chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypersensitivity, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Allergic reaction from shingles shot Friday. Received Shingle vaccination Friday on left deltoid muscle. Saturday, developed painful red lump on left upper arm with redness and itchiness, fever/chills. Per patient, also with painful lymph nodes left under arm. Left upper arm (deltoid) with redness, indurated. Vitals: most recent BMI: 31.4 Temp: 98.8 F [37.1 C] (08/05/2013 10:21) Pulse: 97 (08/05/2013 10:21) Resp: 18 (08/05/2013 10:21) BP: 135/75 (08/05/2013 10:21) Pain: 8 (08/05/2013 10:21) Pulse oximetry: Measurement DT POx.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Lymph node pain, Pyrexia
Clinical narrative: Allergic reaction from shingles shot Friday. Received Shingle vaccination Friday on left deltoid muscle. Saturday, developed painful red lump on left upper arm with redness and itchiness, fever/chills. Per patient, also with painful lymph nodes left under arm. Left upper arm (deltoid) with redness, indurated. Vitals: most recent BMI: 31.4 Temp: 98.8 F [37.1 C] (08/05/2013 10:21) Pulse: 97 (08/05/2013 10:21) Resp: 18 (08/05/2013 10:21) BP: 135/75 (08/05/2013 10:21) Pain: 8 (08/05/2013 10:21) Pulse oximetry: Measurement DT POx.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding approximately 175 unspecified patients of unknown age and gender. There was no information on medical history and drug reactions or allergies. On an unknown date, the patients were vaccinated with PROQUAD (Merck) (strength, dose, route not reported) that were exposed to temperatures outside of the recommended storage range. No adverse effect reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiry date were not reported) that was improperly stored on unknown date. No adverse event was reported. This one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist via other company (Pfizer manufacturer control number 2014282049) refers to an elderly male patient (>65 years). The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (route, lot number and expiration date were not provided); and at same time patient received a dose of PREVNAR 13 (route, lot number and expiration date were not provided). The pharmacist stated that then he read that it should be given spaced apart and queried what were the ramifications of giving at same time. No further information was provided. Additional information has been requested
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 20-OCT-2014 the patient was vaccinated with an expired dose of MMR II Batch: J018945, lot # 1505AA, expiration date: 18-OCT-2014, 0.5 ml, subcutaneous. No adverse effects were reported. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 84 year old male patient. On 15-OCT-2014 (reproted as today) the patient was vaccinated with PNEUMOVAX 23, injection (lot # J004080, expiry: 22-AUG-2014), 0.5 ml, right deltoid. It was reported that the patient was administered with expired PNEUMOVAX23 and also reported that potency supported and no adverse effects were noted by patient. No product quality complaint (PQC) was involved. The outcome of the events was unknown. No other information was reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. The patient had none pertinent medical history and none drug reactions or allergies. On 20-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 lot # K004281, expiration date: 22-MAR-2015 in the arm (dose, route of administration were not reported). The patient did not take any concomitant medications. On an unspecified date in October 2014 (reported as last night), the patient began to experience discomfort at the injection site. The pharmacist reported that the discomfort changed to pain and itching overnight and then in the morning, on 21-OCT-2014, the patient began to experience redness at the injection site and swelling in the injection arm's biceps area, along with pain and itching. The pharmacist also reported that, on 21-OCT-2014 (reported as "now") the swelling has spread down to the patient's elbow. The patient applied a cool compress to his arm this afternoon to treat the symptoms. There was none lab diagnostics studies performed. The patient sought medical attention by coming back to pharmacy. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and the vaccination with PNEUMOVAX 23 was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. On 20-OCT-2014, the patient was vaccinated with RECOMBIVAX H B (dose, route of administration were not reported), lot # J008505, expiry date: 07-FEB-2016) that was improperly stored on unknown date. No adverse event was reported. This one of many several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEPAB
Symptoms: Haemoptysis
Clinical narrative: This case was reported by a pharmacist and described the occurrence of coughing up blood in a 31-year-old male patient who received TWINRIX (batch number 3EX72, expiry date 22nd March 2016). On 23rd September 2014 15:00, the patient received TWINRIX (intramuscular) 1 ml. On 24th September 2014, less than a day after receiving TWINRIX, the patient experienced coughing up blood. On an unknown date, the outcome of the coughing up blood was unknown. It was unknown if the reporter considered the coughing up blood to be related to TWINRIX. Additional information received: On 24 September 2014, the patient coughed up blood in the morning, when he woke up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates since 10-SEP-2014 the patients were vaccinated with doses of ROTATEQ oral (strength, dose and lot # were not reported). These vaccine were exposed to a supported temperature excursion which occurred from 10-SEP-2014 until 11-SEP-2014. No adverse effects were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient. No medical history or concurrent conditions were reported. On 22-SEP-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous route (1 time shot; Lot number reported as: K007984). Co-suspect or concomitant therapies were reported. On approximately 2014, reported as after receiving ZOSTAVAX, the patient experienced rash 2 inches in diameter at the injection site. Patient sought medical attention. At the time of the report, the outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Blister, Cellulitis, Injection site rash, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient. No medical history or concurrent conditions were reported. On 22-SEP-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous route (1 time shot; Lot number reported as: K007984). Co-suspect or concomitant therapies were reported. On approximately 2014, reported as after receiving ZOSTAVAX, the patient experienced rash 2 inches in diameter at the injection site. Patient sought medical attention. At the time of the report, the outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient. No medical history or concurrent conditions were reported. On 22-SEP-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous route (1 time shot; Lot number reported as: K007984). Co-suspect or concomitant therapies were reported. On approximately 2014, reported as after receiving ZOSTAVAX, the patient experienced rash 2 inches in diameter at the injection site. Patient sought medical attention. At the time of the report, the outcome of the event was unknown. The causal relationship between the event and ZOSTAVAX was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A) refers to a male patient of unknown age. Concomitant medication, pertinent medical history, drug reactions and allergies were not reported. On 03-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 0.5ml, intramuscular, lot # K007773 expiry date 01-MAY-2015, (dose was not reported), that had been improperly stored, No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. On 25-SEP-2014, the patient was vaccinated with a dose of (Merck) VARIVAX lot # J004812, expiration date 18-APR-2015 (route was not provided). On 25-SEP-2014, the patient received improperly stored (Merck) VARIVAX. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. Additional information is not expected. No further information is available.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Red area about size of a half dollar and now spread to greater part of upper arm. Some itching, used hydrocortisone and ice packs.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: (R) arm swollen, red and hot to touch.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other registered nurse refers to a 5 year old patient. On 15-MAR-2011, the patient was vaccinated with the first dose of (Merck) VARIVAX (dose and lot # not reported) subcutaneously. On 19-SEP-2014, the patient received a second dose of (Merck) VARIVAX (dose and lot # not reported) subcutaneously and on 06-OCT-2014, the patient received a third dose of (Merck) VARIVAX (dose and lot # not reported) subcutaneously. No known adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A) refers to a male patient of unknown age. Concomitant medication, pertinent medical history, drug reactions and allergies were not reported. On 03-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 0.5ml, intramuscular, lot # K007773 expiry date 01-MAY-2015, (dose was not reported), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. On 20-JAN-2014, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly and on 23-OCT-2014, the patient was vaccinated with the second 0.5 ml dose of GARDASIL (Lot # K004204 exp 12-JAN-2017) intramuscularly. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. In October 2014, the patient was vaccinated with the second dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). In September 2014 patient was vaccinated with the first dose of dose of ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported. No adverse effect reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Diarrhoea, Rash, Rash macular, Urticaria
Clinical narrative: Pt. developed hives about 12-24 hrs after vaccines (see attached) including large welt at site of PV13 ??? any contraindications to boosters?? Patient is in because of rash that developed to day, and perhaps a little last night. She received her routine vaccinations yesterday, and this morning mom noted a blotch rash on most of her stomach, as well as in the area of the shot on her (L) leg. On the way to the office, she also began breaking out on her face. She had cream cheese and another kind of cheese yesterday for the first time, and also had a little diarrhea yesterday morning. Mom gave her some (purple) acetaminophen after the shot yesterday, before the rash started...one dose. She has had it once before without a reaction. No hx insect bites or previous such rashes.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from an unspecified reporter, refers to a female patient in her 50's with no medical conditions or allergies. In approximately 2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported, lot # J011714, expiration date: 20-FEB-2015). It was reported that the recommended dose was given to the patient. On an unknown date in approximately 2014 the patient experienced reactions on her left arm: redness, swelling, warm to touch. She caller her doctor on 15-OCT-2014 and the doctor prescribed her antibiotics (unspecified). The outcome of the events was reported as recovering/resolving (reported as "she is OK now".) Relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: This spontaneous report as received from an unspecified reporter, refers to a female patient in her 50's with no medical conditions or allergies. In approximately 2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were not reported, lot # J011714, expiration date: 20-FEB-2015). It was reported that the recommended dose was given to the patient. On an unknown date in approximately 2014 the patient experienced reactions on her left arm: redness, swelling, warm to touch. She caller her doctor on 17-OCT-2014 and the doctor prescribed her antibiotics (unspecified). The outcome of the events was reported as recovering/resolving (reported as "she is OK now"). Relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.06
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Convulsion, Electroencephalogram
Clinical narrative: Pt had a seizure 6 days after MMR was given. No previous neuro history.
Age: 46.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 46 year old male patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, strength, dose and route not reported). The patient complained of pain and unspecified swelling at injection site of the ZOSTAVAX on an unspecified date. The outcome of "pain and unspecified swelling at injection site" was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse regarding approximately 175 unspecified patients of unknown age and gender. There was no information on medical history and drug reactions or allergies. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (strength, dose, route not reported) that were exposed to temperatures outside of the recommended storage range. No adverse effect reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Antibody test, Blood thyroid stimulating hormone, Borrelia test, C-reactive protein
Clinical narrative: Mom states "has #2 HPV 1 mo. after HPV #1". Since then c/o belly issues, fatigue - however appt in Aug '14 day rec'd HPV #1 child and parent c/o belly issues and fatigue now mom claims this all happened after GARDASIL #2.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fatigue, Full blood count, Glycosylated haemoglobin, Laboratory test, Red blood cell sedimentation rate
Clinical narrative: Mom states "has #2 HPV 1 mo. after HPV #1". Since then c/o belly issues, fatigue - however appt in Aug '14 day rec'd HPV #1 child and parent c/o belly issues and fatigue now mom claims this all happened after GARDASIL #2.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Thyroxine free, Tri-iodothyronine
Clinical narrative: Mom states "has #2 HPV 1 mo. after HPV #1". Since then c/o belly issues, fatigue - however appt in Aug '14 day rec'd HPV #1 child and parent c/o belly issues and fatigue now mom claims this all happened after GARDASIL #2.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: 9/20/14 approx 1800 noticed numbness/tingling to bilat hands from wrists - circumferential. Temperature sensitive - burning sensation to hot/cold/wind. Lasted approx 2 wks. Also - numbness/tingling bilat toes. 10/14/14 noted thoracic right sided numbness/tingling on back. Size of approx 3" x 6" area.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from nurse regarding approximately 175 unspecified patients of unknown age and gender. There was no information on medical history and drug reactions or allergies. On an unknown date, the patients were vaccinated with ZOSTAVAX (strength, dose, route not reported) that were exposed to temperatures outside of the recommended storage range. No adverse effect reported. There was no product quality complaint involved. The outcome of the events was unknown. This is one of the several reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Swelling
Clinical narrative: Pt. reported redness and swelling experienced 24-48 hours after vaccination. She described it being like "an egg", and the swelling was over an area of about 6 inches in diameter around the site of injection. At 72 hours - post-vaccine, swelling subsided.
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received vaccine on 10/16/14 in left thigh. Pt presented with red, tender spot on same thigh. Around 10/20/14 area doubled in size, became puffy and tender.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Infection, Pain, Pyrexia, Rash
Clinical narrative: Swelling, soreness, low-grade fever, MD stated it is infected (cellulitis), rash on torso.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling, soreness, low-grade fever, MD stated it is infected (cellulitis), rash on torso.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Mom states that the girl was vaccinated on 21 Oct. 2014 with KINRIX, MMR & Varicella. Her right arm is swollen and warm.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus generalised
Clinical narrative: 1645 - client called complaining of itching all over her body. No fever, no rash. 10-21-2014 200AM Client had symptoms (itchy) for about 5 hrs stopped about 7AM.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Injection site pain, Injection site swelling
Clinical narrative: 10/1/14 That night "felt funny". Next day 10/2/14 - (L) upper arm swollen/no redness, no fever. Arm cont. to hurt mildly during day - worse at night.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Some redness and pain on palpation on (L) upper arm.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Fatigue, Heart rate increased, Pain in extremity
Clinical narrative: Painful arm (L) aches for a month plus; fast heartbeats; weakness; fatigue etc.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient had no drug reactions/allergies. On 22-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# K0091998, expiration date 27-SEP-2015, dose 0.65 ml, subcutaneously in the right upper arm). Concomitant medications were not provided(reported as "Nothing immunosuppressive"). The pharmacist reported that the patient was reporting she had what appeared to be e vesicular rash on her "flank and chest" on 23-OCT-2014. The patient reported to the pharmacist that a nurse, who worked at the facility where the patient worked, observed the rash and told the patient that the rash "looks like shingles." The patient sought medical attention by calling the pharmacy and asking a pharmacist what she should do about her rash. The pharmacist did not observe the rash, nor did the patient described any other symptoms to the pharmacist. At the time of this report, the pharmacist did not think that the patient had notified her healthcare provider. No treatment was given for the event. No lab diagnostics studies were performed. Outcome of the event was reported as not recovered. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Erythema, Headache, Nausea, Pain
Clinical narrative: Swelling, pain, headache, nausea, hot to touch, redness, vision troubles, shaky, difficulty breathing.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Swelling, Tremor, Visual impairment
Clinical narrative: Swelling, pain, headache, nausea, hot to touch, redness, vision troubles, shaky, difficulty breathing.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy, Blindness, Decreased appetite, Diabetes mellitus, Disorientation
Clinical narrative: Swelling, pain, headache, nausea, hot to touch, redness, vision troubles, shaky, difficulty breathing.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Infection, Injection site swelling, Local swelling, Vision blurred
Clinical narrative: Swelling, pain, headache, nausea, hot to touch, redness, vision troubles, shaky, difficulty breathing.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist and a 52 year old female patient refers to the patient. The patient had no drug allergies/reactions. On 18-SEP-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 ( lot # K009809, expiration date 16-MAY-2015), 0.5 ml, subcutaneous and a dose of ZOSTAVAX (dose, frequency, lot number # J013449, expiration date 24-JAN-2015) 0.5 ml, subcutaneous in the same arm. Concomitant therapies included VENTOLIN INHALER.On 19-SEP-2014, the patient experienced fever of 103F within 4 hours of receiving the above vaccine and a very swollen and red right arm from the shoulder to the elbow after receiving PNEUMOVAX 23 and ZOSTAVAX. Patient stated that she developed this "tickle" in her chest which made her cough and she noticed this feeling of tickle after vaccination with PNEUMOVAX 23 and ZOSTAVAX. On Monday (date unspecified) after vaccination, patient went to see her physician and she was prescribed prednisone for 5 days however, after she finished 5 day course of prednisone, her cough came back and she was having bronchial spasm and asthma-like symptoms. Patient said she never had history of asthma. Patient went back to physician on unspecified date and received budesonide, SYMBICORT, SINGULAIR and unspecified rescue inhaler for asthma-like symptoms and patient tried these medications for a week but her asthma-like symptoms did not improve much (MARRS# 1410USA015413) and she was put on another course of prednisone and she will be finishing prednisone in a couple of days. The patient was treated with prednisone and triamcinolone cream. At the time of reporting, the outcome of fever, swollen and red right arm from the shoulder to the elbow was unknown. The outcome of tickle in her chest, cough, bronchial spasm and asthma-like symptoms was not recovered. The causality of the events was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Asthma, Bronchospasm, Chest discomfort, Cough, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist and a 52 year old female patient refers to the patient. The patient had no drug allergies/reactions. On 18-SEP-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 ( lot # K009809, expiration date 16-MAY-2015), 0.5 ml, subcutaneous and a dose of ZOSTAVAX (dose, frequency, lot number # J013449, expiration date 24-JAN-2015) 0.5 ml, subcutaneous in the same arm. Concomitant therapies included VENTOLIN INHALER.On 19-SEP-2014, the patient experienced fever of 103F within 4 hours of receiving the above vaccine and a very swollen and red right arm from the shoulder to the elbow after receiving PNEUMOVAX 23 and ZOSTAVAX. Patient stated that she developed this "tickle" in her chest which made her cough and she noticed this feeling of tickle after vaccination with PNEUMOVAX 23 and ZOSTAVAX. On Monday (date unspecified) after vaccination, patient went to see her physician and she was prescribed prednisone for 5 days however, after she finished 5 day course of prednisone, her cough came back and she was having bronchial spasm and asthma-like symptoms. Patient said she never had history of asthma. Patient went back to physician on unspecified date and received budesonide, SYMBICORT, SINGULAIR and unspecified rescue inhaler for asthma-like symptoms and patient tried these medications for a week but her asthma-like symptoms did not improve much (MARRS# 1410USA015413) and she was put on another course of prednisone and she will be finishing prednisone in a couple of days. The patient was treated with prednisone and triamcinolone cream. At the time of reporting, the outcome of fever, swollen and red right arm from the shoulder to the elbow was unknown. The outcome of tickle in her chest, cough, bronchial spasm and asthma-like symptoms was not recovered. The causality of the events was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist and a 52 year old female patient refers to the patient. The patient had no drug allergies/reactions. On 18-SEP-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 ( lot # K009809, expiration date 16-MAY-2015), 0.5 ml, subcutaneous and a dose of ZOSTAVAX (dose, frequency, lot number # J013449, expiration date 24-JAN-2015) 0.5 ml, subcutaneous in the same arm. Concomitant therapies included VENTOLIN INHALER.On 19-SEP-2014, the patient experienced fever of 103F within 4 hours of receiving the above vaccine and a very swollen and red right arm from the shoulder to the elbow after receiving PNEUMOVAX 23 and ZOSTAVAX. Patient stated that she developed this "tickle" in her chest which made her cough and she noticed this feeling of tickle after vaccination with PNEUMOVAX 23 and ZOSTAVAX. On Monday (date unspecified) after vaccination, patient went to see her physician and she was prescribed prednisone for 5 days however, after she finished 5 day course of prednisone, her cough came back and she was having bronchial spasm and asthma-like symptoms. Patient said she never had history of asthma. Patient went back to physician on unspecified date and received budesonide, SYMBICORT, SINGULAIR and unspecified rescue inhaler for asthma-like symptoms and patient tried these medications for a week but her asthma-like symptoms did not improve much (MARRS# 1410USA015413) and she was put on another course of prednisone and she will be finishing prednisone in a couple of days. The patient was treated with prednisone and triamcinolone cream. At the time of reporting, the outcome of fever, swollen and red right arm from the shoulder to the elbow was unknown. The outcome of tickle in her chest, cough, bronchial spasm and asthma-like symptoms was not recovered. The causality of the events was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Started experiencing severe arm pain which runs from my neck to my fingertips, numbness in fingers. Have seen my family doctor who prescribed pain medication, am currently awaiting appointment with orthopedic doctor, and a nerve specialist. My insurance company has denied an MRI, which my doctor referred. Am currently suffering with severe pain.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Started experiencing severe arm pain which runs from my neck to my fingertips, numbness in fingers. Have seen my family doctor who prescribed pain medication, am currently awaiting appointment with orthopedic doctor, and a nerve specialist. My insurance company has denied an MRI, which my doctor referred. Am currently suffering with severe pain.
Age: 57.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Conjunctival haemorrhage, Hypertension, Injection site cellulitis, Injection site infection, Injection site pain
Clinical narrative: Pt. reported redness at site of injection to urgent care Doctor along w/ increased blood pressure and broken eye capillary.
Age: 57.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Ocular hyperaemia
Clinical narrative: Pt. reported redness at site of injection to urgent care Doctor along w/ increased blood pressure and broken eye capillary.
Age: 57.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Blood pressure increased, Capillary fragility, Injection site erythema
Clinical narrative: Pt. reported redness at site of injection to urgent care Doctor along w/ increased blood pressure and broken eye capillary.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness
Clinical narrative: Dizziness beginning several hours after injection and lasting for 4 days.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Convulsion, Headache, Lethargy, Loss of consciousness, Nausea
Clinical narrative: Almost immediately had headache, progressed through the evening. Became lethargic, nauseated. She went to bed at 9:30 after "passing out" on the couch.  She was checking on son during the night at 1:30 am.  She passed out, and had a seizure. Called Rescue Squad, taken to ED, given IV fluids.  No cause found.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Drug administered at inappropriate site, Joint stiffness
Clinical narrative: Joint pain and stiffness after resting arm for awhile. The shot was administered directly under acromion process, not 2-3 finger widths down. No treatment sought, yet. Waiting to see if there is improvement over time. Taking ibuprofen at night to sleep. Pain is the not improving five days later.
Sex: M
Vaccine: FLU3
Symptoms: Blindness, Thrombosis
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 20-Oct-2014) concerns a male patient. On an unspecified date, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient developed a blood clot in his eye. Initially, the patient experienced a loss of vision. The blood clot resolved and his vision was completely restored. Outcome was reported as recovered.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Blister, Erythema
Clinical narrative: Blister a little smaller than a dime. Has since grown a little and gotten very red including a dark red ring around it.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Headache, Syncope, Vaccination site induration, Vaccination site warmth
Clinical narrative: Patient was in the bathroom at home when she felt dizzy and fainted.  Afterwards she was very dizzy and lightheaded. Patient reports 10/29/14 of bad headache and area where vaccine (Pneumovax) was given she says area is warm and has a hard spot. Also received Fluzone same day in different arm.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site urticaria
Clinical narrative: Reports reaction appeared as a 3.5 inch radius red itchy edematous wheal around injection site. Area remained red and itchy for 5 days, decreasing daily.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Musculoskeletal chest pain
Clinical narrative: My right arm where injection was given still hurts badly, the pain has also gone into my ribs. I can't raise my arm up over my head, I can't sleep on right side as it hurts. I know there is some soreness for a few days. This is 3 weeks of pain not lessening at all.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Patient received Fluzone HD around 2:45 PM. Around 10-11 PM, she said she started vomiting and it continued for several days.  She was really nauseous and had a slight fever.  She reported the incidence to her physician and her physician advised her to tell the pharmacy so that we could report it.  Her physician did not give her any treatment.  She said she started feeling a little better on the 27th.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 34-year-old female subject was enrolled in a study. On 15th October 2014, the subject received Flu Seasonal QIV Dresden .5 ml. On an unknown date, an unknown time after receiving Flu Seasonal QIV Dresden the subject developed exposure during pregnancy (Non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the exposure during pregnancy to be related to Flu Seasonal QIV Dresden.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 34-year-old female subject was enrolled in a study during pregnancy or within 28 days preceding conception. On 15 th October 2014, the subject received Flu QIV .5 ml. On an unknown date, an unknown time after receiving Flu QIV the subject developed exposure during pregnancy (non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing.
Age: 0.77
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Fever average of 101 10/24/14 - 10/27/14 and rash about an inch in diameter around injection site during those dates. Rash spread to neck area 10/27/14 then on 10/28/14 spread to entire chest, stomach, back, upper legs. Rash is still present as of 10/29/14.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient complained of soreness and redness at injection site.
Age: 16.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Covered in hives all over chest, back, legs, face.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Patient broke out over large area of body.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Dizziness, Malaise, Myalgia, Oropharyngeal pain
Clinical narrative: Myalgia in upper arms, upper back, and neck.  Slightly sore throat, slight light headedness began 10/28/2014 around 5PM.  Generalized malaise and myalgia began 10/29/2014 around 6AM.  Taking ibuprofen for discomfort.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Chills, Headache, Oropharyngeal pain, Pyrexia, Tremor
Clinical narrative: Shaking chills, fever, sore throat, headache. All symptoms relieved by ibuprofen.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Fatigue, Headache, Pain, Palatal oedema
Clinical narrative: Achy, headache, fatigue at first. The following day on 10/29/2014 I woke up about 4:00 AM because my uvula was very swollen making it difficult to swallow.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 33-year-old female subject was enrolled in a study. On 8th October 2014, the subject received the 1st dose of Flu Seasonal QIV Dresden (injection). Concomitant products included no therapy (None) and Vitamins. the subject's last menstrual period was on 22nd July 2014 and estimated date of delivery was 30th April 2015. The subject received Flu Seasonal QIV Dresden at week 11 of the pregnancy and during the first trimester of pregnancy. On 8th October 2014, an unknown time after received Flu Seasonal QIV Dresden the subject developed exposure during pregnancy (Non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the exposure during pregnancy to be related to Flu Seasonal QIV Dresden. Additional details: Caller stated she received the FLUARIX QUADRIVALENT vaccine last week at her job, it was administered by the Employee Health Department at her job. She doesn't know the dose that was given or the lot and expiration date of the product.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Autism
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of autism in a 2-year-old male patient who received PEDIARIX (batch number AC21B201AA, expiry date March 2011). Previously administered products included PEDIARIX with an associated reaction of no adverse event (Batch number AC21B201AA, expiry date March 2011), PREVNAR with an associated reaction of no adverse event (Batch number D06803, expiry date 01 May 2011), ROTATEQ with an associated reaction of no adverse event (Batch number 1271X, expiry date 23 May 2010) and Hepatitis B vaccine with an associated reaction of no adverse event. Concomitant products included PEDIARIX, PREVNAR, ROTATEQ and ranitidine. On 23rd April 2009, the patient received the 3rd dose of PEDIARIX (unknown). On an unknown date, the dose was an unknown dose. In July 2011, 2 years and 69 days after receiving PEDIARIX, the patient experienced autism (serious criteria disability, GSK medically significant and clinically significant/intervention required). On an unknown date, the outcome of the autism was unknown. The reporter considered the autism to be probably related to PEDIARIX. Additional information: A patient received a first Hepatitis B vaccine at birth and then later received 3 doses of PEDIARIX at 2, 4 and 6 months. The dates of PEDIARIX administration were 12/17/2008 (upper thigh), 02/26/2009 (right upper thigh), and 04/23/2009. The dosages were unknown. The patient was diagnosed with autism in July 2011. The patient's mother is not sure if PEDIARIX caused the autism but she thinks it probably at least contributed. She was never told by the doctor office that her son would be receiving additional doses of Hepatitis B and therefore extra aluminum with the PEDIARIX. She would feel more comfortable if GSK had actual studies that infants getting extra Hepatitis B is safe. Instead, our data is limited and yet we still market the vaccine to physician offices to administer in children like her son. The reporter reported another case of autism after vaccination with PEDIARIX. See case US2014011246.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Autism
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of autism in a female patient who received PEDIARIX. Previously administered products included Hepatitis B vaccine with an associated reaction of no adverse event (At birth). On an unknown date, the patient received PEDIARIX (unknown). On an unknown date, unknown after receiving PEDIARIX, the patient experienced autism (serious criteria GSK medically significant). On an unknown date, the outcome of the autism was not reported. It was unknown if the reporter considered the autism to be related to PEDIARIX. Additional information received: The daughter of the reporter's friend received a Hepatitis B vaccine at birth and then later received extra doses of Hepatitis B with PEDIARIX. The patient now has autism. The reporter also reported the case of her own son who experienced autism after vaccination with PEDIARIX. See case US2014011245.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 31-year-old female subject was enrolled in a study during pregnancy or within 28 days preceding conception. On 15th October 2014, the subject received Flu QIV .5 ml. On an unknown date, an unknown time after receiving Flu QIV the subject developed exposure during pregnancy (Non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the exposure during pregnancy to be related to Flu QIV.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Abnormal behaviour, Cough, Erythema, Lethargy, Nasal congestion
Clinical narrative: His preschool noticed he was not acting like his normal self, he started to look warm so they took his temperature and he had a 101 degree fever. For the next 2 days he was lethargic, red cheeked and had a fever between 101-103. He got a "cold" symptoms, stuffy/runny nose, sneezing, a few coughs for the week following.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Nasopharyngitis, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: His preschool noticed he was not acting like his normal self, he started to look warm so they took his temperature and he had a 101 degree fever. For the next 2 days he was lethargic, red cheeked and had a fever between 101-103. He got a "cold" symptoms, stuffy/runny nose, sneezing, a few coughs for the week following.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye pain, Eye pruritus, Fatigue, Headache
Clinical narrative: Sore red, itchy eyes; cough; fever; aches; sore throat and sinus drainage; fatigue; headaches. Treated with ibuprofen, Afrin. This has been ongoing since 10/25 and symptoms are just subsiding today 10/29.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Pain, Paranasal sinus hypersecretion, Pyrexia
Clinical narrative: Sore red, itchy eyes; cough; fever; aches; sore throat and sinus drainage; fatigue; headaches. Treated with ibuprofen, Afrin. This has been ongoing since 10/25 and symptoms are just subsiding today 10/29.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Swollen tongue
Clinical narrative: Tongue swelling and sore throat.  Patient took an Allegra with some partial sx relief.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Chills, Chromaturia, Dehydration, Fatigue
Clinical narrative: I received both the flu and pneumonia shots on my left arm a couple inches apart. After a few hours I had a very sore shot sight and very sore neck pain. Later that night I had flu like symptoms such as; headache, body aches, chills, fever, fatigue that lasted for two days. I was also very dehydrated and my urine was a dark brown color. I also had a swollen arm/shoulder and could not move my arm. The swelling moved down my arm about three inches. It was painful to touch and very warm. It is now 8 days later and I still have a sore bump where the injection sight is. I called the clinic and they suggested I go to the ER where I could possibly get an IV for the dehydration. At the ER they released me with the diagnoses of cellulitis of the arm and an allergic reaction. I went home with pain killers and an antibiotic. On 10/22/2014 I woke up with a terrible headache and neck pain. I was seen at the ER because I thought it was because of the shot. I was diagnosed with a tension headache caused from all the stress my body was under.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Hypersensitivity, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: I received both the flu and pneumonia shots on my left arm a couple inches apart. After a few hours I had a very sore shot sight and very sore neck pain. Later that night I had flu like symptoms such as; headache, body aches, chills, fever, fatigue that lasted for two days. I was also very dehydrated and my urine was a dark brown color. I also had a swollen arm/shoulder and could not move my arm. The swelling moved down my arm about three inches. It was painful to touch and very warm. It is now 8 days later and I still have a sore bump where the injection sight is. I called the clinic and they suggested I go to the ER where I could possibly get an IV for the dehydration. At the ER they released me with the diagnoses of cellulitis of the arm and an allergic reaction. I went home with pain killers and an antibiotic. On 10/22/2014 I woke up with a terrible headache and neck pain. I was seen at the ER because I thought it was because of the shot. I was diagnosed with a tension headache caused from all the stress my body was under.