chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: TYP
Symptoms: Migraine
Clinical narrative: Migrane after 1st dose.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Borrelia test negative, VIIth nerve paralysis
Clinical narrative: (R) sided Bell's Palsy within 24 hours.
Age: 42.0
Sex: F
Vaccine: TYP
Symptoms: Back pain, Pelvic pain
Clinical narrative: Patient experienced aches in back and ovaries area after 2nd capsule.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient experienced pain in the injection site - having difficulty raising her left arm. On November 6th, she claimed there was 50% improvement.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Pt had 2 episodes of brief febrile seizures beginning early am on 11/8/13, quickly resolving. Temp 102.7 while in ED. Pt discharged with DIASTAT script 10mg to use if needed following further seizure activity. Follow up appointment to be scheduled with Pedi Neuro.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Mild itchiness across chest 24 - 48 hrs following vaccine administration.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient received Zostavax 11/5/13 woke up 11/6/13 with a stiff neck and neck pain and it has lasted 1 week.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Pain
Clinical narrative: Stated day after, really sore when reaching behind or above. Went to MD, taking anti-inflammatory, returning on 2 weeks. No structural problem, just inflammation.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: After getting shot on 10/29/13, pt developed active case of shingles on 11/3/13. Seen Dr and getting antiviral and pain medication.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Musculoskeletal stiffness, Paraesthesia, Skin irritation
Clinical narrative: Patient reported tingling sensation at inj site, stiff neck, scalp irritation...Pt had not sought medical attention as of 11/12/13. Condition was improving. Symptoms began 3 days after receiving vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Feeling abnormal, Somnolence, Vision blurred
Clinical narrative: Blurry vision, head felt funny felt sleepy.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient got a FLUZONE High Dose shot on 11/6/13 at pharmacy. She already had one flu shot on 10/1/13 at Dr's office too. It was a duplication. Patient did not have any side effects and did not need any treatment of any kind.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Wrong drug administered
Clinical narrative: Pt received HD instead of reg had flu-like symptoms did not go to hospital.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Fainting.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder/upper arm soreness x 5 weeks, ongoing. Treatment with heat patches and NSAIDs.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Rash pustular
Clinical narrative: 11/7/2013 Pt described to have rashes on her chest, itchy and pustules. the day after the shot (10/18). It was on an off for 1 week. We have ruled out all other factors. Benadryl and ketonazole were helping to relief her rashes.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Myalgia, Neuralgia, Tenderness
Clinical narrative: Muscle soreness, tenderness, and nerve pain from neck, injection site and arm. Soreness has subsided, however nerve pain from neck to arm after 6 days persists.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Patient received flu shot on 10/7/13. Came to store 11/6/13 to complain still experiencing soreness in injection arm. Went to MD, did MRI revealing nothing. Says MD may guess tendonitis if injected in tendon. Do not know at this time.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Syringe issue
Clinical narrative: When shot was given in arm, prefilled syringe did not fully depress - that was reported to Merck. Pt came back to pharmacy on 11/9/13 to report pain in left arm - started mild on day 3 - 3 weeks later major pain. Unable to move arm.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope, Vomiting
Clinical narrative: Syncope, vomiting. Patient stated 60-70 minutes for observation and was transferred to ER.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Condition aggravated, Convulsion, Fatigue, Headache, Influenza B virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 14 year old female patient with a history of seizure disorder controlled on medications. On 28-Oct-2013 the patient received nasal FLUMIST Quadrivalent (intranasal). On 01-Nov-2013 the patient had a positive test for influenza b. The reporter also stated that the patient had symptoms of fever (103f), headache, and fatigue and had seizure. The outcome of the seizure, positive test for influenza b, fever (103f), headache, and fatigue were unknown. According to the reporter the seizure was serious as an important medical event. All other events were considered to be non-serious.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: A report has been received from a Health Professional concerning a 14 year old female patient with a history of seizure disorder controlled on medications. On 28-Oct-2013 the patient received nasal FLUMIST Quadrivalent (intranasal). On 01-Nov-2013 the patient had a positive test for influenza b. The reporter also stated that the patient had symptoms of fever (103f), headache, and fatigue and had seizure. The outcome of the seizure, positive test for influenza b, fever (103f), headache, and fatigue were unknown. According to the reporter the seizure was serious as an important medical event. All other events were considered to be non-serious.
Age: 53.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient described to human resources of pain, swelling and rd around the injection site.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient with mild hypertension. Patient with no drug reactions or allergies. On an unknown date (years ago when it first came out) the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported) for vaccination. Concomitant therapies included atenolol. Pharmacist stated that patient came to the pharmacy on approximately 29-OCT-2013 (one week ago, the end of October) with a very light rash on the abdomen, around the side and up the back. Pharmacist noted that the rash had no blistering or oozing. Patient was diagnosed with shingles by her primary care physician. Pharmacist reported that patient was prescribed ZOVIRAX ointment and gabapentin 300 mg three times daily for the postherpetic pain. Pharmacist reported that the patient said this did not work for the pain and her primary care physician increased the dose of gabapentin to 600 mg three times daily and additionally added on an unspecified non-steroidal anti-inflammatory drug (NSAID) therapy. Pharmacist reported that patient stated that this has provided more relief, but not completely. Pharmacist reported that the rash has faded quite a bit. On an unknown date the patient sought medical attention and was prescribed with treatment for the event. No lab diagnostics studies were performed. The outcome of the event was reported as recovering/resolving. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a consumer regarding his son a 2 year old male patient. The patient was vaccinated with VARIVAX (manufacturer unspecified) when he was 1 year of age (in approximately December 2011). On 14-OCT-2013, the patient received PROQUAD (Merck) one shot (lot #, dose and concentration were not reported) rather than received M-M-R II vaccine. No adverse reaction was reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Biopsy, Biopsy lymph gland abnormal, Chills, Computerised tomogram thorax abnormal, Histiocytic necrotising lymphadenitis
Clinical narrative: This case was reported in a literature article and described the occurrence of Kikuchi's disease in a 45-year-old female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). Soon after vaccination with Influenza vaccine (unspecified), the subject noted repeated spikes in fever with chills. Approximately 6 weeks after vaccination with Influenza vaccine (unspecified), the subject experienced fever, night sweats and poor oral intake. The subject was treated with ibuprofen, ACETAMINOPHEN and azithromycin. Two weeks later, the subject was hospitalised. Approximately 2 days prior to admission, the subject complained about swelling in the left axilla. A physical exam did not reveal any hepatosplenomegaly nor tenderness in the left axilla. CT scan of the chest with contrast revealed multiple enlarged lymph nodes (LN) measuring up to 3 cm, localized in the left axilla. She underwent excisional LN biopsy. The pathology report of the LN revealed lymphoid tissue with extensive geographic necrosis suggestive of Kikuchi's disease. She was discharged home and initially felt better after excisional biopsy, only to note recurrence of fevers and chills within a week. She was treated with low dose prednisone with dramatic improvement in symptoms and no recurrence.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Hypophagia, Lymphadenopathy, Night sweats, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: This case was reported in a literature article and described the occurrence of Kikuchi's disease in a 45-year-old female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). Soon after vaccination with Influenza vaccine (unspecified), the subject noted repeated spikes in fever with chills. Approximately 6 weeks after vaccination with Influenza vaccine (unspecified), the subject experienced fever, night sweats and poor oral intake. The subject was treated with ibuprofen, ACETAMINOPHEN and azithromycin. Two weeks later, the subject was hospitalised. Approximately 2 days prior to admission, the subject complained about swelling in the left axilla. A physical exam did not reveal any hepatosplenomegaly nor tenderness in the left axilla. CT scan of the chest with contrast revealed multiple enlarged lymph nodes (LN) measuring up to 3 cm, localized in the left axilla. She underwent excisional LN biopsy. The pathology report of the LN revealed lymphoid tissue with extensive geographic necrosis suggestive of Kikuchi's disease. She was discharged home and initially felt better after excisional biopsy, only to note recurrence of fevers and chills within a week. She was treated with low dose prednisone with dramatic improvement in symptoms and no recurrence.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Soft tissue necrosis, White blood cell count decreased
Clinical narrative: This case was reported in a literature article and described the occurrence of Kikuchi's disease in a 45-year-old female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). Soon after vaccination with Influenza vaccine (unspecified), the subject noted repeated spikes in fever with chills. Approximately 6 weeks after vaccination with Influenza vaccine (unspecified), the subject experienced fever, night sweats and poor oral intake. The subject was treated with ibuprofen, ACETAMINOPHEN and azithromycin. Two weeks later, the subject was hospitalised. Approximately 2 days prior to admission, the subject complained about swelling in the left axilla. A physical exam did not reveal any hepatosplenomegaly nor tenderness in the left axilla. CT scan of the chest with contrast revealed multiple enlarged lymph nodes (LN) measuring up to 3 cm, localized in the left axilla. She underwent excisional LN biopsy. The pathology report of the LN revealed lymphoid tissue with extensive geographic necrosis suggestive of Kikuchi's disease. She was discharged home and initially felt better after excisional biopsy, only to note recurrence of fevers and chills within a week. She was treated with low dose prednisone with dramatic improvement in symptoms and no recurrence.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of unspecified patients. It was reported that on 01-AUG-2013, doses of MMR II were exposed to 54F for 15 hours. Healthcare worker stated that unspecified number of unspecified patients might have been administered these improperly stored MMR II doses on unspecified dates. Healthcare worker could not provide any lot numbers or expiration dates of any of these improperly stored MMR II doses at this time. No adverse effect reported. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Abasia, Activities of daily living impaired, Axonal neuropathy, Back pain, Cough
Clinical narrative: This case was reported in a literature article and described the occurrence of Guillain Barre syndrome in a 6-year-old male subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of influenza vaccine unspecified (administration site and route unknown, batch number not provided). 10 days after vaccination with influenza vaccine unspecified, the subject experienced collapse (unconscious), cough, fever, limping, headache, back pain and low extremity weakness. The subject was hospitalised. A lumbar puncture was performed and the diagnosis of Guillain-Barre syndrome was made. The subject was treated with normal immunoglobulin during 5 days but it was still noted to have impaired motor function, left greater than right, with intact sensation in bilateral lower extremities. 3 weeks after diagnosis, the subject was admitted to acute inpatient rehab secondary to his inability to ambulate. While in rehab, the subject underwent electromyogram which was consisted with severe axonal motor neuropathy which is a variant of Guillain-Barre syndrome. At the time of discharge, 12 weeks after admission to acute inpatient rehab, the subject was able to ambulate a distance of 15 feet using a posterior walker utilizing bilateral hip-knee-ankle-foot-orthoses requiring moderate level of assistance. He was able to transfer with supervision and performed activities of daily living with minimal assist.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome, Headache, Immunoglobulin therapy
Clinical narrative: This case was reported in a literature article and described the occurrence of Guillain Barre syndrome in a 6-year-old male subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of influenza vaccine unspecified (administration site and route unknown, batch number not provided). 10 days after vaccination with influenza vaccine unspecified, the subject experienced collapse (unconscious), cough, fever, limping, headache, back pain and low extremity weakness. The subject was hospitalised. A lumbar puncture was performed and the diagnosis of Guillain-Barre syndrome was made. The subject was treated with normal immunoglobulin during 5 days but it was still noted to have impaired motor function, left greater than right, with intact sensation in bilateral lower extremities. 3 weeks after diagnosis, the subject was admitted to acute inpatient rehab secondary to his inability to ambulate. While in rehab, the subject underwent electromyogram which was consisted with severe axonal motor neuropathy which is a variant of Guillain-Barre syndrome. At the time of discharge, 12 weeks after admission to acute inpatient rehab, the subject was able to ambulate a distance of 15 feet using a posterior walker utilizing bilateral hip-knee-ankle-foot-orthoses requiring moderate level of assistance. He was able to transfer with supervision and performed activities of daily living with minimal assist.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Loss of consciousness, Lumbar puncture abnormal, Motor dysfunction, Muscular weakness, Pyrexia
Clinical narrative: This case was reported in a literature article and described the occurrence of Guillain Barre syndrome in a 6-year-old male subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of influenza vaccine unspecified (administration site and route unknown, batch number not provided). 10 days after vaccination with influenza vaccine unspecified, the subject experienced collapse (unconscious), cough, fever, limping, headache, back pain and low extremity weakness. The subject was hospitalised. A lumbar puncture was performed and the diagnosis of Guillain-Barre syndrome was made. The subject was treated with normal immunoglobulin during 5 days but it was still noted to have impaired motor function, left greater than right, with intact sensation in bilateral lower extremities. 3 weeks after diagnosis, the subject was admitted to acute inpatient rehab secondary to his inability to ambulate. While in rehab, the subject underwent electromyogram which was consisted with severe axonal motor neuropathy which is a variant of Guillain-Barre syndrome. At the time of discharge, 12 weeks after admission to acute inpatient rehab, the subject was able to ambulate a distance of 15 feet using a posterior walker utilizing bilateral hip-knee-ankle-foot-orthoses requiring moderate level of assistance. He was able to transfer with supervision and performed activities of daily living with minimal assist.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Syncope, Walking aid user
Clinical narrative: This case was reported in a literature article and described the occurrence of Guillain Barre syndrome in a 6-year-old male subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of influenza vaccine unspecified (administration site and route unknown, batch number not provided). 10 days after vaccination with influenza vaccine unspecified, the subject experienced collapse (unconscious), cough, fever, limping, headache, back pain and low extremity weakness. The subject was hospitalised. A lumbar puncture was performed and the diagnosis of Guillain-Barre syndrome was made. The subject was treated with normal immunoglobulin during 5 days but it was still noted to have impaired motor function, left greater than right, with intact sensation in bilateral lower extremities. 3 weeks after diagnosis, the subject was admitted to acute inpatient rehab secondary to his inability to ambulate. While in rehab, the subject underwent electromyogram which was consisted with severe axonal motor neuropathy which is a variant of Guillain-Barre syndrome. At the time of discharge, 12 weeks after admission to acute inpatient rehab, the subject was able to ambulate a distance of 15 feet using a posterior walker utilizing bilateral hip-knee-ankle-foot-orthoses requiring moderate level of assistance. He was able to transfer with supervision and performed activities of daily living with minimal assist.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. Medical assistant reported that on 22-OCT-2013 the patient was administered PNEUMOVAX 23 (lot number, dose and route were not reported). Concomitant medications were not reported. On an unspecified date, in October 2013, the patient developed redness and arm swelling in the arm she received the routine immunization. The outcome of redness and arm swelling was not reported. The relationship between the PNEUMOVAX 23 and the events was not reported. This case is linked to case 1310USA011956 via same reporter link. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient. Patient with allergy to codeine. On 30-SEP-2013 (also reported as one month ago) the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous for immunization, lot number and expiration date not reported. There was no concomitant medication reported. On an unknown date in 2013 the patient went to the pharmacy and showed the pharmacist a rash on her chest under her neck which looked like sunburn. The pharmacist stated that there were no vesicles of pustules present and the rash was not unilateral. The patient reported that it burns and was painful. On an unknown date the patient sought for medical attention and visit the pharmacy. No treatment was given for the event. The patient has not yet received any treatment. No lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site warmth
Clinical narrative: Information was received from a pharmacist via a company representative regarding a 58 year old female patient. On an unknown date, the patient was vaccinated at a different pharmacy with ZOSTAVAX, 0.65 ml. Immediately after the injection, the patient experienced an injection site reaction of a hot, burning sensation. The patient also had the "same effect" with an unspecified "TD shot." (see case #1311USA004572). The outcome of the injection site reaction of a hot, burning sensation was reported as recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: This spontaneous report as received from a pharmacist via a field employee refers to 2 unspecified patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medication was not reported. On an unknown date, reported as "2 to 3 days later", the patient developed diarrhea and an "upset" stomach. The pharmacist stated that both patients received the ZOSTAVAX in the pharmacy and the patients reported the reaction to the pharmacist during a "follow up" phone call "2 to 3 days" after receiving the ZOSTAVAX. The outcome of developing diarrhea and an upset stomach was unknown. Causality was not reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 82 year old female patient. On 28-SEP-2013 or 29-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000435, expiration date 10-APR-2014, dose, route not reported) in one arm and a dose of influenza virus vaccine (manufacturer unknown) (lot#, expiration date, dose, route not reported) in the opposite arm. On an unknown date the patient experienced severe itching under the skin at both the injection site of the ZOSTAVAX and the influenza virus vaccine (manufacturer unknown) as of 06-NOV-2013 ("today"). Patient had sought out medical attention on an unspecified date. Patient visited an unspecified dermatologist who prescribed anti-itch cream and hydrocortisone. Pharmacist stated that patient had been using unspecified anti-itch medication prior to receiving the ZOSTAVAX and unspecified flu vaccine. The outcome of the event was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a physician refers to two unspecified female patients in their 50's. The patients' medical history included postherpetic neuralgia. On an unknown date the patients were vaccinated with ZOSTAVAX, vial, (lot #, expiration date, dose and route unspecified) for Shingles Vaccination. Concomitant medication included Unspecified Pain Medication. On an unknown date, within two weeks both patients stated that their postherpetic neuralgia had gone away. The pain had not come back as of reporting date. The patients had not sought medical attention. The event outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age. On 05-NOV-2013, the patient was vaccinated with an expired dose oral ROTATEQ lot # reported as 0578AE, expiration date: 26-OCT-2013 (dose and route were not reported). No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Information was received from a male consumer concerning his wife. On 17-OCT-2013, she was vaccinated with ZOSTAVAX. It was reported that after she and her husband (MARRS# 1310USA014844) they both experienced "a little redness and itching at the injection site". It was reported that she experienced these symptoms "a little more" than he did. It was reported that the symptoms lasted about three days and the injection site was sore after that. Additional information is requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to his 68 year old female wife with "cholesterol" and high blood pressure and no drug reactions/allergies. On 28-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX, VIAL, (lot #, expiration date, dose and route unspecified) for vaccination. Concomitant therapies included atorvastatin and atenolol. On 29-OCT-2013, the patient developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as a reddish, warm, "knot" at the injection site of the ZOSTAVAX vaccination. The consumer reported that the injection site reaction peaked on Wednesday (30-OCT-2013) and seemed to be getting better (less red and less warm). At the time of report, the patient was recovering from the events. No lab diagnostics studies performed. The patient had not sought medical attention. No treatment was given. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PEDVAXHIB (injection) that went through an unsupported temperature excursion from 29-OCT-2013 to 06-NOV-2013 (dose, route and lot number were not provided). No concomitant medications were reported. No adverse effect reported. This is one of several reports received from the same source (MARRS# 1311USA003162, MARRS# 1311USA004587 and MARRS# 1311USA004588). Additional information has been requested.
Sex: M
Vaccine: HPV2
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a male patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot#, expiration, dose, route unspecified). On an unknown date when the patient came to the office for the second dose, he was inadvertently given CERVARIX (lot#, expiration, dose, route unspecified). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to three patient of unknown age. On an unknown date each of the patients was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose not reported, injection) for prevention of shingles. On an unknown date, within a day of receiving ZOSTAVAX, each patient experienced injection site redness, warmth to touch and swelling. The patient sought medical attention. The outcome of the events was reported as resolved. The pharmacist noted that he had not come across similar cases of injection site reactions "for some time". Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to a patient of unknown age. On 05-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX, lot #, dose unspecified, expiration date of 28-SEP-2013, subcutaneous. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with RECOMBIVAX that went through an unsupported temperature excursion from 29-OCT-2013 to 06-NOV-2013 (dose, route and lot number were not provided). No concomitant medications were reported. No adverse effect reported. This is one of several reports received from the same source (MARRS# 1311USA003162, MARRS# 1311USA004586 and MARRS#1311USA004588). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with PEDVAXHIB (injection) that went through an unsupported temperature excursion from 29-OCT-2013 to 06-NOV-2013 (dose, route and lot number were not provided). No concomitant medications were reported. No adverse effect reported. This is one of several reports received from the same source (MARRS# 1311USA004586, MARRS# 1311USA004587 and MARRS# 1311USA004588). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with RECOMBIVAX that went through an unsupported temperature excursion from 29-OCT-2013 to 06-NOV-2013 (dose, route and lot number were not provided). No concomitant medications were reported. No adverse effect reported. This is one of several reports received from the same source (MARRS# 1311USA003162, MARRS# 1311USA004586 and MARRS# 1311USA004587). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Blister, Erythema, Local swelling, Skin warm
Clinical narrative: Arm red, swollen, blisters, warm to touch - right arm.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information was received from a male consumer. On 17-OCT-2013 the patient was vaccinated with ZOSTAVAX. The patient reported that after he and his wife (MARRS# 1311USA004568) they both experienced "a little redness and itching at the injection site". He also reported that his wife experienced these symptoms "a little more" than he did. The patient reported that the symptoms lasted about three days and the injection site was sore after that. Additional information is requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Delirium, Fatigue, Feeling hot, Speech disorder
Clinical narrative: 3 hrs after receiving vaccines c/o feeling warm, (not temp checked). Mom noted pt. acting "delirious" talking but not making sense - lasted approx. 10 minutes. He felt tired into early evening. (Mother just reported this all to us today 11/12/13).
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a 76 year old female patient reporting on herself. On 09-AUG-2013, the patient was vaccinated with ZOSTAVAX (dose, therapy route and indication not reported) (Lot # not reported). On 15-AUG-2013, the patient experienced blisters that appeared at her waist, the doctor confirmed shingles. The physician prescribed valacyclovir. On 18-AUG-2013, the patient had experienced allergic reaction to medication and redness all over her body. On an unspecified day, had visited the emergency room (ER). On 20-AUG-2013, the patient returned to the emergency room (ER) and the rash persisted. On 21-AUG-2013, the physician administered to the patient prednisolone shot and prescribed 6 days of oral drug. The rash had subsided after several days (approximately in August 2013). After two months, the patient still had redness in the area of blisters. This is a case of two of the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Generalised erythema, Herpes zoster, Hypersensitivity, Rash
Clinical narrative: This spontaneous report as received from a 76 year old female patient reporting on herself. On 09-AUG-2013, the patient was vaccinated with ZOSTAVAX (dose, therapy route and indication not reported) (Lot # not reported). On 15-AUG-2013, the patient experienced blisters that appeared at her waist, the doctor confirmed shingles. The physician prescribed valacyclovir. On 18-AUG-2013, the patient had experienced allergic reaction to medication and redness all over her body. On an unspecified day, had visited the emergency room (ER). On 20-AUG-2013, the patient returned to the emergency room (ER) and the rash persisted. On 21-AUG-2013, the physician administered to the patient prednisolone shot and prescribed 6 days of oral drug. The rash had subsided after several days (approximately in August 2013). After two months, the patient still had redness in the area of blisters. This is a case of two of the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Conduct disorder, Fatigue, Mood altered, Sinusitis
Clinical narrative: In May joint pain, fatigue, extremely tired, mood swings, sore throat.  Was put on an antibiotic for sore throat. Noticed thinning of the hair just a little. Had shot again in July same thing tired, joint pain, a weird cough that just would not go away.  Fatigue, started really noticing hair thinning. Joints really hurting, same as his sister.  Her joints were hurting. along with her ongoing sinus issue that has lasted her since her first shot.  Must of cause extra inflammation.    This is when I knew for sure this shot is causing a problem with both of my children.  Right now they have the exact same joint pain, in hip, her is in hip and back  complains of brain fog.  Forgetfulness just weird stuff that was not happening before the Gardasil shot.  My son had 2 shots, my daughter had one and I stopped the rest of the shots.  It definitely has been worse since the second shot my son received.  I will not be giving anymore shots to either of my children.  Daughter is still seeing a orthopedic who wants to put her under and give her a shot to relieve the pain. Had MRI on daughter and it is believed she has arthritis. Never had arthritis until this shot of Gardasil. Son will be going to ortho. Dr. soon if it does not improve. Had my son and daughter to peds. and they have no info for us on this matter.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Swelling face
Clinical narrative: In May joint pain, fatigue, extremely tired, mood swings, sore throat.  Was put on an antibiotic for sore throat. Noticed thinning of the hair just a little. Had shot again in July same thing tired, joint pain, a weird cough that just would not go away.  Fatigue, started really noticing hair thinning. Joints really hurting, same as his sister.  Her joints were hurting. along with her ongoing sinus issue that has lasted her since her first shot.  Must of cause extra inflammation.    This is when I knew for sure this shot is causing a problem with both of my children.  Right now they have the exact same joint pain, in hip, her is in hip and back  complains of brain fog.  Forgetfulness just weird stuff that was not happening before the Gardasil shot.  My son had 2 shots, my daughter had one and I stopped the rest of the shots.  It definitely has been worse since the second shot my son received.  I will not be giving anymore shots to either of my children.  Daughter is still seeing a orthopedic who wants to put her under and give her a shot to relieve the pain. Had MRI on daughter and it is believed she has arthritis. Never had arthritis until this shot of Gardasil. Son will be going to ortho. Dr. soon if it does not improve. Had my son and daughter to peds. and they have no info for us on this matter.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Arthralgia, Blood test abnormal, Cough, Fatigue
Clinical narrative: In May joint pain, fatigue, extremely tired, mood swings, sore throat.  Was put on an antibiotic for sore throat. Noticed thinning of the hair just a little. Had shot again in July same thing tired, joint pain, a weird cough that just would not go away.  Fatigue, started really noticing hair thinning. Joints really hurting, same as his sister.  Her joints were hurting. along with her ongoing sinus issue that has lasted her since her first shot.  Must of cause extra inflammation.    This is when I knew for sure this shot is causing a problem with both of my children.  Right now they have the exact same joint pain, in hip, her is in hip and back  complains of brain fog.  Forgetfulness just weird stuff that was not happening before the Gardasil shot.  My son had 2 shots, my daughter had one and I stopped the rest of the shots.  It definitely has been worse since the second shot my son received.  I will not be giving anymore shots to either of my children.  Daughter is still seeing a orthopedic who wants to put her under and give her a shot to relieve the pain. Had MRI on daughter and it is believed she has arthritis. Never had arthritis until this shot of Gardasil. Son will be going to ortho. Dr. soon if it does not improve. Had my son and daughter to peds. and they have no info for us on this matter.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Incomplete course of vaccination, Mood swings, Oropharyngeal pain
Clinical narrative: In May joint pain, fatigue, extremely tired, mood swings, sore throat.  Was put on an antibiotic for sore throat. Noticed thinning of the hair just a little. Had shot again in July same thing tired, joint pain, a weird cough that just would not go away.  Fatigue, started really noticing hair thinning. Joints really hurting, same as his sister.  Her joints were hurting. along with her ongoing sinus issue that has lasted her since her first shot.  Must of cause extra inflammation.    This is when I knew for sure this shot is causing a problem with both of my children.  Right now they have the exact same joint pain, in hip, her is in hip and back  complains of brain fog.  Forgetfulness just weird stuff that was not happening before the Gardasil shot.  My son had 2 shots, my daughter had one and I stopped the rest of the shots.  It definitely has been worse since the second shot my son received.  I will not be giving anymore shots to either of my children.  Daughter is still seeing a orthopedic who wants to put her under and give her a shot to relieve the pain. Had MRI on daughter and it is believed she has arthritis. Never had arthritis until this shot of Gardasil. Son will be going to ortho. Dr. soon if it does not improve. Had my son and daughter to peds. and they have no info for us on this matter.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Cellulitis, Serum sickness
Clinical narrative: Cellulitis NOS on 2013-10-04, Ot serum react d/t vacc on 2013-10-04, clinician comment: cellulitis at Tdap site.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Injection site cellulitis, Serum sickness
Clinical narrative: Cellulitis NOS on 2013-10-04, Ot serum react d/t vacc on 2013-10-04, clinician comment: cellulitis at Tdap site.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Chest discomfort, Chills, Dyspnoea, Malaise
Clinical narrative: Initial report was received from a healthcare professional on 31 October 2013. This reporter was the same reporter for case number 2013SA112457. A 66-year-old female patient had received an intramuscular injection of FLUZONE HIGH-DOSE, lot number U4758AA, on 15 October 2013 (site not reported) and two hours later developed chest tightness, difficulty breathing and felt like she couldn't move. She took BENADRYL and a rescue inhaler she had for bronchitis. The patient felt better in one hour but took until the next day for symptoms to resolve. The patient had no illness at the time of vaccination and no known allergies (NKA). Outcome was recovered. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: Initial report was received from a healthcare professional on 31 October 2013. This reporter was the same reporter for case number 2013SA112457. A 66-year-old female patient had received an intramuscular injection of FLUZONE HIGH-DOSE, lot number U4758AA, on 15 October 2013 (site not reported) and two hours later developed chest tightness, difficulty breathing and felt like she couldn't move. She took BENADRYL and a rescue inhaler she had for bronchitis. The patient felt better in one hour but took until the next day for symptoms to resolve. The patient had no illness at the time of vaccination and no known allergies (NKA). Outcome was recovered. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Dyspnoea, Laboratory test, Mobility decreased
Clinical narrative: Initial report was received from a healthcare professional on 31 October 2013. This reporter was the same reporter for case number 2013SA112457. A 66-year-old female patient had received an intramuscular injection of FLUZONE HIGH-DOSE, lot number U4758AA, on 15 October 2013 (site not reported) and two hours later developed chest tightness, difficulty breathing and felt like she couldn't move. She took BENADRYL and a rescue inhaler she had for bronchitis. The patient felt better in one hour but took until the next day for symptoms to resolve. The patient had no illness at the time of vaccination and no known allergies (NKA). Outcome was recovered. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Flushing, Migraine, Nausea, Photopsia
Clinical narrative: Initial report was received from a healthcare professional on 31 October 2013. A 52-year-old female patient had received an injection in the left deltoid of FLUZONE, lot number UH926BA, on 30 October 2013 at 11:45 AM. On the same day at 12:30 PM, the patient experienced migraine type headache with flashing lights, vision in periphery going in and out, flushing, nausea, dizziness and tachycardia. The patient had no illness at the time of vaccination and was allergic to sulfa drugs. Medical history included "reflux and others". Outcome was recovered. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tachycardia, Visual field defect
Clinical narrative: Initial report was received from a healthcare professional on 31 October 2013. A 52-year-old female patient had received an injection in the left deltoid of FLUZONE, lot number UH926BA, on 30 October 2013 at 11:45 AM. On the same day at 12:30 PM, the patient experienced migraine type headache with flashing lights, vision in periphery going in and out, flushing, nausea, dizziness and tachycardia. The patient had no illness at the time of vaccination and was allergic to sulfa drugs. Medical history included "reflux and others". Outcome was recovered. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Flushing, Laboratory test, Migraine, Nausea
Clinical narrative: Initial report was received from a healthcare professional on 31 October 2013. A 52-year-old female patient had received an injection in the left deltoid of FLUZONE, lot number UH926BA, on 30 October 2013 at 11:45 AM. On the same day at 12:30 PM, the patient experienced migraine type headache with flashing lights, vision in periphery going in and out, flushing, nausea, dizziness and tachycardia. The patient had no illness at the time of vaccination and was allergic to sulfa drugs. Medical history included "reflux and others". Outcome was recovered. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Photopsia, Tachycardia, Visual field defect
Clinical narrative: Initial report was received from a healthcare professional on 31 October 2013. A 52-year-old female patient had received an injection in the left deltoid of FLUZONE, lot number UH926BA, on 30 October 2013 at 11:45 AM. On the same day at 12:30 PM, the patient experienced migraine type headache with flashing lights, vision in periphery going in and out, flushing, nausea, dizziness and tachycardia. The patient had no illness at the time of vaccination and was allergic to sulfa drugs. Medical history included "reflux and others". Outcome was recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Oral herpes
Clinical narrative: Information was received from a pharmacist regarding a female patient of unknown age with allergy to OxyContin. On 21-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J005719, exp. 13-AUG-2014), 0.65 ml, subcutaneous. It was noted that the patient also was vaccinated with AFLURIA, (lot # R54410, exp. 01-JUN-2014) 0.5 ml, intramuscularly. Concomitant medications included, EFFEXOR, VALIUM and NEURONTIN. On 22-OCT-2013, the patient developed two cold sores on her lip. At the time of this report the patient has not recovered. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Injection site inflammation, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: PAIN IN RIGHT ARM.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: X-ray limb abnormal
Clinical narrative: PAIN IN RIGHT ARM.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: PAIN IN RIGHT ARM.
Age: 0.04
Sex: M
Vaccine: HEP, HEP
Symptoms: Death
Clinical narrative: The vaccine was given on Nov 4, 2013. My son died that night in his sleep. He was 15 days old.
Age: 0.04
Sex: M
Vaccine: HEP, HEP
Symptoms: Death neonatal, Large for dates baby, Toxicologic test, Unresponsive to stimuli
Clinical narrative: The vaccine was given on Nov 4, 2013. My son died that night in his sleep. He was 15 days old.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Dehydration, Nausea, Vomiting
Clinical narrative: Nausea/vomiting and dehydration. Treatment - antiemetics and rehydration.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: Red rash appeared around site of injection.  Rash was warm and painful to the touch, swollen, and blanched around its periphery.