chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Swelling face
Clinical narrative: Fever x 3 days, facial swelling, treated self with BENADRYL, Chinese herbs, developed within 24 hours - not reported until 2-3-17 (one year later).
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Drug screen negative, Immediate post-injection reaction, Laboratory test normal, Panic attack
Clinical narrative: Patient became dizzy and light-headed immediately after her 1st and 2nd HPV vaccine. She was observed x 30 minutes in the office then went home. Reports dizziness without other disability or symptoms x 24 hours. 3 days after HPV #2, she had a panic attack after a stressful volleyball practice.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Got shots 2/13. (L) leg red tender last night worse. This AM-no fever. Walking well. No lip, no joint swelling. 2x3 1in.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: Fever, Skin Rash and Urticaria Pruritus.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Cold sweat, Haemoglobin normal, Hypotension, Pallor, Pulse abnormal
Clinical narrative: Patient fainted (was pale, clammy, not responsive with thready pulse), was not able to see for 5 min after recovery, was hypotensive. Legs elevated, smelling salt, glucose tablet and water. 4:55 pm to 5:30. Symptoms resolved (S/P felt norm).
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope, Unresponsive to stimuli, Visual impairment
Clinical narrative: Patient fainted (was pale, clammy, not responsive with thready pulse), was not able to see for 5 min after recovery, was hypotensive. Legs elevated, smelling salt, glucose tablet and water. 4:55 pm to 5:30. Symptoms resolved (S/P felt norm).
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Muscle spasms
Clinical narrative: Intermittent cramping, spasms presumably in GI tract. No blood in stools.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Right thigh red and swollen the size of a grape fruit.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Fatigue, Influenza virus test negative, Malaise, Oropharyngeal pain
Clinical narrative: Given Hepatitis B vaccination - 3rd dose on 2/13/2017. Next day developed malaise, weakness, fatigue, fever up to 104.7 and mild sore throat.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Streptococcus test negative, Urine analysis normal
Clinical narrative: Given Hepatitis B vaccination - 3rd dose on 2/13/2017. Next day developed malaise, weakness, fatigue, fever up to 104.7 and mild sore throat.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events at this time.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain, Pain in extremity, Spinal X-ray abnormal
Clinical narrative: Case number PHHY2017US024740, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 662884) website on 23 Jan 2017. This report refers to a 60 years old female patient. Past medical history was not reported. Concomitant medications included as diclofenac potassium, Cholecalciferol and Albuterol Sulfate HFA. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 17 Oct 2016. On the same day after vaccination, the patient experienced constant aching pain from shot area, traveling to whole arm, shoulder and neck. On scale from 1 to 10 would said 9 being extreme pain, still to this day 01 Nov 2016. It was reported that, physician scheduled an X-Ray cervical spine (4 Views) (right arm getting this test done on 01 Nov 2016). The patient visited emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. Seriousness assessment of musculoskeletal pain, neck pain, vaccination site pain and pain in extremity was upgraded to serious (medically significant) based on the information available in the source document.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Pain in extremity
Clinical narrative: Case number PHEH2016US026579, is a spontaneous report initially received from a consumer on 11 Oct 2016. This report refers to a 62 years old female patient. Medical history and concomitant medications were not reported. Current conditions included that could not exercise or perform other activities. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 10 Sep 2016. On the same day after vaccination, the patient experienced extreme sore arm right after she received vaccine. It was reported that till date her arm was sore and she could not exercise or perform other activities due to pain in her arm. The patient's arm was almost feeling normal now and stated that she never went to her physician and did not expect the health maintenance organization to do anything for her. On an unspecified date the patient experienced suspected mitochondrial metabolic myopathy. The patient stated that no one in her state treat this and she did not want to see physician again to just hear that they did not know what to do for her. The outcome of the event sore arm was reported as condition improving and outcome of the event mitochondrial myopathy was not reported. The seriousness of the event sore arm was reported as non-serious by the consumer. The seriousness of the event mitochondrial myopathy was not reported. The causality of the events was not reported. The seriousness assessment of the event mitochondrial myopathy was upgraded (medically significant) based on the information available in the source document. Follow up report received from nurse on 11 Oct 2016: Updated consumer information. Follow up report received from a consumer on 14 Feb 2017: added event (mitochondrial myopathy), outcome of the event (condition improving) and reporter's comment (the patient stated that no one in her state treat this and she did not want to see physician again to just hear that they did not know what to do for her) and updated outcome of the event pain arm to condition improving.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Mitochondrial myopathy, Pain in extremity
Clinical narrative: Case number PHEH2016US026579, is a spontaneous report initially received from a consumer on 11 Oct 2016. This report refers to a 62 years old female patient. Medical history and concomitant medications were not reported. Current conditions included that could not exercise or perform other activities. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 10 Sep 2016. On the same day after vaccination, the patient experienced extreme sore arm right after she received vaccine. It was reported that till date her arm was sore and she could not exercise or perform other activities due to pain in her arm. The patient's arm was almost feeling normal now and stated that she never went to her physician and did not expect the health maintenance organization to do anything for her. On an unspecified date the patient experienced suspected mitochondrial metabolic myopathy. The patient stated that no one in her state treat this and she did not want to see physician again to just hear that they did not know what to do for her. The outcome of the event sore arm was reported as condition improving and outcome of the event mitochondrial myopathy was not reported. The seriousness of the event sore arm was reported as non-serious by the consumer. The seriousness of the event mitochondrial myopathy was not reported. The causality of the events was not reported. The seriousness assessment of the event mitochondrial myopathy was upgraded (medically significant) based on the information available in the source document. Follow up report received from nurse on 11 Oct 2016: Updated consumer information. Follow up report received from a consumer on 14 Feb 2017: added event (mitochondrial myopathy), outcome of the event (condition improving) and reporter's comment (the patient stated that no one in her state treat this and she did not want to see physician again to just hear that they did not know what to do for her) and updated outcome of the event pain arm to condition improving.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying
Clinical narrative: Persistent, inconsolable crying for 3-4 hours.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Fever, chills, muscular and joint aches, headache, nausea.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever, chills, muscular and joint aches, headache, nausea.
Age: 10.0
Sex: F
Vaccine: FLU4, JEVX, MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient arm warm to touch with reddened raised area 70 mm long in length. Patient denies any pain.
Sex: F
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 76-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-JAN-2017, the patient was inadvertently vaccinated with PEDVAXHIB injection (0.5 ml/once, intramuscularly; lot# and expiration date were not provided). No adverse events was reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report was received from a certified medical assistant via a company representative and refers to a 16 year old non-pregnant female patient, who was the primary reporter's daughter. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. In approximately October 2016 (reported as about 4 months ago), the patient was vaccinated with a dose of GARDASIL 9 (lot #, expiration date, site and dose were not reported; intramuscularly). On an unknown date, the patient experienced injection site redness, bumps and swelling. She received an unspecified treatment for the events. No lab diagnostic studies were performed.  The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not reported.  Additional information is not expected as no further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a female patient of unspecified age, referring to herself. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patient received three shots of unidentified Merck HPV vaccine intramuscular injection (name and lot number were not reported) for prophylaxis of human papilloma virus (HPV) infection. Patient reported that she did not know if the vaccine was GARDASIL or GARDASIL 9. She reported that while receiving the third shot of vaccine her physician used a larger needle and a bigger vial (drug administered in wrong device). She mentioned that she thinks the last shot was administered incorrectly (wrong technique in product usage process) and an incorrect dosage was administered. She developed pain and swelling at the injection site. Patient reported that she contacted doctor's office but no one answered her questions. No treatment was provided for the adverse events. Outcome of the events, pain and swelling at injection site was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N.) and refers to multiple unspecified patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot number: M033334, expiry date: 11-AUG-2018, route of administration was not reported. Temperature time excursion was 1 hour > 46 degree of Fahrenheit but < 77 degree of Fahrenheit , and 3 hours between 32 degree of Fahrenheit  and 36 degree of Fahrenheit. There was no previous temperature excursion. Data logger was involved. No adverse event was reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US--009507513-1702USA007041: US--009507513-1702USA007042: US--009507513-1702USA007040:
Sex: F
Vaccine: TTOX
Symptoms: Swelling
Clinical narrative: Initial unsolicited report received from a physician via Pfizer under reference number 2015427606 on 06 February 2017. This case involves a 64 year old female patient who was vaccinated with a dose of TETANUS TOXOID (batch number, expiry date, dose, route and site of administration were not reported) on unspecified date. Patient's medical history and concomitant medications were not reported. On 18 April 2012, following the vaccination the patient experienced swelling. Lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pyrexia, Skin discolouration
Clinical narrative: Initial unsolicited report received from a nurse on 14-OCT-2016. This case involves a female patient (onset age not reported) who was vaccinated with ADACEL (batch number, expiry date, route and site of administration were not reported) on April-2016. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed a large dark area around the upper arm; injection site was warm and feverish to the touch. The patient's laboratory data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Abdominal pain upper, Abnormal behaviour, Activities of daily living impaired, Aggression, Anger
Clinical narrative: 2/10 Wellness appointment. Pt received the dtap vaccine. Even though I reminder Dr he has Mitochondrial dysfunction. I said no to the MMR vaccine. Dr still pushed for the dtap vaccine anyways. Unfortunately I said yes to it, even though my gut flipped. 2/11/17 Pt woke up in the morning complaining about the pain around the shot area. Fell asleep at 6:40pm. Woke up at 8pm crying about stomach and knee pains. Also felt warm. Temp was 99.5. He settled off. Then about 15mins later same thing woke up crying about his knees.   Stayed up until about midnight and couldn't sleep. 2/12 All day pt looked run down. Started regressing with chewing on blankets. Mentioned several times his arm hurts where the shot was given. I could feel a stiff bump at the injection site. Turns out he has a large bruise in the injection area. Nighttime (around 1:30am) he had a 103.4 fever. Gave him Aleve (About 1 3/4 of a tsp since he falls in between with weight.) Used a cold face rag with ice packs to help bring down his temp. He stayed awake until 4ish. 2/13 Pt stayed home from school. He slept in until 7am. He was sluggish and 'little' all day. 2/14. 9:30pm and at 11:25pm waking up screaming, crying and moaning. Unable to tell me what's wrong. Violently kicking and twisting in his bed. Asked for water but didn't drink it. Has a slight cough. Stayed up from 11:25 until 2ish he didn't want to go back to bed. Still chewing on blankets. During these episodes. 2/15 am pt didn't want to go to school. (Which never happens) gave me a hard time to get dressed and then to go outside for the bus. He was also grunting unable to express himself. Making the same kind of noise when he was unable to speak as a toddler. He wasn't listening and acting out. Not normal behavior for pt. Pt came home from school moody, hiding from me and crying. I can't seam to help him. Anytime I get close he acts out in anger.  I took a  video of how he is behaving. Which again is not normal behavior for pt! 9:30pm woke up screaming and crying. He can't talk to us and say what's bothering him. Moaning noises with him mumbling. Just angry with kicking and swing his arms. Had to walk around with him in our arms. After about 20 minutes able to place him in the couch to sleep. Refuses to stay in his bed. This is not normal!
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Arthralgia, Body temperature increased, Cough, Crying, Grunting
Clinical narrative: 2/10 Wellness appointment. Pt received the dtap vaccine. Even though I reminder Dr he has Mitochondrial dysfunction. I said no to the MMR vaccine. Dr still pushed for the dtap vaccine anyways. Unfortunately I said yes to it, even though my gut flipped. 2/11/17 Pt woke up in the morning complaining about the pain around the shot area. Fell asleep at 6:40pm. Woke up at 8pm crying about stomach and knee pains. Also felt warm. Temp was 99.5. He settled off. Then about 15mins later same thing woke up crying about his knees.   Stayed up until about midnight and couldn't sleep. 2/12 All day pt looked run down. Started regressing with chewing on blankets. Mentioned several times his arm hurts where the shot was given. I could feel a stiff bump at the injection site. Turns out he has a large bruise in the injection area. Nighttime (around 1:30am) he had a 103.4 fever. Gave him Aleve (About 1 3/4 of a tsp since he falls in between with weight.) Used a cold face rag with ice packs to help bring down his temp. He stayed awake until 4ish. 2/13 Pt stayed home from school. He slept in until 7am. He was sluggish and 'little' all day. 2/14. 9:30pm and at 11:25pm waking up screaming, crying and moaning. Unable to tell me what's wrong. Violently kicking and twisting in his bed. Asked for water but didn't drink it. Has a slight cough. Stayed up from 11:25 until 2ish he didn't want to go back to bed. Still chewing on blankets. During these episodes. 2/15 am pt didn't want to go to school. (Which never happens) gave me a hard time to get dressed and then to go outside for the bus. He was also grunting unable to express himself. Making the same kind of noise when he was unable to speak as a toddler. He wasn't listening and acting out. Not normal behavior for pt. Pt came home from school moody, hiding from me and crying. I can't seam to help him. Anytime I get close he acts out in anger.  I took a  video of how he is behaving. Which again is not normal behavior for pt! 9:30pm woke up screaming and crying. He can't talk to us and say what's bothering him. Moaning noises with him mumbling. Just angry with kicking and swing his arms. Had to walk around with him in our arms. After about 20 minutes able to place him in the couch to sleep. Refuses to stay in his bed. This is not normal!
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Insomnia, Moaning
Clinical narrative: 2/10 Wellness appointment. Pt received the dtap vaccine. Even though I reminder Dr he has Mitochondrial dysfunction. I said no to the MMR vaccine. Dr still pushed for the dtap vaccine anyways. Unfortunately I said yes to it, even though my gut flipped. 2/11/17 Pt woke up in the morning complaining about the pain around the shot area. Fell asleep at 6:40pm. Woke up at 8pm crying about stomach and knee pains. Also felt warm. Temp was 99.5. He settled off. Then about 15mins later same thing woke up crying about his knees.   Stayed up until about midnight and couldn't sleep. 2/12 All day pt looked run down. Started regressing with chewing on blankets. Mentioned several times his arm hurts where the shot was given. I could feel a stiff bump at the injection site. Turns out he has a large bruise in the injection area. Nighttime (around 1:30am) he had a 103.4 fever. Gave him Aleve (About 1 3/4 of a tsp since he falls in between with weight.) Used a cold face rag with ice packs to help bring down his temp. He stayed awake until 4ish. 2/13 Pt stayed home from school. He slept in until 7am. He was sluggish and 'little' all day. 2/14. 9:30pm and at 11:25pm waking up screaming, crying and moaning. Unable to tell me what's wrong. Violently kicking and twisting in his bed. Asked for water but didn't drink it. Has a slight cough. Stayed up from 11:25 until 2ish he didn't want to go back to bed. Still chewing on blankets. During these episodes. 2/15 am pt didn't want to go to school. (Which never happens) gave me a hard time to get dressed and then to go outside for the bus. He was also grunting unable to express himself. Making the same kind of noise when he was unable to speak as a toddler. He wasn't listening and acting out. Not normal behavior for pt. Pt came home from school moody, hiding from me and crying. I can't seam to help him. Anytime I get close he acts out in anger.  I took a  video of how he is behaving. Which again is not normal behavior for pt! 9:30pm woke up screaming and crying. He can't talk to us and say what's bothering him. Moaning noises with him mumbling. Just angry with kicking and swing his arms. Had to walk around with him in our arms. After about 20 minutes able to place him in the couch to sleep. Refuses to stay in his bed. This is not normal!
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Mood altered, Pyrexia, Screaming, Skin warm, Sluggishness
Clinical narrative: 2/10 Wellness appointment. Pt received the dtap vaccine. Even though I reminder Dr he has Mitochondrial dysfunction. I said no to the MMR vaccine. Dr still pushed for the dtap vaccine anyways. Unfortunately I said yes to it, even though my gut flipped. 2/11/17 Pt woke up in the morning complaining about the pain around the shot area. Fell asleep at 6:40pm. Woke up at 8pm crying about stomach and knee pains. Also felt warm. Temp was 99.5. He settled off. Then about 15mins later same thing woke up crying about his knees.   Stayed up until about midnight and couldn't sleep. 2/12 All day pt looked run down. Started regressing with chewing on blankets. Mentioned several times his arm hurts where the shot was given. I could feel a stiff bump at the injection site. Turns out he has a large bruise in the injection area. Nighttime (around 1:30am) he had a 103.4 fever. Gave him Aleve (About 1 3/4 of a tsp since he falls in between with weight.) Used a cold face rag with ice packs to help bring down his temp. He stayed awake until 4ish. 2/13 Pt stayed home from school. He slept in until 7am. He was sluggish and 'little' all day. 2/14. 9:30pm and at 11:25pm waking up screaming, crying and moaning. Unable to tell me what's wrong. Violently kicking and twisting in his bed. Asked for water but didn't drink it. Has a slight cough. Stayed up from 11:25 until 2ish he didn't want to go back to bed. Still chewing on blankets. During these episodes. 2/15 am pt didn't want to go to school. (Which never happens) gave me a hard time to get dressed and then to go outside for the bus. He was also grunting unable to express himself. Making the same kind of noise when he was unable to speak as a toddler. He wasn't listening and acting out. Not normal behavior for pt. Pt came home from school moody, hiding from me and crying. I can't seam to help him. Anytime I get close he acts out in anger.  I took a  video of how he is behaving. Which again is not normal behavior for pt! 9:30pm woke up screaming and crying. He can't talk to us and say what's bothering him. Moaning noises with him mumbling. Just angry with kicking and swing his arms. Had to walk around with him in our arms. After about 20 minutes able to place him in the couch to sleep. Refuses to stay in his bed. This is not normal!
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: Unattended death of infant reported via 911 dispatch by parents.
Age: 58.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness to right arm injection site, warm to touch, itchy, tender. Treated with oral prednisone.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Autopsy, Death, Unresponsive to stimuli
Clinical narrative: ER called morning of 2-2-17. Child was found unresponsive. Pronounced deceased at the ER. Cause still being investigated, but vaccines were given on 1-31-17.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 vaccine (Lot number, expiration date, strength, dose, frequency and route of administration were not reported) for prophylaxis. Additionally, it was reported that on an unspecified date, GARDASIL 9 vaccines were exposed to light. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications were not reported. On 03-FEB-2017, the patient was vaccinated with an improperly stored dose of VAQTA intramuscularly, with lot # M047658 and expiration date on 28-OCT-2017 for prophylaxis. It was stated by the reported that, VAQTA was exposed to a temperature of 34 °F, for a 2 hours and 12 minutes time frame. Additionally, the vaccine was not involved in any previous temperature excursions and data logger was involved.  It was also reported, that no adverse effects were suffered and that no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007052:
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from an physician assistant via a company representative refers to a 80 year old female patient. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis (dose, application site and lot # were not reported). On an unknown date, the patient developed a full blown of shingles less than 24 hours after receiving ZOSTAVAX. The patient's outcome was unknown. Upon internal review, the event full blown of shingles was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N.) and refers to multiple unspecified patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot number: M027879 expiry date: 24-JAN-2018, route of administration was not reported. Temperature time excursion was 1 hour > 46 degree of Fahrenheit but < 77 degree of Fahrenheit, and 3 hours between 32 degree of Fahrenheit and 36 degree of Fahrenheit. There was no previous temperature excursion. Data logger was involved. No adverse event was reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA007041: US-009507513-1702USA007042: US-009507513-1702USA006595.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N.) and refers to multiple unspecified patient of unknown age and gender.  The patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot number: M024261, expiry date: 30-JUL-2018), route of administration was not reported. Temperature time excursion was 1 hour >46 degree of Fahrenheit but< 77 degree of Fahrenheit , and 3 hours between 32 degree of Fahrenheit  and 36 degree of Fahrenheit. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA006595: US-009507513-1702USA007042: US-009507513-1702USA007040:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse (L.P.N.) and refers to multiple unspecified patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot number: M035455, expiry date: 22-APR-2018. Temperature time excursion was 1 hour >46 degree of Fahrenheit but< 77 degree of Fahrenheit , and 3 hours between 32 degree of Fahrenheit  and 36 degree of Fahrenheit. There was no previous temperature excursion. Data logger was involved. No adverse event was reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007041: US-009507513-1702USA006595: US-009507513-1702USA007040:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications were not reported. On 03-FEB-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB intramuscularly, with lot # M039642 and expiration date on 20-JUL-2019 for prophylaxis. It was stated by the reporter that, RECOMBIVAX HB was exposed to a temperature of 34 °F, for a 2 hours and 12 minutes time frame. Additionally, the vaccine was not involved in any previous temperature excursions and data logger was involved. It was also reported, that no adverse effects were suffered and that no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002808.
Sex: M
Vaccine: PNC13
Symptoms: Anaphylactic reaction
Clinical narrative: This is a spontaneous report from a contactable consumer communicated to a Pfizer sales representative. The patient's wife informed the Sales Representatives wife who informed the Sales Representative. A male patient of an unspecified age received PREVNAR 13, intramuscular on 13Feb2017 at 0.5 ml, single for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction on 13Feb2017 after receiving the vaccine and went to the ER with outcome of recovered.  The patient was was sent home in the evening.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Body temperature increased, Swelling, Urticaria
Clinical narrative: Intermittent swelling across various parts of the body, hives, running a  temperature higher than normal, throughout the day which continued to get worse and hives spread all over body for following 4 days.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Hyperhidrosis, Pallor, Syncope, Vomiting
Clinical narrative: Soon after child received shots, patient was seen by a different staff member carrying child to the outside to get air. Child had eyes closed and appeared to have fainted a that time.  By the time this nurse got to child, child was laying down, was very pale and sweating but coherent and responded to questions.  Child was given juice and an ice pack to the back of her neck.  Child remained laying down until color returned to her face.   Child was sat up, given a cracker which she vomited.  Child stayed in clinic until she stated she felt better and left clinic ambulatory with mother.
Age: 9.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Condition aggravated, Nephrotic syndrome
Clinical narrative: Admitted to hospital with recurrence of nephrotic syndrome.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Aggression, Blister, Clumsiness, Fall, Head injury
Clinical narrative: Child kept falling down when walking and acted clumsy. Banged head on floor frequently and would throw fits which was unusual for him. This lasted for 2 months. He wore sandals frequently but got a blister on his toe, so they changed him to tennis shoes 4 days after his shots. Shoes did not correct the falling. Went to Chiropractic and had an adjustment. Slowly got over it on his own.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Burning sensation, Cellulitis, Condition aggravated, Drug withdrawal syndrome, Hypertension
Clinical narrative: Cellulitis. Muscle cramps, uncontrolled hypertension, nausea and vomiting, withdrawal from opioids, infection, pneumonia. Patient was administered vaccination and six days later went to the emergency room with burn thigh severely. She went to her doctor the next day and then was sent to the hospital for four days.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Infection, Muscle spasms, Nausea, Pneumonia, Vomiting
Clinical narrative: Cellulitis. Muscle cramps, uncontrolled hypertension, nausea and vomiting, withdrawal from opioids, infection, pneumonia. Patient was administered vaccination and six days later went to the emergency room with burn thigh severely. She went to her doctor the next day and then was sent to the hospital for four days.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Erythema, Injection site swelling, Peripheral swelling, Skin warm
Clinical narrative: Swelling at injection site a few hours after injection. The next day (02/10/2017) patients entire arm was swollen and pain in the joints. Patient in today (02/16/2017) with redness, warmth, and swelling in the hand of the arm he received the immunization in. Treated with Solu-Medrol injection and Keflex.
Age: 1.08
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Injection site swelling
Clinical narrative: At 7:00pm noticed redness and today daycare called and stated also very swollen 3 inches wide 4 inches long on left leg.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient did not have an adverse reaction. He was scheduled to receive the DTAP/HIB/Polio combo and it was given without the DTAP/Polio. The vaccine was administered again 4 weeks later. He did not have any adverse reaction from the 2nd dose of DTAP/HIB/Polio combination.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On 28-JAN-2017, 29-JAN-2017 and 30-JAN-2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M027882 with expiry date of 14-APR-2019, lot # M001814 with expiry date of 15-OCT-2018, lot # M036056 with expiry date of 18-MAY-2019 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of below 32 degrees Fahrenheit (with minimum temperature of 25 degrees Fahrenheit) for 14 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006371: US-009507513-1702USA006372: US-009507513-1702USA006370.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions, and concomitant medications were not reported. On 01-FEB-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (dose not reported) (lot # L039095 and expiration date 08-JAN-2017) subcutaneously for prophylaxis. There was not known adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX subcutaneous (dose, lot number and expiration date were not reported) for prophylaxis instead of ZOSTAVAX. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, lot# and the expiration date were not reported) for prophylaxis. No adverse symptoms reported. The temperature excursion registered was 32°F during 15 hours, registered by the data logger. There was no previous temperature excursion and no Product Quality Complaint (PQC) involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007067:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patient of unknown age and gender.  The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, 12 doses of improperly stored VARIVAX Lot# M027343, expiration date 01-JUN-2018 and lot # reported M037642, expiration date 01-SEP-2018, were administered to the patients for prophylaxis. It was reported that the doses were exposed to a range of temperature of 14°F and 46°F for 2 hours and 25 minutes. It was reported that there were no previous temperature excursions and the event was detected because a data logger. This is one of several reports from the same reporter. Additional information is not expected as the reporter did not consent for follow up attempts.; Sender's Comments: US-009507513-1702USA007065:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On 28-JAN-2017, 29-JAN-2017 and 30-JAN-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M032650 with expiry date of 31-MAR-2019 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of below 32 degrees Fahrenheit (with minimum temperature of 25 degrees Fahrenheit) for 14 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA014176:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On 28-JAN-2017, 29-JAN-2017 and 30-JAN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L035510 with expiry date of 13-MAY-2017 (dose was not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of below 32 degrees Fahrenheit (with minimum temperature of 25 degrees Fahrenheit) for 14 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014176.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of patient of unknown age and gender.  The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, 5 doses of improperly stored PROQUAD Lot# M035144, expiration date 30-JAN-2018 and lot # reported M038862, expiration date 01-SEP-2018, were administered to the patients for prophylaxis. It was reported that the doses were exposed to a range of temperature of 14°F and 46°F for 2 hours and 25 minutes. It was reported that there were no previous temperature excursions and the event was detected because a data logger. This is one of several reports from the same reporter. Additional information is not expected as the reporter did not consent for follow up attempts.; Sender's Comments: US-009507513-1702USA002401:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to an unspecified patients of unknown age and gender.     Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose, lot# and the expiration date were not reported) for prophylaxis. No adverse symptoms reported. The temperature excursion registered was 36°F during 15 hours, registered by the data logger. There was no previous temperature excursion nor Product Quality Complaint (PQC) involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA002307:
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Abdominal pain upper, Blood pressure increased, Dizziness postural, Nausea, Pyrexia
Clinical narrative: High fever of 103 degrees and stomach ache. Fever continued consistently around 102-103'degrees from 02/12/2017 - 02/16/2017. On  02/16/2017, fever lowered to 100 degrees without medicine, but he became very nauseous and can't get up without feeling dizzy, also has vomited several times. Doctors have seen him and checked for other illnesses like the flu and strep throat. Doctors were surprised how fast his reaction came after receiving the vaccine. He was very anxious when receiving the vaccine and had to lay down after. Nurse said his blood pressure rose very high very fast and may have contributed to some of the symptoms.
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Vomiting
Clinical narrative: High fever of 103 degrees and stomach ache. Fever continued consistently around 102-103'degrees from 02/12/2017 - 02/16/2017. On  02/16/2017, fever lowered to 100 degrees without medicine, but he became very nauseous and can't get up without feeling dizzy, also has vomited several times. Doctors have seen him and checked for other illnesses like the flu and strep throat. Doctors were surprised how fast his reaction came after receiving the vaccine. He was very anxious when receiving the vaccine and had to lay down after. Nurse said his blood pressure rose very high very fast and may have contributed to some of the symptoms.
Age: 58.0
Sex: F
Vaccine: HIBV
Symptoms: Blood test, Chest X-ray, Laboratory test normal, Neck pain, Nuclear magnetic resonance imaging
Clinical narrative: Ear ringing, sore arm, went to the emergency room on 2-11-17 because her neck was sore and ear ringing got louder.
Age: 58.0
Sex: F
Vaccine: HIBV
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Ear ringing, sore arm, went to the emergency room on 2-11-17 because her neck was sore and ear ringing got louder.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever of 101.1, irritability.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Febrile convulsion, Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Febrile seizure, patient had a seziure episode <5 minutes, tonic clonic. no medications adminitered. Fever 103.4F on presentation to the ED.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left lateral aspect upper left arm 5x5cm swelling, warmth, left arm pain, no AROM in this arm, sent to ER ASAP.
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received on 17-JAN-2017 from a physician who was reporting on a six month infant (no age or gender reported). On 16-JAN-2017, the patient inadvertently received a dose of  RECOMBIVAX HB (no lot or injection site reported)"2.5/0.5 ml" (pediatric dose 5 mcg/0.5ml)  instead of  ACTHIB (Sanofi Pasteur)(lot, dose and injection site not reported) that was given concomitantly with a dose of PEDIARIX) (GLAXOSMITHKLEIN)(lot, dose and injection site not reported). The physician reported that the error occurred because she inadvertently verbally ordered "PEDIARIX and hepatitis B vaccine" when she had intended to say "PEDIARIX and Hib vaccine". No adverse effect reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Injection site pustule, Injection site vesicles, Local reaction
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history or concomitant medications were not reported. In December 2016 (reported as about four weeks ago), the patient was inadvertently administered a dose of VARIVAX and PROQUAD at the same time (dose, route of administration and lot number not reported). On an unknown date, the patient developed vesicular/pustular area about 6 inches from where the VARIVAX was administered and a more localized reaction at the site that the PROQUAD was administered.     The outcome of the events was unknown. The relationship between vaccination with VARIVAX; PROQUAD and 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 4 patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of  GARDASIL (lot # L040460 exp date 27-MAY-2017) (dose and route not reported). The temperature of excursion was 51 F for 144 hours. There was no previous temperature excursion. A data logger issue was reported. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007072: US-009507513-1702USA007073: