chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Arthralgia, Burning sensation, Erythema, Inflammation, Loss of personal independence in daily activities
Clinical narrative: Shingles; Cold sore on lip; "Festering under skin like pimple"; Acne on shoulder; Exacerbation of eczema; Skin is tender; Itch; Rash/ Pain with rash; Pain with rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th January 2020, 2 weeks after receiving Shingrix, the patient experienced pruritus, rash, pain, skin tenderness and eczema aggravated. On an unknown date, the patient experienced shingles, cold sores lip, subcutaneous abscess and acne. The patient was treated with steroids nos (Steroids). On 11th February 2020, the outcome of the cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated were recovered/resolved. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles, cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. This case was reported by patient himself. The patient received first dose of Shingrix sometime in mid January. The patient reported that about 2 weeks later he started developing symptoms of what he thinks was Shingles. The patient went to the emergency room and received steroid cream to treat affected areas. The patient expereinced itch, rash, pain, festering under his skin like a pimple, tender skin on affected areas, cold sore on his lip, acne on his shoulder and exacerbation of his eczema. The patient was being treated by his health care professional. Provided him with phone number for Medical Information department so his health care professional can call for further information. The reporter consented to follow up. Emergency visit required.
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Pain in extremity, Pain of skin, Paraesthesia, Pruritus, Skin exfoliation
Clinical narrative: Shingles; Cold sore on lip; "Festering under skin like pimple"; Acne on shoulder; Exacerbation of eczema; Skin is tender; Itch; Rash/ Pain with rash; Pain with rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th January 2020, 2 weeks after receiving Shingrix, the patient experienced pruritus, rash, pain, skin tenderness and eczema aggravated. On an unknown date, the patient experienced shingles, cold sores lip, subcutaneous abscess and acne. The patient was treated with steroids nos (Steroids). On 11th February 2020, the outcome of the cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated were recovered/resolved. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles, cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. This case was reported by patient himself. The patient received first dose of Shingrix sometime in mid January. The patient reported that about 2 weeks later he started developing symptoms of what he thinks was Shingles. The patient went to the emergency room and received steroid cream to treat affected areas. The patient expereinced itch, rash, pain, festering under his skin like a pimple, tender skin on affected areas, cold sore on his lip, acne on his shoulder and exacerbation of his eczema. The patient was being treated by his health care professional. Provided him with phone number for Medical Information department so his health care professional can call for further information. The reporter consented to follow up. Emergency visit required.
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: Shingles; Cold sore on lip; "Festering under skin like pimple"; Acne on shoulder; Exacerbation of eczema; Skin is tender; Itch; Rash/ Pain with rash; Pain with rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th January 2020, 2 weeks after receiving Shingrix, the patient experienced pruritus, rash, pain, skin tenderness and eczema aggravated. On an unknown date, the patient experienced shingles, cold sores lip, subcutaneous abscess and acne. The patient was treated with steroids nos (Steroids). On 11th February 2020, the outcome of the cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated were recovered/resolved. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles, cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. This case was reported by patient himself. The patient received first dose of Shingrix sometime in mid January. The patient reported that about 2 weeks later he started developing symptoms of what he thinks was Shingles. The patient went to the emergency room and received steroid cream to treat affected areas. The patient expereinced itch, rash, pain, festering under his skin like a pimple, tender skin on affected areas, cold sore on his lip, acne on his shoulder and exacerbation of his eczema. The patient was being treated by his health care professional. Provided him with phone number for Medical Information department so his health care professional can call for further information. The reporter consented to follow up. Emergency visit required.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 83-year-old female patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   On 20th November 2019, the patient received the 1st dose of Shingrix. On 12th February 2020, 84 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: At the time of reporting, the patient was diagnosed with shingles.   The reporter asked following appropriate treatment were there any guidelines or recommendations about when she could receive her second dose. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at site of injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced arm soreness at site of injection that lasted about a day. The reporter did not consent to follow up. For tolerance of 2nd dose refer case US2020AMR025547, reported by same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter reported that she heard at the pharmacy that some people were having flu like symptoms from Shingrix that were lasting longer than a day or two. Reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dyspnoea, Lymphoedema, Malaise, Pyrexia
Clinical narrative: sinus congestion; hard time breathing; low grade fever; flare up of lymph edema in her legs; Condition aggravated; Not feeling well / Really sick; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included shingles (prior shingles outbreak) and sjogren's disease. Concurrent medical conditions included lymphedema (lymph edema in both legs).   On 7th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 7th February 2020, 4 hrs after receiving Shingrix, the patient experienced malaise. On 8th February 2020, the patient experienced sinus congestion, difficulty breathing, fever, lymphedema and condition aggravated. On 9th February 2020, the outcome of the malaise, difficulty breathing and fever were recovered/resolved. On an unknown date, the outcome of the sinus congestion, lymphedema and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the malaise, sinus congestion, difficulty breathing, fever, lymphedema and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and started not feeling well then later that day feeling sick.  She stated that she woke up with sinus congestion, hard time breathing, low grade fever, and a flare up of lymph edema in her legs. She states at this time she still has sinus congestion and the lymph edema has not resolved.  The reporter consented to follow up. The reporter did not have vaccine information for this adverse event. This case linked with US2020025208, reported by same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinus congestion
Clinical narrative: sinus congestion; hard time breathing; low grade fever; flare up of lymph edema in her legs; Condition aggravated; Not feeling well / Really sick; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included shingles (prior shingles outbreak) and sjogren's disease. Concurrent medical conditions included lymphedema (lymph edema in both legs).   On 7th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 7th February 2020, 4 hrs after receiving Shingrix, the patient experienced malaise. On 8th February 2020, the patient experienced sinus congestion, difficulty breathing, fever, lymphedema and condition aggravated. On 9th February 2020, the outcome of the malaise, difficulty breathing and fever were recovered/resolved. On an unknown date, the outcome of the sinus congestion, lymphedema and condition aggravated were not recovered/not resolved.   It was unknown if the reporter considered the malaise, sinus congestion, difficulty breathing, fever, lymphedema and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and started not feeling well then later that day feeling sick.  She stated that she woke up with sinus congestion, hard time breathing, low grade fever, and a flare up of lymph edema in her legs. She states at this time she still has sinus congestion and the lymph edema has not resolved.  The reporter consented to follow up. The reporter did not have vaccine information for this adverse event. This case linked with US2020025208, reported by same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Injection site pain
Clinical narrative: New white spot and under the arm in the lymph node area; headache; vertigo; UTI; I did not feel like myself, I was not as upbeat. I was rundown; Rotator cuff syndrome; chills; Sore arm at injection site; Tired / Fatigue/more tired; Malaise/didn't feel good; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rotator cuff syndrome. Concurrent medical conditions included autoimmune disorder (which attacks the mucus in her mouth). Concomitant products included dapsone.   On 4th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a month after receiving Shingrix, the patient experienced injection site pain, fatigue, malaise, chills, feeling abnormal and rotator cuff syndrome. In December 2019, the patient experienced urinary tract infection. On an unknown date, the patient experienced skin discoloration, headache and vertigo. On an unknown date, the outcome of the injection site pain, skin discoloration and vertigo were not recovered/not resolved and the outcome of the fatigue, urinary tract infection, chills and headache were recovered/resolved and the outcome of the malaise, feeling abnormal and rotator cuff syndrome were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, malaise, urinary tract infection, chills, headache, vertigo, feeling abnormal and rotator cuff syndrome to be related to Shingrix. The reporter considered the skin discoloration to be possibly related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm deltoid. She did not recall if it was intramuscular or not and had sore arm at injection site arm got progressively worse first couple of weeks and at the time of reporting it was starting to get better.  The injection site arm and felt that it was possibly a rotator cuff issue like what she had with her other arm.  The patient had Tired, Malaise, Fatigue and did not feel good and was more tired. The patient did not feel like myself and was not as upbeat. I was rundown on and off. The patient had Urinary tract infection she had never had one before. The patient finding on mammogram and she had a yearly physical and mammogram and was called back because of a new white spot and under the arm in the lymph node area. She spoke to the nurse about how she thinks it could be related to the Shingrix shot.  The reporter told her that the shingles shot can cause pain problems, chills, headache, Vertigo. The caller was joking about how she could not find the paperwork which she had which had the information about the injection. She jokingly said it's not fun getting old and losing things. The reporter consented to follow up.      Lab Comments: she had a yearly physical and mammogram  and was back because of a new white spot and under the arm in the lymph node area.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: New white spot and under the arm in the lymph node area; headache; vertigo; UTI; I did not feel like myself, I was not as upbeat. I was rundown; Rotator cuff syndrome; chills; Sore arm at injection site; Tired / Fatigue/more tired; Malaise/didn't feel good; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rotator cuff syndrome. Concurrent medical conditions included autoimmune disorder (which attacks the mucus in her mouth). Concomitant products included dapsone.   On 4th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a month after receiving Shingrix, the patient experienced injection site pain, fatigue, malaise, chills, feeling abnormal and rotator cuff syndrome. In December 2019, the patient experienced urinary tract infection. On an unknown date, the patient experienced skin discoloration, headache and vertigo. On an unknown date, the outcome of the injection site pain, skin discoloration and vertigo were not recovered/not resolved and the outcome of the fatigue, urinary tract infection, chills and headache were recovered/resolved and the outcome of the malaise, feeling abnormal and rotator cuff syndrome were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, malaise, urinary tract infection, chills, headache, vertigo, feeling abnormal and rotator cuff syndrome to be related to Shingrix. The reporter considered the skin discoloration to be possibly related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm deltoid. She did not recall if it was intramuscular or not and had sore arm at injection site arm got progressively worse first couple of weeks and at the time of reporting it was starting to get better.  The injection site arm and felt that it was possibly a rotator cuff issue like what she had with her other arm.  The patient had Tired, Malaise, Fatigue and did not feel good and was more tired. The patient did not feel like myself and was not as upbeat. I was rundown on and off. The patient had Urinary tract infection she had never had one before. The patient finding on mammogram and she had a yearly physical and mammogram and was called back because of a new white spot and under the arm in the lymph node area. She spoke to the nurse about how she thinks it could be related to the Shingrix shot.  The reporter told her that the shingles shot can cause pain problems, chills, headache, Vertigo. The caller was joking about how she could not find the paperwork which she had which had the information about the injection. She jokingly said it's not fun getting old and losing things. The reporter consented to follow up.      Lab Comments: she had a yearly physical and mammogram  and was back because of a new white spot and under the arm in the lymph node area.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix on 26-Sep-2018 and now wants to administer the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th September 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter wants to administer the second dose. The VAERS details were provided for 1st dose. The reporter consented to follow up. This case has been linked with case US2020025234, reported for same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Coagulopathy, Condition aggravated, Dizziness, Headache
Clinical narrative: nausea; Headache was severe at first and described as a spinal headache; shivering; fever; not feeling well since she got vaccine; History of thin blood but usually measures between 2.0 -3.5 and sometimes even 1.0 but today her INR was 4.2 and last week it was 4.1; Dizziness; Vaginal issues / Started with itching; Vaginal issues / clear discharge; Vaginal issues / Burning; open ulcers in the vaginal area; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included clotting disorder (history of thin blood but usually measures between 2 to 3.5, sometimes even 1). Concurrent medical conditions included multiple sclerosis.   On 4th February 2020, the patient received the 2nd dose of Shingrix. On 4th February 2020, 9 hrs after receiving Shingrix, the patient experienced headache, shivering and fever. On 12th February 2020, the patient experienced nausea. In February 2020, the patient experienced feeling unwell, dizziness, vaginal itching, vaginal discharge, vaginal burning sensation, vaginal ulceration and clotting disorder. In February 2020, the outcome of the nausea, shivering, fever and dizziness were resolved with sequelae and the outcome of the vaginal itching, vaginal discharge, vaginal burning sensation and vaginal ulceration were recovered/resolved. On an unknown date, the outcome of the feeling unwell was unknown and the outcome of the headache was recovering/resolving and the outcome of the clotting disorder was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, nausea, headache, shivering, fever, dizziness, vaginal itching, vaginal discharge, vaginal burning sensation, vaginal ulceration and clotting disorder to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. At 1:00 PM, the patient receieved a dose of Shingrix on the left arm. Most of the symptoms presented by 10 PM that night. The patient was not feeling well since she got the vaccine. The patient experienced nausea which was resolved at time of reporting. The headache was severe at first and described as a spinal headache.  It has improved but was still present in between her temples. The fever lasted for 4 days. The dizziness lasted 5 days. The onset date of the vaginal issues was unknown.  It started with itching and clear discharge and 24 hours later burning presented which was caused by open ulcers in the vaginal area.  The issues resolved within 3 days.  The patient had a history of thin blood but usually International normalised ratio measures between 2 to 3.5 and sometimes even 1 but on day of reporting her International normalised ratio was 4.2 and a week ago it was 4.1
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: International normalised ratio increased, Malaise, Nausea, Pyrexia, Vaginal discharge
Clinical narrative: nausea; Headache was severe at first and described as a spinal headache; shivering; fever; not feeling well since she got vaccine; History of thin blood but usually measures between 2.0 -3.5 and sometimes even 1.0 but today her INR was 4.2 and last week it was 4.1; Dizziness; Vaginal issues / Started with itching; Vaginal issues / clear discharge; Vaginal issues / Burning; open ulcers in the vaginal area; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included clotting disorder (history of thin blood but usually measures between 2 to 3.5, sometimes even 1). Concurrent medical conditions included multiple sclerosis.   On 4th February 2020, the patient received the 2nd dose of Shingrix. On 4th February 2020, 9 hrs after receiving Shingrix, the patient experienced headache, shivering and fever. On 12th February 2020, the patient experienced nausea. In February 2020, the patient experienced feeling unwell, dizziness, vaginal itching, vaginal discharge, vaginal burning sensation, vaginal ulceration and clotting disorder. In February 2020, the outcome of the nausea, shivering, fever and dizziness were resolved with sequelae and the outcome of the vaginal itching, vaginal discharge, vaginal burning sensation and vaginal ulceration were recovered/resolved. On an unknown date, the outcome of the feeling unwell was unknown and the outcome of the headache was recovering/resolving and the outcome of the clotting disorder was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, nausea, headache, shivering, fever, dizziness, vaginal itching, vaginal discharge, vaginal burning sensation, vaginal ulceration and clotting disorder to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. At 1:00 PM, the patient receieved a dose of Shingrix on the left arm. Most of the symptoms presented by 10 PM that night. The patient was not feeling well since she got the vaccine. The patient experienced nausea which was resolved at time of reporting. The headache was severe at first and described as a spinal headache.  It has improved but was still present in between her temples. The fever lasted for 4 days. The dizziness lasted 5 days. The onset date of the vaginal issues was unknown.  It started with itching and clear discharge and 24 hours later burning presented which was caused by open ulcers in the vaginal area.  The issues resolved within 3 days.  The patient had a history of thin blood but usually International normalised ratio measures between 2 to 3.5 and sometimes even 1 but on day of reporting her International normalised ratio was 4.2 and a week ago it was 4.1
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaginal ulceration, Vulvovaginal burning sensation, Vulvovaginal pruritus
Clinical narrative: nausea; Headache was severe at first and described as a spinal headache; shivering; fever; not feeling well since she got vaccine; History of thin blood but usually measures between 2.0 -3.5 and sometimes even 1.0 but today her INR was 4.2 and last week it was 4.1; Dizziness; Vaginal issues / Started with itching; Vaginal issues / clear discharge; Vaginal issues / Burning; open ulcers in the vaginal area; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included clotting disorder (history of thin blood but usually measures between 2 to 3.5, sometimes even 1). Concurrent medical conditions included multiple sclerosis.   On 4th February 2020, the patient received the 2nd dose of Shingrix. On 4th February 2020, 9 hrs after receiving Shingrix, the patient experienced headache, shivering and fever. On 12th February 2020, the patient experienced nausea. In February 2020, the patient experienced feeling unwell, dizziness, vaginal itching, vaginal discharge, vaginal burning sensation, vaginal ulceration and clotting disorder. In February 2020, the outcome of the nausea, shivering, fever and dizziness were resolved with sequelae and the outcome of the vaginal itching, vaginal discharge, vaginal burning sensation and vaginal ulceration were recovered/resolved. On an unknown date, the outcome of the feeling unwell was unknown and the outcome of the headache was recovering/resolving and the outcome of the clotting disorder was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, nausea, headache, shivering, fever, dizziness, vaginal itching, vaginal discharge, vaginal burning sensation, vaginal ulceration and clotting disorder to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. At 1:00 PM, the patient receieved a dose of Shingrix on the left arm. Most of the symptoms presented by 10 PM that night. The patient was not feeling well since she got the vaccine. The patient experienced nausea which was resolved at time of reporting. The headache was severe at first and described as a spinal headache.  It has improved but was still present in between her temples. The fever lasted for 4 days. The dizziness lasted 5 days. The onset date of the vaginal issues was unknown.  It started with itching and clear discharge and 24 hours later burning presented which was caused by open ulcers in the vaginal area.  The issues resolved within 3 days.  The patient had a history of thin blood but usually International normalised ratio measures between 2 to 3.5 and sometimes even 1 but on day of reporting her International normalised ratio was 4.2 and a week ago it was 4.1
Age: 64.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Abdominal discomfort, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: I experienced the common effects of pain,minimal redness & swelling at injection site, muscle pain, tiredness, chills, slight upset stomach & lastly a herpes fever blister on my lip (which is normal for me if I do not feel well).
Age: 64.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Injection site swelling, Malaise, Myalgia, Oral herpes
Clinical narrative: I experienced the common effects of pain,minimal redness & swelling at injection site, muscle pain, tiredness, chills, slight upset stomach & lastly a herpes fever blister on my lip (which is normal for me if I do not feel well).
Age: 2.0
Sex: M
Vaccine: DTAP, UNK
Symptoms: Immediate post-injection reaction, Injection site cellulitis, Injection site discharge, Injection site erythema, Injection site swelling
Clinical narrative: Thigh instantly turned red after injection. When we got home a few hours later it had swollen almost double in size. 2 days after injection we went back to the dr cause it?s scanned over and oozing liquid now. They diagnosed him with cellulitis and he?s now on antibiotics and cream for 10 days
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Muscle aches, shivering, fatigue.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: Pediatric patient (17 years old) received adult dose of Havrix. Follow-up with patient the following clinic day, patient reported soreness at injection site, denied any other signs/symptoms of adverse reaction or complication.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Discomfort, Rash, Rash erythematous, Rash morbilliform, Rash pruritic
Clinical narrative: Patient broke out in bumps all over his body. They started out subtle and after a few days were bright red and all over. They looked exactly like measles and were very itchy and uncomfortable for him. When we brought him to the emergency room they freaked out and put us in a type of quarantine room thinking that he really had the measles. They were finally able to determine that it was a strong reaction to the vaccines. We treated with Benadryl and calamine lotion. He also got RSV at the same time.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Vaccination complication
Clinical narrative: Patient broke out in bumps all over his body. They started out subtle and after a few days were bright red and all over. They looked exactly like measles and were very itchy and uncomfortable for him. When we brought him to the emergency room they freaked out and put us in a type of quarantine room thinking that he really had the measles. They were finally able to determine that it was a strong reaction to the vaccines. We treated with Benadryl and calamine lotion. He also got RSV at the same time.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Day after injection  2-20-2020 severe headache, fatigue - felt flu like, some joint pain - not terrible, very sore at injection site.  2nd day after injection 2-21-2020 most of flu like symptoms were gone - still painful at injection site and now having muscle spasms in the area of the injection.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: Day after injection  2-20-2020 severe headache, fatigue - felt flu like, some joint pain - not terrible, very sore at injection site.  2nd day after injection 2-21-2020 most of flu like symptoms were gone - still painful at injection site and now having muscle spasms in the area of the injection.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Pain in extremity, Pruritus
Clinical narrative: Left arm red from shoulder to just above elbow by the end of the day received the vaccine.  c/o arm hurts and itches.  Cold compress applied to arm.  Mother applied benadryl/cortisone cream to reddened area as instructed by ER.  Took child to PCP 2/21/20.  Instructed to continue with cold compress 6-10 hours qd, continue with benadryl/cortisone cream to reddened area, and also ordered claritin.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching that started on the evening of 02/20/2020, did not report specific time. At school school nurse observed that child was very itchy and contacted the parent. PCP confirmed no respiratory distress and advised that child be evaluated in office. Child seen in office and noted to have  Hive right arm, backs of bilat legs and abdomen. Dose of ala-hist given in office and pt discharged.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Feeling abnormal, Mobility decreased
Clinical narrative: Pt states she just felt really tired and couldn't really move her body as much"I just didn't feel good" , Pt never came in and get evaluated pt never told us about the Sx after the vaccine that lasted 1 day until pt was seen again in clinic and we offered 2nd dose of MenB Vaccine.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms, including chills, stuffy head, headache, tiredness, body ache
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Respiratory tract congestion
Clinical narrative: Flu-like symptoms, including chills, stuffy head, headache, tiredness, body ache
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Chills
Clinical narrative: Uncontrollable shivering for 3 evenings. Temperature between 99.3 to 100.5 for 9 days and still continuing during evenings
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Uncontrollable shivering for 3 evenings. Temperature between 99.3 to 100.5 for 9 days and still continuing during evenings
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Nausea, tiredness, fever, body aches day after Extremely sore arm one week later (2/22/2020)
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain
Clinical narrative: Soreness in left arm at injection site; treated with Tylenol Between 24-48 hours after injection, I experienced body aches similar to flu symptoms; treated with Tylenol After 48 hours, all symptoms slowly subsided; continues treatment with Tylenol After 4 days, the only remaining symptom is very slight soreness at injection site
Sex: F
Vaccine: HEP
Symptoms: Headache, Injection site paraesthesia, Paraesthesia, Swelling of eyelid, Urticaria
Clinical narrative: left eye swollen shut. tingling in limb from point of shot to fingers  hives Headache.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Extra dose administered
Clinical narrative: had titers drawn and they were low; patient received MMR II 2 doses as a child and 3 doses as adult; This spontaneous report was received from a physician refers to a 47-year-old female patient who was a health care personnel. Her concomitant therapies included sterile diluent. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. On an unknown dates as a child, the patient received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) an three doses on an unknown dates as an adult (exact dose, route and site of administration, lot# and expiration date). On an unknown date, the patient had titers drawn and they were low. The outcome of low titers was reported as not recovered/not resolved. The outcome of inappropriate schedule of product administration is unknown. The relatedness between the low titers and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional adverse effects; the patient received one dose each proquad and varivax during the same office visit; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 13-FEB-2020, the patient was vaccinated with one dose each of: measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin  (rHA) (PROQUAD) lot # S003172, expiration date 30-JUL-2020 (exact dose, dose # and route of administration were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, dose #, route of administration, lot # and expiration date were not reported) both for prophylaxis. The vaccines were reconstituted with sterile diluent (STERILE DILUENT) (strength, dose, frequency, route of administration, lot # and expiration date were not reported). No additional effects reported.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Blepharospasm, Cheilitis, Pain, Rhinorrhoea
Clinical narrative: Pain; Left side eye twitching; Rash on lip; Runny nose; This case was reported by a consumer via call center representative and described the occurrence of pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2019, the patient received Shingrix. On 12th February 2020, 87 days after receiving Shingrix, the patient experienced pain, blepharospasm, rash lips and runny nose. On an unknown date, the outcome of the pain, blepharospasm, rash lips and runny nose were not recovered/not resolved.   It was unknown if the reporter considered the pain, blepharospasm, rash lips and runny nose to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced pain left side eye twitching and rash on lip and runny nose. The patient wanted to know how long the vaccine could last. Reporter consented to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: redness and warmth to arm; redness and warmth to arm; This is a spontaneous report from a contactable other HCP and consumer. A 64-years-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), via an unspecified route of administration in arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced redness and warmth to arm and she never had that with same vaccine in past. The patient agreed to notify MD.   Information on the Lot/Batch number has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pain, Pyrexia, Rash
Clinical narrative: allergic reaction: Rash across upper left , fever, severe pain
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Rash located distal to vaccination site approx. 2 inches in length, 1 in width, erythema present with itching and burning sensation, no edema
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Abnormal behaviour, Eye movement disorder, Facial paralysis, Magnetic resonance imaging brain normal, Strabismus
Clinical narrative: We noticed our child?s eyes crossing the morning of 02/16/2020. By Wednesday, 02/19/2020, her left eye was completely turned inward (esotropia) and the left side of her face was drooping. She was not acting like herself which warranted a visit to her doctor. We saw the doctor on Thursday, 02/20/2020, where he completed a physical exam and suggested we go to the emergency room at the Medical hospital for a MRI. That evening, the MRI showed a normal brain scan without abnormalities. Given her history, it was determined that she had sixth cranial nerve palsy, most likely caused by her recent MMR vaccination.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: VIth nerve paralysis
Clinical narrative: We noticed our child?s eyes crossing the morning of 02/16/2020. By Wednesday, 02/19/2020, her left eye was completely turned inward (esotropia) and the left side of her face was drooping. She was not acting like herself which warranted a visit to her doctor. We saw the doctor on Thursday, 02/20/2020, where he completed a physical exam and suggested we go to the emergency room at the Medical hospital for a MRI. That evening, the MRI showed a normal brain scan without abnormalities. Given her history, it was determined that she had sixth cranial nerve palsy, most likely caused by her recent MMR vaccination.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Decreased appetite, Disorientation, Disturbance in attention, Dizziness
Clinical narrative: extreme photsensitivityand audio sens, chroni fatigue, insomnia, inability to regulate temp, migratory hot prickles and joint pain, head and neck pain, vision change, memory problems, dizziness, disorientation, loss of appetite, swollen lyph nodes and sore throat, withdrawn from school for about 4 months lack of attention - reported by mom,
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Feeling hot, Headache, Hyperacusis, Insomnia
Clinical narrative: extreme photsensitivityand audio sens, chroni fatigue, insomnia, inability to regulate temp, migratory hot prickles and joint pain, head and neck pain, vision change, memory problems, dizziness, disorientation, loss of appetite, swollen lyph nodes and sore throat, withdrawn from school for about 4 months lack of attention - reported by mom,
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Memory impairment, Neck pain, Oropharyngeal pain, Photosensitivity reaction
Clinical narrative: extreme photsensitivityand audio sens, chroni fatigue, insomnia, inability to regulate temp, migratory hot prickles and joint pain, head and neck pain, vision change, memory problems, dizziness, disorientation, loss of appetite, swollen lyph nodes and sore throat, withdrawn from school for about 4 months lack of attention - reported by mom,
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Social avoidant behaviour, Temperature regulation disorder, Visual impairment
Clinical narrative: extreme photsensitivityand audio sens, chroni fatigue, insomnia, inability to regulate temp, migratory hot prickles and joint pain, head and neck pain, vision change, memory problems, dizziness, disorientation, loss of appetite, swollen lyph nodes and sore throat, withdrawn from school for about 4 months lack of attention - reported by mom,
Sex: F
Vaccine: TYP
Symptoms: Urinary tract infection
Clinical narrative: Got an urinary tract infection (UTI) the day she was to take the second dose of Vivotif; Took first dose of Vivotif on 03JAN2020 and started taking Augmentin on 05JAN2020; Spontaneous report received on 09JAN2020. Additional information received on 13JAN2020.  A 59-year-old female pharmacist reported that she "got an urinary tract infection (UTI) the day she was to take the second dose of Vivotif" (PT: Urinary tract infection) and also she "took first dose of Vivotif on 03JAN2020 and started taking Augmentin on 05JAN2020" (PT: Labelled drug-drug interaction medication error). She was receiving Vivotif for immunisation and Augmentin (amoxicillin/clavulanate) for UTI. The consumer took first dose of Vivotif on 03JAN2020 and developed urinary tract infection on 05JAN2020. She took Augmentin as a treatment medication for urinary tract infection from 05JAN2020 to 11JAN2020. Moreover, she stated that she did not take the remaining three doses of Vivotif. Action taken with Vivotif with respect to the reported event "got an urinary tract infection (UTI) the day she was to take the second dose of Vivotif" was drug withdrawn, while with respect to the event "took first dose of Vivotif on 03JAN2020 and started taking Augmentin on 05JAN2020" was not applicable. Action taken with Augmentin with respect to the reported events was not applicable. The consumer had recovered from the event "got an urinary tract infection (UTI) the day he was to take the second dose of Vivotif" while the outcome of the event "took first dose of Vivotif on 03JAN2020 and started taking Augmentin on 05JAN2020" was unknown.  Company Comment: A consumer took first dose of Vivotif on 03-Jan-2020 and was diagnosed with urinary tract infection on 05-Jan-2020, and on the same day she started taking amugmentin ( Labelled drug-drug interaction medication error). The consumer stopped taking Vivotif doses and urinary tract infection was resolved with augmentin course. Considering the infectious pathogenesis of urinary tract infection, the causality of the event is assessed as not related to Vivotif. There should be at least three days gap between Vivotif dose and antibiotic dose. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif on 03-Jan-2020 and was diagnosed with urinary tract infection on 05-Jan-2020, and on the same day she started taking amugmentin ( Labelled drug-drug interaction medication error). The consumer stopped taking Vivotif doses and urinary tract infection was resolved with augmentin course. Considering the infectious pathogenesis of urinary tract infection, the causality of the event is assessed as not related to Vivotif. There should be at least three days gap between Vivotif dose and antibiotic dose. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif.