chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix. On 25th September 2019, 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.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced pain at the injection site. The patient planned to follow up with her physician. The reporter consented to follow up. For tolerances of 2nd dose, refer case US2019229366, reported by same reporter for the same patient.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: experienced a sore arm after receiving the first dose; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of shingrix in the left arm. The reporter stated that, after vaccination, the patient experienced arm pain. The reporter consented to follow up. For tolerance to 2nd dose of Shingrix, refer case US2019229370.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months 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 case details were reported as follows: The reporter stated that the patient experienced soreness after her first dose in October 2019. The reporter consented to follow up. No further details were provided at the time of reporting.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Paraesthesia
Clinical narrative: numbness; tingling; soreness; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received the 1st dose of Shingrix. On 29th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On 30th November 2019, the patient experienced numbness in feet and tingling of extremity. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the numbness in feet and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, numbness in feet and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of the Shingrix vaccine and experienced soreness and redness at the injected site, which resolved in a few days.  On 30th November 2019, she started to feel numbness and tingling in the right foot which had been ongoing.  No additional information provided. Did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness at the injection site; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 1st dose of Shingrix. On 2nd December 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of the Shingrix vaccine and experienced pain at the injection site. The patient still had redness at the injection site which was over 4 inches in length. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (had a small patch of Shingles at the time she received the vaccine ).   In October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows At the time of vaccination patent was in early 60's. The patient received her first dose of Shingrix in October. She had a small patch of Shingles at the time she received the vaccine but was told by the pharmacist it was okay to receive the vaccine. The patient has not received but the one dose of Shingrix thus far. A few days ago, she developed shingles again.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Local reaction, Myalgia
Clinical narrative: very Fatigue; Muscle aches; expected local reactions; This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th December 2019, the patient received the 1st dose of Shingles vaccine. In December 2019, less than a week after receiving Shingles vaccine, the patient experienced fatigue, muscle pain and local reaction. On an unknown date, the outcome of the fatigue, muscle pain and local reaction were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, muscle pain and local reaction to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication The health care professional stated that, on friday evening before the day of reporting, the patient received dos of Shingles vaccine and was still very fatigued with muscle aches with the expected local reactions. No further information provided.It was not confirmed that shingles vaccine was Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Gastrointestinal disorder, Headache, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Flu Like Symptoms; Body ache; Fever; Cold; Headache; Fatigue; Shakiness; GI Symptoms; Drug dose administration interval too short; 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.   Concomitant products included Herpes zoster (Shingrix).   On 9th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, fever, cold, headache, fatigue, tremor, gastrointestinal symptom nos and drug dose administration interval too short. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, cold, headache, fatigue, tremor, gastrointestinal symptom nos and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, cold, headache, fatigue, tremor and gastrointestinal symptom nos to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient stated he received the first dose of Shingrix vaccine about a month ago. The patient received his second dose of Shingrix vaccine. With the second dose of Shingrix he experienced flu like symptoms, body ache, fever, cold, headache, fatigue, shakiness and GI symptoms. The reporter did not described what kind of GI symptoms he experienced. No further details were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pain, Pyrexia, Tremor
Clinical narrative: Flu Like Symptoms; Body ache; Fever; Cold; Headache; Fatigue; Shakiness; GI Symptoms; Drug dose administration interval too short; 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.   Concomitant products included Herpes zoster (Shingrix).   On 9th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, fever, cold, headache, fatigue, tremor, gastrointestinal symptom nos and drug dose administration interval too short. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever, cold, headache, fatigue, tremor, gastrointestinal symptom nos and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever, cold, headache, fatigue, tremor and gastrointestinal symptom nos to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient stated he received the first dose of Shingrix vaccine about a month ago. The patient received his second dose of Shingrix vaccine. With the second dose of Shingrix he experienced flu like symptoms, body ache, fever, cold, headache, fatigue, shakiness and GI symptoms. The reporter did not described what kind of GI symptoms he experienced. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pain, Skin mass
Clinical narrative: Lump; painful lump; Wrong route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of skin mass in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced skin mass, pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the skin mass and pain were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the skin mass and pain to be related to Shingrix.  Additional details were provided as follows: The dose of Shingrix was administered subcutaneously which led to intramuscular formulation administered by other route. The patient received dose one approximately three months ago, no exact date provided. It was patient experienced a lump following dose one of Shingrix.  The health care professional described the lump as painful Lump was ongoing, no additional details were provided. The health care professional could not provide lot number or expiration date because the patient received dose one at another location.  No additional details provided. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: an adverse reaction as expected; This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in an unspecified number of adult patients 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 adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had adverse reaction as expected per the VIS or PI. The reporter asked should we proceed differently with the 2nddose. The reporter did not consent to follow up. No communication with health care professional from call center.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: body aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient stated that her arm hurt worse after the first dose. The patient consented to follow up. This case has been linked to US2019229313, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccine positive rechallenge
Clinical narrative: redness at injection site; This case was reported by a consumer 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.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site erythema. Rechallenge with Shingrix was positive. 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 event was lasted for few days and then resolved. The reporter consented to follow up. This case has been linked with case US2019229380 and US2019AMR231840, reported by same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Pain in extremity
Clinical narrative: headache; upset stomach presented; experinced sore arm; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16th October 2019).   On 15th December 2019, the patient received the 2nd dose of Shingrix. On 15th December 2019, 12 hrs after receiving Shingrix, the patient experienced headache, upset stomach and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, upset stomach and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the headache, upset stomach and pain in arm to be related to Shingrix.  Additional details were provided as follows: Six hours after vaccination with dose of Shingrix, the patient experienced sore arm and approximately 12 hours after vaccination, experienced headache and upset stomach. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: experienced shingles after the first dose.; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient's demographic details were not provided. The age at vaccination was not provided. The age group of the patient was not reported but selected as an adult as per vaccine indication. The pharmacist reported that, in 2018, the patient received dose of Shingrix and experienced shingles. By the time this report was performed, the patient did not receive 2nd dose of Shingrix vaccine because of shingles after 1st dose. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes simplex
Clinical narrative: HSV Keratitis; This case was reported by a other health professional via sales rep and described the occurrence of herpes simplex keratitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 17 days 12 hrs after receiving Shingrix, the patient experienced herpes simplex keratitis (serious criteria GSK medically significant). On an unknown date, the outcome of the herpes simplex keratitis was unknown.   It was unknown if the reporter considered the herpes simplex keratitis to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient developed herpes simplex virus (HSV) keratitis in one eye with no trauma. The patient has seen ophthalmologist and was now in consultation with her primary care physician. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Received two doses of Shingrix and then had shingles/suspected vaccination failure; Shingles; This case was reported by a nurse via sales rep and described the occurrence of suspected vaccination failure in a 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, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received two doses of Shingrix and then experienced shingles. No further information was provided by field representative at the time of reporting. This case was considered as suspected vaccination failure since the details regarding time to onset for the event at the time of reporting were unknown.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Dyspnoea, Fatigue, Influenza, Injection site erythema
Clinical narrative: Anaphylactic Shock; Flu; Difficulty in breathing; Difficulty in swallowing; Body aches; Fatigue / Tiredness; Itching; redness in the injection site; Swollen throat; This case was reported by a nurse via sales rep and described the occurrence of anaphylactic shock in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number ZH79H, expiry date 28th March 2022) for prophylaxis.   On 13th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced anaphylactic shock (serious criteria GSK medically significant), influenza, difficulty breathing, swallowing difficult, general body pain, fatigue, pruritus, injection site erythema and throat swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylactic shock, influenza, difficulty breathing, swallowing difficult, general body pain, fatigue, pruritus, injection site erythema and throat swelling were unknown.   It was unknown if the reporter considered the anaphylactic shock, influenza, difficulty breathing, swallowing difficult, general body pain, fatigue, pruritus, injection site erythema and throat swelling to be related to Shingrix.  Additional details were provided as follows: The patient experienced anaphylactic shock, flu, difficulty in breathing, difficulty in swallowing, body aches, fatigue, tiredness, itching and redness in the injection site. The patient went to the emergency department and was given Benadryl and later discharged home The reporter consented to follow up. The batch number was changed from CH79H to ZH79H as per sales data sheet.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pharyngeal swelling, Pruritus
Clinical narrative: Anaphylactic Shock; Flu; Difficulty in breathing; Difficulty in swallowing; Body aches; Fatigue / Tiredness; Itching; redness in the injection site; Swollen throat; This case was reported by a nurse via sales rep and described the occurrence of anaphylactic shock in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number ZH79H, expiry date 28th March 2022) for prophylaxis.   On 13th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced anaphylactic shock (serious criteria GSK medically significant), influenza, difficulty breathing, swallowing difficult, general body pain, fatigue, pruritus, injection site erythema and throat swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the anaphylactic shock, influenza, difficulty breathing, swallowing difficult, general body pain, fatigue, pruritus, injection site erythema and throat swelling were unknown.   It was unknown if the reporter considered the anaphylactic shock, influenza, difficulty breathing, swallowing difficult, general body pain, fatigue, pruritus, injection site erythema and throat swelling to be related to Shingrix.  Additional details were provided as follows: The patient experienced anaphylactic shock, flu, difficulty in breathing, difficulty in swallowing, body aches, fatigue, tiredness, itching and redness in the injection site. The patient went to the emergency department and was given Benadryl and later discharged home The reporter consented to follow up. The batch number was changed from CH79H to ZH79H as per sales data sheet.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity, Poor quality sleep
Clinical narrative: sore arm; didnt sleep very well due to the soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received Shingrix. On 17th December 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and sleeplessness. On an unknown date, the outcome of the pain in arm and sleeplessness were recovering/resolving.   It was unknown if the reporter considered the pain in arm and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix at 4 pm, on the day before reporting. After vaccination in last night, the patient experienced sore arm and did nnot sleep well due to the soreness in the left arm. On the day of reporting, the patient felt better. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: pain at injection site; sensation of shocks running down arms and legs; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain 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, less than a month after receiving Shingrix, the patient experienced injection site pain and paresthesia. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the paresthesia was recovered/resolved.   It was unknown if the reporter considered the injection site pain and paresthesia to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix at a different pharmacy about one month ago and patient experienced pain at the injection site which persists and experienced sensation of shocks running down arms and legs which lasted for about 2 weeks. The reporter did not have initials or date of birth or exact date of vaccination available regarding this patient.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the friend's son got sick from Shingrix vaccine. This case has been linked to US2019180830, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: faint; This case was reported by a other health professional via sales rep and described the occurrence of faint in a adult patient 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 faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown.   It was unknown if the reporter considered the faint 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 was captured as an adult as per the vaccine indication. The patient fainted after receiving Shingrix. No other details on events were reported. This case was 1 of 2 cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: bad reaction after receiving the; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 92-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, unknown after receiving Shingrix, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was recovering/resolving.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a bad reaction after receiving the vaccination and resulted in hospitalization for 3 days. The details of the events are unknown. The follow up consent was not granted
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Joint stiffness, Skin warm
Clinical narrative: Arm was getting infected with cellulitis; Right wrist getting tight; Hot to the touch; This case was reported by a nurse via call center representative and described the occurrence of cellulitis of arm in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 9th December 2019, less than a day after receiving Shingrix, the patient experienced cellulitis of arm (serious criteria GSK medically significant), joint tightness and skin warm. The patient was treated with sulfamethoxazole + trimethoprim (Bactron) and vancomycin. On an unknown date, the outcome of the cellulitis of arm, joint tightness and skin warm were recovered/resolved.   It was unknown if the reporter considered the cellulitis of arm, joint tightness and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and then went to play tennis that afternoon and he felt his right wrist getting tight and it was hot to the touch. The patient went to the doctor and his arm was getting infected with cellulitis and they put him on oral Bactron. The cellulitis started to get worse so,he went to the emergency room and they administered Vancomycin and his issue resolved. The follow up consent was granted.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Nausea, Nervousness
Clinical narrative: Fever, chills, joint aches, dizzy, lightheaded, nausea, ringing in ears, almost fainted. Took ibuprofen. 10 am on the 24th, feel better but still dizzy and shaky.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Presyncope, Pyrexia, Tinnitus
Clinical narrative: Fever, chills, joint aches, dizzy, lightheaded, nausea, ringing in ears, almost fainted. Took ibuprofen. 10 am on the 24th, feel better but still dizzy and shaky.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: PT IS EXPERIENCING SORE ARMS AND REDNESS ON THE ARM
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Flu like symptoms appeared about 12 hours after the shot.  I felt fine following the shot and when I went to bed that night.  When I woke up the next morning I was achy, feverish, slightly nauseous, very tired.  Symptoms persisted all day.  Slept well that night and by the next morning all the symptoms were gone and did not return.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Joint range of motion decreased, Magnetic resonance imaging spinal, Muscle spasms
Clinical narrative: Continued pain in left shoulder beyond 48 hours - limited range of motion.  Shooting "pins and needles" pain down left arm.  Constant numbness in thumb, index and middle fingers of left hand.  Muscle spasms under armpit of left arm.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Continued pain in left shoulder beyond 48 hours - limited range of motion.  Shooting "pins and needles" pain down left arm.  Constant numbness in thumb, index and middle fingers of left hand.  Muscle spasms under armpit of left arm.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Chills, Decreased appetite, Diarrhoea
Clinical narrative: As per patient - " About 6 hours after the vaccination, I noticed my lower back was achy and then during the night, had chills.  The chills and aches continued for about 48 hours.  I have also had a loss of appetite and diarrhea."
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Insomnia, Pain
Clinical narrative: Flu Like Symptoms; Chills; Body ache; Difficulty sleeping; Fatigue; Sore arm; 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 17th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, chills, general body pain, difficulty sleeping and fatigue. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, chills, general body pain, difficulty sleeping and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, chills, general body pain, difficulty sleeping and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The patient received dose of Shingrix vaccine and experienced sore arm for 24 hrs. About 8 hours post vaccination she experienced flu like symptoms, chills, body aches, difficulty sleeping and fatigue.  The side effects resolved by lunchtime yesterday. No further details were provided. The follow up consent was not granted.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Flu Like Symptoms; Chills; Body ache; Difficulty sleeping; Fatigue; Sore arm; 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 17th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, influenza-like symptoms, chills, general body pain, difficulty sleeping and fatigue. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, chills, general body pain, difficulty sleeping and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms, chills, general body pain, difficulty sleeping and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The patient received dose of Shingrix vaccine and experienced sore arm for 24 hrs. About 8 hours post vaccination she experienced flu like symptoms, chills, body aches, difficulty sleeping and fatigue.  The side effects resolved by lunchtime yesterday. No further details were provided. The follow up consent was not granted.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Pain in extremity, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: dripping nose; sneezing; sore arm; fever,Slight temperature; stomach ache; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 66 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and developed sneezing(Sneezing), fever , slight temperature(Pyrexia), sore arm (pain in extremity) ,stomach ache (abdominal pain upper) and dripping nose (Rhinorrhoea).  The patient's past vaccination(s) included Fluzone and patient got sick. The medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Diabetes mellitus and has only one kidney.  On 08-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiration date not reported) via intramuscular route in the left arm..  On 09-Nov-2019, the patient developed a non-serious slight temperature (pyrexia), sore arm (pain in extremity), stomach ache (abdominal pain upper) one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On 18-Nov-2019, the patient developed a non-serious sneezing (sneezing) 10 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On 19-Nov-2019, the patient developed a non-serious fever (pyrexia), dripping nose (rhinorrhoea) 11 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Final diagnosis was sneezing, pyrexia, rhinorrhea, pain in extremity and abdominal pain upper.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for all the events.  Information on the batch number was requested.
Sex: F
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: started having dizziness and lightheadedness; Initial information received on 05-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 42 years old female patient who experienced started having dizziness and lightheadedness(Dizziness) while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6321AA of expiration date 07-Jun-2019, via unknown route in unknown administration site.  On 15-Aug-2019, the patient developed a non-serious dizziness and lightheadedness (Dizziness) within 24 hours following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Other relevant tests were not reported.  Final diagnosis was started having dizziness and lightheadedness.   It was not reported if the patient received a corrective treatment.  The patient event outcome is reported as Unknown.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: a patient was accidentally injected with expired Ipol/no AE; Initial information was received on 10-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.  This case involves a patient who was accidentally injected with an expired dose of POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (lot, expiration date, route and site of administration were not reported).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  It was not reported whether the patient had any adverse effect.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: only DTaP-IPV component of Pentacel was inadvertently administered to a patient/No AE; Initial information was received on 10-Dec-2019 regarding an unsolicited valid non-serious case from other health professional.  This case involves a patient of an unknown age who received only DTaP-IPV component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number not reported and expiration date unknown), via an unknown route at an unknown administration site.  Medical history, past medical treatments, vaccinations and family history were not provided.  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: U
Vaccine: FLU3
Symptoms: Bursitis
Clinical narrative: bursitis; Initial information received on 12-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2019SA348246.  This case involves two patient (unknown demography) who experienced bursitis (bursitis), while they received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patients received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the two patients developed a non-serious bursitis (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was bursitis.  It was not reported if the patients received a corrective treatment.  The event outcome is reported as Unknown for bursitis.  Information on the batch number was requested.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Pertussis
Clinical narrative: developed Whooping Cough; Initial information received on 17-Dec-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves a 17 years old male patient who experienced whooping cough (pertussis), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Jun-2013, the patient received standard 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U4612AA and expiry date: 20-Sep-2015) via unknown route in the left deltoid.  On 06-Jul-2019, the patient developed a serious whooping cough (pertussis) 6 years 22 days, following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. He continues to have the cough. This event was assessed as medically significant.  No lab data was reported.  Final diagnosis was whooping cough.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as  not recovered for whooping cough. He continues to have the cough; Sender's Comments: This case concerns 17 years old male patient who experienced pertussis after vaccination with ADACEL. The time to onset is compatible. However, there is no information regarding patient's condition at time of vaccination, immune status, predisposition to respiratory tract infections. There is no confirmation of the infection through lab tests. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Eye movement disorder, Tremor, Urinary incontinence
Clinical narrative: Per mom, while he was sitting his arms started to shake & eyes rolled back. Also urinated on himself
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient complained about pain at the site of injection which lasted about a week
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site pain, Injection site reaction, Muscle spasms
Clinical narrative: Patient called office on 12-23-19 @ 1620 to report that since his flu vaccine on 11-21-19 he had been having intermittent cramping to (L) upper arm at injection site. Denied any redness, or swelling at site. Provider called patient back on 12-24-19 and he described a "pinching", "achy" "Charlie Horse" feeling to (L) upper arm that started the day after he received the vaccination, worsens with increased ROM of (L) arm and subsides when arm still. (continued)
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Headache, Influenza like illness, Nasal congestion, Rhinorrhoea
Clinical narrative: Nine Days after my injection, flu like symptoms, (I never get sick) worst Nasal Congestion, then worst throat drip almost like a poison, had trouble breathing, worst headache ever in my life on the 12th day, I never get headaches, by the 15th day I felt a little better. I had more nasal and throat mucus in the last 2 weeks than most of my life time. I will think long and hard before I consider another Flu Shot.    I understand in is an Inactive Virus, I  "BEG TO DIFFER" ,  I work in a home office and was not near any customers for 95% of the 9 Days after my Injection. I felt somewhat better 12/23/2019.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Secretion discharge
Clinical narrative: Nine Days after my injection, flu like symptoms, (I never get sick) worst Nasal Congestion, then worst throat drip almost like a poison, had trouble breathing, worst headache ever in my life on the 12th day, I never get headaches, by the 15th day I felt a little better. I had more nasal and throat mucus in the last 2 weeks than most of my life time. I will think long and hard before I consider another Flu Shot.    I understand in is an Inactive Virus, I  "BEG TO DIFFER" ,  I work in a home office and was not near any customers for 95% of the 9 Days after my Injection. I felt somewhat better 12/23/2019.
Age: 58.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: urticaria all over body- started on right arm and extended down to her hand, spread to full body. patient also reported that she had hives in her throat but denied any issues with breathing. Fever  reported fever of 101 on 12/14/19. patient went to ER on 12/15/19.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Tenderness
Clinical narrative: Patient reported red golf ball size knot , red and tender  but improving
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse events; The patient received improperly stored vaccine of Pneumovax 23; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 16-DEC-2019 the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), lot # S006778, expiration date 28-NOV-2020 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion above 47°F/9°C 49.8F for 43 minutes, as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.