chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable medical assistant received via a sales representative. A 17-year-old female patient of an unspecified race and ethnicity received a single dose of TRUMENBA (lot M77282) via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, headache and malaise on an unspecified date. Outcome of the events was unknown.
Age: 24.0
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, TYP
Symptoms: Diarrhoea, Fatigue, Nausea, Vomiting
Clinical narrative: In the evening patient starting with N/V, this was day 7 of oral typhoid.  Next day he also had diarrhea.  Did not report fevers/chills, did feel fatigued and spent most of the day sleeping on Sunday.  On 2/22/17 he was feeling better and eating more solid foods(able to keep down).
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Significant redness and swelling at injection site. Large area of the back of the arm was red, tender to the touch and inflamed - approximately 1-2 inches in diameter.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain to injection site.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting for 2 days.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with a dose of RECOMBIVAX HB (dose, frequency, route, lot # and expiration date were unknown by the reporter) for vaccination. On an unknown date, the patients had been determinate to have low antibody titers after administration of RECOMBIVAX HB (Hepatitis B surface antibody negative). The patients sought an unknown type of medical attention but, it was unknown if the patients received any treatment. The outcome of the event was not reported. The causality between the event and RECOMBIVAX HB was not reported. Additional information is not expected because no consent for follow up was provided.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Influenza virus test negative
Clinical narrative: Was feeling good at time of pneumonia vaccine. The day after experienced dyspnea, cough and went to the ER 1/17/17. Was transferred and hospitalized with severe pneumonia. WBC elevated for weeks (30+). Recent echo shows loss of heart function Ejection Fraction decreased to 10%.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia, White blood cell count increased
Clinical narrative: Was feeling good at time of pneumonia vaccine. The day after experienced dyspnea, cough and went to the ER 1/17/17. Was transferred and hospitalized with severe pneumonia. WBC elevated for weeks (30+). Recent echo shows loss of heart function Ejection Fraction decreased to 10%.
Age: 21.0
Sex: M
Vaccine: ANTH, HPV9, JEV1, SMALL, TYP, ANTH, HPV9, JEV1, SMALL, TYP
Symptoms: Chest X-ray, Chest pain, Full blood count, Laboratory test, Metabolic function test
Clinical narrative: Chest burning and pain centrally and across both pectoral muscles.
Age: 21.0
Sex: M
Vaccine: ANTH, HPV9, JEV1, SMALL, TYP, ANTH, HPV9, JEV1, SMALL, TYP
Symptoms: Myalgia
Clinical narrative: Chest burning and pain centrally and across both pectoral muscles.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Antinuclear antibody negative, Arthralgia, Borrelia test negative, Butterfly rash, C-reactive protein normal
Clinical narrative: Seen 2 months after 2nd HPV for migraines; on second visit for migraines was referred to neurology; seen 3 months later for malar rash, joint pain and swelling and syncope.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Double stranded DNA antibody, Electrocardiogram normal, Joint swelling, Migraine
Clinical narrative: Seen 2 months after 2nd HPV for migraines; on second visit for migraines was referred to neurology; seen 3 months later for malar rash, joint pain and swelling and syncope.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Nuclear magnetic resonance imaging normal, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Syncope
Clinical narrative: Seen 2 months after 2nd HPV for migraines; on second visit for migraines was referred to neurology; seen 3 months later for malar rash, joint pain and swelling and syncope.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Crying, Injection site erythema, Pyrexia, Vaccination site pain, Vaccination site pustule
Clinical narrative: Patient presented to clinic on 02/23/17 with two red pustule-like bumps at the site of vaccine administration. Mom reports patient not wanting to allow anyone touch the area. During examination by the provider, patient cried when area was touched. Seems to be painful. Slightly swollen. Not currently hot to touch. Mom reported fevers that started 2 days after vaccination.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Vaccination site swelling
Clinical narrative: Patient presented to clinic on 02/23/17 with two red pustule-like bumps at the site of vaccine administration. Mom reports patient not wanting to allow anyone touch the area. During examination by the provider, patient cried when area was touched. Seems to be painful. Slightly swollen. Not currently hot to touch. Mom reported fevers that started 2 days after vaccination.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Electromyogram, Erythema, Feeling hot, Hypoaesthesia, Inflammation
Clinical narrative: Continuous pain/discomfort with motion at site of injection and in joint. Some numbness/tingling noted with inflammation. Times of redness, swelling, and heat noted.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site joint discomfort, Injection site joint pain, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Continuous pain/discomfort with motion at site of injection and in joint. Some numbness/tingling noted with inflammation. Times of redness, swelling, and heat noted.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Paraesthesia, Swelling, X-ray
Clinical narrative: Continuous pain/discomfort with motion at site of injection and in joint. Some numbness/tingling noted with inflammation. Times of redness, swelling, and heat noted.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Feeling hot, Headache, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: She reports experiencing strong neck pain and stiffness yesterday and then felt the pain move up covering her head. States she cannot raise her arm. Patient states she is also experiencing nausea and stomach pain. States her cheeks feel very hot and she feels pressure in her eyes.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Neck pain, Ocular discomfort
Clinical narrative: She reports experiencing strong neck pain and stiffness yesterday and then felt the pain move up covering her head. States she cannot raise her arm. Patient states she is also experiencing nausea and stomach pain. States her cheeks feel very hot and she feels pressure in her eyes.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: Patient came in to receive PREVNAR 13 vaccination. Immediately after giving vaccination, the patient's arm swelled and bled at injection site. At the injection site blood pooled to the size of a silver dollar. Patient says she is only taking aspirin and has had no previous reactions to any shots in the past. After checking back in with patient she did say she experienced something similar in the right arm at Dr. office after receiving a shot. Patient is feeling fine, and having no symptoms of an allergic reaction. Patient applied pressure with ice and stayed in the pharmacy for 30 minutes so we could observe her for any other symptoms. Patient and son left voluntarily after checking on her again, and swelling had not changed. Throughout the incident the patient did not report any pain. Will follow up with patient this evening and again tomorrow morning. Also called Dr.  and had to leave message, to keep them informed of the incident.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Electrocardiogram, Erythema, Flushing, Malaise
Clinical narrative: After immunization, approximately 10-15 minutes after. Patient received PNEUMOVAX 23 vaccine for the first time in the exam per protocol. Patient walked half-way down the hall following injection and stopped, leaned forward a bit and looked unsteady. Writer called out to patient asking if she was okay and moved toward her. Saw patient stop and moved toward her also. Patient moved herself to chair sitting in the hallway and said she didn't feel well (we reached right after she sat down). Writer noted that her face and arms were bright red. Dr. notified of reaction and she assessed patient right away.  BP became elevated. Patient was wheezing, very flushed, Oxygen started per N/C.  After about 3-4 minutes patient started to look not quite as flushed, but respirations tight.  Patient transferred to ED for further assistance, patient was discharged from ED without further incident.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Respiration abnormal, Wheezing
Clinical narrative: After immunization, approximately 10-15 minutes after. Patient received PNEUMOVAX 23 vaccine for the first time in the exam per protocol. Patient walked half-way down the hall following injection and stopped, leaned forward a bit and looked unsteady. Writer called out to patient asking if she was okay and moved toward her. Saw patient stop and moved toward her also. Patient moved herself to chair sitting in the hallway and said she didn't feel well (we reached right after she sat down). Writer noted that her face and arms were bright red. Dr. notified of reaction and she assessed patient right away.  BP became elevated. Patient was wheezing, very flushed, Oxygen started per N/C.  After about 3-4 minutes patient started to look not quite as flushed, but respirations tight.  Patient transferred to ED for further assistance, patient was discharged from ED without further incident.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Injection site erythema, Nausea, Pain, Pyrexia
Clinical narrative: I have developed a big (3 inch) reddish swelling locally where the vaccine shot was given. I had swinging fever, generalized moderate-sever body ache, particularly back pain.  I developed nausea and vomiting. I went to clinic and they asked me to pay a Co-Payment , and of course, I will pay for the medicine as well, so I refused to be seen by a doctor because buying non inflammatory pain relief medicine is much cheaper over the counter.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: I have developed a big (3 inch) reddish swelling locally where the vaccine shot was given. I had swinging fever, generalized moderate-sever body ache, particularly back pain.  I developed nausea and vomiting. I went to clinic and they asked me to pay a Co-Payment , and of course, I will pay for the medicine as well, so I refused to be seen by a doctor because buying non inflammatory pain relief medicine is much cheaper over the counter.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called to say she has redness, swelling, itching and pain at injection site.  Treated with taking a pain reliever. Called patient back on 2/23/2017 at 3:30pm- patient says no more pain, still some swelling and redness around area.  The patient will take an antihistamine to help this time.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Injection site pain, Pain in extremity
Clinical narrative: Pain left arm after vaccination.  Developed erythema 3 days after vaccination.  Erythema resolved after 1 week when pt started 10 course of antibiotics with PMD.  Pt still has left arm pain at injection site 1 month after vaccination.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Extreme red, swollen and warm left deltoid.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Blood test, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: Experienced Nausea, vomiting, dizziness. Dizziness and nausea persisted for about two weeks, along with increased heart rate. Symptoms are still on going. I experience a racing heart and lightheaded on a daily basis. I was not able to stand up and walk without feeling dizzy. The nausea still returns. I am unable to resume my normal daily activities such as running and being active for extended periods of time. I went to see an autonomic neurologist, who suspects that I have POTS. Gardasil is the only vaccine that has induced a dysfunction in autonomic nervous system. Treatment consists of lifestyle changes and is still to be determined.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Electrocardiogram ambulatory, Heart rate increased, Nausea, Nuclear magnetic resonance imaging brain, Palpitations
Clinical narrative: Experienced Nausea, vomiting, dizziness. Dizziness and nausea persisted for about two weeks, along with increased heart rate. Symptoms are still on going. I experience a racing heart and lightheaded on a daily basis. I was not able to stand up and walk without feeling dizzy. The nausea still returns. I am unable to resume my normal daily activities such as running and being active for extended periods of time. I went to see an autonomic neurologist, who suspects that I have POTS. Gardasil is the only vaccine that has induced a dysfunction in autonomic nervous system. Treatment consists of lifestyle changes and is still to be determined.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Postural orthostatic tachycardia syndrome, Tilt table test, Urine analysis, Vomiting
Clinical narrative: Experienced Nausea, vomiting, dizziness. Dizziness and nausea persisted for about two weeks, along with increased heart rate. Symptoms are still on going. I experience a racing heart and lightheaded on a daily basis. I was not able to stand up and walk without feeling dizzy. The nausea still returns. I am unable to resume my normal daily activities such as running and being active for extended periods of time. I went to see an autonomic neurologist, who suspects that I have POTS. Gardasil is the only vaccine that has induced a dysfunction in autonomic nervous system. Treatment consists of lifestyle changes and is still to be determined.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Inflammation and soreness in soft tissue on the back of the upper arm.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, HPV9
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase normal, Asthenia, Blood creatinine normal, Blood urea normal
Clinical narrative: Redness and swelling to arm around injection site. Since injection, patient has experienced cough, fever, fatigue. Mom states child has no energy, sleeps often.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, HPV9
Symptoms: Cough, Fatigue, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Redness and swelling to arm around injection site. Since injection, patient has experienced cough, fever, fatigue. Mom states child has no energy, sleeps often.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, HPV9
Symptoms: Injection site erythema, Injection site swelling, Mononucleosis heterophile test negative, Pyrexia, Somnolence
Clinical narrative: Redness and swelling to arm around injection site. Since injection, patient has experienced cough, fever, fatigue. Mom states child has no energy, sleeps often.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, HPV9
Symptoms: White blood cell count normal
Clinical narrative: Redness and swelling to arm around injection site. Since injection, patient has experienced cough, fever, fatigue. Mom states child has no energy, sleeps often.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, HPV9
Symptoms: Erythema, Feeling abnormal, Headache, Nausea, Peripheral swelling
Clinical narrative: Redness and swelling to arm around injection site. Since injection, patient has experienced cough, fever, fatigue. Mom states child has no energy, sleeps often.
Age: 11.0
Sex: F
Vaccine: HPV9, MEN, HPV9
Symptoms: Pyrexia, Serum sickness, Somnolence
Clinical narrative: Redness and swelling to arm around injection site. Since injection, patient has experienced cough, fever, fatigue. Mom states child has no energy, sleeps often.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site pain, Injection site rash, Malaise
Clinical narrative: Headache, nausea, fatigue, fever, pain at site of shot & rash at site of shot.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Headache, nausea, fatigue, fever, pain at site of shot & rash at site of shot.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Angina pectoris, Inflammation, Paraesthesia, Pyrexia, Rash
Clinical narrative: Fever, rash, inflammation, heartache and Sleeping hand and arm.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Pallor, Screaming
Clinical narrative: This case was reported by a physician and described the occurrence of unconscious in a 16-year-old female patient who received BEXSERO (batch number 151501, expiry date 31st December 2016). Concomitant products included MENACTRA. On 14th July 2016, the patient received BEXSERO. On 14th July 2016, immediately after receiving BEXSERO, the patient experienced unconscious (serious criteria GSK medically significant), screaming, pallor, fainting and dizziness. On an unknown date, the outcome of the unconscious, screaming and pallor were unknown and the outcome of the fainting and dizziness were recovered/resolved. The reporter considered the unconscious, screaming, pallor and fainting to be probably related to BEXSERO. It was unknown if the reporter considered the dizziness to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in the left arm and MENACTRA in the right arm. Immediately after the vaccination, the patient experienced fainting. The patient had weird screaming noise, become ashened and had unconsciousness. The patient wake up after a couple of seconds and the patient kept for observation for additional 20 to 30 minutes. The patient was also dizzy. The physician think it was BEXSERO due to temporal association and the patient had MENACTRA before. The reporter did not have territory ID. There were no seriousness associated with the reported event. This case is linked with US2017GSK024125, as reported by the same reporter.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: This case was reported by a physician and described the occurrence of unconscious in a 16-year-old female patient who received BEXSERO (batch number 151501, expiry date 31st December 2016). Concomitant products included MENACTRA. On 14th July 2016, the patient received BEXSERO. On 14th July 2016, immediately after receiving BEXSERO, the patient experienced unconscious (serious criteria GSK medically significant), screaming, pallor, fainting and dizziness. On an unknown date, the outcome of the unconscious, screaming and pallor were unknown and the outcome of the fainting and dizziness were recovered/resolved. The reporter considered the unconscious, screaming, pallor and fainting to be probably related to BEXSERO. It was unknown if the reporter considered the dizziness to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in the left arm and MENACTRA in the right arm. Immediately after the vaccination, the patient experienced fainting. The patient had weird screaming noise, become ashened and had unconsciousness. The patient wake up after a couple of seconds and the patient kept for observation for additional 20 to 30 minutes. The patient was also dizzy. The physician think it was BEXSERO due to temporal association and the patient had MENACTRA before. The reporter did not have territory ID. There were no seriousness associated with the reported event. This case is linked with US2017GSK024125, as reported by the same reporter.
Sex: F
Vaccine: HEPA, TYP
Symptoms: Cellulitis, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cellulitis of arm in a 79-year-old female patient who received HAVRIX 1440 adult. Co-suspect products included Typhoid vaccine. On 29th December 2016, the patient received the 1st dose of HAVRIX 1440 adult 1 ml and Typhoid vaccine. On 30th December 2016, 1 days after receiving HAVRIX 1440 adult and Typhoid vaccine, the patient experienced cellulitis of arm (serious criteria GSK medically significant) and pain. The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis of arm and pain were unknown. It was unknown if the reporter considered the cellulitis of arm and pain to be related to HAVRIX 1440 adult and Typhoid vaccine. Additional details were provided as follows: The reporter did not know where the site of injection was, but both vaccines were given on the same arm. The nurse reported that the patient received 2 courses of antibiotics. No other information was provided.
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Rhinorrhoea, Vaccination failure
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 42-year-old female patient who received Influenza vaccine Quadrivalent. Previously administered products included BREO ELLIPTA with an associated reaction of upper-airway cough syndrome (affecting voice, nasal congestion, head congestion with drainage into throat and head, refer case US2017GSK004660). On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza A virus infection and nasal discharge. On an unknown date, the outcome of the vaccination failure and nasal discharge were unknown and the outcome of the influenza A virus infection was recovered/resolved. It was unknown if the reporter considered the vaccination failure, influenza A virus infection and nasal discharge to be related to Influenza vaccine Quadrivalent. Rerun narrative: Additional details were provided as follows: The case was reported by patient's mother. The age at vaccination was not reported. The patient reported noticing nasal drainage. The patient takes BREO for asthma (unknown dose) however, she did not report the event to be related to BREO. There were no seriousness criteria (death, hospitalization, disabling, congenital anomaly, life-threatening and clinical intervention required) associated with the reported event.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Mobility decreased, Pain in extremity, Vaccination complication, X-ray
Clinical narrative: 01-30-17 4PM Sudden, excruciating pain in Left arm from shoulder to elbow. Unable to raise arm. I called pharmacy and was told by the pharmacist to go immediately to the Emergency Dept. that I was having a reaction to the shot. Blood work and X-rays were taken. I was given ROBAXIN and MOBIC and icy sling.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Injection site induration, Injection site pain
Clinical narrative: 5cm x 5cm area of induration and tenderness in right deltoid.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Erythema, Injected limb mobility decreased, Insomnia, Joint swelling
Clinical narrative: His (L) arm was red and swollen special in elbow area. He had fever and chill. He couldn't raise arm and couldn't sleep at night.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: His (L) arm was red and swollen special in elbow area. He had fever and chill. He couldn't raise arm and couldn't sleep at night.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Vaccines administered at 2:52 PM. Pt left W/O C/O's. Returned at 4:18 PM C/O feeling lightheaded, nausea, headache. Pt encouraged to sit and place head between legs. Always eat before receiving vaccines. Offered a lollipop. VS: 110/80, Temp 100.3 degrees F, P: 88, R: 16. Observed for 20 mins until she started to feel better.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling, Pain, Skin warm
Clinical narrative: Pt. came in to pharmacy and asked that I look at her arm. About 1-1/2" below inj site was a raised light red patch about 3" in diameter. It felt warm.. Pt said it was painful. I recommended she see her MD.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left upper extremity.
Age: 34.0
Sex: F
Vaccine: TYP
Symptoms: Fatigue, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain in left upper arm, where shot was given and extreme fatigue in lower arm to palm. Limited range of movement because of pain in upper arm. Pain felt immediately after shot. Took a yoga class and felt fatigue increase and pain increase within an hour.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Erythematous spot RD area with pain and pruritus of this area. Approximately 4 x 3 cm.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: The patient is describing severe pain at the site of the injection. It was severe overnight but has gotten better.
Age: 50.0
Sex: M
Vaccine: HEPAB
Symptoms: Eye contusion, Facial bones fracture, Head injury, Laceration, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient fainted and hit his head. Paramedics were called to help him. Pt had deep cut on eyebrow and slight cut and fracture on side of his nose. Pt received stitches on his eyebrow. Pt also has black eye. (all on left side).
Age: 50.0
Sex: M
Vaccine: HEPAB
Symptoms: Nuclear magnetic resonance imaging spinal, Suture insertion, Syncope
Clinical narrative: Patient fainted and hit his head. Paramedics were called to help him. Pt had deep cut on eyebrow and slight cut and fracture on side of his nose. Pt received stitches on his eyebrow. Pt also has black eye. (all on left side).
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal pain
Clinical narrative: 2-22-17 patient reported sever shoulder pain.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Pt. given typhoid pills to take at home for travel overseas. Patient's mother reports patient had episodes of vomiting the day after taking the first pill.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Muscle spasms, Rash, Swelling
Clinical narrative: Sharp and sudden, neck and head spasms starting a few days after the swelling and rash. Lasted about 6 weeks.
Age: 28.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Pyrexia
Clinical narrative: Fever. Localized reaction, swelling, pain, redness at injection site.
Age: 71.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3, PNC13
Symptoms: Rash
Clinical narrative: Rash on neck and chest.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Red band type area about 2 inches below injection site. Warm to touch and swollen.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt received flu shot 2/7/17 Rt deltoid. Presented today 2/9/17 with red arm (Rt.), some swelling and warm to touch. Reddened area was measured >70mm long and 50mm wide. Pt. states she had a flu shot in Oct.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Neck pain, Pain
Clinical narrative: 1 day after receiving Pneumo 13 he experienced pain in (R) shoulder that continued to increase. Shoots into neck and biceps. (+) associated headache. A week later pain is beginning to subside.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event noted. A fourth dose of PENTACEL was given when it was not due.
Age: 30.0
Sex: F
Vaccine: PNC13
Symptoms: Disorientation, Dizziness, Immediate post-injection reaction, Malaise, Pallor
Clinical narrative: Immediately after receiving vaccine patient said she did not feel well, felt dizzy, lips pale, became disoriented with eyes closed. This lasted for 5-10 seconds before she responded to her name. Placed supine. Gradually back to baseline in about 10 minutes. Monitored in clinic for 45 minutes left independently. Vasovagal syncope secondary to vaccine procedure.
Age: 30.0
Sex: F
Vaccine: PNC13
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Immediately after receiving vaccine patient said she did not feel well, felt dizzy, lips pale, became disoriented with eyes closed. This lasted for 5-10 seconds before she responded to her name. Placed supine. Gradually back to baseline in about 10 minutes. Monitored in clinic for 45 minutes left independently. Vasovagal syncope secondary to vaccine procedure.
Age: 78.0
Sex: F
Vaccine: FLU4, PNC13, FLUX, PNC13
Symptoms: Bedridden, Dizziness, Fatigue, Injected limb mobility decreased, Insomnia
Clinical narrative: PCV13 given 2/17/17 at 10:43 AM. Patient reported fever of 99 degree F, dizziness, extreme fatigue, vomiting, inability to move arm, bedbound, muscle pain in injection arm, and not being able to sleep for 2 days. Patient reported symptoms lasted for a few days but is feeling better today, 2/23/17. Patient still has some fatigue, but otherwise is okay. Patient declined appointment to be seen for symptoms.
Age: 78.0
Sex: F
Vaccine: FLU4, PNC13, FLUX, PNC13
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: PCV13 given 2/17/17 at 10:43 AM. Patient reported fever of 99 degree F, dizziness, extreme fatigue, vomiting, inability to move arm, bedbound, muscle pain in injection arm, and not being able to sleep for 2 days. Patient reported symptoms lasted for a few days but is feeling better today, 2/23/17. Patient still has some fatigue, but otherwise is okay. Patient declined appointment to be seen for symptoms.
Age: 78.0
Sex: F
Vaccine: FLU4, PNC13, FLUX, PNC13
Symptoms: Fatigue, Pain in extremity
Clinical narrative: PCV13 given 2/17/17 at 10:43 AM. Patient reported fever of 99 degree F, dizziness, extreme fatigue, vomiting, inability to move arm, bedbound, muscle pain in injection arm, and not being able to sleep for 2 days. Patient reported symptoms lasted for a few days but is feeling better today, 2/23/17. Patient still has some fatigue, but otherwise is okay. Patient declined appointment to be seen for symptoms.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Blood glucose normal, Cold sweat, Feeling cold, Hypoaesthesia
Clinical narrative: Pt received vaccine approximately 6 PM. She woke up at 3 AM  feeling cold, clammy unable to feel her legs. Crawled to BG monitor-sugar level approximately 159 (normal). Crawled to bed woke up ok.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Dizziness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of light headedness in a 17-year-old male patient who received BEXSERO (batch number 151501, expiry date 31st December 2016). Concomitant products included BEXSERO and MENACTRA. On 27th June 2016, the patient received BEXSERO. On 27th June 2016, less than a day after receiving BEXSERO, the patient experienced light headedness and weakness. On an unknown date, the outcome of the light headedness and weakness were recovered/resolved. The reporter considered the light headedness and weakness to be possibly related to BEXSERO. Additional details were provided as follows: On 26th May 2016, the patient received BEXSERO and MENACTRA and experienced related to BEXSERO. The patient received BEXSERO and the patient experienced felt weak and light headed.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Feeling cold, Nausea
Clinical narrative: This morning weak feel cold nausea. He may contact clinic - has not as of this writing (per wife - interpreter).
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash, Rash erythematous
Clinical narrative: Patient received PNEUMOVAX 23 on 2/20/17, she woke up 2/21/17 with sore arm - got worse throughout the day. 2/22/17 started with red spots to arm, and arm pits. Tx w/steroid ointment on 2/22/17 from Dr. dermatologist.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Administration site rash, Injection site erythema, Injection site pruritus, Pruritus, Rash
Clinical narrative: Patient presented itching, rash on administration site. Also redness on IMZ site. Patient also refer lower extremities rash and itching on left arm due to ZOSTAVAX inj.
Age: 73.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Rash
Clinical narrative: Patient developed a rash upon receiving flu vaccine.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Development of shingles around the right orbital socket leading dorsally to the apex of the cranium.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Induration, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Felt very uncomfortable, arm really swollen, hard, warm, itchy. Called pharmacist who recommended ice and TYLENOL. Not quite as hard, warm today. Not as painful but has limited movement.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Skin warm
Clinical narrative: Felt very uncomfortable, arm really swollen, hard, warm, itchy. Called pharmacist who recommended ice and TYLENOL. Not quite as hard, warm today. Not as painful but has limited movement.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pruritus, Rash, Swelling
Clinical narrative: Rash, swollen, red, itchy, extremely sore arm. Pt went to PCP for treatment (steroid, BENADRYL).
Sex: F
Vaccine: MENB
Symptoms: Vaginal haemorrhage
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of vaginal bleeding in a 17-year-old female patient who received BEXSERO. On 5th January 2017, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced vaginal bleeding. On an unknown date, the outcome of the vaginal bleeding was not reported. It was unknown if the reporter considered the vaginal bleeding to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. In 2017, the patient experienced vaginal bleeding. The batch number and anatomical location of the vaccine were unknown.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 17-year-old female patient who received BEXSERO (batch number 166801, expiry date 31st May 2018). On 2nd February 2017, the patient received BEXSERO .5 ml. On 2nd February 2017, less than a day after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The patient had complained of still feeling soreness at the injection site 11 days after the vaccination with BEXSERO. There was no sign of swelling, redness or bruising. The nurse called to find out if there had been other reports. She was given the number for medical information. Follow up was urgent as the same patient was scheduled for another vaccine on 2nd March 2017. The reporter also said that she had given 10 shots from the same lot without any other complaints.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for 3 patients. This is the first of 3 reports. An elderly female patient of an unspecified age (reported as 65 years or older), race and ethnicity received PREVNAR 13 via an unspecified route of administration on an unspecified date at 0.5 ml single for immunization. The patient medical history and concomitant medications were not reported, however the reporter mentioned that patient was probably on other concomitant unspecified medicines. The patient experienced hard swollen arm and redness around injection site on an unspecified date in 2017. The patient recovered from the reported events on an unspecified date in 2017. The events were assessed as related to the vaccine. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017081303 same reporter/suspect product/event, different patient;US-PFIZER INC-2017081535 same reporter/suspect product/event, different patient.
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Pruritus, Rash, Rash maculo-papular
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-FEB-2017, the patient was vaccinated with the doses of VAQTA (dose, route of administration, lot # and expiration date were not reported) and VARIVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis (also reported as hepatitis A vaccine and prevention of chicken pox). On 09-FEB-2017, four hours after the vaccination, the patient experienced rash on the back. The patient sought medical attention via contacting the nurse practitioner. The outcome of rash on the back was reported as not recovered. The relatedness between the adverse event and VAQTA and VARIVAX was not provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-FEB-2017, the patient was vaccinated with the doses of VAQTA (dose, route of administration, lot # and expiration date were not reported) and VARIVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis (also reported as hepatitis A vaccine and prevention of chicken pox). On 09-FEB-2017, four hours after the vaccination, the patient experienced rash on the back. The patient sought medical attention via contacting the nurse practitioner. The outcome of rash on the back was reported as not recovered. The relatedness between the adverse event and VAQTA and VARIVAX was not provided. Additional information has been requested.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: High pitch crying lasting nearly 3 hours, swelling, redness, and heat at injection site.  Severe pain at injection site.  Muscle cramping.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Muscle spasms
Clinical narrative: High pitch crying lasting nearly 3 hours, swelling, redness, and heat at injection site.  Severe pain at injection site.  Muscle cramping.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX lot # L012034, expiration date 04-JUL-2017, Lot number: L019128, expiration date: 27-MAY-2017 and Lot number: M008172, expiration date: 16-FEB-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The VARIVAX vaccine was exposed to a temperature of >5 Fahrenheit degrees but <14 Fahrenheit degrees for 2 hours and 4 minutes. There was a previous temperature excursion of <5 Fahrenheit degrees but 14< Fahrenheit degrees for 13 hours, 26 minutes for VARIVAX vaccine. This excursion was detected due to a data logger. No adverse effects  were reported. This is one of several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008543.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 3-year-old, male patient who did not have any known drug reactions or allergies. There was no information about the patient's concomitant therapies or medical history provided. On 12-OCT-2015 at 10:15, the patient was vaccinated with improperly stored dose of VARIVAX lot # L013068, subcutaneously in the right arm for prophylaxis (dose and expiration date were not reported). The vaccination was in privates doctor's office and administered VARIVAX was purchase with public funds. The patient did not have any illnesses at the time of vaccination. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion that the administered VARIVAX experienced were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004104: US-009507513-1702USA004102: US-009507513-1611USA008278: US-009507513-1702USA004110: US-009507513-1702USA004109: US-009507513-1702USA004108: US-009507513-1702USA004107: US-009507513-1702USA004106: US-009507513-1702USA004105.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Concurrent conditions, pertinent medical history or concomitant medications were not reported. On 08-FEB-2017, the patient was inadvertently vaccinated with an expired dose of VAQTA lot # L027735, expiration date: 12-JAN-2017 (route of administration was unspecified) for prophylaxis. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Skin irritation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history was not provided. Her concurrent conditions included hypertension and an unspecified blood clotting issue. Concomitant therapies included warfarin and an unspecified blood pressure medication. None known drug reactions/allergies were reported. On 13-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneously on the lower arm between the elbow and wrist, lot # M027348, expiration date 27-JUL-2017; dose was not reported) for prevention of shingles. In February 2017, the patient experienced some irritation on the skin. Due to this, the patient saw her primary care physician. None lab diagnostic studies were performed. The outcome of skin irritation was unknown. The relatedness between the adverse event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and a nurse referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. Since 24-JAN-2017, the patients were vaccinated with an improperly stored PROQUAD Lot # M031945, expiration date: 27-DEC-2017 (strength, dose, frequency and route of administration were not reported) for prophylaxis, with a temperature of >5 Farenheit degrees <14 Farenheit degrees for 84 minutes. Additionally, previous temperature excursions were reported on an unspecified dates: >5 Farenheit degrees but < 14 Farenheit degrees for 6 minutes, >14 Farenheit degrees but < 46 Farenheit degrees for 1 hour and 48 minutes, >46 Farenheit degrees but < 77 Farenheit degrees for 2 hours and 42 minutes. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA006115.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist, referring to 3 patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with 3 doses of improperly stored PNEUMOVAX 23 (lot # L014458, expiration date 11-FEB-2017) for prophylaxis. The vaccines were stored at 62 degrees Fahrenheit (F) for 11 hours. The previous temperature excursion was recorded as 51F for 13 hours 30 minutes. No adverse effects were reported. The outcome of events was unknown. Follow up information was received from a worker from the pharmacist's office on 22-FEB-2017. The reporter noted there was only one vaccine given on 17-DEC-2016, and the patient's initials were identified. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA011009.
Age: 45.0
Sex: M
Vaccine: FLUX, HEPAB, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 17-FEB-2017, the patient was vaccinated with an expired dose of PNEUMOVAX 23, intramuscular, lot number L035687 with expiration date 16-FEB-2017 (dose and anatomical location were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Pt received Anthrax vaccine 02/22/2017 in left arm IM.  Patient had normal soreness after vaccine and claims swelling and redness started occurring the next morning (23 Feb 2017).  Pt claims swelling and redness have remained the same and that is why he came back to see us on 24 Feb 2017.  Provider saw patient and treated with antibiotics for cellulitis.  Pt will be f/u on mon/tues of next week and told if sx become worse over the weekend to go to ER.  Pt agreed and understands plan.
Age: 35.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain upper, Dyspepsia, Headache, Sinusitis
Clinical narrative: Headache for 2 weeks. Heartburn and stomach pain and sinusitis. Heartburn and stomach pain still ongoing.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Peripheral swelling, Testicular swelling
Clinical narrative: Swelling from the right arm to the (R) side of the neck. Severe headache initially - HA persistent 10/25/16 through form completion date.