chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 14 patients of unknown age and gender. On an unknown date, 14 patients were vaccinated with VARIVAX (Merck) (Lot number, expiry date, route and dose were not reported) that was exposed to unknown temperatures greater than 8 Fahrenheit (F) for an unknown period of time. Nurse was unable to provide any specific temperature excursion details, administration dates and lot number and expiration dates for the VARIVAX (Merck) in question. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse event was reported. This is one of the two reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown age and gender patient. on 26-JUN-2013 the patient was vaccinated with less than a full dose of ZOSTAVAX (lot# unspecified), formulation and route unspecified, (dose and frequency unspecified) due to a syringe leakage. No adverse symptoms reported. 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 healthcare worker refers to a patient of unknown age and gender. Information on pertinent medical history was not reported. On 11-JUN-2013 the patient was vaccinated with the third dose of GARDASIL (dose and LOT number was not reported). It was reported that the patient received two doses of GARDASIL (dose and LOT number was not reported) more than a year before receiving the third dose. No adverse event was reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a healthcare student regarding a 70 year old female patient with no pertinent medical history or drug reactions or allergies. On 24-JUN-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot # H016230, expiration date 13-NOV-2013) (subcutaneous in the arm, dose not reported). Concomitant therapies included fluticasone, vitamin d (unspecified), desloratadine (manufacturer unknown) and simvastatin (manufacturer unknown). On 25-JUN-2013 the patient developed "a red hard spot at the injection site, with redness that spread down the patients' arm from the injection site to the elbow" after receiving ZOSTAVAX. The reporter also mentioned that the patient stated this area felt hot to touch and it was painful to sleep on the affected side of her arm. The outcome for the above mentioned events was reported as recovering. No laboratory diagnostic studies were performed. It was reported that the patient sought medical attention by calling to the pharmacy. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a 61 years old consumer refers to herself with no medical history or drug allergies. On approximately 13-JUN-2013 "about two weeks ago" the patient was vaccinated with 0.65ml dose of ZOSTAVAX, subcutaneously. Concomitant therapies included celecoxib, NEXIUM and nefazodone. On approximately 13-JUN-2013 "about two weeks ago", the patient had a small injection site rash, that was "itchy", this occurred the day after receiving ZOSTAVAX. The patient did not seek medical attention. The outcome of the event was reported as completely recovered in June 2013. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Oropharyngeal pain
Clinical narrative: This spontaneous report as received from a 62 year old male consumer with (abnormal) cholesterol refers to himself. The patient had none drug allergies. ON 07-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # not reported) (subcutaneous in the left arm, 1 time vaccine, strength and total daily dose not reported). Concomitant therapies included LIPITOR. On 07-JUN-2013, he had gotten a symptom similar to a sore throat after getting ZOSTAVAX. He stated it had not gone away after taking 2 round of antibiotics. He also stated that on 07-JUN-2013, his glands were swollen on both side of his throat, to behind the ears. No lab diagnostics studies were performed. He would go back to his physician. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old patient who on 28-JUN-2013, was inadvertently vaccinated with a dose of PROQUAD (lot # H020134, Exp. Date: 07-MAY-2014) subcutaneous (dose not reported). The patient had an unknown vaccination history and it was unspecified if this was the first dose of varicella vaccine that the patient ever received. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a 17 year old patient of unknown gender. On an unknown date, a 17 year old patient was vaccinated with a dose of PROQUAD (Merck) (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a male consumer of unknown age refers to himself. On an unknown date the patient was vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). He contracted the shingles after receiving ZOSTAVAX. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 38 years old female patient with sulfa allergy. The patient had no pertinent medical history and did not take concomitant medication. On 18-JUN-2013 the patient was vaccinated with ZOSTAVAX lot # J001002, exp. date 25-APR-2014, 0.65 ml subcutaneously. The patient reported that she was "fine but a few days later" in June 2013, she developed "a bump, itchiness and pain at the injection site". Verified that there was no rash, just "one bump" on the patient's arm "at the injection site". No treatment was given. The patient was recovering from the events. The patient came to see pharmacist to seek medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
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 25-JUN-2013 the patient was vaccinated with an expired dose of GARDASIL (route not specified). Healthcare worker reported that this was the first dose of the GARDASIL series, with lot number and expiration date: 1511Z dose, exp. date 26-APR-2013 (reported as 29-APR-2013). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to female patient of approximately 68 years of age. On 28-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as J00494). On an unknown date in 2013, the patient had experienced redness and swelling at the injection site after receiving ZOSTAVAX. The outcome of redness and swelling at the injection site was reported as recovered. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a healthcare worker (medical assistant) refers to an unknown number of patients of unknown age and gender. The healthcare worker reported that PROQUAD had been transported for the past six months to a sister clinic that was about 15 minutes down the road. The healthcare worker was unable to provide the temperature that the PROQUAD was exposed to or exact time frame. One box of PROQUAD was transported an unspecified amount of times. She reported that the lot # and expiration date for the PROQUAD (Merck) was H020854 and expiration: 26-MAY-2014. She reported that the PROQUAD had been administered but she was unable to provide the dates of administration for the PROQUAD. She did not have patient details or the amount of patients that the PROQUAD were administered to at the time of the call. She did not have physician demographics at the time of the call either. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a 71 year old male patient, reporting on his wife, who on 05-APR-2013 was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). On an unknown date his wife experienced a small red rash around the injection site "for a few days after which has since disappeared". This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a Registered Nurse via a company representative refers to 10 unspecified patients of unknown age and gender. On an unknown date, the 10 patients were vaccinated with a dose of PNEUMOVAX23 (lot # H017759, expiry: 04-JUL-2014). On an unknown date, the patients presented with complaints of severe cellulitis. The patients sought medical attention (unspecified). The outcome of severe cellulitis was unknown. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age, the patient had no pertinent medical history or drug reactions or allergies. On 25-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001004, expiry date 24-APR-2014, route was subcutaneous). No concomitant medications were reported. On an unknown date, the patient experienced a swollen, hot red, rash around the injection site. There was no treatment rendered for the events. There was no lab tests performed. The outcome of the reported events were not recovered. The patient sought medical attention (called the reporting pharmacist). Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash pruritic, Scab
Clinical narrative: This spontaneous report as received from a 71 year old male patient, reporting on himself. The patient's medical history included enlarged prostate. On 05-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported), upper left arm. Concomitant therapies included finasteride, SPIRIVA and SEREVENT. "Three weeks ago", approximately on 30-MAY-2013, the patient experienced itchy rash that was blistering across both shoulders. Some blisters were drying over and scabbing over, but he was still getting new blisters. No other adverse symptoms have been noted. The patient did not seek medical attention. No treatment was given. None lab diagnostics studies were performed. The outcome of patient was reported as not recovered/not resolved. Causality was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Flushing, Lacrimation increased, Sneezing, Urticaria, Wheezing
Clinical narrative: This spontaneous report was received from a other health professional refers to a 4 year old male patient with unspecified preservative allergy, jello allergy, and neomycin allergy. The patient's medical history included Kawasaki's disease. On 08-MAR-2006, the patient was vaccinated with a dose of M-M-R II (lot# 649509/0773P), 0.5 ml, subcutaneously. Concomitant therapies included IPOL (Manufactured by PMC per the caller) and INFANRIX (Manufactured by GlaxoSmithKline). On 08-MAR-2006, the patient became flushed, developed sneezing and watery eyes after receiving M-M-R II. No treatment was given and the symptoms resolved within an hour of the onset of symptoms on 08-MAR-2006. On 20-MAR-2006, the patient was vaccinated with VARIVAX (Merck) and experienced wheezing and hives (see related case 1307USA002101). Laboratory diagnostic tests performed was none. Patient sought medical attention as adverse events occurred in the doctor's office. The outcome of became flushed, sneezing and watery eyes was reported as recovered. This is 1 of 2 reports regarding the same patient. Additional information is not expected.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: This spontaneous report was received from a pharmacy student refers to a male patient of unknown age. The patients medical history included history of previous cold sores. The patient had no drug reactions or allergies. on 08-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number was J00494, expiry date was 04-APR-2014, route was not reported). On an unknown date in MAY-2013, the patient had an outbreak of cold sores after receiving ZOSTAVAX. There was no treatment rendered for the event. The outcome of outbreak of cold sores was reported as not recovered. The patient sought medical attention (contacted pharmacy). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning 3 patients of unknown age and gender. It was reported that on an unknown date, patients may have vaccinated with a dose of GARDASIL (lot number and expiry date reported as 0459AE and 13-DEC-2014 respectively, dose and route unspecified) which was exposed to 31 degrees Fahrenheit (F) for 27 days (648 hours), which was found to be an unsupported excursion by in-house stability data. The reporter was unable to provide the dates that these patients received this unsupported GARDASIL. No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse concerning a 35 year old female with a history of papilloma viral infection who on unspecified dates, was vaccinated with the first and second dose of GARDASIL. 04-APR-2007, the patient was vaccinated with a third dose of GARDASIL (lot # 654702/0011U) 0.5 ml IM into the left deltoid. Concomitant therapy included ORTHO TRI-CYCLEN, and ALLEGRA-D. On 05-APR-2007, the patient sought medical attention by contacting the physician's office. The patient reported that on 04-APR-2007, immediately after being vaccinated with the third dose of vaccine, she noticed symptoms. She had severe shoulder pain. The patient could not lift her arm laterally and could not sleep due to the pain. The patient was ordered MEDROL Dose Pack, heat and LORCET PLUS. The patient had also been seen at an orthopedic's office. She was given 2 steroid injections and she is being set up for physical therapy. The patient did not have any symptoms with the first two doses of vaccine. In follow-up received 04-MAY-2007, the physician reported that the patient was scheduled to begin physical therapy and may have considerable medical bills as a result of the GARDISIL vaccination. The physician also mentioned that the patient's condition was improving. The reporter felt that the events were disabling. Follow up information was received from assistant: The patient's last name was changed. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Loss of consciousness, Rash erythematous
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. On 20-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H021346, expiry date 01-OCT-2015, 0.5 ml) intramuscularly in the left arm. No concomitant medication was reported. On 20-JUL-2013, the patient "passed out" 10 minutes after injection. The patient was sitting at the time, but the nurse stated that smelling salts were used to revive the patient. She stated that 10-12 minutes after injection the patient developed a flat red rash at the injection site on the left deltoid and on her chest. The patient stayed at the office for two hours afterwards for observation, by which time the rash resolved. No treatment given. The patient had sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site rash, Loss of consciousness, Rash erythematous
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. On 20-JUL-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H021346, expiry date 01-OCT-2015, 0.5 ml) intramuscularly in the left arm. No concomitant medication was reported. On 20-JUL-2013, the patient "passed out" 10 minutes after injection. The patient was sitting at the time, but the nurse stated that smelling salts were used to revive the patient. She stated that 10-12 minutes after injection the patient developed a flat red rash at the injection site on the left deltoid and on her chest. The patient stayed at the office for two hours afterwards for observation, by which time the rash resolved. No treatment given. The patient had sought unspecified medical attention. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Demyelinating polyneuropathy, Electromyogram abnormal, Gait disturbance, Headache, Myalgia
Clinical narrative: Woke up May 29 3AM complaining of back pain also complained of a headache during the day on May 29th.  Woke up May 30th during the early morning hours complaining of back pain.  Made return visit to pediatrician's office on May 30 at 1PM due to her waking up the previous 2 night's with back pain and a constant headache.  They tested for urinary tract infection and results came back negative.  She also started vomiting on May 30 at 1PM and lasted until 1AM.   May 31 I (mom) noticed her limping on her right leg and she said it hurt.  She still had a headache off and on by now.  June 1 she was limping, more like not putting her foot all the way down more and more.  She was still having headaches off and on with sensitivity to light and complaining that her neck hurt.  June 2 she got up in the morning and was not putting either right nor left foot all the way down to walk, still had a headache and sensitive to light, felt miserable.  This is the day dad looked up the reactions to a Hep A shot and she had several of the symptoms that said see a doctor immediately.  We took her to urgent care since it was a Sunday.  They urgent care doctor didn't give us a diagnosis but was not able to get reflexes on her lower extremities.  She sent us to ER.  We took her there and they also were not able to get reflexes or give us a diagnosis.  They sent us to main hospital to be consulted by a neurological team. She was admitted there, this is still June 2.  She went through several blood tests, a CT scan of her head, an EMG, an MRI of her head and spine. On June 4 she was diagnosed with Guillain Barre Syndrome following the EMG and MRI results.  She was not released from the hospital until July 2 and is home now having to still do physical and occupational therapy as well as use a wheelchair and a walker.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Paraesthesia, Photophobia, Rash
Clinical narrative: Woke up May 29 3AM complaining of back pain also complained of a headache during the day on May 29th.  Woke up May 30th during the early morning hours complaining of back pain.  Made return visit to pediatrician's office on May 30 at 1PM due to her waking up the previous 2 night's with back pain and a constant headache.  They tested for urinary tract infection and results came back negative.  She also started vomiting on May 30 at 1PM and lasted until 1AM.   May 31 I (mom) noticed her limping on her right leg and she said it hurt.  She still had a headache off and on by now.  June 1 she was limping, more like not putting her foot all the way down more and more.  She was still having headaches off and on with sensitivity to light and complaining that her neck hurt.  June 2 she got up in the morning and was not putting either right nor left foot all the way down to walk, still had a headache and sensitive to light, felt miserable.  This is the day dad looked up the reactions to a Hep A shot and she had several of the symptoms that said see a doctor immediately.  We took her to urgent care since it was a Sunday.  They urgent care doctor didn't give us a diagnosis but was not able to get reflexes on her lower extremities.  She sent us to ER.  We took her there and they also were not able to get reflexes or give us a diagnosis.  They sent us to main hospital to be consulted by a neurological team. She was admitted there, this is still June 2.  She went through several blood tests, a CT scan of her head, an EMG, an MRI of her head and spine. On June 4 she was diagnosed with Guillain Barre Syndrome following the EMG and MRI results.  She was not released from the hospital until July 2 and is home now having to still do physical and occupational therapy as well as use a wheelchair and a walker.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Toe walking, Vomiting
Clinical narrative: Woke up May 29 3AM complaining of back pain also complained of a headache during the day on May 29th.  Woke up May 30th during the early morning hours complaining of back pain.  Made return visit to pediatrician's office on May 30 at 1PM due to her waking up the previous 2 night's with back pain and a constant headache.  They tested for urinary tract infection and results came back negative.  She also started vomiting on May 30 at 1PM and lasted until 1AM.   May 31 I (mom) noticed her limping on her right leg and she said it hurt.  She still had a headache off and on by now.  June 1 she was limping, more like not putting her foot all the way down more and more.  She was still having headaches off and on with sensitivity to light and complaining that her neck hurt.  June 2 she got up in the morning and was not putting either right nor left foot all the way down to walk, still had a headache and sensitive to light, felt miserable.  This is the day dad looked up the reactions to a Hep A shot and she had several of the symptoms that said see a doctor immediately.  We took her to urgent care since it was a Sunday.  They urgent care doctor didn't give us a diagnosis but was not able to get reflexes on her lower extremities.  She sent us to ER.  We took her there and they also were not able to get reflexes or give us a diagnosis.  They sent us to main hospital to be consulted by a neurological team. She was admitted there, this is still June 2.  She went through several blood tests, a CT scan of her head, an EMG, an MRI of her head and spine. On June 4 she was diagnosed with Guillain Barre Syndrome following the EMG and MRI results.  She was not released from the hospital until July 2 and is home now having to still do physical and occupational therapy as well as use a wheelchair and a walker.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Areflexia, Back pain, Blood test, Computerised tomogram head, Electromyogram abnormal
Clinical narrative: Woke up May 29 3AM complaining of back pain also complained of a headache during the day on May 29th.  Woke up May 30th during the early morning hours complaining of back pain.  Made return visit to pediatrician's office on May 30 at 1PM due to her waking up the previous 2 night's with back pain and a constant headache.  They tested for urinary tract infection and results came back negative.  She also started vomiting on May 30 at 1PM and lasted until 1AM.   May 31 I (mom) noticed her limping on her right leg and she said it hurt.  She still had a headache off and on by now.  June 1 she was limping, more like not putting her foot all the way down more and more.  She was still having headaches off and on with sensitivity to light and complaining that her neck hurt.  June 2 she got up in the morning and was not putting either right nor left foot all the way down to walk, still had a headache and sensitive to light, felt miserable.  This is the day dad looked up the reactions to a Hep A shot and she had several of the symptoms that said see a doctor immediately.  We took her to urgent care since it was a Sunday.  They urgent care doctor didn't give us a diagnosis but was not able to get reflexes on her lower extremities.  She sent us to ER.  We took her there and they also were not able to get reflexes or give us a diagnosis.  They sent us to main hospital to be consulted by a neurological team. She was admitted there, this is still June 2.  She went through several blood tests, a CT scan of her head, an EMG, an MRI of her head and spine. On June 4 she was diagnosed with Guillain Barre Syndrome following the EMG and MRI results.  She was not released from the hospital until July 2 and is home now having to still do physical and occupational therapy as well as use a wheelchair and a walker.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Feeling abnormal, Gait disturbance, Guillain-Barre syndrome, Headache, Neck pain
Clinical narrative: Woke up May 29 3AM complaining of back pain also complained of a headache during the day on May 29th.  Woke up May 30th during the early morning hours complaining of back pain.  Made return visit to pediatrician's office on May 30 at 1PM due to her waking up the previous 2 night's with back pain and a constant headache.  They tested for urinary tract infection and results came back negative.  She also started vomiting on May 30 at 1PM and lasted until 1AM.   May 31 I (mom) noticed her limping on her right leg and she said it hurt.  She still had a headache off and on by now.  June 1 she was limping, more like not putting her foot all the way down more and more.  She was still having headaches off and on with sensitivity to light and complaining that her neck hurt.  June 2 she got up in the morning and was not putting either right nor left foot all the way down to walk, still had a headache and sensitive to light, felt miserable.  This is the day dad looked up the reactions to a Hep A shot and she had several of the symptoms that said see a doctor immediately.  We took her to urgent care since it was a Sunday.  They urgent care doctor didn't give us a diagnosis but was not able to get reflexes on her lower extremities.  She sent us to ER.  We took her there and they also were not able to get reflexes or give us a diagnosis.  They sent us to main hospital to be consulted by a neurological team. She was admitted there, this is still June 2.  She went through several blood tests, a CT scan of her head, an EMG, an MRI of her head and spine. On June 4 she was diagnosed with Guillain Barre Syndrome following the EMG and MRI results.  She was not released from the hospital until July 2 and is home now having to still do physical and occupational therapy as well as use a wheelchair and a walker.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Photophobia
Clinical narrative: Woke up May 29 3AM complaining of back pain also complained of a headache during the day on May 29th.  Woke up May 30th during the early morning hours complaining of back pain.  Made return visit to pediatrician's office on May 30 at 1PM due to her waking up the previous 2 night's with back pain and a constant headache.  They tested for urinary tract infection and results came back negative.  She also started vomiting on May 30 at 1PM and lasted until 1AM.   May 31 I (mom) noticed her limping on her right leg and she said it hurt.  She still had a headache off and on by now.  June 1 she was limping, more like not putting her foot all the way down more and more.  She was still having headaches off and on with sensitivity to light and complaining that her neck hurt.  June 2 she got up in the morning and was not putting either right nor left foot all the way down to walk, still had a headache and sensitive to light, felt miserable.  This is the day dad looked up the reactions to a Hep A shot and she had several of the symptoms that said see a doctor immediately.  We took her to urgent care since it was a Sunday.  They urgent care doctor didn't give us a diagnosis but was not able to get reflexes on her lower extremities.  She sent us to ER.  We took her there and they also were not able to get reflexes or give us a diagnosis.  They sent us to main hospital to be consulted by a neurological team. She was admitted there, this is still June 2.  She went through several blood tests, a CT scan of her head, an EMG, an MRI of her head and spine. On June 4 she was diagnosed with Guillain Barre Syndrome following the EMG and MRI results.  She was not released from the hospital until July 2 and is home now having to still do physical and occupational therapy as well as use a wheelchair and a walker.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Urine analysis, Vomiting, Walking aid user, Wheelchair user
Clinical narrative: Woke up May 29 3AM complaining of back pain also complained of a headache during the day on May 29th.  Woke up May 30th during the early morning hours complaining of back pain.  Made return visit to pediatrician's office on May 30 at 1PM due to her waking up the previous 2 night's with back pain and a constant headache.  They tested for urinary tract infection and results came back negative.  She also started vomiting on May 30 at 1PM and lasted until 1AM.   May 31 I (mom) noticed her limping on her right leg and she said it hurt.  She still had a headache off and on by now.  June 1 she was limping, more like not putting her foot all the way down more and more.  She was still having headaches off and on with sensitivity to light and complaining that her neck hurt.  June 2 she got up in the morning and was not putting either right nor left foot all the way down to walk, still had a headache and sensitive to light, felt miserable.  This is the day dad looked up the reactions to a Hep A shot and she had several of the symptoms that said see a doctor immediately.  We took her to urgent care since it was a Sunday.  They urgent care doctor didn't give us a diagnosis but was not able to get reflexes on her lower extremities.  She sent us to ER.  We took her there and they also were not able to get reflexes or give us a diagnosis.  They sent us to main hospital to be consulted by a neurological team. She was admitted there, this is still June 2.  She went through several blood tests, a CT scan of her head, an EMG, an MRI of her head and spine. On June 4 she was diagnosed with Guillain Barre Syndrome following the EMG and MRI results.  She was not released from the hospital until July 2 and is home now having to still do physical and occupational therapy as well as use a wheelchair and a walker.
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pain, itchiness, redness, excessive swelling, hot around injection site and 3 inch perimeter.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Inflammation, Injection site erythema, Injection site pruritus, Pain
Clinical narrative: Patient get vaccines on 6/4/13 at clinic. Tdap and MCV 4 at 1. Mother came to the clinic with fever, headache, itching on right deltoid arm and redness; since five days with those inflammation and pain area after get MCV-4 vaccines.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Patient get vaccines on 6/4/13 at clinic. Tdap and MCV 4 at 1. Mother came to the clinic with fever, headache, itching on right deltoid arm and redness; since five days with those inflammation and pain area after get MCV-4 vaccines.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Immunology test, Rotavirus infection, Rotavirus test positive
Clinical narrative: Pt diagnosed with Rotavirus.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mom called stating patient woke up the morning after varicella vaccine with a red 3 inch circle, swelling and pain at injection site. They applied ice and stared BENADRYL. Redness and swelling still present 72 hours later, but improving. No fevers.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt returned to pharmacy 6/6/13 and reported itching, swelling and redness, localized around the site of injection. Pt did not report any shortness of breath, difficulty breathing or fever. Pharmacy manager said that he would follow up with patient to check on her progress. On 6/7/13 the pharmacy manager followed up with the patient who was concerned enough to consult with her dermatologist (unknown). Prescribed clobetasol ointment and prednisolone tablets.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fall, Fatigue, Headache, Nausea, Syncope
Clinical narrative: Syncope episode after MENACTRA & GARDASIL vaccine given. Fell to floor from exam table. Pt with headache, nausea, fatigue, vomit x 1. Sent to ER for evaluation.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Vomiting
Clinical narrative: Syncope episode after MENACTRA & GARDASIL vaccine given. Fell to floor from exam table. Pt with headache, nausea, fatigue, vomit x 1. Sent to ER for evaluation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling, Vaccination complication
Clinical narrative: (R) shoulder swelling. Adverse reaction to KINRIX.
Age: 0.55
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Swelling left arm on day of vaccine.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Ear pain, Headache, Injected limb mobility decreased, Oropharyngeal pain, Pain
Clinical narrative: Pt reports that after receiving vaccines, her left arm felt like dead weight. Additionally, she developed a sore throat with shooting pain on left side of jaw and left ear pain. Also developed headache. Arm symptoms resolved in 24 hours. Other symptoms did not
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Pain in jaw
Clinical narrative: Pt reports that after receiving vaccines, her left arm felt like dead weight. Additionally, she developed a sore throat with shooting pain on left side of jaw and left ear pain. Also developed headache. Arm symptoms resolved in 24 hours. Other symptoms did not
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Pyrexia
Clinical narrative: Headache, fever 102
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. Requiring visit to ER.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Anti-thyroid antibody positive, Atrial fibrillation, Basedow's disease, Blood thyroid stimulating hormone decreased, Cardioversion
Clinical narrative: Patient received inactivated influenza vaccine on 25 Oct '12. During the next month he developed fatigue, increased defecation and insomnia. Patient unsure if he had any of those sxs beginning before he received the vaccine, but knows definitively that he experienced them following the vaccine. On 19 Nov '12 he developed 'flashing lights' in the peripheral vision of left eye, evaluation negative for lesion. On 22 Nov '12 he developed palpitations and HR irregularity and was diagnosed with A-fib and admitted to CCU and cardioverted. One week later he again developed Afib. He was then diagnosed with hyperthyroidism and thyroid autoantibodies found. Currently receiving treatment for Graves Disease and symptoms starting to resolve. Had normal TSH in July. The clinic went into the serum repository with pt permission and tested his serum drawn prior to July 2013 and found it positive for thyroid autoantibodies, although pt had no clinical disease at that time.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Frequent bowel movements, Heart rate irregular, Hyperthyroidism, Insomnia
Clinical narrative: Patient received inactivated influenza vaccine on 25 Oct '12. During the next month he developed fatigue, increased defecation and insomnia. Patient unsure if he had any of those sxs beginning before he received the vaccine, but knows definitively that he experienced them following the vaccine. On 19 Nov '12 he developed 'flashing lights' in the peripheral vision of left eye, evaluation negative for lesion. On 22 Nov '12 he developed palpitations and HR irregularity and was diagnosed with A-fib and admitted to CCU and cardioverted. One week later he again developed Afib. He was then diagnosed with hyperthyroidism and thyroid autoantibodies found. Currently receiving treatment for Graves Disease and symptoms starting to resolve. Had normal TSH in July. The clinic went into the serum repository with pt permission and tested his serum drawn prior to July 2013 and found it positive for thyroid autoantibodies, although pt had no clinical disease at that time.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Palpitations, Photopsia, Thyroid stimulating immunoglobulin increased
Clinical narrative: Patient received inactivated influenza vaccine on 25 Oct '12. During the next month he developed fatigue, increased defecation and insomnia. Patient unsure if he had any of those sxs beginning before he received the vaccine, but knows definitively that he experienced them following the vaccine. On 19 Nov '12 he developed 'flashing lights' in the peripheral vision of left eye, evaluation negative for lesion. On 22 Nov '12 he developed palpitations and HR irregularity and was diagnosed with A-fib and admitted to CCU and cardioverted. One week later he again developed Afib. He was then diagnosed with hyperthyroidism and thyroid autoantibodies found. Currently receiving treatment for Graves Disease and symptoms starting to resolve. Had normal TSH in July. The clinic went into the serum repository with pt permission and tested his serum drawn prior to July 2013 and found it positive for thyroid autoantibodies, although pt had no clinical disease at that time.
Age: 65.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Biopsy skin abnormal, Drug eruption, Pyrexia, Rash
Clinical narrative: Initial report was received from a healthcare professional on 21 June 2013. A 65-year-old female patient received an intramuscular injection of ADACEL vaccine, lot number unknown (site and side of administration not reported), and a subcutaneous injection of Yellow Fever vaccine, lot number unknown (site and side of administration not reported) on 07 May 2013. Patient also received Hepatitis A vaccine (other manufacturer) within 4 weeks of other vaccinations (also reported as "on that date"). On 13 June 2013, 37 days post vaccination, the patient developed a rash on her neck and a fever which persisted to date. The physician did not think the events were related to the vaccine but he could not be sure. Shortly after the rash developed, the patient was admitted to the hospital and treated with antibiotics (records not immediately available, so unknown). The patient subsequently developed a diffuse rash biopsy of which suggested a drug related rash. The reporter has never seen such a localized rash (original rash) at a site away from administration site. He did not feel the event was related to the vaccine administration. The patient's outcome was not recovered.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 17 year old female patient with ATIVAN, KEPPRA, BENADRYL and COMPAZINE allergy and seizures that had been controlled with medication and diet. On 01-JUL-2013 the patient was vaccinated with the first dose of GARDASIL lot # H021346, 0.5 ml, intramuscular. Concomitant therapies included TOPAMAX, ZOLOFT and clonazepam. The patient had three seizures (medically significant) since received the vaccine. The nurse reported that the patient had two seizures on 01-JUL-2013 and one seizure on 02-JUL-2013. The nurse also stated that she was unsure of when the patient had a seizure last prior to receiving the GARDASIL. The nurse reported that the patient was in the physician office at the time of the call and that no particular treatment had been given yet. No lab was performed. Outcome of the patient and causality was not reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Large swelling at site of injection (size of orange).
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site cellulitis, Pain, Swelling, Tenderness
Clinical narrative: Acute cellulitis of left deltoid.  She had pain with swelling and tenderness and spiked temp to 38.6.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth at site of MMRV injection. Due to multiple allergies patient was treated with Benadryl and ranitidine.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Erythema, Immediate post-injection reaction, Injection site bruising, Nodule, Oedema peripheral
Clinical narrative: 07/03/13 Left arm swelling with golf ball size knot developed immediately after injection. Right arm injection site bruising. 07/04/13 increased swelling and redness Left arm. Seen by family physician. 07/05/13 seen by family physician. Instructed to use warm compresses on left arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Pt has 2-3 raised spots on each ankle-says they itch and is treating with OTC BENADRYL cream and hydrocortisone cream.
Age: 1.37
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Decreased appetite, Ear discomfort, Haemoglobin normal, Injection site erythema, Injection site rash
Clinical narrative: Rash over entire body. Pulling at ears. Fussy. Decreased appetite. Erythemic viral appearing exanthem blanches when palpated w/rough texture cheeks, back of neck, chest and back; started where she got her shots".
Age: 1.37
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site reaction, Irritability, Pallor, Rash erythematous, Rash generalised
Clinical narrative: Rash over entire body. Pulling at ears. Fussy. Decreased appetite. Erythemic viral appearing exanthem blanches when palpated w/rough texture cheeks, back of neck, chest and back; started where she got her shots".
Age: 1.37
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Streptococcus test negative, Viral rash
Clinical narrative: Rash over entire body. Pulling at ears. Fussy. Decreased appetite. Erythemic viral appearing exanthem blanches when palpated w/rough texture cheeks, back of neck, chest and back; started where she got her shots".
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pruritus
Clinical narrative: Pneumonia vaccine adult administered 7.2.13 pt called 7-3-13 c/o redness chest, arms associated with itching. Advised patient to take BENADRYL. Redness fading-itching gone.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date in 2007, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On an unknown date in 2011, the patient was vaccinated with second and third dose of GARDASIL (lot number, expiry date and route was not reported). Concomitant medications were not reported. The patient reported that the dosing schedule of GARDASIL was interrupted. The second and third doses were administered at the recommended 4month interval. No adverse effect were reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Cellulitis, Chills, Oedema peripheral, Pyrexia
Clinical narrative: ADACEL left arm, ENGERIX-B, and PNEUMOVAX (R) arm were given to pt. on 6/30/13. Pt. called 7/1 and said he has chills and fevers. Recommended TYLENOL/MOTRIN for fever and recommended Dr's visit if symptoms worsen. Pt. called back 7/15/13, stated he is being hospitalized for cellulitis due to swelling to his (L) arm.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Rash, Urticaria
Clinical narrative: Patient taken to ER for rash/hives on abdomen. Upon assessment at ER no hives noted at injection site, rash also noted on legs and upper arms. Patient given Benadryl 6.25mg and prednisone 15mg in ER and discharged.
Age: 33.0
Sex: F
Vaccine: HEP, JEV1, RAB
Symptoms: Abdominal pain, Cheilitis, Cough, Dyspnoea, Palmar erythema
Clinical narrative: 12:31 pm   Female received Imovax (rabies #1), Ixiaro #1 and booster hep B @ 11:00 am today. Pt was at her desk and started experiencing breathing difficulty. Upon arrival to the clinic--- slight erythema noted on upper lip, anterior chest and palms. No hives. + coughing spasms. Talking in full, complete sen. Lungs cta, no wheezes. VS: Pox 97% - 98% ra, rr 18 even, unlabored, hr 89, bp 130/89. All: --cillins family  Meds: bcp  PHx: none sig. 12:32 pm   Benadryl 50 mg IM to lt deltoid. EMS activated. 12:50 pm   VSS; palms' erythema subsided along w/her coughing spasms. EMS arrived. Pt signed out AMA w/EMS crew @ 12:50PM. 13:25   Pt signed out AMA w/EMS crew outside on drive way. Returned back to clinic c/o severe abd. cramps 10+/10 (0-10). Denied nausea. Temp 97.3 /tym. Appear. in severe distress d/t abd pain. +  abd. guarding, doubled over in pain. No c/o breathing difficulty, hives or skin erythema noted at this time. Adamantly refused to go to ER. Pt verb no recent change in bowel pattern. Last BM this AM--nl.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: Pt c/o pain, mother noted redness, warm to touch, low grade temp - 99.9. On 6/27/13 came in office with increase pain, redness (20 mm) and warm to touch. Orders for Tylenol- with alternate of Motrin and Benadryl 12.5 mg prn.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Localized swelling to left upper arm in the deltoid area (approximately 3x3 inches).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Warm, swollen, tender, erythematous.