chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: 10/27/18 Patient seen in urgent care for painful, red, swollen left arm. Prescribed topical (triamcinolone) cream. 10/29/18 Patient seen in pcp office. Patient reports left arm is getting slightly less painful, less pruritic, and the redness seems to be decreasing. Left deltoid was marked in urgent care with marker. Area of erythema-induration is approximately 9-11 cm. Tender to palpation, more so in the area of induration. No lymphadenopathy cervical or axillary.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Tenderness
Clinical narrative: 10/27/18 Patient seen in urgent care for painful, red, swollen left arm. Prescribed topical (triamcinolone) cream. 10/29/18 Patient seen in pcp office. Patient reports left arm is getting slightly less painful, less pruritic, and the redness seems to be decreasing. Left deltoid was marked in urgent care with marker. Area of erythema-induration is approximately 9-11 cm. Tender to palpation, more so in the area of induration. No lymphadenopathy cervical or axillary.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date in October 2018 (reported as between 08-OCT-2018 and 15-OCT-2018), the patient received unspecified doses of GARDASIL 9 (lot # R003557 with expiration date 20-NOV-2020; strength, dose and route were not reported) for prophylaxis, which was improperly stored. Current temperature excursion was 7.7 Fahrenheit degrees for 1 hours and 6 minutes. No previous temperature excursion was reported. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter (linked case # 1810USA008298; case # 1810USA008299). Sender's Comments: US-009507513-1810USA008298: US-009507513-1810USA008299.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Tinnitus
Clinical narrative: This spontaneous report was received from a physician and refers to a 14 year old male patient. The patient's concurrent conditions included asthma. The patient's concomitant therapies included QVAR and albuterol. The patient had not drug allergies. Information regarding the patient's pertinent medical history and historical drugs was not provided. On 12-APR-2018, the patient was vaccinated with his first dose of GARDASIL 9 (dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. The reporter stated that there were not adverse effects after this first dose. However, on 22-OCT-2018, the patient was vaccinated with his second dose of GARDASIL 9 (dose, route and anatomical location were not provided) lot # R008163, expiration date 18-NOV-2020, for Human Papilloma Virus (HPV) prevention. Since this date, the patient had been experiencing ringing in the ears (tinnitus). The patient was scheduled to be seen in the physician's office on 30-OCT-2018. At the reporting time, the patient was not given any treatment and no laboratory diagnostic studies were performed. The outcome of tinnitus was reported as not recovered/not resolved. The causality between the event tinnitus and GARDASIL 9 was unknown.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 12 months old male patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 24-OCT-2018, the patient was vaccinated with a dose of VAQTA for prophylaxis, lot # N020689 with expiration date of 22-OCT-2018 (dose, route of administration and anatomical location were not reported). No adverse effects were reported.
Sex: M
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient has severe arm pain hard to lift arm.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Acute respiratory distress syndrome, Acute respiratory failure, Asthma, Bilevel positive airway pressure, Blood gases
Clinical narrative: 42 y/o with moderate persistent asthma on XOLAIR, HTN, SVT, fatty liver, DM, TIA/CVA s/p PFO repair admitted with acute respiratory failure/distress secondary to what appears to be an allergic reaction to influenza shot with severe asthma exacerbation/status, which did not respond to steroids and nebs, requiring initially a BiPAP and then intubation. He was extubated the next day and has been improving since. Post extubation he had episodes of blood in the sputum.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose, Chest X-ray, Condition aggravated, Electrocardiogram, Endotracheal intubation
Clinical narrative: 42 y/o with moderate persistent asthma on XOLAIR, HTN, SVT, fatty liver, DM, TIA/CVA s/p PFO repair admitted with acute respiratory failure/distress secondary to what appears to be an allergic reaction to influenza shot with severe asthma exacerbation/status, which did not respond to steroids and nebs, requiring initially a BiPAP and then intubation. He was extubated the next day and has been improving since. Post extubation he had episodes of blood in the sputum.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count, Glycosylated haemoglobin, Haemoptysis, Hypersensitivity, Metabolic function test
Clinical narrative: 42 y/o with moderate persistent asthma on XOLAIR, HTN, SVT, fatty liver, DM, TIA/CVA s/p PFO repair admitted with acute respiratory failure/distress secondary to what appears to be an allergic reaction to influenza shot with severe asthma exacerbation/status, which did not respond to steroids and nebs, requiring initially a BiPAP and then intubation. He was extubated the next day and has been improving since. Post extubation he had episodes of blood in the sputum.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Myocardial necrosis marker
Clinical narrative: 42 y/o with moderate persistent asthma on XOLAIR, HTN, SVT, fatty liver, DM, TIA/CVA s/p PFO repair admitted with acute respiratory failure/distress secondary to what appears to be an allergic reaction to influenza shot with severe asthma exacerbation/status, which did not respond to steroids and nebs, requiring initially a BiPAP and then intubation. He was extubated the next day and has been improving since. Post extubation he had episodes of blood in the sputum.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Patient states that his arm was very sore the day of injection and became very red, warm and swollen. He did not take anything the night of for symptoms, but did take ADVIL PM two days later. As of now, patient is only experiencing swelling and redness. He states he does not have pain now.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: I had the first dose on 8-17 and that night felt like I was burning up throughout the night. The next night I developed pain in my left hip that lasted for a bout 3 days. Also felt very tired. The 2nd dose was on 10-26-18 in the afternoon. I developed chills in the evening about 7 pm that lasted throughout the night and had high fevers. On 10-27 I awoke and had a headache, fatigue and felt like I had the flu. No appetite and continued to have the chills and headache throughout the day. On 10-28 I developed back pain to left lower back and this is just now going away. Tylenol was taken throughout this to help relieve the symptoms.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: I had the first dose on 8-17 and that night felt like I was burning up throughout the night. The next night I developed pain in my left hip that lasted for a bout 3 days. Also felt very tired. The 2nd dose was on 10-26-18 in the afternoon. I developed chills in the evening about 7 pm that lasted throughout the night and had high fevers. On 10-27 I awoke and had a headache, fatigue and felt like I had the flu. No appetite and continued to have the chills and headache throughout the day. On 10-28 I developed back pain to left lower back and this is just now going away. Tylenol was taken throughout this to help relieve the symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Fever 102 degrees, nausea, headache, achy muscles, injection site pain swelling and redness. Resolved after 24 hours of bed rest.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Fever 102 degrees, nausea, headache, achy muscles, injection site pain swelling and redness. Resolved after 24 hours of bed rest.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: On Oct. 30, 2018 I broke out with Shingles on the back left shoulder, front left shoulder and left side of the back of the neck.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Nodule, Swelling
Clinical narrative: REDNESS, SWELLING, BRUISING, AND KNOT LASTED OVER 24 HOURS PATIENT SAID ADVERSE REACTION WAS SUBSIDING, BUT STILL VERY VISIBLE OVER 24 HOURS LATER.
Age: 0.5
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: High dose flu was given to a 6 month old as opposed to pediatric.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Paraesthesia, Seizure like phenomena, Syncope
Clinical narrative: Seizure like activity. Tingling, face, hands, legs. Syncopal episode. EMS called results in pt. to ER (local).
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Muscular weakness, Pain in extremity, Sleep disorder, Weight bearing difficulty
Clinical narrative: Patient received FLUZONE HD and PNEUMOVAX 23 on the same arm on 8/6/2018. Following administration, patient reports persistent pain and muscle weakness in that arm, leading to limited ability to pick up household objects and disruption of sleep.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Asthenia, Injection site pain, Pain
Clinical narrative: Patient received FLUZONE HD and PNEUMOVAX 23 on the same arm on 8/6/2018. Following administration, patient reports persistent pain and muscle weakness in that arm, leading to limited ability to pick up household objects and disruption of sleep.
Age: 14.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Eye pain, Full blood count, Headache, Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: Received HPV vaccine in right arm on 10/23/18. Went to unknown pharmacy after and received Flu shot to left arm. Reported numbness to left upper arm and felt nauseous and numb to hands. Reported HA and eye pain as well. Seen at local ER at 13:52.
Age: 14.0
Sex: M
Vaccine: FLUX, HPV9
Symptoms: Metabolic function test, Nausea, Urine analysis
Clinical narrative: Received HPV vaccine in right arm on 10/23/18. Went to unknown pharmacy after and received Flu shot to left arm. Reported numbness to left upper arm and felt nauseous and numb to hands. Reported HA and eye pain as well. Seen at local ER at 13:52.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eye movement disorder, Fatigue, Irritability, Respiratory tract congestion, Seizure
Clinical narrative: Patient is a 4mo healthy boy who presented to ED after a seizure that occurred in the evening. He had his 4mo WCC in the morning and received vaccines. Was in normal state of health at that appt. In the evening, he had an episode of 3 minutes where his eyes were rolling and he was shaking (dad took video). Mom called 911. He had some mild congestion in the afternoon and seemed more tired than usual. His oldest sister was sick with URI symptoms, but otherwise no sick contacts. He has never had a seizure before. He is now back at baseline, except for being a little fussy. Mom and dad denied the following: emesis, cough, cyanosis, swelling, diarrhea, constipation, decreased urine. A referral to neuro was ordered prior to discharge so pt could be evaluated with an outpt EEG given family history of seizures. It was recommended that the patient follow-up with PMD within 1-2 days.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Tremor
Clinical narrative: Patient is a 4mo healthy boy who presented to ED after a seizure that occurred in the evening. He had his 4mo WCC in the morning and received vaccines. Was in normal state of health at that appt. In the evening, he had an episode of 3 minutes where his eyes were rolling and he was shaking (dad took video). Mom called 911. He had some mild congestion in the afternoon and seemed more tired than usual. His oldest sister was sick with URI symptoms, but otherwise no sick contacts. He has never had a seizure before. He is now back at baseline, except for being a little fussy. Mom and dad denied the following: emesis, cough, cyanosis, swelling, diarrhea, constipation, decreased urine. A referral to neuro was ordered prior to discharge so pt could be evaluated with an outpt EEG given family history of seizures. It was recommended that the patient follow-up with PMD within 1-2 days.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Injected limb mobility decreased, Pain
Clinical narrative: 20 hours later woke up the following morning with severe pain and loss of muscle strength in right arm (injection site). No increased erythema, no site reaction at injection site, no loss of tactile sensation. Cannot lift or move arm above head or control for fine motor movements.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Employee has had shoulder pain and decreased range of motion for one month. Physician feels this could be a sterile abscess or supraspinatus tendinitis. Conservative treatment for now and then possible referral to orthopedics if pain worsens.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Sensation of foreign body
Clinical narrative: At 10:11 AM patient received flu vaccine 5-10 minutes later, patient delivered flat red rash to torso and patient said throat "felt like something was in it" At 10:27 AM administered 25mg BENADRYL PO per MD standing orders 10:35 AM, vitals stable, HR 74, B/P 130/90 Per MD standing orders 911 was called to assess patient. Patient was stable and taken to local ED for assessment via ambulance.
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot and swollen within hours, and has continued to spread. Now it is from his left shoulder almost to his elbow, and has spread onto his chest. Mom marked the edge at 9 pm last night, and the redness is spreading another 3-4 cm past that on his arm and is almost full circumference on his arm. it is hard to move his arm and shoulder.
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: Skin warm, Swelling
Clinical narrative: Red, hot and swollen within hours, and has continued to spread. Now it is from his left shoulder almost to his elbow, and has spread onto his chest. Mom marked the edge at 9 pm last night, and the redness is spreading another 3-4 cm past that on his arm and is almost full circumference on his arm. it is hard to move his arm and shoulder.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: At 3:00 pm, developed chills/shaking, stiff neck, headache, fever of 99.5. Took 650mg aspirin. (Typical temp for me is 96-97). At 7:00 pm, fever of 100.1. All other symptoms continued. At 9:00 pm, fever of 102. Took 1000mg TYLENOL and used ice pack on forehead. All other symptoms continued. At 9:45 pm, fever down to 101.3. All other symptoms continued. On 10/23/2018, at 7:00 am, temp down to 99.6. Symptoms continued but lessened. Slept on and off all day on the 23rd. On 10/24/2018, temp returned to normal. Symptoms gone. Tiredness persisted.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: At 3:00 pm, developed chills/shaking, stiff neck, headache, fever of 99.5. Took 650mg aspirin. (Typical temp for me is 96-97). At 7:00 pm, fever of 100.1. All other symptoms continued. At 9:00 pm, fever of 102. Took 1000mg TYLENOL and used ice pack on forehead. All other symptoms continued. At 9:45 pm, fever down to 101.3. All other symptoms continued. On 10/23/2018, at 7:00 am, temp down to 99.6. Symptoms continued but lessened. Slept on and off all day on the 23rd. On 10/24/2018, temp returned to normal. Symptoms gone. Tiredness persisted.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever up to 100.5º, muscle aches, nausea, exhaustion, strong headache over a 32-hour period.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Drop attacks, Seizure
Clinical narrative: Seizure changed to drop attacks 2 days after shot he has not had any relief since.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Mom says she had a really high fever and rash all over her body the next day.
Age: 72.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Asthenia, Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Redness, swelling, warmth to touch of left arm, 101 fever, weak, pain occurred at 1am the next day. Pt took TYLENOL, applied heat, elevated arm.
Age: 72.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Skin warm
Clinical narrative: Redness, swelling, warmth to touch of left arm, 101 fever, weak, pain occurred at 1am the next day. Pt took TYLENOL, applied heat, elevated arm.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Pain / soreness at injection site lasting 2-3 days. Headache beginning around 12-15 hours after shot, lasting about 2-3 days. Stomach ache and nausea beginning around 18 hrs after shot and lasted 10-12 hrs. Fever up to 101.8 beginning around 18 hours after shot and lasting around 6-8 hours (came down w/ medication).
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Neck pain, Photophobia, Pyrexia
Clinical narrative: Headache, neck pain, photophobia, low grade fever.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Mobility decreased, Pain
Clinical narrative: Almost immediately, could not raise arm out to the side, painful in general in very specific movements. Improvement in overall pain after first 4 days; used ice heat and ibuprofen but has continued pain when moving arm in certain positions. Cannot tolerate any resistance in those positions, weakness.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Head injury, Lethargy, Loss of consciousness, Nausea
Clinical narrative: APPROXIMATELY 20-25 MINUTES AFTER INJECTION, PT WAS STILL IN THE BUILDING VISITING GRANDMOTHER AND PASSED OUT IN SEPARATE LOBBY. HE HIT HEAD ON COUNTER TOP AS HE FELL. HE WAS WALKING BEHIND HIS MOTHER AND SHE DID NOT SEE HIM PRIOR TO FALLING. HE WAS UNCONSCIOUS FOR APX 3-4 MINUTES. WHEN HE DID RESPOND, HE WAS VERY LETHARGIC AND THEN BECAME NAUSEATED AND VOMITED X1. GRANDMOTHER STATES HE WAS LETHARGIC FOR THE REST OF THE DAY.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: APPROXIMATELY 20-25 MINUTES AFTER INJECTION, PT WAS STILL IN THE BUILDING VISITING GRANDMOTHER AND PASSED OUT IN SEPARATE LOBBY. HE HIT HEAD ON COUNTER TOP AS HE FELL. HE WAS WALKING BEHIND HIS MOTHER AND SHE DID NOT SEE HIM PRIOR TO FALLING. HE WAS UNCONSCIOUS FOR APX 3-4 MINUTES. WHEN HE DID RESPOND, HE WAS VERY LETHARGIC AND THEN BECAME NAUSEATED AND VOMITED X1. GRANDMOTHER STATES HE WAS LETHARGIC FOR THE REST OF THE DAY.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Significant redness and swelling down to the wrist. Pt went to doctors office and got a steroid 3 days later. Steroid decreased swelling almost immediately and patient is doing well.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: Red area around flu shot injection site. Approximately 3" by 2". Patient states it is irritated and warm to the touch.
Age: 15.0
Sex: F
Vaccine: FLUX, HPV9, MNQ
Symptoms: Crying, Inappropriate affect, Psychotic disorder, Screaming, Speech disorder
Clinical narrative: She started laughing hysterically, screaming, crying, nonsensical speech, sent to ER, dx Brief Psychotic Event. Also given: MCV4, FLU-IIV4 and HPV9.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pruritus, Tenderness
Clinical narrative: On October 15, 2018 at around 11 am patient was injected via IM both FLUZONE HD and PNEUMOVAX 23 on the left arm 1 inch apart. But, came back on the 17th and showed her pinkish swollen tender left arm and it felt warm around the injection site. I told her to put some ice pack (4 inch band) and she said it disappear the following day. And she said until the 20th of October it was a little bit itchy.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature, Headache, Pain in extremity
Clinical narrative: Headache, temperature, arm soreness, joint pain - 4 day duration.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Local Pain, Fever, sweating, body aches.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a physician and refers to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with a pediatric dose of VAQTA (dose, route of administration, lot# and expiration date not provided) for prophylaxis. No adverse effects reported.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B core antibody negative, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative, Hepatitis B test negative, Therapy non-responder
Clinical narrative: This spontaneous report has been received from a nurse referring to a 18 year old female patient. Information about concurrent condition, concomitant medication and medical history was unknown. On unknown dates, the patient was vaccinated with a series of RECOMBIVAX HB (strength, dose, route, lot #, expiration date and therapy type were not reported) during an unspecified time frame for prophylaxis. On unknown dates, when blood work was performed, the results indicated that the patient failed to seroconvert (anti-HBs antibody negative). The result of hepatitis (Hep) B core antibody IGM was not reactive; the result of Hep B surface immunity QN was L less than 5; the result of Hepatitis B Virus (HBV) genotype was not detected. The outcome of the event was not recovered. Information about treatment given for the event was unknown by the reporter. The patient had sought medical attention. The causality between the event and RECOMBIVAX HB was not reported.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This initial spontaneous report was received on 25-OCT-2018 from a physician via a company field representative and refers to a 12 year old patient of unknown gender. The patient had no pertinent medical history or drug reactions/allergies and was taking no concomitant medications. On an unspecified date, the patient received GARDASIL intramuscularly for the indication of human papilloma virus (HPV) vaccination (dose and lot # not provided). It was unspecified how many doses in the series the patient received. An unspecified period of time after receiving GARDASIL, the patient died. Cause of death was not specified. There were no lab diagnostics/studies performed. The physician did not provide causality assessment. The physician told the field representative that Merck was sued.  Upon internal review, death was considered medically significant. Additional information has been requested.; Reported Cause(s) of Death: Cause of Death: Unknown by reporter.
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a physician assistant referring to a female patient of unknown age. Concomitant therapies included sterile diluent. The patient's pertinent medical history, drug reactions/allergies and current condition were not provided. On 25-OCT-2018, the patient received an expired dose of PROQUAD (therapy type was recombinant Human albumin (rHA); lot # N010114, expiration date was on 24-SEP-2018) subcutaneously for prophylaxis(expired product administered). No adverse effect was reported.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient experienced injection site pain that worsened for the past 4 days. Patient complains of pain so severe that she cannot move her arm.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired driving ability, Injected limb mobility decreased, Pain
Clinical narrative: Patient states that she has difficulty rotating her left arm following vaccination as it is painful. She says the pain is consistent and has not gotten better or worse throughout the past few weeks. She has difficulty driving, lifting her arm up or plain using it as it hurts. It hurts to sleep on it as well. She has tried to use heat, warm shower, and advil to relieve the pain but it has not resulted in any improved or lasting pain relief.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dyspnoea, Rash
Clinical narrative: Hours after receiving flu vaccine started having rash, difficulty breathing. Went to ER and diagnosed with anaphylaxis to flu vaccine.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever started on 10/30/2018 and red dos like rash started on 10/31/2018- first on arms and legs then spread to torso.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Bed rest, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Achy, tiredness, headache, chills, fever, nausea muscle aches. Bed rest and ADVIL 3 days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Achy, tiredness, headache, chills, fever, nausea muscle aches. Bed rest and ADVIL 3 days.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Swelling, Urticaria
Clinical narrative: 15 minutes after the vaccine she had lip tingling and mild swelling and hives on her chest. Patient was given Benadryl and monitored for 30 minutes without symptom changes. 1 hour after symptoms remained the same and patient went home with instructions to seek emergency care if any other symptoms developed.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pruritus, Rash generalised
Clinical narrative: Child started c/o itching inside ears within 10 minutes of receiving the shot. States that this lead to rash all over body except at injection site. Zyrtec was given & symptoms improved. Has been doing fine since.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Chest discomfort, Immediate post-injection reaction, Presyncope
Clinical narrative: MT, MA and Dr. initially present at the time of vasovagal reaction after Pneumococcal 23 vaccine administration. No reaction noted after Influenza vaccine received at beginning of appt. Assumed care of pt at 1145. Pt sitting on bed with head elevated and legs extended. Vitals obtained x1. Allergies verified. Pt given bottle of water. Pt reported immediately feeling chest tightness and abdominal pain after administration of vaccine. Pt denies nausea, dizziness, lightheadedness, and vision changes. Pt reports H/O COPD and inhaler use PRN. Pt's last meal was last night-only had coffee this morning. Dr. at bedside at 1153. Report given. Continued to monitor patient per Dr.'s request. Repeat vitals obtained x5. Pt reported all symptoms resolved. Dr back at bedside to reassess pt at 1214. Vitals reviewed by MD. MD discussed precautions with pt. Pt released home in stable condition.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Patient received Shot on 10/26 roughly around 11am. On the following Sunday 10/28, patient felt soreness and pain in upper arm and axillary area, worsening throughout day. Pain and discomfort peaked around hours 72-96 after shot. Patient took celebrex that he had been prescribed for lower back pain in the past. Patient now is taking prednisone due to possibility of brachial plexopathy.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Injection site nodule, Injection site swelling, Lip swelling, Swelling of eyelid
Clinical narrative: Swelling of eye lids and under eyes, swelling of lips and tongue, hives on chest, neck, face, and upper back, inside and on the back of legs, a little bit of wheezing, swolen knot at injection sight.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue, Urticaria, Wheezing
Clinical narrative: Swelling of eye lids and under eyes, swelling of lips and tongue, hives on chest, neck, face, and upper back, inside and on the back of legs, a little bit of wheezing, swolen knot at injection sight.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and hot to touch at injection site. Area measures 6 cm x 8 cm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Febrile convulsion
Clinical narrative: Per dad - Patient woke up in the middle of the night and had a febrile seizure. Patient has had these before. Patient recovered easily and TYLENOL was administered. No other treatment was done.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient stated she had a rash break out across her neck and face, she took BENADRYL and the symptoms subsided with no reoccurrence.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Large bruise on patients left shoulder. She says she noticed yesterday (10/30) around noon.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The patient stated that her arm was red and slightly warm to the touch from the injection site to the elbow 1 day after the injection. It was recommended that she go to an urgent care to get it looked at. The patient refused.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Papule, Pruritus, Rash, Rash erythematous
Clinical narrative: That afternoon they were at home she started to present rash with red bumps and itchiness on her legs, then mother noticed it was up to her thighs when she was in dancing class. They applied CAMPHO PHENIQUE which helped a little. Three days later the same rash also appeared on her arms and trunk. Since then it is still there and not going away, Nobody else at home has anything similar. On exam has erythematous papules on trunk and extremities, some with scab on top.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Scab
Clinical narrative: That afternoon they were at home she started to present rash with red bumps and itchiness on her legs, then mother noticed it was up to her thighs when she was in dancing class. They applied CAMPHO PHENIQUE which helped a little. Three days later the same rash also appeared on her arms and trunk. Since then it is still there and not going away, Nobody else at home has anything similar. On exam has erythematous papules on trunk and extremities, some with scab on top.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Onset of erythema, swelling, heat over entire deltoid region on the morning after vaccine was given. Mother applied ice and topical BENADRYL. Also gave oral TYLENOL and ibuprofen as needed. Mother called our clinic for advice on how to manage. Symptoms eventually resolved. All physical findings were resolved at time of subsequent unrelated sick visit on 10/18/18.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Eye pain, Headache, Lacrimation increased, Ocular hyperaemia, Pain
Clinical narrative: Four days after influenza injection had two days of Right red and painful eye with watery discharge, also associated with headache with movement.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site pruritus, Injection site reaction, Injection site warmth, Peripheral swelling
Clinical narrative: Patiet was given FLUZONE HD on the morning of October 30, 2018. She has gotten flu vaccine in the past with no reactions. This is the first time she has gotten the High Dose. She came back to the pharmacy at 6:15 PM on October 30, 2018 and said she had an allergic reaction. Her left was swollen and red rash about 5 inches down from where the vaccine was given on her left arm (deltoid). It was warm and itchy. I put cold pack on her arm and also gave her 1 dose of BENADRYL 25 mg tablet.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Patiet was given FLUZONE HD on the morning of October 30, 2018. She has gotten flu vaccine in the past with no reactions. This is the first time she has gotten the High Dose. She came back to the pharmacy at 6:15 PM on October 30, 2018 and said she had an allergic reaction. Her left was swollen and red rash about 5 inches down from where the vaccine was given on her left arm (deltoid). It was warm and itchy. I put cold pack on her arm and also gave her 1 dose of BENADRYL 25 mg tablet.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Influenza like illness, Nausea, Pyrexia, Urticaria
Clinical narrative: Patient stated she had hives soon after vaccination. She went home and had flu like symptoms including headache, nausea, and fever. When I spoke to her this morning, 10/31 she stated fever has since resolved and had taken MOTIRN to help relieve symptoms.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pt had SHINGIRX 5/2/18 and developed pain at site of injection, shoulder pain, and later decreased ROM shoulder. Did not follow-up with exam by MD until 10/11/18.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, IPV
Symptoms: Hyperhidrosis, Pallor, Presyncope
Clinical narrative: Presyncopal episode S/S pallor, diaphoretic about 6 mins. after vaccine - gave cold H2O. Pt was sitting, took BP 114/48, P.84, RR 12. Cool pack to back of neck, assisted to couch and put feet up then BP taken again approximately 12 min. after episode BP 121/68, P. 87, RR 14. Pt. stayed in office then released with Mom after 30 minutes. Mom was called at 2 PM to follow up on patient, Mom reports patient okay.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Cough, Urticaria, Wheezing
Clinical narrative: Hives, cough, wheezing.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 14-AUG-2013, a pharmacist at a pharmacy administered ZOSTAVAX. The patient was inoculated with ZOSTAVAX to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # were not provided).  On or about 17-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events were unknown.  Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration, Injection site rash, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 66-year-old patient of an unspecified gender received PREVNAR 13, (Solution for injection in pre-filled syringe, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for immunization and PNEUMOVAX, via an unspecified route of administration at single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient got PREVNAR 13 too early after PNEUMOVAX 23 (according to ACIP they should wait a year and it was less than a year). Additionally, the reporter stated that the patient had rash at the injection site (about 3 inches in diameter) and also stated that the injection site was warm to touch but no pain. The outcome of the events was unknown.
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: Pt requested FLUBLOK for egg allergy described as GI upset, nausea and loose stools, no resp issues, no hives no other symptoms with eggs. FLUBLOK vaccine given. Apprx 5 min post vaccination was sitting in chair and C/O feeling dizzy and light headed. Had pt lay down on adjacent floor mat. Called in coworker RN BSN. Pt remained awake, no loss of consciousness, skin warm and dry, color Pink. Nurse remained with patient while I went across hall for my supervisor, MPH RN to further evaluate pt. Upon entering clinic room with pt and nurse, Pt was lying on mat with an ice pack to forehead, speaking clearly and sucking on a lollipop. Supervisor present. Pt pulse 72 and strong, BP 106/70, color pink, skin warm and dry. Supervisor and Nurse then left the room. After approximately 15 min pt requested to sit up and said she felt better. Sat up on mat w/o any difficulty. Given a cup of water which was held w/ (R) hand-drank cup of water w/o difficulty. Continued to talk and remained alert and oriented. Took a short walk to chair just outside clinic room w/steady gait. Requested she remain seated for further observation. Given another cup of water (pt request) and a lollipop. Observed drinking water, sucking on lollipop and texting on phone. After apprx 45 min pt said her (R) arm was tingling and felt numb - was holding cup w/(R) hand and demonstrated full ROM (R) arm - Asked her to stand up and try to walk - she stood up quickly and said she felt a little dizzy had her sit back in chair. She then said her (R) leg felt a little numb. Asker her if she had anyone to pick her up and take home. She said no but only lived 1 mile away. Relayed all of the above (numbness, standing up quickly and feeling dizzy and non one to drive her home) to my Supervisor. Requested for supervisor to evaluate pt. Supervisor went over to evaluate and talk to pt - I was not present. Supervisor told pt that when she felt up to it she was free to leave. When I returned pt was gone. Pt was at clinic under observation for at least 1 hour. On 10-29-18 supervisor left a voice message on pt phone (phone had a message w/her name) w/an inquiry of how she was doing. Pt did not return call.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Activated partial thromboplastin time normal, Circumstance or information capable of leading to medication error, Crying, Full blood count normal, Injection site discolouration
Clinical narrative: Mom called 9/24/18 reported R thigh with red, pin point rash at injection site and swollen area size of baseball denies hot to touch, no itch, doesn't seem to bother him. Symptoms occurred more than 48h after vaccines given. Did not sound like typical reaction. Appt was scheduled 9/25. Exam 9/25 petechial rash, sl. raised (R) ant thigh. Researching by Dr. showed this was not allergic reaction but due to crying vigorously, fighting shot; study reported "discolored leg syndrome). Pt developed slightly tender raised area right ant thigh where HAV given 24h after injection; purple reddish, raised; now fading and flattened out; no other SXs. No hemophilia or bleeding do in family; no excessive bruising or bleeding with teething. No recent viral illness.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, International normalised ratio normal
Clinical narrative: Mom called 9/24/18 reported R thigh with red, pin point rash at injection site and swollen area size of baseball denies hot to touch, no itch, doesn't seem to bother him. Symptoms occurred more than 48h after vaccines given. Did not sound like typical reaction. Appt was scheduled 9/25. Exam 9/25 petechial rash, sl. raised (R) ant thigh. Researching by Dr. showed this was not allergic reaction but due to crying vigorously, fighting shot; study reported "discolored leg syndrome). Pt developed slightly tender raised area right ant thigh where HAV given 24h after injection; purple reddish, raised; now fading and flattened out; no other SXs. No hemophilia or bleeding do in family; no excessive bruising or bleeding with teething. No recent viral illness.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Petechiae, Prothrombin time normal
Clinical narrative: Mom called 9/24/18 reported R thigh with red, pin point rash at injection site and swollen area size of baseball denies hot to touch, no itch, doesn't seem to bother him. Symptoms occurred more than 48h after vaccines given. Did not sound like typical reaction. Appt was scheduled 9/25. Exam 9/25 petechial rash, sl. raised (R) ant thigh. Researching by Dr. showed this was not allergic reaction but due to crying vigorously, fighting shot; study reported "discolored leg syndrome). Pt developed slightly tender raised area right ant thigh where HAV given 24h after injection; purple reddish, raised; now fading and flattened out; no other SXs. No hemophilia or bleeding do in family; no excessive bruising or bleeding with teething. No recent viral illness.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure increased, Dyspnoea, Intensive care
Clinical narrative: Trouble breathing, SOB, increased BP. Admitted to ICU 4 days after vaccine.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reports still having arm pain and is also having difficulty moving arm. Recommended she reach out to PCP - waiting to hear back if she did that.
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Headache, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: Pt. developed headache, subjective fever and body aches twelve hours after vaccine, lasting until 7am on October 31st.
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Urticaria
Clinical narrative: Hives over whole body and not eating well. The hive come and go and on day 3 are still ocurring.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Patient reported developing a large, itchy, red, rash with raised hives across her chest/stomach. Lasted about a week.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Woke up the following morning after shots- vomited twice and then got a fever of 103. Reduced fever with TYLENOL. Completely fine by 3 pm.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Discomfort, Injection site erythema, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pt. came in and said that his arm hurt more than usual and thought that the shot was given higher than it should have been. I didnt notice any swelling around the injection site however there was some redness closer to the elbow. He said he already used ice, took ibuprofen and the discomfort had significantly reduced since the first day. After 4 days on a follow up call he said his arm felt much better. Pt was advised to see his PCP but he decided not to.
Age: 44.0
Sex: F
Vaccine: FLUN4
Symptoms: Condition aggravated, Cough, Dyspnoea, Oropharyngeal pain, Throat irritation
Clinical narrative: "I opted for the FLUMIST. The mist was administered at approximately 11am 10/15/18. One hour later I got a scratchy throat-but doable. Hour 2-5 I had a really sore throat and unproductive cough. No rash present so I went on with my day. I got home at 6pm and noticed I had inspiratory and expiratory wheezes. At 715pm I got up to visit the restroom in my house and began having extreme shortness of breath with expiratory and inspiratory wheezes. I promptly drove 3 miles to urgent care (calling 911 in my rural area would have taken much longer). They emergently treated me with Epi 0.3mg IM/SOLUMEDROL 150 mls, aerosol treatment and BENADRYL 50ml plus ZANTAC PO. None of these worked to their surprise. My airway became tighter and tighter and I feared for my life-literally. Urgent Care promptly called 911 and I was transferred to hospital-incurring quite the cost for transport but I was too sick to drive myself. There at hospital things became fuzzy as I was drifting in and out. I know I was given Racemic Epi and ATIVAN and CT scans of throat/lungs and head were done. I was discharged with no prescriptions (as suggested by urgent care I should be on 60 prednisone/BENADRYL) x 3 days."
Age: 44.0
Sex: F
Vaccine: FLUN4
Symptoms: Wheezing
Clinical narrative: "I opted for the FLUMIST. The mist was administered at approximately 11am 10/15/18. One hour later I got a scratchy throat-but doable. Hour 2-5 I had a really sore throat and unproductive cough. No rash present so I went on with my day. I got home at 6pm and noticed I had inspiratory and expiratory wheezes. At 715pm I got up to visit the restroom in my house and began having extreme shortness of breath with expiratory and inspiratory wheezes. I promptly drove 3 miles to urgent care (calling 911 in my rural area would have taken much longer). They emergently treated me with Epi 0.3mg IM/SOLUMEDROL 150 mls, aerosol treatment and BENADRYL 50ml plus ZANTAC PO. None of these worked to their surprise. My airway became tighter and tighter and I feared for my life-literally. Urgent Care promptly called 911 and I was transferred to hospital-incurring quite the cost for transport but I was too sick to drive myself. There at hospital things became fuzzy as I was drifting in and out. I know I was given Racemic Epi and ATIVAN and CT scans of throat/lungs and head were done. I was discharged with no prescriptions (as suggested by urgent care I should be on 60 prednisone/BENADRYL) x 3 days."
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Starting that evening the patient was having numbness in the left arm that lasted for 15 minutes. This occured a few days following with decreasing time of numbness. Patient appears to be having reduced numbness and improvement with time.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore left arm for 2 days after with limited mobility. Unable to lift arm over 90 degrees or to lift.  Pain 7/10.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site swelling, Malaise
Clinical narrative: Patient stated it swelled significantly at injection site, today she has a bruise from just below site to elbow 75% of arm. Stated she felt not well, run down.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives requiring IV BENADRYL.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: (L) deltoid with swelling and erythema - (L) upper arm. Redness migrates down to elbow with assoc. pruritis.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Lymphadenitis
Clinical narrative: Patient experienced bright red inflammation of his right arm that has extended all the way to underneath his armpit.