chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: Discomfort, Swollen tongue, Throat tightness, Tongue discomfort, Urticaria
Clinical narrative: Got a flu shot  After a few hours my  tounge swollen  Throat a little closed  Hives all over body   I took a benydryal call the help line and reported it  They told me if I feel like I cant breathe to go to the emergency  I can still breath but this is very hard in me and uncomfortable and my tounge is burning
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Erythema, Headache, Influenza like illness
Clinical narrative: Severe redness and swelling in upper arm, which covered most of the upper arm. Blood underneath skin (I believe) moved into underside of arm. Area covered with redness was most of the upper arm except directly underneath. Flu-like symptoms, body aches, low-grade fever, chills, headache, nausea, loss of appetite, lethargy. No treatment except self-treatment with Tylenol.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Nausea, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Severe redness and swelling in upper arm, which covered most of the upper arm. Blood underneath skin (I believe) moved into underside of arm. Area covered with redness was most of the upper arm except directly underneath. Flu-like symptoms, body aches, low-grade fever, chills, headache, nausea, loss of appetite, lethargy. No treatment except self-treatment with Tylenol.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Ten (10) minutes after receiving injection, patient's arm became swollen and uncomfortable.  No redness, rash, SOB or other symptoms noted.  Ice pack was applied to site and patient was observed for an additional 15 minutes.  In follow up calls, family reported that patient's arm remained swollen and red for several days but she remained asymptomatic, otherwise.  Note:  though patient and family had denied any prior adverse reactions to flu vaccines, subsequent conversations revealed that she had had a similar event in past at another office.  Family attributed reaction to patient receiving both a flu shot and a pneumonia vaccine in the same arm.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Lethargy
Clinical narrative: Patient reported being very dizzy,  developed diarrhea, lethargy that lasted for almost 3 weeks.  Patient reported these effects to her PCP who recommended that she rest and did not recommend any further treatment at that time.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fluid retention, Induration, Laboratory test, Pain in extremity
Clinical narrative: redness, swelling, and "fluid in the arm."; redness, swelling, and "fluid in the arm."; redness, swelling, and "fluid in the arm."/ arm felt spongie; arm felt "spongie and hard at the same time"; her arm hurt; This spontaneous report was received from a 72-year-old female patient who refers to herself. The patient had an allergy to penicillin. Her current conditions included ileostomy and unspecified thyroid issues. The patient's medical history included acute ulcerative colitis. Concomitant medications included levothyroxine sodium, unspecified allergies pills and unspecified nasal spray.  On 11-APR-2013, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, strength, dose, frequency, route of administration were not provided) for prophylaxis. She did not report any adverse effects after receiving the vaccine. On 09-OCT-2019, she was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, strength, dose, frequency, route of administration were not provided) for prophylaxis and also received unspecified flu vaccine; both were administered in the left arm.  The patient stated that since receiving the vaccines her arm hurt. On 11-OCT-2019, the patient additionally developed redness, swelling and fluid in the arm; her arm was spongy and hard at the same time. On an unknown day in October 2019, the patient went to an unspecified emergency room for medical attention and later she was sent to home. She received cephalexin (KEFLEX) as a treatment for the events. On an unknown date, she had unspecified laboratory tests to rule out cancers (results were not provided). The outcome of the events was reported as recovering.  The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: redness, swelling, and "fluid in the arm."; redness, swelling, and "fluid in the arm."; redness, swelling, and "fluid in the arm."/ arm felt spongie; arm felt "spongie and hard at the same time"; her arm hurt; This spontaneous report was received from a 72-year-old female patient who refers to herself. The patient had an allergy to penicillin. Her current conditions included ileostomy and unspecified thyroid issues. The patient's medical history included acute ulcerative colitis. Concomitant medications included levothyroxine sodium, unspecified allergies pills and unspecified nasal spray.  On 11-APR-2013, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, strength, dose, frequency, route of administration were not provided) for prophylaxis. She did not report any adverse effects after receiving the vaccine. On 09-OCT-2019, she was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #, expiration date, strength, dose, frequency, route of administration were not provided) for prophylaxis and also received unspecified flu vaccine; both were administered in the left arm.  The patient stated that since receiving the vaccines her arm hurt. On 11-OCT-2019, the patient additionally developed redness, swelling and fluid in the arm; her arm was spongy and hard at the same time. On an unknown day in October 2019, the patient went to an unspecified emergency room for medical attention and later she was sent to home. She received cephalexin (KEFLEX) as a treatment for the events. On an unknown date, she had unspecified laboratory tests to rule out cancers (results were not provided). The outcome of the events was reported as recovering.  The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect reported.; a patient was inadvertently administered a dose ofMMRll via the intramuscular route; Information has been received from a pharmacist, referring to a 25 years old patient of unknown gender. The patient's concurrent condition, historical condition and concomitant medication were not provided.     On 29-OCT-2019, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (a dose, lot number R031629, expiration date 01-NOV-2020) Albumin status rHA (recombinant Human albumin)  via the intramuscular route for prophylaxis (Incorrect route of product administration). No adverse effect was reported.
Sex: M
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age, Product prescribing issue
Clinical narrative: the nurse had asked a question regarding administration of GARDASIL 9 in a 6 year old wilh HPV on his vocal cords; the nurse had asked a question regarding administration of GARDASIL 9 in a 6 year old wilh HPV on his vocal cords; the nurse had asked a question regarding administration of GARDASIL 9 in a 6 year old wilh HPV on his vocal cords; This spontaneous report was received from a nurse concerning a 6-year-old male patient. The patient's pertinent medical history, concomitant medications, concurrent conditions and drug allergies or reactions were not reported.      The nurse had asked a question regarding the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in a 6-year-old with human papilloma virus (HPV) on his vocal cords (circumstance or information capable of leading to medication error, product administered to patient of inappropriate age and product prescribing issue). The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was recommended by the surgeon for treatment, but bas not been given yet.  Also, the nurse mentioned that the surgeon had said that they had treated another patient with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for HPV that was non-genital warts, and it had slowed the process down a little bit.
Sex: M
Vaccine: PPV
Symptoms: Vaccination failure
Clinical narrative: poor pneumococcal vaccine response; Literature report.  A literature article has been received from the authors of a marketed literature article, titled as above, referring to a currently 50 year old male patient. The patient had no history of abnormal immunoglobulin A (IgA) or abnormal immunoglobulin M(IgM) levels. The patient's concomitant medication was not provided.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, batch/lot# and expiration date were unknown) for prophylaxis.   On an unknown date, the patient showed poor pneumococcal vaccine response (vaccine response impaired). The outcome of poor pneumococcal vaccine response was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).     A copy of the published article has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL, VARZOS
Symptoms: Papule, Polymerase chain reaction, Pyrexia, Rhinorrhoea, Varicella post vaccine
Clinical narrative: varicella vaccine-associated primary varicella infection; A 4-year-old female with ataxia-telangiectasia was vaccinated;    This literature marketed report was received from  the authors of the published article as stated above, concerning a 4-year old female child. The patient's concurrent conditions included ataxia-telangiectasia. The pertinent drug reactions/allergies and concomitant medications were not provided.    On an unspecified date, the female child with ataxia-telangiectasia presented for question of vaccination. Family was  concerned to travel with patient's immunocompromised state in the setting of the measles outbreak. The immune system evaluation showed adequate T cell function testing, and it was thought that she should be able to tolerate live vaccines (Product use issue).    She proceeded with the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) or Zoster Vaccine Live (manufacturer unknown) for prophylaxis (doses, route, lot #, expiration date, and anatomical location were not provided).   Subsequently, 12 days later, the patient developed a runny nose and 104 F fever. She broke out in papules that returned positive on varicella zoster PCR. She only required supportive care, with no use of antivirals or hospitalizations. Testing showed the strain she had was the same as the varicella vaccine, confirming a varicella vaccine-associated primary varicella infection.    The authors considered that patient's lymphocyte function testing was adequate, and it was thought her T cells should appropriately be able to respond to the vaccine, but unfortunately this was not the case. It may not be enough to determine if a patient can appropriately respond to vaccines as the patient was self-limited and may have prevented a future more significant varicella infection.    The authors considered the event varicella zoster virus infection to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown) or Zoster Vaccine Live (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL, VARZOS
Symptoms: Varicella virus test positive
Clinical narrative: varicella vaccine-associated primary varicella infection; A 4-year-old female with ataxia-telangiectasia was vaccinated;    This literature marketed report was received from  the authors of the published article as stated above, concerning a 4-year old female child. The patient's concurrent conditions included ataxia-telangiectasia. The pertinent drug reactions/allergies and concomitant medications were not provided.    On an unspecified date, the female child with ataxia-telangiectasia presented for question of vaccination. Family was  concerned to travel with patient's immunocompromised state in the setting of the measles outbreak. The immune system evaluation showed adequate T cell function testing, and it was thought that she should be able to tolerate live vaccines (Product use issue).    She proceeded with the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) or Zoster Vaccine Live (manufacturer unknown) for prophylaxis (doses, route, lot #, expiration date, and anatomical location were not provided).   Subsequently, 12 days later, the patient developed a runny nose and 104 F fever. She broke out in papules that returned positive on varicella zoster PCR. She only required supportive care, with no use of antivirals or hospitalizations. Testing showed the strain she had was the same as the varicella vaccine, confirming a varicella vaccine-associated primary varicella infection.    The authors considered that patient's lymphocyte function testing was adequate, and it was thought her T cells should appropriately be able to respond to the vaccine, but unfortunately this was not the case. It may not be enough to determine if a patient can appropriately respond to vaccines as the patient was self-limited and may have prevented a future more significant varicella infection.    The authors considered the event varicella zoster virus infection to be related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown) or Zoster Vaccine Live (manufacturer unknown).   A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; 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. In 2017, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: 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. In 2011, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a  pharmacist for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated by a healthcare provider for hearing loss. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   Upon internal review, deafness was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a lawyer refers to a female patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 15-AUG-2014, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient received an improperly stored ROTATEQ; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on patient's pertinent medical history, concomitant medications and drug reaction or allergies was provided.     On 05-NOV-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S010564, expiration date 17-JAN-2021, dose was not provided) orally for prophylaxis. The vaccine underwent excursion with temperature 47.1 Fahrenheit degrees for 30 minutes. There was a previous excursion with temperature 32.9 Fahrenheit degrees for 24 hours. The call was placed because of data logger. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; 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 about 05-APR-2017, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: U
Vaccine: PNC13, PPV
Symptoms: No adverse event, Product confusion
Clinical narrative: patient was inadverently administered second dose of prevnar instead of being administered pneumovax 23; type of product confusion that occured was unknown; no adverse effect; This spontaneous report was received from a pharmacist refers to a 66 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. Approximately in November 2018 (reported as "last year"), the patient was vaccinated with first dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dose, strength, #lot, expiry date unspecified) for prophylaxis. On an unknown date, the patient was inadvertently administered with a second dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dosing details unspecified) instead of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). It was also reported that, there was a possibility of product confusion might have occurred. The type of product confusion that occurred was unknown. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: treat pain after vaccination; This case was reported by a consumer via call center representative and described the occurrence of pain 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, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient received dose of Shingrix and experienced pain. The patient asked, how to treat pain after vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Incorrect route of product administration
Clinical narrative: Bad adverse reaction; Administered Shingrix SQ instead of IM; This case was reported by a nurse via sales rep and described the occurrence of adverse drug reaction in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number NE3TG, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse drug reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse drug reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 53 or 54 years. The patient was administered Shingrix subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The patient experienced bad adverse reactions after receiving Shingrix. It was unknown if the reporter agreed to follow up from GSK. The batch number for Shingrix was updated from NE3TD to NE3TG as per the sales data sheet.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Incorrect dose administered, Product preparation issue, Pyrexia
Clinical narrative: Chills; Fever; Feeling bad; Inappropriate Reconstitution Technique; Inappropriate dose of vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of chills in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and nerve pain. Previously administered products included Shingrix (1st dose received on 12th August 2019, refer case US2019201169).   On 4th November 2019, the patient received the 2nd dose of Shingrix. On 4th November 2019, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 5th November 2019, the patient experienced chills, fever and feeling bad. On an unknown date, the outcome of the chills, fever and feeling bad were not recovered/not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the chills, fever and feeling bad to be related to Shingrix.  Additional case details were reported as follows: The reporter was patient's wife. The patient initially received only the adjuvant part of the vaccine, it was not reconstituted before, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The patient then received a full dose of the vaccine. On day of reporting, the patient wake up with chills, fever and feeling bad. The reporter consent to follow up. This case had been linked to the case US2019201169, reported for same patient.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site that lasted for a couple days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included epilepsy (experienced all her life) and seizure (experienced all her life).   On 31st August 2019, the patient received the 1st dose of Shingrix (intramuscular). 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 recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The report was a patient's husband. The patient received vaccine in left arm. The patient experienced soreness at injection site that lasted for a couple days. No further details were provided. The reporter consent to follow up. For tolerance of 2nd dose, refer case US2019201978.
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Fatigue, Influenza like illness
Clinical narrative: flu lkie; fatigue; beddriden; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 1 and 3 months after receiving Shingrix, the patient experienced influenza-like symptoms, fatigue and bedridden. On an unknown date, the outcome of the influenza-like symptoms, fatigue and bedridden were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fatigue and bedridden to be related to Shingrix.  Additional details were received as follows: The patient experienced flu-like symptoms, fatigued, could only lay around for 2 days then they recovered.  The reporter consented to follow up.  This was 1 of the 4 cases reported by same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: soreness; redness; This case was reported by a consumer via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included intervertebral disc protrusion.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and erythema. On an unknown date, the outcome of the pain and erythema were recovered/resolved.   It was unknown if the reporter considered the pain and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after vaccination experienced soreness and it was really red. The patient refused to provide any additional details. This case has been linked with case US2019198548, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Glomerular filtration rate decreased
Clinical narrative: lower GFR; This case was reported by a consumer via call center representative and described the occurrence of glomerular filtration rate low in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2019). Concurrent medical conditions included solitary kidney (has one kidney).   In August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced glomerular filtration rate low. On an unknown date, the outcome of the glomerular filtration rate low was not recovered/not resolved.   It was unknown if the reporter considered the glomerular filtration rate low to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had a glomerular filtration rate in April and then again last week and the glomerular filtration rate rate was lower last week than it was in April 2019 prior to the Shingrix vaccines. The reporter declined follow up
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Induration, Swelling
Clinical narrative: swelling; heat; bad reactions described as a firm induration of 10mm in size; This case was reported by a nurse via call center representative and described the occurrence of swelling in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling, feeling hot and induration. On an unknown date, the outcome of the swelling, feeling hot and induration were unknown.   It was unknown if the reporter considered the swelling, feeling hot and induration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the several patients experienced swelling, heat and bad reactions, which she describes as a firm induration of 10mm in size. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Post herpetic neuralgia, Pruritus
Clinical narrative: Dermatome under her right breast, almost like post-herpetic neuraliga; Difficulty swallowing; Pruritis; This case was reported by a other health professional via call center representative and described the occurrence of post herpetic neuralgia in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 10 days after receiving Shingrix, the patient experienced post herpetic neuralgia, swallowing difficult and pruritus. On an unknown date, the outcome of the post herpetic neuralgia, swallowing difficult and pruritus were unknown.   It was unknown if the reporter considered the post herpetic neuralgia, swallowing difficult and pruritus to be related to Shingrix.  Additional details were provided as follows: The reporter was veterinarian reported for his friend. About 10 days after vaccination with dose of Shingrix, the patient experienced prurities along a dermatome under her right breast, almost like post herpetic neuraliga. Less than 2 years after vaccination, the patient experienced some difficultly in swallowing. The patient was evaluated at medical center by neurologist but no formal diagnosis at this time.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Petit mal epilepsy
Clinical narrative: Absence seizurez aggravated; This case was reported by a consumer via call center representative and described the occurrence of absence seizure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (receoved 1st dose on 31st August 2019 and experienced soreness at injection site, refer case US2019AMR203300). Concurrent medical conditions included epilepsy (experienced all her life) and seizure (experienced all her life).   On 4th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 5th November 2019, 1 days after receiving Shingrix, the patient experienced absence seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the absence seizure was recovered/resolved.   It was unknown if the reporter considered the absence seizure to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient experienced absence seizure in the afternoon and early evening the next day after receiving Shingrix. The absence seizure lasted for several minutes instead of seconds like she usually used to get.  The patient was advised to see her primary care physician as she experienced absence seizure. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Inappropriate schedule of vaccine; Rash; Felt ill; Red injection site; Swollen injection site; Sore injection site; This case was reported by a consumer via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In June 2018, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, feeling unwell, injection site erythema, injection site swelling and injection site pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the rash and injection site erythema were recovered/resolved and the outcome of the feeling unwell, injection site swelling, injection site pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash, feeling unwell, injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 65 or 66 years. The patient experienced red, swollen, sore injection site, a rash, and felt ill for three days.  It was reported that the red, swollen injection site lasted longer than 3 days. Till the time of reporting, the patient had not received the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Inappropriate schedule of vaccine; Rash; Felt ill; Red injection site; Swollen injection site; Sore injection site; This case was reported by a consumer via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In June 2018, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, feeling unwell, injection site erythema, injection site swelling and injection site pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the rash and injection site erythema were recovered/resolved and the outcome of the feeling unwell, injection site swelling, injection site pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash, feeling unwell, injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 65 or 66 years. The patient experienced red, swollen, sore injection site, a rash, and felt ill for three days.  It was reported that the red, swollen injection site lasted longer than 3 days. Till the time of reporting, the patient had not received the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Blood pressure decreased, Dehydration, Dyspnoea, Intensive care, Rash
Clinical narrative: whole body shaking, radical symptoms of everything shaking; having a rash to the legs; blood pressure dropped with having labored breathing; severely dehydrated; blood pressure dropped with having labored breathing; Initial information received on 04-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case is linked with case 2019SA312694 (same reporter, Fluzone HD)  This case involves a 76 years old female patient who experienced whole body shaking, radical symptoms of everything shaking (Tremor), having a rash to the legs (Rash), blood pressure dropped with having labored breathing (blood pressure decreased and Dyspnoea) and dehydrated (dehydration), while she received vaccine INFLUENZA VACCINE.  The patient's past vaccination included Fluzone High-Dose in 2016 and experienced arms began flaying uncontrollably (Skin exfoliation) that afternoon after getting the vaccine. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Breast cancer.  On 01-Oct-2019, the patient received a dose of suspect INFLUENZA VACCINE (INFLUENZA VACCINE) produced by unknown manufacturer lot number not reported via intramuscular route in the right arm.  On 01-Oct-2019, the patient developed a serious whole body shaking, radical symptoms of everything shaking (tremor) shaking (Tremor), having a rash to the legs (Rash), blood pressure dropped with having labored breathing (blood pressure decreased and Dyspnoea) and dehydrated (dehydration) same day following the administration of INFLUENZA VACCINE. She was then sent to the ER. She was admitted to the hospital and placed in the intensive care unit (ICU). She was discharged on 27-Oct-2019  (Other relevant tests included blood pressure dropped.)  Final diagnosis was dehydrated, blood pressure dropped with having labored breathing, having a rash to the legs and whole body shaking, radical symptoms of everything shaking.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for all the events.  Information on the batch number was requested.; Sender's Comments: This case concerns a 76 years old female patient who presented with Tremor, Rash, blood pressure decreased, Dyspnoea and dehydration after vaccination with INFLUENZA VACCINE. The time to onset is compatible with the role of the vaccine. Patient had ongoing Breast cancer. Detailed information regarding patients past medical history apart from Breast cancer, concomitant medication at the time of onset, laboratory details is needed to fully assess the case.Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 76.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: whole body shaking, radical symptoms of everything shaking; having a rash to the legs; blood pressure dropped with having labored breathing; severely dehydrated; blood pressure dropped with having labored breathing; Initial information received on 04-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case is linked with case 2019SA312694 (same reporter, Fluzone HD)  This case involves a 76 years old female patient who experienced whole body shaking, radical symptoms of everything shaking (Tremor), having a rash to the legs (Rash), blood pressure dropped with having labored breathing (blood pressure decreased and Dyspnoea) and dehydrated (dehydration), while she received vaccine INFLUENZA VACCINE.  The patient's past vaccination included Fluzone High-Dose in 2016 and experienced arms began flaying uncontrollably (Skin exfoliation) that afternoon after getting the vaccine. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Breast cancer.  On 01-Oct-2019, the patient received a dose of suspect INFLUENZA VACCINE (INFLUENZA VACCINE) produced by unknown manufacturer lot number not reported via intramuscular route in the right arm.  On 01-Oct-2019, the patient developed a serious whole body shaking, radical symptoms of everything shaking (tremor) shaking (Tremor), having a rash to the legs (Rash), blood pressure dropped with having labored breathing (blood pressure decreased and Dyspnoea) and dehydrated (dehydration) same day following the administration of INFLUENZA VACCINE. She was then sent to the ER. She was admitted to the hospital and placed in the intensive care unit (ICU). She was discharged on 27-Oct-2019  (Other relevant tests included blood pressure dropped.)  Final diagnosis was dehydrated, blood pressure dropped with having labored breathing, having a rash to the legs and whole body shaking, radical symptoms of everything shaking.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as Unknown for all the events.  Information on the batch number was requested.; Sender's Comments: This case concerns a 76 years old female patient who presented with Tremor, Rash, blood pressure decreased, Dyspnoea and dehydration after vaccination with INFLUENZA VACCINE. The time to onset is compatible with the role of the vaccine. Patient had ongoing Breast cancer. Detailed information regarding patients past medical history apart from Breast cancer, concomitant medication at the time of onset, laboratory details is needed to fully assess the case.Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: FLUR4
Symptoms: Candida infection, Stevens-Johnson syndrome
Clinical narrative: The patient developed unknown symptoms on 26Oct2019 and was diagnosed with Steven Johnson's syndrome; Initial information and follow-up information received on 05-Nov-2019 regarding an unsolicited valid serious case received from a Pharmacist.  This case involves a 69 years old female patient who experienced developed unknown symptoms and was diagnosed with Steven Johnson's syndrome (Stevens-Johnson syndrome ), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Ongoing medical condition included Postmenopausal.   Concomitant medications included LISINOPRIL (LISINOPRIL) 20mg daily by mouth each night a bedtime that was started on 09-Oct-2019 and ATORVASTATIN (ATORVASTATIN)  unknown dosage/frequency that was started on 17-Oct-2019.  On 18-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number QSAA1928 expiry date 30 June 2020 via intramuscular route in left deltoid.  On 26-Oct-2019, 8 days post vaccination, patient developed unknown symptoms (not reported) and on 30-Oct-2019 the patient was diagnosed with Steven Johnson's syndrome (Stevens-Johnson syndrome),12 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Patient went to ED and Primary Care Physician due to the events.  This event was assessed as medically significant.  Treatment included stopping all medications Lisinopril 20 mg daily by mouth that was started on 09-Oct-2019 and atorvastatin unknown dosage/frequency that was started on 17-Oct-2019. diagnosed Thrust anti fungal treatment.   (Other relevant tests included No lab data.)  Final diagnosis was Steven Johnson's syndrome.  The patient outcome is reported as Unknown for Steven Johnson syndrome.
Age: 9.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Headache, Pyrexia
Clinical narrative: My daughter received a flu shot and the next morning had a low grade fever, a stomach and headach
Age: 58.0
Sex: M
Vaccine: RAB
Symptoms: Feeling hot, Headache, Hyperhidrosis, Nasal congestion, Paraesthesia
Clinical narrative: Symptoms occurred off-site post-immunization beginning 7/6/17.  Donor experienced fever, headache, feeling of warmth, nasal congestion, sweating, and paresthesia in left hand.  He did not seek medical care. Donor stated he took one-time dose of Ibuprofen on 7/6/17.
Age: 58.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: Symptoms occurred off-site post-immunization beginning 7/6/17.  Donor experienced fever, headache, feeling of warmth, nasal congestion, sweating, and paresthesia in left hand.  He did not seek medical care. Donor stated he took one-time dose of Ibuprofen on 7/6/17.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR
Symptoms: Injection site rash
Clinical narrative: Patient got a rash on left deltoid, being stated in medical chart that she had a reaction to vaccines administered. Patient was seen in clinic by her PCP. Told to return to clinic if symptoms worsened.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Fall, Gait disturbance, Tremor, Vomiting
Clinical narrative: Child received the influenza vaccine on Thursday, 11/7/19, child seemed fine afterwards and went home with mom. Mom states child vomited three times around 9:00 pm that night, then mom noticed child was stumbling when he walked. Mom put child to bed. The next morning mom states child would not walk and every time he tried to stand up he would fall to the ground; mom also noticed his legs were shaking. Mom brought child to our clinic that day, on 11/8/19 at 3:00 pm to be evaluated. In the exam room, the child starting walking but was very unsteady on his feet and stumbled several times throughout the course of the exam . Mom states this was the first time he has walked the entire day, at 3:00 pm.  I performed an examination and advised mom to take child to hospital if symptoms continued and/or worsened. Spoke to mom Monday, 11/11/19 to check on child. Mom states child seemed ok over the weekend , still somewhat off balance/unsteady but child has not worsened and does seem to be improving. Informed mom that this incident would be reported to VAERS.
Age: 27.0
Sex: M
Vaccine: RAB
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Symptoms occurred off-site post-immunization.  Donor reported on 2/26/19 that he had been experiencing hives, a rash, and itching on bilateral arms, bilateral lower legs, and on entire front area of the abdomen/waist since 2/22/19. Donor reported using anti-itch hydrocortisone cream PRN, Benydryl  PO every night, and Loratidine PO every morning starting on the day symptoms started (2/22/19).