chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 29-OCT-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (route, anatomical location were not reported), lot number J013900, expiration date 30-OCT-2015. No adverse effects were reported. There was no concomitant medication reported. Additional informatiton has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Herpes zoster, Influenza like illness, Pain
Clinical narrative: Four days after receiving the shingles vaccine, pt. reported flu-like symptoms, headache, body aches, and fatigue lasting 3 days. 2 days later, skin soreness began and increased. 72 hours later, rash appeared on left side waist area. Rash sores persisted on abdomen and back. MD visit on 10/27/15 and MD diagnosed patient being confirmed to having "shingles".
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin, Rash, Ulcer
Clinical narrative: Four days after receiving the shingles vaccine, pt. reported flu-like symptoms, headache, body aches, and fatigue lasting 3 days. 2 days later, skin soreness began and increased. 72 hours later, rash appeared on left side waist area. Rash sores persisted on abdomen and back. MD visit on 10/27/15 and MD diagnosed patient being confirmed to having "shingles".
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Emotional distress, Fatigue, Headache, Herpes zoster, Influenza like illness
Clinical narrative: Four days after receiving the shingles vaccine, pt. reported flu-like symptoms, headache, body aches, and fatigue lasting 3 days. 2 days later, skin soreness began and increased. 72 hours later, rash appeared on left side waist area. Rash sores persisted on abdomen and back. MD visit on 10/27/15 and MD diagnosed patient being confirmed to having "shingles".
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain of skin, Rash
Clinical narrative: Four days after receiving the shingles vaccine, pt. reported flu-like symptoms, headache, body aches, and fatigue lasting 3 days. 2 days later, skin soreness began and increased. 72 hours later, rash appeared on left side waist area. Rash sores persisted on abdomen and back. MD visit on 10/27/15 and MD diagnosed patient being confirmed to having "shingles".
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. Since 13-OCT-2015, these patients were vaccinated with doses of oral, ROTATEQ (lot # L013188, expiration date 02-NOV-2016, oral; dose and frequency not reported) which were exposed to temperatures outside of the recommended range. No adverse experiences had been reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Redness, pain at injection site; itching.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 45-year-old female patient who received BOOSTRIX (batch number 9N74F, expiry date 19th August 2017). On 25th September 2015, the patient received BOOSTRIX .5 ml. On 26th October 2015, 31 days after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. The reporter considered the injection site pain to be almost certainly related to BOOSTRIX. Additional details provided were as follows: This case was not previously reported to anyone. The patient experienced soreness at the injection site one month after receiving a dose of BOOSTRIX vaccine.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Mobility decreased, Pain
Clinical narrative: Hematoma sort of bump on shoulder deltoid at site of injection. Pt. was feeling pain and trouble raising arm for few days thereafter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD (Lot#K010211, expiration date 17-JAN-2016; lot# L005297, expiration date 17-AUG-2016; lot#L010142, expiration date 24-SEP-2016; lot# L027634, expiration date 21-JAN-2017; or lot#L031602, expiration date 18-FEB-2017). (Strength, dose and route were not provided). Concomitant medications was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose or oral ROTATEQ (Lot # K015816, expiration date 29-MAY-2016; Lot # K023534, expiration date 22-MAY-2016; Lot # K016261, expiration date 23-JUN-2016 or Lot # reported as L008057, expiration date 01-DEC-2016) (Strength, dose and route were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (Lot#L000610, expiration date 31-JAN-2017) (Strength, dose and route were not provided. Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (lot # L012042, expired date as 18-NOV-2016, route, dose, dose number and strength were unspecified) that were improperly stored. No adverse effects were reported. This is one of the two reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of GARDASIL (lot # L007560, expired date as 15-JUN-2017, route, dose, dose number and strength were unspecified) that were improperly stored. No adverse effects were reported. This is one of the two reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. Since 13-OCT-2015, these patients were vaccinated with doses of GARDASIL 9 (lot # L013429, expiration date 21-JUL-2015; dose, frequency and route not reported) which were exposed to temperatures outside of the recommended range. No adverse experiences had been reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patient were vaccinated with an improperly stored dose of M-M-R II (Lot # J008153, expiration date 08-JUL-2015; lot #J010208, expiration date 23-AUG-2015; or lot # K000738, expiration date 16-JAN-2016) (Strength, dose and route were not provided). Concomitant medication was not reported. The healthcare worker confirmed that improperly stored M-M-R II (Lot # J008153, expiration date 08-JUL-2015) was not administered after the expiration date, but administered on unspecified dates prior to 08-JUL-2015. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Chest pain, Dyspnoea, Electrocardiogram normal, Presyncope
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 65 year-old female patient who had no medical history and no illness at the time of vaccination. Concomitant medication included levothyroxine. On the 12-Jan-2015, the patient received AFLURIA injection (batch number provided). On the 13-Jan-2015, the patient developed a chest pain, SOB (shortness of breath), and near syncope. These lasted for 10 minutes. EKG (electrocardiogram) and blood test was negative for the cardiac event. The outcome was recovered. Reporter's comments: The health authority assessed the case as non-serious, and reported the terms 'blood test normal' and 'electrocardiogram normal'.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 58 year-old female patient. On the 12-Nov-2014, the patient received AFLURIA injection (batch number T51808) on the left arm. On the 14-Jan-2015, the patient had a sore arm at the injection site and was recommended to follow-up with the PCP (primary care physician) or MD (medical doctor). The outcome was unknown. Reporter's comments: The health authority assessed the case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 57 year old female patient. On 01-Nov-2014, the patient received intramuscular AFLURIA injection (batch number T58706) at an unknown site. On 08-Nov-2014, the patient developed pain down left arm into the wrist and fingers. The pain started two to three days after the shot. The outcome was reported as not yet recovered.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 64 year-old female patient. On the 04-Jan-2015, the patient received AFLURIA injection, (batch number T51708) on the left arm. On the 05-Jan-2015, the patient developed a red patchy area that was growing larger and warm to the touch. The outcome was recovered. Reporter's comments: The health authority assessed the case as non-serious.
Age: 32.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 32 year old male patient. The patient had medical history of allergy to penicillin. He had no current illness at the time of vaccination. His concomitant medications included loratadine and triamcinolone acetonide. On 08-Oct-2014, the patient received AFLURIA injection (batch number: 10049211A) in the right arm. On 15-Oct-2014, the patient developed hives/urticaria that appeared at random parts the body. It slowly spread apart throughout the day and then disappeared. The skin welts can be aggravated with physical contact and grow larger. The patient was prescribed prednisone and prescription cortisone cream. After the treatment, the hives were still prevalent. The patient was scheduled to see an allergist and had also submitted blood work. The outcome was reported as not yet recovered. Reporter's comments: The health authority assessed the events as non-serious.
Age: 32.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood test, Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 32 year old male patient. The patient had medical history of allergy to penicillin. He had no current illness at the time of vaccination. His concomitant medications included loratadine and triamcinolone acetonide. On 08-Oct-2014, the patient received AFLURIA injection (batch number: 10049211A) in the right arm. On 15-Oct-2014, the patient developed hives/urticaria that appeared at random parts the body. It slowly spread apart throughout the day and then disappeared. The skin welts can be aggravated with physical contact and grow larger. The patient was prescribed prednisone and prescription cortisone cream. After the treatment, the hives were still prevalent. The patient was scheduled to see an allergist and had also submitted blood work. The outcome was reported as not yet recovered. Reporter's comments: The health authority assessed the events as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Burning sensation, Joint range of motion decreased, Muscle tightness, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 62 year old female patient. The patient had no medical history or current illness. On 25-Oct-2014, the patient received AFLURIA injection (batch number T53309) in the left arm. On 26-Oct-2014, the patient developed persistent pain in the left deltoid, very limited range of movement with abduction, pain, burning, weakness and deltoid tightness that at times radiated in muscle to elbow. The symptoms remained from administration to date. The patient had more pain and developed SIRVA (shoulder injury related to vaccine administration). The patient was scheduled to undergo MRI on 22-Jan-2015. The outcome was reported as not yet recovered.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 62 year old female patient. The patient had no medical history or current illness. On 25-Oct-2014, the patient received AFLURIA injection (batch number T53309) in the left arm. On 26-Oct-2014, the patient developed persistent pain in the left deltoid, very limited range of movement with abduction, pain, burning, weakness and deltoid tightness that at times radiated in muscle to elbow. The symptoms remained from administration to date. The patient had more pain and developed SIRVA (shoulder injury related to vaccine administration). The patient was scheduled to undergo MRI on 22-Jan-2015. The outcome was reported as not yet recovered.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site injury, Injection site pain, Injection site reaction, Muscle tightness
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 62 year old female patient. The patient had no medical history or current illness. On 25-Oct-2014, the patient received AFLURIA injection (batch number T53309) in the left arm. On 26-Oct-2014, the patient developed persistent pain in the left deltoid, very limited range of movement with abduction, pain, burning, weakness and deltoid tightness that at times radiated in muscle to elbow. The symptoms remained from administration to date. The patient had more pain and developed SIRVA (shoulder injury related to vaccine administration). The patient was scheduled to undergo MRI on 22-Jan-2015. The outcome was reported as not yet recovered.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 62 year old female patient. The patient had no medical history or current illness. On 25-Oct-2014, the patient received AFLURIA injection (batch number T53309) in the left arm. On 26-Oct-2014, the patient developed persistent pain in the left deltoid, very limited range of movement with abduction, pain, burning, weakness and deltoid tightness that at times radiated in muscle to elbow. The symptoms remained from administration to date. The patient had more pain and developed SIRVA (shoulder injury related to vaccine administration). The patient was scheduled to undergo MRI on 22-Jan-2015. The outcome was reported as not yet recovered.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 55 year old male patient who had no medical history and no current illness. On the 18-Nov-2014, the patient received AFLURIA injection (batch number T58706) via syringe in the left arm. On an unspecified date, the patient's arm hurt where the shot was given. He stated that he felt he had just had the shot but it had been two months. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Influenza virus test negative, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 76 year old female patient who had a medical history of glaucoma and no drug allergies. Concomitant medications included latanoprost and dorzolamide/timolol. The patient had no current illness. On the 02-Feb-2015, the patient received AFLURIA injection (batch number T58906) via the intramuscular route in the left arm. On the 02-Feb-2015, the patient complained of breathing difficulties four hours after receiving the flu vaccine. The patient said she also had a fever and received breathing treatment in the emergency room. The patient filled two scripts, fluticasone and albuterol. The patient had a negative flu test. Outcome was recovered. Reporter's comments: The regulator reported the case as non-serious. The doctor was unsure if the breathing problems were due the flu vaccine. The regulator reported the symptoms 'influenza virus test negative'.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 67 year old male patient. On the 18-Oct-2014, the patient received the AFLURIA injection (batch number T51808) via an unknown route in the left arm. On the 30-Oct-2014, the patient went to the pharmacy to report trouble fully moving the arm and arm pain. Outcome was unknown. Reporter comments: The regulator reported the cases as non-serious.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 67 year old male patient. On the 18-Oct-2014, the patient received the AFLURIA injection (batch number T51808) via an unknown route in the left arm. On the 30-Oct-2014, the patient went to the pharmacy to report trouble fully moving the arm and arm pain. Outcome was unknown. Reporter comments: The regulator reported the cases as non-serious.
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 78 year-old female patient. On the 13-Oct-2014, the patient received AFLURIA (batch number T51808) in the left arm. On the 18-Oct-2014, the patient had arm pain (severe) and had trouble moving arm fully. The outcome was unknown.
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 78 year-old female patient. On the 13-Oct-2014, the patient received AFLURIA (batch number T51808) in the left arm. On the 18-Oct-2014, the patient had arm pain (severe) and had trouble moving arm fully. The outcome was unknown.
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Disorientation, Dyspnoea, Malaise, Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 21-year-old female patient. The patient had medical history of latex allergy. The patient had no current illness and was not taking any medications at the time of vaccination. On 08-Feb-2015, the patient received intramuscular AFLURIA (batch number T51408). On 08-Feb-2015, 10 to 15 minutes after receiving the vaccine, the patient did not feel well and generalised not feeling well, she thought it was because she hadn't eaten, so she got lunch and left the store. After getting home, she felt worse, disoriented, had difficulty breathing, hives and increased blood pressure, one hour after the shot. She went to the ER for treatment. The outcome was reported as recovered. Reporter's comments: The health authority assessed the events as non-serious. The reported onset date was 09-Feb-2015.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Injection site pain, Muscle spasms, Musculoskeletal pain, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial report 20-Apr-2015) concerns a 49 year old female patient. The patient had medical history of allergy to penicillin, hypertension and 'BPD'. Her concomitant medications included lithium, amlodipine, lamotrigine, hydrochlorothiazide and lisinopril. No current illness was reported. On 19-Oct-2014, the patient received intramuscular AFLURIA injection (batch number T59907) in the left arm. On 21-Oct-2014, the patient developed initial soreness that led to pain traveling to left shoulder, lower back, right side buttocks and down right leg. The patient was seen in the emergency room and was diagnosed with muscle spasm. The patient was experiencing pain in left shoulder when driving, turning or talking on phone and in right leg. Laboratory data was not performed. The outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as non-serious.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Pruritus, Urticaria
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 17 year-old female patient who had no current illness, no history and was not on any medications at the time of vaccination. The patient received a tuberculosis (TB) test two days prior to vaccination. On the 12-Feb-2015, the patient received AFLURIA injection (batch number not provided) on the left arm. On the 13-Feb-2015, the patient developed a red eye on the side of the body that the AFLURIA shot was given (left). The patient also had hives/itchy legs. Her primary care doctor was contacted. Treatment included diphenhydramine. The outcome was recovered. Reporter's comments: The health authority assessed the case as non-serious.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Joint range of motion decreased, Joint stiffness, Pain in extremity, Paraesthesia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 38 year-old female patient who had no illness and no known conditions/allergies/birth defects/medical conditions at the time of vaccination. On the 08-Feb-2015, the patient received AFLURIA injection (batch number T51308) via the intramuscular route on the right arm, and BOOSTRIX (batch number AG7KY) via the intramuscular route on the left arm. On the 08-Feb-2015, the patient experienced soreness/tightness in arm, difficulty lifting arm, limited range of motion, and tingling sensation in the middle and ring finger in the affected arm. The outcome was unknown. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 38.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Joint range of motion decreased, Mobility decreased, Pain in extremity, Paraesthesia, Skin tightness
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 38 year-old female patient who had no illness and no known conditions/allergies/birth defects/medical conditions at the time of vaccination. On the 08-Feb-2015, the patient received AFLURIA injection (batch number T51308) via the intramuscular route on the right arm, and BOOSTRIX (batch number AG7KY) via the intramuscular route on the left arm. On the 08-Feb-2015, the patient experienced soreness/tightness in arm, difficulty lifting arm, limited range of motion, and tingling sensation in the middle and ring finger in the affected arm. The outcome was unknown. Reporter's comments: The regulatory authority assessed the case as non-serious.
Age: 80.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Nasal congestion, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns an 80 year old male patient. Concomitant medications included meclizine, citalopram, diazepam, OTC (over-the-counter) allergy relief and fish oil. The patient had no acute illness. The patient did not have cancer/MGUS (Monoclonal gammopathy of undetermined significance). On the 30-Sep-2014, the patient received the AFLURIA injection (batch number 'TS0707') via the intramuscular route in the left arm. On an unspecified date, the patient had cold-like symptoms, a runny nose, nasal congestion, fever, aches and chills. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported that the patient attended the Emergency Room.
Age: 80.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rhinorrhoea
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns an 80 year old male patient. Concomitant medications included meclizine, citalopram, diazepam, OTC (over-the-counter) allergy relief and fish oil. The patient had no acute illness. The patient did not have cancer/MGUS (Monoclonal gammopathy of undetermined significance). On the 30-Sep-2014, the patient received the AFLURIA injection (batch number 'TS0707') via the intramuscular route in the left arm. On an unspecified date, the patient had cold-like symptoms, a runny nose, nasal congestion, fever, aches and chills. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported that the patient attended the Emergency Room.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Activities of daily living impaired, Rash generalised
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 47 year old male patient who had a history with penicillin. Concomitant medications included warfarin, vitamin D, hydroxyzine, lisinopril and tizanidine. The patient was not sick. On the 05-Feb-2015, the patient received AFLURIA (batch number T51608) via the intramuscular route in the right arm. The patient also received PNEUMOVAX (batch number K009107) via the intramuscular route in the right arm. On the 06-Feb-2015, the patient developed a rash over 65% of his body and stayed in bed for approximately two weeks. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the symptom of 'activities of daily living impaired'. The reporter stated the patient attended the 'Emergency Room'.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Activities of daily living impaired, Mobility decreased, Rash generalised
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 47 year old male patient who had a history with penicillin. Concomitant medications included warfarin, vitamin D, hydroxyzine, lisinopril and tizanidine. The patient was not sick. On the 05-Feb-2015, the patient received AFLURIA (batch number T51608) via the intramuscular route in the right arm. The patient also received PNEUMOVAX (batch number K009107) via the intramuscular route in the right arm. On the 06-Feb-2015, the patient developed a rash over 65% of his body and stayed in bed for approximately two weeks. Outcome was recovered. Reporter comments: The regulator reported the case as non-serious and reported the symptom of 'activities of daily living impaired'. The reporter stated the patient attended the 'Emergency Room'.
Age: 86.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns an 86 year old female patient who had no medical history, no current illness and no medications. On the 22-Oct-2014, the patient received AFLURIA injection (batch number T52708) via the intramuscular route in the right arm. On the 22-Oct-2014, the patient developed pain and discomfort at the site of the injection. Outcome was unknown. Regulator comments: The regulator reported the case as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt: 20-Apr-2015) concerns a 57 year old female patient. The patient had medical history of allergy to DIFLUCAN. Her current illness included hypothyroidism. On 11-Oct-2014, the patient received AFLURIA injection, (batch number not reported), , route: UN and site: AR. On 22-Oct-2014, the patient experienced body/joints ache and fatigue. The outcome was reported as resolved without treatment. Reporter's comments: The health authority assessed the events as non-serious.
Age: 62.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Apr-2015) concerns a 62 year old male patient who had chronic lymphocytic leukemia. medications at the time of vaccination included testosterone. The patient had no current illness. On the 15-Oct-2014, the patient received the AFLURIA injection (batch number T57305) via an unknown route in the left arm. On the 15-Oct-2014, immediately upon receiving the shot, the patient developed significant pain which occurred in the left shoulder and arm. Pain was constant and was not going away. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious and reported that the patient attended the Emergency Room.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus generalised
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns a 53 year old female patient. The patient had medical history of Diabetes mellitus, allergic rhinitis, hypertension and GERD. The patient did not have any current illness. Her concomitant medications included atorvastatin calcium, pantoprazole, lisinopril and metformin. On 02-Oct-2014, the patient received intramuscular AFLURIA injection (batch number T57906) in the left arm. On 03-Oct-2014, approximately 24 hours after vaccination, the patient complained of generalised itching. The evening, the patient took diphenhydramine 25 mg at bed time with some relief. On the next consecutive bedtimes, the patient took diphenhydramine at 50 mg, with improved relief. On 07-Oct-2014, the patient sought treatment, she stated she had itching. There were no rash or excoriations on the skin and the patient denied any change impersonal, laundry or environmental products and denied changes in medications. The patient was instructed to continue diphenhydramine 25 mg oral nightly and add loratadine 10 mg (1 oral daily) in the arm. The outcome was reported as recovered. Reporter's comments: The health authority assessed the events as non-serious.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 11-May-2015) concerns a 49-year-old female patient. Her concomitant medications were not listed. On 15-Nov-2014, the patient received intramuscular AFLURIA injection (batch number T57205) in the left arm. On 16-Nov-2014, the patient developed pain in the left arm at the injection area. She could not lift her arms out straight without pain or behind her back. Her arm was achy and throbbing. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious. Case correction (21-Jul-2015): As reported term for AE 4, LLT for AE 4.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 11-May-2015) concerns a 49-year-old female patient. Her concomitant medications were not listed. On 15-Nov-2014, the patient received intramuscular AFLURIA injection (batch number T57205) in the left arm. On 16-Nov-2014, the patient developed pain in the left arm at the injection area. She could not lift her arms out straight without pain or behind her back. Her arm was achy and throbbing. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious. Case correction (21-Jul-2015): As reported term for AE 4, LLT for AE 4.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 11-May-2015) concerns a 36 year-old female patient. On 17-Feb-2015, the patient received AFLURIA injection (batch number T50407) dose 1 on the left arm. On 17-Feb-2015, the patient experienced redness, swelling and itching. The patient took diphenhydramine 50mg once. The outcome was recovered. Reporter's comments: The health authority assessed the case as not serious.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns a 63 year old female patient. The patient had no medical history or current illness. She had no known medications as concomitant medication. On 11-Nov-2014, the patient received intramuscular AFLURIA injection (batch number '753809') in the left arm. On 24-Mar-2015, the patient experienced localised soreness. The outcome was reported as not recovered. Reporter comments: The health authority assessed the event as non-serious. Case correction (26-Jun-2015): AE #2 combined with AE #1.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3
Symptoms: Erythema, Headache, Myalgia, Nausea, Pruritus
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 11-May-2015) concerns a 50 year-old female patient who had a current illness of bilateral foot pain. The patient's medical history included chronic back pain, depression, hysterectomy for menorrhagia in 2010, PFO (patent foramen ovale, asymptomatic, diagnosed incidentally by echo), nummular eczema, tubular adenoma diagnosed by colonoscopy in Jun-2014 (follow-up recommended in 5 years), solar urticaria, penicillin allergy (swelling), and ibuprofen allergy. On 12-Jan-2015, the patient received AFLURIA injection (batch number T53409 and ZOSTAVAX (batch number K009198). Both vaccines were given on the right arm. On 13-Jan-2015, the patient experienced myalgia, headache, urticarial pruritus, nausea, vomiting, swelling, and erythema. Treatment included hydroxyzine 25mg. The outcome was recovered. Reporter's comments: The health authority assessed the case as non-serious.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3
Symptoms: Swelling, Urticaria, Vomiting
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 11-May-2015) concerns a 50 year-old female patient who had a current illness of bilateral foot pain. The patient's medical history included chronic back pain, depression, hysterectomy for menorrhagia in 2010, PFO (patent foramen ovale, asymptomatic, diagnosed incidentally by echo), nummular eczema, tubular adenoma diagnosed by colonoscopy in Jun-2014 (follow-up recommended in 5 years), solar urticaria, penicillin allergy (swelling), and ibuprofen allergy. On 12-Jan-2015, the patient received AFLURIA injection (batch number T53409 and ZOSTAVAX (batch number K009198). Both vaccines were given on the right arm. On 13-Jan-2015, the patient experienced myalgia, headache, urticarial pruritus, nausea, vomiting, swelling, and erythema. Treatment included hydroxyzine 25mg. The outcome was recovered. Reporter's comments: The health authority assessed the case as non-serious.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Exfoliative rash, Injection site pruritus, Rash erythematous
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns a 57 year old male patient. The patient has no medical history or current illness. On 15-Jan-2015, the patient received AFLURIA injection (batch number: T54009) in the right arm (dose 1, route: SYR) and the same day he also received PNEUMOVAX (batch number K018528) in the left arm (dose 1, route: SYR). On 15-Jan-2015, the night after vaccine administration, the patient complained of injection site itching. Subsequently, a rash (scaly and red) formed within three days after administration. The size of rash was approximately 1.5 cm x 1 cm. The outcome was reported as recovered. Reporter's comments: The regulatory authority assessed the events as non-serious.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 11-May-2015) concerns a 59 year-old female patient who had no medical history. On the 09-Sep-2014, the patient received AFLURIA injection (batch number T57005) via the intramuscular route. On the 09-Sep-2014, the patient experienced pain in arm which increased over the next 2 days, the shot was painful, and lost range of motion/flexibility in arm. The pain was severe. The patient saw the doctor. The pain continued even more and the patient went to the physical therapy trying to get the range of motion back in the arm. The outcome was not recovered. Reporter's comments: The health authority assessed the case as non-serious.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site hypoaesthesia, Injection site reaction, Muscular weakness
Clinical narrative: This medically confirmed health authority report (initial receipt 11-May-2015) concerns a 50-year-old male patient. The patient's concomitant medication included atorvastatin. The patient had no medical history or current illness. On 27-Sep-2014, the patient received intramuscular AFLURIA injection (batch number T57906) in the right arm. On 29-Sep-2014, a day or two after vaccine administration, the patient's muscle of upper right arm became weak and numb. The patient did not seek treatment until 06-Apr-2015, he stated that his right upper arm still felt weak but remained functional. He stated that there were no other reactions. The outcome was reported as recovered.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 11-May-2015) concerns a 43 year-old female patient who had no current illness, lab data and medical history. Concomitant medications included omeprazole, SYNTHROID and amlodipine/benazepril. On the 07-Oct-2014, the patient received AFLURIA injection (batch number T58706) via the intramuscular route on the left arm. On an unspecified date, the patient expereinced soreness at the injection site which was greater than usual and lasted for several days. The patient still felt sore if she pressed on it. She began to feel an intense pain radiating down the arm within a few days, had limited range of motion for months, and could not lift or reach with the arm. It improved. No medical attention was sought. The outocme was unknown. Reporter's comments: The health authority assessed the case as non-serious.
Age: 66.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 66 year old male patient who had a medical history of hypertension and Diabetes type 2. Medications at the time of vaccination included labetalol, atenolol and metformin. The patient had no current illness at the time of vaccination. On the 26-Nov-2014, the patient received the AFLURIA injection (batch number T52608) via the intramuscular route in the AR. On the 27-Nov-2014, the patient developed pain in the left shoulder joint - it became worse when the patient moved the left arm. No treatment was given. Outcome was not recovered. Reporter comments: The regulator reported the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 64 year old female patient. On the 03-Oct-2014, the patient received the AFLURIA injection (batch number T50407) via an unknown route at an unknown site. On the 01-Nov-2014, the patient developed loss of some mobility and was very sore and had trouble lifting the left arm. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt 20-Jul-2015) concerns a 64 year old female patient. On the 03-Oct-2014, the patient received the AFLURIA injection (batch number T50407) via an unknown route at an unknown site. On the 01-Nov-2014, the patient developed loss of some mobility and was very sore and had trouble lifting the left arm. Outcome was unknown. Reporter comments: The regulator reported the case as non-serious.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Flushing, Immediate post-injection reaction, Malaise, Skin tightness
Clinical narrative: This medically confirmed health authority report (initial receipt date 20-Jul-2015) concerns a 65 year old male patient. On 04-Nov-2014, the patient received AFLURIA (batch number: T52808) in the left arm (site: 'SYR'). On 04-Nov-2014, within seconds of receiving flu shot, the patient complained of not feeling unwell. The patient felt tightness around the nose and flushed but denied shortness of breath. His vital were 122/70, pulse was 63, O2 was 94% and temperature was 99.0. The outcome was reported as recovered.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: This medical confirmed health authority report (initial receipt 20-Jul-2015) concerns a 64 year old female patient. The patient had no current illness or medical history. Her concomitant medication included levothyroxine sodium. On 17-Sep-2014, the patient received intramuscular AFLURIA injection (batch number T59807A). On 01-Oct-2014, the patient's left arm was down for a period and .t was not easily able to pull up without hurting. The patient had achy feeling up to shoulder and down pass elbow. She had trouble sleeping at night if the arm was left in permanent position. She visited the doctor in Nov-2014 and it was thought to be "tennis elbow". The outcome was reported as not yet recovered. Reporter's comments: The health authority assessed the events as non-serious
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Epicondylitis, Insomnia, Pain, Pain in extremity
Clinical narrative: This medical confirmed health authority report (initial receipt 20-Jul-2015) concerns a 64 year old female patient. The patient had no current illness or medical history. Her concomitant medication included levothyroxine sodium. On 17-Sep-2014, the patient received intramuscular AFLURIA injection (batch number T59807A). On 01-Oct-2014, the patient's left arm was down for a period and .t was not easily able to pull up without hurting. The patient had achy feeling up to shoulder and down pass elbow. She had trouble sleeping at night if the arm was left in permanent position. She visited the doctor in Nov-2014 and it was thought to be "tennis elbow". The outcome was reported as not yet recovered. Reporter's comments: The health authority assessed the events as non-serious
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Bone pain, Injection site reaction, Myalgia
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt date 20-Jul-2015) concerns a 56 year old female patient. The patient's current illness included fibromyalgia, lumbosacral disc degeneration, prophylaxis and she had no drug allergies. Her concomitant medications included potassium, duloxetine hydrochloride, OXYCOCET, acetaminophen-butalbital-caffeine, eszopiclone, diazepam, cyclobenzaprine hydrochloride, furosemide, omeprazole, ropinirole, atorvastatin calcium, pregabalin, pilocarpine and lisinopril. On 30-Sep-2014, the patient received AFLURIA (batch number not reported) at site "AR". The same day, she also received intramuscular PNEUMOVAX (batch number K009809) site AR, in the other arm. On 30-Sep-2014, the patient experienced "throbbing pain down the muscle and bone" at the injection site of PNEUMOVAX 23. The patient called the pharmacist. No treatment was given for the event and no laboratory diagnostic studies were performed. The outcome was reported as not yet recovered. Reporter's comments: The health authority assessed the events as non-serious and reported the PT 'injection site reaction'.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Bone pain, Injection site pain, Injection site reaction
Clinical narrative: This non-serious medically confirmed health authority report (initial receipt date 20-Jul-2015) concerns a 56 year old female patient. The patient's current illness included fibromyalgia, lumbosacral disc degeneration, prophylaxis and she had no drug allergies. Her concomitant medications included potassium, duloxetine hydrochloride, OXYCOCET, acetaminophen-butalbital-caffeine, eszopiclone, diazepam, cyclobenzaprine hydrochloride, furosemide, omeprazole, ropinirole, atorvastatin calcium, pregabalin, pilocarpine and lisinopril. On 30-Sep-2014, the patient received AFLURIA (batch number not reported) at site "AR". The same day, she also received intramuscular PNEUMOVAX (batch number K009809) site AR, in the other arm. On 30-Sep-2014, the patient experienced "throbbing pain down the muscle and bone" at the injection site of PNEUMOVAX 23. The patient called the pharmacist. No treatment was given for the event and no laboratory diagnostic studies were performed. The outcome was reported as not yet recovered. Reporter's comments: The health authority assessed the events as non-serious and reported the PT 'injection site reaction'.