chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: The patient reports developing a painful itchy rash on right shoulder around 6/8/2020. Rash progressed up right side of her neck to her ear. The patient was evaluated by me with a televisit on 6/18/2020. Photos were taken of the rash and it was diagnosed as herpes zoster. The patient started treatment with valtrex.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Chest discomfort, Oropharyngeal pain
Clinical narrative: She developed sore throat and tightness in chest 10 minutes after vaccines were given. Patient was given Zyrtec, then Solumedrol and 2 puff of Albuterol.    She did feel better.  Mom left office to pick up epipen and Benadryl from pharmacy while patient stayed with us.  AuviQ was on hand if needed.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: erthema
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Injection site swelling, Pain in extremity, Weight bearing difficulty
Clinical narrative: Leg slightly swollen and pt does not want to put any pressure on her left leg at all and states her feet hurt
Age: 0.17
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient was accidently given Hep A vaccine
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Arthropod bite, Erythema, Induration, Injection site rash, Injection site swelling
Clinical narrative: CLARIFICATION FOR KINRIX (There was not room to put this info: DTAP DOSE #5, IPV DOSE #4  Vaccines administered on 6/2/20. Patient's mother called on 6/4/20 and left a message for the nurse to call her back. The nurse called her back but was unable to reach the mother. On 6/9/20, patient's mother sent pictures via digital media. The message (with pictures) was forwarded to our NP for recommendation. NP recommended an in person visit for the following day. NP responded to mother's digital media message with this recommendation. (Mother's initial description of symptoms/reaction was "red, hard, itchy, swollen & warm to the touch".  On 6/4/20 patient's mother stated the patient had a rash on his arm. Mother had him seen at her PCP. She was told it was a reaction to the vaccines. On 6/8/20 the rash spread to his legs, "looked like hives" per mother. "Not itchy, he's not bothered by the rash", per mother. On 6/9/20 patient's mother called to inform our office that the patient's symptoms seemed to worsen on 6/8/20. The nurse instructed the patient's mother to bring the patient in on 6/10/20. On 6/10/20 the patient was seen in our office. Dx for visit: (1) skin eruption (2) immunization reaction (3) insect bite. An RX for Bactroban was written for insect bites. Swelling of injection sites noted to be "resolved" . Mother informed to continue to monitor the patient's symptoms and call us with any other questions/concerns.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash, Skin warm, Swelling, Urticaria
Clinical narrative: CLARIFICATION FOR KINRIX (There was not room to put this info: DTAP DOSE #5, IPV DOSE #4  Vaccines administered on 6/2/20. Patient's mother called on 6/4/20 and left a message for the nurse to call her back. The nurse called her back but was unable to reach the mother. On 6/9/20, patient's mother sent pictures via digital media. The message (with pictures) was forwarded to our NP for recommendation. NP recommended an in person visit for the following day. NP responded to mother's digital media message with this recommendation. (Mother's initial description of symptoms/reaction was "red, hard, itchy, swollen & warm to the touch".  On 6/4/20 patient's mother stated the patient had a rash on his arm. Mother had him seen at her PCP. She was told it was a reaction to the vaccines. On 6/8/20 the rash spread to his legs, "looked like hives" per mother. "Not itchy, he's not bothered by the rash", per mother. On 6/9/20 patient's mother called to inform our office that the patient's symptoms seemed to worsen on 6/8/20. The nurse instructed the patient's mother to bring the patient in on 6/10/20. On 6/10/20 the patient was seen in our office. Dx for visit: (1) skin eruption (2) immunization reaction (3) insect bite. An RX for Bactroban was written for insect bites. Swelling of injection sites noted to be "resolved" . Mother informed to continue to monitor the patient's symptoms and call us with any other questions/concerns.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination complication
Clinical narrative: CLARIFICATION FOR KINRIX (There was not room to put this info: DTAP DOSE #5, IPV DOSE #4  Vaccines administered on 6/2/20. Patient's mother called on 6/4/20 and left a message for the nurse to call her back. The nurse called her back but was unable to reach the mother. On 6/9/20, patient's mother sent pictures via digital media. The message (with pictures) was forwarded to our NP for recommendation. NP recommended an in person visit for the following day. NP responded to mother's digital media message with this recommendation. (Mother's initial description of symptoms/reaction was "red, hard, itchy, swollen & warm to the touch".  On 6/4/20 patient's mother stated the patient had a rash on his arm. Mother had him seen at her PCP. She was told it was a reaction to the vaccines. On 6/8/20 the rash spread to his legs, "looked like hives" per mother. "Not itchy, he's not bothered by the rash", per mother. On 6/9/20 patient's mother called to inform our office that the patient's symptoms seemed to worsen on 6/8/20. The nurse instructed the patient's mother to bring the patient in on 6/10/20. On 6/10/20 the patient was seen in our office. Dx for visit: (1) skin eruption (2) immunization reaction (3) insect bite. An RX for Bactroban was written for insect bites. Swelling of injection sites noted to be "resolved" . Mother informed to continue to monitor the patient's symptoms and call us with any other questions/concerns.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: extreme pain - given higher dose of ibuprofen and topical steroid
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Brain injury, Cognitive disorder, Dysstasia, Ear infection, Gait inability
Clinical narrative: After my son received these specific vaccines, which I had expressed concern before vaccinating because of previous fevers/reactions, and I was told they were all "just boosters".  He immediately felt unwell.  By the time we got home, he had a fever.  I did call in and was advised to give Tylenol.  Shortly after my son complained that he couldn't stand or get up to go to the restroom.  I attempted to help him and he collapsed to the ground.  For the next couple of days, he could not stand or walk and screamed in pain.  I called the office several times regarding my concern and was advised on the last day if he did not improve to take him to the ER.  He got up shortly after that and started walking assisted.  During this time he had a high fever that I was not able to break and was losing cognitive and speech function.  Over the course of months following this, he cognitively regressed as well as his speech.  He has been a mystery of diagnosis.  He is not as severe as Autism and is on the spectrum with SPD.  He has brain damage but what exactly is unknown.  He did have chronic ear and strep infections following this set of shots as well.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Malaise, Pain, Pyrexia, Screaming
Clinical narrative: After my son received these specific vaccines, which I had expressed concern before vaccinating because of previous fevers/reactions, and I was told they were all "just boosters".  He immediately felt unwell.  By the time we got home, he had a fever.  I did call in and was advised to give Tylenol.  Shortly after my son complained that he couldn't stand or get up to go to the restroom.  I attempted to help him and he collapsed to the ground.  For the next couple of days, he could not stand or walk and screamed in pain.  I called the office several times regarding my concern and was advised on the last day if he did not improve to take him to the ER.  He got up shortly after that and started walking assisted.  During this time he had a high fever that I was not able to break and was losing cognitive and speech function.  Over the course of months following this, he cognitively regressed as well as his speech.  He has been a mystery of diagnosis.  He is not as severe as Autism and is on the spectrum with SPD.  He has brain damage but what exactly is unknown.  He did have chronic ear and strep infections following this set of shots as well.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Sensory processing disorder, Speech disorder, Streptococcal infection, Syncope, Walking aid user
Clinical narrative: After my son received these specific vaccines, which I had expressed concern before vaccinating because of previous fevers/reactions, and I was told they were all "just boosters".  He immediately felt unwell.  By the time we got home, he had a fever.  I did call in and was advised to give Tylenol.  Shortly after my son complained that he couldn't stand or get up to go to the restroom.  I attempted to help him and he collapsed to the ground.  For the next couple of days, he could not stand or walk and screamed in pain.  I called the office several times regarding my concern and was advised on the last day if he did not improve to take him to the ER.  He got up shortly after that and started walking assisted.  During this time he had a high fever that I was not able to break and was losing cognitive and speech function.  Over the course of months following this, he cognitively regressed as well as his speech.  He has been a mystery of diagnosis.  He is not as severe as Autism and is on the spectrum with SPD.  He has brain damage but what exactly is unknown.  He did have chronic ear and strep infections following this set of shots as well.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Fever to 100.8 22 hours later with headache, abdominal pain, body ache and vomiting
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation, Needle issue, Underdose
Clinical narrative: During injecting, vaccine leaked out of needle from opposite end. Due to this, the exact dose the patient received could not be determined. Arm was cleaned with alcohol pad and patient reported no skin irritation following. ACIP and MD (Dr. per employee 2/26/20) recommended revaccination as this was most likely a sub-therapeutic dose. Patient agreed to come in for revaccination. She did not end up coming in and she was then contacted again a few times in April to come back. She did end up coming in 5/23/20 and received the revaccination. First dose of shingrix was received on 11/14/2019.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: erythemia at site, warmth to touch, first day felt severe aches
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia, Rash, Swelling
Clinical narrative: LOW GRADE FEVER,  A RASH ABOUT 5 INCHES IN DIAMETER, REDNESS, SWELLING AND PAIN.  PATIENT HAS BEEN TAKING IBUPROFEN AND ICE TREATMENT
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: 11/14/2019 I received a flu shot at Pharmacy in my right arm/shoulder. The pain of the needle going into my arm was much more painful than any other shot I have received. I noticed the band-aid was placed very high up on my shoulder. Immediately I had trouble moving my arm and by that evening symptoms had progressed to extreme pain and I needed assistance dressing. The pain continued to worsen the following days and I lost mobility of any upward or outward motions due to intense pain.   (continued on continuation page)
Sex: F
Vaccine: FLUC4
Symptoms: Pain, X-ray
Clinical narrative: 11/14/2019 I received a flu shot at Pharmacy in my right arm/shoulder. The pain of the needle going into my arm was much more painful than any other shot I have received. I noticed the band-aid was placed very high up on my shoulder. Immediately I had trouble moving my arm and by that evening symptoms had progressed to extreme pain and I needed assistance dressing. The pain continued to worsen the following days and I lost mobility of any upward or outward motions due to intense pain.   (continued on continuation page)
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Malaise, Muscular weakness, Nausea
Clinical narrative: Muscle weakness. High Fever (102) Chills Nauseous severe Stomach Pains Generally unwell Sore arm
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Muscle weakness. High Fever (102) Chills Nauseous severe Stomach Pains Generally unwell Sore arm
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Headache
Clinical narrative: Pt cAlled today 6/18. C/O HeAdAche Approx. 1 hour After receiving Bexsero no fever no vomiting. 1 episode of diarrheA. HAd virtuAl visit with Dr todAy.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hypoaesthesia, Myalgia, Paraesthesia, Peripheral swelling
Clinical narrative: Patient received immunization on 6/10/20 and experienced muscle pain for a few days, then on 613/20 noticed that both hands were swollen, red, and experiencing tingling with numbness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Adverse event reported by mother that there was redness and swelling in the area of the injection site. Recommended to give Tylenol and apply cool compress. Mother was instructed to call or return for worsening or persistent symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever 102.0 Myalgias HA - Severe
Sex: F
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: seizure; This case was reported by a consumer via sales rep and described the occurrence of seizure in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix several months ago from the date of reporting. After receiving Shingrix, the patient had a seizure the following day of vaccination. The patient had visited a neurologist and other causes had not been found.
Age: 1.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea and vomiting.
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient received a dose of PNEUMOVAX 23 following a temperature excursion; no adverse effects were reported; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S036495 (expiration date 13-SEP-2021), 0.5 milliliter, for prophylaxis (route of administration was not reported). No adverse effects were reported.  The vaccine was exposed to a temperature excursion above 47 Fahrenheit degrees, for a timeframe of 1 hour and 10 minutes. There were no previous excursions.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: painful blistering rash and was diagnosed with herpes zoster; This spontaneous report was received from a lawyer and refers to an elderly female patient (pt) of unspecified age. No information was provided regarding the pt's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On or about 20-OCT-2012,  the pt was vaccinated, at a local pharmacy, with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) (previously prescribed by a healthcare provider) for the long-term prevention of shingles and zoster-related conditions.  On an unknown date (reported as "subsequently"), the pt experienced a painful blistering rash and was diagnosed with herpes zoster. The pt was treated (unspecified) by a provider. At the repotting time, the outcome of herpes zoster was not reported.   The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX). Loss of consortium was filed.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Mobility decreased, Pain, Skin warm
Clinical narrative: 1. Soreness-severe, extremely difficult to lift arm for 2 days 2. Redness/hot to the touch-large area (approx. 6 in. Rough diameter) on arm, lasted 3 days 3. Fatigue-extreme, lasted 3 days
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Headache, Myalgia
Clinical narrative: Muscle and joint paint (arms, legs, knees, hips, ankles) from 12:30pm on 6/18/2020 until bedtime 9:30pm and during sleep Headache- woke with headache on 6/19/2020 Weakness / Feeling faint - upon awakening on 6/19/2020
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: Intense (7/10) muscle pain in left arm and back several hours after vaccination.  I took 800 mg ibuprofen before bed.  The next morning I had severe muscle pain (9/10) over my whole body, fever and chills. I had to use sick leave because I could not perform my work duties.  I remained in bed the entire day.  I took 800 mg ibuprofen at 3 pm on 6/18.  The pain was reduced to moderate (4/10) that evening.  On 6/19, I only had slight pain (2/10) in my left shoulder.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Patient reported redness and heat at site of injection and pain in the left arm (injection arm) that has persisted for 4 days. Reports feeling feverish however do not have a temperature value at this time. Reports that adverse reaction symptoms are resolved with tylenol. Reports that this started the day of injection and has persisted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effect; patient received GARDASIL 9 by subcutaneous injection; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. This report concerns 1 patient and 1 combination product.   On 03-JUN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, subcutaneous, lot # S004578, expiry date 29-SEP-2021, formulation was not reported, but upon internal validation established as syringe (anatomical location, dose number and frequency were not reported) for prophylaxis. Subcutaneous route of administration was considered inappropriate. No adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004578; expirationdate: 29-SEP-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not reported.   In 2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) by a pharmacist, for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not reported).   Subsequently, on an unspecified date, the pt was treated by a health care provider at an office and urgent care, for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The event was considered to be not recovered.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Postherpetic Neuralgia; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His medical history, concurrent conditions and concomitant medications were not provided. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided), as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to vaccination, the patient was treated by a physician at a medical office for postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, he had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of those injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The postherpetic neuralgia injury was considered to be ongoing.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. In or about 25-JUL-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a hospital, for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. Outcome of the event was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no patients experienced symptoms; improperly stored doses administered; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. No  information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.  On 05-JUN-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ ) orally, (lot # 1660666, expiration date 22-MAR-2021) (dose, frequency and strength were not provided) for prophylaxis. Administered dose of vaccine had temperature of 9,4 degrees Celsius) during a time frame of 35 minutes. There was no previous temperature excursion. Digital data logger was involved.   The patient did not experience any symptoms.  This is one of several reports from the same reporter.; Sender's Comments:  US- 009507513-2006USA005638: US- 009507513-2006USA005637: US- 009507513-2006USA005636: US- 009507513-2006USA005639: US- 009507513-2006USA005595:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced symptoms; improperly stored doses administered; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. No  information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.  On 08-JUN-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, (lot # 1660666, expiration date 22-MAR-2021) (dose, frequency and strength were not provided) for prophylaxis. Administered dose of vaccine had temperature of 9.4 degrees Celsius during a time frame of 35 minutes. There was no previous temperature excursion. Digital data logger was involved.   The patient did not experience any symptoms.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2006USA005638: US-009507513-2006USA005637: US-009507513-2006USA005639: US-009507513-2006USA005635: US-009507513-2006USA005595:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no patients experienced symptoms; improperly stored doses administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown gender and age. No  information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided.  On 10-JUN-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ ) orally, (lot # 1660666, expiration date 22-MAR-2021) (dose, frequency and strength were not provided) for prophylaxis. Administered dose of vaccine was exposed to temperature of  9.4 degrees Celsius during a time frame of 35 minutes. There was no previous temperature excursion. Digital data logger was involved.   The patient did not experience any symptoms.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2006USA005595: US-009507513-2006USA005637: US-009507513-2006USA005636: US-009507513-2006USA005639: US-009507513-2006USA005635:
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Deafness, Erythema multiforme, Herpes simplex, Pneumonitis
Clinical narrative: loss of both vision and hearing; herpes simplex; erythema multiforme; pneumonitis; loss of both vision and hearing; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 25-JAN-2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date in 2016 (reported as shortly after the vaccination), the patient was diagnosed with both forms of herpes simplex, erythema multiforme and pneumonitis, and suffered the loss of both vision and hearing. The patient's symptoms had resulted in physical limitations not present prior to using the vaccination. Patient also experiences mental and emotional distress due to physical limitations and seriousness of his condition. As the result of vaccine live(ZOSTAVAX), the patient suffered severe, 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. He also suffered medical expenses, the loss of accumulations and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, loss of both vision and hearing, and erythema multiforme were determined to be medically significant. All the events were considered to be disabled by the reporter.
Sex: F
Vaccine: HPV9
Symptoms: Tonic clonic movements
Clinical narrative: the patient experienced tonic clonic movements intermittently for about ten minutes; This spontaneous report was received from a nurse via company representative, referring to a female patient of unknown age. The patient did not have any pertinent concurrent conditions, medical history or previous drug reactions or allergies. It was unknown by the reporter if the patient took any concomitant medication.   On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and on 04-JUN-2020, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) both by intramuscular route as prophylaxis (concentration, vaccination scheme frequency and anatomical location were not reported; lot number and expiration date were unknown by the reporter).   On 04-JUN-2020, within 5 minutes of the administration of the second dose, the patient experienced tonic clonic movements intermittently for about 10 minutes. The patient received attention in the physician office because she was still there, however no laboratory diagnostic or studies were performed and no treatment was given to the patient.  At the time of this report, the outcome of tonic clonic movements was reported as recovered.   The causality assessment between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the aforementioned event was not reported.  Upon internal review, tonic clonic movements  was determined to be medically significant event.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dermatitis contact, Limb discomfort
Clinical narrative: discomfort on my legs arms and hands; This case was reported by a consumer and described the occurrence of leg discomfort in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included poison ivy rash (at the time of the shot had beginning of a poison ivy reaction occurring on my forearm).   On 5th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix and an unknown time after starting triamcinolone, the patient experienced leg discomfort. The patient was treated with triamcinolone and prednisone. On an unknown date, the outcome of the leg discomfort was not recovered/not resolved.   It was unknown if the reporter considered the leg discomfort to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had poison ivy reaction and levels of discomfort on my legs, arms and hands. The reporter suggested topical triamcinolone acetate cream versus an intermuscular shot or oral prednisone due to the concerns of the effect of introducing systemic steroids and its adverse effect regarding the vaccines ability to prompt my body to create antibodies relative to the herpes zoster virus. The reporter asked at what point the patient receive systemic corticosteroids to treat my worsening reaction, inflammatory response to the poison ivy so as not to interfere with the efficacy of the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Very red; swollen after 3 days; painful after 3 days; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced erythema, swelling and pain. The patient was treated with paracetamol (Tylenol), antihistamine and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the erythema, swelling and pain were unknown.   It was unknown if the reporter considered the erythema, swelling and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient asked recommendation on how to treat negative reaction to Shingrix and had very red, swollen and painful after 3 days and taken tylenol, an antihistamine and applying ice.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Malaise, Musculoskeletal pain, Myalgia
Clinical narrative: pain / whole body was in pain; felt like she was being hit by truck; muscle aches; hip pain; shoulder is still sore; headache; Sleeping through the pain; This case was reported by a consumer via call center representative and described the occurrence of generalized aching in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder (batch number 2N9L, expiry date 30th September 2021) for pain.   On 8th June 2020, the patient received the 2nd dose of Shingrix (intramuscular). In June 2020, the patient started Trelegy Ellipta (inhaled) 1 puff(s) once daily (1 puff(s) daily). In June 2020, less than a day after receiving Shingrix and Trelegy Ellipta, the patient experienced generalized aching, feeling unwell, muscle pain, pain in hip, shoulder pain, headache and sleepiness. On an unknown date, the outcome of the generalized aching, muscle pain, pain in hip, shoulder pain, headache and sleepiness were recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the generalized aching, feeling unwell, muscle pain, pain in hip, shoulder pain, headache and sleepiness to be related to Shingrix and Trelegy Ellipta.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and she also took Trelegy ellipta that morning before her injection and was in pain all night from the injection.   The patient claims that her whole body was in pain and that it felt like she was being hit by truck and experienced muscle aches and pains and hip pain.   At the date of reporting the patient was ok because she slept through the pain although her shoulder was still sore from the injection. The hip and muscle pain had resolved as well as her headache.   She also reported that she never gets a headache and started the Trelegy ellipta medication approximately 3 weeks ago.   The patient missed her Trelegy dose this morning due to sleeping through the pain from the Shingrix vaccine. The reporter did not consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Somnolence
Clinical narrative: pain / whole body was in pain; felt like she was being hit by truck; muscle aches; hip pain; shoulder is still sore; headache; Sleeping through the pain; This case was reported by a consumer via call center representative and described the occurrence of generalized aching in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder (batch number 2N9L, expiry date 30th September 2021) for pain.   On 8th June 2020, the patient received the 2nd dose of Shingrix (intramuscular). In June 2020, the patient started Trelegy Ellipta (inhaled) 1 puff(s) once daily (1 puff(s) daily). In June 2020, less than a day after receiving Shingrix and Trelegy Ellipta, the patient experienced generalized aching, feeling unwell, muscle pain, pain in hip, shoulder pain, headache and sleepiness. On an unknown date, the outcome of the generalized aching, muscle pain, pain in hip, shoulder pain, headache and sleepiness were recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the generalized aching, feeling unwell, muscle pain, pain in hip, shoulder pain, headache and sleepiness to be related to Shingrix and Trelegy Ellipta.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and she also took Trelegy ellipta that morning before her injection and was in pain all night from the injection.   The patient claims that her whole body was in pain and that it felt like she was being hit by truck and experienced muscle aches and pains and hip pain.   At the date of reporting the patient was ok because she slept through the pain although her shoulder was still sore from the injection. The hip and muscle pain had resolved as well as her headache.   She also reported that she never gets a headache and started the Trelegy ellipta medication approximately 3 weeks ago.   The patient missed her Trelegy dose this morning due to sleeping through the pain from the Shingrix vaccine. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Discomfort, Pain
Clinical narrative: discomfort; pain / achiness; put her down for two days at home; This case was reported by a consumer via call center representative and described the occurrence of discomfort in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced discomfort, pain and bedridden. On an unknown date, the outcome of the discomfort, pain and bedridden were resolved with sequelae.   It was unknown if the reporter considered the discomfort, pain and bedridden to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix about 5 months ago and she did experience achiness, pain, discomfort.  The patient's husband can not remember well her symptoms but they did show up 6 to 8 hours after the vaccination and put her down for two days at home.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: SEVERE HEADACHE; JOINT PAIN; NAUSEA; VOMITING; FEVER; This case was reported by a nurse via call center representative and described the occurrence of headache in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 9th June 2020, the patient received Bexsero. In June 2020, less than a week after receiving Bexsero, the patient experienced headache, joint pain, nausea, vomiting and fever. On an unknown date, the outcome of the headache, joint pain, nausea, vomiting and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, joint pain, nausea, vomiting and fever to be related to Bexsero.  Additional details were provided as follows: The reporter was the patient's grandmother who was also a nurse.  The patient received Bexsero and had severe headache, joint pain, nausea, vomiting and fever. The patient was experiencing all the symptoms after receiving this vaccine and not certain when the symptoms presented.   The reporter was concerned about patient symptoms which had not resolved. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness and pain in a large area on the injection site; redness and pain in a large area on the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3553N, expiry date 26th November 2021) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced redness and pain in a large area on the injection site that lasted for almost three weeks. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pain in extremity
Clinical narrative: experiencing a reaction at the site of injection; Soreness of the arm; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site reaction and pain in arm. On an unknown date, the outcome of the injection site reaction and pain in arm were unknown.   It was unknown if the reporter considered the injection site reaction and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix shot back and experiencing a reaction at the site of injection and soreness of the arm. The reporter did not consent to follow up. Not all information was available.  Unable to collect date of birth and other adverse event details because caller abruptly disconnected.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Head discomfort, Musculoskeletal chest pain, Myalgia
Clinical narrative: "almost died"; Pain/"Agony"; "Abnormal feeling in head, joints and feet"; Weakness; cracked ribs; Muscle pain; abnormal feeling in feet/abnormal feeling in joints,and feet",; This case was reported by a consumer via call center representative and described the occurrence of feeling lifeless in a female patient who received Herpes zoster (Shingrix) (batch number 23LD9, expiry date 2nd April 2022) for prophylaxis.   On 1st June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2020, less than 2 weeks after receiving Shingrix, the patient experienced feeling lifeless, pain, head discomfort, weakness, rib pain, muscle pain and abnormal sensation of limbs. In June 2020, the outcome of the feeling lifeless was recovered/resolved. On an unknown date, the outcome of the pain, head discomfort, weakness and muscle pain were recovered/resolved and the outcome of the rib pain and abnormal sensation of limbs were unknown.   It was unknown if the reporter considered the feeling lifeless, pain, head discomfort, weakness, rib pain, muscle pain and abnormal sensation of limbs to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had multiple adverse reactions to the vaccine including almost died, pain, abnormal feeling in head, joints,and feet, weakness, cracked ribs, agony and muscle pain.   The reporter declined providing HCP information.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rib fracture, Sensory disturbance
Clinical narrative: "almost died"; Pain/"Agony"; "Abnormal feeling in head, joints and feet"; Weakness; cracked ribs; Muscle pain; abnormal feeling in feet/abnormal feeling in joints,and feet",; This case was reported by a consumer via call center representative and described the occurrence of feeling lifeless in a female patient who received Herpes zoster (Shingrix) (batch number 23LD9, expiry date 2nd April 2022) for prophylaxis.   On 1st June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2020, less than 2 weeks after receiving Shingrix, the patient experienced feeling lifeless, pain, head discomfort, weakness, rib pain, muscle pain and abnormal sensation of limbs. In June 2020, the outcome of the feeling lifeless was recovered/resolved. On an unknown date, the outcome of the pain, head discomfort, weakness and muscle pain were recovered/resolved and the outcome of the rib pain and abnormal sensation of limbs were unknown.   It was unknown if the reporter considered the feeling lifeless, pain, head discomfort, weakness, rib pain, muscle pain and abnormal sensation of limbs to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had multiple adverse reactions to the vaccine including almost died, pain, abnormal feeling in head, joints,and feet, weakness, cracked ribs, agony and muscle pain.   The reporter declined providing HCP information.  The reporter did not consent to follow up.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: no antibody titers in antibody testing.; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a child female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient that was going to nursery school so they made antibody testing but no antibody titers were found for hep-B.  The patient already received 3 doses for hep-b when she was a child. The reporter consented to follow up. The gender was captured as females as customer mentioned she referring to the patient during the conversation.  No further details were provided.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fever (100.5 degrees) lasting from roughly 6pm to 11pm (or later), fatigue, muscle soreness at injection site, general muscle soreness in body