chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Peripheral swelling
Clinical narrative: Case number PHHY2014US170083, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546681) website on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 345066) on 29 Jan 2015. This report refers to a 33 year old female patient. Her medical history and concomitant medication was not reported. On 18 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1413301) IM into right arm. On the same day she also received PNEUMOVAX (batch number: K009809, other manufacturer) IM into right arm and BOOSTRIX (batch number: 3H432, other manufacturer) IM into left arm. On 19 Sep 2014, she experienced painful right arm at site of injection with flu-like symptoms. On 20 Sep 2014, she went to emergency room (ER) and discharged same night with arm sling. She returned to ER on 22 Sep 2014, due to increased arm pain and swelling. MRI of right humerus was taken on 22 Sep 2014 but results were not reported. She was admitted and treated for cellulitis with IV antibiotics. She was discharged on 25 Sep 2014. Final outcome of the events was recovered. Causality assessment was not reported. Events were reported as serious (hospitalization). Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1413301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 345066) on 06 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 345066) on 29 Jan 2015: Updated FLUVIRIN vaccine batch review report.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Blood culture negative, Ear swelling, Full blood count normal, Headache
Clinical narrative: Diffuse body rash, pain, swelling (L) ear and neck. Arthralgia, HA, nausea, fever on 10/8 at 0156 when presented to ER. Treated, discharged, Dx: Viral syndrome. WBC = 3.6 flu test (-). Pt returned to ER 10/8 at 1909 w/fever. Rash N/V placed in hosp as obs status. Dx Acute Allergic rxn.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Influenza virus test negative, Local swelling, Metabolic function test normal, Nausea
Clinical narrative: Diffuse body rash, pain, swelling (L) ear and neck. Arthralgia, HA, nausea, fever on 10/8 at 0156 when presented to ER. Treated, discharged, Dx: Viral syndrome. WBC = 3.6 flu test (-). Pt returned to ER 10/8 at 1909 w/fever. Rash N/V placed in hosp as obs status. Dx Acute Allergic rxn.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia, Rash generalised, Urine analysis normal, Viral infection
Clinical narrative: Diffuse body rash, pain, swelling (L) ear and neck. Arthralgia, HA, nausea, fever on 10/8 at 0156 when presented to ER. Treated, discharged, Dx: Viral syndrome. WBC = 3.6 flu test (-). Pt returned to ER 10/8 at 1909 w/fever. Rash N/V placed in hosp as obs status. Dx Acute Allergic rxn.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting, White blood cell count decreased
Clinical narrative: Diffuse body rash, pain, swelling (L) ear and neck. Arthralgia, HA, nausea, fever on 10/8 at 0156 when presented to ER. Treated, discharged, Dx: Viral syndrome. WBC = 3.6 flu test (-). Pt returned to ER 10/8 at 1909 w/fever. Rash N/V placed in hosp as obs status. Dx Acute Allergic rxn.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Erythema, Laboratory test abnormal, Lymphadenopathy, Peripheral swelling
Clinical narrative: Case number PHHY2014US170671, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549453) website on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 344976) on 29 Jan 2015. This report refers to a 60-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 146302) intramuscularly and ZOSTAVAX (batch number: K007987, other manufacturer) via subcutaneous route, on 06 Oct 2014. On 07 Oct 2014, she experienced red swollen arm and lymph nodes. She was diagnosed with cellulitis in the lab test (unspecified). The events reported as non-serious. Seriousness assessment of the events (cellulitis and red swollen arm) was upgraded based on the available information in the source document. The event cellulitis was reported as a medication side effect. The causality of the event swollen lymph nodes was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 146302) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 344976) on 05 Jan 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 344976) on 29 Jan 2015: Updated FLUVIRIN vaccine batch review report.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, HPV4, MEN, TDAP
Symptoms: Arthralgia, Balance disorder, Blood test, Chest X-ray, Computerised tomogram
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 12 year old female patient (daughter). The patient's concurrent conditions included unspecified seasonal allergies. On 24-SEP-2014 the patient was vaccinated with a GARDASIL, dose first of series of 3, intramuscularly. Concomitant vaccines administered to the patient on the same day included T-DAP and meningococcal vaccine. The patient's mother said that the daughter had been experiencing chronic long-term side effects after receiving GARDASIL. The patient developed a fever and decreased appetite within 24-hours after receiving first dose of a series of three recommended doses of GARDASIL (estimated date September 2014). The other patient's symptoms developed in the first weeks of October 2014 which included chronic cough, shortness of breath, loss of balance, hip pain, pain down her leg, "shaking hand" headaches and nerve pain. The patient experienced also vomiting, nausea, loss of appetite, loss of weight of 20 lbs, persistent fever, "she could not hold any fluid" therefore she went to the emergency room and was diagnosed with Mesenteric Adenitis on 28-OCT-2014. The patient's fever "maintained" at about 101 degrees and lasted for a total of 6 weeks. The patient sought a medical attention, she was under Pediatric Care since October 2014. There were lab diagnostics studies performed: computerized tomography (CT) scan, chest X-rays, bloodwork. There was no treatment given for the adverse events, because they were of viral origin and would resolve on their own. The outcome of mesenteric adenitis, pain down her leg, hip pain, headaches, chronic cough, nerve pain, hand shaking, weight loss, loss of balance and shortness of breath was unknown. The outcome of decreased appetite was reported as recovered/resolved (reported also as "appetite is back") (date unspecified). The relatedness between the event and GARDASIL was not reported. Lot number U006236 is an invalid lot number for GARDASIL. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, HPV4, MEN, TDAP
Symptoms: Cough, Decreased appetite, Dyspnoea, Headache, Lymphadenitis
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 12 year old female patient (daughter). The patient's concurrent conditions included unspecified seasonal allergies. On 24-SEP-2014 the patient was vaccinated with a GARDASIL, dose first of series of 3, intramuscularly. Concomitant vaccines administered to the patient on the same day included T-DAP and meningococcal vaccine. The patient's mother said that the daughter had been experiencing chronic long-term side effects after receiving GARDASIL. The patient developed a fever and decreased appetite within 24-hours after receiving first dose of a series of three recommended doses of GARDASIL (estimated date September 2014). The other patient's symptoms developed in the first weeks of October 2014 which included chronic cough, shortness of breath, loss of balance, hip pain, pain down her leg, "shaking hand" headaches and nerve pain. The patient experienced also vomiting, nausea, loss of appetite, loss of weight of 20 lbs, persistent fever, "she could not hold any fluid" therefore she went to the emergency room and was diagnosed with Mesenteric Adenitis on 28-OCT-2014. The patient's fever "maintained" at about 101 degrees and lasted for a total of 6 weeks. The patient sought a medical attention, she was under Pediatric Care since October 2014. There were lab diagnostics studies performed: computerized tomography (CT) scan, chest X-rays, bloodwork. There was no treatment given for the adverse events, because they were of viral origin and would resolve on their own. The outcome of mesenteric adenitis, pain down her leg, hip pain, headaches, chronic cough, nerve pain, hand shaking, weight loss, loss of balance and shortness of breath was unknown. The outcome of decreased appetite was reported as recovered/resolved (reported also as "appetite is back") (date unspecified). The relatedness between the event and GARDASIL was not reported. Lot number U006236 is an invalid lot number for GARDASIL. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, HPV4, MEN, TDAP
Symptoms: Nausea, Neuralgia, Pain in extremity, Pyrexia, Tremor
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 12 year old female patient (daughter). The patient's concurrent conditions included unspecified seasonal allergies. On 24-SEP-2014 the patient was vaccinated with a GARDASIL, dose first of series of 3, intramuscularly. Concomitant vaccines administered to the patient on the same day included T-DAP and meningococcal vaccine. The patient's mother said that the daughter had been experiencing chronic long-term side effects after receiving GARDASIL. The patient developed a fever and decreased appetite within 24-hours after receiving first dose of a series of three recommended doses of GARDASIL (estimated date September 2014). The other patient's symptoms developed in the first weeks of October 2014 which included chronic cough, shortness of breath, loss of balance, hip pain, pain down her leg, "shaking hand" headaches and nerve pain. The patient experienced also vomiting, nausea, loss of appetite, loss of weight of 20 lbs, persistent fever, "she could not hold any fluid" therefore she went to the emergency room and was diagnosed with Mesenteric Adenitis on 28-OCT-2014. The patient's fever "maintained" at about 101 degrees and lasted for a total of 6 weeks. The patient sought a medical attention, she was under Pediatric Care since October 2014. There were lab diagnostics studies performed: computerized tomography (CT) scan, chest X-rays, bloodwork. There was no treatment given for the adverse events, because they were of viral origin and would resolve on their own. The outcome of mesenteric adenitis, pain down her leg, hip pain, headaches, chronic cough, nerve pain, hand shaking, weight loss, loss of balance and shortness of breath was unknown. The outcome of decreased appetite was reported as recovered/resolved (reported also as "appetite is back") (date unspecified). The relatedness between the event and GARDASIL was not reported. Lot number U006236 is an invalid lot number for GARDASIL. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, HPV4, MEN, TDAP
Symptoms: Viral infection, Vomiting, Weight decreased
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 12 year old female patient (daughter). The patient's concurrent conditions included unspecified seasonal allergies. On 24-SEP-2014 the patient was vaccinated with a GARDASIL, dose first of series of 3, intramuscularly. Concomitant vaccines administered to the patient on the same day included T-DAP and meningococcal vaccine. The patient's mother said that the daughter had been experiencing chronic long-term side effects after receiving GARDASIL. The patient developed a fever and decreased appetite within 24-hours after receiving first dose of a series of three recommended doses of GARDASIL (estimated date September 2014). The other patient's symptoms developed in the first weeks of October 2014 which included chronic cough, shortness of breath, loss of balance, hip pain, pain down her leg, "shaking hand" headaches and nerve pain. The patient experienced also vomiting, nausea, loss of appetite, loss of weight of 20 lbs, persistent fever, "she could not hold any fluid" therefore she went to the emergency room and was diagnosed with Mesenteric Adenitis on 28-OCT-2014. The patient's fever "maintained" at about 101 degrees and lasted for a total of 6 weeks. The patient sought a medical attention, she was under Pediatric Care since October 2014. There were lab diagnostics studies performed: computerized tomography (CT) scan, chest X-rays, bloodwork. There was no treatment given for the adverse events, because they were of viral origin and would resolve on their own. The outcome of mesenteric adenitis, pain down her leg, hip pain, headaches, chronic cough, nerve pain, hand shaking, weight loss, loss of balance and shortness of breath was unknown. The outcome of decreased appetite was reported as recovered/resolved (reported also as "appetite is back") (date unspecified). The relatedness between the event and GARDASIL was not reported. Lot number U006236 is an invalid lot number for GARDASIL. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP, HPV4, MEN, TDAP
Symptoms: Vomiting, Weight decreased
Clinical narrative: This spontaneous report as received from a consumer (patient's mother) refers to a 12 year old female patient (daughter). The patient's concurrent conditions included unspecified seasonal allergies. On 24-SEP-2014 the patient was vaccinated with a GARDASIL, dose first of series of 3, intramuscularly. Concomitant vaccines administered to the patient on the same day included T-DAP and meningococcal vaccine. The patient's mother said that the daughter had been experiencing chronic long-term side effects after receiving GARDASIL. The patient developed a fever and decreased appetite within 24-hours after receiving first dose of a series of three recommended doses of GARDASIL (estimated date September 2014). The other patient's symptoms developed in the first weeks of October 2014 which included chronic cough, shortness of breath, loss of balance, hip pain, pain down her leg, "shaking hand" headaches and nerve pain. The patient experienced also vomiting, nausea, loss of appetite, loss of weight of 20 lbs, persistent fever, "she could not hold any fluid" therefore she went to the emergency room and was diagnosed with Mesenteric Adenitis on 28-OCT-2014. The patient's fever "maintained" at about 101 degrees and lasted for a total of 6 weeks. The patient sought a medical attention, she was under Pediatric Care since October 2014. There were lab diagnostics studies performed: computerized tomography (CT) scan, chest X-rays, bloodwork. There was no treatment given for the adverse events, because they were of viral origin and would resolve on their own. The outcome of mesenteric adenitis, pain down her leg, hip pain, headaches, chronic cough, nerve pain, hand shaking, weight loss, loss of balance and shortness of breath was unknown. The outcome of decreased appetite was reported as recovered/resolved (reported also as "appetite is back") (date unspecified). The relatedness between the event and GARDASIL was not reported. Lot number U006236 is an invalid lot number for GARDASIL. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Lymphadenopathy, Nodule, Nuclear magnetic resonance imaging, Swelling
Clinical narrative: Severe redness, swelling, swelling approx. 3-4 inches wide by 6-8 inches long followed by nodule on right neck and by nodule on left side by ear and swollen glands and lymph nodes along the neck area.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: BECAME PALE, PASSED OUT, ARMS BECAME STIFF AND FLEXED IN A SPASM FOR ABOUT 20- 30 SECONDS. BREATHING WAS HEAVY. AFTER THIS TIME SHE BREATHED NORMALLY, BECAME LIGHT HEADED AND AWARE, AND REMAINED WHITE AS A SHEET. SHE WAS PLACED SUPINE WITH HER FEET ELEVATED WITH A COOL MOIST CLOTH OVER HER FOREHEAD. SHE BECAME MORE AWARE AND COHERENT OVER THE MINUTES AND IN ABOUT 10 MINUTES STARTED TO HAVE SOME COLOR IN HER CHEEKS. SHE REMAINED IN THE ROOM FOR ABOUT 20-30 MINUTES AND THEN WAS ABLE TO WALK OUT WITH NORMAL VITAL SIGNS
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor
Clinical narrative: BECAME PALE, PASSED OUT, ARMS BECAME STIFF AND FLEXED IN A SPASM FOR ABOUT 20- 30 SECONDS. BREATHING WAS HEAVY. AFTER THIS TIME SHE BREATHED NORMALLY, BECAME LIGHT HEADED AND AWARE, AND REMAINED WHITE AS A SHEET. SHE WAS PLACED SUPINE WITH HER FEET ELEVATED WITH A COOL MOIST CLOTH OVER HER FOREHEAD. SHE BECAME MORE AWARE AND COHERENT OVER THE MINUTES AND IN ABOUT 10 MINUTES STARTED TO HAVE SOME COLOR IN HER CHEEKS. SHE REMAINED IN THE ROOM FOR ABOUT 20-30 MINUTES AND THEN WAS ABLE TO WALK OUT WITH NORMAL VITAL SIGNS
Age: 28.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus generalised, Swelling face
Clinical narrative: Employee received the intradermal flu shot and within minutes c/o itching all over, then felt face was swelling.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Given Adult dose of Hep B Vaccine (1.0ml) instead of child dose (0.5ml);  Not negative symptoms post injection.
Age: 37.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: Employee received an Intradermal flu shot, she came to me to show me her arm which was swollen and reddened more than normal intradermal reactions. I sent her to the ER for evaluation, diagnosis with local allergic reaction.
Age: 37.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Musculoskeletal stiffness
Clinical narrative: Employee received an Intradermal flu shot, she came to me to show me her arm which was swollen and reddened more than normal intradermal reactions. I sent her to the ER for evaluation, diagnosis with local allergic reaction.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Hypersensitivity, Pruritus generalised, Rash, Throat irritation
Clinical narrative: Employee came back to the flu clinic to show me her rash that she had, which was hives. She was itching all over and while we were talking I notice she was clearing her throat and she was hoarse. I immediately took her to the ER with acute allergic reaction.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Employee came back to the flu clinic to show me her rash that she had, which was hives. She was itching all over and while we were talking I notice she was clearing her throat and she was hoarse. I immediately took her to the ER with acute allergic reaction.
Age: 22.0
Sex: M
Vaccine: ANTH, JEV1, TYP
Symptoms: Dizziness, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Pt. are required to stay in clinic for 20 mins after receiving JEV vaccine, Pt. came back inside immz clinic to checked back to say he's good to go. Approximately after 5 to 10 mins pt. came back and said his feeling lightheaded & nauseated. Took pt inside the room to monitor, had pt. sips of water refused to lay down. This morning (2/3/2015) came to see his PCM and reported to have reactions such as fever, headache, body aches, slight nausea, tenderness on the site.
Age: 22.0
Sex: M
Vaccine: ANTH, JEV1, TYP
Symptoms: Pyrexia
Clinical narrative: Pt. are required to stay in clinic for 20 mins after receiving JEV vaccine, Pt. came back inside immz clinic to checked back to say he's good to go. Approximately after 5 to 10 mins pt. came back and said his feeling lightheaded & nauseated. Took pt inside the room to monitor, had pt. sips of water refused to lay down. This morning (2/3/2015) came to see his PCM and reported to have reactions such as fever, headache, body aches, slight nausea, tenderness on the site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Chills, Fatigue, Influenza like illness, Pain
Clinical narrative: Left arm hot, hard and swollen. Severe ache, cannot lift arm to do daily tasks. 5:30 PM at home - shaking - heart palpatating - chills - went to bed at 7PM and slept all night. 2/3/15 Arm a little better, but have chills and flu like aches.  Tired - want to leave work to go home and sleep.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Palpitations, Peripheral swelling, Skin induration, Skin warm, Tremor
Clinical narrative: Left arm hot, hard and swollen. Severe ache, cannot lift arm to do daily tasks. 5:30 PM at home - shaking - heart palpatating - chills - went to bed at 7PM and slept all night. 2/3/15 Arm a little better, but have chills and flu like aches.  Tired - want to leave work to go home and sleep.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE ONGOING.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist who was told about the event by patient's friend. The report refers to a patient of unknown age and gender with a history of epilepsy. Current conditions and drug allergies were not specified by the reporter. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration, lot# and expiration date were not specified). Concomitant medication was not specified by the reporter. On an unknown date, the patient experienced shingles of the brain which caused the patient's death on an unknown date. It was not specified whether any treatment was given for the adverse event and whether the patient sought any medical attention. Laboratory test were not specified by the reporter. It was also reported that the deceased person had never had the chicken pox and the pharmacist asked if a patient who had never had the chicken pox can be vaccinated with ZOSTAVAX. The physician correlated the death to receipt of the ZOSTAVAX without having a prior case of the chickenpox. No product quality complain (PQC) was filed. Additional information is not expected, because the reporter did not wish to be contacted.
Age: 0.88
Sex: M
Vaccine: FLU3
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Oedema peripheral, Pyrexia, Spleen scan normal
Clinical narrative: 2-25-14 Received influenza vaccine to leg. 3-3-14 - Went to Hosp  transport via ambulance. 3-4-14 Admitted to hosp for limb edema to lower arms, legs below knees, AST - ALT enzymes where elevated ultrasound to liver. Spleen was negative for enlargement. Fever of 103 (highest).
Age: 0.88
Sex: M
Vaccine: FLU3
Symptoms: Ultrasound liver normal
Clinical narrative: 2-25-14 Received influenza vaccine to leg. 3-3-14 - Went to Hosp  transport via ambulance. 3-4-14 Admitted to hosp for limb edema to lower arms, legs below knees, AST - ALT enzymes where elevated ultrasound to liver. Spleen was negative for enlargement. Fever of 103 (highest).
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Pain in extremity, Peripheral swelling
Clinical narrative: Immunization (PROQUAD) given in (L) arm. At injection site mom states there is a welt in the middle with smaller red welts around site. Arm swollen, red, slightly painful to touch initially.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Condition aggravated, Electromyogram, Muscular weakness, Neuralgic amyotrophy, Neuropathy peripheral
Clinical narrative: Parsonage Turner Syndrome. Lt arm weakness and Neuropathy since 2010. On going.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients with unknown ages and genders. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (oral, lot# and dose were unknown). No symptoms reported. It was not specified if the patients sought for medical attention. This is one of several reports received from the same reporter. Additional information is not expected as the medical assistant did not want to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 18-NOV-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Dysstasia, Fall, Gait disturbance, Grip strength decreased, Guillain-Barre syndrome
Clinical narrative: Started with hand numbness, then feet numbness then leg weakness and then arm numbness, hard time walking, standing up, frequent falls, hard time gripping things.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Lumbar puncture abnormal, Muscular weakness
Clinical narrative: Started with hand numbness, then feet numbness then leg weakness and then arm numbness, hard time walking, standing up, frequent falls, hard time gripping things.
Age: 0.84
Sex: F
Vaccine: HIBV, PPV
Symptoms: Crying, Decreased appetite, Diarrhoea, Fatigue, Hyperhidrosis
Clinical narrative: Tired, fever, sweaty, anorexia, diarrhea, crying, rash. Monitored closely, gave Tylenol and Motrin. She started feeling better in 5 days. Back to normal in 10 days.
Age: 0.84
Sex: F
Vaccine: HIBV, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Tired, fever, sweaty, anorexia, diarrhea, crying, rash. Monitored closely, gave Tylenol and Motrin. She started feeling better in 5 days. Back to normal in 10 days.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at injection site.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, VARCEL
Symptoms: Pain
Clinical narrative: Parent reported the patient had body aches for one week.
Age: 43.0
Sex: M
Vaccine: MMR
Symptoms: VIIth nerve paralysis
Clinical narrative: Developed Bells palsy.
Age: 1.27
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Had temperature of 103-105 F that did not come down with fever reducing medications for approximately 48 hrs.
Age: 5.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 5.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthma, Chills, Dyspnoea, Electrocardiogram
Clinical narrative: HOT AND COLD CHILLS; MUSCLE ACHES; JOINT PAIN; SEVERE MIGRAINES; RHEUMATOID ARTHRITIS; ASTHMA; SHORTNESS OF BREATH.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling of body temperature change, Full blood count, Migraine, Myalgia, Rheumatoid arthritis
Clinical narrative: HOT AND COLD CHILLS; MUSCLE ACHES; JOINT PAIN; SEVERE MIGRAINES; RHEUMATOID ARTHRITIS; ASTHMA; SHORTNESS OF BREATH.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray abnormal
Clinical narrative: HOT AND COLD CHILLS; MUSCLE ACHES; JOINT PAIN; SEVERE MIGRAINES; RHEUMATOID ARTHRITIS; ASTHMA; SHORTNESS OF BREATH.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Infection, Injection site swelling, Local reaction
Clinical narrative: Increased pain 2 hours after recieiving vaccine, pt developed a large localized reaction in her arm including a large amount of swelling that went from the injection site radiating distal and proximal, increased pain, redness, hot when touched.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Skin warm
Clinical narrative: Increased pain 2 hours after recieiving vaccine, pt developed a large localized reaction in her arm including a large amount of swelling that went from the injection site radiating distal and proximal, increased pain, redness, hot when touched.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Pruritus generalised
Clinical narrative: Patient described a serious headache occurring about an hour after the vaccination when the patient had arrived at home. She stated that she started itching all over her body and felt sick. She did not describe a rash or shortness or breath. This reaction was not observed by any healthcare provider, and was not reported to the pharmacist until 2/3/15.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Injection site bruising, Vomiting
Clinical narrative: Patient reported having chills, vomiting, fatigue, loss of appetite, and bruise at site of injection.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Headache, Hypersensitivity
Clinical narrative: Got vaccination on Monday evening stomach pain, Tuesday calls from school with headache, dizziness, stomach pains, weak. Returned to school on Wednsday and felt light headache sick to stomach and dizzy and swelling then came home that Wednsday night a rash had developed and so he went to physician and she ran some test on him like strep. I told her he hasn't been sick he's been perfectly fine until this vaccine he got. Test were sent off and reported back to her on 2/3/2015 with the whole weekend of rashes and swelling all over his body. The Dr then confirmed it was the HPV vaccine and that he may have short to long term of this rash with other possible side effects!
Age: 11.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Nausea, Rash generalised, Renal function test normal, Streptococcus test negative, Swelling
Clinical narrative: Got vaccination on Monday evening stomach pain, Tuesday calls from school with headache, dizziness, stomach pains, weak. Returned to school on Wednsday and felt light headache sick to stomach and dizzy and swelling then came home that Wednsday night a rash had developed and so he went to physician and she ran some test on him like strep. I told her he hasn't been sick he's been perfectly fine until this vaccine he got. Test were sent off and reported back to her on 2/3/2015 with the whole weekend of rashes and swelling all over his body. The Dr then confirmed it was the HPV vaccine and that he may have short to long term of this rash with other possible side effects!
Age: 11.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Abdominal discomfort, Cyanosis, Headache, Hyperhidrosis, Hypersensitivity
Clinical narrative: Got vaccination on Monday evening stomach pain, Tuesday calls from school with headache, dizziness, stomach pains, weak. Returned to school on Wednsday and felt light headache sick to stomach and dizzy and swelling then came home that Wednsday night a rash had developed and so he went to physician and she ran some test on him like strep. I told her he hasn't been sick he's been perfectly fine until this vaccine he got. Test were sent off and reported back to her on 2/3/2015 with the whole weekend of rashes and swelling all over his body. The Dr then confirmed it was the HPV vaccine and that he may have short to long term of this rash with other possible side effects!
Age: 11.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Hypoaesthesia, Nausea, Peripheral swelling, Rash, Streptococcus test
Clinical narrative: Got vaccination on Monday evening stomach pain, Tuesday calls from school with headache, dizziness, stomach pains, weak. Returned to school on Wednsday and felt light headache sick to stomach and dizzy and swelling then came home that Wednsday night a rash had developed and so he went to physician and she ran some test on him like strep. I told her he hasn't been sick he's been perfectly fine until this vaccine he got. Test were sent off and reported back to her on 2/3/2015 with the whole weekend of rashes and swelling all over his body. The Dr then confirmed it was the HPV vaccine and that he may have short to long term of this rash with other possible side effects!
Age: 11.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Urine analysis, Urticaria
Clinical narrative: Got vaccination on Monday evening stomach pain, Tuesday calls from school with headache, dizziness, stomach pains, weak. Returned to school on Wednsday and felt light headache sick to stomach and dizzy and swelling then came home that Wednsday night a rash had developed and so he went to physician and she ran some test on him like strep. I told her he hasn't been sick he's been perfectly fine until this vaccine he got. Test were sent off and reported back to her on 2/3/2015 with the whole weekend of rashes and swelling all over his body. The Dr then confirmed it was the HPV vaccine and that he may have short to long term of this rash with other possible side effects!
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Immediate post-injection reaction, Injection site pain, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Very painful injection. Shoulder very stiff and sore immediately following injection. Increasing pain in following weeks. Range of motion not very good. Given steroid pack 11/18/2013. Had a little relief for the week of steroid pack. Pain came back after completion of steroid pack.  Referred to orthopedic surgeon. Was given a cortisone injection 12/3/2013 and started physical therapy. Some pain relief but not complete. Surgery performed 3/18/2014 followed by physical therapy.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Rotator cuff syndrome, Shoulder operation
Clinical narrative: Very painful injection. Shoulder very stiff and sore immediately following injection. Increasing pain in following weeks. Range of motion not very good. Given steroid pack 11/18/2013. Had a little relief for the week of steroid pack. Pain came back after completion of steroid pack.  Referred to orthopedic surgeon. Was given a cortisone injection 12/3/2013 and started physical therapy. Some pain relief but not complete. Surgery performed 3/18/2014 followed by physical therapy.
Sex: F
Vaccine: VARZOS
Symptoms: Skin swelling, Throat tightness
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a female patient of unknown age. The patient's medical history included unspecified allergy to neomycin. On 29-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot # were not reported). The reporter reported the patient experienced swelling of the skin and throat closing up while in the office. The patient was administered EPIPEN while in the office. The reporter did not verify if the patient was sent home or a hospital. The outcome of adverse events was unknown. Upon internal review, the adverse events treated with EPIPEN were considered as other medically significant events. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of local reaction in a unk patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to FLULAVAL QUADRIVALENT. Additional information: Sales representative was told by a medical assistant today that a patient had a reaction to FLULAVAL QUADRIVALENT. She said it was a local reaction. No further details provided. Patient purchased the vaccine from a pharmacy. No further details provided. No lot number provided. No patient information provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 08-DEC-2014 the patient was vaccinated with the third dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 47-year-old female patient who received FLULAVAL (batch number XZ3SP, expiry date 30th June 2015). On 29th October 2014, the patient receivd FLULAVAL (intramuscular) .5 ml. In October 2014, less than a day after receiving FLULAVAL, the patient experienced injection site erythema, injection site warmth, injection site tenderness and injection site swelling. FLULAVAL was continued with no change. In 2014, the outcome of the injection site erythema, injection site warmth, injection site tenderness and injection site swelling were recovered/resolved. The reporter considered the injection site erythema, injection site warmth, injection site tenderness and injection site swelling to be probably related to FLULAVAL. Additional information was provided: A clinic reported that 5 different patients have experienced pretty severe injection reactions within 24 hours (not immediate) of receiving 0.5 ml of FLULAVAL. All the patients have had flu shots before with no previous reactions. Specifically, the injection site reaction consisted of redness, swelling, and tender and warm to the touch. All reactions were the size of a small apple/orange. The reactions were quite large and not a normal reaction that the clinic would expected. All the patients were later seen by the doctor with an office visit and the events have since resolved. This is one of the 5 cases reported by the same reporter for the same vaccine and with the same events.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received FLULAVAL (batch number XZ3SP, expiry date 30th June 2015). Concomitant products included PNEUMOVAX 23. On 30th October 2014, the patient received FLULAVAL (intramuscular) .5 ml. In October 2014, less than a day after receiving FLULAVAL, the patient experienced injection site erythema, injection site warmth, injection site tenderness and injection site swelling. FLULAVAL was continued with no change. In 2014, the outcome of the injection site erythema, injection site warmth, injection site tenderness and injection site swelling were recovered/resolved. The reporter considered the injection site erythema, injection site warmth, injection site tenderness and injection site swelling to be probably related to FLULAVAL. Additional information was provided: A clinic reported that 5 different patients have experienced pretty severe injection site reactions within 24 hours (not immediate) of receiving 0.5 ml of FLULAVAL. All the patients have had flu shots before with no previous reactions. Specifically, the injection site reaction consisted of redness, swelling, and tender and warm to the touch. All reactions were the size of a small apple/orange. The reactions were quite large and not a normal reaction that the clinic would expect. All the patients were later seen by the doctor with an office visit and the events have since resolved. This is one of the 5 cases reported by the same reporter for the same vaccine and with the same events.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 10-year-old female patient who received FLULAVAL QUADRIVALENT (batch number XZ3SP, expiry date 30th June 2015). On 11th November 2014, the patient received FLULAVAL QUADRIVALENT (intramuscular). In November 2014, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site erythema, injection site warmth, injection site tenderness and injection site swelling. FLULAVAL QUADRIVALENT was continued with no change. In November 2014, the outcome of the injection site erythema, injection site warmth, injection site tenderness and injection site swelling were recovered/resolved. The reporter considered the injection site erythema, injection site warmth, injection site tenderness and injection site swelling to be probably related to FLULAVAL QUADRIVALENT. Additional information was provided: A clinic reported that 5 different patients have experienced pretty severe injection site reactions within 24 hours (not immediate) of receiving 0.5 ml of FLULAVAL QUADRIVALENT. All the patients have had flu shots before with no previous reactions. Specifically, the injection site reaction consisted of redness, swelling, and tender and warm to the touch. All reactions were the size of a small apple/orange. The reactions were quite large and not a normal reaction that the clinic would expect. All the patients were later seen by the doctor with an office visit and the events have since resolved. This is one of the 5 cases reported by the same reporter for the same vaccine and with the same events.
Age: 76.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received FLULAVAL QUADRIVALENT (batch number XZ3SP, expiry date 30th June 2015). Concomitant products included PNEUMOVAX-23. On 30th October 2014, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. In October 2014, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site erythema, injection site warmth, injection site tenderness and injection site swelling. FLULAVAL QUADRIVALENT was continued with no change. In 2014, the outcome of the injection site erythema, injection site warmth, injection site tenderness and injection site swelling were recovered/resolved. The reporter considered the injection site erythema, injection site warmth, injection site tenderness and injection site swelling to be probably related to FLULAVAL QUADRIVALENT. Additional information was provided: A clinic reported that 5 different patients have experienced pretty severe injection site reactions within 24 hours (not immediate) of receiving 0.5 ml of FLULAVAL QUADRIVALENT. All the patients have had flu shots before with no previous reactions. Specifically, the injection site reaction consisted of redness, swelling, and tender and warm to the touch. All reactions were the size of a small apple/orange. The reactions were quite large and not a normal reaction that the clinic would expect. All the patients were later seen by the doctor with an office visit and the events have since resolved. This is one of the 5 cases reported by the same reporter for the same vaccine and with the same events.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical condition were reported. On 12-JAN-2015 the patient was vaccinated with the third dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of the several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Syncope
Clinical narrative: This case was reported by a nurse and described the occurrence of fainting in a 34-year-old female patient who received FLUARIX (batch number 3227Z, expiry date 30th June 2015). Previously administered products included FLUARIX with an associated reaction of no reaction on previous exposure to drug. Concurrent medical conditions included drug allergy. On 3rd December 2014, the patient received FLUARIX .5 mg. On 3rd December 2014, an unknown time after receiving FLUARIX, the patient experienced fainting, lightheadedness and sweating. On 3rd December 2014, the outcome of the fainting, lightheadedness and sweating were recovered/resolved. It was unknown if the reporter considered the fainting, lightheadedness and sweating to be related to FLUARIX. Additional information received: The reporter is a Nurse Practitioner who reports a patient experienced a fainting episode with the symptoms noted above that lasted about 3 minutes before the patient improved. She treated the patient by elevating her legs, gave her water to drink, having her take deep breaths, gave her a cold damp washcloth for her forehead, the patient's blood pressure read as 100/80 and pulse was 68, when taken 2 minutes later her blood pressure was 110/80 and her pulse was 78 and the patient felt better. The Nurse Practitioner states she believes this was a psychological response and not systemic or local reaction to the vaccine.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 12-NOV-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 11-NOV-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.