chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Haematoma, Injection site discolouration, Injection site pain, Injection site swelling, Skin discolouration
Clinical narrative: hematoma; Injection site pain / Injection site soreness; Injection site swelling; Black and blue down the injected arm from the shoulder down to just past the elbow; This case was reported by a consumer via call center representative and described the occurrence of hematoma in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included heart valve replacement and chickenpox. Concomitant products included warfarin sodium (Coumadin).   On 2nd December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd December 2019, less than a day after receiving Shingrix, the patient experienced hematoma, injection site pain, injection site swelling and skin discoloration. The patient was treated with lidocaine hydrochloride (Lidocaine) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the hematoma, injection site pain, injection site swelling and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the hematoma, injection site pain, injection site swelling and skin discoloration to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced injection site reaction consisting of pain, swelling, and soreness. The patient reports that she needed to go to the emergency department reporting black and blue down the injected arm from the shoulder down to just past the elbow. The ER physician diagnosed a hematoma, and recommended ice packs and lidocaine patches. Events have not improved at time of report. The reporter consented to follow up. Emergency room visit required.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Haematoma, Injected limb mobility decreased, Injection site rash, Pain in extremity, Peripheral swelling
Clinical narrative: hematoma; Injection site pain / Injection site soreness; Injection site swelling; Black and blue down the injected arm from the shoulder down to just past the elbow; This case was reported by a consumer via call center representative and described the occurrence of hematoma in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included heart valve replacement and chickenpox. Concomitant products included warfarin sodium (Coumadin).   On 2nd December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd December 2019, less than a day after receiving Shingrix, the patient experienced hematoma, injection site pain, injection site swelling and skin discoloration. The patient was treated with lidocaine hydrochloride (Lidocaine) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the hematoma, injection site pain, injection site swelling and skin discoloration were not recovered/not resolved.   It was unknown if the reporter considered the hematoma, injection site pain, injection site swelling and skin discoloration to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced injection site reaction consisting of pain, swelling, and soreness. The patient reports that she needed to go to the emergency department reporting black and blue down the injected arm from the shoulder down to just past the elbow. The ER physician diagnosed a hematoma, and recommended ice packs and lidocaine patches. Events have not improved at time of report. The reporter consented to follow up. Emergency room visit required.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea
Clinical narrative: feel chills; difficulty breathing; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In November 2019, 10 hrs after receiving Shingrix, the patient experienced chills and difficulty breathing. On an unknown date, the outcome of the chills and difficulty breathing were recovered/resolved.   It was unknown if the reporter considered the chills and difficulty breathing to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and about 10 hours later the patient started to feel chills and was having difficulty breathing.  The patient was okay. No additional information was provided.
Age: 9.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient who is 9 years old received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old female patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix at an unknown dose. On an unknown date, unknown after receiving Infanrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: Batch number and expiration date were not available. The patient received dose of Infanrix at an 9 year of age, which led to inappropriate age at vaccine administration. The consented to follow up. This case is 1 of 4 cases reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test abnormal
Clinical narrative: Shingles after 1st dose of SHingrix; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4M2C7, expiry date unknown) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix. On 22nd December 2019, 5 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: On 22nd December 2019, the patient went to urgent care and was diagnosed with shingles. The reporter did not had have lot or expiration date of shingrix. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: HLA-B*27 positive, Nonspecific reaction, Rash
Clinical narrative: Reaction to first Shingrix shot; rash on both legs/rash on feet; This case was reported by a consumer via call center representative and described the occurrence of nonspecific reaction in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of months after receiving Shingrix, the patient experienced nonspecific reaction and rash. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the nonspecific reaction was unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the nonspecific reaction and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A couple of months before the time of reporting, after receiving the Shingrix vaccine, the patient developed a rash on both legs and feet, he took antibiotics and it cleared up. The reporter would liked to knew whether his status as genetic biomarker HLA-B27 positive makes that an autoimmune response to Shingrix. The reporter wanted to knew whether he would get the second shot. The reporter denied consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 29-DEC-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) in a pharmacy by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequently to zoster vaccine live (ZOSTAVAX) inoculation, the experienced shingles and post herpetic neuralgia and was treated by a physician for the events. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was reported as not recovered. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was related.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Retinal artery occlusion
Clinical narrative: central retinal artery occlusion of the left eye; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 17-OCT-2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered an acute onset of left eye vision loss. The patient was admitted to the hospital and she was ultimately diagnosed with central retinal artery occlusion of the left eye and was completely blind in her left eye, at the reporting time. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms had resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX) use, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review, the event of central retinal artery occlusion of the left eye was considered to be medically significant.  The event of central retinal artery occlusion of the left eye was considered to be disabling.
Sex: F
Vaccine: MMR
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: No other adverse effects have been reported in the patient; a patient who is breastfeeding received a dose of MMR II today; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information about medical history and concurrent conditions was not provided. Concomitant therapy included sterile diluent.  On 27-DEC-2019, the patient who was breastfeeding received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # reported as S010704 and expiration date 08-APR-2021, dose and route were not provided) for prophylaxis (Maternal exposure during breast feeding). No other adverse effects had been reported in the patient. No adverse effects had been reported in the breastfeeding infant.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No known adverse effects; a 16 year old patient received a dose of PROQUAD; This spontaneous report was received from a nurse referring to a 16 years old patient of unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.     On 23-DEC-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S006829, expiration date 02-SEP-2020, dose and route were not provided) for prophylaxis (product administered to patient of inappropriate age). No known adverse effects were reported.
Age: 0.33
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient did not experience any symptoms; a four month old infant was inadvertently administered one dose of GARDASIL 9; This spontaneous report was received from a physician referring to a 4-month-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 30-DEC-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (1 dose; dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). It was reported that the patient did not experience any symptoms.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA012617:
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: redness on spot; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was unknown.   It was unknown if the reporter considered the localized erythema to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had redness on spot. For tolerances of 2nd dose of Shingrix, refer case US2019AMR211850.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Lower back pain; This case was reported by a consumer via interactive digital media and described the occurrence of back pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 2nd dose of Shingrix. On 18th December 2019, 1 days after receiving Shingrix, the patient experienced back pain. On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided, but selected as an adult as per vaccine indication. The day before reporting, the patient received dose of Shingrix and on the day of reporting in the afternoon had major lower back pain. The pain was like somebody plunged a knife. The patient asked, if any side effect connection with Shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Gait inability
Clinical narrative: Major pain in lower back / like someone had plunged a knife into my lower back; Couldn't walk; This case was reported by a consumer and described the occurrence of low back pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 2nd dose of Shingrix. On 18th December 2019, 1 days after receiving Shingrix, the patient experienced low back pain and unable to walk. On an unknown date, the outcome of the low back pain was recovering/resolving and the outcome of the unable to walk was recovered/resolved.   It was unknown if the reporter considered the low back pain and unable to walk to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The day bofeore reporting, the patient received dose of Shingrix and in the afternoon of day of reporting suddenly had major lower back pain like someone had plunged a knife into lower back. It made the patient double over in pain and could not able to walk for at least 5 minutes. The patient almost went to hospital but the pain then started to subside. The patient still had sore in lower back but was not like earlier. The patient asked, if any known connection which might be a side effect of the shot.
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: It has been more than a year since initial dose; This case was reported by a pharmacist via out of hour services and described the occurrence of drug dose administration interval too long in a male patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy (splenectomy done in May 2014). Previously administered products included Bexsero (1st dose received in May 2018).   In December 2019, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The patient received 1st dose of Bexsero in May 2018 and 2nd dose was received in December 2019 which led to drug dose administration interval too long. This case was considered as medication error without harm.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site vesicles
Clinical narrative: pain in arm; fatigue; nausea; blisters around injection site; itching at injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer.   On 13th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, fatigue, nausea, injection site blisters, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site pain, fatigue, nausea, injection site blisters, injection site itching and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, nausea, injection site blisters, injection site itching and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in arm at injection site, fatigue, nausea, itching at injection site, blisters around injection site, redness around injection site. The patient would not take the 2nd dose. The patient consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: pain in arm; fatigue; nausea; blisters around injection site; itching at injection site; redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cancer.   On 13th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, fatigue, nausea, injection site blisters, injection site itching and injection site erythema. On an unknown date, the outcome of the injection site pain, fatigue, nausea, injection site blisters, injection site itching and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, nausea, injection site blisters, injection site itching and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain in arm at injection site, fatigue, nausea, itching at injection site, blisters around injection site, redness around injection site. The patient would not take the 2nd dose. The patient consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Outbreak of Shingles after first dose of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 7F33X, expiry date 11th December 2021) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix. On 18th December 2019, 30 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: All patient identifiers were given as well as Batch number and expiration date. The patient received Shingrix and developed an outbreak of Shingles. The reporter consented to follow up.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Product administered at inappropriate site
Clinical narrative: shoulder pain; unable to move his left arm; twinge of pain; vaccine was administered higher up on his shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 18th December 2019 04:00, the patient received the 2nd dose of Shingrix. On 18th December 2019 07:00, 3 hrs after receiving Shingrix, the patient experienced shoulder pain, injected limb mobility decreased, injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved and the outcome of the injected limb mobility decreased, injection site pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the shoulder pain, injected limb mobility decreased and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in left arm. The patient received dose of Shingrix at 4 pm  and by 7 pm, the patient was unable to move left arm due to pain in shoulder. Immediately after vaccination with Shingrix, the patient experienced  injection site pain. The patient stated that, the injection site was different from the 1st dose. The reporter reported that, the vaccine was administered higher up on shoulder and felt a twinge of pain as the needle went in, which led to vaccine administered at inappropriate site. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza, Influenza B virus test positive
Clinical narrative: Positive Flu B test; This case was reported by a other health professional via call center representative and described the occurrence of influenza b virus infection in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced influenza b virus infection. On an unknown date, the outcome of the influenza b virus infection was unknown.   It was unknown if the reporter considered the influenza b virus infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but it was selected as an adult as per vaccine indication. Twelve hours after vaccination, the patient was tested positive for influenza B virus. The reporter did not consent to follow up.       Lab Comments: Lab test performed on an unknown date
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Loss of personal independence in daily activities, Malaise
Clinical narrative: affected her ability to teach; sick/flu-like symptoms; felt really bad; Sick; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, feeling bad, sickness and activities of daily living impaired. On an unknown date, the outcome of the influenza-like symptoms, feeling bad and sickness were recovered/resolved and the outcome of the activities of daily living impaired was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, feeling bad, sickness and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. The reporter reported that, after vaccination had sick or flu like symptoms for 3 days and then resolved, but it affected the patient's ability to teach. The reporter did not have further information.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Injection site pain, Knee arthroplasty
Clinical narrative: Felt bad; flu-like symptoms; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included unspecified disorder of knee joint. Previously administered products included Shingles vaccine (Recived 10 years ago prior to reporting).   On 12th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, 16 hrs after receiving Shingrix, the patient experienced influenza-like symptoms and feeling bad. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were recovered/resolved and the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient herself. On 12th November 2019, patient had knee replacement and wondered whether it would be okay for her to get the 2nd dose of Shingrix vaccine. It was reported that the knee problem was pre-existing and she did not feel that the knee surgery was related to having received the first Shingrix shot. On 12th August 2019, around 6pm , the patient received her 1st dose of Shingrix. The next day, around 10 am, she felt bad with flu like symptoms that lasted about 24 hours. The reporter asked if the injection was given intramuscularly and she said she assumes so because her left arm where she received the injection was sore. The soreness resolved within 24 hours. She did not see the lot and the expiration date on the paperwork that her pharmacy gave her. The patient had pre-existing knee problems. The reporter consented to follow up. This case has been linked with case US2019232371 and US2019232378, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site joint pain, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Pain at injection site and shoulder; Fever; Sickness; Redness at injection site and shoulder; Swelling; This case was reported by a physician via call center representative and described the occurrence of fever in a 93-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, sickness, injection site erythema, injection site swelling and injection site joint pain. On an unknown date, the outcome of the fever, sickness and injection site joint pain were resolved with sequelae and the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the fever, sickness, injection site erythema, injection site swelling and injection site joint pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced fever and sickness for the first two days after the administration of vaccine. The patient also experienced redness, swelling and pain at the injection site in the arm and shoulder. Redness and swelling last for 8 days and pain had gone at the time this report was performed The reporter consented to follow up. Batch number and expiration date were not provided since the vaccine was administered in a pharmacy and the physician was calling from his house.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain at injection site and shoulder; Fever; Sickness; Redness at injection site and shoulder; Swelling; This case was reported by a physician via call center representative and described the occurrence of fever in a 93-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, sickness, injection site erythema, injection site swelling and injection site joint pain. On an unknown date, the outcome of the fever, sickness and injection site joint pain were resolved with sequelae and the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the fever, sickness, injection site erythema, injection site swelling and injection site joint pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced fever and sickness for the first two days after the administration of vaccine. The patient also experienced redness, swelling and pain at the injection site in the arm and shoulder. Redness and swelling last for 8 days and pain had gone at the time this report was performed The reporter consented to follow up. Batch number and expiration date were not provided since the vaccine was administered in a pharmacy and the physician was calling from his house.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Ultrasound scan normal
Clinical narrative: Painful arm; Pain at injection site; can not even lift his arm to put a shirt on; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. In October 2019, the patient experienced injected limb mobility decreased. On an unknown date, the patient experienced pain localized. The patient was treated with non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain was unknown and the outcome of the injected limb mobility decreased and pain localized were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and pain localized to be related to Shingrix.  Additional details were provided as follows: The patient received dose of shingrix in the left arm. The batch number of Shingrix was updated from M9PS2 to M9P52, as per sale's data sheet. The reporter stated that on the day of vaccination, the patient had injection site pain and about a wek later pain was present from shoulder down to the elbow.  Less than 3 months after vaccination, the patient could not not even lift arm to put a shirt on. The patient visited the primary care physician. The patient performed an ultrasound test, but did not show anything. The patient tried putting ice on the arm and it was not helping and the arm was still painfull. No further details were provided The reporter consented to follow up.      Lab Comments: Lab test performed on an unknown date
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Injection site extravasation, Wrong technique in product usage process
Clinical narrative: vaccine leaked out of the injection site; Accidental undersdose; Attempted administration of vaccine twice; Inadvertent exposure to vaccine; Exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose and Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix and Shingrix, the patient experienced injection site leaking, accidental underdose, wrong technique in drug usage process, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the injection site leaking, accidental underdose, wrong technique in drug usage process, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A pharmacist reported that he attempted to administer Shingrix and the vaccine leaked out of the injection site after 2 attempts.  The pharmacist reported that the patient only received approximately 20% of both doses attempted.  The reporter consented to follow up. The pharmacist stated he did not have details.
Sex: M
Vaccine: VARZOS
Symptoms: Dyspepsia, Fatigue, Headache, Nausea, Pain
Clinical narrative: Fever; pain; headache; tiredness; nausea; indigestion; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 2 weeks after receiving Shingrix, the patient experienced fever, pain, headache, tiredness, nausea and indigestion. In December 2019, the outcome of the fever, pain, headache and tiredness were recovered/resolved. On an unknown date, the outcome of the nausea and indigestion were unknown.   It was unknown if the reporter considered the fever, pain, headache, tiredness, nausea and indigestion to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix in his left arm at a local pharmacy.  The reporter did not want to provide any identifying information. The reporter stated he started to experience fever, body aches, headache, tiredness which resolved and was continuing to experience nausea and indigestion symptoms.  No additional information provided. Did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; pain; headache; tiredness; nausea; indigestion; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 2 weeks after receiving Shingrix, the patient experienced fever, pain, headache, tiredness, nausea and indigestion. In December 2019, the outcome of the fever, pain, headache and tiredness were recovered/resolved. On an unknown date, the outcome of the nausea and indigestion were unknown.   It was unknown if the reporter considered the fever, pain, headache, tiredness, nausea and indigestion to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix in his left arm at a local pharmacy.  The reporter did not want to provide any identifying information. The reporter stated he started to experience fever, body aches, headache, tiredness which resolved and was continuing to experience nausea and indigestion symptoms.  No additional information provided. Did not consent to follow up.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging, Mobility decreased, Neck pain, Neuralgic amyotrophy, Pain
Clinical narrative: Patient received Shingrix vaccine and Pneumoxax 23 in left arm on 29 May 2019.  Patient contacted clinic on 04 June 2019 complaining of reduced mobility and "burning pain that radiates to his neck".   Conservative tx.  Seen by orthopedics 27 September 2019. Orthopedic surgeon dx patient with  Neuralgic amyotrophy post MRI.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: 4.5 cm x 2.5 cm reddened area  around injection site
Age: 79.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Condition aggravated, Lyme disease, Mobility decreased
Clinical narrative: Patient received Flucelvax on 10-18-19. Within 3 days, his mobility & energy declined significantly. His Md believes that it triggered a relapse of Lyme disease contracted in 1997.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Cephalocaudally spreading maculopapular rash and fever (T max 104), self-resolving.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Patient contracted mild case of shingles 2 weeks later
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, headache.
Sex: U
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products
Clinical narrative: the patient was administered one dose of Rotarix on 21-AUG-2019 and then was administered one dose of ROTATEQ on 23-OCT-2019; This spontaneous report was received from a medical assistant referring to a 4 month old patient. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 21-AUG-2019, the patient received a dose of rotavirus g1 p1 vaccine live (89-12) (ROTARIX) (dose, route of administration, lot #, and expiration date were not reported), for prophylaxis. Subsequently, on 23-OCT-2019, the patient received a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dose, lot #, and expiration date were not reported), for prophylaxis (interchange of vaccine products). It was reported that the patient may be administered another dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) on 30-DEC-2019.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shingles after receiving 1st dose of Shingrix. Till the time of reporting, the patient had not received the 2nd dose of Shingrix and asked if the 2nd dose could be received after the shingles goes away.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Oral herpes, Product supply issue, Vaccination failure
Clinical narrative: little strip of shingles on my lip / it is in my mouth and tongue; little strip of shingles on my lip / it is in my mouth and tongue; severe out break of fever blisters; They painful and are difficult to treat; first Shingrix shot on 9-14-19 due to short supply I got my second Shingrix shot 10-4-19; This case was reported by a consumer via out of hour services and described the occurrence of suspected  vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2019, the patient received the 1st dose of Shingrix. On 4th October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), fever blister, blister, shingles and product supply issue. On an unknown date, the outcome of the vaccination failure, fever blister, blister, shingles and product supply issue were unknown.   It was unknown if the reporter considered the vaccination failure, fever blister, blister and shingles to be related to Shingrix and Shingrix.  Additional information was 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 2nd dose too early due to short supply. The patient experienced severe out break of fever blisters that last 6 weeks or so, as soon as it got clear up another one poped up. The patient never had a fever blister in his/her life, blisters were painful and difficult to treat. The patient also had a little strip of shingles on lip that has cleared up but in it is in the mouth and tongue at the time of reporting. The patient was very upset and wanted to know how to get it corrected. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Erythema, Fatigue, Hypersensitivity, Influenza like illness
Clinical narrative: her arm blew up; redness at injection site/ below the injection site; tingles arm; the nerves of her arm were irritated; arm still hurts; Labelled drug-drug interaction medication error; Allergic reaction; flu-like symptoms; sick for 3 days/ she still felt cruddy; fever; chills; achiness; exhaustion; nausea; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX 23) for prophylaxis.   On 24th September 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) and PNEUMOVAX 23. In September 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced sickness, chills, pain, exhaustion and nausea. On 26th September 2019, the patient experienced allergic reaction, influenza-like symptoms and fever. On an unknown date, the patient experienced swelling arm, erythema, tingling, neuralgia, pain in arm and labeled drug-drug interaction medication error. On an unknown date, the outcome of the allergic reaction and labeled drug-drug interaction medication error were unknown and the outcome of the influenza-like symptoms was resolved with sequelae and the outcome of the sickness, fever, chills, pain, exhaustion and nausea were recovered/resolved and the outcome of the swelling arm, erythema, tingling, neuralgia and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, influenza-like symptoms, sickness, fever, chills, pain, exhaustion, nausea, swelling arm, erythema, tingling, neuralgia and pain in arm to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patients birth date was reported as 16th July (no year reported). The patient was vaccinated with FluLaval Tetra and Pneumovax 23 on the same day in left deltoid, side by side, about 2 inches apart. The vaccine FluLaval Tetra was given by pre filled syringe intramuscularly. Post vaccination the patient was sick for 3 days. The patient elaborated the symptoms as fever, chills, achiness, exhaustion, and nausea. On 26th September 2019, the patient's fever broke but she felt cruddy for the next 3 days. Till the time of reporting the patient's arm was not right. The patient stated that her arm blew up, was red and it still tingles and hurted. The patient thought that maybe the nerves of her arm were irritated.  The patient said this occurred below the injection site. The patient wanted to know the ingredients in FLULAVAL Quadrivalent 2019-2020 Season because she feels that she may have had an allergic reaction to it or the Pneumovax 23. The reporter consented to follow up.