chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: Pain began the night of the injection for the flu shot in my right arm where the injection was given. The regular pharmacist was out that day my injection was given so  called in a temporary student to give the injection, a male, and in training. The temporary (student) gave the injection high on my arm near my shoulder. Normally with the pharmacist last year and years prior they gave lower down on my arm but the student gave way up high near the shoulder blade. He didn't shake the serum before injecting it. The pain got worse but my friends kept saying just wait it will go away but it never did it got worse and when I went to Dr, his assistant took note of the pain going on and said to keep watch on it to see if it gets worse. I have an appointment to go to the Dr. to get an x-ray as my right arm has gotten so bad I cannot reach very far without extreme pain it has gotten so bad over the months that the pain is excruciating. It feels like the muscles are damaged in the area the student that  hired in place of the pharmacist, is severely damaged. I cannot touch that area without pain. I am going to get x-rays as the pain is so bad when I raise my arm that I can't even raise it like I used to - the entire arm is unusable.  It feels like someone has beat it with a hammer. Extreme muscle pain in that arm that it make me cry with pain. I have called  about it and they said it was a student that gave the shot that day to me since their regular pharmacist was out. They didn't warn me ahead of time that the man that gave me the shot was a student in training. Had I been informed I would have gotten the shot (flu injection) at my regular Dr.'s office. I didn't find out it was a temporary student in training giving me the flu injection until I called to inform them that the pain is getting worse over time and not improving.  informed me to contact your site to fill out the form for damage to my right arm due from the flu injection.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Crying, Injected limb mobility decreased, Injection site pain, Musculoskeletal disorder, Myalgia
Clinical narrative: Pain began the night of the injection for the flu shot in my right arm where the injection was given. The regular pharmacist was out that day my injection was given so  called in a temporary student to give the injection, a male, and in training. The temporary (student) gave the injection high on my arm near my shoulder. Normally with the pharmacist last year and years prior they gave lower down on my arm but the student gave way up high near the shoulder blade. He didn't shake the serum before injecting it. The pain got worse but my friends kept saying just wait it will go away but it never did it got worse and when I went to Dr, his assistant took note of the pain going on and said to keep watch on it to see if it gets worse. I have an appointment to go to the Dr. to get an x-ray as my right arm has gotten so bad I cannot reach very far without extreme pain it has gotten so bad over the months that the pain is excruciating. It feels like the muscles are damaged in the area the student that  hired in place of the pharmacist, is severely damaged. I cannot touch that area without pain. I am going to get x-rays as the pain is so bad when I raise my arm that I can't even raise it like I used to - the entire arm is unusable.  It feels like someone has beat it with a hammer. Extreme muscle pain in that arm that it make me cry with pain. I have called  about it and they said it was a student that gave the shot that day to me since their regular pharmacist was out. They didn't warn me ahead of time that the man that gave me the shot was a student in training. Had I been informed I would have gotten the shot (flu injection) at my regular Dr.'s office. I didn't find out it was a temporary student in training giving me the flu injection until I called to inform them that the pain is getting worse over time and not improving.  informed me to contact your site to fill out the form for damage to my right arm due from the flu injection.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Product administered at inappropriate site, Wrong technique in product usage process
Clinical narrative: Pain began the night of the injection for the flu shot in my right arm where the injection was given. The regular pharmacist was out that day my injection was given so  called in a temporary student to give the injection, a male, and in training. The temporary (student) gave the injection high on my arm near my shoulder. Normally with the pharmacist last year and years prior they gave lower down on my arm but the student gave way up high near the shoulder blade. He didn't shake the serum before injecting it. The pain got worse but my friends kept saying just wait it will go away but it never did it got worse and when I went to Dr, his assistant took note of the pain going on and said to keep watch on it to see if it gets worse. I have an appointment to go to the Dr. to get an x-ray as my right arm has gotten so bad I cannot reach very far without extreme pain it has gotten so bad over the months that the pain is excruciating. It feels like the muscles are damaged in the area the student that  hired in place of the pharmacist, is severely damaged. I cannot touch that area without pain. I am going to get x-rays as the pain is so bad when I raise my arm that I can't even raise it like I used to - the entire arm is unusable.  It feels like someone has beat it with a hammer. Extreme muscle pain in that arm that it make me cry with pain. I have called  about it and they said it was a student that gave the shot that day to me since their regular pharmacist was out. They didn't warn me ahead of time that the man that gave me the shot was a student in training. Had I been informed I would have gotten the shot (flu injection) at my regular Dr.'s office. I didn't find out it was a temporary student in training giving me the flu injection until I called to inform them that the pain is getting worse over time and not improving.  informed me to contact your site to fill out the form for damage to my right arm due from the flu injection.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Furuncle, Rash, Skin irritation
Clinical narrative: Allergic reaction; rash on both arms; patches of discolored skin; hairloss on arms; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced allergic reaction, rash, skin discoloration and hair loss. On an unknown date, the outcome of the allergic reaction, rash, skin discoloration and hair loss were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, rash, skin discoloration and hair loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 69 years or 70 years. Two months ago, from the date of reporting, the patient received a dose of Shingrix and had an allergic reaction. The patient described the symptoms as rash on both arms and legs, patches of discoloured skin and loss of hair on arms. These symptoms started days after the dose. The patient did not have the vaccine information for these adverse events.  At the time of this report, the symptoms were persisting. The patient agreed and consented to follow up with the physician (MD) and provided contact details for the same. There is a discrepancy with respect to the outcome of the events allergic reaction, rash on both arms and legs, patches of discoloured skin and loss of hair on arms. In source document, the outcome is reported as recovering/ resolving for all the symptoms, however as per narrative description it is not recovered/ not resolved. The outcome of all the symptoms retains as per the narrative description.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Alopecia, Hypersensitivity, Rash, Skin discolouration
Clinical narrative: Allergic reaction; rash on both arms; patches of discolored skin; hairloss on arms; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced allergic reaction, rash, skin discoloration and hair loss. On an unknown date, the outcome of the allergic reaction, rash, skin discoloration and hair loss were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, rash, skin discoloration and hair loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 69 years or 70 years. Two months ago, from the date of reporting, the patient received a dose of Shingrix and had an allergic reaction. The patient described the symptoms as rash on both arms and legs, patches of discoloured skin and loss of hair on arms. These symptoms started days after the dose. The patient did not have the vaccine information for these adverse events.  At the time of this report, the symptoms were persisting. The patient agreed and consented to follow up with the physician (MD) and provided contact details for the same. There is a discrepancy with respect to the outcome of the events allergic reaction, rash on both arms and legs, patches of discoloured skin and loss of hair on arms. In source document, the outcome is reported as recovering/ resolving for all the symptoms, however as per narrative description it is not recovered/ not resolved. The outcome of all the symptoms retains as per the narrative description.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: directly following the shot a bump and sharp muscular pain was at the injection site preventing full movement of my left arm, with every movement sending a sharp pain through upper left arm/left shoulder. Two days after the shot a fever and pounding headache developed that lasted for hours but subsided with the use of Tylenol, the medics attributed this fever and headache to the anthrax shot as I did not have any other symptoms that would have explained the fever and headache.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MENB, MNQ, TDAP
Symptoms: Areflexia, Blood test, Body temperature increased, Nuclear magnetic resonance imaging spinal, Pain in extremity
Clinical narrative: Rapid onset of bilateral leg pain, loss of her Achilles reflexes.  Woke with temp of 101.9.  Patient was admitted.   Blood work performed as well as an MRI
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MENB, MNQ, TDAP
Symptoms: Areflexia, Arthralgia, Constipation, Decreased activity, Decreased appetite
Clinical narrative: Rapid onset of bilateral leg pain, loss of her Achilles reflexes.  Woke with temp of 101.9.  Patient was admitted.   Blood work performed as well as an MRI
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MENB, MNQ, TDAP
Symptoms: Dizziness, Ear congestion, Eye pain, Fatigue, Gait inability
Clinical narrative: Rapid onset of bilateral leg pain, loss of her Achilles reflexes.  Woke with temp of 101.9.  Patient was admitted.   Blood work performed as well as an MRI
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MENB, MNQ, TDAP
Symptoms: Headache, Muscular weakness, Musculoskeletal disorder, Musculoskeletal stiffness, Nasal congestion
Clinical narrative: Rapid onset of bilateral leg pain, loss of her Achilles reflexes.  Woke with temp of 101.9.  Patient was admitted.   Blood work performed as well as an MRI
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MENB, MNQ, TDAP
Symptoms: Neck pain, Pain, Pain in extremity, Photophobia, Pyrexia
Clinical narrative: Rapid onset of bilateral leg pain, loss of her Achilles reflexes.  Woke with temp of 101.9.  Patient was admitted.   Blood work performed as well as an MRI
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MENB, MNQ, TDAP
Symptoms: Respiratory tract congestion
Clinical narrative: Rapid onset of bilateral leg pain, loss of her Achilles reflexes.  Woke with temp of 101.9.  Patient was admitted.   Blood work performed as well as an MRI
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal dreams, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever, fatigue, vivid dreams, muscle aches
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Albumin globulin ratio normal, Alpha 1 globulin normal, Alpha 2 globulin normal, Basophil percentage, Blood albumin normal
Clinical narrative: About 4 days after immunization, she experienced fever as high as 103 F, but not much else in the way of symptoms.  This resolved without intervention.  About 4 days prior to office visit (15 days after immunization) she developed a diffuse numbness starting around the neck and going diffusely with no other symptoms.  Has not changed since.  Feels some fatigue.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Blood calcium normal, Blood chloride increased, Blood creatinine normal, Blood glucose normal, Blood potassium normal
Clinical narrative: About 4 days after immunization, she experienced fever as high as 103 F, but not much else in the way of symptoms.  This resolved without intervention.  About 4 days prior to office visit (15 days after immunization) she developed a diffuse numbness starting around the neck and going diffusely with no other symptoms.  Has not changed since.  Feels some fatigue.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Blood sodium normal, Blood thyroid stimulating hormone normal, Blood urea normal, Carbon dioxide normal, Eosinophil percentage
Clinical narrative: About 4 days after immunization, she experienced fever as high as 103 F, but not much else in the way of symptoms.  This resolved without intervention.  About 4 days prior to office visit (15 days after immunization) she developed a diffuse numbness starting around the neck and going diffusely with no other symptoms.  Has not changed since.  Feels some fatigue.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Globulin, Glomerular filtration rate normal, Haematocrit normal, Haemoglobin normal, Hypoaesthesia
Clinical narrative: About 4 days after immunization, she experienced fever as high as 103 F, but not much else in the way of symptoms.  This resolved without intervention.  About 4 days prior to office visit (15 days after immunization) she developed a diffuse numbness starting around the neck and going diffusely with no other symptoms.  Has not changed since.  Feels some fatigue.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Immunoglobulins normal, Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: About 4 days after immunization, she experienced fever as high as 103 F, but not much else in the way of symptoms.  This resolved without intervention.  About 4 days prior to office visit (15 days after immunization) she developed a diffuse numbness starting around the neck and going diffusely with no other symptoms.  Has not changed since.  Feels some fatigue.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Mononuclear cell percentage, Neutrophil percentage decreased, Platelet count normal, Protein total normal, Pyrexia
Clinical narrative: About 4 days after immunization, she experienced fever as high as 103 F, but not much else in the way of symptoms.  This resolved without intervention.  About 4 days prior to office visit (15 days after immunization) she developed a diffuse numbness starting around the neck and going diffusely with no other symptoms.  Has not changed since.  Feels some fatigue.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Red blood cell count normal, Red blood cell sedimentation rate abnormal, Red cell distribution width normal, Vitamin B12 normal, White blood cell count normal
Clinical narrative: About 4 days after immunization, she experienced fever as high as 103 F, but not much else in the way of symptoms.  This resolved without intervention.  About 4 days prior to office visit (15 days after immunization) she developed a diffuse numbness starting around the neck and going diffusely with no other symptoms.  Has not changed since.  Feels some fatigue.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Headache, Myalgia
Clinical narrative: Fever, body (muscle/joint) aches, chills, headache - lasting about 24 hours Weakness - still experiencing at 48 hours
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, body (muscle/joint) aches, chills, headache - lasting about 24 hours Weakness - still experiencing at 48 hours
Sex: U
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: vaccinated with RECOMBIVAX, PEDIARIX (manufacturer unknown) PREVNAR 13 (manufacturer unknown) and ROTATEQ during the same office visit/Patient received 2 doses of hepatitis B vaccine; No adverse symptoms reported; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided.  On an unknown date the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, dose, route, batch/lot number and expiration date were not provided), rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength, dose, batch/lot number and expiration date were not provided) orally, diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid(PEDIARIX) (strength, dose, route, batch/lot number and expiration date were not provided) and pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (strength, dose, route, batch/lot number and expiration date were not provided), all for prophylaxis during a same office visit (overdose). No adverse symptoms reported (no adverse event).
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Vaccination error
Clinical narrative: No adverse effects have been reported; only the bevel of the needle was inserted into the patient; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided. On 08-MAY-2019, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneously, lot # R023737, expiration date  20-AUG-2020 (dose, strength and dose number were not reported) for prophylaxis. The dose was reconstituted with a sterile diluent. The needle was not inserted correctly during administration, only the bevel of the needle was inserted into the patient. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product use issue
Clinical narrative: the patient, who is taking ENBREL (Etanercept), was vaccinated with M-M-R II; no adverse symptoms reported; Information has been received from a physician assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date, the patient, who was taking etanercept (ENBREL), was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot# and expiration date unknown) for prophylaxis (product use issue). No adverse symptoms were reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse affects; two doses of MMR II were reconstitured and administered with expired MERCK STERILE diluent; two doses of MMR II were reconstitured and administered with expired MERCK STERILE diluent; This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 09-MAY-2019,  the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, anatomical location, lot and expiration date were not reported) for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstituted and administered with expired sterile diluent (MERCK STERILE DILUENT) (lot # M010690 and expiration date 02-SEP-2018) administered subcutaneously. No adverse effects reported.This one of two reports from the same reporter.; Sender's Comments:  US-009507513-1905USA006145:
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: She was administered MMRII and on a later unspecified date, had "titers" checked for an unspecified reason and the results showed "no developement of immnunity to measles".; This spontaneous report was received from a nurse prescriber of unknown age, reporting to herself. The patient's medical history, concurrent conditions, previously drug reactions, allergies, and her concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), 1 dosage form for prophylaxis (frequency, route of administration, lot number and expiration date were not reported), which was reconstituted using an sterile diluent (MERCK STERILE DILUENT) (it was not reported that the sterile diluent was expedited or poorly stored).  On a later unspecified date, the patient had an antibody titer test, for an in unspecified reason and the results showed: "No development of immunity to measles" (measles antibody negative).   The outcome of the event measles antibody negative was unknown. The causality relationship with the reported event and the therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), was not provided.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse affects; two doses of MMR II were reconstitured and administered with expired MERCK STERILE diluent; two doses of MMR II were reconstitured and administered with expired MERCK STERILE diluent; This spontaneous report has been received from a pharmacist,concerning a patient of unknown age and gender.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 09-MAY-2019,  the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, anatomical location, lot and expiration date were not reported) as prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine was reconstituted and administered with expired sterile diluent (MERCK STERILE DILUENT) (lot # M010690 and expiration date 02-SEP-2018) administered subcutaneously. No adverse effects reported.This one of two reports from the same reporter.; Sender's Comments:  US-009507513-1905USA005458:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Developed HZ despite vaccination; Information has been received from the authors of the article titled as stated below, and refers to 324 female patients of unknown age. The patients' medical history, concurrent conditions, and concomitant therapies were not provided.   On unspecified dates, the patients were vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, dose number, route and anatomical location were unspecified).   On unspecified dates between 18-JAN-2012 and 26-FEB-2015, the patients developed herpes zoster despite vaccination (vaccination failure).   The outcome of the vaccination failure was unknown.  The authors considered the vaccination failure to be related to zoster vaccine live (ZOSTAVAX).   This is one of two cases received from the same source (US-009507513-1905USA008145)  A copy of the published article is attached as further documentation of the patient's experience.   Sender's Comments:  US-009507513-1905USA008145:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse events; the patient was supposed to be administered a dose of PEDVAX HIB but was instead administered a dose a RECOMBIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 14-MAY-2019, the patient was supposed to be administered a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), but was instead administered a dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # R012001, expiration date 06-NOV-2020, intramuscular, in error (strength, dose and anatomical location were not provided). No adverse effects were reported.
Sex: U
Vaccine: MMRV, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: No adverse effects reported; one patient received one dose of PROQUAD that was reconstituted with MENACTRA instead of sterile diluent; one patient received one dose of PROQUAD that was reconstituted with MENACTRA instead of sterile diluent; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 15-MAY-2019, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # R018778, expiration date 29-DEC-,2019 subcutaneously (strength and anatomical location were not provided), that was was reconstituted with meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) lot # U5916AA and expiration date of 27-JUN-2019 instead of sterile diluent. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect; Patient received dose of GARDASIL 9 in August 2018 and 2nd dose of GARDASIL 9 on 15-MAY-2019; Patient received dose of GARDASIL 9 in August 2018 and 2nd dose of GARDASIL 9 on 15-MAY-2019; This spontaneous report was received from a nurse refers to a patient of unknown age and gender.  The patient's medical history, current conditions and concomitant medications were not reported.  On an unknown date in August 2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis.  It was reported that on 15-MAY-2019 the patient received a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration and circumstance or information capable of leading to medication error).  The patient experienced no adverse event.  No PQC (product quality complaint) was present.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: No adverse effects reported; a female patient was administered a M-M-R II vaccine by intramuscular rather than subcutaneous route; This spontaneous report was received from a registered pharmacist referring to a  28 years old female patient. No information was provided regarding patient's medical history, current conditions, drug reactions or allergies.  On 16-APR-2019,  the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) intramuscularly rather than the subcutaneous route (incorrect route of product administration) for prophylaxis (strength, dose, dose number and frequency was not reported). The suspect vaccine was reconstituted with a properly stored sterile diluent.   Lot No. R031681 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported as 01-APR-2020, but upon internal validation established as 01-NOV-2020.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Developed HZ despite vaccination; Information has been received from the authors of the article titled as stated below, and refers to 185 male patients of unknown age. The patients' medical history, concurrent conditions, and concomitant therapies were not provided.   On unspecified dates, the patients were vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, dose number, route and anatomical location were unspecified).   On unspecified dates between 18-JAN-2012 and 26-FEB-2015, the patients developed herpes zoster despite vaccination (vaccination failure).   The outcome of the vaccination failure was unknown.  The authors considered the vaccination failure to be related to zoster vaccine live (ZOSTAVAX).   This is one of two cases received from the same source (US-009507513-1905USA006682)  A copy of the published article is attached as further documentation of the patient's experience.   Sender's Comments:  US-009507513-1905USA006682:
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash, Rash vesicular
Clinical narrative: rash/ Chicken-pox-like; itching; Pain; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th April 2019, the patient received the 1st dose of Shingrix. On 25th April 2019, 9 days after receiving Shingrix, the patient experienced varicella-like rash, pruritus and pain. On an unknown date, the outcome of the varicella-like rash, pruritus and pain were unknown.   It was unknown if the reporter considered the varicella-like rash, pruritus and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient started developing a rash on torso which looked like hives, but it was more chicken-pox-like than hives-like. The patient reported that it was really itched horribly for about 10 days but now it became fairly bearable without an analgesic.  The patient reported the patient's co-worker who had shingles and the patient prefer the itching to pain.  The patient hesitant to take the 2nd dose. The patient asked about the any information on the recurrence of this side-effect. The patient had read, having only one vaccination seems to be almost as effective as having two.
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Cough, Laryngitis
Clinical narrative: Cough; Laryngitis; This case was reported by a consumer via call center representative and described the occurrence of cough in a 78-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received Shingrix. On 4th May 2019, 1 days after receiving Shingrix, the patient experienced cough and laryngitis. On an unknown date, the outcome of the cough and laryngitis were unknown.   It was unknown if the reporter considered the cough and laryngitis to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix last Friday and next day started to cough and got laryngitis. The patient asked whether it was side effect of the shot. The patients demographic details were updated.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Feeling jittery, Headache, Malaise
Clinical narrative: felt awful; Headache; dizzy feeling; hard to focus my eyes; nauseous; my head is spinning; Jittery; felt too sick to drink; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose, refer case US2019GSK087398.). Concomitant products included mepolizumab (Nucala), prednisone and methotrexate.   On 4th May 2019, the patient received the 2nd dose of Shingrix. On 5th May 2019, 1 days after receiving Shingrix and an unknown time after starting Nucala, the patient experienced feels awful, headache, dizziness, difficulty focusing eyes, nausea and head spinning. In May 2019, the patient experienced jitteriness and feeling unwell. On an unknown date, the outcome of the feels awful, headache, dizziness, difficulty focusing eyes, nausea, head spinning, jitteriness and feeling unwell were unknown.   It was unknown if the reporter considered the feels awful, headache, dizziness, difficulty focusing eyes, nausea, head spinning, jitteriness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient receiving monthy Nucala injection. The age at vaccination was not reported. The patient had Shingrix vaccine this past Saturday before the date of reporting. On next morning, the patient felt awful headaches, dizzy feeling, hard to focus my eyes, nauseous, it feels like my head was spinning. The patient was very jittery inside as if I am over caffeinated, which the patient felt too sick to drink it.  The patient started a new job this week and this had made it extremely difficult.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Vertigo, Vision blurred
Clinical narrative: felt awful; Headache; dizzy feeling; hard to focus my eyes; nauseous; my head is spinning; Jittery; felt too sick to drink; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose, refer case US2019GSK087398.). Concomitant products included mepolizumab (Nucala), prednisone and methotrexate.   On 4th May 2019, the patient received the 2nd dose of Shingrix. On 5th May 2019, 1 days after receiving Shingrix and an unknown time after starting Nucala, the patient experienced feels awful, headache, dizziness, difficulty focusing eyes, nausea and head spinning. In May 2019, the patient experienced jitteriness and feeling unwell. On an unknown date, the outcome of the feels awful, headache, dizziness, difficulty focusing eyes, nausea, head spinning, jitteriness and feeling unwell were unknown.   It was unknown if the reporter considered the feels awful, headache, dizziness, difficulty focusing eyes, nausea, head spinning, jitteriness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient receiving monthy Nucala injection. The age at vaccination was not reported. The patient had Shingrix vaccine this past Saturday before the date of reporting. On next morning, the patient felt awful headaches, dizzy feeling, hard to focus my eyes, nauseous, it feels like my head was spinning. The patient was very jittery inside as if I am over caffeinated, which the patient felt too sick to drink it.  The patient started a new job this week and this had made it extremely difficult.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Influenza virus test negative, Injection site erythema
Clinical narrative: like zoster rash; Injection site swelling; redness; fever; fatigue; Chills; Myalgia; heart palpitations; gastrointestinal upset; This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, fever, fatigue, chills, myalgia, palpitation, gastrointestinal upset and rash zosteriform. In April 2019, the outcome of the injection site swelling, injection site erythema, fever, fatigue, chills, myalgia, palpitation and gastrointestinal upset were recovered/resolved. On an unknown date, the outcome of the rash zosteriform was recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site erythema, fever, fatigue, chills, myalgia, palpitation, gastrointestinal upset and rash zosteriform to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that Within 72 hours post injection, the patient experienced swelling at injection site, redness, fever 102 degree F, chills, fatigue, myalgia, heart palpitations for 24 hours. The patient experienced GI upset for 48 hours post dose. The patient did get rash above right eye brow size of nickel that presented like zoster rash. Rash was healing, still vaguely present. The patient had tested for flu, the results were negative. The patient had consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Palpitations, Pyrexia, Rash vesicular
Clinical narrative: like zoster rash; Injection site swelling; redness; fever; fatigue; Chills; Myalgia; heart palpitations; gastrointestinal upset; This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, fever, fatigue, chills, myalgia, palpitation, gastrointestinal upset and rash zosteriform. In April 2019, the outcome of the injection site swelling, injection site erythema, fever, fatigue, chills, myalgia, palpitation and gastrointestinal upset were recovered/resolved. On an unknown date, the outcome of the rash zosteriform was recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site erythema, fever, fatigue, chills, myalgia, palpitation, gastrointestinal upset and rash zosteriform to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that Within 72 hours post injection, the patient experienced swelling at injection site, redness, fever 102 degree F, chills, fatigue, myalgia, heart palpitations for 24 hours. The patient experienced GI upset for 48 hours post dose. The patient did get rash above right eye brow size of nickel that presented like zoster rash. Rash was healing, still vaguely present. The patient had tested for flu, the results were negative. The patient had consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Chicken pox; This case was reported by a consumer via call center representative and described the occurrence of chickenpox in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In May 2019, less than a month after receiving Shingrix, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In 2019, the patient received a dose of Shingrix and developed a mild case of chicken pox. The patient was asked about the follow up vaccination.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Extremity contracture
Clinical narrative: staying curled back; This case was reported by a consumer via call center representative and described the occurrence of finger contracture in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2018, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced finger contracture. On an unknown date, the outcome of the finger contracture was unknown.   It was unknown if the reporter considered the finger contracture to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine and sent in the paperwork with the adverse reaction that the patient was having. The patient went to a hand surgeon.  The patient had to get a shot in my hand so the patient could straighttmymiddle finger.  It was staying curled back.
Sex: M
Vaccine: UNK
Symptoms: Ear disorder, Epilepsy, Hypoacusis, Immediate post-injection reaction, Intellectual disability
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of mental retardation in a child male patient who received Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential MENVEO)) for prophylaxis. On an unknown date, the patient received Meningococcal ACWY Vaccine (potential MENVEO) at an unknown dose. On an unknown date, unknown after receiving Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced mental retardation (serious criteria GSK medically significant), epilepsy (serious criteria GSK medically significant), ear disorder and hearing impaired. On an unknown date, the outcome of the mental retardation, epilepsy, ear disorder and hearing impaired were not recovered/not resolved. It was unknown if the reporter considered the mental retardation, epilepsy, ear disorder and hearing impaired to be related to Meningococcal ACWY Vaccine (potential MENVEO). Additional detail were provided as follows: The age at vaccination was not reported. Immediately after this vaccine (Meningitis ACWY), the patient experienced epilepsy and severe ear problems, with severe hearing impairment. The patient received this vaccine as a travel vaccine, it was not yet (at the time of reporting) included in the schedule. At the moment the patient was fortunately better, but unfortunately the mental retardation that the patient had left due to these years of problems was still there. These symptoms were also likely to occurred after experiencing the disease. So the patient only got them immediately after the vaccine. The reporter asked that what reactions the patient received.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included mepolizumab (Nucala Injection).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was also receiving monthly Nucala injections. The patient had no reaction to the Shingrix vaccination aside from soreness at the injection site. For tolerances of 2nd dose, refer case US2019AMR084184.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Rash, Swelling face
Clinical narrative: Swollen cheeks; Red cheeks/ Red ears; Rash/ rash on her trunk that goes down both legs; Soreness/soreness at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of cheek swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number CA374, expiry date 28th June 2021) for prophylaxis.   On 2nd May 2019, the patient received the 1st dose of Shingrix .5 ml. On 3rd May 2019, 1 days after receiving Shingrix, the patient experienced cheek swelling, red face, rash and injection site pain. On an unknown date, the outcome of the cheek swelling, red face, rash and injection site pain were unknown.   It was unknown if the reporter considered the cheek swelling, red face, rash and injection site pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that a patient had a major reaction after receiving her 1st dose of Shingrix. The patient received the shot yesterday and this morning had red and swollen cheeks, ears are red, and a rash on her trunk that goes down both legs. The patient also had soreness at the injection site. The patient did not notice the reactions until this morning and she had not done anything differently or eaten anything different. The patient had not seen a doctor.
Age: 80.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Influenza like illness, Loss of consciousness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 80-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOVAX 23 for prophylaxis. On 17th April 2019, the patient received the 1st dose of SHINGRIX and the 1st dose of PNEUMOVAX 23 .5 ml. On 17th April 2019, 12 hrs after receiving SHINGRIX, the patient experienced fever, shivering, fatigue, nausea, discomfort in joints, influenza-like symptoms and pain. On 18th April 2019, the patient experienced appetite lost. On 20th April 2019, the patient experienced fainting (serious criteria GSK medically significant). The patient was treated with paracetamol (Tylenol), nutritional supplement nos (Ensure) and antiemetics and antinauseants (Nausea Medication (Nos)). On 19th April 2019, the outcome of the shivering and nausea were recovered/resolved. On 20th April 2019, the outcome of the fainting, fever, discomfort in joints, influenza-like symptoms and pain were recovered/resolved. On 21st April 2019, the outcome of the appetite lost was recovered/resolved. On 26th April 2019, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the fainting, fever, shivering, fatigue, appetite lost, nausea, discomfort in joints, influenza-like symptoms and pain to be related to SHINGRIX. Addtional details were provided as follows: The patient received 1st dose of SHINGRIX on left arm. In the evening of vaccination day, the patient experienced fever of 101. 8 degree F, shivering, fatigue, nausea, joint discomfort or achy flu-like symptoms. One date after vaccination, the patient experienced loss of appetite. Three days after vaccination, in the morning, the patient passed out in bathroom because, the patient went to bathroom to use commode but woke up on floor. Fatigue lasted about a week after seeing doctor. Consented to follow up.