chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt received a SHINGRIX vaccine, reports there arm swelled up significantly, became bright red and was giving off heat. Pt reported 4 days after and most of the swelling had retreated. Asked to have event reported.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Injection site reaction, hives.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and shivering 12 hours after receiving 2nd dose of SHINGRIX vaccine. I received the first dose of the vaccine about two months ago, and did not experience any side effects.
Age: 16.0
Sex: M
Vaccine: MNQ, TYP
Symptoms: Asthenia, Blood pressure decreased, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient experienced vasovagal reaction (diaphoresis, nausea, pallor, weakness) after injection of MENACTRA and Typhoid vaccines. Blood pressure dropped to 58/28, HR 42, SpO2 96%, RR 18. Patient was helped to a near supine position and was given comfort and support. Five minutes after onset, his BP rebounded to 68/26, HR 47. At 10 minutes after the onset of the reaction, the patient's BP was 81/40, HR 69 and was 89/56, BP 61 while the patient was sitting upright. Patient was given juice, his color improved, and the diaphoresis resolved. At this point, patient felt back to normal. Patient was alert at all times, followed commands, and answered questions. Patient also reported blurry vision at onset of the reaction, but it resolved with the other symptoms. Time from onset to recovery was approximately 25 minutes. Left office with mother in good spirits, MD was summoned to the room soon after onset to assess patient. RN, MA, and MD stayed with patient until full recovery.
Age: 16.0
Sex: M
Vaccine: MNQ, TYP
Symptoms: Presyncope, Vision blurred
Clinical narrative: Patient experienced vasovagal reaction (diaphoresis, nausea, pallor, weakness) after injection of MENACTRA and Typhoid vaccines. Blood pressure dropped to 58/28, HR 42, SpO2 96%, RR 18. Patient was helped to a near supine position and was given comfort and support. Five minutes after onset, his BP rebounded to 68/26, HR 47. At 10 minutes after the onset of the reaction, the patient's BP was 81/40, HR 69 and was 89/56, BP 61 while the patient was sitting upright. Patient was given juice, his color improved, and the diaphoresis resolved. At this point, patient felt back to normal. Patient was alert at all times, followed commands, and answered questions. Patient also reported blurry vision at onset of the reaction, but it resolved with the other symptoms. Time from onset to recovery was approximately 25 minutes. Left office with mother in good spirits, MD was summoned to the room soon after onset to assess patient. RN, MA, and MD stayed with patient until full recovery.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia
Clinical narrative: SHINGRIX 2nd vaccination. Headache for approximately 3 days, muscle soreness in back of neck.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 6/29/18 Parent was contacted and informed that child was given "extra" doses that were not needed and that she may have increased site soreness. No adverse events reported by parent.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Chills, Dizziness, Headache, Injection site pain, Vision blurred
Clinical narrative: Approx 2 hrs. after imm. given complained of sudden onset headache, dizziness, chills, blurred vision, pain at injection site. Seen in office approx 4 1/2 hrs. after imm. headache continued, less dizziness, chills, blurred vision.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site cellulitis
Clinical narrative: Pt had gone to ER 2 days after receiving immunizations DTaP and Hep A. Final Dx cellulitis of left thigh.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm moderate swelling and redness localized to the left deltoid. It is mildly tender to palpation. Symptoms started at 2PM 7/10/18.
Age: 18.0
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Pruritus generalised, Urticaria
Clinical narrative: 12 hours after receiving vaccine pt developed hives, on back and arms (both) treated with BENADRYL. Have resolved but pt began with generalized pruritus. No respiratory symptoms. Left arm site of administration is red and indurated.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Pain, Rash erythematous, Swelling
Clinical narrative: Started a little bigger than 1/2 dollar, red, raised, sore, hard. Today at office light red rash, getting smaller, not hard. TX - BENADRYL SPRAY.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Blindness transient, Deafness, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Within one minute of giving vaccine patient started to feel like she was passing out. She briefly lost consciousness and eyes closed followed by unresponsiveness. This lasted about 1 minute. When she came to she was laid on floor and reported her vision and hearing were gone but then returned. She felt better after lying on floor.
Age: 53.0
Sex: M
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Patient developed Guillian-Barre Syndrome and was treated at the Medical Center. Patient later transferred to another Medical Center and the patient's status past his stay at first hospital is unknown.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Erythema, Headache, Pain in extremity
Clinical narrative: Patient came in today July 12th 2018 and complained of having an allergic reaction to SHINGRIX vaccine given on June 20th 2018, she came in today and said she had some side effects like swelling around the site of injection, she also say she was having nausea and vomiting, which stopped by the next day.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Patient came in today July 12th 2018 and complained of having an allergic reaction to SHINGRIX vaccine given on June 20th 2018, she came in today and said she had some side effects like swelling around the site of injection, she also say she was having nausea and vomiting, which stopped by the next day.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Injection site swelling, Nausea, Vomiting
Clinical narrative: Patient came in today July 12th 2018 and complained of having an allergic reaction to SHINGRIX vaccine given on June 20th 2018, she came in today and said she had some side effects like swelling around the site of injection, she also say she was having nausea and vomiting, which stopped by the next day.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Sore and swollen injection site, low grade fever, chills, head and body aches, tired.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Sore and swollen injection site, low grade fever, chills, head and body aches, tired.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: Redness around injection site on day 2 after the vaccination got very red and warm. Pain was moderate for first 24 hours then became mild as redness intensified. Day 3 redness is lessening and area is not as warm. Effected area roughly the size of a plum.
Age: 35.0
Sex: M
Vaccine: IPV, YF
Symptoms: Discomfort, Injection site discomfort, Injection site swelling, Oedema peripheral
Clinical narrative: Left upper arm and armpit swelling with discomfort which occurred on day 4 post vaccines. Area swollen but no redness/hardness/drainage/fever reported. Presented to Urgent Care and was prescribed ZITHROMAX and ADVIL.
Age: 16.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: High fever 103, severe pain in arm at injection site, muscle aches, extreme tiredness.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 4-year-old child. The patient's concurrent condition, medical history and concomitant therapies were not reported. On 11-JUN-2018, the patient was inadvertently vaccinated with VARIVAX injection, for prophylaxis. On the same day, the patient was also vaccinated with PROQUAD for prophylaxis. Expiration dates and lot# for both vaccines were unknown. No adverse effect was reported.
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from a registered nurse via company representative and refers to a 14 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On an unknown date in June 2018, reported as "the last week", the patient received a dose of GARDASIL 9 for prevention of human papillomaviruses (HPV) related cancers and diseases (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). It was reported that the patient fainted, immediately after receiving the GARDASIL 9. It was unknown if the patient sought medical attention, if received treatment or if laboratory diagnostics or studies were performed. The outcome of the event syncope was unknown and the reporter did not assess the causal relationship between vaccination with GARDASIL 9 and the event. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1807USA004955.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non valid report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot # reported as N019282, expiration date 09-JAN-2019 and VARIVAX lot # N021581, expiration date 09-AUG-2019 (for both strength, dose number, route and anatomical location were not provided). The vaccines were reconstituted with properly stored sterile diluent (MERCK). Administered dose of PROQUAD and VARIVAX experienced the temperature excursion of -9 Celsius degrees to 8 Celsius degrees (also reported as 7.3 Celsius degrees) for 1 hour and 9 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from a nurse on 12-JUN-2018 and refers to a 4-year-old patient. On 01-FEB-2018, the patient was vaccinated with improperly stored dose of PROQUAD lot # N019828 (previously reported as N019282) and VARIVAX. This is one of six reports received from the same reporter. Albumin status for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, for lot # N019828 has been verified as recombinant human albumin (rHA). Sender's Comments: US-009507513-1806USA007938: US-009507513-1801USA006139: US-009507513-1806USA007940: US-009507513-1806USA007936: US-009507513-1806USA007937.
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via Regulatory Authority regarding a 27 year old male patient. Information on medical history, current conditions and concomitant therapies was not reported. On 20-JUN-2018, the patient was vaccinated with first dose of M-M-R II of lot # N005774 with an expiry date of 17-DEC-2019 via intramuscular route for prophylaxis (strength, anatomical location not reported). Other suspect therapies included sterile diluent of lot # N009799 with an expiry date of 29-NOV-2018, once via intramuscular route for reconstitution of M-M-R II. The pharmacist reported that the patient was advised to contact the pharmacy if he has an adverse experience, however, at the time of the report, the patient had not communicated any adverse experiences. Lot Number N009799 is not a valid lot for STERILE DILUENT.
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Mobility decreased, Nausea
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 67 year old female patient with SPIRIVA hypersensitivity. On 19-JUN-2018, the patient received the first dose of PNEUMOVAX 23 lot # R002084, expiration date 26-OCT-2019 for prophylaxis. On 21-JUN-2018, the patient received the second dose of PNEUMOVAX 23 lot # R002084, expiration date 26-OCT-2019 in the right arm for prophylaxis. In approximately June 2018, the patient experienced swelling in the right arm, bilateral arm pain from shoulder to elbow making it hard to move her arms, chills, nausea, and vomiting. She called the office on 22-JUN-2018 and was seen by a nurse practitioner. The nurse practitioner prescribed an unspecified treatment for the patient to control her symptoms. The outcome of swelling in the right arm, bilateral arm pain from shoulder to elbow making it hard to move her arms, chills, nausea, and vomiting was unknown. Causality assessment was not provided.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 67 year old female patient with SPIRIVA hypersensitivity. On 19-JUN-2018, the patient received the first dose of PNEUMOVAX 23 lot # R002084, expiration date 26-OCT-2019 for prophylaxis. On 21-JUN-2018, the patient received the second dose of PNEUMOVAX 23 lot # R002084, expiration date 26-OCT-2019 in the right arm for prophylaxis. In approximately June 2018, the patient experienced swelling in the right arm, bilateral arm pain from shoulder to elbow making it hard to move her arms, chills, nausea, and vomiting. She called the office on 22-JUN-2018 and was seen by a nurse practitioner. The nurse practitioner prescribed an unspecified treatment for the patient to control her symptoms. The outcome of swelling in the right arm, bilateral arm pain from shoulder to elbow making it hard to move her arms, chills, nausea, and vomiting was unknown. Causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unspecified date, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2016, the patient was treated by a physician for a vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2012, the patient was treated by a physician for a vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular, Trigeminal neuralgia
Clinical narrative: The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 17-APR-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. On 18-FEB-2016, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster.  The patient was prescribed famiciclovir for management of her painful symptoms and chronic pain.  On or about 29-FEB-2016, the patient sought subsequent treatment from a physician for pain in the facial region, which was diagnosed as postherpetic trigeminal neuralgia.  The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. On 18-JUN-2016, the patient was treated at a health facility for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history.  In 2014, the patient was inoculated with ZOSTAVAX at a community health center for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2014, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-NOV-2013, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2013, the patient was treated by home health agency for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient brings this action for personal injuries and damages suffered as a result of being inoculated with the ZOSTAVAX. The patient was inoculated with the ZOSTAVAX for the long-term prevention of shingles. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. On or about 07-NOV-2011, the patient was inoculated with the ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. On or about 15-SEP-2015, the patient was treated at a medical center, for a vesicular outbreak, which was diagnosed as herpes zoster. The patient has been prescribed prednisone, KEFLEX, and acyclovir for management of his painful symptoms and chronic pain. On or about 04-OCT-2016, the patient sought subsequent treatment and had extensive follow ups at an eye center for a vesicular outbreak, which was diagnosed as herpes zoster ophthalmicus, a varicella-zoster virus infection that involves the eye. The patient was prescribed DUREZOL and MAXITROL eye drops for to ease his painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, herpes zoster ophthalmicus was considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a Nurse Practitioner referring to a 12 year old male patient. The patient had no medical history, concurrent conditions, concomitant medications, and historical drugs reported. In July 2018 (reported as "last week"), the patient was vaccinated with GARDASIL 9 intramuscular route (frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. On the same date of the vaccination the patient returned to the office where she was vaccinated, because she developed erythema and swelling at the injection site. Nurse Prescriber stated the patient was treated with ibuprofen and BENADRYL. No laboratory diagnostics or studies were performed. At the time of the report, the outcome of injection site erythema and injection site swelling was reported as resolved. The Nurse prescriber did not mention the causality assessment between the events and GARDASIL 9 vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash
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, and concomitant medication. On or about 01-APR-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 28-SEP-2015, the patient was treated by the physician for the onset of a rash, which was diagnosed as herpes zoster, or shingles. On or about 20-OCT-2015, the patient sought subsequent treatment from another physician for the onset of a rash, which was diagnosed as herpes zoster ophthalmic. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, herpes zoster ophthalmic was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Polyneuropathy, Rash
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 08-OCT-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or severe herpes zoster. On an unknown date in 2016, the patient was treated by a physician for the onset of a rash, which was diagnosed as herpes zoster, or shingles. On or about 27-JAN-2016, the patient sought subsequent treatment from another physician for the diagnosis of herpes zoster polyneuropathy. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 15-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed acyclovir and prednisone for management of her painful symptoms and chronic pain. On or about 29-AUG-2016, the patient sought subsequent treatment from another physician for a blistering vesicular outbreak which was diagnosed as chronic post herpetic neuralgia. The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-FEB-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date later in 2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JUL-2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 05-SEP-2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2017, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or 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, 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: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-MAR-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2017, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or 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, 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-SEP-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or 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, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 04-AUG-2016, the patient was treated for the onset of a vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. 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, 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: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from a registered nurse via company representative, and refers to a 21 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On an unknown date in June 2018, reported as "the last week", the patient received a dose of GARDASIL 9 for prevention of human papillomaviruses (HPV) related cancers and diseases (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). It was reported that the patient fainted, immediately after receiving the GARDASIL 9. It was unknown if the patient sought medical attention, if received treatment or if laboratory diagnostics or studies were performed. The outcome of the event syncope was unknown and the reporter did not assess the causal relationship between vaccination with GARDASIL 9 and the event. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1806USA005535.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or 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, 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: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or 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, 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: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 10-JUL-2018, the patient was vaccinated with an expired dose of VAQTA injection, (expiry date: 15-MAY-2018) intramuscularly (lot # and dosage details were not reported) for prophylaxis. No known adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 80 or 81 years. The patient received in SHINGRIX the arm and was asking if she could apply an ice pack to her arm where she received her SHINGRIX vaccination. The patient's arm was sore, otherwise she felt fine. No further information was reported regarding the event. The healthcare professional reported adverse event via click to chat forum.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination for the patients was not specified. The age group was not reported, but was captured as adult as per the vaccine indication. The reporter reported that one of her friend stated that they had friends who expereinced unknown adverse reaction after vaccination with shingle shot. The reporter was not sure if only one person or multiple patients experienced the adverse reaction. The reporter did not specify the adverse reactions experienced by the patients. The reporter had advised the patients to call the company to report the adverse reactions experienced after shingles vaccination. The reporter stated that she was about to tell her friend about it. This case was linked to case US2018117586, reported by the same reporter.