chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nerve conduction studies, Orthosis user, Pain, Pain in extremity, Paraesthesia
Clinical narrative: On 05/01/2019 to PCP office,person bringing me to office exclaimed that the injection site looked kind of low on the left arm. Upon exam she also agreed it looked a little low in location. Red raised bump appx. 3-1/3" in diameter, very warm, itchy. Swelling traveling behind injection site toward the back of the arm just above the elbow. Treated for possible skin infection w/ Cephalexin 250 mg. On 05/08/2019 Calls into and missing the office. Wondering if I should be seen at walk in care. Injection site still tight red,slight itch etc. Area on arm appears lighter but still bothersome. 05/17/2019-05/19/2019 Back and back shoulder pain only. Used ibuprofen for the aches. 05/26/2019-05/27/2019 front shoulder pain. 05/28/2019 Went to work and called PCP office. During the morning @ work on 05/28/2019 the shoulder pain I was having was unlike anything I'd ever had before. I was scared and called the doctors office because it was radiating toward my chest and starting to grip really bad. I was informed by Dr.'s nurse that I should then go to the E.R. which is what I did. Many hours later,tested, treated and released. Robaxin 4x daily. No cardiac results. On 06/05/2019 I went to PCP for the follow up on the E.R. visit. See, series of small checks. Neck x-ray ordered, MEG test and nerve conduction test ordered. Cyclobenzaprine and Prednisone prescribed. No relief when pills are even half gone. MEDS ARE NOT WORKING FOR THE PAIN< TINGLING AND NUMBNESS. The tingling seems to be in the 1st three fingers of the left hand. Arm, left shoulder pain and left sided chest pain are the most significant. 06/07/2019 Burning @ the bra line on back along with stabbing pain. 06/11/2019 tingling and numbness in arm and fingers is more constant now. Heavy area of pain just above and below the elbow area. 06/25/2019 fingers burning. Arm itchy at below elbow. Pointer finger, middle finger more extreme pain and wrist being felt now. Called PCP office to keep track of appt. for EMG. Scheduled for 07/03/2019. 07/03/2019 EMG and nerve conduction test w/ Dr. at 8:50 A.M. Any word I got from Dr. indicated pressure from around elbow area to wrist. He is sending report back to Dr. On 07/19/2019 I follow up with Dr. and see where we go from here. Today is 07/04/2019. I continue to have unexplained extreme arm and shoulder pain. The first three finger on my left hand have been constantly numb since about 06/11/2019. Now I scratch between the fingers daily because they now also itch. Up until now ,muscle relaxants have not worked and over the counter medications do not work. 07/19/2019 Primary care visit with Dr. He gave me a script for a wrist brace. He is treating this as carpal tunnel syndrome. I am to re-visit him in September sometime after having worn the brace.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: On 05/01/2019 to PCP office,person bringing me to office exclaimed that the injection site looked kind of low on the left arm. Upon exam she also agreed it looked a little low in location. Red raised bump appx. 3-1/3" in diameter, very warm, itchy. Swelling traveling behind injection site toward the back of the arm just above the elbow. Treated for possible skin infection w/ Cephalexin 250 mg. On 05/08/2019 Calls into and missing the office. Wondering if I should be seen at walk in care. Injection site still tight red,slight itch etc. Area on arm appears lighter but still bothersome. 05/17/2019-05/19/2019 Back and back shoulder pain only. Used ibuprofen for the aches. 05/26/2019-05/27/2019 front shoulder pain. 05/28/2019 Went to work and called PCP office. During the morning @ work on 05/28/2019 the shoulder pain I was having was unlike anything I'd ever had before. I was scared and called the doctors office because it was radiating toward my chest and starting to grip really bad. I was informed by Dr.'s nurse that I should then go to the E.R. which is what I did. Many hours later,tested, treated and released. Robaxin 4x daily. No cardiac results. On 06/05/2019 I went to PCP for the follow up on the E.R. visit. See, series of small checks. Neck x-ray ordered, MEG test and nerve conduction test ordered. Cyclobenzaprine and Prednisone prescribed. No relief when pills are even half gone. MEDS ARE NOT WORKING FOR THE PAIN< TINGLING AND NUMBNESS. The tingling seems to be in the 1st three fingers of the left hand. Arm, left shoulder pain and left sided chest pain are the most significant. 06/07/2019 Burning @ the bra line on back along with stabbing pain. 06/11/2019 tingling and numbness in arm and fingers is more constant now. Heavy area of pain just above and below the elbow area. 06/25/2019 fingers burning. Arm itchy at below elbow. Pointer finger, middle finger more extreme pain and wrist being felt now. Called PCP office to keep track of appt. for EMG. Scheduled for 07/03/2019. 07/03/2019 EMG and nerve conduction test w/ Dr. at 8:50 A.M. Any word I got from Dr. indicated pressure from around elbow area to wrist. He is sending report back to Dr. On 07/19/2019 I follow up with Dr. and see where we go from here. Today is 07/04/2019. I continue to have unexplained extreme arm and shoulder pain. The first three finger on my left hand have been constantly numb since about 06/11/2019. Now I scratch between the fingers daily because they now also itch. Up until now ,muscle relaxants have not worked and over the counter medications do not work. 07/19/2019 Primary care visit with Dr. He gave me a script for a wrist brace. He is treating this as carpal tunnel syndrome. I am to re-visit him in September sometime after having worn the brace.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Myalgia, Pyrexia, Rash, Rash erythematous
Clinical narrative: Client's mother reports child has a fever, headache, muscle aches, and generalized non-raised, red, itchy rash over arms and trunk.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Rash pruritic
Clinical narrative: Client's mother reports child has a fever, headache, muscle aches, and generalized non-raised, red, itchy rash over arms and trunk.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Cough, Ear congestion, Eye pain, Fatigue, Headache
Clinical narrative: Started fatigue, then muscle aches, headache, sore throat, eyes hurt, then congestion nasal, ears progressed to chest cough, flunofproductiveproductive
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Influenza, Myalgia, Nasal congestion, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Started fatigue, then muscle aches, headache, sore throat, eyes hurt, then congestion nasal, ears progressed to chest cough, flunofproductiveproductive
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Given MMRV in left arm on 08/28/2019. On 08/29/2019 a 7-8 cm area on left arm that is hot, swollen, and  tender to touch was noted by grandmother. Seen office on 08/30/2019 and treated for cellulitis by PA-C
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling hot, Loss of consciousness
Clinical narrative: Donor reported that he rode the bus approximately 30 minutes after leaving the center and started feeling hot. Donor states he then lost consciousness for approximately 10-15 seconds. Donor states when he regained consciousness, he drank a bottle of water and felt better.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Sharp pain in left arm with warmness at site of injection.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Fall, Seizure, Seizure like phenomena
Clinical narrative: Patient fell to the floor as soon as the  shot was given and started convulsing and making jerky movements (looked as if he was having a seizure).   Lasted 30 seconds.  First shot that was given was HPV, then Tdap, then MCV4
Age: 1.08
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given extra varicella dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Dyskinesia, Loss of consciousness, Pallor, Posture abnormal, Urinary incontinence
Clinical narrative: Patient was seen at office for 4 year well child visit and given routine 4 year vaccines (MMRV, Quadracel) Patient was fine after the vaccinations and left the office. On the way to school mom states she was trying to get patient's attentions and he was passed out and he urinated on himself during the episode in the car.  Episode lasted 30 seconds. He dropped his head and during the episode his arms went up "like he was dabbing".  When they arrived here his lips were pale, he was awake and alert.  He was oriented in office with normal vitals.  He was observed for 10-15 minutes and was stating he wanted to go home.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Induration, Pain, Pruritus
Clinical narrative: 8/30/19 presented with 6x6 reddened, itchy area with 15mm indurated center that is sore. Ice to area and secured with coban, Benadryl 25mg given. Afebrile 98.1.  To return next week to see NP. Employee returned the same day for NP to evaluate site and placed on antibiotics since float employee lives hours away and not sure she will be at work next week.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: painful at injection site, redness and swelling
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Encephalomyelitis
Clinical narrative: neuro encephalomyelitis on going treatment
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Laboratory test, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: MYALGIA , TINGLING SENSATION OF UPPER AND LOWER EXTREMITIES, FEVER 100.4, REDUCED APPETITE
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pruritus, Rash
Clinical narrative: About six days after I received the Shingrix injection, I awoke to discover what appeared to be a group of insect bites clustered in a circle about 1 inch in diameter on the upper interior portion of my right buttock  (bad place!). I couldn't think of any way I could have received insect bites in that location during the night. They were slightly raised welts that itched and were tender to the touch.  For several days I applied diphenhydramine cream, which helped with the itching. The "insect bites" appeared to be getting better.  However,  on 8/17/19, about 5 days  after they first appeared,  the lesions took on a more rash-like appearance, with multiple small blisters and general  redness in the area. I was out of the country at the time, so I sent photos of the affected area to my personal physician at home. He said  it looked like a shingles outbreak and advised me to see a doctor promptly. I  was examined by a doctor on 8/20/19,  who agreed that this appeared to be a herpes zoster outbreak. Over the next several days the pustules  gradually dried up and faded away. They did not itch or hurt further after the first few days.  I have never had shingles before. I did received a Zostavax injection in October 2013, with no adverse effects.  It would appear to be an incredible coincidence if this minor shingles outbreak just happened to  occur within a few days after I received my first Shingrix injection. Hence, I am reporting this as a possible adverse event associated with the Shingrix  injection, although I realize that that  vaccine uses a killed virus and should not trigger a shingles reaction.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness, Urticaria
Clinical narrative: About six days after I received the Shingrix injection, I awoke to discover what appeared to be a group of insect bites clustered in a circle about 1 inch in diameter on the upper interior portion of my right buttock  (bad place!). I couldn't think of any way I could have received insect bites in that location during the night. They were slightly raised welts that itched and were tender to the touch.  For several days I applied diphenhydramine cream, which helped with the itching. The "insect bites" appeared to be getting better.  However,  on 8/17/19, about 5 days  after they first appeared,  the lesions took on a more rash-like appearance, with multiple small blisters and general  redness in the area. I was out of the country at the time, so I sent photos of the affected area to my personal physician at home. He said  it looked like a shingles outbreak and advised me to see a doctor promptly. I  was examined by a doctor on 8/20/19,  who agreed that this appeared to be a herpes zoster outbreak. Over the next several days the pustules  gradually dried up and faded away. They did not itch or hurt further after the first few days.  I have never had shingles before. I did received a Zostavax injection in October 2013, with no adverse effects.  It would appear to be an incredible coincidence if this minor shingles outbreak just happened to  occur within a few days after I received my first Shingrix injection. Hence, I am reporting this as a possible adverse event associated with the Shingrix  injection, although I realize that that  vaccine uses a killed virus and should not trigger a shingles reaction.
Age: 89.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Injection site vesicles, Skin disorder, Swelling
Clinical narrative: Distal Blistering to the immunization site, Erythema in the upper left arm, visible swelling and striation that were ascending up the arm noted.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Developed large red like rash below the injection site. Very hot to touch 2 days after injection. Returned to Clinic on 8/28/2019 and was prescribed to take Cephalexin 500 MG twice a day for 10 days and Triamcinolone Cream 0.1 % 30 GM twice a day.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hypotension, Nausea
Clinical narrative: 0830pm while patient was out at a friends house started feeling dizzy, room spinning, called mom, who took her to Urgent Care (report attached) Dx:  possibly a reaction to Menveo, Hypotension with dizziness and nausea
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Face injury, Fall, Haemorrhage, Loss of consciousness
Clinical narrative: Pt. states that he passed out in the room approximately 5 min after injection.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Patient seen by PCP on 8/27/19 for Annual Physical. No illness at time of visit. Received MMRV  and DTap/IPV immunizations. On 8/29/19, Mom called triage line @ 10:25AM to report an immunization reaction. Child exhibited the expected symptoms: Fever and pain at the injection site. However, Mom also reported "vomiting once daily (twice total)", itchiness on the right arm, redness 2-3inches on the left arm. Child feels well, otherwise, eating and drinking normally. Mom agreed to clinical eval and was seen at the clinic the same day.  MD saw patient @ 10:40am.  Visit Diagnoses    Adverse effect of vaccine, initial encounter    -  Primary   Relevant Medications   triamcinolone (KENALOG) 0.1 % cream   I suspect a local reaction to his vaccine. The more significant reaction is the site of his MMRV on the right arm. He has now completed the series for MMR, Varicella, and polio. He should have Tdap when due in the future. Fever has resolved and I don't suspect infection at this time but I did draw a circle around each area of erythema and asked mom to watch carefully. Follow up if he redevelops fever or if erythema is increasing. Antihistamines, ice pack, and topical triamcinolone cream also recommended.   Patient Instructions Claritin or Zyrtec 5 mg daily for the next 3 days, then as needed. Continue ice pack to the affected area twice daily for 10 minutes. Benadryl 25 mg at bedtime if needed for itching. Triamcinolone cream to the affected area 3 times daily until improved. Follow up if area of swelling/erythema worsening tomorrow or recurrent fever.       Return in about 10 days (around 9/8/2019) for recheck if not improving..  Subjective: Patient is a 5 y.o. male who presents today with mom with concerns about vaccine reaction. The patient had vaccines two days ago. He had the vaccines at 9 AM on Tuesday. By Tue night he had fever. Mom reports fever was high but she didn't check a temperature. He had one episode of emesis on Tue and one on Wed. No fever since last night. He has usually had fever every time he has had vaccines but this has been worse. She also noticed swelling and itching at the injection sites this morning. Activity and appetite normal today.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: Patient seen by PCP on 8/27/19 for Annual Physical. No illness at time of visit. Received MMRV  and DTap/IPV immunizations. On 8/29/19, Mom called triage line @ 10:25AM to report an immunization reaction. Child exhibited the expected symptoms: Fever and pain at the injection site. However, Mom also reported "vomiting once daily (twice total)", itchiness on the right arm, redness 2-3inches on the left arm. Child feels well, otherwise, eating and drinking normally. Mom agreed to clinical eval and was seen at the clinic the same day.  MD saw patient @ 10:40am.  Visit Diagnoses    Adverse effect of vaccine, initial encounter    -  Primary   Relevant Medications   triamcinolone (KENALOG) 0.1 % cream   I suspect a local reaction to his vaccine. The more significant reaction is the site of his MMRV on the right arm. He has now completed the series for MMR, Varicella, and polio. He should have Tdap when due in the future. Fever has resolved and I don't suspect infection at this time but I did draw a circle around each area of erythema and asked mom to watch carefully. Follow up if he redevelops fever or if erythema is increasing. Antihistamines, ice pack, and topical triamcinolone cream also recommended.   Patient Instructions Claritin or Zyrtec 5 mg daily for the next 3 days, then as needed. Continue ice pack to the affected area twice daily for 10 minutes. Benadryl 25 mg at bedtime if needed for itching. Triamcinolone cream to the affected area 3 times daily until improved. Follow up if area of swelling/erythema worsening tomorrow or recurrent fever.       Return in about 10 days (around 9/8/2019) for recheck if not improving..  Subjective: Patient is a 5 y.o. male who presents today with mom with concerns about vaccine reaction. The patient had vaccines two days ago. He had the vaccines at 9 AM on Tuesday. By Tue night he had fever. Mom reports fever was high but she didn't check a temperature. He had one episode of emesis on Tue and one on Wed. No fever since last night. He has usually had fever every time he has had vaccines but this has been worse. She also noticed swelling and itching at the injection sites this morning. Activity and appetite normal today.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Musculoskeletal discomfort, Musculoskeletal pain, Paraesthesia, X-ray
Clinical narrative: Patient with severe left shoulder pain and weakness in the days following the shot that continues to worsen. we are now one week out and she essentially is unable to lift the arm. she also has associated numbness/tingling down the arm as well.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored doses of PNEUMOVAX 23 were administered; No adverse effect; This non-valid spontaneous report was received from a nurse and refers to an unspecified group of unspecified patients. Their medical history, concurrent conditions and concomitant drugs were not reported.  On unknown dates, the patients were vaccinated with improperly stored doses of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, lot# R021045, expiration date 14-APR-2020 (exact doses were not reported) for prophylaxis. The vaccines were stored in a temperature below 36 Fahrenheit degrees (F) (average 34.2F) for 65.5 hours. No previous temperature excursion occurred. Digital data logger was involved. No adverse effects reported.  This case is non-valid due to lack of patients' identifiers provided.  Follow up information has been received on 28-AUG-2019. As of that day, all telephone attempts to obtain additional information have been unsuccessful.
Sex: U
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration
Clinical narrative: No adverse effects; was administered intramuscularly versus subcutaneously; This spontaneous report was received from a registered nurse and refers to a 60-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 01-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S004120, expiration date 11-FEB-2021, intramuscularly versus subcutaneously (exact dose and site of administration were not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with sterile diluent. The outcome of the events was unknown.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: patient had breakthrough rash developed/ rash appeared approximately 2 minutes after the injection; This spontaneous report as received from a nurse via company representative refers to a patient of unknown demographics. The patient' medical history, concurrent conditions and concomitant medications were not reported. On 01-JUL-2019, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) one dose (1 dosage form) (strength, lot number and expiration date were not reported) through an unknown route for prophylaxis. On an unknown date in 2019, after receiving the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) the patient experienced a breakthrough rash (varicella). The outcome of varicella was unknown. The reporter's causality assessment was not reported. No product quality complaints were involved. The reporter also inquired when the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) should be administered.   This is a non-valid case due to lack of patient identifier.  Follow-up information was received from the nurse on 28-AUG-2019 referred to a 53-year-old female patient. The patient was not pregnant. On 01-JUL-2019, the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose was reported as "5 g"). Approximately 2 minutes after the injection the patient had rash. The outcome of the event was unknown. Causality assessment was not provided.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects reported; improperly stored MMR II was administered; Information has been received from a pharmacy tech referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.        On 15-AUG-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R027063, expiration date: 20-SEP-2020; strength and dose were not reported) subcutaneously for prophylaxis. Data logger was involved. The vaccine was stored with temperature of 70 degrees Fahrenheit (F) for 4 days. There was not previous temperature excursion. No additional information reported. No adverse effects reported. No product quality complaint.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored MMR II was administered; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 15-AUG-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) subcutaneously, lot# R027063, expiration date: 20-SEP-2020 (exact dose, frequency and site of administration were not reported).  Administered dose of vaccine was exposed to a temperature excursion of 70 degrees Fahrenheit for 4 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported.
Age: 1.0
Sex: F
Vaccine: MMR, UNK, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: rednessat the injection site; swelling at the injection site; This spontaneous report was received from a safety clinical coordinator and a nurse referring to a 12-months-old female patient. Her concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not provided.  On 15-AUG-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis, lot# R036582 expiration date on 17-DEC-2020 (dose, strength and route of administration were not provided) and varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis, lot# R035225 expiration date on 04-DEC-2020 (dose, strength and route of administration were not provided). Other suspect therapies included sterile diluent, with Lot number: N030845 and expiration date: 12-JUN-2020 lot number: N028091 and expiration date:10-MAR-2020; lot number: R036582 and expiration date: 17-DEC-2020; and lot number: N028744 and expiration date: 11-MAR-2020; lot number: N028746 and expiration date: 17-MAR-2020 which the lot check for all numbers was requested by the reporter and upon internal review all number were verified.  On 15-AUG-2019, immediately after the vaccinations, the patient experienced "redness and swelling at the injection site".  The events were treated with Benadryl and ice; Laboratory diagnostic or studies were not reported. The outcome of injection site erythema and injection site swelling was reported as resolved on the same day.  The casualty assessment between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), varicella virus vaccine live (Oka/Merck) (VARIVAX, the sterile diluent and the occurred events was not reported. This is one of several same reporter cases.; Sender's Comments:  US-009507513-1908USA007079: US-009507513-1908USA007014:
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Electrocardiogram, Injection site rash, Pain in extremity
Clinical narrative: experienced pain in their left arm, and a rash over their left shoulder. The left arm where these symptoms ocurred was the same arm that the PNEUMOVAX 23 was administered in.; experienced pain in their left arm, and a rash over their left shoulder. The left arm where these symptoms ocurred was the same arm that the PNEUMOVAX 23 was administered in.; indication: shingles prevention; This spontaneous report was received from a office manager concerning a 73-year-old female patient. Her pertinent medical history included transient ischaemic attack (T.I.A), On an unspecified time in the past, the patient received Sulfa based antibiotics (unspecified), Ibuprofen (considered an historical drug), to which she developed an unspecified drug reaction (also considered a concurrent conditions). The patient had no concomitant medications.   On 20-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered intramuscularly in the left arm, for Shingles prevention (Product use in unapproved indication) (strength and dose were not provided, lot number S013490 has been verified to be a valid number; expiration date reported as 06-MAR-2021, and upon internal validation established as the same date). This day, she experienced pain in their left arm (pain in extremity), and a rash over their left shoulder (rash). The left arm where these events (reported as symptoms) occurred was the same arm that the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered in. The patient stated that she sought for medical attention and went to Emergency room and received ibuprofen, diphenhydramine hydrochloride (BENADRYL) (reported as bendadryl) and ice was applied to site as treatment for the reported events. Also, an electrocardiogram (ECK) was performed, however was not provided. It was reported that the patient was not admitted to hospital. At the time of reporting, the patient was recovering from the events.  The causality assessment between the suspect vaccine administration and the events occurrence was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose number, lot number, expiration date, route of administration and anatomical location not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles.   As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose number, lot number, expiration date, route of administration and anatomical location not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.   As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient with unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  In 2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (dose, route, lot # and expiration date were not reported).        On an unknown date, the patient experienced shingles and was hospitalized. As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX) vaccine, plaintiff has and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2019, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, exact dose, dose# and route not specified) for the long-term prevention of shingles and/ or zoster-related conditions by a pharmacist at a pharmacy. On an unspecified date, the patient experienced shingles and was treated by a healthcare provider at urgent care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine use, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions or concomitant medications.  On or about 28-OCT-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The outcome of the event of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-MAY-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, exact dose, dose# and route not specified) for the long-term prevention of shingles and/ or zoster-related conditions, as prescribed and/or administered by a pharmacist at a pharmacy. On an unspecified date, the patient experienced shingles and post herpetic neuralgia. The patient was treated by healthcare provided at a clinic. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine use, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post-herpetic neuralgia; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient on unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist in a pharmacy. On an unspecified date, the patient experienced shingles and post-herpetic neuralgia. On an unspecified date, the patient was treated by a healthcare provider for the events. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, he had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist in a pharmacy. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future  The outcome of the event of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Zoster conjunctivitis; This initial spontaneous report has been received from a lawyer regarding a case in litigation referring to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history.  On 02-APR-2013, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine for the long-term prevention of shingles (dose, route, and lot number not provided). Subsequently, the patient was treated by a healthcare provider for zoster conjunctivitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was unknown.  Causality assessment was related.  Upon internal review, the event was considered as medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Subsequent to plaintiff's ZOSTAVAX inoculation, Plaintiff was treated by a healthcare provider, for shingles.; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or about 30-SEP-2014, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided), as prescribed and/or administered by a physician, for the long-term prevention of shingles and zoster-related conditions. Alternatively, on or about 30-SEP-2014, the pt's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation (unknown date), pt was treated by a health care provider, at Medical Center, for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding medical history, concurrent condition, or concomitant medication.  In 2015, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was hospitalized. On an unspecified date, the patient was treated by a physician for shingles.  As a direct and proximate result of the patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries;  significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of the shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, exact dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions, as prescribed and/or administered by a healthcare provider at a private doctor's office. On an unspecified date, the patient experienced shingles. The patient was treated by healthcare provided at the private doctor's office. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine use, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).