chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PNC10
Symptoms: Back pain, Dysstasia, Electrocardiogram normal, Musculoskeletal stiffness, Paralysis
Clinical narrative: Pt states that her back was stiff and was having pain in it. Pt could hardly stand and states she felt "paralyzed". This nurse got an EKG that showed normal sinus rhythm and I got the Dr. the Dr. came in and stated he was worried that it might have been related to spinal stenosis so instructed pt and husband to go to ER, that he did not think that it was realted to the vaccine at all but due to the spinal stenosis. Pt and husband did go to ER but left AMA.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Rash, hives started on next day after immunization given, responded to BENADRYL. Reports gets hives with all immunizations.
Age: 1.42
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: MMR given 3/7/17; Varicella 4/4/17.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive, Lymph node pain, Lymphadenopathy, Malaise, Musculoskeletal stiffness
Clinical narrative: Sick for 5 days with swollen, painful lymph nodes, fever, stiff neck.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Sick for 5 days with swollen, painful lymph nodes, fever, stiff neck.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Arthralgia, Blister, Burning sensation, Diarrhoea
Clinical narrative: I've gotten through the worst symptoms with the second Varicella Vaccine, I hope. Had pretty intense stomach cramps and diarrhea for an hour around 4am on Friday night after getting the vaccine, and it was swollen to about 3 inches across and bubbling about one inch across by the time I went to bed that night (so much faster than last time). I took BENADRYL every night and day until Monday, and used the hydrocortisone right away and both seemed to help. It was swollen (hard, hot, itchy/burning/sore) all day Saturday and Sunday, though improving a little Sunday, but not intolerable. My left arm was very achy all day Saturday though, like get from a fever, from my Trapezius down through my inner elbow and into my finger joints, and seemed better the less I used it. Saturday night for about an hour the pain was really intense, deep and aching in my muscles and joints of my left arm, and that was pretty intolerable. Maybe a 7 out of 10? I was thinking I could probably handle it for about two hours and then would need to go to urgent care if it didn't get better. But I took Ibuprofen (which I then read you're not supposed to take with Varicella, so I got TYLENOL) and had a massage therapist friend work on my arm for about twenty minutes (that was handy) and it subsided almost completely. Today and yesterday the muscle ache is gone and the swelling is way down, but the center is still red, bubbly, and quite itchy. I expect that will go away over the next few days.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Myalgia, Pain, Pain in extremity
Clinical narrative: I've gotten through the worst symptoms with the second Varicella Vaccine, I hope. Had pretty intense stomach cramps and diarrhea for an hour around 4am on Friday night after getting the vaccine, and it was swollen to about 3 inches across and bubbling about one inch across by the time I went to bed that night (so much faster than last time). I took BENADRYL every night and day until Monday, and used the hydrocortisone right away and both seemed to help. It was swollen (hard, hot, itchy/burning/sore) all day Saturday and Sunday, though improving a little Sunday, but not intolerable. My left arm was very achy all day Saturday though, like get from a fever, from my Trapezius down through my inner elbow and into my finger joints, and seemed better the less I used it. Saturday night for about an hour the pain was really intense, deep and aching in my muscles and joints of my left arm, and that was pretty intolerable. Maybe a 7 out of 10? I was thinking I could probably handle it for about two hours and then would need to go to urgent care if it didn't get better. But I took Ibuprofen (which I then read you're not supposed to take with Varicella, so I got TYLENOL) and had a massage therapist friend work on my arm for about twenty minutes (that was handy) and it subsided almost completely. Today and yesterday the muscle ache is gone and the swelling is way down, but the center is still red, bubbly, and quite itchy. I expect that will go away over the next few days.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: I've gotten through the worst symptoms with the second Varicella Vaccine, I hope. Had pretty intense stomach cramps and diarrhea for an hour around 4am on Friday night after getting the vaccine, and it was swollen to about 3 inches across and bubbling about one inch across by the time I went to bed that night (so much faster than last time). I took BENADRYL every night and day until Monday, and used the hydrocortisone right away and both seemed to help. It was swollen (hard, hot, itchy/burning/sore) all day Saturday and Sunday, though improving a little Sunday, but not intolerable. My left arm was very achy all day Saturday though, like get from a fever, from my Trapezius down through my inner elbow and into my finger joints, and seemed better the less I used it. Saturday night for about an hour the pain was really intense, deep and aching in my muscles and joints of my left arm, and that was pretty intolerable. Maybe a 7 out of 10? I was thinking I could probably handle it for about two hours and then would need to go to urgent care if it didn't get better. But I took Ibuprofen (which I then read you're not supposed to take with Varicella, so I got TYLENOL) and had a massage therapist friend work on my arm for about twenty minutes (that was handy) and it subsided almost completely. Today and yesterday the muscle ache is gone and the swelling is way down, but the center is still red, bubbly, and quite itchy. I expect that will go away over the next few days.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of sudden infant death syndrome in a 2-month-old patient who received ROTARIX. Co-suspect products included Nystatin unknown for thrush. Concurrent medical conditions included thrush (treated with Nystatin). On 8th March 2017, the patient received the 1st dose of ROTARIX (oral) and Nystatin at an unknown dose and frequency. On 9th March 2017, 1 days after receiving ROTARIX and Nystatin and 1 day after starting ROTARIX and Nystatin, the patient experienced sudden infant death syndrome (serious criteria death and GSK  medically significant). On 9th March 2017, the outcome of the sudden infant death syndrome was fatal. The patient died on 9th March 2017. The reported cause of death was sudden infant death syndrome. The reporter considered the sudden infant death syndrome to be unrelated to ROTARIX and Nystatin. Additional details were provided as follows: On 8th March 2017, in morning, the patient received vaccination with ROTARIX at the physician visit. On the same day, the physician prescribed Nystatin for Thrush of the mouth. It was reported that the patient played all day and was fine. On 8th March 2017, in evening, the patient received a dose of Nystatin. On 9th March 2017, in morning, the patient was found dead. The physician mentioned it was not known if an autopsy was being done but potential Sudden infant death syndrome (SIDS) might be a cause. The sales representative had a little information. The contact details of the reporting physician were provided for the follow up.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea, Headache, Laboratory test
Clinical narrative: My 15 year old daughter received the GARDASIL vaccine. She was transported to the hospital that evening with a severe headache, shortness of breath, chest pains and her blood pressure was 160/130. They treated her at the hospital and discharged her.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Dr. pulled vaccine out of refrigerator and gave to nurse to administer.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Immobile, Pain, Skin warm, Urticaria
Clinical narrative: Aches and pains 6 hrs after shot, Sat A.M.-90% immobile Sat night and Sunday all day-3-18 and 19. Late afternoon Monday, palm size welt on inside of arm shot was given 1" above elbow. Warm to touch. Took antihistamines. Came to pharmacy where shot was given.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Feeling abnormal, Hypersensitivity, Pain, Peripheral swelling
Clinical narrative: Aches and pains 6 hrs after shot, Sat A.M.-90% immobile Sat night and Sunday all day-3-18 and 19. Late afternoon Monday, palm size welt on inside of arm shot was given 1" above elbow. Warm to touch. Took antihistamines. Came to pharmacy where shot was given.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Product quality issue, Skin warm
Clinical narrative: Aches and pains 6 hrs after shot, Sat A.M.-90% immobile Sat night and Sunday all day-3-18 and 19. Late afternoon Monday, palm size welt on inside of arm shot was given 1" above elbow. Warm to touch. Took antihistamines. Came to pharmacy where shot was given.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Pt started complaining of itching at injection site and a burning sensation, about 2 minutes later she started to have whelps and redness diffusely spread with itching. She was given BENADRYL with no relief, then given oral Prednisolone about 5 minutes later. Pt. continued to itch and was then given a shot of Celestone. Itching and whelps improved. Total time was about 30 minutes. No respiratory distress noted.
Age: 1.67
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Urticaria
Clinical narrative: Developed hives within 24 hours of vaccine administration - no wheezing or shortness of breath.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from two registered nurses referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in October and December 2016, the patient received the first and second dose respectively of GARDASIL 9 and on 28-FEB-2017, the patient received the third dose of GARDASIL 9 (inappropriate schedule of drug administration) (route of administration, lot numbers and expiration dates for all doses were not provided) for prophylaxis. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unspecified date, the patient was vaccinated with subcutaneous ZOSTAVAX (strength, dose, lot number and expiration date were not reported) to prevent shingles.  On an unknown date, after the patient received ZOSTAVAX, the patient developed shingles. The outcome of the event shingles was unknown and the causal relationship between the event and the ZOSTAVAX were not reported. Additional information is not expected because there was no consent to contact physician.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cough, Erythema, Laryngitis, Local reaction, Local swelling
Clinical narrative: Information has been received from a retired licensed practical nurse concerning herself, a 74 year old female patient. The patient's medical history included a fracture of the left knee. Her concurrent conditions included osteoporosis and cephalosporin allergy. Historical drugs included a vaccination with ZOSTAVAX on an unknown date 10 years ago, she had a local reaction described as "developed 1 inch by1 inch area red and swollen located above the elbow" (MARRS 1703USA008228). The patient did not take concomitant medications. On 01-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot number M038359 with expiration date: 03-MAY-2018 (dose, dose number and anatomical location were not provided) for prophylaxis. On the same day, after receiving PNEUMOVAX 23, the patient developed a local reaction of "redness, swelling and itching located about 2 inches above the elbow", the area on her arm that was affected was not at the PNEUMOVAX 23 injection site and that the area of redness and swelling grew to a 3 inch by 2 inch area. She took BENADRYL, as treatment. On 03-MAR-2017 the patient experienced a "runny nose". Then, on 04-MAR-2017 the patient was recovered from the redness and swelling located area and experienced cough. In addition, on 05-MAR-2017, the patient developed laryngitis. The patient did not seek medical attention and there was not lab diagnostics studies performed. At the time of the report, the patient was not recovered from the runny nose, laryngitis and cough, and the outcome of the itching was unknown. The relatedness between the events and the PNEUMOVAX 23 was not reported. There was no product quality complaint involved. Additional information has been requested. Sender's Comments: US-009507513-1703USA008228.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pruritus, Rhinorrhoea
Clinical narrative: Information has been received from a retired licensed practical nurse concerning herself, a 74 year old female patient. The patient's medical history included a fracture of the left knee. Her concurrent conditions included osteoporosis and cephalosporin allergy. Historical drugs included a vaccination with ZOSTAVAX on an unknown date 10 years ago, she had a local reaction described as "developed 1 inch by1 inch area red and swollen located above the elbow" (MARRS 1703USA008228). The patient did not take concomitant medications. On 01-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot number M038359 with expiration date: 03-MAY-2018 (dose, dose number and anatomical location were not provided) for prophylaxis. On the same day, after receiving PNEUMOVAX 23, the patient developed a local reaction of "redness, swelling and itching located about 2 inches above the elbow", the area on her arm that was affected was not at the PNEUMOVAX 23 injection site and that the area of redness and swelling grew to a 3 inch by 2 inch area. She took BENADRYL, as treatment. On 03-MAR-2017 the patient experienced a "runny nose". Then, on 04-MAR-2017 the patient was recovered from the redness and swelling located area and experienced cough. In addition, on 05-MAR-2017, the patient developed laryngitis. The patient did not seek medical attention and there was not lab diagnostics studies performed. At the time of the report, the patient was not recovered from the runny nose, laryngitis and cough, and the outcome of the itching was unknown. The relatedness between the events and the PNEUMOVAX 23 was not reported. There was no product quality complaint involved. Additional information has been requested. Sender's Comments: US-009507513-1703USA008228.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Conjunctivitis, Cough, Injection site erythema, Injection site pruritus, Rhinorrhoea
Clinical narrative: Information has been received from a retired licensed practical nurse concerning herself, a 74 year old female patient. The patient's medical history included a fracture of the left knee. Her concurrent conditions included osteoporosis and cephalosporin allergy. Historical drugs included a vaccination with ZOSTAVAX on an unknown date 10 years ago, she had a local reaction described as "developed 1 inch by1 inch area red and swollen located above the elbow" (MARRS 1703USA008228). The patient did not take concomitant medications. On 01-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot number M038359 with expiration date: 03-MAY-2018 (dose, dose number and anatomical location were not provided) for prophylaxis. On the same day, after receiving PNEUMOVAX 23, the patient developed a local reaction of "redness, swelling and itching located about 2 inches above the elbow", the area on her arm that was affected was not at the PNEUMOVAX 23 injection site and that the area of redness and swelling grew to a 3 inch by 2 inch area. She took BENADRYL, as treatment. On 03-MAR-2017 the patient experienced a "runny nose". Then, on 04-MAR-2017 the patient was recovered from the redness and swelling located area and experienced cough. In addition, on 05-MAR-2017, the patient developed laryngitis. The patient did not seek medical attention and there was not lab diagnostics studies performed. At the time of the report, the patient was not recovered from the runny nose, laryngitis and cough, and the outcome of the itching was unknown. The relatedness between the events and the PNEUMOVAX 23 was not reported. There was no product quality complaint involved. Additional information has been requested. Sender's Comments: US-009507513-1703USA008228.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin irritation
Clinical narrative: Information has been received from a retired licensed practical nurse concerning herself, a 74 year old female patient. The patient's medical history included a fracture of the left knee. Her concurrent conditions included osteoporosis and cephalosporin allergy. Historical drugs included a vaccination with ZOSTAVAX on an unknown date 10 years ago, she had a local reaction described as "developed 1 inch by1 inch area red and swollen located above the elbow" (MARRS 1703USA008228). The patient did not take concomitant medications. On 01-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot number M038359 with expiration date: 03-MAY-2018 (dose, dose number and anatomical location were not provided) for prophylaxis. On the same day, after receiving PNEUMOVAX 23, the patient developed a local reaction of "redness, swelling and itching located about 2 inches above the elbow", the area on her arm that was affected was not at the PNEUMOVAX 23 injection site and that the area of redness and swelling grew to a 3 inch by 2 inch area. She took BENADRYL, as treatment. On 03-MAR-2017 the patient experienced a "runny nose". Then, on 04-MAR-2017 the patient was recovered from the redness and swelling located area and experienced cough. In addition, on 05-MAR-2017, the patient developed laryngitis. The patient did not seek medical attention and there was not lab diagnostics studies performed. At the time of the report, the patient was not recovered from the runny nose, laryngitis and cough, and the outcome of the itching was unknown. The relatedness between the events and the PNEUMOVAX 23 was not reported. There was no product quality complaint involved. Additional information has been requested. Sender's Comments: US-009507513-1703USA008228.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patient were vaccinated with improperly stored doses of ROTATEQ 1 dose, orally, lot # M038209, expiration date: 23-APR-2018, as prophylaxis (Strength was not reported), which experienced a temperature excursion between 0 to 1 Celsius degrees for 59 hours and 30 minutes. There were no previous temperature excursions reported. Data logger was not involved. No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 16 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in August 2015, the patient was vaccinated with a first dose of GARDASIL lot # L018286 (dose, route of administration, expiration date were not reported). On 12-AUG-2016 , the patient was vaccinated with a second dose with GARDASIL 9 lot# L043214 (dose, route of administration, expiration date were not reported). On 25-OCT-2016, the patient received the third dose of GARDASIL 9 lot# M017983 (dose, route of administration, expiration date were not reported) for prophylaxis. No adverse effects were reported. The outcome of the event of interchange of vaccine products was unknown. The relatedness between the event of interchange of vaccine products and GARDASIL and GARDASIL 9 was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report received from a pharmacy technician regarding a 76-year-old female who received a dose of ZOSTAVAX on an unknown date in 2003 (lot # not reported). On an unknown date in October of 2016, the patient developed shingles on the forehead. The patient has not recovered. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Emotional distress, Herpes zoster, Injury, Pain
Clinical narrative: Information was received on 20-MAR-2017 from a lawyer regarding a case in litigation. It is alleged in litigation that a female (age not reported) in 2015, was inoculated with the ZOSTAVAX (dose, route of administration, site of administration, lot number, expiration date were not reported) for the prevention of shingles as part of a routine adult medical examination. The vaccine was recommended and administered by the female patient's primary care physician. Prior to receiving the ZOSTAVAX vaccine, the female had never suffered from or been diagnosed with herpes zoster, or any other ailment collectively referred to as "shingles." As a direct result of the vaccine, the patient suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, she 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. On or about 14-JUN-2016, the female patient returned to her primary care provider. The patient addressed symptoms of a painful rash to her primary care physician, who identified the ailment as shingles on the patient's right flank. The patient was prescribed VALTREX, gabapentin, and acyclovir as directed for treatment of the patient's ongoing herpes zoster outbreak. As a direct and proximate consequence of ZOSTAVAX, patient sustained serious personal injuries and related losses including, but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses, and other losses and damages. The events of shingles on the right flank and emotional distress were considered disabling. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Physical disability, Quality of life decreased, Rash
Clinical narrative: Information was received on 20-MAR-2017 from a lawyer regarding a case in litigation. It is alleged in litigation that a female (age not reported) in 2015, was inoculated with the ZOSTAVAX (dose, route of administration, site of administration, lot number, expiration date were not reported) for the prevention of shingles as part of a routine adult medical examination. The vaccine was recommended and administered by the female patient's primary care physician. Prior to receiving the ZOSTAVAX vaccine, the female had never suffered from or been diagnosed with herpes zoster, or any other ailment collectively referred to as "shingles." As a direct result of the vaccine, the patient suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, she 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. On or about 14-JUN-2016, the female patient returned to her primary care provider. The patient addressed symptoms of a painful rash to her primary care physician, who identified the ailment as shingles on the patient's right flank. The patient was prescribed VALTREX, gabapentin, and acyclovir as directed for treatment of the patient's ongoing herpes zoster outbreak. As a direct and proximate consequence of ZOSTAVAX, patient sustained serious personal injuries and related losses including, but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses, and other losses and damages. The events of shingles on the right flank and emotional distress were considered disabling. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Blister, Emotional distress, Eyelid oedema, Herpes zoster
Clinical narrative: Information has been received on 20-MAR-2017 from an attorney in the form of an initial legal complaint regarding a female consumer (age not reported) who received  ZOSTAVAX vaccine for the prevention of shingles as part of a routine adult medical examination (date not reported). Prior to receiving ZOSTAVAX, the patient had never suffered from or been diagnosed with herpes zoster, or any other ailment collectively referred to as "shingles." On or about 20-JUN-2016, the patient went to her primary care physician, where she was treated for complaints of painful bumps, which were diagnosed as shingles. The patient was prescribed valacyclovir and was referred to an ophthalmologist. On or about 21-JUN-2016 the patient was treated by the ophthalmologist for swollen eyelids and painful blisters. The physician identified shingled on the right side of the face and a vesicle on the right upper lid and periorbital skin. The physician reaffirmed the prior diagnosis of herpes zoster keratoconjunctivitis. The patient was prescribed valacyclovir (VALTREX) and "viroptix" 1% to prevent the spread of the blisters deeper into her right eye. As a direct result of the vaccine, the patient suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries. Furthermore 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. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injury, Ophthalmic herpes zoster, Physical disability, Quality of life decreased, Rash
Clinical narrative: Information has been received on 20-MAR-2017 from an attorney in the form of an initial legal complaint regarding a female consumer (age not reported) who received  ZOSTAVAX vaccine for the prevention of shingles as part of a routine adult medical examination (date not reported). Prior to receiving ZOSTAVAX, the patient had never suffered from or been diagnosed with herpes zoster, or any other ailment collectively referred to as "shingles." On or about 20-JUN-2016, the patient went to her primary care physician, where she was treated for complaints of painful bumps, which were diagnosed as shingles. The patient was prescribed valacyclovir and was referred to an ophthalmologist. On or about 21-JUN-2016 the patient was treated by the ophthalmologist for swollen eyelids and painful blisters. The physician identified shingled on the right side of the face and a vesicle on the right upper lid and periorbital skin. The physician reaffirmed the prior diagnosis of herpes zoster keratoconjunctivitis. The patient was prescribed valacyclovir (VALTREX) and "viroptix" 1% to prevent the spread of the blisters deeper into her right eye. As a direct result of the vaccine, the patient suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries. Furthermore 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. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Emotional distress, Erythema, Herpes zoster
Clinical narrative: Information was received on 20-MAR-2017 from a lawyer regarding a case in litigation concerning a male patient (age unknown). On or about 20-JAN-2011, the patient was inoculated with the ZOSTAVAX vaccine for the prevention of shingles (lot, expiration date and injection site not reported). The patient was prescribed a dose of 0.65 ml of ZOSTAVAX subcutaneous solution, administered by a physician and filled at a pharmacy. Prior to receiving the ZOSTAVAX vaccine, the patient never suffered from or been diagnosed with herpes zoster or any other zoster ailment collectively referred to as "shingles". On or about 16-DEC-2015, the patient was treated by his physician for a painful rash that spread across the patient's body, including his back and trunk. He displayed red papules and early vesicle formation which the physician assessed as herpes zoster virus, also known as shingles outbreak. The patient was prescribed valacyclovir for treatment of the virus. On or about 22-JAN-2016, the patient was seen for a follow-up visit with his physician for complaints of persistent (sic). The patient was diagnosed with ongoing herpes zoster, which had worsened in severity despite being treated with valacyclovir. The physician noted new open blisters with sensitivity and burning and existing blisters which had begun to form scabs. The physician noted that the patient had extensive scarring on this upper back and chest, typical for chronic singles outbreaks. On or about 22-JAN-2016, the patient was diagnosed with post herpetic neuralgia, a chronic painful condition affecting the nerves that general (sic) caused by repeat herpes zoster outbreaks. The patient was prescribed gabapentin to treat the conditions of herpes zoster and post herpetic neuralgia. The patient will continue to suffer from nerve damage as a result of post herpetic neuralgia. As a result of ZOSTAVAX, the patient has sustained severe and chronic personal injuries. Further, as a tragic consequence, 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 patient has incurred and will continue to incur medical expenses and other economic harm as a result of use of ZOSTAVAX. Post herpetic neuralgia, herpes zoster, and emotional distress were considered disabling. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injury, Nerve injury, Papule, Physical disability
Clinical narrative: Information was received on 20-MAR-2017 from a lawyer regarding a case in litigation concerning a male patient (age unknown). On or about 20-JAN-2011, the patient was inoculated with the ZOSTAVAX vaccine for the prevention of shingles (lot, expiration date and injection site not reported). The patient was prescribed a dose of 0.65 ml of ZOSTAVAX subcutaneous solution, administered by a physician and filled at a pharmacy. Prior to receiving the ZOSTAVAX vaccine, the patient never suffered from or been diagnosed with herpes zoster or any other zoster ailment collectively referred to as "shingles". On or about 16-DEC-2015, the patient was treated by his physician for a painful rash that spread across the patient's body, including his back and trunk. He displayed red papules and early vesicle formation which the physician assessed as herpes zoster virus, also known as shingles outbreak. The patient was prescribed valacyclovir for treatment of the virus. On or about 22-JAN-2016, the patient was seen for a follow-up visit with his physician for complaints of persistent (sic). The patient was diagnosed with ongoing herpes zoster, which had worsened in severity despite being treated with valacyclovir. The physician noted new open blisters with sensitivity and burning and existing blisters which had begun to form scabs. The physician noted that the patient had extensive scarring on this upper back and chest, typical for chronic singles outbreaks. On or about 22-JAN-2016, the patient was diagnosed with post herpetic neuralgia, a chronic painful condition affecting the nerves that general (sic) caused by repeat herpes zoster outbreaks. The patient was prescribed gabapentin to treat the conditions of herpes zoster and post herpetic neuralgia. The patient will continue to suffer from nerve damage as a result of post herpetic neuralgia. As a result of ZOSTAVAX, the patient has sustained severe and chronic personal injuries. Further, as a tragic consequence, 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 patient has incurred and will continue to incur medical expenses and other economic harm as a result of use of ZOSTAVAX. Post herpetic neuralgia, herpes zoster, and emotional distress were considered disabling. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Quality of life decreased, Rash, Rash generalised, Scab
Clinical narrative: Information was received on 20-MAR-2017 from a lawyer regarding a case in litigation concerning a male patient (age unknown). On or about 20-JAN-2011, the patient was inoculated with the ZOSTAVAX vaccine for the prevention of shingles (lot, expiration date and injection site not reported). The patient was prescribed a dose of 0.65 ml of ZOSTAVAX subcutaneous solution, administered by a physician and filled at a pharmacy. Prior to receiving the ZOSTAVAX vaccine, the patient never suffered from or been diagnosed with herpes zoster or any other zoster ailment collectively referred to as "shingles". On or about 16-DEC-2015, the patient was treated by his physician for a painful rash that spread across the patient's body, including his back and trunk. He displayed red papules and early vesicle formation which the physician assessed as herpes zoster virus, also known as shingles outbreak. The patient was prescribed valacyclovir for treatment of the virus. On or about 22-JAN-2016, the patient was seen for a follow-up visit with his physician for complaints of persistent (sic). The patient was diagnosed with ongoing herpes zoster, which had worsened in severity despite being treated with valacyclovir. The physician noted new open blisters with sensitivity and burning and existing blisters which had begun to form scabs. The physician noted that the patient had extensive scarring on this upper back and chest, typical for chronic singles outbreaks. On or about 22-JAN-2016, the patient was diagnosed with post herpetic neuralgia, a chronic painful condition affecting the nerves that general (sic) caused by repeat herpes zoster outbreaks. The patient was prescribed gabapentin to treat the conditions of herpes zoster and post herpetic neuralgia. The patient will continue to suffer from nerve damage as a result of post herpetic neuralgia. As a result of ZOSTAVAX, the patient has sustained severe and chronic personal injuries. Further, as a tragic consequence, 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 patient has incurred and will continue to incur medical expenses and other economic harm as a result of use of ZOSTAVAX. Post herpetic neuralgia, herpes zoster, and emotional distress were considered disabling. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Scar
Clinical narrative: Information was received on 20-MAR-2017 from a lawyer regarding a case in litigation concerning a male patient (age unknown). On or about 20-JAN-2011, the patient was inoculated with the ZOSTAVAX vaccine for the prevention of shingles (lot, expiration date and injection site not reported). The patient was prescribed a dose of 0.65 ml of ZOSTAVAX subcutaneous solution, administered by a physician and filled at a pharmacy. Prior to receiving the ZOSTAVAX vaccine, the patient never suffered from or been diagnosed with herpes zoster or any other zoster ailment collectively referred to as "shingles". On or about 16-DEC-2015, the patient was treated by his physician for a painful rash that spread across the patient's body, including his back and trunk. He displayed red papules and early vesicle formation which the physician assessed as herpes zoster virus, also known as shingles outbreak. The patient was prescribed valacyclovir for treatment of the virus. On or about 22-JAN-2016, the patient was seen for a follow-up visit with his physician for complaints of persistent (sic). The patient was diagnosed with ongoing herpes zoster, which had worsened in severity despite being treated with valacyclovir. The physician noted new open blisters with sensitivity and burning and existing blisters which had begun to form scabs. The physician noted that the patient had extensive scarring on this upper back and chest, typical for chronic singles outbreaks. On or about 22-JAN-2016, the patient was diagnosed with post herpetic neuralgia, a chronic painful condition affecting the nerves that general (sic) caused by repeat herpes zoster outbreaks. The patient was prescribed gabapentin to treat the conditions of herpes zoster and post herpetic neuralgia. The patient will continue to suffer from nerve damage as a result of post herpetic neuralgia. As a result of ZOSTAVAX, the patient has sustained severe and chronic personal injuries. Further, as a tragic consequence, 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 patient has incurred and will continue to incur medical expenses and other economic harm as a result of use of ZOSTAVAX. Post herpetic neuralgia, herpes zoster, and emotional distress were considered disabling. Additional information has been requested.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Cold sweat, Dizziness, Pallor
Clinical narrative: This is a spontaneous report from a contactable other HCP via a Pfizer sales Representative. A male patient (16, unit was not provided) of an unspecified race received TRUMENBA and MENACTRA both on unknown date, via unspecified route of administration, at single dose for immunization. Patient was feeling light headed, turned pale and clammy after receiving the vaccines. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program Unbranded social media Pilot. A contactable consumer reported for a female patient of an unspecified age and race (Mother) that received  pneumococcal 13-val conj vac (dipht crm197 protein) on unknown date at single dose for immunization. The patient has had pneumonia twice, and almost died from it once and that was after getting the pneumococcal vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood cholesterol normal, Erythema, Influenza like illness, Mobility decreased, Pain in extremity
Clinical narrative: The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on 15Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer reporting for herself. This 65-year-old black female consumer received PREVNAR 13 (lot: R28320, expiry date: Feb2018) on 09Mar2017, around 1 or 2 P.M., in right arm, at single dose, for immunisation.  No other vaccines were given on the same day or within 4 weeks. Medical history included ongoing diabetes, knee replacement, hip replacement, spinal stenosis, ongoing blood pressure abnormal, ongoing nerve pain and ongoing sinus disorder. The patient previously took an unspecified pneumococcal vaccine on an unknown date, for immunization, experiencing no adverse effect. Ongoing concomitant medications included insulin aspart, protamine (NOVOLOG MIX 70/30) 24 IU twice a day shot, for diabetes, fast acting insulin aspart (NOVOLOG) sliding scale if bood sugar high, for diabetes, losartan 50 mg once per day, for blood pressure, metoprolol succinate (TOPROL XL) 25 mg once per day, for blood pressure, montelukast sodium (SINGULAIR) 10 mg once a day, for sinus, gabapentin, for nerve pain, 300 mg capsule once three times as needed, for nerve pain and an unspecified statin 10 mg for cholesterol. Since an unspecified date in Mar2017 the consumer arm was very swollen, red, painful, warm to touch, she felt almost kind of flu like symptoms and she had fever. She took her temperature on 14Mar2017 evening and it was 99.8. She noticed the redness to her right arm one or two days after the injection. The pain started two days after. The pain was the worst four days after; the arm was so painful that she could barely move her arm. At time of report the pain was not so severe. She was prescribed tramadol 50 mg up to three times a day as needed for pain. It took a while for it to help calm it down. No ER or physician office visit were required. The consumer measured blood cholesterol which was 10 mg on an unspecified date in Mar2017. Pain and swelling were resolving and redness had not yet resolved at the time of report. The outcome of the other events was unknown. She was informed by the Pharmacy that she would need a follow-up vaccine in a year, it was the same vaccine, but they were probably referring to PNEUMOVAX 23. It was recommended by her diabetes doctor.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on 15Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer reporting for herself. This 65-year-old black female consumer received PREVNAR 13 (lot: R28320, expiry date: Feb2018) on 09Mar2017, around 1 or 2 P.M., in right arm, at single dose, for immunisation.  No other vaccines were given on the same day or within 4 weeks. Medical history included ongoing diabetes, knee replacement, hip replacement, spinal stenosis, ongoing blood pressure abnormal, ongoing nerve pain and ongoing sinus disorder. The patient previously took an unspecified pneumococcal vaccine on an unknown date, for immunization, experiencing no adverse effect. Ongoing concomitant medications included insulin aspart, protamine (NOVOLOG MIX 70/30) 24 IU twice a day shot, for diabetes, fast acting insulin aspart (NOVOLOG) sliding scale if bood sugar high, for diabetes, losartan 50 mg once per day, for blood pressure, metoprolol succinate (TOPROL XL) 25 mg once per day, for blood pressure, montelukast sodium (SINGULAIR) 10 mg once a day, for sinus, gabapentin, for nerve pain, 300 mg capsule once three times as needed, for nerve pain and an unspecified statin 10 mg for cholesterol. Since an unspecified date in Mar2017 the consumer arm was very swollen, red, painful, warm to touch, she felt almost kind of flu like symptoms and she had fever. She took her temperature on 14Mar2017 evening and it was 99.8. She noticed the redness to her right arm one or two days after the injection. The pain started two days after. The pain was the worst four days after; the arm was so painful that she could barely move her arm. At time of report the pain was not so severe. She was prescribed tramadol 50 mg up to three times a day as needed for pain. It took a while for it to help calm it down. No ER or physician office visit were required. The consumer measured blood cholesterol which was 10 mg on an unspecified date in Mar2017. Pain and swelling were resolving and redness had not yet resolved at the time of report. The outcome of the other events was unknown. She was informed by the Pharmacy that she would need a follow-up vaccine in a year, it was the same vaccine, but they were probably referring to PNEUMOVAX 23. It was recommended by her diabetes doctor.