chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: By 7:30 pm of the day the client received the vaccine she had experienced at least 2 fainting spells and ended up going to the Emergency room at hospital at 7:30 pm where she was seen and observed until 2am on September 26, 2017.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea
Clinical narrative: Mild nausea and mild headache.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Hyperhidrosis, Pyrexia
Clinical narrative: Fever 100 degrees, weakness, sweating, slept remainder of day.
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Blood pressure decreased, Electrocardiogram normal, Fall, Loss of consciousness
Clinical narrative: After receiving the HPV vaccine patient fainted, fell and loss consciousness for about 10 seconds.
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: After receiving the HPV vaccine patient fainted, fell and loss consciousness for about 10 seconds.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 09-AUG-2017 to 30-AUG-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 expiration date 17-JUL-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 89 hours. Data logger was not involved. There were no previous excursions reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (exact dose, lot #, expiration date and route of administration were not reported) for prevention of shingles. Other suspect therapy included sterile diluent (MERCK STERILE DILUENT) injection (dose, lot #, expiration date and route of administration were not reported) also received on an unknown date. On an unknown date in approximately January 2017 (reported as 8 months ago), the patient was diagnosed by a physician with shingles, at an unspecified location. It was unknown by the reporter if there was any treatment given for the shingles. The outcome of the event of shingles was unknown. There was no product quality complaint involved. The pharmacist declined Varicella-Zoster Virus (VZV) packet. The relatedness between the event of shingles and ZOSTAVAX was not reported. Additional information is not expected since there was no consent to further contact the reporter.
Age: 47.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Asthenia, Erythema, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Next morning, extreme pain in right arm, redness and swelling. Body aches all over. Felt weak. Took TYLENOL and stayed in bed for most of following 48 hours. Today is 5 days later and still pain/ redness swelling in shoulder.
Age: 8.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: There is NO adverse reaction as of this reporting. The HPV vaccine was  given in error today.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMRV, UNK
Symptoms: Crying, Decreased appetite, Nasal congestion, Pyrexia, Rash
Clinical narrative: Patient's mother reports urgent care visit on Saturday, 9/23 due to episodes of crying, fever and rash all over the body. She is seen for follow up in our office today for continued symptoms including nasal congestion, nasal discharge, fever to 102, poor appetite and rash. Patient was started on amoxicillin by urgent care for OM in the left ear. His symptoms are improving since urgent care visit but not yet resolved.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMRV, UNK
Symptoms: Rash generalised, Rhinorrhoea
Clinical narrative: Patient's mother reports urgent care visit on Saturday, 9/23 due to episodes of crying, fever and rash all over the body. She is seen for follow up in our office today for continued symptoms including nasal congestion, nasal discharge, fever to 102, poor appetite and rash. Patient was started on amoxicillin by urgent care for OM in the left ear. His symptoms are improving since urgent care visit but not yet resolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Aggression, Muscular weakness, Pallor, Syncope
Clinical narrative: Patient was given KINRIX (5th dtap dose and 4th IPV dose in vaccine series) and PRO QUAD (2nd dose of MMR and Varicella in vaccine series). Patient had syncopal episode 5 minutes following MMRV and KINRIX vaccine administration. Patient was sitting in exam room chair and RN noticed facial pallor and extremity weakness. RN performed sternal rubs, and patient was able to voice " I need to go potty". RN transferred patient to exam table while calling for additional RN. RN auscultated breath sounds and HR with stethoscope while additional RN assisted in applying oxygen 2 L via peds mask. Patient was combative while RN attempted to place  pulse ox probe on hand, so one was placed on foot. Once probe was placed, patient's oxygen saturation was 100%. MOC reported that similar episode occurred while patient had hemoglobin testing performed at WIC office. MOC also reports patient did not eat much for lunch today. Patient requested chocolate milk to drink. After a few sips of chocolate milk patient was jumping in office excited to go get a slurpee. RN walked patient and MOC out of office. MOC reported no further concerns or questions.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: 24 hrs after MENACTRA was given area in Left arm was red, swollen and warm. Overnight blistering developed in the central portion of the red area. The blistering area is about 1 in round surrounded by tiny little satellite blistering. The red and induration area is about 4-1/2 inches round.
Age: 17.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Feeling abnormal, Headache, Pain, Pyrexia
Clinical narrative: No complaints after vaccines, played soccer after school came home and ate dinner and started feeling "horrible" after then...Per mom fever of 101 and patient c/o headache and achey all over. Called mom the following day who states patient felt fine after taking ibuprofen 9/25/2017 and was able to attend school on 9/26/2017 because he woke up feeling fine.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: Same day of vaccine, in the evening and thru the night, felt achy, chills, shaking, and felt feverish.  She did not take her temperature.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Seconds after giving the immunization the child had a stomach ache, and became very pale.  Next, he got very sweaty and experienced nausea to the point of near vomiting. This was treated with allowing the child to sit and applying a cold rag.  After about 5 minutes the child although still somewhat pale left.  I followed up with mom the next day and she reports the child is doing just fine.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Meningitis, Vaccination failure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a female patient who received MENVEO. On 7th May 2012, the patient received MENVEO. On an unknown date, unknown after receiving MENVEO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningitis were unknown. It was unknown if the reporter considered the vaccination failure and meningitis to be related to MENVEO. Additional details were provided as follows: The health care professional called in to find out the effectiveness of MENVEO. The health care professional stated the patient received the vaccine and was in the hospital at the reporting time with suspected meningitis. It was stated that there had been no lab work returned and the patient had not yet been diagnosed with meningitis. The vaccine administration facility was not known by the health care professional who reported the adverse event. This case was considered as suspected vaccination failure, since the time to onset and confirmation of sero type were unknown.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Flushing, Urticaria
Clinical narrative: Approximately 28 hours after receiving vaccine, patient flushed bright red on face, torso, extremities. Hives formed on upper back. No difficulty breathing. Taken to ER; symptoms had subsided by the time she was seen. She was given Benadryl and discharged.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Given too early at 5 months.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Patient called 9/27/2017 saying the right arm was red and inflamed. She stated yesterday she applied cold compress which seemed to reduce inflammation. Patient was counseled to seek attention from her MD to ensure there is no infection. She stated she would contact her MD.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Right arm red, warm, indurated.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Tremor, Vomiting
Clinical narrative: Patient felt lightheadedness, dizziness, vomiting, and shakes the next day after spending a few hours in the sun on a hot day. Unsure of correlation to flu shot but reporting to err on the side of caution.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient's arm turned red and painful in the area beneath where the shot was administered. The red area was several inches wide when she presented to the pharmacy.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: SWELLING AND PAIN.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Diarrhoea, Incorrect dose administered, Irritability, Pyrexia
Clinical narrative: Infant received flu vaccine 5 days ago. Dose given was 0.5mL, instead of the typical 0.25 mL dose.  Mom has noted child has been fussy, irritable, has loose stools, decreased appetite and low grade fever. No emesis. No rash. No local swelling at injection site.
Sex: M
Vaccine: MENB
Symptoms: Meningitis, Musculoskeletal stiffness, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of meningitis in a adolescent male patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, 1 day after receiving BEXSERO, the patient experienced meningitis (serious criteria hospitalization and GSK medically significant) and fever (serious criteria hospitalization). On an unknown date, the outcome of the meningitis and fever were recovered/resolved. The reporter considered the meningitis and fever to be almost certainly related to BEXSERO. Additional details were provided as follows: The office manager reported this case. The patient was high school aged. The patient's mother who was a nurse practitioner administered the vaccine. The patient had meningitis like symptoms, spiked a high fever and could not touch his chin to his chest. The patient's mother (nurse practitioner) took patient to the emergency room (ER) and hospitalized for a couple of days. At that point, the patient got better and the symptoms were resolved. It was unknown if any other vaccines were administered.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # M039202 with expiry date 11-MAR-2018 and lot # N005796 with expiry date 26-MAY-2018 (dose, route of administration and vaccination site were not reported) for prophylaxis. Administered doses of VAQTA underwent a temperature excursion between 32 Fahrenheit degrees and 35 Fahrenheit degrees for 10 days. There was no previous temperature excursion. Data Logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA013078: US-009507513-1709USA013077: US-009507513-1709USA013075: US-009507513-1709USA013076:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified amount of patients of unknown age and gender. The patients' concurrent conditions, medical history, allergies, and concomitant therapies were not reported. From 31-AUG-2017 until 21-SEP-2017, the patients were vaccinated with improperly storage doses of VARIVAX lot numbers N014369 with expiration date 09-MAY-2019 and N012487 with expiration date 20-APR-2019, for prophylaxis (strength, dosage schedule, route of administration and anatomical location were not reported). No adverse events were reported. The vaccine doses were exposed to a temperature of 15 degree Fahrenheit (°F) to 46 °F (22.5 °F) for 4 hours and 1 minute. There was a previous temperature excursion of -15 °F to 46 °F for 12 hours and 7 minutes. The data logger was involved. This is one of two reports from the same reporter.; Sender's Comments: US-009507513-1709USA013232:
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician and refers to a female patient of unknown age. The patient's concurrent conditions, medical history, allergies, and concomitant therapies were not reported. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known. On an unknown date, at four weeks of pregnancy, the patient was vaccinated with M-M-R II for prophylaxis (strength, dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported) (exposure during pregnancy). No adverse events were reported. In addition, it was reported that the patient sought an unspecified medical attention on an unknown date. At the time of reporting, the pregnancy outcome was pending.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Influenza like illness
Clinical narrative: This spontaneous report as received from a female patient of unknown age, who referred to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 21-SEP-2017, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route of administration, lot # and expiration date were not reported). On 22-SEP-2017, the patient was feeling weak, had a headache and flu like symptoms. The patient sought medical attention by calling a doctor's office. The outcome of the events and the relatedness between the events and ZOSTAVAX were not reported.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Chills, Injected limb mobility decreased, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist, who referred to a 62-year-old male patient with no pertinent medical history. The patient had no drug reactions or allergies. On 23-SEP-2017, the patient was vaccinated with ZOSTAVAX in the right arm (lot# N013274 and expiration date: 04-JUL-2018; dose and route administration were not reported) for prophylaxis, which was reconstituted with sterile diluent (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported). On the same date, the patient also received PNEUMOVAX 23 injection, intramuscularly (lot# N020502 and expiration date: 08-FEB-2019; dose was not reported) for prevention of pneumonia and FLUARIX (dose, route of administration, lot# and expiration date were not reported), both in the patient's left arm, at separate sites. The patient's concomitant medications included LIPITOR. On 24-SEP-2017, the patient began experiencing fever, chills and the inability to lift or move his left arm. On the same date, the patient began taking BENADRYL, ADVIL and started applying ice to the affected arm, as a treatment. The patient sought a medical attention by calling the pharmacist. No laboratory diagnostic studies were performed. The patient did not recover from the adverse events at the time of this report. No product quality complaint was involved. The reporter considered the event of inability to lift or move his left arm to cause the patient a significant disability, because the patient could not move his arm.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unspecified gender and age. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 21-SEP-2017, an improperly stored dose of RECOMBIVAX HB 2 ml, once, lot number N009802, expiration date 19-DEC-2019 (route of administration and anatomical location were not reported) was administered to the patient. The dose was stored in temperature 33.8 degrees Fahrenheit for 20 minutes and in temperature 35.8 degrees Fahrenheit for 2 minutes. No previous temperature excursions were reported. No adverse effects have been reported. Data logger was involved. Product quality complaint was not involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA011805: US-009507513-1709USA012898: US-009507513-1709USA012896: US-009507513-1709USA012897.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received a consumer on 15 SEP 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS TOXOID) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following vaccination, patient developed allergies include tetanus toxoid. Lab tests and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Impaired driving ability, Injected limb mobility decreased, Insomnia, Pain, Peripheral swelling
Clinical narrative: 8-16-17 Rec'd shot 10:45 AM no pain-4 PM pain onset 10/10 scale could not move R.A.-no fever, rash, little swelling. 8-17-17 Pain 24 hrs, contact MD office-cannot drive pain 10/10 use wife's TYLENOL codeine 120/12 for relief 8/10. 8-18-17 Pain 24 hrs, contact MD office, cannot drive, make appt. for 8-21-17 (Monday)-use total 75 mls TYLENOL/codeine. 8-19-17 Less pain all 24 hrs-lose sleep-more swelling, R. A. 8-20-17 Less pain all 24 hrs. 8-21-17 Visit Dr.-never seen in 50 yrs-no complaints-master vial OK. RN remarked vaccine came in pre-filled syringe.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Per Dr., pt was prescribed PENTACEL immunization, two-part vaccine not properly prepared, sterile diluent utilized instead of vaccine specific diluent. Dr., pediatrics lead, direct supervisor, and floor manager, notified of medication error. Per Dr., pt at no risk of ASE and needs to be revaccinated with PENTACEL.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Pain in jaw
Clinical narrative: Face swelling, extreme pain in jaw, muscle pain throughout, sweating/chills, headache.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling face
Clinical narrative: Face swelling, extreme pain in jaw, muscle pain throughout, sweating/chills, headache.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Per Dr., pt was prescribed PENTACEL immunization, two-part vaccine not properly prepared, sterile diluent utilized instead of vaccine specific diluent. Dr. pediatrics lead, direct supervisor, and floor manager, notified of medication error. Per Dr. at no risk of ASE and needs to be revaccinated with PENTACEL.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Per Dr., pt was prescribed PENTACEL immunization, two-part vaccine not properly prepared, sterile diluent utilized instead of vaccine specific diluent. Dr. pediatrics lead, direct supervisor, and floor manager, notified of medication error. Per Dr. pt at no risk of ASE and needs to be revaccinated with PENTACEL.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site erythema, Pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: Within 2 hours of vaccine receipt, patient noted vaccination site pain, warmth and redness. Denies axillary lymphadenopathy, fever or chills, joint pain, and upper extremity numbness and tingling. Within 24 hours of vaccine receipt, reports feeling achy and tired, with increased immunization site reaction ? redness, warmth, pain, and swelling, which involved an oblong area of approximately 6? by 4?. No self-treatment.  On 21 Sep, patient reported significant improvement of site reaction over past 24 hours. Denied dyspnea, chest pain, nasal discharge, N/V, hives/rashes, shoulder pain, and lightheadedness. No other vaccines were received that day. EXAM on 21 Sep: LUE: vaccination site placement in anterior mid-deltoid (almost in biceps). Oblong area, approximately 4? x 2? ? red, warm, tender, with minimal swelling. No induration. Full ROM of UE.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccination site warmth
Clinical narrative: Within 2 hours of vaccine receipt, patient noted vaccination site pain, warmth and redness. Denies axillary lymphadenopathy, fever or chills, joint pain, and upper extremity numbness and tingling. Within 24 hours of vaccine receipt, reports feeling achy and tired, with increased immunization site reaction ? redness, warmth, pain, and swelling, which involved an oblong area of approximately 6? by 4?. No self-treatment.  On 21 Sep, patient reported significant improvement of site reaction over past 24 hours. Denied dyspnea, chest pain, nasal discharge, N/V, hives/rashes, shoulder pain, and lightheadedness. No other vaccines were received that day. EXAM on 21 Sep: LUE: vaccination site placement in anterior mid-deltoid (almost in biceps). Oblong area, approximately 4? x 2? ? red, warm, tender, with minimal swelling. No induration. Full ROM of UE.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Pyrexia
Clinical narrative: Patient received shot on 9/26/17. He called on 9/27/2017 stating that he started feeling cold around 7 pm and he had up to 101 degree fever last night. He took some advil and went to bed. He said he felt okay today without having any fever.
Age: 18.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Urticaria chronic
Clinical narrative: Chronic urticaria that developed about 2 wks after the vaccinations, have continued.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain lower, Faecal volume decreased, Faecal volume increased, Faeces soft
Clinical narrative: 9/13/17 6:55pm - lower abdominal pain and small bowel movement. Continued abdominal pain followed by large formed bowel movement. 7:00pm- continued abdominal pain treated with baking soda and water.  7:40pm - large formed bowel movement and continued abdominal pain.  8:25pm - very large soft bowel movement. 8:45pm very soft/not watery large bowel movement and resolved pain.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: PT CAME IN 6 DAYS AFTER HIS VACCINATION WITH A PRESCRIPTION WRITTEN FOR AN ANTIBIOTIC AND PREDNISONE.  HIS ARM WAS VERY RED AND SWOLLEN WHERE HE RECEIVED THE VACCINATION.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: At injection site on left arm it became red, warm and tender.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Skin warm, Swelling, Tenderness
Clinical narrative: 4 cm raised rash, warm and tender to touch, with localized swelling.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Syncope after vaccination.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Haemorrhage
Clinical narrative: Patient reported having redness and bruising post vaccination. Also mentioned bleeding when vaccine was given.
Age: 102.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Malaise, Vomiting
Clinical narrative: The vaccine was administered on 09-21-2017. On 09-22-2017 the patient became ill; experiencing diarrhea and vomiting. Her caregiver came to the retail pharmacy, and picked up EMETROL and IMODIUM over the counter; symptoms persisted. The evening of 09-22-2017 the patient went to an urgent care facility; it was determined she was dehydrated and was sent to the hospital. She was admitted to the ER, and was treated with IV fluids and ZOFRAN. She was released from the ER the same evening, 09-22-2017. The patient has been well since her release from the ER.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Amino acid level, Antibody test, Antinuclear antibody, Asthenia, Biopsy skin abnormal
Clinical narrative: Five days following the flu vaccine, I began to experience numbness, tingling, and burning in my Arms and hands. I had difficulty with dexterity and fine motor coordination. It then spread to my feet and legs, I had the sensation of weakness and difficulty with gait. I initially went to my primary care physician who referred me to a neurologist. The neurologist performed nerve conduction studies, ordered MRI, and did bloodwork. All were negative but my symptoms continued to progress. I got 2 more neurology opinions and more testing and was told I had neuropathy likely from the flu shot but I was given no definite diagnosis. After living with these horrible symptoms for 3 years, I sought the opinion of another neurologist who performed a skin biopsy and diagnosed me with small fiber neuropathy caused by the flu vaccine.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood copper, Blood creatinine, Blood lead, Blood mercury, Blood test normal
Clinical narrative: Five days following the flu vaccine, I began to experience numbness, tingling, and burning in my Arms and hands. I had difficulty with dexterity and fine motor coordination. It then spread to my feet and legs, I had the sensation of weakness and difficulty with gait. I initially went to my primary care physician who referred me to a neurologist. The neurologist performed nerve conduction studies, ordered MRI, and did bloodwork. All were negative but my symptoms continued to progress. I got 2 more neurology opinions and more testing and was told I had neuropathy likely from the flu shot but I was given no definite diagnosis. After living with these horrible symptoms for 3 years, I sought the opinion of another neurologist who performed a skin biopsy and diagnosed me with small fiber neuropathy caused by the flu vaccine.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood thyroid stimulating hormone, Blood urea, Burning sensation, Electromyogram, Fine motor skill dysfunction
Clinical narrative: Five days following the flu vaccine, I began to experience numbness, tingling, and burning in my Arms and hands. I had difficulty with dexterity and fine motor coordination. It then spread to my feet and legs, I had the sensation of weakness and difficulty with gait. I initially went to my primary care physician who referred me to a neurologist. The neurologist performed nerve conduction studies, ordered MRI, and did bloodwork. All were negative but my symptoms continued to progress. I got 2 more neurology opinions and more testing and was told I had neuropathy likely from the flu shot but I was given no definite diagnosis. After living with these horrible symptoms for 3 years, I sought the opinion of another neurologist who performed a skin biopsy and diagnosed me with small fiber neuropathy caused by the flu vaccine.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Full blood count, Gait disturbance, Glycosylated haemoglobin, Hypoaesthesia, Immunoglobulins
Clinical narrative: Five days following the flu vaccine, I began to experience numbness, tingling, and burning in my Arms and hands. I had difficulty with dexterity and fine motor coordination. It then spread to my feet and legs, I had the sensation of weakness and difficulty with gait. I initially went to my primary care physician who referred me to a neurologist. The neurologist performed nerve conduction studies, ordered MRI, and did bloodwork. All were negative but my symptoms continued to progress. I got 2 more neurology opinions and more testing and was told I had neuropathy likely from the flu shot but I was given no definite diagnosis. After living with these horrible symptoms for 3 years, I sought the opinion of another neurologist who performed a skin biopsy and diagnosed me with small fiber neuropathy caused by the flu vaccine.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Nerve conduction studies normal, Neuropathy peripheral, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging normal, Nuclear magnetic resonance imaging spinal
Clinical narrative: Five days following the flu vaccine, I began to experience numbness, tingling, and burning in my Arms and hands. I had difficulty with dexterity and fine motor coordination. It then spread to my feet and legs, I had the sensation of weakness and difficulty with gait. I initially went to my primary care physician who referred me to a neurologist. The neurologist performed nerve conduction studies, ordered MRI, and did bloodwork. All were negative but my symptoms continued to progress. I got 2 more neurology opinions and more testing and was told I had neuropathy likely from the flu shot but I was given no definite diagnosis. After living with these horrible symptoms for 3 years, I sought the opinion of another neurologist who performed a skin biopsy and diagnosed me with small fiber neuropathy caused by the flu vaccine.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Nuclear magnetic resonance imaging thoracic, Paraesthesia, Small fibre neuropathy, Toxicologic test, Vaccination complication
Clinical narrative: Five days following the flu vaccine, I began to experience numbness, tingling, and burning in my Arms and hands. I had difficulty with dexterity and fine motor coordination. It then spread to my feet and legs, I had the sensation of weakness and difficulty with gait. I initially went to my primary care physician who referred me to a neurologist. The neurologist performed nerve conduction studies, ordered MRI, and did bloodwork. All were negative but my symptoms continued to progress. I got 2 more neurology opinions and more testing and was told I had neuropathy likely from the flu shot but I was given no definite diagnosis. After living with these horrible symptoms for 3 years, I sought the opinion of another neurologist who performed a skin biopsy and diagnosed me with small fiber neuropathy caused by the flu vaccine.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: Hip pain and swelling fingers.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Influenza vaccine Quadrivalent unspecified season.  The patient's past medical history included low blood pressure. Concurrent medical conditions included tetanus. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. When the patient received Influenza vaccine, she always experienced flu. As a result she no longer received the Influenza vaccine. This case has been considered as a suspected vaccination failure case since the confirmation of lab test and the time to event onset for influenza was unknown at the time of reporting. This case has been linked with case US2017GSK146824 (same patient).
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: I don't remember all the specifics, and patient's complaints were restated by another pharmacist, but the patient came in for a flu shot. She questioned the shot location being too high and towards her back, but I reassured her that I needed access to her deltoid muscle, which is higher up on her shoulder, and I placed the shot slightly off center (1/2 inch maximum from dead center) of her deltoid. The patient later complained the following day about radiating pain from her shoulder towards her arm and neck. A couple weeks later on 9/27/17, the patient still complained of lingering pain but concentrated primarily in her shoulder.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Injection site erythema, Limb discomfort
Clinical narrative: Patient called 9/27 to report she started experiencing redness of injection site which then radiated down her arm and into her chest area. She reported feeling a numbness and heaviness of her arm.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Considerable redness and pain at and surrounding the injection site... approximately 5 inches in diameter.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner, and refers to an unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were administered an unspecified number of improperly stored doses of PNEUMOVAX 23, lot number M035104, expiration date 06-MAY-2018, for prophylaxis (routes of administration were not provided). On unknown dates, the doses of PNEUMOVAX 23 underwent temperature excursions of 47 degrees Fahrenheit (°F) to 77°F for a time frame of 12 hours and 47°F to 77°F for 9 hours, which were detected by the data logger. No adverse effects were reported. This is one of two cases received from the same reporter. Sender's Comments: US-009507513-1709USA009358.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally, lot # M040268 and expiration date on 14-MAY-2018, (dose was not reported) for prophylaxis. The reporter stated that the vaccines were reconstituted with improperly stored sterile diluent (MRK) lot # L046300 and expiration date on 17-JUN-2018, lot # L006552 and expiration date on 12-NOV-2017 and with lot # M034911, expiration date on 05-MAY-2019. It was unspecified which vaccines were reconstituted with improperly stored diluents. The doses of ROTATEQ and the sterile diluent (MRK) were exposed to a temperature excursion of 0 degrees Celsius (°C) to 1 °C during a time frame of 53 minutes, which was detected by the data logger. Previous temperature excursion was reported as 9°C to 25°C for 5 hours 58 minutes and 0°C to 1°C for 11 hours 28 minutes. No adverse events were reported and no product quality complaint were present.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 21 year old non pregnant female patient. The patient did not have concurrent conditions, medical history, historical drugs or concomitant medication. On 19-JAN-2012, the patient was vaccinated with GARDASIL first and only dose (dose, route, lot number and expiration date were not reported) for prophylaxis. In September 2017, the patient had a "positive pap smear for HPV". The outcome of human papilloma virus test positive was reported as recovering/resolving. The causal relationship between the event and GARDASIL was not reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses (about 4-5 doses) of PNEUMOVAX 23 lot # N011867, expiry date 08-NOV-2018 (dose, route of administration were not reported) for prophylaxis. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77°F for 10 hours (h) and from 32°F to 35°F for 12 h. No previous temperature excursions were detected. Digital data logger was not involved. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who referred to an unspecified patient of unknown demographics. No information regarding the patient's pertinent medical history, concurrent conditions and drug reactions or allergies was provided. On 25-SEP-2017, the patient was vaccinated with one dose of improperly stored PNEUMOVAX23 lot # N014188 with expiration date: 22-JAN-2019 (route not reported) as prophylaxis. It was reported that the vaccine was stored in temperature between 47 degrees Fahrenheit (F) to 77F to 72 hours. No previous temperature excursions were reported. The temperature excursion was detected by a data logger. No adverse events were reported. No product quality complaint was involved.
Age: 80.0
Sex: F
Vaccine: TYP
Symptoms: Asthenia, Dizziness, Fatigue, Laboratory test, Nausea
Clinical narrative: Initial unsolicited case received from a nurse on 15 Sep 2017. This case involves 80-year-old female patient who was vaccinated with 0.5 ml dose of TYPHIM VI (Batch number, expiry date, dose in series and site of administration were not reported) via intramuscular route on 06 Sep 2017. The patient medical history was reported as Patient had bulging disc in the neck, which apparently patient had before getting vaccine and saw a chiropractor in the past for treatment. Concomitant medications were not reported. On 06 Sep 2017, same day after the vaccination, the patient developed nausea, but no fever. On 07 Sep 2017, one day after the vaccination, the patient developed neck pain her pain worsened 2 days later on 08 Sep 2017 and after patient had chiropractor. On 09 Sep 2017 three days after the vaccination, the patient went to ER (emergency room) and had IV with normal saline and TORADOL and felt better and then ER staff gave her VALIUM and VICODIN then patient threw up, felt dizziness, weak and lightheaded. On 15 Sep 2017, the patient daughter called to the clinic and explained all the above actions, and stated that she is still in pain and feels very weak, fatigued and lightheaded. She has been eating and drinking fluids, and advised patient to go to primary care physician or ER to have her condition worked up. On 16 Sep 2017, the patient again went to ER and admitted in the hospital and lab tests were drawn from the patient and MRI of neck and brain scan done and the patient was also given IVs/narcotic drugs that made her ill. The patient other relevant lab tests and other corrective treatment was not reported. The outcome of the events were reported as unknown. List of documents held by sender: none. Sender's Comments: Patient experienced Neck pain, vomiting and felt lightheaded, weak, nauseatic after vaccination. Reporter also mentions that the patient had bulging disc in the neck before vaccination and visited chiropractor in the past .Therefore, additional information regarding patient medical history, infectious history, vaccination history, immune status at the time of vaccination, concomitant medication and investigation results to rule out the alternative causes are needed for complete assessment of the case. Based on available information the role of vaccine can not be assessed.
Age: 80.0
Sex: F
Vaccine: TYP
Symptoms: Neck pain, Nuclear magnetic resonance imaging spinal, Scan brain, Vomiting
Clinical narrative: Initial unsolicited case received from a nurse on 15 Sep 2017. This case involves 80-year-old female patient who was vaccinated with 0.5 ml dose of TYPHIM VI (Batch number, expiry date, dose in series and site of administration were not reported) via intramuscular route on 06 Sep 2017. The patient medical history was reported as Patient had bulging disc in the neck, which apparently patient had before getting vaccine and saw a chiropractor in the past for treatment. Concomitant medications were not reported. On 06 Sep 2017, same day after the vaccination, the patient developed nausea, but no fever. On 07 Sep 2017, one day after the vaccination, the patient developed neck pain her pain worsened 2 days later on 08 Sep 2017 and after patient had chiropractor. On 09 Sep 2017 three days after the vaccination, the patient went to ER (emergency room) and had IV with normal saline and TORADOL and felt better and then ER staff gave her VALIUM and VICODIN then patient threw up, felt dizziness, weak and lightheaded. On 15 Sep 2017, the patient daughter called to the clinic and explained all the above actions, and stated that she is still in pain and feels very weak, fatigued and lightheaded. She has been eating and drinking fluids, and advised patient to go to primary care physician or ER to have her condition worked up. On 16 Sep 2017, the patient again went to ER and admitted in the hospital and lab tests were drawn from the patient and MRI of neck and brain scan done and the patient was also given IVs/narcotic drugs that made her ill. The patient other relevant lab tests and other corrective treatment was not reported. The outcome of the events were reported as unknown. List of documents held by sender: none. Sender's Comments: Patient experienced Neck pain, vomiting and felt lightheaded, weak, nauseatic after vaccination. Reporter also mentions that the patient had bulging disc in the neck before vaccination and visited chiropractor in the past .Therefore, additional information regarding patient medical history, infectious history, vaccination history, immune status at the time of vaccination, concomitant medication and investigation results to rule out the alternative causes are needed for complete assessment of the case. Based on available information the role of vaccine can not be assessed.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Aphonia, Cough, Dyspnoea, Malaise, Nasopharyngitis
Clinical narrative: Preface: My daughter rarely gets sick. 10 days after the shot she was feeling unwell and had a fever of 102.8. We gave her ibuprofen as we were about to get on a flight. She threw up that night and continued to have a high fever for several days, with vomiting. She developed a croupy cough that caused her severe distress. At our destination a doctor prescribed Zofran and dexamethasone (since she had taken these once before) in addition to the ibuprofen. She was in more distress from this illness than I have ever seen her in, probably because her throat was so swollen and she had trouble breathing and would panic from not being able to breathe. She was extremely clingy and acutely sick with fever and respiratory distress for at least five days.  She lost her voice as part of the illness.  Milder symptoms lingered for several days after. As she was beginning to get better, she acquired a cold from her brother, who was teething (2 year molar). My son (who is usually much more likely to catch things, and always catches what she has) did not get the severe illness.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Panic reaction, Pharyngeal oedema, Pyrexia, Respiratory distress, Vomiting
Clinical narrative: Preface: My daughter rarely gets sick. 10 days after the shot she was feeling unwell and had a fever of 102.8. We gave her ibuprofen as we were about to get on a flight. She threw up that night and continued to have a high fever for several days, with vomiting. She developed a croupy cough that caused her severe distress. At our destination a doctor prescribed Zofran and dexamethasone (since she had taken these once before) in addition to the ibuprofen. She was in more distress from this illness than I have ever seen her in, probably because her throat was so swollen and she had trouble breathing and would panic from not being able to breathe. She was extremely clingy and acutely sick with fever and respiratory distress for at least five days.  She lost her voice as part of the illness.  Milder symptoms lingered for several days after. As she was beginning to get better, she acquired a cold from her brother, who was teething (2 year molar). My son (who is usually much more likely to catch things, and always catches what she has) did not get the severe illness.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Product preparation error
Clinical narrative: Patient was given HIB vaccine that was diluted with sterile diluent instead of the diluent that the powder is supposed to be reconstituted with. Patient did not have any reaction or require treatment. Patient will have to get revaccinated with another dose of HIB.
Age: 63.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: On 9/10/2017 starting feeling sick to stomach with diarrhea, with no fever, and headache which lasted til 09/21/2017.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Decreased appetite, Pyrexia, Rash, Rash erythematous
Clinical narrative: 9/24- began with fever of 101.8. 9/25- fever continued after alternating Tylenol and Motrin every 4 hours. Inconsolable crying. Decreased appetite. 9/26- saw pediatrician, told it was a virus. Fever continued, even with Tylenol and Motrin given. Still inconsolable. Appetite almost nonexistent. Only 7oz of similac go and grow all day. Refusing any and everything else by mouth. Around 730pm, pinkish/light red rash began on face. Called pediatrician, advised was most likely a virus again. Given option of taking her to the ER or bringing her to the office in the AM. Fever has been consistently between 101.4-101.8 (rectal temperature). 9/27- rash worse on face but as day went on slowly less noticeable but more visible on chest, abdomen, and back, with rash starting to appear on upper extremities as well.