chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Wrong product administered
Clinical narrative: Patient marked form for flu vaccine but received pneumonia vaccine
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Electrocardiogram normal, Herpes zoster, Injection site pain, Pain
Clinical narrative: Shingles; Thick skin; she is in pain; the bones on her chest are hurting; Rash is Itching; injection site on the left arm is still sore; Torn rotator cuff; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rheumatoid arthritis, ehlers-danlos syndrome and rotator cuff repair (had three rotator cuff surgeries). Concomitant products included tofacitinib citrate (Xeljanz).   On 4th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th March 2020, less than a day after receiving Shingrix and an unknown time after starting Valacyclovir and capsaicin, the patient experienced rotator cuff tear. On 6th March 2020, the patient experienced shingles, skin thickening, pain, bone pain, itchy rash and injection site pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir), capsaicin, trolamine salicylate (Aspercreme) and steroids nos (Steroids). On an unknown date, the outcome of the shingles, skin thickening, pain, bone pain and rotator cuff tear were recovering/resolving and the outcome of the itchy rash and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, skin thickening, pain, bone pain, itchy rash, injection site pain and rotator cuff tear to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of shingrix in left arm and when she went to a store and tried to pick up a heavy bag of potatoes and tore her rotator cuff. Then she went to the orthopedic physician who gave her a steroid shot in the arm.  The patient had a history of Ehlers-Danlos syndrome and that makes her prone to tendons tearing easily hence she did not think the rotator cuff injury was related to the Shingrix vaccine. The patient said that by Friday or Saturday of that week, she was breaking out with a rash on her back and went over the right side of her body and in between her breasts. The patient had thick skin and rash but no blisters. The patient stated that she went to urgent care on 9th March 2020 and that she was told she has shingles. The patient was in pain and that the bones on her chest were hurt and that the rash were itching. She stated that she had an electrocardiogram performed after this happened and it came back negative. The patient stated that the injection site on the left arm was still sore but she had range of motion. The patient had history of rheumatoid arthritis for which she takes Xeljanz. The patient received Valacyclovir to treat the Shingles and Capsaicin and Aspercreme for the itching. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rotator cuff syndrome, Skin hypertrophy
Clinical narrative: Shingles; Thick skin; she is in pain; the bones on her chest are hurting; Rash is Itching; injection site on the left arm is still sore; Torn rotator cuff; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rheumatoid arthritis, ehlers-danlos syndrome and rotator cuff repair (had three rotator cuff surgeries). Concomitant products included tofacitinib citrate (Xeljanz).   On 4th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On 4th March 2020, less than a day after receiving Shingrix and an unknown time after starting Valacyclovir and capsaicin, the patient experienced rotator cuff tear. On 6th March 2020, the patient experienced shingles, skin thickening, pain, bone pain, itchy rash and injection site pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir), capsaicin, trolamine salicylate (Aspercreme) and steroids nos (Steroids). On an unknown date, the outcome of the shingles, skin thickening, pain, bone pain and rotator cuff tear were recovering/resolving and the outcome of the itchy rash and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, skin thickening, pain, bone pain, itchy rash, injection site pain and rotator cuff tear to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of shingrix in left arm and when she went to a store and tried to pick up a heavy bag of potatoes and tore her rotator cuff. Then she went to the orthopedic physician who gave her a steroid shot in the arm.  The patient had a history of Ehlers-Danlos syndrome and that makes her prone to tendons tearing easily hence she did not think the rotator cuff injury was related to the Shingrix vaccine. The patient said that by Friday or Saturday of that week, she was breaking out with a rash on her back and went over the right side of her body and in between her breasts. The patient had thick skin and rash but no blisters. The patient stated that she went to urgent care on 9th March 2020 and that she was told she has shingles. The patient was in pain and that the bones on her chest were hurt and that the rash were itching. She stated that she had an electrocardiogram performed after this happened and it came back negative. The patient stated that the injection site on the left arm was still sore but she had range of motion. The patient had history of rheumatoid arthritis for which she takes Xeljanz. The patient received Valacyclovir to treat the Shingles and Capsaicin and Aspercreme for the itching. The reporter consented to follow up.
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenitis
Clinical narrative: DEVELOPED ACUTE LYMPHADENITIS
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Chemotherapy, Pyrexia, Rash erythematous, Rash papular, Rash vesicular
Clinical narrative: 1/27/20 at 0545 Patient presented to ED with rash concerning for Varicella, first noticed on this date. He has a history of B ALL. He received chemo on 1/27/20 at 1100. Completed Cytarabine on 1/26/20, takes Thioguanine daily ordered 1/23/20-2/6/20. He was noted to have small clusters of erythematous vesicular papules on left forearm, left upper arm, left trunk and left back. Fever T max 99.5.  Treatment: admitted to Hospital. started on Acyclovir 500mg/m2/dose Q 8 hr. Follow up lesion and blood testing. Concerns for VZV being wild-type or vaccine strain re-activation given immunocompromised state. Sent to CDC for strain testing. Continued Acyclovir until 2/6/20 (date of last chemo).   Patient admitted on 1/27/20 to hospital. Patient discharged on 2/7/20. Patient?s mother reports he?s doing well since discharge per a progress note from MD on 2/13/20. Patient has not had any new lesions and current lesions are healing.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Skin lesion, Varicella virus test positive
Clinical narrative: 1/27/20 at 0545 Patient presented to ED with rash concerning for Varicella, first noticed on this date. He has a history of B ALL. He received chemo on 1/27/20 at 1100. Completed Cytarabine on 1/26/20, takes Thioguanine daily ordered 1/23/20-2/6/20. He was noted to have small clusters of erythematous vesicular papules on left forearm, left upper arm, left trunk and left back. Fever T max 99.5.  Treatment: admitted to Hospital. started on Acyclovir 500mg/m2/dose Q 8 hr. Follow up lesion and blood testing. Concerns for VZV being wild-type or vaccine strain re-activation given immunocompromised state. Sent to CDC for strain testing. Continued Acyclovir until 2/6/20 (date of last chemo).   Patient admitted on 1/27/20 to hospital. Patient discharged on 2/7/20. Patient?s mother reports he?s doing well since discharge per a progress note from MD on 2/13/20. Patient has not had any new lesions and current lesions are healing.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal disorder, Paraesthesia
Clinical narrative: On Feb 3, 2020 I was given the first Shingles shot in my upper right arm. It was painful and remains painful to this day. For the last two months  I have suffered from  limited use of my left arm if I try to dress, reach or move my arm in a certain direction. I also have a non-stop tingling sensation as if the needle where still in my arm. Very annoying. After 2 months of pain I thought it was best to report it to my doctor and the Pharmacy located on
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Injection site pain
Clinical narrative: Temperature 100.4 at 7:00 am on 4/5/2020, accompanied by Severe headache. Left upper injection site sore.  Administered 500 mg accetaminaphin every 6 hours for the next 36hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Psoriasis, Vaccination complication
Clinical narrative: SEVERE ONSET OF PSORIASIS LASTING UNTIL CURRENT DATE AND BEYOND. HAD HISTORY OF PSORIASIS, BUT ONLY A COUPLE 'BUMPS' ONCE IN A WHILE.  THIS ONSET TOOK OVER ENTIRE LEFT ARM AND SPREAD TO RIGHT ARM.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site pain
Clinical narrative: pt came into the pharmacy on 4/6/2020 and stated that her left arm was still hurting from her flu vaccine.  She described the pain to be in her upper arm.  I looked up the date the vaccine was given.  She stated that her other arm did not hurt.
Age: 55.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Extreme pain and difficulty raising arm for thet full days 10 days after injection Some pain at site for two days.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives started 4/2/20 both arms
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain
Clinical narrative: redness at injection site; pain ay injection site; received the first dose of Shingrix via subcutaneous route; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number DJ3FL, expiry date 5th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional information was provided as follows: The nurse reported that 17 patients received the first dose of Shingrix via subcutaneous route, which led to intramuscular formulation administered by other route. Some of them were female patients. Nurse did not provide initials, date of birth, lot number and expiration dates of the vaccines. She did not said how many patients were male and how many were female. This is 1 of the 17 cases, reported by same reporter.   Follow up information received from the nurse on 3rd April 2020: The patient's demographic details were updated. Concurrent medical conditions included asthma (started on 4th December 2014), hypertension (started on 9th May 2016) and hyperlipidemia (started on 9th May 2016).  On 24th January 2020, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. The batch number and expiry date details were updated. On 24th January 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site pain. The reporter considered the injection site erythema and injection site pain to be unrelated to Shingrix. The VAERS details were updated.  Upon internal review, the classification exclude was removed.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: Pain at injection site; received the first dose of Shingrix via subcutaneous route; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 22S3B, expiry date 25th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional information was provided as follows: The nurse reported that 17 patients received the first dose of Shingrix via subcutaneous route, which led to intramuscular formulation administered by other route. Some of them were female patients. Nurse did not provide initials, date of birth, lot number and expiration dates of the vaccines. She did not said how many patients were male and how many were female. This is 1 of the 17 cases, reported by same reporter.   Follow up information received from the nurse on 3rd April 2020: The patient's demographic details were updated. Concurrent medical conditions included osteoporosis (started on 3rd March 2019) and hypothyroidism (started on 15th January 2015).  On 21st January 2020, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. The batch number and expiry date details were updated. On 21st January 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be unrelated to Shingrix. The VAERS details were updated.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site rash
Clinical narrative: Rash at injection site; received the first dose of Shingrix via subcutaneous route; This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. Nurse reported that 17 patients received the first dose of Shingrix via subcutaneous route, which led to intramuscular formulation administered by other route. Some of them were female patients. Nurse did not provide initials, date of birth, lot number and expiration dates of the vaccines. She did not said how many patients were male and how many were female. This is 1 of the 17 cases, reported by same reporter.   Follow up information received from the nurse on 3rd April 2020: The patient's demographic details were updated. Concurrent medical conditions included coronary artery disease (CAD since 30th April 2015), mixed hyperlipidemia (since 30th April 2015), osteoarthritis (since 2015), degenerative joint disease (since 2018) and hypertension (since 30th April 2015).  On an unknown date, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved. The reporter considered the injection site rash to be unrelated to Shingrix. The VAERS details were updated.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site pain, Injection site pruritus
Clinical narrative: injection site pain; injection site pain; received the first dose of Shingrix via subcutaneous route; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number Y5J27, expiry date 8th November 2021) for prophylaxis.    On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional information was provided as follows: The nurse reported that 17 patients received the first dose of Shingrix via subcutaneous route, which led to intramuscular formulation administered by other route. Some of them were female patients. Nurse did not provide initials, date of birth, lot number and expiration dates of the vaccines. She did not said how many patients were male and how many were female. This is 1 of the 17 cases, reported by same reporter.   Follow up information received from the nurse on 3rd April 2020: The patient's demographic details were updated. The patient's past medical history included myocardial infarction (MI in 2010). Concurrent medical conditions included hypertension (since 14th June 2014), dyslipidemia (since 14th June 2017), hypertension (since 14th June 2017) and gastroesophageal reflux disease (since 14th June 2017). On 2nd December 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. The batch number and expiry date details were updated. On 2nd December 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site itching. On an unknown date, the outcome of the injection site pain and injection site itching were recovered/resolved. The reporter considered the injection site pain and injection site itching to be unrelated to Shingrix. The VAERS details were updated.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: injection site pain; received the first dose of Shingrix via subcutaneous route; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 22S3B, expiry date 25th March 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. Nurse reported that 17 patients received the first dose of Shingrix via subcutaneous route, which led to intramuscular formulation administered by other route. Some of them were female patients. Nurse did not provide initials, date of birth, lot number and expiration dates of the vaccines. She did not said how many patients were male and how many were female. This is 1 of the 17 cases, reported by same reporter.   Follow up information received from the nurse on 3rd April 2020: The patient's demographic details were updated. Concurrent medical conditions included hypertension (since 23rd April 2015), hypothyroidism (since 23rd April 2015), irritable bowel syndrome (IBS since 23rd April 2015) and hearing loss (since 23rd April 2015). On 31st January 2020, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 31st January 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. The outcome of the injection site pain was unknown. The reporter considered the injection site pain to be unrelated to Shingrix. The VAERS details were updated.  Upon internal review, the classification exclude was removed.
Sex: F
Vaccine: TYP
Symptoms: Concussion, Fall, Head injury, Syncope, Vomiting
Clinical narrative: CONCUSSION; SYNCOPAL EPISODE; HEAD INJURY; VOMITING; This spontaneous case (802951-1) was extracted through VAERS database on 24-May-2019. The case was reported by a healthcare professional. It describes a 25-year-old female consumer who had vomiting, syncopal episode, and concussion, after the administration of oral Vivotif (lot number: 3003239) for an unknown indication. She also reported that she fell and had a "head injury".  Case report: The consumer took the first dose of Vivotif on 20-Feb-2019 and the second dose on 23-Feb-2019. Then, after 2-3 hours, she vomited and had a syncopal episode. She also fell down and had a head injury. Later, she went to the emergency room and was diagnosed with a concussion.  The consumer had no medical history.  Concomitant medication included Estrostep (norethindrone acetate).  Action taken with Vivotif with respect to the events vomiting, syncopal episode, concussion, and "head injury" was unknown.  The consumer had recovered from the events vomiting, syncopal episode, concussion, and "head injury".  Company's Comment: In this case, it was reported that a 25-year-old female consumer had vomiting, syncopal episode, and concussion; she fell and had a "head injury" after the administration of oral Vivotif. There seems to be a temporal relationship between the intake of vaccine and events "vomiting and syncopal episode". Hence, the causality of the events with Vivotif has been assessed as possible. However, considering the nature of events, the causality of the event "concussion" and "head injury" was considered as not related. ; Sender's Comments: Company's Comment: In this case, it was reported that a 25-year-old female consumer had vomiting, syncopal episode, and concussion; she fell and had a "head injury" after the administration of oral Vivotif. There seems to be a temporal relationship between the intake of vaccine and events "vomiting and syncopal episode". Hence, the causality of the events with Vivotif has been assessed as possible.  However, considering the nature of events, the causality of the event "concussion" and "head injury" was considered as not related.
Sex: F
Vaccine: TYP, VARZOS
Symptoms: Blister, Herpes zoster, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: SHINGLES; CELLULITIS AT INJECTION SITE; This spontaneous case report (825765-1) was extracted through VAERS database on 25-Oct-2019. It described a 70-year-old female consumer who had "cellulitis at injection site" (PT: Injection site cellulitis) and "shingles" (PT: Herpes Zoster), while being on Vivotif and Shingrix vaccine (zoster vaccine) (non-company suspect) for an unknown indication.  Case report: The consumer took a dose of Vivotif on 26-Jul-2019, along with second dose of Shingrix vaccine. On 28-Jul-2019, she had a swollen, erythematous area on left deltoid area measuring 6.5x7 cm with cellulitis of injection site. She also had a complaint of itching of right forearm and upper back and fluid filled vesicles along the T2 dermatone on the underside of right forearm. It was reported that no rash was noted on back, but the intensely itchy area on right upper back was also along the T2 dermatone. She was finally diagnosed with shingles.  The consumer's medical history included hypothyroidism and had no allergies.  The consumer's concomitant medication included Synthroid (levothyroxine) for an unknown indication.  Action taken with Vivotif and Shingrix with respect to reported events was unknown.  The consumer had not recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer developed shingles and injection site reaction following administration of Vivotif and Shingrix. Although the events have been reported with reasonable time after intake of Vivotif, owing to the nature of the events the causality of the events was assessed as not related with Vivotif. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer developed shingles and injection site reaction following administration of Vivotif and Shingrix. Although the events have been reported with reasonable time after intake of Vivotif, owing to the nature of the events the causality of the events was assessed as not related with Vivotif.
Sex: F
Vaccine: TYP, VARZOS
Symptoms: Pruritus
Clinical narrative: SHINGLES; CELLULITIS AT INJECTION SITE; This spontaneous case report (825765-1) was extracted through VAERS database on 25-Oct-2019. It described a 70-year-old female consumer who had "cellulitis at injection site" (PT: Injection site cellulitis) and "shingles" (PT: Herpes Zoster), while being on Vivotif and Shingrix vaccine (zoster vaccine) (non-company suspect) for an unknown indication.  Case report: The consumer took a dose of Vivotif on 26-Jul-2019, along with second dose of Shingrix vaccine. On 28-Jul-2019, she had a swollen, erythematous area on left deltoid area measuring 6.5x7 cm with cellulitis of injection site. She also had a complaint of itching of right forearm and upper back and fluid filled vesicles along the T2 dermatone on the underside of right forearm. It was reported that no rash was noted on back, but the intensely itchy area on right upper back was also along the T2 dermatone. She was finally diagnosed with shingles.  The consumer's medical history included hypothyroidism and had no allergies.  The consumer's concomitant medication included Synthroid (levothyroxine) for an unknown indication.  Action taken with Vivotif and Shingrix with respect to reported events was unknown.  The consumer had not recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer developed shingles and injection site reaction following administration of Vivotif and Shingrix. Although the events have been reported with reasonable time after intake of Vivotif, owing to the nature of the events the causality of the events was assessed as not related with Vivotif. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer developed shingles and injection site reaction following administration of Vivotif and Shingrix. Although the events have been reported with reasonable time after intake of Vivotif, owing to the nature of the events the causality of the events was assessed as not related with Vivotif.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: Not felling well; Bug bite; rash on her body; Rash also described as itchy; Shingles; at the site of injection her arm became reddish/ injection site slightly pink; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox as a child and has not received any varicella vaccines or herpes zoster vaccines in the past.). Previously experienced adverse reactions included hives (Hives after iodine dye). Concurrent medical conditions included autoimmune disorder.   On 20th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced injection site erythema. On 21st February 2020, the patient experienced generalized rash, itchy rash, shingles and bug bite. On 25th February 2020, the patient experienced feeling unwell. The patient was treated with valaciclovir hydrochloride (Valacyclovir), benadryl (nos) (Benadryl) and hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the injection site erythema, generalized rash and itchy rash were not recovered/not resolved and the outcome of the shingles, feeling unwell and bug bite were unknown.   It was unknown if the reporter considered the injection site erythema, generalized rash, itchy rash, shingles, feeling unwell and bug bite to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix vaccine in the left arm. The patient had chickenpox, immune disorder and hives after iodine dye as an historical condition. The reporter stated that, on the day of reporting, the injection site was slightly pink and estimates it was approximately 80 percent resolved. The day after vaccination, the patient had rash on body and was taking long time to gone away and thought it was getting bigger. The patient described rash on back and lower right side of abdomen as an island that spread, initially the patient thought the rash was bug bites but it spread. The next day after vaccination, the patient had shingles and was seen by the doctor on the day of reporting and on the day of reporting stated that not felt well. The patient received Benadryl, Hydrocortisone cream and valcyclovir as a treatment medication. The patient did not receive any varicella vaccines or herpes zoster vaccines in the past and not had shingles in the past. The reporter consented to follow up. This case has been linked with case US2020AMR033749, reported by same reporter.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Malaise, Rash, Rash pruritic
Clinical narrative: Not felling well; Bug bite; rash on her body; Rash also described as itchy; Shingles; at the site of injection her arm became reddish/ injection site slightly pink; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox as a child and has not received any varicella vaccines or herpes zoster vaccines in the past.). Previously experienced adverse reactions included hives (Hives after iodine dye). Concurrent medical conditions included autoimmune disorder.   On 20th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced injection site erythema. On 21st February 2020, the patient experienced generalized rash, itchy rash, shingles and bug bite. On 25th February 2020, the patient experienced feeling unwell. The patient was treated with valaciclovir hydrochloride (Valacyclovir), benadryl (nos) (Benadryl) and hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the injection site erythema, generalized rash and itchy rash were not recovered/not resolved and the outcome of the shingles, feeling unwell and bug bite were unknown.   It was unknown if the reporter considered the injection site erythema, generalized rash, itchy rash, shingles, feeling unwell and bug bite to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix vaccine in the left arm. The patient had chickenpox, immune disorder and hives after iodine dye as an historical condition. The reporter stated that, on the day of reporting, the injection site was slightly pink and estimates it was approximately 80 percent resolved. The day after vaccination, the patient had rash on body and was taking long time to gone away and thought it was getting bigger. The patient described rash on back and lower right side of abdomen as an island that spread, initially the patient thought the rash was bug bites but it spread. The next day after vaccination, the patient had shingles and was seen by the doctor on the day of reporting and on the day of reporting stated that not felt well. The patient received Benadryl, Hydrocortisone cream and valcyclovir as a treatment medication. The patient did not receive any varicella vaccines or herpes zoster vaccines in the past and not had shingles in the past. The reporter consented to follow up. This case has been linked with case US2020AMR033749, reported by same reporter.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Burning sensation, Eye infection, Feeding disorder
Clinical narrative: Not felling well; Bug bite; rash on her body; Rash also described as itchy; Shingles; at the site of injection her arm became reddish/ injection site slightly pink; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox as a child and has not received any varicella vaccines or herpes zoster vaccines in the past.). Previously experienced adverse reactions included hives (Hives after iodine dye). Concurrent medical conditions included autoimmune disorder.   On 20th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced injection site erythema. On 21st February 2020, the patient experienced generalized rash, itchy rash, shingles and bug bite. On 25th February 2020, the patient experienced feeling unwell. The patient was treated with valaciclovir hydrochloride (Valacyclovir), benadryl (nos) (Benadryl) and hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the injection site erythema, generalized rash and itchy rash were not recovered/not resolved and the outcome of the shingles, feeling unwell and bug bite were unknown.   It was unknown if the reporter considered the injection site erythema, generalized rash, itchy rash, shingles, feeling unwell and bug bite to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix vaccine in the left arm. The patient had chickenpox, immune disorder and hives after iodine dye as an historical condition. The reporter stated that, on the day of reporting, the injection site was slightly pink and estimates it was approximately 80 percent resolved. The day after vaccination, the patient had rash on body and was taking long time to gone away and thought it was getting bigger. The patient described rash on back and lower right side of abdomen as an island that spread, initially the patient thought the rash was bug bites but it spread. The next day after vaccination, the patient had shingles and was seen by the doctor on the day of reporting and on the day of reporting stated that not felt well. The patient received Benadryl, Hydrocortisone cream and valcyclovir as a treatment medication. The patient did not receive any varicella vaccines or herpes zoster vaccines in the past and not had shingles in the past. The reporter consented to follow up. This case has been linked with case US2020AMR033749, reported by same reporter.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Hepatitis, Herpes zoster, Insomnia, Pain, Pruritus
Clinical narrative: Not felling well; Bug bite; rash on her body; Rash also described as itchy; Shingles; at the site of injection her arm became reddish/ injection site slightly pink; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox as a child and has not received any varicella vaccines or herpes zoster vaccines in the past.). Previously experienced adverse reactions included hives (Hives after iodine dye). Concurrent medical conditions included autoimmune disorder.   On 20th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced injection site erythema. On 21st February 2020, the patient experienced generalized rash, itchy rash, shingles and bug bite. On 25th February 2020, the patient experienced feeling unwell. The patient was treated with valaciclovir hydrochloride (Valacyclovir), benadryl (nos) (Benadryl) and hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the injection site erythema, generalized rash and itchy rash were not recovered/not resolved and the outcome of the shingles, feeling unwell and bug bite were unknown.   It was unknown if the reporter considered the injection site erythema, generalized rash, itchy rash, shingles, feeling unwell and bug bite to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix vaccine in the left arm. The patient had chickenpox, immune disorder and hives after iodine dye as an historical condition. The reporter stated that, on the day of reporting, the injection site was slightly pink and estimates it was approximately 80 percent resolved. The day after vaccination, the patient had rash on body and was taking long time to gone away and thought it was getting bigger. The patient described rash on back and lower right side of abdomen as an island that spread, initially the patient thought the rash was bug bites but it spread. The next day after vaccination, the patient had shingles and was seen by the doctor on the day of reporting and on the day of reporting stated that not felt well. The patient received Benadryl, Hydrocortisone cream and valcyclovir as a treatment medication. The patient did not receive any varicella vaccines or herpes zoster vaccines in the past and not had shingles in the past. The reporter consented to follow up. This case has been linked with case US2020AMR033749, reported by same reporter.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Rash, Skin lesion
Clinical narrative: Not felling well; Bug bite; rash on her body; Rash also described as itchy; Shingles; at the site of injection her arm became reddish/ injection site slightly pink; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox as a child and has not received any varicella vaccines or herpes zoster vaccines in the past.). Previously experienced adverse reactions included hives (Hives after iodine dye). Concurrent medical conditions included autoimmune disorder.   On 20th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a day after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced injection site erythema. On 21st February 2020, the patient experienced generalized rash, itchy rash, shingles and bug bite. On 25th February 2020, the patient experienced feeling unwell. The patient was treated with valaciclovir hydrochloride (Valacyclovir), benadryl (nos) (Benadryl) and hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the injection site erythema, generalized rash and itchy rash were not recovered/not resolved and the outcome of the shingles, feeling unwell and bug bite were unknown.   It was unknown if the reporter considered the injection site erythema, generalized rash, itchy rash, shingles, feeling unwell and bug bite to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix vaccine in the left arm. The patient had chickenpox, immune disorder and hives after iodine dye as an historical condition. The reporter stated that, on the day of reporting, the injection site was slightly pink and estimates it was approximately 80 percent resolved. The day after vaccination, the patient had rash on body and was taking long time to gone away and thought it was getting bigger. The patient described rash on back and lower right side of abdomen as an island that spread, initially the patient thought the rash was bug bites but it spread. The next day after vaccination, the patient had shingles and was seen by the doctor on the day of reporting and on the day of reporting stated that not felt well. The patient received Benadryl, Hydrocortisone cream and valcyclovir as a treatment medication. The patient did not receive any varicella vaccines or herpes zoster vaccines in the past and not had shingles in the past. The reporter consented to follow up. This case has been linked with case US2020AMR033749, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On an unspecified date in 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions.  On an unspecified date (reported as "subsequent to inoculation"), the pt was hospitalized and treated for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment and quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. Outcome was not recovered and causality was reported as related.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer on 02-APR-2020, regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (no additional dosage regimen information was reported). Subsequently, on an unknown date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of vaccination, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and cost included care for hospitalization, physician care, monitoring treatment, medications and supplies; diminished capacity for enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; information had been received on from a lawyer and the patient (pt), regarding a case in litigation referring a female pt of unknown age.  In 2016, the pt was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (route anatomical location, lot number and expiration date were not provided) for Long term prevention of shingles and/or zoster-related conditions.  Subsequent to pt´s Zoster Vaccine Live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result Zoster Vaccine Live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 05-OCT-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescriber/administered by a pharmacist (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was not recovered.  The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).