chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Sleep disorder, X-ray limb normal
Clinical narrative: Pain in left shoulder; tingling and numbness in left index finger; pain disrupted sleep during night; passed out because of the pain on 11/14/2016 and was rushed to emergency room; doctor attributed indicent to pain; no other likely causes found; pain responded to Gabapentin and Prednisone, but returned immediately after stopping Prednisone; nerve study on 11/28/2016 did not reveal cause of problems (althought slight entrapments of median nerve at wrist and of ulnar nerve at elbow were detected); X-ray on 12/14/2016 were negative; problems with left are persist until this day, although sleep disruption is not as bad as earlier on; tingling/slight pain persists.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Had rash reaction to shot. took Benadryl and is getting better.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint movement impairment, Injection site pain
Clinical narrative: Loss of full range of motion in right shoulder due to debilitating pain.
Age: 38.0
Sex: M
Vaccine: YF
Symptoms: Pigmentation disorder
Clinical narrative: REACTION STARTED ON THE ARM, PT STARTED TO LOSE PIGMENTATION ON THE ARM AND SPREAD TO OTHER PARTS OF BODY INCLUDING CHEST.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Swelling of upper arm; redness: pain: extreme limitation of mobility of arm - diagnosed as cellulitis.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Terrible soreness in shoulder, eventually soreness moved to elbow and up to neck.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: 101 temp., painful, red, swollen, inflamed area by injection site. Nauseous first 12 hours. 24 hours of 101 temp.with inflamed area spreading encircling his entire upper arm.  With his auto-inflammatory disease we increased his prednisone to 20 mg.for 2 days, then 10 mg.for 2 days, then back to his normal daily 6 mg. No longer has temperature, arm still red, hot and painful.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Nausea, Pain in extremity, Skin warm
Clinical narrative: 101 temp., painful, red, swollen, inflamed area by injection site. Nauseous first 12 hours. 24 hours of 101 temp.with inflamed area spreading encircling his entire upper arm.  With his auto-inflammatory disease we increased his prednisone to 20 mg.for 2 days, then 10 mg.for 2 days, then back to his normal daily 6 mg. No longer has temperature, arm still red, hot and painful.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: I massaged the injection sight several times the date of injection as directed by the RN. My shoulder started getting very sore within minutes of the injection. I started taking ibuprofen about 2 hours after injection. The medication relieves a little of the pain but doesn't take it away. The pain has been getting worse the more time passes. It's extremely painful to put on and take off my bra, shirts, jackets. I can lift my arm straight out from my shoulder with great pain but lifting it higher than that is not only painful, but it feels like the muscles in my shoulder stop helping with the process. I don't really know how to explain that better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Redness at injection site. Small bump at injection site. Soreness of arm. Warm soaks advised. Advised to call office with new or worsening symptoms.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Rash papular, Urticaria
Clinical narrative: Diarrhea, hives / rash on hands.
Age: 51.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Insomnia, Myalgia
Clinical narrative: Abdominal pain, myalgia, insomnia, diarrhea.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Decreased appetite, Fatigue, Myalgia, Pyrexia
Clinical narrative: Abdominal pain, fatigue, anorexia, myalgia, fever.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Cough, Headache, Nausea
Clinical narrative: Patient developed a non-productive cough, fever, chills, arthralgias, joint pain, nausea and headache.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Patient developed a non-productive cough, fever, chills, arthralgias, joint pain, nausea and headache.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: Throat swelling, hard to breathe.  Took 2 Benadryl immediately.
Age: 45.0
Sex: M
Vaccine: DTAP
Symptoms: Pain in extremity
Clinical narrative: Patient related to another Pharmacy his arm was still sore from injection received on 12/30/2016 that was not being relieved by ibuprofen so he switched to naproxen.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Loss of consciousness, Tremor
Clinical narrative: Patient immediately began shaking and then passed out. Didn't remember anything afterwards. The doctor stated this vaccine is recommended for ALL teens and is very critical to receive. That is untrue based on what I have read. I am VERY upset.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Mouth breathing, Oral pain, Stomatitis
Clinical narrative: Mouth sores which cause pain and bleeding. This is ongoing.
Age: 39.0
Sex: F
Vaccine: ANTH, JEV1
Symptoms: Dizziness, Urticaria
Clinical narrative: Hives along shoulders, chest, neck area. Felt lightheaded and dizzy.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Muscle tightness, Swelling
Clinical narrative: INJECTION SITE REACTION, SWELLING, MUSCLE TIGHTNESS.
Age: 69.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Blood test normal, Dizziness, Vertigo, Vomiting
Clinical narrative: Tried to get out of bed about 11:00 pm, was terribly dizzy. Got back in bed, went back to sleep. Woke up at 8 am and called my boyfriend to take me to the ER, I was so dizzy couldn't open my eyes and was vomiting. Er Dr. said I had Vertigo and sent me home with Meclazine, and one other med, can't remember the name. I went to my medical dr. on the following tuesday and he sent me to a therapist that treats vertigo. I had three treatments that helped some, so that I could go back to work. Then this past Friday evening the 6th of January, it came back. Nothing open to treat me this weekend, so waiting to get into an ENT tomorrow.
Age: 69.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Diplopia, Dizziness, Electronystagmogram normal, Impaired driving ability, Impaired work ability
Clinical narrative: Tried to get out of bed about 11:00 pm, was terribly dizzy. Got back in bed, went back to sleep. Woke up at 8 am and called my boyfriend to take me to the ER, I was so dizzy couldn't open my eyes and was vomiting. Er Dr. said I had Vertigo and sent me home with Meclazine, and one other med, can't remember the name. I went to my medical dr. on the following tuesday and he sent me to a therapist that treats vertigo. I had three treatments that helped some, so that I could go back to work. Then this past Friday evening the 6th of January, it came back. Nothing open to treat me this weekend, so waiting to get into an ENT tomorrow.
Age: 69.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Vertigo
Clinical narrative: Tried to get out of bed about 11:00 pm, was terribly dizzy. Got back in bed, went back to sleep. Woke up at 8 am and called my boyfriend to take me to the ER, I was so dizzy couldn't open my eyes and was vomiting. Er Dr. said I had Vertigo and sent me home with Meclazine, and one other med, can't remember the name. I went to my medical dr. on the following tuesday and he sent me to a therapist that treats vertigo. I had three treatments that helped some, so that I could go back to work. Then this past Friday evening the 6th of January, it came back. Nothing open to treat me this weekend, so waiting to get into an ENT tomorrow.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: The shot was administered very high on my arm, almost at the joint, and I felt the vaccine flow down my arm. Several hours later I was already feeling a great deal of pain, and could not lift my arm. That evening I was woken up by severe shoulder pain, much more than ever felt previously with vaccines, making it impossible to lift arm or even move without a sharp pain in my shoulder. Since onset, the pain has continued in varying degrees of severity. Sometimes it is just an ache, other times it makes it impossible to lift my arm in certain directions, grasp items, turn or roll over without strong pain throughout shoulder and/or arm. I have tried resting it, warm compresses, massage and gentle yoga in addition to pain meds. Everything I have tried only works temporarily, and often the pain returns worse the next day after gentle exercise or massage. I am seeing my GP tomorrow to discuss the matter.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Eye pain, Headache
Clinical narrative: Everyday it was something different. The first three days I had diarrhea, stomach pain, nauseated and exhibited flu symptoms. Aches and pains throughout my body, sore throat, swollen glands, headache, eyes hurt to move, wheezing. The 5th day I became week in my arms and had pain in my elbow which moved into the arm muscle, wrist and fingers. I was unable to lift without pain and my muscles giving out. The sixth day it presented in the left elbow as well same symptoms...Weak, painful from elbow through arm muscle, wrist and fingers. It has been over 2 months and I still have these symptoms with the right side  being more affected than the left. I was put on naproxen for 2 weeks to no avail. I'm hoping I will get better rather than this turning into a permanent disability but it's been over 2 months!
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Lymphadenopathy, Muscle fatigue, Muscular weakness, Myalgia
Clinical narrative: Everyday it was something different. The first three days I had diarrhea, stomach pain, nauseated and exhibited flu symptoms. Aches and pains throughout my body, sore throat, swollen glands, headache, eyes hurt to move, wheezing. The 5th day I became week in my arms and had pain in my elbow which moved into the arm muscle, wrist and fingers. I was unable to lift without pain and my muscles giving out. The sixth day it presented in the left elbow as well same symptoms...Weak, painful from elbow through arm muscle, wrist and fingers. It has been over 2 months and I still have these symptoms with the right side  being more affected than the left. I was put on naproxen for 2 weeks to no avail. I'm hoping I will get better rather than this turning into a permanent disability but it's been over 2 months!
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Oropharyngeal pain, Pain, Pain in extremity, Wheezing
Clinical narrative: Everyday it was something different. The first three days I had diarrhea, stomach pain, nauseated and exhibited flu symptoms. Aches and pains throughout my body, sore throat, swollen glands, headache, eyes hurt to move, wheezing. The 5th day I became week in my arms and had pain in my elbow which moved into the arm muscle, wrist and fingers. I was unable to lift without pain and my muscles giving out. The sixth day it presented in the left elbow as well same symptoms...Weak, painful from elbow through arm muscle, wrist and fingers. It has been over 2 months and I still have these symptoms with the right side  being more affected than the left. I was put on naproxen for 2 weeks to no avail. I'm hoping I will get better rather than this turning into a permanent disability but it's been over 2 months!
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Sore are pain can't left above head can't lay on it hurts bad with dot where shot was given.
Age: 63.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Sore are pain can't left above head can't lay on it hurts bad with dot where shot was given.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Dry mouth, Hyperhidrosis, Weight decreased
Clinical narrative: 2 days of chills and sweating - I stayed in bed, drunk some water but didn't eat anything. Mouth dry - managed to sleep for an hour or two at a time (wound up losing 12 pounds).
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Pyrexia, Urticaria
Clinical narrative: Had a low grade fever for 48 hours after vaccines. On 1/7 the fever went up to 103.4 and mom treated with TYLENOL and ibuprofen. On 1/8, he broke out in hives from the neck up.
Age: 75.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Asthma, Chills, Diarrhoea, Feeling abnormal, Headache
Clinical narrative: Initial unsolicited report received from consumer via other company (Pfizer) on 03-Jan-2017. Manufacture report number: 2016586690. This case involves a 75-years-old female patients who was vaccinated with a first dose of FLUZONE and first dose of PREVNAR 13 (dose, batch number and expiry date: unknown for both vaccine) both intramuscularly in left upper arm on 15-Nov-2016 at 4 P.M. Patient had history of Asthma. From 2014 patient was taking paracetamol (Q-40) inhalant twice a day and montelukast pill once at night for asthma and benzonatate 100 mg as needed at night for cough as a concomitant medication. On, 15-Nov-2016, same day around 7 to 8 PM, three to four hours following the vaccination, patient felt sick or felt sick for couple of days, had chills, fever, diarrhea, headache and shoulder pain; patient felt like had flu. Patient felt really bad for 24 hours and then for 2-3 days felt like hell. Patient had no laboratory investigations. Corrective treatment was not reported. On 19-Nov-2016, patient was recovered from event felt sick for couple of days. Outcome of other events was not reported. List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Influenza like illness, Malaise, Musculoskeletal pain, Pyrexia
Clinical narrative: Initial unsolicited report received from consumer via other company (Pfizer) on 03-Jan-2017. Manufacture report number: 2016586690. This case involves a 75-years-old female patients who was vaccinated with a first dose of FLUZONE and first dose of PREVNAR 13 (dose, batch number and expiry date: unknown for both vaccine) both intramuscularly in left upper arm on 15-Nov-2016 at 4 P.M. Patient had history of Asthma. From 2014 patient was taking paracetamol (Q-40) inhalant twice a day and montelukast pill once at night for asthma and benzonatate 100 mg as needed at night for cough as a concomitant medication. On, 15-Nov-2016, same day around 7 to 8 PM, three to four hours following the vaccination, patient felt sick or felt sick for couple of days, had chills, fever, diarrhea, headache and shoulder pain; patient felt like had flu. Patient felt really bad for 24 hours and then for 2-3 days felt like hell. Patient had no laboratory investigations. Corrective treatment was not reported. On 19-Nov-2016, patient was recovered from event felt sick for couple of days. Outcome of other events was not reported. List of documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site cellulitis, Injection site swelling, Lymphadenopathy, Nausea
Clinical narrative: This spontaneous report as received from a 60-year-old female patient who is also a nurse practitioner refers to herself. The patient's concurrenct conditions included arthritis, chronic lymphocytic leukaemia, Factor V Leiden, hypertension and allergies for nafcillin, erythromycin and ANCEF. Concomitant therapies included BYSTOLIC, ZANTAC, supplements (unspecified) and Chinese herbs (unspecified). On 23-DEC-2016, the patient was vaccinated with a dose of PNEUMOVAX23 and FLUVIRIN both in the left arm for prophylaxis. The nurse reported that, the PNEUMOVAX23 was administered using what appeared to be an intramuscular needle, into an area below the deltoid muscle. She did not feel that the PNEUMOVAX23 was administered either intramuscularly or subcutaneously, but she could not describe the route of administration any further. Later the same day, she developed erythema of the left arm and fever of 101 Fahrenheit degree. On 24-DEC-2016, she experienced severe fatigue, her fever rose to 103 Fahrenheit degree and the arm swelling increased to a "baseball sized" area. The nurse practitioner self-treated with ice compresses and MOTRIN. On 27-DEC-2016, the nurse practitioner was evaluated at a local emergency room and was diagnosed with cellulitis. She sought medical attention in emergency room, was administered clindamycin intravenously, and was released with a prescription for clindamycin orally for 10 days. At the time of the report, she was recovering from the event. The relatedness between vaccination with the suspect vaccines and the event was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Product contamination, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a 60-year-old female patient who is also a nurse practitioner refers to herself. The patient's concurrenct conditions included arthritis, chronic lymphocytic leukaemia, Factor V Leiden, hypertension and allergies for nafcillin, erythromycin and ANCEF. Concomitant therapies included BYSTOLIC, ZANTAC, supplements (unspecified) and Chinese herbs (unspecified). On 23-DEC-2016, the patient was vaccinated with a dose of PNEUMOVAX23 and FLUVIRIN both in the left arm for prophylaxis. The nurse reported that, the PNEUMOVAX23 was administered using what appeared to be an intramuscular needle, into an area below the deltoid muscle. She did not feel that the PNEUMOVAX23 was administered either intramuscularly or subcutaneously, but she could not describe the route of administration any further. Later the same day, she developed erythema of the left arm and fever of 101 Fahrenheit degree. On 24-DEC-2016, she experienced severe fatigue, her fever rose to 103 Fahrenheit degree and the arm swelling increased to a "baseball sized" area. The nurse practitioner self-treated with ice compresses and MOTRIN. On 27-DEC-2016, the nurse practitioner was evaluated at a local emergency room and was diagnosed with cellulitis. She sought medical attention in emergency room, was administered clindamycin intravenously, and was released with a prescription for clindamycin orally for 10 days. At the time of the report, she was recovering from the event. The relatedness between vaccination with the suspect vaccines and the event was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a 60-year-old female patient who is also a nurse practitioner refers to herself. The patient's concurrenct conditions included arthritis, chronic lymphocytic leukaemia, Factor V Leiden, hypertension and allergies for nafcillin, erythromycin and ANCEF. Concomitant therapies included BYSTOLIC, ZANTAC, supplements (unspecified) and Chinese herbs (unspecified). On 23-DEC-2016, the patient was vaccinated with a dose of PNEUMOVAX23 and FLUVIRIN both in the left arm for prophylaxis. The nurse reported that, the PNEUMOVAX23 was administered using what appeared to be an intramuscular needle, into an area below the deltoid muscle. She did not feel that the PNEUMOVAX23 was administered either intramuscularly or subcutaneously, but she could not describe the route of administration any further. Later the same day, she developed erythema of the left arm and fever of 101 Fahrenheit degree. On 24-DEC-2016, she experienced severe fatigue, her fever rose to 103 Fahrenheit degree and the arm swelling increased to a "baseball sized" area. The nurse practitioner self-treated with ice compresses and MOTRIN. On 27-DEC-2016, the nurse practitioner was evaluated at a local emergency room and was diagnosed with cellulitis. She sought medical attention in emergency room, was administered clindamycin intravenously, and was released with a prescription for clindamycin orally for 10 days. At the time of the report, she was recovering from the event. The relatedness between vaccination with the suspect vaccines and the event was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Laryngospasm, Pyrexia, Streptococcus test negative
Clinical narrative: About 2 minutes after injection pt had syncopal episode lasting estimated 5 minutes. Her fever spiked from 99.6 to over 102. She was given oxygen, ibuprofen 800 mg. She was transported by ambulance to ER. We gave her Racemic Epi, SOLU-MEDROL, BENADRYL and PEPCID. Started IV and observed her. She had a coughing episode that led to laryngospasm and difficulty moving air.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: About 2 minutes after injection pt had syncopal episode lasting estimated 5 minutes. Her fever spiked from 99.6 to over 102. She was given oxygen, ibuprofen 800 mg. She was transported by ambulance to ER. We gave her Racemic Epi, SOLU-MEDROL, BENADRYL and PEPCID. Started IV and observed her. She had a coughing episode that led to laryngospasm and difficulty moving air.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Asthenia, Decreased appetite, Pain in extremity, Rash, Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for his wife. A 73-year-old female patient started to receive PREVENAR 13, via an unspecified route of administration from 02Dec2016 to an unspecified date at UNK for immunization. Medical history included ongoing high cholesterol. Concomitant medication included ongoing simvastatin 20 mg alternate day for high cholesterol. On the "04Dec or 05Dec2016" the patient was experiencing chills. On 05Dec2016, the patient reported that she lost 10 pounds. This was elaborated that she had probably weighed at about 127 or 130 pounds, and she had lost about 10 pounds on this reaction. On 05Dec2016, the patient experienced leg pain, dizziness, lack of appetite/ very little appetite, a rash, overall no energy and vomiting. Therapeutic measure included prednisone 10 mg. Laboratory data included weight loss of 10 pounds in Dec2016. The clinical outcome of the event, vomiting was recovered on an unknown date. The clinical outcome of events, leg pain, dizziness, lack of appetite, a rash, overall no energy, very little appetite, and chills, was not recovered.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Arthralgia, Asthenia, Decreased appetite, Dizziness, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for his wife. A 73-year-old female patient started to receive PREVENAR 13, via an unspecified route of administration from 02Dec2016 to an unspecified date at UNK for immunization. Medical history included ongoing high cholesterol. Concomitant medication included ongoing simvastatin 20 mg alternate day for high cholesterol. On the "04Dec or 05Dec2016" the patient was experiencing chills. On 05Dec2016, the patient reported that she lost 10 pounds. This was elaborated that she had probably weighed at about 127 or 130 pounds, and she had lost about 10 pounds on this reaction. On 05Dec2016, the patient experienced leg pain, dizziness, lack of appetite/ very little appetite, a rash, overall no energy and vomiting. Therapeutic measure included prednisone 10 mg. Laboratory data included weight loss of 10 pounds in Dec2016. The clinical outcome of the event, vomiting was recovered on an unknown date. The clinical outcome of events, leg pain, dizziness, lack of appetite, a rash, overall no energy, very little appetite, and chills, was not recovered.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Joint swelling, Myalgia, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for his wife. A 73-year-old female patient started to receive PREVENAR 13, via an unspecified route of administration from 02Dec2016 to an unspecified date at UNK for immunization. Medical history included ongoing high cholesterol. Concomitant medication included ongoing simvastatin 20 mg alternate day for high cholesterol. On the "04Dec or 05Dec2016" the patient was experiencing chills. On 05Dec2016, the patient reported that she lost 10 pounds. This was elaborated that she had probably weighed at about 127 or 130 pounds, and she had lost about 10 pounds on this reaction. On 05Dec2016, the patient experienced leg pain, dizziness, lack of appetite/ very little appetite, a rash, overall no energy and vomiting. Therapeutic measure included prednisone 10 mg. Laboratory data included weight loss of 10 pounds in Dec2016. The clinical outcome of the event, vomiting was recovered on an unknown date. The clinical outcome of events, leg pain, dizziness, lack of appetite, a rash, overall no energy, very little appetite, and chills, was not recovered.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for his wife. A 73-year-old female patient started to receive PREVENAR 13, via an unspecified route of administration from 02Dec2016 to an unspecified date at UNK for immunization. Medical history included ongoing high cholesterol. Concomitant medication included ongoing simvastatin 20 mg alternate day for high cholesterol. On the "04Dec or 05Dec2016" the patient was experiencing chills. On 05Dec2016, the patient reported that she lost 10 pounds. This was elaborated that she had probably weighed at about 127 or 130 pounds, and she had lost about 10 pounds on this reaction. On 05Dec2016, the patient experienced leg pain, dizziness, lack of appetite/ very little appetite, a rash, overall no energy and vomiting. Therapeutic measure included prednisone 10 mg. Laboratory data included weight loss of 10 pounds in Dec2016. The clinical outcome of the event, vomiting was recovered on an unknown date. The clinical outcome of events, leg pain, dizziness, lack of appetite, a rash, overall no energy, very little appetite, and chills, was not recovered.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13, FLU4, PNC13, FLU4, PNC13
Symptoms: Rash, Vomiting, Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for his wife. A 73-year-old female patient started to receive PREVENAR 13, via an unspecified route of administration from 02Dec2016 to an unspecified date at UNK for immunization. Medical history included ongoing high cholesterol. Concomitant medication included ongoing simvastatin 20 mg alternate day for high cholesterol. On the "04Dec or 05Dec2016" the patient was experiencing chills. On 05Dec2016, the patient reported that she lost 10 pounds. This was elaborated that she had probably weighed at about 127 or 130 pounds, and she had lost about 10 pounds on this reaction. On 05Dec2016, the patient experienced leg pain, dizziness, lack of appetite/ very little appetite, a rash, overall no energy and vomiting. Therapeutic measure included prednisone 10 mg. Laboratory data included weight loss of 10 pounds in Dec2016. The clinical outcome of the event, vomiting was recovered on an unknown date. The clinical outcome of events, leg pain, dizziness, lack of appetite, a rash, overall no energy, very little appetite, and chills, was not recovered.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLUX, HEP, MMRV, DTAPIPV, FLUX, HEP, MMRV
Symptoms: Nasopharyngitis, Pyrexia, Rash generalised
Clinical narrative: Patient started with fever and cold symptoms but broke out in a head to toe rash.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLUX, HEP, MMRV, DTAPIPV, FLUX, HEP, MMRV
Symptoms: Pyrexia, Rash generalised, Viral upper respiratory tract infection
Clinical narrative: Patient started with fever and cold symptoms but broke out in a head to toe rash.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Anaphylactic shock, Cyanosis, Dizziness, Dysgeusia, Dyspnoea
Clinical narrative: 0120 - RECEIVED VACCINE, ZERO PAIN/ZERO REACTION. 0127 - DRIVING HOME FELT LIKE I WAS HIGH AND FLOATING (SAME FEELING OF GOING DOWN ROLLERCOASTER HILL). 0150 - ARRIVED HOME, FELT DRUNK ROOM SPINNING FEELING AND PUKED (3 GAGS). 0205- STRONG METAL TASTE IN MOUTH. 0210 - TASTED ALUMIMUM FOIL FOR COMPARISON, FOIL MUCH LIGHTER, MY METAL TASTE WAS BECOMING RIDICULOUSLY STRONG (ZERO PAIN OR SWELLING AT INJECTION SITE). 0215 - GOOGLED METAL TASTE, BECOMING MORE DIZZY - REFERRED TO ANAPHALICTIC SHOCK WEBSITE THAT SAID TO ER OR CALL 911. 0235 - FACE BECOMING NUMB, TONGUE SWELLING - DETERMINED I WAS GOING INTO ANAPHYLACTIC SHOCK AND DROVE TO ER. 1456-CHECKED INTO TRIAGE, WITH DOCTOR PRESENT - RESTING HEART RATE 150/82, NUMB FACE, HANDS TURNING BLUE, TONGUE SWELLING, RAPID HEART RATE INCREASING, LIPS BEGAN BURNING, BREATHING THROUGH NOSE OK WITH MOUTH CLOSED, BREATHING THROUGH MOUTH DIFFICULT ALL WITH DOCTOR PRESENT. PROMPTLY ADMINISTERED 125 MG SOLU-MEDROL VIA HIP INJECTION. ADMINISTERED 50 MG DIPHENHYDRAMINE VIA HIP INJECTION. NOW ON HYDROXYZINE HCL 25 MG EVERY SIX HOURS FOR SIX DAYS. NOW ON PREDNISONE 20 MG 1 A DAY FOR SIX DAYS. MY DOCTOR STILL THINKS I SHOULD NOT BE EXEMPT FROM IMMUNIZATIONS EVEN THOUGH 100+ OTHER MEDICAL PROFESSIONS WITH REVIEW OF MY MED RECORDS HAVE DETERMINED IM ALLERGIC. MY DOCTOR DOES NOT FEEL A DOCTORS REFUSAL TO PROVIDE A VACCINE DUE TO FATAL REACTION IS JUSTIFIABLE. MY OWN MED CLINIC REFUSED TO ADMINISTER IT, SO I HAD TO GET IT MYSELF.  UNDER LAW THIS CONSTITUTES NEGLIGENCE ON MY DOCTOR AND FALLS UNDER STATUTE OF FIRST DEGREE DRUG INDUCED ATTEMPTED MURDER AS SHE IS FULLY AWARE OF MY ALLERGIES YET REFUSES TO ACKNOWLEDGE THEM.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Euphoric mood, Feeling abnormal, Feeling drunk, Heart rate increased, Hypoaesthesia
Clinical narrative: 0120 - RECEIVED VACCINE, ZERO PAIN/ZERO REACTION. 0127 - DRIVING HOME FELT LIKE I WAS HIGH AND FLOATING (SAME FEELING OF GOING DOWN ROLLERCOASTER HILL). 0150 - ARRIVED HOME, FELT DRUNK ROOM SPINNING FEELING AND PUKED (3 GAGS). 0205- STRONG METAL TASTE IN MOUTH. 0210 - TASTED ALUMIMUM FOIL FOR COMPARISON, FOIL MUCH LIGHTER, MY METAL TASTE WAS BECOMING RIDICULOUSLY STRONG (ZERO PAIN OR SWELLING AT INJECTION SITE). 0215 - GOOGLED METAL TASTE, BECOMING MORE DIZZY - REFERRED TO ANAPHALICTIC SHOCK WEBSITE THAT SAID TO ER OR CALL 911. 0235 - FACE BECOMING NUMB, TONGUE SWELLING - DETERMINED I WAS GOING INTO ANAPHYLACTIC SHOCK AND DROVE TO ER. 1456-CHECKED INTO TRIAGE, WITH DOCTOR PRESENT - RESTING HEART RATE 150/82, NUMB FACE, HANDS TURNING BLUE, TONGUE SWELLING, RAPID HEART RATE INCREASING, LIPS BEGAN BURNING, BREATHING THROUGH NOSE OK WITH MOUTH CLOSED, BREATHING THROUGH MOUTH DIFFICULT ALL WITH DOCTOR PRESENT. PROMPTLY ADMINISTERED 125 MG SOLU-MEDROL VIA HIP INJECTION. ADMINISTERED 50 MG DIPHENHYDRAMINE VIA HIP INJECTION. NOW ON HYDROXYZINE HCL 25 MG EVERY SIX HOURS FOR SIX DAYS. NOW ON PREDNISONE 20 MG 1 A DAY FOR SIX DAYS. MY DOCTOR STILL THINKS I SHOULD NOT BE EXEMPT FROM IMMUNIZATIONS EVEN THOUGH 100+ OTHER MEDICAL PROFESSIONS WITH REVIEW OF MY MED RECORDS HAVE DETERMINED IM ALLERGIC. MY DOCTOR DOES NOT FEEL A DOCTORS REFUSAL TO PROVIDE A VACCINE DUE TO FATAL REACTION IS JUSTIFIABLE. MY OWN MED CLINIC REFUSED TO ADMINISTER IT, SO I HAD TO GET IT MYSELF.  UNDER LAW THIS CONSTITUTES NEGLIGENCE ON MY DOCTOR AND FALLS UNDER STATUTE OF FIRST DEGREE DRUG INDUCED ATTEMPTED MURDER AS SHE IS FULLY AWARE OF MY ALLERGIES YET REFUSES TO ACKNOWLEDGE THEM.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Oral discomfort, Retching, Swollen tongue, Vertigo, Vomiting
Clinical narrative: 0120 - RECEIVED VACCINE, ZERO PAIN/ZERO REACTION. 0127 - DRIVING HOME FELT LIKE I WAS HIGH AND FLOATING (SAME FEELING OF GOING DOWN ROLLERCOASTER HILL). 0150 - ARRIVED HOME, FELT DRUNK ROOM SPINNING FEELING AND PUKED (3 GAGS). 0205- STRONG METAL TASTE IN MOUTH. 0210 - TASTED ALUMIMUM FOIL FOR COMPARISON, FOIL MUCH LIGHTER, MY METAL TASTE WAS BECOMING RIDICULOUSLY STRONG (ZERO PAIN OR SWELLING AT INJECTION SITE). 0215 - GOOGLED METAL TASTE, BECOMING MORE DIZZY - REFERRED TO ANAPHALICTIC SHOCK WEBSITE THAT SAID TO ER OR CALL 911. 0235 - FACE BECOMING NUMB, TONGUE SWELLING - DETERMINED I WAS GOING INTO ANAPHYLACTIC SHOCK AND DROVE TO ER. 1456-CHECKED INTO TRIAGE, WITH DOCTOR PRESENT - RESTING HEART RATE 150/82, NUMB FACE, HANDS TURNING BLUE, TONGUE SWELLING, RAPID HEART RATE INCREASING, LIPS BEGAN BURNING, BREATHING THROUGH NOSE OK WITH MOUTH CLOSED, BREATHING THROUGH MOUTH DIFFICULT ALL WITH DOCTOR PRESENT. PROMPTLY ADMINISTERED 125 MG SOLU-MEDROL VIA HIP INJECTION. ADMINISTERED 50 MG DIPHENHYDRAMINE VIA HIP INJECTION. NOW ON HYDROXYZINE HCL 25 MG EVERY SIX HOURS FOR SIX DAYS. NOW ON PREDNISONE 20 MG 1 A DAY FOR SIX DAYS. MY DOCTOR STILL THINKS I SHOULD NOT BE EXEMPT FROM IMMUNIZATIONS EVEN THOUGH 100+ OTHER MEDICAL PROFESSIONS WITH REVIEW OF MY MED RECORDS HAVE DETERMINED IM ALLERGIC. MY DOCTOR DOES NOT FEEL A DOCTORS REFUSAL TO PROVIDE A VACCINE DUE TO FATAL REACTION IS JUSTIFIABLE. MY OWN MED CLINIC REFUSED TO ADMINISTER IT, SO I HAD TO GET IT MYSELF.  UNDER LAW THIS CONSTITUTES NEGLIGENCE ON MY DOCTOR AND FALLS UNDER STATUTE OF FIRST DEGREE DRUG INDUCED ATTEMPTED MURDER AS SHE IS FULLY AWARE OF MY ALLERGIES YET REFUSES TO ACKNOWLEDGE THEM.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Burning sensation, Chest discomfort, Defaecation urgency, Dyspnoea, Facial pain
Clinical narrative: 12/26-27:tingling in legs evening only; 12/27-1/2:tingling all over evening only; 1/3-1/8:tingling all over all day; 1/9:tingling all over + burning sensation in hands & feet all day; 12/26-1/9:off/on sensation of urgent bowel movement (w or w/o actual BM); 1/6-9: frequent, scanty urination & off/on mild chest tightness & shortness of breath; 12/26-1/9:increased neck & face pain & headache intensity.  Neurologist eliminated Sinemet (started 10/2016) & cut dose of Azilect in half (now .5 mg) on 1/6/2017.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache, Neck pain, Oliguria, Paraesthesia
Clinical narrative: 12/26-27:tingling in legs evening only; 12/27-1/2:tingling all over evening only; 1/3-1/8:tingling all over all day; 1/9:tingling all over + burning sensation in hands & feet all day; 12/26-1/9:off/on sensation of urgent bowel movement (w or w/o actual BM); 1/6-9: frequent, scanty urination & off/on mild chest tightness & shortness of breath; 12/26-1/9:increased neck & face pain & headache intensity.  Neurologist eliminated Sinemet (started 10/2016) & cut dose of Azilect in half (now .5 mg) on 1/6/2017.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache, Neck pain, Paraesthesia, Pollakiuria, Urine output decreased
Clinical narrative: 12/26-27:tingling in legs evening only; 12/27-1/2:tingling all over evening only; 1/3-1/8:tingling all over all day; 1/9:tingling all over + burning sensation in hands & feet all day; 12/26-1/9:off/on sensation of urgent bowel movement (w or w/o actual BM); 1/6-9: frequent, scanty urination & off/on mild chest tightness & shortness of breath; 12/26-1/9:increased neck & face pain & headache intensity.  Neurologist eliminated Sinemet (started 10/2016) & cut dose of Azilect in half (now .5 mg) on 1/6/2017.
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative and refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 14-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX23 injection (dose, route of vaccination, lot# and expiration date were not reported) for prophylaxis. Since an unknown date in October 2016, after the vaccination, the patient was unable to move the arm where he received the injection. As of 18-OCT-2016, the outcome of the event was not resolved. The relatedness between the event and PNEUMOVAX23 was not provided. Additional information is not expected. Sender's Comments: MERCK 1610USA010455: Mfr number.
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site discomfort, Injection site erythema, Injection site reaction, Pain
Clinical narrative: This spontaneous report was received from a physician, referring to a female patient of unknown age. Information regarding patient's concurrent conditions, pertinent medical history or drug reactions was not mentioned. On 18-AUG-2016 the patient was vaccinated with ZOSTAVAX which had a lot # L036823 with expiry date on 24-DEC-2016, 0.65 ml, subcutaneously for prophylaxis. Concomitant therapies included atorvastatin calcium (LIPITOR) and propranolol hydrochloride (manufacturer unknown). On an unknown date in December 2016, the patient sought medical attention because since an unspecified date she experienced redness at the injection site (injection site erythema) and the site was uncomfortable (injection site discomfort). On 06-DEC-2016, the patient was seen in the physician's office because she had developed hyperalgesia at the injection site (injection site hyperaesthesia) and basically persistent pain since an unreported date. There was no product quality complaint involved. The outcome of pain, injection site erythema, and injection site hyperaesthesia was unknown.  No causal relationship was provided between vaccination with ZOSTAVAX and the events. {Additional information has been requested. / Additional information is not expected.}
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender, reporting on themself. The patient's concurrent conditions included diabetes; pertinent medical history, drug reactions and allergies were not reported. On unknown dates, the patient was vaccinated with ten doses of VARIVAX injection (dose, route of administration, lot# and expiration date were not reported). Concomitant therapies included NOVOLOG and LANTUS. The patient was receiving one dose of VARIVAX every month. The patient stated, that with every dose of VARIVAX, they needed less and less insulin. According to the patient, it cured their diabetes and "made the patient beautiful". No further information was provided. Product quality complaint (PQC) was not involved. Additional information is not expected, as there was no contact details.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza, Malaise
Clinical narrative: Information has been received from a pharmacist via a company representative referring to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unspecified time after receiving ZOSTAVAX, the patient got sick, she developed the flu. The outcome of the events was unknown. Causality was not provided.     Additional information is not expected as follow up with the pharmacist is not permitted.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a 60 year old female patient with sulfonamide allergy concerning herself. Concomitant therapies included hydroxyurea and vitamin D (unspecified). On 14-DEC-2016, the patient was vaccinated with PNEUMOVAX23 (single dose of 0.5 ml, lot # M026317, expiration date ??-JAN-2018) intramuscularly for prophylaxis. On the same day, the area below the injection site on the patient's right arm began to turn red and swollen after receiving the PNEUMOVAX23. The patient also stated that her temperature was 100.4 (unit unknown) when she visited her physician about this. The patient received treatment for the events. The outcome of the events was unknown. The causality between PNEUMOVAX23 and the event was unknown. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 61 year old male patient. The patient did not have any pertinent medical history or drug reactions/allergies and was not taking any concomitant medication. On 08-NOV-2016, the patient was vaccinated with ZOSTAVAX 19400 "PFU" (lot # M033335, expiration date 11-OCT-2017), subcutaneously, for immunization (dose and frequency were not reported). On 14-DEC-2016, the patient experienced rash on arms and torso and, on an unspecified date in December 2016, he experienced itching (pruritus) and, due to it, he went to the hospital on 18-DEC-2016 (reported as yesterday). Treatment was given for the adverse events and no laboratory tests were performed. It was informed that the patient had influenza virus vaccine inactivated (unspecified) within four weeks of administration of ZOSTAVAX. No product quality complaint was involved. The outcome of pruritus and rash was unknown at the time of this report. Causality relationship between the events and ZOSTAVAX administration was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV4
Symptoms: Exposure during pregnancy, No adverse event, Prenatal screening test
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician and a patient refers to a 25 year old female patient. There was no information about the patient's concurrent conditions, medical history and drug reactions or allergies provided. On 21-DEC-2016, the pregnant patient was vaccinated with a dose of GARDASIL injection, lot # reported as M031557 (verified to be invalid), expiration date 07-APR-2019 to prevent human papillomavirus (HPV) infection (site, dose and route of administration were not reported). Concomitant vaccines included influenza virus vaccine (unspecified) (reported as a flu shot) administered on 21-DEC-2016, 15 minutes prior to receiving GARDASIL. At the time of report, the patient was 17 weeks pregnant. The last menstrual period (LMP) date was 24-AUG-2016 (calculated based on number of weeks of pregnancy at the time of report). Estimated date of delivery (EDD) was 31-MAY-2017. Initial exposure to GARDASIL was at 17 weeks of pregnancy (second trimester). No adverse effects reported. Lab diagnostic studies included test for Down syndrome for the patient's unborn child (date and result were not reported). No product quality complaint was involved. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a patient of unknown age and gender referring to himself/herself. Information about concurrent condition, concomitant medication and medical history was not provided. On 19-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX(strength, dose, lot # and expiration date were not reported) subcutaneously for prophylaxis. On an unknown date (in December 2016), the patient had injection site reactions after receiving the ZOSTAVAX. The outcome of the event was unknown. The causality between ZOSTAVAX and the event was unknown. Additional information is not expected as no contact details were provided.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a consumer regarding an approximately 25 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 22-OCT-2015, the patient was vaccinated with GARDASIL 9 (lot#, expiration date and dosing details unknown) intramuscular for prophylaxis. At the time of the report, she was now 6 week's pregnant (Drug exposure before pregnancy). Her last menstrual period was approximately on 10-NOV-2016 and Estimated due date is 17-AUG-2017. The outcome of pregnancy was pending. The patient did not receive any treatment and did not sought medical attention for the event. It was reported that the patient did not discontinue the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from an administrator referring to a few patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. The administrator reported "a few" of their patients (no demographics provided) had been non-compliant with the dosing regimen for GARDASIL (dose and frequency: three dose series; route: Intramuscular injection) (product use issue). No adverse effect was reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information regarding the patient's concomitant medications, medical history and drug reactions/allergies was not reported. On 14-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose and route were not reported) for prophylaxis. It was reported that the vaccine was improperly stored at -3.5 degrees Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1610USA011245.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information regarding the patient's concomitant medications, medical history and drug reactions/allergies was not reported. On 12-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose and route were not reported) for prophylaxis. It was reported that the vaccine was improperly stored at -3.5 degrees Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1610USA011133: US-009507513-1610USA011245.
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from an other health professional refers to a female patient of unknown age. The historical drug included Penicillin. The patient's current conditions included back pain, osteoarthritis, rheumatoid arthritis and type 2 diabetes mellitus. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route, lot/batch # and expiration date were not reported) for prophylaxis. The concomitant therapies included insulin glargine (LANTUS), insulin aspart (NOVOLOG) and metformin (manufacturer unknown). On an unknown date, the patient experienced allergy. The outcome of the event was unknown. The causality assessment was not provided by the reporter. Additional information has been requested.