chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Chills, Dysarthria, Eye pruritus, Facial paralysis
Clinical narrative: Got the flu shot on 9-15-15 by the afternoon he complained having chills and body ache. 9-16-15 was unable to go to work he felt tired and body ache. 9-17-15 unable to go to work he had fever all night. 9-18-15 around 2:00 am woke up throwing up unable to get out of bed unable to hold a towel with right arm very weak rushed him to ER he was treated for a stroke we told ER dr. he had just got flu shot to check for virus he got released same day with right arm total paralyzed. 9-21-15 Primary dr referred him to have steroids pak and labs and see neurologist. 9-23-15 neurologist prescribed Methylprednisolone (MEDROL Pak) 4 mg oral dose. 9-25-15 due to his pain on his shoulder and back gabapentin 600 three times a day and consider referral for output IV SOLUMEDROL treatment. 9-21-15 went to ER with neck pain Monoplegia right arm. Weakness of left arm. Bilat brachial plexopathy. Discharged same day. I mentioned the flu shot again to check for virus due to his slurred speech and neck pain per nurse note RUE paralysis; LUE plus 4/5 strength slow speech and slightly slurred he is diaphoretic. Neurologist gave SOLUMEDROL 1 gram IV and arranged 2 more infusion he was identified as high risk for fall due to his weakness both arms and body, brain MRI normal. MRI c-spine normal diagnosed with brachial plexitis. 9-30-15 ER 3rd time lazy left eye blinking and itching left lip drooping lumbar puncture was done at 1:20 pm MRI brain w/wo contrast was admitted for 5 days today March 13 2017 with no diagnose first diagnose west nile and when I ask neurologist how he was based and if he was going to report it he said he was not sure now he said he doesn't know my husband is going to therapy acupuncture, is helping his right arm still paralyzed unable to move. Per neurologist it will take time to recuperate 100% or he can diagnose him with permanent disable. I called to report to CDC they took all the information and never hear from them. My husband still gets cramps on his shoulder and neck and gets tire he back to work light duties unable to move his right arm.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Hyperhidrosis, Impaired work ability, Lumbar puncture, Mobility decreased
Clinical narrative: Got the flu shot on 9-15-15 by the afternoon he complained having chills and body ache. 9-16-15 was unable to go to work he felt tired and body ache. 9-17-15 unable to go to work he had fever all night. 9-18-15 around 2:00 am woke up throwing up unable to get out of bed unable to hold a towel with right arm very weak rushed him to ER he was treated for a stroke we told ER dr. he had just got flu shot to check for virus he got released same day with right arm total paralyzed. 9-21-15 Primary dr referred him to have steroids pak and labs and see neurologist. 9-23-15 neurologist prescribed Methylprednisolone (MEDROL Pak) 4 mg oral dose. 9-25-15 due to his pain on his shoulder and back gabapentin 600 three times a day and consider referral for output IV SOLUMEDROL treatment. 9-21-15 went to ER with neck pain Monoplegia right arm. Weakness of left arm. Bilat brachial plexopathy. Discharged same day. I mentioned the flu shot again to check for virus due to his slurred speech and neck pain per nurse note RUE paralysis; LUE plus 4/5 strength slow speech and slightly slurred he is diaphoretic. Neurologist gave SOLUMEDROL 1 gram IV and arranged 2 more infusion he was identified as high risk for fall due to his weakness both arms and body, brain MRI normal. MRI c-spine normal diagnosed with brachial plexitis. 9-30-15 ER 3rd time lazy left eye blinking and itching left lip drooping lumbar puncture was done at 1:20 pm MRI brain w/wo contrast was admitted for 5 days today March 13 2017 with no diagnose first diagnose west nile and when I ask neurologist how he was based and if he was going to report it he said he was not sure now he said he doesn't know my husband is going to therapy acupuncture, is helping his right arm still paralyzed unable to move. Per neurologist it will take time to recuperate 100% or he can diagnose him with permanent disable. I called to report to CDC they took all the information and never hear from them. My husband still gets cramps on his shoulder and neck and gets tire he back to work light duties unable to move his right arm.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Monoplegia, Muscle spasms, Muscular weakness, Musculoskeletal pain, Neck pain
Clinical narrative: Got the flu shot on 9-15-15 by the afternoon he complained having chills and body ache. 9-16-15 was unable to go to work he felt tired and body ache. 9-17-15 unable to go to work he had fever all night. 9-18-15 around 2:00 am woke up throwing up unable to get out of bed unable to hold a towel with right arm very weak rushed him to ER he was treated for a stroke we told ER dr. he had just got flu shot to check for virus he got released same day with right arm total paralyzed. 9-21-15 Primary dr referred him to have steroids pak and labs and see neurologist. 9-23-15 neurologist prescribed Methylprednisolone (MEDROL Pak) 4 mg oral dose. 9-25-15 due to his pain on his shoulder and back gabapentin 600 three times a day and consider referral for output IV SOLUMEDROL treatment. 9-21-15 went to ER with neck pain Monoplegia right arm. Weakness of left arm. Bilat brachial plexopathy. Discharged same day. I mentioned the flu shot again to check for virus due to his slurred speech and neck pain per nurse note RUE paralysis; LUE plus 4/5 strength slow speech and slightly slurred he is diaphoretic. Neurologist gave SOLUMEDROL 1 gram IV and arranged 2 more infusion he was identified as high risk for fall due to his weakness both arms and body, brain MRI normal. MRI c-spine normal diagnosed with brachial plexitis. 9-30-15 ER 3rd time lazy left eye blinking and itching left lip drooping lumbar puncture was done at 1:20 pm MRI brain w/wo contrast was admitted for 5 days today March 13 2017 with no diagnose first diagnose west nile and when I ask neurologist how he was based and if he was going to report it he said he was not sure now he said he doesn't know my husband is going to therapy acupuncture, is helping his right arm still paralyzed unable to move. Per neurologist it will take time to recuperate 100% or he can diagnose him with permanent disable. I called to report to CDC they took all the information and never hear from them. My husband still gets cramps on his shoulder and neck and gets tire he back to work light duties unable to move his right arm.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Pain, Pyrexia, Scan with contrast
Clinical narrative: Got the flu shot on 9-15-15 by the afternoon he complained having chills and body ache. 9-16-15 was unable to go to work he felt tired and body ache. 9-17-15 unable to go to work he had fever all night. 9-18-15 around 2:00 am woke up throwing up unable to get out of bed unable to hold a towel with right arm very weak rushed him to ER he was treated for a stroke we told ER dr. he had just got flu shot to check for virus he got released same day with right arm total paralyzed. 9-21-15 Primary dr referred him to have steroids pak and labs and see neurologist. 9-23-15 neurologist prescribed Methylprednisolone (MEDROL Pak) 4 mg oral dose. 9-25-15 due to his pain on his shoulder and back gabapentin 600 three times a day and consider referral for output IV SOLUMEDROL treatment. 9-21-15 went to ER with neck pain Monoplegia right arm. Weakness of left arm. Bilat brachial plexopathy. Discharged same day. I mentioned the flu shot again to check for virus due to his slurred speech and neck pain per nurse note RUE paralysis; LUE plus 4/5 strength slow speech and slightly slurred he is diaphoretic. Neurologist gave SOLUMEDROL 1 gram IV and arranged 2 more infusion he was identified as high risk for fall due to his weakness both arms and body, brain MRI normal. MRI c-spine normal diagnosed with brachial plexitis. 9-30-15 ER 3rd time lazy left eye blinking and itching left lip drooping lumbar puncture was done at 1:20 pm MRI brain w/wo contrast was admitted for 5 days today March 13 2017 with no diagnose first diagnose west nile and when I ask neurologist how he was based and if he was going to report it he said he was not sure now he said he doesn't know my husband is going to therapy acupuncture, is helping his right arm still paralyzed unable to move. Per neurologist it will take time to recuperate 100% or he can diagnose him with permanent disable. I called to report to CDC they took all the information and never hear from them. My husband still gets cramps on his shoulder and neck and gets tire he back to work light duties unable to move his right arm.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Slow speech, Vomiting
Clinical narrative: Got the flu shot on 9-15-15 by the afternoon he complained having chills and body ache. 9-16-15 was unable to go to work he felt tired and body ache. 9-17-15 unable to go to work he had fever all night. 9-18-15 around 2:00 am woke up throwing up unable to get out of bed unable to hold a towel with right arm very weak rushed him to ER he was treated for a stroke we told ER dr. he had just got flu shot to check for virus he got released same day with right arm total paralyzed. 9-21-15 Primary dr referred him to have steroids pak and labs and see neurologist. 9-23-15 neurologist prescribed Methylprednisolone (MEDROL Pak) 4 mg oral dose. 9-25-15 due to his pain on his shoulder and back gabapentin 600 three times a day and consider referral for output IV SOLUMEDROL treatment. 9-21-15 went to ER with neck pain Monoplegia right arm. Weakness of left arm. Bilat brachial plexopathy. Discharged same day. I mentioned the flu shot again to check for virus due to his slurred speech and neck pain per nurse note RUE paralysis; LUE plus 4/5 strength slow speech and slightly slurred he is diaphoretic. Neurologist gave SOLUMEDROL 1 gram IV and arranged 2 more infusion he was identified as high risk for fall due to his weakness both arms and body, brain MRI normal. MRI c-spine normal diagnosed with brachial plexitis. 9-30-15 ER 3rd time lazy left eye blinking and itching left lip drooping lumbar puncture was done at 1:20 pm MRI brain w/wo contrast was admitted for 5 days today March 13 2017 with no diagnose first diagnose west nile and when I ask neurologist how he was based and if he was going to report it he said he was not sure now he said he doesn't know my husband is going to therapy acupuncture, is helping his right arm still paralyzed unable to move. Per neurologist it will take time to recuperate 100% or he can diagnose him with permanent disable. I called to report to CDC they took all the information and never hear from them. My husband still gets cramps on his shoulder and neck and gets tire he back to work light duties unable to move his right arm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Vaccination site inflammation, Vaccination site swelling
Clinical narrative: MOTHER NOTICED AREAS WHERE VACCINES WERE GIVEN WERE RED, SWOLLEN AND INFLAMED. PARENT CALLED NURSE ADVICE LINE AND WAS TOLD TO TAKE CHILD TO AN URGENT CARE CENTER FOR EVALUATION. MOTHER RETURNS CALL TODAY TO GIVE UPDATE ON PATIENT'S CONDITION. AREAS ON BOTH LEGS ARE DIMINISHED IN SIZE. THERE IS STILL A QUARTER SIZED AREA ON PATIENT'S LEFT THIGH WHERE THE PROQUAD WAS GIVEN. MOTHER IS USING BENADRYL, ZYRTEC, AND CALAMINE LOTION TO AFFECTED AREAS.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Dizziness, Head discomfort, Malaise, Somnolence
Clinical narrative: Full head, groogy, dizzy, sick feeling.
Age: 64.0
Sex: M
Vaccine: YF
Symptoms: Haematospermia, Malaise, Pyrexia, Rash erythematous
Clinical narrative: Reported developing fever, generalized malaise, full body erythematous non-itchy rash which resolved with Benadryl. Also, one episode of blood in his semen.
Sex: M
Vaccine: PPV
Symptoms: Joint swelling, Skin irritation
Clinical narrative: This spontaneous report was received from an unspecified person via Henry Schein Inc and refers to two patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (lot # M038359, expiration date: 13-MAY-2018) for prophylaxis. On an unknown date, the patients experienced major swelling in their left elbow area and irritation. Both patients were given antibiotic to reduce swelling. No other medical attention was required and the patients were fine at the time of the report. The outcome of the events was not reported. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself.  A female patient of an unspecified age received PREVNAR 13 at 0.5 ml single in Mar2017 for immunisation. Patient stated that she had burning when pneumococcal 13-val conj vaccine went in; in Mar2017 she also had soreness in her arm and there was big redness and swelling in the arm (arm was a little bit flared up) . She had no fatigue, anaphylactic shock or anything like that. The patient's medical history and concomitant medications were not reported. The final outcome of the events was unknown.
Age: 32.0
Sex: M
Vaccine: YF
Symptoms: Swelling face, Throat irritation
Clinical narrative: Facial swelling and throat itchiness.
Age: 64.0
Sex: F
Vaccine: YF
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: Reported Fever, Fatigue, general malaise. Could not get out of bed due to fatigue. Symptoms lasted less than 48 hours and resolved on own with no sequelae.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Death
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history included unspecified kidney problems. No information regarding the patient's drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of unspecified pneumococcal vaccine (manufacturer unknown) (dose, route and site of administration, lot # and expiry date were not reported). Other suspect vaccines included influenza virus vaccine (unspecified) (date, dose, route and site of administration, lot # and expiry date were not reported). Concomitant therapies included ENBREL. On an unknown date, the patient was hospitalized for an unknown reason. The outcome of the event leading to hospitalization was not reported. On an unknown date, the patient died due to an unspecified cause. The relatedness between the events and pneumococcal vaccine (manufacturer unknown) and influenza virus vaccine (unspecified) was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M028551, expiration date: 07-JUN-2018) (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion more then (>) 5 degrees Fahrenheit but less then (<)14 degrees Fahrenheit for 1 hour. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA002294:
Sex: M
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report was received from a physician via Pfizer and refers to a currently 62-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (strength, dose, frequency, route of administration, lot#, expiry date and indication were not reported).       On an unknown date, the patient experienced allergy to ZOSTAVAX. The outcome of the event was not reported. The reporter considered allergy to be related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age an gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown date in March 2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, lot# and expiration date were not reported) for prophylaxis. On 04-MAR-2017, the patient was vaccinated with a second dose of ZOSTAVAX subcutaneously, lot # M035148, expiration date 25-OCT-2017 (dose was not reported) for prophylaxis.  No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-MAR-2017, the patient was vaccinated with M-M-R II (dose, route of administration, lot# and expiration date were not reported) that was reconstituted with Sodium Chloride instead of sterile diluent. No adverse effects were reported. No product quality complaint (PQC) was involved.    Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Limb discomfort, Myalgia
Clinical narrative: This is a spontaneous report from a contactable office manager (non-HCP).  A 71-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot S15227, Expiration Date 01Feb2018, NDC number 0005-1971-02) intramuscular in right deltoid on 27Feb2017 13:30 at 0.5 ml, single for immunisation . The patient medical history was not reported. Concomitant medication included fluticasone, lisinopril, xantofyl (LUTEIN), ascorbic acid (VITAMIN C), ergocalciferol (VITAMIN D) , fish oil, tocopherol (OMEGA 3), ascorbic acid, biotin, calcium, calcium pantothenate, colecalciferol, copper, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ergocalciferol, ferrous fumarate, folic acid, iodine, iron, magnesium, magnesium oxide, manganese, manganese sulfate, nicotinamide, pantothenic acid, phosphorus, potassium, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, zinc, zinc sulfate (CENTRUM), ubidecarenone (COQ-10), carbidopa, levodopa (SINEMET), tocopherol (VITAMIN E). The patient experienced muscle ache in her thighs, her back and her upper arms (both arms) and she felt like she had weights on her thighs on an unspecified date.  Therapeutic measures as a result of muscle ache in her thighs, her back and her upper arms (both arms) included taking some ADVIL. The outcome of the events was unknown.
Sex: F
Vaccine: DTAP
Symptoms: Anaphylactic reaction, Respiratory distress, Throat tightness, Wheezing
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the above reference who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 11-year-old female patient had received an injection of Tdap vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and while driving home from the pediatricians, she developed anaphylaxis with symptoms of throat tightness, wheezing and respiratory distress. Corrective treatments consisted of epinephrine. The patient had a history of asthma, and milk allergy demonstrated by vomiting after milk-based formula as an infant and angioedema of hands after contact with spilled milk at one year of age. Laboratory testing showed the patient had increased IgE levels (96.1) within two years of vaccination. Outcome was not reported. Follow-up information received 24 August 2011 from a physician who stated that they did not administer the vaccine to the patient. The patient was vaccinated by their primary physician; therefore, the reporter was unable to provide information pertaining to the name of the vaccine manufacturer, lot number, site and exact date of administration, symptom duration and stop dates/times, and specific medication dates and dosages received as treatment. No additional information was provided at the time of the report. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, 2011-03275, 2011-03276, 2011-03277, 2011-03278, 2011-03280 and 2011-03281. Documents held by sender: None Follow up information received from literature (via physician) on 06-MAR-2017. This case found duplicate of 2016SA073846. Hence case 2016SA073846 was deleted. Documents held by sender: None; Sender's Comments: Follow-up information received on 06-Mar-2017, amends the medical assessment as follows: This case concerns a 11-years-old female patient who was vaccinated with a booster dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and experienced anaphylaxis with symptoms of throat tightness, wheezing and respiratory distress while driving home from pediatrician's clinic. Time to onset is compatible with the role of vaccine. The patient had an underlying allergic condition which may increase the chance to trigger the reported events by many other allergens. Further information on medical history including birth history, immune status at the time of vaccination, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Sex: F
Vaccine: FLU4
Symptoms: Cough, Influenza, Influenza virus test positive, Pneumonia, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of vaccination failure in a female patient who received Influenza vaccine Quadrivalent. Co-suspect products included VENTOLIN HFA inhaler (batch number Unknown, expiry date unknown) for exercise induced asthma and BREO ELLIPTA inhalation powder for cough. Concurrent medical conditions included exercise induced asthma. In November 2016, the patient received Influenza vaccine Quadrivalent. On an unknown date, the patient started VENTOLIN HFA (inhaled) 1 puff as needed and BREO ELLIPTA at an unknown dose and frequency. In February 2017, 91 days after receiving Influenza vaccine Quadrivalent and not applicable after starting VENTOLIN HFA and BREO ELLIPTA, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the patient experienced pneumonia (serious criteria GSK medically significant), cough and off label use. The patient was treated with prednisone. The action taken with VENTOLIN HFA was unknown. The action taken with BREO ELLIPTA was unknown. On an unknown date, the outcome of the vaccination failure, influenza, pneumonia, cough and off label use were unknown. It was unknown if the reporter considered the vaccination failure, influenza, pneumonia and cough to be related to Influenza vaccine Quadrivalent. It was unknown if the reporter considered the influenza, pneumonia and cough to be related to VENTOLIN HFA. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient was taking VENTOLIN for years. In Feb 2017, approximately 3 months after receiving Influenza vaccine Quadrivalent the patient experienced influenza. The influenza was diagnosed by a nasal swab. Less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced pneumonia and cough. After recovering from the flu, the patient developed a cough that was initially treated with one week of prednisone. After the patient completed the prednisone, the cough came back and the patient started taking BREO ELLIPTA to treat the cough, which led to off label use as the BREO ELLIPTA was not indicated to treat cough.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Nodule, Pruritus, Skin warm, Swelling
Clinical narrative: Pt has a significant knot in her arm which is slightly warm to the touch and around 4  inches in diameter. She has slight itching at the time of vaccination, but swelling came up approximately 4 hours after injection.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: No Adverse Reaction At Time of Administration. Patient's parents deny any adverse reaction at 3:00pm of 3/20/2017.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Haemoglobin normal, Petechiae, Platelet count decreased, Rash, White blood cell count normal
Clinical narrative: Petechial rash on legs and shoulders.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A 16-month-old male patient of an unspecified race received PREVNAR 13 on unknown date at single dose for immunization. The patient medical history and concomitant medications were not reported. 7 days later was diagnosed with pneumonia. He had a fever a 104.9.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: DTAP
Symptoms: Anaphylactic reaction, Flushing, Respiratory distress, Wheezing
Clinical narrative: Initial report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the above reference who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A 17-year-old male patient had received an injection of Tdap vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and within 20 minutes after vaccination, he developed anaphylaxis with symptoms of wheezing, respiratory distress, and flushing of the face and neck. Corrective treatments consisted of epinephrine. The patient had a history of asthma, and milk allergy demonstrated by hives, lip and tongue swelling, diarrhea and abdominal pain at four years of age. Laboratory testing showed the patient had increased IgE levels (>100) within two years of vaccination. Outcome was not reported. Follow-up information received 24 August 2011 from a physician who stated that they did not administer the vaccine to the patient. The patient was vaccinated by their primary physician; therefore, the reporter was unable to provide information pertaining to the name of the vaccine manufacturer, lot number, site and exact date of administration, symptom duration and stop dates/times, and specific medication dates and dosages received as treatment. No additional information was provided at the time of the report. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03272, 2011-03275, 2011-03276, 2011-03277, 2011-03278, 2011-03279 and 2011-03280. Follow up report received from a physician on 06 March 2017. This case was found duplicate of case number 2016SA073853. Hence, case 2016SA073853 was deleted. No further information was received. List of documents held by sender: none.; Sender's Comments: Follow-up information received on 06-Mar-2017, amends the medical assessment as follows: This case concerns a 17-years-old male patient who was vaccinated with a booster dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and experienced anaphylaxis with symptoms of wheezing, respiratory distress and flushing of face and neck within 20 minutes. Time to onset is compatible with the role of vaccine. The patient had an underlying allergic condition which may increase the chance to trigger the reported events by many other allergens. Further information on immune status at the time of vaccination, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Platelet count decreased, Pyrexia, White blood cell count decreased
Clinical narrative: Patient reported developing a fever and feeling fatigue approximately two weeks following vaccine administration. These symptoms she reports continue until today, approximately 39 days from when the vaccine was administered. She followed up with her doctor and reported to us that follow up tests found her to have Low Platelets and Low WBC counts, that are continue to be low.
Age: 76.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: RASH AND RAISED RED AREA APPROXIMATELY 2INCHES BY 1 INCH AROUND INJECTION SITE.
Age: 1.5
Sex: F
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left redness and swollen, slightly warm to touch. Redness extended past knee.
Age: 36.0
Sex: F
Vaccine: HEP, HEPA, PPV, TDAP
Symptoms: Eyelid oedema, Urticaria
Clinical narrative: Hive around abdomen area, eyelid swelling.
Age: 42.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Itching and burning at site of injection. Stinging also and redness light headache. Headache could be due to sinus infection as well though?
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cyanosis, Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: 6 weeks  old found unresponsive by foster parents at 1230 PM. Cyanotic and CPR initiated- brought to ED via ambulance, patient transferred. Now deceased. Coroner's office.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt's arm was swelled, red, purple in color, tender, warm to touch, half of upper arm.
Age: 55.0
Sex: F
Vaccine: PPV, VARCEL, PPV, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Varicella Vaccine but the order was for Zoster. Not noted until after patient left facility when documentation was being added to EMR. Provider notified pt notified.
Age: 55.0
Sex: F
Vaccine: PPV, VARCEL, PPV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given Varicella Vaccine but the order was for Zoster. Not noted until after patient left facility when documentation was being added to EMR. Provider notified pt notified.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Given PCV13 on 14 Mar 2017, saw PCM on 20 Mar 2017 (today)- 15x19cm region of erythema of left arm without rubor, non-tender, no lymphadenopathy, appears as site reaction to vaccine and unlikely cellulitis given the size of involvement and absence of pain, lymphadenopathy, and warmth on clinical exam.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Limb discomfort, Mobility decreased, Musculoskeletal pain, Paraesthesia, Tenderness
Clinical narrative: Pt stated the onset of severe pain in shoulder and inability to lift arm "as if it was heavy". Some tingling pain radiating down arm to hand. Nurse recommended applying ice to area and followed up next day. Pt stated that sx had improved however arm was still tender in one location.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Pt had an injection site reaction with itching and a small bump.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Vomiting
Clinical narrative: EMPLOYEE INTITIALLY FELT LIGHT HEADED AFTER VACCINE ADMINISTRATION. LIGHT HEADEDNESS RESOLVED AND EMPLOYEE STATED SHE FELT FINE. EMPLOYEE WENT TO BATHROOM WHERE EMPLOYEE VOMITTED X2. EMPLOYEE THEN SAT DOWN IN BREAK ROOM AND STATED SHE FELT LIGHT HEADED AND DIZZY. EMPLOYEE TREATMENT CONSISTED OF APPLYING COLD WATER TO NECK AND TAKING VITALS AT 06:20PM. EMPLOYEE PULSE WAS 85 AND BLOOD PRESSURE 137/102 RESPIRATIONS 16 PER MINUTE UNLABORED. EMPLOYEE RESTED FOR APPROXIMATELY 20 MINUTES AND HAD NO FURTHER COMPLAINTS EMPLOYEE STATES SHE DID TAKE HER BLOOD PRESSURE MEDICINE TODAY.
Age: 41.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Joint range of motion decreased, Pain in extremity, Sleep disorder
Clinical narrative: Pt stated that in the middle of the night (14th), her arm became very painful and tender, to the point that it woke her up. Proceeded to be very tender to the touch and decreased ROM all day of the 15th. Reports large irregular redness pattern on arm. Denies tingling and numbness. Returned to office on 03/16 with continuing sx. Diagnosed with cellulitis. Given cephalexin (500 mg BID) and instructed to inform us if sx worsen or do not improve.
Age: 41.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Tenderness
Clinical narrative: Pt stated that in the middle of the night (14th), her arm became very painful and tender, to the point that it woke her up. Proceeded to be very tender to the touch and decreased ROM all day of the 15th. Reports large irregular redness pattern on arm. Denies tingling and numbness. Returned to office on 03/16 with continuing sx. Diagnosed with cellulitis. Given cephalexin (500 mg BID) and instructed to inform us if sx worsen or do not improve.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Reddened area at site of injection. It is neither raised, hot to the touch nor itchy nor sore.The area is only red and patient was concerned.
Age: 19.0
Sex: F
Vaccine: ANTH, HEP, JEV1, SMALL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Patient vaccinated with Anthrax, JEV, smallpox, and Hep B on 14March 2017. On 19March, patient found out she was pregnant with home pregnancy test. On 20March, pregnancy verified by HCG qual. Pt indicated she was not / could not be pregnant on pre-vaccine questionnaires.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site urticaria, Local reaction, Urticaria
Clinical narrative: Large local reaction to MMRV approx. noticed 3 days ago (3-10-17). Left upper arm and on abdomen and hives on back. BENADRYL 4 times a day for 2 days.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Swelling
Clinical narrative: Had dizziness, mild swelling, abdominal pain after HPV 2-3 hrs ago.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, itching, redness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: 2/16/17 Child (R) deltoid erythema 6x8cm warm, swollen, st. tender-no d/c. DTP Vaccine reaction local.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt. presented approximately 3 hours after injecting FLUVIRIN and PNEUMOVAX 23 in same arm. Pt. was experiencing redness/swelling/pain at injection site. Was referred to local ED for examination. Patient was given diphenhydramine at pharmacy.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Swelling
Clinical narrative: Right swelling approximately 1 wk after and resolved after 2 weeks.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Irritability, Tenderness
Clinical narrative: 3/15/17- redness (2cm) and swelling (R) arm at site of VARIVAX inj. /gf and fussy, sensitive to touch. treating w/ cephalexin to cover possible cellulitis.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Previously received flu shot 11/11/16. Duplicate flu shot given 3/17/17. No adverse reaction noted.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: 48 hours after vaccine administration mom called with pt's symptoms of red rash below injection site at time of visit (3/17/17) pt presented with 17 x 12 cm erythematous, indurated, warm, slightly tender area to left upper arm. Treatment: TYLENOL/ibuprofen as needed and heat as needed.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Rash erythematous
Clinical narrative: 48 hours after vaccine administration mom called with pt's symptoms of red rash below injection site at time of visit (3/17/17) pt presented with 17 x 12 cm erythematous, indurated, warm, slightly tender area to left upper arm. Treatment: TYLENOL/ibuprofen as needed and heat as needed.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fever for 24 hours after injection. Arm red and hot to touch with tenderness in left deltoid region.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood test, Chest pain, Erythema, Fatigue
Clinical narrative: After receiving the pneumonia vaccine on March 9th, the next day (March 10th) I noticed a raised red area on the underside of my arm. Over the weekend, I began having slight chest pains, achy joints, especially in my hips, back, and shoulders. By Tuesday, March 14th, I was very congested and coughing up/blowing out yellow mucus. On the 15th, I called my doctor and was prescribed medication to help get rid of the infection. After starting the medication, my headaches started to decrease in intensity but, I began experiencing laryngitis. By Saturday the 18th, I continued to have body aches, nausea, mild headaches, and extreme fatigue. Consequently, I sought out medical attention again. This time, I was told to keep taking the medication for the next 3 days and come back if my symptoms worsened. This was a potentially dangerous side effect for me because I was diagnosed with sickle cell at two years of age. In addition, I just recently had pneumonia back in early January so I was afraid that I would be back in the hospital again.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Laryngitis, Nausea, Pain, Peripheral swelling
Clinical narrative: After receiving the pneumonia vaccine on March 9th, the next day (March 10th) I noticed a raised red area on the underside of my arm. Over the weekend, I began having slight chest pains, achy joints, especially in my hips, back, and shoulders. By Tuesday, March 14th, I was very congested and coughing up/blowing out yellow mucus. On the 15th, I called my doctor and was prescribed medication to help get rid of the infection. After starting the medication, my headaches started to decrease in intensity but, I began experiencing laryngitis. By Saturday the 18th, I continued to have body aches, nausea, mild headaches, and extreme fatigue. Consequently, I sought out medical attention again. This time, I was told to keep taking the medication for the next 3 days and come back if my symptoms worsened. This was a potentially dangerous side effect for me because I was diagnosed with sickle cell at two years of age. In addition, I just recently had pneumonia back in early January so I was afraid that I would be back in the hospital again.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Productive cough, Respiratory tract congestion, Sputum discoloured
Clinical narrative: After receiving the pneumonia vaccine on March 9th, the next day (March 10th) I noticed a raised red area on the underside of my arm. Over the weekend, I began having slight chest pains, achy joints, especially in my hips, back, and shoulders. By Tuesday, March 14th, I was very congested and coughing up/blowing out yellow mucus. On the 15th, I called my doctor and was prescribed medication to help get rid of the infection. After starting the medication, my headaches started to decrease in intensity but, I began experiencing laryngitis. By Saturday the 18th, I continued to have body aches, nausea, mild headaches, and extreme fatigue. Consequently, I sought out medical attention again. This time, I was told to keep taking the medication for the next 3 days and come back if my symptoms worsened. This was a potentially dangerous side effect for me because I was diagnosed with sickle cell at two years of age. In addition, I just recently had pneumonia back in early January so I was afraid that I would be back in the hospital again.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to the left thigh.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Rash at injection site, starting 3 days after injection.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Rash Lt. leg 2 days after immunizations. Spread to abdomen. Appears to be itchy.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Nausea and unable to move arm x 3 days regaining movement of arm.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Extra dose administered
Clinical narrative: Client given third dose of BEXSERO.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Nausea, Pain
Clinical narrative: Pain and redness at injection site followed by body aches, head aches, nausea, fever, vomiting starting approx 2 hours after vaccines administered treated with TAMIFLU and TYLENOL. Pt to return to clinic in one week.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pain and redness at injection site followed by body aches, head aches, nausea, fever, vomiting starting approx 2 hours after vaccines administered treated with TAMIFLU and TYLENOL. Pt to return to clinic in one week.
Sex: U
Vaccine: MNQ
Symptoms: Facial paralysis
Clinical narrative: This case was reported in a literature article and described the occurrence of facial palsy in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, 1 day after receiving Meningococcal ACWY-CRM vaccine, the subject developed facial palsy. Serious criteria included GSK medically significant. The outcome of facial palsy was unknown. It was unknown if the investigator considered the facial palsy to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of idiopathic facial nerve palsy in a patient aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (32), Tdap (776) and HPV (608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (43)]. On an unspecified date, between 1-21 days after vaccination, the patient developed idiopathic facial nerve palsy. The case met the definition of Brighton level 1. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between the event idiopathic facial nerve palsy and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 valid cases in the same literature article.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen, Vaginal haemorrhage
Clinical narrative: This spontaneous report was received from a registered nurse referring to a female patient of unknown age. Information about concomitant medication and medical history was not provided. On 07-OCT-2016, the patient was vaccinated with GARDASIL 9 (lot # M009378, expiry date: 23-APR-2018) for prophylaxis (vaccine exposure during pregnancy). On 22-FEB-2017, the patient performed ultrasound due to vaginal bleeding which was started from an unknown date. The ultrasound showed that the patient was pregnant "25 weeks and 1 day". The patient became pregnant with last menstrual date: 16-AUG-2016 (estimate due date: 23-MAY-2017).  The outcome of vaginal bleeding was unknown. The causality between vaginal bleeding and GARDASIL 9 was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to multiple unspecified patients. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L036301, expiration date 20-DEC-2017) via intramuscular injection for prophylaxis. No adverse effect was reported. No product quality complaint (PQC) was involved. The vaccine was stored in temperature between 46 degrees Fahrenheit and 77 degrees Fahrenheit for 5 hours and 50 minutes. "Data logger" was involved and there was no previous temperature excursion. This is one of several reports from the some source. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA009130: US-009507513-1703USA009129: