chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 07-OCT-2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On or about 03-OCT-2015, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Influenza like illness, Injection site erythema
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 55-year-old male patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX. On 17th October 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema and influenza-like symptoms. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and influenza-like symptoms were recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: On Tuesday, the patient received SHINGRIX on left deltoid. The day after vaccination with SHINGRIX, the patient experienced flu-like symptoms, injection site redness and swelling (extensive swelling of vaccinated limb). The area affected had been expanding to cover a 3 by 6 inch area. These symptoms had almost completely resolved. It was beginning to resolve.
Age: 76.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Groin pain, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of buttock pain in a 76-year-old male patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. Concomitant products included FLUZONE HIGH DOSE. On 25th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 25th October 2018, less than an hour after receiving SHINGRIX, the patient experienced buttock pain, pain in thigh and groin pain. On an unknown date, the outcome of the buttock pain, pain in thigh and groin pain were recovering/resolving. It was unknown if the reporter considered the buttock pain, pain in thigh and groin pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid and FLUZONE HIGH DOSE on the left arm on the same day at the same time. The patient complained of severe tingling pain of buttock, thigh and groin within 4 to 5 minutes of vaccine administration. The pharmacist stated the patient reported feeling better before leaving the pharmacy, but went home so unknown if symptoms resolved at the time of reporting.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Skin warm, Urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of erythema urticarial in a elderly female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received SHINGRIX and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema urticarial, skin warm, pain and drug administration error. On an unknown date, the outcome of the erythema urticarial, skin warm, pain and drug administration error were unknown. It was unknown if the reporter considered the erythema urticarial, skin warm and pain to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient received flu vaccine (not sure which prescribed) and SHINGRIX in same arm at same time, which led to drug administration error. The patient experienced large red whelp, warm to touch and painful. The reporter did not agree to be contacted for follow up.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Ocular hyperaemia, Pain, Superficial injury of eye
Clinical narrative: Chills, fatigue, body aches, red scratchy eyes. Improved the next day.
Sex: U
Vaccine: HPV4
Symptoms: Multiple sclerosis
Clinical narrative: This spontaneous report was received form social medial via vendor, concerning two teenager patients of unknown age and gender.  The patients' concurrent, historical conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with a dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (dosage, frequency, route of administration, lot number and expiration date, were not provided) for prophylaxis. On unspecified date, at a recent forum in San Diego, researchers presented two cases of multiple sclerosis (MS) that had developed in teenagers , on unknown dates, after receiving Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine. The outcome of the event was not reported. Upon internal review, multiple sclerosis was considered to be a medical significant event.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a pharmacist at a pharmacy, recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a pharmacist administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. In 2016, the patient was treated by a physician at a healthcare facility (hospital) for shingles (It was not further specified if this was an inpatient hospitalization in 2016.) The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization (Dates of inpatient hospitalization not reported), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: This case was reported by a other health professional and described the occurrence of swelling arm in a adult patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On 29th October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. In October 2018, less than a week after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced swelling arm, erythema of extremities, skin warm and raised rash. On an unknown date, the outcome of the swelling arm, erythema of extremities, skin warm and raised rash were unknown. It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and raised rash to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The reporting medical assistant was a patient herself. The patient's arm was swollen, red and warm to touch. The patient also had tiny bumps covering the area. The patient called to report the adverse reactions she was having, but no one answered so she decided to email.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. In seeing reporter during an influenza vaccination event, the patient stated that he had recently received their SHINGRIX vaccine and that one really hurt. The reporter had no additional details available at time of report, but agreed to follow-up by safety department.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain 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, immediately after receiving SHINGRIX, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were unknown. It was unknown if the reporter considered the injection site pain and fatigue to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient experienced some local pain after injection immediately, with fatigue 28 hours later. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 59-year-old female patient who received SHINGRIX (batch number 4LP5Y, expiry date unknown) for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient had swelling in the deltoid area which was the size of a tennis ball within 24 hours of vaccination. It was associated with redness and a little pain. The events persisted for 5 to 6 days and fully resolved. There was no streaking, fever, lump or hardness observed. The reporter did not agree to be followed up and did not provide the contact details. For tolerance after 1st dose of SHINGRIX, refer case US2018GSK189804.
Sex: M
Vaccine: MEN
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 Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, less than an hour after receiving Meningococcal B 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 Meningococcal B vaccine. Additional details were reported as follows: The case was reported by the patient's father. The age at vaccination was not reported. Less than 5 minutes after vaccination, the patient experienced a terrible reaction. The patient would not be getting the 2nd dose. The patient never had a problem with any other vaccinations ever, but this one scared the patient's father.
Sex: F
Vaccine: TDAP
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received DTaP vaccine for prophylaxis. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, less than a week after receiving DTaP vaccine, 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 DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient was forced to get a TDaP vaccine in the reporting week and had been sick all week.
Sex: M
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, immediately after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were reported as follows: This case was reported by a nurse who gave the 2nd injection of BEXSERO. The age at vaccination was not reported. Few years before the date of reporting, the patient received a dose of BEXSERO. The patient reported that, the injection was painful and was not able to dress himself. The nurse gave consent to follow up. For tolerance after 2nd dose of SHINGRIX, refer case US2018199518.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a elderly male patient who received 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. No information on first dose of SHINGRIX was provided. Consent to follow up was provided. For tolerance to 2nd dose please refer case US2018203342.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced fever, injection site pain, injection site swelling, erythema, feeling unwell, injection site warmth and injected limb mobility decreased. On an unknown date, the outcome of the fever, injection site pain, injection site swelling, erythema, feeling unwell, injection site warmth and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the fever, injection site pain, injection site swelling, erythema, feeling unwell, injection site warmth and injected limb mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The vaccine was administered at the end of August at 11:00 or 1:00 in the afternoon. That same day the injection site was hot to the touch and swollen and painful. The less than a week after receiving SHINGRIX, the patient could not move her arm due to the pain. The patient said less than a week after receiving SHINGRIX, she felt sick but couldn't remember details regarding feeling sick. The next morning 1 day after receiving SHINGRIX, she woke with a fever of 102 or 103. The fever reduced the following day to 99.3 or 4.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced fever, injection site pain, injection site swelling, erythema, feeling unwell, injection site warmth and injected limb mobility decreased. On an unknown date, the outcome of the fever, injection site pain, injection site swelling, erythema, feeling unwell, injection site warmth and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the fever, injection site pain, injection site swelling, erythema, feeling unwell, injection site warmth and injected limb mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The vaccine was administered at the end of August at 11:00 or 1:00 in the afternoon. That same day the injection site was hot to the touch and swollen and painful. The less than a week after receiving SHINGRIX, the patient could not move her arm due to the pain. The patient said less than a week after receiving SHINGRIX, she felt sick but couldn't remember details regarding feeling sick. The next morning 1 day after receiving SHINGRIX, she woke with a fever of 102 or 103. The fever reduced the following day to 99.3 or 4.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 27th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site swelling and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid and experienced the severe pain at the injection site, swelling that was 3 cm in diameter, and redness at the injection site. The swelling and the redness were subsiding but she was experiencing severe pain at the injection site at the time of reporting. It felt like a major league baseball player threw the baseball at her left deltoid. The reporter did not had additional product details.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Ear discomfort, Injection site pain, Middle insomnia, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 16th August 2018, the patient received SHINGRIX. In August 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On 26th August 2018, the patient experienced vertigo, sensation of pressure in ear and dizziness. The patient was treated with prednisone. On an unknown date, the outcome of the vertigo, injection site pain, sensation of pressure in ear and dizziness were unknown.  It was unknown if the reporter considered the vertigo, injection site pain, sensation of pressure in ear and dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient reported that she experienced soreness at injection site that woke her up at night when she would roll over onto the arm. Ten days after receiving vaccination, the patient experienced pressure in her ears that progressed to feeling dizzy and currently she had performed (Nuclear magnetic resonance imaging) MRI and a balance test and had been diagnosed with vertigo. The patient was being treated with prednisone taper that had helped but as the taper goes down they had to start over with a higher dose. The reporter consented to follow up. Lab Comments: The patient had balance test done and had been diagnosed with vertigo.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vertigo in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 16th August 2018, the patient received SHINGRIX. In August 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On 26th August 2018, the patient experienced vertigo, sensation of pressure in ear and dizziness. The patient was treated with prednisone. On an unknown date, the outcome of the vertigo, injection site pain, sensation of pressure in ear and dizziness were unknown.  It was unknown if the reporter considered the vertigo, injection site pain, sensation of pressure in ear and dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient reported that she experienced soreness at injection site that woke her up at night when she would roll over onto the arm. Ten days after receiving vaccination, the patient experienced pressure in her ears that progressed to feeling dizzy and currently she had performed (Nuclear magnetic resonance imaging) MRI and a balance test and had been diagnosed with vertigo. The patient was being treated with prednisone taper that had helped but as the taper goes down they had to start over with a higher dose. The reporter consented to follow up. Lab Comments: The patient had balance test done and had been diagnosed with vertigo.
Sex: F
Vaccine: VARZOS
Symptoms: Drug interaction, Feeling hot, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of welts in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included ENBREL for ear disorder. Previously administered products included ENBREL (1st dose received on 31st October 2008). On 13th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 18th September 2018, the patient started ENBREL (unknown) at an unknown dose and frequency. On 18th September 2018, 5 days after receiving SHINGRIX, the patient experienced welts, itchy legs, extremities hot feeling of and drug interaction. The action taken with ENBREL was unknown. On an unknown date, the outcome of the welts, itchy legs, extremities hot feeling of and drug interaction were unknown. It was unknown if the reporter considered the welts, itchy legs, extremities hot feeling of and drug interaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left arm. The patient received ENBREL in the right leg. The patient experienced a welt, itching, and hot to touch on her right leg. The patient believed it was from the SHINGRIX having an interaction with her ENBREL that caused the injection site reactions on her right leg, which led to drug interaction. It was unknown if the reporter considered the welts, itchy legs, extremities hot feeling of and drug interaction to be related to ENBREL as well. The patient gave consent to be followed up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination, Interchange of vaccine products, Product supply issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received TWINRIX for prophylaxis. On an unknown date, the patient received TWINRIX. On an unknown date, unknown after receiving TWINRIX, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were reported as follows: The age at vaccination was not reported. The Health care professional stated they started a vaccination with TWINRIX, however do not have any more TWINRIX, which led to product availability issue. And want to finished the patients vaccination with HAVRIX( batch number 595AS expiry date 30-AUG-2020). Did not consent to follow-up. The Vaccine Administration Facility was the same as Primary Reporter. The Health care professional does not want to be contacted about this.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The pharmacist reported that the patient called in the day before the reporting that she was experiencing a rash after receiving SHINGRIX. The patient had the rash for 3 days. No additional details were available. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 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 localized erythema, local swelling and skin warm. On an unknown date, the outcome of the localized erythema, local swelling and skin warm were recovered/resolved.  It was unknown if the reporter considered the localized erythema, local swelling and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in late May or early June. After receiving SHINGRIX, the patient experienced some redness and swelling and also it was hot, a couple of inches below the injection site. This occurred not right at the injection site. It took a while for the events to go away. It took more than 3 days for the events to go away. The patient did not give consent to follow-up. Events considered without marking them at the injection site since the patient emphasized that it was not right at the injection site. The patient declined providing her information. She also ended the conversation so unable to clarify further information.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unwell in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 6th June 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. The reporter stated that the patient received a dose of SHINGRIX and became ill soon after.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 87-year-old female patient who received SHINGRIX for prophylaxis. On 31st October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The patient received the vaccine on the left arm. The pharmacist reported that, the patient experienced redness with a raised area at the injection site that was growing down to her arm towards the elbow. On an unknown date, the patient planned to follow-up with her physician. The limited information was provided. The pharmacist wanted to be transferred to medical information.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received SHINGRIX for prophylaxis.  On 25th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain and headache. On an unknown date, the outcome of the influenza-like symptoms, general body pain and headache were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on right arm. The patient experienced flu-like symptoms, including body aches and headache.  These symptoms resolved within a day. There was no consent to follow up. The reporter was unable to provide additional information.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included herpes zoster (multiple zoster virus outbreaks). On 29th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 12th April 2018, 14 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in the left deltoid. Two weeks after receiving SHINGRIX, the patient experienced shingles. The patient took Valtrex for treatment. The administering pharmacist instructed her to keep moving her arm after the vaccine was administered and she did not experience any injection site reactions. The patient missed to receive 2nd dose of SHINGRIX, which led to incomplete course of vaccination.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 65-year-old male patient who received SHINGRIX for prophylaxis. On 23rd October 2018, the patient received the 1st dose of SHINGRIX. On 23rd October 2018, less than a day after receiving SHINGRIX, the patient experienced malaise, muscle pain and joint pain. On an unknown date, the outcome of the malaise, muscle pain and joint pain were recovered/resolved. It was unknown if the reporter considered the malaise, muscle pain and joint pain to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced horrible sore muscles, sore joints and malaise that was very severe for the 1st 3 days after being vaccinated with SHINGRIX. These reactions started to get better after the 3rd day, but still persisted for up to 12 days after vaccination, although the reaction was much less severe from day 4 to day 12. In November 2018, these reactions have now all resolved. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, 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 64-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, injection site rash and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site rash and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site pain, injection site rash and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The caller was a patient who reported that she experienced swelling, pain, rash and itching at injection site. The caller reported that issues resolved in 5 days after dose. The caller did not consent to follow up.
Age: 83.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 83-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. Concomitant products included FLUZONE. On 23rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th September 2018, 14 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the left deltoid. On 23rd August 2018, the patient received FLUZONE in the right deltoid (batch number: UI977AB, expiry date: 9th March 2019). The patient experienced rash on the back of her leg and ankle. The patient went to urgent care for treatment. The urgent care did not consider FLUZONE as suspect.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a male patient who received SHINGRIX for prophylaxis. On 1st November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site rash, injection site erythema, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site rash, injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The age vaccination was not reported. The patient declined demographics and questions for adverse event completion, other than what stated initially. The patient reported that he received a dose of SHINGRIX last Thursday from the reporting date and he had redness, swelling, pain and a rash at the injection site. He stated the diameter was increasing. The patient did not give other details for the report. The patient denied consent to be follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of leg pain in a elderly female patient who received SHINGRIX for prophylaxis. Concomitant products included Pravastatin. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced leg pain. On an unknown date, the outcome of the leg pain was not recovered/not resolved. It was unknown if the reporter considered the leg pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported however it could be 67 or 68 years. The received a dose of SHINGRIX 2 months ago from the reporting date. The patient experienced leg pain about a week later which continued till the reporting time. The patient reported she had seen her doctor and was discontinued from pravastatin. The patient did not provide physician information because she was in between physician meeting at the time of report.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 82-year-old female patient who received SHINGRIX for prophylaxis. On 5th November 2018, the patient received SHINGRIX. On 5th November 2018, several days after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site warmth were recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The patient received the injection a day prior to the reporting date, at mid morning in the left arm and experienced pain, swelling and warm to touch at the injection site that evening. The patient said it was painful to lie in the arm. The patient did not give consent to be followed up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 80-year-old male patient who received SHINGRIX (batch number 3Z53C, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose, refer case US2018GSK208641). On 6th November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The reporter reported, the patient developed flu like symptoms after both doses of SHINGRIX. Consent to follow up was provided.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.  Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Influenza vaccine and the 2nd dose of Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine and not applicable after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure, influenza, vaccination failure and influenza were unknown.  It was unknown if the reporter considered the vaccination failure, influenza, vaccination failure and influenza to be related to Influenza vaccine. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient did not trust shots. The patient received flu shot twice and experienced the flu twice. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for influenza, time to onset for event and laboratory confirmation for influenza were not provided. The patient was not going to take the chance on the whooping cough shot and get the whooping cough. She like the odds of just not getting the shots better that was her opinion and she was sticking to it.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient stated has left arm pain without redness, swelling, fever (etc). He states he has had it since vaccine administration on 9/22/18 and has not gone away. He mentioned it to his doctor during an unrelated office visit but was not addressed. I recommended NSAIDs, ice, and a follow up with HCP as the normal body healing time has now exceeded.
Age: 65.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: At Hepatitis A Outreach, box of Hepatitis A vaccine in cooler was pediatric instead of adult. Used vial of pediatric instead of adult to vaccinate adult. Will receive repeat #2 dose in Dec 2018 Clinic.
Age: 59.0
Sex: F
Vaccine: HEPA
Symptoms: Immunisation, Underdose
Clinical narrative: At Clinic took vial of Hepatitis A out of box, was pediatric instead of adult dose. Revaccinated on 11-2-2018 with Adult Hepatitis A VAQTA R018775 in Right Deltoid. 2019Aug09.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Back pain, Balance disorder, Chest X-ray, Computerised tomogram abdomen
Clinical narrative: 10/31/18 Hot/Cold sensitivity. 11/1/18 Paraesthesia BUE, back pain. 11/2/18 Balance Issues. 11/3/18 Paraesthesia moving down back into legs and feet. 11/4/18 Right Abdominal/flank pain and facial numbness. 11/5/18 ER VISIT with Abdominal CT, Vaginal US, labs. 11/6/18 Increased back pain. 11/8/18 PCP VISIT Dropping things, exaggerated movement. Labs completed. 11/11/18 ER VISIT Pain/numbness/sensation in legs, arms worsening, unable to sleep. Impaired gait, ambulates with assist of 2. Brain MRI, Lumbar CT, CXR, labs. 11/14/18 Symptoms constant, at times worse. Multiple falls now. 11/16/18 NEURO VISIT, decreased sensation below C5. Direct admit to hospital for Full Spine MRI, LP. *SUSPECTED MYELITIS*
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram spine, Dyskinesia, Fall, Flank pain, Gait disturbance
Clinical narrative: 10/31/18 Hot/Cold sensitivity. 11/1/18 Paraesthesia BUE, back pain. 11/2/18 Balance Issues. 11/3/18 Paraesthesia moving down back into legs and feet. 11/4/18 Right Abdominal/flank pain and facial numbness. 11/5/18 ER VISIT with Abdominal CT, Vaginal US, labs. 11/6/18 Increased back pain. 11/8/18 PCP VISIT Dropping things, exaggerated movement. Labs completed. 11/11/18 ER VISIT Pain/numbness/sensation in legs, arms worsening, unable to sleep. Impaired gait, ambulates with assist of 2. Brain MRI, Lumbar CT, CXR, labs. 11/14/18 Symptoms constant, at times worse. Multiple falls now. 11/16/18 NEURO VISIT, decreased sensation below C5. Direct admit to hospital for Full Spine MRI, LP. *SUSPECTED MYELITIS*
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Grip strength decreased, Hypoaesthesia, Insomnia, Laboratory test, Lumbar puncture
Clinical narrative: 10/31/18 Hot/Cold sensitivity. 11/1/18 Paraesthesia BUE, back pain. 11/2/18 Balance Issues. 11/3/18 Paraesthesia moving down back into legs and feet. 11/4/18 Right Abdominal/flank pain and facial numbness. 11/5/18 ER VISIT with Abdominal CT, Vaginal US, labs. 11/6/18 Increased back pain. 11/8/18 PCP VISIT Dropping things, exaggerated movement. Labs completed. 11/11/18 ER VISIT Pain/numbness/sensation in legs, arms worsening, unable to sleep. Impaired gait, ambulates with assist of 2. Brain MRI, Lumbar CT, CXR, labs. 11/14/18 Symptoms constant, at times worse. Multiple falls now. 11/16/18 NEURO VISIT, decreased sensation below C5. Direct admit to hospital for Full Spine MRI, LP. *SUSPECTED MYELITIS*
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Myelitis, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Pain in extremity, Paraesthesia
Clinical narrative: 10/31/18 Hot/Cold sensitivity. 11/1/18 Paraesthesia BUE, back pain. 11/2/18 Balance Issues. 11/3/18 Paraesthesia moving down back into legs and feet. 11/4/18 Right Abdominal/flank pain and facial numbness. 11/5/18 ER VISIT with Abdominal CT, Vaginal US, labs. 11/6/18 Increased back pain. 11/8/18 PCP VISIT Dropping things, exaggerated movement. Labs completed. 11/11/18 ER VISIT Pain/numbness/sensation in legs, arms worsening, unable to sleep. Impaired gait, ambulates with assist of 2. Brain MRI, Lumbar CT, CXR, labs. 11/14/18 Symptoms constant, at times worse. Multiple falls now. 11/16/18 NEURO VISIT, decreased sensation below C5. Direct admit to hospital for Full Spine MRI, LP. *SUSPECTED MYELITIS*