ITPKB gene revealed three variants, two of them were missense variants and third was a synonymous variant. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#, dose, dose# and route unknown) for prophylaxis. On an unknown date, the patient did not respond to any of the 14 serotypes of Streptococcus pneumoniae following PNEUMOVAX 23 vaccination (therapy non-responder). Streptococcus pneumonia antibodies (14 serotypes) were 0.00.3 microgram/ml (reference range: more than 1.3 microgram/ml). The patient showed markedly impaired response to T-independent pneumococcal polysaccharide antigens. The outcome of therapy non-responder was unknown. The author considered therapy non-responder to be related to PNEUMOVAX 23.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On 16-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (°F) to 77°F (53°F) during a time frame of 5 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA001303:Original Case : 1805USA001303, US-009507513-1809USA011188:Original Case : 1809USA010671, US-009507513-1809USA011189:Original Case : 1809USA010671, US-009507513-1809USA011190:Original Case : 1809USA010671, US-009507513-1809USA010671:Original Case : 1809USA010671, US-009507513-1809USA011185:Original Case : 1809USA010671, US-009507513-1809USA011184:Original Case : 1809USA010671, US-009507513-1809USA011187:Original Case : 1809USA010671.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On 16-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (°F) to 77°F (53°F) during a time frame of 5 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA001303: Original Case: 1805USA001303; US-009507513-1809USA010671: Original Case: 1809USA010671; US-009507513-1809USA011188:Original Case : 1809USA010671; US-009507513-1809USA011189:Original Case : 1809USA010671; US-009507513-1809USA011186:Original Case : 1809USA010671; US-009507513-1809USA011190:Original Case : 1809USA010671; US-009507513-1809USA011184:Original Case : 1809USA010671; US-009507513-1809USA011185:Original Case : 1809USA010671.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On 16-APR-2018, the patient was vaccinated with improperly stored doses of M-M-R II intramuscularly, lot # N020927, expiration date 01-AUG-2019, (strength, dose and frequency were not provided) for prophylaxis. The M-M-R II was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degree Fahrenheit (°F) to 77°F (53°F) during a time frame of 5 hours. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA001303: Original Case: 1805USA001303; US-009507513-1809USA011187: Original Case: 1809USA010671; US-009507513-1809USA010671: Original Case: 1809USA010671; US-009507513-1809USA011189: Original Case: 1809USA010671; US-009507513-1809USA011186: Original Case: 1809USA010671; US-009507513-1809USA011190: Original Case: 1809USA010671; US-009507513-1809USA011184: Original Case: 1809USA010671; US-009507513-1809USA011185: Original Case: 1809USA010671.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 10-SEP-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (dose and route were unknown), lot # R012501 expiration date 08-JAN-2020 for prophylaxis. This was the first temperature excursion. There was no Digital Data Logger involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1809USA011221; US-009507513-1809USA004863.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Fatigue, Injection site erythema, Injection site swelling, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bruising of arm in a 69-year-old female patient who received SHINGRIX (batch number MY2B2, expiry date February 2019) for prophylaxis. On 4th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 5th September 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue, fever and pain. In September 2018, the patient experienced bruising of arm, injection site erythema and injection site swelling. On an unknown date, the outcome of the bruising of arm, fatigue, fever, pain, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the bruising of arm, fatigue, fever, pain, injection site erythema and injection site swelling to be related to SHINGRIX. Additional information was received as follows: This case was previously reported to the doctor. The patient received SHINGRIX on the right arm. The reporter stated that 16 to 18 hours after receiving SHINGRIX the patient had swelling, redness at the injection site and couple of inches below the injection site, the patient had some bruising on the right arm. The reporter stated that the patient called her physician and set an appointment however, the appointment was set for a few weeks away and till the time of reporting, the patient had not been seen by the physician. This case was 1 of 3 cases, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bruising of arm in a 69-year-old female patient who received SHINGRIX (batch number MY2B2, expiry date February 2019) for prophylaxis. On 4th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 5th September 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue, fever and pain. In September 2018, the patient experienced bruising of arm, injection site erythema and injection site swelling. On an unknown date, the outcome of the bruising of arm, fatigue, fever, pain, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the bruising of arm, fatigue, fever, pain, injection site erythema and injection site swelling to be related to SHINGRIX. Additional information was received as follows: This case was previously reported to the doctor. The patient received SHINGRIX on the right arm. The reporter stated that 16 to 18 hours after receiving SHINGRIX the patient had swelling, redness at the injection site and couple of inches below the injection site, the patient had some bruising on the right arm. The reporter stated that the patient called her physician and set an appointment however, the appointment was set for a few weeks away and till the time of reporting, the patient had not been seen by the physician. This case was 1 of 3 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Influenza like illness, Rash, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a adult female patient who received SHINGRIX 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, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, influenza-like symptoms and influenza-like symptoms. On an unknown date, the outcome of the vaccination failure, shingles, rash, influenza-like symptoms and influenza-like symptoms were unknown. It was unknown if the reporter considered the vaccination failure, shingles and influenza-like symptoms to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, shingles, rash and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however it could be 73 or 74 days. The healthcare professional (HCP) reported that the patient experienced red on breast, almost like shingles coming. The HCP also reported patient experienced flu like symptoms. The symptoms were worse after second dose as compared to 1st dose. This case was considered as suspected vaccination failure as time to onset for the event was unknown. This case has been linked to the US2018169160, reported by the same reporter.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Tenderness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 73-year-old male patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) and (batch number 2453L, expiry date 12th February 2021) for prophylaxis. Concurrent medical conditions included transient ischemic attack (2 times). On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In September 2018, less than a week after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. This case was reported by the patient's wife. The patient received SHINGRIX in the left deltoid. The patient experienced tenderness on the left side of his head, it was tender to the touch, like he was hit. This had not gotten worse or improved till the time of reporting. It was stated that, the patient had not broken out and did not felt bad. The patient's wife planned to take the patient to the doctor office on the day of reporting.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Gait disturbance, Head discomfort, Headache, Mucous membrane disorder
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pneumonia in a 59-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received on an unknown date, refer case US2018GSK173665). On 17th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain, head pressure, headache and balance disorder. On 30th August 2018, the patient experienced pneumonia (serious criteria GSK medically significant) and mucous membrane disorder. Rechallenge with SHINGRIX was positive. In August 2018, the outcome of the pain, head pressure, headache and balance disorder were recovered/resolved. On an unknown date, the outcome of the pneumonia and mucous membrane disorder were not reported.  The reporter considered the pneumonia and mucous membrane disorder to be unrelated to SHINGRIX. It was unknown if the reporter considered the pain, head pressure, headache and balance disorder to be related to SHINGRIX. Additional information received as follows: The case was reported by the registered nurse. The patient experienced more pain with the second dose of SHINGRIX compared to the first dose of SHINGRIX. The patient experienced pain to the point where the patient felt off balance while walking. The reporter did not clarify where was the pain was located. The patient also complained about a pressure sensation with his forehead and headaches. The pain radiated to the back to his head. The symptoms slowly resolved over 2 weeks. On 30th August 2018, the patient was feeling better. On 30th August 2018, the patient was developing mucus build up. No clarification was provided on location of mucus build up.  The patient was diagnosed with pneumonia on 30th September 2018.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pneumonia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pneumonia in a 59-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received on an unknown date, refer case US2018GSK173665). On 17th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced pain, head pressure, headache and balance disorder. On 30th August 2018, the patient experienced pneumonia (serious criteria GSK medically significant) and mucous membrane disorder. Rechallenge with SHINGRIX was positive. In August 2018, the outcome of the pain, head pressure, headache and balance disorder were recovered/resolved. On an unknown date, the outcome of the pneumonia and mucous membrane disorder were not reported.  The reporter considered the pneumonia and mucous membrane disorder to be unrelated to SHINGRIX. It was unknown if the reporter considered the pain, head pressure, headache and balance disorder to be related to SHINGRIX. Additional information received as follows: The case was reported by the registered nurse. The patient experienced more pain with the second dose of SHINGRIX compared to the first dose of SHINGRIX. The patient experienced pain to the point where the patient felt off balance while walking. The reporter did not clarify where was the pain was located. The patient also complained about a pressure sensation with his forehead and headaches. The pain radiated to the back to his head. The symptoms slowly resolved over 2 weeks. On 30th August 2018, the patient was feeling better. On 30th August 2018, the patient was developing mucus build up. No clarification was provided on location of mucus build up.  The patient was diagnosed with pneumonia on 30th September 2018.
Sex: F
Vaccine: MENB
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Peripheral swelling, Skin warm, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vomiting in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced vomiting, pain in arm, swelling arm and skin warm. On an unknown date, the outcome of the vomiting, pain in arm, swelling arm and skin warm were recovered/resolved. It was unknown if the reporter considered the vomiting, pain in arm, swelling arm and skin warm to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The reporter's daughter received BEXSERO vaccine but she had severe side effects which included vomiting and an extremely sore arm. It was swollen and warm to the touch and it literally took almost a week to feel better. She wound up missing two days of school. Her doctor said she should get the second dose but the reporter was afraid to give it to her. In the frequently asked questions it said those who had an allergic reaction shouldn't take it. The reporter asked for any advice.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Stem cell therapy, Vaccination failure
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concomitant products included Stem Cell Infusion. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and several months after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had no reaction after her first dose of SHINGRIX. Several months before the date of reporting, the patient received her second dose of SHINGRIX in her left arm. An unspecified period later, the patient received a stem cell injection in her right arm. The patient called the nurse office and reported that she had developed shingles. This was all the information nurse had and she agreed to be contacted for follow up. The reporter was unaware of the patient's initials and date of birth. This case was considered as suspected vaccination failure cases as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 24 years old female patient who was exposed to vaccine TENIVAC, while she was pregnant. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported that they had a 24 year old pregnant female who received the Tenivac, no AE occurred at unknown gestation period the gestation period at onset and gestation period at exposure data needs to be populated, if available. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. no other vaccines were given to the patient. The patient had unknown previous pregnancies. On 18-Sep-2018, the patient received a 0.5 ml once dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5882AA. It was a case of exposure during pregnancy. The patient did not experience any adverse event. Relevant prenatal testing after exposure was not reported. No Lab data was reported. It was not reported if any corrective treatment was given. Additionally, at time of reporting, the outcome of the pregnancy is unknown. List of documents held by the sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional. This case involves a 65 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE via intramuscular route in the left deltoid on 04-Sep-2018 (lot no UJ004AB, expiry date: 30-APR-2019) and 19-Sep-2018 (lot no UJ010AC expiry date: 22-APR-2019) respectively. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to extra dose administered. It was reported that a 65 year old female received the Fluzone High Dose vaccine twice in error. It was reported that patient had no adverse reaction and has not gone to the emergency room. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender- none.
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial unsolicited report received from consumer on 20-Sep-2018. This case involves a unknown age male patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was a case of actual medication error due to extra dose administered (received the vaccine twice last week). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Blood creatine phosphokinase increased, Blood potassium decreased, Dysstasia, Gait disturbance, Lumbar puncture normal
Clinical narrative: 1 day after receiving vaccines had muscle pain and needed help to stand and walk. Potassium level at admission 2.9. Potassium replaced and had plasmapheresis. CK enzymes also elevated but trended downward with IV fluids. Lumbar puncture and spinal MRI also done LP and MRI (including brain) were WNL.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Myalgia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Plasmapheresis
Clinical narrative: 1 day after receiving vaccines had muscle pain and needed help to stand and walk. Potassium level at admission 2.9. Potassium replaced and had plasmapheresis. CK enzymes also elevated but trended downward with IV fluids. Lumbar puncture and spinal MRI also done LP and MRI (including brain) were WNL.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Significant pain, redness, and swelling from the left hip down to the left knee. Circumference of left leg measures 12.5 inches. Circumference of right unaffected leg measures 10.75 inches. Treated with Tylenol, ibuprofen, and ice to the site. Returned to the clinic the next day for an evaluation. Was told it is a mild localized reaction and no treatment necessary. Physician did recommend using Benadryl. Benadryl given 9/25/2018 at bedtime. Circumference of left leg measured 12 inches the next morning.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Redness, soreness, warmth for 24 hours starting 24 hours after vaccination.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, whole body aches, low grade fever.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain
Clinical narrative: Severe low back pain.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: FLU AND PNEUMOVAS WAS ADMINISTERED IN THE LEFT ARM AS REQUESTED BY PT. PT STATES HE COULD NOT USE THE RIGHT ARM BECAUSE HE WAS HAVING PHYSICAL THERAPY ON THAT ARM. PT STATES DAY AFTER INJ HIS LEFT ARM WAS SWOLLEN AND HURT SO HE WENT TO THE LOCAL ER. PT RECEIVED AN RX FOR HYDROCODONE/APAP 5/325 AND KETORALAC 10 MG.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Pt received two shots on 9/24/18. FLUZONE was in right arm and PNEUMOVAX in the left arm. She states that 2 to 3  hours after receiving shots her left arm showed redness and became warm to touch. She experienced pain and saw a doctor on 9/25/18. He prescribed Amoxicillin 250mg three times daily for 5 days.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Gave injection to patient (never had a flu shot in past) at 630 am. Kept patient for 7 minutes - no adverse effects. Patient returned at 7 am with c/o of pain, heat and itching to injection area. No respiratory issues or N/V. Site warm to touch, no redness or rash noted. Applied ice pack to site. Pt. c/o ice made it more warm feeling as well as radiation to top of shoulder towards neck. Kept ice in place for 20 mins. At 730 am. patient said no heat or itching noted at site however still some warmth to top of shoulder. Still no respiratory issues. Pt returned to work with ice pack. Instructed to see own MD if continued symptoms or worsening.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Limb discomfort, Pain in extremity
Clinical narrative: Right arm was sore right away and gradually became red and swollen becoming uncomfortable by 9pm. When patient went to the ER at 10pm the redness and swelling had spread from shoulder to elbow. Pt was given benadryl and prednisone in the ER which has stopped the progression of the reaction.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Pain
Clinical narrative: Numbness from injection site, spreading down the arm and up to the neck, "excruciating pain" and unable to move her left arm starting during the night after her injection and proceeding through the next 2 days. Patient reports taking a Norco for pain with no beneficial outcome. Improvement noted on day 3, still some pain but a lot more manageable.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Intense shivering, headache, muscle soreness, fatigue.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Redness, soreness at injection site within 2 hours; feverish, chills, muscle pain, headache  beginning 9 hours after injection and lasting for 12 hours.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness, soreness at injection site within 2 hours; feverish, chills, muscle pain, headache  beginning 9 hours after injection and lasting for 12 hours.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: On-set of symptoms within hours of injection, body aches, joint pain, chills and sweats, fever (low and high) persisted over 2 1/2 days. Treated at home with OTC pain relievers, bed rest.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Information has been received from a physician referring to a 70 year old female patient with "allergies, hypertension, asthma and hypothyroidism". The patient had no known drug allergies. On 03-SEP-2018 at 14:00, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, batch/lot # and expiration date were not reported) for prophylaxis at an unspecified Pharmacy. On 04-SEP-2018, the patient went to the Emergency Room "with systemic chills, malaise, nausea, the injection site was swollen 12 1/2x7 cm, and was red and hot". The patient received BENADRYL, calamine (manufacturer unknown), and KEFLEX at the Emergency Room. On 06-SEP-2018 the patient was seen in physician's office and "seemed to be better" (the outcome of the events considered to be recovering). The causality between the events and PNEUMOVAX 23 was not reported.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Information has been received from a physician referring to a 70 year old female patient with "allergies, hypertension, asthma and hypothyroidism". The patient had no known drug allergies. On 03-SEP-2018 at 14:00, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, batch/lot # and expiration date were not reported) for prophylaxis at an unspecified Pharmacy. On 04-SEP-2018, the patient went to the Emergency Room "with systemic chills, malaise, nausea, the injection site was swollen 12 1/2x7 cm, and was red and hot". The patient received BENADRYL, calamine (manufacturer unknown), and KEFLEX at the Emergency Room. On 06-SEP-2018 the patient was seen in physician's office and "seemed to be better" (the outcome of the events considered to be recovering). The causality between the events and PNEUMOVAX 23 was not reported.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome 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, less than a year after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 70 or 71 years old. The patient presented with guillain barre syndrome and was referred to a neurologist for further evaluation. There were no other circumstances to make her think it was attributed to anything else. Neurologist was treating for guillain barre syndrome according to the reporter. The reporter agreed to be followed up from GlaxoSmithKline. No other information was known.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness & itching began at injection site beginning afternoon/evening after injections were given. The next day, 9/25/18, pt reports itching stopped but redness had darkened & spread around arm & down to 1/3 length of upper arm. Area of redness noted to be the size of an outstretched hand, hot to touch & painful, causing difficulty raising arm to shoulder level or higher.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Influenza like illness, Peripheral swelling
Clinical narrative: Patient reported minor swelling in left arm and fatigue, flu-like symptoms beginning on day after vaccination.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy, Swelling, Tenderness
Clinical narrative: Patient presents with two days increased tenderness in the arm, swelling, supraclavicular lymphadenopathy. No fevers or chills. No erythema or fluctuance noted. Normal ROM of left shoulder.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Weight bearing difficulty
Clinical narrative: The patient cannot lift the left arm or cannot even carry a coffee cup, doctor suggested to go for MRI.
Age: 1.0
Sex: M
Vaccine: HEP, HIBV
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, unwell.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient experienced redness and pain on the upper part of her arm for 36 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pain, Rash, Skin warm
Clinical narrative: Large lump, red, warm and pain. 10 cm area of redness w/a 1 cm lump. Mild rash on torso. The patient received KEFLEX and prednisone. Also tried BENADRYL.
Sex: M
Vaccine: HPV9, MEN
Symptoms: Headache, Injection site cellulitis, Injection site pain, Injection site warmth, Pain
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 and an unspecified meningococcal vaccine for prophylaxis. On an unknown date, the patient experienced cellulitis at the injection site, the area was hot and painful, a fever, body aches and headaches. The patient visited an unspecified pediatric physician on an unspecified date and the physician did not prescribe any treatment for these problems. The outcome of events was not reported. Causality assessment was not provided.
Sex: M
Vaccine: HPV9, MEN
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 and an unspecified meningococcal vaccine for prophylaxis. On an unknown date, the patient experienced cellulitis at the injection site, the area was hot and painful, a fever, body aches and headaches. The patient visited an unspecified pediatric physician on an unspecified date and the physician did not prescribe any treatment for these problems. The outcome of events was not reported. Causality assessment was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). In August 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The reporter indicated that, she gave the patient SHINGRIX vaccine subcutaneously approximately three weeks ago, which led to inappropriate route of vaccination. The patient experienced fevers two times which were resolved. The reporter was unwilling to provide any additional details and was transferred to Medical Information.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 68-year-old male patient who received SHINGRIX (batch number M224F, expiry date 8th February 2021) for prophylaxis. The patient's past medical history included migraine.  On 10th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving SHINGRIX, the patient experienced headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache was recovered/resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. In 2018, the patient experienced severe headache which lasted for 12 hours. The patient sat in a dark room, had a caffeinated beverage and took Tylenol, and the headache resolved. The healthcare professional reported that the patient also had a history of migraines, but the headache he experienced was described by the patient as a different kind of headache.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 84-year-old male patient who received SHINGRIX (batch number P45M9, expiry date unknown) for prophylaxis. On 6th September 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 6th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the right deltoid. The reporter had a consumer that developed soreness at the injection site the evening after receiving the SHINGRIX vaccine. They called the pharmacy to report that they were still experiencing the symptom 13 days after receiving the vaccine. The call was transferred to Medical Information. reporter believed this was the second dose for the consumer but cannot verify this with her records.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of runny nose in a 62-year-old male patient who received SHINGRIX (batch number 4FS5N, expiry date 8th March 2021) for prophylaxis. On 16th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th September 2018, less than a day after receiving SHINGRIX, the patient experienced runny nose and cold symptoms. On an unknown date, the outcome of the runny nose and cold symptoms were unchanged. It was unknown if the reporter considered the runny nose and cold symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The same day after receiving the vaccine the patient experienced runny nose and cold like symptoms. No further details were provided by the pharmacist.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Fall
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced dizziness and fall. On an unknown date, the outcome of the dizziness and fall were unknown. It was unknown if the reporter considered the dizziness and fall to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The health care professional reported that the patient experienced severe dizziness hours after receiving a dose of the SHINGRIX vaccine. This dizziness caused the patient to fall. The health care professional did not have vaccine or patient details because this patient was given the vaccine at a different location. The health care professional did not believe that the patient had any medical treatment or emergency room visit.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 67-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 1st August 2018, the patient received SHINGRIX. On 7th September 2018, 37 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovering/resolving. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that, her patient noted a rash around the site where SHINGRIX was injected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 70-year-old female patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. In August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 29th August 2018, 7 days after receiving SHINGRIX, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved. It was unknown if the reporter considered the dizziness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's son. The healthcare professional reported that, the patient developed severe dizziness, 1 week after receiving the SHINGRIX vaccine. The patient was taken to the emergency room to be examined. The adverse event had not resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a female 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 influenza-like symptoms, fever, chills, pain and tiredness. On an unknown date, the outcome of the influenza-like symptoms, fever, chills, pain and tiredness were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) stated that the patient got a dose of SHINGRIX and had flu-like symptoms, achiness, tiredness, fever and chills. The symptoms lasted 1 day and then went away.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Nausea, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 53-year-old male patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than 4 months after receiving SHINGRIX, the patient experienced nausea, general body pain and joint pain. On an unknown date, the outcome of the nausea, general body pain and joint pain were unknown. It was unknown if the reporter considered the nausea, general body pain and joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported his patient had experienced above events following vaccination with SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a male patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than 4 months after receiving SHINGRIX, the patient experienced nausea and general body pain. On an unknown date, the outcome of the nausea and general body pain were unknown. It was unknown if the reporter considered the nausea and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported his patient had body aches and nausea following vaccination with SHINGRIX. The healthcare professional was unable to provide lot or expiry date or date of birth of the patient.