chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Heart rate increased, Laboratory test abnormal, Mobility decreased, Muscle spasms, Muscular weakness
Clinical narrative: Patient had 1st adverse symptoms when she collapsed to the floor and was unable to move her lower extremities. These symptoms resolved within 7 days and she gradually regained the strength in her legs. In Dec '15 she developed pain in legs and shoulders. In the next months she developed fatigue, intermittent muscle spasm, tingling in the legs, leg weakness, cognitive dysfunction, dry mouth , night sweats, headaches, and episodes of dizziness. While hospitalized in May '16 she tested positive for POTS- postural orthostatic tachycardia syndrome.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Musculoskeletal pain, Night sweats, Pain in extremity, Paraesthesia, Postural orthostatic tachycardia syndrome
Clinical narrative: Patient had 1st adverse symptoms when she collapsed to the floor and was unable to move her lower extremities. These symptoms resolved within 7 days and she gradually regained the strength in her legs. In Dec '15 she developed pain in legs and shoulders. In the next months she developed fatigue, intermittent muscle spasm, tingling in the legs, leg weakness, cognitive dysfunction, dry mouth , night sweats, headaches, and episodes of dizziness. While hospitalized in May '16 she tested positive for POTS- postural orthostatic tachycardia syndrome.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Presyncope, Syncope
Clinical narrative: Patient had 1st adverse symptoms when she collapsed to the floor and was unable to move her lower extremities. These symptoms resolved within 7 days and she gradually regained the strength in her legs. In Dec '15 she developed pain in legs and shoulders. In the next months she developed fatigue, intermittent muscle spasm, tingling in the legs, leg weakness, cognitive dysfunction, dry mouth , night sweats, headaches, and episodes of dizziness. While hospitalized in May '16 she tested positive for POTS- postural orthostatic tachycardia syndrome.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable other HCP via a Pfizer sales representative. This other HCP reported the same event for two patients. This is the first of two reports. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5ml single. The patient medical history and the patient's concomitant medications were not reported. The patient experienced cellulitis on an unspecified date with outcome of unknown.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report obtained from a contactable Health Care Professional through a Pfizer sales representative. This Health Care Professional reported the same event for two patients. This is the second of two reports. A patient of unspecified age ethnicity and gender received, on an unspecified date, PREVNAR 13 at 0.5 ml, single dose. Relevant medical history and concomitant medications were unknown. The patient experienced cellulitis on an unspecified date. Clinical outcome of the event was unknown at time of this report.
Age: 18.0
Sex: F
Vaccine: MENB, UNK
Symptoms: Seizure
Clinical narrative: This is a spontaneous report from a contactable nurse received via a sales representative. A 18-years-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. The patient received other two unspecified vaccines. The patient medical history and concomitant medications were not reported. The patient experienced seizure on an unspecified date with outcome of unknown. The reporter does not think it was a real seizure because the patient did not have the symptoms that would have went along with a seizure. No follow-up attempts possible. No further information expected.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: SHE PRESENTED TO THE PHARMACY TODAY WITH A RASH ON THE ARM WHERE THE VACCINE WAS GIVEN.  SHE STATED IT WAS FEVERISH.  IT DID NOT HAPPEN RIGHT AWAY.  I TOLD HER TO TAKE BENADRYL AND IBUPROFEN AND COLD COMPRESS.
Age: 34.0
Sex: M
Vaccine: HEPA, TDAP, TYP, HEPA
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on back right side of neck.
Age: 34.0
Sex: M
Vaccine: HEPA, TDAP, TYP, HEPA
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Pain
Clinical narrative: Numbness on back right side of neck.
Age: 34.0
Sex: M
Vaccine: HEPA, TDAP, TYP, HEPA
Symptoms: Hypoaesthesia
Clinical narrative: Pain, numbness on the right neck, right shoulder, right arm that evening. Went away the next day but symptoms re-occurred the next day.
Age: 34.0
Sex: M
Vaccine: HEPA, TDAP, TYP, HEPA
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Pain
Clinical narrative: Pain, numbness on the right neck, right shoulder, right arm that evening. Went away the next day but symptoms re-occurred the next day.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Electroencephalogram normal, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Respirovirus test positive, Tremor
Clinical narrative: 6-18-16 Pt had 1 min of "shaking".
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Urticaria
Clinical narrative: Patient was weak, tired, dizzy and had no appetite.  An hour and a half later developed widespread hives.  Symptoms persisted the next day. No fever, rapid heart rate or trouble breathing.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Same day as vaccine administration patient developed fever of 103 degrees and full body rash, started on abdomen and spread to extremities.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest pain, Dyspnoea, Heart rate increased, Hyperhidrosis
Clinical narrative: Chest pain, Shortness of breathe, elevated blood pressure, rash & swelling on right hand, sweating, fast heartbeat.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Rash
Clinical narrative: Chest pain, Shortness of breathe, elevated blood pressure, rash & swelling on right hand, sweating, fast heartbeat.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Large reaction on back of arm, covered half of back of arm from injection site to elbow, red, swollen, bruised.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Hypersensitivity, Peripheral swelling, Skin tightness
Clinical narrative: Large reaction to vaccine, 1/3 of back of arm not quite to elbow red, swollen, armpit tightness/swelling and center part blistered. Went to walk in clinic, got VISTARIL, told her it was the gelatin she was allergic to, but she didn't know she was allergic to gelatin, has some reaction with flu vaccine in past as well.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Large reaction to vaccine, 1/3 of back of arm not quite to elbow red, swollen, armpit tightness/swelling and center part blistered. Went to walk in clinic, got VISTARIL, told her it was the gelatin she was allergic to, but she didn't know she was allergic to gelatin, has some reaction with flu vaccine in past as well.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test normal, Chest X-ray normal, Pyrexia
Clinical narrative: Pt developed fever of 100.8 which he had for 4 days. On the fifth day his fever was 105.7 and he went to his PMD and then ED. He was discharged home after tests were done.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site mass
Clinical narrative: Lump started to appear at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site mass, Rash vesicular
Clinical narrative: Lump started to appear at injection site.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chest pain, Chills
Clinical narrative: 6/19 5:30pm started running fever 101.5, chills, cough, chest hurting when coughing. Took Advil.  On 6/20 temp was 101, had nausea, had loose bowel movement, chest hurting when coughing (felt "tight"). 6/21--fever 101, no diarrhea, felt fatigued. 6/22--no fever, but suddenly nausea came and diarrhea, never vomited. Patient noticed a red rash had developed from ankles to mid-calf, spots further up to hip. Still fatigued. 6/24-rash still there, patient given steroid shot and given rx for oral prednisone.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: 6/19 5:30pm started running fever 101.5, chills, cough, chest hurting when coughing. Took Advil.  On 6/20 temp was 101, had nausea, had loose bowel movement, chest hurting when coughing (felt "tight"). 6/21--fever 101, no diarrhea, felt fatigued. 6/22--no fever, but suddenly nausea came and diarrhea, never vomited. Patient noticed a red rash had developed from ankles to mid-calf, spots further up to hip. Still fatigued. 6/24-rash still there, patient given steroid shot and given rx for oral prednisone.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash erythematous, Skull X-ray, Urine analysis
Clinical narrative: 6/19 5:30pm started running fever 101.5, chills, cough, chest hurting when coughing. Took Advil.  On 6/20 temp was 101, had nausea, had loose bowel movement, chest hurting when coughing (felt "tight"). 6/21--fever 101, no diarrhea, felt fatigued. 6/22--no fever, but suddenly nausea came and diarrhea, never vomited. Patient noticed a red rash had developed from ankles to mid-calf, spots further up to hip. Still fatigued. 6/24-rash still there, patient given steroid shot and given rx for oral prednisone.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had a red, swollen, slightly warm to the touch area around the injection site.  Patient presented to the pharmacy 6/23/16 to show pharmacist her arm. Her arm was still somewhat red, and warm to the touch.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Cold sweat, Confusional state, Dark circles under eyes, Lethargy
Clinical narrative: Confused, Body Aches, Constricted pupils, grey tone to skin, black under eyes, clammy, fever. 48 hours later, projectile vomiting, stomach pain, confusion, lethargy.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Miosis, Pain, Pyrexia, Skin discolouration, Vomiting projectile
Clinical narrative: Confused, Body Aches, Constricted pupils, grey tone to skin, black under eyes, clammy, fever. 48 hours later, projectile vomiting, stomach pain, confusion, lethargy.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Injected limb mobility decreased, Injection site nerve damage, Injection site pain, Muscle contractions involuntary
Clinical narrative: Needle inserted in left arm muscle hit a nerve that made that muscle clench involuntarily. Tightness subsided gradually until around 3 PM when the whole arm clenched/tightened in the same arm, making movement impossible or painful, depending on what she tried to do. About 1 hour later (4 PM), she had an onset of visual disturbances that precede a faint. She put her head down but the visual disturbances did not subside. She became nauseous and crawled to the sofa, where she lay for approximately 2 hours, after which time visual disturbances and nausea started to subside. She was then able to call her doctor and was told to call 9-1-1. When the medics arrived, they checked her vital signs, which were okay. She refused to go to the hospital, although she felt weak and shaky. The tight, sore muscles in the injection arm continued to bother her but gradually improved over several days. By the date of this report (6/23/16), there is residual soreness in the muscle at the site of injection.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Muscle tightness, Nausea, Pain, Tremor, Visual impairment
Clinical narrative: Needle inserted in left arm muscle hit a nerve that made that muscle clench involuntarily. Tightness subsided gradually until around 3 PM when the whole arm clenched/tightened in the same arm, making movement impossible or painful, depending on what she tried to do. About 1 hour later (4 PM), she had an onset of visual disturbances that precede a faint. She put her head down but the visual disturbances did not subside. She became nauseous and crawled to the sofa, where she lay for approximately 2 hours, after which time visual disturbances and nausea started to subside. She was then able to call her doctor and was told to call 9-1-1. When the medics arrived, they checked her vital signs, which were okay. She refused to go to the hospital, although she felt weak and shaky. The tight, sore muscles in the injection arm continued to bother her but gradually improved over several days. By the date of this report (6/23/16), there is residual soreness in the muscle at the site of injection.
Age: 67.0
Sex: M
Vaccine: PNC13, TD
Symptoms: Asthenia, Bacteraemia, Chills, Decreased appetite, Dyspnoea
Clinical narrative: Gradual onset of constellation of symptoms starting 5/19/16 including weakness, cold chills, poor appetite, worsening dyspnea, myalgias to legs upper arms and neck, splotchy red rash on left upper thigh starting 6/8/16, pt was evaluated 6/10/16 and referred to local ER but pt declined, on 6/19/16 ex-wife called 911 and pt is currently hospitalized with diagnosis of bacterial meningitis and gram-negative bacteremia.
Age: 67.0
Sex: M
Vaccine: PNC13, TD
Symptoms: Feeling cold, Meningitis bacterial, Myalgia, Rash, Rash erythematous
Clinical narrative: Gradual onset of constellation of symptoms starting 5/19/16 including weakness, cold chills, poor appetite, worsening dyspnea, myalgias to legs upper arms and neck, splotchy red rash on left upper thigh starting 6/8/16, pt was evaluated 6/10/16 and referred to local ER but pt declined, on 6/19/16 ex-wife called 911 and pt is currently hospitalized with diagnosis of bacterial meningitis and gram-negative bacteremia.
Age: 67.0
Sex: M
Vaccine: PNC13, TD
Symptoms: Rash macular
Clinical narrative: Gradual onset of constellation of symptoms starting 5/19/16 including weakness, cold chills, poor appetite, worsening dyspnea, myalgias to legs upper arms and neck, splotchy red rash on left upper thigh starting 6/8/16, pt was evaluated 6/10/16 and referred to local ER but pt declined, on 6/19/16 ex-wife called 911 and pt is currently hospitalized with diagnosis of bacterial meningitis and gram-negative bacteremia.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Blood insulin decreased, Blood pressure increased
Clinical narrative: Case number PHEH2016US009232 is an initial spontaneous report received from a consumer (patient's sister) via medical information on 12 Apr 2016. This report refers to a 60 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with an inactivated seasonal influenza vaccine (manufacturer and batch number: not reported) vial at a dose of 0.5 ml intramuscularly on Nov 2015. In Dec 2015, his blood pressure increased (values were not reported) and he needed increased amounts of insulin since his insulin levels were low (values were not reported). The events outcome was unknown. The events were reported as non-serious. The causality of the events was not reported. The reporter did not provide consent for follow up contact.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Hypoaesthesia, Myalgia, Rash
Clinical narrative: Rec'd Men B (BEXSERO) 6/14/16 at physical in office. Seen 6/23/16 D/T reported tenderness x 3 days and recent "LG", throbbing lump to (L) arm no erythema warmth or fever. Tx: Ibuprofen 600 (2-3x/day with food x 5-7 days.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Laboratory test, Mass, Tenderness
Clinical narrative: Rec'd Men B (BEXSERO) 6/14/16 at physical in office. Seen 6/23/16 D/T reported tenderness x 3 days and recent "LG", throbbing lump to (L) arm no erythema warmth or fever. Tx: Ibuprofen 600 (2-3x/day with food x 5-7 days.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients. At an unspecified time in the past the patients were vaccinated with unspecified doses of PEDVAXHIB (lot # M001813, expiration date 14-OCT-2018; L042835, expiration date 19-AUG-2018) which were improperly stored at 8.2 degree centigrade. There was no prior excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified patient (age and gender unknown). The patient's concurrent conditions and medical history were not mentioned by the reporter. On 20-JUN-2016, the patient was vaccinated with an expired dose of GARDASIL 9 of batch# K023432, expiry date: 18-JUN-2016; (dose#, route and site of administration not reported). Concomitant medication was not mentioned. No adverse effect was reported. No further details were provided. Additional information is not expected as the reporter did not have time to participate in the filing of this Adverse Event report.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abnormal behaviour, Dizziness, Headache, Hypersomnia, Nausea
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative, refers to a 13 year old female patient. The patient's medical history included asthma. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9 (dose, route not reported) (lot# reported as L040459, expiration date was reported as 06-APR-2017). Concomitant therapies included albuterol sulfate (manufacturer unknown) and generic montelukast sodium (manufacturer unknown). On an unknown date, the patient slept a lot the following 2 days after getting the vaccination. On an unknown date, she experienced nausea, vomiting and headaches. The patient "became very "giddy", she was "laughing at the clouds". On an unknown date, the patient decided to discontinued series of the GARDASIL 9 due to events. The outcome of patient was reported as recovered (dates not provided). The relatedness between the events and vaccination of GARDASIL 9 was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a nurse practitioner via company representative, refers to a 13 year old female patient. The patient's medical history included asthma. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9 (dose, route not reported) (lot# reported as L040459, expiration date was reported as 06-APR-2017). Concomitant therapies included albuterol sulfate (manufacturer unknown) and generic montelukast sodium (manufacturer unknown). On an unknown date, the patient slept a lot the following 2 days after getting the vaccination. On an unknown date, she experienced nausea, vomiting and headaches. The patient "became very "giddy", she was "laughing at the clouds". On an unknown date, the patient decided to discontinued series of the GARDASIL 9 due to events. The outcome of patient was reported as recovered (dates not provided). The relatedness between the events and vaccination of GARDASIL 9 was not reported. 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 medical assistant refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patients were inadvertently administered with improperly stored oral ROTATEQ (lot # L029934, expiry date: 01-JUL-2017; lot # M004885, expiry date: 23-OCT-2017; lot # L029934, expiry date: 01-MAY-2017) orally. The vaccine was stored at a temperature of 9.9 UC at an unknown time frame. Data logger was involved and there was no previous temperature excursion. No adverse effect reported. The outcome of the events was not reported. 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 medical assistant refers to multiple unspecified patients of unknown ages and genders, On multiple unspecified dates, the patients were inadvertently administered with improperly stored GARDASIL 9 (lot # M004116, expiry date: 12-OCT-2017; lot # L004475, expiry date: 12-MAY-2017). The vaccine was stored at a temperature of 9.9 UC at an unknown time frame. Data logger was involved and there was no previous temperature excursion. No adverse effect reported. The outcome of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patients were inadvertently administered with improperly stored PNEUMOVAX 23 (lot # L040181, expiry date: 18-AUG-2017; lot # M005287, expiry date: 08-OCT-2017). The vaccine was stored at a temperature of 9.9 UC at an unknown time frame. Data logger was involved and there was no previous temperature excursion. No adverse effect reported. The outcome of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patients were inadvertently administered with improperly stored PEDIVAXHIB (Lot # L042258, expiry date: 18-AUG-2018; Lot# L051124, expiry date: 14-OCT-2018; Lot @ L033690, expiry date: 14-JUN-2018) (route of administration: intramuscular) (incorrect product storage). The vaccine was store at a temperature of 9.9 UC at an unknown time frame. Data logger was involved and there was no previous temperature excursion. No adverse effect reported. The outcome of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patients were inadvertently administered with improperly stored GARDASIL (lot # L038135, expiry date: 27-MAY-2017) (route of administration: intramuscular). The vaccine was stored at a temperature of 9.9 degrees C at an unknown time frame. Data logger was involved and there was no previous temperature excursion. No adverse effect reported. The outcome of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history was not reported. On unknown dates, the patients were late to received second doses of GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported). Concomitant medications were not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history was not reported. On unknown dates, the patients were late to receive second and third doses of GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported). Concomitant medications were not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history was not reported. On unknown dates, the patients were late receiving third doses of GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported). Concomitant medications were not reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report has been receiving from a healthcare professional referring to a patient of unknown age and gender. Information regarding medical history, drug reactions or allergies was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (route of administration, dose, lot# and expiration date were not provided). Concomitant therapies were not provided. On an unknown date, the patient had an "allergic reaction" to ZOSTAVAX. No product quality complaint was involved. At the time of reporting, the outcome of "allergic reaction" was unknown. Additional information is not expected as no reporter details were provided.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from pharmacy technician regarding multiple unspecified patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates unspecified number of patients were vaccinated with improperly stored GARDASIL (lot # L048237; expiry date 08-MAY-2017) dosing details unknown, intramuscularly. Concomitant medications were not reported. It was reported that the vaccines administered were subjected to temperature excursion of 31 degree Celsius for a time frame of 16 hours and these vaccines were not subjected to previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Erythema, Pyrexia, Skin warm
Clinical narrative: Warm to the touch expanding redness, fever, chills, weak, vomiting.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Warm to the touch expanding redness, fever, chills, weak, vomiting.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with VARIVAX lot#, dosing details and route unknown for prophylaxis which was reconstituted with 0.9% sodium chloride (wrong solution used in drug reconstitution). Concomitant medications were not reported. No adverse symptoms were reported. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Inflammation, Pain, Pruritus, Rash
Clinical narrative: Painful rash and pruritus. Described as erythematous, inflamed and itchy. Onset: 1 day ago. Location is right leg. Denies relieving factors. She received the MMR/VARIVAX yesterday in that leg.
Age: 2.0
Sex: M
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: MA administered MMRV, instead of MMR, along with Varicella. Child received 2 doses of Varicella.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL  (exact dose, dose number and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 21.04 degrees Celsius for 36 hours and 25 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring a patient of an unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 07-JUN-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection 5/0.5 mcrg/ml, once, intramuscular (lot # K008986, expiration date 01-APR-2016). No adverse effects were reported. Also was reported that the nurse called to inquire about the stability of expired RECOMBIVAX HB and informed that they had data to support the potency of the vaccine. No product quality complaint was reported. 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 a multiple unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant medications and medical histories reported. On an unknown dates between 02-FEB-2016 and 04-FEB-2016, the patients was vaccinated with an improperly stored doses of GARDASIL 9 (lot# L026602, expiration date 19-OCT-2017; lot# M003659, expiration date 20-SEP-2017, dose, anatomical location and route of administration were not reported). It was also reported that an improperly stored sterile diluent (lot# K023007, expiration date 24-SEP-2017, lot# L017417, expiration date 02-FEB-2018, lot# L015432, expiration date 24-JAN-2018, lot# L03221 and expiration date was not reported; dose, frequency and route of administration were not reported) was used. No adverse events were reported. Temperature 49.3 Fahrenheit degrees (F) for 48 hours, 31.2 F for 16 hours and 16.5 F for 2400 hours. There was no previous temperature excursion and no data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Rash
Clinical narrative: Patient complaints two days after she got the single shot (April 16, 2016) she has rashes developed on both of her palms and sometime they're inflamed.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients current conditions, concomitant medications and medical histories reported. On an unknown dates between 02-FEB-2016 and 02-APR-2016, the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23 (lot# L033707 with expiration date 18-MAY-2017; lot# L038522 with expiration date 11-AUG-2017; dose, anatomical location and route of administration were not reported). It was also reported that an improperly stored sterile diluent (lot# L015432, expiration date 24-JAN-2018; lot# reported as K023007 with expiration date 24-SEP-2017, lot# L017417 with expiration date 02-FEB-2018 and lot# L03221, expiration date was not reported; dose and route of administration were not reported) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) for 48 hours, 31.2 F for 16 hours and 16.5 F for 2400 hours. There was no previous temperature excursion and no data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy site unspecified normal, Dermatologic examination normal, Emotional disorder, HIV test negative, Hepatitis viral test negative
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient was allergic to every treatment she was given. On an unknown date in July 2015, the patient was vaccinated with a dose of ZOSTAVAX (dosage information, lot number and expiry date were not reported), subcutaneously. Concomitant medications was not reported. On an unknown date in July 2015, the patient experienced shingles and had been in pain since after the vaccination. The shingles had not gone away and it continued to spread. The patient reported that, on an unknown date, her mind was snapping, her emotions were crashing and it was stressful to be in pain for almost a whole year. On 17-JUN-2016, the patient visited the unspecified physician and she was told that, "it looked like shingles". On an unknown date, the patient underwent biopsy examination, human immunodeficiency virus (HIV) test, hepatitis test and numerous dermatology test and the results were negative. The outcome of the event was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Irritability, Pain, Stress
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. The patient was allergic to every treatment she was given. On an unknown date in July 2015, the patient was vaccinated with a dose of ZOSTAVAX (dosage information, lot number and expiry date were not reported), subcutaneously. Concomitant medications was not reported. On an unknown date in July 2015, the patient experienced shingles and had been in pain since after the vaccination. The shingles had not gone away and it continued to spread. The patient reported that, on an unknown date, her mind was snapping, her emotions were crashing and it was stressful to be in pain for almost a whole year. On 17-JUN-2016, the patient visited the unspecified physician and she was told that, "it looked like shingles". On an unknown date, the patient underwent biopsy examination, human immunodeficiency virus (HIV) test, hepatitis test and numerous dermatology test and the results were negative. The outcome of the event was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse (via company representative) refers to a patient of unknown age. On  09-JUN-2016 the patient was inadvertently administered an expired dose of VARIVAX (Lot # K007976, Expiry date: 03-JUN-2016) subcutaneously (expired product administered). No adverse effect report. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Back pain, Dizziness, Dysphagia, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site started 6/22/16 and got worse on 6/23/16 redness/swelling approx. 6 cm. Light headed started 6/21/16. Pain in lower back left side started 6/21/16. Pain in ribcage area in the muscles started 6/21/16. Trouble swallowing 6/21/16.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Musculoskeletal chest pain, Myalgia
Clinical narrative: Redness and swelling at injection site started 6/22/16 and got worse on 6/23/16 redness/swelling approx. 6 cm. Light headed started 6/21/16. Pain in lower back left side started 6/21/16. Pain in ribcage area in the muscles started 6/21/16. Trouble swallowing 6/21/16.
Age: 1.31
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema multiforme, Full blood count normal, Metabolic function test normal, Rash
Clinical narrative: 18 days after receiving MMR and VARIVAX, presented to ER with erythema multiforme rash of face, trunk and 4 extremities.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Neck pain
Clinical narrative: 30" after shot pt felt pain (R) side f neck, shot (L) deltoid. Felt better after 3 hrs.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Redness, minor swelling, fever, soreness vaccines given in same arm. Patient waited 3 days to report.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Heart rate increased, Throat tightness
Clinical narrative: 15-20 minutes past vaccination, client c/o increased heart rate, dizziness and throat closing. VSS-B/P 140/80, HR-70. Client able to talk and walk, 911 called for further evaluation. Client transported by medic to hospital.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Movement disorder, Nerve injury, Pain
Clinical narrative: Patient having pain after vaccination complain about hard to move her hand. Complain about nerve damage.
Age: 1.04
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives. Treatment - BENADRYL.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Blister, Local reaction, Rash macular, Skin warm
Clinical narrative: Large blotchy, warm local reaction with small cluster bullae (no vesicles).
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt reported a swollen, red arm around administration site of ZOSTAVAX. Instructed her to watch for worsening and see MD if it gets worse.
Age: 10.0
Sex: M
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Expired product administered, Headache, Pyrexia
Clinical narrative: Hep-B and TD were given and both were expired. Pts mom was notified by doctor. Pts dad said the next day after shots pt had a headache and only a low grade fever and temp. He took some ADVIL. There was no pain/redness/or swelling at injection sites and they were to call if any additional concerns and he was to hydrate well.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Hypotension, Immediate post-injection reaction, Nausea, Pain, Syncope
Clinical narrative: Administered first dose of GARDASIL - HPV vaccine to left deltoid. Patient immediately complained of pain and experienced syncope, nausea. Lasted approx. 2 mins then awoke, didn't remember event. B/P was low at 80/32 given fluids, rest. Felt better after 30 mins, left office - normal next day.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Vaccination site nodule, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Day after vaccine given had swelling, area around vaccine puncture (size of baseball, warm to touch and knot felt).
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Palpitations, Vertigo
Clinical narrative: Vertigo and heart racing. Employee reported today 6-23-16. States symptoms lasted a few hours and then subsided. 1st vaccine given 5-16-16 10:44.
Age: 0.17
Sex: M
Vaccine: DTAP, IPV, RV5
Symptoms: Constipation, Irritability, Vomiting
Clinical narrative: Fussiness, vomiting, constipation.
Age: 1.76
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Child developed hives on her body few hours after receiving the vaccine (only one was given). BENADRYL 12.5 mg/5 ml 3/4 teaspoon then 1/2 teaspoon po q 6 hours x 2 more days.
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blood test, Burning sensation, Erythema, Peripheral swelling
Clinical narrative: In upper R-Arm-Red down to pink very wide with swelling line from top of outside arm down and into inside of arm past elbow, burning feeling. (Still light pink-6-16-2016. Very little burning). In ER IV with Morphine and antibodies/home with clindamycin 300mg NORCO EQ/325 mg.
Age: 21.0
Sex: F
Vaccine: HEPAB, HPV4, IPV, MMR, MNQ, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient seen 10/15/14 and given IPV, TWINRIX, MMR, VZV, MCV4 and HPV4. She denied having intercourse since LMP of 9/24/14. She returned for shelter services 3/22/16 - at which time I needed to give her daughter born her one year vaccines. (Let me know if I need to complete VAERS on her).
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Case number PHHY2016US027942, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 596807) website on 19 Feb 2016. This report refers to an unknown age of female patient. Past medical history included as malaise. Current condition included as drug hypersensitivity (2013), allergic to codeine and prophylaxis. Historical medication included as AFLURIA. Concomitant medications was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date of 02 years ago (approximately in 2013). On an unknown date, the patient experienced very sick. The outcome of the event was reported as complete recovery on an unknown date. The seriousness and causality of the event was not reported.
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Case number PHHY2016US026367 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 608725) on 19 FEB 2016. This report refers to a 39 year old female patient. Medical history was not reported. Concurrent conditions included cough variant asthma, contact allergy to formaldehyde, nickel and gold, ingestion allergy to codeine and sensitivity to dairy and avocados. Concomitant medication included TRIVORA, citalopram, loratadine and ibuprofen. The patient was vaccinated with influenza vaccine (unknown, manufacturer and batch number: not reported) on an unknown date in Nov 2015. On 06 Nov 2015, three days after flu vaccination, the patient was also vaccinated with polyvalent Pneumococcal Vaccine (other manufacturer, batch number: not reported). On 06 Nov 2015, the patient experienced severe muscle pain. It was reported that the pain was serious but the patient was fine was afterwards. The outcome of the event was reported as complete recovery. Event was reported as non-serious. Causality of the events was not reported.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2016US024679, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number:  609699) website on 19 Feb 2016. This report refers to a 63 year old male patient. Historical condition included stroke. Vaccination history included administration of an unspecified vaccine and "pain sore shoulder". concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number:  not reported) on 14 Nov 2015. On the same day, after vaccination the patient experienced pain at site of injection. Outcome of the event was reported as condition unchanged. Event was reported as non-serious. Causality was not reported.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Case number PHHY2016US024707, is an initial spontaneous report received from the Vaccine Adverse Reporting System (reference number:  609705) website on 19 Feb 2016. This report refers to a 60 year old female patient. Historical condition included diabetes. This polymedicated patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number:  not reported) intramuscularly in right arm on 29 Sep 2015. On 05 Oct 2015, the patient developed severe pain in entire arm where flu shot was given and weakness. The patient was taken to an emergency room. Outcome of the events was not reported. Events were reported as non-serious. Causality was not reported.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Case number PHHY2016US025714, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number:  609715) website on 19 Feb 2016. This report refers to a 70 year old female patient. Historical conditions included asthma and high blood pressure. This polymedicated patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number:  not reported) intramuscularly in left arm on 13 Nov 2015. On 14 Nov 2015, the patient developed headache for two days (as of the date of reporting to VAERS). Patient did not take ibuprofen and acetaminophen as she felt that these could suppress her immunity.  Outcome of the even was unknown. Event was report as non-serious. Causality was not reported.
Age: 34.0
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: Case number PHHY2016US027315, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 609963) website on 19 Feb 2016. This report refers to a 34-years-old female patient. Past medical history was not reported. Concomitant medications included birth control medications (unspecified). She was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), measles, mumps and Varicella vaccine (manufacturer unknown and batch number: not reported) all on 14 Nov 2015. On 15 Nov 2015, she experienced larger red, raised hive at injection site and also itchy and tender hive. The outcome of the events was not reported (reporting as missing). The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Myositis, Pain in extremity, X-ray normal
Clinical narrative: Case number PHHY2016US027191, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 610026) website on 19 Feb 2016. This report refers to 74 years old male patient. Past medical history and concomitant medication was not reported. He was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 26 Oct 2015, on left arm. He was also vaccinated with PREVNAR 13 (other manufacturer and batch number: not reported) on 26 Oct 2015, on left arm. On 28 Oct 2015, the he experienced severe diffuse myalgias. The outcome of the event was complete recovery. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13
Symptoms: Myalgia
Clinical narrative: Case number PHHY2016US027191, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 610026) website on 19 Feb 2016. This report refers to 74 years old male patient. Past medical history and concomitant medication was not reported. He was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on 26 Oct 2015, on left arm. He was also vaccinated with PREVNAR 13 (other manufacturer and batch number: not reported) on 26 Oct 2015, on left arm. On 28 Oct 2015, the he experienced severe diffuse myalgias. The outcome of the event was complete recovery. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Age: 79.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Case number PHHY2016US024986, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number: 610141) on 19 Feb 2016. This report refers to a 79 years old male patient. Medical history was not reported. Concurrent conditions were none. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and PREVNAR 13 (batch number: not reported, other manufacturer); both into right arm on 21 Sep 2015. Post vaccination the patient's arm was very and its hurts when moved. It was reported that the arm was still very sore 7 weeks later. Final outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.