chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, HEPA, HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored ROTATEQ lot # M016918, expiration date: 15-FEB-2018, given orally, RECOMBIVAX HB lot # M033334, expiration date:11-AUG-2018 given via intramuscular injection, GARDASIL 9 lot # L037554, expiration date: 25-DEC-2017 given via intramuscular injection, and VAQTA lot # M036459, expiration date: 18-JAN-2018 given via intramuscular injection (strength, dosage, and anatomical location were not reported). Concomitant medications were not provided. No adverse effects reported. Excursion information below: ROTATEQ lot # M016918, expiration date: 15-FEB-2018, RECOMBIVAX HB lot # M033334, expiration date:11-AUG-2018, GARDASIL 9 lot # L037554, expiration date: 25-DEC-2017, and VAQTA lot # M036459, expiration date: 18-JAN-2018 .Temperature: 34F;Time frame: 8 Hours and 18 Minutes.There were no previous temperature excursion and the call was because of a data logger. 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 registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 04-JAN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection (lot # M034894, expiration date: 11-NOV-2018; dose and route of administration were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of between 32 to 36 degrees Fahrenheit for 6.5 hours. The digital data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007859.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reaction or allergies were not reported. On an unknown date in 2011, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiry date were not reported). Then, on 07-NOV-2016, the patient was vaccinated a dose of GARDASIL 9 injection, lot # L048459 with expiry date 22-FEB-2018 (dose, route of administration were not reported). No adverse effects were reported. 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 registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 04-JAN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection (lot # M034894, expiration date: 11-NOV-2018; dose and route of administration were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of between 32 to 36 degrees Fahrenheit for 6.5 hours. The digital data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1701USA002329:
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 15 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported.  On 14-NOV-2016, the patient was vaccinated with a dose of improperly stored Measles, Mumps, and Rubella Virus Vaccine (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849:
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A non-contactable nurse reported for herself. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) at single dose in 2014 for immunization. Relevant medical history and concomitant medication were unknown. On unknown date in Jan2016 the patient experienced pneumonia. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities. Sender's Comments: Based on the information provided in the case, a lack of efficacy withpneumococcal 13-val conj vac (dipht crm197 protein) in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment.
Age: 40.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A non-contactable nurse reported for herself. A 40-year-old female patient received PREVNAR 13 at single dose in Apr2016 for immunization. Relevant medical history included eye surgery. Concomitant medication were unknown. On unknown date in Sep2016 the patient experienced pneumonia. The patient had cough and nasopharyngitis at the time of vaccination. The pneumonia was diagnosed at Emergency Department and treatment started. The patient had had the another shot of pneumococcal 13-val conj vac (dipht crm197 protein) in 2014 and she had experienced pneumonia in Jan2016. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like causative agent and serotyping results is needed for a full medical assessment.
Sex: F
Vaccine: PNC13
Symptoms: Altered state of consciousness, Dizziness, Injection site erythema, Insomnia, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist who reported on behalf of the patient. This female patient of an unspecified age and race received PREVNAR 13 on 10Jan2017, at 0.5 ml single, in the arm, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.   Since an unspecified date in Jan2017, arm where pharmacist did give the vaccine was red, blown up and warm, started to flare up and got hot and obnoxious (so the patient took a cold compress), she could not sleep and she felt dizzy. The patient thought she was passing out in the morning (so she was all night long). When she put a cold compress, it heated, all in there was red and she called the pharmacist and told her about it. The patient did not know what to do, whether it was infected because it was very hot and she put on the compress which would let her get out and drive the car because she was afraid of driving. She felt so dizzy so it was going to be some sort of infection there probably. Events outcome was unknown at the time of report. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site warmth
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist who reported on behalf of the patient. This female patient of an unspecified age and race received PREVNAR 13 on 10Jan2017, at 0.5 ml single, in the arm, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.   Since an unspecified date in Jan2017, arm where pharmacist did give the vaccine was red, blown up and warm, started to flare up and got hot and obnoxious (so the patient took a cold compress), she could not sleep and she felt dizzy. The patient thought she was passing out in the morning (so she was all night long). When she put a cold compress, it heated, all in there was red and she called the pharmacist and told her about it. The patient did not know what to do, whether it was infected because it was very hot and she put on the compress which would let her get out and drive the car because she was afraid of driving. She felt so dizzy so it was going to be some sort of infection there probably. Events outcome was unknown at the time of report. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 17-year-old female patient of an unspecified race received TRUMENBA for immunization at single dose on an unknown date via an unspecified route in the arm. On the same date the patient also received MENACTRA in the same arm. On unknown date the patient experienced redness, swollen, hard and painful. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Injection site paraesthesia, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site tingling in a adult female patient who received ENGERIX B Pediatric (batch number 9232L, expiry date unknown). Co-suspect products included ENGERIX B Pediatric (batch number 9232L, expiry date unknown). On an unknown date, the patient received the 1st dose of ENGERIX B Pediatric and the 1st dose of ENGERIX B Pediatric. On an unknown date, less than a day after receiving ENGERIX B Pediatric and ENGERIX B Pediatric, the patient experienced injection site tingling, inappropriate age at vaccine administration and inappropriate age at vaccine administration. On an unknown date, the outcome of the injection site tingling was not recovered/not resolved and the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown. The reporter considered the injection site tingling to be possibly related to ENGERIX B Pediatric and ENGERIX B Pediatric. Additional details were provided as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The caller stated that she received her 1st dose in the hospital as a hospital worker. She stated the nurse used two vials for the vaccine but she did not have the lot or know if it was two paediatric doses used. She planned to contact them back. She stated she only received the one vaccine that day. She stated that day she experienced tingling of pins and needles in her right arm, which was the arm she received the vaccine in and continued to experience that 2 weeks afterwards. She refused to provide contact information or demographics. Serial number was provided for her to call back with additional details from facility. Consumer called back and provided name, which had been correct on initial form. She provided the lot number of the product used and it was two paediatric doses that she was given, which led to an inappropriate age at vaccine administration for both the pediatric doses of ENGERIX B. It was unknown if the patient received both the pediatric doses of ENGERIX B on same arm or different arm.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 12-year-old female patient who received BEXSERO (batch number 15B201, expiry date October 2017). On 1st December 2016, the patient received the 1st dose of BEXSERO .5 ml. In December 2016, less than a month after receiving BEXSERO, the patient experienced injection site swelling and injection site induration. On an unknown date, the outcome of the injection site swelling and injection site induration were unknown. It was unknown if the reporter considered the injection site swelling and injection site induration to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO (left deltoid) and experienced swelling and hard lump at injection site. This case has been linked with the case US2016GSK187851, reported by the same reporter.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site warmth, Pruritus
Clinical narrative: Quarter sized warm area at inj site, afebrile 1-17-17. 1-17-17 at 8:00P area increased to Lacrosse ball sized C/O itchiness.
Sex: F
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, Therapy non-responder
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of therapy non-responder in a female patient who received ENGERIX B. Co-suspect products included ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B and not applicable after receiving ENGERIX B, the patient experienced therapy non-responder and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the therapy non-responder and circumstance or information capable of leading to medication error were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B. Additional details were provided as follows: The patient received ENGERIX B at unknown date and unknown dose. The pharmacist stated that the physician wanted to double the patient's dose since ENGERIX B did not work. This led to therapy non-responder. If the patient receives double dose of ENGERIX B then it would be overdose and off label use by physician. This led to circumstance or information capable of leading to medication error.
Age: 0.75
Sex: M
Vaccine: FLU4, HEP, IPV
Symptoms: Extra dose administered
Clinical narrative: Patient given extra flu vaccine.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Vomited X 2 day of flu vaccine #2. Tolerated first without symptoms.
Age: 17.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Wrong drug administered
Clinical narrative: Patient given inappropriate vaccine.
Age: 17.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient given inappropriate vaccine.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Cough, Eye irritation, Pyrexia, Rash
Clinical narrative: Fever lasting more than 3 days. Cough lasting more than 3 days.  Irritated eyes lasting more than 3 days. Rash.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMRV, PNC13
Symptoms: Pyrexia, Seizure, Urinary incontinence
Clinical narrative: Fever and awoke from nap having wet pants, went to bathroom and had seizure activity while in bathroom. Grandparent called 911.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Shingles and nerve pain on lower back, buttocks, down left leg. Lasted about 6 weeks.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Case number PHEH2016US027044 is an initial spontaneous report from a healthcare professional (pharmacy student) received on 14 Oct 2016. This report refers to a 64 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 29 Sep 2016. On 30 Sep 2016, the patient experienced rash lasted 12 days. The outcome of event was reported as unknown. Seriousness and causality of the event were not reported.
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Case number PHEH2016US026128, is an initial spontaneous report received from a pharmacist on 06 Oct 2016. This report refers to a male patient. Historical condition was not reported. Current condition included neomycin allergy. Concomitant medication was not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number not reported) at a dose of 0.5 ml intramuscular in the last season 2015-2016. The patient had muscle ache for a couple of months. The outcome of the event was complete recovery. Seriousness of the event was not reported. Causality was reported as suspected.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture positive, Herpes zoster, Hypertension, Hyperthyroidism, Incontinence
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a 89 year old female patient. The patient did not have any known drug reactions or allergies. There was no information's about her concurrent conditions or medical history provided. On an unknown date approximately in 2007, (reported as "10 years ago" and also reported as "either in 2010 or 2011"), the patient was vaccinated with a dose of ZOSTAVAX to prevent shingles (dose, route of administration, anatomical location, lot# and expiration were not reported). On an unknown date, the patient experienced normal pressure hydrocephalus, non specific codes lymphoma, hyperthyroidism, high blood pressure and incontinence. The patient received unspecified high blood pressure and thyroid medicine as a treatment. On unknown date in 2009, (reported as "8 years ago"), the patient experienced shingles. On 09-JAN-2017 (reported as "today"), the patient had culture test done and was diagnosed with shingles again. The patient sought unspecified medical attention and received unspecified treatment for shingles. Product quality complaint (PQC) was not reported. The outcomes of events were not reported. Causality assessment was not provided. Upon internal review, the events of normal pressure hydrocephalus, non specific codes lymphoma and hyperthyroidism were determined to be medically significant. Additional information is not expected as there was no consent to contact with the patient's physician.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphoma, Normal pressure hydrocephalus
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a 89 year old female patient. The patient did not have any known drug reactions or allergies. There was no information's about her concurrent conditions or medical history provided. On an unknown date approximately in 2007, (reported as "10 years ago" and also reported as "either in 2010 or 2011"), the patient was vaccinated with a dose of ZOSTAVAX to prevent shingles (dose, route of administration, anatomical location, lot# and expiration were not reported). On an unknown date, the patient experienced normal pressure hydrocephalus, non specific codes lymphoma, hyperthyroidism, high blood pressure and incontinence. The patient received unspecified high blood pressure and thyroid medicine as a treatment. On unknown date in 2009, (reported as "8 years ago"), the patient experienced shingles. On 09-JAN-2017 (reported as "today"), the patient had culture test done and was diagnosed with shingles again. The patient sought unspecified medical attention and received unspecified treatment for shingles. Product quality complaint (PQC) was not reported. The outcomes of events were not reported. Causality assessment was not provided. Upon internal review, the events of normal pressure hydrocephalus, non specific codes lymphoma and hyperthyroidism were determined to be medically significant. Additional information is not expected as there was no consent to contact with the patient's physician.
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist and refers to a 1-year-old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 28-DEC-2016, the patient was inadvertently vaccinated with a dose of GARDASIL 9 injection, intramuscularly, lot # M024261 with expiry date 18-APR-2019 (exact dose was not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial unsolicited report received from physician on 09-Jan-2017. This case linked to 2017SA004554, 2017SA004557, 2017SA004559, 2017SA004560, 2016SA186099 (master case), and 2017SA004563 (same reporter). This involves 33-year-old female patient who was vaccinated with dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (batch number: UI640AB, expiry date: 30 Jun 2017 and route of administration was not reported) in arm, on 18-Oct-2016. The patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defect, medical conditions was reported as no known drug allergy. Any other vaccination within 4 weeks prior to suspect vaccination was reported as no and other medication was unknown. On 18 Oct 2016, immediately following the vaccination, the patient had severe itching with redness at injection site, bulge at site. Lab data and corrective treatment was not reported. On an unknown date, the patient recovered from the severe itching with redness at injection site (duration 48 hour) and bulge at site (duration 7 days). List of documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Electroencephalogram, Epilepsy, Nuclear magnetic resonance imaging, Seizure, Status epilepticus
Clinical narrative: Dx Frontal Lobe Seizures 12/5/14 post 24 hr EEG and started on AED's. 7/27/16 dx ESES and Intractable Seizures as seizures are not controlled. Txmt: High dose steroids (IV) 8-29-16 to 8-31-16 to treat ESES (subclinical seizures) High dose IV steroids and high dose VALIUM 11/14/16 to 11/16/16. AED's KEPPRA, DEPAKOTE, ONFI.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Grip strength decreased, Injection site erythema, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: (L) arm from injection site down to left hand, mild redness, warmth at injection site, stiffness in hand/trouble grasping.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: (L) arm from injection site down to left hand, mild redness, warmth at injection site, stiffness in hand/trouble grasping.
Age: 75.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: The patient's wife stated that the patient's right arm was very painful and stiff and that he could not lift the arm after getting a PPSV23 vaccination in the arm. She said the arm was not red or swollen, just painful for 3 days after. She said pain was relieved by the patient's regular pain medication that he was taking.
Sex: U
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Case number PHEH216US026715, is an initial spontaneous report received from a healthcare professional on 14 Oct 2016. This report refers to a patient of an unknown age and unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (unknown whether seasonal or pandemic, batch number: not reported) on an unknown date. On an unspecified date, the patient experienced rash for about 12 days so far. The outcome, seriousness and causality of the event were not reported.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Case number PHEH2016US000982, is a spontaneous report initially received from a health care professional on 07 Jan 2016. This report refers to a 40 year old female patient. Medical history was not reported. Current condition included allergic to Thimerosal. Concomitant medication was not reported. This Thimerosal allergic patient was vaccinated with an initial dose of FLUVIRIN (batch number: 158005) intramuscularly in the right arm on 07 Jan 2016 at 1:51. The reporter confirmed that the patient did not present any adverse event following this administration error. Following an internal review done on 20 Jan 2016, for the data received on 07 Jan 2016 the following correction was done. Coding of the event FLUVIRIN PFS was administered to a patient with a Thimerosal allergy was changed from inadvertent exposure to vaccine to contraindication to vaccination. Follow up information received from the health care professional on 23 Feb 2016: Updated dose number, batch number, route and site of administration of suspect vaccine.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: Case number PHEH2015US026500 is an initial spontaneous report received from a health care professional on 14 Dec 2015. This report refers to a 59 year female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 518001) multi dose vial (MDV) intramuscularly in the arm on 07 Dec 2015. On the same day, the patient experienced soreness in the arm of injection site as well as a white bump where the needle was inserted. The events outcome was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Pain in extremity
Clinical narrative: Case number PHEH2016US026579, is an initial spontaneous report received from a consumer on 11 Oct 2016. This report refers to a 62 years old female patient. Medical history and concomitant medications were not reported. Current conditions included could not exercise or perform other activities. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 10 Sep 2016. On the same day after vaccination, the patient experienced extreme sore arm right after she received vaccine. It was reported that, till date, her arm was sore and she could not exercise or perform other activities due to pain in her arm. The outcome of the event sore arm was reported as condition unchanged. The seriousness of the event sore arm was reported as non serious by the consumer. The causality of the event was not reported. The case was lost to follow up at initial.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Immediate post-injection reaction, Mitochondrial myopathy, Pain in extremity
Clinical narrative: Case number PHEH2016US026579, is an initial spontaneous report received from a consumer on 11 Oct 2016. This report refers to a 62 years old female patient. Medical history and concomitant medications were not reported. Current conditions included could not exercise or perform other activities. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 10 Sep 2016. On the same day after vaccination, the patient experienced extreme sore arm right after she received vaccine. It was reported that, till date, her arm was sore and she could not exercise or perform other activities due to pain in her arm. The outcome of the event sore arm was reported as condition unchanged. The seriousness of the event sore arm was reported as non serious by the consumer. The causality of the event was not reported. The case was lost to follow up at initial.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pharyngeal oedema
Clinical narrative: Case number PHEH2015US026370, is a combined initial spontaneous report received from a pharmacist on 15 Dec 2015. This report refers to a 55-year-old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517801 and expiry date: Jun 2016) intramuscularly on 13 Dec 2015. On the same day after vaccination in the evening, the patient experienced swelling of lymph nodes in throat/swelling around his throat. The patient was advised to take antihistamine and he was treated with CLARITIN, because the patient did not want to be drowsy at work. The patient did not experience any difficulty breathing or swallowing. The outcome of the event was reported as condition deteriorated (swelling gotten worse). Seriousness and causality of the event was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHEH2015US025894, is an initial spontaneous report received from a consumer (patient) on 09 Dec 2015. This report refers to a female patient of an unknown age. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515901) in to right arm at the end of Oct 2015. After vaccination, the patient could hardly move her right arm and was still experiencing the same arm pain. The patient's doctor indicated that patient might be allergic to the vaccine. The outcome of the event arm pain was reported as condition unchanged and for other events it was not reported. Seriousness and causality of the events were not reported.
Age: 16.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Swollen tongue
Clinical narrative: Patient reported to the clinic for vaccine administration for school.  Patient was administered IPV 0.5 ml IM left arm and varicella 0.5ml SQ left arm. Parent and parent were advised to wait in clinic for 15 minutes to observe for vaccine reaction as a precaution. Approximately 10 minutes after receiving vaccine patient and parent complained of patients tongue swelling.  Patient vital signs were stable, patient did not have labored breathing or wheezing.  Provider assessed patient.  ER physician was consulted, EMS transport was arranged and patient was administered epi pen 0.3mg in right thigh and vital signs remained within normal limits.  Patient transported to emergency room via EMS.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Pain in extremity, Tenderness
Clinical narrative: Patient states arm was sore immediately after getting the flu shot and has remained that way ever since.  She states it feels bruised and applying pressure to the area hurts.  Today she woke to it feeling numb but is unsure if that is related to her previous neck problems.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Decreased activity, Diet refusal, Headache, Irritability
Clinical narrative: Child was sleepy and irritable, then complained of head hurting then body and tummy hurting. Curled in ball for 5 hours whimpering with eyes closed, would not play, eat or speak. Then began vomiting.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Moaning, Pain, Somnolence, Speech disorder, Vomiting
Clinical narrative: Child was sleepy and irritable, then complained of head hurting then body and tummy hurting. Curled in ball for 5 hours whimpering with eyes closed, would not play, eat or speak. Then began vomiting.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHEH2015US025196, is an initial spontaneous report received from a pharmacist on 01 Dec 2015. This report refers to a 53-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number and expiry date: not reported) on 12 Oct 2015. She experienced arm hurting on an unknown date. The outcome, seriousness and causality of the event was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHEH2015US024709, is an initial spontaneous report from a consumer (patient's mother) received on 23 Nov 2015. This report refers to a 7 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on an unknown date. On 20 Nov 2015 the patient felt itchy and experienced hives. The patient was treated with BENADRYL and within an hour the hives went down. On 21 Nov 2015 (almost 24 hours later) the hives came back but not bad as the first day. The patient was treated with ALLEGRA. Further it was reported that the hives came back again on 22 Nov 2015 and the pediatrician was aware of the same. Final outcome of the events was condition unchanged. The seriousness and causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache
Clinical narrative: Case number PHEH2015US024201 is an initial spontaneous report received from a pharmacist on 16 Nov 2015. This report refers to a 60 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1517001) intramuscularly on an unknown date in Nov 2015. On 14 Nov 2015, three days following the injection, the patient experienced headache and dizziness. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Lymphadenopathy, Pain
Clinical narrative: Case number PHEH2015US024109 is an initial spontaneous report received from a health care professional on 16 Nov 2015. This report refers to a 65 year old female patient. Medical history and concomitant medications were not reported. Her vaccination history included administration of FLUVIRIN (batch number: not reported) on an unknown date which was well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 1516901) intramuscularly on 10 Nov 2015. On 12 Nov 2015, the patient experienced radiating pain into underarm and felt like lymph-nodes were swelling. Outcome of the events was not reported. Seriousness of the events was unknown. Causality was not reported.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHEH2015US023718 is an initial spontaneous report from a pharmacist received on 12 Nov 2015. This report refers to a 27-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 151201) intramuscularly. On 27 Oct 2015, one day after vaccination the patient experienced arm pain. The event resolved on the same date and returned about 2 weeks later. The final outcome of the event was unknown. The seriousness and causality of the event were not reported.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Case number PHEH2015US023677, is an initial spontaneous report from a physician received on 11 Nov 2015. This report refers to a 48 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number not reported) on 25 Aug 2015. Two weeks after vaccination the patient developed pain at the injection site that was radiating to her neck and arm on the right side. The pain was getting worse. Seriousness and causality of the events were not reported.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Injection site pain, Muscular weakness
Clinical narrative: Case number PHEH2015US023677, is an initial spontaneous report from a physician received on 11 Nov 2015. This report refers to a 48 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number not reported) on 25 Aug 2015. Two weeks after vaccination the patient developed pain at the injection site that was radiating to her neck and arm on the right side. The pain was getting worse. Seriousness and causality of the events were not reported.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Case number PHEH2015US023735, is an initial spontaneous report from a pharmacy technician received on 11 Nov 2015. This report refers to a 47 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157404) intramuscular on 25 Aug 2015. Shortly after the vaccination the patient felt a burning sensation. Then a week later the patient began to feel pain in left arm at injection site and weak hands. The patient would see her physician this Saturday. Outcome of the events was unknown. Seriousness and causality of the events were not reported.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Injection site pain, Muscular weakness
Clinical narrative: Case number PHEH2015US023735, is an initial spontaneous report from a pharmacy technician received on 11 Nov 2015. This report refers to a 47 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157404) intramuscular on 25 Aug 2015. Shortly after the vaccination the patient felt a burning sensation. Then a week later the patient began to feel pain in left arm at injection site and weak hands. The patient would see her physician this Saturday. Outcome of the events was unknown. Seriousness and causality of the events were not reported.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Rash
Clinical narrative: Case number PHEH2015US023409, is an initial spontaneous report from a pharmacist received on 10 Nov 2015. This report refers to an 89 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date after vaccination the patient experienced swelling in the arm of injection site and a rash. The outcome of the events was unknown. Seriousness and causality of the events were not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHEH2015US023327, is an initial spontaneous report received from a health care professional on 06 Nov 2015. This report refers to a 55 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on 15 Oct 2015. After vaccination, the patient started experiencing throbbing pain in her arm. Outcome of the event was reported as condition unchanged. Event was reported as non serious and causality was not reported.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue
Clinical narrative: Case number PHEH2015US026639, is a combined spontaneous report initially received from a physician on 17 Dec 2015 and follow up report from Quality assurance department on 21 Dec 2015. This report refers to a patient of an unknown age and gender. Past medical history and concomitant medications were not reported. The physician opened a new bottle of FLUVIRIN and when he popped the orange lid off a small portion of an orange plastic remained on the lid. The patient received FLUVIRIN (batch number: not reported) intramuscularly on 17 Dec 2015. The physician reported that, the liquid was clear and there was no particles in it. The physician did not push through the plastic part and only the rubber portion. No adverse event was reported following this administration error. Following an internal review on 30 Dec 2015 for the information received on 17 Dec 2015: Following correction was dose to the case: An additional event syringe issue was added in the case.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Blood magnesium normal, Blood phosphorus normal, Dyskinesia, Electroencephalogram normal, Full blood count normal
Clinical narrative: 13 hours after 6 mo vaccines and flu shot were administered, child spiked fever to 101.5 and started jerking spasms of head and arm. Admitted to Hospital for evaluation for infantile spasms. MRI-normal. EEG-normal-but needs follow up as spasms have continued. Working diagnosis is myoclonic jerks, but infantile spasms not fully ruled out.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Infantile spasms, Metabolic function test normal, Muscle spasms, Myoclonus, Nuclear magnetic resonance imaging normal
Clinical narrative: 13 hours after 6 mo vaccines and flu shot were administered, child spiked fever to 101.5 and started jerking spasms of head and arm. Admitted to Hospital for evaluation for infantile spasms. MRI-normal. EEG-normal-but needs follow up as spasms have continued. Working diagnosis is myoclonic jerks, but infantile spasms not fully ruled out.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: 13 hours after 6 mo vaccines and flu shot were administered, child spiked fever to 101.5 and started jerking spasms of head and arm. Admitted to Hospital for evaluation for infantile spasms. MRI-normal. EEG-normal-but needs follow up as spasms have continued. Working diagnosis is myoclonic jerks, but infantile spasms not fully ruled out.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026593 is a spontaneous report initially received from a medical assistant on 16 Dec 2015. This report refers to a 65 year old male patient. Past medical history was none known. His vaccination history included administration of seasonal influenza vaccines (manufacturer and batch number: not reported) yearly. Previous vaccinations were well tolerated. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 151301) at 0.5 ml intramuscularly on 14 Dec 2015 at 16:15 hours. It was reported that given FLUVIRIN was stored above temperature range before administration. The case was assessed as non-serious. No adverse event reported following this administration error. Follow-up information received from a medical assistant on 23 Feb 2016: Time of vaccination, seriousness criteria and other clinically relevant information updated in the narrative.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026592, is a spontaneous report initially received from a medical assistant on 16 Dec 2015. This report refers to a 64 years old female patient. Past vaccination history included FLUVIRIN was tolerated in the past. Concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515301) at a dose of 0.5 ml intramuscularly on 14 Dec 2015 at 16:00 hours which was stored above the recommended temperature range. No adverse event reported following this medication errors (incorrect storage of drug). The medication error was reported as non serious. Reporter stated that FLUVIRIN was not above the normal range parameters and patient was doing fine. Reporter would fill out the follow up form. Follow up report received from health care professional on 09 Feb 2016: Updated reporter's comment. Follow up information received from health care professional (medical assistant) on 23 Feb 2016: Updated batch number, added vaccination history, time and site of vaccination.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026589, is a spontaneous report initially received from health care professional (medical assistant) on 16 Dec 2015. This report refers to a 66 year old male patient. Past vaccination history included FLUVIRIN was tolerated in the past. Concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515301) at a dose of 0.5 ml intramuscularly on 14 Dec 2015 at 13:30 hours. It was reported that given FLUVIRIN was stored above temperature range. No adverse event reported following this administration error. Follow up information received from health care professional (medical assistant) on 23 Feb 2016: Updated patient's date of birth and batch number, added vaccination history, time and site of vaccination and seriousness.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Headache, Incorrect route of drug administration, Myalgia
Clinical narrative: Case number PHEH2015US026578, is an initial spontaneous report received from a consumer on 14 Dec 2015. This report refers to a 63 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number and expiry: not reported) subcutaneously on 09 Dec 2015. FLUVIRIN was given under skin and not in muscle (administration error). It was reported that health care professional gave two vaccines at the same visit (unspecified). The patient experienced headache, fever, muscle aches, some diarrhea and he was really tired. The outcome of the events headache, fever, muscle aches, some diarrhea and really tired was reported as complete recovery on 09 Dec 2015. The seriousness and causality of the events were not reported.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Case number PHEH2015US026578, is an initial spontaneous report received from a consumer on 14 Dec 2015. This report refers to a 63 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number and expiry: not reported) subcutaneously on 09 Dec 2015. FLUVIRIN was given under skin and not in muscle (administration error). It was reported that health care professional gave two vaccines at the same visit (unspecified). The patient experienced headache, fever, muscle aches, some diarrhea and he was really tired. The outcome of the events headache, fever, muscle aches, some diarrhea and really tired was reported as complete recovery on 09 Dec 2015. The seriousness and causality of the events were not reported.