chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site pain, Mobility decreased, Pyrexia
Clinical narrative: Patient developed fever, chills, and left shoulder pain. He is having difficulty raising his arm. Site is not tender touch or warm. He was evaluated by resident physician.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Lymph node pain, Lymphadenopathy, Tenderness
Clinical narrative: Swollen lymph gland in neck, possibly under arm (pit) Sore deltoid, tender arm pit. Pain/tender lymph node in neck. also visibly red
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Basophil count normal, Basophil percentage, Blood albumin normal
Clinical narrative: Chest pain 9 days post vaccination. Troponin elevation and ekg changes. Diagnosed with myocarditis.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: Chest pain 9 days post vaccination. Troponin elevation and ekg changes. Diagnosed with myocarditis.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal
Clinical narrative: Chest pain 9 days post vaccination. Troponin elevation and ekg changes. Diagnosed with myocarditis.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Chest X-ray normal, Chest pain, Dyspnoea exertional, Electrocardiogram normal, Eosinophil count normal
Clinical narrative: Chest pain 9 days post vaccination. Troponin elevation and ekg changes. Diagnosed with myocarditis.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Eosinophil percentage, Full blood count normal, Glomerular filtration rate, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Chest pain 9 days post vaccination. Troponin elevation and ekg changes. Diagnosed with myocarditis.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Lymphocyte count normal, Lymphocyte percentage, Malaise, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased
Clinical narrative: Chest pain 9 days post vaccination. Troponin elevation and ekg changes. Diagnosed with myocarditis.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Mean cell volume decreased, Mean platelet volume normal, Metabolic function test normal, Monocyte count increased, Monocyte percentage increased
Clinical narrative: Chest pain 9 days post vaccination. Troponin elevation and ekg changes. Diagnosed with myocarditis.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Neutrophil count normal, Neutrophil percentage decreased, Platelet count normal, Protein total increased, Pyrexia
Clinical narrative: Chest pain 9 days post vaccination. Troponin elevation and ekg changes. Diagnosed with myocarditis.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Red blood cell count normal, Red cell distribution width normal, Troponin I increased, White blood cell count normal
Clinical narrative: Chest pain 9 days post vaccination. Troponin elevation and ekg changes. Diagnosed with myocarditis.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest pain, Echocardiogram normal, Electrocardiogram change
Clinical narrative: Chest pain 9 days post vaccination. Troponin elevation and ekg changes. Diagnosed with myocarditis.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Myocarditis, Red blood cell sedimentation rate increased, Troponin I increased, Viral test negative
Clinical narrative: Chest pain 9 days post vaccination. Troponin elevation and ekg changes. Diagnosed with myocarditis.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: redness, itching, and swollen left arm; redness, itching, and swollen left arm; redness, itching, and swollen left arm; This is a spontaneous report from a contactable other HCP. This other HCP reported similar events for two patients. This is the first of two reports. A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13; lot number X35262; expiration date Oct2020) intramuscular in the left deltoid at physician office on 09Apr2019 at 14:30 at 0.5 ml single for immunisation/Booster. Relevant medical history included chronic sinusitis from 09Apr2019 (prescription for treatment with amoxicillin/clavulanic acid [AUGMENTIN]). There were no concomitant medications. On 15Apr2019, at 11:45, the patient experienced local reactions, redness, itching, and swollen left arm. The events were considered medically significant. The patient was seen in the office on 09Apr2019 because she had sinusitis. She had history of chronic sinusitis and was given the pneumococcal 13-val conj vac (dipht crm197 protein) that day and a prescription for amoxicillin/clavulanic acid (AUGMENTI) for her sinuses to start that night. She returned to the office on 15Apr2019 with redness, itching and swollen left arm at the injection site. At the time of the report, the patient was recovering from the events.; Sender's Comments: A causal association between administration of PREVENAR 13 and the onset of "local reactions, redness, itching, and swollen left arm" cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. ,Linked Report(s) : US-PFIZER INC-2019172687 same reporter/different patient, same product, same event
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: redness, itching, and swollen left arm; redness, itching, and swollen left arm; redness, itching, and swollen left arm; This is a spontaneous report from a contactable other HCP. This other HCP reported similar events for two patients. This is the first of two reports. A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13; lot number X35262; expiration date Oct2020) intramuscular in the left deltoid at physician office on 09Apr2019 at 14:30 at 0.5 ml single for immunisation/Booster. Relevant medical history included chronic sinusitis from 09Apr2019 (prescription for treatment with amoxicillin/clavulanic acid [AUGMENTIN]). There were no concomitant medications. On 15Apr2019, at 11:45, the patient experienced local reactions, redness, itching, and swollen left arm. The events were considered medically significant. The patient was seen in the office on 09Apr2019 because she had sinusitis. She had history of chronic sinusitis and was given the pneumococcal 13-val conj vac (dipht crm197 protein) that day and a prescription for amoxicillin/clavulanic acid (AUGMENTI) for her sinuses to start that night. She returned to the office on 15Apr2019 with redness, itching and swollen left arm at the injection site. At the time of the report, the patient was recovering from the events.; Sender's Comments: A causal association between administration of PREVENAR 13 and the onset of "local reactions, redness, itching, and swollen left arm" cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. ,Linked Report(s) : US-PFIZER INC-2019172687 same reporter/different patient, same product, same event
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Chills, Hypoaesthesia, Pyrexia
Clinical narrative: (1) Fever over 101' (2) Severe chills and shaking as though the body was convulsing (3) Rt. Arm as if it went dead. Could Not move it without using other hand. Could Not bend wrist or use hand. (4) Discomfort in upper Rt. chest. These symptoms Lasted about 12 hours and subsiding over the next 4 hours. However, These symptoms caused a flare-up of my RA for which I am Trying to Get under control Eight days Later as of doing These forms. I Rarely use steroids for the RA as I Try To Keep it fairly under Control with the hydroxyl, walking, and diet. Therefore, Not Expecting such a Reaction after having NONE after first dose, a better warning could prove to be beneficial. First dose in February. Thanks!
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest discomfort, Chills, Condition aggravated, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: (1) Fever over 101' (2) Severe chills and shaking as though the body was convulsing (3) Rt. Arm as if it went dead. Could Not move it without using other hand. Could Not bend wrist or use hand. (4) Discomfort in upper Rt. chest. These symptoms Lasted about 12 hours and subsiding over the next 4 hours. However, These symptoms caused a flare-up of my RA for which I am Trying to Get under control Eight days Later as of doing These forms. I Rarely use steroids for the RA as I Try To Keep it fairly under Control with the hydroxyl, walking, and diet. Therefore, Not Expecting such a Reaction after having NONE after first dose, a better warning could prove to be beneficial. First dose in February. Thanks!
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal disorder, Pyrexia, Rheumatoid arthritis, Seizure like phenomena, Tremor
Clinical narrative: (1) Fever over 101' (2) Severe chills and shaking as though the body was convulsing (3) Rt. Arm as if it went dead. Could Not move it without using other hand. Could Not bend wrist or use hand. (4) Discomfort in upper Rt. chest. These symptoms Lasted about 12 hours and subsiding over the next 4 hours. However, These symptoms caused a flare-up of my RA for which I am Trying to Get under control Eight days Later as of doing These forms. I Rarely use steroids for the RA as I Try To Keep it fairly under Control with the hydroxyl, walking, and diet. Therefore, Not Expecting such a Reaction after having NONE after first dose, a better warning could prove to be beneficial. First dose in February. Thanks!
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Facial pain, Malaise, Pyrexia
Clinical narrative: Nerve Pain on face / right side face pain; chills; fever; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of facial neuralgia in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 2nd dose of Shingrix. On 19th April 2019, less than a day after receiving Shingrix, the patient experienced facial neuralgia, chills, fever and influenza-like symptoms. On an unknown date, the outcome of the facial neuralgia, chills, fever and influenza-like symptoms were unknown.   It was unknown if the reporter considered the facial neuralgia, chills, fever and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient experienced nerve pain on face, chills, fever, flu like symptoms and right side of face pain after receiving a dose of Shingrix. There were no marks. No adverse events occurred after 1st dose.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Facial neuralgia, Influenza like illness, Pyrexia
Clinical narrative: Nerve Pain on face / right side face pain; chills; fever; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of facial neuralgia in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 2nd dose of Shingrix. On 19th April 2019, less than a day after receiving Shingrix, the patient experienced facial neuralgia, chills, fever and influenza-like symptoms. On an unknown date, the outcome of the facial neuralgia, chills, fever and influenza-like symptoms were unknown.   It was unknown if the reporter considered the facial neuralgia, chills, fever and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient experienced nerve pain on face, chills, fever, flu like symptoms and right side of face pain after receiving a dose of Shingrix. There were no marks. No adverse events occurred after 1st dose.
Age: 85.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable other HCP on behalf of Physician. This Other-HCP reported similar events for 2 patients. This is 1st of 2 reports. An 85-years-old female patient received PREVNAR 13, intramuscular on 16Apr2019 10:00 at 0.5 ml, single (Lot Number: X35262, Expiration date: Oct2020) for immunisation. Medical history included asthma. There were no concomitant medications. The patient experienced local reactions /significant site reaction on 15Apr2019 (pending clarification). The reaction occurred and was noticed yesterday and was worse this morning (19Apr2019). Outcome of event was not recovered (worsened). A seriousness criterion for event significant site reaction was provided as medically significant. Causality assessment of event significant site reaction was related. Sender's Comments: A causal association between administration of PREVENAR 13 and the onset of local reactions /significant site reaction cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2019174845 same reporter/different patient, same product, same event.
Age: 85.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This is a spontaneous report from a contactable other HCP on behalf of Physician. This Other-HCP reported similar events for 2 patients. This is 1st of 2 reports. An 85-years-old female patient received PREVNAR 13, intramuscular on 16Apr2019 10:00 at 0.5 ml, single (Lot Number: X35262, Expiration date: Oct2020) for immunisation. Medical history included asthma. There were no concomitant medications. The patient experienced local reactions /significant site reaction on 15Apr2019 (pending clarification). The reaction occurred and was noticed yesterday and was worse this morning (19Apr2019). Outcome of event was not recovered (worsened). A seriousness criterion for event significant site reaction was provided as medically significant. Causality assessment of event significant site reaction was related. Sender's Comments: A causal association between administration of PREVENAR 13 and the onset of local reactions /significant site reaction cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2019174845 same reporter/different patient, same product, same event.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: The patients was administered a dose of varivax and the patient was pregnant; This spontaneous prospective pregnancy report as received from registered nurse regarding a 30 year old female patient. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant medication included sterile diluent. On an unknown date, the patient became pregnant. On 27-FEB-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) via subcutaneous route (strength, dose, not reported) for prophylaxis and she was still pregnant (exposure during pregnancy). The last menstrual period (LMP) and estimated date of delivery (EDD) was unknown. The pregnancy outcome was pending.There was no product quality complaint associated with this report.  Lot No. R012531 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck)(VARIVAX), expiration date not reported, but upon internal validation established as 01-MAY-2020.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL, DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Wrong product administered
Clinical narrative: NO KNOWN ADVERSE EVENT
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL, DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: NO KNOWN ADVERSE EVENT
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Severe local redness, swelling, pain and heat.  Diffuse myalgias, constipation, nausea, feeling off balance, foggy.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Balance disorder, Constipation, Erythema, Feeling abnormal, Feeling hot
Clinical narrative: Severe local redness, swelling, pain and heat.  Diffuse myalgias, constipation, nausea, feeling off balance, foggy.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Myalgia, Nausea, Pain, Swelling
Clinical narrative: Severe local redness, swelling, pain and heat.  Diffuse myalgias, constipation, nausea, feeling off balance, foggy.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: 4/28/2019: 7pm - pain at injection site, very cold, shivering,  muscle soreness throughout the entire body, like flu.
Age: 56.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Blood potassium decreased, Pyrexia
Clinical narrative: This spontaneous report was received from a 56 year old male consumer referring to himself. Information on patient's concurrent conditions, medical history and concomitant medication were not reported. On an unknown date, the patient started therapy with losartan potassium(COZAAR) (Lot# and expiration date unknown), 100/12.5mg once daily orally for hypertension. Other suspect therapies included metformin given 500mg once daily. On an unknown date, the patient experienced blood potassium decreased. On an unknown date in 2018 (also reported as in November 2018 or late October 2018), therapy with losartan potassium(COZAAR) was discontinued. The outcome of blood potassium decreased was unknown. Causality was not reported. Follow up information received on 19-APR-2019 from consumer via physician. The patient's historical vaccines included FLULAVAL (twice), AFLURIA, FLULAVAL, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDaP) and PREVNAR 13. On 19-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 milliliter (lot#/expiration date: R012497/08-JAN-2020) given at right deltoid for prophylaxis and on 25-MAR-2019, the patient was vaccinated with BOOSTRIX 0.5 milliliter (lot#/expiration date:MF9EA/ 12-JUN-2021) given at left deltoid for prophylaxis. On unknown date in September 2018, the patient got the vaccination shot and had high fever. It was reported that the patient was hospitalized on 25-SEP-2018 due to high fever.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse reactions reported; received a dose of PROQUAD, when he was scheduled to receive a dose of MMR II; Route of Administration: intramuscular; Product administered to patient of inappropriate age; This spontaneous report was received from a medical assistant concerning to a 57-year-old patient of unknown gender. The patient's historical conditions, previous drug reactions, allergies, and concurrent condition were not provided.     On 17-APR-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (product administered to patient of inappropriate age) intramuscularly (Incorrect route of product administration) for prophylaxis (strength and dose were not reported; lot # R022566 with expiration date 04-FEB-2020); which was previously reconstituted with a properly stored MERCK sterile diluent when the patient was scheduled to receive a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered) due to travel plans. No adverse reactions reported.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Blister, Headache, Herpes zoster, Rash
Clinical narrative: herpes zoster; loss of balance; Information was received from a lawyer regarding a case in litigation concerning a male (age and medical history not provided).  In or around 02-JUN-2018 the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Approximately three weeks after receiving the vaccine the patient suffered a severe headache, rash, blisters and loss of balance and was diagnosed with herpes zoster and loss of balance.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX) the patient symptoms have resulted in physical imitations not present prior to using the vaccine.  The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of condition.    Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 09-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011974: USA-009507513-1904USA011975: USA-009507513-1904USA011976: USA-009507513-1904USA011977: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Receive one dose of M-M-R II with diluent through the intramuscular route; No adverse effect; This spontaneous report as received from a pharmacist and refers to a patient of unknown age and gender. Patient's current conditions, medical history, concomitant medications, drug allergies or reactions were not reported.       On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rha) (M-M-R II) by intramuscular route (incorrect route of product administration) lot # R028003, expiration date 01-OCT-2020, (strength, dose and anatomical site were not provided)  for prophylaxis. Also it was reported the used of sterile diluent lot # N002579, expiration date 10-JUL-2019. No adverse event was reported. And the outcome of the event was  unknown.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects were reported in the patient; A patient received "an extra dose of VAQTA"; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent condition, concomitant therapies and drugs or allergies reactions.   On 24-APR-2019, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA), 25/0.5 (units not provided), by intramuscular route, lot #S002460, expiration date of 15-MAY-2020, for prophylaxis (dose and anatomical site of injection were not reported).   On the same date, the patient received an extra dose of Hepatitis A Vaccine, Inactivated (VAQTA) (extra dose administered). No adverse effects were reported.   The outcome for the event was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 09-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011974: USA-009507513-1904USA011975: USA-009507513-1904USA011976: USA-009507513-1904USA011977: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 10-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011971: USA-009507513-1904USA011973: USA-009507513-1904USA011974: USA-009507513-1904USA011975: USA-009507513-1904USA011976: USA-009507513-1904USA011977: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 11-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011974: USA-009507513-1904USA011975: USA-009507513-1904USA011976: USA-009507513-1904USA011977: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 12-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011975: USA-009507513-1904USA011976: USA-009507513-1904USA011977: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 16-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011974: USA-009507513-1904USA011976: USA-009507513-1904USA011977: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 16-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011974: USA-009507513-1904USA011975: USA-009507513-1904USA011977: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 17-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011974: USA-009507513-1904USA011975: USA-009507513-1904USA011976: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 18-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011974: USA-009507513-1904USA011975: USA-009507513-1904USA011976: USA-009507513-1904USA011977: USA-009507513-1904USA011979:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 19-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: the patient received M-M-R II intramuscularly.; No adverse symptoms reported.; This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information reported about the patient's concomitant medication, pertinent medical history and drug reactions/allergies.   On an unspecified date, the patient received a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, lot number and expiration date not provided) intramuscularly for prophylaxis. No adverse symptoms were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reactions were reported; administered one dose of improperly stored ROTATEQ; administered one dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant referring to a 9 weeks old patient of an unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 05-DEC-2018 and 05-FEB-2019, the patient was respectively vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R002059 with expiration date 03-JUN-2019, orally (dose details were not reported) for prophylaxis. The vaccines experienced improperly stored and were stored at below 36 Fahrenheit degrees (F), the detail temperature and time frame information included: 34.2 F for 2hours and 20 minutes, 33.3 F for 30minutes, 34.3 F for 1 hour, 35.4 F for 10 minutes, 34.5 F for 10 minutes, 34.9 F for 30 minutes, 35.6 F for 10 minutes, 32.9 F for 10 minutes and 34 F for 10 minutes. There was no previous temperature excursion and the call was because of a data logger involved. No adverse reactions were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; one expired dose of MMR II was administered to a patient; This spontaneous report was received from a nurse referring to a patient of an unknown age and an unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 24-APR-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N009168 with expiration date with 20-MAR-2019, subcutaneously (dose detail was not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: HPVX
Symptoms: Loss of consciousness, Tooth fracture
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis. On an unknown date, the patient received HPV vaccine at an unknown dose. On an unknown date, 30 min after receiving HPV vaccine, the patient experienced passed out (serious criteria GSK medically significant) and tooth fracture. On an unknown date, the outcome of the passed out and tooth fracture were unknown. It was unknown if the reporter considered the passed out and tooth fracture to be related to HPV vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient received HPV vaccine and 30 min later she passed out and broke her tooth. This case has been linked to case US2019AMR070838, reported by the same reporter. There is descrepancy in suspect vaccine, as per narrative HPV vaccine consider as suspect as nothing was mentioned regarding flu shot. The clarification has been raised for confirmation of suspect product.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: Red rash; Raised rash; burning/burning at the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 4th September 2018, refer case US2019069962).   On 4th November 2018, the patient received the 2nd dose of Shingrix .5 ml. On 4th November 2018, less than a day after receiving Shingrix, the patient experienced injection site burning. On an unknown date, the patient experienced red rash and raised rash. Rechallenge with Shingrix was positive. On 5th November 2018, the outcome of the injection site burning was recovered/resolved. On an unknown date, the outcome of the red rash and raised rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site burning, red rash and raised rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix on right arm. The patient experienced burning at the injection site that lasted a day. Three weeks before the reporting date a rash presented above the buttock area. The patient described it as at the coccyx area.  It resolved after a couple of weeks and then presented again last night.  It was red and slightly raised. The reporter did not give consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperaesthesia, Nausea, Pain in extremity
Clinical narrative: shivering; headache; nausea; sore arm; touch sensitivity increased; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th April 2019, the patient received the 1st dose of Shingrix. On 10th April 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and touch sensitivity increased. On 11th April 2019, the patient experienced headache, nausea and shivering. On 11th April 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the pain in arm, touch sensitivity increased, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, touch sensitivity increased, headache, nausea and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose and within 2 hours her arm became very sore. She could not even touch it without pain. It was still sore at the time of reporting. On 11th April 2019 at 1:00, she experienced shivering, a headache and nausea.  The shivering resolved after 5 hours. The headache was better but was still present. The nausea was also better but not completely resolved.  The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: shivering; headache; nausea; sore arm; touch sensitivity increased; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th April 2019, the patient received the 1st dose of Shingrix. On 10th April 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and touch sensitivity increased. On 11th April 2019, the patient experienced headache, nausea and shivering. On 11th April 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the pain in arm, touch sensitivity increased, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, touch sensitivity increased, headache, nausea and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose and within 2 hours her arm became very sore. She could not even touch it without pain. It was still sore at the time of reporting. On 11th April 2019 at 1:00, she experienced shivering, a headache and nausea.  The shivering resolved after 5 hours. The headache was better but was still present. The nausea was also better but not completely resolved.  The reporter did not consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: swelling at the injection site; itching at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number BF4J5, expiry date 5th July 2021) for prophylaxis.   On 9th April 2019, the patient received the 2nd dose of Shingrix .5 ml. On 9th April 2019, less than a day after receiving Shingrix, the patient experienced injection site itching. On 11th April 2019, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix on left arm. The patient started to itch at the injection site and still continues to itch.  On 11th April 2019, 2 days after vaccination the patient also developed swelling at the injection site.  The swelling is the size of a softball.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis.   On 9th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On 9th February 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of Shingrix in the left arm and experienced pain at injection site. From the pharmacy, the reporter has been contacted for follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: SHINGLES; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2018, the patient received the 1st dose of Shingrix. On 13th August 2018, 1 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on an unknown arm. The patient did not recall if injection was given on the left or right arm. The representative did not ask for batch number and route of administration of Shingrix. The patient experienced Shingles fiare ups had been ongoing and the patient had shingles to date. The patient was seen by an immunologist and his doctor recommended not to get the second dose of the Shingrix. The patient gave consent to be followed up.