chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Arthralgia, Fatigue, Hypersensitivity, Inflammatory marker increased, Insomnia
Clinical narrative: Case number PHEH2015US021398 is an initial spontaneous report received from a consumer (patient's husband) on 19 Oct 2015. This report refers to a 64 year old female patient. Past medical history and concomitant medications were not reported. There was a bat in patient's house and hence the doctor recommended vaccination for protection in the event the patient was bitten. Her vaccination history included three dose of post exposure RABAVERT (batch number: 556011A (for first and second dose), 559011A (for third dose) on unknown dates following which she experienced fatigue, tiredness and needles poking on her skin (see related case numbers: PHEH2015US022072, PHEH2015US022073 and PHEH2015US022074). She received fourth dose of RABAVERT (batch number: 559011A) on an unspecified date. On an unknown date after vaccination, she experienced fatigue and was really tired after the injection. She felt like she had needles poking on her skin throughout the day. She also experienced right ankle and hand swelling which were very painful, right foot spasms at night, body stiffness, soreness of shoulder that woke her up at night and body soreness due to which she could not turn over in bed. She stated that it was so painful that she could not sleep. She had tight and burning muscles in her body. She also had swelling (unspecified). She had an emergency room visit in Aug 2015 in which she was told that she had an allergic reaction to the vaccine and she was asked to take ADVIL for pain. Her symptoms did not improve and hence she went to health care professional's (HCP) office in Aug 2015 where she was diagnosed with rheumatoid arthritis based on her inflammatory test. She was informed by the nurse in the office that RABAVERT can create false positive rheumatoid arthritis results. The final outcome of the events was not reported. The events were reported as disabling. The causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Joint swelling, Laboratory test abnormal, Mobility decreased, Muscle spasms, Muscle tightness
Clinical narrative: Case number PHEH2015US021398 is an initial spontaneous report received from a consumer (patient's husband) on 19 Oct 2015. This report refers to a 64 year old female patient. Past medical history and concomitant medications were not reported. There was a bat in patient's house and hence the doctor recommended vaccination for protection in the event the patient was bitten. Her vaccination history included three dose of post exposure RABAVERT (batch number: 556011A (for first and second dose), 559011A (for third dose) on unknown dates following which she experienced fatigue, tiredness and needles poking on her skin (see related case numbers: PHEH2015US022072, PHEH2015US022073 and PHEH2015US022074). She received fourth dose of RABAVERT (batch number: 559011A) on an unspecified date. On an unknown date after vaccination, she experienced fatigue and was really tired after the injection. She felt like she had needles poking on her skin throughout the day. She also experienced right ankle and hand swelling which were very painful, right foot spasms at night, body stiffness, soreness of shoulder that woke her up at night and body soreness due to which she could not turn over in bed. She stated that it was so painful that she could not sleep. She had tight and burning muscles in her body. She also had swelling (unspecified). She had an emergency room visit in Aug 2015 in which she was told that she had an allergic reaction to the vaccine and she was asked to take ADVIL for pain. Her symptoms did not improve and hence she went to health care professional's (HCP) office in Aug 2015 where she was diagnosed with rheumatoid arthritis based on her inflammatory test. She was informed by the nurse in the office that RABAVERT can create false positive rheumatoid arthritis results. The final outcome of the events was not reported. The events were reported as disabling. The causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHEH2015US021398 is an initial spontaneous report received from a consumer (patient's husband) on 19 Oct 2015. This report refers to a 64 year old female patient. Past medical history and concomitant medications were not reported. There was a bat in patient's house and hence the doctor recommended vaccination for protection in the event the patient was bitten. Her vaccination history included three dose of post exposure RABAVERT (batch number: 556011A (for first and second dose), 559011A (for third dose) on unknown dates following which she experienced fatigue, tiredness and needles poking on her skin (see related case numbers: PHEH2015US022072, PHEH2015US022073 and PHEH2015US022074). She received fourth dose of RABAVERT (batch number: 559011A) on an unspecified date. On an unknown date after vaccination, she experienced fatigue and was really tired after the injection. She felt like she had needles poking on her skin throughout the day. She also experienced right ankle and hand swelling which were very painful, right foot spasms at night, body stiffness, soreness of shoulder that woke her up at night and body soreness due to which she could not turn over in bed. She stated that it was so painful that she could not sleep. She had tight and burning muscles in her body. She also had swelling (unspecified). She had an emergency room visit in Aug 2015 in which she was told that she had an allergic reaction to the vaccine and she was asked to take ADVIL for pain. Her symptoms did not improve and hence she went to health care professional's (HCP) office in Aug 2015 where she was diagnosed with rheumatoid arthritis based on her inflammatory test. She was informed by the nurse in the office that RABAVERT can create false positive rheumatoid arthritis results. The final outcome of the events was not reported. The events were reported as disabling. The causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Peripheral swelling, Rheumatoid arthritis, Swelling, Vaccination complication
Clinical narrative: Case number PHEH2015US021398 is an initial spontaneous report received from a consumer (patient's husband) on 19 Oct 2015. This report refers to a 64 year old female patient. Past medical history and concomitant medications were not reported. There was a bat in patient's house and hence the doctor recommended vaccination for protection in the event the patient was bitten. Her vaccination history included three dose of post exposure RABAVERT (batch number: 556011A (for first and second dose), 559011A (for third dose) on unknown dates following which she experienced fatigue, tiredness and needles poking on her skin (see related case numbers: PHEH2015US022072, PHEH2015US022073 and PHEH2015US022074). She received fourth dose of RABAVERT (batch number: 559011A) on an unspecified date. On an unknown date after vaccination, she experienced fatigue and was really tired after the injection. She felt like she had needles poking on her skin throughout the day. She also experienced right ankle and hand swelling which were very painful, right foot spasms at night, body stiffness, soreness of shoulder that woke her up at night and body soreness due to which she could not turn over in bed. She stated that it was so painful that she could not sleep. She had tight and burning muscles in her body. She also had swelling (unspecified). She had an emergency room visit in Aug 2015 in which she was told that she had an allergic reaction to the vaccine and she was asked to take ADVIL for pain. Her symptoms did not improve and hence she went to health care professional's (HCP) office in Aug 2015 where she was diagnosed with rheumatoid arthritis based on her inflammatory test. She was informed by the nurse in the office that RABAVERT can create false positive rheumatoid arthritis results. The final outcome of the events was not reported. The events were reported as disabling. The causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Arthralgia, Arthritis, Condition aggravated, Discomfort, Fatigue
Clinical narrative: Case number PHEH2015US021398 is an initial spontaneous report received from a consumer (patient's husband) on 19 Oct 2015. This report refers to a 64 year old female patient. Past medical history and concomitant medications were not reported. There was a bat in patient's house and hence the doctor recommended vaccination for protection in the event the patient was bitten. Her vaccination history included three dose of post exposure RABAVERT (batch number: 556011A (for first and second dose), 559011A (for third dose) on unknown dates following which she experienced fatigue, tiredness and needles poking on her skin (see related case numbers: PHEH2015US022072, PHEH2015US022073 and PHEH2015US022074). She received fourth dose of RABAVERT (batch number: 559011A) on an unspecified date. On an unknown date after vaccination, she experienced fatigue and was really tired after the injection. She felt like she had needles poking on her skin throughout the day. She also experienced right ankle and hand swelling which were very painful, right foot spasms at night, body stiffness, soreness of shoulder that woke her up at night and body soreness due to which she could not turn over in bed. She stated that it was so painful that she could not sleep. She had tight and burning muscles in her body. She also had swelling (unspecified). She had an emergency room visit in Aug 2015 in which she was told that she had an allergic reaction to the vaccine and she was asked to take ADVIL for pain. Her symptoms did not improve and hence she went to health care professional's (HCP) office in Aug 2015 where she was diagnosed with rheumatoid arthritis based on her inflammatory test. She was informed by the nurse in the office that RABAVERT can create false positive rheumatoid arthritis results. The final outcome of the events was not reported. The events were reported as disabling. The causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Musculoskeletal stiffness
Clinical narrative: Case number PHEH2015US021398 is an initial spontaneous report received from a consumer (patient's husband) on 19 Oct 2015. This report refers to a 64 year old female patient. Past medical history and concomitant medications were not reported. There was a bat in patient's house and hence the doctor recommended vaccination for protection in the event the patient was bitten. Her vaccination history included three dose of post exposure RABAVERT (batch number: 556011A (for first and second dose), 559011A (for third dose) on unknown dates following which she experienced fatigue, tiredness and needles poking on her skin (see related case numbers: PHEH2015US022072, PHEH2015US022073 and PHEH2015US022074). She received fourth dose of RABAVERT (batch number: 559011A) on an unspecified date. On an unknown date after vaccination, she experienced fatigue and was really tired after the injection. She felt like she had needles poking on her skin throughout the day. She also experienced right ankle and hand swelling which were very painful, right foot spasms at night, body stiffness, soreness of shoulder that woke her up at night and body soreness due to which she could not turn over in bed. She stated that it was so painful that she could not sleep. She had tight and burning muscles in her body. She also had swelling (unspecified). She had an emergency room visit in Aug 2015 in which she was told that she had an allergic reaction to the vaccine and she was asked to take ADVIL for pain. Her symptoms did not improve and hence she went to health care professional's (HCP) office in Aug 2015 where she was diagnosed with rheumatoid arthritis based on her inflammatory test. She was informed by the nurse in the office that RABAVERT can create false positive rheumatoid arthritis results. The final outcome of the events was not reported. The events were reported as disabling. The causality of the events was not reported.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Blood heavy metal test, Blood test, Cognitive disorder, Hypoaesthesia, Laboratory test
Clinical narrative: Initial unsolicited report received from a consumer on 19 October 2015. This case involves a 52-years-old male patient who was vaccinated with a dose of Flu shot (manufacturer: unknown, batch number: UI260AA, dose, dose in series, expiry date, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient was diagnosed with acute disseminated encephalomyelitis (ADEM). Laboratory data and corrective treatment were not reported. The case was considered serious due to events that were immediately life threatening, caused permanent or significant disability/incapacity and due to intervention required to prevent permanent impairment or damage. The patient was not recovered from the event. List of documents held by sender: none.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Physical disability
Clinical narrative: Initial unsolicited report received from a consumer on 19 October 2015. This case involves a 52-years-old male patient who was vaccinated with a dose of Flu shot (manufacturer: unknown, batch number: UI260AA, dose, dose in series, expiry date, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient was diagnosed with acute disseminated encephalomyelitis (ADEM). Laboratory data and corrective treatment were not reported. The case was considered serious due to events that were immediately life threatening, caused permanent or significant disability/incapacity and due to intervention required to prevent permanent impairment or damage. The patient was not recovered from the event. List of documents held by sender: none.
Age: 52.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Initial unsolicited report received from a consumer on 19 October 2015. This case involves a 52-years-old male patient who was vaccinated with a dose of Flu shot (manufacturer: unknown, batch number: UI260AA, dose, dose in series, expiry date, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient was diagnosed with acute disseminated encephalomyelitis (ADEM). Laboratory data and corrective treatment were not reported. The case was considered serious due to events that were immediately life threatening, caused permanent or significant disability/incapacity and due to intervention required to prevent permanent impairment or damage. The patient was not recovered from the event. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: HPV4, FLU3, HEPA, HPV4, MNQ
Symptoms: Electrocardiogram normal, Palpitations, Tachycardia
Clinical narrative: Information has been received from a father via a company representative referring to his 17 year old male son. No pertinent or historical conditions were reported. On approximately 17-SEP-2015 (reported as approximately 6 weeks ago), the patient was administered an unspecified dose in the series of GARDASIL 9 or GARDASIL (strength, dose and route unknown). There was no concomitant medication reported. A few weeks after the vaccination, the patient experienced heart palpitations, the patient stated it felt like it was beating out of his chest. The father said the palpitations "come and go" and the patient was seen by his physician for an electrocardiogram and a "cardiac work up", the results were not reported. The outcome of thee vent was unknown. The causality between this event and GARDASIL 9 or GARDASIL was unknown. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, FLU3, HEPA, HPV4, MNQ
Symptoms: Cardiac function test, Electrocardiogram, Palpitations
Clinical narrative: Information has been received from a father via a company representative referring to his 17 year old male son. No pertinent or historical conditions were reported. On approximately 17-SEP-2015 (reported as approximately 6 weeks ago), the patient was administered an unspecified dose in the series of GARDASIL 9 or GARDASIL (strength, dose and route unknown). There was no concomitant medication reported. A few weeks after the vaccination, the patient experienced heart palpitations, the patient stated it felt like it was beating out of his chest. The father said the palpitations "come and go" and the patient was seen by his physician for an electrocardiogram and a "cardiac work up", the results were not reported. The outcome of thee vent was unknown. The causality between this event and GARDASIL 9 or GARDASIL was unknown. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Started with noticing some hives were appearing on my upper body. By late in the evening, I was starting to have aches and pains.  I woke up this morning (11/1) with a bad headache which stayed with me off and on throughout the day.  I noticed that since this morning, my body seems to be getting more stiff.  I checked the injection site this afternoon and the redness and swelling are continuing to get worse.  The spot is a little larger than the palm of my hand and is continuing to grow. The hives seem to be lessening and there were very few to begin with. My head still hurts, as does just about every muscle in my body.  I have the chills too. I have a vaccination every year and this is the first time I've had a reaction.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Pain, Urticaria
Clinical narrative: Started with noticing some hives were appearing on my upper body. By late in the evening, I was starting to have aches and pains.  I woke up this morning (11/1) with a bad headache which stayed with me off and on throughout the day.  I noticed that since this morning, my body seems to be getting more stiff.  I checked the injection site this afternoon and the redness and swelling are continuing to get worse.  The spot is a little larger than the palm of my hand and is continuing to grow. The hives seem to be lessening and there were very few to begin with. My head still hurts, as does just about every muscle in my body.  I have the chills too. I have a vaccination every year and this is the first time I've had a reaction.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test positive, Biopsy skin abnormal, Hypersensitivity, Pruritus, Rash
Clinical narrative: Hives, itching, rash.  Met with Dermatologist, Allergist, and Primary Care Physician.  Ran allergy tests.  Nothing came back.  Going on 5 weeks now and still constant itching and rash not controlled by any anti-histamine.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives, itching, rash.  Met with Dermatologist, Allergist, and Primary Care Physician.  Ran allergy tests.  Nothing came back.  Going on 5 weeks now and still constant itching and rash not controlled by any anti-histamine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection: sore, swollen, red, Itchy, warm. Rash?
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Oropharyngeal pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Aching muscles, low fever (99 degrees), sore and swollen throat.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: FEVER, SWELLING, REDNESS. 3 DAYS AFTER VACCINATION, THE PATIENT PRESENTED TO PHARMACY WITH REACTION. PATIENT STATED THAT SYMPTOMS HAVE IMPROVED SINCE VACCINATION DATE. TREATMENT: TYLENOL, COLD PACK.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Soreness and difficulty moving arm where vaccine was administered starting 9/20/15 and continuing through office visit 10/30/15. Pain in shoulder and upper arm with raising arm. Potentially SIRVA.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Apnoea, Bradycardia, Mechanical ventilation, Oxygen saturation decreased
Clinical narrative: 10/28 at 1202 received PREVNAR. 10/29 at 0300 received DTAP - Hepatitis B - IPV (PEDIARIX). 10/29 at 1407 received PEDVAX HIB. On 10/28 was on room air, weaned off High flow nasal cannula at 1021 am, was on caffeine and had no events, on 10/29 am had some quick desats but self recovered and continued till 2043 when had apnea, bradycardia and desat which required PPV.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus, Rash, Vomiting
Clinical narrative: Pruritis approx. 3 hours after immunization followed by rash over trunk and then arms, legs. Tingling in hands and feet approx. 12 hr after immunization followed by vomiting.
Age: 31.0
Sex: M
Vaccine: FLUN4
Symptoms: Headache, Vomiting
Clinical narrative: Headache with profuse vomiting. 1 episode every half hour until controlled with 4mg Zofran. All sx lasted 30 hours.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Burning sensation, Erythema, Pruritus, Swelling
Clinical narrative: Swelling, redness, burning, hardness, then itching.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Asthma, Condition aggravated, Dyspnoea, Respiratory distress
Clinical narrative: This medically confirmed spontaneous report (initial receipt 19-Oct-2015) concerns a patient (unknown demographics) who was not pregnant and required a rescue inhaler "once in a blue moon". On 16-Oct-2015, the patient received Afluria (Influenza virus vaccine polyvalent, batch number U55106) 0.5mL via the intramuscular route for the prevention of influenza. On 16-Oct-2015, the patient developed respiratory distress after receiving Afluria. 12 hours after receiving the vaccine, the patient had difficulty breathing and required a PRN (when required) albuterol nebulizer treatment and a rescue inhaler. This treatment helped the patient, in which the symptoms resolved in less than 24 hours. The outcome was recovered. Reporter's Comments: Reporter's comments: The reporter considered the events related to Afluria. Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, respiratory distress is unlisted. Causality: Possible. Time to onset is same day of vaccination. Past history of suspected asthma as patient required inhaler occasionally. Respiratory symptoms responded to and resolved with nebulised bronchodilator within 24 hours is suggestive of asthma exacerbation which is plausible following vaccination.  Influenza vaccination causally attributable due to temporal association and no other triggers specified.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Bone pain, Chills, Dyspnoea, Fatigue, Feeling cold
Clinical narrative: This medically confirmed spontaneous report (initial receipt 19-Oct-2015) concerns a patient (unknown demographics) who was not pregnant and required a rescue inhaler "once in a blue moon". On 16-Oct-2015, the patient received Afluria (Influenza virus vaccine polyvalent, batch number U55106) 0.5mL via the intramuscular route for the prevention of influenza. On 16-Oct-2015, the patient developed respiratory distress after receiving Afluria. 12 hours after receiving the vaccine, the patient had difficulty breathing and required a PRN (when required) albuterol nebulizer treatment and a rescue inhaler. This treatment helped the patient, in which the symptoms resolved in less than 24 hours. The outcome was recovered. Reporter's Comments: Reporter's comments: The reporter considered the events related to Afluria. Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, respiratory distress is unlisted. Causality: Possible. Time to onset is same day of vaccination. Past history of suspected asthma as patient required inhaler occasionally. Respiratory symptoms responded to and resolved with nebulised bronchodilator within 24 hours is suggestive of asthma exacerbation which is plausible following vaccination.  Influenza vaccination causally attributable due to temporal association and no other triggers specified.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Headache, Mechanical ventilation, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt 19-Oct-2015) concerns a patient (unknown demographics) who was not pregnant and required a rescue inhaler "once in a blue moon". On 16-Oct-2015, the patient received Afluria (Influenza virus vaccine polyvalent, batch number U55106) 0.5mL via the intramuscular route for the prevention of influenza. On 16-Oct-2015, the patient developed respiratory distress after receiving Afluria. 12 hours after receiving the vaccine, the patient had difficulty breathing and required a PRN (when required) albuterol nebulizer treatment and a rescue inhaler. This treatment helped the patient, in which the symptoms resolved in less than 24 hours. The outcome was recovered. Reporter's Comments: Reporter's comments: The reporter considered the events related to Afluria. Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, respiratory distress is unlisted. Causality: Possible. Time to onset is same day of vaccination. Past history of suspected asthma as patient required inhaler occasionally. Respiratory symptoms responded to and resolved with nebulised bronchodilator within 24 hours is suggestive of asthma exacerbation which is plausible following vaccination.  Influenza vaccination causally attributable due to temporal association and no other triggers specified.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt 19-Oct-2015) concerns a patient (unknown demographics) who was not pregnant and required a rescue inhaler "once in a blue moon". On 16-Oct-2015, the patient received Afluria (Influenza virus vaccine polyvalent, batch number U55106) 0.5mL via the intramuscular route for the prevention of influenza. On 16-Oct-2015, the patient developed respiratory distress after receiving Afluria. 12 hours after receiving the vaccine, the patient had difficulty breathing and required a PRN (when required) albuterol nebulizer treatment and a rescue inhaler. This treatment helped the patient, in which the symptoms resolved in less than 24 hours. The outcome was recovered. Reporter's Comments: Reporter's comments: The reporter considered the events related to Afluria. Sender's Comments: Company comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the Afluria PI, respiratory distress is unlisted. Causality: Possible. Time to onset is same day of vaccination. Past history of suspected asthma as patient required inhaler occasionally. Respiratory symptoms responded to and resolved with nebulised bronchodilator within 24 hours is suggestive of asthma exacerbation which is plausible following vaccination.  Influenza vaccination causally attributable due to temporal association and no other triggers specified.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: EE had her shingles vaccine on 10-26-15. She states two days later she had red area at injection site that was firm and warm to touch. She indicated the size to be approx. 3-4 cm in diameter. She states she was too busy to report it at the time. The only symptom she has now is it is still a "little itchy" at time. No visual symptoms to report.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient broke out on hives all over her body.  It was very itchy.  She calmed down after a dose of Zyrtec, but the hives come back after the meds wear off.  Patient has never had hives before.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Injection site was itchy.  After I scratched at the site, the lymph nodes in the left underarm (near the site) began to hurt and swell.  The lymph node swelling is still present, as well as the injection site swelling.  I am using acetaminophen and generic Allegra to control the symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Erythema, Injection site swelling, Local reaction, Local swelling, Skin warm
Clinical narrative: Local reaction.  Red, swollen, warm to touch.  Swelling from injection site to the elbow.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth that has spread.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Her arm is very sore and she can't move it above her head.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient had localized reaction that mother reported looked like a "welt". Mother denied any other signs and symptoms at this time. Nurse consulted Immunization Consultant. Nurse instructed mother to bring patient in to Health Department so nurse could observe reaction. Patient and mother came to Health Department at approximately 3:00 pm. At site of Varicella injection, patient's arm had developed redness, itching and approx. a quarter size area of swelling. Area of swelling was warm to touch. Nurse educated mother to take patient to urgent care so physician could assess site. Nurse asked mother to sign release at urgent care and have report of visit faxed to HD. Per report Urgent Care physician assistant treated patient by prescribing cool compresses as needed and OTC Benadryl 25-50mg PO q6hrs as needed for itching. Nurse spoke with patient's mother on Monday November 2, 2015 at 10:35 am, mother of patient reported that symptoms have resolved and no further adverse events occurred over the weekend.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient had localized reaction that mother reported looked like a "welt". Mother denied any other signs and symptoms at this time. Nurse consulted Immunization Consultant. Nurse instructed mother to bring patient in to Health Department so nurse could observe reaction. Patient and mother came to Health Department at approximately 3:00 pm. At site of Varicella injection, patient's arm had developed redness, itching and approx. a quarter size area of swelling. Area of swelling was warm to touch. Nurse educated mother to take patient to urgent care so physician could assess site. Nurse asked mother to sign release at urgent care and have report of visit faxed to HD. Per report Urgent Care physician assistant treated patient by prescribing cool compresses as needed and OTC Benadryl 25-50mg PO q6hrs as needed for itching. Nurse spoke with patient's mother on Monday November 2, 2015 at 10:35 am, mother of patient reported that symptoms have resolved and no further adverse events occurred over the weekend.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Chest pain, Hypoaesthesia, Middle insomnia
Clinical narrative: AIN - Anterior Interosseus Neuropathy - Parsonage Turner Syndrome. Tested by facility over several weeks to determine the AIN with Electrical needle measurements - painful arm, sharp back pain (like knife in shoulder) & chest, 50% loss of pinching strength between thumb and first two index fingers. Numbness in fore arm. Weakness spread at time progressed. Waking up several times a night with severe arm pain, sometime chest pain.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Neuralgic amyotrophy, Neurological examination abnormal, Neuropathy peripheral, Pain in extremity
Clinical narrative: AIN - Anterior Interosseus Neuropathy - Parsonage Turner Syndrome. Tested by facility over several weeks to determine the AIN with Electrical needle measurements - painful arm, sharp back pain (like knife in shoulder) & chest, 50% loss of pinching strength between thumb and first two index fingers. Numbness in fore arm. Weakness spread at time progressed. Waking up several times a night with severe arm pain, sometime chest pain.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: X-ray
Clinical narrative: AIN - Anterior Interosseus Neuropathy - Parsonage Turner Syndrome. Tested by facility over several weeks to determine the AIN with Electrical needle measurements - painful arm, sharp back pain (like knife in shoulder) & chest, 50% loss of pinching strength between thumb and first two index fingers. Numbness in fore arm. Weakness spread at time progressed. Waking up several times a night with severe arm pain, sometime chest pain.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red raised area around injection site.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Respiratory failure, Shock
Clinical narrative: Reported Possible Anaphylaxis, possible respiratory failure and shock. Client was evaluated at Emergency Room and another Hospital.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: 10/20/15 Vaccine administered in the PM. 10/31/15: Around 8-9AM when pt woke up, she had a tender red area "the size of a baseball" at the vaccinated area. 11/1/15: Redness was widened to 5"x4".
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Frequent bowel movements, Tremor
Clinical narrative: Pt received shot at 12 PM 10/23/15 and woke up with chills, shaking, upset stomach and more than normal bowel "movement", not previously know to be adverse effects from vaccine.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site pain, Joint range of motion decreased, X-ray
Clinical narrative: "Severe pain and inflammation" at injection site (left deltoid). Pt went to urgent care referred to orthopedics, received x-rays, states "no range of motion.
Age: 95.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Soreness in left arm in the area of flu shot. Started within 3 days of vaccination.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Nasal congestion, Ocular hyperaemia, Pruritus, Vision blurred
Clinical narrative: Received flu shot 10/30/15 at 4:30p: Between 7:30p and 9p  - c/o coughing sensation, blurred vision, bloodshot eyes and itching, nasal congestion. By morning recovered.
Age: 67.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at inj site back of RT arm. Noticed swelling and redness 2 days after imm given. Area of redness 2 inches wide and 2 1/2 inches long warm to touch (top to bottom).
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Dyskinesia, Fall
Clinical narrative: Pt. received a Flu vaccine in (L) arm and approximately 5-7 mins later, while writing on a chalkboard, she fell and had 1-2 tonic jerks (she fell on a padded surface). When I reached the room, she was alert and spoke to me (1-2mins later) PE wnl.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Differential white blood cell count, Flushing, Full blood count, Metabolic function test
Clinical narrative: Patient presented to the ER having had several episodes of feeling shaky and flushed throughout the day. Spiked temp. Temp in ER 101. Empirically placed on Amoxicillin 500 mg po TID x 7 days due to myelodysplastic syndrome. Advised to avoid flu shots in the future.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Myelodysplastic syndrome, Nervousness, Pyrexia, Urine analysis
Clinical narrative: Patient presented to the ER having had several episodes of feeling shaky and flushed throughout the day. Spiked temp. Temp in ER 101. Empirically placed on Amoxicillin 500 mg po TID x 7 days due to myelodysplastic syndrome. Advised to avoid flu shots in the future.
Age: 47.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis of right arm.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis of arm.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Anti-cyclic citrullinated peptide antibody, Arthralgia, Blood immunoglobulin M, Blood thyroid stimulating hormone, C-reactive protein
Clinical narrative: Multiple joint pain starting around 12-13 hrs following vaccine. Joint pain persists to present date. Symptoms staying the same or slightly worse. Associated joint redness and swelling. Treatment MEDROL dose pack, PERCOCET QHS PRN.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Full blood count, Joint swelling, Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Multiple joint pain starting around 12-13 hrs following vaccine. Joint pain persists to present date. Symptoms staying the same or slightly worse. Associated joint redness and swelling. Treatment MEDROL dose pack, PERCOCET QHS PRN.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Rheumatoid factor
Clinical narrative: Multiple joint pain starting around 12-13 hrs following vaccine. Joint pain persists to present date. Symptoms staying the same or slightly worse. Associated joint redness and swelling. Treatment MEDROL dose pack, PERCOCET QHS PRN.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Had redness and swelling 2.5" diameter at area of shot. Was itchy and painful. MOTRIN/TYLENOL.
Age: 1.07
Sex: M
Vaccine: FLU3, HEPA, PNC13
Symptoms: Urticaria
Clinical narrative: Urticaria started day after vaccines.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient experienced pain in arm vaccine was administered. Patient also did not have full range of motion in arm.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: Nausea, chills, fever, sweats, myalgias, fatigue, red/hot/firm/swollen at immunization site.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea, chills, fever, sweats, myalgias, fatigue, red/hot/firm/swollen at immunization site.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Flu shot arm very tender and a little swollen--painful enough that patient went to the emergency room for assessment.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular, Rash pruritic, Skin warm
Clinical narrative: 2 pinkish blotches around bicep/tricep area way below deltoid/area of injection.  Onset about 12 hours after injection and lasted about 2-3 days.  Blotches/rash were a little itchy, hot to touch, and about 2-3 inches in diameter.  Denied fever.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neuralgia, X-ray limb
Clinical narrative: Pain in upper left arm across the shoulder that appears to become from the nerve ( neurophatic pain). Over the course of the day the pain increasingly persisted. I went to the doctor for treatment on 10/27/2015 & 10/30/2015.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site hypoaesthesia
Clinical narrative: After flu shot administered to right upper arm, upper arm, neck and face on right is numb.  Still has not gone away but has subsided some.  Did not seek treatment.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Pain
Clinical narrative: Soreness in upper right arm. Can be sharply painful on certain activity such as opening door.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Nausea, Syncope
Clinical narrative: Pt received FLUVIRIN PFS vaccine, within 5 mins fainted in store. Pt reported to be dizzy and felt like throwing up and was hot, 911 was called. She was breathing fine and no symptoms of anaphylaxis when paramedics arrived.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (Lot # K011801, expiry date: 21-AUG-2016) (Incorrect product storage). No adverse events reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2 inch diameter area of redness and swelling of entire thigh.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Mobility decreased, Neuralgic amyotrophy
Clinical narrative: Felt soreness at sight, L deltoid, immediately after injection, thought pain would improve, it did not.  It worsened kept her up at night and limited ROM.  Treated with ibuprofen, naproxyn, diagnosed with brachial plexitis and after 6 weeks still having some pain but improved.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Arm with shot hurts I can not lift it. Pain is bad redness around shoulder. Joint pain as well as muscle.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Arm with shot hurts I can not lift it. Pain is bad redness around shoulder. Joint pain as well as muscle.
Age: 19.0
Sex: F
Vaccine: FLUN4, IPV, TYP, YF
Symptoms: Erythema, Pruritus
Clinical narrative: Localized redness/itching.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling, pain.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Injection site scar, Injection site vesicles
Clinical narrative: Developed blister and scar around the injection area.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Computerised tomogram head normal, Diplopia, Electrocardiogram normal, Eye movement disorder, Laboratory test normal
Clinical narrative: Received flu shot and was driving home when about 30 min later, I developed double vision. Was sent to ER when doctors thought it was my brain tumors growing. Had a CT and MRI of brain which shown tumors weren't growing. Sent home after EKG and labs were good. Double vision continued and right became crooked and turned inward and vision worsen. Given steroids and symptoms cleared about an hour later. Then returned on and off during weekend. Continue on steroids.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging brain normal, Visual impairment
Clinical narrative: Received flu shot and was driving home when about 30 min later, I developed double vision. Was sent to ER when doctors thought it was my brain tumors growing. Had a CT and MRI of brain which shown tumors weren't growing. Sent home after EKG and labs were good. Double vision continued and right became crooked and turned inward and vision worsen. Given steroids and symptoms cleared about an hour later. Then returned on and off during weekend. Continue on steroids.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's Palsy, R-sided.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Serious arm and shoulder pain- could not lift arm.
Age: 19.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Broke out in hives 11/1/15.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Heart rate increased, Nausea, Pruritus
Clinical narrative: Itching, elevated heart rate, rash, difficulty breathing and swallowing, nausea.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Itching, elevated heart rate, rash, difficulty breathing and swallowing, nausea.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This case concerns a 48 year-old female patient who received AFLURIA IM (lot 01549211A) at right deltoid on 09-SEP-2009 at 07:40. The patient was not ill at the time of vaccination. The patient has a medical history of controlled hypertension. No concomitant medications were provided. On 09-SEP-2009 after AFLURIA was started, the patient developed a hard red hot area around the injection site. Per the reporter, the patient has recovered from the event. The reporter considered events as non-serious. No further information is expected.  ADDENDUM: 24-sep-2009: Patient is not pregnant. Batch Review Result received on 02-NOV-2009. Batch number: 01549211AS. Result: In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported. 19-AUG-2013: Case reported to unflag the insignificant change in case approval field as the corrections made previously were medically significant, age group changed back to blank in the patient field, core unlisted for all the event changed back to blank in the vaccine relatedness field, company causality was entered as possible (per the narrative) in the company seriousness field, core unlisted was changed to unlisted int he company seriousness field, new event added in the adverse event field "hard (red spot) around the injection site". 18-JUN-2015: This case was reopened and the listedness of the individual events were reviewed. This activity was carried out as part of the company's commitant to the MHRA to improve quality and consistency of company safety database. Listedness: Listed (according to the CSI Inactivated Influenza Virus Vaccine CCDS and AFLURIA US PI).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: Patient received FLUZONE HD Thursday 10/8/15 in the early afternoon. By Friday 10/9/15 in the evening, patient started to develop a rash on her left neck/top of left shoulder area. By Saturday 10/10/15, rash spread to front of chest and continued to spread to front torso area. Patient went to a clinic which prescribed her triamcinolone 0.1% cream. Patient stated that rash cleared up by Thurs 10/15/15.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Death, Dyspnoea, Pyrexia
Clinical narrative: On or about 10/2/15 the pneumonia shot was administered. On 10/11/15 he began to have difficulty breathing and spiked a fever. He was transported to the hospital and treated with antibiotics and oxygen.
Age: 52.0
Sex: F
Vaccine: FLUN4
Symptoms: Lumbar puncture, Meningitis viral
Clinical narrative: Pt states 2 days after vaccine (FLUMIST) she contracted viral meningitis. Was hospitalized for 11 days.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 6 cm raised red injection site, hot. No tx - warm compresses PRN.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Heart rate increased, Pyrexia, Tremor
Clinical narrative: 5 hours after shot had fever/chills/shaking/fast heartbeat for 4-5 hours. Did not go to doctor's office. Pt was fine by the morning except for being tired.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Antinuclear antibody positive, Borrelia test negative, Cytomegalovirus test negative, Electrocardiogram normal, Epstein-Barr virus test negative
Clinical narrative: Pt received FLUVIRIN on 8-30-15. On 9-21-15 he was seen/tx/admitted 5 days for presumed viral transverse myelitis.