chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. In September 2012, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) that expired on 30-AUG-2012. No other co-suspects and no concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. This case has been cross referenced with case 1210USA004308 and 1211USA000608, which concerned 2 patients which received the same expired vaccine (no adverse event was reported in these 2 cases either). Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure during pregnancy, Vaccination failure, Varicella post vaccine
Clinical narrative: This spontaneous prospective pregnancy report as received from a healthcare worker via a company representative refers to a female patient of unknown age. The patient was vaccinated with first and second dose of VARIVAX (Merck) (dates, dose, route and Lot # were not reported). On an unknown date the patient became pregnant (LMP and EDD unknown). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date "greater than 2 weeks" age, 56 patients had Chicken Pox due to vaccine failure. 23 patients had two doses of VARIVAX (MARRS case #1211USA001359 and MARRS case #1211USA001898 respectively, Same reporter link). One of the 23 patients was reported to be pregnant (current case). There was no correlation between lot number, age or provider. No treatment information was reported. The outcome of vaccine failure, chicken pox and Vaccine exposure during pregnancy is unknown. The relatedness for vaccine failure and chicken pox was not reported for VARIVAX (Merck). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Myalgia, Oedema peripheral
Clinical narrative: This spontaneous report as received from an other health professional refers to a 65 years old female patient. The patient's medical history included drug allergy to sulfa, drug allergy to iodine, drug allergy to codeine, ULTRAM and drug allergy to hydrocodone. The patient had no pertinent medical history. The patient was vaccinated intramuscularly with dose 1, 0.5 ml, PNEUMOVAX23 (no lot number was provided) on 30-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The health professional reports that the patient who received a dose of PNEUMOVAX23 on 30-OCT-2012, developed myalgia, redness and swelling of the arm within 20 minutes following vaccination. The health professional reports that the patient returned to the practice on 02-NOV-2012, and that the arm appeared bruised, red and swollen down the upper arm. And past the elbow onto a portion of the forearm. No warmth or fever noted. The outcome of the adverse events, was reported as not recovered/not resolved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient. The patient was vaccinated with, .5 ml PNEUMOVAX23 (route unknown, dose 0.5 ml, product Lot number H013581, expiry 03-MAR-2014) on 02-NOV-2012. No other co-suspects were reported. Concomitant medications Baby Aspirin. On 02-NOV-2012 the patient experienced little was swelling around injection site and induration around injection site, both after receiving PNEUMOVAX23. No treatment information was reported. The outcome of little swelling around injection site and induration around injection site was reported as not recovered/not resolved. The reporters relatedness for little swelling around injection site and induration around injection site is unknown for PNEUMOVAX23. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 years old male patient with no pertinent medical history. The patient was vaccinated with ZOSTAVAX on an unspecified date 2 years ago. No other co-suspects were reported. No concomitant medications were reported. The patient has experienced several recurrent episodes of shingles since administration of ZOSTAVAX on an unspecified date 2 years ago. No treatment information was reported. The outcome of several recurrent episodes of shingles was reported as recovered/resolved. The relatedness for several recurrent episodes of shingles was unknown for ZOSTAVAX. Additional information has not been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to 33 patients of unknown age and gender. On an unknown date the patients were vaccinated with (Merck) VARIVAX (dose, route and Lot # were not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date "greater than 2 weeks" ago, 56 patients had Chicken Pox due to vaccine failure. 23 patients had two doses of VARIVAX (MARRS case # 1211USA001898, Same reporter link). One of the 23 patients was reported to be pregnant (MARRS case # 1211USA001899, Same reporter link). There was no correlation between lot number, age or provider. No treatment information was reported. The outcome of vaccine failure and chicken pox is unknown. The relatedness for vaccine failure and chicken pox was not reported for (Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On 08-OCT-2012, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) that expired on 30-AUG-2012. No other co-suspects and no concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. This case has been cross referenced with case 1210USA004308 and 1211USA000607, which concerned 2 patients who received the same expired vaccine (no adverse event was reported in these 2 cases either). Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a healthcare worker via a company representative refers to 22 patients of unknown age and gender. The patients were vaccinated with first and second dose of VARIVAX (Merck) (dates, dose, route and lot # were not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date "greater than 2 weeks"age, 56 patients had chicken pox due to vaccine failure (MARRS case # 1211USA001359, same reporter link). 23 patients had two doses of VARIVAX (of which 22 are covered by the current case). One of the 23 patients was reported to be pregnant (MARRS case # 1211USA001899, same reporter link). There was no correlation between lot number, age or provider. No treatment information was reported. The outcome of vaccine failure and chicken pox is unknown. The relatedness for vaccine failure and chicken pox was not reported for VARIVAX (Merck). Additional information has been requested.
Age: 1.41
Sex: F
Vaccine: FLU3, HIBV, MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 16 months old female patient. The patient was vaccinated with M-M-R II on 08-NOV-2012. Lot# was reported as H012142 with expiration date on 29-JUN-2014. It was reported that the M-M-R II was exposed to 60 degrees Fahrenheit for 12 hours. This was unsupported storage conditions and M-M-R II should not had been administered. No adverse effect reported. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 94 years old female patient, who on unspecified date received the second dose of ZOSTAVAX (dose, route and lot # not reported) at the patient's pharmacy (unspecified). In checking the patient's records she had received the ZOSTAVAX in 2008. No adverse event was reported. The patient did not seek 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 a registered pharmacist concerning an unknown number of patients who on unspecified dates were vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not provided). The pharmacist reported that an unknown number of doses of VARIVAX (Merck) that were transported between their facilities on dry ice, "possibly" below -58 degrees F (exact temperatures unknown) had been administered to an unknown number of patients. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Nodule, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a female patient of unknown age, who on an unknown date was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. NO concomitant medications were reported. On 02-NOV-2012 the patient experienced redness, swelling and "hard knot" in the arm that the ZOSTAVAX was administered. No treatment was given for the events. At the time of reporting the outcome of the events was unknown. Patient did not seek medical assistance. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient was vaccinated with a dose of ZOSTAVAX (lot number unspecified) in on an unknown date. Route was not reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, very soon after getting vaccinated, the patient developed "shingles like blisters". No treatment information was reported. The patient sought medical attention (unspecified). The outcome of the event was not provided. This is 1 of 2 reports from the same source (other case ID 1211USA002570). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 years old female patient with anemia and sulfa allergy. The patient was vaccinated with pneumococcal vaccine (manufacturer unknown and PNEUMOVAX 23 could not be ruled out) in approximately May 2011 "2 and 1/2 years ago" for doctor's recommendation. Route and lot # were unspecified. On the same day as vaccination, the patient experienced right arm blew up from swelling that was from the shoulder to down the elbow. BENADRYL was given as treatment. The patient was recovered on an unspecified date. The patient sought medical attention via offer visit. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old male patient with asthma. The patient was vaccinated with ZOSTAVAX (lot# unspecified) on 04-JUL-2012 ("one week ago"). No concomitant medications were reported. In 2012 the patient had a asthma exacerbation. The pharmacist didn't think the patient's symptoms were related to the ZOSTAVAX. The patient brought prescriptions to the pharmacy for MEDROL, ipratropium bromide, albuterol, SPIRIVA and DULERA. Pharmacist said the ZOSTAVAX was administered at a different Pharmacy. No treatment information was reported. The outcome of asthma exacerbation was unknown. The patient had sought medical attention via office visit. Additional information has been requested.
Age: 0.09
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 4 weeks old patient. The patient was vaccinated with a dose of M-M-R II on 04-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient. The patient was vaccinated with the first 2 ml dose of ROTATEQ (lot number unspecified) orally on 05-NOV-2012, when he was 31 days old. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient was vaccinated with a dose of ZOSTAVAX (lot number unspecified) in July 2011. Route was not reported. No other co-suspects were reported. No concomitant medications were reported. "Recently" the patient came down with shingles. No treatment information was reported. The patient sought medical attention (not specified). The outcome of shingles was not provided. This is 1 of 2 reports from the same source (other case ID 1211USA004986). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient is experiencing redness and soreness in the arm where she got the ZOSTAVAX injection. She has not checked with a doctor about this but has a regular appointment soon and will discuss then. Patient declined to be transferred to submit report. This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced redness of the arm where ZOSTAVAX was injected and soreness at injection site. No treatment information was reported. The outcome of redness of the arm where ZOSTAVAX was injected and soreness at injection site is unknown. The relatedness for redness of the arm where ZOSTAVAX was injected is unknown for ZOSTAVAX. 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 registered pharmacist concerning an unknown number of patients who on unspecified dates were vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). The pharmacist reported that an unknown number of doses of ZOSTAVAX that were transported between their facilities on dry ice, "possibly" below -58 degrees F (exact temperatures unknown) had been administered to an unknown number of patients. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Anaemia haemolytic autoimmune, Arthralgia, Back pain, Benign prostatic hyperplasia, Birth mark
Clinical narrative: Progress notes from hosp/clinic attached.
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Calculus urinary, Carpal tunnel syndrome, Cerebral arteriosclerosis, Contusion, Deficiency anaemia
Clinical narrative: Progress notes from hosp/clinic attached.
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Depression, Dermatitis, Diabetic neuropathy, Diabetic retinopathy, Dyspnoea
Clinical narrative: Progress notes from hosp/clinic attached.
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Eczema, Epicondylitis, Essential hypertension, Gastritis, Gastroduodenitis
Clinical narrative: Progress notes from hosp/clinic attached.
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Haemorrhagic anaemia, Haemorrhoids, Helicobacter infection, Hypothyroidism, Intervertebral disc displacement
Clinical narrative: Progress notes from hosp/clinic attached.
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Lumbar radiculopathy, Major depression, Musculoskeletal disorder, Musculoskeletal pain, Myocardial ischaemia
Clinical narrative: Progress notes from hosp/clinic attached.
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Neuralgia, Ocular hypertension, Osteoarthritis, Pain, Pigmentation disorder
Clinical narrative: Progress notes from hosp/clinic attached.
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Rectal haemorrhage, Refraction disorder, Respiratory disorder, Retinal degeneration, Tinea infection
Clinical narrative: Progress notes from hosp/clinic attached.
Age: 63.0
Sex: M
Vaccine: ANTH
Symptoms: Type 2 diabetes mellitus, VIIth nerve paralysis, Xerosis
Clinical narrative: Progress notes from hosp/clinic attached.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: Patient presented to office with chicken pox on 8-24-12.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient presented to office with chicken pox on 8-24-12.
Age: 69.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Musculoskeletal stiffness, Myalgia
Clinical narrative: At 6 PM date of injection - left arm became immobile (could not use arm). Lasted til 10/21/12. Then arm became mobile but felt like a 100 lb weight was attached. Impeded sleep and normal activity. Took up to 2000mg Bayer from 10/24/12 every day. Feels like I just received injection. Still occurring.
Age: 69.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Sleep disorder
Clinical narrative: At 6 PM date of injection - left arm became immobile (could not use arm). Lasted til 10/21/12. Then arm became mobile but felt like a 100 lb weight was attached. Impeded sleep and normal activity. Took up to 2000mg Bayer from 10/24/12 every day. Feels like I just received injection. Still occurring.
Age: 69.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Immobile, Sensation of heaviness, Sleep disorder
Clinical narrative: At 6 PM date of injection - left arm became immobile (could not use arm). Lasted til 10/21/12. Then arm became mobile but felt like a 100 lb weight was attached. Impeded sleep and normal activity. Took up to 2000mg Bayer from 10/24/12 every day. Feels like I just received injection. Still occurring.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Asthenia, Asthma, Body temperature increased, Eye irritation, Oral discomfort
Clinical narrative: This spontaneous consumer report (initial receipt: 25-Oct-2012) concerns a 45-year-old female patient, who had a medical history of asthma. Concomitant medication included ethyinylestradiol; drospirenone combination. On 24-Oct-2012 the patient received influenza vaccine (manufacturer, brand name and batch number were not provided) injection. She had never received the influenza vaccine in previous years. About 1.5 hours after administration of vaccine, the patient had an asthma attack. She inhaled 1 breath from 2 different PROAIR HFA (batch number: PAA77B, exp: Mar-2013) 90 mcg, which may have been empty. Therefore, she inhaled a second breath from different PROAIR inhaler (batch number: PAA41B), which had expired in Jul-2012. The PROAIR relieved asthma symptoms, and later she felt a lot of mucous in her mouth, which had happened before with use of PROAIR. Mucous resolved, but later she developed a sore throat, swollen tongue, pain and irritation in mouth, and felt hot. Her physician recommended that she took 2 diphenhydramine tablets, which did not fully resolve symptoms. She had a fever of 99.1 F (Fahrenheit), her mouth was very painful and numb, and lips felt like 'jalapeno peppers had been dragged across them'. At the time of reporting, the patient no longer feeling hot or had fever but not fully recovered. She was undecided about the action to take with the product (PROAIR). The patient was advised to discard the expired PROAIR. At the time of reporting, the outcome of the AEs were: 'Felt a lot of mucous in mouth', 'Felt hot', 'Fever of 99.1F' were recovered / resolved; 'Swollen tongue', 'Irritation in mouth', 'Mouth was numb', 'Lips felt like jalapeno peppers had been dragged across mouth', 'Sore throat', 'Pain in mouth' were not recovered not resolved.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Oral mucosal blistering, Pharyngeal oedema, Swollen tongue
Clinical narrative: This spontaneous consumer report (initial receipt: 25-Oct-2012) concerns a 45-year-old female patient, who had a medical history of asthma. Concomitant medication included ethyinylestradiol; drospirenone combination. On 24-Oct-2012 the patient received influenza vaccine (manufacturer, brand name and batch number were not provided) injection. She had never received the influenza vaccine in previous years. About 1.5 hours after administration of vaccine, the patient had an asthma attack. She inhaled 1 breath from 2 different PROAIR HFA (batch number: PAA77B, exp: Mar-2013) 90 mcg, which may have been empty. Therefore, she inhaled a second breath from different PROAIR inhaler (batch number: PAA41B), which had expired in Jul-2012. The PROAIR relieved asthma symptoms, and later she felt a lot of mucous in her mouth, which had happened before with use of PROAIR. Mucous resolved, but later she developed a sore throat, swollen tongue, pain and irritation in mouth, and felt hot. Her physician recommended that she took 2 diphenhydramine tablets, which did not fully resolve symptoms. She had a fever of 99.1 F (Fahrenheit), her mouth was very painful and numb, and lips felt like 'jalapeno peppers had been dragged across them'. At the time of reporting, the patient no longer feeling hot or had fever but not fully recovered. She was undecided about the action to take with the product (PROAIR). The patient was advised to discard the expired PROAIR. At the time of reporting, the outcome of the AEs were: 'Felt a lot of mucous in mouth', 'Felt hot', 'Fever of 99.1F' were recovered / resolved; 'Swollen tongue', 'Irritation in mouth', 'Mouth was numb', 'Lips felt like jalapeno peppers had been dragged across mouth', 'Sore throat', 'Pain in mouth' were not recovered not resolved.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Asthenia, Asthma, Condition aggravated, Eye irritation, Nausea
Clinical narrative: This spontaneous consumer report (initial receipt: 25-Oct-2012) concerns a 45-year-old female patient, who had a medical history of asthma. Concomitant medication included ethyinylestradiol; drospirenone combination. On 24-Oct-2012 the patient received influenza vaccine (manufacturer, brand name and batch number were not provided) injection. She had never received the influenza vaccine in previous years. About 1.5 hours after administration of vaccine, the patient had an asthma attack. She inhaled 1 breath from 2 different PROAIR HFA (batch number: PAA77B, exp: Mar-2013) 90 mcg, which may have been empty. Therefore, she inhaled a second breath from different PROAIR inhaler (batch number: PAA41B), which had expired in Jul-2012. The PROAIR relieved asthma symptoms, and later she felt a lot of mucous in her mouth, which had happened before with use of PROAIR. Mucous resolved, but later she developed a sore throat, swollen tongue, pain and irritation in mouth, and felt hot. Her physician recommended that she took 2 diphenhydramine tablets, which did not fully resolve symptoms. She had a fever of 99.1 F (Fahrenheit), her mouth was very painful and numb, and lips felt like 'jalapeno peppers had been dragged across them'. At the time of reporting, the patient no longer feeling hot or had fever but not fully recovered. She was undecided about the action to take with the product (PROAIR). The patient was advised to discard the expired PROAIR. At the time of reporting, the outcome of the AEs were: 'Felt a lot of mucous in mouth', 'Felt hot', 'Fever of 99.1F' were recovered / resolved; 'Swollen tongue', 'Irritation in mouth', 'Mouth was numb', 'Lips felt like jalapeno peppers had been dragged across mouth', 'Sore throat', 'Pain in mouth' were not recovered not resolved.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Odynophagia, Oral discomfort, Oral mucosal blistering, Pain in extremity, Pharyngeal oedema
Clinical narrative: This spontaneous consumer report (initial receipt: 25-Oct-2012) concerns a 45-year-old female patient, who had a medical history of asthma. Concomitant medication included ethyinylestradiol; drospirenone combination. On 24-Oct-2012 the patient received influenza vaccine (manufacturer, brand name and batch number were not provided) injection. She had never received the influenza vaccine in previous years. About 1.5 hours after administration of vaccine, the patient had an asthma attack. She inhaled 1 breath from 2 different PROAIR HFA (batch number: PAA77B, exp: Mar-2013) 90 mcg, which may have been empty. Therefore, she inhaled a second breath from different PROAIR inhaler (batch number: PAA41B), which had expired in Jul-2012. The PROAIR relieved asthma symptoms, and later she felt a lot of mucous in her mouth, which had happened before with use of PROAIR. Mucous resolved, but later she developed a sore throat, swollen tongue, pain and irritation in mouth, and felt hot. Her physician recommended that she took 2 diphenhydramine tablets, which did not fully resolve symptoms. She had a fever of 99.1 F (Fahrenheit), her mouth was very painful and numb, and lips felt like 'jalapeno peppers had been dragged across them'. At the time of reporting, the patient no longer feeling hot or had fever but not fully recovered. She was undecided about the action to take with the product (PROAIR). The patient was advised to discard the expired PROAIR. At the time of reporting, the outcome of the AEs were: 'Felt a lot of mucous in mouth', 'Felt hot', 'Fever of 99.1F' were recovered / resolved; 'Swollen tongue', 'Irritation in mouth', 'Mouth was numb', 'Lips felt like jalapeno peppers had been dragged across mouth', 'Sore throat', 'Pain in mouth' were not recovered not resolved.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: This spontaneous consumer report (initial receipt: 25-Oct-2012) concerns a 45-year-old female patient, who had a medical history of asthma. Concomitant medication included ethyinylestradiol; drospirenone combination. On 24-Oct-2012 the patient received influenza vaccine (manufacturer, brand name and batch number were not provided) injection. She had never received the influenza vaccine in previous years. About 1.5 hours after administration of vaccine, the patient had an asthma attack. She inhaled 1 breath from 2 different PROAIR HFA (batch number: PAA77B, exp: Mar-2013) 90 mcg, which may have been empty. Therefore, she inhaled a second breath from different PROAIR inhaler (batch number: PAA41B), which had expired in Jul-2012. The PROAIR relieved asthma symptoms, and later she felt a lot of mucous in her mouth, which had happened before with use of PROAIR. Mucous resolved, but later she developed a sore throat, swollen tongue, pain and irritation in mouth, and felt hot. Her physician recommended that she took 2 diphenhydramine tablets, which did not fully resolve symptoms. She had a fever of 99.1 F (Fahrenheit), her mouth was very painful and numb, and lips felt like 'jalapeno peppers had been dragged across them'. At the time of reporting, the patient no longer feeling hot or had fever but not fully recovered. She was undecided about the action to take with the product (PROAIR). The patient was advised to discard the expired PROAIR. At the time of reporting, the outcome of the AEs were: 'Felt a lot of mucous in mouth', 'Felt hot', 'Fever of 99.1F' were recovered / resolved; 'Swollen tongue', 'Irritation in mouth', 'Mouth was numb', 'Lips felt like jalapeno peppers had been dragged across mouth', 'Sore throat', 'Pain in mouth' were not recovered not resolved.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Asthma, Condition aggravated, Feeling hot, Hypoaesthesia oral, Oral discomfort
Clinical narrative: This spontaneous consumer report (initial receipt: 25-Oct-2012) concerns a 45-year-old female patient, who had a medical history of asthma. Concomitant medication included ethyinylestradiol; drospirenone combination. On 24-Oct-2012 the patient received influenza vaccine (manufacturer, brand name and batch number were not provided) injection. She had never received the influenza vaccine in previous years. About 1.5 hours after administration of vaccine, the patient had an asthma attack. She inhaled 1 breath from 2 different PROAIR HFA (batch number: PAA77B, exp: Mar-2013) 90 mcg, which may have been empty. Therefore, she inhaled a second breath from different PROAIR inhaler (batch number: PAA41B), which had expired in Jul-2012. The PROAIR relieved asthma symptoms, and later she felt a lot of mucous in her mouth, which had happened before with use of PROAIR. Mucous resolved, but later she developed a sore throat, swollen tongue, pain and irritation in mouth, and felt hot. Her physician recommended that she took 2 diphenhydramine tablets, which did not fully resolve symptoms. She had a fever of 99.1 F (Fahrenheit), her mouth was very painful and numb, and lips felt like 'jalapeno peppers had been dragged across them'. At the time of reporting, the patient no longer feeling hot or had fever but not fully recovered. She was undecided about the action to take with the product (PROAIR). The patient was advised to discard the expired PROAIR. At the time of reporting, the outcome of the AEs were: 'Felt a lot of mucous in mouth', 'Felt hot', 'Fever of 99.1F' were recovered / resolved; 'Swollen tongue', 'Irritation in mouth', 'Mouth was numb', 'Lips felt like jalapeno peppers had been dragged across mouth', 'Sore throat', 'Pain in mouth' were not recovered not resolved.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Oral pain, Oropharyngeal pain, Pyrexia, Salivary hypersecretion, Stomatitis
Clinical narrative: This spontaneous consumer report (initial receipt: 25-Oct-2012) concerns a 45-year-old female patient, who had a medical history of asthma. Concomitant medication included ethyinylestradiol; drospirenone combination. On 24-Oct-2012 the patient received influenza vaccine (manufacturer, brand name and batch number were not provided) injection. She had never received the influenza vaccine in previous years. About 1.5 hours after administration of vaccine, the patient had an asthma attack. She inhaled 1 breath from 2 different PROAIR HFA (batch number: PAA77B, exp: Mar-2013) 90 mcg, which may have been empty. Therefore, she inhaled a second breath from different PROAIR inhaler (batch number: PAA41B), which had expired in Jul-2012. The PROAIR relieved asthma symptoms, and later she felt a lot of mucous in her mouth, which had happened before with use of PROAIR. Mucous resolved, but later she developed a sore throat, swollen tongue, pain and irritation in mouth, and felt hot. Her physician recommended that she took 2 diphenhydramine tablets, which did not fully resolve symptoms. She had a fever of 99.1 F (Fahrenheit), her mouth was very painful and numb, and lips felt like 'jalapeno peppers had been dragged across them'. At the time of reporting, the patient no longer feeling hot or had fever but not fully recovered. She was undecided about the action to take with the product (PROAIR). The patient was advised to discard the expired PROAIR. At the time of reporting, the outcome of the AEs were: 'Felt a lot of mucous in mouth', 'Felt hot', 'Fever of 99.1F' were recovered / resolved; 'Swollen tongue', 'Irritation in mouth', 'Mouth was numb', 'Lips felt like jalapeno peppers had been dragged across mouth', 'Sore throat', 'Pain in mouth' were not recovered not resolved.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Swollen tongue
Clinical narrative: This spontaneous consumer report (initial receipt: 25-Oct-2012) concerns a 45-year-old female patient, who had a medical history of asthma. Concomitant medication included ethyinylestradiol; drospirenone combination. On 24-Oct-2012 the patient received influenza vaccine (manufacturer, brand name and batch number were not provided) injection. She had never received the influenza vaccine in previous years. About 1.5 hours after administration of vaccine, the patient had an asthma attack. She inhaled 1 breath from 2 different PROAIR HFA (batch number: PAA77B, exp: Mar-2013) 90 mcg, which may have been empty. Therefore, she inhaled a second breath from different PROAIR inhaler (batch number: PAA41B), which had expired in Jul-2012. The PROAIR relieved asthma symptoms, and later she felt a lot of mucous in her mouth, which had happened before with use of PROAIR. Mucous resolved, but later she developed a sore throat, swollen tongue, pain and irritation in mouth, and felt hot. Her physician recommended that she took 2 diphenhydramine tablets, which did not fully resolve symptoms. She had a fever of 99.1 F (Fahrenheit), her mouth was very painful and numb, and lips felt like 'jalapeno peppers had been dragged across them'. At the time of reporting, the patient no longer feeling hot or had fever but not fully recovered. She was undecided about the action to take with the product (PROAIR). The patient was advised to discard the expired PROAIR. At the time of reporting, the outcome of the AEs were: 'Felt a lot of mucous in mouth', 'Felt hot', 'Fever of 99.1F' were recovered / resolved; 'Swollen tongue', 'Irritation in mouth', 'Mouth was numb', 'Lips felt like jalapeno peppers had been dragged across mouth', 'Sore throat', 'Pain in mouth' were not recovered not resolved.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Activities of daily living impaired, Cellulitis
Clinical narrative: Fever 102 degrees+. Headache. Muscle ache. Swelling and pain at injection site followed by cellulitis at PNEUMOVAX injection site only - swelling more than 10cm across (13cm x 8cm).
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Granulocyte percentage, Headache, Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Fever 102 degrees+. Headache. Muscle ache. Swelling and pain at injection site followed by cellulitis at PNEUMOVAX injection site only - swelling more than 10cm across (13cm x 8cm).
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Laboratory test, Lymphocyte percentage decreased, Myalgia, Pyrexia, White blood cell count increased
Clinical narrative: Fever 102 degrees+. Headache. Muscle ache. Swelling and pain at injection site followed by cellulitis at PNEUMOVAX injection site only - swelling more than 10cm across (13cm x 8cm).
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: Initial report was received from a consumer on 03 November 2012. A 65-year-old male patient had received an injection of FLUZONE HIGH-DOSE, lot number U4490AA, on 23 October 2012. On 30 October 2012, the patient felt achy and had leg pain. The patient's wife found the patient in a chair and thought he was sleeping. However, the patient started to moan, was shaking all over and did not respond or communicate. The patient was taken to the hospital and admitted to the intensive care unit (ICU). Treatment included antibiotics. The patient was on a breathing machine for assisted breathing and had a peripherally inserted central catheter (PICC) line. The patient had two electroencephalograms (EEG's) with first one being negative and no results available yet for the second. The patient was unresponsive until 03 November 2012 when he opened his eyes and was able to follow simple command. The patient had no illness at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: None.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram head, Culture urine, Electroencephalogram, Encephalitis, Encephalitis viral
Clinical narrative: Initial report was received from a consumer on 03 November 2012. A 65-year-old male patient had received an injection of FLUZONE HIGH-DOSE, lot number U4490AA, on 23 October 2012. On 30 October 2012, the patient felt achy and had leg pain. The patient's wife found the patient in a chair and thought he was sleeping. However, the patient started to moan, was shaking all over and did not respond or communicate. The patient was taken to the hospital and admitted to the intensive care unit (ICU). Treatment included antibiotics. The patient was on a breathing machine for assisted breathing and had a peripherally inserted central catheter (PICC) line. The patient had two electroencephalograms (EEG's) with first one being negative and no results available yet for the second. The patient was unresponsive until 03 November 2012 when he opened his eyes and was able to follow simple command. The patient had no illness at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: None.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gastrointestinal tube insertion, Incoherent, Intensive care, Laboratory test normal, Lumbar puncture
Clinical narrative: Initial report was received from a consumer on 03 November 2012. A 65-year-old male patient had received an injection of FLUZONE HIGH-DOSE, lot number U4490AA, on 23 October 2012. On 30 October 2012, the patient felt achy and had leg pain. The patient's wife found the patient in a chair and thought he was sleeping. However, the patient started to moan, was shaking all over and did not respond or communicate. The patient was taken to the hospital and admitted to the intensive care unit (ICU). Treatment included antibiotics. The patient was on a breathing machine for assisted breathing and had a peripherally inserted central catheter (PICC) line. The patient had two electroencephalograms (EEG's) with first one being negative and no results available yet for the second. The patient was unresponsive until 03 November 2012 when he opened his eyes and was able to follow simple command. The patient had no illness at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: None.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Malaise, Mechanical ventilation, Moaning, Nuclear magnetic resonance imaging spinal, Pain
Clinical narrative: Initial report was received from a consumer on 03 November 2012. A 65-year-old male patient had received an injection of FLUZONE HIGH-DOSE, lot number U4490AA, on 23 October 2012. On 30 October 2012, the patient felt achy and had leg pain. The patient's wife found the patient in a chair and thought he was sleeping. However, the patient started to moan, was shaking all over and did not respond or communicate. The patient was taken to the hospital and admitted to the intensive care unit (ICU). Treatment included antibiotics. The patient was on a breathing machine for assisted breathing and had a peripherally inserted central catheter (PICC) line. The patient had two electroencephalograms (EEG's) with first one being negative and no results available yet for the second. The patient was unresponsive until 03 November 2012 when he opened his eyes and was able to follow simple command. The patient had no illness at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: None.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: Initial report was received from a consumer on 03 November 2012. A 65-year-old male patient had received an injection of FLUZONE HIGH-DOSE, lot number U4490AA, on 23 October 2012. On 30 October 2012, the patient felt achy and had leg pain. The patient's wife found the patient in a chair and thought he was sleeping. However, the patient started to moan, was shaking all over and did not respond or communicate. The patient was taken to the hospital and admitted to the intensive care unit (ICU). Treatment included antibiotics. The patient was on a breathing machine for assisted breathing and had a peripherally inserted central catheter (PICC) line. The patient had two electroencephalograms (EEG's) with first one being negative and no results available yet for the second. The patient was unresponsive until 03 November 2012 when he opened his eyes and was able to follow simple command. The patient had no illness at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: None.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Central venous catheterisation, Electroencephalogram normal, Intensive care, Mechanical ventilation, Moaning
Clinical narrative: Initial report was received from a consumer on 03 November 2012. A 65-year-old male patient had received an injection of FLUZONE HIGH-DOSE, lot number U4490AA, on 23 October 2012. On 30 October 2012, the patient felt achy and had leg pain. The patient's wife found the patient in a chair and thought he was sleeping. However, the patient started to moan, was shaking all over and did not respond or communicate. The patient was taken to the hospital and admitted to the intensive care unit (ICU). Treatment included antibiotics. The patient was on a breathing machine for assisted breathing and had a peripherally inserted central catheter (PICC) line. The patient had two electroencephalograms (EEG's) with first one being negative and no results available yet for the second. The patient was unresponsive until 03 November 2012 when he opened his eyes and was able to follow simple command. The patient had no illness at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: None.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Tremor, Unresponsive to stimuli
Clinical narrative: Initial report was received from a consumer on 03 November 2012. A 65-year-old male patient had received an injection of FLUZONE HIGH-DOSE, lot number U4490AA, on 23 October 2012. On 30 October 2012, the patient felt achy and had leg pain. The patient's wife found the patient in a chair and thought he was sleeping. However, the patient started to moan, was shaking all over and did not respond or communicate. The patient was taken to the hospital and admitted to the intensive care unit (ICU). Treatment included antibiotics. The patient was on a breathing machine for assisted breathing and had a peripherally inserted central catheter (PICC) line. The patient had two electroencephalograms (EEG's) with first one being negative and no results available yet for the second. The patient was unresponsive until 03 November 2012 when he opened his eyes and was able to follow simple command. The patient had no illness at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3, PER, PPV, FLU3, PER, PPV
Symptoms: Back pain, Chills, Feeling abnormal, Hypersomnia, Influenza
Clinical narrative: This spontaneous consumer report (initial receipt: 29-Oct-2012) concerns an adult female patient, who had a medical history of hepatitis C (diagnosed in Jan-2005), tubes tied 12 years ago, degenerative bone mass, hips not good and problem walking. Concomitant medications included peginterferin alfa-2B and ribavirin. On an unknown date the patient received pneumonia, flu (manufacturer, brand name and batch number were not provided) and pertussis vaccines. She received vaccines due to new grandbaby who was born premature, so the family decided to take vaccines. The patient reported last weeks her arms were sore after taking pneumonia, flu and pertussis vaccines. She reported after her first shot (of pneumonia vaccine), she felt awful, like was going to die, clarified as flu symptoms. She slept most of the day of first shot and on that Sunday she could not remember most of day, even going to church. She reported after second shot (of pneumonia vaccine), she only had little chills. She also reported her back had been killing her but had been using crutches to help her walk. When she switched to a walker, the pain improved.
Sex: F
Vaccine: FLU3, PER, PPV, FLU3, PER, PPV
Symptoms: Memory impairment, Pain in extremity, Walking aid user
Clinical narrative: This spontaneous consumer report (initial receipt: 29-Oct-2012) concerns an adult female patient, who had a medical history of hepatitis C (diagnosed in Jan-2005), tubes tied 12 years ago, degenerative bone mass, hips not good and problem walking. Concomitant medications included peginterferin alfa-2B and ribavirin. On an unknown date the patient received pneumonia, flu (manufacturer, brand name and batch number were not provided) and pertussis vaccines. She received vaccines due to new grandbaby who was born premature, so the family decided to take vaccines. The patient reported last weeks her arms were sore after taking pneumonia, flu and pertussis vaccines. She reported after her first shot (of pneumonia vaccine), she felt awful, like was going to die, clarified as flu symptoms. She slept most of the day of first shot and on that Sunday she could not remember most of day, even going to church. She reported after second shot (of pneumonia vaccine), she only had little chills. She also reported her back had been killing her but had been using crutches to help her walk. When she switched to a walker, the pain improved.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood culture negative, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Cellulitis dx 10/29/12 treated with IM ROCEPHIN seen again 10/29/12 in ED, oral abx initiated.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: White blood cell count increased
Clinical narrative: Cellulitis dx 10/29/12 treated with IM ROCEPHIN seen again 10/29/12 in ED, oral abx initiated.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, White blood cell count increased
Clinical narrative: Cellulitis dx 10/29/12 treated with IM ROCEPHIN seen again 10/29/12 in ED, oral abx initiated.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Blood test, Erythema, Full blood count, Injection site reaction, Injection site warmth
Clinical narrative: Received PNEUMOVAX left deltoid 11/6/12. On 11/7/12, patient went to ER/UC for redness/swelling of left axilla/breast area. Pending diagnosis: cellulitis. Dc'd on KEFLEX.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Rash erythematous
Clinical narrative: Received PNEUMOVAX left deltoid 11/6/12. On 11/7/12, patient went to ER/UC for redness/swelling of left axilla/breast area. Pending diagnosis: cellulitis. Dc'd on KEFLEX.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Received PNEUMOVAX left deltoid 11/6/12. On 11/7/12, patient went to ER/UC for redness/swelling of left axilla/breast area. Pending diagnosis: cellulitis. Dc'd on KEFLEX.
Age: 1.61
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 101 degrees Fahrenheit, lasted about 36 hours. One week later a rash appeared on trunk and spread to back of neck and behind the ears.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Vomiting, three times in one hour.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test, Chest X-ray, Chills, Dehydration, Dizziness
Clinical narrative: Started out with a sore throat, turned into what felt like the full blown flu. Headache, shortness of breath, vomiting, dehydration, dizziness, bodyaches, chills, fever, muscle aches.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Headache, Influenza, Myalgia, Oropharyngeal pain
Clinical narrative: Started out with a sore throat, turned into what felt like the full blown flu. Headache, shortness of breath, vomiting, dehydration, dizziness, bodyaches, chills, fever, muscle aches.