chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Pallor, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Approximately 10 minutes after mother and child left the clinic the mother returned to lobby stating that her daughter had passed out in the car. Mother stated they were driving and patient was upright in front passenger seat on her cell phone when she suddenly slumped to the left side and was briefly unresponsive. When RN reached the car, patient was awake and pale in a semi-reclined position in the front passenger seat. Her seat was reclined fully. The air conditioning was on in car but it was extremely warm from being closed up in the summer heat while they were inside the clinic. All A/C vents were directed to patient. An ice pack was placed under her neck and on her forehead. Her feet were elevated on the dashboard. She was given peanut butter crackers to eat. She remained reclined in the car and was conscious throughout time attended by RN staff. After approximately 20 minutes, patient's color had returned and she felt better. Mother was comfortable to drive her home. She was advised to have her eat and take fluids and to continue to observe for any further issues. On 7/27/18, this RN called and spoke to her mother, who stated that patient had not experienced any further issues after they left the clinic the second time.  She stated that she did fine the rest of the day and was "doing great" on 7/27/18.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Chest X-ray normal, Chills, Electrocardiogram normal, Headache
Clinical narrative: Chills; fever; muscle soreness; injection site red/inflamed/sensitive to touch; headache; temperature of 103; Trip to ER July 27 approximately 9:00pm. Diagnosis: Injection site infection along with UTI.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Hyperaesthesia, Injection site erythema, Injection site infection, Injection site inflammation, Injection site reaction
Clinical narrative: Chills; fever; muscle soreness; injection site red/inflamed/sensitive to touch; headache; temperature of 103; Trip to ER July 27 approximately 9:00pm. Diagnosis: Injection site infection along with UTI.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia, Urinary tract infection, White blood cells urine positive
Clinical narrative: Chills; fever; muscle soreness; injection site red/inflamed/sensitive to touch; headache; temperature of 103; Trip to ER July 27 approximately 9:00pm. Diagnosis: Injection site infection along with UTI.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Pt states she experienced a seizure.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site induration, Pain, Pyrexia
Clinical narrative: Red induration at site, 6-8 cm, chills, body aches, fever of 101.6. Similar reaction after first injection 5/4/18.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Erythema, Fatigue, Injection site pain, Myalgia
Clinical narrative: This was second dose/booster. Both times: for 24+ hours afterwards, muscle aches, fatigue, inappetance. Sore arm at injection site. Second dose: arm was red, swollen, hot, itchy. All side effects worse with second dose. Muscle aches, etc. lasting more like 48 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This was second dose/booster. Both times: for 24+ hours afterwards, muscle aches, fatigue, inappetance. Sore arm at injection site. Second dose: arm was red, swollen, hot, itchy. All side effects worse with second dose. Muscle aches, etc. lasting more like 48 hours.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Immediate post-injection reaction, Rash macular, Skin discolouration
Clinical narrative: Patient immediately reacted with fierce crying and signs of Discolored Leg Syndrome as both LE developed a flat, blotchy, purple discoloration. Patient was able to be consoled by parents, fell asleep in parents arms and discoloration resolved within 10-15 min. Patient did not exhibit any additional adverse reactions at the time or within 48 hours of vaccination.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Localized redness and swelling, pain, fever, chills.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site, fever, chills, headache, fatigue, body aches.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pain and swelling at injection site, fever, chills, headache, fatigue, body aches.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Injection site swelling, Pain
Clinical narrative: Swelling at the injection site, large area of redness, chills, overall body pains.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Pain
Clinical narrative: Large 3 inch diameter of redness at shot site, swelling at shot site, muscular pain in left arm and overall body pain.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Swollen arm, itching.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Musculoskeletal stiffness
Clinical narrative: With both shots, my neck would be too stiff to turn and I would have flu-like symptoms. With the 2nd shot, I had uncontrollable shivering and then a fever. All of my joints ached and I was too tired to do anything the following day.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: With both shots, my neck would be too stiff to turn and I would have flu-like symptoms. With the 2nd shot, I had uncontrollable shivering and then a fever. All of my joints ached and I was too tired to do anything the following day.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Ear tube insertion, Fine motor delay, Gross motor delay, Language disorder, Limb asymmetry
Clinical narrative: Patient was administered 6 vaccinations that day she the record listed noted that DO NOT USE next to the Hep A vaccine. His records also listed that he was previously given 3 adult dosages of Hep B.  Patient was later recommended for speech and language evaluation by Dr. and treated for fluid in the middle ear. Patient underwent surgery and had tubes placed in his ear. He is now being treated for speech and language processing disorder and he has a significant fine and gross motor skill development receiving therapy in schools.  One of his legs is shorter than the other although he wasn?t born that way.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Middle ear effusion, Speech disorder, Surgery
Clinical narrative: Patient was administered 6 vaccinations that day she the record listed noted that DO NOT USE next to the Hep A vaccine. His records also listed that he was previously given 3 adult dosages of Hep B.  Patient was later recommended for speech and language evaluation by Dr. and treated for fluid in the middle ear. Patient underwent surgery and had tubes placed in his ear. He is now being treated for speech and language processing disorder and he has a significant fine and gross motor skill development receiving therapy in schools.  One of his legs is shorter than the other although he wasn?t born that way.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Sleep disorder
Clinical narrative: Severe chills (woke me up) approximately 12 hours after receiving the vaccine with possible mild fever. Treated with ADVIL and no further issues other than soreness at injection site.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site in a large 1x3 inch area.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, CSF culture negative, Cytomegalovirus test negative, Encephalitis, Headache
Clinical narrative: Patient diagnosed with aseptic meningoencephalitis. Symptoms include altered mental status and headache, both of which had mostly resolved by day 5 of treatment. Treated with IV acyclovir for 5 days, stopped when CSF cultures returned negative.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes simplex test negative, Meningitis aseptic, Mental status changes, Polymerase chain reaction, Varicella virus test negative
Clinical narrative: Patient diagnosed with aseptic meningoencephalitis. Symptoms include altered mental status and headache, both of which had mostly resolved by day 5 of treatment. Treated with IV acyclovir for 5 days, stopped when CSF cultures returned negative.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: Patient diagnosed with aseptic meningoencephalitis. Symptoms include altered mental status and headache, both of which had mostly resolved by day 5 of treatment. Treated with IV acyclovir for 5 days, stopped when CSF cultures returned negative.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site reaction, Pyrexia, Urticaria, Varicella post vaccine, Vomiting
Clinical narrative: Welt on thigh of the injection site, fever, vomiting, and chicken pox outbreak on back, abdomen, and groin.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: 7/28  about 1am - onset of flu-like symptoms (headache, muscle aches, chills, fevers, nausea) primarily grade 2, symptoms were almost neglible on 7/29; however, 7/29 about 2pm shingles type rash on left wrist and upper left arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: 7/28  about 1am - onset of flu-like symptoms (headache, muscle aches, chills, fevers, nausea) primarily grade 2, symptoms were almost neglible on 7/29; however, 7/29 about 2pm shingles type rash on left wrist and upper left arm.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Dry mouth, Eye swelling, Hyperhidrosis, Injection site rash, Neck mass
Clinical narrative: Claimant states experienced sweating, dry mouth, felt shaky. Inflammation to left eye. Localized rash at injection site.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Nervousness
Clinical narrative: Claimant states experienced sweating, dry mouth, felt shaky. Inflammation to left eye. Localized rash at injection site.
Age: 33.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Dry mouth, Eye inflammation, Hyperhidrosis, Injection site rash, Tremor
Clinical narrative: Claimant states experienced sweating, dry mouth, felt shaky. Inflammation to left eye. Localized rash at injection site.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX (batch number 32PE4, expiry date unknown) for prophylaxis. On 13th July 2018, the patient received the 2nd dose of SHINGRIX.5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, swelling, skin warm, erythema, headache, fever and nausea. On an unknown date, the outcome of the injection site pain, swelling, skin warm, headache, fever and nausea were recovering/resolving and the outcome of the erythema was unknown. It was unknown if the reporter considered the injection site pain, swelling, skin warm, erythema, headache, fever and nausea to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient experienced pain at the injection site, large raised area that was hot to the touch. The patient also experienced headache, fever and nausea occurred on the day after vaccination. The patient's body temperature was recorded as 101.5 Degree F. By the day 3 following vaccination, the events were pretty much returned to normal although redness persisted.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Malaise, Nausea, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX (batch number 32PE4, expiry date unknown) for prophylaxis. On 13th July 2018, the patient received the 2nd dose of SHINGRIX.5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, swelling, skin warm, erythema, headache, fever and nausea. On an unknown date, the outcome of the injection site pain, swelling, skin warm, headache, fever and nausea were recovering/resolving and the outcome of the erythema was unknown. It was unknown if the reporter considered the injection site pain, swelling, skin warm, erythema, headache, fever and nausea to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient experienced pain at the injection site, large raised area that was hot to the touch. The patient also experienced headache, fever and nausea occurred on the day after vaccination. The patient's body temperature was recorded as 101.5 Degree F. By the day 3 following vaccination, the events were pretty much returned to normal although redness persisted.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX (batch number 32PE4, expiry date unknown) for prophylaxis. On 13th July 2018, the patient received the 2nd dose of SHINGRIX.5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, swelling, skin warm, erythema, headache, fever and nausea. On an unknown date, the outcome of the injection site pain, swelling, skin warm, headache, fever and nausea were recovering/resolving and the outcome of the erythema was unknown. It was unknown if the reporter considered the injection site pain, swelling, skin warm, erythema, headache, fever and nausea to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient experienced pain at the injection site, large raised area that was hot to the touch. The patient also experienced headache, fever and nausea occurred on the day after vaccination. The patient's body temperature was recorded as 101.5 Degree F. By the day 3 following vaccination, the events were pretty much returned to normal although redness persisted.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX (batch number 32PE4, expiry date unknown) for prophylaxis. On 13th July 2018, the patient received the 2nd dose of SHINGRIX.5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, swelling, skin warm, erythema, headache, fever and nausea. On an unknown date, the outcome of the injection site pain, swelling, skin warm, headache, fever and nausea were recovering/resolving and the outcome of the erythema was unknown. It was unknown if the reporter considered the injection site pain, swelling, skin warm, erythema, headache, fever and nausea to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient experienced pain at the injection site, large raised area that was hot to the touch. The patient also experienced headache, fever and nausea occurred on the day after vaccination. The patient's body temperature was recorded as 101.5 Degree F. By the day 3 following vaccination, the events were pretty much returned to normal although redness persisted.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Nausea
Clinical narrative: Severe nausea; severe dizziness; severe vertigo; 24-36 hours.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Severe nausea; severe dizziness; severe vertigo; 24-36 hours.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Herpes zoster, Hyperaesthesia, Pain of skin, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 14 days after receiving SHINGRIX, the patient experienced shingles, skin tenderness, blister and rash. On an unknown date, the outcome of the shingles, skin tenderness, blister and rash were unknown. It was unknown if the reporter considered the shingles, skin tenderness, blister and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine around the 27th June 2018 in right arm. She reported that approximately two weeks after receiving the vaccination, certain parts of her skin became tender to the touch. Then one tiny blister erupted right before she went on vacation. Within a day after that the rash started on her right thigh and right buttock. On 16th July 2018, she went to a walk-in clinic and was diagnosed with Shingles.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Scab
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 14 days after receiving SHINGRIX, the patient experienced shingles, skin tenderness, blister and rash. On an unknown date, the outcome of the shingles, skin tenderness, blister and rash were unknown. It was unknown if the reporter considered the shingles, skin tenderness, blister and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine around the 27th June 2018 in right arm. She reported that approximately two weeks after receiving the vaccination, certain parts of her skin became tender to the touch. Then one tiny blister erupted right before she went on vacation. Within a day after that the rash started on her right thigh and right buttock. On 16th July 2018, she went to a walk-in clinic and was diagnosed with Shingles.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain of skin, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, 14 days after receiving SHINGRIX, the patient experienced shingles, skin tenderness, blister and rash. On an unknown date, the outcome of the shingles, skin tenderness, blister and rash were unknown. It was unknown if the reporter considered the shingles, skin tenderness, blister and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine around the 27th June 2018 in right arm. She reported that approximately two weeks after receiving the vaccination, certain parts of her skin became tender to the touch. Then one tiny blister erupted right before she went on vacation. Within a day after that the rash started on her right thigh and right buttock. On 16th July 2018, she went to a walk-in clinic and was diagnosed with Shingles.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Uncontrollable shivering began approximately 4 hours after vaccination. This was accompanied by general body aching. This lasted for 3-4 hours until sleep was achieved. The following day, body aches and general soreness were present. The symptoms subsided by the second day after the injection.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Shivering, headache, muscle aches.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Cough, Flushing, Pyrexia, Rash, Rash generalised
Clinical narrative: Approximately 30 minutes post vaccination, he developed a constant cough. I checked on him and he had a new rash on his abdomen, and flushing to cheeks. Called the pediatrician office and a nurse answered the phone, I described his symptoms and she told me "allergic reaction is impossible after vaccines, if you feel he is possibly having an allergic reaction to something he ate, take him to emergency room". He had not eaten anything after leaving pediatrician office. These symptoms continued for 1 week, then he developed a new rash all over his entire body and a high fever that lasted for about a week.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: After 10 min pt developed hypotensive vasovagal syncope.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Chlamydia test, Hepatitis C virus test, Herpes virus test, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from an office manager, and refers to a 45 year old female patient. Concomitant therapies included ESTRACE cream for birth control. The patient had no pertinent medical history and no drug reactions or allergies. Historical drugs were not reported. On 01-JUL-2015, 05-AUG-2018 and 13-JAN-2016, the patient was vaccinated with the first, second and third doses respectively, of RECOMBIVAX HB (Thimerosal free) 5/0.5 microgram/ml Injection, intramuscular, 2 vials per vaccination (10 microgram per dose), lot # L003193, expiration date 10-NOV-2016 (also reported as 01-NOV-2016), for prophylaxis (anatomical location was not reported). The office manager informed that on 16-JAN-2018, titers were drawn in the office and were found to be negative. Other tests performed included Hepatitis C infection test, herpes infection test, Chlamydia infection test and gonorrhea infection test (results were not provided). Treatment was given for the event (not specified); the patient sought medical attention. The outcome of the event was not reported. The reporting office manager did not provide a causal relationship between the event of negative titers and vaccination with RECOMBIVAX HB.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Laboratory test
Clinical narrative: This spontaneous report was received from an office manager, and refers to a 45 year old female patient. Concomitant therapies included ESTRACE cream for birth control. The patient had no pertinent medical history and no drug reactions or allergies. Historical drugs were not reported. On 01-JUL-2015, 05-AUG-2018 and 13-JAN-2016, the patient was vaccinated with the first, second and third doses respectively, of RECOMBIVAX HB (Thimerosal free) 5/0.5 microgram/ml Injection, intramuscular, 2 vials per vaccination (10 microgram per dose), lot # L003193, expiration date 10-NOV-2016 (also reported as 01-NOV-2016), for prophylaxis (anatomical location was not reported). The office manager informed that on 16-JAN-2018, titers were drawn in the office and were found to be negative. Other tests performed included Hepatitis C infection test, herpes infection test, Chlamydia infection test and gonorrhea infection test (results were not provided). Treatment was given for the event (not specified); the patient sought medical attention. The outcome of the event was not reported. The reporting office manager did not provide a causal relationship between the event of negative titers and vaccination with RECOMBIVAX HB.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a registered nurse, concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On multiple unspecified dates on or after 21-FEB-2018, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #, expiration date, strength, dose, route of administration, and anatomical location were not reported), administered for prophylaxis. The storage temperature and time frame were unknown by the reporter. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HEPA
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: Information was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On 17-JUL-2018, the patient was vaccinated with VAQTA for prophylaxis (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported). On the same day, after the pre filled syringe needle was pulled out of the skin, there was amount of leakage at the injection site (injection site leaking); however, no side effects were reported. The outcome of injection site leaking was unknown. The relatedness between injection site leaking and VAQTA was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Hypoaesthesia, Neuralgia, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On 05-AUG-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), 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 ZOSTAVAX, the patient developed facial and nerve pain accompanied by numbness originating on the right side of his face. On 02-SEP-2016, the patient presented to medical clinic, his primary care physician, and was assessed as suffering from nerve pain and trigeminal neuralgia believed to be a reaction to ZOSTAVAX vaccine. Shortly thereafter, on 05-OCT-2016, the patient underwent a magnetic resonance imaging (MRI) of his brain which indicated worsening of the patient's trigeminal neuralgia. 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. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. The events of Trigeminal neuralgia, nerve pain and persistent strain of herpes zoster were disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Quality of life decreased, Trigeminal neuralgia
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On 05-AUG-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), 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 ZOSTAVAX, the patient developed facial and nerve pain accompanied by numbness originating on the right side of his face. On 02-SEP-2016, the patient presented to medical clinic, his primary care physician, and was assessed as suffering from nerve pain and trigeminal neuralgia believed to be a reaction to ZOSTAVAX vaccine. Shortly thereafter, on 05-OCT-2016, the patient underwent a magnetic resonance imaging (MRI) of his brain which indicated worsening of the patient's trigeminal neuralgia. 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. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. The events of Trigeminal neuralgia, nerve pain and persistent strain of herpes zoster were disabling. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 13 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 03-JUN-2015, the patient was vaccinated with the first dose of an unspecified human papillomavirus (HPV) vaccine (manufacturer unknown) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported) (Product origin unknown). On 25-JUL-2018, the patient was vaccinated with the second dose of the GARDASIL 9 intramuscularly for prophylaxis lot number R003557 (dose, anatomical location and expiration date were not reported). No adverse effect was reported. However, lot number R003557 is valid for GARDASIL. The outcome of product origin unknown was unknown. Additionally, the reporter did not provide causality assessment between the event and vaccination with GARDASIL 9 and the unspecified human papillomavirus (HPV) vaccine (manufacturer unknown).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 23-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (degrees F) to 14 degrees F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA012253; US-009507513-1807USA012256; US-009507513-1807USA012264; US-009507513-1807USA012258; US-009507513-1807USA012259; US-009507513-1807USA012260; US-009507513-1807USA012261; US-009507513-1807USA012262; US-009507513-1807USA012263; US-009507513-1807USA012255; US-009507513-1807USA012254; US-009507513-1807USA012257.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 65 year old female patient with drug hypersensitivity to sulfa and erythromycin. The patient's medical history included breast cancer with radiation. The patient received a dose of PREVNAR on 23-JUL-2018. On 23-JUL-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N022650, expiration date 31-MAR-2019, intramuscularly (strength, dose and frequency were not provided) for prophylaxis. On an unspecified date in July 2018, the patient complaint of pain underneath the arm where she was vaccinated. Moreover, the reporter stated that the patient did not have injection site pain. It was reported that the patient visited a doctor's office because of the event. The outcome of pain in extremity was reported as not recovered. At the time of this report, the causality between the event and PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 19-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA012257: Original Case: 1807USA011606: US-009507513-1807USA011606: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012254.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 25-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012257:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 18-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012254: US-009507513-1807USA012257:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 20-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 18-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA012254: US-009507513-1807USA012255: US-009507513-1807USA012263: US-009507513-1807USA012262: US-009507513-1807USA012261: US-009507513-1807USA012260: US-009507513-1807USA012259: US-009507513-1807USA012258: US-009507513-1807USA012264: US-009507513-1807USA012256: US-009507513-1807USA012253: US-009507513-1807USA011606:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 23-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 25-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 23-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256 : US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263 : US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257 :
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 25-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 18-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257: