chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Cellulitis, Ear pain, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Saturday-Wednesday Severe headaches, moderate temperature 100.5(while on Tylenol), extreme fatigue (slept for more than 22 hours straight ) swelling in ijections arm and expanding redness, serious pain 5-8 pain scale Sunday-Monday vomiting when awake.  Monday Pharmacist called to ask about my condition.She stated they had had several adverse from the same day and lot no and advised me to see my physician. Tuesday I went to see Dr I was diagnosed with cellulitis in my injection arm. I was given a 5 day course of Cephalexin 500. I am still suffering form headaache arm pain swelling
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Lymphadenopathy, Pyrexia, Somnolence, Vomiting
Clinical narrative: Saturday-Wednesday Severe headaches, moderate temperature 100.5(while on Tylenol), extreme fatigue (slept for more than 22 hours straight ) swelling in ijections arm and expanding redness, serious pain 5-8 pain scale Sunday-Monday vomiting when awake.  Monday Pharmacist called to ask about my condition.She stated they had had several adverse from the same day and lot no and advised me to see my physician. Tuesday I went to see Dr I was diagnosed with cellulitis in my injection arm. I was given a 5 day course of Cephalexin 500. I am still suffering form headaache arm pain swelling
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Body temperature increased, Cellulitis, Erythema, Fatigue, Headache
Clinical narrative: Saturday-Wednesday Severe headaches, moderate temperature 100.5(while on Tylenol), extreme fatigue (slept for more than 22 hours straight ) swelling in ijections arm and expanding redness, serious pain 5-8 pain scale Sunday-Monday vomiting when awake.  Monday Pharmacist called to ask about my condition.She stated they had had several adverse from the same day and lot no and advised me to see my physician. Tuesday I went to see Dr I was diagnosed with cellulitis in my injection arm. I was given a 5 day course of Cephalexin 500. I am still suffering form headaache arm pain swelling
Age: 61.0
Sex: F
Vaccine: FLUC4, PPV, FLUC3, PPV, PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: Saturday-Wednesday Severe headaches, moderate temperature 100.5(while on Tylenol), extreme fatigue (slept for more than 22 hours straight ) swelling in ijections arm and expanding redness, serious pain 5-8 pain scale Sunday-Monday vomiting when awake.  Monday Pharmacist called to ask about my condition.She stated they had had several adverse from the same day and lot no and advised me to see my physician. Tuesday I went to see Dr I was diagnosed with cellulitis in my injection arm. I was given a 5 day course of Cephalexin 500. I am still suffering form headaache arm pain swelling
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Dyspnoea, Intensive care, Pharyngeal swelling, Stridor, Throat tightness
Clinical narrative: Anaphylactic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   The reporter considered the anaphylactic reaction to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a anaphylactic reaction to FluLaval Quadrivalent 2018-2019 season. The pharmacist reported that she saw several patients but she was vague. She only stated severe reaction or anaphylaxis and would not specify. The reporter did not consent to follow-up.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Wheezing
Clinical narrative: Anaphylactic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   The reporter considered the anaphylactic reaction to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a anaphylactic reaction to FluLaval Quadrivalent 2018-2019 season. The pharmacist reported that she saw several patients but she was vague. She only stated severe reaction or anaphylaxis and would not specify. The reporter did not consent to follow-up.
Sex: U
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   The reporter considered the anaphylactic reaction to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a anaphylactic reaction to FluLaval Quadrivalent 2018-2019 season. The pharmacist reported that she saw several patients but she was vague. She only stated severe reaction or anaphylaxis and would not specify. The reporter did not consent to follow-up.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: patient states they felt pain and burning during vaccine, had fever for several days after, and that he still has pain in his arm and cannot move his arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: patient had redness, swelling, and pain develop over a large area where the immunization was given. The area was about 3-4 inches across when I saw it. She had seen a physician, who diagnosised it  as possible cellulitis, per the patient. She was given antibiotics, cephalexin, to treat this.
Age: 92.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: About 9:00 pm there was onset of nausea. Patient went to bed and at 9:30 pm began vomiting. This continued throughout the night, episodic about 12 times. The facility nurse came in and reported fever of 102 degrees at 10:30 pm and again at 12:00 am. Gave patient sips of water which she could not hold down. Put on "sea bands" at 1:00 am to help relieve nausea which helped enough to give patient Tylenol to help reduce fever. Vomiting subsided at about 2:00 am. At 10:00 am patient had some diarrhea and when she drank a sip of juice she vomitted twice. There was lingering nausea throughout the day but patient improved throughout the weekend.
Age: 54.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever (~100°) lasting more than 24 hours, severe body aches starting 8-9 hours after shots and lasting about 16 hours.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Eye pain, Eye swelling
Clinical narrative: Swollen eyes Eye pain
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: The following morning after the flu injection I had severe pain to the bottom of my feet causing major difficulty in walking. The pain became progressively worse that day and had to stop walking several times that day. The pain was better by the evening and progressively improved by 9pm.  Still have tolerable mild pain but able to function.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Influenza like illness, Middle insomnia
Clinical narrative: Flu like symptoms. Woke up in middle of the night feeling feverish, achy and shivering. No elevated temperature. Worked only a half day the following day due to similar, less severe symptoms and fatigue.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Flu like symptoms. Woke up in middle of the night feeling feverish, achy and shivering. No elevated temperature. Worked only a half day the following day due to similar, less severe symptoms and fatigue.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; patient received improperly stored PROQUAD; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.     On 13-AUG-2019, the patient was vaccinated with one of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live albumin status rHA (PROQUAD) vaccines: lot # R023499, expiration date 13-FEB-2020 or lot # R026722, expiration date 17-MAR-2020 (strength, dose, frequency, route of administration and anatomical location were not reported). The vaccines were reconstituted with properly stored sterile diluent. The nurse stated that the vaccine experienced two temperature excursions on 12-AUG-2019 and on 13-AUG-2019. Neither were reported to the nurse until 06-SEP-2019. Administered dose of vaccine experienced the temperature excursion between minus 14 to minus 10 degrees Celsius, multiple minus 11.91 degrees Celsius for 8 hours. Data logger was involved. There was no previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; patient received a "booster dose" ofMMR II (R031680 exp 11/1/2020) on 5/15/2019 and then the patient received another dose of MMR II (S014430 exp 5/9/2021) on 9/13/2019; This spontaneous report as received from a medical assistant refers to a 44 year old patient of unknown gender. No information on patient's pertinent medical history, concomitant medication and drug reactions or allergies was provided.      On 15-MAY-2019, the patient was vaccinated with "booster dose" of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant human albumin (rHA) lot # R031680  has been verified to be a valid lot number, expiration date 01-NOV-2020, dose was not reported) ) subcutaneously, for prophylaxis. On 13-SEP-2019, the patient was vaccinated with another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant human albumin(rHA) lot # S014430 has been verified to be a valid lot number, expiration date 09-MAY-2021, dose was not reported) ) subcutaneously, for prophylaxis. No adverse event was reported.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the Patient received improperly stored VARN AX; This spontaneous report was received from a medical assessment and refers to a 13-year-old patient. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 13-AUG-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023513, expiration date 16-AUG-2020 (strength, route of administration and dose were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot # S000130, expiration date 23-AUG-2021). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14 Celsius degrees (C) to -10 C (also reported as -13.2 C) for 46 minutes. The digital data logger was involved in recording the temperature excursion details. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA007312: US-009507513-1909USA006939: US-009507513-1909USA007512: US-009507513-1909USA007118:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient receied the second dose of GARDASIL 9, 30 days later.; no adverse effects reported; This spontaneous report was received from a consumer via company representative and refers to a 26-year-old patient of unknown gender. Patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies, historical drugs or medical history were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The second dose was administered 30 days later, on an unspecified date (strength, dose, frequency, route of administration, anatomical location, indication, lot #, and expiration date were not reported for both doses) (Drug dose administration interval too short). No adverse effects reported.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects were reported; Administered a fourth dose of GARDASIL 9; This spontaneous report was received from a nurse, via company representative, referring to a 15-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies/reactions and concomitant medications were not reported.  On unspecified dates, the patient received the first, second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, anatomical location, route of administration, lot number and expiration date were not provided), as prophylaxis. On 23-SEP-2019, the patient was vaccinated with a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)(extra dose administered)(concentration, dose, anatomical location, route of administration were not provided; lot number S008151 has been verified to be a valid lot number, and expiration date was reported and internally confirmed as 20-NOV-2021) as prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: NO ADVERSE EFFECT; Nurse reports a patient received a dose of PROQUAD, when the patient should have received their second dose of MMR II; Patient receiveied their first dose of MMR II on 08/28/2019 and received the dose of PROQUAD on 09/25/2019.; Nurse reports a patient received a dose of PROQUAD, when the patient should have received their second dose of MMR II; This spontaneous report was received from a nurse referring to a 7 years patient of unknown gender. The patient's current condition, pertinent medical history, concomitant medications, drug reaction/ allergies were not reported. On 28-AUG-2019, patient received their first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, lot number, expiry date, frequency, route of administration were not reported) for prophylaxis. On 25-SEP-2019, the patient was administered with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) of lot number R030804, expiry date 22-APR-2020, therapy type rHA(dose, strength, frequency were not reported) via subcutaneous route for prophylaxis, when the patient should have received their second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, lot number, expiry date, frequency, route of administration were not reported) for prophylaxis(interchange of vaccine products) (wrong product administered)(inappropriate schedule of product administration)(adverse event onset date was also reported as 26-SEP-2019). No adverse effects were reported. There was no product quality complaint (PQC) present. The outcome of the events was unknown.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: A patient received a dose of VARIVAX, then on 09/25/2019, the patient had a positive urine pregnancy test; This spontaneous prospective pregnancy report was received from a physician concerning to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.     On 17-SEP-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneously, for prophylaxis (strength, dose, frequency, lot # and expiration date were not provided), then on 25-SEP-2019, a urine pregnancy test was performed and showed that the patient was pregnant (exposure during pregnancy). The gestation was 4 weeks and 3 days as of 30-SEP-2019. The last menstrual period was estimated as 30-AUG-2019 and the estimated date of conception was estimated to 05-JUN-2020.The pregnancy outcome was outcome pending.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects.; A patient was administered improperly stored PROQUAD.; This spontaneous report was received from a Medical Assistant referring to a 4 year old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 30-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) with lot # S009759 and expiration date 27-SEP-2020 (strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. The sterile diluent(MERCK STERILE DILUENT) that was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD)  was properly stored.   The administered dose of the vaccines experienced the temperature excursion of 15°F to 46°F (17.6 °F) degrees Fahrenheit  for 56 hours and 40 minutes and a previous excursion of 6 °F to 14°F (6.2 °F) degrees Fahrenheit  for 10 minutes  There was no digital data logger invloved,and no adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: experienced soreness in the arm; This spontaneous report was received from a consumer referring to herself, a female patient of unknown age. The patient did not have any pertinent medical history, concurrent conditions, drug reactions or allergies. No information was provided regarding the patient's concomitant medications.  On an unknown date in 2013, the patient was vaccinated with an unspecified zoster vaccine live (manufacturer unknown) in the left arm as prevention of shingles (dose, dose number, route of administration, lot number and expiration date were not reported).  On an unknown date in 2013, the patient experienced soreness in the arm (pain in extremity). The patient did not seek for medical attention and did not received any treatment; but she recovered from the event.  At the time of the report, the causality assessment between pain in extremity and zoster vaccine live (manufacturer unknown) was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling
Clinical narrative: A pient experienced a lot of swelling in her arm  after receiving her first dose of GARDASIL 9; This spontaneous report was received from a physician via company representative referring to a 14 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.     On an unknown date, during a routine checkup, the patient experienced  a lot of swelling in her arm (peripheral swelling ) after receiving her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) for prophylaxis.    At the time of the report, the outcome of peripheral swelling was unknown. The reporter did not mention the causality assessment between the event and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse effect; 2 doses administered over the age of 65 years and more than 5 years apart; This spontaneous report as received from a pharmacist refers to a 86 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.       On an unknown date in 2013 and 2019, the patient was subsequently vaccinated with first and second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, anatomical location, Lot # and expiry date was not reported) for prophylaxis (inappropriate schedule of product administration). On an unknown date in 2015, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (dose, anatomical location, Lot # and expiry date was not reported). There was no adverse event reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; expired dose of VAQTA was administered; This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 30-SEP-2019 the patient was vaccinated with  expired dose of hepatitis a vaccine, inactivated(VAQTA) (lot # R027431, expiry date: 08-SEP-2019, route and anatomical location were not reported) for prophylaxis (expired product administered). No adverse effect reported. No additional information provided.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Palpable purpura
Clinical narrative: Several pin sizes to quart size non inflammed and non-colored palpulas; Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2014US001265).  This spontaneous report was received from a health professional refers to a 16 years old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 24-AUG-2019, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (batch/lot number# H021608, expiry date not reported but upon internal validation established as 13-AUG-2015) one dosage form via intramuscular route for immunization and varicella virus vaccine live (oka/merck) (VARIVAX) (batch/lot number# J003219, expiry date not reported but upon internal validation established as 15-MAR-2015) one dosage form via subcuteneous route for immunization.  On the same day, the patient received other co suspects included meningococcal acyw conj vaccine (crm197) (MENVEO) injection(batch/lot number# M12130, expiry date not reported) one dosage form(1 DF) via intramuscular route for immunisation and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid( ADACEL) (batch/lot number#U4567AA, expiry date not reported) one dosage form via intramuscular route for immunization.  On 31-AUG-2013, the patient experienced several pin sizes to quart size non inflammed and non-colored palpulas (palpable purpura). The outcome of palpable purpura was reported as recovered. The relatedness between the event and meningococcal acyw conj vaccine (crm197) (MENVEO) was suspected. The relatedness between the event and other suspect therapies was not provided.  The Agency considered the event palpable purpura as medically siginificant.; Sender's Comments:  509674:
Sex: F
Vaccine: FLUX
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis.   On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced guillain barre syndrome (serious criteria death and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was fatal. The reported cause of death was guillain barre syndrome.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu trivalent vaccine  Additional details were received as follows: The age at vaccination was not reported. The patient had a flu injection in 1978, and experienced Guillain-Barre Syndrome, and died on 23rd August 2018. The reporter consented to follow up. This case was linked with case US2019170062, reported by same reporter.; Reported Cause(s) of Death: Guillain Barre syndrome
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Swelling; This case was reported by a physician via call center representative and described the occurrence of swelling arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient received the Shingrix vaccine and experienced swelling of her whole upper arm. Unable to obtain additional details. This is 1 of 3 cases reported by same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Condition aggravated, Gait disturbance, Headache
Clinical narrative: pain; chileed; can´t walk; worsened condition; fever; nausea; headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received in June 2019, experienced right knee and ankle sore, refer linked case US2019172858).   On 19th September 2019, the patient received the 2nd dose of Shingrix. On 19th September 2019, less than a day after receiving Shingrix, the patient experienced headache, fever and nausea. On 20th September 2019, the patient experienced knee pain, chills, walking difficulty and condition aggravated. On 21st September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the headache, knee pain, nausea, chills, walking difficulty and condition aggravated were unknown.   It was unknown if the reporter considered the headache, knee pain, fever, nausea, chills, walking difficulty and condition aggravated to be related to Shingrix.  Additional information received were as follows: On Thursday, the patient received Shingrix in her left arm. On the same night, the patient experienced headache with a fever and nausea. 1 day after receiving Shingrix, the patient was chilled and knees started to hurt. The patients left knee was sore and her left ankle. The knee pain was still unresolved after 10 days but the others side effects had resolved. The patient reported that the second injection had a lot more side effects than the first vaccination. The patient had a fever for two days. The patient reported that she was in pain and she cannot walk. The patient had previous flares of knee pain but the pain had worsened after the vaccination. The patient use to run two miler per day and at the reporting date, she cannot walk across her house. The reporter consented to follow up. The reporter reported that they follow-up directly with the patient.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pyrexia
Clinical narrative: pain; chileed; can´t walk; worsened condition; fever; nausea; headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received in June 2019, experienced right knee and ankle sore, refer linked case US2019172858).   On 19th September 2019, the patient received the 2nd dose of Shingrix. On 19th September 2019, less than a day after receiving Shingrix, the patient experienced headache, fever and nausea. On 20th September 2019, the patient experienced knee pain, chills, walking difficulty and condition aggravated. On 21st September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the headache, knee pain, nausea, chills, walking difficulty and condition aggravated were unknown.   It was unknown if the reporter considered the headache, knee pain, fever, nausea, chills, walking difficulty and condition aggravated to be related to Shingrix.  Additional information received were as follows: On Thursday, the patient received Shingrix in her left arm. On the same night, the patient experienced headache with a fever and nausea. 1 day after receiving Shingrix, the patient was chilled and knees started to hurt. The patients left knee was sore and her left ankle. The knee pain was still unresolved after 10 days but the others side effects had resolved. The patient reported that the second injection had a lot more side effects than the first vaccination. The patient had a fever for two days. The patient reported that she was in pain and she cannot walk. The patient had previous flares of knee pain but the pain had worsened after the vaccination. The patient use to run two miler per day and at the reporting date, she cannot walk across her house. The reporter consented to follow up. The reporter reported that they follow-up directly with the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain; This case was reported by a consumer and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced muscle pain which still persisted at the reporting date. The patient asked that how long would the muscle pain continue.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient was just wondering how high the fever could get as a side effect of taking the Shingrix. The patient thanked and asked how high the fever could get low grade or 102.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Pyrexia, Rash
Clinical narrative: fever; chills; rash on her breast; This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (breast cancer in one breast treated with radiation). Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in early June 2019, refer linked case US2019172899).   On 12th August 2019, the patient received the 2nd dose of Shingrix. On 12th August 2019, less than a day after receiving Shingrix, the patient experienced fever and chills. In August 2019, the patient experienced generalized rash. The patient was treated with cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the fever, chills and generalized rash were unknown.   It was unknown if the reporter considered the fever, chills and generalized rash to be related to Shingrix.  Additional information received were as follows: The patient's medical condition included hyperimmune system. The patient experienced fever and chills which started later the day of vaccination. The patient missed work the following day but these symptoms resolved and she was able to go to work on 14th August 2019. Within 2 weeks of the 2nd dose, the patient experienced a small triangle size rash on one of her breast. The patient kept an eye on it and it continued to get bigger.  The patient was given cortisone cream which helped but at the reporting date it had come back and spread to her other breasts and parts of her body. The reporter consented to follow up. Emergency room visit required.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient experienced fever with Shingrix. The patient prefered not to give information.
Age: 73.0
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Abdominal pain upper, Chills, Influenza like illness, Malaise, Pyrexia
Clinical narrative: vomiting; like having the flu; severe rash; swelling; fever; chills; aching in my stomach; gut wrenching; been sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   The patient's past medical history included measles (had red measles). Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on unknown date and had sickness).   On 19th September 2019, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2018-2019 season. On 22nd September 2019, 3 days after receiving Shingrix and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced stomach pain and gut wrenching. On an unknown date, the patient experienced sickness, vomiting, influenza like illness, rash, swelling, fever and chills. On an unknown date, the outcome of the sickness and vomiting were recovered/resolved and the outcome of the influenza like illness, rash, swelling, fever, chills, stomach pain and gut wrenching were unknown.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm and flu vaccine in the left arm. After vaccination, the patient had sickness for 2days after each dose. The patient laso had vomitting but not diarrhea and crunching on ice and having like flu. After vaccination, the patient had severe rash, swelling, fever and chills and contacted with doctor's because of more concern for heart. After vaccination, the patient had gut wrenching, aching in stomach before bed time. Less than a week, after vaccination with dose of shingrix and Flu vaccine, the patient had sickness, vomiting, influenza like illness, rash, swelling, fever, chills and adverse drug reaction.  It was unknown if the reporter considered the sickness, vomiting, influenza like illness, rash, swelling, fever, chills, stomach pain and gut wrenching to be related to Shingrix and Influenza vaccine Quadrivalent 2018-2019 season.
Age: 73.0
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Swelling, Vomiting
Clinical narrative: vomiting; like having the flu; severe rash; swelling; fever; chills; aching in my stomach; gut wrenching; been sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   The patient's past medical history included measles (had red measles). Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on unknown date and had sickness).   On 19th September 2019, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2018-2019 season. On 22nd September 2019, 3 days after receiving Shingrix and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced stomach pain and gut wrenching. On an unknown date, the patient experienced sickness, vomiting, influenza like illness, rash, swelling, fever and chills. On an unknown date, the outcome of the sickness and vomiting were recovered/resolved and the outcome of the influenza like illness, rash, swelling, fever, chills, stomach pain and gut wrenching were unknown.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm and flu vaccine in the left arm. After vaccination, the patient had sickness for 2days after each dose. The patient laso had vomitting but not diarrhea and crunching on ice and having like flu. After vaccination, the patient had severe rash, swelling, fever and chills and contacted with doctor's because of more concern for heart. After vaccination, the patient had gut wrenching, aching in stomach before bed time. Less than a week, after vaccination with dose of shingrix and Flu vaccine, the patient had sickness, vomiting, influenza like illness, rash, swelling, fever, chills and adverse drug reaction.  It was unknown if the reporter considered the sickness, vomiting, influenza like illness, rash, swelling, fever, chills, stomach pain and gut wrenching to be related to Shingrix and Influenza vaccine Quadrivalent 2018-2019 season.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Felt ill; This case was reported by a pharmacist via sales rep and described the occurrence of feeling unwell in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose on unknown date, refer case US2019AMR174219).   On 20th September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and felt ill. The reporter would amend report with additional details once received.  The report incomplete as the reporter did not have adequate time to discuss.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Felt ill; This case was reported by a pharmacist via sales rep and described the occurrence of feeling unwell in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and felt ill. The reporter would amend report with additional details once received.  The report incomplete as the reporter did not have adequate time to discuss. For tolerances of 2nd dose, refer case US2019AMR174202, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pain
Clinical narrative: The injection itself was extremely painful; Burning feeling, while it was being administered; This case was reported by a nurse and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain and burning sensation. On an unknown date, the outcome of the injection site pain and burning sensation were unknown.   It was unknown if the reporter considered the injection site pain and burning sensation to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that the injection itself was extremely painful, in addition to a burning feeling, while it was being administered. The nurse giving the injection stated that this vaccine is always extremely painful to patients. The patient wanted to know that neither  Z-track method or changing the needle after reconstituting the vaccine was mentioned in the Shingrix video or insert also will lyophilized antigen Ig used to reconstitute Shingrix interfere with an IgE blood level test which was drawn the same day?
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Area is red; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group adult was selected as per vaccine indication. The patient got shingles 2nd shot and the area was red.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient experienced flu like symptoms after the 2nd dose of Shingrix. The patient asked how long did flu like symptoms last?
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Visual impairment
Clinical narrative: Headache; My vision is off; This case was reported by a consumer and described the occurrence of headache in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2019, the patient received Shingrix. On 24th September 2019, 1 days after receiving Shingrix, the patient experienced headache and visual impairment. On an unknown date, the outcome of the headache and visual impairment were unknown.   It was unknown if the reporter considered the headache and visual impairment to be related to Shingrix.  Additional details were provided as follows: The patient reported that the after receiving Shingrix shot yesterday, the patient woke up with a monster of a head ache. The patient's vision was off.
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dysphagia, Hypersensitivity, Palpitations
Clinical narrative: Allergic reaction; Racing heart rate; Feeling dizzy; Trouble swallowing; This case was reported by a consumer and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3N4F7, expiry date 30th June 2020) for prophylaxis.   On 23rd September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 23rd September 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced allergic reaction, heart racing, dizziness and swallowing difficult. On an unknown date, the outcome of the allergic reaction, heart racing, dizziness and swallowing difficult were unknown.   It was unknown if the reporter considered the allergic reaction, heart racing, dizziness and swallowing difficult to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Fluarix QIV vaccine yesterday and experienced an allergic reaction, within 10 minutes started having a racing heart rate, feeling dizzy, and trouble swallowing. The patient contacted with pharmacy but she was looking to report the reaction to the manufacturer as well. The patient would like a list of ingredients of this specific vaccine so she could know what to avoid in future vaccines.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Pyrexia
Clinical narrative: Fever; Weakness; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, weakness and fatigue. On an unknown date, the outcome of the fever, weakness and fatigue were unknown.   It was unknown if the reporter considered the fever, weakness and fatigue to be related to Shingrix.  Additional case details were provided as follows: The patient reported for himself. The age at vaccination was not reported. The patient experienced fever, weakness and fatigue after receiving Shingrix. The patient declined to provide his contact information.