chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Viral infection
Clinical narrative: Case number PHHY2013US083978 is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 488609) website on 06 Aug 2013 with a follow-up received from quality assurance department (QA ref. no.: 246003) on 03 Apr 2014. This report refers to a 62-year-old male patient. His medical history included hyperlipidemia, heart disease (unspecified) and seizures (last seizure on 19 Nov). His concomitant medication included atenolol, LIPITOR, phenytoin, Aspirin, BENADRYL and melatonin. He was vaccinated with FLUVIRIN (batch number: 123123) intramuscularly into left arm on 07 Dec 2012. On 09 Feb 2013, he experienced flu like symptoms, neck pain, headaches, and loss of ability to support himself, loss of ability to walk and loss of ability to protect airways. On 11 Feb 2013, he visited emergency department at hospital and then hospitalized from 14 Feb 2013 to 21 Feb 2013. He was in intensive care unit and his multiple systems were monitored. He underwent laryngoscopy, electronic testing, MRI (nuclear magnetic resonance imaging) of head (brain) and neck, lumbar puncture, complete blood count (CBC) test, comprehensive metabolic panel (CMP) test and liver function test (LFT). The results were not reported. He was diagnosed with post-vaccination viral syndrome. Guillain Barre Syndrome was ruled out. He received IV immunoglobulin (therapy) in the hospital. The outcome was reported as complete recovery as of 24 Mar 2013. Reporter assessed the case as serious (life threatening). Based on the batch review report received from the quality assurance department, it was concluded that the concerned FLUVIRIN (batch number: 123123) was manufactured in accordance with approved internal procedures and is in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality assurance department on 03 Apr 2014: Updated batch review report.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness unilateral, Blood test, Disability, Guillain-Barre syndrome, Malaise
Clinical narrative: Case number PHHY2013US069516, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 490546) website on 03 Jul 2013 and a follow up report from the QA department received on 03 Apr 2014. This report refers to a 75-year-old female patient. Her medical history included hypertension which is controlled for 10 years with hydrochlorothiazide at a dose of 25 mg. On 14 Jan 2013, she was vaccinated with FLUVIRIN (batch number: 1206901) intramuscularly in the left arm. On the same day of vaccination, she experienced ascending paralysis in the right leg. On 15 Jan 2013, she woke up with partial blindness in her right eye. On 19 Jan 2013, she had total blindness in her left eye. It was also reported that she was hospitalized from 23 Jan 2013 to 26 Jan 2013 for extreme illness. Lab tests such as multiple blood tests and multiple vision tests were performed (results not reported). The event outcome was reported as condition unchanged as of 01 May 2013. The seriousness was reported as permanent disability. The causality was not reported. Batch review report (240040) received from quality assurance department on 03 Apr 2014. Based on the document review, it was stated that the concerned FLUVIRIN batch number 1206901 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 03 Apr 2014: Updated QA batch review report.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Visual acuity tests, Visual impairment
Clinical narrative: Case number PHHY2013US069516, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 490546) website on 03 Jul 2013 and a follow up report from the QA department received on 03 Apr 2014. This report refers to a 75-year-old female patient. Her medical history included hypertension which is controlled for 10 years with hydrochlorothiazide at a dose of 25 mg. On 14 Jan 2013, she was vaccinated with FLUVIRIN (batch number: 1206901) intramuscularly in the left arm. On the same day of vaccination, she experienced ascending paralysis in the right leg. On 15 Jan 2013, she woke up with partial blindness in her right eye. On 19 Jan 2013, she had total blindness in her left eye. It was also reported that she was hospitalized from 23 Jan 2013 to 26 Jan 2013 for extreme illness. Lab tests such as multiple blood tests and multiple vision tests were performed (results not reported). The event outcome was reported as condition unchanged as of 01 May 2013. The seriousness was reported as permanent disability. The causality was not reported. Batch review report (240040) received from quality assurance department on 03 Apr 2014. Based on the document review, it was stated that the concerned FLUVIRIN batch number 1206901 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department received on 03 Apr 2014: Updated QA batch review report.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema, Haematochezia, Intussusception
Clinical narrative: Intussusception; Fever; Shaking; Abdominal Pain; Vomiting; Bloody stool & vomit.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia, Tremor, Ultrasound abdomen, Vomiting
Clinical narrative: Intussusception; Fever; Shaking; Abdominal Pain; Vomiting; Bloody stool & vomit.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Streptococcus test negative
Clinical narrative: Case number PHHY2014US000806, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507701) website on 06 Jan 2014 with a follow-up received from quality assurance department (QA ref. no.: 288745) on 02 Apr 2014. This report refers to 62-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1303901) and PNEUMOVAX (other manufacturer, batch number: 0006242) both intramuscularly in the left arm on 09 Oct 2013. On 10 Oct 2013, she experienced cellulitis and received an antibiotic (unspecified). Lab data included negative streptococcus test. She visited the emergency room. The outcome was reported as complete recovery as of 14 Oct 2013. The seriousness and causality were not reported. Based on the document review, it was stated that, the concerned FLUVIRIN (batch number: 1303901) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from consumer and quality assurance department on 02 Apr 2014: Updated batch review report.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old female with depression and shellfish allergy. The patient's medical history included bilateral ear surgery; details not provided. The mother was noted to have no passive smoke exposure. On 04-OCT-2013 the 16-year old mother of the fetal subject received unspecified dose of GARDASIL lot # J003727, Expiration Date: 07-NOV-2015, (.5 ml, route unknown), a dose of BOOSTRIX lot # E5957, (.5 ml, transplacentary, unknown), unspecified dose of Meningococcal B c vaccine, lot # M12132 (.5 ml, route unknown), unspecified dose of Varicella virus vaccine (manufacturer unknown), lot # J003713 exp 27-MAR-2015, (.5 ml, route unknown). Concomitant medications included Ondansetron hydrochloride and prenatal vitamins. The mother's last menstrual period (LMP) occurred on 20-AUG-2013. The nurse reported the mother was exposed to with BOOSTRIX, GARDASIL, Meningococcal B C vaccine and Varicella virus vaccine at three to four weeks gestation, during the 1st trimester, however based on LMP she was calculated to be 6 weeks gestation. Estimated date of delivery was calculated to be 27-May-2014. On 04-OCT-2013, the pregnancy test confirmed pregnancy. On an unspecified date, within months of vaccination with BOOSTRIX, GARDASIL, Meningococcal B c vaccine and Varicella virus vaccine, the fetus experienced congenital anomaly and maternal vaccine exposure. The nurse reported there was a possibility of congenital anomaly, specific details were not provided (MARRS case 1403USA012467). At the time of reporting the outcome of the congenital anomaly was unspecified, the mother's pregnancy was ongoing. Follow-up information was received from a registered nurse regarding the 16 year old female patient. The mother is still pregnant (EDD 27-MAY-2014) and there had been no diagnoses of congenital anomalies to the date. The nurse may return correspondence once the patient delivers to report the outcome of the pregnancy. No further information was available at the time. This is one of two cases on the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Ear operation, Exposure during pregnancy, Foetal disorder, Pregnancy test positive
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old female with depression and shellfish allergy. The patient's medical history included bilateral ear surgery; details not provided. The mother was noted to have no passive smoke exposure. On 04-OCT-2013 the 16-year old mother of the fetal subject received unspecified dose of GARDASIL lot # J003727, Expiration Date: 07-NOV-2015, (.5 ml, route unknown), a dose of BOOSTRIX lot # E5957, (.5 ml, transplacentary, unknown), unspecified dose of Meningococcal B c vaccine, lot # M12132 (.5 ml, route unknown), unspecified dose of Varicella virus vaccine (manufacturer unknown), lot # J003713 exp 27-MAR-2015, (.5 ml, route unknown). Concomitant medications included Ondansetron hydrochloride and prenatal vitamins. The mother's last menstrual period (LMP) occurred on 20-AUG-2013. The nurse reported the mother was exposed to with BOOSTRIX, GARDASIL, Meningococcal B C vaccine and Varicella virus vaccine at three to four weeks gestation, during the 1st trimester, however based on LMP she was calculated to be 6 weeks gestation. Estimated date of delivery was calculated to be 27-May-2014. On 04-OCT-2013, the pregnancy test confirmed pregnancy. On an unspecified date, within months of vaccination with BOOSTRIX, GARDASIL, Meningococcal B c vaccine and Varicella virus vaccine, the fetus experienced congenital anomaly and maternal vaccine exposure. The nurse reported there was a possibility of congenital anomaly, specific details were not provided (MARRS case 1403USA012467). At the time of reporting the outcome of the congenital anomaly was unspecified, the mother's pregnancy was ongoing. Follow-up information was received from a registered nurse regarding the 16 year old female patient. The mother is still pregnant (EDD 27-MAY-2014) and there had been no diagnoses of congenital anomalies to the date. The nurse may return correspondence once the patient delivers to report the outcome of the pregnancy. No further information was available at the time. This is one of two cases on the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Congenital anomaly, Foetal exposure during pregnancy, Pregnancy
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old female with depression and shellfish allergy. The patient's medical history included bilateral ear surgery; details not provided. The mother was noted to have no passive smoke exposure. On 04-OCT-2013 the 16-year old mother of the fetal subject received unspecified dose of GARDASIL lot # J003727, Expiration Date: 07-NOV-2015, (.5 ml, route unknown), a dose of BOOSTRIX lot # E5957, (.5 ml, transplacentary, unknown), unspecified dose of Meningococcal B c vaccine, lot # M12132 (.5 ml, route unknown), unspecified dose of Varicella virus vaccine (manufacturer unknown), lot # J003713 exp 27-MAR-2015, (.5 ml, route unknown). Concomitant medications included Ondansetron hydrochloride and prenatal vitamins. The mother's last menstrual period (LMP) occurred on 20-AUG-2013. The nurse reported the mother was exposed to with BOOSTRIX, GARDASIL, Meningococcal B C vaccine and Varicella virus vaccine at three to four weeks gestation, during the 1st trimester, however based on LMP she was calculated to be 6 weeks gestation. Estimated date of delivery was calculated to be 27-May-2014. On 04-OCT-2013, the pregnancy test confirmed pregnancy. On an unspecified date, within months of vaccination with BOOSTRIX, GARDASIL, Meningococcal B c vaccine and Varicella virus vaccine, the fetus experienced congenital anomaly and maternal vaccine exposure. The nurse reported there was a possibility of congenital anomaly, specific details were not provided (MARRS case 1403USA012467). At the time of reporting the outcome of the congenital anomaly was unspecified, the mother's pregnancy was ongoing. Follow-up information was received from a registered nurse regarding the 16 year old female patient. The mother is still pregnant (EDD 27-MAY-2014) and there had been no diagnoses of congenital anomalies to the date. The nurse may return correspondence once the patient delivers to report the outcome of the pregnancy. No further information was available at the time. This is one of two cases on the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Exposure during pregnancy, Foetal disorder, Pregnancy test positive
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old female with depression and shellfish allergy. The patient's medical history included bilateral ear surgery; details not provided. The mother was noted to have no passive smoke exposure. On 04-OCT-2013 the 16-year old mother of the fetal subject received unspecified dose of GARDASIL lot # J003727, Expiration Date: 07-NOV-2015, (.5 ml, route unknown), a dose of BOOSTRIX lot # E5957, (.5 ml, transplacentary, unknown), unspecified dose of Meningococcal B c vaccine, lot # M12132 (.5 ml, route unknown), unspecified dose of Varicella virus vaccine (manufacturer unknown), lot # J003713 exp 27-MAR-2015, (.5 ml, route unknown). Concomitant medications included Ondansetron hydrochloride and prenatal vitamins. The mother's last menstrual period (LMP) occurred on 20-AUG-2013. The nurse reported the mother was exposed to with BOOSTRIX, GARDASIL, Meningococcal B C vaccine and Varicella virus vaccine at three to four weeks gestation, during the 1st trimester, however based on LMP she was calculated to be 6 weeks gestation. Estimated date of delivery was calculated to be 27-May-2014. On 04-OCT-2013, the pregnancy test confirmed pregnancy. On an unspecified date, within months of vaccination with BOOSTRIX, GARDASIL, Meningococcal B c vaccine and Varicella virus vaccine, the fetus experienced congenital anomaly and maternal vaccine exposure. The nurse reported there was a possibility of congenital anomaly, specific details were not provided (MARRS case 1403USA012467). At the time of reporting the outcome of the congenital anomaly was unspecified, the mother's pregnancy was ongoing. Follow-up information was received from a registered nurse regarding the 16 year old female patient. The mother is still pregnant (EDD 27-MAY-2014) and there had been no diagnoses of congenital anomalies to the date. The nurse may return correspondence once the patient delivers to report the outcome of the pregnancy. No further information was available at the time. This is one of two cases on the same reporter. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Areflexia, Back pain, Balance disorder, Blepharospasm, CSF test abnormal
Clinical narrative: 44yF presented to ER with c/o progressive gait ataxia x 2 weeks along with paresthesias of feet & hands. Also c/o low burning back pain, increased weakness from knees down, headache & inability to sleep. Pt states she did recieve her first flu shot 3 weeks prior, & has never gotten a flu shot before. CSF notable for cytoalbuminologic dissociation (0 cells, high protein (109)), is highly suggestive of GBS. Pt has recieved 4 tx IVIG. Discharged home 2/7 with prednisone taper for headache.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray, Chest discomfort, Computerised tomogram abdomen, Electrocardiogram, Fall
Clinical narrative: 44yF presented to ER with c/o progressive gait ataxia x 2 weeks along with paresthesias of feet & hands. Also c/o low burning back pain, increased weakness from knees down, headache & inability to sleep. Pt states she did recieve her first flu shot 3 weeks prior, & has never gotten a flu shot before. CSF notable for cytoalbuminologic dissociation (0 cells, high protein (109)), is highly suggestive of GBS. Pt has recieved 4 tx IVIG. Discharged home 2/7 with prednisone taper for headache.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Immunoglobulin therapy, Insomnia
Clinical narrative: 44yF presented to ER with c/o progressive gait ataxia x 2 weeks along with paresthesias of feet & hands. Also c/o low burning back pain, increased weakness from knees down, headache & inability to sleep. Pt states she did recieve her first flu shot 3 weeks prior, & has never gotten a flu shot before. CSF notable for cytoalbuminologic dissociation (0 cells, high protein (109)), is highly suggestive of GBS. Pt has recieved 4 tx IVIG. Discharged home 2/7 with prednisone taper for headache.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle spasms, Muscular weakness, Musculoskeletal pain, Neck pain, Nerve conduction studies abnormal
Clinical narrative: 44yF presented to ER with c/o progressive gait ataxia x 2 weeks along with paresthesias of feet & hands. Also c/o low burning back pain, increased weakness from knees down, headache & inability to sleep. Pt states she did recieve her first flu shot 3 weeks prior, & has never gotten a flu shot before. CSF notable for cytoalbuminologic dissociation (0 cells, high protein (109)), is highly suggestive of GBS. Pt has recieved 4 tx IVIG. Discharged home 2/7 with prednisone taper for headache.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging spinal, Pain, Paraesthesia, Sensation of heaviness, Urine analysis
Clinical narrative: 44yF presented to ER with c/o progressive gait ataxia x 2 weeks along with paresthesias of feet & hands. Also c/o low burning back pain, increased weakness from knees down, headache & inability to sleep. Pt states she did recieve her first flu shot 3 weeks prior, & has never gotten a flu shot before. CSF notable for cytoalbuminologic dissociation (0 cells, high protein (109)), is highly suggestive of GBS. Pt has recieved 4 tx IVIG. Discharged home 2/7 with prednisone taper for headache.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ataxia, Back pain, CSF protein increased, Guillain-Barre syndrome, Headache
Clinical narrative: 44yF presented to ER with c/o progressive gait ataxia x 2 weeks along with paresthesias of feet & hands. Also c/o low burning back pain, increased weakness from knees down, headache & inability to sleep. Pt states she did recieve her first flu shot 3 weeks prior, & has never gotten a flu shot before. CSF notable for cytoalbuminologic dissociation (0 cells, high protein (109)), is highly suggestive of GBS. Pt has recieved 4 tx IVIG. Discharged home 2/7 with prednisone taper for headache.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immunoglobulin therapy, Insomnia, Muscular weakness, Pain, Paraesthesia
Clinical narrative: 44yF presented to ER with c/o progressive gait ataxia x 2 weeks along with paresthesias of feet & hands. Also c/o low burning back pain, increased weakness from knees down, headache & inability to sleep. Pt states she did recieve her first flu shot 3 weeks prior, & has never gotten a flu shot before. CSF notable for cytoalbuminologic dissociation (0 cells, high protein (109)), is highly suggestive of GBS. Pt has recieved 4 tx IVIG. Discharged home 2/7 with prednisone taper for headache.
Age: 2.0
Sex: F
Vaccine: HEPA, MMRV, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a 2 year old female patient (reported as 2 years and 9 months) with no pertinent medical history, who on 21-MAR-2014 was vaccinated with dose 1 of PROQUAD (Merck) lot # J011330, expiration date 13-MAR-2015, 0.5 ml, subcutaneous. No co-suspect or concomitant medications were reported. The certified medical assistant reported that the patient was behind on her vaccination series; on 30-MAR-2014, the mother of the patient reported that the patient developed a fever; on 31-MAR-2014 the mother of the patient reported that the patient developed a mild rash on torso along with continuing fever. On 01-APR-2014, the patient was bought into the clinic and seen by the nurse and was diagnosed with varicella rash. The patient did not received treatment for the event. No laboratory tests were performed. At the time of the report, the patient's outcome was not provided. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA, MMRV, MMRV
Symptoms: Pyrexia, Rash, Varicella
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a 2 year old female patient (reported as 2 years and 9 months) with no pertinent medical history, who on 21-MAR-2014 was vaccinated with dose 1 of PROQUAD (Merck) lot # J011330, expiration date 13-MAR-2015, 0.5 ml, subcutaneous. No co-suspect or concomitant medications were reported. The certified medical assistant reported that the patient was behind on her vaccination series; on 30-MAR-2014, the mother of the patient reported that the patient developed a fever; on 31-MAR-2014 the mother of the patient reported that the patient developed a mild rash on torso along with continuing fever. On 01-APR-2014, the patient was bought into the clinic and seen by the nurse and was diagnosed with varicella rash. The patient did not received treatment for the event. No laboratory tests were performed. At the time of the report, the patient's outcome was not provided. Additional information has been requested.
Age: 1.49
Sex: F
Vaccine: VARCEL
Symptoms: Bacterial infection, Bronchitis, Cystitis, Haemorrhage
Clinical narrative: Blood in her diaper. Rushed her to hospital - SEVERE bladder infection. She had to go onto her first dose of antibiotics ever. Then looked up side effects from chicken pox vaccine - "secondary bacterial infections".
Age: 21.0
Sex: M
Vaccine: ANTH, HPV4
Symptoms: Injection site pruritus, Skin lesion, Swelling
Clinical narrative: Swelling following day after immunization and lesions 2 days after immunization. Site of the injection is itchy.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Polymerase chain reaction, Rash vesicular, Skin lesion, Varicella post vaccine, Varicella virus test
Clinical narrative: This spontaneous report as received from a physician refers to a 13 years old immunocompromised female patient. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (dose, frequency, route and lot number not reported). In approximately 2014 (reported as "currently"), the patient was hospitalized with a rash which they suspected to be varicella. The patient had lesions on her face, arms and legs and had been treated with acyclovir for 2 weeks. The reporter mentioned that the patient was also treated with VARIZIG on 30-MAR-2014. The reporter did not have the patient's vaccination information but stated that would follow-up with her primary care physician to see when she was vaccinated with VARIVAX (Merck). Submitting samples to the program were discussed and VZVIP program information would be faxed to the reporter. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. The outcome of the event was unknown. The reporter did not provide causality assessment between the event and VARIVAX (Merck). Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Electromyogram abnormal, Injection site pain, Joint stiffness, Muscular weakness, Musculoskeletal pain
Clinical narrative: On 3/14/2013, I received a ZOSTAVAX injection in the back of my upper left arm. The injection was administered by a Pharmacist. Within a week of receiving the injection I began to experience pain around my left shoulder and scapula and radiating down the left arm. Initially, I thought I may have injured my neck, as the pain was similar to that of a pinched nerve I had several years previously. When I went to see a physician in early April he ordered x-rays and an MRI of the neck. After reviewing these he concluded that the symptoms did not match anything noted on the tests. By this time the pain was subsiding and I was left with a weakness in the lower left arm and hand, primarily on extension. He suggested that it appeared to be Parsonage Turner Syndrome. He then ordered an EMG to test nerve conduction. The EMG showed that it was primarily the ulnar nerve that was affected. It was not until later when I got home and looked up information on Parsonage Turner Syndrome that I realized the probable connection between the vaccination and the symptoms. I have since seen a neurologist who agreed that it was probably Parsonage Turner Syndrome and that there could be a connection between the vaccination and my symptoms. I continue to have weakness in my left hand and an inability to extend the fingers.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Pain in extremity, Ulnar nerve injury, X-ray
Clinical narrative: On 3/14/2013, I received a ZOSTAVAX injection in the back of my upper left arm. The injection was administered by a Pharmacist. Within a week of receiving the injection I began to experience pain around my left shoulder and scapula and radiating down the left arm. Initially, I thought I may have injured my neck, as the pain was similar to that of a pinched nerve I had several years previously. When I went to see a physician in early April he ordered x-rays and an MRI of the neck. After reviewing these he concluded that the symptoms did not match anything noted on the tests. By this time the pain was subsiding and I was left with a weakness in the lower left arm and hand, primarily on extension. He suggested that it appeared to be Parsonage Turner Syndrome. He then ordered an EMG to test nerve conduction. The EMG showed that it was primarily the ulnar nerve that was affected. It was not until later when I got home and looked up information on Parsonage Turner Syndrome that I realized the probable connection between the vaccination and the symptoms. I have since seen a neurologist who agreed that it was probably Parsonage Turner Syndrome and that there could be a connection between the vaccination and my symptoms. I continue to have weakness in my left hand and an inability to extend the fingers.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Erythropsia
Clinical narrative: Erythropsia in both eyes - pink/red tinged vision (happens with febrile illnesses) that has been recurrent since May 2013 - one month after Tdap vaccine.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Convulsion, Nuclear magnetic resonance imaging normal
Clinical narrative: My 14 year old daughter had her first GARDASIL shot on May 24, 2013. She was taken by ambulance both times to the hospital where she was given meds and stabilized. Bloodwork and an MRI came back fine. There is no family history of seizures at all. We have been referred to a Neurologist and we will also be doing an EEG. Prognosis is that my daughter is going to have to be put on medication for seizures.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history was provided. On an unknown date the patients were vaccinated with VARIVAX (Merck) that had been exposed to 7 F for an unknown period of time. It was reported that it seemed that the product was stored at 7 F for months. No concomitant medication was reported. No adverse symptoms were reported. No outcome was reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt describe pain at site of injection that was given on 2/22/14. Pt states she has pain lifting her arm and feels pain/tingle on her fingertips.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Hallucination, Initial insomnia, Pain in extremity
Clinical narrative: This spontaneous report as received from a 68 year old female consumer refers to herself with drug reactions/allergies to LEVAQUIN. Patient medical history included high blood pressure. On 25-MAR-2014, some time in the afternoon, the patient was vaccinated with unspecified vaccination pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot#, expiration date, dose, route of administration, location of administration were not reported). Concomitant therapies included losartan potassium (manufacturer unknown). On 25-MAR-2014 the patient experienced trouble falling asleep that evening since her arm hurt. She also reported that around 3 am in the morning of 26-MAR-2014 she experienced hallucinations. After that morning, she had no further reactions. There were no laboratory tests performed. There was no treatment given for the reported events. The outcome of the events was reported as recovered/resolved on 26-MAR-2014. The patient sought medical attention by calling physician. The relatedness between the reported events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Ear infection, Pyrexia
Clinical narrative: This spontaneous report was received from a patient's mother regarding her son of 13 months. Patient's current condition included ear infections. On 27-MAR-2014 the patient was vaccinated with VARIVAX (Merck) injection (dose number, dose unit, lot# and expiry date, therapy route unknown). No concomitant medications were reported. On 31-MAR-2014, the patient was diagnosed with an ear infection and low grade fever. Patient was treated with an unspecified antibiotics at the time of the report. It was reported that patient was scheduled for a placement of tubes in the ears on 04-MAR-2014 but was cancelled until the ear infection would resolve. Outcome of the events was reported as not recovered. Causality of events with respect to VARIVAX (Merck) was unknown. Additional information is not expected.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Blood creatine phosphokinase, Diarrhoea, Full blood count, Metabolic function test, Urine analysis
Clinical narrative: This spontaneous report as received from a nurse (L.P.N) refers to a 9 week old male patient with medium-chain acyl-coA dehydrogenase (MCAD) deficiency and with no other known allergies. On 31-MAR-2014 the patient was vaccinated with ROTATEQ (dose not reported, lot# reported as K000487, expired date 27-SEP-2015). Concomitant therapies included carnitine. On 31-MAR-2014, the nurse reported that a patient developed diarrhea about an hour after administration of ROTATEQ and had 2 to 3 loose stools per hour for about 12 hours. Complete blood count (CBC), Comprehensive Metabolic Panel (CMP), Creatine phosphokinase (CPK) and urinalysis were performed with unknown results. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention by contacting the office. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to herself, a 60 year old female with drug allergy on ULTRAM and AUGMENTIN XR. Concomitant medication and no medical history were not reported. On 29-MAR-2014 the patient was vaccinated with ZOSTAVAX (batch/lot was not reported), single dose subcutaneous in the left arm. On 30-MAR-2014 the patient developed red, painful, hard lump at the injection site. Then she developed redness and swelling extending from the left shoulder down to the elbow. The patient contacted her physician's office but no treatment was prescribed. No lab diagnostics performed. The outcome of red, painful, hard lump at the injection site and redness and swelling extending from the left shoulder down to the elbow was reported as improving. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Body temperature, Cough, Dyspnoea
Clinical narrative: Initial report was received from a non health care professional on 02 April 2014. This case is one of a cluster of two identified patients who experienced similar adverse events following administration of ADACEL. The events for the other patient was captured in case 2014SA042582. A 16 year-old male patient with a history of asthma had received on 30 May 2012 an intramuscular first dose of ADACEL, lot number U3554CA and approximately 21 months later developed wheezing, coughing, SOB (shortness of breath), vomiting and fever of 104. The patient's Mother thought it was an asthma attack. The patient was evaluated by a physician on 12 March 2014 and was treated with Azithromycin pack times two. On 27 March 2014, the patient was evaluated by a pulmonologist and was diagnosed with pertussis. Laboratory data included an IgG of 75 (units not reported) and IgM of 1.9 (units not reported). No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Pertussis, Pyrexia, Vomiting, Wheezing
Clinical narrative: Initial report was received from a non health care professional on 02 April 2014. This case is one of a cluster of two identified patients who experienced similar adverse events following administration of ADACEL. The events for the other patient was captured in case 2014SA042582. A 16 year-old male patient with a history of asthma had received on 30 May 2012 an intramuscular first dose of ADACEL, lot number U3554CA and approximately 21 months later developed wheezing, coughing, SOB (shortness of breath), vomiting and fever of 104. The patient's Mother thought it was an asthma attack. The patient was evaluated by a physician on 12 March 2014 and was treated with Azithromycin pack times two. On 27 March 2014, the patient was evaluated by a pulmonologist and was diagnosed with pertussis. Laboratory data included an IgG of 75 (units not reported) and IgM of 1.9 (units not reported). No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, dose (unknown), and route of administration (unknown), for unknown indication. No concomitants were reported. On an unknown date, the patient developed a case of shingles after receiving the ZOSTAVAX. On an unknown date, the patient broke up in a rash with blisters around her torso. Also felt nerve pain around her abdomen. No product quality complaint was involved. The outcome of event was unknown. Causality was not provided. The reporter did not wish to document or share any contact information. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Cough, Dyspnoea, Pertussis
Clinical narrative: Initial report was received from a non health care professional on 02 April 2014. This case is one of a cluster of two identified patients who experienced similar adverse events following administration of ADACEL. The events for the other patient were captured in case 2014SA042580. A 15 year-old male patient with a history of asthma had received on 08 June 2009 an intramuscular first dose of ADACEL, lot number C3057AA and approximately 57 months later developed wheezing, coughing, SOB (shortness of breath), vomiting and fever of 104. The patient's Mother thought it was an asthma attack. The patient was evaluated by a physician on 12 March 2014 and was treated with Azithromycin pack times two. On 26 March 2014 (also reported as 27 March 2014), the patient was evaluated by a pulmonologist and was diagnosed with pertussis. Laboratory data included an IgG and IgM (results were not reported). No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting, Wheezing
Clinical narrative: Initial report was received from a non health care professional on 02 April 2014. This case is one of a cluster of two identified patients who experienced similar adverse events following administration of ADACEL. The events for the other patient were captured in case 2014SA042580. A 15 year-old male patient with a history of asthma had received on 08 June 2009 an intramuscular first dose of ADACEL, lot number C3057AA and approximately 57 months later developed wheezing, coughing, SOB (shortness of breath), vomiting and fever of 104. The patient's Mother thought it was an asthma attack. The patient was evaluated by a physician on 12 March 2014 and was treated with Azithromycin pack times two. On 26 March 2014 (also reported as 27 March 2014), the patient was evaluated by a pulmonologist and was diagnosed with pertussis. Laboratory data included an IgG and IgM (results were not reported). No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. In 2007 the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, lot # and expiration date was not reported). On an unknown date, reported as "recently" the patient was diagnosed with shingles on the back of her leg. The outcome of shingles on the back of her leg was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to three patients of unknown demographics. The reporting physician stated that over the course of the last three years, on unspecified date three patients were vaccinated with ZOSTAVAX (lot #, route of administration, expiration date, dose not provided), and later, on unspecified date developed full-on shingles. At the time of vaccination all three patients were 65 years of age or older. The outcome of the event for all three patients was reported as recovered from shingles (date of recovery not provided). The relatedness between the event and vaccination with ZOSTAVAX was not reported. This case is liked to MARRS# 1404USA002472 (same reporter link). Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash morbilliform, Rash pruritic
Clinical narrative: 2 days of itchy rash that resembled measles. 10 days after MMR given.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient in her mid-twenties. The patient's current conditions or medical history were not reported. On an unspecified date in 1994, reported as about 20 years ago, the patient was vaccinated with a dose (reported as original) of VARIVAX (Merck) subcutaneous and the booster (dose, lot numbers and expiration dates were not reported). On an unspecified date in 2014, reported as a few weeks ago, a physician, partner of the reporting physician, examined the patient who had received the VARIVAX (Merck) vaccine, original and booster, and the patient was diagnosed with herpes zoster. At the time of the report outcome of herpes zoster was unknown. The patient visited the doctor for medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Vomiting
Clinical narrative: Took oral Typhoid dose #1 4/3/14, dose #2 4/5/14, dose #3 4/7/14 and vomited pill up and 5 more times.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Body temperature increased, Injection site erythema, Rash macular, Urticaria
Clinical narrative: 25 Mom phoned said patient "broke out in hives and blotches" while driving home from PCP office. Resolved by the time arrived home. 27 Mom phoned said temp. 101.7 on 3/26/14. Afebrile today. (L) arm red at top of arm (i.e. at DTaP-IPV injection site). Advised MOTRIN and cold compresses. Picture sent by mom. Dr reviewed pictures 3/27/14.
Age: 48.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site mass
Clinical narrative: 3/24/14 Lump in left upper arm. Onset approx 1 month post vaccine. ? abscess. Treated with BACTRIM 3/27/14 increased sx pt sent to ED and changed antibiotics to clindamycin 300mg QID.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Immediately after receiving immunization - (R) deltoid became red, swollen at site of MENVEO, (R) side of face red with some spot. Pt txd with BENADRYL and SOLU-MEDROL and observed.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain. Started 1 day after. Seen 4 days later - 98.5. Dx: Cellulitis. Doxycycline Hyclate 100mg PO caps one pill by mouth twice a day for 7 days.
Age: 25.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: 2 hrs after GARDASIL vaccine had overall skin numbness and tingling ("pins and needles") feeling lasting about 24 hrs before resolved, (-) rash (-) edema.
Age: 25.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia
Clinical narrative: 2 hrs after GARDASIL vaccine had overall skin numbness and tingling ("pins and needles") feeling lasting about 24 hrs before resolved, (-) rash (-) edema.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Computerised tomogram head normal, Dizziness, Head discomfort, Headache, Syncope
Clinical narrative: After reeiving immunizations patient walked down hallway, fainted collapsed, hitting door. Responded right away. BS 102, BP 99/50, P 50. Stated he was dizzy and discomfort back of head. Patient had not eaten that morning. Patient was examined by doctor and was given water and Gatorade. Patient rested a while and walked out under parental supervision. Pt returned 4/2/14 c/o HA.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Computerised tomogram head normal, Syncope
Clinical narrative: After reeiving immunizations patient walked down hallway, fainted collapsed, hitting door. Responded right away. BS 102, BP 99/50, P 50. Stated he was dizzy and discomfort back of head. Patient had not eaten that morning. Patient was examined by doctor and was given water and Gatorade. Patient rested a while and walked out under parental supervision. Pt returned 4/2/14 c/o HA.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Anti-NMDA antibody positive, CSF test abnormal, Catatonia, Convulsion, Encephalitis autoimmune
Clinical narrative: Seizures. Child had 8 seizures in 7 hrs. which put her in a state of catatonia and was hospitalized for 19 days.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Alopecia
Clinical narrative: CLIENT REPORTS EXPERIENCING HAIR LOSS, 24 HOURS POST VACCINATION ADMINISTRATION. HAIR LOSS HAS NOT SUBSIDED.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthritis, Contusion, Drug administered at inappropriate site, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Immense bruising upper arm. Excruciating shoulder pain - ongoing. Inflamed shoulder joint. Partial tear roto cuff. Shot given high and in back of arm.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rotator cuff syndrome, X-ray limb
Clinical narrative: Immense bruising upper arm. Excruciating shoulder pain - ongoing. Inflamed shoulder joint. Partial tear roto cuff. Shot given high and in back of arm.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthritis, Contusion, Musculoskeletal pain, Nuclear magnetic resonance imaging, Rotator cuff syndrome
Clinical narrative: Immense bruising upper arm. Excruciating shoulder pain - ongoing. Inflamed shoulder joint. Partial tear roto cuff. Shot given high and in back of arm.
Age: 61.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: X-ray limb
Clinical narrative: Immense bruising upper arm. Excruciating shoulder pain - ongoing. Inflamed shoulder joint. Partial tear roto cuff. Shot given high and in back of arm.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itchy rash. serious enough to prompt patient to call physician.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Injection site pain, Injection site swelling, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Pain and swelling at injection site.
Age: 1.08
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Local redness to right leg noted fifteen minutes after vaccine was given. MD in to assess. Antihystamine 5ml given PO as ordered.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Progressive redness, swelling and itching down arm from injection site to elbow. Generalized joint pain by the following day. "Lump" at injection site larger and more painful that usual/expected. She delayed seeking treatment for 1 week. Symptoms slowly resolved. In 1 week she had about 4 cm raised hard tender area at injection site with sl larger area of erythema. Joint pain, rash, and pruritus were resolved.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Progressive redness, swelling and itching down arm from injection site to elbow. Generalized joint pain by the following day. "Lump" at injection site larger and more painful that usual/expected. She delayed seeking treatment for 1 week. Symptoms slowly resolved. In 1 week she had about 4 cm raised hard tender area at injection site with sl larger area of erythema. Joint pain, rash, and pruritus were resolved.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site bruising, Injection site pruritus, Local swelling, Pruritus
Clinical narrative: Pt describes a localized skin reaction as a 2" by 1" area that was raised and hot.  The next morning her "entire upper arm was raised to a 5" by 5" raised, itchy and burning hot area".  She also reports feeling "light-headed".   Today, 4/7/14, she reports the site is not swollen or hot just "very itchy" with a "light bruise".