chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Scleritis
Clinical narrative: This spontaneous report was received from an 41 year old female consumer reporting on herself. Consumer reported she usually experiences diarrhea after taking penicillin (unspecified). The patient had no pertinent medical history. On 15-AUG-2013 the patient was vaccinated with RECOMBIVAX HB (dose, route and lot number were not reported). Concomitant therapies included SYNTHROID and an unspecified treatment for birth control. About two days later of RECOMBIVAX HB vaccination, on approximately 17-AUG-2013, patient experienced "inflammation diagnosed as sclera", severe joint pain in one of her hands, extreme fatigue and swollen and red eyes. The vaccine was recommended by a Nurse Practitioner. Based on her experience after the RECOMBIVAX HB first dose, consumer stated she planned to return to the physician's office to discuss whether she should receive the second dose of RECOMBIVAX HB and might decide to discontinue RECOMBIVAX HB therapy. It was reported that the patient did not received treatment for the adverse events. Steroid (not specified) was prescribed for the eye. Patient performed a not specified type of blood test. Patient was seen in the office. The outcome of inflammation diagnosed as sclera, red eyes, swollen eyes, extreme fatigue and joint pain in one of her hands was reported as not recovered/not resolved. The relationship between RECOMBIVAX HB and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ROTATEQ vial, lot # H17671m expiration date 25-MAR-2014 (dose and route were not reported) that was exposed to 12C for 173.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. No concomitant medications were reported. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ vial, lot# H17671, expiration date 25-MAR-2014 (dose and route were not reported) that was exposed to 12C for 173.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. No concomitant medications were reported. This is one of several reports received from same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness lower than in injection site inside arm to outer about 3 inches diameter. Advised to take Benadryl and call MD.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 12-24 hrs after receiving flu shot pt experienced swelling/redness/warmness/no bumps/rash at the site (about 2" in diameter)
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Injection site swelling, Local swelling, Pain
Clinical narrative: Within 24 hours pt experienced tenderness, pain, warmth, redness, and slight swelling in the left arm from the deltoid down, was still experience symptoms 48 hours after administration.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Within 24 hours pt experienced tenderness, pain, warmth, redness, and slight swelling in the left arm from the deltoid down, was still experience symptoms 48 hours after administration.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Myalgia, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Rash all over his face. Swelling to injection site (allergic reaction). Sick all weekend as per pt.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Hypersensitivity, Injection site swelling, Malaise, Rash
Clinical narrative: Rash all over his face. Swelling to injection site (allergic reaction). Sick all weekend as per pt.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site reaction, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: Lump and red rash at site of injection. Pain radiating down to wrist. Fever starting 12 hours after injection - treating with ADVIL and ice pack.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Eyelid oedema, Fatigue, Hallucination, Ocular hyperaemia
Clinical narrative: Received vaccination FLUZONE at 1400. Felt very tired at 20:00 and went to sleep. Awoke at 2200 and had temp. 103 with both eyes only swollen shut. No medication taken. Went back to sleep and awoke at 2400 with hallucinations to time and place. Went back to sleep and in AM felt fine with both eyes very red.
Age: 1.7
Sex: M
Vaccine: FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Pt was seen in our office on 9/30/13 at 900 AM bug bites pt did not have a fever at that time was give the flu vaccine. At 4:30 pt developed a fever and had a febrile seizure at 5pm. Went to ER. Told to give TYLENOL/MOTRIN Q 4hrs. Had another febrile seizure at 3am. Seen in our office today at 10am fever was 98.7.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: 9/9/13 Patient stated I received the shingles injection on 9/6/13 and did not have a reaction within the first 24 hours now area red and warm. Seen by dr per dr notes patient did not take band aid off for 24 hrs. 5 x 3 cm, red area noted. Oral antihistamine ordered. Recheck 9/14/13 area redness receding per dr note. Assessment local vaccine reaction.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site pain
Clinical narrative: This spontaneous report was received from a Registered Nurse refers to a 22 year old female patient. The patient had come into the office yesterday, 23-SEP-2013, and was administered her third dose of GARDASIL (lot# expiry not reported). The patient had received her first dose of GARDASIL on 23-MAY-2011, and her second dose on 13-JUL-2011. Patient stated that the reason for her delay in coming back for the third dose of GARDASIL was that "the second dose of GARDASIL was more painful than the first dose and she did not want to experience the pain of the injection. No medical attention sought. No treatment was given. The outcome of pain of the injection was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Injection site vesicles
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 63 year old male patient. On 11-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On 24-SEP-2013, the patient experienced two blisters on his head that looked like mosquito bites and about four blisters near the injection site, that also looked like mosquito bites. The outcome of two blisters on his head that looked like mosquito bites and four blisters near the injection site, that also looked like mosquito bites were unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 18 year old female patient with no pertinent medical history and no drug reactions or allergies. On an unspecified dates the patient received three doses of GARDASIL injection (lot number, doses, routes and sites of administration were not reported). Concomitant therapies included ORTHO TRI-CYCLEN. On 30-JUL-2013 the patient went to her physician's office for routine visit and her pap smear resulted high risk positive on an unspecified HPV type. There was no treatment given for the adverse event. The patient sought medical attention. The patient did not recover from the adverse event. The relatedness between therapy with GARDASIL and adverse event was not reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Injection site swelling
Clinical narrative: This spontaneous report as received from a 55 year old female patient regarding herself. Patient's relevant medical history was unknown. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). Concomitant medication was unknown. On an unknown date in 2012, the patient experienced swelling at injection site, missed work for several days and returned to the doctor. Diagnostic tests carried out were unknown. The outcome of swelling at injection site, missed work for several days was reported as recovering/resolving (also reported as resolved). The reporter considered the event to be related to ZOSTAVAX. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 66 year old male patient. On 13-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not report). On 17-SEP-2013, the patient experience shingles on T12, L1, and right hip. Patient sought medical attention (visited physician's office) and was treated with Valtrex. The outcome of shingles on T12, L1 and right hip was reported as not recovered/not resolved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient with no drug reactions/allergies. On 14-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J002869, expiry date 14-JUN-2014, route and dose were not reported) vial and FLUZONE in the same arm. Concomitant therapies included lisinopril (manufacturer unknown). Approximately on an unknown date in September 2013, the patient had a 4.5 inch "reddened bull's eye mark" around the ZOSTAVAX injection site. Patient sought medical attention (pharmacy visit). No treatment was given. It was reported that the patient's rash at the time of this report was resolved. Approximately on an unknown date in September 2013, the event was recovered/resolved. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: RAB
Symptoms: Agitation, Asthenia, Blood test, Blood urine present, Burning sensation
Clinical narrative: The Side Effects [I was told that these side effects following the improper injection of Dose #3 on 10/2/12 of the Rabies vaccine were not reported to the CDC by the ER. [1] The immediate side effect [within 30 seconds] following the 10/2 injection was an intense burning, hot sensation that started in my abdomen area and then traveled up into my upper chest [heart and lung areas] and throat. I informed the nurse of this side effect. She did not respond, nor check my vital signs, nor inform the ER physician. I sat there until this intense burning sensation diminished; and then I left the ER. [2] The next side effect happened about 30 minutes after the injection. I suddenly and rapidly developed major breathing problems, including forceful inhalation efforts and loud wheezing. My breathing was labored. In short order, my head and neck began to ache. There was a substantial tightness [in muscles] in the back of the neck, the sides around the head [very bad at the forehead, sinus areas]. My sinus areas felt blocked. Upper body nervousness and chills set in. My eyes were bloodshot; and my throat became more painful. These side effects continued for about 30 minutes. [3] The issues described in [2] lessened somewhat about noontime. I then tried to eat some lunch, but quickly developed nausea and a general feeling of illness. [4] Shortly thereafter, I became extremely agitated and irritable to any/all stimuli, including all touch and noise. My entire body felt like it was trembling in a significant way. There was obvious trembling in arms, hands and upper body. I then became very dizzy. The hot, burning sensation in the throat and upper chest/lungs continued. My whole body was weak. My eyes were bloodshot.
Age: 66.0
Sex: M
Vaccine: RAB
Symptoms: Chills, Computerised tomogram head, Computerised tomogram thorax, Cystitis noninfective, Dizziness
Clinical narrative: The Side Effects [I was told that these side effects following the improper injection of Dose #3 on 10/2/12 of the Rabies vaccine were not reported to the CDC by the ER. [1] The immediate side effect [within 30 seconds] following the 10/2 injection was an intense burning, hot sensation that started in my abdomen area and then traveled up into my upper chest [heart and lung areas] and throat. I informed the nurse of this side effect. She did not respond, nor check my vital signs, nor inform the ER physician. I sat there until this intense burning sensation diminished; and then I left the ER. [2] The next side effect happened about 30 minutes after the injection. I suddenly and rapidly developed major breathing problems, including forceful inhalation efforts and loud wheezing. My breathing was labored. In short order, my head and neck began to ache. There was a substantial tightness [in muscles] in the back of the neck, the sides around the head [very bad at the forehead, sinus areas]. My sinus areas felt blocked. Upper body nervousness and chills set in. My eyes were bloodshot; and my throat became more painful. These side effects continued for about 30 minutes. [3] The issues described in [2] lessened somewhat about noontime. I then tried to eat some lunch, but quickly developed nausea and a general feeling of illness. [4] Shortly thereafter, I became extremely agitated and irritable to any/all stimuli, including all touch and noise. My entire body felt like it was trembling in a significant way. There was obvious trembling in arms, hands and upper body. I then became very dizzy. The hot, burning sensation in the throat and upper chest/lungs continued. My whole body was weak. My eyes were bloodshot.
Age: 66.0
Sex: M
Vaccine: RAB
Symptoms: Dyspnoea, Headache, Hyperacusis, Hyperaesthesia, Immediate post-injection reaction
Clinical narrative: The Side Effects [I was told that these side effects following the improper injection of Dose #3 on 10/2/12 of the Rabies vaccine were not reported to the CDC by the ER. [1] The immediate side effect [within 30 seconds] following the 10/2 injection was an intense burning, hot sensation that started in my abdomen area and then traveled up into my upper chest [heart and lung areas] and throat. I informed the nurse of this side effect. She did not respond, nor check my vital signs, nor inform the ER physician. I sat there until this intense burning sensation diminished; and then I left the ER. [2] The next side effect happened about 30 minutes after the injection. I suddenly and rapidly developed major breathing problems, including forceful inhalation efforts and loud wheezing. My breathing was labored. In short order, my head and neck began to ache. There was a substantial tightness [in muscles] in the back of the neck, the sides around the head [very bad at the forehead, sinus areas]. My sinus areas felt blocked. Upper body nervousness and chills set in. My eyes were bloodshot; and my throat became more painful. These side effects continued for about 30 minutes. [3] The issues described in [2] lessened somewhat about noontime. I then tried to eat some lunch, but quickly developed nausea and a general feeling of illness. [4] Shortly thereafter, I became extremely agitated and irritable to any/all stimuli, including all touch and noise. My entire body felt like it was trembling in a significant way. There was obvious trembling in arms, hands and upper body. I then became very dizzy. The hot, burning sensation in the throat and upper chest/lungs continued. My whole body was weak. My eyes were bloodshot.
Age: 66.0
Sex: M
Vaccine: RAB
Symptoms: Immunoglobulin G4 related sclerosing disease, Immunology test, Irritability, Lumbar puncture, Malaise
Clinical narrative: The Side Effects [I was told that these side effects following the improper injection of Dose #3 on 10/2/12 of the Rabies vaccine were not reported to the CDC by the ER. [1] The immediate side effect [within 30 seconds] following the 10/2 injection was an intense burning, hot sensation that started in my abdomen area and then traveled up into my upper chest [heart and lung areas] and throat. I informed the nurse of this side effect. She did not respond, nor check my vital signs, nor inform the ER physician. I sat there until this intense burning sensation diminished; and then I left the ER. [2] The next side effect happened about 30 minutes after the injection. I suddenly and rapidly developed major breathing problems, including forceful inhalation efforts and loud wheezing. My breathing was labored. In short order, my head and neck began to ache. There was a substantial tightness [in muscles] in the back of the neck, the sides around the head [very bad at the forehead, sinus areas]. My sinus areas felt blocked. Upper body nervousness and chills set in. My eyes were bloodshot; and my throat became more painful. These side effects continued for about 30 minutes. [3] The issues described in [2] lessened somewhat about noontime. I then tried to eat some lunch, but quickly developed nausea and a general feeling of illness. [4] Shortly thereafter, I became extremely agitated and irritable to any/all stimuli, including all touch and noise. My entire body felt like it was trembling in a significant way. There was obvious trembling in arms, hands and upper body. I then became very dizzy. The hot, burning sensation in the throat and upper chest/lungs continued. My whole body was weak. My eyes were bloodshot.
Age: 66.0
Sex: M
Vaccine: RAB
Symptoms: Muscle tightness, Nausea, Neck pain, Nervousness, Nuclear magnetic resonance imaging brain
Clinical narrative: The Side Effects [I was told that these side effects following the improper injection of Dose #3 on 10/2/12 of the Rabies vaccine were not reported to the CDC by the ER. [1] The immediate side effect [within 30 seconds] following the 10/2 injection was an intense burning, hot sensation that started in my abdomen area and then traveled up into my upper chest [heart and lung areas] and throat. I informed the nurse of this side effect. She did not respond, nor check my vital signs, nor inform the ER physician. I sat there until this intense burning sensation diminished; and then I left the ER. [2] The next side effect happened about 30 minutes after the injection. I suddenly and rapidly developed major breathing problems, including forceful inhalation efforts and loud wheezing. My breathing was labored. In short order, my head and neck began to ache. There was a substantial tightness [in muscles] in the back of the neck, the sides around the head [very bad at the forehead, sinus areas]. My sinus areas felt blocked. Upper body nervousness and chills set in. My eyes were bloodshot; and my throat became more painful. These side effects continued for about 30 minutes. [3] The issues described in [2] lessened somewhat about noontime. I then tried to eat some lunch, but quickly developed nausea and a general feeling of illness. [4] Shortly thereafter, I became extremely agitated and irritable to any/all stimuli, including all touch and noise. My entire body felt like it was trembling in a significant way. There was obvious trembling in arms, hands and upper body. I then became very dizzy. The hot, burning sensation in the throat and upper chest/lungs continued. My whole body was weak. My eyes were bloodshot.
Age: 66.0
Sex: M
Vaccine: RAB
Symptoms: Nuclear magnetic resonance imaging spinal, Nuclear magnetic resonance imaging thoracic, Ocular hyperaemia, Oropharyngeal pain, Sinus congestion
Clinical narrative: The Side Effects [I was told that these side effects following the improper injection of Dose #3 on 10/2/12 of the Rabies vaccine were not reported to the CDC by the ER. [1] The immediate side effect [within 30 seconds] following the 10/2 injection was an intense burning, hot sensation that started in my abdomen area and then traveled up into my upper chest [heart and lung areas] and throat. I informed the nurse of this side effect. She did not respond, nor check my vital signs, nor inform the ER physician. I sat there until this intense burning sensation diminished; and then I left the ER. [2] The next side effect happened about 30 minutes after the injection. I suddenly and rapidly developed major breathing problems, including forceful inhalation efforts and loud wheezing. My breathing was labored. In short order, my head and neck began to ache. There was a substantial tightness [in muscles] in the back of the neck, the sides around the head [very bad at the forehead, sinus areas]. My sinus areas felt blocked. Upper body nervousness and chills set in. My eyes were bloodshot; and my throat became more painful. These side effects continued for about 30 minutes. [3] The issues described in [2] lessened somewhat about noontime. I then tried to eat some lunch, but quickly developed nausea and a general feeling of illness. [4] Shortly thereafter, I became extremely agitated and irritable to any/all stimuli, including all touch and noise. My entire body felt like it was trembling in a significant way. There was obvious trembling in arms, hands and upper body. I then became very dizzy. The hot, burning sensation in the throat and upper chest/lungs continued. My whole body was weak. My eyes were bloodshot.
Age: 66.0
Sex: M
Vaccine: RAB
Symptoms: Sjogren's syndrome, Surgery, Tension headache, Tremor, Ulcer
Clinical narrative: The Side Effects [I was told that these side effects following the improper injection of Dose #3 on 10/2/12 of the Rabies vaccine were not reported to the CDC by the ER. [1] The immediate side effect [within 30 seconds] following the 10/2 injection was an intense burning, hot sensation that started in my abdomen area and then traveled up into my upper chest [heart and lung areas] and throat. I informed the nurse of this side effect. She did not respond, nor check my vital signs, nor inform the ER physician. I sat there until this intense burning sensation diminished; and then I left the ER. [2] The next side effect happened about 30 minutes after the injection. I suddenly and rapidly developed major breathing problems, including forceful inhalation efforts and loud wheezing. My breathing was labored. In short order, my head and neck began to ache. There was a substantial tightness [in muscles] in the back of the neck, the sides around the head [very bad at the forehead, sinus areas]. My sinus areas felt blocked. Upper body nervousness and chills set in. My eyes were bloodshot; and my throat became more painful. These side effects continued for about 30 minutes. [3] The issues described in [2] lessened somewhat about noontime. I then tried to eat some lunch, but quickly developed nausea and a general feeling of illness. [4] Shortly thereafter, I became extremely agitated and irritable to any/all stimuli, including all touch and noise. My entire body felt like it was trembling in a significant way. There was obvious trembling in arms, hands and upper body. I then became very dizzy. The hot, burning sensation in the throat and upper chest/lungs continued. My whole body was weak. My eyes were bloodshot.
Age: 66.0
Sex: M
Vaccine: RAB
Symptoms: Wheezing
Clinical narrative: The Side Effects [I was told that these side effects following the improper injection of Dose #3 on 10/2/12 of the Rabies vaccine were not reported to the CDC by the ER. [1] The immediate side effect [within 30 seconds] following the 10/2 injection was an intense burning, hot sensation that started in my abdomen area and then traveled up into my upper chest [heart and lung areas] and throat. I informed the nurse of this side effect. She did not respond, nor check my vital signs, nor inform the ER physician. I sat there until this intense burning sensation diminished; and then I left the ER. [2] The next side effect happened about 30 minutes after the injection. I suddenly and rapidly developed major breathing problems, including forceful inhalation efforts and loud wheezing. My breathing was labored. In short order, my head and neck began to ache. There was a substantial tightness [in muscles] in the back of the neck, the sides around the head [very bad at the forehead, sinus areas]. My sinus areas felt blocked. Upper body nervousness and chills set in. My eyes were bloodshot; and my throat became more painful. These side effects continued for about 30 minutes. [3] The issues described in [2] lessened somewhat about noontime. I then tried to eat some lunch, but quickly developed nausea and a general feeling of illness. [4] Shortly thereafter, I became extremely agitated and irritable to any/all stimuli, including all touch and noise. My entire body felt like it was trembling in a significant way. There was obvious trembling in arms, hands and upper body. I then became very dizzy. The hot, burning sensation in the throat and upper chest/lungs continued. My whole body was weak. My eyes were bloodshot.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dyspnoea, Headache
Clinical narrative: Throat swelled causing difficulty breathing, chills, fever, nausea, stomach cramps, headache, diarrhea.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pharyngeal oedema, Pyrexia
Clinical narrative: Throat swelled causing difficulty breathing, chills, fever, nausea, stomach cramps, headache, diarrhea.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report refers to one or more of 8 to 10 patients of unknown gender and age. Information was received from the registered nurse. She stated that PROQUAD (Merck) lot # J001052, expiration date: 28-JUL-2014 was stored in refrigerator 36F to 46F up to the middle of August. Improperly stored PROQUAD (Merck) was administered to one or more of 8 to 10 patients on 19-JUL-2013. No symptoms were reported. This case is linked with MARRS # 1310USA000176 MARRS # 1310USA000177 and MARRS # 1308USA014956 (Same Reporter link). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as receive from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that the patient received a dose of ZOSTAVAX (dose, route, site of administration, indication and lot number were not reported) on an unspecified date in December 2012 at an unspecified physician's office. The patient received a second dose of ZOSTAVAX (dose, route, site of administration, indication and lot number were not reported) on 31-AUG-2013. No adverse events were reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Acoustic stimulation tests, Speech disorder developmental
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 1 year old male patient. On 24-DEC-2012, the patient was vaccinated with a dose of MMR II (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Mother of the patient was concerned about the development of the patient and stated that there was a regression in language skills. It was reported that the patient said more words at 1 year of age than now (2013). The patient sought medical attention (office visit). The patient was sent for a hearing test. The outcome of the event was unknown.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with no drug reactions/allergies. Patient's pertinent medical history was none. On 23-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J003360, expiry date 21-JUN-2013) vial, 0.65 milliliter (ml), subcutaneous. Concomitant medications were none. On 23-SEP-2013, the patient developed redness and itching at injections site. No rash was present. Patient sought medical attention (called the pharmacist). Lab diagnostic test performed was none. The patient was treated with Benadryl. The outcome of redness and itching at injections site was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient developed an injections site reaction following administration of PNEUMOVAX23. The injections site reaction was described as a doubling of the arm at the site the PNEUMOVAX23 was administered. The outcome of injections site reaction was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report refers to one or more of 8 to 10 patients of unknown gender and age. Information was received from the registered nurse. She stated that PROQUAD (Merck) lot # J001052, expiration date: 28-JUL-2014 was stored in refrigerator 36F to 46F up to the middle of August. Improperly stored PROQUAD (Merck) was administered to one or more of 8 to 10 patients on 12-AUG-2013. No symptoms were reported. This case is linked with MARRS # 1310USA000175 MARRS # 1308USA014956 and MARRS # 1310USA000175(Same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report refers to one or more of 8 to 10 patients of unknown gender and age. Information was received from the registered nurse. She stated that PROQUAD (Merck) lot # J001052, expiration date: 28-JUL-2014 was stored in refrigerator 36F to 46F up to the middle of August. Improperly stored PROQUAD (Merck) was administered to one or more of 8 to 10 patients on 02-AUG-2013. No symptoms were reported. This case is linked with MARRS # 1310USA000175 MARRS # 1310USA000177 and MARRS # 1308USA014956 (Same reporter link). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This spontaneous report as received from a register nurse refers to her husband of unknown age. Pertinent medical history, drug reaction and allergies were not reported. On 19-SEP-2013 the patient was vaccinated with ZOSTAVAX. Concentration, route of administration and duration were not reported. Concomitant medications were not reported. On 19-SEP-2013, when the pharmacist inserted the needle into patient's arm, he felt a sting and pulled away and the needle came out. He was revaccinated successfully the second time (19-Sep-2013). The outcome of sting was unknown. The relationship between the adverse event and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. Medical history and drug allergies were not reported. On 23-SEP-2013, the patient was vaccinated with PNEUMOVAX23 lot # 672041/1477AA, 0.5 ml, intramuscular for an unknown indication. Concomitant medications were not reported. The PNEUMOVAX23 administered was expired. No adverse effects reported. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Started to itch one hour after she received vaccine. Took BENADRYL 25 mg - itching better.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Differential white blood cell count, Dysgeusia, Flushing
Clinical narrative: Patient went to emergency room after experiencing flushing, itching, nose/mouth tingling, diarrhea, weakness, hot flash, bad taste in mouth. The doctor gave her prednisone 50mg daily for 2 days.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Hot flush, Metabolic function test, Paraesthesia oral, Pruritus
Clinical narrative: Patient went to emergency room after experiencing flushing, itching, nose/mouth tingling, diarrhea, weakness, hot flash, bad taste in mouth. The doctor gave her prednisone 50mg daily for 2 days.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash generalised, Rash pruritic, Sluggishness, Vision blurred
Clinical narrative: Blurry vision on 09/29/2013, then on 09/30/2013, rash on torso, low grade fever, feeling sluggish, then on 10/01/2013, rash spread to entire body and itchy, patient sought medical attention.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Myalgias.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash. Patient developed a rash on chest, arms, and legs. Physician attributed rash to vaccine. Patient given diphenhydramine 50 mg IV once.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Excoriation, Mobility decreased, Pain, Swelling, X-ray limb
Clinical narrative: Sharp, stabbing pain, inability to raise arm, swelling with abrasion.
Age: 35.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Body temperature increased, Chills, Headache, Hyperhidrosis
Clinical narrative: Approximately 6 hrs post immunization with IIV3 and PPSV23, the patient reported onset of sweats/chillls, T = 102 degrees F, muscle aches, low back back, headache, tremulousness, nausea, and severe pain around injection sites (upper left arm/shoulder).  Pt. self-treated with acetaminophen.  On 9/28/13, T = 100.5 degrees F; symptoms listed above continued, but to a slightly lesser extent.  On the evening of 9/29/13, symtopms had resolved except for moderate pain, redness, swelling in the left arm at the injection sites.  On 9/30/13, pt. reports a mild headache and mild pain at injections sites; redness and swelling are diminishing.
Age: 35.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Nausea
Clinical narrative: Approximately 6 hrs post immunization with IIV3 and PPSV23, the patient reported onset of sweats/chillls, T = 102 degrees F, muscle aches, low back back, headache, tremulousness, nausea, and severe pain around injection sites (upper left arm/shoulder).  Pt. self-treated with acetaminophen.  On 9/28/13, T = 100.5 degrees F; symptoms listed above continued, but to a slightly lesser extent.  On the evening of 9/29/13, symtopms had resolved except for moderate pain, redness, swelling in the left arm at the injection sites.  On 9/30/13, pt. reports a mild headache and mild pain at injections sites; redness and swelling are diminishing.
Age: 35.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tremor
Clinical narrative: Approximately 6 hrs post immunization with IIV3 and PPSV23, the patient reported onset of sweats/chillls, T = 102 degrees F, muscle aches, low back back, headache, tremulousness, nausea, and severe pain around injection sites (upper left arm/shoulder).  Pt. self-treated with acetaminophen.  On 9/28/13, T = 100.5 degrees F; symptoms listed above continued, but to a slightly lesser extent.  On the evening of 9/29/13, symtopms had resolved except for moderate pain, redness, swelling in the left arm at the injection sites.  On 9/30/13, pt. reports a mild headache and mild pain at injections sites; redness and swelling are diminishing.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness
Clinical narrative: Dizziness, clammy for 20 minutes then dissipated with rest.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hyperhidrosis, Injection site erythema, Injection site pain, Rash macular
Clinical narrative: Injection site started to burn area became red and deltoid area tender to touch. Redness spread to shoulder, back, chest area and hairline with some blotches to face. C/o being diaphoretic.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Eye swelling, Pruritus
Clinical narrative: Itching exterior of throat, itching between fingers, extreme difficulty breathing, swelling around eyes.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Immediate post-injection reaction, Incorrect route of drug administration, Injected limb mobility decreased, Injection site pain
Clinical narrative: Vaccine appeared to be given too high in deltoid muscle.  Had immediate pain in shoulder. Over next 6 weeks had excruciating arm and shoulder pain and limited ROM.  Took 8-9 weeks for all pain to resolve.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Rash generalised, Rash pruritic
Clinical narrative: ITCHY UNCOMFORTABLE RASH THROUGHOUT BODY.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Nausea, Oropharyngeal pain, Throat irritation
Clinical narrative: Pt received Fluzone HD at 5pm and around 9:30pm starting complaining of burning sensation in throat and sore throat. Pt had diarrhea, nausea and vomiting and went to ER where they gave her a IV for dehydration. Pt was disharged later that evening.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Pt received Fluzone HD at 5pm and around 9:30pm starting complaining of burning sensation in throat and sore throat. Pt had diarrhea, nausea and vomiting and went to ER where they gave her a IV for dehydration. Pt was disharged later that evening.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: SWELLING ABOUT 2 INCHES REDNESS AND HOT AROUND THE SWOLLEN AREA.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Pruritus, Throat tightness
Clinical narrative: C/o itching on injection arm, chest constriction, and cough and throat tightening, reported back to health unit. Given 50ml Benadryl IM, O2 per mask and 911 called. Transported to ER via EMS.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Right after I received flu shot my are began to hurt.  Upper left shoulder VERY sore and painful.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient complained of pronounced burning on injection of the vaccine. Patient communicated to the vaccination administrator that this was different from what he had experienced with previous vaccinations.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Sending in separate email.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Rhinorrhoea
Clinical narrative: Within 20 minutes, brain was vibrating, or pulsing, 20 minutes later, servere headache started. By the next morning, I had severe dizziness, headache, brain fog, runny nose, and severe fatigue. This was my first flu shot.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Acute onset of muscle & joint pain, fever, headache, chills, sweating, weakness & fatigue.  Fever broke at 9:00 PM on 9/27/13. The following day my other symptoms were improved but not resolved.  I felt 100% when I awoke on 9/29/13.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Acute onset of muscle & joint pain, fever, headache, chills, sweating, weakness & fatigue.  Fever broke at 9:00 PM on 9/27/13. The following day my other symptoms were improved but not resolved.  I felt 100% when I awoke on 9/29/13.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Back pain, Cough, Ear pain, Eye irritation
Clinical narrative: 2:30pm: Bloodshot eyes, fatigue, cough. 4:00pm: Swollen tongue and lower lip, earaches. 8:00pm: Fever, abs and lower back pain. 11:00pm: Bloodshot and burning eyes, endless tearing.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Lacrimation increased, Lip swelling, Ocular hyperaemia, Pyrexia
Clinical narrative: 2:30pm: Bloodshot eyes, fatigue, cough. 4:00pm: Swollen tongue and lower lip, earaches. 8:00pm: Fever, abs and lower back pain. 11:00pm: Bloodshot and burning eyes, endless tearing.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: 2:30pm: Bloodshot eyes, fatigue, cough. 4:00pm: Swollen tongue and lower lip, earaches. 8:00pm: Fever, abs and lower back pain. 11:00pm: Bloodshot and burning eyes, endless tearing.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Chills, Fatigue, Pyrexia
Clinical narrative: Fever, chills, weak, tired.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Immediately following injection a large raised, red, hot to the touch, rash developed and spread over arm and down thorax to midline and bottom of rib cage.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Haemoglobin, Syncope
Clinical narrative: Fainted. Lasted only seconds, was sitting at the time. Had also had finger poke for hemoglobin. No injury occurred.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms
Clinical narrative: Muscle cramping in the legs. Enough to wake spouse up the first night. Then progressively worse. Now gone.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Hypersensitivity, Injection site reaction, Pruritus, Rash
Clinical narrative: CHIEF COMPLAINT: Allergic reaction HISTORY OF PRESENT ILLNESS: Patient is a 43 year old female seen with complaints of the below issues. Patient received her employee influenza vaccination today and within 15 minutes, began to have severe itching of her face, sensation of facial swelling, itching of her upper body.  No history of allergic reaction to influenza vaccination.  Denies lip, tongue, or throat swelling.  No wheezing, nausea, vomiting, dizziness, or any other associated symptoms.  REVIEW OF SYSTEMS:  Has a history of asthma, but no fever or wheezing. ALLERGIES: Review of patient's allergies indicates no known allergies. PHYSICAL EXAM: BP 112/80 | Pulse 75 | Temp 97.8 °F (36.6 °C) | SpO2 99%   General:  No apparent distress and appears stated age.    Eyes:  The conjunctiva are non-injected with no lid edema.  Exam of the pupils are equally round and reactive to light.  The irides appear normal. Mouth & Throat:  Exam of the oropharynx reveals no erythema or exudates of the tongue, tonsils, and mucosa. Neck:  Symmetrical with no masses or thyromegaly.    Respiratory:  Assessment of respiratory effort reveals no use of accessory muscles.  Auscultation reveals no wheezing bilaterally. Cardiovascular:  Auscultation of the heart reveals a regular rate and rhythm with no audible murmurs.  Exam of the extremities reveals no edema. Lymphatic:  There is no lymphadenopathy of the head or cervical regions. Musculoskeletal:  The patient exhibits a normal gait and station with no clubbing or cyanosis of the digits. Psychiatric:  Normal mood and affect.  Answers questions appropriately.   Skin:  1 cm erythematous macular rash on left deltoid injection site where bandaid was placed, very faint erythematous rash on back of neck.   ASSESSMENT AND PLAN: Likely systemic reaction to influenza vaccination.  She was given Benadryl 25 mg and observed for one hour.  Only residual was slight chin itching.  Rash resolved.  Vitals stable.  Will have her off from work today.  Will likely need to skin test with influenza vaccination next year, and if negative, give in 2 doses, 10%, and if no reaction after 30 minutes, 90% of dose.  If any worsening, new, or concerning symptoms, seek medical help immediately.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Rash macular, Swelling face
Clinical narrative: CHIEF COMPLAINT: Allergic reaction HISTORY OF PRESENT ILLNESS: Patient is a 43 year old female seen with complaints of the below issues. Patient received her employee influenza vaccination today and within 15 minutes, began to have severe itching of her face, sensation of facial swelling, itching of her upper body.  No history of allergic reaction to influenza vaccination.  Denies lip, tongue, or throat swelling.  No wheezing, nausea, vomiting, dizziness, or any other associated symptoms.  REVIEW OF SYSTEMS:  Has a history of asthma, but no fever or wheezing. ALLERGIES: Review of patient's allergies indicates no known allergies. PHYSICAL EXAM: BP 112/80 | Pulse 75 | Temp 97.8 °F (36.6 °C) | SpO2 99%   General:  No apparent distress and appears stated age.    Eyes:  The conjunctiva are non-injected with no lid edema.  Exam of the pupils are equally round and reactive to light.  The irides appear normal. Mouth & Throat:  Exam of the oropharynx reveals no erythema or exudates of the tongue, tonsils, and mucosa. Neck:  Symmetrical with no masses or thyromegaly.    Respiratory:  Assessment of respiratory effort reveals no use of accessory muscles.  Auscultation reveals no wheezing bilaterally. Cardiovascular:  Auscultation of the heart reveals a regular rate and rhythm with no audible murmurs.  Exam of the extremities reveals no edema. Lymphatic:  There is no lymphadenopathy of the head or cervical regions. Musculoskeletal:  The patient exhibits a normal gait and station with no clubbing or cyanosis of the digits. Psychiatric:  Normal mood and affect.  Answers questions appropriately.   Skin:  1 cm erythematous macular rash on left deltoid injection site where bandaid was placed, very faint erythematous rash on back of neck.   ASSESSMENT AND PLAN: Likely systemic reaction to influenza vaccination.  She was given Benadryl 25 mg and observed for one hour.  Only residual was slight chin itching.  Rash resolved.  Vitals stable.  Will have her off from work today.  Will likely need to skin test with influenza vaccination next year, and if negative, give in 2 doses, 10%, and if no reaction after 30 minutes, 90% of dose.  If any worsening, new, or concerning symptoms, seek medical help immediately.
Age: 11.0
Sex: F
Vaccine: HEP, HPV4, MNQ, TDAP, VARCEL
Symptoms: Nausea
Clinical narrative: Patient received vaccinations and sat for 5 minutes. When she got up to leave she said she was gonna throw up. I laid her down on exam table. She felt better BP 120/71. BP sitting up 110/61 and BP standing 101/64. She drank a cup of water and ate crackers since she hadn't eaten since breakfast. I walked her to her car and told her to go eat something and if symptoms worsen go to ER.
Age: 0.47
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RV5
Symptoms: Condition aggravated, Diarrhoea, Pyrexia, Rash
Clinical narrative: Fever, rash, diarrhea.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache
Clinical narrative: Complained of severe headache & fatigue lasting approximately 48 hours.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Patient received vaccinations and while sitting she stated she felt dizzy. I laid her on exam table and she felt better. BP 104/58.BP sitting 104/62 and BP standing 99/67. Patient drank water and ate crackers since she hadn't eaten since breakfast. I walked patient to car and stated to her to go eat something and if symptoms worsened to go to ER.