chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Burning sensation, Erythema, Peripheral swelling, Pruritus, Skin exfoliation
Clinical narrative: Patient started itching and scaling skin (no blisters) about 3 weeks ago, on extremities, hands, body, legs feels like "fire". Feet are swollen and red. She said she took Aspirin and BENADRYL. Have not seen doctor yet, told her to see a doctor.
Age: 76.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Red bumpy rash on large part of upper arm and very itchy (larger rash than we usually see in pts). Pt thinks it was flu shot but by records probably PREVNAR.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Pain at the injection site over 1 month later. Decreased range of motion.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Mouth ulceration, Pain in extremity, Pyrexia
Clinical narrative: Fever developed 3 days after flu vaccine given-seen in office at day 5 of having fevers, feet hurting and mouth ulcer-sent to ER for further eval.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Injection site bruising, Injection site erythema, Injection site inflammation
Clinical narrative: 09/05/2017 12:00PM Left upper arm irritation. Left arm irritation x 1 week. Patient had a flu shot and reports itching and mild irritation at the time. Symptoms have progressed to pain and warmth. More redness is appearing. She tried ice. Pain is 6/10 and worse if someone touches it. She denies previous vaccine reactions. 09/06/2017 3:00PM Acute Visit Urgent Care follow up---flu injection site is inflamed and painful. Patient is here to follow-up for urgent care visit She had her flu vaccine week ago, she started with swelling, redness, small bruise around injection site within the next 24-48 hours. She continue to have his redness and itching and pain, she was advised to follow up she was diagnosed with the cellulitis, she was given antibiotic her redness is slowly getting better, pain is slowly getting better.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site pain, Injection site swelling, Pain, Pruritus
Clinical narrative: 09/05/2017 12:00PM Left upper arm irritation. Left arm irritation x 1 week. Patient had a flu shot and reports itching and mild irritation at the time. Symptoms have progressed to pain and warmth. More redness is appearing. She tried ice. Pain is 6/10 and worse if someone touches it. She denies previous vaccine reactions. 09/06/2017 3:00PM Acute Visit Urgent Care follow up---flu injection site is inflamed and painful. Patient is here to follow-up for urgent care visit She had her flu vaccine week ago, she started with swelling, redness, small bruise around injection site within the next 24-48 hours. She continue to have his redness and itching and pain, she was advised to follow up she was diagnosed with the cellulitis, she was given antibiotic her redness is slowly getting better, pain is slowly getting better.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Skin irritation, Skin warm
Clinical narrative: 09/05/2017 12:00PM Left upper arm irritation. Left arm irritation x 1 week. Patient had a flu shot and reports itching and mild irritation at the time. Symptoms have progressed to pain and warmth. More redness is appearing. She tried ice. Pain is 6/10 and worse if someone touches it. She denies previous vaccine reactions. 09/06/2017 3:00PM Acute Visit Urgent Care follow up---flu injection site is inflamed and painful. Patient is here to follow-up for urgent care visit She had her flu vaccine week ago, she started with swelling, redness, small bruise around injection site within the next 24-48 hours. She continue to have his redness and itching and pain, she was advised to follow up she was diagnosed with the cellulitis, she was given antibiotic her redness is slowly getting better, pain is slowly getting better.
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea and vomiting extremely sore arm.
Age: 1.42
Sex: M
Vaccine: HIBV
Symptoms: Injection site reaction, Rash papular, Rash pruritic
Clinical narrative: Erythematous papular, slightly pruritus rash area (L) anterior thigh.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives after intradermal flu vaccine. Relieved with OTC ZYRTEC.
Age: 1.17
Sex: M
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site reaction, Rash papular
Clinical narrative: Erythematous papular rash over injection site - slightly pruritic is extending approximately 5 x 3 cm.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: Incorrect vaccine was given. PNEUMOVAX 23 was ordered, but PREVNAR 13 (second dose) was given in error.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness, Weight bearing difficulty
Clinical narrative: Persistent weakness in muscle, difficulty bearing weight with affected arm, difficulty moving arm laterally.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Pt had PNEUMOVAX 23 in (L) arm and FLUZONE HD in (R) arm on 10/30/17 (afternoon). That evening she experienced severe arm pain and pt almost sought care in ER. She did see MD on 10/31 and they recommended ibuprofen and ice.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Pruritus, Rash
Clinical narrative: Rash was just noted the night before clinic visit, no fever, was complaining of itching, no other associated S/S.
Age: 9.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: 21 cm x 24 cm red hot area on left thigh largest local reaction I have ever seen vs cellulitis.
Age: 51.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Bed rest, Disturbance in attention, Dizziness, Nausea
Clinical narrative: PNEUMOVAX 23 25 Mcg/0.5ml inj and Flu shot administered on 10/3/2017, Localized pain 3/10 in arm began 2 hours after. Pain overnight increased to 7/10 and 10/10 upon palp, arm had localized swelling. Within 12 hours of injection pain remained at 7/10, onset of nausea, dizziness, vertigo, mild fever, overall body ache, joint pain 4/10, unable o concentrate i.e. count to 10. Swelling and pain subsided within 48 hours of injection to 3/10, patient was on bed rest until 53 hrs after injection.
Age: 51.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: PNEUMOVAX 23 25 Mcg/0.5ml inj and Flu shot administered on 10/3/2017, Localized pain 3/10 in arm began 2 hours after. Pain overnight increased to 7/10 and 10/10 upon palp, arm had localized swelling. Within 12 hours of injection pain remained at 7/10, onset of nausea, dizziness, vertigo, mild fever, overall body ache, joint pain 4/10, unable o concentrate i.e. count to 10. Swelling and pain subsided within 48 hours of injection to 3/10, patient was on bed rest until 53 hrs after injection.
Age: 51.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Vertigo
Clinical narrative: PNEUMOVAX 23 25 Mcg/0.5ml inj and Flu shot administered on 10/3/2017, Localized pain 3/10 in arm began 2 hours after. Pain overnight increased to 7/10 and 10/10 upon palp, arm had localized swelling. Within 12 hours of injection pain remained at 7/10, onset of nausea, dizziness, vertigo, mild fever, overall body ache, joint pain 4/10, unable o concentrate i.e. count to 10. Swelling and pain subsided within 48 hours of injection to 3/10, patient was on bed rest until 53 hrs after injection.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness, Pallor, Seizure, Skin discolouration
Clinical narrative: My 12 year old received her 1st shot of GARDASIL. Walking out of the MD office she told me she was dizzy. I helped her to sit and then she passed out. She twisted her hands and opened her eyes big in a letargid way and didn't blinking. Her skin turned pale and bit green. I called by her name but she didn't respond.MD and RNs assisted her laying down and gave her a candy; they also checked her blood pressure. She does not recalled any of it. I am not giving her the 2nd dose.I'm worry about long term/permanent side effect derive from the seizure.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: My 12 year old received her 1st shot of GARDASIL. Walking out of the MD office she told me she was dizzy. I helped her to sit and then she passed out. She twisted her hands and opened her eyes big in a letargid way and didn't blinking. Her skin turned pale and bit green. I called by her name but she didn't respond.MD and RNs assisted her laying down and gave her a candy; they also checked her blood pressure. She does not recalled any of it. I am not giving her the 2nd dose.I'm worry about long term/permanent side effect derive from the seizure.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthropathy, Chills, Headache, Injection site joint pain, Muscular weakness
Clinical narrative: Got FLUAD shot. Within hours, had high fever and severe chills (made my teeth ache). Shoulder joint of shot arm painful and muscle weak. Within a week, started having problems with other joints. Aching in neck (creating headaches), fingers especially. Overall weakness in muscles. Never had any of these issues before the shot. Never had a bad reaction to a flu shot before. Been getting flu shots for years. How long will these side effects last?
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Neck pain, Pain in extremity, Pyrexia, Toothache
Clinical narrative: Got FLUAD shot. Within hours, had high fever and severe chills (made my teeth ache). Shoulder joint of shot arm painful and muscle weak. Within a week, started having problems with other joints. Aching in neck (creating headaches), fingers especially. Overall weakness in muscles. Never had any of these issues before the shot. Never had a bad reaction to a flu shot before. Been getting flu shots for years. How long will these side effects last?
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: I had the PREVNAR 13 shot as recommended by the MD for age over 65. My arm became extremely swollen where the shot was given. This didn't resolve for several days and I had to take multiple doses of BENADRYL.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Blood urea nitrogen/creatinine ratio, Dizziness, Full blood count normal, Hypotension, Metabolic function test normal
Clinical narrative: Patient received PNEUMOVAX 23 in clinic and presented to primary care provider the following day with fever and rash. Patient denied any s/sx of troubled breathing. Patient quickly became hypotensive while in clinic w/ c/o dizziness w/o loss of consciousness. IM triamcinolone and  dexamethasone was administered in clinic and patient was quickly transferred to ED for further treatment. Patient received IV fluids in ED, which allowed BP to recover and normalize. Difficult to determine if episode was a hypersensitivity type reaction of or  if the patient had underlying dehydration. As the patient's BUN:SCr BUN:SC  ratio was <20, it's difficult to r/o PNEUMOVAX 23 as cause of hypotension.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: Patient received PNEUMOVAX 23 in clinic and presented to primary care provider the following day with fever and rash. Patient denied any s/sx of troubled breathing. Patient quickly became hypotensive while in clinic w/ c/o dizziness w/o loss of consciousness. IM triamcinolone and  dexamethasone was administered in clinic and patient was quickly transferred to ED for further treatment. Patient received IV fluids in ED, which allowed BP to recover and normalize. Difficult to determine if episode was a hypersensitivity type reaction of or  if the patient had underlying dehydration. As the patient's BUN:SCr BUN:SC  ratio was <20, it's difficult to r/o PNEUMOVAX 23 as cause of hypotension.
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Muscle spasms
Clinical narrative: After getting flu shot, FLUZONE High-Dose 2017-18 0.5ML. SYR I got diarrhea, muscle cramps in legs, headache. Needed to rest and sleep day after injection.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint crepitation, Loss of personal independence in daily activities, Pain
Clinical narrative: Pain initially at the sight injection, then moved higher around the joint. Pain while rotating my arm-hard to put clothing on and jackets, pain while sleeping, overall unable to use arm as normally would; also cracking in joint.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Nodule
Clinical narrative: Patient described right arm injection site symptoms as itching and swelling that is beginning to resolve. Initially it was a raised area about the size of nickel and now described as a "marble sized" knot in her arm.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin ulcer
Clinical narrative: The patient presents with a chief complaint of constant (but worse at times) skin sores of the mid-back since approximately 7 days ago. It has the following qualities: erythematous and pruritic. The patient describes the severity as mild. The problem is made worse by clothing and application of heat. Context: The patient reports that it had a gradual onset. The patient had no similar problems in the past. The patient reports no contact with a person with similar symptoms. Recent varicella vaccination.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: (L) arm pain, radiating from shoulder down to hand. Began after vaccine and continuing (1 month). MD visit required. Patient says now taking anti-inflammatory medication.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Dyspnoea, Hypersensitivity, Pruritus, Rash
Clinical narrative: As per Emergency Room note on 10/11/17: States rash began and itchy welts to extensor surfaces of b/l arms and thighs then progressed to larger, raised lesions. Rash has not resolved but new areas continue to appear, more macular, to back of neck, sacrum, and posterior knees. Patient denies pain, denies fevers. Did have isolated episode of dyspnea 3 days ago with mild cough but stated this has since resolved. No headache, nausea, vomiting, diarrhea, dysuria, or arthralgias. Rash: Somewhat atypical and prolonged for allergic reaction but discussed with derm, who believe allergy plausible and possibility prolonged given older age of patient. Also on ddx would be infectious causes or even paraneoplastic syndrome, though these are far less likely. For now treating allergy: Cetirizine 5m daily until rash resolves, Triamcinolone Lotion to affected skin 0.1% BID, Sarna QID as needed, PREVNAR added to Allergies in chart, f/u PRN if no improvement or worsening. Rash and Urticaria Pruritus. Triamcinolone BID, Cetirizine 5 mg every day, Camphor/menthol PRN.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Rash macular, Urticaria
Clinical narrative: As per Emergency Room note on 10/11/17: States rash began and itchy welts to extensor surfaces of b/l arms and thighs then progressed to larger, raised lesions. Rash has not resolved but new areas continue to appear, more macular, to back of neck, sacrum, and posterior knees. Patient denies pain, denies fevers. Did have isolated episode of dyspnea 3 days ago with mild cough but stated this has since resolved. No headache, nausea, vomiting, diarrhea, dysuria, or arthralgias. Rash: Somewhat atypical and prolonged for allergic reaction but discussed with derm, who believe allergy plausible and possibility prolonged given older age of patient. Also on ddx would be infectious causes or even paraneoplastic syndrome, though these are far less likely. For now treating allergy: Cetirizine 5m daily until rash resolves, Triamcinolone Lotion to affected skin 0.1% BID, Sarna QID as needed, PREVNAR added to Allergies in chart, f/u PRN if no improvement or worsening. Rash and Urticaria Pruritus. Triamcinolone BID, Cetirizine 5 mg every day, Camphor/menthol PRN.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt states that site became itchy after infection, then site turned red, swollen warm to touch.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Whole upper arm moderate swelling and redness with heat. Redness opposite side of injection site (lymph nodes).
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Neurological examination normal, Oedema peripheral, Pain in extremity
Clinical narrative: Pt. c/o LUE "dead arm" sensation since the vaccination 10/11/17. Reaching upwards today, Pt experienced sharp pain ever injection site. Pt c/o (L) hand/wrist joint edema-radiating pain from deltoid to thumb. M/S and Neuro exams area all normal. "Dead arm" resolved after ice application. Given Ibuprofen 400 mg PO q 6-8 hours PRN. PMD follow-up.
Age: 83.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Haematoma, Haemorrhage
Clinical narrative: Very sick in the evening, had to call 911. Blood pressure over 200. Throwing up, shaking. 30 minutes later BP down to 160. Dr said I could stay home. Went to sleep next day all seemed normal.
Age: 83.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Malaise, Tremor, Vomiting
Clinical narrative: Very sick in the evening, had to call 911. Blood pressure over 200. Throwing up, shaking. 30 minutes later BP down to 160. Dr said I could stay home. Went to sleep next day all seemed normal.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP, FLU4, TDAP
Symptoms: Computerised tomogram head normal, Electroencephalogram normal, Influenza virus test negative, Seizure, Streptococcus test negative
Clinical narrative: Initial unsolicited report received from consumer (patient's mother) on 19-Oct-2017. This case involves a 11-year-old male patient who was vaccinated with 0.5 ml dose of ADACEL and dose of FLUZONE QIV (frequency once, batch number, expiration date, dose and site of administration was not reported) via intramuscular route on an 17 Oct 2017 at 02:30 PM. The patient's medical history and concomitant medications were not reported. On an unspecified date in the midnight, few hours following the vaccination, the patient experienced felt sick to his stomach and had a headache, he felt warm like low-grade temperature. On 18-Oct-2017 at about 2:30 am, few hours following the vaccination, patient was moving his legs and hands around when she rolled to look at him he was stiff and his eyes were pinpoint. Patient was picked up and transported to the ER he was still rigid and had mid seizure (for the seizure the whole time was about 15 minutes). His temperature in the ER was in the 99's but wasn't taken immediately. He had blood indicators of a seizure and then the patient was admitted on an unspecified date. Lab data includes CT EKG EEG, that was D/C'd the next afternoon. The patient received corrective treatment with Zofran and Advil for felt sick in stomach, headache and low grade temp. Received Ativan and Ketamine for seizure. On an unspecified date, the patient recovered from events. It was reported that the reporter felt the events was due to the Adacel. List of documents held by sender: none. Sender's Comments: The patient experienced seizure and fever post vaccination with Adacel and Fluzone QIV. Time to onset was compatible. The patient was simultaneously vaccinated with two vaccines. No information regarding patient's medical history or tolerance to previous vaccination was reported. Seizure might have been due to fever or due to any undetected underlying condition. Discharge summary from the hospital should be requested. Based upon the reported information the role of one particular vaccine cannot be assessed.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP, FLU4, TDAP
Symptoms: Abdominal discomfort, Blood test abnormal, Body temperature increased, Computerised tomogram, Dyskinesia
Clinical narrative: Initial unsolicited report received from consumer (patient's mother) on 19-Oct-2017. This case involves a 11-year-old male patient who was vaccinated with 0.5 ml dose of ADACEL and dose of FLUZONE QIV (frequency once, batch number, expiration date, dose and site of administration was not reported) via intramuscular route on an 17 Oct 2017 at 02:30 PM. The patient's medical history and concomitant medications were not reported. On an unspecified date in the midnight, few hours following the vaccination, the patient experienced felt sick to his stomach and had a headache, he felt warm like low-grade temperature. On 18-Oct-2017 at about 2:30 am, few hours following the vaccination, patient was moving his legs and hands around when she rolled to look at him he was stiff and his eyes were pinpoint. Patient was picked up and transported to the ER he was still rigid and had mid seizure (for the seizure the whole time was about 15 minutes). His temperature in the ER was in the 99's but wasn't taken immediately. He had blood indicators of a seizure and then the patient was admitted on an unspecified date. Lab data includes CT EKG EEG, that was D/C'd the next afternoon. The patient received corrective treatment with Zofran and Advil for felt sick in stomach, headache and low grade temp. Received Ativan and Ketamine for seizure. On an unspecified date, the patient recovered from events. It was reported that the reporter felt the events was due to the Adacel. List of documents held by sender: none. Sender's Comments: The patient experienced seizure and fever post vaccination with Adacel and Fluzone QIV. Time to onset was compatible. The patient was simultaneously vaccinated with two vaccines. No information regarding patient's medical history or tolerance to previous vaccination was reported. Seizure might have been due to fever or due to any undetected underlying condition. Discharge summary from the hospital should be requested. Based upon the reported information the role of one particular vaccine cannot be assessed.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP, FLU4, TDAP
Symptoms: Electrocardiogram, Electroencephalogram, Feeling hot, Headache, Miosis
Clinical narrative: Initial unsolicited report received from consumer (patient's mother) on 19-Oct-2017. This case involves a 11-year-old male patient who was vaccinated with 0.5 ml dose of ADACEL and dose of FLUZONE QIV (frequency once, batch number, expiration date, dose and site of administration was not reported) via intramuscular route on an 17 Oct 2017 at 02:30 PM. The patient's medical history and concomitant medications were not reported. On an unspecified date in the midnight, few hours following the vaccination, the patient experienced felt sick to his stomach and had a headache, he felt warm like low-grade temperature. On 18-Oct-2017 at about 2:30 am, few hours following the vaccination, patient was moving his legs and hands around when she rolled to look at him he was stiff and his eyes were pinpoint. Patient was picked up and transported to the ER he was still rigid and had mid seizure (for the seizure the whole time was about 15 minutes). His temperature in the ER was in the 99's but wasn't taken immediately. He had blood indicators of a seizure and then the patient was admitted on an unspecified date. Lab data includes CT EKG EEG, that was D/C'd the next afternoon. The patient received corrective treatment with Zofran and Advil for felt sick in stomach, headache and low grade temp. Received Ativan and Ketamine for seizure. On an unspecified date, the patient recovered from events. It was reported that the reporter felt the events was due to the Adacel. List of documents held by sender: none. Sender's Comments: The patient experienced seizure and fever post vaccination with Adacel and Fluzone QIV. Time to onset was compatible. The patient was simultaneously vaccinated with two vaccines. No information regarding patient's medical history or tolerance to previous vaccination was reported. Seizure might have been due to fever or due to any undetected underlying condition. Discharge summary from the hospital should be requested. Based upon the reported information the role of one particular vaccine cannot be assessed.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP, FLU4, TDAP
Symptoms: Muscle rigidity, Musculoskeletal stiffness, Seizure
Clinical narrative: Initial unsolicited report received from consumer (patient's mother) on 19-Oct-2017. This case involves a 11-year-old male patient who was vaccinated with 0.5 ml dose of ADACEL and dose of FLUZONE QIV (frequency once, batch number, expiration date, dose and site of administration was not reported) via intramuscular route on an 17 Oct 2017 at 02:30 PM. The patient's medical history and concomitant medications were not reported. On an unspecified date in the midnight, few hours following the vaccination, the patient experienced felt sick to his stomach and had a headache, he felt warm like low-grade temperature. On 18-Oct-2017 at about 2:30 am, few hours following the vaccination, patient was moving his legs and hands around when she rolled to look at him he was stiff and his eyes were pinpoint. Patient was picked up and transported to the ER he was still rigid and had mid seizure (for the seizure the whole time was about 15 minutes). His temperature in the ER was in the 99's but wasn't taken immediately. He had blood indicators of a seizure and then the patient was admitted on an unspecified date. Lab data includes CT EKG EEG, that was D/C'd the next afternoon. The patient received corrective treatment with Zofran and Advil for felt sick in stomach, headache and low grade temp. Received Ativan and Ketamine for seizure. On an unspecified date, the patient recovered from events. It was reported that the reporter felt the events was due to the Adacel. List of documents held by sender: none. Sender's Comments: The patient experienced seizure and fever post vaccination with Adacel and Fluzone QIV. Time to onset was compatible. The patient was simultaneously vaccinated with two vaccines. No information regarding patient's medical history or tolerance to previous vaccination was reported. Seizure might have been due to fever or due to any undetected underlying condition. Discharge summary from the hospital should be requested. Based upon the reported information the role of one particular vaccine cannot be assessed.
Age: 84.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Localized reaction, on 10/27/17, after 1 week it was 2 inches across. The next day it had increased in size, patient went to see doctor. Placed on prednisone for treatment (10/28/17).
Age: 84.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Local reaction
Clinical narrative: Localized reaction, on 10/27/17, after 1 week it was 2 inches across. The next day it had increased in size, patient went to see doctor. Placed on prednisone for treatment (10/28/17).
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Asthenia, Diarrhoea, Feeling abnormal, Gastrointestinal disorder, Headache
Clinical narrative: I developed "influenza-like-illness" in the days immediately following vaccination. On the day following vaccination (day 1), I had a headache and felt miserable. On day 2, I was physically weak. A fever developed on day 3, which continued into days 4 and 5. Gastrointestinal symptoms presented on day 4, with projectile vomiting and diarrhea.
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Influenza like illness, Pyrexia, Vomiting projectile
Clinical narrative: I developed "influenza-like-illness" in the days immediately following vaccination. On the day following vaccination (day 1), I had a headache and felt miserable. On day 2, I was physically weak. A fever developed on day 3, which continued into days 4 and 5. Gastrointestinal symptoms presented on day 4, with projectile vomiting and diarrhea.
Age: 58.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: Patient had injection site reaction and a fever on 10/28/17.  Went to the ER around 2am on 10/29/17. Followed up with PCP on 10/31/17. Prescribed diphenhydramine.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Immediate pain throughout left arm with nerve involvement causing tingling of skin starting at shoulder, over triceps, and extending through fingers of left hand. Tingling and numbness extended up left side of neck involving left ear and left cheekbone. 12 days later pain in left shoulder is resolved but numbness and tingling still reported in left hand and left side of face.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Pharyngeal oedema
Clinical narrative: This incident was reported by the patient, not the nurse, as the reaction happened several hours after the injection: "Yesterday I received a flu shot here at around 4:15. My vaccine lot number is 00844611A. 7:30 last night I was in the ER with my throat swelling up, I couldn't swallow. I felt better after receiving steroids and BENADRYL and went home around 11:45 pm." The ER the patient went to is unknown, but the patient can be contacted if that information is needed.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Eye irrigation, No adverse event
Clinical narrative: This spontaneous report has been received from a 42 year old non-pregnant female pharmacist who was also the patient, reporting on herself. The patient had no pertinent medical history, drug reactions or allergies, or concomitant medication. The patient stated that on 11-OCT-2017 she got a few drops of ZOSTAVAX (lot number N022036 and expiration date on 11-NOV-2018) in her eye. The patient did not sought medical attention. It was reported that she rinsed her eye out and then she stated that she was fine; therefore the outcome of the event was reported as recovered at the time of reporting. No adverse effects were reported.
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning to a 52 year old male patient who was a smoker. Concomitant therapies included LIPITOR. On 12-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N022303, the expiration date: 01-MAR-2019, (dose was not reported) for vaccination. On the same date, at the same site in the deltoid area of the same arm, the patient received a dose of FLUZONE (dose, route, lot# and the expiration date were not provided). On 15-OCT-2017, the patient developed "cellulitis like symptom" from the area below the injection site down to the elbow. The patient sought medical attention, visited the physician and received unspecified treatment for the event. At the time of reporting, the outcome of Cellulitis of upper arm was unknown. The relatedness between the suspect therapies and the Cellulitis of upper arm was not reported. Upon internal review, the Cellulitis of upper arm was determined to be medically significant.
Age: 23.0
Sex: F
Vaccine: FLU4, HEP, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 25-OCT-2017, the patient was inadvertently vaccinated with an expired dose of VARIVAX (lot # L041204, expiry date: 20-OCT-2017) which was reconstituted with sterile diluent (MERCK) (lot # N023308, expiry date: 04-FEB-2020) for prophylaxis. Dosing details and route of administration were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Lot # N023308 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck).
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid oedema, Toothache
Clinical narrative: This spontaneous report was received from a female patient of unknown age referring on herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On approximately 30-AUG-2017 (reported as "a month ago"), the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in approximately 2017, the patient experienced swelling in her eyelid and toothache. After a few days, the patient had recovered from the swelling in her eyelid and toothache. The causality assessment between the events and the ZOSTAVAX was not reported.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a male patient of an unknown age. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On an unspecified date, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot #, expiration date, strength, dose, route of administration, and anatomical location were not provided), for prophylaxis. Then, after 3 weeks of the first dose administration, the patient received a second dose of PNEUMOVAX 23 (lot #, expiration date, strength, dose, route of administration, and anatomical location were not provided) for the same indication; which was considered as an inappropriate schedule of vaccine administration. It was also reported that an unspecified time after receiving PNEUMOVAX 23; the patient experienced arm soreness; so he sought medical attention and was seen by the pharmacist, but it was unknown if any treatment was given for the event. No laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. The outcome of the arm soreness was unknown. The causal relationship between the arm soreness and the PNEUMOVAX 23 was not provided.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant concerning an 11 year old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 21-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 with lot number N004798 and expiration date on 31-OCT-2019 (dose, dose number, route of administration and anatomical location were not provided) administered for prophylaxis. It was reported that on an unspecified date, the vaccine was exposed to a temperature between 32 Fahrenheit degrees and 35 Fahrenheit degrees for 72 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA016179: US-009507513-1710USA001257:
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer. An 84-year-old male patient of an unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm hurt real bad, it is swollen, real swollen puffy, red down 3 inches, passed his elbow. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
Age: 1.33
Sex: M
Vaccine: HEP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult doses inadvertently given.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Blister, Influenza like illness, Pruritus, Skin lesion, Stevens-Johnson syndrome
Clinical narrative: Stevens-Johnson like reaction: multiple blister forming lesions that turned into bruise-like appearance, very pruritic, started w/ mild flu like symptoms. Lesions primarily on trunk, neck, buttocks/genitals, and corners of the mouth.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: The patient noticed a few days after the immunization that he was starting to develop small itchy red bumps on his legs. He didn't seek medical attention immediately because he thought they would go away. On 10/31/2017 he came to the pharmacy to report the rash and it had spread all over his trunk and in smaller amounts on his arms and legs. He denies any contact with new chemical substances other than the flu shot.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Pain
Clinical narrative: Patient reports a lot of pain and whole upper arm is bruised.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Inflammation, Skin warm, Swelling
Clinical narrative: Cellulitis-red,swollen, inflamed, hot 6" spot.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye swelling, Eyelid oedema, Oropharyngeal pain
Clinical narrative: Patient states that approximately around 6:30pm on the evening that she received the vaccine she experienced swelling around the eyes and eyelids (more so on the left eye) along with a sore throat and cough. The swelling began to dissipate within a few hours and has been gradually "going down" since the reaction. The sore throat and cough lasted through to the following day, for which the patient self-treated with OTC analgesic. Patient states that she has "sensitive eyes" as well and perhaps that may have contributed.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Cough, Fatigue, Headache
Clinical narrative: At 4:30 PM I started developing a cough when I took any type of deep breath. Then the glands in my neck started swelling and it was uncomfortable to breath. Then I started to get a lot of fluid or drainage in the back of my throat. I developed a rapid heartbeat, 84 BPM compared to my usual 69 to 74 BPM. I started running a low grade temperature 99.1 to 100 degrees. I started having chills at 9:00 PM. I took BENADRYL for the swelling in my throat and TYLENOL for my temperature. Then I went to bed. At approximately 1:00 AM my symptoms started to subside. This morning I do not have any of the above symptoms. I do feel drained and have a very mild headache.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate increased, Increased upper airway secretion, Lymphadenopathy, Painful respiration, Pharyngeal oedema
Clinical narrative: At 4:30 PM I started developing a cough when I took any type of deep breath. Then the glands in my neck started swelling and it was uncomfortable to breath. Then I started to get a lot of fluid or drainage in the back of my throat. I developed a rapid heartbeat, 84 BPM compared to my usual 69 to 74 BPM. I started running a low grade temperature 99.1 to 100 degrees. I started having chills at 9:00 PM. I took BENADRYL for the swelling in my throat and TYLENOL for my temperature. Then I went to bed. At approximately 1:00 AM my symptoms started to subside. This morning I do not have any of the above symptoms. I do feel drained and have a very mild headache.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: PATIENT REPORTS PAIN IN ARM STARTING 4 TO 5 DAYS AFTER SHOT ADMINISTERED. PAIN HAS PERSISTED, SOMEWHAT MITIGATED BY ACETAMINOPHEN OR IBUPROFEN. MOVEMENT MAKES THE PAIN WORST.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: Patient developed severe body aches, fever of 102.1, and diarrhea lasting about 2 days.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity, Sleep disorder
Clinical narrative: My right should joint was sore immediately. It's been two weeks now, and the pain is worse than at the time of the injection. My range of motion is severely limited with my right arm due to the pain in the shoulder joint which radiates down the arm. Doing simple tasks like getting dressed cause pain. Sleeping has also been affected. I plan to make an appointment with an orthopedic doctor today since the pain has not subsided.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Blood potassium decreased, Chest X-ray normal, Computerised tomogram thorax normal, Dyspnoea, Echocardiogram normal
Clinical narrative: Received MENACTRA on 10/24/2017, later that evening began with headache, body ache, stiff neck "felt like I was hit by a truck". Next day continued with those symptoms, then trouble breathing and rapid heart rate. Saw family doctor who ran blood tests and potassium was low. Was given fluids and extra potassium but symptoms continued over the weekend. October 30, went back to doctor for shortness of breath and rapid heart rate. Echo performed was negative. Chest X ray negative. CT scan with and without contrast was negative. November 1st, Dr. told mother that child's body aches, shortness of breathe and rapid heart rate was pleurisy caused by the MENACTRA shot. He referred her to a pulmonologist. Mother is a nurse and demanded a VAERS report to be completed.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Feeling abnormal, Headache, Heart rate increased, Musculoskeletal stiffness, Pain
Clinical narrative: Received MENACTRA on 10/24/2017, later that evening began with headache, body ache, stiff neck "felt like I was hit by a truck". Next day continued with those symptoms, then trouble breathing and rapid heart rate. Saw family doctor who ran blood tests and potassium was low. Was given fluids and extra potassium but symptoms continued over the weekend. October 30, went back to doctor for shortness of breath and rapid heart rate. Echo performed was negative. Chest X ray negative. CT scan with and without contrast was negative. November 1st, Dr. told mother that child's body aches, shortness of breathe and rapid heart rate was pleurisy caused by the MENACTRA shot. He referred her to a pulmonologist. Mother is a nurse and demanded a VAERS report to be completed.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pleurisy, Scan with contrast normal
Clinical narrative: Received MENACTRA on 10/24/2017, later that evening began with headache, body ache, stiff neck "felt like I was hit by a truck". Next day continued with those symptoms, then trouble breathing and rapid heart rate. Saw family doctor who ran blood tests and potassium was low. Was given fluids and extra potassium but symptoms continued over the weekend. October 30, went back to doctor for shortness of breath and rapid heart rate. Echo performed was negative. Chest X ray negative. CT scan with and without contrast was negative. November 1st, Dr. told mother that child's body aches, shortness of breathe and rapid heart rate was pleurisy caused by the MENACTRA shot. He referred her to a pulmonologist. Mother is a nurse and demanded a VAERS report to be completed.
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal disorder, Periarthritis
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A female patient received pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein (unspecified trade name) via an unspecified route of administration in Nov2016 (reported as "last November") at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient got one pneumococcal vaccination last November (don't know the name). Afterwards, she could not go back to using her arm. It gave be frozen shoulder. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: FLU4, FLUR3
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram normal, Dyspnoea, Electrocardiogram normal
Clinical narrative: Initial unsolicited case received from a consumer on 20 Oct 2017. This case involves 19-year-old female patient who was vaccinated with a one dose of FLUBLOK QUADRIVALENT (Batch number, expiry date, dose, dose in series were not reported) intramuscularly in right arm on 13 Oct 2017 and also a dose of FLUZONE QIV (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient medical history and concomitant medications were not reported. On 16 Oct 2017, three days after the vaccination with FLUBLOK QUADRIVALENT and unspecified time frame after the vaccination with FLUZONE QIV, patient began having shortness of breath (SOB) due to weak chest muscle, and due to which she was seen in ER twice and seen by primary care. Diagnostic testing included CT scan, chest x-ray, EKG, blood work and pulmonary function tests, all tests normal and was referred to neurologist. Other lab tests were not reported. Corrective treatment was not reported. Outcome of both the events were reported as unknown. List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: FLU4, FLUR3
Symptoms: Muscular weakness, Pulmonary function test normal
Clinical narrative: Initial unsolicited case received from a consumer on 20 Oct 2017. This case involves 19-year-old female patient who was vaccinated with a one dose of FLUBLOK QUADRIVALENT (Batch number, expiry date, dose, dose in series were not reported) intramuscularly in right arm on 13 Oct 2017 and also a dose of FLUZONE QIV (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient medical history and concomitant medications were not reported. On 16 Oct 2017, three days after the vaccination with FLUBLOK QUADRIVALENT and unspecified time frame after the vaccination with FLUZONE QIV, patient began having shortness of breath (SOB) due to weak chest muscle, and due to which she was seen in ER twice and seen by primary care. Diagnostic testing included CT scan, chest x-ray, EKG, blood work and pulmonary function tests, all tests normal and was referred to neurologist. Other lab tests were not reported. Corrective treatment was not reported. Outcome of both the events were reported as unknown. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: FLUR4
Symptoms: Diarrhoea, Nausea, Swelling face, Urticaria, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer on 23-Oct-2017. This case involves 11 years old female patient who was vaccinated with 0.5 ml dose of FLUBLOK QUADRIVALENT (Frequency: once, batch number: U4698CB, expiry date and site of administration were not reported) intramuscularly on 08 Jan 2014. The patient's medical history and concomitant medication were not reported. On 9 Jan 2014 one day post vaccination (Reported as next day after vaccination) patient had nausea, diarrhea, hives, vomiting and facial swelling. On an unspecified date he was hospitalized and went to ER via 911 and released. Laboratory investigation and corrective treatment were not reported. Outcome of events was unknown. List of documents held by sender: none. Sender's Comments: The patient experienced nausea, vomiting, diarrhea, hives and swelling of face post vaccination with Fluzone. Time to onset is compatible. The events are suggestive of an allergic response. Patient's medical history and response to previous vaccinations has not been reported. Additional information about previous alergic reactions if any or any allergic testing results should be requested. There is a possibility that the events were a result of an alternate etiology unrelated to vaccination. The response could have been triggered by an alternate allergen. Based upon reported information the role of the vaccine cannot be assessed.