chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia, Vertigo
Clinical narrative: I had my first Shingrix 0.5ML shot on 02/19/2019. 24 hours later I experienced a fever of 102.8, chills, headache,and body aches. 4 days later I was seen in the emergency room for a severe headache and moderate to severe vertigo. I had my 2nd Shingrix 0.5ML shot on 05/11/2019.Within 12 hrs, I had a fever of 102.5 and the chills. My arm hurt at the sight of the injection. There was a 9cm diameter hot, hard, raised, painful circle. Went to the nearest urgent care 48hrs later and was told I had Cellulitis. I don't know if I was administered the shot with a dirty needle.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: I had the Zoster/Shingles shot in 2012 and currently have an active case of shingles. I have had this episode for almost a month. I had to go to the doctor twice and am on 3 medications to help with pain and skin lesions.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Erythema, induration & warmth to oval epidermal region adjacent to vaccine administration RUE, 5cm x 4cm
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: I received the Shingrex shot on 5/9/2019 (NDC: 58160-0823-11). It was very painful and I sat for awhile as I was afraid I would get faint. Over 48 hours later, I developed a 2" swollen red area around the injection. By the next day, the area had expanded and I went to Urgent Care, where the doctor said it could be an infection or an allergic reaction and put me on both antihistamines and Keflex. By the next day the area had expanded to a 6" diameter and continued sore and swollen. I also continued shaking chills for several days, but no fever. It eventually mostly resolved although now, 2 weeks later, I can still feel a lump at the injection site. Because of the timing of of the local reaction, I believe it was an infection and not an allergic reaction and wonder whether the vaccine itself or the administration was contaminated.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Tremor
Clinical narrative: I received the Shingrex shot on 5/9/2019 (NDC: 58160-0823-11). It was very painful and I sat for awhile as I was afraid I would get faint. Over 48 hours later, I developed a 2" swollen red area around the injection. By the next day, the area had expanded and I went to Urgent Care, where the doctor said it could be an infection or an allergic reaction and put me on both antihistamines and Keflex. By the next day the area had expanded to a 6" diameter and continued sore and swollen. I also continued shaking chills for several days, but no fever. It eventually mostly resolved although now, 2 weeks later, I can still feel a lump at the injection site. Because of the timing of of the local reaction, I believe it was an infection and not an allergic reaction and wonder whether the vaccine itself or the administration was contaminated.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Just reporting side effects of Shingrix 50mcg immunization shot - extreme exhaustion for two days, moderate headaches, moderate nausea, 101 degree fever for two days. All symptoms gone by day 4.
Age: 53.0
Sex: F
Vaccine: PER
Symptoms: Anal incontinence, Chest pain, Chills, Condition aggravated, Cough
Clinical narrative: I went to pharmacy and I had got the whooping cough shot because my niece had a baby and I was trying to protect him from getting it because his grandma got the shot and the mother and I'm older than the grandmother which is my sister I have been having this constant coughing and I have not been able to get rid of the doctor has tried me on different medication I am still going through this today this happened eight months ago it affects my back which I have two herniated disc arthritis and a pinched nerve which messes with my legs and my feet because of the constant coughing it is pushing down on the nerves and affecting my bodies why I can't get it to a point where I can hardly walk I coughed so hard that it makes me pee on myself and it makes me also have ball movements without any notice now I'm wearing underwear for bladder control and keeping toilet paper in between my cheeks to keep it from messing up my underwear this is a inconvenience for me now that's trying to send me to a bladder surgeon and send me to a colon surgeon because it's making the muscles in my area that hold in the feces is weak and it also trying to push me into getting back surgery because all the constant pain I'm in and the pinching down on my nerves in my back and making my herniated disc worse because it's not stabilize it moves like a grinding because racing against each other and the other ones because of the constant coughing my doctor have had tried me on an inhaler that didn't do nothing but make it worse Seaside these Pearl looking pills for coughing that doesn't work and nasal spray also and that doesn't help I get the sweats I get chills and the coughing is making my chest hurt
Age: 53.0
Sex: F
Vaccine: PER
Symptoms: Gait disturbance, Hyperhidrosis, Intervertebral disc protrusion, Laboratory test, Nerve compression
Clinical narrative: I went to pharmacy and I had got the whooping cough shot because my niece had a baby and I was trying to protect him from getting it because his grandma got the shot and the mother and I'm older than the grandmother which is my sister I have been having this constant coughing and I have not been able to get rid of the doctor has tried me on different medication I am still going through this today this happened eight months ago it affects my back which I have two herniated disc arthritis and a pinched nerve which messes with my legs and my feet because of the constant coughing it is pushing down on the nerves and affecting my bodies why I can't get it to a point where I can hardly walk I coughed so hard that it makes me pee on myself and it makes me also have ball movements without any notice now I'm wearing underwear for bladder control and keeping toilet paper in between my cheeks to keep it from messing up my underwear this is a inconvenience for me now that's trying to send me to a bladder surgeon and send me to a colon surgeon because it's making the muscles in my area that hold in the feces is weak and it also trying to push me into getting back surgery because all the constant pain I'm in and the pinching down on my nerves in my back and making my herniated disc worse because it's not stabilize it moves like a grinding because racing against each other and the other ones because of the constant coughing my doctor have had tried me on an inhaler that didn't do nothing but make it worse Seaside these Pearl looking pills for coughing that doesn't work and nasal spray also and that doesn't help I get the sweats I get chills and the coughing is making my chest hurt
Age: 53.0
Sex: F
Vaccine: PER
Symptoms: Urinary incontinence
Clinical narrative: I went to pharmacy and I had got the whooping cough shot because my niece had a baby and I was trying to protect him from getting it because his grandma got the shot and the mother and I'm older than the grandmother which is my sister I have been having this constant coughing and I have not been able to get rid of the doctor has tried me on different medication I am still going through this today this happened eight months ago it affects my back which I have two herniated disc arthritis and a pinched nerve which messes with my legs and my feet because of the constant coughing it is pushing down on the nerves and affecting my bodies why I can't get it to a point where I can hardly walk I coughed so hard that it makes me pee on myself and it makes me also have ball movements without any notice now I'm wearing underwear for bladder control and keeping toilet paper in between my cheeks to keep it from messing up my underwear this is a inconvenience for me now that's trying to send me to a bladder surgeon and send me to a colon surgeon because it's making the muscles in my area that hold in the feces is weak and it also trying to push me into getting back surgery because all the constant pain I'm in and the pinching down on my nerves in my back and making my herniated disc worse because it's not stabilize it moves like a grinding because racing against each other and the other ones because of the constant coughing my doctor have had tried me on an inhaler that didn't do nothing but make it worse Seaside these Pearl looking pills for coughing that doesn't work and nasal spray also and that doesn't help I get the sweats I get chills and the coughing is making my chest hurt
Sex: U
Vaccine: VARZOS
Symptoms: Acute respiratory failure, Asthenia, Confusional state, Death, Headache
Clinical narrative: This initial spontaneous report was received regarding a case in litigation from a lawyer and the patient's daughter, referring to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. Approximately in March 2017, the patient was vaccinated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (strength, dosage schedule, route, lot number and expiration date were not provided). On an unspecified date in 2017 (reported as "shortly after receiving the vaccine"), the patient suffered painful vesicular rash along the C2 distribution, headache, confusions, nausea, vomiting, fevers, generalized weakness, pneumonia and acute respiratory failure. The patient was diagnosed with herpes zoster, pneumonia and acute respiratory failure. As a direct and proximate result of ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 18-MAY-2017. The cause of death was not reported and it was unknown if an autopsy was performed. As a direct and proximate result of ZOSTAVAX vaccine, the patient suffered serious, progressive and dangerous side effects, including death, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also suffered incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster, pneumonia and acute respiratory failure was unknown. The reporter considered herpes zoster, pneumonia, acute respiratory failure and death to be related to ZOSTAVAX. Upon internal review, the pneumonia and acute respiratory failure were considered as medically significant events. Herpes zoster, pneumonia and acute respiratory failure were considered to be disabling. Additional information has been requested. Reported Cause(s) of Death: death.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Nausea, Pneumonia, Pyrexia, Rash
Clinical narrative: This initial spontaneous report was received regarding a case in litigation from a lawyer and the patient's daughter, referring to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. Approximately in March 2017, the patient was vaccinated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (strength, dosage schedule, route, lot number and expiration date were not provided). On an unspecified date in 2017 (reported as "shortly after receiving the vaccine"), the patient suffered painful vesicular rash along the C2 distribution, headache, confusions, nausea, vomiting, fevers, generalized weakness, pneumonia and acute respiratory failure. The patient was diagnosed with herpes zoster, pneumonia and acute respiratory failure. As a direct and proximate result of ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 18-MAY-2017. The cause of death was not reported and it was unknown if an autopsy was performed. As a direct and proximate result of ZOSTAVAX vaccine, the patient suffered serious, progressive and dangerous side effects, including death, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also suffered incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster, pneumonia and acute respiratory failure was unknown. The reporter considered herpes zoster, pneumonia, acute respiratory failure and death to be related to ZOSTAVAX. Upon internal review, the pneumonia and acute respiratory failure were considered as medically significant events. Herpes zoster, pneumonia and acute respiratory failure were considered to be disabling. Additional information has been requested. Reported Cause(s) of Death: death.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular, Vomiting
Clinical narrative: This initial spontaneous report was received regarding a case in litigation from a lawyer and the patient's daughter, referring to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. Approximately in March 2017, the patient was vaccinated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (strength, dosage schedule, route, lot number and expiration date were not provided). On an unspecified date in 2017 (reported as "shortly after receiving the vaccine"), the patient suffered painful vesicular rash along the C2 distribution, headache, confusions, nausea, vomiting, fevers, generalized weakness, pneumonia and acute respiratory failure. The patient was diagnosed with herpes zoster, pneumonia and acute respiratory failure. As a direct and proximate result of ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 18-MAY-2017. The cause of death was not reported and it was unknown if an autopsy was performed. As a direct and proximate result of ZOSTAVAX vaccine, the patient suffered serious, progressive and dangerous side effects, including death, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also suffered incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster, pneumonia and acute respiratory failure was unknown. The reporter considered herpes zoster, pneumonia, acute respiratory failure and death to be related to ZOSTAVAX. Upon internal review, the pneumonia and acute respiratory failure were considered as medically significant events. Herpes zoster, pneumonia and acute respiratory failure were considered to be disabling. Additional information has been requested. Reported Cause(s) of Death: death.
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Chest pain, Echocardiogram normal, Ejection fraction normal, Electrocardiogram abnormal, Malaise
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA concerning an 18-year-old male patient. The patient did not have any concurrent condition, medical history or concomitant therapies. Information about the patient's prior vaccination was not provided. On 25-SEP-2017, the patient was vaccinated with GARDASIL 9 intramuscularly, in the left arm, (lot # N019923 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 28-APR-2019), (exact dose was not provided), FLUZONE intramuscularly, in the left arm, lot# UI815AB, (expiration date and exact dose were not provided), BOOSTRIX intramuscularly, in the left arm, lot# G932P, (expiration date and exact dose were not provided) and MENVEO intramuscularly, in the right arm, lot# Ml7002, (expiration date and exact dose were not provided), all for prophylaxis. On 25-SEP-2017, the patient felt ill in the afternoon. The patient had fever on 26-SEP-2017 and 27-SEP-2017. On 28-SEP-2017, the patient felt OK. On 29-SEP-2017, the patient experienced chest pain and admitted to hospital on 30-SEP-2017 with pericarditis and myocarditis. On an unknown dates, the patient had following tests: echocardiogram (Echo) normal, electrocardiogram (EKG) abnormal, troponin elevated and ejection fraction normal. The outcome of events was reported as not recovered. The causality between the events and suspect vaccines was not provided. Follow up information was received from physician via FDA regarding a male patient on 25-FEB-2019. The patient current conditions included mild sesame allergy and mold allergy. Follow up information has been received on 22-MAY-2019. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Myocarditis, Pericarditis, Pyrexia, Troponin increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA concerning an 18-year-old male patient. The patient did not have any concurrent condition, medical history or concomitant therapies. Information about the patient's prior vaccination was not provided. On 25-SEP-2017, the patient was vaccinated with GARDASIL 9 intramuscularly, in the left arm, (lot # N019923 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 28-APR-2019), (exact dose was not provided), FLUZONE intramuscularly, in the left arm, lot# UI815AB, (expiration date and exact dose were not provided), BOOSTRIX intramuscularly, in the left arm, lot# G932P, (expiration date and exact dose were not provided) and MENVEO intramuscularly, in the right arm, lot# Ml7002, (expiration date and exact dose were not provided), all for prophylaxis. On 25-SEP-2017, the patient felt ill in the afternoon. The patient had fever on 26-SEP-2017 and 27-SEP-2017. On 28-SEP-2017, the patient felt OK. On 29-SEP-2017, the patient experienced chest pain and admitted to hospital on 30-SEP-2017 with pericarditis and myocarditis. On an unknown dates, the patient had following tests: echocardiogram (Echo) normal, electrocardiogram (EKG) abnormal, troponin elevated and ejection fraction normal. The outcome of events was reported as not recovered. The causality between the events and suspect vaccines was not provided. Follow up information was received from physician via FDA regarding a male patient on 25-FEB-2019. The patient current conditions included mild sesame allergy and mold allergy. Follow up information has been received on 22-MAY-2019. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: F
Vaccine: FLUR4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging brain abnormal, Paralysis, Paraplegia
Clinical narrative: Initial information received on 22-May-2019 regarding an unsolicited valid serious case downloaded from the VAERS database received from a consumer/non-HCP with VAERS ID-784597. This case involves a 66 years old female patient who experienced cardiac Areflexia, Bilevel positive airway pressure, Carbon dioxide increased, Dyspnoea, Functional gastrointestinal disorder, Gait disturbance,Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Loss of control of legs, Muscular weakness, Nuclear magnetic resonance imaging, brain abnormal, Paralysis, muscle weakness worsened, lost ability to walk, paralysis waist down, ended up on bipap (Bilevel positive airway pressure) while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 17-Sep-2018, the patient received a dose of suspect FLUBLOK QIV lot number QFAA1818 via unknown route in unknown administration site. On 30-Sep-2018, the patient developed a Areflexia, Bilevel positive airway pressure, Carbon dioxide increased, Dyspnoea, Functional gastrointestinal disorder, Gait disturbance, Gait inability, Guillain-Barre syndrome, Hypoesthesia, Loss of control of legs, Muscular weakness, Nuclear magnetic resonance imaging, brain abnormal, Paralysis, muscle weakness worsened, lost ability to walk, paralysis waist down, ended up on bipap (Bilevel positive airway pressure) 13 days following the administration of FLUBLOK QIV. All the events were assessed as medically significant. Final diagnosis was Areflexia, Bilevel positive airway pressure, Carbon dioxide increased, Dyspnoea, Functional gastrointestinal disorder, Gait disturbance,Gait inability, Guillain-Barre syndrome, Hypoaesthesia, Loss of control of legs, Muscular weakness, Nuclear magnetic resonance imaging, brain abnormal, Paralysis, muscle weakness worsened, lost ability to walk, paralysis waist down, ended up on bipap (Bilevel positive airway pressure). It was not reported if the patient received a corrective treatment. Outcome of all the events were not reported. List of documents held by send one. Sender's Comments: This case involves a 66 years old female patient presented with Areflexia, Bilevel positive airway pre ssure, Carbon dioxide increased, Dyspnoea, Functional gastrointestinal disorder, Gait disturbance, Gait inability, Hypoaesthesia, Loss of control of legs, Muscular weakness, Nuclear magnetic resonance imaging, brain abnormal, Paralysis and diagnosed with Guillain-Barre syndrome after vaccination with FLUBLOK QIV. Time to onset is compatible. The exact cause of Guillain-Barre syndrome is unknown. But it is often preceded by an infectious illness, recent surgery or immunization. Additional information viz. medical history, any similar episodes to previous immunization, laboratory investigations results ruling out other infectious etiology is needed to complete the assessment. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Concussion, Dizziness, Head injury, Headache
Clinical narrative: Patient experienced syncope after receiving HPV vaccine, fainted and hit her head on the floor.  Pt was monitored and discharged home by physician.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Patient experienced syncope after receiving HPV vaccine, fainted and hit her head on the floor.  Pt was monitored and discharged home by physician.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Head injury, Syncope
Clinical narrative: Patient experienced syncope after receiving HPV vaccine, fainted and hit her head on the floor.  Pt was monitored and discharged home by physician.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Tenderness
Clinical narrative: Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 7PS9E, expiry date 10th September 2021) for prophylaxis.   On 19th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st May 2019, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient reported rash which extended down from the injection site to the elbow.  The patient received the product on Sunday then developed a rash the evening of 21st May 2019. There is a discrepancy with respect to the outcome of the events rash. In database the outcome is reported as not recovered, however in provided source document it is recovering/resolving. The outcome of this events retains as per the database structural field.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 7PS9E, expiry date 10th September 2021) for prophylaxis.   On 19th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st May 2019, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient reported rash which extended down from the injection site to the elbow.  The patient received the product on Sunday then developed a rash the evening of 21st May 2019. There is a discrepancy with respect to the outcome of the events rash. In database the outcome is reported as not recovered, however in provided source document it is recovering/resolving. The outcome of this events retains as per the database structural field.
Sex: U
Vaccine: MMR, MMR
Symptoms: Incorrect route of product administration
Clinical narrative: No adverse effect reported; A patient was inadvertently administered a dose of M-M-R II via intramuscular route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.       On 23-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) intramuscularly in the left deltoid (Vaccine administered at inappropriate site), lot # R036581, expiration date 17-DEC-2020, (strength, dosage schedule, frequency not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR, MMR
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: No adverse effect reported; A patient was inadvertently administered a dose of M-M-R II via intramuscular route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.       On 23-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) intramuscularly in the left deltoid (Vaccine administered at inappropriate site), lot # R036581, expiration date 17-DEC-2020, (strength, dosage schedule, frequency not provided) for prophylaxis. No adverse effects were reported.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt called to say he had a rash on his chest following Shingrix.  He did not specify exact time/date when it started.  Reported to pharmacy about 5 AM 5-29-19.  Denies SOB, difficulty breathing
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Rash on chest next day on 5/22/2019 at 4pm. Cleared with benadryl. Swollen lymph nodes in groin on right side of body 5/28/2019. Same side as injection, being monitored.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or around 01-JUL-2017, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. On 15-AUG-2017, she presented to her primary care doctor with "rash" and "rash back thoracic region" for which he prescribed VALTREX (one gram) and BACTROBAN cream. Diagnosis was Zoster. On 31-AUG-2017, she presented rash on her back "left thoracic region", with diagnoses supporting zoster and treatment including BACTROBAN cream and VALTREX. On 12-OCT-2017, her disease had progressed to "face rash - behind and inside left ear". On 20-DEC-2018, she was diagnosed and treated for "post-herpetic neuralgia". As a direct and proximate result of ZOSTAVAX, patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. As a result of ZOSTAVAX, she sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Herpes zoster, herpes zoster oticus and postherpetic neuralgia were considered to be disabling. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Received an improperly stored dose; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and historical drugs, drug reactions and allergies was not provided. The patient's concomitant therapies included sterile diluent.   On 09-MAY-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # N034551, expiration date 05-DEC-2019 (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature range of -14°C to -10°C (-14.3°C) during 2 hours and 7 minutes. There was previous temperature from -14°C to -10°C (-12.8°C) for 51 minutes and from -9°C to 8°C (-8.2°C) for 37 minutes. It was reported that digital data logger was involved. No adverse effects were reported.  This is one of 4 reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA012683: US-009507513-1905USA012682: US-009507513-1905USA012684:
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Injection site hypoaesthesia, Vertigo
Clinical narrative: numbness at the site of M-M-R II injection; vertigo; Information has been received from a pharmacist referring to a 42 years old female patient who was not pregnant. The patient's concomitant medications and medical history were not reported. The patient had no drug reactions or allergies.  On 22-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot number: R024905; expiration date: 30-AUG-2020; strength was not reported), subcutaneously for prophylaxis. On 23-MAY-2019, the patient developed numbness at the site of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) injection. She also developed vertigo. There was no treatment given for events. Lab diagnostics or studies was not performed. The patient called the pharmacist to seek medical attention. At the time of reporting, the patient had not recovered. The causality between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was unknown.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; the patient was administered a dose of improperly stored ROTATEQ; This spontaneous has been received from a medical assistant, concerning an approximately 9 week patient of unknown gender and ethnicity.    The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 16-MAR-2019, the patient received a dose of improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R002700 and expiration date 24-AUG-2019), taken orally as prophylaxis.  In addition, the vaccine was exposed to temperature: 1.2C for timeframe 30 minutes with previous excursion: -2.13C for 3 hours. The excursion call was made by a data logger. No adverse effects reported.  This is a one of the three patients.; Sender's Comments:  US-009507513-1905USA012681: US-009507513-1905USA012679:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product reconstitution quality issue
Clinical narrative: no adverse effects; a patient was administered a dose of PROQUAD that did not dissolve completely following reconstitution; the color of the reconstituted product was CLEAR.; office manager reported she thought this ocurred because the medical assisstant did not agitate the vial enough following reconstitution; This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 23-MAY-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, (lot # R008203 with an expiration date in 16-SEP-2019), subcutaneously, for prophylaxis (dose, strength and frequency were not provided), that was reconstituted with sterile diluent injection (lot # R008203 with an expiration date in 29-AUG-2020) (strength, dose, frequency, route and indication were not provided).     On the same date, it was noted that the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) did not dissolve completely following reconstitution (product reconstitution quality issue). Additionally, it was also stated that the reporter thought that this occurred because the medical assistant did not agitate the vial enough following reconstitution, and it was also mentioned that the color of the reconstituted product was clear (product colour issue). No adverse effects were reported.    At the time of reporting, the outcome of product reconstitution quality issue and product colour issue was unknown.     The causality assessment between the reported suspect therapies and the reported events was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received third dose of GARDASIL 9 series at a shorter interval than recommended (2 months after second dose).; no adverse effects reported; This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.       On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided). On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided) and subsequently, on an unknown date (reported as "2 months after second dose") , the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided). No adverse effects reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored administered doses of PNEUMOVAX 23; No reported adverse affected; Information has been received from a health care worker referring to a patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies.   On 20-MAY-2019, the patient was administered an improperly stored dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, with lot number R018136 and expiration date on 10-JUL-2020 (strength, dose, dose number and anatomical injection site were not reported) for prophylaxis.   It was reported that on an unknown date, the vaccine was exposed to a temperature excursion above 47 degrees Fahrenheit (F) (49 degrees F) for 171 (units not reported). There was a previous temperature excursion reported. The call was not placed because of a Digital Data logger report. No reported adverse affected.; Sender's Comments:  US-009507513-1905USA012688:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; patient was administered improperly stored varivax; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on patient's medical history, concurrent condition and drug allergies/reactions were not reported. On 22-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)( product storage error) subcutaneously (dose, dose number were not reported) lot # R017642, expiration date:20-JUN-2020 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine was stored at a temperature of minus 12 degree Celsius(minus 14 degree Celsius to minus 10 degree Celsius) for 51 minutes. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Received an improperly stored dose; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and historical drugs, drug reactions and allergies was not provided. The patient's concomitant therapies included sterile diluent.   On 19-MAR-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(rha) lot # R004441, expiration date 12-AUG-2019 (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature range of -14°C to -10°C (-14.3°C) for 2 hours and 7 minutes. There was previous temperature from -14°C to -10°C (-12.8°C) for 51 minutes and from -9°C to 8°C (-8.2°C) for 37 minutes. It was reported that digital data logger was involved. No adverse effects were reported.  This is one of 4 reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA012684: US-009507513-1905USA009915: US-009507513-1905USA012683:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Received an improperly stored dose; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and historical drugs, drug reactions and allergies was not provided. The patient's concomitant therapies included sterile diluent.   On 19-APR-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(rha) lot # R004441, expiration date 12-AUG-2019 (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature range of -14°C to -10°C (-14.3°C) for 2 hours and 7 minutes. There was previous temperature excursion from -14°C to -10°C (-12.8°C) for 51 minutes and from -9°C to 8°C (-8.2°C) for 37 minutes. It was reported that digital data logger was involved. No adverse effects were reported.  This is one of 4 reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA012682: US-009507513-1905USA009915: US-009507513-1905USA012684:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored administered doses of  GARDASIL 9; No reported adverse affected; Information has been received from a health care worker referring to a patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies.   On 20-MAY-2019, the patient was administered improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) with lot number N020353 and expiration date on 28-APR-2020 (strength, dose, dose number, anatomical injection site and route of administration were not reported) for prophylaxis.   It was reported that on an unknown date, the vaccine was exposed to a temperature excursion above 47 degrees Fahrenheit (F) (49 degrees F) for 171 (units not reported). There was a previous temperature excursion reported. The call was not placed because of a Digital Data logger report. No reported adverse affected.; Sender's Comments:  US-009507513-1905USA012025:
Sex: M
Vaccine: VARZOS
Symptoms: Gingival pain, Oral herpes, Oral pain
Clinical narrative: cold sores; sensitive gums; sore spots; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix. On 14th April 2019, 2 days after receiving Shingrix, the patient experienced cold sores, sensitivity of gums and sore mouth. On an unknown date, the outcome of the cold sores, sensitivity of gums and sore mouth were unknown.   It was unknown if the reporter considered the cold sores, sensitivity of gums and sore mouth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 66 to 67 years. The patient received Shingrix vaccination 3 days ago.  It was the first injection. The patient had no arm pain or other side effects other than on day 2 the patient started getting Cold Sores and very sensitive gums with some minor sore spots.  The patient did not know if the event was just coincidental or related to the injection  but it has been several years since the patient had sores of this type and magnitude. The patient did not expect any other side effects at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: Tiredness; muscle pain; pain at the shot area; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness, muscle pain and injection site pain. On an unknown date, the outcome of the tiredness, muscle pain and injection site pain were unknown.   It was unknown if the reporter considered the tiredness, muscle pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced the tiredness, muscle pain and pain at the shot area. The reporter asked if he/she could expect the side effects to go away within 24 to 48 hours or so.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Gastric disorder, Pyrexia
Clinical narrative: chills; fever; stomach issues; This case was reported by a consumer via call center representative and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th April 2019, the patient received the 1st dose of Shingrix. On 3rd May 2019, 4 days after receiving Shingrix, the patient experienced chills, fever and gastric disorder. On an unknown date, the outcome of the chills, fever and gastric disorder were unknown.   It was unknown if the reporter considered the chills, fever and gastric disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced chills, fever and stomach issues and asked if it was possible to have these reactions after 4 days of vaccination.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccination failure; shingles; This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 9th May 2018, the patient received the 1st dose of Shingrix. On 17th August 2018, the patient received the 2nd dose of Shingrix. On 1st May 2019, 357 days after receiving Shingrix and 257 days after receiving Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the could be of 73 or 74 years. The patient had shingles after being vaccinated with Shingrix two doses.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Upper respiratory tract congestion
Clinical narrative: cold; stuffiness; This case was reported by a consumer via call center representative and described the occurrence of cold in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced cold and upper respiratory tract congestion. On an unknown date, the outcome of the cold and upper respiratory tract congestion were recovered/resolved.   It was unknown if the reporter considered the cold and upper respiratory tract congestion to be related to Shingrix.  Additional details were provided as follows: This case was reported by a patient's husband. The patient experienced cold and stuffiness in her upper respiratory tract but it did not last over 7 days. The reporter consented to follow up. For tolerance to the 2nd dose of Shingrix refer case US2019080546, reported by same reporter.