chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Sudden hearing loss, Therapeutic procedure
Clinical narrative: sudden right hearing loss; sudden right hearing loss; bilateral sensorineural hearing loss; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided.  On or around 21-OCT-2016, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(lot number, dosage, and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live(ZOSTAVAX), the pt suffered sudden right hearing loss and bilateral sensorineural hearing loss and had multiple intratympanic dexamethasone perfusion procedures to no avail. As a direct and proximate result of zoster vaccine live(ZOSTAVAX),the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Sudden hearing loss, deafness unilateral and deafness neurosensory were considered to be disability.   Upon internal review, sudden hearing loss, deafness unilateral and deafness neurosensory were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac failure acute, Dyspnoea, Herpes zoster, Hypertensive emergency, Pulmonary oedema
Clinical narrative: acute hypertensive emergency with pulmonary edema and acute heart failure; acute hypertensive emergency with pulmonary edema and acute heart failure; acute hypertensive emergency with pulmonary edema and acute heart failure; Herpes zoster across the chest, upper back and under the right arm; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On 21-OCT-2016, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live(ZOSTAVAX), the pt suffered herpes zoster across the chest, upper back and under the right arm. A few weeks later pt started to experienced shortness of breath, fever and dyspnea. The pt was subsequently diagnosed with acute hypertensive emergency with pulmonary edema and acute heart failure. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Cardiac failure acute, herpes zoster, hypertensive emergency and pulmonary oedema were considered to be disability.   Upon internal review, cardiac failure acute, hypertensive emergency and pulmonary oedema were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: acute hypertensive emergency with pulmonary edema and acute heart failure; acute hypertensive emergency with pulmonary edema and acute heart failure; acute hypertensive emergency with pulmonary edema and acute heart failure; Herpes zoster across the chest, upper back and under the right arm; Information has been received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On 21-OCT-2016, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live(ZOSTAVAX), the pt suffered herpes zoster across the chest, upper back and under the right arm. A few weeks later pt started to experienced shortness of breath, fever and dyspnea. The pt was subsequently diagnosed with acute hypertensive emergency with pulmonary edema and acute heart failure. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Cardiac failure acute, herpes zoster, hypertensive emergency and pulmonary oedema were considered to be disability.   Upon internal review, cardiac failure acute, hypertensive emergency and pulmonary oedema were determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Neck pain, Pain in jaw, Retinal detachment
Clinical narrative: herpes zoster; detached retina; Information has been received from lawyers referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or around 11-OCT-2016, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the prevention of shingles (herpes zoster) and routine health maintenance.   On an unknown date, the patient suffered facial swelling, left sided facial redness, pain which radiated down left jaw and into her neck, and crusting lesions along ophthalmic nerve. The patient was ultimately diagnosed with herpes zoster and detached retina. The patient did not recover from the events. As per the reporter, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were disabling.   The reporter considered the events were related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of detached retina was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Skin lesion, Swelling face
Clinical narrative: herpes zoster; detached retina; Information has been received from lawyers referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or around 11-OCT-2016, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the prevention of shingles (herpes zoster) and routine health maintenance.   On an unknown date, the patient suffered facial swelling, left sided facial redness, pain which radiated down left jaw and into her neck, and crusting lesions along ophthalmic nerve. The patient was ultimately diagnosed with herpes zoster and detached retina. The patient did not recover from the events. As per the reporter, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were disabling.   The reporter considered the events were related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of detached retina was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Patient was hospitalized; This spontaneous report was received from a Healthcare worker via a company representative referring to a female patient of unknown age. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 11-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot # and expiration date were not reported), for prophylaxis.  On 15-OCT-2019, the patient was hospitalized (adverse event) and discharged on 18-OCT-2019. No further information was provided about where or why the patient was hospitalized. The outcome of the event was unknown.  A causality assessment was not provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Infection, Musculoskeletal pain, Neck pain
Clinical narrative: she had an outbreak of a rash on her spine about 2 inches long and also on the back of her neck that appears to be shingles; This spontaneous report was received from a female patient regarding herself. The patient's concurrent conditions included thyroid issues and heartburn. The patient's medical history, drug reactions or allergies were not reported.  Concomitant therapy included levothyroxine and unspecified heartburn medicine.  On an unknown date in 2006, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX), (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On 17-OCT-2019, the patient had an outbreak of a rash on her spine about to 2inces long and on the back of her neck that appears to be shingles (herpes zoster). The patient also reported that she was having headaches, as well, as pain in her shoulders and neck. The patient sought medical attention by speaking with her physician and she was treating the rash with unspecified cream, the pain was treated with ice and for the infection, she was being treating with acyclovir and acetaminophen (TYLENOL) for the headaches.  At the time of the report, the patient did not recovered from the herpes zoster.  The relatedness between the event of herpes zoster and therapy with zoster vaccine live(ZOSTAVAX) was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: she had an outbreak of a rash on her spine about 2 inches long and also on the back of her neck that appears to be shingles; This spontaneous report was received from a female patient regarding herself. The patient's concurrent conditions included thyroid issues and heartburn. The patient's medical history, drug reactions or allergies were not reported.  Concomitant therapy included levothyroxine and unspecified heartburn medicine.  On an unknown date in 2006, the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX), (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On 17-OCT-2019, the patient had an outbreak of a rash on her spine about to 2inces long and on the back of her neck that appears to be shingles (herpes zoster). The patient also reported that she was having headaches, as well, as pain in her shoulders and neck. The patient sought medical attention by speaking with her physician and she was treating the rash with unspecified cream, the pain was treated with ice and for the infection, she was being treating with acyclovir and acetaminophen (TYLENOL) for the headaches.  At the time of the report, the patient did not recovered from the herpes zoster.  The relatedness between the event of herpes zoster and therapy with zoster vaccine live(ZOSTAVAX) was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect reported; a patient received an expired dose of M-M-R II; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.  On 17-OCT-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant Human albumin) (M-M-R II), lot # N026828, expiration date 27-SEP-2019, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient was administered a dose of improperly stored VARlVAX; Information has been received from a nurse, referring to a patient of unknown age and gender. Information about medical history and concurrent condition was unknown. Concomitant medication included sterile diluent. It could not be determined if the sterile diluent was properly stored.  On 14-OCT-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S015460, expiration date: 20-MAY-2021; dose and strength were unknown) subcutaneously for prophylaxis.  The vaccine was exposed to temperature of -11.5 Celsius degrees for 76 hours. There was no previous temperature excursion. A digital data logger was involved. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration
Clinical narrative: doesnt remember if she received third dose of gardasil 9, 10 years ago, when she was 13 years old; doesnt remember if she received third dose of gardasil 9, 10 years ago, when she was 13 years old; This spontaneous report was received from a pharmacist referring to a currently 23-year-old female patient. Her concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported.  On an unknown date in 2009 (also reported as ten years ago), it was unknown whether she was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, unit, route, lot # and expiration date were not reported) (inappropriate schedule of product administration and circumstance or information capable of leading to medication error). The patient reported that she does not remember being vaccinated with third dose. The outcome of inappropriate schedule of product administration and circumstance or information capable of leading to medication error was unknown. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effects reported; 9 month old patient was administered an adult dose of vaqta; This spontaneous report was received from a health professional (Registered nurse) refers to a 9 month old patient. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 24-MAY-2019, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) (strength, dosage information and route of administration were unknown) of lot # R024007 with an expiry date of 12-OCT-2019 for prophylaxis (product administered to patient of inappropriate age). No adverse effects were not reported. The outcome of product administered to patient of inappropriate age was unknown. No product quality complaint reported.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: first dose of gardasil in 2013/ patient was in the office at the time of the phone call for her booster (GARDASIL 9); no adverse effect; This spontaneous report was received from a nurse prescriber refers to a female patient of unknown age. The patient's medical history, concurrent conditions, historical drugs, drug reactions/ allergies and concomitant medications were not reported. On an unknown date 2013 (at the age of 16 to 17 years), the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), (strength, dose, frequency, route, lot # and expiration date not reported) for prophylaxis. At the time of the reporting, the patient came to the nurse office for her booster of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No adverse effects were reported. No product quality complaint (PQC) was present.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO ADVERSE EFFECT; inadvertantly received Varivax after receiving proquad; This spontaneous report was received from a certified medical assistant referred to a patient of unknown age and gender. Information regarding medical history and concurrent conditions were not reported. On 22-OCT-2019 the patient was vaccinated with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live (Wistar RA 27/3), varicella virus vaccine live (Oka/Merck) PROQUAD (concomitant medication). On 22-OCT-2019 the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, with lot # R030606 and expiry date 23-OCT-2020 for prophylaxis (dose and route were not reported) after receiving measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live (Wistar RA 27/3), varicella virus vaccine live (Oka/Merck) (PROQUAD) (Inappropriate schedule of product administration). The patient did not experience any adverse effects.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect; the patient was 24 years old and received the first dose of GARDASIL 9 and will receive the second dose of GARDASIL 9 22-OCT-2019,; the patient was 24 years old and received the first dose of GARDASIL 9 and will receive the second dose of GARDASIL 9 22-OCT-2019,; received fisrt dose of gardasil on 17/5/2016 and second dose will recived on 22/10/2019; This spontaneous report as received from a nurse refers to a 24-year-old patient.     No information was provided regarding the patient's medical history, concomitant therapies and concurrent conditions.  On 17-MAY-2016, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 (lot# and expiry date was not reported) for prophylaxis.  The nurse reported that on 22-OCT-2019, the patient was in the office and would receive the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration, circumstance or information capable of leading to medication error, product administered to patient of inappropriate age). No adverse effect reported. No further information was reported.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Bedridden, Cough, Dyspnoea exertional, Feeling abnormal, Loss of personal independence in daily activities
Clinical narrative: Congestion; Lower leg pain; Low grade fever; Cough; Shortness of breath upon exertion; Feeling poorly; Bed-bound; Activities of daily living impaired; This case was reported by a pharmacist via call center representative and described the occurrence of nasal congestion in a 34-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date 30th June 2020) for prophylaxis.   On 13th September 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). In September 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced nasal congestion, leg pain, low grade fever, cough, exertional dyspnea, feels poorly, bedridden and activities of daily living impaired. On an unknown date, the outcome of the nasal congestion, leg pain, low grade fever, cough, exertional dyspnea, feels poorly, bedridden and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the nasal congestion, leg pain, low grade fever, cough, exertional dyspnea, feels poorly, bedridden and activities of daily living impaired to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The director of pharmacy reported that the patient received the Flulaval vaccine on an unknown deltoid. Within 24 hours after receiving Flulaval vaccine, the patient started feeling poorly with symptoms of congestion, cough, low grade fever and lower leg pain. Within 2 days after receiving Flulaval vaccine, the leg pain continued and the patient noted shortness of breath upon exertion. The patient presented at the emergency room for evaluation. The neurology consult in the the emergency room had concerned for neuropathy or myopathy and the employee was referred to outpatient neurology for follow up. The employee has been out of work on leave since this occurred and she was still bed-bound with no improvement at the time of this call. The reporter consented to follow up.  Emergency room visit required. No further details available at the time of this call. The director of pharmacy consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Nasal congestion, Pain in extremity, Pyrexia
Clinical narrative: Congestion; Lower leg pain; Low grade fever; Cough; Shortness of breath upon exertion; Feeling poorly; Bed-bound; Activities of daily living impaired; This case was reported by a pharmacist via call center representative and described the occurrence of nasal congestion in a 34-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date 30th June 2020) for prophylaxis.   On 13th September 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). In September 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced nasal congestion, leg pain, low grade fever, cough, exertional dyspnea, feels poorly, bedridden and activities of daily living impaired. On an unknown date, the outcome of the nasal congestion, leg pain, low grade fever, cough, exertional dyspnea, feels poorly, bedridden and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the nasal congestion, leg pain, low grade fever, cough, exertional dyspnea, feels poorly, bedridden and activities of daily living impaired to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The director of pharmacy reported that the patient received the Flulaval vaccine on an unknown deltoid. Within 24 hours after receiving Flulaval vaccine, the patient started feeling poorly with symptoms of congestion, cough, low grade fever and lower leg pain. Within 2 days after receiving Flulaval vaccine, the leg pain continued and the patient noted shortness of breath upon exertion. The patient presented at the emergency room for evaluation. The neurology consult in the the emergency room had concerned for neuropathy or myopathy and the employee was referred to outpatient neurology for follow up. The employee has been out of work on leave since this occurred and she was still bed-bound with no improvement at the time of this call. The reporter consented to follow up.  Emergency room visit required. No further details available at the time of this call. The director of pharmacy consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Facial spasm
Clinical narrative: facial tick; This case was reported by a physician via call center representative and described the occurrence of facial spasm in a 7-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. In September 2019, several weeks after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced facial spasm. On an unknown date, the outcome of the facial spasm was not recovered/not resolved.   The reporter considered the facial spasm 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 dose of flu vaccine in the fall of 2018. Few weeks after vaccination with dose of Flu vaccine, the patient experienced facial tick. The reporter described that, the patient tick as pulling face to the right. The reporter stated that, the patient's parents thought that, the facial tick might be related to the vaccine. The reporter did not provide any additional information.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever; shivering; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 17th October 2019, 1 days after receiving Shingrix, the patient experienced fever and shivering. On an unknown date, the outcome of the fever and shivering were not recovered/not resolved.   It was unknown if the reporter considered the fever and shivering to be related to Shingrix.  Additional details were provided as follows: On the day of reporting, in the morning the patient experienced shivering and fever. Her fever was 100.4 degrees F. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Injection site rash; rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number KC9C4, expiry date 30th March 2020) for prophylaxis.   On 7th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site rash and generalized rash. On an unknown date, the outcome of the injection site rash and generalized rash were unknown.   It was unknown if the reporter considered the injection site rash and generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced an injection site rash, which then spread to other parts of her body including legs and feet.  No time frame was known about initial onset of events. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood calcium increased
Clinical narrative: increased serum calcium levels; This case was reported by a consumer via call center representative and described the occurrence of serum calcium increased in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced serum calcium increased (serious criteria hospitalization). On an unknown date, the outcome of the serum calcium increased was not recovered/not resolved.   It was unknown if the reporter considered the serum calcium increased to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix on left arm. In August 2019, the patient was hospitalised for increased serum calcium levels. This case was linked with US2019AMR189454 having same reporter and same patient (dose 2)
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2019, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient's demographic details were not provided. The age at vaccination was not reported. The patient experienced pain at the injection site. The patient had not experienced any other symptoms. The patient asked how long would the event persist and asked if there was anything specific that could help alleviate it. The reporter consented to follow up.
Age: 102.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Rash from the injection site to all the way down to the wrist; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 102-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 30th September 2021) for prophylaxis.   On 8th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced a rash from the injection site to all the way down to the wrist. It appeared 3 days after vaccination and it resolved about 4 days later. The reporter consented to follow up. No further details were provided.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Feel feverish; This case was reported by a consumer via call center representative and described the occurrence of headache in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th June 2019, less than a day after receiving Shingrix, the patient experienced headache and fever. On 29th June 2019, the outcome of the headache and fever were recovered/resolved.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional case details were reported as follows: The reporter was the patient's wife. The patient received vaccine in unknown arm. On 28 June 2019, night the patient began to felt feverish and developed a headache. All symptoms were resolved in approximately one day. Unable to obtain additional information. The reporter consent to follow up. This is 1 of the 3 linked cases reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: HEPA
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Upper arm pain, discomfort continuing for greater than 30 days.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Headache, Lethargy, Limb discomfort, Myalgia
Clinical narrative: Slight tenderness in the left arm. Chills in the morning with slight headache and muscle aches not associated with the arm discomfort. Generally feel lethargic.  It is 9:00 A.M. so I have not recovered yet (see item 20).
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Tenderness
Clinical narrative: Slight tenderness in the left arm. Chills in the morning with slight headache and muscle aches not associated with the arm discomfort. Generally feel lethargic.  It is 9:00 A.M. so I have not recovered yet (see item 20).
Age: 39.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Skin test, Urticaria
Clinical narrative: - Patient is a 39yo female with a past medical history significant for autoimmune thyroiditis and previous zoster infection who experienced a severely pruritic facial dermatitis and general pruritus with onset 4-5 hours after receipt of post exposure prophylaxis RabAvert rabies vaccine #2 which was self treated with benadryl 75 mgs with partial benefit. The bite was deemed high risk and the animal was not found. Given rabies is uniformly fatal, completion of the post exposure protocol was indicated, however additional evaluation was warranted for safety. The reaction is less suggestive of IgE induced urticaria due to the later onset and continued duration, however, due to the extremely pruritic nature of the symptoms indicating allergic response and the symptom onset at the tail of typically accepted window for anaphylaxis response after vaccine, out of an abundance of precaution  the  decision was to defer vaccination and evaluate for allergy via prick testing and to change to Imovax brand.Prick skin testing was  performed to full-strength vaccine. Appropriate positive and negative controls were identified at the appropriate time interval. Results of the skin test were interpreted approximately 15 minutes after placement. After prick skin testing was determined to be negative, the patient underwent further evaluation with a 1:100 dilution of the Imovax brand rabies vaccine intradermal with appropriate controls. The patient tolerated the procedure well without any immediate adverse reactions. Both prick skin tests and intradermal skin tests were interpreted as negative, supporting the dermatitis was not IgE mediated and there is no identified risk of anaphylaxis. The patient was subsequently vaccinated with full dose Imovax vaccine and observed for 1 hour post vaccination. The patient tolerated the vaccination well without evidence of adverse reaction. The initial topical dermatitis was mostly resolved after 3 days of topical steroid. and oral fexofenadine. the dermatitis did not recur with next two Imovax doses.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Pruritus, Rash pruritic, Urticaria
Clinical narrative: On the day following vaccination pt reported "a couple of allergic-like bumps" that were itchy On the evening of the 2nd day post vaccination pt said "those bumps turned into welts" and was still very itchy On  the 3rd day post vaccination pt reported "welts all over" as well as being "very itchy". Also had to take OTC Benadryl for symptoms. The previous day pt stated symptoms cleared up.  No SOB reported at all.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Local reaction
Clinical narrative: Local reaction to Left arm. Severe redness. Cellulitis. Treated with Bactrim, hydrocortisone cream and ice.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports arm the had injection is swollen, red and hot, with itching around injection site.  Patient reports red area is the size of a coffee saucer.  Patient also reports bruising at injection site.    Patient reports this started the morning after the injection and continues today 10-21-19. Patient reports that she took Zyrtec for the itching.  Advised patient to call and discuss this with her Primary care Physician, and they could decide on further treatment.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Muscle/body aches, fever, chills, tiredness
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Cyanosis, Febrile convulsion, Pyrexia, Resuscitation, Somnolence
Clinical narrative: 9 days after the vaccination, the patient suddenly developed a high fever (104 at home, 107 at the hospital) and turned blue and unresponsive.  She had what was determined to be a febrile seizure.  Parents were unsure what was happening and began CPR.  Called 911.  Patient drowsy for a couple of days and has seemingly recovered completely.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Unresponsive to stimuli
Clinical narrative: 9 days after the vaccination, the patient suddenly developed a high fever (104 at home, 107 at the hospital) and turned blue and unresponsive.  She had what was determined to be a febrile seizure.  Parents were unsure what was happening and began CPR.  Called 911.  Patient drowsy for a couple of days and has seemingly recovered completely.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: I was 6 weeks pregnant at the time of my flu shot. I had went to my OB that day and everything with the pregnancy was fine. 12 hours after my flu shot I had a miscarriage. I have had two previous healthy pregnancies with no history of miscarriage. The estimated due date was June 14th.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Diffuse maculopapular erythematous raised rash on torso, back, buttocks, dorsal aspect of feet. Sparing legs. Face with erythema, hives. Low grade fever to 100C. Started 10/23 & worse when seen 10/24. Treated with benadryl, tylenol, prednisolone 10mg QD x3 d.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Urticaria
Clinical narrative: Diffuse maculopapular erythematous raised rash on torso, back, buttocks, dorsal aspect of feet. Sparing legs. Face with erythema, hives. Low grade fever to 100C. Started 10/23 & worse when seen 10/24. Treated with benadryl, tylenol, prednisolone 10mg QD x3 d.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Feeling abnormal, Hypoglycaemia
Clinical narrative: about 30 min after vaccination pt reported feeling "out of it", weak, spacy, and dizzy, appeared to be in hypoglycemic state, but is not diabetic and eating doughnut at time of event, sx resolved about 20 min later
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Chills, Cyanosis, Febrile convulsion, Foaming at mouth, Generalised tonic-clonic seizure
Clinical narrative: Patient had a febrile seizure (possibly two) two days after recieveing the vaccine.  She spiked a very high fever earlier in the day (104.5) and was taken to the hopsital for what they thought was "rigor" and lethargy.  She was given motrin and tylenol.  Four hours later she was given more motrin but her fever was still 102.2.  She had a grand mal type seizure (full body shakes, turned blue, foaming at the mouth) for about 3 minutes.  We were taken by ambulance back to the hosiptal.   Patient continues to suffer from complex febrile seziures.  She usually has more than one in a day.  Her last event (10/4/19), she had cluster seziures lasting over 7 1/2 minutes.  She needed emergency medication to stop the seizures.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Influenza A virus test positive, Lethargy, Pyrexia, Seizure cluster, Tremor
Clinical narrative: Patient had a febrile seizure (possibly two) two days after recieveing the vaccine.  She spiked a very high fever earlier in the day (104.5) and was taken to the hopsital for what they thought was "rigor" and lethargy.  She was given motrin and tylenol.  Four hours later she was given more motrin but her fever was still 102.2.  She had a grand mal type seizure (full body shakes, turned blue, foaming at the mouth) for about 3 minutes.  We were taken by ambulance back to the hosiptal.   Patient continues to suffer from complex febrile seziures.  She usually has more than one in a day.  Her last event (10/4/19), she had cluster seziures lasting over 7 1/2 minutes.  She needed emergency medication to stop the seizures.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Ear swelling, Injection site swelling, Myositis, Peripheral swelling
Clinical narrative: 10/17/19 Dr.'s office sent an email stating this employee has a serious reaction to the egg-free flu vaccine yesterday.  Dr. will start her on steroids and document findings. Cellulitis and myositis documented. She is said to have swelling on her left side, left shoulder, chest (breast), back, neck and left arm and into her ear.  Treated with Decadron 10/17/19; Depomedrol 80 mg 10/21/19 10/24/19 F/U employee is recovering but the symptoms are not completely resolved as of today.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Swelling, Vaccination complication
Clinical narrative: 10/17/19 Dr.'s office sent an email stating this employee has a serious reaction to the egg-free flu vaccine yesterday.  Dr. will start her on steroids and document findings. Cellulitis and myositis documented. She is said to have swelling on her left side, left shoulder, chest (breast), back, neck and left arm and into her ear.  Treated with Decadron 10/17/19; Depomedrol 80 mg 10/21/19 10/24/19 F/U employee is recovering but the symptoms are not completely resolved as of today.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Dizziness, Dyspepsia, Eating disorder, Fatigue
Clinical narrative: After receiving the flu shot, Patient woke up around 3am the morning after the vaccine with "severe body aches?like my blankets felt too heavy my legs and arms and back were so sore. I also felt dizzy, fatigued and had awful heartburn all day?like radiating into my back kind of heartburn that made it hard to eat. I?m not sure how the heartburn fits but the rest felt much like the flu and I could write off to an immune response to the vaccine except I?ve never felt like that before. I ended up leaving work early that day, sleeping 3 hours in the afternoon, went to bed at 8:30 pm, slept all night and woke up 100% better the next day
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Pain, Pain in extremity
Clinical narrative: After receiving the flu shot, Patient woke up around 3am the morning after the vaccine with "severe body aches?like my blankets felt too heavy my legs and arms and back were so sore. I also felt dizzy, fatigued and had awful heartburn all day?like radiating into my back kind of heartburn that made it hard to eat. I?m not sure how the heartburn fits but the rest felt much like the flu and I could write off to an immune response to the vaccine except I?ve never felt like that before. I ended up leaving work early that day, sleeping 3 hours in the afternoon, went to bed at 8:30 pm, slept all night and woke up 100% better the next day
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 6cm in diameter circle of erythema, induration and swelling to R thigh around injection site
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Arm pain, fatigue, headache, generalized muscle pain, chills
Age: 8.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Report received from parent  Raised erythema about 4 inches large on rt arm, not itching, no pain per report of a parent. Parent denies any other adverse symptoms. Advised to have cold compresses for arm, and to give child antihistamine Benardyl and follow up in the clinic in am on 10/24/2019. Parent reported via phone on 10/24 that the swelling is down, erythema persistent, Ibuprofen given, no other signs and symptoms noted. Parent did not bring the child into the office.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: 30 mins after subcutaneous vaccine was administered into patient's right thigh area, mother returned to practice stating the site was red & swollen.  By the site of the Varivax injection there was a one inch red spot with heat and a lump within the swollen area.  Patient felt pain with slight touch.  A cold pack was given and applied to site.  Benadryl was given.  Called mother 3 hours later and mother stated that the redness had subsided.  At 24 and 48 hours after vaccine, patient's mother reported that patient had extreme fatigue and muscle weakness with fever.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site warmth, Muscular weakness, Pyrexia
Clinical narrative: 30 mins after subcutaneous vaccine was administered into patient's right thigh area, mother returned to practice stating the site was red & swollen.  By the site of the Varivax injection there was a one inch red spot with heat and a lump within the swollen area.  Patient felt pain with slight touch.  A cold pack was given and applied to site.  Benadryl was given.  Called mother 3 hours later and mother stated that the redness had subsided.  At 24 and 48 hours after vaccine, patient's mother reported that patient had extreme fatigue and muscle weakness with fever.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Lethargy
Clinical narrative: Extreme Nausea  Headache Chills Joint pain Lethargy  Flu like symptoms
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Extreme Nausea  Headache Chills Joint pain Lethargy  Flu like symptoms
Age: 54.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Arthralgia, Inflammation, Injection site mass
Clinical narrative: Severe joint pain in right arm, similar to pain I had when I had a torn rotator cuff.   Have taken 800mg Ibuprofen for inflammation and pain every 8 hours. Does not help. Tried taking Tramadol HCL  50 mg for pain as well to no avail. Ice and heat do not help. There is also a lump about the size of a penny at the injection site.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Diplopia
Clinical narrative: Patient reported double vision and lower back pain within 24 hours after receiving the vaccination. Symptoms resolved within 15 minutes of onset and has not reported permanent symptoms.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Dehydration, Dizziness, Dyspnoea, Hypoaesthesia oral, Swollen tongue
Clinical narrative: Started with mouth going numb- 15 minutes after injection; tongue started swelling and boughts of dizziness- I believed it was due to dehydration; officially 20 minutes after injection- I requested an appt bc my tongue would block my air way and it was getting hard to breath- I was hooked up to an IV and Benadryl through IV- my sense of time became fuzzy- I know that I was hooked up to oxygen and my Blood pressure was high - 147/106, 139/100, 148/99, 145/105. I was put on an ambulance- given epinephrine. This would be an hour 1/2 after injection
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Erythema, Fatigue, Pruritus, Rash
Clinical narrative: rash extending from shoulder to elbow - red, warm, itchy lack of energy - tired - slept all day as of 10/24 symptoms were subsiding
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Skin warm
Clinical narrative: rash extending from shoulder to elbow - red, warm, itchy lack of energy - tired - slept all day as of 10/24 symptoms were subsiding
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain upper, Asthenia, Fatigue, Gastrointestinal sounds abnormal, Headache
Clinical narrative: - Pt reports immediate fussinesss, irritable, with no energy (around 10 am after injection)  - After dinner felt fatigued, stomach rumbling/hurting - Felt nauseous with a headache and a low grade fever < 100 F overnight. - The next morning pt reported arm swelling with a large white outline the size of her palm, lower than where injection site was.