chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscular weakness, Neuralgic amyotrophy, Paraesthesia, Sensory loss
Clinical narrative: Pt undergoing w/u for breast cancer. MRI breast next day 9/12 showed marked lymphadenopathy with enhancement. LN biopsy 9/19 showed reactive lymph node. However, starting 9/19 or at least 9/25 pt developing sx of Parsonage Turner Syndrome (left brachial plexitis) which worsened post-op on day of lumpectomy 9/29 causing significant left arm weakness/sensory loss/paresthesias, LMN signs, absent DTRs, fascinulations.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Epistaxis, Extra dose administered, Nasal congestion
Clinical narrative: Nosebleed - a real gusher, subsided by 10 minutes with stuffing nose and lying down Not a big deal but seems like something that should be counted Also had a nosebleed after 1st booster which was Moderna, this was 3rd booster.  No problem after 2nd booster which was Pfizer
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomiting, diarrhea, mild fever
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse event occurred
Age: 28.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Acute psychosis, Anxiety, Chest X-ray normal, Chest pain, Decreased appetite
Clinical narrative: -Acute psychosis resulting in severe anxiety and intrusive thoughts -Chest pain, shortness of breath, diarrhea, loss of appetite, fatigue
Age: 28.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Diarrhoea, Dyspnoea, Electrocardiogram normal, Fatigue, Full blood count normal
Clinical narrative: -Acute psychosis resulting in severe anxiety and intrusive thoughts -Chest pain, shortness of breath, diarrhea, loss of appetite, fatigue
Age: 28.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Intrusive thoughts, Metabolic function test normal
Clinical narrative: -Acute psychosis resulting in severe anxiety and intrusive thoughts -Chest pain, shortness of breath, diarrhea, loss of appetite, fatigue
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The Pharmacist accidentally used a bottle of Moderna that was punctured over 24 hours ago. While assisting the drive-thru, I was asked by my colleague which vial was which, I pointed to the differences, Monavalent which was capped, and the bivalent which should be in a black holder, but is located in a blue one. From there, I turned to finish with my covid appt. The bivalent was then handed to the staff pharmacist, then administered as a booster. After the administering of the vaccine, the staff pharmacist then approached my colleague and I to ask what dose number was this taken from the vial, because it was open and had no dose sticker wrapped around it. Thats when I let her know that she is the first one since I clocked in at 2 to use the vial. And if it was open, then it was the vial from the day prior which obviously was not strong packed. She should have asked that before administering. I was
Age: 42.0
Sex: U
Vaccine: COVID19-2
Symptoms: Lip swelling
Clinical narrative: Swelling lips started 09/27/22
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID19
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Arthralgia, Eczema, Mobility decreased, Myalgia, Pain
Clinical narrative: I was fine with the first and second vaccine- I had hips on down pain and discomfort especially in my knees, I said I was not getting the booster. 4mths later, the pain went away. I said ok, I'll go ahead and get the booster. On 1.7.22 I got the booster. It wasnt too long after I got that booster. Now I have that discomfort from hips on down, bad! and now Ezema, it got bad. From the tops of my hand and it started up to my elbows. Also, when I saw that healthcare provider, I said I believe the booster did it, because of the timing. She said "I believe you're spot right on". All the stuff I am going through: terrible pain from my hips on down, standing more than 5 mins, it hurts so bad, the ezema, great fatigue, shortness of breath, tips of my fingers are cold, I am having to take benadryl  every night, if I dont I itch from head to toe, you cant see where it's itching, I try not to scratch, my left heel has started to have pain when I step down, until I walk a little bit.  I saw physicians.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Photosensitivity reaction, Pruritus
Clinical narrative: I was fine with the first and second vaccine- I had hips on down pain and discomfort especially in my knees, I said I was not getting the booster. 4mths later, the pain went away. I said ok, I'll go ahead and get the booster. On 1.7.22 I got the booster. It wasnt too long after I got that booster. Now I have that discomfort from hips on down, bad! and now Ezema, it got bad. From the tops of my hand and it started up to my elbows. Also, when I saw that healthcare provider, I said I believe the booster did it, because of the timing. She said "I believe you're spot right on". All the stuff I am going through: terrible pain from my hips on down, standing more than 5 mins, it hurts so bad, the ezema, great fatigue, shortness of breath, tips of my fingers are cold, I am having to take benadryl  every night, if I dont I itch from head to toe, you cant see where it's itching, I try not to scratch, my left heel has started to have pain when I step down, until I walk a little bit.  I saw physicians.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Asthenia, Depression, Dyspnoea, Eczema, Fatigue
Clinical narrative: I was fine with the first and second vaccine- I had hips on down pain and discomfort especially in my knees, I said I was not getting the booster. 4mths later, the pain went away. I said ok, I'll go ahead and get the booster. On 1.7.22 I got the booster. It wasnt too long after I got that booster. Now I have that discomfort from hips on down, bad! and now Ezema, it got bad. From the tops of my hand and it started up to my elbows. Also, when I saw that healthcare provider, I said I believe the booster did it, because of the timing. She said "I believe you're spot right on". All the stuff I am going through: terrible pain from my hips on down, standing more than 5 mins, it hurts so bad, the ezema, great fatigue, shortness of breath, tips of my fingers are cold, I am having to take benadryl  every night, if I dont I itch from head to toe, you cant see where it's itching, I try not to scratch, my left heel has started to have pain when I step down, until I walk a little bit.  I saw physicians.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Hand dermatitis, Insomnia, Joint stiffness, Pain, Pruritus
Clinical narrative: I was fine with the first and second vaccine- I had hips on down pain and discomfort especially in my knees, I said I was not getting the booster. 4mths later, the pain went away. I said ok, I'll go ahead and get the booster. On 1.7.22 I got the booster. It wasnt too long after I got that booster. Now I have that discomfort from hips on down, bad! and now Ezema, it got bad. From the tops of my hand and it started up to my elbows. Also, when I saw that healthcare provider, I said I believe the booster did it, because of the timing. She said "I believe you're spot right on". All the stuff I am going through: terrible pain from my hips on down, standing more than 5 mins, it hurts so bad, the ezema, great fatigue, shortness of breath, tips of my fingers are cold, I am having to take benadryl  every night, if I dont I itch from head to toe, you cant see where it's itching, I try not to scratch, my left heel has started to have pain when I step down, until I walk a little bit.  I saw physicians.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Sunburn
Clinical narrative: I was fine with the first and second vaccine- I had hips on down pain and discomfort especially in my knees, I said I was not getting the booster. 4mths later, the pain went away. I said ok, I'll go ahead and get the booster. On 1.7.22 I got the booster. It wasnt too long after I got that booster. Now I have that discomfort from hips on down, bad! and now Ezema, it got bad. From the tops of my hand and it started up to my elbows. Also, when I saw that healthcare provider, I said I believe the booster did it, because of the timing. She said "I believe you're spot right on". All the stuff I am going through: terrible pain from my hips on down, standing more than 5 mins, it hurts so bad, the ezema, great fatigue, shortness of breath, tips of my fingers are cold, I am having to take benadryl  every night, if I dont I itch from head to toe, you cant see where it's itching, I try not to scratch, my left heel has started to have pain when I step down, until I walk a little bit.  I saw physicians.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Arthralgia, Dyspnoea, Dysstasia, Eczema, Fatigue
Clinical narrative: I was fine with the first and second vaccine- I had hips on down pain and discomfort especially in my knees, I said I was not getting the booster. 4mths later, the pain went away. I said ok, I'll go ahead and get the booster. On 1.7.22 I got the booster. It wasnt too long after I got that booster. Now I have that discomfort from hips on down, bad! and now Ezema, it got bad. From the tops of my hand and it started up to my elbows. Also, when I saw that healthcare provider, I said I believe the booster did it, because of the timing. She said "I believe you're spot right on". All the stuff I am going through: terrible pain from my hips on down, standing more than 5 mins, it hurts so bad, the ezema, great fatigue, shortness of breath, tips of my fingers are cold, I am having to take benadryl  every night, if I dont I itch from head to toe, you cant see where it's itching, I try not to scratch, my left heel has started to have pain when I step down, until I walk a little bit.  I saw physicians.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Musculoskeletal discomfort, Pain in extremity, Peripheral coldness, Pruritus
Clinical narrative: I was fine with the first and second vaccine- I had hips on down pain and discomfort especially in my knees, I said I was not getting the booster. 4mths later, the pain went away. I said ok, I'll go ahead and get the booster. On 1.7.22 I got the booster. It wasnt too long after I got that booster. Now I have that discomfort from hips on down, bad! and now Ezema, it got bad. From the tops of my hand and it started up to my elbows. Also, when I saw that healthcare provider, I said I believe the booster did it, because of the timing. She said "I believe you're spot right on". All the stuff I am going through: terrible pain from my hips on down, standing more than 5 mins, it hurts so bad, the ezema, great fatigue, shortness of breath, tips of my fingers are cold, I am having to take benadryl  every night, if I dont I itch from head to toe, you cant see where it's itching, I try not to scratch, my left heel has started to have pain when I step down, until I walk a little bit.  I saw physicians.
Age: 22.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: CSF protein increased, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: PT. IN CLINIC TODAY, 10/03/2022.  STATES SHE WAS HOSPITALIZED APPROXIMATELY 4 HOURS AFTER LEAVING CLINIC POST PLASMA DONATION AND RECEIVING A TDAP VACCINE.  PLEASE SEE VAERS FORM FROM HOSPITAL.
Age: 22.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Blood donor
Clinical narrative: PT. IN CLINIC TODAY, 10/03/2022.  STATES SHE WAS HOSPITALIZED APPROXIMATELY 4 HOURS AFTER LEAVING CLINIC POST PLASMA DONATION AND RECEIVING A TDAP VACCINE.  PLEASE SEE VAERS FORM FROM HOSPITAL.
Age: 44.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2
Symptoms: Rash, Urticaria
Clinical narrative: Hives
Age: 44.0
Sex: F
Vaccine: COVID19-2, FLU4, COVID19-2
Symptoms: Urticaria
Clinical narrative: Hives
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Incorrect dose administered, Product administration error
Clinical narrative: Patient presented for monovalent Moderna COVID-19 2nd in series. Patient received Moderna COVID-19 bivalent vaccine in error. Patient contacted to schedule monovalent vaccine injection.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient presented for monovalent Moderna COVID-19 2nd in series. Patient received Moderna COVID-19 bivalent vaccine in error. Patient contacted to schedule monovalent vaccine injection.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Rash, Varicella
Clinical narrative: Chicken Pox outbreak - hundreds of chicken pox all over his torso, arms, legs, back, hands, feet, face.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Varicella
Clinical narrative: Chicken Pox outbreak - hundreds of chicken pox all over his torso, arms, legs, back, hands, feet, face.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; patient received an extra dose of both MMRII and VARIVAX; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On an unspecified date in February 2022, the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, lot number, expiration date, anatomical location, and route of administration were not provided); and a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, lot #, expiry date, anatomical location, and route of administration were not provided) per de recommended schedule, both given as prophylaxis.  On 16-SEP-2022, the patient was inadvertently vaccinated with a third dose (extra dose administered) of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U032852, expiration date: 20-OCT-2023 (strength, anatomical location, and route of administration were not provided); and with an extra dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) 0.5 milliliter, lot #U014655, expiration date: 07-MAY-2023 (strength, anatomical location, and route of administration were not provided) both given as prophylaxis. The reporter stated that at the time of the report, the patient had no symptoms or adverse events of receiving those vaccines.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Customer reported expired MMR II was administered to a patient; Spontaneous information has been received from nurse regarding a 3-year-old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 20-SEP-2022, the patient was vaccinated with an expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R-II) 0.5 mL quantity 1 (valid lot # T031437 with expiration date reported on 15-SEP-2022) (route was not provided) for prophylaxis. No additional adverse event reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; a patient was inadvertently administered VAQTA instead of a COVID-19 vaccine; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 22-SEP-2022, the patient was inadvertently vaccinated with hepatitis A vaccine, inactivated (VAQTA) 0.3 milliliter, lot #U024094, expiration date: 10-MAY-2023 (strength, anatomical location, and route of administration were not provided) as prophylaxis, instead of a COVID-19 vaccine (manufacturer unknown) (wrong vaccine administered). The reporter stated that the patient received a partial dose of hepatitis A vaccine, inactivated (VAQTA). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired PROQUAD which was reconstituted with STERILE DILUENT was administered to Patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.   On 22-SEP-2022 at 1:30 p.m., the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot# U009259, expiration date: 19-SEP-2022 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis (expired vaccine used). No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Nurse reporting a GARDASIL 9 was administered to a pregnant woman; No adverse event; This spontaneous report was received from a nurse and refers to a 36-year-old female patient. The patient's medical history, previous drug reaction or allergies were not reported. The patient's concurrent conditions included  gestational diabetes. Her concomitant include prenatal ( manufacture unknown).  On 26-SEP-2022, the pregnancy patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml, lot #W010663, expiration date: 11-MAR-2024, administrated as prophylaxis (strength, route of administration, and anatomical site injection were not provided)(exposure during pregnancy). On an unknown date, the patient recovered from the event. Information regarding the date when the patient became pregnant, last menstrual period (LMP), and the estimated date of delivery were not reported. The pregnancy outcome was not provided at the time of the report therefore, the fetal outcome was unknown.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller is a state vaccine coordinator who reports a vaccines were administered following a temperature excursion.; This spontaneous report has been received from a state vaccine coordinator concerning a 4-month-old patient. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 27-SEP-2022, the patient was vaccinated with an improper stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # W004501, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and upon internal validation established as 20-APR-2023) (dose, anatomical location and route of administration were not reported) for prophylaxis. The vaccine was stored at a temperature of 8.6C for 18 minutes (Product storage error). The vaccine suffered previous temperature excursions (11.5C for 1 hour 6 minutes, 8.8C for 21 minutes and 9.6C for 6 hours 41 minutes).  No additional adverse event was reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2209USA010872:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Vaccines were administered following a temperature excursion; This spontaneous report has been received from a vaccine coordinator concerning a 2-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 28-SEP-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number W004501 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and confirmed as 20-APR-2023) (exact dose was not provided) administered orally as prophylaxis. The vaccine administered had been suffered a temperature excursion of 8.6 Celsius (C) degrees for a time frame of 18 minutes, and had also suffered the following previous temperature excursions: 11.5C for 1 hour 6 minutes; 8.8C for 21 minutes; and 9.6C for 6 hours 41 minutes (Product storage error).   No other information was available. No other adverse event (AE) or product quality complaint (PQC) were reported.  This is one of nine reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010872:
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Vaccines were administered following a temperature excursion; This spontaneous report has been received from a vaccine coordinator concerning a 7-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 27-SEP-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number W004501 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date reported and confirmed as 20-APR-2023) (exact dose was not provided) administered orally as prophylaxis. The vaccine administered had been suffered a temperature excursion of 8.6 Celsius (C) degrees for a time frame of 18 minutes, and had also suffered the following previous temperature excursions: 11.5C for 1 hour 6 minutes; 8.8C for 21 minutes; and 9.6C for 6 hours 41 minutes (Product storage error).   No other information was available. No other adverse event (AE) or product quality complaint (PQC) were reported.  This is one of nine reports received from the same reporter; Sender's Comments:  US-009507513-2209USA010872:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A nurse reported that PROQUAD and VARIVAX were administered concomitantly to a patient.  No Additional AE's and no PQC's were reported.; This spontaneous report was received from a nurse via an administrator and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, unk, Lot number W017571 (expiration date: 29-NOV-2023) has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (strength, and route of administration were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, unk, Lot number T041687, (expiration date: 10-DEC-2022) has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (strength, and route of administration were not provided) diluted in sterile diluent (manufacturer unknown) use as directed with vaccine (strength, lot #, expiry date, route of administration, and indication were not provided). Both vaccines were administered concomitantly for prophylaxis (Inappropriate schedule of vaccine administered).
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed to take her 4th dose; took it 3 days later; A spontaneous report was received from a pharmacist on 15SEP2022. It described a female patient of unknown age who "missed to take her 4th dose; took it 3 days later" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took the first 3 doses of Vivotif as per recommended schedule but did not take her fourth dose of Vivotif as per schedule and took it 3 days later. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient missed to take her 4th dose; took it 3 days later (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient missed to take her 4th dose; took it 3 days later (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took first dose of unrefrigerated Vivotif; A spontaneous report was received from a pharmacist on 21SEP2022. It described a 52-years-old male patient who "took first dose of unrefrigerated Vivotif" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: 3003661) for immunisation. It was reported that the patient was prescribed Vivotif on 02SEP2022 and he took the first dose on 21SEP2022 which he left unrefrigerated for 10 days. Reportedly, no side effects were reported yet. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took first dose of unrefrigerated Vivotif (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.; Sender's Comments: It was reported that a consumer took first dose of unrefrigerated Vivotif (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered first 2 doses of Vivotif consecutively; A spontaneous report was received from a pharmacist on 22SEP2022. It described a 65-year-old female patient who "administered first 2 doses of Vivotif consecutively" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient administered the first 2 doses of Vivotif consecutively instead of following the recommended schedule. Additionally, the patient did not experience any side effects. Furthermore, it was reported that prescribing physician was notified about the same. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient was administered the first 2 doses of Vivotif consecutively (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient was administered the first 2 doses of Vivotif consecutively (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeding disorder, Herpes zoster, Hypoaesthesia, Pain, Vaccination failure
Clinical narrative: both shots, very bad case of shingles/suspected vaccination failure; bad case of shingles; left leg and foot numb, through stomach and bowel; lost 30 lbs; can't eat right; pain for a month; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, numbness, pain, weight loss and unable to eat. On an unknown date, the outcome of the vaccination failure, shingles, numbness and weight loss were unknown and the outcome of the pain was recovered/resolved and the outcome of the unable to eat was not recovered/not resolved.   The reporter considered the vaccination failure, shingles, numbness, pain, weight loss and unable to eat to be possibly related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's Comments: This case was reported by a patient via  interactive digital media. The patient had both shots and had very bad case of shingles. The patients left leg and foot were numb from it, and numb through his/her stomach and bowels.  The patient was in pain for a month, lost 30 lbs, still could not ate right. The patient thought vaccines were poisonous. Additional supportive information:This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Weight decreased
Clinical narrative: both shots, very bad case of shingles/suspected vaccination failure; bad case of shingles; left leg and foot numb, through stomach and bowel; lost 30 lbs; can't eat right; pain for a month; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, numbness, pain, weight loss and unable to eat. On an unknown date, the outcome of the vaccination failure, shingles, numbness and weight loss were unknown and the outcome of the pain was recovered/resolved and the outcome of the unable to eat was not recovered/not resolved.   The reporter considered the vaccination failure, shingles, numbness, pain, weight loss and unable to eat to be possibly related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's Comments: This case was reported by a patient via  interactive digital media. The patient had both shots and had very bad case of shingles. The patients left leg and foot were numb from it, and numb through his/her stomach and bowels.  The patient was in pain for a month, lost 30 lbs, still could not ate right. The patient thought vaccines were poisonous. Additional supportive information:This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got both vaccines but still get a mild case/suspected vaccination failure; started on my back an came all around my torso under my breasts.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had a terrible case of shingles started on  back an came all around torso under  breasts that was so painful an can not remember ever being so sick an in pain).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date :24-Sep-2022 Reporters comment: This case was reported by a consumer via interactive digital media  The patient had shingles started on his/her back an came all around his/her torso under his/her breasts. that was so painful an he/she not remember ever being so sick an in pain after received the two shots of shingle vaccine Additional Supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.  .
Age: 16.0
Sex: U
Vaccine: TDAP
Symptoms: Product packaging confusion, Wrong product administered
Clinical narrative: Dtap vaccine administered instead of flu vaccine; Dtap vaccine to a 16 year old instead of the flu vaccine due to exactly the same box; This case was reported by a other health professional via other manufacturer and described the occurrence of wrong vaccine administered in a 16-year-old patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   On an unknown date, the patient received dTpa vaccine. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced wrong vaccine administered and product packaging confusion. On an unknown date, the outcome of the wrong vaccine administered and product packaging confusion were unknown.       Additional Information: GSK receipt date: 21-SEP-2022 Reporters comment:  The reporter reported that during a call a few years ago the GSK vaccines, Dtap and Fluarix had exactly the same box color and a nurse given the Dtap vaccine to a 16 year old instead of the flu vaccine. The reporter stated that this was reported and that the box colors are no longer the same and did not provide patient information or any additional information to further clarify these details.  The reporter consent to follow-up. Additional Supportive information: The nurse given the Dtap vaccine to a 16 year old instead of the flu vaccine due to exactly the same box color, which led to wrong vaccine administered and product packaging confusion.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Crazy side affects, fever; Shivering; Headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, shivering and headache. On an unknown date, the outcome of the fever, shivering and headache were unknown.   The reporter considered the fever, shivering and headache to be possibly related to Shingrix.  Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the Shingrix shot and was surprised that, she had a crazy side effects, fever, shivering and headache. The reporter thought that the event might had been related to Shingrix vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: Pharmacy mailed Shingrix, No refrigeration used; This case was reported by a nurse via sales rep and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The nurse reported that 4 patients that had an prescription which was sent to pharmacy, the pharmacy mailed the Shingrix to their home for the patient to bring in office to be administered.  These were patients.  No refrigeration was used by pharmacy.  In one case the Shingrix vials were put in a pill bottle and mailed.  All doses were spoiled, and patients sent back to pharmacy.  The nurse was checking with patients to see if the patient had got the vaccination after that. The reporter agrees to follow up from GlaxoSmithKline. Additional Supportive Information: All doses were spoiled, and patient had not received the doses, which led to Intercepted product storage error. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR136866:Same reporter- Patient 4 US-GSK-US2022AMR136885:Same reporter- Patient 3 US-GSK-US2022AMR136883:Same reporter- Patient 1
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: Pharmacy mailed Shingrix, No refrigeration used; This case was reported by a nurse via sales rep and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comment: The reporter reported that, a patient that had a e-prescription sent to pharmacy. The pharmacy mailed the Shingrix to their home for the patient to bring in office to be administered.  No refrigeration was used by pharmacy.  In one case the Shingrix vials were put in a pill bottle and mailed.  The dose was spoiled and patient sent back to pharmacy.  The reporter was checking with patients to see if got the vaccination after that. The reporter agreed to follow up from GlaxoSmithKline. Additional Supportive Information: The reporter reported that Shingrix was not refrigerated, which led to intercepted product storage error. This was 1 of 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR136884:Same reporter - Patient 2 US-GSK-US2022AMR136866:Same reporter - Patient 4 US-GSK-US2022AMR136883:Same reporter - Patient 1
Sex: U
Vaccine: VARZOS
Symptoms: Blood test abnormal
Clinical narrative: Affect blood results; This case was reported by a contact via interactive digital media and described the occurrence of blood test abnormal in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced blood test abnormal. On an unknown date, the outcome of the blood test abnormal was unknown.   It was unknown if the reporter considered the blood test abnormal to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments:  This case was received from Patient via interactive digital media. The patient reported that affect blood test result The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Bedridden, Bone pain, Pain
Clinical narrative: so much body pain/ most painful thing; I though my bones were breaking in; spend 3 days in bed; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced general body pain, bedridden and bone pain. On an unknown date, the outcome of the general body pain, bedridden and bone pain were recovered/resolved.   It was unknown if the reporter considered the general body pain, bedridden and bone pain to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 21-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. When the patient got the vaccine, he/she had made the mistake by taking both the vaccine on same day, Shingles and flu shot and it was the most painful thing the patient had experienced.  The patient though his/her bones were breaking in.  The patient was in so much body pain and had spent 3 days in bed, and when it was time for his/her second shot of shingles it was fine. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Bone pain, Peripheral swelling, Pruritus
Clinical narrative: arm is swollen; itching; bones hurt; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced swelling arm, pruritus and bone pain. Shingles vaccine was discontinued. On an unknown date, the outcome of the swelling arm, pruritus and bone pain were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, pruritus and bone pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got his/her first shot and left arm was still swollen a week later (itching, bones hurt). The patient said he/she was not getting the next one. Additional Supportive Information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles; I got the shot years ago; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR139470   Additional Information: GSK receipt date :22-SEP-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient had shingles shot years ago and he/she currently had shingles. The patient stated get the shot immediately. He/she put it off to received the flu shot and it was bad choice. Additional Supportive information:Till the time of reporting, the patient did not receive 2nd dose of Shingle vaccine which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022AMR139470:Same Reporter
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 4 year old patient was administered Kinrix as the third dose in the DTaP series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old patient who received DTaP-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Sep-2022 Reporter's comment: The nurse reported that a 4 year old patient was administered Kinrix as the third dose in the DTaP series. At the time of reporting, the nurse did not have the patient details, date of administration, lot number/expiration date, or the information of what vaccines were given for the first two DTaP series.  The vaccine administration facility was the same as primary reporter.   The consent to follow up was granted. Additional Supportive information: The patient was administered Kinrix as the third dose in the DTaP series which led to inappropriate age at vaccine administration. This case was one of 10 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136456:Same reporter US-GSK-US2022136459:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136466:Same reporter