chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial report received from a non-healthcare professional via other company on 01 December 2014. A 49-year-old female patient, whose medical history and concomitant medication was not reported, had received a dose of FLUZONE (batch number, dose, dose in series, route of administration and site of administration was not reported) on 31 August 2014. On 01 September 2014 one day after vaccination, the patient experienced pain and unable to lift her arm completely. Laboratory investigations and corrective treatment was not reported. At the time of this report the patient was not recovered from the events. Documents held by sender: none. Follow up information received from a non-healthcare professional via other company on 30 January 2015. It was reported that case was reviewed and no further information to provide and patient had full recovery and last office visit was on 14 November 2014.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Initial report received from a non-healthcare professional via other company on 01 December 2014. A 49-year-old female patient, whose medical history and concomitant medication was not reported, had received a dose of FLUZONE (batch number, dose, dose in series, route of administration and site of administration was not reported) on 31 August 2014. On 01 September 2014 one day after vaccination, the patient experienced pain and unable to lift her arm completely. Laboratory investigations and corrective treatment was not reported. At the time of this report the patient was not recovered from the events. Documents held by sender: none. Follow up information received from a non-healthcare professional via other company on 30 January 2015. It was reported that case was reviewed and no further information to provide and patient had full recovery and last office visit was on 14 November 2014.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: Initial report received from a non-healthcare professional (consumer) on 16 October 2014. A patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of FLUZONE Intradermal (Batch number, expiry date, route and site of vaccination not reported), on an unspecified dates. On an unspecified date, after vaccination the patient developed larger than usual red circle at injection site (about size of baseball) and stiffness in arm as if it was an IM injection. Laboratory data and corrective treatment were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none. Follow-up information received from a non-healthcare professional on 12 January 2015. A 38-year-old female patient was vaccinated with FLUZONE Intradermal on an unspecified date. Illness at the time of vaccination and Pre-existing physician diagnosed allergies was reported as unknown. At the time of this report, the outcome of the patient was reported as recovered on an unspecified date. List of Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Musculoskeletal stiffness
Clinical narrative: Initial report received from a non-healthcare professional (consumer) on 16 October 2014. A patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of FLUZONE Intradermal (Batch number, expiry date, route and site of vaccination not reported), on an unspecified dates. On an unspecified date, after vaccination the patient developed larger than usual red circle at injection site (about size of baseball) and stiffness in arm as if it was an IM injection. Laboratory data and corrective treatment were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none. Follow-up information received from a non-healthcare professional on 12 January 2015. A 38-year-old female patient was vaccinated with FLUZONE Intradermal on an unspecified date. Illness at the time of vaccination and Pre-existing physician diagnosed allergies was reported as unknown. At the time of this report, the outcome of the patient was reported as recovered on an unspecified date. List of Documents held by sender: None.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tinnitus
Clinical narrative: Initial unsolicited report received from a  nurse (consumer) on 10 September 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD (batch number, route and site of administration was not reported) on 9 September 2015. The patient received annually FLUZONE HD in the past. The patient had a medical history of Eustachian tube dysfunction last month. Concomitant medications were not reported. On 10 September 2015, few hours following the vaccination at 2 am, the patient awakened with a RAGING tinnitus in my left ear which lasted for half an hour (by raging mean sounding like an air raid warning). This had just recurred at 2pm and is now slightly resolving after an hour. It was reported that the patient never experienced anything like this. Lab data and corrective treatments were not reported. The patient was recovering from the event. List of documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 12 September 2015. This case involves a 60-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE QIV (batch number UI431AB, expiration date 30 June 2016, dose in series was not reported) in left deltoid on an unspecified date (10 days before the date of reporting). The patient did not have any illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as unknown. Concomitant medications were not reported. On an unspecified date post vaccination, the patient experienced tingling and numbness from injection site to left hand. Lab data and corrective treatments were not reported. At the time of this report, the patient had not recovered from the events. List of documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Paraesthesia
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 12 September 2015. This case involves a 60-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE QIV (batch number UI431AB, expiration date 30 June 2016, dose in series was not reported) in left deltoid on an unspecified date (10 days before the date of reporting). The patient did not have any illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects and medical conditions were reported as unknown. Concomitant medications were not reported. On an unspecified date post vaccination, the patient experienced tingling and numbness from injection site to left hand. Lab data and corrective treatments were not reported. At the time of this report, the patient had not recovered from the events. List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Influenza like illness, Injection site bruising
Clinical narrative: Chills, fever, loss of appetite, weak - these symptoms began within about 6-8 hours after receiving the vaccine and lasted overnight and all day the next day. I was in bed and sleeping all day. My arm was red and swollen and feverish. This lasted a week. It became so itchy and red, I had to go to the emergency room.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Chills, fever, loss of appetite, weak - these symptoms began within about 6-8 hours after receiving the vaccine and lasted overnight and all day the next day. I was in bed and sleeping all day. My arm was red and swollen and feverish. This lasted a week. It became so itchy and red, I had to go to the emergency room.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Chills, Decreased appetite, Erythema, Peripheral swelling
Clinical narrative: Chills, fever, loss of appetite, weak - these symptoms began within about 6-8 hours after receiving the vaccine and lasted overnight and all day the next day. I was in bed and sleeping all day. My arm was red and swollen and feverish. This lasted a week. It became so itchy and red, I had to go to the emergency room.
Age: 75.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pruritus, Pyrexia
Clinical narrative: Chills, fever, loss of appetite, weak - these symptoms began within about 6-8 hours after receiving the vaccine and lasted overnight and all day the next day. I was in bed and sleeping all day. My arm was red and swollen and feverish. This lasted a week. It became so itchy and red, I had to go to the emergency room.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site. Patient instructed to use cold compress, take Tylenol if needed, take Benadryl 1 to 2 capsules every 4 to 6 hours. Call doctor in morning if not better.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Vaccine Site Reaction including Pain, Redness, Swelling. Size: Greatest Concentration 2.5 cm x 4 cm, Full Extent 8 cm x 20 cm. Injection Site in Upper Triceps Muscle.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: Pt had flu vaccine on 11/17/2015. Stated no allergies and never had flu vaccine previously. Presented to clinic on 11/18/15 stated started to have severe itching 2 hours after vaccine. No other symptoms on exam - no hives or edema/swelling. Appears to allergic reaction from flu vaccine.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain
Clinical narrative: Severe back ache necessitating days off from work (until 11/18/2015).  Never experienced anything like this.  This is the only second time I have taken the vaccine.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Insomnia, Musculoskeletal pain, Nausea
Clinical narrative: Severe rt. shoulder pain which spread to rt. neck area, down rt. arm to fingers, through right shoulder blade to lower back, through buttocks and hip to lower leg pain in thigh and shin. Felt very weak. Was in pain through the night. Advil did not help. Could not sleep. 2nd day more weak and nauseous from pain. Went to ER. Did nothing but give more Advil. Went home and slept for 12 hrs. Third day beginning to feel better, but rt. side of body still aches.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Severe rt. shoulder pain which spread to rt. neck area, down rt. arm to fingers, through right shoulder blade to lower back, through buttocks and hip to lower leg pain in thigh and shin. Felt very weak. Was in pain through the night. Advil did not help. Could not sleep. 2nd day more weak and nauseous from pain. Went to ER. Did nothing but give more Advil. Went home and slept for 12 hrs. Third day beginning to feel better, but rt. side of body still aches.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Pt has lack of mobility in arm, went to Primary MD, got muscle relaxants, still no improvement.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Body temperature increased, Dizziness, Mobility decreased
Clinical narrative: This medically confirmed spontaneous report (initial receipt 06-Nov-2015) concerns a 12-year old male patient. The patient had received a seasonal influenza vaccine in the past and the patient did not tolerate the previous vaccination. The patient currently was not taking any other medications, vitamins or herbal supplements. On 26-Oct-2015, at 4pm, the patient received intramuscular Afluria (influenza virus vaccine polyvalent, batch number U54806) for protection against the influenza virus. On 27-Oct-2015, at 03:00 am, the patient woke up and felt like he could not move describing it as he felt paralysed. He was also dizzy and weak. The patient informed his mother, who took his temperature with a thermal scan via his forehead and had temeperature of 101.7 Degree F. The patient was treated with acetaminophen. A few hours later the patient felt fine and went to school. The outcome was reported as recovered on 27-Oct-2015. Reporter's Comments: n/a. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus and the Afluria PI, felt paralysed" and other events are unlisted except fever and malaise which are listed. Causality: Possible. Time to onset is within 24 hours of vaccination. Patient recovered within 3 hours excluding any significant neurological event.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blindness, Decreased eye contact, Diet refusal, Dyskinesia, Emotional distress
Clinical narrative: He started suddenly screaming. I could not console him. He appeared, in his reactions, that he could not see. He was flailing his arms in the air in a state of panic. He also appeared to be in extreme pain. His body would jerk and he would scream even louder. His screaming continued for several hours. He could not look at me or other family members and would avoid eye contact. He could not nurse and appeared to not be able to latch on. He continues now to whimper and his legs are in a lot of pain. I can't even touch them lightly. He continues to jerk and be hypersensitive.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Hypersensitivity, Injection site pain, Pain, Pain in extremity, Panic attack
Clinical narrative: He started suddenly screaming. I could not console him. He appeared, in his reactions, that he could not see. He was flailing his arms in the air in a state of panic. He also appeared to be in extreme pain. His body would jerk and he would scream even louder. His screaming continued for several hours. He could not look at me or other family members and would avoid eye contact. He could not nurse and appeared to not be able to latch on. He continues now to whimper and his legs are in a lot of pain. I can't even touch them lightly. He continues to jerk and be hypersensitive.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Screaming
Clinical narrative: He started suddenly screaming. I could not console him. He appeared, in his reactions, that he could not see. He was flailing his arms in the air in a state of panic. He also appeared to be in extreme pain. His body would jerk and he would scream even louder. His screaming continued for several hours. He could not look at me or other family members and would avoid eye contact. He could not nurse and appeared to not be able to latch on. He continues now to whimper and his legs are in a lot of pain. I can't even touch them lightly. He continues to jerk and be hypersensitive.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Left Arm swelling after Pneumovax 23 vaccine.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: Redness, swelling of arm, great pain, slept in chair for 2 nights.  Doctor ordered ultrasound of arm after seeing it on second day.  Very Very sore and inflamed.  Said it was a very bad reaction.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Ligament injury
Clinical narrative: Dr's injection hit ligament gave prednisone.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site reaction, Injection site warmth, Local reaction
Clinical narrative: Localized reaction (L) upper arm after Tdap, MCV4 warm to touch, not hard, 4" area.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain in left shoulder, that radiates into bicep. No chronic. Patient will make appt to see MD.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Laboratory test normal, Pain in extremity
Clinical narrative: Hematoma, arm pain. Next day continuous.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Vaccine in AM. That evening, lightheaded, then syncope. W/U (-).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to 8 unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored dose of VAQTA (lot # L023232, exp. 25-FEB-2017). No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patient of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215, exp. 05-MAY-2015). No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to 7 unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L008034, exp. 05-AUG-2016). No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to GARDASIL 9. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker referring to unspecified number of patients. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with GARDASIL 9 (dose, frequency and route not reported, lot # L016428, expired date: 30-JUL-2017). No adverse event were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Condition aggravated, Febrile convulsion
Clinical narrative: 3 brief febrile seizures.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Full blood count, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 11/13/15, 65 yo F was seen in clinic for nurse only visit for immunizations. During this visit, pt received Flu vaccine, age 3yo, preservative free, IM (QUADRIVALENT) 0.5 mL in left deltoid (NDC #49281-415-50, Lot #UI493AB, exp: 6/30/2016). On 11/16, pt called clinic and reported that on 11/15, she developed redness and mild swelling to left deltoid area, accompanied by mild fatigue, malaise, nausea and low grade fever. Pt had self-treated with acetaminophen and ibuprofen. Pt was offered office visit, but initially declined this due to travel. Pt was advised to apply intermittent ice to area and continue to monitor reaction. On 11/17, with symptoms unchanged, the pt returned to clinic for evaluation. MD exam found "On the left arm, extending from the deltoid inferiorly, there is erythema and warmth. Mild tenderness at the injection site." A CBC and comprehensive metabolic panel was ordered to evaluate for infection given left lower quadrant tenderness. Pt was advised to seek emergency care for any worsening symptoms. Pt told to monitor border of area of erythema and call for any enlargement. On 11/19, pt was called and pt reported "left deltoid side is slightly less red, slightly less warm and has better mobility of her arm today". WBC resulted were elevated at 15.3. Pt continues to monitor site and again agreed to seek care if elevation in fever or any new or concerning symptoms.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Malaise, Metabolic function test, Mobility decreased, Nausea
Clinical narrative: On 11/13/15, 65 yo F was seen in clinic for nurse only visit for immunizations. During this visit, pt received Flu vaccine, age 3yo, preservative free, IM (QUADRIVALENT) 0.5 mL in left deltoid (NDC #49281-415-50, Lot #UI493AB, exp: 6/30/2016). On 11/16, pt called clinic and reported that on 11/15, she developed redness and mild swelling to left deltoid area, accompanied by mild fatigue, malaise, nausea and low grade fever. Pt had self-treated with acetaminophen and ibuprofen. Pt was offered office visit, but initially declined this due to travel. Pt was advised to apply intermittent ice to area and continue to monitor reaction. On 11/17, with symptoms unchanged, the pt returned to clinic for evaluation. MD exam found "On the left arm, extending from the deltoid inferiorly, there is erythema and warmth. Mild tenderness at the injection site." A CBC and comprehensive metabolic panel was ordered to evaluate for infection given left lower quadrant tenderness. Pt was advised to seek emergency care for any worsening symptoms. Pt told to monitor border of area of erythema and call for any enlargement. On 11/19, pt was called and pt reported "left deltoid side is slightly less red, slightly less warm and has better mobility of her arm today". WBC resulted were elevated at 15.3. Pt continues to monitor site and again agreed to seek care if elevation in fever or any new or concerning symptoms.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: On 11/13/15, 65 yo F was seen in clinic for nurse only visit for immunizations. During this visit, pt received Flu vaccine, age 3yo, preservative free, IM (QUADRIVALENT) 0.5 mL in left deltoid (NDC #49281-415-50, Lot #UI493AB, exp: 6/30/2016). On 11/16, pt called clinic and reported that on 11/15, she developed redness and mild swelling to left deltoid area, accompanied by mild fatigue, malaise, nausea and low grade fever. Pt had self-treated with acetaminophen and ibuprofen. Pt was offered office visit, but initially declined this due to travel. Pt was advised to apply intermittent ice to area and continue to monitor reaction. On 11/17, with symptoms unchanged, the pt returned to clinic for evaluation. MD exam found "On the left arm, extending from the deltoid inferiorly, there is erythema and warmth. Mild tenderness at the injection site." A CBC and comprehensive metabolic panel was ordered to evaluate for infection given left lower quadrant tenderness. Pt was advised to seek emergency care for any worsening symptoms. Pt told to monitor border of area of erythema and call for any enlargement. On 11/19, pt was called and pt reported "left deltoid side is slightly less red, slightly less warm and has better mobility of her arm today". WBC resulted were elevated at 15.3. Pt continues to monitor site and again agreed to seek care if elevation in fever or any new or concerning symptoms.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Cough, Dysphonia, Oropharyngeal pain, Secretion discharge
Clinical narrative: Deep cough.  Mild sore throat with mucus.  Deep, somewhat hoarse voice.  Weakness.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthenia, Headache, Nausea, Pallor
Clinical narrative: Headache, nausea, weakness, pale. Onset morning 11/18/2015 and unresolved as of this report on 11/19/2015 10 AM.  Severe enough to miss school.
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Weight gain poor
Clinical narrative: This spontaneous report was received fro a mother of the patient refers to a newborn male patient of unknown age. No concurrent condition or medical history was reported. On 23-SEP-2015 and 28-SEP-2015, the patient was vaccinated with RECOMBIVAX HB. No concomitant therapy was reported. On an unknown date in November 2015, also reported as in last couple weeks, the patient experienced diarrhoea, and was unable to gain or loose weight. The physician stated that the patient was below the height and weight chart. No treatment was given for the events. The outcome of the event was reported as recovering. The causality assessment was not reported. No product quality issue was involved. Additional information is not expected as reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report has been received from a healthcare worker referring to unspecified number of patients. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with GARDASIL (dose, frequency and route not reported, lot # K008931, expired date: 04-MAR-2017). No adverse event were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 17-NOV-2015, the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # K005402, exp. 07-NOV-2015). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unknown number of patients (unknown age and gender). The patients were vaccinated with improperly stored GARDASIL (dose, dose #, lot #, route and application site were not reported), since 01-OCT-2015. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unknown number of patients (unknown age and gender). The patients were vaccinated with improperly stored ROTATEQ (oral route, dose, dose # and lot # were not reported), since 01-OCT-2015. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of PEDVAXHIB (dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to PEDVAXHIB. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L008574, expiration date 22-NOV-2016 and/or lot # K02353, expiration date 22-MAY-2016, dose not provided) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to ROTATEQ. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 21 year old female patient. On 03-NOV-3025, the patient was vaccinated with PNEUMOVAX 23 lot # K021881, intramuscular. Concomitant therapies included PROAIR and budesonide, SYMBICORT. On 03-NOV-2015, the patient experienced swelling at injection site region (right arm) from her shoulder and extending to her elbow. No treatment was given. No lab tests were performed. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unknown number of patients (unknown age and gender). The patients were vaccinated with improperly stored PEDVAXHIB (dose, dose #, lot #, route and application site were not reported), since 01-OCT-2015. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unknown number of patients (unknown age and gender). The patients were vaccinated with improperly stored M-M-R II (dose, dose #, lot #, route and application site were not reported), since 01-OCT-2015. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a healthcare worker referring to unspecified number of patients. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with M-M-R II (dose, frequency and route not reported, lot# reported as K002136, expired date: 10-FEB-2015; K011168, expired date: 12-AUG-2016). No adverse event were reported. This is one of the several reports from the same reporter. Lot # K002136 and K011168 are invalid lot number for M-M-R II. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional concerning an unknown number of unspecified patients. In November 2015, the patients were vaccinated with improperly stored M-M-R II (lot # L015281, expiry date: 30-APR-2017) and, also in November 2015, with another lot of the vaccine (lot # L024268, expiry date: 01-JUL-2017). Route and dose for both lots were not reported. It was mentioned that the vaccinations took place "since 09-NOV-2015", but since another vaccine was also involved, the exact date of vaccination is unknown. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report has been received from a healthcare worker referring to unspecified number of patients. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with ROTATEQ (dose, frequency and route not reported, lot # K015816, expired date: 29-MAY-2016; K010221, expired date: 12-MAY-2016). No adverse event were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient states the day after the injection her arm began to hurt. She continues to have pain at rest and with movement of arm despite being 4 weeks out from her injection date.
Age: 0.46
Sex: F
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: Pt. was given expired PREVNAR 13 vaccine. Pt will be revaccinated with appro dose in December 2015.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. Information about concurrent conditions medical history and concomitant medication was not provided. On unknown dates the patient were vaccinated with doses of improperly stored M-M-R II (lot # L010488, expiration date 26-MAR-2017, dose, dose# and roué unknown). No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Blood pressure increased, Musculoskeletal stiffness, Rash, Urticaria
Clinical narrative: 10-21-15 Spoke with client on phone. Stated broke out in hives on Saturday and neck was stiff. Stated she bath in some cream from the hosp. and was taking BENADRYL. States rash on back, legs, and neck. Strongly encouraged pt to go to ER. She stated she called Dr and can't see her till tomorrow (10-22) and instructed pt to make sure she went to MD appt if she does not go to ER. Denies trouble breathing. States neck no longer stiff. Went to see Dr (10-22) and BP 240/140 (NP) sent to ER with rash no better and elevated BP.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Pain, Swelling
Clinical narrative: Presented 11-6-15 with redness of left arm at injection site about 4-5 cm diameter also redness about 5-6 cm diameter just below 1st site on inner aspect of arm and minimal swelling c/o some pain. Noticed redness 11-4-15.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Influenza, Pyrexia
Clinical narrative: Flu shot was given at 4:30 pm and at 9:00 pm I was having chills - fever - headache, all the symptoms of flu with temperature of 101 - had to take an antibiotic to get over flu.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Decreased appetite
Clinical narrative: Fever, chills, joint pain, myalgia, restlessness, headache, loss of appetite, pain at injection site, frequent urination, back pain, fatigue, weakness.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Myalgia, Pollakiuria, Pyrexia
Clinical narrative: Fever, chills, joint pain, myalgia, restlessness, headache, loss of appetite, pain at injection site, frequent urination, back pain, fatigue, weakness.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Restlessness
Clinical narrative: Fever, chills, joint pain, myalgia, restlessness, headache, loss of appetite, pain at injection site, frequent urination, back pain, fatigue, weakness.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Febrile convulsion, Pyrexia, Streptococcus test
Clinical narrative: Pt was at daycare and had a 4 minute febrile seizure.  Fever of 102.2.
Age: 1.64
Sex: M
Vaccine: DTAP
Symptoms: Abdominal discomfort, Crying, Diarrhoea, Pyrexia
Clinical narrative: Crying for 3 hrs. Then on 11/14 fever 102 (lasted one day). Then on 11/19 upset stomach/diarrhea.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Extra dose administered
Clinical narrative: Accidental Vaccination.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Malaise, Respiratory symptom
Clinical narrative: Swelling and redness at injection site, worsening over several days, joint pain, upper respiratory symptoms, general malaise, symptoms worsened over several days and then began improving by day 4 after immunization.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: She received the shot on Saturday and arm became red and painful Saturday night. Fever developed Saturday night and continued through Sunday Has been taking Tylenol for fever. She denies any nausea or vomiting.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Chills for approx 1 hour, fever, and vomited day of vaccine administered and chills day after.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via direct contact, 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. No patient's concurrent conditions, medical history or concomitant medications were reported. On an unknown date, while the patient (who was a pharmacist) was drawing up ZOSTAVAX (strength, dose, LOT#, expiration date were not reported), the vial broke on an unspecified was and the vaccine got on the patient's skin (unspecified location). On an unknown date, an unspecified time after being topically exposed to ZOSTAVAX, patient developed shingles. The outcome of herpes zoster was reported as unknown. The causality between shingles and ZOSTAVAX was not specified. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unspecified patients (demographics unknown). There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # K021485 with expiration date: 03-NOV-2016; number of doses administered was unspecified). No concomitant therapy was provided. No adverse effects were reported. This is one of the two cases received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 06-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # H014282, expiration date 09-APR-2014 (strength, dose and route of administration were not provided). On 19-NOV-2014, the patient was vaccinated with an extra dose of PNEUMOVAX 23 lot # K006681, expiration date 21-OCT-2015 (strength, dose and route of administration were not provided). The nurse stated that the patient had not experienced adverse effect. The reporter was asking to clarify whether or not the patient received PNEUMOVAX 23 or another pneumococcal vaccine for the physician. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain
Clinical narrative: Pt. stated that during vaccine given on 5/27/15 she had extreme pain.  Pain lasted a few days but went away. One month later she experienced a few days of burning pain at injection site, then recurred again on 11/15/15. Cannot tell if she has a rash or redness at site as it is too far back on arm.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm is red, warm, pain, swollen currently taking Ibuprofen. 1 day after getting injection and still currently.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received a second influenza vaccine on this date. Patient received influenza vaccine prior to today at her place of employment.
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Initial unsolicited report received from a nurse on 04-Nov-2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of FLUZONE INTRADERMAL QUADRIVALENT (manufacturer: Sanofi Pasteur, batch number, expiry date, dose details, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date in 2014, patient developed cellulitis of the upper arm. Laboratory investigations and corrective treatment were not provided. The outcome of the event was not reported. Upon internal review this case was considered serious due to important medical event: cellulitis of upper arm. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Tenderness
Clinical narrative: Right upper arm pt had erythema and tenderness.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Computerised tomogram thorax, Cough, Hallucination, Pain
Clinical narrative: Initial unsolicited report received from a non healthcare professional (patient's daughter) on 04-Nov-2015. This case involves a 76 years old male patient (age reported as 77 years) who was vaccinated with a first dose of FLUZONE HD via intramuscular route (manufacturer: Sanofi Pasteur, batch number: UI437AB, expiry date: 29-Mar-2016, dose details and site of administration were not reported) on 22-Sep-2015. The patient had no illness at the time of vaccination and no known drug allergies. Patient had a history of hypertension and congestive heart failure. Birth defects were not reported. On 24-Sep-2015, two days post vaccination, the patient started with a cough, fever and general body aches which continued since then and he had lost 15 lbs by the time of reporting. On an unspecified date post vaccination, he had suffered a cracked rib from coughing. Multiple outpatient doctors had seen him without a diagnosis. On the day of reporting, the patient began hallucinating and his wife took him to the cardiologist who referred him to other clinic. His daughter expressed her concern that her dad was dying and would not make it through the night let alone visiting the clinic. The daughter stated that she would be taking him to the emergency room for evaluation (the patient requiring Emergency Room/Doctor Visit). Laboratory investigations included chest x-ray, CAT (Computerized Axial Tomography) scan of chest, results were not provided. Corrective treatment was not reported. The patient had not recovered from the above mentioned events. Upon internal review this case was considered serious due to important medical event: suffered a cracked rib from coughing. List of documents held by sender: none.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Rib fracture, Weight decreased
Clinical narrative: Initial unsolicited report received from a non healthcare professional (patient's daughter) on 04-Nov-2015. This case involves a 76 years old male patient (age reported as 77 years) who was vaccinated with a first dose of FLUZONE HD via intramuscular route (manufacturer: Sanofi Pasteur, batch number: UI437AB, expiry date: 29-Mar-2016, dose details and site of administration were not reported) on 22-Sep-2015. The patient had no illness at the time of vaccination and no known drug allergies. Patient had a history of hypertension and congestive heart failure. Birth defects were not reported. On 24-Sep-2015, two days post vaccination, the patient started with a cough, fever and general body aches which continued since then and he had lost 15 lbs by the time of reporting. On an unspecified date post vaccination, he had suffered a cracked rib from coughing. Multiple outpatient doctors had seen him without a diagnosis. On the day of reporting, the patient began hallucinating and his wife took him to the cardiologist who referred him to other clinic. His daughter expressed her concern that her dad was dying and would not make it through the night let alone visiting the clinic. The daughter stated that she would be taking him to the emergency room for evaluation (the patient requiring Emergency Room/Doctor Visit). Laboratory investigations included chest x-ray, CAT (Computerized Axial Tomography) scan of chest, results were not provided. Corrective treatment was not reported. The patient had not recovered from the above mentioned events. Upon internal review this case was considered serious due to important medical event: suffered a cracked rib from coughing. List of documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a nurse refers to an 18 year old male patient with an allergy to azithromycin and cefixime. The patient's pertinent medical history and concomitant medication were reported as none. On unknown dates in the past, the patient was vaccinated with the complete set of three pediatric doses of RECOMBIVAX HB (lot numbers, expiration dates and routes of administration were not specified). Then, on 21-JUL-2015, a blood titer was negative for hepatitis B antibodies for the patient. On 16-OCT-2015, the patient received an adult dose of RECOMBIVAX HB (lot# L014419, expiration date 15-APR-2017). However, the patient was 18 years old at the time of receiving the adult dose of RECOMBIVAX HB. The patient's present status and the causality assessment between the adverse event and the therapy with RECOMBIVAX HB were not specified. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Vaccine administered Wed afternoon. By Thursday AM pt had severe pain and stiffness in shoulder. Pain progress to entire arm to max. Pain on Sat and it lessened by Sun. Monday night she got itching to upper arm when injection occurred. With itching was a bright red area like bulls eye around inj. site. 7 days after injection there is a red raised area 5" x7" covering injection area downward to elbow. Pain gone.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site warmth, Vaccination site swelling
Clinical narrative: The area vaccinated turned red and raised the day given. The redness increased each day and the redness spread down her arm about 8inches a week later. It was warm to touch and raised.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Malaise, Nausea, Pyrexia, Tremor
Clinical narrative: She shook, had a fever over 100, feeling sick last night nausea not throwing up. today pt feeling quezzie, sick no fever better today.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient noticed a red, itchy area a couple inches below the site of injection that began about 4 or 5 days after the injection of Prevnar13. No pain or swelling, but itching has persisted for a few days. She will use hydrocortisone.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation
Clinical narrative: Burning feeling in face.