chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Axillary pain, Body temperature increased, Crying, Full blood count, Metabolic function test
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old female patient with acne and no drug reactions or allergies. On 22-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot #L040164 exp date 20-FEB-2018) intramuscularly. On 27-APR-2016, the patient received the second dose of GARDASIL 9 (lot # reported as L048459 exp date 22-FEB-2018) intramuscularly and the first dose of VAQTA (lot # M003011 exp date 15-NOV-2017) (dose and route not reported). Concomitant therapies included tretinoin, azelaic acid, TRI-SPRINTEC and minocycline. The physician reported that on 29-APR-2016, the patient developed swelling and extreme pain and tenderness in her bilateral axillary areas. The patient was unable to lift either of her arms due to the intensity of the pain and tenderness. The patient visited the physician on 02-MAY-2016, at which time she burst out crying due to the intensity of the pain and tenderness in her axillary areas upon palpation. The patient's vital signs taken at the visit were: temperature of 38.2 degrees C (fever), blood pressure 104/60, respiratory rate 16 and weight 51.7 kg. It was unable to be clarified whether any of these values (besides temperature) were abnormal for the patient. The physician drew patient's blood on 02-MAY-2016 to have complete blood count and basic metabolic panel performed (results were pending). The patient was treated with ibuprofen. At the time of the report, the patient had not recovered. Extreme pain and tenderness in her bilateral axillary areas and unable to lift either of her arms were considered to be disabling by the physician. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Mobility decreased, Swelling, Tenderness
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old female patient with acne and no drug reactions or allergies. On 22-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot #L040164 exp date 20-FEB-2018) intramuscularly. On 27-APR-2016, the patient received the second dose of GARDASIL 9 (lot # reported as L048459 exp date 22-FEB-2018) intramuscularly and the first dose of VAQTA (lot # M003011 exp date 15-NOV-2017) (dose and route not reported). Concomitant therapies included tretinoin, azelaic acid, TRI-SPRINTEC and minocycline. The physician reported that on 29-APR-2016, the patient developed swelling and extreme pain and tenderness in her bilateral axillary areas. The patient was unable to lift either of her arms due to the intensity of the pain and tenderness. The patient visited the physician on 02-MAY-2016, at which time she burst out crying due to the intensity of the pain and tenderness in her axillary areas upon palpation. The patient's vital signs taken at the visit were: temperature of 38.2 degrees C (fever), blood pressure 104/60, respiratory rate 16 and weight 51.7 kg. It was unable to be clarified whether any of these values (besides temperature) were abnormal for the patient. The physician drew patient's blood on 02-MAY-2016 to have complete blood count and basic metabolic panel performed (results were pending). The patient was treated with ibuprofen. At the time of the report, the patient had not recovered. Extreme pain and tenderness in her bilateral axillary areas and unable to lift either of her arms were considered to be disabling by the physician. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist, refers to a female patient, who is currently 66 years old. Although no concurrent conditions were reported, she did have a history of adverse reactions with an unspecified penicillin and SULFA. On 29-MAR-2016, the patient was vaccinated with 0.65 ml dose of ZOSTAVAX, subcutaneously (which had a lot # of L031271 and expiration date of 19-NOV-2016; however, dosage number and anatomical location were not reported). No concomitant medications were reported. Subsequently, on an unspecified date in 2016, the patient experienced an injection site reaction described as something that looked like a bruise at the site of injection. Reportedly, it did not hurt unless a push was applied on the site (injection site bruising)(injection site pain). The patient sought medical attention by contacting the pharmacist. Furthermore, it was reported that the events had lasted for over 30 days and at the time of reporting, the patient had recovered from them. The reporter failed to provide any causal relationship between the events and the vaccination with ZOSTAVAX. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Blood culture, Chills, Malaise, Pyrexia
Clinical narrative: Pt had vaccine at 4:54 pm and started to feel sick with fever and chills at 8pm. Pt arrived at our unit with temp 38 degrees C and chills.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not provided. On an unknown date, the patient was vaccinated with (Oka/Merck) (manufacturer unknown) (lot number, expiration date, dose, route and anatomical location were unknown). There was no concomitant medication reported. On an unknown date, the patient was diagnosed with varicella. According to the reporter, two doses of vaccine are required for attendance in all state schools. At the time of the report, the outcome of varicella was unknown. The reporting nurse did not assess the causal relationship between the adverse event with the varicella virus vaccine live (Oka/Merck) (manufacturer unknown). Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: TDAP given 01/18/16. Patient experiencing left shoulder pain ever since.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Injection site pain
Clinical narrative: Redness appeared 5-5-16 and spreading. Sore deltoid (right).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Fungal infection, Fungal test positive, Injection site reaction
Clinical narrative: Fungal infection developed surrounding the injection area.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Immediate post-injection reaction, Injection site swelling, Mobility decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain started immediately 5-5-16, continued 5-6-16 cannot raise her arm, minimal swelling (R) deltoid.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 07-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (injection, lot # L044058, expiration date 02-MAY-2017) (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Skin warm
Clinical narrative: Area on (R) arm 4cm x 3cm, occurred day after received the pneumonia vaccination (4/29/16), and has persisted since despite unsuccessful treatment at home. Pt reports slightly warm to the touch, slightly sore to the touch. Has cont. redness since injection. Treatment: Cont. BENADRYL 25mg Q 6 hours PRN itching, prescribed prednisone 10mg x3 days, if symptoms worsen, need to be re-examined.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pediatrician via company representative referring to unspecified number of patients of unknown ages and genders. The patient's concurrent and historical conditions were not reported. On unknown dates the patients were vaccinated with the second dose of GARDASIL 9 (lot number, expiration date, dose and route were not reported). The reporting physician stated that the patients received the first dose on unknown dates and then did not come back to office for the second dose, but returned one year later and received the second dose of GARDASIL 9, they received dosing outside recommended schedule (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complain was involved. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: This spontaneous report was received from a 82 year old female patient reporting on herself, who is also a Registered Nurse. The patient concurrent conditions and medical history included hypertension, hypercholesterolaemia, hypothyroidism, arrhythmia and allergy to AUGMENTIN. On 03-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose number, strength, route, lot number and expiration date were not provided). Concomitant therapies included lisinopril (manufacturer unknown), SYNTHROID, amiodarone, and LIPITOR. On 04-MAY-2016, the patient experienced mild headache and lightheadedness (dizziness). TYLENOL was given for the adverse events. The outcome of headache and dizziness was reported as recovering. The case did not involve cancer or overdose. The reporter did not assess the relatedness between the event and suspect therapy. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Urticaria
Clinical narrative: Redness, hives. Treated with BENADRYL, hydrocortisone.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Osteoarthritis, X-ray limb
Clinical narrative: Received flu shot 16 Sep 15. Next day I could hardly move my left arm. (Meloxicam) Reaction. Physical therapy. No help. 4 Jan 2016 xray of left shoulder. Osteoarthritis. Injection of MEDROL. Oct 2015 had cortisone shot. Also on 4 Jan 16 had a cortisone shot. Please see attached.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 13-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (injection, lot # L044058, expiration date 02-MAY-2017) (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.21
Sex: M
Vaccine: HIBV, MMR
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccine 5/5/16. At site where MMR given, appears warm and swollen (Left upper arm/posterior).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 11-APR-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX injection, lot # L044524, expiration date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes.  There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (injection, lot # L044058, expiration date 02-MAY-2017) (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (injection, lot # L044058, expiration date 11-MAY-2017) (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67 year old female patient. The patient did not have medical history, concurrent conditions and drug reactions. On 25-APR-2016, the patient was vaccinated in her arm with a dose of PNEUMOVAX23 intramuscularly (strength, dose number, lot number and expiration date were not provided). The patient did not take concomitant medications. On 25-APR-2016, the patient experienced in her arm (unspecified if right or left) injection site swelling, injection site pain, injection site pruritus and had a six to eight inch area of redness around the injection site (injection site erythema). No treatment was given for the adverse events. No laboratory diagnostics studies were performed. The case did not involve cancer or overdose. The outcome of injection site pain, injection site erythema, injection site pruritus and injection site swelling was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 0.65
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Culture, Injection site abscess
Clinical narrative: Abscess to left and right thigh. Cephalexin 5ml oral BID x 10 days. Ibuprofen 0.5ml oral TID PRN pain. Warm compress.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 11-APR-2016, the patient was vaccinated with an improperly stored dose VARIVAX injection, lot #L044524, expiration date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis inferior to injection site.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (injection, lot # L044058, expiration date 02-MAY-2017) (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (injection, lot # L044058, expiration date 02-MAY-2017) (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.26
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash suspicious for shingles.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 11-APR-2016, the patient was vaccinated with an improperly stored dose VARIVAX injection, lot # L044524, expiration date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (injection, lot # L044058, expiration date 02-MAY-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Breast pain, Breast tenderness, Erythema, Pain
Clinical narrative: This spontaneous report has been received from a 74 year old female patient reporting on herself. The patient's concurrent conditions included penicillin allergy, none pertinent medical history were reported. In April 2011 (reported as "5 years ago"), the patient was vaccinated with ZOSTAVAX 19400 (plaque forming units), (lot #, expiry date, strength and route of administration were not provided), 0.65 ml "one shot in her left arm" for shingles prevention. None concomitant medication were reported. on 25-APR-2016 (reported as yesterday), the patient noticed that there was a sore tender area developing on her left breast and on 26-APR-2016 (reported as today), there was an area that appeared "red, bumpy and it was blister looking", which run from the side of the patient's left breast up to under her arm. Additionally, the patient also mentioned she was experiencing pain around the same area and she though it might was shingles. Subsequently, she purchased from her local pharmacy an Aloe spray mist called "cool blue" and a topical ointment called "burn gel" to treat her affected area. The patient sought medical attention and stated that the nurse practitioner prescribed her Acyclovir 800mg to take as well to help treat her shingles. None lab diagnostics studies were performed. At the reporting time, the patient did not recover from shingles. The causal assessment between shingles to ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-APR-2016, the patient was vaccinated with an improperly stored dose VARIVAX injection, lot #L044524, expiration date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-APR-2016, the patient was vaccinated with an improperly stored dose VARIVAX injection, lot # L044524, expiration date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-APR-2016, the patient was vaccinated with an improperly stored dose VARIVAX, lot #L044524, expiration date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-APR-2016, the patient was vaccinated with an improperly stored dose VARIVAX injection, lot # L044524, expiration date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (injection, lot # L044058, expiration date 02-MAY-2017)(dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) deltoid with swelling and redness extended down arm to elbow. No pain associated with above symptoms.
Age: 1.01
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Blood test normal, Chest X-ray normal, Cytogenetic analysis normal, Electroencephalogram normal, Generalised tonic-clonic seizure
Clinical narrative: Tonic clonic seizure 8:42 AM 5 min long. Complex tonic clonic seizure 9:18 AM 5 min long. Tonic clonic seizure 5:30 PM 3 min long. 2/19 Tonic clonic seizure 10:00 AM 3 min long. Tonic clonic seizure 1:30 PM 2 min long.
Age: 1.01
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Nuclear magnetic resonance imaging normal, Urine analysis normal
Clinical narrative: Tonic clonic seizure 8:42 AM 5 min long. Complex tonic clonic seizure 9:18 AM 5 min long. Tonic clonic seizure 5:30 PM 3 min long. 2/19 Tonic clonic seizure 10:00 AM 3 min long. Tonic clonic seizure 1:30 PM 2 min long.
Age: 20.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site rash, Pain, Pruritus, Skin irritation
Clinical narrative: Extreme irritation and itch, pain when pressure applied (ex. sleeping on area), 2in diameter original bump/rash in injection site, after benedryl ointment (reccommended by doctor's office who administered vaccine) applied for temporary treatment the area grew to nearly twice the size.
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Blood test, Influenza like illness, Pain, Polyarteritis nodosa, Pyrexia
Clinical narrative: He began with a high fever the first day. Within that week he started having flu like symptoms, severe body aches, fever but no sinus activity. This continued for a month. After several pediatrician visits, xrays and two blood work ups we were directed to Hospital, Infectious Disease Department. More blood work, xrays and scans revealed what they believe to be Polyarteritis Nodosa, a vasculitis disease. He was perfectly healthy the day of his yearly checkup.
Age: 15.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Scan, X-ray
Clinical narrative: He began with a high fever the first day. Within that week he started having flu like symptoms, severe body aches, fever but no sinus activity. This continued for a month. After several pediatrician visits, xrays and two blood work ups we were directed to Hospital, Infectious Disease Department. More blood work, xrays and scans revealed what they believe to be Polyarteritis Nodosa, a vasculitis disease. He was perfectly healthy the day of his yearly checkup.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Arthritis, Gait disturbance
Clinical narrative: Severe joint inflammation. Could hardly get dressed or walk.  This lasted for about 2 1/2 months before it started to ease up.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Pyrexia
Clinical narrative: Experienced fever and a lump at inject site???
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Eyelid oedema
Clinical narrative: Left eye area (not actual eyeball) became swollen and puffy. Have school picture showing it. No discoloration.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Skin warm
Clinical narrative: Itchy, achy, warm to touch, pt noticed on 5/6/16 in the afternoon. Area approx. 3" x 9".
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site pain, Insomnia
Clinical narrative: First, extreme pain at the injection site (left upper arm) as if someone punched me hard in the arm. I could not sleep because the pain was so intense. The next morning, I could not lift my arm above shoulder height and the pain radiated down my arm to about my elbow, both inner and outer arm. Several hours later, I took my temperature and it was 100. There was slight bruising under the skin in a radius about 5 inches around the injection site and some redness, but no red streaking. I was concerned so called the pharmacy that administered the vaccination. Said my reaction was atypical. It took 4 days to feel any relief from the pain. Mild fever lasted for 2 days.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: First, extreme pain at the injection site (left upper arm) as if someone punched me hard in the arm. I could not sleep because the pain was so intense. The next morning, I could not lift my arm above shoulder height and the pain radiated down my arm to about my elbow, both inner and outer arm. Several hours later, I took my temperature and it was 100. There was slight bruising under the skin in a radius about 5 inches around the injection site and some redness, but no red streaking. I was concerned so called the pharmacy that administered the vaccination. Said my reaction was atypical. It took 4 days to feel any relief from the pain. Mild fever lasted for 2 days.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, MNQ, RVX
Symptoms: Brain injury, Emotional distress, Encephalitis, Lethargy, Noninfective encephalitis
Clinical narrative: Inconsolable, high pitched, odd screaming unrecognizable to me, (his mother.) Signs of brain inflammation, encephalitis, potential brain damage.. extreme sleepiness and lethargy followed. No treatment.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, MNQ, RVX
Symptoms: Screaming
Clinical narrative: Inconsolable, high pitched, odd screaming unrecognizable to me, (his mother.) Signs of brain inflammation, encephalitis, potential brain damage.. extreme sleepiness and lethargy followed. No treatment.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site warmth, Pruritus, Swelling
Clinical narrative: Swollen, red, itching, injection area site hot.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Injection site pain, Pyrexia, Tremor
Clinical narrative: Patient report shaking, fever of 104.0, following PREVNAR 13 vaccination, states he presented to hospital ER for evaluation. Reports multiple lab work performed, states he was discharged  the same day. Patient reports joint pain on left arm, shoulder, hand, elbow pain, states location of vaccination, states it also feels like someone punched me real hard where they gave me the shot.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 11.0
Sex: M
Vaccine: MENB, MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Got shots and in 24 hours got red and swollen.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to an unknown number of patients of unknown age. Since 05-APR-2016, the patients were vaccinated with an improperly stored RECOMBIVAX HB lot # L033343, 13-SEP-2017. Temperature excursion 34 Fahrenheit for 93 minutes. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown demographics. On an unspecified date since 18-APR-2016, the patient was administered a dose of ZOSTAVAX (lot #L044530; expiry date: 09-FEB-2017) that was improperly stored. No adverse effects were reported. Temperature/Time frame was 46F for 240 hours. There were no previous temperature excursions. This call was not because of a data logger. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to an unknown number of patients of unknown age. Since 05-APR-2016, the patients were vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) lot # L023936, 15-MAR-2017. Temperature excursion 34 Fahrenheit for 93 minutes. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: PNC13
Symptoms: Blood lactic acid increased, Computerised tomogram abdomen normal, Erythema, Nausea, Pyrexia
Clinical narrative: Severe nausea and vomiting, shaking, fever, chest redness, burning sensation on chest, throat "like the worst sunburn I every had"  elevated lactic acid.
Age: 47.0
Sex: F
Vaccine: PNC13
Symptoms: Skin burning sensation, Throat irritation, Tremor, Vomiting
Clinical narrative: Severe nausea and vomiting, shaking, fever, chest redness, burning sensation on chest, throat "like the worst sunburn I every had"  elevated lactic acid.
Age: 35.0
Sex: M
Vaccine: MMR
Symptoms: Influenza like illness, Influenza virus test positive, Rash
Clinical narrative: Patient received her MMR on April 25 from her primary care doctor.  Then on May 5th, she developed flu like symptoms and rash on May 7th.  Tested positive flu today.  Unclear if rash is from MMR.  Seen in urgent care today. Pt will follow up with her primary care doctor tomorrow.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: Patient noticed itchy rash in the evening. No difficulty breathing or reaction at the injection site. No pain at the injection site. Took Benadryl at bedtime and applied anti-itch cream to the rash.
Age: 60.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Axillary pain, Breast pain, Herpes zoster, Rash
Clinical narrative: Bumpy rash on left shoulder blade, aching pain in armpit and stinging pains in left breast. Dr. thought it was beginning of Shingles. Gave me Acyclovir 800 mg 5x a day.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Productive cough
Clinical narrative: Patient has been problem breathing, unable to breath and excessive phlegm.
Age: 57.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site joint pain, Injection site pain, Injection site warmth, Weight bearing difficulty
Clinical narrative: Muscle ache at injection site (upper left arm near shoulder) soreness continues and now I have pain in joint area. Pain is getting progressively worse. upper shoulder area feels warm to the touch. Cannot left 3lb weight.
Age: 57.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Injection site pain, Muscular weakness, Skin warm
Clinical narrative: Muscle ache at injection site (upper left arm near shoulder) soreness continues and now I have pain in joint area. Pain is getting progressively worse. upper shoulder area feels warm to the touch. Cannot left 3lb weight.
Age: 64.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Phlebitis, Pyrexia, Swelling, Thrombophlebitis
Clinical narrative: Swelling on 04.20.16, fever of 102 degrees F on 04.21.16.  Diagnosed with phlebitis/thrombophlebitis 04.22.16 -given Zpak.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site paraesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Based on additional information received on 03 March 2016. The case become medically confirmed. Initial unsolicited report received from a consumer on 04 December 2015. This case involves a 76-year-old patient who was vaccinated with an intramuscular dose of FLUZONE HD (batch number was unknown, dose, dose in series was not reported) in left deltoid on 29 September 2015. Medical history and concomitant medications were not reported. On 29 September 2015, same day following the vaccination, the patient experienced soreness at injection site. 30 September 2015, one day following vaccination, patient's left arm from shoulder to elbow was painful, arm had become increasingly sore, involves entire arm, and now had tingling down entire arm and had difficulty moving arm. On an unspecified date the patient went to own healthcare professional about 2 or 3 weeks ago (required emergency room or physician visit) but symptoms had been possibly attributed to arthritis. Lab data and corrective treatments were not reported. Patient was not recovered from events. List of documents held by sender: none. Follow up report received from Pharmacist on 03 March 2016. Batch number and expiration date was updated as UI453AA and 30 April 2016 respectively.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Information has been received from a physician via a company representative referring to a 14 year old male patient. On an unknown date the patient was vaccinated with GARDASIL 9 (dose, lot# and route were unknown). Concomitant therapy included Hepatitis A vaccine (manufacturer unknown). On 02-MAR-2016 the patient passed out and hit his head on the door. The patient visited the doctor for the events on an unknown date. The patient recovered from the events in March 2016. Causality was not provided. Follow up information has been received on 05-MAY-2016 from a healthcare professional referring to the 14 year old male patient. On 02-MAR-2016, at 15:29, the patient was vaccinated with his second dose of GARDASIL 9 (dose was unknown, lot#: L020015, expiry date unknown, intramuscular). Other suspect therapy vaccinated on the same day at 15:29 included the second dose of HAVRIX (lot#49LH2), intramuscularly (dose unknown). The patient was standing at checkout counter and said on 02-MAR-2016, at 15:29, everything got dark and he lost consciousness and fell backward, hitting his head on the door. The reporter immediately was able to get the patient on a bench and lay down with feet up. The patient was OK (also reported as recovered) after 15 to 20 minutes on the same day and was able to leave. Upon internal review, loss of consciousness was determined to be medically significant. Additional information has been requested. Reporter information, patient information, product, event, seriousness criteria, narrative were updated.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Information has been received from a physician via a company representative referring to a 14 year old male patient. On an unknown date the patient was vaccinated with GARDASIL 9 (dose, lot# and route were unknown). Concomitant therapy included Hepatitis A vaccine (manufacturer unknown). On 02-MAR-2016 the patient passed out and hit his head on the door. The patient visited the doctor for the events on an unknown date. The patient recovered from the events in March 2016. Causality was not provided. Follow up information has been received on 05-MAY-2016 from a healthcare professional referring to the 14 year old male patient. On 02-MAR-2016, at 15:29, the patient was vaccinated with his second dose of GARDASIL 9 (dose was unknown, lot#: L020015, expiry date unknown, intramuscular). Other suspect therapy vaccinated on the same day at 15:29 included the second dose of HAVRIX (lot#49LH2), intramuscularly (dose unknown). The patient was standing at checkout counter and said on 02-MAR-2016, at 15:29, everything got dark and he lost consciousness and fell backward, hitting his head on the door. The reporter immediately was able to get the patient on a bench and lay down with feet up. The patient was OK (also reported as recovered) after 15 to 20 minutes on the same day and was able to leave. Upon internal review, loss of consciousness was determined to be medically significant. Additional information has been requested. Reporter information, patient information, product, event, seriousness criteria, narrative were updated.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with drug allergies to CEFZIL, AMOXIL and erythromycin derivatives. The patient had no concomitant medication or pertinent medical history, and was not pregnant. On 30-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 (dose not reported, Lot # L027282 and expiration date 21-SEP-2017) intramuscularly. On 28-DEC-2015 and 29 APR-2016, she received the second dose (dose unknown, Lot # L028083 and expiration date 03-SEP-2017, route: intramuscular) and third dose (Lot # L040164 and expiration date 20-FEB-2018, route: intramuscular) respectively. On 03-MAY-2016, after receiving the third dose of the vaccine, the patient was complaining of arm numbness and pain in the leg (unspecified arm and leg). The patient had sought medical attention by calling to the office. She was treated with ice compress and TYLENOL. The outcome of the events was unknown. The causal relationship between the events and GARDASIL 9 was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with drug allergies to CEFZIL, AMOXIL and erythromycin derivatives. The patient had no concomitant medication or pertinent medical history, and was not pregnant. On 30-OCT-2015, the patient was vaccinated with the first dose of GARDASIL 9 (dose not reported, Lot # L027282 and expiration date 21-SEP-2017) intramuscularly. On 28-DEC-2015 and 29 APR-2016, she received the second dose (dose unknown, Lot # L028083 and expiration date 03-SEP-2017, route: intramuscular) and third dose (Lot # L040164 and expiration date 20-FEB-2018, route: intramuscular) respectively. On 03-MAY-2016, after receiving the third dose of the vaccine, the patient was complaining of arm numbness and pain in the leg (unspecified arm and leg). The patient had sought medical attention by calling to the office. She was treated with ice compress and TYLENOL. The outcome of the events was unknown. The causal relationship between the events and GARDASIL 9 was not reported. Additional information has been requested.
Sex: M
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a nurse via other company (Pfizer) (manufacturer reference number- 2016219468) on 21 April 2016. This case involves a male patient who was vaccinated with a dose of TETANUS TOXOID (Tetanus) (batch number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced allergy to tetanus vaccine (moderate). Laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Shock
Clinical narrative: Initial unsolicited report received from a health care professional (physician's assistant) on 21 April 2016. This case involves a (age and gender not reported) patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient went into shock. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event shock. List of documents held by sender: none.; Sender's Comments: Shock is unlisted with the role of the vaccine. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Abdominal pain, Autopsy, Death
Clinical narrative: Initial unsolicited report received from a physician on 27 April 2016. This case involves a four-year-old female patient who was vaccinated with a dose of DAPTACEL (batch number C4709AA, expiration date: 24 February 2017, via intramuscular route, dose, dose in series and site of administration was not reported) and a dose of IPOL (batch number L1001-1, expiry date: 14 January 2017, via intramuscular route, dose, dose in series and site of administration was not reported), both on 18 March 2016. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not provided. On an unspecified date following the vaccination, the patient developed abdominal pain and returned to the physician's office on 23 March 2016 who requested that the child be taken immediately to the emergency room. It was reported that there was no information on what medical facility the patient was taken to or whether the patient was actually taken. On 24 March 2016, six days following vaccination, the patient died. Lab data and corrective treatment were not reported. Patient had not recovered from abdominal pain event at the time of death. It was reported that autopsy was pending. List of documents held by sender: none. Sender's Comments: This is a poorly documented death case of a child who was vaccinated with diphtheria-15/tetanus/5 AC pertussis vaccine and IPV (VERO). Five days after vaccination, patient experienced abdominal pain and died the next day. Patient was taken for physician consultation on having abdominal pain, however was referred to emergency room and no further details were provided. No information regarding any previous history of abdominal pain, relevant medical and birth history, underlying cause of death and any diagnostic testing reports were provided. Autopsy result was not available. Due to the very limited available information, causality cannot be assessed for now. Reported Cause(s) of Death: abdominal pain; death nos.