chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Arm soreness; Fever; could hardly move the arm; pain in the arm woke her up; This case was reported by a consumer and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2019, the patient received Shingrix. On 21st August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, mobility decreased and sleep disturbance. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, fever, mobility decreased and sleep disturbance were unknown.   It was unknown if the reporter considered the pain in arm, fever, mobility decreased and sleep disturbance to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and her arm sore for the rest of the day.  That night of vaccination, pain in the arm woke her up and she had a fever and could hardly move the arm. She got up and took Tylenol and could go back to sleep.  The next day of vaccination, the fever continued until about mid-afternoon day after vaccination.  It then got much better. This case linked with US2019AMR206279, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Shingrix vaccination made you sore; This case was reported by a consumer and described the occurrence of pain in an unspecified number of elderly female 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 pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The consumer reported that, if the 1st Shingrix vaccination made you sore then the second one would not be as painful and if the first one was not bad then the second one would be very painful. This case linked with US2019AMR206249, reported by same reporter.
Sex: M
Vaccine: DTAP
Symptoms: Musculoskeletal stiffness, Screaming
Clinical narrative: scream an ear piercing scream; body tensed all day; This case was reported by a consumer via interactive digital media and described the occurrence of stiffness in a 33-year-old male patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Infanrix. On an unknown date, less than a day after receiving Infanrix, the patient experienced stiffness and screaming. On an unknown date, the outcome of the stiffness was recovered/resolved and the outcome of the screaming was unknown.   It was unknown if the reporter considered the stiffness and screaming to be related to Infanrix.  Additional details were provided as follows:  The age at vaccination was not reported. Post vaccination the patient's body tensed all day and he would scream an ear piercing Scream. The physician was informed and the next time, the physician did not administer the Pertussis portion of the shot. The patient was now 33 and still has not been immunized for Pertussis.
Age: 83.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fluid retention, Headache, Hypotension
Clinical narrative: shaking chill 12 hours after the injection; headache; No appetite for 4 days; retained fluid weight gain 5 pounds.; small and minor redness at the injection site; my blood pressure is down; Cold; This case was reported by a consumer via call center representative and described the occurrence of chills in a 83-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in september 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced chills, headache, appetite lost, fluid retention, injection site erythema, low blood pressure and cold. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills, headache, appetite lost, fluid retention, injection site erythema, low blood pressure and cold were unknown.   It was unknown if the reporter considered the chills, headache, appetite lost, fluid retention, injection site erythema, low blood pressure and cold to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had a shaking chill, cold and had headache and shooyingvpaus from neck down. No appetite for 4 days retained fluid weight gain 5 pounds.  The reporter reported that did all they said was it happens take tylenol and drink water and the blood pressure was up and at the time of reporting it was down. The patient said just that arm at the site of injection was negative. Nothing but a small and minor redness barely noticeable.      Lab Comments: lab test performed on unknown date
Age: 83.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Nasopharyngitis, Weight increased
Clinical narrative: shaking chill 12 hours after the injection; headache; No appetite for 4 days; retained fluid weight gain 5 pounds.; small and minor redness at the injection site; my blood pressure is down; Cold; This case was reported by a consumer via call center representative and described the occurrence of chills in a 83-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in september 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced chills, headache, appetite lost, fluid retention, injection site erythema, low blood pressure and cold. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the chills, headache, appetite lost, fluid retention, injection site erythema, low blood pressure and cold were unknown.   It was unknown if the reporter considered the chills, headache, appetite lost, fluid retention, injection site erythema, low blood pressure and cold to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had a shaking chill, cold and had headache and shooyingvpaus from neck down. No appetite for 4 days retained fluid weight gain 5 pounds.  The reporter reported that did all they said was it happens take tylenol and drink water and the blood pressure was up and at the time of reporting it was down. The patient said just that arm at the site of injection was negative. Nothing but a small and minor redness barely noticeable.      Lab Comments: lab test performed on unknown date
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Injection site reaction
Clinical narrative: shingles; ring at injection site; condition aggravated; This case was reported by a pharmacist via other manufacturer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (previously had Shingles had it vaginally in the outer).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles, injection site reaction and condition aggravated. On an unknown date, the outcome of the shingles, injection site reaction and condition aggravated were unknown.   It was unknown if the reporter considered the shingles, injection site reaction and condition aggravated to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had a severe ring at the injection side for several days afterwards, but the big thing was that the patient said that she also previously when she had it vaginally in the outer. The reporter said that it was ongoing and she said that has also reactivated.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Pain, Tremor
Clinical narrative: hurt like heck; felt miserable; overcoming sensation with chills; overcoming sensation with shakes; This case was reported by a pharmacist via sales rep and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 18 hrs after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced pain, chills, tremor and feeling miserable. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the pain was unknown and the outcome of the chills, tremor and feeling miserable were recovered/resolved.   It was unknown if the reporter considered the pain, chills, tremor and feeling miserable to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced hurt like heck and had an overcoming sensation with shakes and chills. The patient also felt miserable. The patient will receive the 2nd dose in January. This case has been linked to US2019203750, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: had fevers of 102F-103F; vomiting; This case was reported by a physician via sales rep and described the occurrence of fever in a child patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   In 2019, the patient received Fluarix Quadrivalent 2019-2020 season. In 2019, less than a week after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced fever and vomiting. On an unknown date, the outcome of the fever and vomiting were unknown.   It was unknown if the reporter considered the fever and vomiting to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The age at vaccination was not reported. The batch number was not reported. The physician stated that the patient age of 6 months to 5 years old received Fluarix Quadrivalent 2019-2020 season vaccine and within 24-48 hours the patient had fever of 102F-103F and vomiting.
Sex: U
Vaccine: TDAP
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction bad; This case was reported by a consumer via interactive digital media (facebook) and described the occurrence of allergic reaction in a patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to DTPa vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Dtap vaccine and had a allergic reaction bad.
Sex: U
Vaccine: TDAP, VARZOS
Symptoms: Headache, Hypertension
Clinical narrative: really bad headache; blood pressure also got extremely high; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix and the 1st dose of Boostrix. In December 2019, 1 day after receiving Shingrix and Boostrix, the patient experienced headache and blood pressure high. On an unknown date, the outcome of the headache and blood pressure high were unknown.   It was unknown if the reporter considered the headache and blood pressure high to be related to Shingrix and Boostrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication.  The patient recently received a dose of Shingrix and Boostrix, a day or two after patient began experienced really bad headache which was a side effect. The patients' blood pressure also got extremely high and have been having a problem getting it back under control. The patient asked was the blood pressure issue a reported side effect. Further information was not reported.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel horrible; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019, the patient received the 2nd dose of Shingrix. On 13th December 2019, 1 days after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine on day before reporting and on day of reporting the patient felt horrible. The patient asked how long did the side effects last. The reporter requesting consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: pain at injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, immediately after receiving Bexsero, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter reported that when the patient was given the vaccine she said that Bexsero "hurts". She explained further and said was referring to injection site pain. Consent to follow up was denied.
Sex: U
Vaccine: FLU4
Symptoms: Adverse drug reaction
Clinical narrative: reaction; This case was reported by a nurse via patient support programs and described the occurrence of adverse drug reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent 2018-2019 season, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to FluLaval Quadrivalent 2018-2019 season.  Additional details were received as follows: The age at vaccination was not reported. The reporter called requesting 2018 insert for the Flulaval quad pfs product. The reporter stated that the patient had a reaction to the product and the patients mother was looking to receive the insert.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 69-year-old female 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 injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, after vaccination with dose of shingrix, experienced injection site redness, which lasted for few days and then resolved. The reporter consented to follow up. This case has been linked with case US2019229382, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on back; This case was reported by a consumer via call center representative and described the occurrence of rash in a female 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and developed a rash on her back. The reporter asked was that a normal reaction to the vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: severe pain at injection site/tender to touch at injection site; redness at injection site; swelling at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 227FL, expiry date 30th November 2020) for prophylaxis.   On 3rd November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. The patient was treated with cortisone (non-proprietary) (Cortisone Injection) and lidocaine (Lidocaine Patch). On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had injection site pain, injection site erythema and injection site swelling and tender to touch at injection site. The pharmacist reported that the patient went to the emergency room twice, on unknown dates, and received a cortisone injection and lidocaine patch. The reporter consented to follow up. Emergency room visit required. Limited information was provided by the pharmacist.
Sex: F
Vaccine: VARZOS
Symptoms: Eye discharge, Eyelid margin crusting, Pain in extremity, Skin discolouration, Swelling face
Clinical narrative: Arm soreness; Left eye sealed up with yellowgunk; left side of her face was turning yellow and was swollen / some swelling at the jaw line; skin discoloration; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix. On 6th November 2019, 2 days after receiving Shingrix, the patient experienced pain in arm, eye discharge, facial swelling and skin discoloration. On an unknown date, the outcome of the pain in arm, facial swelling and skin discoloration were unknown and the outcome of the eye discharge was recovered/resolved.   It was unknown if the reporter considered the pain in arm, eye discharge, facial swelling and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 4th November 2019, the patient receive the 1st dose of Shingrix vaccine and two days later when she got up in the morning she noted her left eye was sealed up with yellow gunk on it, and the left side of her face was turning yellow and was swollen. She also experienced arm soreness and states there was still some swelling present at her jawline. The reporter was requested to provide consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: fever; shivering/could not get warm; headache; knocked down/ sickness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immune system disorder.   On 4th December 2019, the patient received the 1st dose of Shingrix. On 4th December 2019, less than a day after receiving Shingrix, the patient experienced fever, shivering, headache and feeling unwell. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, shivering, headache and feeling unwell were not recovered/not resolved.   The reporter considered the fever and headache to be related to Shingrix. It was unknown if the reporter considered the shivering and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's daughter  The last night before the time of reporting, she started experiencing a fever, shivering, could not get warm, and headache. The reporter could not find the heating pad last night to keep her warm. The patient was knocked down. The patient was not recovered.  The patient treated with Tylenol. The reporter did not know if her mother received the shot intramuscularly or not. The reporter did not have the lot number of the Shingrix which was administered in front of her she said that her mother may have that information but she did not want to disturb her as she was resting/sleeping. The reporter stated that she called the pharmacy where her mother got the injection to let them know that her mom was sick and they said that every once in a while people will be knocked down for a few days after getting injection with Shingrix.  The reporter wanted to find out what was in Shingrix that was making people sick for days. She wanted to know if it had preservatives in it.  The reporter was upset because her mother was supposed to go away but now that she is sick she cannot travel.  The pharmacist informed her that the median duration of side effect was 2-3 days. This case has been linked to the case US2019AMR232958, reported by same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; shivering/could not get warm; headache; knocked down/ sickness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immune system disorder.   On 4th December 2019, the patient received the 1st dose of Shingrix. On 4th December 2019, less than a day after receiving Shingrix, the patient experienced fever, shivering, headache and feeling unwell. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, shivering, headache and feeling unwell were not recovered/not resolved.   The reporter considered the fever and headache to be related to Shingrix. It was unknown if the reporter considered the shivering and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's daughter  The last night before the time of reporting, she started experiencing a fever, shivering, could not get warm, and headache. The reporter could not find the heating pad last night to keep her warm. The patient was knocked down. The patient was not recovered.  The patient treated with Tylenol. The reporter did not know if her mother received the shot intramuscularly or not. The reporter did not have the lot number of the Shingrix which was administered in front of her she said that her mother may have that information but she did not want to disturb her as she was resting/sleeping. The reporter stated that she called the pharmacy where her mother got the injection to let them know that her mom was sick and they said that every once in a while people will be knocked down for a few days after getting injection with Shingrix.  The reporter wanted to find out what was in Shingrix that was making people sick for days. She wanted to know if it had preservatives in it.  The reporter was upset because her mother was supposed to go away but now that she is sick she cannot travel.  The pharmacist informed her that the median duration of side effect was 2-3 days. This case has been linked to the case US2019AMR232958, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash pruritic
Clinical narrative: clusters of bumps at the base of her back, both shoulders, one on the left hip, and under the right breast and the front left side of her neck; Blisters; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced itchy rash and blister. On an unknown date, the outcome of the itchy rash and blister were recovering/resolving.   It was unknown if the reporter considered the itchy rash and blister to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after getting the Shingrix vaccine, she broke out in, she got more break outs in her vaginal area, on the right thigh, right base of the head, and the front left side of her neck. The patient described that the rash was itchy and they were blisters. This case has been linked to US2019222795, reported by the same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: headache; body ache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2019, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, less than a week after receiving Shingrix, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were unknown.   It was unknown if the reporter considered the headache and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was  reported by the patient's wife. After receiving Shingrix, the patient experienced headache and body ache. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Mobility decreased, Off label use, Pain
Clinical narrative: Stay in bed; Difficult to move; Pain; off label use; This case was reported by a pharmacist via call center representative and described the occurrence of bedridden in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced bedridden, mobility decreased, pain and off label use. On an unknown date, the outcome of the bedridden, mobility decreased, pain and off label use were unknown.   It was unknown if the reporter considered the bedridden, mobility decreased and pain to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix 2 months ago. The patient experienced an adverse reaction as stay in bed with difficult to move, pain following the dose of Shingrix.  The health care professional wanted to know if the patient should receive the 2nd dose, and in the case she received it, if the same adverse reaction was going to happen. The health care professional also stated that the patient had Shingles prior the administration of the first dose of the vaccine, that the patient went to a doctor who recommended her to receive the Shingrix shot, which led to off label use. Consented to follow up was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Fever blisters are severe again; This case was reported by a other health professional via call center representative and described the occurrence of fever blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fever blister (had history of fever blisters).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had fever blisters are severe again. No other information was provided. The reporter stated that the fever blisters not occurring regularly, but at the time of reporting, once one was gone, another pop right up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: severe itching on the palms of her hands; This case was reported by a consumer via call center representative and described the occurrence of itching both hands in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th December 2019, 2 days after receiving Shingrix, the patient experienced itching both hands. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the itching both hands was recovering/resolving.   It was unknown if the reporter considered the itching both hands to be related to Shingrix.  Additional details were received as follows: The patient stated that she got the 2nd dose of Shingrix and had severe itching on the palms of her hands. The patient took some Benedryl and it went away for awhile before coming back. The patient did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Circumstance or information capable of leading to medication error, Fatigue, Inappropriate schedule of product administration, Nausea
Clinical narrative: tired; fever; nausea; chills; circumstance or information capable of leading to medication error; 2nd dose 10 day before the 2 month; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tiredness, fever, nausea, chills, circumstance or information capable of leading to medication error and drug dose administration interval too short. On an unknown date, the outcome of the tiredness, fever, nausea and chills were recovering/resolving and the outcome of the circumstance or information capable of leading to medication error and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the tiredness, fever, nausea and chills to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix about a month and a half ago and experienced the effects as noted in this report the day after her vaccination. She would like to receive her 2nd dose 10 day before the 2-month mark so she may travel out of the country, which led to circumstance or information capable of leading to medication error and shortening of vaccination schedule. The reporter did not consent to follow up. The call was transferred from MI and the patient did not want to provide her contact information.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: tired; fever; nausea; chills; circumstance or information capable of leading to medication error; 2nd dose 10 day before the 2 month; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tiredness, fever, nausea, chills, circumstance or information capable of leading to medication error and drug dose administration interval too short. On an unknown date, the outcome of the tiredness, fever, nausea and chills were recovering/resolving and the outcome of the circumstance or information capable of leading to medication error and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the tiredness, fever, nausea and chills to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix about a month and a half ago and experienced the effects as noted in this report the day after her vaccination. She would like to receive her 2nd dose 10 day before the 2-month mark so she may travel out of the country, which led to circumstance or information capable of leading to medication error and shortening of vaccination schedule. The reporter did not consent to follow up. The call was transferred from MI and the patient did not want to provide her contact information.
Sex: F
Vaccine: VARZOS
Symptoms: Thyroglobulin increased
Clinical narrative: Thyroglobulin test that had very high results; This case was reported by a consumer via call center representative and described the occurrence of thyroglobulin increased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included thyroidectomy (had Thyroidectomy in 2017). Concomitant products included DENOSUMAB (PROLIA).   On 11th November 2019, the patient received the 1st dose of Shingrix. On 11th November 2019, less than a day after receiving Shingrix, the patient experienced thyroglobulin increased. On an unknown date, the outcome of the thyroglobulin increased was unknown.   It was unknown if the reporter considered the thyroglobulin increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after receiving Shingrix just had  a thyroglobulin test that had very high results. The reporter stated to report for retesting to determine if there was a fluke and was awaiting results. The reporter did not consent to follow up.
Sex: M
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 a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In November 2019, less than a month after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was resolved with sequelae.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows.  This case was reported by the patient's father. The age at vaccination was not reported. The patient had flu like symptoms after vaccination a month before the time of reporting. The reporter did not consent to follow up. This case has been linked with case US2019230480, reported by the same reporter.
Sex: M
Vaccine: FLUR4
Symptoms: Back pain, Blood pressure increased, Blood test, Computerised tomogram abnormal, Injection site pain
Clinical narrative: blood pressure was also elevated; severe pain in the upper, right, injection arm and the middle of the back of his neck; severe pain in the upper, right, injection arm and the middle of the back of his neck; Initial information received on 16-Dec-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves a 72 years old male patient who experienced severe pain in the upper, right, injection arm and the middle of the back of his neck (Pain in extremity and neck pain) and blood pressure was also elevated (blood pressure increased), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  On 21-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot 2SAA1937 and expiry date: 16-Jun-2022) via unknown route in the right arm.  On an unknown date, the patient developed a serious severe pain in the upper, right, injection arm and the middle of the back of his neck (Pain in extremity and neck pain), and blood pressure was also elevated (blood pressure increased) 2 week  following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The patient was hospitalized for this event during 5 days. The patient was admitted 07-Nov-2019 and discharged on 12-Nov-2019 (hospitalization during 5 days).  Reporter informed that the pain occurred for 4 weeks. The patient was given many tests but the could not determine a diagnosis. Nothing helped the pain, they tried everything.  (Other relevant tests included CT scans, MRIs and blood work.)  Final diagnosis was pain, vaccination site reaction and blood pressure increased.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient outcome was reported as unknown for the all events.; Sender's Comments: This case concerns an 72 years old male patient who presented with pain, vaccination site reaction and blood pressure increased after vaccination FLUBLOK QIV. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLUR4
Symptoms: Magnetic resonance imaging, Neck pain, Vaccination site reaction
Clinical narrative: blood pressure was also elevated; severe pain in the upper, right, injection arm and the middle of the back of his neck; severe pain in the upper, right, injection arm and the middle of the back of his neck; Initial information received on 16-Dec-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves a 72 years old male patient who experienced severe pain in the upper, right, injection arm and the middle of the back of his neck (Pain in extremity and neck pain) and blood pressure was also elevated (blood pressure increased), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  On 21-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot 2SAA1937 and expiry date: 16-Jun-2022) via unknown route in the right arm.  On an unknown date, the patient developed a serious severe pain in the upper, right, injection arm and the middle of the back of his neck (Pain in extremity and neck pain), and blood pressure was also elevated (blood pressure increased) 2 week  following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The patient was hospitalized for this event during 5 days. The patient was admitted 07-Nov-2019 and discharged on 12-Nov-2019 (hospitalization during 5 days).  Reporter informed that the pain occurred for 4 weeks. The patient was given many tests but the could not determine a diagnosis. Nothing helped the pain, they tried everything.  (Other relevant tests included CT scans, MRIs and blood work.)  Final diagnosis was pain, vaccination site reaction and blood pressure increased.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient outcome was reported as unknown for the all events.; Sender's Comments: This case concerns an 72 years old male patient who presented with pain, vaccination site reaction and blood pressure increased after vaccination FLUBLOK QIV. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Red, hard lump at site of injection.
Age: 52.0
Sex: F
Vaccine: FLU4, HEPAB, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had complaints of swelling, itching and pain at the injection site. The injection site was warm to the touch with erythema measuring  80 mm x 70 mm and an induration of 40mm. Patient stated that she had used a cold compress at the injection site. Patient was referred to Urgent Care.
Age: 52.0
Sex: F
Vaccine: FLU4, HEPAB, MMR, TDAP, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Patient had complaints of swelling, itching and pain at the injection site. The injection site was warm to the touch with erythema measuring  80 mm x 70 mm and an induration of 40mm. Patient stated that she had used a cold compress at the injection site. Patient was referred to Urgent Care.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Injection site pain
Clinical narrative: 101 fever. Shivers, nausea, dizziness, severe muscle aches, pain at injection site, severe stomach pain, exhaustion
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: 101 fever. Shivers, nausea, dizziness, severe muscle aches, pain at injection site, severe stomach pain, exhaustion
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itchy small welt areas on forehead; Red small welt areas on forehead; Red small welt areas on forehead; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 78-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received Shingrix. In November 2019, less than 2 weeks after receiving Shingrix, the patient experienced pruritus, erythema and welts. On an unknown date, the outcome of the pruritus, erythema and welts were unknown.   It was unknown if the reporter considered the pruritus, erythema and welts to be related to Shingrix.  Additional details were provided as follows: Post vaccination with Shingrix the patient had itchy red small welt areas on his forehead. The patient inquired if had any connection to the shingles shot.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Painful for 24 hrs / Very painful; This case was reported by a consumer via call center representative and described the occurrence of pain in a 71-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 pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's 1st dose was painful for 24 hours.  This case is linked to another case US2019AMR211993 for the same patient (2nd dose).
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise, Oral herpes, Pain in extremity
Clinical narrative: bumps; cold sore; felt like flu; tired; sore arm; felt sick; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 5th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 6th June 2019, 1 days after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced influenza like illness, tiredness and pain in arm. On 4th November 2019, the patient experienced cold sores. On 10th November 2019, the patient experienced papular rash. On an unknown date, the patient experienced feeling unwell. On an unknown date, the outcome of the influenza like illness, tiredness, pain in arm and feeling unwell were recovered/resolved and the outcome of the cold sores and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the influenza like illness, tiredness, pain in arm, feeling unwell, cold sores and papular rash to be related to Shingrix. It was unknown if the reporter considered the cold sores and papular rash to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received dose of Shingrix and felt like flu and was tired and had a sore arm. The patient felt sick for about 1 week before the symptoms resolved. On 4th November 2019, the patient experienced cold sore and last night before day of reporting, the patient noticed some bumps coming up on body. The reporter consented to follow up.