chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Mobility decreased, Musculoskeletal stiffness, Skin warm
Clinical narrative: This spontaneous report has been received from a 69 year old female patient reporting on herself. The patient's concurrent conditions included hypoactive thyroid and osteopenia (also reported as osterepenia). The drug reactions/allergies included sulfa and codeine. The concomitant therapies included unspecified multivitamins, levothyroxine, progesterone and denosumab (PROLIA) (also reported as prolea). On 25-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, dose number, lot number, expiration date and anatomical location were not provided), for prophylaxis. The route of administration was reported as injection. On 26-SEP-2017 (reported as "the next morning"), the patient began to experience swelling, redness, pain and she could not lift her arm above her waist (injected limb mobility decreased). The patient had been icing the injection site area for three days. It was reported that the swelling was getting a little better, but the pain was still there and it was still hot to the touch (injection site warmth). On 28-SEP-2017, the patient visited the physician for a previously scheduled appointment. The physician recommended diphenhydramine hydrochloride (BENADRYL) in addition to the icing. It was also reported that no lab diagnostics or studies were performed. At the time of reporting, the patient had not recovered from the events and the causal relationship between PNEUMOVAX23 and the events was unknown.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report has been received from a 69 year old female patient reporting on herself. The patient's concurrent conditions included hypoactive thyroid and osteopenia (also reported as osterepenia). The drug reactions/allergies included sulfa and codeine. The concomitant therapies included unspecified multivitamins, levothyroxine, progesterone and denosumab (PROLIA) (also reported as prolea). On 25-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, dose number, lot number, expiration date and anatomical location were not provided), for prophylaxis. The route of administration was reported as injection. On 26-SEP-2017 (reported as "the next morning"), the patient began to experience swelling, redness, pain and she could not lift her arm above her waist (injected limb mobility decreased). The patient had been icing the injection site area for three days. It was reported that the swelling was getting a little better, but the pain was still there and it was still hot to the touch (injection site warmth). On 28-SEP-2017, the patient visited the physician for a previously scheduled appointment. The physician recommended diphenhydramine hydrochloride (BENADRYL) in addition to the icing. It was also reported that no lab diagnostics or studies were performed. At the time of reporting, the patient had not recovered from the events and the causal relationship between PNEUMOVAX23 and the events was unknown.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chest discomfort, Computerised tomogram, Hot flush, Hypertension, Hypoaesthesia
Clinical narrative: Initial unsolicited report received from a pharmacist on 03-Oct-2017. This case involves a 40-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE QUADRIVALENT (batch number: UI829AA) in left deltoid via intramuscular route on 03-Oct-2017. The patient's medical history and concomitant medications were not reported. On 03-Oct-2017, within 10 minutes following the vaccination, the patient developed a hot flash, nausea, Left facial numbness, left arm heaviness, chest heaviness, and a burning sensation in her tongue. It was reported that two hours after vaccination patient still reports left facial numbness, Left arm heaviness and the right side of her lip is numb. The patient's blood pressure was reported to be: 142/93. A CT scan was performed. Patient visited to the Emergency department for evaluation. The events outcome reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Limb discomfort, Nausea, Tongue discomfort, Vomiting
Clinical narrative: Initial unsolicited report received from a pharmacist on 03-Oct-2017. This case involves a 40-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE QUADRIVALENT (batch number: UI829AA) in left deltoid via intramuscular route on 03-Oct-2017. The patient's medical history and concomitant medications were not reported. On 03-Oct-2017, within 10 minutes following the vaccination, the patient developed a hot flash, nausea, Left facial numbness, left arm heaviness, chest heaviness, and a burning sensation in her tongue. It was reported that two hours after vaccination patient still reports left facial numbness, Left arm heaviness and the right side of her lip is numb. The patient's blood pressure was reported to be: 142/93. A CT scan was performed. Patient visited to the Emergency department for evaluation. The events outcome reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chest discomfort, Computerised tomogram, Hot flush, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Initial unsolicited report received from a pharmacist on 03-Oct-2017. This case involves a 40-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE QUADRIVALENT (batch number: UI829AA) in left deltoid via intramuscular route on 03-Oct-2017. The patient's medical history and concomitant medications were not reported. On 03-Oct-2017, within 10 minutes following the vaccination, the patient developed a hot flash, nausea, Left facial numbness, left arm heaviness, chest heaviness, and a burning sensation in her tongue. It was reported that two hours after vaccination patient still reports left facial numbness, Left arm heaviness and the right side of her lip is numb. The patient's blood pressure was reported to be: 142/93. A CT scan was performed. Patient visited to the Emergency department for evaluation. The events outcome reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Limb discomfort, Nausea, Tongue discomfort
Clinical narrative: Initial unsolicited report received from a pharmacist on 03-Oct-2017. This case involves a 40-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE QUADRIVALENT (batch number: UI829AA) in left deltoid via intramuscular route on 03-Oct-2017. The patient's medical history and concomitant medications were not reported. On 03-Oct-2017, within 10 minutes following the vaccination, the patient developed a hot flash, nausea, Left facial numbness, left arm heaviness, chest heaviness, and a burning sensation in her tongue. It was reported that two hours after vaccination patient still reports left facial numbness, Left arm heaviness and the right side of her lip is numb. The patient's blood pressure was reported to be: 142/93. A CT scan was performed. Patient visited to the Emergency department for evaluation. The events outcome reported as unknown. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Erythema, Headache, Injected limb mobility decreased, Injection site erythema
Clinical narrative: From the PNEUMOVAX 23 Injection: Severe headache and neck pain with right arm weakness, tingling, swelling, severe arm pain and inability to move the right arm for at least 2 days. Progressed to redness over the entire right upper arm front and back of the arm and on the 4th day it appeared as a splotchy rash that felt like a sunburn. Also 4th day bruising appeared on upper mid arm in the front and redness spread as far as the elbow on the back of the arm. There was nausea for two days. There was no redness at the exact injection site.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscular weakness, Nausea, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: From the PNEUMOVAX 23 Injection: Severe headache and neck pain with right arm weakness, tingling, swelling, severe arm pain and inability to move the right arm for at least 2 days. Progressed to redness over the entire right upper arm front and back of the arm and on the 4th day it appeared as a splotchy rash that felt like a sunburn. Also 4th day bruising appeared on upper mid arm in the front and redness spread as far as the elbow on the back of the arm. There was nausea for two days. There was no redness at the exact injection site.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Rash macular
Clinical narrative: From the PNEUMOVAX 23 Injection: Severe headache and neck pain with right arm weakness, tingling, swelling, severe arm pain and inability to move the right arm for at least 2 days. Progressed to redness over the entire right upper arm front and back of the arm and on the 4th day it appeared as a splotchy rash that felt like a sunburn. Also 4th day bruising appeared on upper mid arm in the front and redness spread as far as the elbow on the back of the arm. There was nausea for two days. There was no redness at the exact injection site.
Age: 42.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Patient noticed swelling of his right supraclavicular lymph nodes beginning 2 days after vaccine administration. Patient admits to mild tenderness of the lymph nodes. Denies any other symptoms. Admits to performing yard work over the weekend.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Hot, red, raised/swollen, painful arm.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Limb discomfort, Mobility decreased, Nausea
Clinical narrative: This spontaneous report was received from a pharmacist who was also a patient's daughter and refers to a 70-year-old female patient. The patient's medical history included a vaccination with PREVNAR 13 on an unknown date in approximately 2015 (reported as "two years ago"). No information regarding the concomitant medications and concurrent conditions was provided. On 24-SEP-2017, at 14:30, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 injection in the left deltoid lot # N013541 with expiration date on 23-JAN-2019. It was also reported that the patient received a dose of PNEUMOVAX 23 on 17-SEP-2017, however it was not disclosed it was not reported if actual two separate doses were given on 24-SEP-2017 and 17-SEP-2017. The reporting pharmacist was also unsure if it was her mother's first dose of the vaccine. On 17-SEP-2017, half an hour after the vaccination, the patient experienced tremor and vomiting. On 24-SEP-2017, at approximately 23:30, the patient started having a "severe reaction" with extreme chills, nausea, vomiting, her arms and legs were feeling heavy and very hard to lift, but she was able to walk to the bathroom and she had a fever of 100.2 (units not provided). The patient did not have any trouble breathing or difficulty swallowing but it was hard for her to talk because of the fever and chills. She experienced normal injection site pain with no redness or inflammation and no other injection site reactions. Since symptoms started at 23:30 she had gotten better, then worse again and it had gone in a cycle. Her daughter was concerned because her mother did not usually complain at all. The pharmacist wondered if there could be something wrong with the specific batch number her mother received. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: This spontaneous report was received from a pharmacist who was also a patient's daughter and refers to a 70-year-old female patient. The patient's medical history included a vaccination with PREVNAR 13 on an unknown date in approximately 2015 (reported as "two years ago"). No information regarding the concomitant medications and concurrent conditions was provided. On 24-SEP-2017, at 14:30, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 injection in the left deltoid lot # N013541 with expiration date on 23-JAN-2019. It was also reported that the patient received a dose of PNEUMOVAX 23 on 17-SEP-2017, however it was not disclosed it was not reported if actual two separate doses were given on 24-SEP-2017 and 17-SEP-2017. The reporting pharmacist was also unsure if it was her mother's first dose of the vaccine. On 17-SEP-2017, half an hour after the vaccination, the patient experienced tremor and vomiting. On 24-SEP-2017, at approximately 23:30, the patient started having a "severe reaction" with extreme chills, nausea, vomiting, her arms and legs were feeling heavy and very hard to lift, but she was able to walk to the bathroom and she had a fever of 100.2 (units not provided). The patient did not have any trouble breathing or difficulty swallowing but it was hard for her to talk because of the fever and chills. She experienced normal injection site pain with no redness or inflammation and no other injection site reactions. Since symptoms started at 23:30 she had gotten better, then worse again and it had gone in a cycle. Her daughter was concerned because her mother did not usually complain at all. The pharmacist wondered if there could be something wrong with the specific batch number her mother received. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 65 year old female patient. She had no pertinent medical history and drug reactions or allergies. On 20-SEP-2017, the patient was vaccinated with ZOSTAVAX injection, 0.65 ml, subcutaneously, lot # N013274, expiry date 08-AUG-2019 (vaccination site was not reported) to prevent shingles which was reconstituted with sterile diluent (MERCK STERILE DILUENT) injection (dose, lot # and expiry date were not reported). Concomitant therapies included meloxicam (MOBIC), gabapentin and tizanidine hydrochloride (ZANAFLEX). On an unspecified date in September 2017, the patient developed bronchitis. On 26-SEP-2017, she sought medical attention and was seen by an unspecified physician. At the time of reporting, the patient was visiting the pharmacy to fill a prescription for prednisone (manufacturer unknown) to use as a treatment for bronchitis. No lab diagnostic studies were performed. The outcome of the event was reported as not recovered/not resolved. The reporter did not provide the causality assessment between the event and the suspect products.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Retching
Clinical narrative: This spontaneous report was received from a licensed practical nurse concerning a 12 year old male patient. The patient's concurrent conditions included henoch-schonlein purpura. The patient's medical history included gastrointestinal disorder. The patient did not have history of drug reactions or allergies. On 03-OCT-2017, the patient was vaccinated with an unspecified dose of GARDASIL 9 lot # N013276, expiration date 21-JAN-2020, for prophylaxis (dose and route of administration were not reported). On the same date, following the administration of GARDASIL 9, the patient experienced  severe nausea and dry heaving (retching); he was at the reporter's office and was administered an unspecified treatment, however no laboratory diagnostic tests were performed.).The reporter also indicated that she checked on patient through call and he was getting better. The causal relationship between the events nausea and retching and therapy with GARDASIL 9 was not reported.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant regarding a 2 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2017 at 1:30 pm, the patient received second dose of improperly stored VAQTA lot # N005796 with expiration date: 26-MAY-2018 (dose and route were not reported), in the left arm for prophylaxis (Incorrect product storage). The patient was vaccinated at private doctor's office/hospital and the vaccine was purchased with public funds. No adverse reactions were reported.; Sender's Comments: US-009507513-1708USA001493:
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant regarding a 3 year old male patient. The patient's medical history and concomitant medications were not reported. Concurrent conditions included soy, peanut, egg allergy. On 03-AUG-2017 at 3 pm, the patient received second dose of improperly stored VAQTA lot # N005796 with expiration date: 26-MAY-2018, (dose and route were not reported) in the left arm for prophylaxis (Incorrect product storage). The patient was vaccinated at private doctor's office/hospital and the vaccine was purchased with public funds. No adverse symptoms or reactions were reported.; Sender's Comments: US-009507513-1708USA001493:
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a health care professional refers to a 2 year old male patient with Asthma. The patient's medical history was not reported. On 03-AUG-2017, at 1:46 PM, the patient was vaccinated with a second dose of incorrectly stored VAQTA (Strength, dose, frequency, route and expiration date were not reported) of lot # N005796, in the left arm for prophylaxis. There were no concomitant medications reported. The patient did not experience any adverse symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 13-OCT-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 04-JUN-2012 at a VA facility 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 13-AUG-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. 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, pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # M047662 with expiration date 02-DEC-2018, (dose and route of administration were not reported) for prophylaxis (incorrect product storage). Properly stored sterile diluent (DILUENT MERCK INJ) was used to reconstitute the improperly stored VARIVAX. It was stated that the VARIVAX was exposed to a temperature between 15 and 46 Fahrenheit degrees for 2 hours and 50 minutes. Digital data logger was involved. No previous temperature excursion was reported. No adverse effect was reported. There was no product quality complaint(PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1710USA007380: US-009507513-1710USA007379: US-009507513-1709USA007245: US-009507513-1710USA007381: US-009507513-1710USA007383:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored doses of VARIVAX lot # M047662 with expiration date 02-DEC-2018, (dose and route of administration were not reported) for prophylaxis(incorrect product storage). Properly stored sterile diluent (DILUENT MERCK INJ) was used to reconstitute the improperly stored VARIVAX. It was stated that the VARIVAX was exposed to a temperature between 15 and 46 Fahrenheit degrees for 2 hours and 50 minutes. Digital data logger was involved. No previous temperature excursion was reported. No adverse effect was reported. There was no product quality complaint(PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1710USA007379: US-009507513-1709USA007245: US-009507513-1710USA007382: US-009507513-1710USA007380: US-009507513-1710USA007381:
Age: 38.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Hyperhidrosis, Influenza like illness, Pain
Clinical narrative: Red, swollen, painful right arm along with flu like symptoms of chills, sweating, body aches. Presented to ER to address the symptoms.
Age: 38.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Red, swollen, painful right arm along with flu like symptoms of chills, sweating, body aches. Presented to ER to address the symptoms.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin test, Urticaria
Clinical narrative: Local swelling, warmth, redness 2 hr after injection with a few scattered hives, L cheek and 2 near injection site.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site streaking, Pain in extremity, Peripheral swelling
Clinical narrative: Red, swollen, painful arm. Streaking occurring from injection site up arm toward chest.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Very swollen arm, redness, pain, warmth on arm.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on injected arm and up neck.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Area became red 24 post injection, then 48 hours later area red and very hot.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Injection site pain, Pallor, Pulse abnormal, Seizure
Clinical narrative: As the flu vaccine was being administered the patient indicated it was hurting. After the injection was complete she stated that she felt dizzy. I instructed her to take a seat at which time she became pale, and collapsed to her right. I informed a technician to call 911 and hand me an emergency epinephrine pen. I laid the patient on her back and tilted her head to open her airway. She was unresponsive, with a faint pulse and so I administered epinephrine. She became responsive within 10 seconds of epinephrine administration. I noticed that she urinated following the event, at which time the patient and myself realized she had seized as well. EMS arrived and took her to the ambulance for further evaluation.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: As the flu vaccine was being administered the patient indicated it was hurting. After the injection was complete she stated that she felt dizzy. I instructed her to take a seat at which time she became pale, and collapsed to her right. I informed a technician to call 911 and hand me an emergency epinephrine pen. I laid the patient on her back and tilted her head to open her airway. She was unresponsive, with a faint pulse and so I administered epinephrine. She became responsive within 10 seconds of epinephrine administration. I noticed that she urinated following the event, at which time the patient and myself realized she had seized as well. EMS arrived and took her to the ambulance for further evaluation.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Received dose at incorrect age. No adverse event.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthritis infective, Blood test, Osteomyelitis, Peripheral swelling, Skin discolouration
Clinical narrative: SWOLLEN/DISCOLORED UPPER ARM WITH A DEFINED MARGIN. ED DIAGNOSED WITH A BONE AND JOINT INFECTION OF THE SHOULDER/UPPER ARM.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Skin warm, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient had no history of having chicken pox. No additional medical history, concurrent conditions and concomitant therapies were provided. On 22-SEP-2017, the patient was vaccinated with ZOSTAVAX injection, subcutaneous (dose, lot # and expiration date were unspecified) for prophylaxis. On unknown date in September 2017, the patient experienced a large red welt 3 inches in diameter near the injection site, which was red and warm. The patient experienced also pain between the injection site and her elbow. The patient sought medical attention by calling pharmacist. On unknown date, the patient consulted the symptoms with an unknown healthcare professional, who prescribed diphenhydramine hydrochloride (BENADRYL) (unknown dose and frequency), acetaminophen(TYLENOL) (unknown dosage and frequency) and external compresses (unspecified). The outcome of adverse events was reported as currently unresolved. The relatedness between adverse events and ZOSTAVAX injection was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M047662 with expiration date 02-DEC-2018, (strength, dose# and route of administration were not reported) for prophylaxis. Properly stored sterile diluent (MERCK INJ) was used to reconstitute the improperly stored VARIVAX. It was stated that the VARIVAX was exposed to a temperature of 15 to 46 Fahrenheit for 2 hours and 50 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect was reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1709USA007245: US-009507513-1710USA007380: US-009507513-1710USA007381: US-009507513-1710USA007382: US-009507513-1710USA007383.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M047662 with expiration date 02-DEC-2018, (strength, dose# and route of administration were not reported) for prophylaxis. Properly stored sterile diluent (MERCK INJ) was used to reconstitute the improperly stored VARIVAX. It was stated that the VARIVAX was exposed to a temperature of 15 to 46 Fahrenheit for 2 hours and 50 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect was reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1710USA007379: US-009507513-1709USA007245: US-009507513-1710USA007381: US-009507513-1710USA007382: US-009507513-1710USA007383.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M047662 with expiration date 02-DEC-2018, (strength, dose# and route of administration were not reported) for prophylaxis. Properly stored sterile diluent (MERCK INJ) was used to reconstitute the improperly stored VARIVAX. It was stated that the VARIVAX was exposed to a temperature between 15 and 46 Fahrenheit for 2 hours and 50 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect was reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1710USA007380: US-009507513-1709USA007245: US-009507513-1710USA007379: US-009507513-1710USA007382: US-009507513-1710USA007383.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Joint swelling, Neck pain, Pain
Clinical narrative: Symptoms began as neck pain/soreness and the progressed to back pain (from the tailbone all the way up to the neck). It later spread to whole body pain, with the sensation that all other joints (fingers, toes, knees, elbows, shoulders, jaw, etc.) were swollen and very painful.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Red, hard, warm to the touch at injection site, warm compresses and ice packs, also BENADRYL for and itching that may occur.
Age: 34.0
Sex: F
Vaccine: JEV1
Symptoms: Exposure during pregnancy, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling of left side of face.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Myalgia, Vaccination site movement impairment
Clinical narrative: Muscle soreness reported 12 days after vaccination; cannot lift arm.
Age: 76.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Abdominal pain upper, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Per patient, she had a stomach ache, headache, felt weak and very tired. These symptoms improved, but did not resolve beginning on 10/13/17. All symptoms resolved by 10/16/17. Five pounds lost during this time when did not feel well. Also with 1 episode of chills. Also had a sore arm, for about 3-4 days, but thinks this was within what was to be expected.
Age: 76.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Malaise, Pain in extremity, Weight decreased
Clinical narrative: Per patient, she had a stomach ache, headache, felt weak and very tired. These symptoms improved, but did not resolve beginning on 10/13/17. All symptoms resolved by 10/16/17. Five pounds lost during this time when did not feel well. Also with 1 episode of chills. Also had a sore arm, for about 3-4 days, but thinks this was within what was to be expected.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity
Clinical narrative: Stated after receiving vaccine in the morning no issues, but started to develop pain in left arm around 5:00pm. Unable to have full range of motion without pain, did warm compress last night. pain appears to be improving since last night.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Lymphadenopathy, Nausea, Post vaccination autoinoculation
Clinical narrative: Pt has cross-inoculation around the injection site on left deltoid. Pt was seen at off base physicians office for nausea and severe lymph nodes swelling.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: Patient experiencing sore arm with warmth, unable to lift beyond shoulder-height, pain has been easing off over the past almost 3 weeks.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash
Clinical narrative: Patient noticed bumps, starting itching on left arm, left upper chest, and face, decided to go to the ER.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt states pain at injection site and had limited range of motion in that arm.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Productive cough, Secretion discharge
Clinical narrative: Patient has been experiencing productive cough, cloudy white mucus present. Tried DAYQUIL, which suppressed cough, but patient was unable to cough mucus up after taking. Stopped DAYQUIL and patient was able to cough mucus up again. Also tried VICK'S vapor rub and an OTC nasal spray, but is still experiencing the cough almost 3 weeks later.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Injection site pain, Muscular weakness, Myositis
Clinical narrative: THE MORNING AFTER THE INJECTION, EMPLOYEE STATES THAT HER LEFT LATERAL ASPECT OF THE ARM CLOSEST TO THE ELBOW WAS SWOLLEN AND EXTREMELY SORE, TO THE POINT OF WEAKNESS WHEN ATTEMPTING TO LIFT ANYTHING, EVEN A LIGHT ITEM LIKE A PATIENT CHART. LEFT UNDERARM WAS ALSO PAINFUL. INJECTION SITE WAS NOT ABNORMAL, ONLY SLIGHTLY SORE.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Joint range of motion decreased, Pain in extremity, Paraesthesia
Clinical narrative: Immediate pain in vaccinated arm with numbness and tingling to same hand and fingers. Extreme limitation with range of motion.
Age: 1.33
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Injection site and surrounding area became raised, red, hot, and hard. Patient got a fever overnight. Fever broke in the morning, but local reaction has persisted the past 3 days.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Telephone call from patient. Patient stated her upper arm, about 4-5 inches below injection site, became red and hot the day after the injection, then became itchy; it remained so for a day, then on the following day (10/12/17) symptoms began to resolve. She states on 10/13/17 that "I can barely see that area, it is not firm or warm, but it is tender if I push on it."
Age: 71.0
Sex: M
Vaccine: FLUR3, PNC13
Symptoms: Injection site erythema
Clinical narrative: PATIENT HAD REDNESS SPREAD DOWNWARD FROM INJECTION SITE WITH ABOUT 4 INCHES WIDE AND 7 INCHES LONG. PATIENTS PHYSICIAN PRESCRIBED BETAMETHASONE VALERATE 0.1% CREAM TO BE APPLIED TWICE A DAY AND PREDNISONE 10 MG TABLETS 2 TAB PO BID FOR 3 DAYS, THEN 1 TAB QD FOR 4 DAYS.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Within 15 minutes of injection began itching and had whelps on arms and trunk.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Abdominal discomfort, Cellulitis, Erythema, Feeling abnormal, Injection site swelling
Clinical narrative: Patient had swelling of the left upper arm where the PNEUMOVAX had been administered. Presented to pharmacy instructed to see physician who diagnosed as similar to a cellulitis. Patient's arm was red with 1/8 inch thick hard red line separating healthy tissue from non healthy tissue. The left arm was very warm to the touch. Patient was given two prescriptions for cephalexin (10-day) and naproxen(month supply) which were started on 10/14. Patient had been unable to sleep for two nights and now on Monday with follow-up is able to sleep and function, although not feeling 100% better. The antibiotic treatment is causing stomach issues. Patient is taking yogurt to treat stomach upset and assist with GI flora.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Insomnia, Skin warm
Clinical narrative: Patient had swelling of the left upper arm where the PNEUMOVAX had been administered. Presented to pharmacy instructed to see physician who diagnosed as similar to a cellulitis. Patient's arm was red with 1/8 inch thick hard red line separating healthy tissue from non healthy tissue. The left arm was very warm to the touch. Patient was given two prescriptions for cephalexin (10-day) and naproxen(month supply) which were started on 10/14. Patient had been unable to sleep for two nights and now on Monday with follow-up is able to sleep and function, although not feeling 100% better. The antibiotic treatment is causing stomach issues. Patient is taking yogurt to treat stomach upset and assist with GI flora.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Vertigo and headache. The following day he developed headache and vertigo that continues today. Headache is 6/10 with standing and is improved with sitting and laying. No fever. He has been drinking good PO fluids and eating well/normal. He has had nausea but no vomiting or diarrhea. His injection site in his arm is swollen but the overlying skin does not demonstrate erythema like an infection. The swollen area is warm to touch and mildly tender.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Vertigo
Clinical narrative: Vertigo and headache. The following day he developed headache and vertigo that continues today. Headache is 6/10 with standing and is improved with sitting and laying. No fever. He has been drinking good PO fluids and eating well/normal. He has had nausea but no vomiting or diarrhea. His injection site in his arm is swollen but the overlying skin does not demonstrate erythema like an infection. The swollen area is warm to touch and mildly tender.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Discomfort, Hypoaesthesia, Injection site hypoaesthesia, Injection site pain
Clinical narrative: On 6 October 2017, employee had Influenza vaccine placed to left deltoid(relatively high ) 1 in from acromion process, pain started at 0600 next morning with pain 7/10 with numbness and tingling from left axilla to fingertips down Left arm. Still has discomfort and tingling/numbness today. Her provider ordered an Ultrasound completed on 10 October 2017, resulting in two cm borderline enlarged lymph nodules. Today, she has pain 4/10 to left axilla with numbness and tingling to fingertips.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site paraesthesia, Lymphadenopathy, Pain in extremity, Paraesthesia, Ultrasound scan abnormal
Clinical narrative: On 6 October 2017, employee had Influenza vaccine placed to left deltoid(relatively high ) 1 in from acromion process, pain started at 0600 next morning with pain 7/10 with numbness and tingling from left axilla to fingertips down Left arm. Still has discomfort and tingling/numbness today. Her provider ordered an Ultrasound completed on 10 October 2017, resulting in two cm borderline enlarged lymph nodules. Today, she has pain 4/10 to left axilla with numbness and tingling to fingertips.
Age: 67.0
Sex: F
Vaccine: FLUR3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT HAD REDNESS SPREAD FROM INJECTION SITE UPWARD AND DOWNARD INCLUDING ENTIRE SHOULDER ABOUT 10 INCHES LONG AND 5 INCHES WIDE. SITE WAS WARM TO THE TOUCH AND HAD SOME SWELLING.
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Lip swelling, Speech disorder, Swelling, Swelling face
Clinical narrative: Patient presented to Hospital with swelling to the lips, tongue, face, and neck. Was able to breath adequately but was having difficulty swallowing and speaking. She was sent on to a hospital for further evaluation.
Age: 90.0
Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue
Clinical narrative: Patient presented to Hospital with swelling to the lips, tongue, face, and neck. Was able to breath adequately but was having difficulty swallowing and speaking. She was sent on to a hospital for further evaluation.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain. Seen by PCP and prescribed pain medication. Is now being referred to the orthopedic MD.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Hypoaesthesia, Oropharyngeal pain
Clinical narrative: Pt got flu shot on 10/13/2017, pt called back on 10/14/2017 saying that she got a flu shot in her left arm and she was experiencing left side numbness, left side ear pain, and a sore throat. She went to the Dr on 10/14/2017 and got a Rx for prednisone 20mg, 2 tabs Q AM for 3 days.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Feeling hot, Flushing, Hot flush
Clinical narrative: Flushing, warmth, clammy skin to face, similar to hot flash.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Redness in 2-3 diameter around injection site.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle pain.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 13-OCT-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 21-SEP-2011 at a pharmacy, 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 14-JAN-2014, the patient was treated by a physician, for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as severe herpes zoster, or shingles. The patient has ben prescribed acyclovir (manufacturer unknown) for management of his 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 13-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 10-OCT-2014 at a pharmacy, 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 22-DEC-2016, the patient was treated at a clinic, for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX 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. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MENB
Symptoms: Loss of consciousness
Clinical narrative: This initial spontaneous report was received from a Nurse Practitioner (NP) via a company representative and refers to two patients of unknown age and gender. Medical history and concurrent medications were not provided. In August 2017 (reported as about two months ago), the patients were vaccinated with GARDASIL 9 (dose and route not provided.) It was unknown which dose in the series the patients received. While waiting at the office 15 minutes after receiving the vaccine, the patients passed out. It was noted that another patient also passed out and hit their head and went to the Emergency Room (see case # 1710USA007799). Two of the three injections came from the same lot # (lot # not provided). The outcome of the events were unknown. The NP did not provide causality assessment. Upon internal review, passed out was considered medically significant. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1710USA007799:
Sex: M
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A report has been received from a health professional concerning a male patient. No concomitant drug, past medical history or concurrent disease were reported. On an unknown date the patient received FLUMIST QUADRIVALENT (intranasal). The patient received FLUMIST and contracted the flu, 3 years ago (2014), with exact dates unknown. The outcome of the event of contracted flu was unknown. The report was considered to be non-serious by the company physician.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Dehydration, Dizziness, Headache, Loss of consciousness, Syncope
Clinical narrative: Received a phone call 10/13/17 in regards to this patient with a one day history headache and one episode of syncope that day. She received influenza and meningitis vaccines on 10/12/17 (the day prior). She had headache all day - up to 6/10 on pain scale - on 10/13 and felt lightheaded and dizzy/vertigo on and off during the day. She was eating well and was not dehydrated. She took ADVIL with resolution of her headache. However, a few minutes after standing up and walking, she felt lightheaded and had a syncopal event witnessed by parent. LOC was momentary such that patient didn't feel like she had a complete syncopal event (parent confirms she was unresponsive briefly). No seizure like activities. She returned to her baseline within a few minutes and was not sleepy. No fevers. No myalgias. No other symptoms. They called nurse advice as they were concerned it could be a reaction to vaccination. Nursing advice was recommending UC/ER evaluation for the syncope.
Age: 16.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Unresponsive to stimuli, Vertigo
Clinical narrative: Received a phone call 10/13/17 in regards to this patient with a one day history headache and one episode of syncope that day. She received influenza and meningitis vaccines on 10/12/17 (the day prior). She had headache all day - up to 6/10 on pain scale - on 10/13 and felt lightheaded and dizzy/vertigo on and off during the day. She was eating well and was not dehydrated. She took ADVIL with resolution of her headache. However, a few minutes after standing up and walking, she felt lightheaded and had a syncopal event witnessed by parent. LOC was momentary such that patient didn't feel like she had a complete syncopal event (parent confirms she was unresponsive briefly). No seizure like activities. She returned to her baseline within a few minutes and was not sleepy. No fevers. No myalgias. No other symptoms. They called nurse advice as they were concerned it could be a reaction to vaccination. Nursing advice was recommending UC/ER evaluation for the syncope.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site discharge, Injection site erythema, Injection site rash
Clinical narrative: Patient was given flu shot 10/13 in clinic. Later that day she began to notice redness at the injection site and a rash developed. Over the weekend the rash began to spread and became itchy. Today 10/16 she came to clinic on the advice of her cardiologist who thought it looked infected. The rash was measured in clinic and it was 9x9 cm and red in color and warm to the touch. Patient reports that she noticed pus coming off the rash today in the shower. No fever in clinic, temp was 97.9 Fahrenheit orally. Dr. examined patient and diagnosed with cellulitis. Was started on a 7 day course of BACTRIM.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Redness, heat, knot, and swelling at injection site. Hives on other parts of the body.