chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: MNQ
Symptoms: Accidental exposure to product, Limb injury, Product quality issue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injury to finger nos in a 45-year-old female patient who received MENVEO (batch number: M14133, expiry date April 2016). This case was vaccinated with a product complaint. On an unknown date, the patient received MENVEO. On an unknown date, immediately after receiving MENVEO, the patient experienced injury to finger nos, pharmaceutical product complaint and inadvertent exposure to vaccine. On an unknown date, the outcome of the injury to finger nos was recovered/resolved and the outcome of the pharmaceutical product complaint and inadvertent exposure to vaccine were unknown. It was unknown if the reporter considered the injury to finger nos to be related to MENVEO. Additional details were received as follows: Nurse reported that there were broken or cracked MENVEO vials (1 liquid conjugate, 1 powder conjugate vial from same box). It was confirmed that MENVEO was not administered to any patient. When the reporter reached in the box of MENVEO with her right hand, she poked the tip of her finger. This also led to an inadvertent expose to vaccine. This issue occurred sometime between 16th JULY 2015 and 25th AUGUST 2015. However, specified date was unknown. She stated that their local representative might have reported this to GlaxoSmithKline in the past but she was unable to fully confirm and was unable to locate previous record. It was reported regarding deft that unknown at what point or step defect was discovered. The package conditions was not damaged or open. It was unknown who opened the box. Staff who were administering the vaccine in the office were all experienced users of MENVEO. No damage to carton or evidence of leakage inside of carton was found. Glass pieces remain the carton. Product was stored refrigerated. Breakage was specified to neck of vials, underneath the bottom of the grey stoppers. Both vials were available for return. The health care provider who had direct account with GSK, submitted the credit template. Filing related adverse event with Global Clinical Safety and Pharmacoviligiance because of injury experienced by the reporter due to cracked vials. When the reporter reached into the box of MENVEO with her right hand, she poked the tip of her finger. She was unable to recall further specifics of the incident since it occurred a while ago. No residual effects were noted from the injury.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Insomnia, Pain in extremity, Pruritus, Ultrasound Doppler
Clinical narrative: Numbness, itching, pain in left thumb beginning 12-16-15 date of high dosage flu vaccine. Nerve medications to no avail. Sleepless nights. Thumb could not touch anything. Office visit dates: 12/23/2015, 01/04/2016, 01/22/2016, 04/06/2016, 04/20/2016, Neuro 01/27/2016, Arterial Doppler Scan bil upper ext 04/15/2016.
Age: 20.0
Sex: F
Vaccine: HEPA, IPV, TD, HEPA, IPV, TD, HEPA, IPV, TD
Symptoms: Local swelling
Clinical narrative: Initial unsolicited report received from non-healthcare professional on 11 April 2016. This case involves a 20-year-old female patient who was vaccinated with a first dose of TENIVAC (batch number: U5251AA, expiry date:27 January 2018), intramuscularly in the right deltoid, first dose of IPOL (batch number: L1597-1, expiry date 13 November 2017) subcutaneously in the left arm, first dose of HAVRIX (manufacturer: GSK, batch number: 5D952, expiry date not reported) intramuscularly in the left deltoid on 08 April 2016. Patient denied illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions included "Byaz" for acne and it was reported that patient had no known allergies. The patient's concomitant medication included MMR (manufacturer: Merck, batch number: unknown, expiry date, site and route of administration not reported) on 18 March 2016. On 09 April 2016, one day following the vaccination, the patient developed soft swelling on the right side of her neck. It was reported that, at that time, the swelling had not got any worse but also had not improved, patient denied to reporter any pain, difficulty breathing or swallowing, denied any systemic symptoms to the reporter such as nausea or vomiting. The patient's laboratory data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: HEPA, IPV, TD, HEPA, IPV, TD, HEPA, IPV, TD
Symptoms: Local swelling, Swelling face
Clinical narrative: Initial unsolicited report received from non-healthcare professional on 11 April 2016. This case involves a 20-year-old female patient who was vaccinated with a first dose of TENIVAC (batch number: U5251AA, expiry date:27 January 2018), intramuscularly in the right deltoid, first dose of IPOL (batch number: L1597-1, expiry date 13 November 2017) subcutaneously in the left arm, first dose of HAVRIX (manufacturer: GSK, batch number: 5D952, expiry date not reported) intramuscularly in the left deltoid on 08 April 2016. Patient denied illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions included "Byaz" for acne and it was reported that patient had no known allergies. The patient's concomitant medication included MMR (manufacturer: Merck, batch number: unknown, expiry date, site and route of administration not reported) on 18 March 2016. On 09 April 2016, one day following the vaccination, the patient developed soft swelling on the right side of her neck. It was reported that, at that time, the swelling had not got any worse but also had not improved, patient denied to reporter any pain, difficulty breathing or swallowing, denied any systemic symptoms to the reporter such as nausea or vomiting. The patient's laboratory data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV4
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of generalized rash in a 15-year-old female patient who received HAVRIX (batch number 59N59, expiry date 5th September 2016). Concomitant products included GARDASIL. On 21st July 2015, the patient received HAVRIX. On an unknown date, less than a year after receiving HAVRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved. It was unknown if the reporter considered the generalized rash to be related to HAVRIX. Additional information was provided as follows: Since receiving the vaccine, the patient had a generalized rash.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV4
Symptoms: Rash generalised
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of generalized rash in a 15-year-old female patient who received HAVRIX (batch number 59N59, expiry date 5th September 2016). Concomitant products included GARDASIL. On 21st July 2015, the patient received HAVRIX. On an unknown date, less than a year after receiving HAVRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved. It was unknown if the reporter considered the generalized rash to be related to HAVRIX. Additional information was provided as follows: Since receiving the vaccine, the patient had a generalized rash.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Erythema, Full blood count normal, Red blood cell sedimentation rate normal, Skin warm, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 47-year-old female patient who received BOOSTRIX (batch number Z9Z4Y, expiry date 1st July 2018). Concomitant products included CLARITIN, ELAVIL, MOBIC, COLACE and verapamil. On 26th April 2016, the patient received BOOSTRIX (intramuscular). On 3rd May 2016, 7 days after receiving BOOSTRIX, the patient experienced extensive swelling of vaccinated limb (serious criteria hospitalization, disability and other). On an unknown date, the patient experienced injection site pain (serious criteria hospitalization, disability and other: As per reporter), injected limb mobility decreased (serious criteria hospitalization, disability and other) and injection site cellulitis. On an unknown date, the outcome of the injection site pain, extensive swelling of vaccinated limb, injected limb mobility decreased and injection site cellulitis were unknown. The reporter considered the injection site pain, extensive swelling of vaccinated limb and injected limb mobility decreased to be possibly related to BOOSTRIX. It was unknown if the reporter considered the injection site cellulitis to be related to BOOSTRIX. Additional details were received as follows: A nurse practitioner reported that, the patient was doing well except for a sore arm until 3rd May 2016, when she developed swelling at the injection site. At the time of reporting, the patient had two times swelling of her entire arm and so she could not raise her arm above her head. The swelling was spreading into her scapular area. The blood work showed no inflammation or elevation of white blood cells. At the time of reporting, the reporter was treating the patient for cellulitis, but blood work does not indicate that as an infection.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood test normal, Extensive swelling of vaccinated limb, Injected limb mobility decreased, Injection site cellulitis, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 47-year-old female patient who received BOOSTRIX (batch number Z9Z4Y, expiry date 1st July 2018). Concomitant products included CLARITIN, ELAVIL, MOBIC, COLACE and verapamil. On 26th April 2016, the patient received BOOSTRIX (intramuscular). On 3rd May 2016, 7 days after receiving BOOSTRIX, the patient experienced extensive swelling of vaccinated limb (serious criteria hospitalization, disability and other). On an unknown date, the patient experienced injection site pain (serious criteria hospitalization, disability and other: As per reporter), injected limb mobility decreased (serious criteria hospitalization, disability and other) and injection site cellulitis. On an unknown date, the outcome of the injection site pain, extensive swelling of vaccinated limb, injected limb mobility decreased and injection site cellulitis were unknown. The reporter considered the injection site pain, extensive swelling of vaccinated limb and injected limb mobility decreased to be possibly related to BOOSTRIX. It was unknown if the reporter considered the injection site cellulitis to be related to BOOSTRIX. Additional details were received as follows: A nurse practitioner reported that, the patient was doing well except for a sore arm until 3rd May 2016, when she developed swelling at the injection site. At the time of reporting, the patient had two times swelling of her entire arm and so she could not raise her arm above her head. The swelling was spreading into her scapular area. The blood work showed no inflammation or elevation of white blood cells. At the time of reporting, the reporter was treating the patient for cellulitis, but blood work does not indicate that as an infection.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, Swelling, White blood cell count normal
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 47-year-old female patient who received BOOSTRIX (batch number Z9Z4Y, expiry date 1st July 2018). Concomitant products included CLARITIN, ELAVIL, MOBIC, COLACE and verapamil. On 26th April 2016, the patient received BOOSTRIX (intramuscular). On 3rd May 2016, 7 days after receiving BOOSTRIX, the patient experienced extensive swelling of vaccinated limb (serious criteria hospitalization, disability and other). On an unknown date, the patient experienced injection site pain (serious criteria hospitalization, disability and other: As per reporter), injected limb mobility decreased (serious criteria hospitalization, disability and other) and injection site cellulitis. On an unknown date, the outcome of the injection site pain, extensive swelling of vaccinated limb, injected limb mobility decreased and injection site cellulitis were unknown. The reporter considered the injection site pain, extensive swelling of vaccinated limb and injected limb mobility decreased to be possibly related to BOOSTRIX. It was unknown if the reporter considered the injection site cellulitis to be related to BOOSTRIX. Additional details were received as follows: A nurse practitioner reported that, the patient was doing well except for a sore arm until 3rd May 2016, when she developed swelling at the injection site. At the time of reporting, the patient had two times swelling of her entire arm and so she could not raise her arm above her head. The swelling was spreading into her scapular area. The blood work showed no inflammation or elevation of white blood cells. At the time of reporting, the reporter was treating the patient for cellulitis, but blood work does not indicate that as an infection.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Crying, Discomfort, Emotional distress, Injection site erythema
Clinical narrative: Patient was uncomfortable, crying, and basically inconsolable that night and into the morning. She didn't sleep well at all, with is unusual for her. She was running a low fever, but nothing too concerning. From then, until now, she has had a dry cough and random little bumps that pop up and go away. Then, on the 11th, she woke up with a large red bump on her right thigh, where her injection would have been, warm to the touch, and a knot underneath. I drew a circle around the spot, and the next morning it had only subsided a tiny bit. Advised by office to do cold compresses and massage, and if in 3 days it hasn't gotten better, to bring her in.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site nodule, Injection site swelling, Injection site warmth, Poor quality sleep, Pyrexia
Clinical narrative: Patient was uncomfortable, crying, and basically inconsolable that night and into the morning. She didn't sleep well at all, with is unusual for her. She was running a low fever, but nothing too concerning. From then, until now, she has had a dry cough and random little bumps that pop up and go away. Then, on the 11th, she woke up with a large red bump on her right thigh, where her injection would have been, warm to the touch, and a knot underneath. I drew a circle around the spot, and the next morning it had only subsided a tiny bit. Advised by office to do cold compresses and massage, and if in 3 days it hasn't gotten better, to bring her in.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Patient was uncomfortable, crying, and basically inconsolable that night and into the morning. She didn't sleep well at all, with is unusual for her. She was running a low fever, but nothing too concerning. From then, until now, she has had a dry cough and random little bumps that pop up and go away. Then, on the 11th, she woke up with a large red bump on her right thigh, where her injection would have been, warm to the touch, and a knot underneath. I drew a circle around the spot, and the next morning it had only subsided a tiny bit. Advised by office to do cold compresses and massage, and if in 3 days it hasn't gotten better, to bring her in.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site reaction, Local reaction, Malaise
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer report number: 2016137196) on 14 March 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose Flu Vaccine (batch number, dose, expiration date, site and route of administration were not reported) on an unspecified date (reported as last year). The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had local reaction at the site of injection and got sick. Lab data and corrective treatment were not reported. Outcome of events was not reported. It was reported that the doctor believed that it may be due to a preservative in the multidose vial of the flu vaccine. List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a non-healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016209502) on 18-Apr-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Tetanus Vaccine (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient developed allergy to vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from other company via physician on 21 April 2016. Manufacturer report number:2016220600. This case involves a 65-year-old female patient who was vaccinated with a dose FLU VACCINE (batch number, expiry date, route and site of administration not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient developed allergy to flu vaccine. The patient's lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: Initial solicited report received on 01 April 2016 from a research analyst participating in the below-mentioned study. This case involves an unknown age, race and gender subject who had a reaction of an unknown descriptions. Medical history and concomitant therapies details were not reported. A doctor during research commented that a subject had called him on a Saturday night claiming that the subject had an influenza shot of unknown manufacturer, which was not administered by the doctor. The subject had received the immunization at an unknown location, probably a grocery store, and administered by an unknown heath care professional at an unknown time. The subject was claiming to have a reaction of an unknown description. The doctor told the subject that he would not take responsibility or advice care as he had not administered the vaccine. The type of reaction was unknown. The manufacturer, brand and presentation of vaccine was unknown to the physician. The lab data and corrective treatment details were not reported. The outcome of "reaction of an unknown descriptions" was unknown at the time of report. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Client reported dizziness, tingling, numbness to top lip, fingers and legs few hours after vaccine given.
Age: 34.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Burning sensation, Decreased appetite, Diarrhoea, Dyspnoea, Eye irritation
Clinical narrative: Client reported dizziness, tingling, numbness to top lip, fingers and legs few hours after vaccine given.
Age: 34.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Hypersensitivity, Hypoaesthesia, Muscle twitching, Muscular weakness, Neuralgia
Clinical narrative: Client reported dizziness, tingling, numbness to top lip, fingers and legs few hours after vaccine given.
Age: 34.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Oral discomfort, Paraesthesia, Paraesthesia oral, Somnolence, Tongue discomfort
Clinical narrative: Client reported dizziness, tingling, numbness to top lip, fingers and legs few hours after vaccine given.
Age: 34.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Tremor
Clinical narrative: Client reported dizziness, tingling, numbness to top lip, fingers and legs few hours after vaccine given.
Age: 58.0
Sex: U
Vaccine: PPV, TDAP
Symptoms: Chills, Malaise, Nausea, Vomiting
Clinical narrative: Woke up on 5-12 feeling fine went to work by 10 AM started to feel sick, nausea, chills, maybe fever (patient had no thermometer) left work went home around 4:30 threw up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with VARIVAX lot #L019999, 02-Jun-2017. 8 doses were administered. Temperature of 32.9F for 6 hours and 30 minutes. There were no previous excursion. This is one of the 2 cases received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Urticaria, Viral infection
Clinical narrative: I noticed small bumps on her wrist, the next day on stomach, face, arm and back and every day since then moving to different areas. They could have started earlier, on back or somewhere I didn't notice since they go away quickly. They appear at different times during the day, not after meals or eating, sometimes when she wakes up in morning. The hives have not resolved yet. I spoke to pediatrician office and daughter seen by doctor. She said the bumps are hives and probably from a virus/infection. She was not ill recently.
Age: 0.35
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Culture, Pain
Clinical narrative: Blisters in groin, painful.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with (Oka/Merck) PROQUAD lot # L046509, 17-MAY-2017. 12 doses were administered. Temperature of 32.9F for 6 hours and 30 minutes. There were no previous excursion. This is one of the 2 cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 11-APR-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ (dosing regimen unspecified) lot #K023537, expiry date 22-JUN-2016. No adverse effects were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. Temperature: 34.1F. Time frame: 48 hours. Data Logger: no. Was it administered (AE): Yes. Previous temperature excursion: no. This is one of the several reports for the same reporter. 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 certified medical assistant refers to a patient of unknown age and gender. On 12-APR-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ (dosing regimen unspecified) lot #K023537, expiry date 22-JUN-2016. No adverse effects were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. Temperature: 34.1F. Time frame: 48 hours. Data Logger: no. Was it administered (AE): Yes. Previous temperature excursion: no. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, lot #L037924, expiry date 22-JUN-2016 (dose was not reported). Concomitant therapies were not provided. Additionally, it was reported that improperly stored doses PEDIARIX (reported as "PEDIRIX"), (lot number, dose, route and frequency were not reported), were also administered. According to the reporter, the vaccines were stored at a temperature of 13.1 degrees Celsius for 1 hour and 16 minutes. There was no previous temperature excursions reported. No adverse effect was reported. No product quality complaint (PQC) was involved. It was also reported that GARDASIL 9 was also improperly stored, however, it was not administered to patients. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 11-APR-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, (dosing regimen unspecified) lot # K026666, expiry date-22-OCT-2016. No adverse effects reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patient's of unknown age. On 01-Mar-2016, 09-MAR-2016 and 29-MAR-2016, the patients were vaccinated with improperly stored and unsupported doses of M-M-R II) (lot reported as L011079, Expiration Date: 08-JUNE-2016), which were stored under 9.5 Celsius degree for 10 hours. There was no data logger and no previous temperature excursion. No adverse effect reported. Lot number L011079 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. 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 nurse refers to an unspecified amount of patients of unknown demographics. Information regarding the patient's concurrent conditions, medial history and drug reactions/allergies was not provided. On unspecified dates, the patients were vaccinated with improperly stored doses and LIQUID PEDVAXHIB) which had a lot # reported as L003690 and expiration date 14-JUNE-2018 (dose, route of administration and anatomical location were not reported). There were no concomitant medications provided. The reporter stated that there was a previously temperature excursion of 9 Celsius (C) for 10 hours. On an unspecified date, the LIQUID PEDVAXHIB were exposed to 15 Celsius (C) for 120 hours. There was no data logger used to capture the excursion. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a pharmacist via a company representative, referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, these patients were vaccinated with ZOSTAVAX (dose, strength, anatomical site, route and lot number were not reported). Subsequently, on unspecified dates, the patients developed unspecified injection site reaction and/or fever. At the time of this report, the outcome of the events and its casual relation with the vaccine were unknown. No product quality complaint was involved. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Abnormal dreams, Dizziness, Fatigue, Headache, Hypoaesthesia
Clinical narrative: The night of 2nd shot in rabies series, experienced vivid dreams and headache/buzzing sensation upon wakening. Assumed this was a normal side-effect of vaccination and would fade in time (read that many patients experience temporary headaches). Proceded to get 3rd and 4th shot in the rabies series. Vivid dreams and morning headaches/buzz have not faded and have continued through present (May 2016). In October 2015, after missing several nights of sleep due to congestion caused by a cold/flu, started experiencing episodes of daytime sleepiness/exhaustion. Worse after exercise/exertion. Sleep became fragmented and disturbed. Also, occasional episodes of facial and leg numbness and weakness, nausea and dizziness, and daytime headaches. Prior to October 2015 (and prior to rabies vaccinations) I did sometimes experience very minor fatigue, dizziness, numbness, primarily when I was ill or stressed out. However, since October all these symptoms have become life-disrupting in intensity and occur on a regular basis (have had to modify my driving patterns, etc, to stay safe). I am not sure if these symptoms are connected to the vaccine or not. I suspect my sleep disturbances/vivid dreams were somehow related to the rabies vaccine, because I did not have these sleep problems prior to being vaccinated, and they began sharply and distinctly on the night of my second vaccination. In April 2015, had an overnight sleep study and MSLT done to check for narcolepsy/other sleeping disorders. The results were normal (but with abnormal sleep architecture and significant alpha intrusion).  I (patient) have received results and notes for sleep study from the sleep lab but have not discussed them yet with a doctor; I have an appointment in late June 2016 to meet with Dr. for this purpose.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Influenza, Muscular weakness, Nasopharyngitis, Nausea, Respiratory tract congestion
Clinical narrative: The night of 2nd shot in rabies series, experienced vivid dreams and headache/buzzing sensation upon wakening. Assumed this was a normal side-effect of vaccination and would fade in time (read that many patients experience temporary headaches). Proceded to get 3rd and 4th shot in the rabies series. Vivid dreams and morning headaches/buzz have not faded and have continued through present (May 2016). In October 2015, after missing several nights of sleep due to congestion caused by a cold/flu, started experiencing episodes of daytime sleepiness/exhaustion. Worse after exercise/exertion. Sleep became fragmented and disturbed. Also, occasional episodes of facial and leg numbness and weakness, nausea and dizziness, and daytime headaches. Prior to October 2015 (and prior to rabies vaccinations) I did sometimes experience very minor fatigue, dizziness, numbness, primarily when I was ill or stressed out. However, since October all these symptoms have become life-disrupting in intensity and occur on a regular basis (have had to modify my driving patterns, etc, to stay safe). I am not sure if these symptoms are connected to the vaccine or not. I suspect my sleep disturbances/vivid dreams were somehow related to the rabies vaccine, because I did not have these sleep problems prior to being vaccinated, and they began sharply and distinctly on the night of my second vaccination. In April 2015, had an overnight sleep study and MSLT done to check for narcolepsy/other sleeping disorders. The results were normal (but with abnormal sleep architecture and significant alpha intrusion).  I (patient) have received results and notes for sleep study from the sleep lab but have not discussed them yet with a doctor; I have an appointment in late June 2016 to meet with Dr. for this purpose.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Sleep disorder, Sleep study, Somnolence, Tinnitus
Clinical narrative: The night of 2nd shot in rabies series, experienced vivid dreams and headache/buzzing sensation upon wakening. Assumed this was a normal side-effect of vaccination and would fade in time (read that many patients experience temporary headaches). Proceded to get 3rd and 4th shot in the rabies series. Vivid dreams and morning headaches/buzz have not faded and have continued through present (May 2016). In October 2015, after missing several nights of sleep due to congestion caused by a cold/flu, started experiencing episodes of daytime sleepiness/exhaustion. Worse after exercise/exertion. Sleep became fragmented and disturbed. Also, occasional episodes of facial and leg numbness and weakness, nausea and dizziness, and daytime headaches. Prior to October 2015 (and prior to rabies vaccinations) I did sometimes experience very minor fatigue, dizziness, numbness, primarily when I was ill or stressed out. However, since October all these symptoms have become life-disrupting in intensity and occur on a regular basis (have had to modify my driving patterns, etc, to stay safe). I am not sure if these symptoms are connected to the vaccine or not. I suspect my sleep disturbances/vivid dreams were somehow related to the rabies vaccine, because I did not have these sleep problems prior to being vaccinated, and they began sharply and distinctly on the night of my second vaccination. In April 2015, had an overnight sleep study and MSLT done to check for narcolepsy/other sleeping disorders. The results were normal (but with abnormal sleep architecture and significant alpha intrusion).  I (patient) have received results and notes for sleep study from the sleep lab but have not discussed them yet with a doctor; I have an appointment in late June 2016 to meet with Dr. for this purpose.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: New daily persistent headache
Clinical narrative: Patient's Mother notified RN of complaint on 5-12-16. Mother reports her daughter has had a Constant, Daily Headache, that is unrelieved from OTC medications: Tylenol/Motrin. The family notified their PMD at some point and was reportedly instructed to contact the local health department. No treatment, assessment, etc completed per Mother's account.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pain
Clinical narrative: Patient noticed Tuesday evening on 5/10/16 reddened area under left axilla and noted pain when tried to sleep on it. Woke up the next morning and had total of 3 red areas of 2 inches in all areas and noted erythematous induration around areas noted petechiae. Saw MD on 5/12/16 and given prednisone.
Age: 1.07
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Dermatitis, Rash, Rash erythematous
Clinical narrative: Red raised bumps noted on face, chest and back by moth on 4/27/16. Called office on 4/29/16 to report rash at 0920am. No fevers recorded. Dr's office notified. Call placed 5/10/16 to follow up. Pediatrician diagnosed as dermatitis not related to vaccines.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diet refusal, Emotional distress, Irritability
Clinical narrative: Increased fussiness hard to console refusing to nurse.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Cellulitis (L) arm - pain, swelling, redness. Received injection of DECADRON and ROCEPHIN.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Labyrinthitis, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for himself. A 73-year-old male patient received PREVNAR 13, via an unspecified route of administration in the left arm on 17Mar2016 10:00 at 0.5 ml, single. Medical history included blood pressure abnormal, ongoing atrial fibrillation, he had to go to hospital to have an ablation. Concomitant medications were not reported. The patient received pneumonia shot and a couple days after he developed an inner ear infection and ringing and buzzing in his ear. The patient was admitted to hospital for this last event. The patient received AUGMENTIN for 10 days. He was wandering if the shot has caused this. The outcome of the events was not resolved. Follow up (03May2016): additional information received from the contactable consumer includes ringing and buzzing in his ear added as adverse event. Hospitalization added as criteria of seriousness. Case upgraded to serious. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Pericarditis
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. An adolescent male patient of an unspecified age and ethnicity received, on an unspecified date, TRUMENBA at 0.5 ml, single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pericarditis. The patient recovered from the adverse event at the time of this report. The reporting physician considered that the reported event was due to TRUMENBA.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Injection site swelling
Clinical narrative: Arm was swollen where vaccine was given, after a couple of days she developed a cough, now a deeper flemmish cough.
Age: 11.0
Sex: F
Vaccine: MENB, MNQ, TDAP
Symptoms: Erythema, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: R arm became red and very warm to touch. Also painful to touch. Swelling of injection began 12 hours later. Pain and swelling gone after 48 hours.  Still a little red but subsiding. Cool compress and TYLENOL given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Febrile convulsion, Generalised tonic-clonic seizure, Incoherent, Incontinence, Pyrexia
Clinical narrative: Gran mal seizure lasting 2 minutes with incontinence. Temp of 99 taken by squad. Transported to Hospital ER and fever 101. Non coherent for 25 minutes; then communicative normally.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Full blood count, Gastrointestinal haemorrhage, Melaena
Clinical narrative: Patient came to clinic referring bright red GI bleeding after dosage of Prevnar 13 vaccine given in the clinic. Melena presented in two occasions and none other since 05/11/16 as explained. He referred to have received a pneumonia vaccine in 2009 (unspecified) and presented GI bleeding afterwards that date as well. Unaware if components of the pneumonia vaccines contain ingredients that may affect patient's with GI conditions.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, PPV, TDAP
Symptoms: Fatigue, Nausea, Pain, Peripheral swelling, Skin warm
Clinical narrative: Left arm swollen and hot, body aches, fatigue, nausea. Offered appointment to see MD. Mom preferred to monitor at home, will continue with Motrin prn and ice to arm. To call back if worsens or new s/s develop.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Headache, Pallor
Clinical narrative: 1020 injections given, 10 seconds later pt became pale and lightheaded. pt was helped to lying position with feet elevated. Pt reported headache. Pt observed in clinic for 90 min before she left clinic with mom.
Age: 1.29
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Patient had a local reaction that included redness and swelling at the injection site where Hib vaccine was administered.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Dysphemia, Irritability, Laboratory test, Pyrexia
Clinical narrative: Patient got high fever ten days after administered, stopped talking, when started to talk again he stuttered and continues to, irritability.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Streptococcal infection
Clinical narrative: Patient got high fever ten days after administered, stopped talking, when started to talk again he stuttered and continues to, irritability.
Age: 18.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Syncope
Clinical narrative: After HPV #3 given patient fainted. He was assisted to a lying down position, woke quickly, and given ginger ale and a cold compress. Dr. assessed patient, BP checked.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Influenza like illness, Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Patient developed a fever the day after the shot. Shot was given on Wednesday May 11th. His arm is also swollen and he feel, tingling in the hand. The fever has subsided but the swelling is still there and tingling in the hand patient says he feel, is getting worse. He also feels flu like symptoms.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left upper arm redness and swelling. Treatment cool compresses, ZYRTEC or BENADRYL OTC hydrocortisone cream.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, warm to touch, swelling, itching.
Age: 0.52
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 6 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 08-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L008059, expiry date 18-DEC-2016) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degree F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. 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 refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDAIL 9 (lot # L045711, expiry date: 08-MAY-2017; lot # L048237, expiry date: 08-MAY-2017; lot # L048237, expiry date: 08-MAY-2017 or lot # L016429, expiry date: 08-AUG-2017). Medical assistant reported that the vaccine underwent temperature excursion on unknown dates with following details: lot # L045711 (exposed at 49 degree Fahrenheit (F) for an unknown time frame), lot # L048237 (48 F for 100 hours and 31 F for 340 hours,  respectively), lot # L045711 (49 F for 720 hours and 30 F for 720 hours, respectively), lot # L016429 (31 F for 1420 hours and 49 F for 700 hours, respectively) and lot # L048237 (34 F for 40 hours). No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding an 8 week old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 25-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L028645, expiry date 25-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degree F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician referring to-11-15 year old male patient, who was enrolled in a Market research. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (route of administration, lot #, expiration date, dose, dosage number and anatomical location were unknown). Concomitant or co-suspect therapies were not provided. On unspecified date (reported as sometime between 2008-2016) the patient fainted when he received GARDASIL. At the time of reporting,, the action taken with GARDASIL was reported as "did not prevent administration of 2, 3 doses". The outcome of the adverse event was reported as recovering. The reporter considered the adverse event to be related to GARDASIL. Additional information is not expected as the reporter did not consent for provide further information.
Age: 0.66
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 7 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 25-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L028645, expiry date 25-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degree F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 9 week old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 26-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L028645, expiry date 25-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degree F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 6 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 27-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L028645, expiry date 25-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degree F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.