chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Injection site pain, Nausea, Pregnancy test negative, Pyrexia
Clinical narrative: anxious; feeling feverish/fever; nauseous; pain in her arm at the injection site; pain in her arm at the injection site; This spontaneous report was received from a consumer referring to a 33-year-old female patient. The patient's drug reactions/allergies included penicillin. Information about pertinent medical history and concomitant medication was not provided. The patient did pregnancy test prior to vaccination which showed negative.  In September 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis. On an unknown date in 2020, the patient experienced pain in her arm at the injection site. She did not experience any fever or nausea. On 26-OCT-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).         Since 5 hours after getting the shot, the patient experienced feeling feverish(fever), nauseous and anxious. On the same day, the patient also experienced pain in her arm at the injection site. The patient did not seek medical attention. The outcome of the events was unknown.     The reporter considered the events to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: burning sensation around the injection site; sore arm; This case was reported by a other health professional via sales rep and described the occurrence of injection site burning in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site burning and pain in arm. On an unknown date, the outcome of the injection site burning was unknown and the outcome of the pain in arm was unchanged.   It was unknown if the reporter considered the injection site burning and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after her first dose of Shingrix just had a sore arm and a burning sensation around the injection site. For tolerance after 2nd dose refer case US2020AMR211569.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR211569:same patient, 2nd dose
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chills, Confusional state, Depressed mood, Feeling abnormal, Feeling cold
Clinical narrative: chills and shivering; trembling; feeling very cold; nausea; headache; confusion; feeling down; Feeling weird; was in bed the next day all day long; pain on injection site; redness on injection site; swelling on injection site; hot on injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on unknown date for further tolerence refer case US2020211104).   On 20th October 2020, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. In October 2020, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth, nausea, headache, confusion, feeling down, weird feeling and somnolence. On 21st October 2020, the patient experienced chills, tremor and feeling cold. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth, chills, tremor, feeling cold, nausea, headache, confusion, feeling down, weird feeling and somnolence were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth, chills, tremor, feeling cold, nausea, headache, confusion, feeling down, weird feeling and somnolence to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not reported. 3 months ago patient had her shingrix and pneumonia vaccine and had events like body ache and arm pain. Patient reported that she received the 2nd dose of Shingrix on 20th October,2020 on right arm and same day she also had Flu vaccine. It was reported that patient experienced pain, redness, and swelling and hot on injection site also on Wednesday October 21st, 2020 in the early morning she had chills and shivering, trembling, and feeling very cold and nausea, headache and confusion. Patient described it as "feeling down and weird" and also she was in bed the next day all day long. It was reported that her symptoms have not resolved. The reporter consented to follow up. This case has been linked with US2020211104 case reported by the same reporter.
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: chills and shivering; trembling; feeling very cold; nausea; headache; confusion; feeling down; Feeling weird; was in bed the next day all day long; pain on injection site; redness on injection site; swelling on injection site; hot on injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on unknown date for further tolerence refer case US2020211104).   On 20th October 2020, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. In October 2020, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth, nausea, headache, confusion, feeling down, weird feeling and somnolence. On 21st October 2020, the patient experienced chills, tremor and feeling cold. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth, chills, tremor, feeling cold, nausea, headache, confusion, feeling down, weird feeling and somnolence were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth, chills, tremor, feeling cold, nausea, headache, confusion, feeling down, weird feeling and somnolence to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not reported. 3 months ago patient had her shingrix and pneumonia vaccine and had events like body ache and arm pain. Patient reported that she received the 2nd dose of Shingrix on 20th October,2020 on right arm and same day she also had Flu vaccine. It was reported that patient experienced pain, redness, and swelling and hot on injection site also on Wednesday October 21st, 2020 in the early morning she had chills and shivering, trembling, and feeling very cold and nausea, headache and confusion. Patient described it as "feeling down and weird" and also she was in bed the next day all day long. It was reported that her symptoms have not resolved. The reporter consented to follow up. This case has been linked with US2020211104 case reported by the same reporter.
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Nausea, Somnolence, Tremor
Clinical narrative: chills and shivering; trembling; feeling very cold; nausea; headache; confusion; feeling down; Feeling weird; was in bed the next day all day long; pain on injection site; redness on injection site; swelling on injection site; hot on injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on unknown date for further tolerence refer case US2020211104).   On 20th October 2020, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. In October 2020, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site warmth, nausea, headache, confusion, feeling down, weird feeling and somnolence. On 21st October 2020, the patient experienced chills, tremor and feeling cold. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site warmth, chills, tremor, feeling cold, nausea, headache, confusion, feeling down, weird feeling and somnolence were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site warmth, chills, tremor, feeling cold, nausea, headache, confusion, feeling down, weird feeling and somnolence to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were as follows: The age at vaccination was not reported. 3 months ago patient had her shingrix and pneumonia vaccine and had events like body ache and arm pain. Patient reported that she received the 2nd dose of Shingrix on 20th October,2020 on right arm and same day she also had Flu vaccine. It was reported that patient experienced pain, redness, and swelling and hot on injection site also on Wednesday October 21st, 2020 in the early morning she had chills and shivering, trembling, and feeling very cold and nausea, headache and confusion. Patient described it as "feeling down and weird" and also she was in bed the next day all day long. It was reported that her symptoms have not resolved. The reporter consented to follow up. This case has been linked with US2020211104 case reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: WAS TERRIBLE FEELING / feel messed up; This case was reported by a consumer via patient support programs and described the occurrence of feeling abnormal in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   The reporter considered the feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced terrible feeling and felt messed up. The patient reported that she felt messed up and  did not knew what to do. The information regarding consent to follow up was not reported. No further information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: zoster within 1-2 days after vaccination; This case was reported by a physician via sales rep and described the occurrence of herpes zoster in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced herpes zoster. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the herpes zoster was recovered/resolved.   It was unknown if the reporter considered the herpes zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix and experienced herpes zoster which was resolved. The patient treated with antiviral therapy. A medical history that is significant for herpes zoster other than age-one patient is in the 60s with diabetes. The reporter consented to follow up. No further information wa available. This case was linked with case US2020AMR214291.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR214291:same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Bedridden, Chills
Clinical narrative: "deathly ill"; fever; headache; general aches; swollen painful arm at injection site; swollen painful arm; Tingling in hands and wrist; scapular pain; inability to sleep; pain in her neck; chills; being bed-ridden; inability to eat; upset stomach; "feeling like I had the flu"; weakness; fatigue; Feeling like I have shingles; inability to move arm; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th October 2020, several hours after receiving Shingrix, the patient experienced feeling unwell, fever, headache, general body pain, injection site swelling, injection site pain, tingling, scapula pain, sleeplessness, neck pain, chills, bedridden, unable to eat, upset stomach, influenza-like symptoms, weakness, fatigue, vesicular rash and injected limb mobility decreased. On 19th October 2020, the outcome of the feeling unwell, headache, sleeplessness, bedridden, unable to eat, upset stomach and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the fever, injection site swelling, injection site pain, tingling, scapula pain, chills, weakness, fatigue and vesicular rash were not recovered/not resolved and the outcome of the general body pain, neck pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix. The reporter considered the fever, headache, general body pain, injection site swelling, injection site pain, tingling, scapula pain, sleeplessness, neck pain, chills, bedridden, unable to eat, upset stomach, influenza-like symptoms, weakness, fatigue, vesicular rash and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. After receiving Shingrix, within couple of hours, the patient experienced side effects.   On 17th October 2020, several hours after receiving Shingrix, the patient experienced swollen painful arm and headache. The patient had feeling deathly ill, fever, general aches, inability to move arm, tingling in hands and wrists, scapular pain, inability to sleep, pain in her neck, chills, being bed-ridden, inability to eat, upset stomach, feeling like she had the flu, weakness, fatigue and feeling like she had shingles.  No lot or expiry date was known.   The reporter did not consent to follow-up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeding disorder, Headache, Influenza like illness, Injected limb mobility decreased
Clinical narrative: "deathly ill"; fever; headache; general aches; swollen painful arm at injection site; swollen painful arm; Tingling in hands and wrist; scapular pain; inability to sleep; pain in her neck; chills; being bed-ridden; inability to eat; upset stomach; "feeling like I had the flu"; weakness; fatigue; Feeling like I have shingles; inability to move arm; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th October 2020, several hours after receiving Shingrix, the patient experienced feeling unwell, fever, headache, general body pain, injection site swelling, injection site pain, tingling, scapula pain, sleeplessness, neck pain, chills, bedridden, unable to eat, upset stomach, influenza-like symptoms, weakness, fatigue, vesicular rash and injected limb mobility decreased. On 19th October 2020, the outcome of the feeling unwell, headache, sleeplessness, bedridden, unable to eat, upset stomach and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the fever, injection site swelling, injection site pain, tingling, scapula pain, chills, weakness, fatigue and vesicular rash were not recovered/not resolved and the outcome of the general body pain, neck pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix. The reporter considered the fever, headache, general body pain, injection site swelling, injection site pain, tingling, scapula pain, sleeplessness, neck pain, chills, bedridden, unable to eat, upset stomach, influenza-like symptoms, weakness, fatigue, vesicular rash and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. After receiving Shingrix, within couple of hours, the patient experienced side effects.   On 17th October 2020, several hours after receiving Shingrix, the patient experienced swollen painful arm and headache. The patient had feeling deathly ill, fever, general aches, inability to move arm, tingling in hands and wrists, scapular pain, inability to sleep, pain in her neck, chills, being bed-ridden, inability to eat, upset stomach, feeling like she had the flu, weakness, fatigue and feeling like she had shingles.  No lot or expiry date was known.   The reporter did not consent to follow-up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Insomnia, Malaise, Neck pain
Clinical narrative: "deathly ill"; fever; headache; general aches; swollen painful arm at injection site; swollen painful arm; Tingling in hands and wrist; scapular pain; inability to sleep; pain in her neck; chills; being bed-ridden; inability to eat; upset stomach; "feeling like I had the flu"; weakness; fatigue; Feeling like I have shingles; inability to move arm; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th October 2020, several hours after receiving Shingrix, the patient experienced feeling unwell, fever, headache, general body pain, injection site swelling, injection site pain, tingling, scapula pain, sleeplessness, neck pain, chills, bedridden, unable to eat, upset stomach, influenza-like symptoms, weakness, fatigue, vesicular rash and injected limb mobility decreased. On 19th October 2020, the outcome of the feeling unwell, headache, sleeplessness, bedridden, unable to eat, upset stomach and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the fever, injection site swelling, injection site pain, tingling, scapula pain, chills, weakness, fatigue and vesicular rash were not recovered/not resolved and the outcome of the general body pain, neck pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix. The reporter considered the fever, headache, general body pain, injection site swelling, injection site pain, tingling, scapula pain, sleeplessness, neck pain, chills, bedridden, unable to eat, upset stomach, influenza-like symptoms, weakness, fatigue, vesicular rash and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. After receiving Shingrix, within couple of hours, the patient experienced side effects.   On 17th October 2020, several hours after receiving Shingrix, the patient experienced swollen painful arm and headache. The patient had feeling deathly ill, fever, general aches, inability to move arm, tingling in hands and wrists, scapular pain, inability to sleep, pain in her neck, chills, being bed-ridden, inability to eat, upset stomach, feeling like she had the flu, weakness, fatigue and feeling like she had shingles.  No lot or expiry date was known.   The reporter did not consent to follow-up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Pyrexia, Rash vesicular
Clinical narrative: "deathly ill"; fever; headache; general aches; swollen painful arm at injection site; swollen painful arm; Tingling in hands and wrist; scapular pain; inability to sleep; pain in her neck; chills; being bed-ridden; inability to eat; upset stomach; "feeling like I had the flu"; weakness; fatigue; Feeling like I have shingles; inability to move arm; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th October 2020, several hours after receiving Shingrix, the patient experienced feeling unwell, fever, headache, general body pain, injection site swelling, injection site pain, tingling, scapula pain, sleeplessness, neck pain, chills, bedridden, unable to eat, upset stomach, influenza-like symptoms, weakness, fatigue, vesicular rash and injected limb mobility decreased. On 19th October 2020, the outcome of the feeling unwell, headache, sleeplessness, bedridden, unable to eat, upset stomach and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the fever, injection site swelling, injection site pain, tingling, scapula pain, chills, weakness, fatigue and vesicular rash were not recovered/not resolved and the outcome of the general body pain, neck pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix. The reporter considered the fever, headache, general body pain, injection site swelling, injection site pain, tingling, scapula pain, sleeplessness, neck pain, chills, bedridden, unable to eat, upset stomach, influenza-like symptoms, weakness, fatigue, vesicular rash and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. After receiving Shingrix, within couple of hours, the patient experienced side effects.   On 17th October 2020, several hours after receiving Shingrix, the patient experienced swollen painful arm and headache. The patient had feeling deathly ill, fever, general aches, inability to move arm, tingling in hands and wrists, scapular pain, inability to sleep, pain in her neck, chills, being bed-ridden, inability to eat, upset stomach, feeling like she had the flu, weakness, fatigue and feeling like she had shingles.  No lot or expiry date was known.   The reporter did not consent to follow-up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Feeling cold, Influenza like illness, Insomnia
Clinical narrative: felt like he was coming down with a cold or the flu; out of work today due to his current symptoms.; feeling cold; soreness in left arm / pain in the arm; fever; cramping in stomach; nausea; exhausted; trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th October 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, stomach cramps, nausea, exhaustion and difficulty sleeping. On 19th October 2020, the patient experienced influenza like illness, activities of daily living impaired and feeling cold. The patient was treated with naproxen (Aleve). On 18th October 2020, the outcome of the pain in arm, fever, stomach cramps and nausea were recovered/resolved. On an unknown date, the outcome of the exhaustion, difficulty sleeping, influenza like illness and feeling cold 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 pain in arm, fever, stomach cramps, nausea, exhaustion, difficulty sleeping, influenza like illness, activities of daily living impaired and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix (intramuscular), pain in arm, fever, stomach cramps, nausea, exhaustion, difficulty sleeping, influenza and activities of daily living impaired feeling cold. The patient reported that took Aleve and put an ice pack on the left arm Saturday evening. The patient reported within 3 hours after receiving vaccine was exhausted and this is still ongoing at till the time of reporting.  The patient reported trouble sleeping Saturday night due to the pain in the arm and this has resolved at till the time of reporting. The reporter consented to follow up. No further information was available.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pain in extremity, Pyrexia
Clinical narrative: felt like he was coming down with a cold or the flu; out of work today due to his current symptoms.; feeling cold; soreness in left arm / pain in the arm; fever; cramping in stomach; nausea; exhausted; trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th October 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, stomach cramps, nausea, exhaustion and difficulty sleeping. On 19th October 2020, the patient experienced influenza like illness, activities of daily living impaired and feeling cold. The patient was treated with naproxen (Aleve). On 18th October 2020, the outcome of the pain in arm, fever, stomach cramps and nausea were recovered/resolved. On an unknown date, the outcome of the exhaustion, difficulty sleeping, influenza like illness and feeling cold 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 pain in arm, fever, stomach cramps, nausea, exhaustion, difficulty sleeping, influenza like illness, activities of daily living impaired and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix (intramuscular), pain in arm, fever, stomach cramps, nausea, exhaustion, difficulty sleeping, influenza and activities of daily living impaired feeling cold. The patient reported that took Aleve and put an ice pack on the left arm Saturday evening. The patient reported within 3 hours after receiving vaccine was exhausted and this is still ongoing at till the time of reporting.  The patient reported trouble sleeping Saturday night due to the pain in the arm and this has resolved at till the time of reporting. The reporter consented to follow up. No further information was available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: rash and itchiness at site of injection; itchiness at site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number GB429, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date.).   On 22nd September 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd September 2020, 1 hr after receiving Shingrix, the patient experienced injection site rash and injection site itching. On an unknown date, the outcome of the injection site rash and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash and injection site itching to be related to Shingrix.  Additional details were reported as follows: The reporter asked how common the duration and intensity for an event in patients was that received Shingrix. The patient had developed a rash and itchiness at site of injection soon after vaccination. The reported batch number 6B429 for Shingrix did not exist and was updated to GB429 as per the sales database. On the day of reporting the patient still had the rash and itchiness present. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Sleep disorder
Clinical narrative: could not sleep; tender to touch at site of injection / intense pain at site of injection; generalized body aches; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and general body pain. On 20th October 2020, the patient experienced difficulty sleeping. On 12th October 2020, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the injection site pain and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, general body pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The reporter called to request information about the adverse reaction experienced by the patient. After the administration of Shingrix in unknown deltoid, the symptoms appeared soon and it was tender to touch at site of injection and then generalized body aches began. First set of symptoms recovered after a few days, number of days was unspecified (presumed to be less than a week by agent). The tenderness at injection site and generalized body aches were recovered on 12th October 2020. Two weeks after the injection, an intense pain at site of injection presented, specially at night and patient could not sleep due to this since it intensified at night. By the description of the patient, reporter compared it to muscle pain like an aching throb. The reporter consented to follow up. The reporter could not specify side of site of injection at the moment of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pain at the injection site with both doses; swelling at the injection site with both doses; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hip surgery (had hip surgery in January 2020). Concurrent medical conditions included degenerative joint disease.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with degenerative hip disease in September 2019. The reporter stated that, after vaccination with 1st dose of Shingrix, the patient experienced pain and swelling at the injection site. The reporter consented to follow up. This was 1 of 2 linked cases, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR213732:Same reporter
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: Bells Palsey / side face paralysis from eye to mouth; This case was reported by a other health professional via call center representative and described the occurrence of bell's palsy in a female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   In November 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). In January 2020, between 1 and 3 months after receiving FluLaval Tetra 2019-2020 season, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was not recovered/not resolved.   It was unknown if the reporter considered the bell's palsy to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received flu vaccine which was believed to be Flulaval quadrivalent in January 2020 experienced bells palsy and also had left side paralysis from eye to mouth. The reporter mentioned that, patient went to emergency room when symptoms developed. The reporter did not had any additional information about medical healthcare. The reporter consented to follow up.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Erythema, Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: redness she had in her arm; soreness she had in her arm; swelling and soreness she had in her arm; This case was reported by a consumer via call center representative and described the occurrence of cellulitis in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season and PNEUMOCOCCAL VACCINE. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced cellulitis (serious criteria GSK medically significant), allergic reaction, swelling arm, pain in arm and erythema of extremities. The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis, allergic reaction, swelling arm, pain in arm and erythema of extremities were unknown.   It was unknown if the reporter considered the cellulitis, allergic reaction, swelling arm, pain in arm and erythema of extremities to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows:  The age at vaccination was not reported. The patient received flu vaccine and pneumococcal vaccine at the same time in same arm and experienced redness, swelling and soreness in arm and was prescribed antibiotics for cellulits. The patient went to urgent care for redness, swelling and soreness in arm. The primary care physician did not think it was cellulitis but just an allergic reaction. The reporter was not sure exactly which vaccine caused the issue. The patient was seeking to get another flu vaccine, but was taking zejula and wanted to know if  She can get the flu vaccine.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves patient who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Also found out that particular strain was only 85 percent effective. I got the shot last week and so far I'm fine.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for flu.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Malaise
Clinical narrative: sick for over an entire month; Initial information was received on 08-Oct-2020.  This case involves a patient with an unknown demographic who was sick for over an entire month (malaise), when received INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE (produced by unknown manufacturer, batch number and expiration date were not provided) via an unknown route in the arm for prophylactic vaccination respectively.  On an unknown date, the patient was sick for over an entire month (malaise), unknown latency following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Underdose
Clinical narrative: female patient did not receive the full dose MENACTRA vaccine/ NO AE; while administering a Menactra  vaccine,  some of the vaccine it leaked from where the needle was attached to the syringe/ NO AE; Initial information received on 06-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17-years-old patient to whom while administering first dose of 0.5 mL vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (frequency: once, lot number: U6585AA, expiry date: 11-Apr-2021 via an Intramuscular route in right Deltoid) some of it leaked from where the needle was attached to the syringe at hub or leur lock (syringe issue) so the patient did not receive the full dose (underdose) on 06-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA, HPV VACCINE (HPV VACCINE) and HEPATITIS A VACCINE (HEPA [HEPATITIS A VACCINE]) for prophylactic vaccination.  It was an actual medication error case due to vaccine underdose and syringe leak.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: FLUR4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: FLUBLOK QUADRIVALENT was administered to a 16 year old, no AE; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 16 years old female patient who was vaccinated with a 0.5 ml dose  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2016 and expiration date : 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination on 15-Oct-2020 (PT: product administered to patient of inappropriate age).  Medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient was given the liquid part of Pentacel and not the powder part, the ActHib, no Ae; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 10 months old female patient who was given 0.5 ml the only the liquid part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch numbers UJ349AAA, U6841AA ,UJ349AA and expiration date: 22-Jun-2021) and not the powder part, the Act-Hib, via intramuscular route in the left thigh for prophylactic vaccination on an unspecified date (PT: product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (same day latency).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: cellulitis; redness of 5cm at the medial portion of the left arm; swelling of 5cm at the medial portion of the left arm; pain of 5cm at the medial portion of the left arm; Initial information was received on 21-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 65 years old female patient who had cellulitis (vaccination site cellulitis) with symptoms redness, swelling and pain of 5cm at the medial portion of the left arm (vaccination site erythema, vaccination site swelling and vaccination site pain) while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On 13-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ468AB, expiry date: 30-Jun-2021, single dose vial) once via intramuscular route in the left deltoid for prophylactic vaccination.  On 14-Oct-2020, the patient developed a non-serious cellulitis (vaccination site cellulitis) with symptoms redness, swelling and pain of 5cm at the medial portion of the left arm (vaccination site erythema, vaccination site swelling and vaccination site pain) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The diagnosis was reported as cellulitis.  No laboratory data was provided.   The patient was prescribed antibiotics to treat the events.  On 20-Oct-2020, the patient went back to the health care professional and it was reported that the cellulitis with symptoms vaccination site erythema, vaccination site swelling was recovering (improved) while the event vaccination site pain was not recovered.
Sex: U
Vaccine: FLUC4
Symptoms: Adverse reaction, Erythema, Pruritus, Swelling
Clinical narrative: Reaction on the deltoid posterior area; Swelling; This spontaneous case was received on 21-Oct-2020 from other health professional (nurse) via Communications (reference number: SEQW20-04044) with additional document received on the same day (being processed together) form other non-health professional via Communications (reference number: SEQW20-04036) and concerned a patient of unknown age and gender.   The patient had no relevant medical history and was not taking any concomitant medications.   On 19-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for flu prevention. The batch number reported was 283847 and expiry date: 30-Jun-2021.   On the same date, the patient experienced redness, swelling, itching and a reaction on the deltoid posterior area.   On an unknown date in Oct-2020, the patient was admitted to the hospital due to the events. The patient was treated with clindamycin intramuscularly, dexamethasone intramuscularly and Benadryl (diphenhydramine hydrochloride).   At the time of initial reporting on 21-Oct-2020, the patient had not recovered from the events and was still hospitalized.   The reporter assessed the case as serious due to hospitalization.  This case is linked to case 202005386 (same reporter).  Company comment: The patient developed erythema, swelling, adverse reaction (reported as ''reaction on the deltoid posterior area'') and pruritus on the same date after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for the event of adverse reaction is assessed as unassessable, while for all other events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).   Sender's Comments:  The patient developed erythema, swelling, adverse reaction (reported as ''reaction on the deltoid posterior area'') and pruritus on the same date after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for the event of adverse reaction is assessed as unassessable, while for all other events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).