chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Dizziness, Erythema, Fall, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient with thiazide diuretic allergy. The patient had no pertinent medical history. On 08-OCT-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H022280), Exp date: 16-JUL-2014), 0.5 ml, intramuscular in the right deltoid. Other suspect therapy included FLUVIRIN, dose, frequency, lot # and route unspecified, on 08-OCT-2013 in the right deltoid. There was no concomitant medication. The pharmacist reported that the patient was unsure if she had ever had PNEUMOVAX23 in the past. The patient reported that shortly afterwards, her arm felt "hot to the touch" and the "top of her arm was whiter than normal and the underside of her arm was very red". The patient reported that her arm was painful when she tried to lift it, and that it "felt full". The patient also reported fever and chills and dizziness and on 13-OCT-2013 she had a fall. The patient's injuries were unspecified, but the patient reported to the pharmacist that she was seen by her physician and that she did go for an Magnetic Resonance Imaging (MRI), but no result provided. No treatment was given for these events. Patient sought medical attention via office visit. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pallor, Pyrexia, Sensory disturbance, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient with thiazide diuretic allergy. The patient had no pertinent medical history. On 08-OCT-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H022280), Exp date: 16-JUL-2014), 0.5 ml, intramuscular in the right deltoid. Other suspect therapy included FLUVIRIN, dose, frequency, lot # and route unspecified, on 08-OCT-2013 in the right deltoid. There was no concomitant medication. The pharmacist reported that the patient was unsure if she had ever had PNEUMOVAX23 in the past. The patient reported that shortly afterwards, her arm felt "hot to the touch" and the "top of her arm was whiter than normal and the underside of her arm was very red". The patient reported that her arm was painful when she tried to lift it, and that it "felt full". The patient also reported fever and chills and dizziness and on 13-OCT-2013 she had a fall. The patient's injuries were unspecified, but the patient reported to the pharmacist that she was seen by her physician and that she did go for an Magnetic Resonance Imaging (MRI), but no result provided. No treatment was given for these events. Patient sought medical attention via office visit. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, FLU3, FLU3
Symptoms: CSF test abnormal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: 9/25/13 - Flu vaccination at primary care clinic. 9/26/13 - Shingles vaccination at pharmacy. Developed numbness and tingling in feet after immunizations. Time frame uncertain. Symptoms progressed to hands, then lower extremities from feet to knees. Reported to ETC on 10/30/13 when experiencing difficulty ambulating. Dx: Guillain-Barre.
Age: 74.0
Sex: M
Vaccine: VARZOS, FLU3, FLU3
Symptoms: CSF protein increased, Guillain-Barre syndrome
Clinical narrative: 9/25/13 - Flu vaccination at primary care clinic. 9/26/13 - Shingles vaccination at pharmacy. Developed numbness and tingling in feet after immunizations. Time frame uncertain. Symptoms progressed to hands, then lower extremities from feet to knees. Reported to ETC on 10/30/13 when experiencing difficulty ambulating. Dx: Guillain-Barre.
Age: 74.0
Sex: M
Vaccine: VARZOS, FLU3, FLU3
Symptoms: Asthenia, CSF test abnormal, Guillain-Barre syndrome, Paraesthesia
Clinical narrative: 9/25/13 - Flu vaccination at primary care clinic. 9/26/13 - Shingles vaccination at pharmacy. Developed numbness and tingling in feet after immunizations. Time frame uncertain. Symptoms progressed to hands, then lower extremities from feet to knees. Reported to ETC on 10/30/13 when experiencing difficulty ambulating. Dx: Guillain-Barre.
Sex: M
Vaccine: DTAPIPV, FLU3, MMR
Symptoms: Local reaction, Local swelling, Pruritus, Skin warm
Clinical narrative: Arm swollen, itchy, warm 3 days after injections. Advised BENADRYL. Reassured local reaction call if change or worse.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a Consumer, refers to a male patient around 72/85 age range. On 18-OCT-2013, the patient was vaccinated with PNEUMOVAX23 (lot # J006242, expiration date 03-AUG-2014, dose not reported). Per the reporter, the patient was affected. On 19-OCT-2013, the patient complained the area being red/hot and swollen the next day after the vaccination. At the time of reporting, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 80-89 years old female patient. In 2010 (3years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot# and dose not reported). On unknown date, the patient developed shingles after receiving ZOSTAVAX. The outcome of the event was reported as not recovered. The patient sought medical attention by saw the physician. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. About 3 or 4 months ago, approximately in June 2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, lot# and route unknown). There was no pertinent medical history. The patient after getting ZOSTAVAX developed a hard, painful nodule at site of injections about 3 or 4 months ago, approximately in June 2013. This reaction occurred "right after" vaccination and lasted "about" 2 days. No lab diagnostic studies were performed. The patient didn't seek medical attention. The patient was recovered from the event at the time of reporting. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a 71 year old female patient regarding herself. Patient's current conditions included occasional migraine headaches, psoriasis-like rash on her lower back, dermatitis, headaches and also patient was allergic to sulfur. On 22-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) in the arm. On the same day, the patient also received influenza virus vaccine (manufacturer unknown) at an unspecified Pharmacy. Concomitant therapies included FIORINAL. On 22-SEP-2013, the patient experienced headache which has continued "most days" since administration. The patient also reported breaking out with a reaction on and around the injection-site, in the form of "itchy-pink" small bumps that tend to spread and sting when scratched, sometimes extending over the breast area and into the underarm area since 22-SEP-2013, also straight pink "lines" or "streaks" on her stomach and stated that any touching or bumping of her skin seemed to lead to an outbreak of these bumps, which emerged and then disappeared. Patient sought medical attention for the same (had appointment with physician). No treatment was provided. The outcome of all the reported events was not recovered/not resolved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a 71 year old female patient regarding herself. Patient's current conditions included occasional migraine headaches, psoriasis-like rash on her lower back, dermatitis, headaches and also patient was allergic to sulfur. On 22-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) in the arm. On the same day, the patient also received influenza virus vaccine (manufacturer unknown) at an unspecified Pharmacy. Concomitant therapies included FIORINAL. On 22-SEP-2013, the patient experienced headache which has continued "most days" since administration. The patient also reported breaking out with a reaction on and around the injection-site, in the form of "itchy-pink" small bumps that tend to spread and sting when scratched, sometimes extending over the breast area and into the underarm area since 22-SEP-2013, also straight pink "lines" or "streaks" on her stomach and stated that any touching or bumping of her skin seemed to lead to an outbreak of these bumps, which emerged and then disappeared. Patient sought medical attention for the same (had appointment with physician). No treatment was provided. The outcome of all the reported events was not recovered/not resolved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Haemorrhage, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Employee develop redness, hardness, swollen, warm to touch area 2 - 3 inches below injection site of flu vaccine in right upper arm on 10/16/13. 10/18/13 went to ED - itchiness, redness and hardness and weeping. BACTRIM x 10 days and steroids x 10 days order for cellulitis. 10/19 area improving.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Vaccination complication
Clinical narrative: Employee develop redness, hardness, swollen, warm to touch area 2 - 3 inches below injection site of flu vaccine in right upper arm on 10/16/13. 10/18/13 went to ED - itchiness, redness and hardness and weeping. BACTRIM x 10 days and steroids x 10 days order for cellulitis. 10/19 area improving.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a consumer via Henry Schein (HSI control# 52255), refers to a female patient around 72-85 age range. On 18-OCT-2013, the patient was vaccinated with PNEUMOVAX23 (lot # J006242, expiration date 03-AUG-2014, dose not reported). Per the reporter, the patient was affected. On 19-OCT-2013, the patient complained the area being red/hot and swollen the next day after the vaccination. At the time of reporting, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Blood heavy metal test, Blood test, Computerised tomogram head, Dizziness
Clinical narrative: 1st dose 8-2-13. 2nd - 4-26-13. 3rd - 8-2-13. Test for Guillain Barre and Bell's Palsy. 8-28-13 - HA, dizzy, nausea, tactile fever, fell to floor shaking, clenched fist, urinary incontinence and drooling - continued well into October. Child went on to homebound in school. Mother has been in contact with Dr. in another state about associated sx's to HPV vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drooling, Fall, Headache, Nausea, Pyrexia
Clinical narrative: 1st dose 8-2-13. 2nd - 4-26-13. 3rd - 8-2-13. Test for Guillain Barre and Bell's Palsy. 8-28-13 - HA, dizzy, nausea, tactile fever, fell to floor shaking, clenched fist, urinary incontinence and drooling - continued well into October. Child went on to homebound in school. Mother has been in contact with Dr. in another state about associated sx's to HPV vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Toxicologic test, Tremor, Urinary incontinence, Urine analysis
Clinical narrative: 1st dose 8-2-13. 2nd - 4-26-13. 3rd - 8-2-13. Test for Guillain Barre and Bell's Palsy. 8-28-13 - HA, dizzy, nausea, tactile fever, fell to floor shaking, clenched fist, urinary incontinence and drooling - continued well into October. Child went on to homebound in school. Mother has been in contact with Dr. in another state about associated sx's to HPV vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Deafness, Dyskinesia, Dyspnoea, Fatigue
Clinical narrative: 1st dose 8-2-13. 2nd - 4-26-13. 3rd - 8-2-13. Test for Guillain Barre and Bell's Palsy. 8-28-13 - HA, dizzy, nausea, tactile fever, fell to floor shaking, clenched fist, urinary incontinence and drooling - continued well into October. Child went on to homebound in school. Mother has been in contact with Dr. in another state about associated sx's to HPV vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Feeling abnormal, Hot flush, Hypoaesthesia, Laboratory test, Menstrual disorder
Clinical narrative: 1st dose 8-2-13. 2nd - 4-26-13. 3rd - 8-2-13. Test for Guillain Barre and Bell's Palsy. 8-28-13 - HA, dizzy, nausea, tactile fever, fell to floor shaking, clenched fist, urinary incontinence and drooling - continued well into October. Child went on to homebound in school. Mother has been in contact with Dr. in another state about associated sx's to HPV vaccine.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle spasms, Muscle twitching, Panic attack, Seizure like phenomena
Clinical narrative: 1st dose 8-2-13. 2nd - 4-26-13. 3rd - 8-2-13. Test for Guillain Barre and Bell's Palsy. 8-28-13 - HA, dizzy, nausea, tactile fever, fell to floor shaking, clenched fist, urinary incontinence and drooling - continued well into October. Child went on to homebound in school. Mother has been in contact with Dr. in another state about associated sx's to HPV vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient injured his foot while mowing the lawn on an unspecified date about a month ago on September 2013. On 08-OCT-2013, after that injury the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On an unknown date in October 2013, the patient was recently prescribed prednisone (manufacturer unknown) for the unspecified foot injury and will begin taking it on an unspecified date in the future. Patient sought medical attention. The pharmacist stated she was busy and disconnected abruptly. The outcome of foot injury was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient. On 19-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU, (lot #, expiration date, dose, route and indication unspecified). On an unknown date the patient had an injection site reaction after receiving ZOSTAVAX. The pharmacist stated that patient had severe swelling and redness that was approximately 12 inches in length, which started on approximately 20-AUG-2013 (one to two days after receiving ZOSTAVAX) and lasted for approximately one week. The patient sought medical attention via contact pharmacist. No treatment was given. The event outcome was reported as recovered in August 2013. Additional information has been requested.
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Epstein-Barr virus test positive, Eyelid oedema, Flank pain, Liver function test abnormal, Lymphocyte count increased
Clinical narrative: This spontaneous report as received from office manager (healthcare worker) and a physician refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, dose, route not reported) and inactive flu vaccine (manufacturer unknown) on the same day. 24 hours after having received both vaccines the patient experienced an elevated temperature, flank pain and eyelids bilaterally swollen. Fever resolved in 72 hours. Eyelids bilaterally swollen still present when the physician last saw the patient (2 days ago) on 09-OCT-2013. No redness/itching etc. Lab work showed mono-like syndrome (Epstein-Barr virus (EBV+)), no proteinuria, renal function normal, elevated Liver function test (LFT) and other lymphocytes. Outcome of the events except for fever was unknown. Additional information is not expected.
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Mononucleosis syndrome, Pyrexia, Renal function test normal
Clinical narrative: This spontaneous report as received from office manager (healthcare worker) and a physician refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, dose, route not reported) and inactive flu vaccine (manufacturer unknown) on the same day. 24 hours after having received both vaccines the patient experienced an elevated temperature, flank pain and eyelids bilaterally swollen. Fever resolved in 72 hours. Eyelids bilaterally swollen still present when the physician last saw the patient (2 days ago) on 09-OCT-2013. No redness/itching etc. Lab work showed mono-like syndrome (Epstein-Barr virus (EBV+)), no proteinuria, renal function normal, elevated Liver function test (LFT) and other lymphocytes. Outcome of the events except for fever was unknown. Additional information is not expected.
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenitis, Rash, Rash erythematous
Clinical narrative: Lymphadenitis - (L) posterior neck. Raised erythematous rash (L) posterior neck and upper chest.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Laryngitis, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: At approximately 14 hrs. after vaccine received, patient developed fever of 101 degrees, body aches, sore throat, laryngitis, nasal congestion. Fever and body aches lasted 48 hrs.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 16-OCT-2013, the patient was inadvertently administered a dose of ZOSTAVAX (lot # 0168AE), subcutaneously that had expired on 06-MAR-2013. No adverse effects were reported. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 69 year old patient. On 17-OCT-2013 the patient was inadvertently received single dose of VARIVAX, 0.5 ml, subcutaneously for shingles prevention instead of ZOSTAVAX. No other effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (lot number not provided) doses which were exposed to -6.8 for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines had been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 10-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash pruritic, Varicella
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 29 year old female patient. Patient's current conditions included psoriasis and also the patient was allergic to latex. On 19-SEP-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (Lot number was reported as J008229 and expiry date was 12-JUL-2015), 0.5 milliliter (ml), subcutaneously. Concomitant therapies included sertraline hydrochloride and LEVOXYL. On 08-OCT-2013 (reported as about 3 weeks later), the patient experienced chickenpox. The patient had called the pharmacist to report that she had noted small red itchy bumps on her bilateral legs, abdomen, bilateral hands and behind the ears. The patient was advised to follow up with her unspecified physician. The patient call the pharmacist today on 11-OCT-2013, to report that the small bumps were still present and as numerous and that she had an appointment with the Unspecified physician today 11-OCT-2013. Patient sought medical attention (was yet to see the physician). No treatment was provided. Lab Diagnostics Studies Performed was none. The outcome of the reported event was not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient's information was updated. On 10-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 12 year old female patient with iga deficiency. Approximately on an unknown date in 2001 (reported as when the patient was 12 months old), the patient was vaccinated with a dose of VARIVAX, (lot number, expiry date was unknown). On an unknown date, the patient experienced developed two episodes of shingles. The outcome of the event was unknown. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with PNEUMOVAX23 dose, route and lot # not specified. On an unknown date after the use of PNEUMOVAX23 the patients experienced cellulitis. The outcome of cellulitis was unknown. The relatedness between PENUMOVAX23 and adverse events was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to some patients of unknown ages and genders with no pertinent medical history and drug reactions/allergies. On 11-OCT-2013 the patients was vaccinated with a dose of GARDASIL injection, 0.5 ml, intramuscular (lot# J008423, expiration date 21-JAN-2016). There was no concomitant medication. The nurse was reporting seven patients fainted in the office. The nurse stated some of the seven patients "passed out". No lab diagnostics studies were performed. Treatment was given for the event and the patients were provided with juice, crackers, and were monitored. Action taken with GARDASIL was unknown. All patients left the office fully recovered on 11-OCT-2013. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: This spontaneous report as received from a nurse refers to some patients of unknown ages and genders with no pertinent medical history and drug reactions/allergies. On 11-OCT-2013 the patients was vaccinated with GARDASIL injection, 0.5 ml, intramuscular (lot# J008423, expiration date 21-JAN-2016). There was no concomitant medication. The nurse was reporting seven patients fainted in the office. The nurse stated some of the seven patients "felt lightheaded". No lab diagnostics studies were performed. Treatment was given for the event and the patients were provided with juice, crackers, and were monitored. All patients left the office fully recovered on 11-OCT-2013. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to approximately 10 unspecified patients. On an unknown date, the patients were vaccinated with approximately 10 doses of PROQUAD (Merck) (Lot # H015875, expiration date 24-FEB-2014) that were exposed to -4C for 720 hours (30 days) which was not supported. No adverse effects were reported. This is one of several reports received from same source. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient's information was updated. On 10-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a consumer, as part of a marketing research program, refers to a 14 year old female patient. In 2011, the patient was vaccinated with a dose of GARDASIL. (dose and lot# not reported). In 2011, the patient experienced "distorted skin" reaction at injection sites. The outcome of the event was reported as probably resolved before the third shot. The reporter considered the event to be related to GARDASIL. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to approximately 10 unspecified patients. On an unknown date, the patients were vaccinated with approximately 10 doses of PROQUAD (Merck) (lot # reported as J00432 was invalid, expiration date 17-OCT-2014) that were exposed to -4C for 720 hours (30 days) which was not supported. No adverse effects were reported. Lot number J00432 is an invalid lot number for PROQUAD (Merck). This is one of several reports received from same source. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report as received from a doctor of pharmacy concerning an approximately 79 year old female patient. Current conditions of the patient included Altace allergy, Oxycodone allergy, Percocet allergy, Codeine allergy, Iodinated contrast media allergy and shellfish derived products allergy. On 15-OCT-2013 (also reported as 15-OCT-2015), the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were report as J004269 and 12-JUL-2014 respectively), subcutaneously in the right arm. No concomitant therapy was reported. Since 15-OCT-2013, after the vaccination, the patient experienced an increasing soreness around shoulder and neck, red hard bump and itchy rash the size of a half dollar. The patient did not seek any medical attention. No treatment was given. It was unspecified if any lab tests were performed. The patient was not recovered from the events. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient around 72-85 age range. On 18-OCT-2013, the patient was vaccinated with PENUMOVAX23 (lot # J006242, expiration date 03-AUG-2014, dose not reported). Per the reporter, the patient was affected. On 19-OCT-2013, the patient complained the area being red/hot and swollen the next day after the vaccination. At the time of reporting, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Viral test positive
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 13 year old male patient. On an unknown date the patient was vaccinated with first and second dose of VARIVAX (Merck), injection, (lot #, expiration, route and indication unspecified). On 07-OCT-2013 the patient experienced shingles on his hand and lower arm. Unspecified diagnostic studies were performed on samples from the rash and it was confirmed as positive for herpes zoster. The patient went to unspecified pediatrician. A cast was placed on the patient's arm to cover the rash and prohibit him from itching it. It was unspecified if any other treatment was given. The patient's rash had improved, however, the patient was not fully recovered. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Transient acantholytic dermatosis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old male patient. Patient was allergy to penicillin resulting in a rash. Approximately on an unknown date in April 2013 (reported as 6 months ago), the patient was vaccinated with a dose of ZOSTAVAX (Lot number and expiry date was not reported) VIAL 19400 PFU, 0.65 milliliter (ml), subcutaneously. Concomitant Medication were none. Approximately on an unknown date in April 2013 (reported as 3 to 4 days after receiving ZOSTAVAX), the patient experienced severe itching, psoriasis-like rash and was diagnosed with "Grover's disease" disease by an unspecified dermatologist. Patient sought medical attention for the same (contacted unspecified physician and pharmacist). Lab Diagnostic Studies Performed was none. Patient was treated with Prednisone, Clobetasol and Ambien. The outcome of the reported event was not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that an unspecified patient was administered with GARDASIL about 1.5 years ago (approximately in March 2012). The second dose of GARDASIL was administered to the patient on an unspecified date about a week ago (approximately 23-SEP-2013). No indication , lot number or dose information was provided. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Livedo reticularis, Rash maculo-papular, Viral rash
Clinical narrative: Rec'd 2 mo imm 10/22/13; pink maculopapular rash to scalp, neck, arms, trunk/back and buttocks. Developed that PM seen for s/s 10/23/13. Also noted on exam rash with cutis marmorata. *Appears to be viral; no TX; referred to I.D and Allergy.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt said he experienced rash over his stomach area several days after receiving the high-dose flu vaccine. Rash lasted for approximately 10 days. Pt cannot think of any other possible cause for the rash.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Pruritus, Rash, Urticaria
Clinical narrative: Friday following vaccine client felt fatigue. 1 day post administration of vaccine (Saturday), client stated "my left arm was red and itching with small welt" client apply hydrocortisone ointment. Return to office Tuesday, October 29. Rash Lt. arm 14x14, red.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Pain in left arm following flu shot administered on 9-26-13. Customer went to physician on 10/24/13 and was diagnosed with Neuralgia. Gabapentin and Diclofenac Sod EC were prescribed for 30 days and Hydro/APAP for 4 days. X-ray and lab work also ordered on 10/24/13.
Age: 72.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Condition aggravated, Dyspnoea, Rubber sensitivity, Sneezing, Throat tightness
Clinical narrative: Pt. says that a few days after the immunizations, he sneezed about a hundred times in a row and soon had to be hospitalized. He said that he was having trouble breathing and it felt like someone had their hands around his throat. He said the Dr's. determined that it must be a latex reaction.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Mobility decreased
Clinical narrative: When vaccine was administered, I felt a sharp pain down to my elbow immediately, could hardly move arm x 2 days. Got better, but pain is present. Still after 15 days when pulling, pushing, or lifting objects. Throbs at night while sleeping.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a neonate patient of unknown gender who was born "sometime this week". In October 2013, the patient was vaccinated with RECOMBIVAX HB (Lot #, route and expiration date not provided) 5 mcg/0.5 ml. In October 2013, the patient inadvertently received two doses of RECOMBIVAX HB pediatric doses in 12 hours period. No adverse effects at this time. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Urticarial rash on trunk/extremities 1 day after FLUZONE (Hi - Dose), resolving on own.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from an other health professional via a field representative refers to a male patient of unknown age. The patient's medical history was not reported. On 24-OCT-2013 the patient was vaccinated intramuscularly with a dose of GARDASIL (dose, frequency, lot number and expiration date were not reported). No concomitant medications were reported. It was reported that on 24-OCT-2013, the patient stood up after waiting 10 minutes after the administration of GARDASIL and then fainted. No other vaccines were administered other than GARDASIL. The outcome of the event was unknown. The patient sought medical attention during doctor's visit. The relatedness between the event and GARDASIL was not reported. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Influenza like illness, Myalgia, Rash
Clinical narrative: Rash, muscle pain, weakness, flu-like symptoms occurring later in day 1 day after immunizations.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Dizziness, Hypoaesthesia, Pain in extremity
Clinical narrative: Chills, dizzy, fever, vomiting, arm numb and tingling, sore arm and joints, sneezing.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Paraesthesia, Pyrexia, Sneezing, Vomiting
Clinical narrative: Chills, dizzy, fever, vomiting, arm numb and tingling, sore arm and joints, sneezing.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient's information was updated. On 11-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Autopsy, Cardiac arrest, Death, Myocarditis, Unresponsive to stimuli
Clinical narrative: Victim was found unresponsive/cardiac arrest in bed at home in the morning of 8/20/13. Autopsy showed cause of death was myocarditis.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's doctor called and said she was there being seen for redness and swelling at injection site on 10/24/13.
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Had (-) mumps titer, hospital policy is to receive IZ MMR 0.5 cc SQ given 10/23/13, employee with generalized flat exanthematous rash to face, neck, torso, arms 24 hours after receiving vaccine.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: 2 small bumps and itching, redness.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: 3 days after the injection, I developed a red, itchy streak down my arm and hives on my opposite hand.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives to bilateral arms 25 min after receiving vaccine. 1105 BENADRYL 50mg/CLARITIN taken per self. 1150 hives spreading to legs, high, buttocks seen by Nurse Practitioner - prescribed Prednisone 10/21/13 hives continue, spread to back and below bilateral breasts.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 23 year old female patient. The patient received her first dose of GARDASIL (dose, route, lot number and expiration date were not reported) on an unspecified date, at age 12 years and she received her second dose of GARDASIL (lot number: H020848, expiration date 03-APR-2015, dose and route of administration were not reported) on 24-OCT-2013. No adverse effect has been observed or reported. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea
Clinical narrative: No previous trouble or sickness. 6:00 AM the following morning had diarrhea. This continued for four days. That is all.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Agitation, Middle insomnia, Tachycardia
Clinical narrative: Patient refers he awakened x 2 nights after immunization with tachycardia, agitated, referred he wanted to run.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain, X-ray
Clinical narrative: Patient felt pain right after injection and couldn't lift her arm after approximately 6 hours of injection. She visited Emergency room and follow-up Dr. visit and also specialist. (X-ray check's done and also alternate physical therapy.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Myalgia, Pain in extremity
Clinical narrative: Swelling and redness at site of injection, about size of tennis ball. Headache (which continues slightly), painful muscle aches in extremities. Continuing.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Redness on arm.
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13
Symptoms: Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging normal
Clinical narrative: Seizure about 7 hours afater vaccine received. Hospital admit, MRI, EEG. No seizure meds at D/C.
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13
Symptoms: Blood culture, CSF culture, Culture urine, Electroencephalogram, Gaze palsy
Clinical narrative: Seizure about 7 hours afater vaccine received. Hospital admit, MRI, EEG. No seizure meds at D/C.
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13
Symptoms: Hypotonia, Lethargy, Muscle twitching, Neurological examination normal, Nuclear magnetic resonance imaging
Clinical narrative: Seizure about 7 hours afater vaccine received. Hospital admit, MRI, EEG. No seizure meds at D/C.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced 2 - 3" wide red, swollen area around injection site, plus general swelling and redness a few inches past that. Pt also experienced flu - like symptoms.
Age: 81.0
Sex: U
Vaccine: FLU3
Symptoms: Dysphagia, Pain, Pyrexia
Clinical narrative: After 4 hrs of injection, fever of 100 degrees; body aches, difficulty in swallowing lasting 24 hours.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dysgeusia, Feeling cold, Headache, Malaise
Clinical narrative: Felt sick when I left the pharmacy. Taste in my mouth. Legs felt shaky. Went home shortly after started to vomit until I had dry heaves. Headache, bad chills, and couldn't get warm. Shaking fever went to 103.5 degrees. So sick all night but didn't call for help as my husband kept track of me. I called the drug store next day and my doctor.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pyrexia, Retching, Tremor, Vomiting
Clinical narrative: Felt sick when I left the pharmacy. Taste in my mouth. Legs felt shaky. Went home shortly after started to vomit until I had dry heaves. Headache, bad chills, and couldn't get warm. Shaking fever went to 103.5 degrees. So sick all night but didn't call for help as my husband kept track of me. I called the drug store next day and my doctor.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site, doctor attributes event to vaccinations, symptoms appeared same day as vaccination and worsened over the next 2 days.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Urticaria
Clinical narrative: Within minutes of vaccination, patient experienced pain at the site of injection. Pain worsened as day progressed, to the point that it was difficult for patient to use arm. Pain continued through the night, but started improving the next morning. The next morning she woke up with hives covering her entire face. No swelling or difficulty breathing. Patient advised to notify her physician and seek immediate medical care if symptoms worsen.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 48 hours after vaccination, onset of pain was noted at injection site. Four hours after onset of pain, induration about 4 inches in diameter was noted at injection site, along with other smaller indurations, redness, swelling and pain down to elbow. Area warm to touch. Symptoms started to subside about 24 hours after onset.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On 10/20 Pt complained the site of injection got hot, itchy. Denied any fever and said she used ice to reduce the swelling.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Oedema, Skin warm, Swelling
Clinical narrative: Got injection on 10/22/13. No problems for 24 hours. Then red, swollen, firm, and hot area 3 inches x 2 inches. Ice applied which seemed to lessen the area redness and edema.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Injection site haemorrhage, Mydriasis, Syncope
Clinical narrative: Post - vaccine small amount of blood at site of injection - soon after had seizure, pupils dilated, checked pulse. Seizure stopped 30 - 45 seconds later, syncope followed x 30 seconds also. Paramedics arrived 5 minutes later and did not proceed to hospital. Pt didn't state this occurred before on VAR nor mentioned to health care provider.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Sensation of heaviness
Clinical narrative: Employee received influenza vaccine (.5cc) into left deltoid at 6pm. About 8pm began having left arm injection site soreness with left arm numbness from elbow down. Took MOTRIN pain decreased to a 4 along with decreased pain at injection site 10/16 - skin had heavy feeling in arm - resolved few days later.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site discomfort, Injection site reaction, Neuritis
Clinical narrative: Employee received influenza vaccine (.5cc) into left deltoid and about 15 minutes later experienced injection site discomfort with a throbbing and numbing down back of arm to pinkie finger. Took EXCEDRIN w/o relief. Saw MD 3 days later. Dx: neuritis.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Employee received influenza vaccine (.5cc) into left deltoid and about 15 minutes later experienced injection site discomfort with a throbbing and numbing down back of arm to pinkie finger. Took EXCEDRIN w/o relief. Saw MD 3 days later. Dx: neuritis.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Oxygen saturation decreased
Clinical narrative: Shortness of breath. Visited MD next day and had oxygen treatment to restore low oxygen and had steroid injection.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Sudden death
Clinical narrative: SUID / ? SIDS.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Papule, Rash papular, Rash pruritic
Clinical narrative: Rec'd GARDASIL #2 10/14; on 10/16 had onset of papular, itchy rash on belly and chest; spread to back and arms. Papules are nonpustular, 1-2mm, no erythema. Pt has prior allergy to uncoated tablets taken orally, no other h/o vaccine rxns.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a claims examiner refers to a patient of unknown age and gender. Medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX lot number reported as J003976, expiration date 28-JUN-2014 (concentration, dose and indication were not reported). Concomitant therapies were not reported. On an unknown date, the patient experienced an adverse reaction to ZOSTAVAX. The outcome of adverse reaction was unknown. Additional information has been requested. Lot number J003976 is an invalid lot number for ZOSTAVAX.