chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 16-OCT-2017, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) (dose was not provided; lot # M042854, expiration date: 18-JAN-2018), reconstituted with sterile diluent (manufacturer unknown) (lot# N000383, expiration date: 28-JUN-2019), given by intramuscular instead of subcutaneous route. The pharmacist stated, that ZOSTAVAX and sterile diluent (manufacturer unknown) did not undergo a temperature excursion. No adverse effects occurred.
Sex: M
Vaccine: PPV
Symptoms: Administration site swelling, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a consumer, and refers to a male patient of unknown age. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (route of administration, lot number and expiration date were not provided). On an unknown date, the patient experienced a lot of redness and swelling around the site of administration (left shoulder). He also mentioned that it felt like he was punched in the arm, so there was also pain at the site. At the reporting time, it was unknown if the patient had recovered from the events. Causality assessment between therapy with PNEUMOVAX 23 and the events was not provided.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician referring to a 27 year old female patient. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 12-APR-2017, the patient was vaccinated with the 1st dose of GARDASIL 9 lot # N000326 with expiration date on 14-OCT-2019 (anatomical route of vaccination was not provided) for prophylaxis. Subsequently, on 14-JUN-2017, the patient was vaccinated with the 2nd dose of GARDASIL 9 lot # N000326 with expiration date on 14-OCT-2019 (anatomical route of vaccination was not provided) for prophylaxis. Approximately in 2017, the patient became pregnant (exposure during pregnancy). Information regarding the patient's last menstrual period (LMP) and estimated date of delivery (EDD) was not known. The pregnancy was outcome unknown. The patient had not received the 3rd GARDASIL 9 to complete the series. Testing had not been conducted to confirm pregnancy, however pregnancy could not be ruled out.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 23-OCT-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 09-SEP-2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-JAN-2015, she was treated (by an unspecified healthcare professional) at a medical group facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The female patient has been prescribed Gabapentin for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 23-OCT-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 18-DEC2010, at a pharmacy, the patient was inoculated (by an unspecified healthcare professional) with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-SEP-2016, she was treated (by an unspecified healthcare professional) at a clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The female patient was prescribed Famciclovir (as reported) and KENALOG CREAM for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse regarding a 10 year old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of PROQUAD subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The PROQUAD was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA013247: US-009507513-1710USA013248: US-009507513-1710USA013249: US-009507513-1710USA013250: US-009507513-1710USA013251: US-009507513-1710USA013252: US-009507513-1710USA013253: US-009507513-1710USA001718:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse regarding a 4 year old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of PROQUAD subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The PROQUAD was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013248: US-009507513-1710USA013249: US-009507513-1710USA013250: US-009507513-1710USA013251: US-009507513-1710USA013252: US-009507513-1710USA013253: US-009507513-1710USA001718.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse regarding a 15 year old patient of unknown gender. The patient´s medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of VARIVAX subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The VARIVAX was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013249: US-009507513-1710USA013250: US-009507513-1710USA013251: US-009507513-1710USA013252: US-009507513-1710USA013253: US-009507513-1710USA001718.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse regarding a 13 year old patient of unknown gender. The patient´s medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of VARIVAX subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The VARIVAX was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013248: US-009507513-1710USA013250: US-009507513-1710USA013251: US-009507513-1710USA013252: US-009507513-1710USA013253: US-009507513-1710USA001718.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse regarding a 16 year old patient of unknown gender. The patient´s medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of VARIVAX subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The VARIVAX was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013248: US-009507513-1710USA013249: US-009507513-1710USA013251: US-009507513-1710USA013252: US-009507513-1710USA013253: US-009507513-1710USA001718.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse regarding a 8 year old patient of unknown gender. The patient´s medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of VARIVAX subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The VARIVAX was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013248: US-009507513-1710USA013249: US-009507513-1710USA013250: US-009507513-1710USA013252: US-009507513-1710USA013253: US-009507513-1710USA001718.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse regarding a 15 year old patient of unknown gender. The patient´s medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of VARIVAX subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The VARIVAX was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013248: US-009507513-1710USA013249: US-009507513-1710USA013250: US-009507513-1710USA013251: US-009507513-1710USA013253: US-009507513-1710USA001718.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse regarding a 13 year old patient of unknown gender. The patient´s medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of VARIVAX subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The VARIVAX was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013248: US-009507513-1710USA013249: US-009507513-1710USA013250: US-009507513-1710USA013251: US-009507513-1710USA013252: US-009507513-1710USA001718.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a field representative, concerning an adult female patient in her 60's. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On approximately 11-AUG-2017 (reported as "6-8 weeks ago"), the patient was vaccinated with ZOSTAVAX (lot #, expiration date, strength, dose, route of administration, an anatomical location were not provided), for prophylaxis (reported as "vaccination"); and developed diffuse redness at the injection site, an inch to an inch and a half in diameter, and there the skin was elevated. No treatment was given for the events and it was unknown if laboratory diagnostic studies were performed. No product quality complaint (PQC) was involved. The outcome of the injection site erythema and the skin disorder was unknown. The causal relationship between the injection site erythema and the skin disorder with ZOSTAVAX was not provided. This is one of two reports received from the same source. Sender's Comments: US-009507513-1710USA004038.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. On 24-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD injection, lot # M042498 with expiration date 17-APR-2018, therapy type: human recombinant albumin (RHA) (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature excursion ranged from minus 14 to minus 10 degrees Celsius for 15 minutes and to 27 degrees Celsius for 30 minutes. There was no previous excursion. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA013407: US-009507513-1710USA013408: US-009507513-1710USA007631.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. On 25-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD injection, lot # M042498 with expiration date 17-APR-2018, therapy type: human recombinant albumin (RHA) (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature excursion ranged from minus 14 to minus 10 degrees Celsius for 15 minutes and to 27 degrees Celsius for 30 minutes. There was no previous excursion. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA007631: US-009507513-1710USA013408: US-009507513-1710USA013406.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. On 27-APR-2017, the patient was vaccinated with improperly stored dose of PROQUAD injection, lot # M042498 with expiration date 17-APR-2018, therapy type: human recombinant albumin (RHA) (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature excursion ranged from minus 14 to minus 10 degrees Celsius for 15 minutes and to 27 degrees Celsius for 30 minutes. There was no previous excursion. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA013407: US-009507513-1710USA013406: US-009507513-1710USA007631:
Age: 57.0
Sex: F
Vaccine: FLUC4, FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient is complaining of shoulder pain from the shot. It was first reported to the pharmacy on 10/24/17 and we advised her to seek care with her primary care physician.
Age: 57.0
Sex: F
Vaccine: FLUC4, FLU3
Symptoms: Injection site pain, Pain in extremity, X-ray limb normal
Clinical narrative: Patient is complaining of shoulder pain from the shot. It was first reported to the pharmacy on 10/24/17 and we advised her to seek care with her primary care physician.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm
Clinical narrative: Extreme swelling of arm/redness/warm/rash.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Asthenia, Blood electrolytes normal, Cardiac monitoring normal, Computerised tomogram head normal
Clinical narrative: 1515 - Extreme weakness throughout entire body...felt like I was going to pass out...felt like my body was heavy like a brick and had a difficult time moving myself.  Went to the ED department at ~1530 and had cardiac monitoring, head CT, blood work and electrolytes drawn.  All came back within normal limits. Began to feel stronger ~ 1930 .  Released from ED ~ 2130 feeling much stronger but extremely weak.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Differential white blood cell count, Discomfort, Electrocardiogram, Fibrin D dimer, Full blood count
Clinical narrative: 1515 - Extreme weakness throughout entire body...felt like I was going to pass out...felt like my body was heavy like a brick and had a difficult time moving myself.  Went to the ED department at ~1530 and had cardiac monitoring, head CT, blood work and electrolytes drawn.  All came back within normal limits. Began to feel stronger ~ 1930 .  Released from ED ~ 2130 feeling much stronger but extremely weak.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Metabolic function test, Mobility decreased, Troponin, Visual acuity tests
Clinical narrative: 1515 - Extreme weakness throughout entire body...felt like I was going to pass out...felt like my body was heavy like a brick and had a difficult time moving myself.  Went to the ED department at ~1530 and had cardiac monitoring, head CT, blood work and electrolytes drawn.  All came back within normal limits. Began to feel stronger ~ 1930 .  Released from ED ~ 2130 feeling much stronger but extremely weak.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin increased
Clinical narrative: Patient was given a BHCG test on 25 Oct 2017. On 26 Oct 2017 patient BHCG was not screened for results. Patient given Anthrax with BHCG result of greater than 15000, positive result.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site mass, Pain, Swelling, Vaccination site induration
Clinical narrative: Patient complained redness the size of a quarter, soreness and swelling with concerns of an infections 3 days after the Vaccination when she called the Pharmacy. She was instructed to take TYLENOL and use Ice packs and if it continues to get worse by day 7 to call her medical doctor. In the mean time she was ask to come in the next day for the Pharmacist to evaluate the site of injections. The Pharmacist reported redness the size of a nickel. On day 7 Pharmacist tried to call patient to follow up with her condition related to the vaccination. Patient did not answer and a message was left to return the call. On 10-25-17 day 13 and second call was made, patient answered and stated her arm is getting better. There was no longer any redness, but she did have a sore hard lump in her muscle were the vaccination was given. Since her condition seemed to be getting better I told her it did not look like she needed to see her Doctor at this time and if she had any other concerns to call the Pharmacy.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site pain
Clinical narrative: Patient complained redness the size of a quarter, soreness and swelling with concerns of an infections 3 days after the Vaccination when she called the Pharmacy. She was instructed to take TYLENOL and use Ice packs and if it continues to get worse by day 7 to call her medical doctor. In the mean time she was ask to come in the next day for the Pharmacist to evaluate the site of injections. The Pharmacist reported redness the size of a nickel. On day 7 Pharmacist tried to call patient to follow up with her condition related to the vaccination. Patient did not answer and a message was left to return the call. On 10-25-17 day 13 and second call was made, patient answered and stated her arm is getting better. There was no longer any redness, but she did have a sore hard lump in her muscle were the vaccination was given. Since her condition seemed to be getting better I told her it did not look like she needed to see her Doctor at this time and if she had any other concerns to call the Pharmacy.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site warmth, Joint range of motion decreased
Clinical narrative: Severed redness and swelling extending to from shoulder to elbow and circumferentially. Discomfort and limited range of movement. Redness and heat radiating from arm.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Severed redness and swelling extending to from shoulder to elbow and circumferentially. Discomfort and limited range of movement. Redness and heat radiating from arm.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site warmth, Joint range of motion decreased
Clinical narrative: 10/24/17-2pm - Flu vaccine given- left deltoid, 4pm- site 2.5"x3.5" red, warm to touch; 10/25/17-4pm- redness extending down L arm to elbow, warm; 10/25/17-540pm- brought back in to clinic- redness, pain, warmth extending down left arm to elbow; MOC continues to monitor, cool compress to area, Tylenol as needed for Pain.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 10/24/17-2pm - Flu vaccine given- left deltoid, 4pm- site 2.5"x3.5" red, warm to touch; 10/25/17-4pm- redness extending down L arm to elbow, warm; 10/25/17-540pm- brought back in to clinic- redness, pain, warmth extending down left arm to elbow; MOC continues to monitor, cool compress to area, Tylenol as needed for Pain.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient called that her injected arm is in pain.
Age: 8.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 05-OCT-2017, the patient was inadvertently administered with VARIVAX lot # was L043622, expiration date was 04-NOV-2017, (dose and frequency were not reported) and M-M-R II therapy type recombinant human albumin (rHA), lot #  M039914, expiration date  26-SEP-2018, (dose and frequency were not reported) with sterile diluent (manufacturer unknown) intramuscularly for prophylaxis (incorrect route of drug administration). No adverse event was reported. Follow up information has been received from an other reporter on 17-OCT-2017. The patient was a 8 years old female. She had no illness at time of vaccination and no pre-existing physician diagnosed allergies, birth defects or medical conditions. Both of the vaccines were the second dose. The vaccines were administered at a private doctor's office/hospital. The vaccines were given intramuscularly instead of subcutaneously. The patient's mother stated the patient was fine and tolerated the vaccines well. The outcome of the event was reported as resolved. Prescription drug treatment for the experiences was not required. Temperature excursion didn't occur as a result of a reading from a digital data logger.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, who referred to a patient of unknown demographics. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 12-OCT-2017, the patient was administered a dose of ZOSTAVAX intramuscularly (lot# N022035 and expiration date: 11-NOV-2018; dose and anatomical location were not reported) as prophylaxis. It was reported that sterile diluent (manufacturer unknown) intramuscularly (dose, lot# and expiration date were not reported) was used together with the ZOSTAVAX. No adverse effects were reported. No product quality complaint was involved.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, who referred to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was provided. On 16-OCT-2017, the patient was administered an expired dose of PNEUMOVAX 23 (lot# M005287 and expiration date: 08-OCT-2017; dose and route of administration were not reported) as prophylaxis. The dose of PNEUMOVAX 23 was stored properly prior to administration. No adverse effects were reported. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 09-MAY-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient was prescribed acyclovir for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 29-MAY-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-JUL-2014, the patient was treated by internal medicine associates for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient was prescribed hydrocodone for management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received 23-OCT-2017 from a lawyer regarding a case in litigation concerning a female plaintiff of unspecified age. It was alleged that on or about 11-SEP-2012 the plaintiff was inoculated with ZOSTAVAX at a health center as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused her to contract a persistent strain of herpes zoster. On or about 09-SEP-2016 the plaintiff was treated at a health services facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster, or shingles with complications. The plaintiff had been prescribed valacyclovir, LYRICA and PERCOCET for the management of her painful symptoms. As a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dehydration, Faecaloma
Clinical narrative: Initial unsolicited report received from a physician on 12-Oct-2017. This case is linked with: 2017SA199365, 2017SA199373, 2017SA199379, 2017SA199386, 2017SA199397 (same reporter). This case involves a male patient (age not reported), who was vaccinated FLUZONE HIGH-DOSE (batch number: UI845AB, expiry date, dose, route and dose in series and site of administration not reported) on an unknown date. Patient's medical history included advanced Parkinson's (ongoing). Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had weakness, dehydration, fecal impaction. On an unknown date, patient got hospital admission. Lab test and corrective treatment was not reported. Outcome of the events were not reported. Documents held by sender: none. Sender's Comments: Patient with underlying advanced Parkinson's received FLUZONE HIGH-DOSE and experienced fecal impaction, dehydration and weakness. Time to onset is unknown. More details regarding patient's medical history, previous vaccination history, concomitant medication and investigation reports are needed for complete assessment. Based on the available information no conclusion can be drawn.
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Bronchitis, Mental status changes
Clinical narrative: Initial unsolicited report received from a physician on 12-Oct-2017. This case is linked with: 2017SA199339, 2017SA199365, 2017SA199379, 2017SA199386, 2017SA199397 (same reporter). This case involves a female patient (age not reported), who was vaccinated FLUZONE HIGH-DOSE (batch number: UI845AB, expiry date, dose, route and dose in series and site of administration not reported) on an unknown date. Patient's medical history reported as underlying new diagnosis of Lewy Body Dementia and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's mental status change, had bronchitis which triggered AFIB. On an unknown date, patient got hospital admission. Lab test and corrective treatment was not reported. Outcome of the events were not reported. Documents held by sender: none. Sender's Comments: Patient experienced Atrial fibrillation, dementia, mental status changes and bronchitis after vaccination. Exact time to onset is unknown. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Hepatic function abnormal
Clinical narrative: Initial unsolicited case received from a physician on 12 Oct 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number, expiry date, dose, dose in series route and site of administration were not reported) on an unknown date. Patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, patient developed abnormal liver function and on an unknown date, she was hospitalized. It was also a case of actual medication error due to extra dose administered as patient received adult dose of twice dosing. Relevant lab tests and corrective treatment was not reported. Outcome of the event was not reported and details about hospital discharge and details were not provided. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Sender's Comments: The patient experienced abnormal liver function post vaccination with INFLUENZA QUADRIVAL A-B VACCINE. Time to onset was not reported. It was also reported that the patient received adult dose of twice dosing. Therefore this was also a case of medication error. The event might be related to extra dose administered and all possible alternate etiologies including underlying etiologies related to preexisting conditions if any should be investigated. Based upon reported information the role of the vaccine cannot be assessed.
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Liver function test increased
Clinical narrative: Initial unsolicited case received from a pharmacist on 12 Oct 2017. This case involves 67-year-old female patient who was vaccinated with dose of FLUZONE HIGH-DOSE) (Batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. Patient medical history and concomitant medications were not reported. On an unknown date, after the vaccination, patient developed pain under her sternum, and went to the emergency room and during that her liver function tests were found to be elevated, and on an unknown date, she was admitted to the hospital. On an unknown date, she was discharged after 4 days. Other relevant lab tests and corrective treatment were not reported. On an unknown date, patient recovered from the event Liver function tests raised (reported as her tests returned to normal). The outcome of the event pain under her sternum was unknown. List of documents held by sender: none. Sender's Comments: This case concerns an elderly patient who received FLUZONE HIGH-DOSE and developed elevated Liver function tests which is unlisted and pain under her sternum which is listed with vaccine. Patient was hospitalized after events. Time to onset is unknown. Further information including patient's medical history, the risks factors including any underlying disease Circumstances and patient's medical condition at the time of vaccination, concomitant medications, previous vaccination and tolerance would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Seizure like phenomena
Clinical narrative: After vaccine patient was found on floor out front after 15 minutes or so. He said he was ok, seemed like he had a seizure..ambulance came and took care of him.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling at site of PNEUMOVAX injection.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Dyspnoea, Throat tightness
Clinical narrative: Throat began to feel like it was tightening. Began to have trouble swallowing and breathing. Was seen in Hospital Emergency Room. No treatment. Released and symptoms were resolving.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Blood test normal, Henoch-Schonlein purpura, Imaging procedure, Joint swelling
Clinical narrative: Patient began to experience joint pain, right ankle swelling, petechiae to both legs and feet 24 hrs after injection. She developed lumbar spinal swelling 2 days after injection. She was admitted to the hospital and diagnosed with HSP. There is no prescribed treatment and it will go away on its own. Drs cannot confirm if the flu shot caused this disease to occur.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Petechiae, Platelet count increased, Swelling, White blood cell count increased
Clinical narrative: Patient began to experience joint pain, right ankle swelling, petechiae to both legs and feet 24 hrs after injection. She developed lumbar spinal swelling 2 days after injection. She was admitted to the hospital and diagnosed with HSP. There is no prescribed treatment and it will go away on its own. Drs cannot confirm if the flu shot caused this disease to occur.
Age: 0.5
Sex: F
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: Vomiting 8 times within 2 hours.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm, tender to touch welt below injection site roughly 3 inches in diameter lasting about 72 hours.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Red, swollen, warm, tender to touch welt below injection site roughly 3 inches in diameter lasting about 72 hours.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose increased, Malaise, Nervousness, Somnolence
Clinical narrative: 15 MIN after giving the vaccine pt reported back to the doctor of feeling shaky, sleep and over all not feeling well.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Patient reported flu like symptoms evening after receiving the shot. Pt reported chills and a fever of over 100 degrees.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Erythema, swelling, itching within a 21cm perimeter from injection site, extending to shoulder to upper chest.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness, Pain
Clinical narrative: Soreness with movement started that day, soreness at injection site at night, arm feels weak.  Soreness continued through 10/21/17, but as of 10/24/17 is "starting to feel better."  Taking OTC motrin which has been effective.  Did not see physician for any follow up.
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Body temperature increased, C-reactive protein increased, Chills, Differential white blood cell count, Dizziness
Clinical narrative: Pt well at wellness visit 4pm 10/23/17 - about 0200 10/24/17 woke up with temp 103, headache, chills and dizziness. Vomited after Motrin. Restless through the rest of night and woke up in the morning with temp  103, headache, dizziness but no chills. Vomited after Tylenol. Spoke to Dad at 1:45 pm still with headache, dizziness and fever, no chills. Sipping fluids, no more vomiting. Appointment set with Dr. at 4pm today 10/24/17. Rapid Flu negative, mild acute distress, hepatomegaly - liver span 2 cm below costal margin. Lab test - CDCD, CMP, CRP, ESR. CRP elevated, LFT elevated. 10/25/17 - went to ED. REpeat labs and abdominal US done in ED. Observation and discharged home.
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Emotional distress, Full blood count, Headache, Hepatomegaly, Influenza virus test negative
Clinical narrative: Pt well at wellness visit 4pm 10/23/17 - about 0200 10/24/17 woke up with temp 103, headache, chills and dizziness. Vomited after Motrin. Restless through the rest of night and woke up in the morning with temp  103, headache, dizziness but no chills. Vomited after Tylenol. Spoke to Dad at 1:45 pm still with headache, dizziness and fever, no chills. Sipping fluids, no more vomiting. Appointment set with Dr. at 4pm today 10/24/17. Rapid Flu negative, mild acute distress, hepatomegaly - liver span 2 cm below costal margin. Lab test - CDCD, CMP, CRP, ESR. CRP elevated, LFT elevated. 10/25/17 - went to ED. REpeat labs and abdominal US done in ED. Observation and discharged home.
Age: 12.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Liver function test increased, Red blood cell sedimentation rate, Restlessness, Ultrasound abdomen, Vomiting
Clinical narrative: Pt well at wellness visit 4pm 10/23/17 - about 0200 10/24/17 woke up with temp 103, headache, chills and dizziness. Vomited after Motrin. Restless through the rest of night and woke up in the morning with temp  103, headache, dizziness but no chills. Vomited after Tylenol. Spoke to Dad at 1:45 pm still with headache, dizziness and fever, no chills. Sipping fluids, no more vomiting. Appointment set with Dr. at 4pm today 10/24/17. Rapid Flu negative, mild acute distress, hepatomegaly - liver span 2 cm below costal margin. Lab test - CDCD, CMP, CRP, ESR. CRP elevated, LFT elevated. 10/25/17 - went to ED. REpeat labs and abdominal US done in ED. Observation and discharged home.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Altered state of consciousness, Dizziness, Electrocardiogram, Hyperhidrosis, Nervousness
Clinical narrative: Before giving the vaccine the patient filled out a questionnaire answering "No" to all questions on form.  However she warned me to say she is afraid/dislikes shots. After giving the vaccine by about 5 minutes patient shouted "help me, I am about to pass out". I ran over to her, told my tech to call 911, laid her on the floor and lifted her legs up unto the chair. She was breathing fine but was perspiring. She told me as she lay on the floor that this has happened to her before (an episode at her Doctor's office before a procedure she was having where she fainted & even vomited). She also stated that she believes her blood sugar dropped because she has not eaten all day. Fire department & EMS arrived quickly on the scene after about 5 minutes. Only symptoms patient experienced include, nervousness, shakiness, sweating, feeling faint.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Syncope, Tremor, Vomiting
Clinical narrative: Before giving the vaccine the patient filled out a questionnaire answering "No" to all questions on form.  However she warned me to say she is afraid/dislikes shots. After giving the vaccine by about 5 minutes patient shouted "help me, I am about to pass out". I ran over to her, told my tech to call 911, laid her on the floor and lifted her legs up unto the chair. She was breathing fine but was perspiring. She told me as she lay on the floor that this has happened to her before (an episode at her Doctor's office before a procedure she was having where she fainted & even vomited). She also stated that she believes her blood sugar dropped because she has not eaten all day. Fire department & EMS arrived quickly on the scene after about 5 minutes. Only symptoms patient experienced include, nervousness, shakiness, sweating, feeling faint.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Joint range of motion decreased
Clinical narrative: Had immediate soreness at injection site, no redness/rash/swelling/warmth. Has ongoing soreness/pain extending into shoulder joint along with decreased range of motion.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain, Injection site reaction
Clinical narrative: The patient stated that her right arm has been tender and sore to the touch between the elbow and shoulder joints. She said this developed over a few days after receiving the flu shot and has not improved since then. The immunization was administered on 9-23-2017 and she reported the problem to us on 10-25-2017. The patient is currently taking several pain medications as previously listed, but is still experiencing pain and some weakness at the site.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Contusion, Nodule
Clinical narrative: Patient noticed a knot in his left arm after immunization. A few days later, the knot turned into a bruise and (as of reporting), it was healing and returning to normal color.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Pruritus, Urticaria
Clinical narrative: Recieved an influenza shot 20 min later started itching with hives. Chest felt heavy.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Sleep disorder, Swelling
Clinical narrative: This is a 73 Y/O female here S/P Pneumonia vaccines PNEUMOVAX-23 4 days ago, she is c/o pain on the injection site (right deltoid) all the way to the neck only right side, redness and swelling, the second day it was bad, unable to move right upper extremity, unable to sleep in that side, took ADVIL, the 3rd day is much better and today is much better than yesterday, initially the pain is 10/10, now pain is 5/10, patient denies systemic symptoms, denies SOB, denies tachycardia.