chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPVX
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a male patient who received HPV 16-18 (HPV vaccine) for prophylaxis. On an unknown date, the patient received HPV vaccine at an unknown dose. On an unknown date, unknown after receiving HPV vaccine, 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 HPV vaccine. Additional details were received as follows: The age at vaccination was not reported. The reporter was concerned about how terrible the vaccine was. It was on the top of the list with so many adverse reactions and side effects. The patient received vaccine and left bad enough reactions. This case was linked with case US2018GSK214693, reported by the same reporter (Daughter's case).
Sex: F
Vaccine: HPVX
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a female patient who received HPV vaccine for prophylaxis. On an unknown date, the patient received HPV vaccine at an unknown dose. On an unknown date, unknown after receiving HPV vaccine, 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 HPV vaccine. Additional details were received as follows: The age at vaccination was not reported. The reporter was concerned about how terrible the vaccine was. It was on the top of the list with so many adverse reactions and side effects. The patient received vaccine and left bad enough reactions. This case was linked with the case US2018GSK214692, reported by the same reporter (son's case).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included cancer (terminal cancer). On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient had two children and a wife. The patient was due for booster dose of SHINGRIX which was suddenly stopped supplying 3 months ago. The patient had a rare terminal cancer and one side effect of the experimental treatments was to contract and spread shingles to other people. The reporter said that since SHINGRIX had been approved, there were an extraordinary amount of demand from patients and healthcare professionals. Due to the remarkably high demand. Hence this vaccine would be temporarily out of stock. If the patient didn't received 2nd dose of SHINGRIX vaccine, this could probably cause a shingles epidemic. The patient reported to representative, this would become dangerous and anyone he come into contact with. The representative suggested to the patient to take suggestion from healthcare physician on how to continue the SHINGRIX series. Individual medical guidance should be provided by medical professionals. The representative provided FDA approval schedule to the patient. 1st dose of SHINGRIX should be at month 0, followed by a second dose 2 to 6 months after the first dose. If the patient was more than 6 months since the first dose, he or she should get the second dose a soon as possible and the patient did not need to restart the vaccine series. The patient suggested to the representative action on it as soon as possible. The experimental treatments the patient had been getting had decimated his immune system and while reporting the patient was already started getting outbreaks of shingles which the vaccine supposed to control. Without the second and final shot the patient might infect anyone who came into contact with him.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Incorrect route of product administration, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 11th September 2018, refer case US2018208355). On 9th November 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 9th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, fever, sweating, muscle soreness and intramuscular formulation administered by other route. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site erythema and muscle soreness were not recovered/not resolved and the outcome of the fever and sweating were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, fever, sweating and muscle soreness to be related to SHINGRIX. Additional details were reported as follows: The patient experienced the same symptoms as 1st dose. However, the second time she experienced fever, sweating, muscle soreness. The patient experienced these symptoms the same day she had the vaccine and they were gone by the next morning. However, the patient said that she still had some redness and soreness at the injection site. The patient received SHINGRIX subcutaneously instead of intramuscularly, which led to incorrect route of vaccine administration. The reporter did not give consent to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 11th September 2018, refer case US2018208355). On 9th November 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 9th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, fever, sweating, muscle soreness and intramuscular formulation administered by other route. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site erythema and muscle soreness were not recovered/not resolved and the outcome of the fever and sweating were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, fever, sweating and muscle soreness to be related to SHINGRIX. Additional details were reported as follows: The patient experienced the same symptoms as 1st dose. However, the second time she experienced fever, sweating, muscle soreness. The patient experienced these symptoms the same day she had the vaccine and they were gone by the next morning. However, the patient said that she still had some redness and soreness at the injection site. The patient received SHINGRIX subcutaneously instead of intramuscularly, which led to incorrect route of vaccine administration. The reporter did not give consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, 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 SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Limited information was provided by the caller. The caller reported that her brother experienced side effects after taking SHINGRIX. For tolerance after 2nd dose refer case US2018208946.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year 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 age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient had a sore arm of 2 months. The pharmacist consented to follow up. This was all the information provided. This case has been linked with the case US2018204750, reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site pain, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 71-year-old female patient who received SHINGRIX (batch number 3Z53C, expiry date 13th March 2021) for prophylaxis. On 7th November 2018, the patient received the 2nd dose of SHINGRIX. On 7th November 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and vaccine administered at inappropriate site. In November 2018, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising, injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site bruising and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient may have received SHINGRIX too far below the deltoid, which might led to vaccine administered at inappropriate site. The patient experienced injection site pain during administration and severe bruising was visible a few days later in the same arm. The reporter did not administer the vaccine and was therefore not certain of this. The reporter did not consent to follow-up. The reporter would prefer follow-up via phone call.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of red rash in a 64-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 6th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 7th November 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, tiredness and pain. On 14th November 2018, the patient experienced red rash and itchy rash. The patient was treated with VALTREX. On 7th November 2018, the outcome of the influenza-like symptoms, tiredness and pain were recovered/resolved. On an unknown date, the outcome of the red rash and itchy rash were recovering/resolving. It was unknown if the reporter considered the red rash, itchy rash, influenza-like symptoms, tiredness and pain to be related to SHINGRIX. Additional details were reported as follows: The patient received 1st dose of SHINGRIX vaccine on left arm. The reporter indicated that the next day after receiving the 2nd dose of the SHINGRIX vaccine, she began to had flu-like symptoms, including feeling tired and achy. These symptoms resolved within a day. On 14th November 2018, 8 days after receiving SHINGRIX, she woke up with a red, itchy rash in the middle of the right side of her stomach. The patient went to her physician and was prescribed VALTREX because he did not know if it could potentially be shingles. The patient reports that the rash was starting to resolve today. The reporter gave permission for her physician to be contacted and provided the information.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of red rash in a 64-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 6th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 7th November 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, tiredness and pain. On 14th November 2018, the patient experienced red rash and itchy rash. The patient was treated with VALTREX. On 7th November 2018, the outcome of the influenza-like symptoms, tiredness and pain were recovered/resolved. On an unknown date, the outcome of the red rash and itchy rash were recovering/resolving. It was unknown if the reporter considered the red rash, itchy rash, influenza-like symptoms, tiredness and pain to be related to SHINGRIX. Additional details were reported as follows: The patient received 1st dose of SHINGRIX vaccine on left arm. The reporter indicated that the next day after receiving the 2nd dose of the SHINGRIX vaccine, she began to had flu-like symptoms, including feeling tired and achy. These symptoms resolved within a day. On 14th November 2018, 8 days after receiving SHINGRIX, she woke up with a red, itchy rash in the middle of the right side of her stomach. The patient went to her physician and was prescribed VALTREX because he did not know if it could potentially be shingles. The patient reports that the rash was starting to resolve today. The reporter gave permission for her physician to be contacted and provided the information.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 11th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain and injection site erythema 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 injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX subcutaneously instead of intramuscularly, which led to incorrect route of vaccine administration. The reporter did not give consent to follow up. For tolerance after 2nd dose refer case US2018GSK216223.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX (batch number YF42409 ?, expiry date 30th June 2019) for prophylaxis. On 23rd October 2018, the patient received SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm, swelling arm and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, swelling arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were reported as follow: The patient received SHINGRIX on the right arm. In 2018, after vaccination the patient had difficulty using right arm due to pain and bad swelling. The patient was not available to asked if it was okay for physician follow up. Clarification has been raised for batch number.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Herpes zoster, Injection site bruising, Injection site haemorrhage, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 83-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (many times before). Previously administered products included flu vaccine, pneumonia vaccine and ZOSTAVAX. Concurrent medical conditions included macular degeneration, hypertension and diabetes. On 12th November 2018, the patient received the 1st dose of SHINGRIX. On 14th November 2018, less than a week after receiving SHINGRIX, the patient experienced feeling cold. In November 2018, the patient experienced injection site pain, injection site hemorrhage, injection site swelling, injection site bruising and shingles. In November 2018, the outcome of the injection site hemorrhage and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site bruising and shingles were not recovered/not resolved and the outcome of the feeling cold was recovered/resolved. It was unknown if the reporter considered the injection site pain, feeling cold, injection site hemorrhage, injection site swelling, injection site bruising and shingles to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right arm. The patient reports that on 14th November 2018 and 15th November 2018, her body felt very cold and she could not get warm. The patient reports that she experienced soreness at the injection site and when she removed the bandage from the site, the site bled quite a bit. The patient states that she used ice at the injection site to help with the swelling that she experienced. The patient states that there was also bruising at the injection site. The patient states that she had a shingles rash on her buttocks. The patient had not been officially diagnosed with shingles by her physician, however, she states that she has had shingles many times and always gets it on her buttocks and she knows what the rash looks like. The reporter did not consent to follow up. The patient did not wish to provide her address or HCP information.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 83-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (many times before). Previously administered products included flu vaccine, pneumonia vaccine and ZOSTAVAX. Concurrent medical conditions included macular degeneration, hypertension and diabetes. On 12th November 2018, the patient received the 1st dose of SHINGRIX. On 14th November 2018, less than a week after receiving SHINGRIX, the patient experienced feeling cold. In November 2018, the patient experienced injection site pain, injection site hemorrhage, injection site swelling, injection site bruising and shingles. In November 2018, the outcome of the injection site hemorrhage and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site bruising and shingles were not recovered/not resolved and the outcome of the feeling cold was recovered/resolved. It was unknown if the reporter considered the injection site pain, feeling cold, injection site hemorrhage, injection site swelling, injection site bruising and shingles to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right arm. The patient reports that on 14th November 2018 and 15th November 2018, her body felt very cold and she could not get warm. The patient reports that she experienced soreness at the injection site and when she removed the bandage from the site, the site bled quite a bit. The patient states that she used ice at the injection site to help with the swelling that she experienced. The patient states that there was also bruising at the injection site. The patient states that she had a shingles rash on her buttocks. The patient had not been officially diagnosed with shingles by her physician, however, she states that she has had shingles many times and always gets it on her buttocks and she knows what the rash looks like. The reporter did not consent to follow up. The patient did not wish to provide her address or HCP information.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 70-year-old female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, fever and tiredness. On an unknown date, the outcome of the shivering and fever were recovered/resolved and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the shivering, fever and tiredness to be related to SHINGRIX. Additional information was reported as follows: The patient was in her early 70s. The reporter did not have any more patient details. In November 2018, about a week ago before the date of reporting, the patient was vaccinated with the second dose of SHINGRIX. The patient was vaccinated around the morning or noon time and started experiencing the events at the midnight. The patient experienced shivering and fever on the same day of vaccination. The patient was recovered from the symptoms. The patient stated that she felt tired as a result of the vaccine, at the time of reporting.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 60-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose refer case, US2018GSK216414). Concurrent medical conditions included diabetes. On 16th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th September 2018, less than a day after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The caller reported that her brother did not feel good (unknown symptoms) after the SHINGRIX. Limited information was provided by the caller. The caller reported that her brother experienced side effects after taking SHINGRIX.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Amblyopia, Computerised tomogram normal, Diplopia, Influenza like illness, Nuclear magnetic resonance imaging normal
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 83-year-old female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, blurred vision, diplopia and lazy eye. In November 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the blurred vision and lazy eye were unknown and the outcome of the diplopia was not recovered/not resolved. The reporter considered the influenza-like symptoms, blurred vision, diplopia and lazy eye to be related to SHINGRIX. Additional details were provided as follows: The patient was the reporter's sister. About 4 days ago from the day of reporting, the patient received 2nd dose of SHINGRIX. The day after the vaccine, the patient had moderately severe flu like symptoms. While watching the television (TV) that day she noticed the captions were blurry. The next day she felt better and did not have any problems. The third day after the vaccine she started experiencing diplopia while driving. The patient had seen her ophthalmologist who said one muscle was weaker than the other causing an effect like lazy eye. A carotid exam, computerised tomogram (CT) or nuclear magnetic resonance imaging (MRI) did not show any problems. They still tried to determine what was the cause of the diplopia, but the reporter thought there was a relationship with the vaccine. Lab Comments: In November 2018, the patient underwent carotid exam which did not show any problems.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound Doppler, Vision blurred
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 83-year-old female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, blurred vision, diplopia and lazy eye. In November 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the blurred vision and lazy eye were unknown and the outcome of the diplopia was not recovered/not resolved. The reporter considered the influenza-like symptoms, blurred vision, diplopia and lazy eye to be related to SHINGRIX. Additional details were provided as follows: The patient was the reporter's sister. About 4 days ago from the day of reporting, the patient received 2nd dose of SHINGRIX. The day after the vaccine, the patient had moderately severe flu like symptoms. While watching the television (TV) that day she noticed the captions were blurry. The next day she felt better and did not have any problems. The third day after the vaccine she started experiencing diplopia while driving. The patient had seen her ophthalmologist who said one muscle was weaker than the other causing an effect like lazy eye. A carotid exam, computerised tomogram (CT) or nuclear magnetic resonance imaging (MRI) did not show any problems. They still tried to determine what was the cause of the diplopia, but the reporter thought there was a relationship with the vaccine. Lab Comments: In November 2018, the patient underwent carotid exam which did not show any problems.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received about 4 to 5 years ago.). In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, pain and feeling unwell. On an unknown date, the outcome of the headache, pain and feeling unwell were unknown. It was unknown if the reporter considered the headache, pain and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX in June 2018, and experienced response. The patient wouldn't call it, a reaction. He experienced headache and felt achy and didn't feel good for a couple days following the 1st dose of SHINGRIX.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 84-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date unknown) for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th September 2018, 13 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: The patient had no history of shingles. The pharmacist reported that one of his patient developed shingles. The patient lived in the patient's assistant living facility. On 24th September 2018, he was informed about the patient developing shingles.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site discomfort, Injection site pruritus
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 63-year-old male patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 8th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site discomfort and injection site itching. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site discomfort and injection site itching were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site discomfort and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. Beginning within 5 days, the patient experienced a reaction described as discomfort, itching and swelling just passed the deltoid towards the elbow. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received 11 years before reporting date). On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: About 2 weeks before reporting date, the patient developed a shingles rash on the left side of his body. The patient was seen by dermatologist and diagnosed with shingles. The shingles was resolving but had not cleared up till the reporting time. The contact details of the physician were provided. The reporter gave consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 19th July 2018, the patient received the 1st dose of SHINGRIX. On 20th July 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, chills and fever. On an unknown date, the outcome of the pain in arm, chills and fever were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a sore arm the next day, which resolved after 4 days. The patient experienced chills and fever which lasted about 2 and a half days. The reporter did not consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: 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 BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular). In November 2018, less than a month after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were received as follows: The age at vaccination was not reported. The patient's mother reported that approximately 2 weeks ago from the reporting date the received BEXSERO and experienced arm pain. The reporter reported that there was no sign of swelling or redness just pain in the arm. The reporter gave consent to follow up.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 83-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 13th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a month after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site discoloration and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site discoloration and injection site erythema were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site discoloration and injection site erythema to be related to SHINGRIX. Additional information received as follows: The patient experienced swelling at injection site of 3 by 4 inches in area. The reporter also describes area was white in color at injection site and then red around.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Reporter stated that he received the 2nd dose of SHINGRIX in right arm sometime in late October 2018 or early November 2018. One day after receiving the vaccine, the patient felt like he was coming down with the flu, but felt better as the day progressed. The reporter did not provide a consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Malaise, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms, fever, chills and feeling unwell were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, chills and feeling unwell to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient presented with flu like symptoms, fever, chills and did not feel well following a dose of SHINGRIX. The patient was out of commission for 1 to 2 days. The lot number and expiration date, date of administration and date of birth were not available at the time of reporting. The injection site and route of administration could not be confirmed.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms that lasted 24 hours after her 1st dose of SHINGRIX about 6 months ago.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received 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 injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The reporter made a call with the patient. Referred caller back to health care professional if symptoms persist. The reporter did not provide any additional information regarding adverse event before ending the call.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA323310, 2018SA323312 and 2018SA323314 (same reporter). This case involves a 18-year-old female patient who was vaccinated with a 0.25 ml dose of suspect FLUZONE QUADRIVALENT (Batch number: UT6315PA, expiration date: 30-Jun-2019, route: intramuscular and site of administration was left deltoid) on 21-NOV-2018 date. The patients medical history and concomitant medications were not reported. It is an actual medication case error due to vaccine underdose. It was reported that they accidentally gave 4 older children ages 11-18 an injection of 0.25mL of FLUZONE QUADRIVALENT instead of the 0.50mL dose.  The patient did not experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324608, 2018SA324603, 2018SA324605, 2018SA324604, 2018SA324607, 2018SA324609, 2018SA324606 and 2018SA324596 (same reporter). This case involves Elderly female patient received 0.5 ml dose of vaccine FLUZONE HIGH DOSE (lot number: UJ048AB, expiry date: 31-May-2019, dose in series was not reported) via intramuscular route in right deltoid. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. This was a case of actual medication error due to incorrect product storage because the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was unknown if any adverse event occurred or not following the vaccination. 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. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324602, 2018SA324603, 2018SA324604, 2018SA324609, 2018SA324606, 2018SA324607, 2018SA324608, 2018SA324605, 2018SA324605 and 2018SA324604 (same reporter). This case involves an elderly male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UJ048AB; expiry date: 31-May-2019) via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage and Deteriorated drug administered. It was not reported whether the patient experienced any adverse events. 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. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse by phone. This case is linked to cases 2018SA324603, 2018SA324602, 2018SA324605, 2018SA324604, 2018SA324607, 2018SA324609, 2018SA324596 and 2018SA324608 (same reporter). This case involves adult female patient (age not reported) was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UJ045AA and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was unknown if any adverse event occurred or not following the vaccination. 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. Documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324603, 2018SA324602, 2018SA324605, 2018SA324604, 2018SA324606, 2018SA324607, 2018SA324608, 2018SA324596 and 2018SA324607 (same reporter). This case involves Elderly male patient (age not reported) was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UJ045AA and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was unknown if any adverse event occurred or not following the vaccination. 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. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse by phone. This case is linked to cases 2018SA324602, 2018SA324605, 2018SA324604, 2018SA324607, 2018SA324609, 2018SA324606, 2018SA324596 and 2018SA324596 (same reporter). This case involves elderly female patient (age not reported) was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UJ045AA and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was unknown if any adverse event occurred or not following the vaccination. 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. Documents held by sender: none.