chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female patient with drug reaction to betadine, amitriptyline, hydrocodone, ATIVAN, KLONOPIN, mirtazapine, tetracycline and blue dye allergy who on 11-MAR-2011 was vaccinated with a single dose of ZOSTAVAX (Merck), 0.65ml, subcutaneous. (Lot number not reported). The pharmacist reported that on 11-MAR-2011 the patient developed an injection site reaction described as a red, swollen, itchy rash in the evening following administration of the vaccine. The rash spread down the rest of the arm, down the hand and into the fingers during the next day, and it continued unabated to the present day. The pharmacist reported that the patient had a pre-planned hospital admission to an unspecified facility, for an unspecified surgical procedure, at an unspecified time during the week following the vaccination; she also reported that the hospital admission was not related to the vaccination. The patient sought medical attention by visiting unspecified physician. The pharmacist reported that patient's physician had sent off samples for unspecified lab work to determine if the patient had developed a case of shingles. BENADRYL and BENADRYL cream were given as a treatment for the experience. At the time of the report, the patient had not recovered. Follow up information has been received from the pharmacist reporting that the 61 year old female patient was still having active break outs with swelling and itching. Her physician (name unspecified) confirmed that she had shingles by doing an unspecified test (previously reported). At the time of the report, the patient had not recovered. Follow up information has been received from the doctor of pharmacy reporting that the 61 year old female patient with drug allergy to DARVOCET, amitriptyline, KLONOPIN, hydrocodone, blue dye, ATIVAN, REMERON, BETADINE and tetracycline, who on 11-MAR-2011 was vaccinated in her right arm, with the first dose of ZOSTAVAX (Merck) (Lot number 669533/1383Z) at 18:30 p.m. in a pharmacy with private funds. On 11-MAR-2011 at 19:00 the patient experienced swelling/redness at injection site. It was reported that later, the patient experienced swelling, redness and itching on entire arm lasted over a month with continued side effects-confirmed active shingles. At the time of the report, the patient had not recovered from active shingles. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female patient with drug reaction to betadine, amitriptyline, hydrocodone, ATIVAN, KLONOPIN, mirtazapine, tetracycline and blue dye allergy who on 11-MAR-2011 was vaccinated with a single dose of ZOSTAVAX (Merck), 0.65ml, subcutaneous. (Lot number not reported). The pharmacist reported that on 11-MAR-2011 the patient developed an injection site reaction described as a red, swollen, itchy rash in the evening following administration of the vaccine. The rash spread down the rest of the arm, down the hand and into the fingers during the next day, and it continued unabated to the present day. The pharmacist reported that the patient had a pre-planned hospital admission to an unspecified facility, for an unspecified surgical procedure, at an unspecified time during the week following the vaccination; she also reported that the hospital admission was not related to the vaccination. The patient sought medical attention by visiting unspecified physician. The pharmacist reported that patient's physician had sent off samples for unspecified lab work to determine if the patient had developed a case of shingles. BENADRYL and BENADRYL cream were given as a treatment for the experience. At the time of the report, the patient had not recovered. Follow up information has been received from the pharmacist reporting that the 61 year old female patient was still having active break outs with swelling and itching. Her physician (name unspecified) confirmed that she had shingles by doing an unspecified test (previously reported). At the time of the report, the patient had not recovered. Follow up information has been received from the doctor of pharmacy reporting that the 61 year old female patient with drug allergy to DARVOCET, amitriptyline, KLONOPIN, hydrocodone, blue dye, ATIVAN, REMERON, BETADINE and tetracycline, who on 11-MAR-2011 was vaccinated in her right arm, with the first dose of ZOSTAVAX (Merck) (Lot number 669533/1383Z) at 18:30 p.m. in a pharmacy with private funds. On 11-MAR-2011 at 19:00 the patient experienced swelling/redness at injection site. It was reported that later, the patient experienced swelling, redness and itching on entire arm lasted over a month with continued side effects-confirmed active shingles. At the time of the report, the patient had not recovered from active shingles. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Laboratory test, Laboratory test abnormal, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female patient with drug reaction to betadine, amitriptyline, hydrocodone, ATIVAN, KLONOPIN, mirtazapine, tetracycline and blue dye allergy who on 11-MAR-2011 was vaccinated with a single dose of ZOSTAVAX (Merck), 0.65ml, subcutaneous. (Lot number not reported). The pharmacist reported that on 11-MAR-2011 the patient developed an injection site reaction described as a red, swollen, itchy rash in the evening following administration of the vaccine. The rash spread down the rest of the arm, down the hand and into the fingers during the next day, and it continued unabated to the present day. The pharmacist reported that the patient had a pre-planned hospital admission to an unspecified facility, for an unspecified surgical procedure, at an unspecified time during the week following the vaccination; she also reported that the hospital admission was not related to the vaccination. The patient sought medical attention by visiting unspecified physician. The pharmacist reported that patient's physician had sent off samples for unspecified lab work to determine if the patient had developed a case of shingles. BENADRYL and BENADRYL cream were given as a treatment for the experience. At the time of the report, the patient had not recovered. Follow up information has been received from the pharmacist reporting that the 61 year old female patient was still having active break outs with swelling and itching. Her physician (name unspecified) confirmed that she had shingles by doing an unspecified test (previously reported). At the time of the report, the patient had not recovered. Follow up information has been received from the doctor of pharmacy reporting that the 61 year old female patient with drug allergy to DARVOCET, amitriptyline, KLONOPIN, hydrocodone, blue dye, ATIVAN, REMERON, BETADINE and tetracycline, who on 11-MAR-2011 was vaccinated in her right arm, with the first dose of ZOSTAVAX (Merck) (Lot number 669533/1383Z) at 18:30 p.m. in a pharmacy with private funds. On 11-MAR-2011 at 19:00 the patient experienced swelling/redness at injection site. It was reported that later, the patient experienced swelling, redness and itching on entire arm lasted over a month with continued side effects-confirmed active shingles. At the time of the report, the patient had not recovered from active shingles. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female patient with drug reaction to betadine, amitriptyline, hydrocodone, ATIVAN, KLONOPIN, mirtazapine, tetracycline and blue dye allergy who on 11-MAR-2011 was vaccinated with a single dose of ZOSTAVAX (Merck), 0.65ml, subcutaneous. (Lot number not reported). The pharmacist reported that on 11-MAR-2011 the patient developed an injection site reaction described as a red, swollen, itchy rash in the evening following administration of the vaccine. The rash spread down the rest of the arm, down the hand and into the fingers during the next day, and it continued unabated to the present day. The pharmacist reported that the patient had a pre-planned hospital admission to an unspecified facility, for an unspecified surgical procedure, at an unspecified time during the week following the vaccination; she also reported that the hospital admission was not related to the vaccination. The patient sought medical attention by visiting unspecified physician. The pharmacist reported that patient's physician had sent off samples for unspecified lab work to determine if the patient had developed a case of shingles. BENADRYL and BENADRYL cream were given as a treatment for the experience. At the time of the report, the patient had not recovered. Follow up information has been received from the pharmacist reporting that the 61 year old female patient was still having active break outs with swelling and itching. Her physician (name unspecified) confirmed that she had shingles by doing an unspecified test (previously reported). At the time of the report, the patient had not recovered. Follow up information has been received from the doctor of pharmacy reporting that the 61 year old female patient with drug allergy to DARVOCET, amitriptyline, KLONOPIN, hydrocodone, blue dye, ATIVAN, REMERON, BETADINE and tetracycline, who on 11-MAR-2011 was vaccinated in her right arm, with the first dose of ZOSTAVAX (Merck) (Lot number 669533/1383Z) at 18:30 p.m. in a pharmacy with private funds. On 11-MAR-2011 at 19:00 the patient experienced swelling/redness at injection site. It was reported that later, the patient experienced swelling, redness and itching on entire arm lasted over a month with continued side effects-confirmed active shingles. At the time of the report, the patient had not recovered from active shingles. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Axillary mass, Axillary pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a 60 year old female with family slow metabolism, lack CYP2D6 Enzyme to metabolize certain drugs normally and a history of shingles in 2006 on right side of her stomach treated with VALTREX 1 g for 7 days who on 25-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). On 03-APR-2011 the patient experienced some muscle pain that started in her shoulder which made her arms hurt the most then went down to her hips and thighs. The patient later on 03-APR-2011 noticed a rash on her stomach, shoulders, upper arms, under her breasts, upper thighs and back. The patient experienced some tiredness and fever as well. The patient was given ADVIL every 8 hours. Fed test was performed, result unknown. The patient sought unspecified medical attention. The status of the patient was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a 60 year old female with family slow metabolism, lack CYP2D6 Enzyme to metabolize certain drugs normally and a history of shingles in 2006 on right side of her stomach treated with VALTREX 1 g for 7 days who on 25-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). On 03-APR-2011 the patient experienced some muscle pain that started in her shoulder which made her arms hurt the most then went down to her hips and thighs. The patient later on 03-APR-2011 noticed a rash on her stomach, shoulders, upper arms, under her breasts, upper thighs and back. The patient experienced some tiredness and fever as well. The patient was given ADVIL every 8 hours. Fed test was performed, result unknown. The patient sought unspecified medical attention. The status of the patient was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Rash, Rash papular, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a 60 year old female with family slow metabolism, lack CYP2D6 Enzyme to metabolize certain drugs normally and a history of shingles in 2006 on right side of her stomach treated with VALTREX 1 g for 7 days who on 25-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). On 03-APR-2011 the patient experienced some muscle pain that started in her shoulder which made her arms hurt the most then went down to her hips and thighs. The patient later on 03-APR-2011 noticed a rash on her stomach, shoulders, upper arms, under her breasts, upper thighs and back. The patient experienced some tiredness and fever as well. The patient was given ADVIL every 8 hours. Fed test was performed, result unknown. The patient sought unspecified medical attention. The status of the patient was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a 60 year old female with family slow metabolism, lack CYP2D6 Enzyme to metabolize certain drugs normally and a history of shingles in 2006 on right side of her stomach treated with VALTREX 1 g for 7 days who on 25-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). On 03-APR-2011 the patient experienced some muscle pain that started in her shoulder which made her arms hurt the most then went down to her hips and thighs. The patient later on 03-APR-2011 noticed a rash on her stomach, shoulders, upper arms, under her breasts, upper thighs and back. The patient experienced some tiredness and fever as well. The patient was given ADVIL every 8 hours. Fed test was performed, result unknown. The patient sought unspecified medical attention. The status of the patient was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 60 year old female with family slow metabolism, lack CYP2D6 Enzyme to metabolize certain drugs normally and a history of shingles in 2006 on right side of her stomach treated with VALTREX 1 g for 7 days who on 25-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). On 03-APR-2011 the patient experienced some muscle pain that started in her shoulder which made her arms hurt the most then went down to her hips and thighs. The patient later on 03-APR-2011 noticed a rash on her stomach, shoulders, upper arms, under her breasts, upper thighs and back. The patient experienced some tiredness and fever as well. The patient was given ADVIL every 8 hours. Fed test was performed, result unknown. The patient sought unspecified medical attention. The status of the patient was unknown. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site atrophy
Clinical narrative: Information has been received from a pharmacist concerning an approximately 57 year old female patient with a "little bit of colitis" and no drug reactions or allergies, who in September 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). Concomitant therapy included unspecified thyroid medicine. The pharmacist reported that the patient "right away" in September 2010 complained of "muscle wasting" at the injection site. It seemed like the amount of muscle between a "golf ball and baseball" was missing from her arm. The patient experienced the soreness and some irritation from her clothing after the vaccination. No treatment for the adverse event was given; laboratory diagnostics studies were not performed. The patient did not seek medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Muscle atrophy, Pain, Skin irritation
Clinical narrative: Information has been received from a pharmacist concerning an approximately 57 year old female patient with a "little bit of colitis" and no drug reactions or allergies, who in September 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). Concomitant therapy included unspecified thyroid medicine. The pharmacist reported that the patient "right away" in September 2010 complained of "muscle wasting" at the injection site. It seemed like the amount of muscle between a "golf ball and baseball" was missing from her arm. The patient experienced the soreness and some irritation from her clothing after the vaccination. No treatment for the adverse event was given; laboratory diagnostics studies were not performed. The patient did not seek medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood creatine phosphokinase, Headache, Neuralgia, Presyncope
Clinical narrative: Information has been received from a 63 year old female (also reported as 62 years old) patient reporting herself with no drug reactions or allergies and no pertinent medical history reported, who on 26-MAR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and site of administration not reported). Concomitant therapy included a small dose of estradiol, 1/2 of tablet. On 26-MAR-2011 "4 hours after the vaccination", the consumer stated that she had not felt like herself, she had general body pain, inflammation in all of her nerve endings, head pain and joint pain. There was even pain in her face and she was cold all of the time. The consumer had to keep her heat up 6 degrees higher than usual. Also, it was reported that the consumer had a low grade fever. The patient had not talked with the doctor yet, but schedule an appointment. At the time of the report the patient did not seek medical attention. No treatment was given for the adverse event. No lab diagnostics were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Facial pain, Feeling abnormal, Feeling cold, Headache
Clinical narrative: Information has been received from a 63 year old female (also reported as 62 years old) patient reporting herself with no drug reactions or allergies and no pertinent medical history reported, who on 26-MAR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and site of administration not reported). Concomitant therapy included a small dose of estradiol, 1/2 of tablet. On 26-MAR-2011 "4 hours after the vaccination", the consumer stated that she had not felt like herself, she had general body pain, inflammation in all of her nerve endings, head pain and joint pain. There was even pain in her face and she was cold all of the time. The consumer had to keep her heat up 6 degrees higher than usual. Also, it was reported that the consumer had a low grade fever. The patient had not talked with the doctor yet, but schedule an appointment. At the time of the report the patient did not seek medical attention. No treatment was given for the adverse event. No lab diagnostics were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Pain, Pyrexia
Clinical narrative: Information has been received from a 63 year old female (also reported as 62 years old) patient reporting herself with no drug reactions or allergies and no pertinent medical history reported, who on 26-MAR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and site of administration not reported). Concomitant therapy included a small dose of estradiol, 1/2 of tablet. On 26-MAR-2011 "4 hours after the vaccination", the consumer stated that she had not felt like herself, she had general body pain, inflammation in all of her nerve endings, head pain and joint pain. There was even pain in her face and she was cold all of the time. The consumer had to keep her heat up 6 degrees higher than usual. Also, it was reported that the consumer had a low grade fever. The patient had not talked with the doctor yet, but schedule an appointment. At the time of the report the patient did not seek medical attention. No treatment was given for the adverse event. No lab diagnostics were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 75 year old female patient who on 13-APR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 669259/1360Z, expiration date: 15-JAN-2012), 0.5 ml, subcutaneously. Suspect secondary therapy included PNEUMOVAX 23 administered before required 4 week interval. On 17-APR2011, the patient experienced injection site redness to the elbow and soreness. Also, it was noticed that the patient was vaccinated with PNEUMOVAX 23 before the required 4 week interval. The patient received unspecified medical attention. ADVIL as treatment of the adverse event. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Pain
Clinical narrative: Information has been received from a registered pharmacist concerning a 75 year old female patient who on 13-APR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 669259/1360Z, expiration date: 15-JAN-2012), 0.5 ml, subcutaneously. Suspect secondary therapy included PNEUMOVAX 23 administered before required 4 week interval. On 17-APR2011, the patient experienced injection site redness to the elbow and soreness. Also, it was noticed that the patient was vaccinated with PNEUMOVAX 23 before the required 4 week interval. The patient received unspecified medical attention. ADVIL as treatment of the adverse event. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Oropharyngeal pain, Stomatitis, Viral infection
Clinical narrative: Information has been received from a registered pharmacist concerning a 69 year old female patient with no pertinent medical history and no drug reactions or allergies who on 15-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669260/0152AA, expire date 30-MAY-2012), 0.65 ml, subcutaneously. There was no concomitant medication. The registered pharmacist stated that on 16-APR-2011 late Saturday afternoon, the patient developed "sores not rash" in her mouth. The patient had applied hydrogen peroxide to the open sore. The registered pharmacist stated that sores were located on the roof of her mouth and patient complained of minor, not severe pain from the sores. There were no laboratory diagnostics studies performed. The patient sought unspecified medical attention. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral pain, Stomatitis
Clinical narrative: Information has been received from a registered pharmacist concerning a 69 year old female patient with no pertinent medical history and no drug reactions or allergies who on 15-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669260/0152AA, expire date 30-MAY-2012), 0.65 ml, subcutaneously. There was no concomitant medication. The registered pharmacist stated that on 16-APR-2011 late Saturday afternoon, the patient developed "sores not rash" in her mouth. The patient had applied hydrogen peroxide to the open sore. The registered pharmacist stated that sores were located on the roof of her mouth and patient complained of minor, not severe pain from the sores. There were no laboratory diagnostics studies performed. The patient sought unspecified medical attention. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARZOS, VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female patient with asthma, penicillin allergy, sulfa allergy and azithromycin allergy who on 20-APR-2011 was vaccinated accidently with a dose of ZOSTAVAX (Merck) 0.65 ml, subcutaneously (Lot number 669263/1361Z, expire date 15-JAN-2012) instead of getting the first dose of VARIVAX (Merck). Concomitant therapy included PROVENTIL as needed. The patient experienced redness at the injection site. The patient sought medical attention by an office visit. Laboratory diagnostics studies were not performed. Treatment for the adverse event included cool compress and BENADRYL as needed. At the time of the report, the patient's outcome was unknown. All telephone attempts to obtain follow up information had been unsuccessful. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARZOS, VARZOS
Symptoms: Injection site erythema, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female patient with asthma, penicillin allergy, sulfa allergy and azithromycin allergy who on 20-APR-2011 was vaccinated accidently with a dose of ZOSTAVAX (Merck) 0.65 ml, subcutaneously (Lot number 669263/1361Z, expire date 15-JAN-2012) instead of getting the first dose of VARIVAX (Merck). Concomitant therapy included PROVENTIL as needed. The patient experienced redness at the injection site. The patient sought medical attention by an office visit. Laboratory diagnostics studies were not performed. Treatment for the adverse event included cool compress and BENADRYL as needed. At the time of the report, the patient's outcome was unknown. All telephone attempts to obtain follow up information had been unsuccessful. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site haematoma, Skin swelling, Skin warm
Clinical narrative: Information has been received from a doctor of pharmacist concerning a 70 year old female who on 22-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route not provided, lot #667609/1354Y, expired date unknown). On 22-APR-2011 the patient developed bruising at the injection site. The area was warm, raised and reddened and might have progressed over the last 3 days. Patient sought medical attention by calling the pharmacist. At the time of reporting, the patient's status was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a doctor of pharmacist concerning a 70 year old female who on 22-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route not provided, lot #667609/1354Y, expired date unknown). On 22-APR-2011 the patient developed bruising at the injection site. The area was warm, raised and reddened and might have progressed over the last 3 days. Patient sought medical attention by calling the pharmacist. At the time of reporting, the patient's status was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female who on 09-MAY-2011 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot#: 669408/1384Z) (Expiration date: 19-JAN-2012). On 11-MAY-2011 the patient came to the store and the pharmacist's colleague noted that at the injection site patient had "a big red bump" that was hot and itching. There was no lab diagnostics performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female who on 09-MAY-2011 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot#: 669408/1384Z) (Expiration date: 19-JAN-2012). On 11-MAY-2011 the patient came to the store and the pharmacist's colleague noted that at the injection site patient had "a big red bump" that was hot and itching. There was no lab diagnostics performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 77 year old female patient with no pertinent medical history reported and allergy to morphine, who on 29-MAR-2011 was vaccinated, subcutaneously, with a dose of 0.65 ml ZOSTAVAX (Merck) (Lot # 667610/1355Z). Pharmacist reported that the injection site was itchy immediately after receiving the ZOSTAVAX (Merck). It was reported that patient was able to walk around the store and a few minutes after the vaccine administration, the area was a little red. The patient sought unspecified medical attention. No lab/diagnostics were performed. No treatment was given for the adverse events. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the pharmacist concerning, the 77 year old female patient, with allergy to morphine, who on 29-MAR-2011 at around 11:30 am was vaccinated subcutaneously in the left deltoid, with her first dose of ZOSTAVAX (Merck) (Lot # 667610/1355Z) at pharmacy. Pharmacist reported that immediately after vaccination, the patient's arm was a little itchy. Patient was not sure if she was having a reaction, so she stayed at the pharmacy for about 15-20 minutes (at least). There were no signs of a rash (hives) or trouble breathing. Patient called to the pharmacy later in that day saying she had no further reaction and was fine. At the time of the report, the patient's outcome was recovered. No further information is available.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 77 year old female patient with no pertinent medical history reported and allergy to morphine, who on 29-MAR-2011 was vaccinated, subcutaneously, with a dose of 0.65 ml ZOSTAVAX (Merck) (Lot # 667610/1355Z). Pharmacist reported that the injection site was itchy immediately after receiving the ZOSTAVAX (Merck). It was reported that patient was able to walk around the store and a few minutes after the vaccine administration, the area was a little red. The patient sought unspecified medical attention. No lab/diagnostics were performed. No treatment was given for the adverse events. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the pharmacist concerning, the 77 year old female patient, with allergy to morphine, who on 29-MAR-2011 at around 11:30 am was vaccinated subcutaneously in the left deltoid, with her first dose of ZOSTAVAX (Merck) (Lot # 667610/1355Z) at pharmacy. Pharmacist reported that immediately after vaccination, the patient's arm was a little itchy. Patient was not sure if she was having a reaction, so she stayed at the pharmacy for about 15-20 minutes (at least). There were no signs of a rash (hives) or trouble breathing. Patient called to the pharmacy later in that day saying she had no further reaction and was fine. At the time of the report, the patient's outcome was recovered. No further information is available.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Nausea, Pain, Rash, Vaccination complication
Clinical narrative: Information has been received from a 75 year old female with allergy to ciprofloxacin and high blood pressure who on 24-NOV-2009 was vaccinated with 0.65 ml of a dose of ZOSTAVAX (Merck) (lot number 664274/0959Y). Concomitant therapy included SYNTHROID and amlodipine besylate. About 3 weeks ago (approximately 24-FEB-2011) one morning she woke up and felt like sand paper on her back and the pain was "really bad"; she came down with shingles. The patient sought unspecified medical attention and was treated with valcyclovir. At the time of the report the patient's shingles persisted. No lab diagnostics studies performed. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain
Clinical narrative: Information has been received from a 75 year old female with allergy to ciprofloxacin and high blood pressure who on 24-NOV-2009 was vaccinated with 0.65 ml of a dose of ZOSTAVAX (Merck) (lot number 664274/0959Y). Concomitant therapy included SYNTHROID and amlodipine besylate. About 3 weeks ago (approximately 24-FEB-2011) one morning she woke up and felt like sand paper on her back and the pain was "really bad"; she came down with shingles. The patient sought unspecified medical attention and was treated with valcyclovir. At the time of the report the patient's shingles persisted. No lab diagnostics studies performed. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Heart rate increased, Injection site mass, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a 63 year old male consumer reporting on himself who on 12-MAY-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (route and lot number not reported). The consumer reported that 2 hours after ZOSTAVAX (Merck) was administered, his heart rate was elevated and returned to normal after a "few" hours. The day after administration (on 13-MAY-2011), the consumer experienced local injection site swelling, redness and warmth. The consumer did not seek medical attention and no treatment was given for the event. The consumer reported that the local reactions were clearing up. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a 63 year old male consumer reporting on himself who on 12-MAY-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (route and lot number not reported). The consumer reported that 2 hours after ZOSTAVAX (Merck) was administered, his heart rate was elevated and returned to normal after a "few" hours. The day after administration (on 13-MAY-2011), the consumer experienced local injection site swelling, redness and warmth. The consumer did not seek medical attention and no treatment was given for the event. The consumer reported that the local reactions were clearing up. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Heart rate increased, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a 63 year old male consumer reporting on himself who on 12-MAY-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (route and lot number not reported). The consumer reported that 2 hours after ZOSTAVAX (Merck) was administered, his heart rate was elevated and returned to normal after a "few" hours. The day after administration (on 13-MAY-2011), the consumer experienced local injection site swelling, redness and warmth. The consumer did not seek medical attention and no treatment was given for the event. The consumer reported that the local reactions were clearing up. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from an 80 year old male consumer reporting himself with a history of a kidney removed and no drug reactions or allergies, who on 03-FEB-2011 was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX (Merck). There was no concomitant medication. The patient reported that after getting the dose of ZOSTAVAX (Merck), three days later (on 06-FEB-2011) (also reported as 07-FEB-2011), he started getting sick, he developed chills with a fever. He reported he was in tremendous pain and he couldn't move. When he did move it hurt. The patient also reported that he went to multiple doctors and nobody knew what it was. After multiple tests done (computed axial tomography, 2 X-Rays, 3 magnetic resonance imaging and "a lot of" blood work (results not provided)) one doctor was able to diagnose him with Fibromyalgia, and he said that it was from the vaccine. All of the other doctors that he spoke with said that it wasn't caused from the vaccine, but they did not know what was wrong with him. The patient reported that "all of the medicines that he was prescribed other than methylprednisolone "was able to work for him". Patient was also treated with muscle relaxers (unspecified) and a "shot" of VALIUM in the neck which made him "very, very hyper instead of relaxing him". Patient reported that he thought that if he stop taking the methylprednisolone (which patient was taking only for 7 days) his symptoms were going to come back. It was reported that the adverse event improved after taking methylprednisolone, however, at the time of the report patient had not recovered. Patient sought medical attention in the Emergency Room and with several doctors. Follow up information has been received from a Nurse via telephone call, she stated that the lot number of the ZOSTAVAX (Merck) administered to the patient was "Lot#145Z, expiration date: 28-JAN-2012". She stated "she had no idea" what the patient meant when he mentioned other problems with this lot number. The nurse stated that the vaccine was administered by other nurse prior to her arrival. Follow up information has been received from a Nurse via telephone call, who stated that the lot number of the ZOSTAVAX (Merck) administered to the patient was Lot#669589/1453Z, no expiration date provided. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Chills, Computerised tomogram, Fibromyalgia, Laboratory test
Clinical narrative: Information has been received from an 80 year old male consumer reporting himself with a history of a kidney removed and no drug reactions or allergies, who on 03-FEB-2011 was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX (Merck). There was no concomitant medication. The patient reported that after getting the dose of ZOSTAVAX (Merck), three days later (on 06-FEB-2011) (also reported as 07-FEB-2011), he started getting sick, he developed chills with a fever. He reported he was in tremendous pain and he couldn't move. When he did move it hurt. The patient also reported that he went to multiple doctors and nobody knew what it was. After multiple tests done (computed axial tomography, 2 X-Rays, 3 magnetic resonance imaging and "a lot of" blood work (results not provided)) one doctor was able to diagnose him with Fibromyalgia, and he said that it was from the vaccine. All of the other doctors that he spoke with said that it wasn't caused from the vaccine, but they did not know what was wrong with him. The patient reported that "all of the medicines that he was prescribed other than methylprednisolone "was able to work for him". Patient was also treated with muscle relaxers (unspecified) and a "shot" of VALIUM in the neck which made him "very, very hyper instead of relaxing him". Patient reported that he thought that if he stop taking the methylprednisolone (which patient was taking only for 7 days) his symptoms were going to come back. It was reported that the adverse event improved after taking methylprednisolone, however, at the time of the report patient had not recovered. Patient sought medical attention in the Emergency Room and with several doctors. Follow up information has been received from a Nurse via telephone call, she stated that the lot number of the ZOSTAVAX (Merck) administered to the patient was "Lot#145Z, expiration date: 28-JAN-2012". She stated "she had no idea" what the patient meant when he mentioned other problems with this lot number. The nurse stated that the vaccine was administered by other nurse prior to her arrival. Follow up information has been received from a Nurse via telephone call, who stated that the lot number of the ZOSTAVAX (Merck) administered to the patient was Lot#669589/1453Z, no expiration date provided. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Mobility decreased, Nuclear magnetic resonance imaging, Pain, Psychomotor hyperactivity
Clinical narrative: Information has been received from an 80 year old male consumer reporting himself with a history of a kidney removed and no drug reactions or allergies, who on 03-FEB-2011 was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX (Merck). There was no concomitant medication. The patient reported that after getting the dose of ZOSTAVAX (Merck), three days later (on 06-FEB-2011) (also reported as 07-FEB-2011), he started getting sick, he developed chills with a fever. He reported he was in tremendous pain and he couldn't move. When he did move it hurt. The patient also reported that he went to multiple doctors and nobody knew what it was. After multiple tests done (computed axial tomography, 2 X-Rays, 3 magnetic resonance imaging and "a lot of" blood work (results not provided)) one doctor was able to diagnose him with Fibromyalgia, and he said that it was from the vaccine. All of the other doctors that he spoke with said that it wasn't caused from the vaccine, but they did not know what was wrong with him. The patient reported that "all of the medicines that he was prescribed other than methylprednisolone "was able to work for him". Patient was also treated with muscle relaxers (unspecified) and a "shot" of VALIUM in the neck which made him "very, very hyper instead of relaxing him". Patient reported that he thought that if he stop taking the methylprednisolone (which patient was taking only for 7 days) his symptoms were going to come back. It was reported that the adverse event improved after taking methylprednisolone, however, at the time of the report patient had not recovered. Patient sought medical attention in the Emergency Room and with several doctors. Follow up information has been received from a Nurse via telephone call, she stated that the lot number of the ZOSTAVAX (Merck) administered to the patient was "Lot#145Z, expiration date: 28-JAN-2012". She stated "she had no idea" what the patient meant when he mentioned other problems with this lot number. The nurse stated that the vaccine was administered by other nurse prior to her arrival. Follow up information has been received from a Nurse via telephone call, who stated that the lot number of the ZOSTAVAX (Merck) administered to the patient was Lot#669589/1453Z, no expiration date provided. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, X-ray
Clinical narrative: Information has been received from an 80 year old male consumer reporting himself with a history of a kidney removed and no drug reactions or allergies, who on 03-FEB-2011 was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX (Merck). There was no concomitant medication. The patient reported that after getting the dose of ZOSTAVAX (Merck), three days later (on 06-FEB-2011) (also reported as 07-FEB-2011), he started getting sick, he developed chills with a fever. He reported he was in tremendous pain and he couldn't move. When he did move it hurt. The patient also reported that he went to multiple doctors and nobody knew what it was. After multiple tests done (computed axial tomography, 2 X-Rays, 3 magnetic resonance imaging and "a lot of" blood work (results not provided)) one doctor was able to diagnose him with Fibromyalgia, and he said that it was from the vaccine. All of the other doctors that he spoke with said that it wasn't caused from the vaccine, but they did not know what was wrong with him. The patient reported that "all of the medicines that he was prescribed other than methylprednisolone "was able to work for him". Patient was also treated with muscle relaxers (unspecified) and a "shot" of VALIUM in the neck which made him "very, very hyper instead of relaxing him". Patient reported that he thought that if he stop taking the methylprednisolone (which patient was taking only for 7 days) his symptoms were going to come back. It was reported that the adverse event improved after taking methylprednisolone, however, at the time of the report patient had not recovered. Patient sought medical attention in the Emergency Room and with several doctors. Follow up information has been received from a Nurse via telephone call, she stated that the lot number of the ZOSTAVAX (Merck) administered to the patient was "Lot#145Z, expiration date: 28-JAN-2012". She stated "she had no idea" what the patient meant when he mentioned other problems with this lot number. The nurse stated that the vaccine was administered by other nurse prior to her arrival. Follow up information has been received from a Nurse via telephone call, who stated that the lot number of the ZOSTAVAX (Merck) administered to the patient was Lot#669589/1453Z, no expiration date provided. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old male patient with a history of shingles in 2007 who in 2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# and expiration date not reported). The nurse reported that the patient received ZOSTAVAX (Merck) and developed shingles again. It was unspecified if the patient sought medical attention. At the time of reporting the patient had not recovered. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old male patient with a history of shingles in 2007 who in 2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# and expiration date not reported). The nurse reported that the patient received ZOSTAVAX (Merck) and developed shingles again. It was unspecified if the patient sought medical attention. At the time of reporting the patient had not recovered. Additional information has been requested.