chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Initial unsolicited report received from a non-healthcare professional via other company (Pfizer) on 24 November 2015. Manufacturing control number: 2015406182. This case involves a 73-year-old female patient who was vaccinated with a first dose of Season flu double dose (batch number, expiration date, dose, dose number, route and site of administration were not reported) in right arm and a dose of PREVENAR 13 (batch number, expiration date, dose, dose number and site of administration were not reported) in left arm on 10 November 2015 at 10:00 hours. The patient's medical history and concomitant medication were not reported. The patient taking flu shot every year. The patient had the regular pneumonia shot 5 or more years ago. On 11 November 2015, one day following the vaccination the patient experienced feverish, coughing, lightheaded, lousy, all joints hurt, really painful in the muscles, couldn't move arm, pain in arm and feeling sick. Laboratory investigation and corrective treatment were not reported. The patient was not recovered from events. List of documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Cough, Decreased appetite, Influenza like illness, Malaise, Secretion discharge
Clinical narrative: Initial unsolicited report received from a non-health care professional via Pfizer on 24 November 2015. This case involves a (71-year-old) male patient who was vaccinated with a [route and dose series not reported] injection dose of FLU SHOT (batch number, expiry date and site of administration were not reported), received PREVNAR (manufacturer Pfizer, batch number, expiry date and site of administration were not reported) on 19 October 2015 and also received 20 mg three times a day dose of REVATIO (manufacturer Pfizer, batch number, expiry date and site of administration were not reported) on August 2013. Medical history were congestive heart failure, heart surgery, heart catheterization, pulmonary hypertension, sleep apnea, connective tissue disease, overlap syndrome, hardening of the arteries in his heart. Concomitant medication were Lisinopril 50mg once a day for high blood pressure, Lipitor for Cholesterol, aspirin, metformin 850mg once a day for Diabetes, Lasix 40mg once a day, amlodipine 10mg once a day, letairis, bystolic 10mg once a day, spironolactone 25mg once a day and treprostinil three puffs inhalation four times a day. On an unspecified date of October 2015, 10 days following the vaccination patient experienced Flu-like symptoms. On an unspecified date of October 2015, following the vaccination patient also experienced No appetite, Coughing, Mucus, He swells and patient is ill/ patient never has gotten sick like this before. It was also reported that, patient did not require an emergency room or doctor visit. Patient laboratory investigation was not reported. Corrective treatment was oxygen for mucus. The outcome of event was recovering Flu-like symptoms, No appetite, Coughing, recovered for Mucus and unknown for He swells and patient is ill/ patient never has gotten sick like this before. List of documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Swelling
Clinical narrative: Initial unsolicited report received from a non-health care professional via Pfizer on 24 November 2015. This case involves a (71-year-old) male patient who was vaccinated with a [route and dose series not reported] injection dose of FLU SHOT (batch number, expiry date and site of administration were not reported), received PREVNAR (manufacturer Pfizer, batch number, expiry date and site of administration were not reported) on 19 October 2015 and also received 20 mg three times a day dose of REVATIO (manufacturer Pfizer, batch number, expiry date and site of administration were not reported) on August 2013. Medical history were congestive heart failure, heart surgery, heart catheterization, pulmonary hypertension, sleep apnea, connective tissue disease, overlap syndrome, hardening of the arteries in his heart. Concomitant medication were Lisinopril 50mg once a day for high blood pressure, Lipitor for Cholesterol, aspirin, metformin 850mg once a day for Diabetes, Lasix 40mg once a day, amlodipine 10mg once a day, letairis, bystolic 10mg once a day, spironolactone 25mg once a day and treprostinil three puffs inhalation four times a day. On an unspecified date of October 2015, 10 days following the vaccination patient experienced Flu-like symptoms. On an unspecified date of October 2015, following the vaccination patient also experienced No appetite, Coughing, Mucus, He swells and patient is ill/ patient never has gotten sick like this before. It was also reported that, patient did not require an emergency room or doctor visit. Patient laboratory investigation was not reported. Corrective treatment was oxygen for mucus. The outcome of event was recovering Flu-like symptoms, No appetite, Coughing, recovered for Mucus and unknown for He swells and patient is ill/ patient never has gotten sick like this before. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: PNC13, UNK
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 30 December 2015. This case involves a 64 years old female patient who was vaccinated with a dose of Flu shot (Batch number, dose, dose in series and site of administration were not reported) in the right arm in September 2015 and 0.5 ml injection of PREVNAR 13 (batch number: M16258, Expiry date: 30 Apr 2020; route and dose in series were not reported) in the left arm on 14 December 2015. The patient had asthma and respiratory problem (ongoing-diagnosed years ago), when she gets cold uses inhaler once a year and allergic to dust, mildew, ash and elm tree pollen. Concomitant medications included 10 mg/day of CRESTOR for cholesterol; half strength of Estratest from 15 years for hormone therapy; Singulair taking for about a year and Zyrtec for allergies, 15 mg Prevacid (once a day) for reflux, Vitamin C (2000mg once a day taking for years) for autoimmune and Multivitamin for years; Primrose oil and Biotin once a day for skin and hair from years; 500 mg two dose once a day of Vitamin D for bones and 1000 mg dose of Calcium plus D once a day for bones, 1500 mg dose of Fish oil with krill once a day for autoimmune and Glucosamine once a day for joints. In September 2015, few seconds (right after the injection) following the vaccination, the patient's arm was sore and could not lift her arm up for 24 hours. Laboratory data was reported as none. Corrective treatments were not reported. On an unknown date, after 24 hours the patient was recovered from the events. List of documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Paraesthesia, Photophobia, Plasmapheresis
Clinical narrative: Initial unsolicited report received from the literature on 29 July 2016. This case is linked to 2016SA140361, 2016SA140381, 2016SA140455, 2016SA140480, 2016SA140494, 2016SA140962, 2016SA140980, 2016SA140990, 2016SA141005, 2016SA141097, 2016SA141105 (same literature). The following is verbatim from the article: Abstract: Background: No comparative review of Vaccine Adverse Event Reporting System (VAERS) submissions following pandemic influenza A (H1N1) 2009 and seasonal influenza vaccinations during the pandemic season has been published. Methods: We compared two populations' adverse event reporting rates. Adverse events (AEs) following vaccination were identified from VAERS for adults aged 17-44 years after pandemic (monovalent influenza [MIV], and seasonal (trivalent inactivated influenza [IIV3], live attenuated influenza [LAIV3]) vaccines. Results: Vaccination coverage was more than four times higher for MIV and more than twenty times higher for LAIV3 in the first population than in the second population. The reporting rate of serious AE reports following MIV in the first population (1.19 per 100,000) was about half that reported by the second population (2.45 per 100,000). Conversely, the rate of serious AE reports following LAIV3 among the first population (1.32 per 100,000) was more than twice that of the second population. Although fewer first population AEs following MIV were reported overall, the rate of Guillain-Barre Syndrome (GBS) (4.01 per million) was four times greater than that in the second population. (1.04 per million). Conclusions: Despite higher vaccination coverage in the first population, the rate of serious AEs following MIV was about half that in the second population. The rate of GBS reported following MIV was higher in the first population. This case involves an 18 year old male patient who was vaccinated with a dose of H1N1 Vaccine (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. The patient's medical history included migraine, depression and penicillin (PCN) allergy. Concomitant medications were not reported. On an unspecified date, 97 days post vaccination, patient experienced paresthesia and numbness in upper and lower limbs, areflexia and photophobia. Patient was diagnosed with Guillain-Barre syndrome (neurologist's Diagnosis). Lab data included: cerebrospinal fluid which showed positive albumin cytologic dissociation. Patient received corrective treatment with Plasmapheresis IVIG. Outcome of events was not reported. Upon internal review, the company decided to consider the event as serious because of important medical event: Guillain-Barre syndrome. Documents held by sender: none. Sender's Comments: This case refers to a patient who received H1N1 VACCINE and 97 days later experienced Guillain-Barre syndrome. The product manufacturer is unknown. Very limited information is provided in this case, however, considering the time to onset of 97 days, the role of the vaccine seems to be unlikely.
Age: 40.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Albumin CSF increased, Asthenia, Guillain-Barre syndrome, Immunoglobulin therapy, Nuclear magnetic resonance imaging brain
Clinical narrative: Initial unsolicited report received from the literature on 29 July 2016. This case is linked to 2016SA140361, 2016SA140381, 2016SA140455, 2016SA140480, 2016SA140494, 2016SA140516, 2016SA140962, 2016SA140980, 2016SA140990, 2016SA141097, 2016SA141105 (same literature). The following is verbatim from the article: Abstract: Background: No comparative review of Vaccine Adverse Event Reporting System (VAERS) submissions following pandemic influenza A (H1N1) 2009 and seasonal influenza vaccinations during the pandemic season has been published. Methods: We compared two populations' adverse event reporting rates. Adverse events (AEs) following vaccination were identified from VAERS for adults aged 17-44 years after pandemic (monovalent influenza [MIV], and seasonal (trivalent inactivated influenza [IIV3], live attenuated influenza [LAIV3]) vaccines.  Results: Vaccination coverage was more than four times higher for MIV and more than twenty times higher for LAIV3 in the first population than in the second population. The reporting rate of serious AE reports following MIV in the first population (1.19 per 100,000) was about half that reported by the second population (2.45 per 100,000). Conversely, the rate of serious AE reports following LAIV3 among the first population (1.32 per 100,000) was more than twice that of the second population. Although fewer first population AEs following MIV were reported overall, the rate of Guillain-Barre Syndrome (GBS) (4.01 per million) was four times greater than that in the second population. (1.04 per million). Conclusions: Despite higher vaccination coverage in the first population, the rate of serious AEs following MIV was about half that in the second population. The rate of GBS reported following MIV was higher in the second population. This case involves a 40 year old male patient who was vaccinated with H1N1 VACCINE (batch number, dose, route and site of administration was not reported) on an unspecified date. The patient had medical history of Gastroesophageal reflux disease, obstructive sleep apnea, seasonal allergies. Concomitant medications were not reported. On an unspecified date, 36 days following vaccination, patient had ascending weakness, paresthesias in all limbs. Patient was diagnosed with Guillain-Barre syndrome. Lab data included cerebrospinal fluid which showed positive albumin cytologic dissociation. MRI of cervical spine and brain was performed. Corrective treatments included IVIG (Intravenous immunoglobulin). Outcome of events was not reported. Upon internal review the case was considered as serious because of important medical event: Guillain-Barre syndrome. Documents held by sender: none. Sender's Comments: Manufacturer of the INFLUENZA VACCINE was not reported. Guillain-Barre syndrome is reported after vaccination with influenza vaccine. More information on past medical history, family history and concomitant medication are required to assess this case further.
Age: 40.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Initial unsolicited report received from the literature on 29 July 2016. This case is linked to 2016SA140361, 2016SA140381, 2016SA140455, 2016SA140480, 2016SA140494, 2016SA140516, 2016SA140962, 2016SA140980, 2016SA140990, 2016SA141097, 2016SA141105 (same literature). The following is verbatim from the article: Abstract: Background: No comparative review of Vaccine Adverse Event Reporting System (VAERS) submissions following pandemic influenza A (H1N1) 2009 and seasonal influenza vaccinations during the pandemic season has been published. Methods: We compared two populations' adverse event reporting rates. Adverse events (AEs) following vaccination were identified from VAERS for adults aged 17-44 years after pandemic (monovalent influenza [MIV], and seasonal (trivalent inactivated influenza [IIV3], live attenuated influenza [LAIV3]) vaccines.  Results: Vaccination coverage was more than four times higher for MIV and more than twenty times higher for LAIV3 in the first population than in the second population. The reporting rate of serious AE reports following MIV in the first population (1.19 per 100,000) was about half that reported by the second population (2.45 per 100,000). Conversely, the rate of serious AE reports following LAIV3 among the first population (1.32 per 100,000) was more than twice that of the second population. Although fewer first population AEs following MIV were reported overall, the rate of Guillain-Barre Syndrome (GBS) (4.01 per million) was four times greater than that in the second population. (1.04 per million). Conclusions: Despite higher vaccination coverage in the first population, the rate of serious AEs following MIV was about half that in the second population. The rate of GBS reported following MIV was higher in the second population. This case involves a 40 year old male patient who was vaccinated with H1N1 VACCINE (batch number, dose, route and site of administration was not reported) on an unspecified date. The patient had medical history of Gastroesophageal reflux disease, obstructive sleep apnea, seasonal allergies. Concomitant medications were not reported. On an unspecified date, 36 days following vaccination, patient had ascending weakness, paresthesias in all limbs. Patient was diagnosed with Guillain-Barre syndrome. Lab data included cerebrospinal fluid which showed positive albumin cytologic dissociation. MRI of cervical spine and brain was performed. Corrective treatments included IVIG (Intravenous immunoglobulin). Outcome of events was not reported. Upon internal review the case was considered as serious because of important medical event: Guillain-Barre syndrome. Documents held by sender: none. Sender's Comments: Manufacturer of the INFLUENZA VACCINE was not reported. Guillain-Barre syndrome is reported after vaccination with influenza vaccine. More information on past medical history, family history and concomitant medication are required to assess this case further.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Intussusception.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-AUG-2016, the patient was vaccinated with her second dose of improperly stored dose of VARIVAX lot # L046884, expiration date 23-NOV-2017, 0.5 ml, subcutaneous. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 23.9 degrees Fahrenheit for 1 hour 25 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reported received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to two patients of unknown age and gender. No information of pertinent medical history, drug reactions/allergies and concomitant medication were provided. On an unknown dates, the patients were vaccinated with a improperly stored dose of VARIVAX, (lot # L034368, expiration date 08-SEP-2017, strength, dose and route were unknown). No adverse effects was reported. It was unspecified if the patients sought medical attention. This is one of two reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dysphagia, Fatigue, Full blood count normal, Malaise, Myalgia
Clinical narrative: Fatigue, Malaise; Myalgias, dysphagia.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates, the patients were administered improperly stored VARIVAX injection (lot #L034368, expired on 08-SEP-2017) (dose and route unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received form a medical assistant referring to multiple patients of unknown age and gender. The unspecified multiple patients were vaccinated with PNEUMOVAX 23 lot # M005287, expiration date 08-OCT-2017, 0.5 ml, route and strength were unknown) and PMEUMOVAX 23 lot # M013156, expirations date 15-OCT-2017,  0.5 m, route and strength were unknown) on multiple unspecified dates (Extra dose administered). No adverse effect were reported. It was unspecified if the patients sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. No information of pertinent medical history, drug reactions/allergies and concomitant medication were provided. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX, (lot # M010472, expiration date 01-JUN-2017, strength, dose and route were unknown). No adverse effects was reported. It was unspecified if the patient sought medical attention. This is one of two reports received form the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 09-AUG-2016, the patient inadvertently received a partial dose of ZOSTAVAX (strength was not reported, lot # L046295, expiration date on 17-FEB-2017) subcutaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown gender and age. On unknown date in 2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23, (lot # L002310, expiration date 08-JUL-2016, strength, route, and dose were not provided). No adverse effects were reported. It was unspecified if the patient sought medical attention. Additional information is not expected as the reporter did not wish further contact.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Decreased appetite, Dizziness, Headache, Vertigo
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 11 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with GARDASIL 9, intramuscularly, lot # M003659 (strength, dose, site of administration and expiry date were not reported). On 07-JUN-2016, the patient experienced vertigo, headaches, dizziness and not wanting to eat. There was no treatment given for the events. The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was vaccinated from a pharmacist refers to 3 unknown patients of unknown age. On an unknown date, the patients experienced some sort reaction. The outcome of the event was unknown. The report considered the event to be related to ZOSTAVAX. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple 6 month old patients of unknown gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The medical assistant reported that on unspecified dates, for about a year, her practice had been routinely administering an initial dose of PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) to patients at the age of 2 months, a second dose at the age of 4 months and a third dose at the age of 6 months (inappropriate schedule of vaccine administered). Then patients were administered a fourth dose of PEDVAXHIB at age 12 to 15 months (extra dose administered). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Age: 0.2
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple 6 month old patients of unknown gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The medical assistant reported that on unspecified dates, for about a year, her practice had been routinely administering an initial dose of PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) to patients at the age of 2 months, a second dose at the age of 4 months and a third dose at the age of 6 months. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MENB, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Meningococcal B vaccine given to pt. not meeting indications.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Muscular weakness
Clinical narrative: Progressive leg weakness and shortness of breath starting shortly after Tdap administered 5/2016.
Age: 1.33
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: None. Urticarial rash-face. BENADRYL. Ibuprofen.
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 multiple patients of unknown age and gender. It was reported that on unknown dates, the patients were vaccinated with ROTATEQ orally, lot number L038536, expiration date 19-AUG-2017 (dose not reported). The vaccine was stored in temperature of 29.8 F for 256 hours (date logger: yes). There were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Mobility decreased, Pain
Clinical narrative: Patient received Men B (BEXSERO) that evening complained of pain following am reported to mom pain and unable to raise arm/fingers due to pain by that evening with red, swelling 4-5" in size at injection site. By day 5 post vaccine use referral, swelling down, but c/o pain for 10 days. This is reported by parent was not seen, patient fully recovered per parent at this time. Parent/patient not seen for event. Parent reported event at next office visit.
Sex: U
Vaccine: HPV4
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. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored Gardasil lot # L033347, expiry date 23-JUL-2017 (strength, dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ, VARCEL
Symptoms: Dizziness, Feeling hot, Flushing
Clinical narrative: After immi's pt became dizzy, light headed and flushed/hot. Pt pale. Pt laid down, ammonia inhalant used along with cool compress. Mother present. Water given. Mother states pt had adverse event after last immi's in 2010. Pt observed x 25 min. No further issues.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Erythema, Hypersensitivity, Peripheral swelling, Skin warm
Clinical narrative: 86 year old male received pneumococcal polysaccharide vaccine PPSV23 IM  x 1 dose right deltoid in clinic afternoon of 7/27/16. On 7/29/16, pt returned to clinic complaining of right arm swelling, warmth, and erythema since 7/27. Patient also had episode of dizziness the evening of 7/27 and almost fell going to the restroom, now resolved. No visible knot or redness at the injection site itself. Pt also had blood drawn in right upper forearm on 7/27, no bruising noted. Right arm cellulitis vs allergic reaction to PNEUMOVAX: prescribed amoxicillin/clavulanate 875 mg/125 mg PO BID x 10 days and diphenhydramine 25 mg PO every 6 hours as needed for allergic reaction.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Induration
Clinical narrative: Localized erythema and induration beginning about 24hr after injection and progressing.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in jaw
Clinical narrative: Pt's mother called pharmacy to ask us about jaw and lower neck pain after receiving flu shot. I suggested she contact the MD as soon as possible. Pt went to PM pediatrics and received a diagnosis of possible Bell's Palsy. Upon further discussion mom also mentioned pt received meningitis vaccine from pediatrician on 8/10/16. The physician at PM pediatric informed pt that she may have possible Bell's Palsy from either vaccine. Pt went to pediatrician for second opinion and was told not Bell's Palsy, to take Ibuprofen for pain and to consult neurologist.
Age: 72.0
Sex: F
Vaccine: TYP
Symptoms: Eye pruritus, Lip pruritus, Paraesthesia oral, Pruritus, Throat irritation
Clinical narrative: Patient took the first dose of oral typhoid vaccine and within 1.5 hours her eyes, nose, lips, and throat began to itch. Her lower lip also felt tingly. These symptoms lasted 4 hours.
Age: 68.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Visual impairment
Clinical narrative: Patient received PREVNAR 13 on 4/6/16 and a few weeks later had vision changes. He saw eye doctors and PCP to assess cause and was referred to endocrinologist to assess thyroid contribution to vision changes. Cause unknown. Patient asked if vaccine could be responsible - no reports of vision changes per Pfizer.
Age: 68.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Corrective lens user, Visual impairment
Clinical narrative: Patient received PREVNAR 13 on 4/6/16 and a few weeks later had vision changes. He saw eye doctors and PCP to assess cause and was referred to endocrinologist to assess thyroid contribution to vision changes. Cause unknown. Patient asked if vaccine could be responsible - no reports of vision changes per Pfizer.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Rash
Clinical narrative: Patient complained of arm pain that had a rash developed, possibly* from the Pneumovax shot she received on her right arm. Patient had received flu vaccines before with no issue but not sure which type of flu shot.
Age: 20.0
Sex: M
Vaccine: MNQ, TTOX, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: NONE.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Diffuse rash.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event; patient was given adult due to size (weight 221lb, height 5'11.5") given outside ACIP recommendations.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Diffuse rash.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Dizziness, Headache, Lymphadenopathy, Malaise
Clinical narrative: Chills, body aches, facial rash, swollen posterior auricular lymph node, headache, malaise, lightheadedness.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Rash
Clinical narrative: Chills, body aches, facial rash, swollen posterior auricular lymph node, headache, malaise, lightheadedness.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and whelps on R forearm and both lower leg extremities. Client reports she applied alcohol to sites affected. Itching ceased but whelps remained. All s/s associated lasted for approx. 1-2 days.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Eye swelling, Lip swelling, Swelling face
Clinical narrative: Facial swelling of both eyes, nose, lips. Mother gave dose of Benadryl. Denies any respiratory distress or any other symptoms.  Declines taking child to doctor at this time.
Age: 11.0
Sex: M
Vaccine: HPV4, MENB, TDAP
Symptoms: Rash, Rash generalised
Clinical narrative: Rash on face that spread all over body.  Evaluated 8/17/16.
Age: 26.0
Sex: M
Vaccine: HEPA
Symptoms: Dehydration, Fatigue
Clinical narrative: Fatigue, exhaustion, dehydration. Still occurring.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Occult blood positive, Ultrasound abdomen abnormal
Clinical narrative: Infant developed bloody stool (heme positive in clinic on 8/15) on morning of 8/15. Developed vomiting 8/14. Symptoms continued, pt taken to ER subsequently diagnosed with intussusception. Successfully treated with air enema.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Infant developed bloody stool (heme positive in clinic on 8/15) on morning of 8/15. Developed vomiting 8/14. Symptoms continued, pt taken to ER subsequently diagnosed with intussusception. Successfully treated with air enema.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Rush of flow in stomach and arm. Nausea, Chest tightness, Hard time breathing, Throat tightness, Heavy sweating, Dizziness, Tingling feeling in whole body.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Sensory disturbance, Throat tightness
Clinical narrative: Rush of flow in stomach and arm. Nausea, Chest tightness, Hard time breathing, Throat tightness, Heavy sweating, Dizziness, Tingling feeling in whole body.
Age: 11.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Erythema, Joint effusion, Joint swelling, Pain, Rheumatoid factor positive
Clinical narrative: Left ankle severely swollen, red, hot, not able to bear weight. The heat and redness proceeded to move up her leg. She went to the ER and had to have the joint effusion tapped. It took weeks before the swelling, heat, pain and inability to bear weight to get better.
Age: 11.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Skin warm, Weight bearing difficulty, White blood cell count increased
Clinical narrative: Left ankle severely swollen, red, hot, not able to bear weight. The heat and redness proceeded to move up her leg. She went to the ER and had to have the joint effusion tapped. It took weeks before the swelling, heat, pain and inability to bear weight to get better.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: SWOLLEN LIPS AND TONGUE.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Headache, Hypersensitivity, Injection site erythema
Clinical narrative: Was at work when I noticed redness, site to touch and itched. Felt nauseous, weak, dizzy, and a headache. Sat for a little and drank water and it went away after about a couple of hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Nausea
Clinical narrative: Was at work when I noticed redness, site to touch and itched. Felt nauseous, weak, dizzy, and a headache. Sat for a little and drank water and it went away after about a couple of hours.
Age: 11.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Activities of daily living impaired, Fatigue, Feeling hot, Joint swelling, Pain
Clinical narrative: L knee and ankle swelling, heat and severe pain. The swelling continued to spread up her leg from both joints. Pt unable to bear weight on either joint. Very fatigued. Rheumatoid factor more positive. Now patient is unable to participate in school sports.
Age: 11.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Peripheral swelling, Rheumatoid factor positive, Weight bearing difficulty, White blood cell count increased
Clinical narrative: L knee and ankle swelling, heat and severe pain. The swelling continued to spread up her leg from both joints. Pt unable to bear weight on either joint. Very fatigued. Rheumatoid factor more positive. Now patient is unable to participate in school sports.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling and warmth at left deltoid injection site, denies difficulty breathing coughing vomiting or widespread rash has been applying ice no other interventions to date.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Culture, Influenza like illness, Mononucleosis heterophile test negative, Muscular weakness, Nausea
Clinical narrative: Flu like symptoms, weakness in legs, nausea, shaky.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Streptococcus test negative, Tremor
Clinical narrative: Flu like symptoms, weakness in legs, nausea, shaky.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Pallor, Syncope
Clinical narrative: PALLOR, REPORTS OF UNEASINESS, FEELINGS OF SYNCOPE - DID NOT LOSE CONSCIOUSNESS, BLOOD PRESSURE 116/73mmHg BPM 64.  HAD PATIENT LIE ON SIDE ON FLOOR FOR 10 MINUTES THEN SIT UPRIGHT FOR 5 MINUTES.  PATIENT RECOVERED AFTER 15 MINUTES.
Age: 22.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site rash, Pain in extremity
Clinical narrative: Rash near right arm injection sight with burning sensation. Accompanied with achiness down arm.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Mild rash/swelling/itching, getting better but not fully resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Fatigue, Herpes virus infection, Impaired work ability, Myalgia
Clinical narrative: Low grade fever, heart palpations, heavy feeling in chest, fatigue 8/02/2106 low grade fever muscle pain in legs and feet, fatigue causing me to miss work. This continued and 13 days later a severe, painful herpes outbreak. My Dr. treated me with anti viral meds on 8/13/16. As of today I still have nerve pain in bottom of feet and fatigue.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Palpitations, Pyrexia
Clinical narrative: Low grade fever, heart palpations, heavy feeling in chest, fatigue 8/02/2106 low grade fever muscle pain in legs and feet, fatigue causing me to miss work. This continued and 13 days later a severe, painful herpes outbreak. My Dr. treated me with anti viral meds on 8/13/16. As of today I still have nerve pain in bottom of feet and fatigue.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (RMA) concerning an unknown number of unspecified patients (unknown ages and genders). Pertinent medical history of the patients and their respective concurred conditions were not provided. It was reported that on 20-MAR-2016 or after, an unknown number of unspecified patients were vaccinated with improperly stored doses of M-M-R II lot # L011528, expiration date 03-APR-2017, (dosages, doses numbers and therapy routes were not reported). No adverse effects were reported at the time of the report. The excursion details were: Temperature: 9.8C- Time frame: 12 hours- There was no previous temperature excursion- It was call due to data logger. No product quality complaint (PQC) was involved. This is one of two reports from the same source (MARRS # WAES1608USA005970). Additional information has been requested.
Sex: F
Vaccine: MU
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from the patient's mother refers to her daughter of unknown age. The patient had no pertinent medical history, drug allergies/reactions  or concomitant medications. On 13-FEB-2010, the patient was vaccinated with  a dose of MUMPSVAX (expiration date: 13-MAR-2010) (lot #, dose, frequency and route were not provided). On an unknown date (reported as recently), the patient had a titer test done and the results showed she was not protected from the mumps virus. The reporter also believed the MUMPSVAX may not have been potent enough to prevent the mumps virus as it was due to expire on 13-MAR-2010. The patient did not seek medical attention and did not receive treatment for the events. A product quality complaint was not involved. At the time of reporting, the outcome of the event was unknown. The reporter did not provide the causality assessment between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (RMA) concerning an unknown number of unspecified patients (unknown ages and genders). Pertinent medical history of the patients and their respective concurred conditions were not provided. It was reported that on 20-MAR-2016 or after, an unknown number of unspecified patients were vaccinated with improperly stored doses of ROTATEQ lots # K020181 and L008054 with expiration dates 24-JUN-2016 and 30-NOV-2016 respectively (dosages and dose numbers were not reported), administered per oral route. Concomitant therapies were not reported. The RMA stated that on 20-MAR-2016 the patients were administered improperly stored doses of ROTATEQ lot # K020181 expiry date 24-JUN-2016 were administered; any improperly stored doses from this lot were administered on unknown dates prior to expiry. No adverse effects were reported at the time of the report. The excursion details were: Temperature: 9.8C- Time frame: 12 hours- There was no previous temperature excursion- It was call due to a data logger. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of two reports from the same source (MARRS # WAES1608USA005915).
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist, via a company representative, concerning an unspecified number of patients (unknown ages and genders). Pertinent medical history of patients and their respective concurrent conditions were not provided. On an unknown date the patients were vaccinated with ZOSTAVAX lots # M013377 and L044529, with expiry dates 25-MAY-2016 and 09-FEB-2016 respectively (concentrations, dosages and therapy routes were not reported). Concomitant therapies were not provided. The pharmacist stated that on an unspecified date in 2016, reported as "over the last month", administering several doses of ZOSTAVAX, the patients had experienced unusually large injection site reaction. The outcomes of injection site reaction were unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a female subject who received Human papilloma type 16 + 18 vaccine + AS04D. On an unknown date, an unknown time after receiving Human papilloma type 16 + 18 vaccine + AS04D, the subject developed uveitis. Serious criteria included GSK medically significant. The outcome of uveitis was unknown. The investigator considered that there was a reasonable possibility that the uveitis may have been caused by Human papilloma type 16 + 18 vaccine + AS04D. Additional information was provided: This case was reported in a literature article and described the occurrence of vaccine-associated uveitis in a female aged between 11 and 29 who was vaccinated with unspecified human papilloma virus (HPV) vaccine (manufacturer unknown). The patient was part of observational study conducted to collect data on cases of vaccine-associated uveitis reported from 1984 to 2014 to three spontaneous reporting databases on adverse drug events. In addition, a literature search was performed using the keywords of uveitis, iritis, iridocyclitis, or vitritis, in combination with vaccines, hepatitis A, hepatitis B, human papilloma virus vaccine (HPV), Bacillus Calmette-Guerin (BCG), Brucella, diphtheria, pertussis and tetanus (DPT), herpes, influenza, measles, measles, mumps, and rubella (MMR), pneumococcal, smallpox, tetanus, typhoid, Heine Medin, varicella, yellow fever, and zoster vaccine. No information on patient's medical history or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified HPV vaccine (administration route and site unspecified; dosages unknown; batch number not provided). (Information on which dose of a particular vaccine was associated with uveitis was not available in the reporting systems.) On an unspecified date between 1984 and 2014, between 2 and 511 days after vaccination with unspecified HPV vaccine, the patient developed uveitis. Treatment was unknown. The outcome for the event was unresolved. The authors considered the event of uveitis associated to unspecified HPV vaccine. The authors concluded "While uveitis may be a rare adverse effect of vaccines, awareness of this potential reaction to vaccines is important, as is reporting such occurrences to adverse drug reaction registries. That hepatitis B vaccine accounted for a disproportionate number of cases certainly piques curiosity about contributing factors for uveitis in association with hepatitis B vaccine. In a similar vein, we are also left with the question of why a disproportionate number of cases of vaccine-associated uveitis occur in females (199 in females versus 77 in males in our data). Future studies of vaccine-associated uveitis could focus on active surveillance and rigorous clinical evaluation of patients presenting with uveitis temporally related to vaccination". This is 1 of 14 valid cases reported in the same literature article. This article is not available for regulatory submission due to copyright restriction.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site nodule, Pain in extremity
Clinical narrative: TDAP admin (R) deltoid 8/11/16, during evening arm achy and injection site Red, tenderness with nodule present. Had fevers with DTAP as infant. TX w/ Clindamycin for possible cellulitis.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site vesicles, Pyrexia
Clinical narrative: Within 12 hours had slight fever on and off, about 101 degrees for 3 days. Did not give medication just used cold compresses. On 2nd day vax site had purple red mark (as big as 50 cent piece). There were 3 blisters within this area. Mom knows it was bothering patient because he tried to scratch it so had to use a cold pack. Area stayed inflamed for about 1 month. Used calamine lotion and tea tree oil. Looked like an open wound for about 1 month. Mark started to fade after 1 1/2 months. A slight bruise still is visible (size of a quarter).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 08-AUG-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # M019708, expiration date 25-OCT-2017, strength and route were not reported). The vaccine had been stored under the temperature of 47.2 Fahrenheit degree for 10 minutes. There was no previous temperature excursions. Digital data logger involved. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product use issue
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 05-AUG-2016, the patient was vaccinated with a dose of PROQUAD (lot # M006105, expiration date: 01-AUG-2014) (dose, frequency and route were not provided) and with a dose of VARIVAX (lot # L048465, expiration date: 02-DEC-2017) (dose, frequency and route were not provided). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Product use issue
Clinical narrative: Information has been received from a Medical assistant concerning to patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. No concomitant medications were provided. On 10-JUL-2008, the patient was vaccinated with the first dose of GARDASIL, at a dose of 0.5 ml, via intramuscular route, (strength, anatomical location, lot number and expiration date were not provided). Subsequently, on 06-JUL-2016, the patient was vaccinated with the second dose of GARDASIL, at a dose of 0.5ml, via intramuscular route, (lot number L028664, with an expiration date of 27-MAY-2017) (strength and anatomical location were not provided), which was greater than the recommended interval. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.