chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MEN
Symptoms: Death
Clinical narrative: Pt passed away in her sleep on 8-22-13 per MDs. Still waiting for autopsy results and cause of death is unknown. Pt received HPV and MENACTRA vaccines 2 weeks prior to death.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MEN
Symptoms: Autopsy, Death
Clinical narrative: Pt passed away in her sleep on 8-22-13 per MDs. Still waiting for autopsy results and cause of death is unknown. Pt received HPV and MENACTRA vaccines 2 weeks prior to death.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MEN
Symptoms: Fatigue, Headache, Pain in extremity, Vomiting
Clinical narrative: Pt passed away in her sleep on 8-22-13 per MDs. Still waiting for autopsy results and cause of death is unknown. Pt received HPV and MENACTRA vaccines 2 weeks prior to death.
Age: 5.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Abasia, Aphasia, Asthenia, Computerised tomogram head, Dyskinesia
Clinical narrative: Patient presented with increased choreiform movements (significantly different from her baseline choreiform movements) several hours after receiving the nasal FLUMIST vaccination. She has never has this type of vaccination in the past. Several hours after receiving the vaccination, parents noted that her gait became extremely abnormal. She was unable to stand up and could not keep her balance. Her arms and legs were also flinging around and the patient states she could not control her movements. Patient was admitted to the hospital for evaluation and monitoring of choreiform movements and seizure-like activity. Patient was discharged on 09/10/2013 as gait had returned to normal and she was cleared from a neurological standpoint.
Age: 5.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Fear, Gait disturbance, Laboratory test, Loss of control of legs, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient presented with increased choreiform movements (significantly different from her baseline choreiform movements) several hours after receiving the nasal FLUMIST vaccination. She has never has this type of vaccination in the past. Several hours after receiving the vaccination, parents noted that her gait became extremely abnormal. She was unable to stand up and could not keep her balance. Her arms and legs were also flinging around and the patient states she could not control her movements. Patient was admitted to the hospital for evaluation and monitoring of choreiform movements and seizure-like activity. Patient was discharged on 09/10/2013 as gait had returned to normal and she was cleared from a neurological standpoint.
Age: 5.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Balance disorder, Chorea, Computerised tomogram head normal, Condition aggravated, Dyskinesia
Clinical narrative: Patient presented with increased choreiform movements (significantly different from her baseline choreiform movements) several hours after receiving the nasal FLUMIST vaccination. She has never has this type of vaccination in the past. Several hours after receiving the vaccination, parents noted that her gait became extremely abnormal. She was unable to stand up and could not keep her balance. Her arms and legs were also flinging around and the patient states she could not control her movements. Patient was admitted to the hospital for evaluation and monitoring of choreiform movements and seizure-like activity. Patient was discharged on 09/10/2013 as gait had returned to normal and she was cleared from a neurological standpoint.
Age: 5.0
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: Dysstasia, Gait disturbance, Nuclear magnetic resonance imaging normal, Seizure like phenomena
Clinical narrative: Patient presented with increased choreiform movements (significantly different from her baseline choreiform movements) several hours after receiving the nasal FLUMIST vaccination. She has never has this type of vaccination in the past. Several hours after receiving the vaccination, parents noted that her gait became extremely abnormal. She was unable to stand up and could not keep her balance. Her arms and legs were also flinging around and the patient states she could not control her movements. Patient was admitted to the hospital for evaluation and monitoring of choreiform movements and seizure-like activity. Patient was discharged on 09/10/2013 as gait had returned to normal and she was cleared from a neurological standpoint.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Night sweats, Pyrexia, Tenderness
Clinical narrative: Information has been received from a healthcare worker regarding a 67 year old male patient. The patient's medical history was not provided and there was no drug reactions or allergies. On 17-SEP-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (0.5 ml, intramuscular) (lot # H022280, expiration date 16-JUL-2014). Concomitant therapies included Norvasc, enalapril maleate (manufacturer unknown), simvastatin (manufacturer unknown), glimepiride and metformin. On an unknown date in 2103, the patient received PNEUMOVAX 23 and developed red rash and fever. The patient did not received treatment for the adverse events. There was no laboratories performed. The patient sought medical attention, called the office. At the time of the report, the patient's outcome was unknown. This is one of several reported from the same source. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a healthcare worker regarding a 67 year old male patient. The patient's medical history was not provided and there was no drug reactions or allergies. On 17-SEP-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (0.5 ml, intramuscular) (lot # H022280, expiration date 16-JUL-2014). Concomitant therapies included Norvasc, enalapril maleate (manufacturer unknown), simvastatin (manufacturer unknown), glimepiride and metformin. On an unknown date in 2103, the patient received PNEUMOVAX 23 and developed red rash and fever. The patient did not received treatment for the adverse events. There was no laboratories performed. The patient sought medical attention, called the office. At the time of the report, the patient's outcome was unknown. This is one of several reported from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Painful at site of injection. Red area about 3 inches in diameter.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Painful at site of injection. Red area about 3 inches in diameter.
Age: 61.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse and a Pharmacy Technician refers to a 61 year old patient of unknown gender. Pertinent medical history and drug reactions/allergies were not reported. On 18-SEP-2013, the patient was vaccinated with PNEUMOVAX23 lot # H022280 (also reported as H02280), 16-JUL-2014) 0.5 ml, intramuscular. Concomitant therapies included CRESTOR and NIACIN and VIAGRA. On 19-SEP-2013, within 24 hours of receiving the PNEUMOVAX23 (also reported as 26-SEP-2013), the patient experienced pain and burning at the injection site within 24 hours of receiving PNEUMOVAX23. In September 2013, the patient was seen in clinic and it was reported that the patient experienced redness, warmth and swelling of the arm, below the injection site after receiving PNEUMOVAX23, according to a note, these reports involved "5x4 area about 5-6 below the injection site", the number represented inches. The patient was treated with ZYZAL. The outcome of the events was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse and a Pharmacy Technician refers to a 61 year old patient of unknown gender. Pertinent medical history and drug reactions/allergies were not reported. On 18-SEP-2013, the patient was vaccinated with PNEUMOVAX23 lot # H022280 (also reported as H02280), 16-JUL-2014) 0.5 ml, intramuscular. Concomitant therapies included CRESTOR and NIACIN and VIAGRA. On 19-SEP-2013, within 24 hours of receiving the PNEUMOVAX23 (also reported as 26-SEP-2013), the patient experienced pain and burning at the injection site within 24 hours of receiving PNEUMOVAX23. In September 2013, the patient was seen in clinic and it was reported that the patient experienced redness, warmth and swelling of the arm, below the injection site after receiving PNEUMOVAX23, according to a note, these reports involved "5x4 area about 5-6 below the injection site", the number represented inches. The patient was treated with ZYZAL. The outcome of the events was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse and Pharmacy Technician refers to a 71 year old patient. Pertinent medical history and drug reactions/allergies were not reported. On 18-SEP-2013, also reported 25-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (lot # H022280 (also reported as H02280), expiration date 16-JUL-2014) 0.5 ml, intramuscular. Concomitant therapies included losartan potassium (manufacturer unknown) and aspirin. On 19-SEP-2013, within 24 hours of receiving the PNEUMOVAX23, the patient experienced pain and burning at the injection site within 24 hours of receiving PNEUMOVAX23. On the same day, the patient was seen in clinic; the patient experienced redness, warmth and swelling of the arm, below the injection site after receiving PNEUMOVAX23, according to a note, these reports involved "5x4 area about 5-6 below the injection site", the number represented inches. The patient was treated with BENADRYL. On 25-SEP-2013, the patient reported that she could not move her arm due to severe pain. The outcome of the events was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse and Pharmacy Technician refers to a 71 year old patient. Pertinent medical history and drug reactions/allergies were not reported. On 18-SEP-2013, also reported 25-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (lot # H022280 (also reported as H02280), expiration date 16-JUL-2014) 0.5 ml, intramuscular. Concomitant therapies included losartan potassium (manufacturer unknown) and aspirin. On 19-SEP-2013, within 24 hours of receiving the PNEUMOVAX23, the patient experienced pain and burning at the injection site within 24 hours of receiving PNEUMOVAX23. On the same day, the patient was seen in clinic; the patient experienced redness, warmth and swelling of the arm, below the injection site after receiving PNEUMOVAX23, according to a note, these reports involved "5x4 area about 5-6 below the injection site", the number represented inches. The patient was treated with BENADRYL. On 25-SEP-2013, the patient reported that she could not move her arm due to severe pain. The outcome of the events was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse and Pharmacy Technician refers to a 71 year old patient. Pertinent medical history and drug reactions/allergies were not reported. On 18-SEP-2013, also reported 25-SEP-2013, the patient was vaccinated with PNEUMOVAX23 (lot # H022280 (also reported as H02280), expiration date 16-JUL-2014) 0.5 ml, intramuscular. Concomitant therapies included losartan potassium (manufacturer unknown) and aspirin. On 19-SEP-2013, within 24 hours of receiving the PNEUMOVAX23, the patient experienced pain and burning at the injection site within 24 hours of receiving PNEUMOVAX23. On the same day, the patient was seen in clinic; the patient experienced redness, warmth and swelling of the arm, below the injection site after receiving PNEUMOVAX23, according to a note, these reports involved "5x4 area about 5-6 below the injection site", the number represented inches. The patient was treated with BENADRYL. On 25-SEP-2013, the patient reported that she could not move her arm due to severe pain. The outcome of the events was unknown. This is one of two reports from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Anaphylactic reaction, Dysphagia, Feeling cold, Hypersensitivity, Local swelling
Clinical narrative: This spontaneous report as received from a 64 year old female patient refers to herself with sulfa drugs, penicillin and iodine allergies, and pertinent medical history mentioned as "autoimmune" disorder. In addition, she once had neomycin and bactrate and turned her skin red. Approximately in October 1994, she had an unspecified pneumonia vaccine 10 years before this adverse event (AE) and at that time, there was no reaction. On 19-OCT-2004 the patient was vaccinated with a dose of PNEUMOVAX23, location arm (dose, route, lot#, expiration date unknown). Other suspect therapy included influenza virus vaccine (manufacturer unknown) (dose, route, lot#, expiration date unknown). On 19-OCT-2004 almost immediately after injection, the patient had a severe injection site reaction on her PNEUMOVAX23 injected arm. It was a very itchy red rash, and then swelling, spreading from wrist to shoulder "maybe beyond" on her arm. When she got home she was "colder than death", couldn't swallow, found it hard to talk, and felt that her throat was closing. She was taken to the emergency room and given histamine blockers and steroids, including prednisone. The patient stated that her arm's circulation had been cut off. She stated her had doubled in size, and her blood pressure dropped. She states she went in and out of consciousness in the emergency room, and "hallucinated." Electrocardiogram (EKG) and ultrasound were performed with unknown results. She was not admitted to the hospital. The patient was prescribed "strong medications" including prednisone and antihistamines. Action taken with PNEUMOVAX23 was unknown. The patient had not had any other vaccine since AE. It took full 2-3 weeks for her arm to stop swelling and for her to recover. Approximately in October 2011, two years ago she had a severe reaction to a computerized tomography (CAT) scan dye that apparently contained iodine. Upon internal review, the events aphonia and loss of consciousness were considered to be medically significant. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Poor peripheral circulation, Rash
Clinical narrative: This spontaneous report as received from a 64 year old female patient refers to herself with sulfa drugs, penicillin and iodine allergies, and pertinent medical history mentioned as "autoimmune" disorder. In addition, she once had neomycin and bactrate and turned her skin red. Approximately in October 1994, she had an unspecified pneumonia vaccine 10 years before this adverse event (AE) and at that time, there was no reaction. On 19-OCT-2004 the patient was vaccinated with a dose of PNEUMOVAX23, location arm (dose, route, lot#, expiration date unknown). Other suspect therapy included influenza virus vaccine (manufacturer unknown) (dose, route, lot#, expiration date unknown). On 19-OCT-2004 almost immediately after injection, the patient had a severe injection site reaction on her PNEUMOVAX23 injected arm. It was a very itchy red rash, and then swelling, spreading from wrist to shoulder "maybe beyond" on her arm. When she got home she was "colder than death", couldn't swallow, found it hard to talk, and felt that her throat was closing. She was taken to the emergency room and given histamine blockers and steroids, including prednisone. The patient stated that her arm's circulation had been cut off. She stated her had doubled in size, and her blood pressure dropped. She states she went in and out of consciousness in the emergency room, and "hallucinated." Electrocardiogram (EKG) and ultrasound were performed with unknown results. She was not admitted to the hospital. The patient was prescribed "strong medications" including prednisone and antihistamines. Action taken with PNEUMOVAX23 was unknown. The patient had not had any other vaccine since AE. It took full 2-3 weeks for her arm to stop swelling and for her to recover. Approximately in October 2011, two years ago she had a severe reaction to a computerized tomography (CAT) scan dye that apparently contained iodine. Upon internal review, the events aphonia and loss of consciousness were considered to be medically significant. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood pressure decreased, Consciousness fluctuating, Dysphagia, Electrocardiogram, Extensive swelling of vaccinated limb
Clinical narrative: This spontaneous report as received from a 64 year old female patient refers to herself with sulfa drugs, penicillin and iodine allergies, and pertinent medical history mentioned as "autoimmune" disorder. In addition, she once had neomycin and bactrate and turned her skin red. Approximately in October 1994, she had an unspecified pneumonia vaccine 10 years before this adverse event (AE) and at that time, there was no reaction. On 19-OCT-2004 the patient was vaccinated with a dose of PNEUMOVAX23, location arm (dose, route, lot#, expiration date unknown). Other suspect therapy included influenza virus vaccine (manufacturer unknown) (dose, route, lot#, expiration date unknown). On 19-OCT-2004 almost immediately after injection, the patient had a severe injection site reaction on her PNEUMOVAX23 injected arm. It was a very itchy red rash, and then swelling, spreading from wrist to shoulder "maybe beyond" on her arm. When she got home she was "colder than death", couldn't swallow, found it hard to talk, and felt that her throat was closing. She was taken to the emergency room and given histamine blockers and steroids, including prednisone. The patient stated that her arm's circulation had been cut off. She stated her had doubled in size, and her blood pressure dropped. She states she went in and out of consciousness in the emergency room, and "hallucinated." Electrocardiogram (EKG) and ultrasound were performed with unknown results. She was not admitted to the hospital. The patient was prescribed "strong medications" including prednisone and antihistamines. Action taken with PNEUMOVAX23 was unknown. The patient had not had any other vaccine since AE. It took full 2-3 weeks for her arm to stop swelling and for her to recover. Approximately in October 2011, two years ago she had a severe reaction to a computerized tomography (CAT) scan dye that apparently contained iodine. Upon internal review, the events aphonia and loss of consciousness were considered to be medically significant. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Feeling cold, Hallucination, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a 64 year old female patient refers to herself with sulfa drugs, penicillin and iodine allergies, and pertinent medical history mentioned as "autoimmune" disorder. In addition, she once had neomycin and bactrate and turned her skin red. Approximately in October 1994, she had an unspecified pneumonia vaccine 10 years before this adverse event (AE) and at that time, there was no reaction. On 19-OCT-2004 the patient was vaccinated with a dose of PNEUMOVAX23, location arm (dose, route, lot#, expiration date unknown). Other suspect therapy included influenza virus vaccine (manufacturer unknown) (dose, route, lot#, expiration date unknown). On 19-OCT-2004 almost immediately after injection, the patient had a severe injection site reaction on her PNEUMOVAX23 injected arm. It was a very itchy red rash, and then swelling, spreading from wrist to shoulder "maybe beyond" on her arm. When she got home she was "colder than death", couldn't swallow, found it hard to talk, and felt that her throat was closing. She was taken to the emergency room and given histamine blockers and steroids, including prednisone. The patient stated that her arm's circulation had been cut off. She stated her had doubled in size, and her blood pressure dropped. She states she went in and out of consciousness in the emergency room, and "hallucinated." Electrocardiogram (EKG) and ultrasound were performed with unknown results. She was not admitted to the hospital. The patient was prescribed "strong medications" including prednisone and antihistamines. Action taken with PNEUMOVAX23 was unknown. The patient had not had any other vaccine since AE. It took full 2-3 weeks for her arm to stop swelling and for her to recover. Approximately in October 2011, two years ago she had a severe reaction to a computerized tomography (CAT) scan dye that apparently contained iodine. Upon internal review, the events aphonia and loss of consciousness were considered to be medically significant. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling, Local swelling, Poor peripheral circulation, Speech disorder, Throat tightness
Clinical narrative: This spontaneous report as received from a 64 year old female patient refers to herself with sulfa drugs, penicillin and iodine allergies, and pertinent medical history mentioned as "autoimmune" disorder. In addition, she once had neomycin and bactrate and turned her skin red. Approximately in October 1994, she had an unspecified pneumonia vaccine 10 years before this adverse event (AE) and at that time, there was no reaction. On 19-OCT-2004 the patient was vaccinated with a dose of PNEUMOVAX23, location arm (dose, route, lot#, expiration date unknown). Other suspect therapy included influenza virus vaccine (manufacturer unknown) (dose, route, lot#, expiration date unknown). On 19-OCT-2004 almost immediately after injection, the patient had a severe injection site reaction on her PNEUMOVAX23 injected arm. It was a very itchy red rash, and then swelling, spreading from wrist to shoulder "maybe beyond" on her arm. When she got home she was "colder than death", couldn't swallow, found it hard to talk, and felt that her throat was closing. She was taken to the emergency room and given histamine blockers and steroids, including prednisone. The patient stated that her arm's circulation had been cut off. She stated her had doubled in size, and her blood pressure dropped. She states she went in and out of consciousness in the emergency room, and "hallucinated." Electrocardiogram (EKG) and ultrasound were performed with unknown results. She was not admitted to the hospital. The patient was prescribed "strong medications" including prednisone and antihistamines. Action taken with PNEUMOVAX23 was unknown. The patient had not had any other vaccine since AE. It took full 2-3 weeks for her arm to stop swelling and for her to recover. Approximately in October 2011, two years ago she had a severe reaction to a computerized tomography (CAT) scan dye that apparently contained iodine. Upon internal review, the events aphonia and loss of consciousness were considered to be medically significant. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Ultrasound scan
Clinical narrative: This spontaneous report as received from a 64 year old female patient refers to herself with sulfa drugs, penicillin and iodine allergies, and pertinent medical history mentioned as "autoimmune" disorder. In addition, she once had neomycin and bactrate and turned her skin red. Approximately in October 1994, she had an unspecified pneumonia vaccine 10 years before this adverse event (AE) and at that time, there was no reaction. On 19-OCT-2004 the patient was vaccinated with a dose of PNEUMOVAX23, location arm (dose, route, lot#, expiration date unknown). Other suspect therapy included influenza virus vaccine (manufacturer unknown) (dose, route, lot#, expiration date unknown). On 19-OCT-2004 almost immediately after injection, the patient had a severe injection site reaction on her PNEUMOVAX23 injected arm. It was a very itchy red rash, and then swelling, spreading from wrist to shoulder "maybe beyond" on her arm. When she got home she was "colder than death", couldn't swallow, found it hard to talk, and felt that her throat was closing. She was taken to the emergency room and given histamine blockers and steroids, including prednisone. The patient stated that her arm's circulation had been cut off. She stated her had doubled in size, and her blood pressure dropped. She states she went in and out of consciousness in the emergency room, and "hallucinated." Electrocardiogram (EKG) and ultrasound were performed with unknown results. She was not admitted to the hospital. The patient was prescribed "strong medications" including prednisone and antihistamines. Action taken with PNEUMOVAX23 was unknown. The patient had not had any other vaccine since AE. It took full 2-3 weeks for her arm to stop swelling and for her to recover. Approximately in October 2011, two years ago she had a severe reaction to a computerized tomography (CAT) scan dye that apparently contained iodine. Upon internal review, the events aphonia and loss of consciousness were considered to be medically significant. Additional information is not expected.
Age: 91.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: Swollen lips and tongue  Given diphenhydramine.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site rash, Injection site urticaria
Clinical narrative: Headache, red welt/rash around injection site.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC13
Symptoms: Crying, Rash, Tremor
Clinical narrative: Had event of uncontrollable "shaking" then broke out in rash, was crying inconsolable.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: Periodic vertigo/dizziness over next 3 days.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Hypoaesthesia oral, Lip swelling, Oropharyngeal pain
Clinical narrative: Rec'd flu shot at 5:15 PM. At 9 PM had chills, fever of 101 and aches.  By midnight face, lips and tongue swollen, throat sore and tight, tightness in chest.  Was given Benadryl at ER and told to take for a few days.  As of 10/16/2013 my lips are still swollen and numb.  Was told to go back to ER today if still numb this evening. Never had ANY reaction (including chills and aches) from a flu shot before.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Rec'd flu shot at 5:15 PM. At 9 PM had chills, fever of 101 and aches.  By midnight face, lips and tongue swollen, throat sore and tight, tightness in chest.  Was given Benadryl at ER and told to take for a few days.  As of 10/16/2013 my lips are still swollen and numb.  Was told to go back to ER today if still numb this evening. Never had ANY reaction (including chills and aches) from a flu shot before.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Blood creatine phosphokinase, Mobility decreased, Musculoskeletal stiffness, Pain, Red blood cell sedimentation rate
Clinical narrative: Patient describes pain and arm stiffness in deltoid starting the evening of the day of vaccination. This got significantly worse the following day- she was unable to move her entire upper arm and was very stiff. This has persisted- currently at day #13 of symptoms with no improvement. No fevers. Patient has had the flu shot every year for at least 10 years and has never had a reaction like this.
Age: 0.19
Sex: F
Vaccine: RV5
Symptoms: Rash papular
Clinical narrative: 3 x 4 cm erythematous papular rash arose with 45 seconds of administration of Rotateq on the childs left flank that resolved 75% within 30 minutes and completely within 6 hours. Resolution occurred with initial central clearing and gradually fading of erythema. No other urticaria, angioedema, or discomfort/pruritis was apparent. No medical interventtion was done. Other vaccines were given after a 30 minute wait after the rash was noted---these were without complications. Child has no history of any rashes or skin conditions and no reash was present prior to Rotateq administration. No Rotateq spilled onto the dressed child during administration.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Crying, Eye pruritus, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Complaint of throat hurting and crying uncontrollably with congestion and itchy eyes.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Reports rash on trunk & arms 1-2 days after receiving vaccine.  States took "something" and it went away but rash returned approx 1 mo later.  Denies breathing difficulty.  Client walked into clinic to report status 10/7/13.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Acute febrile neutrophilic dermatosis, Biopsy skin abnormal, Fungal test negative, Hyperhidrosis, Malaise
Clinical narrative: Received a Flu vaccine on 08/29/2013 and developed a painful red raised rash on the trunk of my body that following Sunday (09-01-13). The rash spread across my abdomen, left side and didn't feel well that day (aching, sweaty) so I was seen in the emergency room on 09/05/2013 where they ruled out shingles and chicken pox.   I didn't even think about the vaccine as a possible cause and made no mention of it. The rash continued to spread so I returned to the ER on 09-11-2013.  The ER MD sent me to a Dermatologist and he took a biopsy of one of the areas. I was give a prednisone taper which I completed and the rash seemed to subside.  The areas are now starting to return.  I wonder if the flu vaccine triggered some reaction in my body to cause the rash.  If I am sensitive to a flu strain in the vaccine will receiving the vaccine again next year trigger the same or even a worse reaction?  I appreciate any advice you could offer. Thank you.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash erythematous, Skin oedema
Clinical narrative: Received a Flu vaccine on 08/29/2013 and developed a painful red raised rash on the trunk of my body that following Sunday (09-01-13). The rash spread across my abdomen, left side and didn't feel well that day (aching, sweaty) so I was seen in the emergency room on 09/05/2013 where they ruled out shingles and chicken pox.   I didn't even think about the vaccine as a possible cause and made no mention of it. The rash continued to spread so I returned to the ER on 09-11-2013.  The ER MD sent me to a Dermatologist and he took a biopsy of one of the areas. I was give a prednisone taper which I completed and the rash seemed to subside.  The areas are now starting to return.  I wonder if the flu vaccine triggered some reaction in my body to cause the rash.  If I am sensitive to a flu strain in the vaccine will receiving the vaccine again next year trigger the same or even a worse reaction?  I appreciate any advice you could offer. Thank you.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Itching, redness, swelling (lump about 2 inches across and redness 2x5 inch area). Unsure when it actually started, noticed it about 24 hours after injection.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting.
Age: 0.22
Sex: M
Vaccine: DTAP, IPV
Symptoms: Apnoea
Clinical narrative: Infant started showing signs of apnea.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Hypoaesthesia oral, Paraesthesia oral, Periorbital oedema
Clinical narrative: After the vaccine pt experienced some numbness and tingling in her tongue, then a tightness in her chest and then found it difficult to breathe.  Developed a facial rash and periorbital edema.  These symptoms waxed and waned.  Pt given PO Benadryl as well as epinephrine by EpiPen.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: After the vaccine pt experienced some numbness and tingling in her tongue, then a tightness in her chest and then found it difficult to breathe.  Developed a facial rash and periorbital edema.  These symptoms waxed and waned.  Pt given PO Benadryl as well as epinephrine by EpiPen.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Decreased appetite, Dizziness, Nausea, Pain
Clinical narrative: 6:00-aches, loss of appetite; 8:30-light headedness in shower, near faint; 9:00-nausea, full body aches and pains; 9:15-serious vomiting episode, major chills; 9:30-drank warm tea, dizzy when sitting though; 10:00-more nausea, no vomiting; drank small amount of 7-up; slept off and on through the night; by morning - appetite had returned.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Presyncope, Vomiting
Clinical narrative: 6:00-aches, loss of appetite; 8:30-light headedness in shower, near faint; 9:00-nausea, full body aches and pains; 9:15-serious vomiting episode, major chills; 9:30-drank warm tea, dizzy when sitting though; 10:00-more nausea, no vomiting; drank small amount of 7-up; slept off and on through the night; by morning - appetite had returned.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: T max 100. Cellulitis left upper arm.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Local swelling, Wheezing
Clinical narrative: Wheezing and swelling of eyes, lips, hands, and feet.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Insomnia, Myalgia
Clinical narrative: 8:00 TO 11:00 PM 10/12; SEVERE MUSCLE AND JOINT PAIN AS WELL AS CHILLS. 11:00PM 10/12 THROUGHOUT NIGHT UNTIL 5:00 AM 10/13 WORSENING ACHES IN BODY, FEVER 100F, CHILLS AND UNCONTROLLABLE SHIVERING THAT KEPT ME AWAKE THROUGHOUT NIGHT. FEVER AND CHILLS STOPPED BY 5AM 10/13. ACHES EXCEPT FOR HEADACHE GONE BY 8AM 10/14. MODERATE TO SEVERE HEADACHE FROM 8PM 10/12 THAT CONTINUES TODAY 10/16/13. ALL OF THESE SYMPTOMS ARE NOT TYPICAL FOR ME WITH MY SEASONAL ALLERGIES, ASTHMA.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: 8:00 TO 11:00 PM 10/12; SEVERE MUSCLE AND JOINT PAIN AS WELL AS CHILLS. 11:00PM 10/12 THROUGHOUT NIGHT UNTIL 5:00 AM 10/13 WORSENING ACHES IN BODY, FEVER 100F, CHILLS AND UNCONTROLLABLE SHIVERING THAT KEPT ME AWAKE THROUGHOUT NIGHT. FEVER AND CHILLS STOPPED BY 5AM 10/13. ACHES EXCEPT FOR HEADACHE GONE BY 8AM 10/14. MODERATE TO SEVERE HEADACHE FROM 8PM 10/12 THAT CONTINUES TODAY 10/16/13. ALL OF THESE SYMPTOMS ARE NOT TYPICAL FOR ME WITH MY SEASONAL ALLERGIES, ASTHMA.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hyperhidrosis, Injection site pain, Musculoskeletal pain
Clinical narrative: Throat swelling, blood shot eyes, neck/shoulder pain, tingling in arms/upper body, nausea, dizziness, sweating profusely, injection site pain (throbbing). Severe headache after reaction.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Neck pain, Ocular hyperaemia, Paraesthesia, Pharyngeal oedema
Clinical narrative: Throat swelling, blood shot eyes, neck/shoulder pain, tingling in arms/upper body, nausea, dizziness, sweating profusely, injection site pain (throbbing). Severe headache after reaction.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Injection site erythema, Musculoskeletal discomfort
Clinical narrative: About 22 minutes after administration of intradermal flu vaccine patient showed redness to left upper extremity at injection site; applied ice pack- about 7 minutes later redness increased up to shoulder area, patient declined Epi-Pen; administered 25 mg Benadryl po; about 12 minutes later patient c/o increased discomfort pacing up and down; again declined Epi Pen; administered second dose of 25 mg Benadryl p.o; continued to c/o of worsening discomfort up his neck, escorted to emergency room for treatment.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Fatigue, Headache, Night sweats, Oropharyngeal pain
Clinical narrative: "I got the flu shot (Wed 10/2/13.)  That Sat or Sun, I started getting a sore throat, cough; feel tired.  My right jaw is painful, TMJ, and right sided headache started the middle of last week.  Hurts to open my mouth.  I went to Urgent Care last Fri (10/11), and they did a strep test.  I don't think she went back deeply enough.  It came back negative, and they didn't do a culture.  She said maybe it's shingles, but I don't have a rash, and have never had shingles.  It was a waste of a visit.  I've been taking left-over Tylenol with Codeine because of the pain.  Take it after work around 6 PM.  I toss and turn at night, but it helps the pain.  It seems like the symptoms are worse at night and in the morning.  Not really coughing, the main problem is this right sided pain, rates 5/10 now.  I considered going to the dentist because of the jaw and lower back teeth pain, but I don't think it's that.  I think it's the swelling and the soreness.  Symptoms are staying the same.  I have had noc sweats."  No N/V, diarrhea or GI symptoms.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in jaw, Poor quality sleep, Streptococcus test negative, Swelling
Clinical narrative: "I got the flu shot (Wed 10/2/13.)  That Sat or Sun, I started getting a sore throat, cough; feel tired.  My right jaw is painful, TMJ, and right sided headache started the middle of last week.  Hurts to open my mouth.  I went to Urgent Care last Fri (10/11), and they did a strep test.  I don't think she went back deeply enough.  It came back negative, and they didn't do a culture.  She said maybe it's shingles, but I don't have a rash, and have never had shingles.  It was a waste of a visit.  I've been taking left-over Tylenol with Codeine because of the pain.  Take it after work around 6 PM.  I toss and turn at night, but it helps the pain.  It seems like the symptoms are worse at night and in the morning.  Not really coughing, the main problem is this right sided pain, rates 5/10 now.  I considered going to the dentist because of the jaw and lower back teeth pain, but I don't think it's that.  I think it's the swelling and the soreness.  Symptoms are staying the same.  I have had noc sweats."  No N/V, diarrhea or GI symptoms.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Temporomandibular joint syndrome, Toothache
Clinical narrative: "I got the flu shot (Wed 10/2/13.)  That Sat or Sun, I started getting a sore throat, cough; feel tired.  My right jaw is painful, TMJ, and right sided headache started the middle of last week.  Hurts to open my mouth.  I went to Urgent Care last Fri (10/11), and they did a strep test.  I don't think she went back deeply enough.  It came back negative, and they didn't do a culture.  She said maybe it's shingles, but I don't have a rash, and have never had shingles.  It was a waste of a visit.  I've been taking left-over Tylenol with Codeine because of the pain.  Take it after work around 6 PM.  I toss and turn at night, but it helps the pain.  It seems like the symptoms are worse at night and in the morning.  Not really coughing, the main problem is this right sided pain, rates 5/10 now.  I considered going to the dentist because of the jaw and lower back teeth pain, but I don't think it's that.  I think it's the swelling and the soreness.  Symptoms are staying the same.  I have had noc sweats."  No N/V, diarrhea or GI symptoms.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Abnormal behaviour, Crying, Fear, Irritability, Screaming
Clinical narrative: Major behavior changes - Out of control behavior, crying, screaming, inconsolable, eventually falling asleep. Next day continued behavior changes, out of control, crying, screaming, freaking out, inconsolable for over an hour, general loss of control, could not be calmed down by anyone, had look of fear in eyes like he couldn't stop himself.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Asthma, Condition aggravated, Dyspnoea, Feeling hot
Clinical narrative: On 10/9/2013 15 minutes after the injection I became nauseated, warm, itchy, and had difficulty breathing.  I used my inhaler and took Benadryl.  I continued to be short of breath over night and my arm became very sore with a hard spot at injection site.  I ended up in the Emergency room the next day with anaphalaxis.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Nausea, Pain in extremity, Pruritus
Clinical narrative: On 10/9/2013 15 minutes after the injection I became nauseated, warm, itchy, and had difficulty breathing.  I used my inhaler and took Benadryl.  I continued to be short of breath over night and my arm became very sore with a hard spot at injection site.  I ended up in the Emergency room the next day with anaphalaxis.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Nuclear magnetic resonance imaging
Clinical narrative: Patient developed severe arm pain at the site of injection. Pain is severe enough that she is unable to abduct her arm. There is no mass, redness, warmth, or swelling at the injection site. There is severe pain wtih palpation at the injection site. MRI of the area is pending.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Apathy, Chills, Fatigue, Inflammation, Injection site pain
Clinical narrative: Feeling nauseated at about 3 pm. Emesis x 1 at 5:30 pm. Chills/shaking after emesis continuing until about 11:00 pm. No fever reported. She was able to drink small amounts of water but food made her more nauseous. Injection site: Painful until about 8 pm. Swelling/inflammation 4 inches in circumference. No redness or bruising reported. 10/09/13 - Chills, nausea and shakiness have subsided but she reports that she feels tired, washed out with no motivation. She did not seek medical attention.  She feels that this is adverse event caused by the flu vaccine.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Nausea, Tremor, Vomiting
Clinical narrative: Feeling nauseated at about 3 pm. Emesis x 1 at 5:30 pm. Chills/shaking after emesis continuing until about 11:00 pm. No fever reported. She was able to drink small amounts of water but food made her more nauseous. Injection site: Painful until about 8 pm. Swelling/inflammation 4 inches in circumference. No redness or bruising reported. 10/09/13 - Chills, nausea and shakiness have subsided but she reports that she feels tired, washed out with no motivation. She did not seek medical attention.  She feels that this is adverse event caused by the flu vaccine.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Ping-pong ball sized swelling at site of injection (left deltoid muscle).  Had patient sit, applied ice and gave Diphenhydramine (25mg tablet).  No systemic symptoms reported.  Patient was able to return to work after.
Age: 52.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Influenza
Clinical narrative: Initial report was received by a healthcare professional, who was also the patient, on 01 October 2013. A 53-year-old female patient had received an injection of influenza vaccine (manufacturer, lot number, route and site of administration unknown) and an injection of Tdap (manufacturer, lot number, route and site of administration unknown) on an unspecified date in September 2012. In January 2013, the patient experienced the flu. No lab work was done to establish which substrain of flu virus she had. The patient had no medical history and an allergy to amoxicillin. Outcome was recovered. Documents held by sender: None.
Sex: M
Vaccine: TTOX
Symptoms: Death
Clinical narrative: Initial report was received on 30 September 2013 from another manufacturer who received the report from a consumer. An unidentified male patient with no reported past medical history had received tetanus adsorbed toxoid (manufacturer, lot number, route, site and date of administration not reported and an unspecified amount of time later died. According to the report, the patient's sister reported that patient died after "12 doses of tetanus vaccine". No further information was available at the time of the report. The patient's outcome was fatal. Addendum 09 October 2013: Upon internal review of this case, the vaccine was amended from tetanus adsorbed toxoid to tetanus toxoid. Documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope, Tremor
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 23 year old female patient with "birth control". No medical history and drug reactions/allergies were reported. On 21-MAR-2013, the patient was vaccinated with a dose of GARDASIL 0.5ml, intramuscular (lot # J002641, Exp date 10-DEC-2015). On 10-OCT-2013, the patient was vaccinated with the third dose of GARDASIL, (anatomical location, dose, route and lot # not reported). Concomitant therapy included unspecified birth control medication. The nurse reported that "about 30 seconds" after the injection on 10-OCT-2013 the patient fainted and began seizing. She stated that the patient's body was shaking for about 15 seconds. She stabilized the patient, and the patient did not sustain any injuries. The patient did not receive any treatment. No lab diagnostics studies were performed. The patient completely recovered after the incident on 10-OCT-2013. The patient sought medical attention. Upon internal review, the event seizing was considered to be medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Erythema, Headache, Local swelling, Nausea, Neutrophil percentage increased
Clinical narrative: This spontaneous report as received from a healthcare student refers to a 13 year old female patient. On 07-OCT-2013 the patient was vaccinated with a first dose of GARDASIL injection (lot #, expiration date, dose, frequency and route not reported). On the same day, she also received a first dose of an unspecified flu shot (manufactory unknown) (lot #, expiration date, dose, frequency, route and indication not reported). There were no concomitant medication, medical history and drug reactions/allergies. On 07-OCT-2013, she developed achiness in her arm, a headache, a fever, nausea, vomiting, redness and swelling in her arm, a white blood cell count of 27.2 and a neutrophil count of 90.5%. She sought unspecified medical attention and was given treatment for adverse events, using clindamycin and BENADRYL. On 09-OCT-2013, the patient was admitted to the hospital. The outcome of events was reported as not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Pain in extremity, Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: This spontaneous report as received from a healthcare student refers to a 13 year old female patient. On 07-OCT-2013 the patient was vaccinated with a first dose of GARDASIL injection (lot #, expiration date, dose, frequency and route not reported). On the same day, she also received a first dose of an unspecified flu shot (manufactory unknown) (lot #, expiration date, dose, frequency, route and indication not reported). There were no concomitant medication, medical history and drug reactions/allergies. On 07-OCT-2013, she developed achiness in her arm, a headache, a fever, nausea, vomiting, redness and swelling in her arm, a white blood cell count of 27.2 and a neutrophil count of 90.5%. She sought unspecified medical attention and was given treatment for adverse events, using clindamycin and BENADRYL. On 09-OCT-2013, the patient was admitted to the hospital. The outcome of events was reported as not recovered. Additional information has been requested.