chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Dizziness, Pain, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23. On an unknown date in October-2012, the patient experienced high fever of 104 degrees, aches and pain, dizziness and excruciating pain in the armpit area after receiving the vaccination. The outcome of the events were unknown at the time of this report. This is one of the several reports received by the same reporter. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Dizziness, Pain, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a physician refers to a 41 year old male patient. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23. On an unknown date, the patient experienced high fever of 104 degrees, aches and pain, dizziness and excruciating pain in the armpit are after receiving the vaccination. The outcome of the events were unknown at the time of this report. This is one of the several reports received by the same reporter. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Dizziness, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a physician refers to a 40 year old male patient. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23. On an unknown date, the patient experienced high fever of 104 degrees, aches and pain, dizziness and excruciating pain in the armpit area after receiving the vaccination. The outcome of the events were unknown at the time of this report. This is one of the several reports received by the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Axillary pain, Dizziness, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23. On an unknown date, the patient experienced high fever of 104 degrees, aches and pain, dizziness and excruciating pain in the armpit area after receiving the vaccination. The outcome of the events were unknown at the time of this report. This is one of the several reports received by the same reporter. 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 doctor of pharmacy refers to two patients of unknown age and gender. It was reported that 2 patients were vaccinated with a dose of PNEUMOVAX 23 (Lot # reported as 09332, exp 25-FEB-2012) on 25-OCT-2012. No adverse symptoms were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was inadvertently vaccinated subcutaneously with a dose of VARIVAX (Merck) (dose and lot # not reported) instead of ZOSTAVAX on 23-OCT-2012. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Two years prior to the reporting date of 10-OCT-2012 the patient was vaccinated with dose 1 ZOSTAVAX, route of administration was not reported. The patient received a second dose of ZOSTAVAX on 10-OCT-2012, route of administration was not reported. No other co-suspects were reported. No concomitant medications were reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker. It was reported that on unspecified dates, 10 to 15 patients (unknown gender and age) had received a dose of possibly improperly stored ZOSTAVAX (dose, route and lot # not reported). No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Approximately 1 month ago on 08-SEP-2012, the patient was vaccinated with a dose of PNEUMOVAX23 (lot# and route not reported). No concomitant medications were reported. Approximately 1 month ago on 08-SEP-2012, the patient experienced persistent arm pain at the injection site since administration of PNEUMOVAX23. No treatment information was reported. The outcome of persistent arm pain at the injection site was unknown. Due to time constraints, the pharmacist was not able to address any additional questions. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with, .65 ml ZOSTAVAX on 31-OCT-2012 with and expire date of 09APR2012. No other co-suspects were reported. On 31-OCT-2012 the patient experienced expired drug used. No treatment information was reported. No adverse effects were reported. Expired drug used is not related to ZOSTAVAX. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: The primary reporter is a Field Representative. The representative was told by the RN (whow as also the patient) that he completed his treatment regimen with RECOMBIVAX and "did not show any evidence of vaccination on titer after completing the regiment".
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Member became diaphoretic, nauseous and lightheaded after receiving flu shot two hours prior. Sent to urgent care for further treatment.
Age: 1.14
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13-month-old, birth weight 7lbs/8ozs, male patient with no pre-existing physician diagnosed allergies, no birth defects and no medical conditions, no illness at the time of vaccination and no adverse event following prior vaccination. The patient was vaccinated with VARIVAX (Merck)(lot # 0569AE) subcutaneously on the right thigh on 24-SEP-2012 at 08:00 a.m. Other suspect therapies included first dose of HAVRIX (lot # AHAVB5228A, expiration date not reported) intramuscularly (IM) on the right thigh on 24-SEP-2012 at 08:00 a.m. and concomitant therapy included first dose of MMR II (lot # 669729/0104AA, expiration date 12-JAN-2012) albumin status of rHA (recombinant human albumin) intramuscularly on the left thigh on 24-SEP-2012 at 08:00 a.m. On 03-OCT-2012 at 10:00 a.m. the patient experienced rash near the injection site on the right thigh. The patient recovered from the event on an unknown date in October 2012. Additional information has been requested.
Age: 1.14
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Incorrect route of drug administration, Injection site rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13-month-old, birth weight 7lbs/8ozs, male patient with no pre-existing physician diagnosed allergies, no birth defects and no medical conditions, no illness at the time of vaccination and no adverse event following prior vaccination. The patient was vaccinated with VARIVAX (Merck)(lot # 0569AE) subcutaneously on the right thigh on 24-SEP-2012 at 08:00 a.m. Other suspect therapies included first dose of HAVRIX (lot # AHAVB5228A, expiration date not reported) intramuscularly (IM) on the right thigh on 24-SEP-2012 at 08:00 a.m. and concomitant therapy included first dose of MMR II (lot # 669729/0104AA, expiration date 12-JAN-2012) albumin status of rHA (recombinant human albumin) intramuscularly on the left thigh on 24-SEP-2012 at 08:00 a.m. On 03-OCT-2012 at 10:00 a.m. the patient experienced rash near the injection site on the right thigh. The patient recovered from the event on an unknown date in October 2012. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Blood test, Crying, Eye swelling, Lymphadenopathy, Oedema peripheral
Clinical narrative: Ok so we notice he had a bad break out of hives on his right arm, and it look like 1000 hives all over his arm then we took him to the E.R. then in the E.R. it broke out in his head and lymph nodes were swollen so they released us then we went to another E.R. AND THEY KEPT US OVERNIGHT BECAUSE OF FACE SWELLING and fear of him losing his breath so now we are in the other hospital right now on our 2nd day of him being monitered through out the night and im nervous so they gave us generic Benadryl and Zyrtec and topical cream that is not working well and his hives pop up at least every 6 hours and it bothers us the  parents he cries out loud and it seems like he is in pain when the breakout occur and the swelling of the eyes and hands and feet are scary.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Pain, Swelling face, Urticaria
Clinical narrative: Ok so we notice he had a bad break out of hives on his right arm, and it look like 1000 hives all over his arm then we took him to the E.R. then in the E.R. it broke out in his head and lymph nodes were swollen so they released us then we went to another E.R. AND THEY KEPT US OVERNIGHT BECAUSE OF FACE SWELLING and fear of him losing his breath so now we are in the other hospital right now on our 2nd day of him being monitered through out the night and im nervous so they gave us generic Benadryl and Zyrtec and topical cream that is not working well and his hives pop up at least every 6 hours and it bothers us the  parents he cries out loud and it seems like he is in pain when the breakout occur and the swelling of the eyes and hands and feet are scary.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Altered state of consciousness, Blood culture, CSF white blood cell count increased, Central venous catheterisation
Clinical narrative: My husband went home early from work because he was feeling achy all over on Tuesday 10/30/12. That afternoon I found him in what appeared to be deep sleep on his recliner. I went upstairs, thinking that he was asleep but then I heard noises. I immediately went down and found my husband with severe shaking of his whole body and he was moaning but he did not recognize me nor did he sound coherent. I called 911 and he was rushed to the emergency room. He had a high fever and his level of consciousness was extremely altered. He was evaluated for stroke, heart attack and other ailments. My husband received many antibiotics that he did not really need because the doctors did not know immediately what was going on. The doctors told me that some of the antibiotics have severe side effects. Everything came back negative except the cerebrospinal fluid was high in white blood cells. He continues to be on antibiotics, blood pressure medications and is being assisted on a ventilator. Heis being cared for by specialists in Neurology, Pulmonary Disease, and Infectious Disease. He is still very ill in the intensive care unit. I told all of his doctors about the flu vaccine that was administered exactly 7 days before the onset of this adverse reaction.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram head, Culture urine, Electroencephalogram, Encephalitis, Encephalitis viral
Clinical narrative: My husband went home early from work because he was feeling achy all over on Tuesday 10/30/12. That afternoon I found him in what appeared to be deep sleep on his recliner. I went upstairs, thinking that he was asleep but then I heard noises. I immediately went down and found my husband with severe shaking of his whole body and he was moaning but he did not recognize me nor did he sound coherent. I called 911 and he was rushed to the emergency room. He had a high fever and his level of consciousness was extremely altered. He was evaluated for stroke, heart attack and other ailments. My husband received many antibiotics that he did not really need because the doctors did not know immediately what was going on. The doctors told me that some of the antibiotics have severe side effects. Everything came back negative except the cerebrospinal fluid was high in white blood cells. He continues to be on antibiotics, blood pressure medications and is being assisted on a ventilator. Heis being cared for by specialists in Neurology, Pulmonary Disease, and Infectious Disease. He is still very ill in the intensive care unit. I told all of his doctors about the flu vaccine that was administered exactly 7 days before the onset of this adverse reaction.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gastrointestinal tube insertion, Incoherent, Intensive care, Laboratory test normal, Lumbar puncture
Clinical narrative: My husband went home early from work because he was feeling achy all over on Tuesday 10/30/12. That afternoon I found him in what appeared to be deep sleep on his recliner. I went upstairs, thinking that he was asleep but then I heard noises. I immediately went down and found my husband with severe shaking of his whole body and he was moaning but he did not recognize me nor did he sound coherent. I called 911 and he was rushed to the emergency room. He had a high fever and his level of consciousness was extremely altered. He was evaluated for stroke, heart attack and other ailments. My husband received many antibiotics that he did not really need because the doctors did not know immediately what was going on. The doctors told me that some of the antibiotics have severe side effects. Everything came back negative except the cerebrospinal fluid was high in white blood cells. He continues to be on antibiotics, blood pressure medications and is being assisted on a ventilator. Heis being cared for by specialists in Neurology, Pulmonary Disease, and Infectious Disease. He is still very ill in the intensive care unit. I told all of his doctors about the flu vaccine that was administered exactly 7 days before the onset of this adverse reaction.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Malaise, Mechanical ventilation, Moaning, Nuclear magnetic resonance imaging spinal, Pain
Clinical narrative: My husband went home early from work because he was feeling achy all over on Tuesday 10/30/12. That afternoon I found him in what appeared to be deep sleep on his recliner. I went upstairs, thinking that he was asleep but then I heard noises. I immediately went down and found my husband with severe shaking of his whole body and he was moaning but he did not recognize me nor did he sound coherent. I called 911 and he was rushed to the emergency room. He had a high fever and his level of consciousness was extremely altered. He was evaluated for stroke, heart attack and other ailments. My husband received many antibiotics that he did not really need because the doctors did not know immediately what was going on. The doctors told me that some of the antibiotics have severe side effects. Everything came back negative except the cerebrospinal fluid was high in white blood cells. He continues to be on antibiotics, blood pressure medications and is being assisted on a ventilator. Heis being cared for by specialists in Neurology, Pulmonary Disease, and Infectious Disease. He is still very ill in the intensive care unit. I told all of his doctors about the flu vaccine that was administered exactly 7 days before the onset of this adverse reaction.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: My husband went home early from work because he was feeling achy all over on Tuesday 10/30/12. That afternoon I found him in what appeared to be deep sleep on his recliner. I went upstairs, thinking that he was asleep but then I heard noises. I immediately went down and found my husband with severe shaking of his whole body and he was moaning but he did not recognize me nor did he sound coherent. I called 911 and he was rushed to the emergency room. He had a high fever and his level of consciousness was extremely altered. He was evaluated for stroke, heart attack and other ailments. My husband received many antibiotics that he did not really need because the doctors did not know immediately what was going on. The doctors told me that some of the antibiotics have severe side effects. Everything came back negative except the cerebrospinal fluid was high in white blood cells. He continues to be on antibiotics, blood pressure medications and is being assisted on a ventilator. Heis being cared for by specialists in Neurology, Pulmonary Disease, and Infectious Disease. He is still very ill in the intensive care unit. I told all of his doctors about the flu vaccine that was administered exactly 7 days before the onset of this adverse reaction.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Central venous catheterisation, Electroencephalogram normal, Intensive care, Mechanical ventilation, Moaning
Clinical narrative: My husband went home early from work because he was feeling achy all over on Tuesday 10/30/12. That afternoon I found him in what appeared to be deep sleep on his recliner. I went upstairs, thinking that he was asleep but then I heard noises. I immediately went down and found my husband with severe shaking of his whole body and he was moaning but he did not recognize me nor did he sound coherent. I called 911 and he was rushed to the emergency room. He had a high fever and his level of consciousness was extremely altered. He was evaluated for stroke, heart attack and other ailments. My husband received many antibiotics that he did not really need because the doctors did not know immediately what was going on. The doctors told me that some of the antibiotics have severe side effects. Everything came back negative except the cerebrospinal fluid was high in white blood cells. He continues to be on antibiotics, blood pressure medications and is being assisted on a ventilator. Heis being cared for by specialists in Neurology, Pulmonary Disease, and Infectious Disease. He is still very ill in the intensive care unit. I told all of his doctors about the flu vaccine that was administered exactly 7 days before the onset of this adverse reaction.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Tremor, Unresponsive to stimuli
Clinical narrative: My husband went home early from work because he was feeling achy all over on Tuesday 10/30/12. That afternoon I found him in what appeared to be deep sleep on his recliner. I went upstairs, thinking that he was asleep but then I heard noises. I immediately went down and found my husband with severe shaking of his whole body and he was moaning but he did not recognize me nor did he sound coherent. I called 911 and he was rushed to the emergency room. He had a high fever and his level of consciousness was extremely altered. He was evaluated for stroke, heart attack and other ailments. My husband received many antibiotics that he did not really need because the doctors did not know immediately what was going on. The doctors told me that some of the antibiotics have severe side effects. Everything came back negative except the cerebrospinal fluid was high in white blood cells. He continues to be on antibiotics, blood pressure medications and is being assisted on a ventilator. Heis being cared for by specialists in Neurology, Pulmonary Disease, and Infectious Disease. He is still very ill in the intensive care unit. I told all of his doctors about the flu vaccine that was administered exactly 7 days before the onset of this adverse reaction.
Age: 7.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Injection site swelling, Pyrexia
Clinical narrative: Swelling at the vaccine site, over the entire deltoid, collarbone, and down to antecubital fossa. Patient then developed fevers for ~48 hr post-vaccine.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Severe hives, severe itch, redness on right breast, entire stomach area, right thigh, back, between breast bone, neck, under chin, left side of neck.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on both arms.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Significant pain, swelling, and redness at the injection site. Symptoms of fatigue and body aches. 48 hours after the vaccine was administered, the injection site is still extremely swollen and red.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Apparent life threatening event
Clinical narrative: PT ADMITTED TO HOSPITAL FOR LIFE THREATENING ANAPHALAXIS.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Herpes zoster
Clinical narrative: Developed shingles 9 days after zoster vaccine administration.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Pale, sweaty, headache, nausea.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Felt very dizzy; the room was spinning when I lied down to go to sleep. Upon awakening at 6 AM, I still felt dizzy and slightly nauseated. Symptoms have subsided (it's 12:45 PM) but I still feel waves of dizziness if I lie down or move my head too suddenly.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Body temperature decreased, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Tired, achy, headache, neck hurts, nausea, stomach cramps, temp of 95.9, sweating. 1st time receiving flu shot.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Neck pain, Pain
Clinical narrative: Tired, achy, headache, neck hurts, nausea, stomach cramps, temp of 95.9, sweating. 1st time receiving flu shot.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injection site pain, Pain, Sleep disorder
Clinical narrative: Extraordinary pain in the shoulder at the site of the injection. The injection was for an influenza vaccine.  Pain is felt intensely with any movement. Very difficult and painful to put on a shirt. Impossible to sleep on the side the shot was given on. Very painful and symptoms have been recurring for 2 months now. Symptoms started immediately after recieving the flu shot.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Feeling of body temperature change, Pain, Pyrexia
Clinical narrative: Woke up with severe aches and pains all over. He said he was freezing, but he was very hot and feverish. He was shivering. He woke up several times throughout the night with the same symptoms. He felt better during the day, but still had the aches and pains, no more fever.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Lethargy, Pain, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, ache, lethargic.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Redness, hot, swelling, hard in the area injected, and sore muscle.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Redness, hot, swelling, hard in the area injected, and sore muscle.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 23 years old female patient. Patient's current conditions included asthma and SUPREX allergy. The patient's medical history included depression, anxiety disorder and attention deficit-hyperactivity disorder (ADHD). On 27-SEP-2012, the patient was vaccinated intramuscularly with 0.5 ml dose of PNEUMOVAX23 (lot # 672369/1850AA, expiry:28-JUL-2013) and was also vaccinated intradermally in the left arm with a dose of Influenza Virus Vaccine (manufacturer unknown)(lot # not reported). Concomitant medications included WELLBUTRIN, TOPAMAX, oral hormonal contraceptives (unspecified) and budesonide, SYMBICORT. On 27-SEP-2012, the patient experienced headache, vomiting, nausea, fever and extreme swelling of her right arm at the injection site after receiving PNEUMOVAX23. The patient went to the emergency room, where she was treated with unspecified pain medication and released after about 3 hours. On an unspecified date an unspecified white blood cell count test was performed with elevated result. The patient was recovering from headache, fever, nausea, vomiting and injection site swelling. The outcome of elevated white blood cell count was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: White blood cell count increased
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 23 years old female patient. Patient's current conditions included asthma and SUPREX allergy. The patient's medical history included depression, anxiety disorder and attention deficit-hyperactivity disorder (ADHD). On 27-SEP-2012, the patient was vaccinated intramuscularly with 0.5 ml dose of PNEUMOVAX23 (lot # 672369/1850AA, expiry:28-JUL-2013) and was also vaccinated intradermally in the left arm with a dose of Influenza Virus Vaccine (manufacturer unknown)(lot # not reported). Concomitant medications included WELLBUTRIN, TOPAMAX, oral hormonal contraceptives (unspecified) and budesonide, SYMBICORT. On 27-SEP-2012, the patient experienced headache, vomiting, nausea, fever and extreme swelling of her right arm at the injection site after receiving PNEUMOVAX23. The patient went to the emergency room, where she was treated with unspecified pain medication and released after about 3 hours. On an unspecified date an unspecified white blood cell count test was performed with elevated result. The patient was recovering from headache, fever, nausea, vomiting and injection site swelling. The outcome of elevated white blood cell count was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Feeling hot, Nausea, Urticaria
Clinical narrative: Ten minutes following her first flu shot, patient returned complaining of pain in her chest and feeling hot and nauseous. We called 911 while observing her and questioning about medical history, etc. Paramedics arrived in 15 minutes and confirmed hives on her spine and administered diphenhydramine and took her for observation.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Three days after vaccine administered patient states she has hives on some parts of her body. Hypersensitivity reaction, slight itching.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Large raised welt around injection site approximately 1 1/2" in diameter. Painful and itchy. Hydrocortisone cream applied. Still visible as of 11/2/12 - 2 months later.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Rash pruritic, Skin warm
Clinical narrative: Patient states that she got a bump that is warm to touch and very itchy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. On 16-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX, intramuscularly (also reported as unknown route) (dose and lot number unspecified) that had expired on 18-AUG-2012. No concomitant medications were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. On 03-OCT-2012, the patient was vaccinated with a dose of 0.5 milliliter PNEUMOVAX 23, intramuscularly and another dose was given on 04-OCT-2012 (lot number unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to an approximately 73 years old female patient with no drug reactions or allergies. On an unspecified date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # and route not reported). No concomitant medications were reported. On an unknown date, the patient experienced rash. No treatment information was reported. The outcome of rash was unknown. The patient experienced similar adverse events with ZOSTAVAX and AFLURIA 1210USA004391 and 1210USA004394. Additional information is not expected.
Age: 50.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of drug administration, Measles antibody negative, Viral titre decreased
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 50-year-old male patient with no drug reactions or allergies and no pertinent medical history. The patient was vaccinated with, 0.5 millimeter (ml) MMR II (lot # 0680AE, expiration date 02-APR-2014) intramuscularly (IM) on 04-OCT-2012. No concomitant medications were reported. Nurse mentioned a patient may have received MMR II in the past and titers done approximately on an unknown date in September 2012 (a month ago) showed low or non-existent titers for measles. The patient had a titer done because he was going to travel and did not remember if he received MMR II. The patient received MMR II IM instead of subcutaneous (SQ) and had no adverse reactions. The patient sought medical attention by office visit. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Musculoskeletal discomfort, Parotitis
Clinical narrative: This spontaneous report as received from a registered nurse refers to an approximately 2-year-old female patient with no known allergies and no pertinent medical history. On 07-OCT-2010 the patient was vaccinated with dose 1, 0.5 milliliter M-M-R II (lot # not reported) subcutaneously in the left arm. Concomitant medications included: diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) te) (reported as DtAP. On 31-OCT-2010 patient presented to the doctor office with a lump on the left side of the neck. Patient was then taken to the emergency room (ER) for follow-up and was diagnosed with Parotitis, which ER staff stated was caused by the M-M-R II. Patient was not hospitalized. On an unknown date the patient recovered from the event. Nurse stated that she was awaiting the reports of the ER for further data. The event Parotitis is related to M-M-R II. Treatment information was unspecified by the reporter. The patient sought medical attention, came into office and went to ER. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hypertension, Nausea, Pain
Clinical narrative: Headache, aching body, nausea, hypertension, dizziness, blurred vision.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Headache, aching body, nausea, hypertension, dizziness, blurred vision.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Intensive care, Laboratory test normal, Oropharyngeal pain, Pain in extremity
Clinical narrative: Gradual onset of sore throat & fever starting on day 1, then gradual onset of severe painful B/L hand/feet paresthesia on day 8, then rapid onset of petechaie & purpura on face, hands, feet, back, & oropharynx on day 10; ED workup on day 10 indicated all labs WNL except platelet count 4,000; pt admitted to ICU, improved to 38,000 after 2 day course of Solu-Medrol, discharged on prednisone taper; hand/feet pain resolving, numbness remains in all fingers, purpura resolving gradually, with scabs peeling from hands, face, EACs and nares.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Petechiae, Platelet count decreased, Purpura, Pyrexia
Clinical narrative: Gradual onset of sore throat & fever starting on day 1, then gradual onset of severe painful B/L hand/feet paresthesia on day 8, then rapid onset of petechaie & purpura on face, hands, feet, back, & oropharynx on day 10; ED workup on day 10 indicated all labs WNL except platelet count 4,000; pt admitted to ICU, improved to 38,000 after 2 day course of Solu-Medrol, discharged on prednisone taper; hand/feet pain resolving, numbness remains in all fingers, purpura resolving gradually, with scabs peeling from hands, face, EACs and nares.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Scab, Skin exfoliation
Clinical narrative: Gradual onset of sore throat & fever starting on day 1, then gradual onset of severe painful B/L hand/feet paresthesia on day 8, then rapid onset of petechaie & purpura on face, hands, feet, back, & oropharynx on day 10; ED workup on day 10 indicated all labs WNL except platelet count 4,000; pt admitted to ICU, improved to 38,000 after 2 day course of Solu-Medrol, discharged on prednisone taper; hand/feet pain resolving, numbness remains in all fingers, purpura resolving gradually, with scabs peeling from hands, face, EACs and nares.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Spinal disorder
Clinical narrative: Severe back ache that continues.  12 days after and my spine is still killing me.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Patient had redness, swelling and pain at the injection site, with pain in the arm pit as well; Lymphadenopathy noted on the left arm.
Age: 50.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Asthenia, Body temperature fluctuation, Hyperaesthesia, Influenza like illness, Injection site pain
Clinical narrative: On Saturday, November 3rd my temperature fluctuated between 100.7 and 102.2 degrees.  I was extremely sore at the injection site, achy, flu-ish and extremely weak. As of today, Sunday, November 4th, my temperature is below 100 degrees, but I still feel very, very weak and I have a 4-6" diameter spot that looks like a sunburn at the site of the injection.  It is very hot and sensitive to the touch. I have been on 500 mg of Azithromycin and 750 mg Levofloxacin since Friday, October 26th, 2012 so I don't think it is an infection.
Age: 50.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site reaction, Injection site warmth, Pain
Clinical narrative: On Saturday, November 3rd my temperature fluctuated between 100.7 and 102.2 degrees.  I was extremely sore at the injection site, achy, flu-ish and extremely weak. As of today, Sunday, November 4th, my temperature is below 100 degrees, but I still feel very, very weak and I have a 4-6" diameter spot that looks like a sunburn at the site of the injection.  It is very hot and sensitive to the touch. I have been on 500 mg of Azithromycin and 750 mg Levofloxacin since Friday, October 26th, 2012 so I don't think it is an infection.
Age: 22.0
Sex: M
Vaccine: UNK
Symptoms: Pallor, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Pale skin, fainting spell with shaking approxiamtely 30 seconds unresponsive.  Oxygen administered via non-rebreather at 15 LPM. Physician evaluated and vitals were reassessed prior to release to escort.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Pruritus, Rash, Throat tightness
Clinical narrative: Developed rash on arms and itching, progressed to shortness of breath and to feeling of throat closing. EMS called.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Dyspnoea, Rash, Throat tightness
Clinical narrative: Developed rash on arms and itching, progressed to shortness of breath and to feeling of throat closing. EMS called.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Red, swelling, pain, lump at injection site.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Pruritus, Urticaria
Clinical narrative: Pt experienced itching on hands, then raised hives on neck, eyelids and got puffy then itching on belly and legs. MD suggested to take 2 Benadryl 25mg. Pt saw MD at about 3:30 pm.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Bone disorder, Culture, Culture positive, Injection site abscess, Injection site movement impairment
Clinical narrative: 3-4 weeks after vaccines given, patient with swelling of thigh and not moving it.  He was otherwise acting well, no fever, no erythema, eating well, no tenderness.  Plain film showed periosteal elevation.  MRI showed muscle abscess.  Patient admitted for IV antibiotics.  Diagnosed with MSSA left quadricep abscess and left femur osteomyelitis.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site swelling, Muscle abscess, Nuclear magnetic resonance imaging abnormal, Osteomyelitis, Staphylococcal abscess
Clinical narrative: 3-4 weeks after vaccines given, patient with swelling of thigh and not moving it.  He was otherwise acting well, no fever, no erythema, eating well, no tenderness.  Plain film showed periosteal elevation.  MRI showed muscle abscess.  Patient admitted for IV antibiotics.  Diagnosed with MSSA left quadricep abscess and left femur osteomyelitis.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: X-ray abnormal
Clinical narrative: 3-4 weeks after vaccines given, patient with swelling of thigh and not moving it.  He was otherwise acting well, no fever, no erythema, eating well, no tenderness.  Plain film showed periosteal elevation.  MRI showed muscle abscess.  Patient admitted for IV antibiotics.  Diagnosed with MSSA left quadricep abscess and left femur osteomyelitis.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Bacterial test positive, Biopsy bone, Incisional drainage, Injection site abscess, Injection site pain
Clinical narrative: 3-4 weeks after vaccines given, patient with swelling of thigh and not moving it.  He was otherwise acting well, no fever, no erythema, eating well, no tenderness.  Plain film showed periosteal elevation.  MRI showed muscle abscess.  Patient admitted for IV antibiotics.  Diagnosed with MSSA left quadricep abscess and left femur osteomyelitis.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site swelling, Myositis, Nuclear magnetic resonance imaging abnormal, Oedema peripheral, Staphylococcus test positive
Clinical narrative: 3-4 weeks after vaccines given, patient with swelling of thigh and not moving it.  He was otherwise acting well, no fever, no erythema, eating well, no tenderness.  Plain film showed periosteal elevation.  MRI showed muscle abscess.  Patient admitted for IV antibiotics.  Diagnosed with MSSA left quadricep abscess and left femur osteomyelitis.
Age: 0.11
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: X-ray limb abnormal
Clinical narrative: 3-4 weeks after vaccines given, patient with swelling of thigh and not moving it.  He was otherwise acting well, no fever, no erythema, eating well, no tenderness.  Plain film showed periosteal elevation.  MRI showed muscle abscess.  Patient admitted for IV antibiotics.  Diagnosed with MSSA left quadricep abscess and left femur osteomyelitis.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Decreased appetite, Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Morning after vaccine red area around injection site approximately 3 inches in diameter, swollen, hot, hard mass. Fever, sleepiness, irritability, loss of appetite, pain in leg. Saw Dr at pediatric urgent care Sunday 11/4/2012 received antibiotics for possible infection. Unable to say for sure if it is an infection or vaccine reaction. Told to follow up with Dr this wed 11/7/2012.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth, Irritability, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Morning after vaccine red area around injection site approximately 3 inches in diameter, swollen, hot, hard mass. Fever, sleepiness, irritability, loss of appetite, pain in leg. Saw Dr at pediatric urgent care Sunday 11/4/2012 received antibiotics for possible infection. Unable to say for sure if it is an infection or vaccine reaction. Told to follow up with Dr this wed 11/7/2012.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain, Pain
Clinical narrative: Debilitating shoulder pain in the arm where the shot was given - especially with lateral raise movement and inward rotation. The shot was given much higher in my arm than I ever remember it being given before - I don't know if it was that or the shot itself. It has not resolved or improved in almost 3 weeks. I will go see my physician this week. I've had discomfort with flu shots before, but never more than a few days and never debilitating like this.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Injection sight reaction, area as large as "baseball" red with edema.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Pain, Palpitations
Clinical narrative: Apr. 6 hours after vaccine pt had SOB, racing heart, dizzy, aches and pains, lasted for 2 hours, did not go to ER.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Vaginal discharge
Clinical narrative: Miscarriage (spontaneous abortion). 3:00PM vaginal discharge. 3:30PM call doctors for advice. 4:30PM arrive at ER. 4:30PM~8PM tests performed, evaluated by Dr. Diagnosed "Spontaneous Abortion".
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Severe, debilitating headache, now continuing on for over 24 hours after vaccination.  Patient not normally prone to headaches. Injection site sore.  Muscle underlying injection site stiff.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Dizziness, Lethargy, Pyrexia
Clinical narrative: Fever, light headedness, diarrhea, lethargy, slightly impaired cognitions.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Epistaxis
Clinical narrative: My daughter received a flu shot about an hour and half or so after getting the injection her nose started bleeding.  She was not in the heat or doing anyting that would cause er nose to bleed. Today 11/04/12 she experienced nose bleed again.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: Left shoulder pain with most movement.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TD, HEPA, HPV4, TD
Symptoms: Abdominal pain upper
Clinical narrative: Severe stomach pain.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TD, HEPA, HPV4, TD
Symptoms: Conjunctivitis infective, Eye swelling, Ocular hyperaemia
Clinical narrative: Severe stomach pain.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TD, HEPA, HPV4, TD
Symptoms: Abdominal pain upper
Clinical narrative: Pink eye symptoms/swollen red eye.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TD, HEPA, HPV4, TD
Symptoms: Conjunctivitis infective, Eye swelling, Ocular hyperaemia
Clinical narrative: Pink eye symptoms/swollen red eye.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Pruritus, Rash, Tenderness
Clinical narrative: A small raised area like a rash that itched and was painful to the touch, the next morning, there were 6 spots and the next morning, they covered his upper back and chest.  He went to the doctor and was diagnosed with shingles and given the antiviral medication.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Bronchitis, Chest discomfort, Cough, Dysphonia, Respiratory disorder
Clinical narrative: Sudden onset of what felt like a deep respiratory illness similar to bronchitis. Included coughing, hoarseness, and a feeling of tightness in my chest when I breath. I did not take any treatment or seek medical attention. I drank a lot of water and went to bed and it was gone by morning. I didn't connect it to the flu shot until now but it was very strange to have an illness come on so strong and so quickly and then to be gone just as fast. I had the DTAP vaccine at the same time as the flu shot earlier that afternoon.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Aphagia, Dysphagia, Mumps, Pain, Swelling face
Clinical narrative: After applying the DTaP, MMR, POLIO, VARICELLA vaccines, to be more specific, on day number four, my four year son woke up with the left side of his face swollen with severe pain and with swallowing problem. And to make it worse a week later the same thing happened to the right side. It should be mentioned during this days he could not eat or drink anything.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Myalgia
Clinical narrative: Redness and induration at injection site, myalgias, diarrhea.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test negative, Anaphylactic reaction, Dysphonia, Dyspnoea, Pharyngeal oedema
Clinical narrative: Swelling of throat and tongue, difficulty breathing, hoarseness, anaphylaxis.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Swelling of throat and tongue, difficulty breathing, hoarseness, anaphylaxis.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Extremely painful at time of injection and still cannot lift arm without extreme pain and arm and fingers go numb.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a registered nurse. It was reported that in 2011, "over the last year", 3 to 4 patients developed redness and swelling at injection site after receiving PNEUMOVAX 23. Lot# were unspecified. All patients received an influenza virus vaccine (unspecified) at the same time that PNEUMOVAX 23 was administered. No exact date reported. The outcome of patients were unknown. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Chills, Injection site pain, Injection site swelling, Malaise, Nausea
Clinical narrative: Patient seen 4 Nov 2012 for suspected vaccine reaction from DTaP given 3 Nov 12. On 3 Nov 12 evening patient developed nausea, chills & not feeling well. No SOB, swelling lips or tongue. Patient (R) arm deltoid painful. On day of exam, patient still with (R)  deltoid pain 5x2cm swelling. No chills but did not feel well. No meds taken. Recommend BENADRYL 50mg at HS & CLARITIN 10mg or ZYRTEC QD x 7D.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Quarter-sized, red rash persisted at injection site for 2 weeks post-injection.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Patient came in on 10/31 to ask about side effects on arm. Pt said arm was swollen, very tender to touch & painful. I recommended BENADRYL, ice pack & ibuprofen. When I called patient on 11/4 to check up on her, she said she broke her fever (low grade) the evening she spoke to me & started to feel better. Redness & swelling are almost gone. Minor tenderness. No MD visit required. Patient says she is feeling better.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Patient received PNEUMOVAX on 10-22. On 10-23-12, she developed a rash from shoulder to elbow in the left arm. Rash was red, raised and warm and covered arm - not just injection site.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness transient, Feeling cold, Tinnitus
Clinical narrative: Vaccine was administered. Approximately 5 minutes later patient complained of temporary vision loss and ringing of ears. Had patient sit down and gave water. Patient complained of feeling cold, but vision had improved and he never lost consciousness.