chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: On Tuesday, October 8 at approximately noon the patient states the injection site was itching, red and warm which covered her shoulder approximately the size of her deltoid muscle.   Additionally, she stated it was bruised.    Wednesday, October 9 at 9:45 a.m. the site had minimal redness was slightly warm to the touch.  Bruising was the size of a half dollar.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: pain in left shoulder and arm;  limited range of motion, wake up at night with pain, needed help with ADLs  symptoms persisted requiring NSAIDs for over 6months
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: pain in left shoulder and arm;  limited range of motion, wake up at night with pain, needed help with ADLs  symptoms persisted requiring NSAIDs for over 6months
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Platelet count decreased, Thrombocytopenia
Clinical narrative: Thrombocytopenia
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; A patient received an expired dose of PNEUMOVAX 23; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.  On 23-SEP-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), intramuscularly, lot # R000579 with expiration date 09-SEP-2019 (strength, dose and frequency were not reported) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: patient had a syncopal event following the administration of the dose; This spontaneous report was received from a registered nurse, via a company representative, referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were unknown by reporter.  On an unknown date, 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) for prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were unknown by reporter) and following the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient had a syncopal event (syncope). It was reported that the patient sought for medical attention, but it was unknown if he received treatment for the event or if any diagnostic laboratories or studies were performed.  At the time of the report, the patient had recovered from the event. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and syncope was not reported.  Upon internal review, syncope was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored varivax; This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.   On 09-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R019237 with expiration date: 04-JUL-2020 or lot # S005078 with expiration date: 19-FEB-2021 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The vaccines were reconstituted with properly stored sterile diluent. The vaccines exposed to a temperature of  -14 degree celsius to -10 degree Celsius (-9.74 degree celsius). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect reported; patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition and medical history was unknown. Concomitant therapy included sterile diluent. On 08-JUN-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S002874 with expiry date 29-JAN-2021 (strength, dose, frequency, route of administration unspecified) for prophylaxis (product storage error). The diluent used to reconstitute the vaccine was properly stored. On an unknown date, the vaccine was exposed to 7.46 Fahrenheit temperature for 20 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect (no adverse event) reported. The outcome of the event was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male 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 2 months after receiving Shingrix, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid and experienced sore left arm and headaches. The reporter consented to follow up. For tolerance of 2nd dose of Shingrix, refer case US2019178962.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Herpes zoster, Myalgia, Pain
Clinical narrative: Shingles; Pain; Itch; Bright red / red area; Burning feeling; Scars; Pain latched on to the muscles on right side from kidney back down of hip; This case was reported by a consumer and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of herpes zoster (1st dose received on an unknown date and experienced lot of side effects that lasted a month, refer linked case US2019AMR117261). Concurrent medical conditions included blood pressure high and blood cholesterol increased (that was not that high).   On 7th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced muscle pain. On 21st September 2019, the patient experienced shingles, pain, pruritus, erythema, burning sensation and scar. On an unknown date, the outcome of the muscle pain, shingles, pain and pruritus were unknown and the outcome of the erythema, burning sensation and scar were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, shingles, pain, pruritus, erythema, burning sensation and scar to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix on right arm. The patient experienced pain latched on to the muscles on right side from kidney down back of hip. 14 days after receiving Shingrix, the patient got shingles on same area which lasted for 5 days. The patient got shingles again same area back of leg and also buttocks. 14 days after receiving Shingrix, the patient experienced pain, itching and bright red burning feeling and scars.  On the reporting date, the red area, burning and scars were still there. The patent had no other medical conditions except medicine for high blodd pressure and high cholesterol (that was not that high). Prior to this shot the patient only had small area of shingles once a month.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Scar
Clinical narrative: Shingles; Pain; Itch; Bright red / red area; Burning feeling; Scars; Pain latched on to the muscles on right side from kidney back down of hip; This case was reported by a consumer and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingrix with an associated reaction of herpes zoster (1st dose received on an unknown date and experienced lot of side effects that lasted a month, refer linked case US2019AMR117261). Concurrent medical conditions included blood pressure high and blood cholesterol increased (that was not that high).   On 7th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced muscle pain. On 21st September 2019, the patient experienced shingles, pain, pruritus, erythema, burning sensation and scar. On an unknown date, the outcome of the muscle pain, shingles, pain and pruritus were unknown and the outcome of the erythema, burning sensation and scar were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, shingles, pain, pruritus, erythema, burning sensation and scar to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix on right arm. The patient experienced pain latched on to the muscles on right side from kidney down back of hip. 14 days after receiving Shingrix, the patient got shingles on same area which lasted for 5 days. The patient got shingles again same area back of leg and also buttocks. 14 days after receiving Shingrix, the patient experienced pain, itching and bright red burning feeling and scars.  On the reporting date, the red area, burning and scars were still there. The patent had no other medical conditions except medicine for high blodd pressure and high cholesterol (that was not that high). Prior to this shot the patient only had small area of shingles once a month.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Lethargy, Pain
Clinical narrative: Felt like had the flu; Lethargic; Hurt terribly for two days / Achy; This case was reported by a consumer and described the occurrence of pain in a 84-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, less than 2 years after receiving Shingrix, the patient experienced pain, influenza-like symptoms and lethargy. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the influenza-like symptoms and lethargy were unknown.   It was unknown if the reporter considered the pain, influenza-like symptoms and lethargy to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient hurt terribly for two days and also felt like had the flu, felt achy and lethargic. The patient would be receiving 2nd dose of Shingrix the day after reporting date and asked whether there something the patient could do to prevent this.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Feeling abnormal, Headache, Insomnia, Tremor
Clinical narrative: Couldn't sleep; Massive headache; Felt like a "truck ran over me"; terrible reaction; Violent shaking; This case was reported by a consumer and described the occurrence of insomnia in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2019, the patient received the 2nd dose of Shingrix. On 30th September 2019, less than a day after receiving Shingrix, the patient experienced tremor and adverse reaction. On an unknown date, the patient experienced insomnia, headache and feeling abnormal. On an unknown date, the outcome of the insomnia, headache, feeling abnormal and adverse reaction were unknown and the outcome of the tremor was recovered/resolved.   It was unknown if the reporter considered the insomnia, tremor, headache, feeling abnormal and adverse reaction to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The reporter was informed of a reaction by a neighbor.  The day before the reporting date, the patient received Shingrix. The patient had terrible reaction. From 9:30 pm to 3:00 am, the patient was violent shaking. Less than a week after receiving Shingrix, the patient could not sleep, massive headache and felt like a truck ran over her.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction, Influenza like illness
Clinical narrative: flu like symptoms; bad reaction; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 52-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, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms and adverse reaction. On an unknown date, the outcome of the influenza-like symptoms and adverse reaction were unknown.   It was unknown if the reporter considered the influenza-like symptoms and adverse reaction to be related to Shingrix.  Additional case details were provided as follows: The age at  vaccination was not reported. The patient had a bad reaction and flu like symptoms after receiving Shingrix.  The patient asks, would that be associated with bad effects of the 2nd dose as well.
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Myalgia, Neck pain, Pain in extremity
Clinical narrative: sore arm; fatigue; myalgia; neck pain; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm, fatigue, myalgia and neck pain. On an unknown date, the outcome of the pain in arm, fatigue, myalgia and neck pain were unknown.   It was unknown if the reporter considered the pain in arm, fatigue, myalgia and neck pain to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient experienced side effects (sore arm, fatigue, myalgia, neck pain) following administration of Bexsero. The reporter was agree to follow up from GlaxoSmithKline.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Tenderness
Clinical narrative: Rash; Tenderness; Redness and tenderness to touch along my right side; This case was reported by a consumer and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in April 2019).   On 25th September 2019, the patient received the 2nd dose of Shingrix. On 30th September 2019, 5 days after receiving Shingrix, the patient experienced rash, tenderness and erythema. On an unknown date, the outcome of the rash, tenderness and erythema were unknown.   The reporter considered the rash, tenderness and erythema to be possibly related to Shingrix.  Additional case details were provided as follows: The patient received 1st dose, 6 months prior o reporting date.  On Wednesday, the patient received Shingrix.  The patient initially stated, she had rash and upon further clarification she stated on the last night (before the reporting date), she developed redness and tenderness to touch along her right side like dermatomal pattern. She was wondering if this was related to the vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: After he received first dose of Shingrix all of his joint pain went away; This case was reported by a nurse via sales rep and described the occurrence of unexpected therapeutic effect in a elderly 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 2 years after receiving Shingrix, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient told the reporter that, after the 1st dose of Shingrix all of his joint pain went away, leading to unexpected therapeutic effect. The patient then received 2nd dose of Shingrix. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional information received were as follows: Around the end of May 2019, the patient received Shingrix on left deltoid. The patient experienced headache for 2 days and then it completely resolved. The reporter consented to follow up. For tolerance to 2nd dose, refer linked case US2019178962.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain; This case was reported by a physician via sales rep and described the occurrence of pain in arm 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, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that, the patient had severe arm pain after shingrix injection. The reporter consented to follow up. This case is 1 of the 2 linked cases, reported by the same reporter.
Sex: U
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: reactions of 4-5cm swelling; This case was reported by a pharmacist via sales rep and described the occurrence of local swelling in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   On an unknown date, the patient received the 1st dose of FluLaval Tetra 2019-2020 season. On an unknown date, less than a year after receiving FluLaval Tetra 2019-2020 season, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown.   It was unknown if the reporter considered the local swelling to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that they just had their first flu clinic (having given about 170 doses). She stated that they saw a little less than 10 percent of patients (might be 10 patients) had local reactions of 4 to 5cm swelling.  She wanted to confirm that this was normal and the sales representative gave information from package insert trials. The reporter did note that their provider was inexperienced (not confident) and the reactions were mostly in the first patients of the day (she felt this was a contributing factor). The reporter did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: Nausea; Fatigue; Muscle aches; This case was reported by a consumer via sales rep and described the occurrence of nausea in a 57-year-old 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, less than 2 years after receiving Shingrix, the patient experienced nausea, fatigue and muscle pain. On an unknown date, the outcome of the nausea, fatigue and muscle pain were recovered/resolved.   It was unknown if the reporter considered the nausea, fatigue and muscle pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced nausea, fatigue, muscle aches lasting for 3 days.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Eye pruritus, Eye swelling, Ocular hyperaemia, Rash
Clinical narrative: Red eyes; Swollen eyes; Itchy eyes; Rash on body; This case was reported by a other health professional via sales rep and described the occurrence of eye red in a 3-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number XM9TB, expiry date 30th June 2020) for prophylaxis.   Previously administered products included Flu vaccine (received the flu shot the past couple of years without any reactions).   On 1st October 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 1st October 2019, immediately after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced eye red, eye swelling, eye pruritus and generalized rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the eye red, eye swelling, eye pruritus and generalized rash were unknown.   It was unknown if the reporter considered the eye red, eye swelling, eye pruritus and generalized rash to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient received vaccine in anterolateral left thigh. The patient received Fluarix vaccine and left the office, but was returned shortly with red, swollen itchy eyes and a rash on her body. The patient received 9cc of Benadryl oral suspension ( 12.5mg per 5ml) and responded well. The patient  had received the flu shot the past couple of years without any reactions. No other vaccine or medication was given prior to the reaction. The patient did not have any difficulty in breathing. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Injection site very fiery / Injection site very sore; Headaches; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site burning in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 2nd October 2019, less than 2 years after receiving Shingrix, the patient experienced injection site burning and headache. On an unknown date, the outcome of the injection site burning and headache were unknown.   It was unknown if the reporter considered the injection site burning and headache to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. At 12:45 hrs, the patient experienced injection site very fiery and sore, headaches.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient had a sore arm after receiving the 1st dose of Shingrix. For tolerance after 2nd dose refer case US2019AMR180635.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Dizziness, Feeling cold, Influenza, Nausea
Clinical narrative: Was in bed and could not get out; Dizzy if stood up; Flu; Fever; Chills; Nausea; This case was reported by a consumer and described the occurrence of bedridden in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in April 2019, refer case US2019AMR180629).   In September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, 7 hrs after receiving Shingrix, the patient experienced bedridden, fever, chills, nausea, dizziness and influenza. On an unknown date, the outcome of the bedridden, fever, chills, nausea, dizziness and influenza were unknown.   It was unknown if the reporter considered the bedridden, fever, chills, nausea, dizziness and influenza to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix received Shingrix last week and excepted the same and was in bed and could not get out. The patient had a fever with chills and nausea for 24 hours.  The patient was dizzy if stood up. The patient never had the flu as bad as this. This was the worse vaccination the patient had ever received.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Was in bed and could not get out; Dizzy if stood up; Flu; Fever; Chills; Nausea; This case was reported by a consumer and described the occurrence of bedridden in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in April 2019, refer case US2019AMR180629).   In September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, 7 hrs after receiving Shingrix, the patient experienced bedridden, fever, chills, nausea, dizziness and influenza. On an unknown date, the outcome of the bedridden, fever, chills, nausea, dizziness and influenza were unknown.   It was unknown if the reporter considered the bedridden, fever, chills, nausea, dizziness and influenza to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix received Shingrix last week and excepted the same and was in bed and could not get out. The patient had a fever with chills and nausea for 24 hours.  The patient was dizzy if stood up. The patient never had the flu as bad as this. This was the worse vaccination the patient had ever received.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: aching; temperature is 101.4; shivering; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 25th June 2019).   On 30th September 2019, the patient received the 2nd dose of Shingrix. In October 2019, 11 hrs 10 min after receiving Shingrix, the patient experienced shivering, pain and fever. On 1st October 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the pain and fever were unknown.   It was unknown if the reporter considered the shivering, pain and fever to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. At 6:50 pm, the day before the reporting date, the patient received Shingrix. At 6 am In the morning of the reporting date, the patient experienced shivering, which lasted for 1 hour and 45 minutes. The patient has aching and his temperature was 101.4 degree C. The patient was able to eat toast and drink tea. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Concussion, Dizziness, Fall, Headache, Nervousness
Clinical narrative: headache; fall; feeling shaky; dizziness; concussion; blurry vision; This case was reported by a consumer via call center representative and described the occurrence of fall in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included fall (history of falls) and stroke. Concurrent medical conditions included type i diabetes mellitus and peripheral vision defective (no peripheral vision as result of stroke in 2013).   On 26th September 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 27th September 2019, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced fall, shaky feelings, dizziness, concussion and blurred vision. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the fall, shaky feelings, concussion and headache were not recovered/not resolved and the outcome of the dizziness and blurred vision were recovered/resolved.   The reporter considered the fall to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. It was unknown if the reporter considered the shaky feelings, dizziness, concussion, blurred vision and headache to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional information received were as follows: The reporter was the patient's wife. The patient received Shingrix and Flu vaccine on unknown arm. On Friday, in the morning, the patient fell and bumped his head. As a result of the fall, the patient developed blurry vision, dizziness, feeling shaky and a concussion. The caller stated that she took the patient to the emergency room. Less than a week after vaccination, the patient expereinced headache. The patient was still feeling a little shaky and had a dull headache. The caller stated that she believed he fell because he received both vaccines at the same time, the day before. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Vision blurred
Clinical narrative: headache; fall; feeling shaky; dizziness; concussion; blurry vision; This case was reported by a consumer via call center representative and described the occurrence of fall in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included fall (history of falls) and stroke. Concurrent medical conditions included type i diabetes mellitus and peripheral vision defective (no peripheral vision as result of stroke in 2013).   On 26th September 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 27th September 2019, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced fall, shaky feelings, dizziness, concussion and blurred vision. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the fall, shaky feelings, concussion and headache were not recovered/not resolved and the outcome of the dizziness and blurred vision were recovered/resolved.   The reporter considered the fall to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. It was unknown if the reporter considered the shaky feelings, dizziness, concussion, blurred vision and headache to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional information received were as follows: The reporter was the patient's wife. The patient received Shingrix and Flu vaccine on unknown arm. On Friday, in the morning, the patient fell and bumped his head. As a result of the fall, the patient developed blurry vision, dizziness, feeling shaky and a concussion. The caller stated that she took the patient to the emergency room. Less than a week after vaccination, the patient expereinced headache. The patient was still feeling a little shaky and had a dull headache. The caller stated that she believed he fell because he received both vaccines at the same time, the day before. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Fatigue, Pyrexia
Clinical narrative: Severe reaction; Very high fever; Tired; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event, fever and tiredness. On an unknown date, the outcome of the adverse event, fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the adverse event, fever and tiredness to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist reported that the reporter's friend had a severe reaction, very high fever and tired. The patient got the second dose. The reporter did not consent to follow-up. The pharmacist reported this was a side note, did not wish to provide patient information.  No vaccine lot number and expiry date available.  It was unknown where the patient received the vaccine. This case has been linked with US2019178174, reported by the same reporter.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV, PNC13
Symptoms: Crying, Somnolence
Clinical narrative: sleeping alot; crying; This case was reported by a consumer via call center representative and described the occurrence of crying in a 2-month-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis, PNEUMOCOCCAL VACCINE (PREVNAR 13) for prophylaxis, HAEMOPHILUS INFLUENZA B VACCINE (PEDVAX HIB) for prophylaxis and POLIOMYELITIS VACCINE (POLIO VACCINE) for prophylaxis.   On 13th May 2019 10:00, the patient received the 1st dose of Infanrix and Engerix B pediatric. On 13th May 2019, the patient received PREVNAR 13 and PEDVAX HIB. On an unknown date, the patient received POLIO VACCINE at an unknown dose. On 13th May 2019, 4 hrs after receiving Infanrix and Engerix B pediatric, the patient experienced crying. On 14th May 2019, the patient experienced sleepiness. The patient was treated with paracetamol (Tylenol). On 13th May 2019 10:00, the outcome of the crying was resolved with sequelae. On an unknown date, the outcome of the sleepiness was resolved with sequelae.   The reporter considered the crying and sleepiness to be related to Infanrix. It was unknown if the reporter considered the crying and sleepiness to be related to Engerix B pediatric.  Additional details were provided as follows: The case was reported by patient's mother. The reporter stated that the patient began crying at 2pm and did not stop until 10pm later the night of vaccination. The patient was given Tylenol. The reporter stated that the patient slept a lot. The reporter denied any localized reactions but noted the patient also received other vaccines that day, she does not know exactly where Infanrix was given. The patient also received Predvax/hib, polio,  engerix B and prevnar 13. The reporter stated that the crying reaction was due to the Infanrix, as that is what her physician stated was the cause for the neurological response. The reporter called concerned about what potential damage or concerns this neurological response could have on the patient. The reporter denied any specific neurological issues seen other than the crying for prolonged time. The reporter was concerned about potential brain swelling that could have been caused by the swelling, but gave no indicators this had occurred. The reporter added that the patient had received the other vaccines again and no reactions followed, but the patient has not received any further doses of Infanrix at the time of the call. The reporter did not relate the events of crying or sleeping to any of the other vaccines given, therefore, they are not captured as co suspects. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles; Rash; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional information received were as follows: On Wednesday, the patient received Shingrix. On Friday, 27th September 2019, the patient went to the doctor for a rash, which the doctor believed was shingles (no definitive diagnosis). The reporter consented to follow up.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Furuncle
Clinical narrative: Blister; Boil; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced blister and boil. On an unknown date, the outcome of the blister and boil were unknown.   It was unknown if the reporter considered the blister and boil to be related to Shingrix.  Additional case details were reported as follows: The patient had the first dose of Shingrix in last week. The patient developed a blister or a boil on his behind.  The reporter did not want to provide any further details at the time of the call. The reporter called to ask if it could be related. The reporter consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash under arms / Rash behind knees; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 774SY, expiry date 2nd October 2021) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient experienced rash under arms and rash behind knees. The adverse event was collected. The reporter enquired about any information on this type of reaction and on how to proceed with 2nd dose of Shingrix. The reporter did not consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pain, Pyrexia
Clinical narrative: blisters; fever; aches; Feels burning; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 3HX44, expiry date 15th November 2021) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 2019, 2 days after receiving Shingrix, the patient experienced blister, fever, pain and burning sensation. On 15th September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the blister and burning sensation were unknown and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the blister, fever, pain and burning sensation to be related to Shingrix.  Additional details were provided as follows: The reporter was reading the information from a note that another pharmacist left. The patient received intramuscular injection of Shingrix and 2 days after she developed blisters which were painful and burning.  The patient also experienced a fever which resolved after 2 days. The patient also experienced aches. The patient was feeling better now and improved but she still feels pain and burning. The reporter did not know if the blisters had resolved or where on the body they were located. The pharmacist stated that the patient has stated she does not want to get the second shot in the series. The pharmacist did not had patient's MD contact information available.
Sex: U
Vaccine: VARZOS
Symptoms: Neurological symptom
Clinical narrative: neurologic episode; This case was reported by a physician via call center representative and described the occurrence of neurological symptom 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, less than 2 years after receiving Shingrix, the patient experienced neurological symptom. On an unknown date, the outcome of the neurological symptom was recovered/resolved.   The reporter considered the neurological symptom to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but was selected as adult as per vaccine indication. The reporter stated that they saw a patient for a physical and the patient reported a neurologic episode that lasted 4-6 weeks after receiving the Shingrix vaccine and they thought the reaction was due to the Shingrix. No additional details were available. The reporter was consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Oral mucosal blistering, Pain in extremity, Paraesthesia oral
Clinical narrative: soreness in the injection arm; tingling sensation in lip; little blisters in mouth; swelling in the lower lip; This case was reported by a consumer via call center representative and described the occurrence of tingling lips in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2019, the patient received the 1st dose of Shingrix. In June 2019, 7 days after receiving Shingrix, the patient experienced tingling lips, blistering of mouth and lip swelling. On an unknown date, the patient experienced pain in arm. The patient was treated with antibiotics nos. On an unknown date, the outcome of the tingling lips, blistering of mouth, lip swelling and pain in arm were recovered/resolved.   It was unknown if the reporter considered the tingling lips, blistering of mouth, lip swelling and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix on left arm. Approximately 1 week after receiving the vaccine, patient developed swelling in the lower lip, a tingling sensation in her lips and little blisters in her mouth. The patient stated that these symptoms lasted for approximately 1 month before resolving. The patient stated that she went to see her doctor and the doctor prescribed an antibiotic and the antibiotic resolved the symptoms. The patient stated that she also developed soreness in the injection arm after receiving the vaccine. The reporter was consented to follow up.
Age: 42.0
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: Negative titers; therapy non-responder; Drug dose administration interval too long; This case was reported by a pharmacist via call center representative and described the occurrence of hepatitis b antibody negative in a 42-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 22nd February 2005, the patient received the 1st dose of Engerix B. On 22nd March 2005, the patient received the 2nd dose of Engerix B. On 17th September 2005, the patient received the 3rd dose of Engerix B. On an unknown date, less than a year after receiving Engerix B, Engerix B and Engerix B, the patient experienced hepatitis b antibody negative, therapy non-responder and drug dose administration interval too long. On an unknown date, the outcome of the hepatitis b antibody negative, therapy non-responder and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the hepatitis b antibody negative and therapy non-responder to be related to Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The batch number and expiry date was unknown. The reporter stated that, the patient received full series of Hepatitis B vaccine(unsure of manufacturer) and experienced hepatitis b antibody negative and therapy non-responder. The patient received 3rd dose late than the recommended schedule, which led to lengthening of vaccination schedule. The patient stated that, he was tested within a year following the series completion because of a change in insurance. The patient received another full series in 2009 with 1st dose on 14 January 2009, 2nd dose 14 February 2009 and 3rd dose 10 July 2009 and titer came back positive. The reporter consented to follow up.