chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Vertigo
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a 60 year old male patient. Approximately on an unknown date in 2013 (reported as within the last three months), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. Approximately on an unknown date in 2013, a day after the vaccination, the patient experienced vertigo. The patient was unable to work due to vertigo. The patient as referred to an unspecified neurologist. Patient sought medical attention (saw physician at office). It was unspecified if the any treatment was given or if any lab test performed. The outcome of the events was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Rash macular, Urticaria
Clinical narrative: 4-9-13 2 hrs after receiving started having headache. Took migraine medicine with no help - name unknown. 4-10-13 developed "hives" blotchy red areas on arms and legs. Called and FNP referred to ER. Per pt. left ER without being seen "hives went away". 4-11-13 no rash. No headaches.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age and gender. On 05-APR-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 672425/1607AA, expiration date 13-JAN-2013 and route not reported). No adverse effect reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema noted to left upper arm at injection site with tenderness to palpation. Treated with BENADRYL 25mg PO.
Sex: F
Vaccine: HPV4
Symptoms: Acne
Clinical narrative: This spontaneous report as received via a company representative from a physician refers to a female patient of unknown age. The patient was vaccinated with standard dose of GARDASIL (lot number, expiry date, route and site not reported) within the last 30 days approximately in March 2013. The patient developed a transient acne problem about 2 weeks after receiving her first dose with GARDASIL, within the last 30 days. The patient had not sought medical attention. No treatment was given for the event. The outcome of transient acne problem was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site anaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Left deltoid with numbness, some redness, and pain with decreased range of motion.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site pain, Injection site reaction, Myalgia, Paraesthesia
Clinical narrative: Persistent pain at site of injection (5 1/2 months elapsed). Physician diagnosed paresthesia; loss of sensation (numbness to touch) centered on site of injection, measuring 10 cm x 9 cm; pain in muscle at site of injection.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Sensory loss
Clinical narrative: Persistent pain at site of injection (5 1/2 months elapsed). Physician diagnosed paresthesia; loss of sensation (numbness to touch) centered on site of injection, measuring 10 cm x 9 cm; pain in muscle at site of injection.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 13-MAR-2013, the patient who was vaccinated with a first dose of PNEUMOVAX23 (lot  # H015749, expiry date 08-JUN-2014) 0.5 milliliter (ml), intramuscularly was inadvertently administered second dose of PNEUMOVAX23 (lot # H015749, expiry date 08-JUN-2014) on 21-MAR-2013. No adverse effect reported. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Pt presented to the ER with left arm swelling and pain after getting a vaccination on Monday 3/15/13. Seen at ER on 03/28/13 at 12PM, mother notes arm swelled up several hours after the shot was given. Warm to touch since then. Pt started on Clindamycin antibiotics.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blood culture negative, Erythema, Full blood count, Injection site haematoma
Clinical narrative: Had PPD (R) forearm and Tdap (R) deltoid with (R) deltoid hematoma, fever / pruritus. (L)UE lymphadenopathy, increased erythema / swelling / fever/ pruritus / pain / sore throat, facial flushing, arthralgia.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Oropharyngeal pain, Pain, Pruritus, Pyrexia
Clinical narrative: Had PPD (R) forearm and Tdap (R) deltoid with (R) deltoid hematoma, fever / pruritus. (L)UE lymphadenopathy, increased erythema / swelling / fever/ pruritus / pain / sore throat, facial flushing, arthralgia.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Had PPD (R) forearm and Tdap (R) deltoid with (R) deltoid hematoma, fever / pruritus. (L)UE lymphadenopathy, increased erythema / swelling / fever/ pruritus / pain / sore throat, facial flushing, arthralgia.
Age: 48.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site pain, Pain
Clinical narrative: Pt. received vaccine on 4/1/13, came in 4/5/13 saying he had severe pain from inj site and appeared to be radiating. Said no swelling of inj site. Stated pain was the worst on 4/4/13 and has subsided now.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 08-MAR-2013 at 10:00 am. the patient was vaccinated with VAQTA (lot # 0273AE and expiration date 06-DEC-2014) (dose, therapy route and anatomical location unspecified). The physician reported that VAQTA was exposed to multiple low temperature excursions. excursion time at -1:62:50 hours (also reported as 17 hours, 238 hours at 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 17 year old male patient. On an unknown date, the patient may have been vaccinated with a dose of (Merck) VARIVAX (Lot number, expiry date, route and dose were not reported) was diagnosed with shingles approximately on an unknown date in October 2012(reported as 6 months ago). The nurse was unable to confirm if the patient had received (Merck) VARIVAX. The patient sought medical attention for the same (Office visit).On an unknown date, the event shingles was recovered/resolved. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Pt experienced injection site reaction, arm very swollen, red, fevered.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pruritus, Skin warm
Clinical narrative: Pt states she had a reaction to pneumonia vaccine on 3/29/13. She states the same day it was a little swollen and sore, but she kept moving it around. On Saturday, pt states swelling was spreading and traveling down inside of her arm. On Sunday she states there was redness and swelling down to her elbow and slightly itchy and warm. Sunday evening she noticed the redness moved about 2 inches below elbow was still warm and swollen. There was also 2 long, dark, red streaks on patient's arm and she decided to go to ER. She was prescribed an abx in the ER and she states she started dose last night and she already noticed a difference and is feeling better. However, pharmacist and doctor at ER wanted her to report situation to PCP in case we may have a bad lot for the vaccine. The doctor at the ER states this was her 3rd case in the past week, with a reaction to pneumonia vaccine. She is concerned that if vaccine is a bad lot, then does that mean pt will need to repeat pneumonia vaccine? Please advise.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Pt states she had a reaction to pneumonia vaccine on 3/29/13. She states the same day it was a little swollen and sore, but she kept moving it around. On Saturday, pt states swelling was spreading and traveling down inside of her arm. On Sunday she states there was redness and swelling down to her elbow and slightly itchy and warm. Sunday evening she noticed the redness moved about 2 inches below elbow was still warm and swollen. There was also 2 long, dark, red streaks on patient's arm and she decided to go to ER. She was prescribed an abx in the ER and she states she started dose last night and she already noticed a difference and is feeling better. However, pharmacist and doctor at ER wanted her to report situation to PCP in case we may have a bad lot for the vaccine. The doctor at the ER states this was her 3rd case in the past week, with a reaction to pneumonia vaccine. She is concerned that if vaccine is a bad lot, then does that mean pt will need to repeat pneumonia vaccine? Please advise.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 01-MAR-2013 the patient was vaccinated with GARDASIL (lot # H010915, expiration date 13-FEB-2015) (dose, therapy route and anatomical location unspecified). The physician reported that on unknown dates, GARDASIL was exposed to multiple low temperature excursions. Excursion time at -1: 18.50 (also reported a 11 hours -1 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncopal event x approximately 1 minute.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 08-MAR-2013 at 04:20 pm, the patient was vaccinated with GARDASIL (lot # H010915, expiration date 13-FEB-2015) (dose, therapy route and anatomical location unspecified). The physician reported that on unknown dates, GARDASIL was exposed to multiple low temperature excursions. Excursion time at -1:66.50 hours (also reported a 17 hours, -1, 172, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Asthenia, Headache, Myalgia
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender who within the last 2 weeks in 2013, was vaccinated with GARDASIL (dose, lot # and route not provided). The Physician stated he use to give GARDASIL vaccinations all the time, even to his own children. However, within the last 2 weeks in 2013, a patient developed severe headache, weakness and muscle aches all over the body. The patient sought medical attention and was seen in the physician's office. Physician states he walked that patient over to the Neurologist. The outcome of severe headache, weakness and muscle aches all over the body was unknown. The relatedness adverse events was unknown for GARDASIL. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 3 patients of unknown age and genders who within the last 2 weeks in 2013, were vaccinated with GARDASIL (dose, lot # and route not provided). The physician states he used to give GARDASIL vaccinations all the time, even to his own children. However, within the last 2 weeks in 2013, 3 of his patients had adverse effects post vaccination with GARDASIL. 3 patients fainted after getting vaccinated. The patients sought medical attention and was seen on the physician's office. 3 of the patients were female and one was a male patient. The outcome of 3 patients fainted after getting vaccinated was unknown. The relatedness adverse events was unknown for GARDASIL. This is one of several reports from same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 29-MAR-2013 at 11:00 am, the patient was vaccinated with GARDASIL (lot # H010915, expiration date 13-FEB-2015) (dose, therapy route and anatomical location unspecified). The physician that on unknown dates, GARDASIL was exposed to multiple low temperature excursions. Excursion time at -1: 221.50 hours (also reported as 17 hours -1, 420 2, -5.4 hours, 228 hours, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning unspecified number of patients of unknown age who on an unknown dates were vaccinated with doses of VAQTA (doses, routes and lot numbers not provided) that were exposed to 28F for an unknown period of time. No adverse symptoms were 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 physician refers to a patient of unknown age and gender. On 01-MAR-2013 at 9:20 am, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 16.50 hours (also reported as 10 hours at -1). The patient was not experiencing any known symptoms. This is one of several reports from the same source. 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 registered nurse concerning unspecified number of patients of unknown age who on an unknown dates were vaccinated with RECOMBIVAX HB (doses, routes and lot numbers not provided) that were exposed to 28F for an unknown period of time. No adverse symptoms were 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 physician refers to a patient of unknown age and gender. On 02-MAR-2013 at 11:00 am, the patient was vaccinated with RECOMBOVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 39.50 hours (also reported as 17 hours -1, then 4 admin (2)). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Facial paresis, Lip swelling, Pupillary light reflex tests normal, Rubella antibody negative, Sensory loss
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 58 years old female patient of unknown age with high blood pressure and smoker. The patient's medical history included bilateral mastectomy. The patient had no known drug reactions/allergies. The patient also had a flu shot in 2011. The patient was not immune to rubella based on her titers so she was administered M-M-R II. The patient was administered M-M-R II on 20-FEB-2013 (lot number was reported as H011885; exp.was 25-JUN-2014) subcutaneously . Concomitant therapies included hydrochlorothiazide (manufacturer unknown). On 21-MAR-2013 the patient woke up and half of her bottom lip was swollen and she was having trouble drinking from a glass. The patient went to the emergency room on 22-MAR-2013. At that emergency room visit the patient had left-sided facial weakness which included her eyebrows, had reduced sensation to light touch on the left side of her face, there was no tongue or ovular deviation, and her pupils were equal and reactive to light; all else was normal on physical exam. Bell's Palsy was diagnosed in the emergency room based on physical exam. She was treated with LACRILUBE and prednisone (manufacturer unknown) (60mg daily for five days). The patient was not admitted to the hospital. As of 02-APR-2013, the patient was improving. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: VIIth nerve paralysis
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 58 years old female patient of unknown age with high blood pressure and smoker. The patient's medical history included bilateral mastectomy. The patient had no known drug reactions/allergies. The patient also had a flu shot in 2011. The patient was not immune to rubella based on her titers so she was administered M-M-R II. The patient was administered M-M-R II on 20-FEB-2013 (lot number was reported as H011885; exp.was 25-JUN-2014) subcutaneously . Concomitant therapies included hydrochlorothiazide (manufacturer unknown). On 21-MAR-2013 the patient woke up and half of her bottom lip was swollen and she was having trouble drinking from a glass. The patient went to the emergency room on 22-MAR-2013. At that emergency room visit the patient had left-sided facial weakness which included her eyebrows, had reduced sensation to light touch on the left side of her face, there was no tongue or ovular deviation, and her pupils were equal and reactive to light; all else was normal on physical exam. Bell's Palsy was diagnosed in the emergency room based on physical exam. She was treated with LACRILUBE and prednisone (manufacturer unknown) (60mg daily for five days). The patient was not admitted to the hospital. As of 02-APR-2013, the patient was improving. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a 65 year old female retired nurse refers to herself. On 04-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# not reported). There was no concomitant therapy. On 06-APR-2013 after receiving ZOSTAVAX she developed a small reddened area on her arm. Patient did not seek medical attention. Patient received treatment by coverning the area with Band-Aid. The outcome of developed small reddened area on her arm was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 18-MAR-2013 at 4:20 pm, the patient was vaccinated with GARDASIL (lot # H010915, expiration date 13-FEB-2015) (dose, therapy route and anatomical location unspecified). The physician reported that on unknown dates, GARDASIL was exposed to multiple low temperature excursions. Excursion time at -1: 130.50 hours (also reported "17 hours-1, 412 2 admin"). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 16-MAR-2013 at 11:20 am, the patient was vaccinated with GARDASIL (lot # H010915, expiration date 13-FEB-2015) (dose, therapy route and anatomical location unspecified). The physician reported that on unknown dates, GARDASIL was exposed to multiple low temperature excursions. Excursion time at -1: 125.50 hours (also reported "17 hours, -1, 359 2 admin"). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 01-MAR-2013 at 11:40 am, the patient was vaccinated with GARDASIL (lot # H010915, expiration date 13-FEB-2015) (dose, therapy route and anatomical location unspecified). The physician reported that on unknown dates, GARDASIL was exposed to multiple low temperature excursions. Excursion time at -1: 18.50 hours (also reported 11 hours), -1 admin. The patient was not experiencing any known symptoms. This is one of several assistant from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician regarding an unknown age and gender patient with no pertinent medical history reported. In August 2012, the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose, route and anatomical location were not reported). The reporter stated that in 09-APR-2013 (reported as "today") the patient received the second dose of GARDASIL (lot number and expiration date not reported) (dose, route and anatomical location were not reported). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning unspecified number of patients of unknown age who on an unknown date were vaccinated with COMVAX (doses, routes and Lot numbers not provided) that were exposed to 28F for an unknown period of time. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning unspecified number of patients of unknown age who on an unknown dates were vaccinated with doses of GARDASIL (dose, route and lot number not provided) that were exposed to 28F for an unknown period of time. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning unspecified number of patients of unknown age who on an unknown dates were vaccinated with doses of PNEUMOVAX23 (dose and route not provided) that were exposed to 28F for an unknown period of time. No adverse symptoms were reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Infection, Injection site erythema, Injection site swelling, Oedema peripheral, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 58 year old male patient with no drug reactions/allergies. Current conditions included hypertension, hyperlipidemia and vitamin d deficiency. On 09-FEB-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot # H019999, expiration date unspecified) subcutaneously. Concomitant therapies included atenolol, omega-3 marine triglycerides, lisinopril and simvastatin. Approximately on 09-FEB-2013 (reported as 12 hours after vaccination) patient experienced sudden chills, anorexia, sweating, diarrhea, redness and slight swelling at the injection site. The patient went to an unspecified physician 3 days after ZOSTAVAX and was diagnosed with cellulitis of arm. Lab diagnostic tests included urinalysis and nasal swab that was determined likely viral due to ZOSTAVAX. Unspecified antibiotics and ibuprofen were given as treatment for the event. The event recovered on an unknown date in 2013. Causality was not reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Chills, Decreased appetite, Diarrhoea, Erythema
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 58 year old male patient with no drug reactions/allergies. Current conditions included hypertension, hyperlipidemia and vitamin d deficiency. On 09-FEB-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot # H019999, expiration date unspecified) subcutaneously. Concomitant therapies included atenolol, omega-3 marine triglycerides, lisinopril and simvastatin. Approximately on 09-FEB-2013 (reported as 12 hours after vaccination) patient experienced sudden chills, anorexia, sweating, diarrhea, redness and slight swelling at the injection site. The patient went to an unspecified physician 3 days after ZOSTAVAX and was diagnosed with cellulitis of arm. Lab diagnostic tests included urinalysis and nasal swab that was determined likely viral due to ZOSTAVAX. Unspecified antibiotics and ibuprofen were given as treatment for the event. The event recovered on an unknown date in 2013. Causality was not reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyperhidrosis, Injection site swelling, Nasal mucosa biopsy, Urine analysis, Viral infection
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 58 year old male patient with no drug reactions/allergies. Current conditions included hypertension, hyperlipidemia and vitamin d deficiency. On 09-FEB-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot # H019999, expiration date unspecified) subcutaneously. Concomitant therapies included atenolol, omega-3 marine triglycerides, lisinopril and simvastatin. Approximately on 09-FEB-2013 (reported as 12 hours after vaccination) patient experienced sudden chills, anorexia, sweating, diarrhea, redness and slight swelling at the injection site. The patient went to an unspecified physician 3 days after ZOSTAVAX and was diagnosed with cellulitis of arm. Lab diagnostic tests included urinalysis and nasal swab that was determined likely viral due to ZOSTAVAX. Unspecified antibiotics and ibuprofen were given as treatment for the event. The event recovered on an unknown date in 2013. Causality was not reported. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Viral test positive
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 58 year old male patient with no drug reactions/allergies. Current conditions included hypertension, hyperlipidemia and vitamin d deficiency. On 09-FEB-2013 the patient was vaccinated with 0.65 milliliter (ml) ZOSTAVAX (lot # H019999, expiration date unspecified) subcutaneously. Concomitant therapies included atenolol, omega-3 marine triglycerides, lisinopril and simvastatin. Approximately on 09-FEB-2013 (reported as 12 hours after vaccination) patient experienced sudden chills, anorexia, sweating, diarrhea, redness and slight swelling at the injection site. The patient went to an unspecified physician 3 days after ZOSTAVAX and was diagnosed with cellulitis of arm. Lab diagnostic tests included urinalysis and nasal swab that was determined likely viral due to ZOSTAVAX. Unspecified antibiotics and ibuprofen were given as treatment for the event. The event recovered on an unknown date in 2013. Causality was not reported. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness at injection site.
Age: 39.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Age: 47.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm warm red and slightly swollen around injection site.
Age: 47.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm warm red and slightly swollen around injection site.
Age: 43.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness/swelling 6 cm around site reported by MD.
Age: 43.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling 6 cm around site reported by MD.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with allergic to sulfa, codeine, DEMEROL and MACRODANTIN. On 06-APR-2013 the patient was vaccinated with ZOSTAVAX (lot# J000433; expired date 10-APR-2014, reported as expired on 01-APR-2014) (dose and injection site were not reported) subcutaneously as shingles vaccine. On an unknown date in April 2013, the patient had a varicella like rash on her arms and legs. The rash was blistering and itchy and appeared to be chicken pox. The outcome was reported as not recovered. There was no treatment given for adverse events. It was unspecified if the patient sought any medical attention. The causality and action taken were not provided at the time of report. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash pruritic, Rash vesicular, Varicella
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with allergic to sulfa, codeine, DEMEROL and MACRODANTIN. On 06-APR-2013 the patient was vaccinated with ZOSTAVAX (lot# J000433; expired date 10-APR-2014, reported as expired on 01-APR-2014) (dose and injection site were not reported) subcutaneously as shingles vaccine. On an unknown date in April 2013, the patient had a varicella like rash on her arms and legs. The rash was blistering and itchy and appeared to be chicken pox. The outcome was reported as not recovered. There was no treatment given for adverse events. It was unspecified if the patient sought any medical attention. The causality and action taken were not provided at the time of report. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Allergy test positive, Food allergy, Milk allergy, Skin test positive
Clinical narrative: Ongoing food allergies. Milk, nuts, eggs.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Localized erythema, edema, tenderness at injection site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Right upper arm red and warm to touch, c/o pain.
Age: 1.44
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Vaccination site pain
Clinical narrative: Erythematous patchy area with mild tenderness on vaccine site. Tx: cold, wet washcloth.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 64 year old male patient. The patient's medical history and concurrent conditions were not provided. On 05-APR-2013 the patient was vaccinated with an expired dose of ZOSTAVAX lot # 0467AE, 0.65 ml, subcutaneous. Expiration date was 04-APR-2013. No concomitant medications were reported. No adverse effects were reported. No further information was available. Additional information has been requested.
Sex: M
Vaccine: HPV2
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. On 06-NOV-2012 the patient was vaccinated with his first dose of GARDASIL. On 09-APR-2013 the patient was given a dose of CERVARIX (instead of GARDASIL). No product confusion just medication error. No adverse event reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Body temperature increased, Irritability, Vomiting
Clinical narrative: Patient received 4mth old shots. On 4/12 - mother reported that about 2 hours after shots patient was fussy, then an hour later patient developed 103 degrees F temp. Mother called MD on call, MD advised mom to give TYLENOL. Mother gave. Patient also vomited 3x on 4/5. And on 4/6 had 101 degrees F and vomited x2. On 4/7 -symptoms had resolved.
Age: 1.31
Sex: M
Vaccine: MMR
Symptoms: Adverse reaction, Angioedema, Rash generalised
Clinical narrative: Mom stated she noted full body rash the morning after vaccines was given, seen at doctor's office for rash on 4/11 and 4/12 and treated with oral steroids. Diagnosed with Angioneurotic Edema/Adverse Reaction.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 17-SEP-2012 the patient was vaccinated with M-M-R II dose 2, subcutaneous. Other suspect therapies included (merck) VARIVAX dose 2, subcutaneous on 14-SEP-2012. No adverse symptoms were 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 physician refers to a patient of unknown age and gender. On 08-MAR-2013 at 12:00 pm, the patient was vaccinated with RECOMBIVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 62.50 hours (also reported 17 hours -1, then 179, 2 admin). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to 3 female patients of unknown age. On an unknown date the patients were vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). On an unknown date the patients developed potential shingles like rash around the injection site. The outcome of potentia; shingles like rash was unknown. Causality was not reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Rash, Urticaria, Vomiting
Clinical narrative: Urticaria 708.9, vomiting, rash. Treatment diphenhydramine 25 mg every 6 hours.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Drug hypersensitivity, Haemoptysis, Headache, Increased upper airway secretion
Clinical narrative: Severe headaches, fever, chills, cold/flu like symptoms, body pain, back pain, sleepless, sore at sight of injection, blood in coughed up phlegm.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza like illness, Injection site pain, Insomnia, Myalgia, Nasopharyngitis
Clinical narrative: Severe headaches, fever, chills, cold/flu like symptoms, body pain, back pain, sleepless, sore at sight of injection, blood in coughed up phlegm.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Productive cough, Pyrexia, Rhinitis allergic
Clinical narrative: Severe headaches, fever, chills, cold/flu like symptoms, body pain, back pain, sleepless, sore at sight of injection, blood in coughed up phlegm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Swelling over left arm over elbow to upper portion of left forearm. Very superficial redness. No warmth. Non tender. Small axillary lymph node. Non tender. No antibiotics necessary. Treated with Benadryl and compresses.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen and red injection site, hot to the touch.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swollen injection site, baseball size diameter, hot.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient was diagnosed on 10/11/2012 with Guillain Barre Syndrome.
Age: 30.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Abdominal pain upper, Blood test, Computerised tomogram abdomen normal, Diarrhoea, Dizziness
Clinical narrative: 1:00 pm, sudden severe stomach pain and nausea, exhaustion, dizziness, dry heaving, by 3:00 pm severe vomiting and diarrhea. Called Dr at 6:30 and was advised to got to ER. Arrived at ER around 7:00 pm, uncontrollable vomiting and severe nausea. Given 2 IVs and intravenous medications; Protonix, ranitidine, Zofran, Benadryl, thorazine, Valium, and Solu-Medrol. Valium finally stopped the vomiting and dry heaving so I was allowed to go home (1:30 AM). Was given prescription for Valium 10 mg every 8 hours for the next 3 days, told not to miss a dose or symptoms could return.
Age: 30.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Fatigue, Nausea, Retching, Urine analysis, Vaccination complication
Clinical narrative: 1:00 pm, sudden severe stomach pain and nausea, exhaustion, dizziness, dry heaving, by 3:00 pm severe vomiting and diarrhea. Called Dr at 6:30 and was advised to got to ER. Arrived at ER around 7:00 pm, uncontrollable vomiting and severe nausea. Given 2 IVs and intravenous medications; Protonix, ranitidine, Zofran, Benadryl, thorazine, Valium, and Solu-Medrol. Valium finally stopped the vomiting and dry heaving so I was allowed to go home (1:30 AM). Was given prescription for Valium 10 mg every 8 hours for the next 3 days, told not to miss a dose or symptoms could return.
Age: 30.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Vomiting
Clinical narrative: 1:00 pm, sudden severe stomach pain and nausea, exhaustion, dizziness, dry heaving, by 3:00 pm severe vomiting and diarrhea. Called Dr at 6:30 and was advised to got to ER. Arrived at ER around 7:00 pm, uncontrollable vomiting and severe nausea. Given 2 IVs and intravenous medications; Protonix, ranitidine, Zofran, Benadryl, thorazine, Valium, and Solu-Medrol. Valium finally stopped the vomiting and dry heaving so I was allowed to go home (1:30 AM). Was given prescription for Valium 10 mg every 8 hours for the next 3 days, told not to miss a dose or symptoms could return.
Age: 30.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Computerised tomogram, Diarrhoea, Urine analysis, Vaccination complication, Vomiting
Clinical narrative: 1:00 pm, sudden severe stomach pain and nausea, exhaustion, dizziness, dry heaving, by 3:00 pm severe vomiting and diarrhea. Called Dr at 6:30 and was advised to got to ER. Arrived at ER around 7:00 pm, uncontrollable vomiting and severe nausea. Given 2 IVs and intravenous medications; Protonix, ranitidine, Zofran, Benadryl, thorazine, Valium, and Solu-Medrol. Valium finally stopped the vomiting and dry heaving so I was allowed to go home (1:30 AM). Was given prescription for Valium 10 mg every 8 hours for the next 3 days, told not to miss a dose or symptoms could return.
Age: 23.0
Sex: F
Vaccine: HEPA, IPV, MNQ, YF
Symptoms: Chills, Dizziness, Hallucination, Hyperhidrosis, Pyrexia
Clinical narrative: Patient reported onset of fever, chills, sweat and hallucinations, also dizziness. Saw her Mom who is in another state.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, big and swollen on most part of left tricep area, 1/2 inch in thickness, mostly hurting. No other concerns, according to patient's wife. Patient is on travel, will see medical. Patient took no meds.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain
Clinical narrative: Derm redness induration pain 4 cm with 10 cm rim of redness.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Bacterial infection, Bacterial test positive, Disorientation
Clinical narrative: 11/14/12 I was given the flu vaccine by a nurse at my corporate office approximately 30 minutes from my office -off site-. After returning to my office, I became weak, disoriented and immediately went to my desk and sat in my chair. Upon sitting, my back seized up, spasms, then severe cramps -much like back labor- and then sharp, shooting pain ran from the right to the left side of my back. Immediately following those pains traveled down my left leg thigh then went to the right. This lasted for about half an hour. I left work and went home, took muscle relaxers and slept on and off for the next couple days. However, the sharp, shooting pain continued and woke me from my sleep throughout the day and night. I suffered a headache similar to a spinal headache. My eyes were also sore and hurt, no drops even touched those symptoms. I also suffered from lightheadedness. There has been no medication, treatment that has touched my pain or even managed my condition. I have a rash on my left that developed two or three days after receiving the vaccine. This rash goes into remission and will redevelop. I've not had any of these symptoms prior to the flu shot, all of this has occurred because of the flu shot. My main symptoms and/or complaints are the pain in my leg and my back. It is documented that I have three bulging discs that have developed since the vaccine; L3. 4. 5. There are days when I struggle to walk because the pain in my left leg is debilitating; however, it is intermittent.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Electromyogram, Eye pain, Gait disturbance, Headache
Clinical narrative: 11/14/12 I was given the flu vaccine by a nurse at my corporate office approximately 30 minutes from my office -off site-. After returning to my office, I became weak, disoriented and immediately went to my desk and sat in my chair. Upon sitting, my back seized up, spasms, then severe cramps -much like back labor- and then sharp, shooting pain ran from the right to the left side of my back. Immediately following those pains traveled down my left leg thigh then went to the right. This lasted for about half an hour. I left work and went home, took muscle relaxers and slept on and off for the next couple days. However, the sharp, shooting pain continued and woke me from my sleep throughout the day and night. I suffered a headache similar to a spinal headache. My eyes were also sore and hurt, no drops even touched those symptoms. I also suffered from lightheadedness. There has been no medication, treatment that has touched my pain or even managed my condition. I have a rash on my left that developed two or three days after receiving the vaccine. This rash goes into remission and will redevelop. I've not had any of these symptoms prior to the flu shot, all of this has occurred because of the flu shot. My main symptoms and/or complaints are the pain in my leg and my back. It is documented that I have three bulging discs that have developed since the vaccine; L3. 4. 5. There are days when I struggle to walk because the pain in my left leg is debilitating; however, it is intermittent.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Intervertebral disc protrusion, Muscle spasms, Nuclear magnetic resonance imaging spinal, Pain in extremity, Pathology test
Clinical narrative: 11/14/12 I was given the flu vaccine by a nurse at my corporate office approximately 30 minutes from my office -off site-. After returning to my office, I became weak, disoriented and immediately went to my desk and sat in my chair. Upon sitting, my back seized up, spasms, then severe cramps -much like back labor- and then sharp, shooting pain ran from the right to the left side of my back. Immediately following those pains traveled down my left leg thigh then went to the right. This lasted for about half an hour. I left work and went home, took muscle relaxers and slept on and off for the next couple days. However, the sharp, shooting pain continued and woke me from my sleep throughout the day and night. I suffered a headache similar to a spinal headache. My eyes were also sore and hurt, no drops even touched those symptoms. I also suffered from lightheadedness. There has been no medication, treatment that has touched my pain or even managed my condition. I have a rash on my left that developed two or three days after receiving the vaccine. This rash goes into remission and will redevelop. I've not had any of these symptoms prior to the flu shot, all of this has occurred because of the flu shot. My main symptoms and/or complaints are the pain in my leg and my back. It is documented that I have three bulging discs that have developed since the vaccine; L3. 4. 5. There are days when I struggle to walk because the pain in my left leg is debilitating; however, it is intermittent.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Sleep disorder
Clinical narrative: 11/14/12 I was given the flu vaccine by a nurse at my corporate office approximately 30 minutes from my office -off site-. After returning to my office, I became weak, disoriented and immediately went to my desk and sat in my chair. Upon sitting, my back seized up, spasms, then severe cramps -much like back labor- and then sharp, shooting pain ran from the right to the left side of my back. Immediately following those pains traveled down my left leg thigh then went to the right. This lasted for about half an hour. I left work and went home, took muscle relaxers and slept on and off for the next couple days. However, the sharp, shooting pain continued and woke me from my sleep throughout the day and night. I suffered a headache similar to a spinal headache. My eyes were also sore and hurt, no drops even touched those symptoms. I also suffered from lightheadedness. There has been no medication, treatment that has touched my pain or even managed my condition. I have a rash on my left that developed two or three days after receiving the vaccine. This rash goes into remission and will redevelop. I've not had any of these symptoms prior to the flu shot, all of this has occurred because of the flu shot. My main symptoms and/or complaints are the pain in my leg and my back. It is documented that I have three bulging discs that have developed since the vaccine; L3. 4. 5. There are days when I struggle to walk because the pain in my left leg is debilitating; however, it is intermittent.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 09-APR-2013, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot number reported as 0567AE), subcutaneously that had expired on 04-APR-2013. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site discolouration
Clinical narrative: Mom left message that patient had a large dark colored spot where vaccine was given, office closed at 12:00 so was told to go to ER/urgent care.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Rash, Rash erythematous
Clinical narrative: Big red bumps on one leg after 1st dose.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 73-year-old patient, gender unspecified. On 10-APR-2013 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 0171AE, expiration date 20-MAR-2013, route not reported). No adverse effects reported. Additional information has been requested.