chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Haemorrhage, Headache, Impaired gastric emptying, Malnutrition, Menorrhagia
Clinical narrative: This spontaneous report was received via a social media from a consumer (the mother of the patient) concerning her 12 year old daughter who received GARDASIL on an unspecified date(s). Concomitant medications and medical history were not provided. The reporter made the following statements on the social media site: "[Daughter's name] menstrual cycle after GARDASIL-constant bleeding/pain like birthing a porcupine, infertility?" "[Daughter's name] life matters. GARDASIL destroyed her/suffering 5 years". "Anxiety, ADHD, bipolar, severe memory loss, depression, suicidal after losing soccer/school/friends". "Headaches, muscle/joint pain, SOB [shortness of breath], excruciating back/rib.shoulder/legs/chest pain, abnormal sensations". "Athlete now has gastroparesis/imagine at 15 your stomach virus is 24/7/365 forever". "Vomits daily, malnourished, nauseated, debilitating pain, chronic fatigue". "My teen is up to date including GARDASIL. Played Russian Roulette/destroyed my daughter's life". "My 12 year old daughter did and is still suffering now at 16 1/2. What she endured is inhumane". The outcome of the events were not recovered. Upon internal review, suicidal after losing soccer/school/friends was considered medically significant. Excruciating back/rib/knee/shoulder/leg pain/debilitating pain was considered disabling. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal chest pain, Musculoskeletal pain, Myalgia, Nausea, Pain
Clinical narrative: This spontaneous report was received via a social media from a consumer (the mother of the patient) concerning her 12 year old daughter who received GARDASIL on an unspecified date(s). Concomitant medications and medical history were not provided. The reporter made the following statements on the social media site: "[Daughter's name] menstrual cycle after GARDASIL-constant bleeding/pain like birthing a porcupine, infertility?" "[Daughter's name] life matters. GARDASIL destroyed her/suffering 5 years". "Anxiety, ADHD, bipolar, severe memory loss, depression, suicidal after losing soccer/school/friends". "Headaches, muscle/joint pain, SOB [shortness of breath], excruciating back/rib.shoulder/legs/chest pain, abnormal sensations". "Athlete now has gastroparesis/imagine at 15 your stomach virus is 24/7/365 forever". "Vomits daily, malnourished, nauseated, debilitating pain, chronic fatigue". "My teen is up to date including GARDASIL. Played Russian Roulette/destroyed my daughter's life". "My 12 year old daughter did and is still suffering now at 16 1/2. What she endured is inhumane". The outcome of the events were not recovered. Upon internal review, suicidal after losing soccer/school/friends was considered medically significant. Excruciating back/rib/knee/shoulder/leg pain/debilitating pain was considered disabling. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Sensory disturbance, Suicidal ideation, Vomiting
Clinical narrative: This spontaneous report was received via a social media from a consumer (the mother of the patient) concerning her 12 year old daughter who received GARDASIL on an unspecified date(s). Concomitant medications and medical history were not provided. The reporter made the following statements on the social media site: "[Daughter's name] menstrual cycle after GARDASIL-constant bleeding/pain like birthing a porcupine, infertility?" "[Daughter's name] life matters. GARDASIL destroyed her/suffering 5 years". "Anxiety, ADHD, bipolar, severe memory loss, depression, suicidal after losing soccer/school/friends". "Headaches, muscle/joint pain, SOB [shortness of breath], excruciating back/rib.shoulder/legs/chest pain, abnormal sensations". "Athlete now has gastroparesis/imagine at 15 your stomach virus is 24/7/365 forever". "Vomits daily, malnourished, nauseated, debilitating pain, chronic fatigue". "My teen is up to date including GARDASIL. Played Russian Roulette/destroyed my daughter's life". "My 12 year old daughter did and is still suffering now at 16 1/2. What she endured is inhumane". The outcome of the events were not recovered. Upon internal review, suicidal after losing soccer/school/friends was considered medically significant. Excruciating back/rib/knee/shoulder/leg pain/debilitating pain was considered disabling. Additional information is not expected.
Age: 85.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Tenderness
Clinical narrative: Rec'd pneumonia vaccine on 8/20/15. Started having pain and swelling within 24 hrs. Now on 8/23/15 pain is 9/10 and (R) deltoid with erythema & swelling. Painful to touch.
Sex: F
Vaccine: DTAP, IPV
Symptoms: Dark circles under eyes, Diarrhoea, Eczema
Clinical narrative: Initial unsolicited report received from a consumer on 12 February 2015. A female patient whose medical history included severe corn allergies and concomitant medications were not reported, had received a dose of DTaP (Manufacturer unknown, batch number, expiry date, dose number, route and site of administration were not reported) and a dose of Polio (manufacturer unknown, batch number, expiry date, dose number, route and site of administration were not reported), both on an unspecified date. On an unspecified date, after vaccination, the patient experienced eczema, dark purple racoon circles under the eyes and diarrhea. The patient was treated with over the counter BENADRYL. Laboratory investigations were not reported. At the time of report, the patient outcome was unknown. Documents held by sender: none.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions,  medical history and concomitant medications reported. On 11-AUG-2015, the patient was administered with expired vaccine of (Merck) PROQUAD, lot# K002039, expired on 10-AUG-2015. No adverse effects reported. No product quality complained involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, Streptococcus test positive
Clinical narrative: This is a prospective pregnancy case. This adult female subject was enrolled in a study. The subject received the 1st dose of BOOSTRIX on an unknown date. Co-suspect products included BOOSTRIX. The subject received BOOSTRIX a week 21 of the pregnancy and during the second and third trimesters of pregnancy. On an unknown date, not applicable after receiving BOOSTRIX, the subject developed extra dose administered (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of extra dose administered was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. Additional details provided as follows: The nurse reported that the pregnant patient received 1st dose of BOOSTRIX at 21 weeks pregnant and then again at 38 weeks pregnant. Follow-up information received on 12 June 2015: This pregnancy was a normal conception. The subject details were provided (age, weight, height and ethnic origin). It was not known if the subject had allergies or relevant medical history. The subject's last menstrual period was on 12th August 2014 and estimated date of delivery was 19th May 2015. The subject received BOOSTRIX at week 28 and 3 days of the pregnancy and during the third trimester of pregnancy. From 01 December 2014, the subject took Prenatal Vitamins. On 22nd May 2015 after 40 weeks and 3 days, the subject gave birth to a live neonate with no apparent congenital anomaly via unknown delivery. The subject was discharged home on postpartum on day 2 with the baby. Follow up information received by a nurse on 22nd July 2015: The subject is non-smoker and non-alcoholic. The subject's current condition included anemia during pregnancy. The subject did not have any other known medical conditions. The subject did not have any previous pregnancies. On 17th April 2015, the subject underwent group B Streptococcus culture, which was found to be positive. So the subject received prophylactic treatment with Penicillin during labour. The subject gave birth to live male neonate via normal delivery method. The infant had an APGAR score of 9 and 9 (the reporter was unsure of hospital timeframe). Upon internal corrections received on 24th August 2015, Group B streptococcus culture positive event was updated in this case.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Lip swelling, Pain in extremity
Clinical narrative: Arm pain, numbness of neck/mouth/cheek, swollen lip on left side resolved in 1 hour.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Erythema, Irritability, Malaise, Myalgia
Clinical narrative: 8/12 Headache prior to vaccine administ. Tmax at 101 degrees, <1cm erythema, (+) myalgia, (+) malaise. 8/13 "Perky", afebrile, asymptomatic.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient returned 2 days after vaccination and showed arm to pharmacist. Swollen spot of 2-3 inches across visible. Redness and warmth felt.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Contusion, Petechiae, Platelet count decreased
Clinical narrative: Bruising and petechiae to body (head to toe).
Age: 21.0
Sex: M
Vaccine: HPV4
Symptoms: Blood electrolytes decreased, Electroencephalogram, Generalised tonic-clonic seizure
Clinical narrative: Grand mal seizure-911-called with police and paramedics responding. Transported by ambulance to hospital. Seizure discovered at 6:30 am awoke in ambulance 7:00 am. Released from hospital 12 noon.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of male patients of unknown age. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, reported as within the last 1-2 years, the patients were vaccinated intramuscularly with doses of GARDASIL injection (dose, frequency, lot # and expiration date were not provided). No concomitant therapy was reported. The patients complained about stinging at the site of injection immediately after vaccination (dates unspecified). The stinging only lasted for a few seconds and all of the patients recovered from the event (dates unspecified). No treatment was given for the events. No product quality complaint (PQC) was involved. The relatedness between GARDASIL and the events was not reported. Follow up information has been received on 13-AUG-2015. All telephone attempts to obtain follow up information has been unsuccessful. Follow up information has been received from a nurse on 18-AUG-2015. The nurse clarified that she was referring to 12 year old males. She was not able to provide identifiers, lot number and expiration date and dates of vaccination. She stated that this was a few years ago at another location. This is one of the several reports from the same reporter. Additional information has been requested. Patient details, event tab and narrative were updated.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Off label use
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to an unspecified number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of patients were vaccinated with a doses of GARDASIL (lot number, dose and route were not reported). The reporter stated that in her clinic, all patients who stated HPV vaccination series with GARDASIL were switched to GARDASIL 9 (lot numbers, dose, and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 15-JAN-2015, the patient was vaccinated with improperly stored GARDASIL lot # J015378, expiry date 09-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TD
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness and itchiness of (L) upper arm from shoulder down to elbow. BENADRYL advised for itchiness.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 03-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 21-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a two licensed practical nurses referring to a 15 year old female patient. The patient had no known allergy. On 13-AUG-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot# was reported as L004014 with expired date 04-MAR-2017, dose and route were unspecified) for HPV prevention. No concomitant medication was taken by the patient On the same day, the patient experienced a syncopal episode immediately following the administration of the vaccine and recovered 15-20 minutes after the injection in the care of the two reporters for medical attention. No lab tests was performed. The patient was fully recovered from the episode on an unknown date in August 2015. Lot number L004014 is an invalid lot number for GARDASIL 9. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from two licensed practical nurse referring to a 12 year old female patient. The patient had no known allergy. On 11-AUG-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot # was reported as L004014 with expired date 04-MAR-2017, dose and route were unspecified) for HPV prevention. No concomitant medication was taken by the patient. On the same day, the patient experienced a syncopal episode immediately following the administration of the vaccine and recovered 15-20 minutes after the injection site in the care of the two reporters for medical attention. No lab tests was performed. The patient was fully recovered from the episode on an unknown date in August 2015. Lot number L004014 is an invalid lot number GARDASIL 9. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Information of this prospective pregnancy report has been received from a physician referring to a female patient of unknown age. The patient became pregnant on an unknown date (date of last menstrual period not provided). On an unknown date the pregnant patient was inadvertently administered VARIVAX (Merck) (lot#, expired date, dose, frequency and route were unknown) (vaccine exposure during pregnancy). The estimated date of delivery and the due date were not provided. The patient had sought unknown type of medical attention. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a female child of unknown age. The patient's pertinent medical history and concurrent condition were not reported. On 07-JUN-2014, the patient was vaccinated with the first dose of PROQUAD (Merck) (lot #, expired date, strength, dose, route and frequency were unknown). On 14-AUG-2015 the patient was vaccinated with the second dose of PROQUAD (Merck) (lot #, expired date, strength, dose and frequency were unknown) intramuscularly (inappropriate schedule of vaccine administered) (subcutaneous injection formulation administered by other route). No concomitant medication was reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, drug reactions/allergies or concomitant therapies provided. On 10-JUL-2015, the patient was vaccinated with the first dose of MMR II (lot # K018990, expiration date 15-OCT-2016, subcutaneously, dose and units were not reported), that was improperly stored. There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored Oral, ROTATEQ (strength, dose, frequency and route were unknown, lot # K023532, expiration date 21-JUN-2016). No symptoms were reported. This is one of several reports from the same reporter. Additional information is not expected as we are not allowed to contact the reporter.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # J013394 with expiration date of 25-AUG-2016, dose strength and route unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored oral, ROTATEQ (lot # K009752 with expiration date of 15-APR-2016, dose and strength unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Stridor
Clinical narrative: Complained of feeling hot 5 minutes after injection. Patient then had upper respiratory stridor with SOB. I put patient on 4 l nc. Lungs sounds were clear. Stridor resolved after 5 minutes. Sats were always in the high 90's with no tachycardia. Respiratory rate between 20-24 till stridor resolved. When home visit was finished patient on O2 at 4 l nc and c/o no SOB. Lungs clear, denies SOB. I called patient at 14:40 for recheck and he states he feels fine and has been off oxygen this afternoon with no SOB.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (physician assistant) referring to a patient of unknown age and gender. The patient's medical history, concurrent condition therapy were not reported. On 20-MAY-2015, the patient was vaccinated with a dose of RECOMBIVAX HB, lot # J012567, expiration date 30-JAN-2016 (dose and route not reported), which was improperly stored. no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patient's medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot # K012457 with expiration date of 04-JUN-2017, lot # K012456 with expiration date of 28-APR-2017, lot# J005010 with unspecified expiration date, lot #K002831 with unspecified expiration date) (strength, dose and route unknown). No adverse effects reported. No product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Herpes zoster, Pneumonia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 67 years old female patient. The patient's medical history and concomitant medications were not reported. Her concurrent conditions included Diabetes. None drug reactions/allergies reported. On an unknown date (reported as at the age of 65 years old), the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route of administration, lot # and expiration date were not reported). On an unknown date (reported as at the age of 67 years old), the patient was diagnosed with Pneumonia. The patient also developed an active case of shingles two days after developing Pneumonia. On an unknown date, the patient had a chest x-ray that confirmed the pneumonia. The patient was prescribed an unspecified antiviral treatment for the shingles and an unspecified antibiotic and prednisone (manufacturer unknown). The patient's lungs cleared five days after using the antibiotic and the prednisone (manufacturer unknown). The outcome of pneumonia was reported as recovered on an unknown date. The outcome of shingles was unknown. The relatedness between the adverse events and the vaccination with PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history and drug allergies were not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot# K008931 with expiration date of 04-MAR-2017) (strength, dose and route unknown). No adverse effects reported. No product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: TD
Symptoms: Diarrhoea, Gait disturbance, Headache, Muscular weakness, Nausea
Clinical narrative: Initial report received from a consumer on 18 November 2014. A 46-year-old male patient had received a dose of TD VACCINE (batch number, route of administration, dose and dose in series was not reported) and TB SKIN TEST (batch number, route of administration, site of administration, dose and dose in series was not reported) on 17 November 2014. Illness at time of vaccination was none as per reporter and patient had no known allergies and pre-existing physician diagnosed allergies birth defects, medical condition and concomitant medications was not reported. On 17 November 2014, same day after vaccination, the patient experienced headache and nausea. On 18 November 2014 the patient experienced head pain, "explosive diarrhea" and weakness of legs that "can barely walk". Laboratory investigations and corrective treatment was not reported. At the time of this report the patient was not recovered from the event. Documents held by sender: none.
Sex: U
Vaccine: TD
Symptoms: Arthralgia, Injection site reaction, Local reaction, Pyrexia
Clinical narrative: Initial unsolicited report received from a physician on 19 December 2014. A patient whose age, gender, medical history and concomitant medications were not reported, had received TD VACCINE (dose details, batch number, route of administration and site of administration was not reported) in the year 1981. On an unspecified date after vaccination, the patient experienced fever, joint pain and local site reaction. It was stated that the patient had not received "Td product" at the reporter's facility and did not have any other information regarding what patient had received or the symptoms experienced following vaccination. Illness at time of vaccination, Pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Laboratory investigations and corrective treatments were not provided. At the time of this report, the patient was recovered. Documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: TD
Symptoms: Contraindication to vaccination
Clinical narrative: Initial unsolicited report received from a healthcare professional on 18 March 2015. A 65-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of Tetanus Diphtheria (batch number, dose, dose number, expiry date and site of administration were not reported) via intramuscular route on unspecified date. It was reported that the Patient had a large reaction in childhood to horse serum and patient can't take Tetanus or Tetanus containing products. No information about prior exposure to vaccine was not reported. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient outcome was recovered. Documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAP, DTPHIB, IPV, PNC13
Symptoms: Crying
Clinical narrative: Initial report received from a healthcare professional on 30 July 2014. A 02-month-old female patient had received first dose of IOL (lot number: K1329, route and site was not reported), received first dose of DAPTACEL (lot number: C4617AA, route and site was not reported), received first dose of ACTHIB (lot number UH827AB, route and site not reported), received a dose of PREVNAR 13 (manufacturer other, lot number, dose in series, route and site was not reported) and had also received a dose of ROTATEQ (manufacturer other, lot number, dose in series, route and site was not reported) on 07 May 2014. The patient had no illness at the time of vaccination. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions was unknown. On 07 May 2014, same day after the vaccination, the patient's developed inconsolable crying. The patient's corrective treatment and laboratory investigations were not reported. The patient recovered on an unspecified date after 3 hours. The patient required ER/doctor visit. Documents held by sender: none.
Age: 0.95
Sex: M
Vaccine: IPV
Symptoms: Allergy test positive, Flushing, Pyrexia, Skin test positive
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Merck) on 02 January 2015. A male patient (age at the time of event not reported), whose medical history and concomitant medications were not reported had received an intramuscular dose of POLIO VACCINE (batch number, dose number and anatomical site of administration and not reported) vaccine on an unspecified date in February 2014. On an unspecified date after vaccination within minutes patient became flushed and developed a fever. Corrective treatment were not reported. Laboratory investigations: Allergy and skin test on an unspecified date revealed that the adverse reactions of flushing and fever were due to components formaldehyde and polymixin B in the polio vaccine. At the time of this report, patient outcome was unknown. List of documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: IPV
Symptoms: Circumstance or information capable of leading to medication error, Exposure during pregnancy, Exposure via direct contact, Muscle tightness, Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a consumer on 12-Dec-2014. A 36 year old female patient, who was allergic to PCN, BENADRYL, Robitussin and concomitant medications were not reported had accidentally received a dose of IPOL (batch number, route of administration and site of administration were not reported) in here right eye on an unspecified date. It was reported that the female patient was holding her son when he was being vaccinated with IPOL. The needle was not on the syringe properly and it squirted out, splashing her in the right eye and the eye was rinsed. The patient consulting to physician and no injury were found on exam. On 12-Dec-2014, patient stated that since this occurred she developed tightness in her jaw on the right side, no pain or discomfort while taking or eating. The right shoulder was a little sore and the right side of her nose was more stuffy than usual. The patient felt this may be just due to all the stress and she has been under today. The patient was 17 weeks pregnant. Laboratory investigations and corrective treatments were not provided. At the time of this report, the patient had not recovered from the events. Documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: IPV
Symptoms: Nasal congestion
Clinical narrative: Initial unsolicited report received from a consumer on 12-Dec-2014. A 36 year old female patient, who was allergic to PCN, BENADRYL, Robitussin and concomitant medications were not reported had accidentally received a dose of IPOL (batch number, route of administration and site of administration were not reported) in here right eye on an unspecified date. It was reported that the female patient was holding her son when he was being vaccinated with IPOL. The needle was not on the syringe properly and it squirted out, splashing her in the right eye and the eye was rinsed. The patient consulting to physician and no injury were found on exam. On 12-Dec-2014, patient stated that since this occurred she developed tightness in her jaw on the right side, no pain or discomfort while taking or eating. The right shoulder was a little sore and the right side of her nose was more stuffy than usual. The patient felt this may be just due to all the stress and she has been under today. The patient was 17 weeks pregnant. Laboratory investigations and corrective treatments were not provided. At the time of this report, the patient had not recovered from the events. Documents held by sender: none.
Age: 50.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Hypoaesthesia, Hyporeflexia
Clinical narrative: The report had been received from a consumer via Vaccine Adverse Event Reporting System (VAERS). The report concerns a 50 years old male patient. The patient's medical history included headache, lethargy and back pain. The patient's concurrent disease included anxiety. The patient's wife and son had 'stomach bug' (gas, bloating, diarrhea) in mid December. Concomitant medications included trazodone. On 29-Dec-2004, the patient received FLUMIST (intranasal). 29-Dec-2004, he developed leg pain, weakness and numbness starting 01-Jan-2005. He was evaluated in PMP on 06-Jan-2005 and admitted w suspected onset of GBS. Exam revealed decreased reflexes and increased CSF protein. Final diagnosis: Guillain-Barre syndrome and spinal headache. He was evaluated and treated by neurologist given 4 courses of plasmapheresis, symptoms improved and was discharged home 13-Jan-2005 with outpatient rehab and Neuro followup. At the time of reporting, the event of Guillain Barre synd and spinal headache was ongoing. The event of spinal headache had been identified from the source document and added as an adverse event by the company physician. The previous events of myalgia, myasthenia and paraesthesia were omitted, because they are symptoms of Guillain Barre syndrome. According to the reporter the event of Guillain Barre syndrome was considered as serious with the serious criteria of hospitalization and the company physician considered the event of spinal headache to serious with the serious criteria of hospitalization. Summary of follow-up information received by AstraZeneca/MedImmune on 25-Feb-2015 from consumer via VAERS: new event of spinal headache added, event of myalgia, myasthenia and paraesthesia were omitted, because they are symptoms of Guillain Barre syndrome, event of Guillain Barre syndrome outcome updated, concomitant disease and relevant history added, narrative updated. Corrected report: FLUMIST route and formulation added, action taken with FLUMIST added, administered by added, other reporter deleted, case unsuppressed, narrative updated.
Age: 50.0
Sex: M
Vaccine: FLUN3
Symptoms: Pain in extremity, Plasmapheresis, Post lumbar puncture syndrome
Clinical narrative: The report had been received from a consumer via Vaccine Adverse Event Reporting System (VAERS). The report concerns a 50 years old male patient. The patient's medical history included headache, lethargy and back pain. The patient's concurrent disease included anxiety. The patient's wife and son had 'stomach bug' (gas, bloating, diarrhea) in mid December. Concomitant medications included trazodone. On 29-Dec-2004, the patient received FLUMIST (intranasal). 29-Dec-2004, he developed leg pain, weakness and numbness starting 01-Jan-2005. He was evaluated in PMP on 06-Jan-2005 and admitted w suspected onset of GBS. Exam revealed decreased reflexes and increased CSF protein. Final diagnosis: Guillain-Barre syndrome and spinal headache. He was evaluated and treated by neurologist given 4 courses of plasmapheresis, symptoms improved and was discharged home 13-Jan-2005 with outpatient rehab and Neuro followup. At the time of reporting, the event of Guillain Barre synd and spinal headache was ongoing. The event of spinal headache had been identified from the source document and added as an adverse event by the company physician. The previous events of myalgia, myasthenia and paraesthesia were omitted, because they are symptoms of Guillain Barre syndrome. According to the reporter the event of Guillain Barre syndrome was considered as serious with the serious criteria of hospitalization and the company physician considered the event of spinal headache to serious with the serious criteria of hospitalization. Summary of follow-up information received by AstraZeneca/MedImmune on 25-Feb-2015 from consumer via VAERS: new event of spinal headache added, event of myalgia, myasthenia and paraesthesia were omitted, because they are symptoms of Guillain Barre syndrome, event of Guillain Barre syndrome outcome updated, concomitant disease and relevant history added, narrative updated. Corrected report: FLUMIST route and formulation added, action taken with FLUMIST added, administered by added, other reporter deleted, case unsuppressed, narrative updated.
Age: 46.0
Sex: F
Vaccine: FLUN(H1N1), FLUN3
Symptoms: Burning sensation, Computerised tomogram, Confusional state, Diarrhoea, Guillain-Barre syndrome
Clinical narrative: A spontaneous report has been received from VAERS concerning a 46 years old male patient. The patient's medical history included diverticulitis, irritable bowel syndrome, bipolar disorder, gall bladder remove and surgery. The patient's concurrent disease included pneumonia. On 09-Nov-2009, patient received FLUMIST (intranasal) and on an unknown date H1N1 (intranasal). It was reported that patient had pain in legs moving upward throughout body within two days also affected hand movement. Leg paralysis leading to hospitalization. From then on headaches body spasms, burning sensation in extremities. Extreme Pain, confusion, nausea, diarrhea, unconfirmed diagnosis of GBS treated with pain medication and intravenous immunoglobulin. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter assessed the event of Guillain-Barre syndrome to be serious as hospitalization.
Age: 46.0
Sex: F
Vaccine: FLUN(H1N1), FLUN3
Symptoms: Headache, Immunoglobulin therapy, Lumbar puncture, Mobility decreased, Monoplegia
Clinical narrative: A spontaneous report has been received from VAERS concerning a 46 years old male patient. The patient's medical history included diverticulitis, irritable bowel syndrome, bipolar disorder, gall bladder remove and surgery. The patient's concurrent disease included pneumonia. On 09-Nov-2009, patient received FLUMIST (intranasal) and on an unknown date H1N1 (intranasal). It was reported that patient had pain in legs moving upward throughout body within two days also affected hand movement. Leg paralysis leading to hospitalization. From then on headaches body spasms, burning sensation in extremities. Extreme Pain, confusion, nausea, diarrhea, unconfirmed diagnosis of GBS treated with pain medication and intravenous immunoglobulin. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter assessed the event of Guillain-Barre syndrome to be serious as hospitalization.
Age: 46.0
Sex: F
Vaccine: FLUN(H1N1), FLUN3
Symptoms: Muscle spasms, Nausea, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: A spontaneous report has been received from VAERS concerning a 46 years old male patient. The patient's medical history included diverticulitis, irritable bowel syndrome, bipolar disorder, gall bladder remove and surgery. The patient's concurrent disease included pneumonia. On 09-Nov-2009, patient received FLUMIST (intranasal) and on an unknown date H1N1 (intranasal). It was reported that patient had pain in legs moving upward throughout body within two days also affected hand movement. Leg paralysis leading to hospitalization. From then on headaches body spasms, burning sensation in extremities. Extreme Pain, confusion, nausea, diarrhea, unconfirmed diagnosis of GBS treated with pain medication and intravenous immunoglobulin. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter assessed the event of Guillain-Barre syndrome to be serious as hospitalization.
Age: 46.0
Sex: F
Vaccine: FLUN(H1N1), FLUN3
Symptoms: X-ray
Clinical narrative: A spontaneous report has been received from VAERS concerning a 46 years old male patient. The patient's medical history included diverticulitis, irritable bowel syndrome, bipolar disorder, gall bladder remove and surgery. The patient's concurrent disease included pneumonia. On 09-Nov-2009, patient received FLUMIST (intranasal) and on an unknown date H1N1 (intranasal). It was reported that patient had pain in legs moving upward throughout body within two days also affected hand movement. Leg paralysis leading to hospitalization. From then on headaches body spasms, burning sensation in extremities. Extreme Pain, confusion, nausea, diarrhea, unconfirmed diagnosis of GBS treated with pain medication and intravenous immunoglobulin. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter assessed the event of Guillain-Barre syndrome to be serious as hospitalization.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Albumin globulin ratio increased, Blood alkaline phosphatase increased, Blood creatinine decreased, Blood phosphorus, CSF protein increased
Clinical narrative: This report to VAERS provides the following narrative: A spontaneous report had been received from FDA concerns a 16 year old, Male patient. The patient medical history and concomitant drugs were not reported. On unspecified date patient had been received FLUMIST (intranasal). The patient experienced Guillain-Barre syndrome. On an unspecified date the patient had blood creatinine decreased, CSF protein increased, CSF test abnormal, electromyogram abnormal, nerve conduction studies abnormal and protein total decreased. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter assessed the event of Guillain-Barre syndrome to be serious with seriousness criteria of Life threatening and Hospitalised.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: CSF test abnormal, CSF white blood cell count increased, Electromyogram abnormal, Guillain-Barre syndrome, Haematocrit decreased
Clinical narrative: This report to VAERS provides the following narrative: A spontaneous report had been received from FDA concerns a 16 year old, Male patient. The patient medical history and concomitant drugs were not reported. On unspecified date patient had been received FLUMIST (intranasal). The patient experienced Guillain-Barre syndrome. On an unspecified date the patient had blood creatinine decreased, CSF protein increased, CSF test abnormal, electromyogram abnormal, nerve conduction studies abnormal and protein total decreased. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter assessed the event of Guillain-Barre syndrome to be serious with seriousness criteria of Life threatening and Hospitalised.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Haemoglobin decreased, Mean cell haemoglobin decreased, Mean cell volume decreased, Monocyte percentage increased, Mycoplasma test positive
Clinical narrative: This report to VAERS provides the following narrative: A spontaneous report had been received from FDA concerns a 16 year old, Male patient. The patient medical history and concomitant drugs were not reported. On unspecified date patient had been received FLUMIST (intranasal). The patient experienced Guillain-Barre syndrome. On an unspecified date the patient had blood creatinine decreased, CSF protein increased, CSF test abnormal, electromyogram abnormal, nerve conduction studies abnormal and protein total decreased. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter assessed the event of Guillain-Barre syndrome to be serious with seriousness criteria of Life threatening and Hospitalised.
Age: 16.0
Sex: M
Vaccine: FLUN3
Symptoms: Nerve conduction studies abnormal, Neurological examination, Platelet count decreased, Protein total decreased, Red blood cell count decreased
Clinical narrative: This report to VAERS provides the following narrative: A spontaneous report had been received from FDA concerns a 16 year old, Male patient. The patient medical history and concomitant drugs were not reported. On unspecified date patient had been received FLUMIST (intranasal). The patient experienced Guillain-Barre syndrome. On an unspecified date the patient had blood creatinine decreased, CSF protein increased, CSF test abnormal, electromyogram abnormal, nerve conduction studies abnormal and protein total decreased. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter assessed the event of Guillain-Barre syndrome to be serious with seriousness criteria of Life threatening and Hospitalised.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal, Borrelia test negative, C-reactive protein normal
Clinical narrative: A report has been received from VAERS concerning a 7 years old male patient. The patient's medical history included VSD, aortic annulus dilatation and recurrent otitis media. Concomitant medications were not reported. On 08-Oct-2010, patient received FLUMIST (intranasal). It was reported that illness began 20 days after vaccine administration with headache, visual changes, progressive weakness, fatigue, and bilateral upper and lower extremity pain. The patient required hospitalization. Multiple labs including CSF studies were obtained as well as a brain and full spinal MRI. The patient was diagnosed with Guillain-Barre Syndrome on 28-Oct-2010, for which he received IVIG. He had required pain control, NG feedings, and physical rehabilitation. He was currently still admitted at Hospital for rehab. Patient had laboratory investigation as initial CBC, CRP, CMP, CK all within normal limits. CSF showed elevated protein (52), normal glucose, normal gram stain, no growth on culture. Negative UA. Negative Enterovirus, HSV, Mycoplasma, EBV, West Nile virus, Lyme serology. Normal T4, TSH. Normal ESR. Repeat CSF studies showed elevated protein (73), normal glucose, gram stain. CSF culture no growth. CT head normal. MRI brain normal. MRI thoracic and cervical spine normal. MRI lumbar spine with enhancement of anterior nerve roots. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter considered the event of Guillain-Barre syndrome to be serious due to hospitalization and Required emergency room/doctor visit. Laboratory values and diagnostic test details are available.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: CSF culture negative, CSF glucose normal, CSF protein increased, Computerised tomogram head, Computerised tomogram normal
Clinical narrative: A report has been received from VAERS concerning a 7 years old male patient. The patient's medical history included VSD, aortic annulus dilatation and recurrent otitis media. Concomitant medications were not reported. On 08-Oct-2010, patient received FLUMIST (intranasal). It was reported that illness began 20 days after vaccine administration with headache, visual changes, progressive weakness, fatigue, and bilateral upper and lower extremity pain. The patient required hospitalization. Multiple labs including CSF studies were obtained as well as a brain and full spinal MRI. The patient was diagnosed with Guillain-Barre Syndrome on 28-Oct-2010, for which he received IVIG. He had required pain control, NG feedings, and physical rehabilitation. He was currently still admitted at Hospital for rehab. Patient had laboratory investigation as initial CBC, CRP, CMP, CK all within normal limits. CSF showed elevated protein (52), normal glucose, normal gram stain, no growth on culture. Negative UA. Negative Enterovirus, HSV, Mycoplasma, EBV, West Nile virus, Lyme serology. Normal T4, TSH. Normal ESR. Repeat CSF studies showed elevated protein (73), normal glucose, gram stain. CSF culture no growth. CT head normal. MRI brain normal. MRI thoracic and cervical spine normal. MRI lumbar spine with enhancement of anterior nerve roots. The outcome of the event of Guillain-Barre syndrome was unknown. Reporter considered the event of Guillain-Barre syndrome to be serious due to hospitalization and Required emergency room/doctor visit. Laboratory values and diagnostic test details are available.