chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: FLU3, FLUN4, HPV4
Symptoms: Anaemia, Dizziness, Epistaxis, Haematemesis, Poor quality sleep
Clinical narrative: A report has been received from a Pharmacist concerning a 13 years old, female patient. Concomitant medications included influenza virus vaccine polyvalent (lot number UI1506AB), and quadrivalent human papilloma virus vaccine (L045700) and human papilloma virus vaccine. The patient's concurrent diseases included constipation, fatigue, heterozygous thalassemia and leg pain. On 14-Jun-2016, patient had received nasal FLUMIST Quadrivalent (intranasal), 0.5 DF (0.2 mL). Patient received FLUMIST 1/2 dose (not sure if it was expired) after this they got the Fluzone and HVP (first dose), 2 days later nose bleed, 4 days later hematemesis and, 12 days later dizziness and had poor sleeping habits and anemia on 15-Jun-2016. The patient recovered from the events hematemesis, nose bleed, dizziness, patient received 1/2 dose of FLUMIST, anemia, poor sleeping habits and perhaps expired med on an unspecified date. Company physician assessed hematemesis and nose bleed, to be serious with the seriousness criteria of important medical event and rest of the events to be non-serious. AZ physician suggested to capture additional non-serious event patient received 1/2 dose of FLUMIST and perhaps expired med from the source narrative. Summary of follow-up information received by AstraZeneca/MedImmune on 05-Jul-2016 from pharmacist via spontaneous source: Event seriousness of the event nose bleed was updated to serious with the seriousness criteria of important medical event. New non-serious events anemia, poor sleeping habits and perhaps expired med were added. Outcome and event onset date of the events hematemesis, dizziness, nose bleed and patient received 1/2 dose of FLUMIST were updated. Concomitant diseases were updated. Patient demographics updated. Narrative amended. Sender's Comments: Haematemesis is not listed in the company core sheet of the FLUMIST. There is limited information on medical history (immunization), trauma, congenital anomaly, etiological, clinical and diagnostic work up (esophagogastroduodenoscopy) which makes causal assessment difficult.
Age: 14.0
Sex: F
Vaccine: FLU3, FLUN4, HPV4
Symptoms: Underdose
Clinical narrative: A report has been received from a Pharmacist concerning a 13 years old, female patient. Concomitant medications included influenza virus vaccine polyvalent (lot number UI1506AB), and quadrivalent human papilloma virus vaccine (L045700) and human papilloma virus vaccine. The patient's concurrent diseases included constipation, fatigue, heterozygous thalassemia and leg pain. On 14-Jun-2016, patient had received nasal FLUMIST Quadrivalent (intranasal), 0.5 DF (0.2 mL). Patient received FLUMIST 1/2 dose (not sure if it was expired) after this they got the Fluzone and HVP (first dose), 2 days later nose bleed, 4 days later hematemesis and, 12 days later dizziness and had poor sleeping habits and anemia on 15-Jun-2016. The patient recovered from the events hematemesis, nose bleed, dizziness, patient received 1/2 dose of FLUMIST, anemia, poor sleeping habits and perhaps expired med on an unspecified date. Company physician assessed hematemesis and nose bleed, to be serious with the seriousness criteria of important medical event and rest of the events to be non-serious. AZ physician suggested to capture additional non-serious event patient received 1/2 dose of FLUMIST and perhaps expired med from the source narrative. Summary of follow-up information received by AstraZeneca/MedImmune on 05-Jul-2016 from pharmacist via spontaneous source: Event seriousness of the event nose bleed was updated to serious with the seriousness criteria of important medical event. New non-serious events anemia, poor sleeping habits and perhaps expired med were added. Outcome and event onset date of the events hematemesis, dizziness, nose bleed and patient received 1/2 dose of FLUMIST were updated. Concomitant diseases were updated. Patient demographics updated. Narrative amended. Sender's Comments: Haematemesis is not listed in the company core sheet of the FLUMIST. There is limited information on medical history (immunization), trauma, congenital anomaly, etiological, clinical and diagnostic work up (esophagogastroduodenoscopy) which makes causal assessment difficult.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity, Pruritus, Rash
Clinical narrative: PT REPORTS HER ARM BECAME SORE AND PAINFUL THE EVENING OF 7/8/16. SHE CALLED A NURSE WHO TOLD HER THIS WAS NORMAL AND COULD TAKE 7 DAYS TO RESOLVE. THE ARM REMAINED VERY PAINFUL, ITCHY, DIFFICULT TO USE ARM AND DEVELOPED A LARGE RASH 5" X 4" THAT WAS VERY SWOLLEN. PT USED IBUPROFEN AND ICE TO SITE AND WAS RX'D ABX BY PCP AFTER 7/15 APPOINTMENT. PT REPORTS IMPROVEMENT TO SITE 7 - 10 DAYS AFTER THE INJECTION.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Dizziness, Dyspnoea, Electrocardiogram, Heart rate increased
Clinical narrative: Fast heart beat, dizziness, breathing trouble.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: X-ray
Clinical narrative: Fast heart beat, dizziness, breathing trouble.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Pt felt dizzy 15 minutes after vaccine administered. Pt instructed to lie down. VS obtained. VSS. Pt given water and ammonia inhalant. Pt dizziness resolved.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Headache, Pyrexia, Syncope
Clinical narrative: Fainted within 5 minutes of vaccine injection.  Low grade fever and headache for 24 hours following.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 104 less than 12 hours after administration. Tylenol given.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red patch of bumps high on left leg. Mom considered bug bites, but twin sister has same rash. Had shots 6 days ago.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: The patient received the PREVNAR 13 vaccination on 6/20/16. He called the clinic on 6/28/16 to inquire about another health issue, but also reported at that time that since the vaccination, he had experienced high fever, chills, and body/joint aches for 4 days, but that he was currently feeling better at that time. Arthralgia and fever.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Myalgia, Pyrexia, Shift to the left, Vomiting
Clinical narrative: 48 hours after vaccine-developed severe headache/muscle aches and fever and vomiting.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: White blood cell count increased
Clinical narrative: 48 hours after vaccine-developed severe headache/muscle aches and fever and vomiting.
Age: 17.0
Sex: M
Vaccine: MENB, MENB, MNQ
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 17-year-old male patient who received BEXSERO (batch number 151401, expiry date December 2016). Concomitant products included MENACTRA. On 6th JULY 2016, the patient received BEXSERO .5 ml in JULY 2016, 1 day 6 hrs after receiving BEXSERO, the patient experienced fever, light headedness and nausea. The patient was treated with ADVIL. On an unknown date, the outcome of the fever, light headedness and nausea were unknown. It was unknown if the reporter considered the fever, light headedness and nausea to be related to BEXSERO. Additional details were provided as follows: The case was previously reported to the manufacturer. The reporter stated that, 30-33 hours after receiving BEXSERO at 1:30 in left deltoid the patient experienced nausea, fever (104 degree F) and light headedness. On 7th JULY 2016, the patient received MENACTRA (non-GSK) for the first time.
Age: 17.0
Sex: M
Vaccine: MENB, MENB, MNQ
Symptoms: Pyrexia, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 17-year-old male patient who received BEXSERO (batch number 151401, expiry date December 2016). Concomitant products included MENACTRA. On 6th JULY 2016, the patient received BEXSERO .5 ml in JULY 2016, 1 day 6 hrs after receiving BEXSERO, the patient experienced fever, light headedness and nausea. The patient was treated with ADVIL. On an unknown date, the outcome of the fever, light headedness and nausea were unknown. It was unknown if the reporter considered the fever, light headedness and nausea to be related to BEXSERO. Additional details were provided as follows: The case was previously reported to the manufacturer. The reporter stated that, 30-33 hours after receiving BEXSERO at 1:30 in left deltoid the patient experienced nausea, fever (104 degree F) and light headedness. On 7th JULY 2016, the patient received MENACTRA (non-GSK) for the first time.
Age: 58.0
Sex: F
Vaccine: SSEV, PNC13
Symptoms: Confusional state, Cough, Dizziness, Erythema, Headache
Clinical narrative: Severe swelling at shot site (arm), redness, itching, headache, soreness, coughing, dizziness, pain, confusion, inability to lift arm.
Age: 58.0
Sex: F
Vaccine: SSEV, PNC13
Symptoms: Injection site swelling, Mobility decreased, Pain, Pruritus
Clinical narrative: Severe swelling at shot site (arm), redness, itching, headache, soreness, coughing, dizziness, pain, confusion, inability to lift arm.
Age: 58.0
Sex: F
Vaccine: SSEV, PNC13
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Severe swelling at shot site (arm), redness, itching, headache, soreness, coughing, dizziness, pain, confusion, inability to lift arm.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Injection site pruritus, Rash, Rash erythematous
Clinical narrative: HAS HALF AN INCH, CLUSTER OF RED, RAISED RASHES ON THE NECK, STOMACH, AND BACK. ITCHING AND PAIN ON THE INJECTION SITES, LEFT AND RIGHT DELTOID.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Blood test abnormal, Pancreatic disorder, Type 1 diabetes mellitus
Clinical narrative: Patient displayed symptoms of Type 1 diabetes for several weeks before we investigated.  He was diagnosed with Type 1 diabetes on March 21, 2016.  Bloodwork revealed patient's pancreas began to decline 6 months prior to diagnosis.  The vaccine was administered nearly 6 months to the day before diabetes was diagnosed.
Age: 0.3
Sex: F
Vaccine: DTAP, RV5
Symptoms: Abdominal pain, Blood culture, Blood test, Body temperature increased, Crying
Clinical narrative: Spiked temp of 101.4, gave TYLENOL. 7am next morning vomiting everything she ate, screaming and crying non-stop, arching back, bringing legs up to chest.
Age: 0.3
Sex: F
Vaccine: DTAP, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Occult blood positive, Opisthotonus
Clinical narrative: Spiked temp of 101.4, gave TYLENOL. 7am next morning vomiting everything she ate, screaming and crying non-stop, arching back, bringing legs up to chest.
Age: 0.3
Sex: F
Vaccine: DTAP, RV5
Symptoms: Screaming, Ultrasound abdomen abnormal, Urinary tract infection, Urine analysis abnormal, Vomiting
Clinical narrative: Spiked temp of 101.4, gave TYLENOL. 7am next morning vomiting everything she ate, screaming and crying non-stop, arching back, bringing legs up to chest.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Patient came in on 7/20/16, he reported that he experienced adverse reactions to ZOSTAVAX vaccine that was given to him on 7/10/16. He reported of skin redness, tender to touch, and also itchiness after one day of injection. Patient reported that the size of skin redness was about the size of his fist. It also raised/swollen about 1/4 inch. Patient did not seek medical help or reported to pharmacy during the duration of adverse event. All the symptoms have resolved on the day of reporting (7/20/16) AM, except, patient still experience itchiness. The site of injection is still slight pinkish. Pharmacist recommended patient to take BENADRYL as needed for itchiness according to label recommendation for OTC product. Also reported to patient's primary care physician.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Patient came in on 7/20/16, he reported that he experienced adverse reactions to ZOSTAVAX vaccine that was given to him on 7/10/16. He reported of skin redness, tender to touch, and also itchiness after one day of injection. Patient reported that the size of skin redness was about the size of his fist. It also raised/swollen about 1/4 inch. Patient did not seek medical help or reported to pharmacy during the duration of adverse event. All the symptoms have resolved on the day of reporting (7/20/16) AM, except, patient still experience itchiness. The site of injection is still slight pinkish. Pharmacist recommended patient to take BENADRYL as needed for itchiness according to label recommendation for OTC product. Also reported to patient's primary care physician.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large, red, swollen area at injection site. Warm to the touch. Patient has been scratching at area.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned to the pharmacy on 7/20 with a red, swollen, warm spot on the back of her arm that appeared shortly after the immunization was given. The patient reports that on 7/19/16, it was the size of a quarter, and it was expanding in size. On 7/20/16 at 1:00 PM when she was seen at the pharmacy, the spot was about 4 inches in diameter, was very slightly raised, red, and the patient reported that it was still warm. Patient was referred to the doctor to determine if it was infected, or if it was an immune reaction, such as arthus.
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh swollen red.
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: Injection site swelling, Muscle twitching
Clinical narrative: Twitch in elbow of some arm. Some swelling in shot area. Counseled to take anti-inflammatory measures and see doctor.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Injury, Syncope
Clinical narrative: Patient fainted and hit door/wall attempting to stand. She mentioned having prior history. Pharmacy made her sit down for 10-15 mins and offered icepack/aid which she declined.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Discomfort, Irritability
Clinical narrative: Fussy 18h after vaccine - 5d (so far); intermittent; uncomfortable and not truly high pitched.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Vomiting
Clinical narrative: Headache, vomiting x1 upon waking, resolved by mid morning. Symptoms gone by 10:30 am.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: Erythema to injection sites.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Approx 24 hrs after vaccination, (L) arm became red, swollen, hard and tender to touch. Approx. 3-4 inches in diameter around site of injection. Pt took BENADRYL to help him sleep. It was not itchy. Begin to resolve over next 24-48 hrs.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 2 PREVNAR vaccines. The first administered on 02/16/15 and 2nd on 4/15/16. No adverse events reported per patient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site ulcer, Injection site vesicles
Clinical narrative: At location of injection (rt arm) fluid filled 'bubble' formed and broke open on day of injection followed by redness surrounding ulcerated area. Applied topical OTC antibiotic, presently less red and drying ulcer.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Mobility decreased, Muscle spasms, Pain in extremity, Pneumonia
Clinical narrative: Patient received # 2 Hep B shot on 7/7/16. Arm (L) became sore on first day and very sore on 2nd day. When she received shot # 1 (on 5/26/16) her arm also was sore. The night of day two she felt aching in her legs-cramps-unable to straighten legs. Became increasingly fatigued. Began to feel better after 3 days. On 7/12/16 she was diagnosed with pneumonia. Does have a documented sensitivity to Hep A vaccine.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: MCV4 given before recommended date.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had redness and swelling to right thigh on side. Patient was give diphenhydramine HCl 12.5 mg/5ml, to take 5 to 7 ml PO every 6-8 hrs PRN for itching. Mother states that day vaccine given patient was itching on injection site, patient scratched and then developed the redness and swelling.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Sore arm.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Fall, Syncope, Tremor
Clinical narrative: Patient received the meningococcal vaccine and was discharged from clinic. Within one minute after leaving room patient bump her on the wall and fell. Started to shake had her lay on her side about 5 minutes and then transferred her back to the room. Where she was kept in observation for 15 minutes. First fainting spell after vaccine.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea
Clinical narrative: Patient felt nauseous. Patient instructed to lie down for 30 mins. Patient felt better and sent home with mother.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fatigue
Clinical narrative: Patient felt very tired after the vaccine. Patient instructed to lie down for 30 mins. Patient felt better and sent home with mom.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Hepatitis B antibody negative, Therapy non-responder, Underdose
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 25-year-old female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine, Hepatitis B vaccine and ENGERIX B pediatric (batch number 392RL, expiry date 21st August 2017). Concomitant products included ENGERIX B adult and ENGERIX B adult. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine and the 3rd dose of ENGERIX B pediatric .5 ml. On an unknown date, an unknown time after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine and not applicable after receiving ENGERIX B pediatric, the patient experienced therapy non-responder, underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the therapy non-responder, underdose and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: The patient had reportedly been vaccinated before (unsure of which Hepatitis vaccine they used for the first series), but did not have adequate titers leading the patient to be a therapy non-responder. Therefore, the patient started 2nd series with ENGERIX B adult and received a pediatric dose of ENGERIX B as her 3rd dose in the series (this was really 6th hepatitis B vaccination). This led to an underdose and an inappropriate age at vaccine administration.
Age: 30.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Erythema, Hypersensitivity, Loss of consciousness
Clinical narrative: After administering the vaccine, patient lost consciouness and turned red. Since it felt like an allergic reaction, administered Epipen and the patient regained conciousness in a few minutes. Paramdeics came and check and the vitals was normal. There is a possibilty the patient had panic attack.
Age: 0.5
Sex: F
Vaccine: DTAP, DTAPHEPBIP, PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient was given an extra Dtap which consisted of the Dtap and the Pediarix.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Loss of consciousness, Posture abnormal, Syncope
Clinical narrative: Patient fainted right after administering the vaccine. She was slumped on the chair for 10 seconds and I tried talking to her. She quickly regained consciousness and told her to stay in the clinic for at least 30 minutes for observation. Meanwhile, I have her water for hydration. The patient came with a friend and there was no further incident before she left the clinic.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Injection site reaction, Rash pruritic
Clinical narrative: Patient woke up with numerous "itchy bumps" on her left arm at the site of the meningitis vaccination. This rash was very bothersome, taking 1 Benadryl pill did nothing. Patient was also dizzy. The doctor's office staff told us to "just go to the ER". The ER would not have her history or record of her shoot, or the manufacture used. I repeatedly asked to bring patient in the office, since she was feeling some what better or at least get doctor's advise. Finally the receptionist agreed to have a doctor call me back, who then said "to take Benadryl and if patient got worse or became short of breath, to then go to the ER." We are waiting to see if she gets better. The doctor office seemed to not care about seeing her reaction site or reporting it, so I am now. If you would like to follow up with me, please do. Since "itchy bumpy rash" is not a side effect on your website.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: Chills, lower back pain, dizziness, general fatigue, nausea.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Cold sweat, Loss of consciousness, Nausea, Pallor, Seizure
Clinical narrative: Patient became faint, paleness to face, cold sweat, convulsing. Nausea after gaining consciousness.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Syncope
Clinical narrative: Patient became faint, paleness to face, cold sweat, convulsing. Nausea after gaining consciousness.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cyanosis, Respiratory arrest
Clinical narrative: Patient was turning blue and stop breathing.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, PNC13, RV5
Symptoms: Abnormal faeces, Constipation, Diarrhoea, Faeces discoloured, Haematochezia
Clinical narrative: Started with constipation followed by an explosive bowel movement, then he started having diarrhea on daily basis, 10+ Diapers a day, dark green mucousy stool with a strong chemical smell. After a week of this I called the Ped's office because according to side effects diarrhea is common, so Ped asked to bring him in. I brought my son in and they tested the diaper and it has blood in it. Doctor suggested MYLANTA to regulate the acidity and acknowledge it was the vaccine. 3 weeks later from the vaccine, we are still having diarrheas green mucousy stool with blood in it.
Age: 0.17
Sex: M
Vaccine: DTAPIPV, HEP, HIBV, PNC13, RV5
Symptoms: Mucous stools, Occult blood positive
Clinical narrative: Started with constipation followed by an explosive bowel movement, then he started having diarrhea on daily basis, 10+ Diapers a day, dark green mucousy stool with a strong chemical smell. After a week of this I called the Ped's office because according to side effects diarrhea is common, so Ped asked to bring him in. I brought my son in and they tested the diaper and it has blood in it. Doctor suggested MYLANTA to regulate the acidity and acknowledge it was the vaccine. 3 weeks later from the vaccine, we are still having diarrheas green mucousy stool with blood in it.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain, Screaming
Clinical narrative: Patient reports limited mobility in arm, not being able to lift arms above shoulders. Patient reports pain so intense that "it makes her scream."
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Patient felt lightheaded and out of it for about 10 minutes.  Was able to answer questions properly the entire time.  Patient did not fall or pass out.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Ear pain, Rash
Clinical narrative: Pain behind both ears for 12 Days. Rash on both ears (Pinna of the ear) for 12 Days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blister, Erythema, Oedema peripheral
Clinical narrative: EDEMA AND ERYTHEMA IN THE LT ARM; 1.5 CM BULLA ALONG THE OUTSIDE EDGE OF THE AREA OF EDEMA AND ERYTHEMA TOWARDS THE EDGE OF WHERE THE BAND AIDE WAS.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: Patient receive Hepatitis A Vaccine Adult IM, then she started complaining of pain and numbness at injection site. Patient was able to move both arm above her head, flex and extend both arm, hand grip was strong in bilateral hands. Patient deny numbness or tingling in hand or finger. No redness or swelling noted at injection sited. Ice pack was applied and patient was encouraged to take Ibuprofen or Tylenol for pain and apply ice at home.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Abdominal pain upper, Paraesthesia, Paraesthesia oral
Clinical narrative: EMPLOYEE REPORTED UPSET STOMACH WITH CRAMPING AND TINGLING OF FINGERS AND ROUND LIPS.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Severe swelling of arm from shoulder to elbow. Redness and itching.  Given prescription of Prednisone at an urgent care facility.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around the injection site.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Pt had episode of syncope lasting 3-4 seconds after administration of vaccines. No seizure or respiratory distress observed. Pt rested on the exam table and was given coke to drink. He reported to be doing well after 15 minutes.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Pneumonia
Clinical narrative: Pt had pneumonia 4/1/16 and was given PNEUMOVAX 6/8/16 but within a month diagnosed another pneumonia which the ER blamed on the vaccine.
Age: 33.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling and induration after 48 hrs following the vaccine, warmth area, itch. Pt went to ED she is taking KEFLEX.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Hyperhidrosis, Injection site pain, Lethargy
Clinical narrative: Patient states the night of 7/18/16 the following symptoms began 101.1 F Temp, Body aches, Chills, sweats, malaise, pain at injection site and lethargy.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Malaise, Pain
Clinical narrative: Patient states the night of 7/18/16 the following symptoms began 101.1 F Temp, Body aches, Chills, sweats, malaise, pain at injection site and lethargy.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Crying, Erythema, Pallor, Tearfulness, Vomiting
Clinical narrative: Child received vaccines and was crying upset. Calmed slightly but tearful. Carried out to the car and vomited up mucus per mother. Vomited several times after that. Brought Pt back into office. Pale, then cleaned by staff with "wipes". Noted to have more diffuse redness w/o hives or raised areas which included around eyes, cheeks, chin and fairly diffuse on trunk, extremities, sparing palms/soles. Child sleepy, due for nap. No glf/r, normal respirations. Mother took child home.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Erythema and swelling of L upper arm approx 12cm x 10cm. Very warm to touch x2 days. Cephalexin RX given cellulitis.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Migraine, Tachycardia
Clinical narrative: Information has been received from a physician via a company representative referring to a 14 year old female patient who had allergic reaction to vaccine. information about pertinent medical history and concomitant medication was unspecified. On 09-OCT-2014 and 09-DEC-2014 the patient was vaccinated with the first and second dose of GARDASIL (intramuscular, dose, dose# and lot# unknown), respectively. On 12-DEC-2014 the patient was taken to the emergency room (ER) at hospital due to migraines and dizziness. The patient was experiencing tachycardia as well. Extensive work up was performed with no result provided. The vaccine was discontinued. The outcome of the events was not recovered. The vaccine was not reintroduced. Follow-up information has been received from a physician on 19-JUL-2016. This report refers to a 14 years old white female patient. On 09-OCT-2014 at 03:27 PM, the patient was vaccinated with first dose of GARDASIL (lot # K008335) and on 09-DEC-2014, at 3:00 PM, vaccinated with second dose of GARDASIL (lot # K011492) via intramuscular route (left deltoid). On 12-DEC-2014, the patient experienced migraine headaches, dizziness, vision disturbance and neuropathic pain which required hospitalization for 2 days (dates not specified). The outcome of the events was reported as not recovered. The causality of the events was not reported. Additional information has been requested. Patient information, product information, event information and narrative were updated.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Migraine, Neuralgia, Tachycardia, Visual impairment
Clinical narrative: Information has been received from a physician via a company representative referring to a 14 year old female patient who had allergic reaction to vaccine. information about pertinent medical history and concomitant medication was unspecified. On 09-OCT-2014 and 09-DEC-2014 the patient was vaccinated with the first and second dose of GARDASIL (intramuscular, dose, dose# and lot# unknown), respectively. On 12-DEC-2014 the patient was taken to the emergency room (ER) at hospital due to migraines and dizziness. The patient was experiencing tachycardia as well. Extensive work up was performed with no result provided. The vaccine was discontinued. The outcome of the events was not recovered. The vaccine was not reintroduced. Follow-up information has been received from a physician on 19-JUL-2016. This report refers to a 14 years old white female patient. On 09-OCT-2014 at 03:27 PM, the patient was vaccinated with first dose of GARDASIL (lot # K008335) and on 09-DEC-2014, at 3:00 PM, vaccinated with second dose of GARDASIL (lot # K011492) via intramuscular route (left deltoid). On 12-DEC-2014, the patient experienced migraine headaches, dizziness, vision disturbance and neuropathic pain which required hospitalization for 2 days (dates not specified). The outcome of the events was reported as not recovered. The causality of the events was not reported. Additional information has been requested. Patient information, product information, event information and narrative were updated.
Age: 49.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Anti-aquaporin-4 antibody positive, Myelitis transverse, Neuromyelitis optica spectrum disorder
Clinical narrative: Back pain was originally diagnosed as a pinch nerve. Went back to clinic the next day with stinging in my legs and painful to walk and painful to touch. I was admitted into clinic on 5/8/2016 and no treatment for three days.  They diagnosed me with Neuromyelitis Optica about a two weeks. More to add if requested on my word document.
Age: 49.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Back pain, Nerve compression, Neuromyelitis optica spectrum disorder, Pain, Plasmapheresis
Clinical narrative: Back pain was originally diagnosed as a pinch nerve. Went back to clinic the next day with stinging in my legs and painful to walk and painful to touch. I was admitted into clinic on 5/8/2016 and no treatment for three days.  They diagnosed me with Neuromyelitis Optica about a two weeks. More to add if requested on my word document.
Age: 49.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Tenderness
Clinical narrative: Back pain was originally diagnosed as a pinch nerve. Went back to clinic the next day with stinging in my legs and painful to walk and painful to touch. I was admitted into clinic on 5/8/2016 and no treatment for three days.  They diagnosed me with Neuromyelitis Optica about a two weeks. More to add if requested on my word document.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV
Symptoms: Apnoea, Syncope
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (office manager) on 12-Jul-2016. This case involves a two-month-old female patient who was vaccinated with first dose of IPOL (batch number: M12051 expiry date: 28-Apr-2018) intramuscularly in right arm, a first dose of ACTHIB (batch number: UI474AAA expiry date: 23-Apr-2017) intramuscularly in right arm and a first dose of DAPTACEL (batch number: C4778BA expiry date: 30-Jul-2017) intramuscularly in left arm on 05-Jul-2016. The patient had no illness at the time of vaccination. Patient had no medical history and allergy was reported as none known. Concomitant medications were not reported. On 05-Jul-2016, immediately following the vaccination, the patient experienced crying, apnea, syncope, and turned blue. It was reported that the patient was monitored in office and then discharged to home and also reported that the patient required hospital ER visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was reported as unknown. Upon internal review, the case was considered to be serious due to important medical event: apnea. List of documents held by sender: none. Sender's Comments: Patient had apnea, syncope, crying and cyanosis following IPV (VERO), HIB (PRP/T) VACCINE and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. Time to onset is compatible, but patient past medical history, concomitant medication, infectious history, any congenital disorder and past vaccination history are need to further assess the case. Also multiple vaccine are administered the role each vaccine cannot be assessed.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV
Symptoms: Apnoea, Crying, Cyanosis, Syncope
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (office manager) on 12-Jul-2016. This case involves a two-month-old female patient who was vaccinated with first dose of IPOL (batch number: M12051 expiry date: 28-Apr-2018) intramuscularly in right arm, a first dose of ACTHIB (batch number: UI474AAA expiry date: 23-Apr-2017) intramuscularly in right arm and a first dose of DAPTACEL (batch number: C4778BA expiry date: 30-Jul-2017) intramuscularly in left arm on 05-Jul-2016. The patient had no illness at the time of vaccination. Patient had no medical history and allergy was reported as none known. Concomitant medications were not reported. On 05-Jul-2016, immediately following the vaccination, the patient experienced crying, apnea, syncope, and turned blue. It was reported that the patient was monitored in office and then discharged to home and also reported that the patient required hospital ER visit. Laboratory investigations and corrective treatments were not reported. The outcome of the event was reported as unknown. Upon internal review, the case was considered to be serious due to important medical event: apnea. List of documents held by sender: none. Sender's Comments: Patient had apnea, syncope, crying and cyanosis following IPV (VERO), HIB (PRP/T) VACCINE and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. Time to onset is compatible, but patient past medical history, concomitant medication, infectious history, any congenital disorder and past vaccination history are need to further assess the case. Also multiple vaccine are administered the role each vaccine cannot be assessed.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Systemic lupus erythematosus
Clinical narrative: Information was received from a physician via a company representative concerning a female patient of unknown age. On 21-NOV-2012 the patient was vaccinated with a first dose of GARDASIL (lot #1696aa, expiration date unknown) (dosage and route of administration not provided). On 08-APR-2013, the patient was vaccinated with a second dose of GARDASIL (lot # 0636ae, expiration date unknown) (dosage and route of administration not provided). The patient was diagnosed with lupus in July 2013. The outcome of lupus was not provided. Upon internal review, lupus was considered medically significant. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: SSEV, PNC13
Symptoms: Confusional state, Cough, Dizziness, Erythema, Headache
Clinical narrative: Softball size whelp, red, hot to touch.
Age: 58.0
Sex: F
Vaccine: SSEV, PNC13
Symptoms: Injection site swelling, Mobility decreased, Pain, Pruritus
Clinical narrative: Softball size whelp, red, hot to touch.
Age: 58.0
Sex: F
Vaccine: SSEV, PNC13
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Softball size whelp, red, hot to touch.
Age: 2.0
Sex: F
Vaccine: JEV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction was observed or stated. Patient received JEV 0.5ml adult/adolescent dose instead of JEV 0.25ml for pediatrics under the age of 3.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pruritus, Urticaria
Clinical narrative: Swelling at injection site and wheals on both arms, hands and legs, neck intense itching, wheals go away after a few days, but new ones pop up every day, still on going (7/21/16) after two trips to doctor, one to family physician and one to dermatologist.
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Vertigo
Clinical narrative: Initial unsolicited report received from a nurse on 30 June 2016. This case involves a male patient (age not reported) who was vaccinated with a fifth dose of DAPTACEL (batch number: C31130AA, expiry date, dose and site of administration were not reported) by intramuscular route on 02 June 2010. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as amoxil. Concomitant medications were not reported. On 04 June 2010, two days (reported as 48 hours) following the vaccination, the patient experienced fever and remembered room spinning with vertigo. Lab data and corrective treatment were not reported. On unspecified date, the patient recovered from events. List of documents held by sender: none.
Sex: U
Vaccine: MEN
Symptoms: Death
Clinical narrative: Initial unsolicited report received from consumer via social media in on 09 Jul 2016. This case is linked to 2016SA128403, 2016SA131479 and 2016SA131486 (same vaccine, same reporter). This case involves a patient (age and gender were not reported) who was vaccinated with dose of MENINGOCOCCAL VACCINE (batch number, expiry date, route, dose and site of administration: not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, two weeks after vaccination the patient died. It was unknown whether autopsy was performed and the cause of death was unknown. Documents held by sender: none. Sender's Comments: This case corresponds to a poorly documented and non-medically confirmed social media report. Patient presumably received meningococcal vaccine for which the manufacturer was unknown. Clinical details- such as patient's age, medical history, vaccination details, the name of the specific vaccine administered, clinical details surrounding the event, diagnostic work-up, cause of death and autopsy reports- are lacking to allow adequate medical assessment. Reported Cause(s) of Death: DEATH NOS.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Contusion, Head injury, Headache, Nausea
Clinical narrative: Initial unsolicited report received from other non-health care professional on 15 July 2016. This case involves a 16-year-old female patient who was vaccinated with a first dose of MENACTRA (Batch number: U5180AA, expiration date: 22 January 2017, dose, route and site of administration was not reported) intramuscularly in left deltoid on 14 July 2016. Patient's illness at the time of vaccination was none. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were unknown. On 14 July 2016, five minutes following the vaccination, the patient fainted and she sustained a contusion from hitting the back of her head and the patient also had nausea and headache 15-20 minutes later. On 15 July 2016, one day post vaccination; the patient had temperature (100 Fahrenheit). Lab data and corrective treatment was not reported. The patient was not yet recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical event: sustained a contusion from hitting the back of her head (Bruise of head). List of documents held by sender: none. Sender's Comments: Patient had received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and fainted after 5min which lead to contusion over back of head associated with headache and nausea, patient also had fever next day. Faint and fever are listed, while injury to head is unlisted and it is sequel to faint. Additional medical history, concomitant medication, infectious history, past vaccination history and its tolerance are needed to further assess the case. Based on the available information role of vaccine cannot be assessed.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Initial unsolicited report received from other non-health care professional on 15 July 2016. This case involves a 16-year-old female patient who was vaccinated with a first dose of MENACTRA (Batch number: U5180AA, expiration date: 22 January 2017, dose, route and site of administration was not reported) intramuscularly in left deltoid on 14 July 2016. Patient's illness at the time of vaccination was none. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were unknown. On 14 July 2016, five minutes following the vaccination, the patient fainted and she sustained a contusion from hitting the back of her head and the patient also had nausea and headache 15-20 minutes later. On 15 July 2016, one day post vaccination; the patient had temperature (100 Fahrenheit). Lab data and corrective treatment was not reported. The patient was not yet recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical event: sustained a contusion from hitting the back of her head (Bruise of head). List of documents held by sender: none. Sender's Comments: Patient had received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and fainted after 5min which lead to contusion over back of head associated with headache and nausea, patient also had fever next day. Faint and fever are listed, while injury to head is unlisted and it is sequel to faint. Additional medical history, concomitant medication, infectious history, past vaccination history and its tolerance are needed to further assess the case. Based on the available information role of vaccine cannot be assessed.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Ear discomfort, Lymph node pain, Rhinorrhoea, Tinnitus
Clinical narrative: Went to bed and when I laid down I heard a ringing in both ears.  Asked my husband if he had the ringing also as we both got the Adacel TDAP at the same time.  He did not hear anything.  Then in about 5 minutes I started with pressure in my ears.  The kind of pressure you get when going up in the air in an airplane.  It hurt and every time I swallowed, my ears cracked.  Then my glands in my neck started to hurt.  Got up and drank a glass of water. Next my nose started to just drip out of me.  Blew my nose which helped relieve some pressure in both ears. There was more pressure in my right ear. The pressure lessened and I was able to go to sleep.  Woke up with ears ringing and pressure in both ears.  It's been 6 days now and sometimes the pressure in my ears is worse than at other times.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site discolouration
Clinical narrative: DEVELOPED 4 YELLOW SPOTS ON LEFT ARM AND 1 YELLOW SPOT ON RIGHT ARM UNDER IMMUNIZATION LOCATION.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 18-month-old female patient who received PEDIARIX. Co-suspect products included PEDIARIX, PEDIARIX and INFANRIX. On an unknown date, the patient received the 1st dose of PEDIARIX, the 2nd dose of PEDIARIX, the 3rd dose of PEDIARIX and the 1st dose of INFANRIX. On an unknown date, an unknown time after receiving PEDIARIX, PEDIARIX, PEDIARIX and INFANRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and pertussis were unknown. It was unknown if the reporter considered the vaccination failure and pertussis to be related to PEDIARIX, PEDIARIX, PEDIARIX and INFANRIX. Additional details were received as follows: The age at vaccination was not reported. The GlaxoSmithKline representative learned of a confirmed case of pertussis, which was reported to the Department of Health. This case was considered as suspected vaccination failure, since the details regarding confirmed laboratory tests for pertussis and the time to onset for pertussis were not provided. No further information was provided by the representative.
Sex: U
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 17-year and 10 month-old patient of unspecified gender and ethnicity received TRUMENBA on unknown date at single dose. Relevant medical history and concomitant medications were not reported. After the vaccination, the patient passed out took about 15 minutes to come around-elevated legs. The patient recovered from the event on unknown date. No follow up attempts possible. No further information expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dysphagia, Hypersensitivity, Pharyngeal oedema, Sensation of foreign body, Throat irritation
Clinical narrative: This is a spontaneous report from a contactable practitioner nurse via a Pfizer sales representative. A 17 year-old female patient of unspecified ethnicity received the first dose of TRUMENBA (lot/batch number J29203, expiry date 30June2016) on 16Jun2016 at 11:45 at 0.5 ml single. Relevant medical history and concomitant medications were not reported. She received no other vaccines at that time. At the time of administration, the patient had no known allergies. Within about 10-15 minutes of receiving the vaccine, the patient started having an allergic reaction, she had swelling in her throat, a lump in her throat, and itchiness and it became difficult for the patient to swallow because it felt like there was a lump. Oral BENADRYL, dose unknown, was administered in the clinic, and the symptoms seemed to resolve in about 30 minutes. Around 18:00 that same evening, the patient started to experience the same symptoms and her mother administered oral BENADRYL again, and by the next day everything had resolved. The patient recovered from the events on 17Jun2016. The patient will not receive the other two injections in the series per healthcare provider guidelines and the product PI.