chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received FLUZONE HD on right arm and PNEUMOVAX 23 on left arm on 10/12/18 by another pharmacist. She called on 10/14/18 saying that on the night of the vaccination her left arm (where she received PNEUMOVAX 23) started to hurt a lot, and the next day it became red and hot to the touch with swelling. On 10/14/18 it still hurts a bit and the redness has traveled downward towards the elbow. She has no wound near the injection site, no discharge. I reviewed the patient's file and assured her that she received the appropriate vaccination (received PREVNAR 13 from us in 2016). I advised the patient to take BENADRYL for the redness and swelling, use an ice pack for the warm sensation, and TYLENOL or ibuprofen if desired for pain. She said she will try the BENADRYL and ice pack, and if it still does get better she will try to go to urgent care.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Swelling
Clinical narrative: Swelling, pain from shoulder up to neck.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Hives developed on trunk late in evening after flu shot.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: PATIENT STATES THAT SHE HAD REDNESS IN IMMUNIZED ARM 3 INCHES IN DIAMETER. IT WAS WARM TO THE TOUCH, BUT NO FEVER WAS PRESENT. THE AREA WAS ITCHY AND SORE FOR 3 DAYS AND HAS SINCE RESOLVED.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: PATIENT EXPERIENCED PAIN UP THE ARM AND UP LEFT SIDE OF NECK AFTER VACCINATION. ARM WAS SORE FOR 5 DAYS WITH NO FEVER PRESENT.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Inflammation, Injected limb mobility decreased, Pain in extremity, Swelling
Clinical narrative: Patient experienced severe pain on left arm about 2.5 hours after getting the vaccine. Patient couldn't lift the arm on top of his head. Patient took 2 tabs of Aspirin 325 mg and put cold compress on Oct 13 and 2 tabs Acetaminophen 500 mg on the morning of Oct 14. I advised the patient to take Ibuprofen (if not allergic) to help with the swelling and inflammation.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: Patient presented to pharmacy 30 days after receiving vaccine. Patient presented with a raised bump on her arm over the deltoid muscle, where she claims the vaccine was injected (this is consistent with the arm the pharmacist documented for where it was administered). Patient denies pain or itching at site of raised bump, but is irritated with the skin growth.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Asthma, Dyspnoea, Exposure during pregnancy
Clinical narrative: I woke up the next day quite early with shortness of breath. The first few days I had nausea and vomiting, but the prolonged symptoms have been dyspnea (worse in the morning), a productive cough, intermittent fever (worse at night), joint pain, and increasing weakness. I have had one outright asthma attack Thursday afternoon; treated with a DUONEB and steroids. Normally, I use my inhaler every 2-3 months, usually related to another illness (a cold caught from my son or a patient, for example). I used my inhaler 8 times on Saturday. Each day I have woken up with more shortness of breath than when I went to sleep, and the last couple of days I've been woken up in the middle of the night as well. When I realized I didn't have the energy to even get up and take care of my son this morning, I called my allergist (who has treated me with allergy shots), and asked for advice; I am taking prednisone, budesonide, and albuterol as a result, as well as dextromethorphan and guaifenesin. I'll see him tomorrow at 9 am. I am currently 29 weeks 5 days pregnant. I'm due 12/25, LMP 3/21/18. Pregnancy has been normal so far.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Middle insomnia, Nausea, Productive cough, Pyrexia, Vomiting
Clinical narrative: I woke up the next day quite early with shortness of breath. The first few days I had nausea and vomiting, but the prolonged symptoms have been dyspnea (worse in the morning), a productive cough, intermittent fever (worse at night), joint pain, and increasing weakness. I have had one outright asthma attack Thursday afternoon; treated with a DUONEB and steroids. Normally, I use my inhaler every 2-3 months, usually related to another illness (a cold caught from my son or a patient, for example). I used my inhaler 8 times on Saturday. Each day I have woken up with more shortness of breath than when I went to sleep, and the last couple of days I've been woken up in the middle of the night as well. When I realized I didn't have the energy to even get up and take care of my son this morning, I called my allergist (who has treated me with allergy shots), and asked for advice; I am taking prednisone, budesonide, and albuterol as a result, as well as dextromethorphan and guaifenesin. I'll see him tomorrow at 9 am. I am currently 29 weeks 5 days pregnant. I'm due 12/25, LMP 3/21/18. Pregnancy has been normal so far.
Age: 56.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Mobility decreased, Nerve injury, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated her arm became increasingly sore post immunization and by the evening of 10/13/2018 she could barely move her arm. She stated her arm was swollen and sore and she could barely move it. The swelling is primarily located in the axillary and neck region. Patient went to the emergency room and was told the injection hit a nerve in her arm. Patient was given prednisone and nausea medication in the emergency room. She was prescribed a muscle relaxer and steroid dose pack that she is going to start on 10/15/18. She will follow up with her primary care physician.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Mass, Neck pain
Clinical narrative: Patient had a baseball size welt a few hours following vaccine and claimed her neck was sore.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hypoaesthesia, Injection site erythema, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt states their arm was hurting from high up in shoulder to elbow. Pt was having tingling/numbing sensation in hands and there was a redness around injection site. Also, there was a rash about an inch tall and 3 inches wide.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash
Clinical narrative: Pt states their arm was hurting from high up in shoulder to elbow. Pt was having tingling/numbing sensation in hands and there was a redness around injection site. Also, there was a rash about an inch tall and 3 inches wide.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site discomfort, Injection site swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient complains of swelling at injection site and inward pressure radiating from shoulder and down into fingers plus she was experiencing pain in these areas.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Pain
Clinical narrative: Patient called 6 days after receiving vaccine c/o of pain that radiated up her neck; she saw her PCP and he said that it probably aggravated her fibromyalgia and pinched nerve that she had surgery on in 2/2017; she feels better now, but does have some pain still.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination site discomfort
Clinical narrative: Vaccination wore sensitive to touch-not painful, but annoying (in deltoid area).
Age: 18.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Feeling abnormal, Loss of consciousness, Seizure
Clinical narrative: After administration of the GARDASIL, the pt lost consciousness and began convulsing for about 1 minute. After 1 minute, the pt regained consciousness but was slightly dazed. Upon Dr.'s validation and recommendation, the pt was moved to a room with a bed to be laid down for the administration of the Hep A vaccine. Pt tolerated the Hep A administration well and w/o complaints.
Age: 18.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Seizure
Clinical narrative: After administration of the GARDASIL, the pt lost consciousness and began convulsing for about 1 minute. After 1 minute, the pt regained consciousness but was slightly dazed. Upon Dr.'s validation and recommendation, the pt was moved to a room with a bed to be laid down for the administration of the Hep A vaccine. Pt tolerated the Hep A administration well and w/o complaints.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU4, VARZOS
Symptoms: Eyelid oedema
Clinical narrative: URTICARIA, ALSO AM NOT QUITE SURE OF EXACT DATE OF SHOT BUT EARLY IN SEPTEMBER AT PHARMACY.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU4, VARZOS
Symptoms: Urticaria
Clinical narrative: URTICARIA, ALSO AM NOT QUITE SURE OF EXACT DATE OF SHOT BUT EARLY IN SEPTEMBER AT PHARMACY.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. On 28th April 2018, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were reported as follows: At 13:00, the patient received SHINGRIX. The patient experienced redness at the injection site which was present down to the elbow the day after the vaccination. The redness at the injection site presented down to the elbow and resolved after 2.5 weeks. For tolerance after 2nd dose of SHINGRIX, refer case US2018178306.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. On 28th April 2018, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were reported as follows: At 13:00, the patient received SHINGRIX. The patient experienced redness at the injection site which was present down to the elbow the day after the vaccination. The redness at the injection site presented down to the elbow and resolved after 2.5 weeks. For tolerance after 2nd dose of SHINGRIX, refer case US2018178306.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling in a 84-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of erythema (1st dose received on 27th April 2018, for tolerance refer US2018178306). On 28th August 2018, the patient received the 2nd dose of SHINGRIX. On 29th August 2018, 1 days after receiving SHINGRIX, the patient experienced swelling, pain in arm, erythema and mobility decreased. On an unknown date, the outcome of the swelling was unknown and the outcome of the pain in arm, erythema and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the swelling, pain in arm, erythema and mobility decreased to be related to SHINGRIX. Additional details were reported as follows: At 1:00 in the afternoon, the patient received SHINGRIX on the right arm. The patient experienced redness and swelling the next day of vaccination. The patient also experienced soreness in her arm. The arm was so sore that, the patient could hardly move it.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Mobility decreased, Pain in extremity, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling in a 84-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of erythema (1st dose received on 27th April 2018, for tolerance refer US2018178306). On 28th August 2018, the patient received the 2nd dose of SHINGRIX. On 29th August 2018, 1 days after receiving SHINGRIX, the patient experienced swelling, pain in arm, erythema and mobility decreased. On an unknown date, the outcome of the swelling was unknown and the outcome of the pain in arm, erythema and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the swelling, pain in arm, erythema and mobility decreased to be related to SHINGRIX. Additional details were reported as follows: At 1:00 in the afternoon, the patient received SHINGRIX on the right arm. The patient experienced redness and swelling the next day of vaccination. The patient also experienced soreness in her arm. The arm was so sore that, the patient could hardly move it.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness postural
Clinical narrative: Dizziness upon standing, turning and walking.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain, limited range of motion, persistent symptoms for 4 weeks, ongoing.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Respiratory tract congestion, Vomiting
Clinical narrative: Vomiting, fatigue, headache, congestion.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient into pharmacy stating that his arm is still sore from the flu shot he received on 9/15/18. He asked if it was normal to still be painful. He can move his arm but states it's sore in the shoulder area when he reaches up.
Age: 1.5
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were not reported. On 06-JUL-2017, the patient was vaccinated with first dose of VAQTA (lot# N005274 and expiration date 03-APR-2018) (anatomical location, route and dosage details were not reported). On 04-OCT-2017, the patient was vaccinated with another dose of VAQTA (lot# N017094 and expiration date 31-AUG-2018). No adverse effects were reported. No product quality complaint was reported. Follow-up information was received from registered nurse on 08-MAY-2018. The registered nurse was unsure what patient was being reported on in this report. It was reported that the registered nurse was hopeful that the original reporter the physician may know which patient was reported on. The registered nurse has no further information to share. Follow-up information was received from physician on 08-OCT-2018. It was confirmed that the age of the patient was currently 2 and half year old and gender was female. On 06-JUL-2017, the patient was vaccinated with first dose of VAQTA (lot# N005274 and expiration date 03-APR-2018) for prophylaxis (anatomical location, route and dosage details were not reported). The nurse in error ordered the second dose too early and at the age of 18 months, on 04-OCT-2017, the patient was vaccinated with the second dose of VAQTA. On the same day, the patient was vaccinated with third dose of influenza vaccine, lot # UT595TNA intramuscularly in left thigh. The patient had no illness at time of vaccination. The patient had no pre-existing physician-diagnosed allergies, birth defects and medical conditions. The patient did not experience any side effects. There was no temperature excursion occurred as a result of a reading from a Digital Data Logger. This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid, as the patient identifiers were provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse referring to a patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was inadvertently administered a dose of improperly stored PROQUAD (lot # R007684, expiration date: 11-SEP-2019; route was unknown) for prophylaxis. The MERCK STERILE DILUENT (batch/lot# and expiration date were unknown) used to reconstitute the PROQUAD was properly stored. The vaccine was exposed to temperature of -1.9 degrees Celsius for 3 hours. Data logger was involved. There was no previous temperature excursion. No adverse effect was reported. Furthermore, no product quality complaint was involved.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 75 year-old female patient. The patient was allergic to NEOSPORIN AF. Concomitant therapies included FLONASE. No pertinent medical history. On 12-SEP-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # R006466 (expiration date 24-OCT-2019), intramuscularly for prophylaxis. On an unknown date in September 2018, the patient developed swollen arms and redness. No lab diagnostics were performed. The patient had sought medical attention and was seen in the office. Treatment was given for the events. At the time of the report, the outcome of the events was not recovered. No causality assessment was provided.
Age: 1.17
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Information has been received from a physician referring to a 14 month old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent. On 10-SEP-2018 or 11-SEP-2018, the patient was inadvertently administered a dose of PROQUAD (route, strength, dose, frequency, batch/lot # and expiration date were not reported) instead of an intended dose of M-M-R II, concomitantly with a dose of VARIVAX (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis. Physician reported the nurse mistakenly administered PROQUAD believing it to be M-M-R II because she had previously worked in a clinic that did not use PROQUAD, and therefore she did not realize that the product she was administering was PROQUAD instead of M-M-R II. No adverse effect was reported.
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Eye swelling, Fatigue, Hunger, Sinusitis
Clinical narrative: Information has been received from a male patient of unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. In approximately August 2018 (reported as about a month ago), the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, batch/lot number and expiration date were not provided) intramuscularly or subcutaneously for prevention of pneumococcal disease. In approximately August 2018 (a day or two after the vaccination with PNEUMOVAX 23), the patient began experiencing dizziness, unusual hunger, swelling under eyes, fatigue, shaking, sinus inflammation and sinus infection. Information about treatment given for the event, lab diagnostics/studies and medical attention was reported as none. Action taken with PNEUMOVAX 23 was not applicable. The outcome of the events not recovered. The causality between the events and PNEUMOVAX 23 was not provided by the reporter.
Sex: M
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Information has been received from a male patient of unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. In approximately August 2018 (reported as about a month ago), the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, batch/lot number and expiration date were not provided) intramuscularly or subcutaneously for prevention of pneumococcal disease. In approximately August 2018 (a day or two after the vaccination with PNEUMOVAX 23), the patient began experiencing dizziness, unusual hunger, swelling under eyes, fatigue, shaking, sinus inflammation and sinus infection. Information about treatment given for the event, lab diagnostics/studies and medical attention was reported as none. Action taken with PNEUMOVAX 23 was not applicable. The outcome of the events not recovered. The causality between the events and PNEUMOVAX 23 was not provided by the reporter.
Sex: F
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning a female patient of unknown age and race. Concurrent conditions, medical history, concomitant medication and drug reactions/allergies were not reported. It was reported that on 02-OCT-2018, the patient received improperly stored doses of  PEDVAXHIB, lot number: R005114 (expiration date: 26-NOV-2020) and ROTATEQ, lot number: R002516 (expiration date: 13-SEP-2019) (strength, doses and frequencies not reported) for prophylaxis. The vaccines were stored in between 32 degrees Fahrenheit (°F) and 35 °F for a timeframe of 4 hours and 11 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: Information has been received on 04-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age and her spouse. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 22-AUG-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, on or about 10-SEP-2016, the patient presented to a physician with complaints of a painful, itchy rash, along with other symptoms. The patient was evaluated and diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 04-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age and her spouse. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving the ZOSTAVAX, the patient presented to a medical center and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs, drug allergies and concomitant therapies were not provided. On 03-OCT-2018, the patient was accidentally vaccinated with a dose of VARIVAX (dose, unit and route were not reported) (lot# M043581 and expiry date not reported) and M-M-R II (dose, unit and route were not reported) (lot# R013129 and expiry date not reported) for prophylaxis (wrong drug administered).It was reported that the patient was meant to received PROQUAD. No adverse effects were reported.The outcome of the event was unknown.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin infection
Clinical narrative: Information has been received from a pharmacist  and refers to an 83 year old female patient. The patient had no drug reactions/allergies. Information of concomitant therapy and pertinent medical history was unknown. On 02-OCT-2018 the patient was vaccinated with one dose of PNEUMOVAX 23 (lot # R009162, expiration date: 20-JAN-2020, route:  intramuscular, strength and frequency were unknown) for prophylaxis. Then later that same day, she developed a red, swollen, painful area at the site of vaccine injection. As a result, she started ibuprofen (MOTRIN) therapy for the pain. On 03-OCT-2018, the redness had spread down her arm, so she went to see an unspecified physician who diagnosed her with a skin infection. The patient started treatment on cephalexin (manufacturer unspecified) therapy on the same day. It was unknown if lab diagnostics or studies were performed for the event. The patient was recovering from the skin infection, pain, swelling, and redness. The causality assessment was not provided by the reporter. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1810USA004732:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 05-OCT-2018 the patient received an expired dose of GARDASIL 9 (intramuscular, lot# M028323 and expiration date 26-SEP-2018, dose was not reported) for prophylaxis. No known adverse effects were reported.
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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 19-DEC-2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-JAN-2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. 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: 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 2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and for the long-term prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. 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. 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, 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 or about 18-SEP-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. 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. 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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 15-JUN-2016, the patient was vaccinated with ZOSTAVAX, (lot # and route unknown) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2016, the patient was treated by a physician 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella zoster pneumonia
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 31-DEC-2015, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 16-SEP-2016, the patient was treated for the onset of varicella pneumonia which is caused by the varicella zoster virus. 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. Upon internal review, varicella pneumonia was determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 08-OCT-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. On or about 21-JAN-2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical center as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 19-SEP-2016, the patient was treated at an urgent care for the onset of a severe vesicular rash, which was diagnosed as severe shingles. The patient was prescribed VALTREX for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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 on 08-OCT-2018 regarding a case in litigation from a lawyer and a consumer of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 01-AUG-2016, the patient was treated at a community hospital emergency department for a persistent vesicular rash, which was diagnosed as chronic herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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, Rash vesicular
Clinical narrative: Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 26-SEP-2016, the patient was treated by a physician at a physician's office for a persistent and severe vesicular rash, which was diagnosed as shingles. 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 the 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
Clinical narrative: Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 27-APR-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 19-SEP-2016, the patient was treated by a physician at a physician's office for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir hydrochloride (VALTREX) and gabapentin for management of her painful symptoms and chronic pain. On or about 17-OCT-2016, the patient sought subsequent treatment from a physician at a physician's office for the onset of a severe vesicular rash, which was diagnosed as herpes zoster and post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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 on 08-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a clinic as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a clinic for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and for the long-term prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, 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. 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 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and for the long-term prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. 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 as 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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for a severe 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. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous report was received from a 22-year-old female patient who was reporting on herself. The patient's drug reactions/allergies included penicillin. Concomitant therapies included birth control pills (hormonal contraceptives (unspecified)). The patient's concurrent conditions was not reported. On an unknown date in late 2011, the patient was vaccinated with GARDASIL 9 0.5 ml, suspension for intramuscular injection at 0, 2 months and 6 months schedule via intramuscular route (strength, lot # and expiry date was unknown) for prophylaxis. The patient reported that she had received her 3rd dose of GARDASIL 9 on 09-MAR-2012 and was not aware that she had become pregnant on 10-FEB-2012. On 19-MAR-2012, the pregnancy test was performed. Patient did not seek for medical attention. No adverse reaction was reported. No product quality complaints (PQC) was involved.
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. In 2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2014, the patient was treated for a severe vesicular outbreak, which was diagnosed as a herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine 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. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2014, the patient was treated by a physician for a vesicular outbreak, which were diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine 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: Decreased immune responsiveness, 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. On or about 15-FEB-2010, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 23-SEP-2016, the patient was treated by a physician, for a vesicular outbreak accompanied by weakened immune symptoms, 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.