chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Ear discomfort, Headache, Hypersomnia, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 20th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On 20th March 2019, the patient experienced headache. On 21st March 2019, the patient experienced ear noises. On 24th March 2019, the patient experienced ear feels clogged, fever, sickness, appetite absent, weight loss and sleep excessive. On an unknown date, the outcome of the injection site erythema, injection site pain, sickness, appetite absent, weight loss and sleep excessive were unknown and the outcome of the headache was recovered/resolved and the outcome of the ear noises was recovering/resolving and the outcome of the ear feels clogged and fever were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, headache, ear noises, ear feels clogged, fever, sickness, appetite absent, weight loss and sleep excessive to be related to SHINGRIX. Additional details were provided as follows: The caller reported that she got SHINGRIX on Wednesday and that night he felt like her head was going to burst. The next day she started hearing a sound in her right ear. It sounds like a high-pitched chime. She mostly heard it when there was no other sound. It might be a little improved, but it has not gone away. She also had some pain and redness at the injection site. The day before reporting day, she started getting sick, so her ears plugged up, she had a 102 degree F fever, she slept for 18 hours, did not eat and lost weight. Till the reporting time, her ears were clogged and her fever was about 100 degree F. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pyrexia, Tinnitus, Weight decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 20th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On 20th March 2019, the patient experienced headache. On 21st March 2019, the patient experienced ear noises. On 24th March 2019, the patient experienced ear feels clogged, fever, sickness, appetite absent, weight loss and sleep excessive. On an unknown date, the outcome of the injection site erythema, injection site pain, sickness, appetite absent, weight loss and sleep excessive were unknown and the outcome of the headache was recovered/resolved and the outcome of the ear noises was recovering/resolving and the outcome of the ear feels clogged and fever were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, headache, ear noises, ear feels clogged, fever, sickness, appetite absent, weight loss and sleep excessive to be related to SHINGRIX. Additional details were provided as follows: The caller reported that she got SHINGRIX on Wednesday and that night he felt like her head was going to burst. The next day she started hearing a sound in her right ear. It sounds like a high-pitched chime. She mostly heard it when there was no other sound. It might be a little improved, but it has not gone away. She also had some pain and redness at the injection site. The day before reporting day, she started getting sick, so her ears plugged up, she had a 102 degree F fever, she slept for 18 hours, did not eat and lost weight. Till the reporting time, her ears were clogged and her fever was about 100 degree F. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: This case was reported by a other health professional (patient) via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX at left arm. After receiving SHINGRIX, the patient had pain in her arm at the injection site and felt tired. This is 1 of the 5 cases, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Chills, fever (110 deg), body aches, fatigue, headache lasting 24 hours.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: Patient received injection on 03/20/2019 and states it was hurting from day of, called office on 03/26/2019 to report and was seen that same day, no redness, swelling or knot noted on exam. Warm compresses and MOTRIN ordered along with follow up appointment given. Patient returned on 03/29/2019 and reports no change in symptoms. Rates pain 6/10 in the mornings and 4/10 by night time. Still no redness, swelling or knot noted. Rx for 5 day Prednisone therapy and follow up on 04/03/2019. Reports no weakness or pain anywhere else. If no improvement noted at next visit, will refer to MD.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Chilling, stiff neck, extreme soreness at injection site reported morning after injection.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Sore arm at injection site, fatigue, weakness, headache at the back of head, chills that lasted about 12 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Severe shivering to the point of teeth chattering.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Unresponsive to stimuli
Clinical narrative: My Son went to the doctor for shots on December 11 2018.  He got DTP/DTap /HIB/PCV/and Influenza (flu shot).  This was his first time getting the flu shot. Research says it takes 2 weeks for the flu shot to start to take effect. Approx 3 weeks later we found our Son unresponsive on 1/3/2019.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Vaccination site pain, Vaccination site reaction, X-ray normal
Clinical narrative: Pain and stiffness in Right Shoulder at vaccination site which never subsided. X-ray taken in February-unremarkable. Physical Therapy began 05MAR19 and is ongoing. Cortisone shot received on 22MAR19 without relief.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Malaise, Myalgia
Clinical narrative: Systemic muscle ache, severe malaise, headache.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Influenza like illness, Limb discomfort, Malaise, Peripheral coldness
Clinical narrative: Not sure if received Flu and Pneumonia vaccines in prior month. Within 2 hours, suddenly became ill with flu-like symptoms. Patient had extreme backache similar to when had surgery years ago. Went to bed and put warm pad that helped with relief; could not use cold packs only warm. Continued using warm pads throughout the day and night. Took Hydrocodone 325 mg as needed which gave some tolerable relief. Back issues subsided after 48 hours but then issues with leg began; leg felt like ice below knees to top of ankle. Patient had to use warm pads to get relief. Patient did not go to the doctor at any point. After 6 weeks, coldness went to feet and still has issues with right toes. No problems if active just when sitting or have knees/leg up. Has been to doctor for other scheduled visits and has not received treatment for legs. Patient has not received the next dose yet.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient reports continued pain in her left arm, deltoid area, which radiates to her shoulder and lower arm since receiving the influenza vaccine in January.
Age: 20.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Rash morbilliform
Clinical narrative: Rash that looks like measles. Given ZYRTEC. Rash began to diminish 5 days after initial outbreak.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: Patient received two Hepatitis  B vaccines (RECOMBIVAX, PEDIARIX). Patient did not have any signs or symptoms. Poison control was contacted and they evaluated the aluminum in vaccine and explain their is no overdose concern.
Age: 1.33
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Seizure
Clinical narrative: Child started convulsing at home 3/28/2019 @ 0100, was taken to hospital where he was kept for approximately 5 hours, discharged with DX Febrile Seizures R/T vaccine administration. Followed up Monday with PCP, mother stated no more episodes.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Vasodilatation
Clinical narrative: Has peculiar large red patchwith blood vessels under the skin from the high dose- she has not had a shot 6x8 inches.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy student referring to a 12 month old patient. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. Concomitant therapies included sterile diluent. On 20-MAR-2019, the patient inadvertently received first dose of PROQUAD 0.5 milliliter, lot # N02592, for prophylaxis; that was past its expiration date. The dose had expiry date on 18-MAR-2019; however, no adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Accidental exposure to product, Exposure via skin contact, Occupational exposure to product, Product quality issue
Clinical narrative: This spontaneous report was received from a medical assistant via company representative referred to a female patient of an unknown age. The patient's pertinent concurrent conditions/drug allergies, medical history and concomitant therapies were not reported. On an unknown date in March 2019 (reported as about 3 weeks ago), the patient sustained a cut to her finger as a result of handling a defective GARDASIL 9 (lot number R011630 and expiration date: 12-DEC-2020) prefilled syringe that broke in her hand. The patient applied a bandage to the cut and it was healed. No patient was administered the dose of GARDASIL 9 from the defective prefilled syringe. The outcome of the product quality issue was unknown. Causality assessment was not provided. Product quality complaint was found and filed.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a consumer, regarding a female patient of unknown age. No patient's medical history, drug reactions, allergies or concurrent conditions were reported. On unknown date, the patient was vaccinated with VARIVAX and PROQUAD (frequency, strength, route of administration, dosage number, lot number and expiration date for both vaccines were not provided) as prophylaxis. On unknown date, the primary reporter stated that her niece was administered one dose of VARIVAX and one dose of PROQUAD. No adverse effects were reported. The outcome of extra dose administered was unknown.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood calcium increased, Blood creatinine increased, Blood potassium decreased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of calcium increased in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 15th August 2018, the patient received SHINGRIX. On 22nd August 2018, 7 days after receiving SHINGRIX, the patient experienced calcium increased (serious criteria hospitalization), potassium decreased (serious criteria hospitalization) and creatinine high (serious criteria hospitalization). On an unknown date, the outcome of the calcium increased, potassium decreased and creatinine high were recovered/resolved. It was unknown if the reporter considered the calcium increased, potassium decreased and creatinine high to be related to SHINGRIX. Additional details were provided as follows: No batch number or expiration date of Shingrix was provided. The patient was hospitalized with calcium as high as 16.1, potassium as low as 2.9 and creatinine as high as 3.0. Extensive workup with multiple specialists was done but showed no definitive cause. The patient had since recovered. Lab Comments: On an unknown date, extensive workup with multiple specialists was done but showed no definitive cause.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Insomnia, Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of influenza like illness in a 56-year-old male patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received the 1st dose of SHINGRIX. On 5th March 2019, less than a day after receiving SHINGRIX, the patient experienced influenza like illness, sleeplessness and feeling unwell. On an unknown date, the outcome of the influenza like illness, sleeplessness and feeling unwell were recovered/resolved. It was unknown if the reporter considered the influenza like illness, sleeplessness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX at left arm. The patient felt sick enough, like he was getting the flu, that he had to go home from work. He could not sleep all night after getting SHINGRIX. This is 1 of the 5 cases, reported by the same reporter.
Sex: M
Vaccine: PPV
Symptoms: Allergy to vaccine, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician. A 64-year-old male patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VALENT CONJUGATED VACCINE (DIPHTHERIA CRM197 PROTEIN, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergies with pneumococcal vaccine, swelling and fever on an unspecified date. The outcome of the event was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities. The following information on the batch number has been requested.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given Hep B #2 six days early.
Age: 12.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Axillary pain, Swelling
Clinical narrative: Received vaccine 3/25/19 in office at 12 year well check, GARDASIL #2 and Hep B #4 (due to timing). Developed sharp pain under (R) arm with swelling the next day. No redness, no fever used Ibuprofen prior to visit.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain, Pyrexia
Clinical narrative: Redness, itchiness, pain at injection site. Achiness, low grade fever.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Screaming
Clinical narrative: Pt. mom called the office on 3/28/19 stating that ever since Patient received his DTP vaccine on 3/22/19 around 6-7pm every night he goes into a screaming fit for 1-2 hours. Dr. saw the patient in follow-up on 3/29/19 and advised the mother to observe the symptoms and give TYLENOL and gripewater routine over the weekend. Pt. mom instructed to call Tuesday 4/2/19 with an update on patient symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Cold sweat, Electrocardiogram, Heart rate decreased, Hypotension
Clinical narrative: 2 hours after, pain increased in arm to point of unbearable. Became clammy, shaking, and when I stood up, all went white but did not pass out. Taken to Urgent Card, heart rate and BP very LOW.   Ambulance was called to take me to ER. IV inserted in right arm. Given meds to get rate up but not working, IV had "blown" and my entire arm swelled up. In ER blood taken (3 attempts), EKG etc. They got heart rate and BP up. Admitted to hospital for overnight observation. Another EKG, tests, etc. Was unable to move arm away from body and if assisted, very painful. Orthopedic Dr called in to examine and xray. It is believed that they hit a nerve when giving the injection or hit scar tissue from shoulder surgery. They are not sure that vaccine was at fault but reporting it as a precaution. Arm is still hurting but hopeful it will return to normal in time.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: 2 hours after, pain increased in arm to point of unbearable. Became clammy, shaking, and when I stood up, all went white but did not pass out. Taken to Urgent Card, heart rate and BP very LOW.   Ambulance was called to take me to ER. IV inserted in right arm. Given meds to get rate up but not working, IV had "blown" and my entire arm swelled up. In ER blood taken (3 attempts), EKG etc. They got heart rate and BP up. Admitted to hospital for overnight observation. Another EKG, tests, etc. Was unable to move arm away from body and if assisted, very painful. Orthopedic Dr called in to examine and xray. It is believed that they hit a nerve when giving the injection or hit scar tissue from shoulder surgery. They are not sure that vaccine was at fault but reporting it as a precaution. Arm is still hurting but hopeful it will return to normal in time.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Presyncope, Tremor, X-ray
Clinical narrative: 2 hours after, pain increased in arm to point of unbearable. Became clammy, shaking, and when I stood up, all went white but did not pass out. Taken to Urgent Card, heart rate and BP very LOW.   Ambulance was called to take me to ER. IV inserted in right arm. Given meds to get rate up but not working, IV had "blown" and my entire arm swelled up. In ER blood taken (3 attempts), EKG etc. They got heart rate and BP up. Admitted to hospital for overnight observation. Another EKG, tests, etc. Was unable to move arm away from body and if assisted, very painful. Orthopedic Dr called in to examine and xray. It is believed that they hit a nerve when giving the injection or hit scar tissue from shoulder surgery. They are not sure that vaccine was at fault but reporting it as a precaution. Arm is still hurting but hopeful it will return to normal in time.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient states after 2 months site of injection is still bruised as well as painful to touch.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pain
Clinical narrative: I experienced the following AEs: pain, soreness, headache, muscle aches, fever, shivering and nausea. Arm pain/soreness lasted 4 days. Headache, muscle aches, fever, shivering and nausea started at least 12 hours after shot was received and lasted about 8 hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I experienced the following AEs: pain, soreness, headache, muscle aches, fever, shivering and nausea. Arm pain/soreness lasted 4 days. Headache, muscle aches, fever, shivering and nausea started at least 12 hours after shot was received and lasted about 8 hours.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Ear discomfort, Paraesthesia oral, Taste disorder, Throat irritation
Clinical narrative: At 10:13 am, asked client if she was experiencing any side effects and she stated she had some tingling around lips, denied other symptoms. No respiratory distress. At 10:17 am, had tingling of upper and lower lips, no other symptom or respiratory distress. 10:27 am, tingling slightly improved, ears felt clogged. At 10:50, no change in symptoms. BP 148/90, complained of burning feeling to throat and when she received injection, "tasted it". Stated she did not take her allergy nose spray this morning. Cup of water given and swallowed without difficulty. Reviewed case with physician consultant and to observe for another 15 minutes. At 11:05, BP 110/70 and HR 76. Stated she feels ok to leave. Symptoms reviewed and went to call 911/ go to ER. Telephone call to client @1:19 pm- stated she is feeling fine, unsure what happened. Did not eat breakfast and maybe it was her "nerves".
Age: 17.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEPA, MENB, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PENTACEL given in Error, no adverse events as of today, day vaccine was given.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Local reaction, Pyrexia, Rash
Clinical narrative: 3/18/19 Had a local reaction to MMRV vaccination erythematous/itching at site w/o other symptoms. Treated with cetirizine with resolution. 3/29/19 fever/rash/and reactivation of local rash. Had URI symptoms so unsure if this was due to virus or separate reaction to the vaccine.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Upper respiratory tract infection
Clinical narrative: 3/18/19 Had a local reaction to MMRV vaccination erythematous/itching at site w/o other symptoms. Treated with cetirizine with resolution. 3/29/19 fever/rash/and reactivation of local rash. Had URI symptoms so unsure if this was due to virus or separate reaction to the vaccine.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Injection site pain, Visual impairment
Clinical narrative: Received GARDASIL/HPV vaccine at our office approximately 11:00 am. Reported feeling well during day with only local pain at injection site. Experienced dizziness approximately 11 pm that night. Had syncopal episode in bathroom. Got up with assist. Felt dizziness/visual changes. Had second syncopal episode. Up with assist. Slept all night. Reported feeling well today (3/27). No treatment provided.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Seizure
Clinical narrative: Seizures.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Dizziness, Erythema, Hyperaesthesia, Pruritus
Clinical narrative: 03-19-19 received vacc. - c/o itching x 2 days. 03-21-19 - c/o localized redness, hot to touch and sensitive to touch - increased swelling (size of softball) also c/o light headedness - mild blurred vision went to ER - Dx with cellulitis - started KEFLEX 500 mg QID.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm, Swelling
Clinical narrative: 03-19-19 received vacc. - c/o itching x 2 days. 03-21-19 - c/o localized redness, hot to touch and sensitive to touch - increased swelling (size of softball) also c/o light headedness - mild blurred vision went to ER - Dx with cellulitis - started KEFLEX 500 mg QID.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia, Pyrexia
Clinical narrative: Within one week of getting the shot, I developed full-blown pneumonia. Had to spend one week in the hospital with a fever of 103 some days. Between the time that I got the shot and the onset of pneumonia, I was not exposed to any potential carrier of it. I never had pneumonia before in my life. I lived by myself in an apartment as I had just moved and did not even know anyone. THE SHOT GAVE ME PNEUMONIA despite the fact that the hospital denied it over and over again.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Nausea, Presyncope
Clinical narrative: 4/1/19 0700 am sudden nausea and dizziness - almost fainted - excessive sweating.
Age: 16.0
Sex: F
Vaccine: HEP, HPV9, MENB, VARCEL
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Client came into clinic limping and complaining of right leg pain. Client not given any immunizations in leg. Client referred to primary care physician for further evaluation.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced pain and swelling at the injection site for 2 days, right deltoid. She also experienced numbness in her right hand for those 2 days. Pain and swelling began a couple of hours after the injection was given and persisted for 2 days and resolved spontaneously.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Swelling
Clinical narrative: Rash on chest and upper arm, painful swelling of shoulder, and a swelling on neck.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: FEVER RASH ITCHING AFTER 10 DAYS.
Age: 0.58
Sex: F
Vaccine: DTAP
Symptoms: Allergy test, Bowel movement irregularity, Insomnia, Irritability, Pain
Clinical narrative: Rash, irritable behavior, screaming in pain, bowl movements changed, not able to sleep and seemed over stimulated.
Age: 0.58
Sex: F
Vaccine: DTAP
Symptoms: Rash, Screaming
Clinical narrative: Rash, irritable behavior, screaming in pain, bowl movements changed, not able to sleep and seemed over stimulated.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Basophil count normal, Basophil percentage, Blood albumin normal
Clinical narrative: Patient began having chest pain, mild shortness of breath on exertion, and general malaise several days after receiving vaccination. Initially seen in the ED at Medical Center on 03/29/2019, had normal EKG, normal labs including troponin, CBC, CMP, and was discharged home. Continued to have symptoms, and was sent to the ED again from his clinic on 04/02/2019 as he had reported a fever orally of 101F on the evening of 04/01/2019. EKG, CBC, CMP again unremarkable; however troponin was elevated at 1.87. Given concern for myocarditis, patient will be admitted to Medical Center for Echocardiogram and further evaluation by medicine and Cardiology services.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: Patient began having chest pain, mild shortness of breath on exertion, and general malaise several days after receiving vaccination. Initially seen in the ED at Medical Center on 03/29/2019, had normal EKG, normal labs including troponin, CBC, CMP, and was discharged home. Continued to have symptoms, and was sent to the ED again from his clinic on 04/02/2019 as he had reported a fever orally of 101F on the evening of 04/01/2019. EKG, CBC, CMP again unremarkable; however troponin was elevated at 1.87. Given concern for myocarditis, patient will be admitted to Medical Center for Echocardiogram and further evaluation by medicine and Cardiology services.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal
Clinical narrative: Patient began having chest pain, mild shortness of breath on exertion, and general malaise several days after receiving vaccination. Initially seen in the ED at Medical Center on 03/29/2019, had normal EKG, normal labs including troponin, CBC, CMP, and was discharged home. Continued to have symptoms, and was sent to the ED again from his clinic on 04/02/2019 as he had reported a fever orally of 101F on the evening of 04/01/2019. EKG, CBC, CMP again unremarkable; however troponin was elevated at 1.87. Given concern for myocarditis, patient will be admitted to Medical Center for Echocardiogram and further evaluation by medicine and Cardiology services.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Chest X-ray normal, Chest pain, Dyspnoea exertional, Electrocardiogram normal, Eosinophil count normal
Clinical narrative: Patient began having chest pain, mild shortness of breath on exertion, and general malaise several days after receiving vaccination. Initially seen in the ED at Medical Center on 03/29/2019, had normal EKG, normal labs including troponin, CBC, CMP, and was discharged home. Continued to have symptoms, and was sent to the ED again from his clinic on 04/02/2019 as he had reported a fever orally of 101F on the evening of 04/01/2019. EKG, CBC, CMP again unremarkable; however troponin was elevated at 1.87. Given concern for myocarditis, patient will be admitted to Medical Center for Echocardiogram and further evaluation by medicine and Cardiology services.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Eosinophil percentage, Full blood count normal, Glomerular filtration rate, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Patient began having chest pain, mild shortness of breath on exertion, and general malaise several days after receiving vaccination. Initially seen in the ED at Medical Center on 03/29/2019, had normal EKG, normal labs including troponin, CBC, CMP, and was discharged home. Continued to have symptoms, and was sent to the ED again from his clinic on 04/02/2019 as he had reported a fever orally of 101F on the evening of 04/01/2019. EKG, CBC, CMP again unremarkable; however troponin was elevated at 1.87. Given concern for myocarditis, patient will be admitted to Medical Center for Echocardiogram and further evaluation by medicine and Cardiology services.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Lymphocyte count normal, Lymphocyte percentage, Malaise, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased
Clinical narrative: Patient began having chest pain, mild shortness of breath on exertion, and general malaise several days after receiving vaccination. Initially seen in the ED at Medical Center on 03/29/2019, had normal EKG, normal labs including troponin, CBC, CMP, and was discharged home. Continued to have symptoms, and was sent to the ED again from his clinic on 04/02/2019 as he had reported a fever orally of 101F on the evening of 04/01/2019. EKG, CBC, CMP again unremarkable; however troponin was elevated at 1.87. Given concern for myocarditis, patient will be admitted to Medical Center for Echocardiogram and further evaluation by medicine and Cardiology services.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Mean cell volume decreased, Mean platelet volume normal, Metabolic function test normal, Monocyte count increased, Monocyte percentage increased
Clinical narrative: Patient began having chest pain, mild shortness of breath on exertion, and general malaise several days after receiving vaccination. Initially seen in the ED at Medical Center on 03/29/2019, had normal EKG, normal labs including troponin, CBC, CMP, and was discharged home. Continued to have symptoms, and was sent to the ED again from his clinic on 04/02/2019 as he had reported a fever orally of 101F on the evening of 04/01/2019. EKG, CBC, CMP again unremarkable; however troponin was elevated at 1.87. Given concern for myocarditis, patient will be admitted to Medical Center for Echocardiogram and further evaluation by medicine and Cardiology services.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Neutrophil count normal, Neutrophil percentage decreased, Platelet count normal, Protein total increased, Pyrexia
Clinical narrative: Patient began having chest pain, mild shortness of breath on exertion, and general malaise several days after receiving vaccination. Initially seen in the ED at Medical Center on 03/29/2019, had normal EKG, normal labs including troponin, CBC, CMP, and was discharged home. Continued to have symptoms, and was sent to the ED again from his clinic on 04/02/2019 as he had reported a fever orally of 101F on the evening of 04/01/2019. EKG, CBC, CMP again unremarkable; however troponin was elevated at 1.87. Given concern for myocarditis, patient will be admitted to Medical Center for Echocardiogram and further evaluation by medicine and Cardiology services.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Red blood cell count normal, Red cell distribution width normal, Troponin I increased, White blood cell count normal
Clinical narrative: Patient began having chest pain, mild shortness of breath on exertion, and general malaise several days after receiving vaccination. Initially seen in the ED at Medical Center on 03/29/2019, had normal EKG, normal labs including troponin, CBC, CMP, and was discharged home. Continued to have symptoms, and was sent to the ED again from his clinic on 04/02/2019 as he had reported a fever orally of 101F on the evening of 04/01/2019. EKG, CBC, CMP again unremarkable; however troponin was elevated at 1.87. Given concern for myocarditis, patient will be admitted to Medical Center for Echocardiogram and further evaluation by medicine and Cardiology services.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest pain, Echocardiogram normal, Electrocardiogram change
Clinical narrative: Patient began having chest pain, mild shortness of breath on exertion, and general malaise several days after receiving vaccination. Initially seen in the ED at Medical Center on 03/29/2019, had normal EKG, normal labs including troponin, CBC, CMP, and was discharged home. Continued to have symptoms, and was sent to the ED again from his clinic on 04/02/2019 as he had reported a fever orally of 101F on the evening of 04/01/2019. EKG, CBC, CMP again unremarkable; however troponin was elevated at 1.87. Given concern for myocarditis, patient will be admitted to Medical Center for Echocardiogram and further evaluation by medicine and Cardiology services.
Age: 20.0
Sex: M
Vaccine: SMALL, ANTH, PPV, SMALL
Symptoms: Myocarditis, Red blood cell sedimentation rate increased, Troponin I increased, Viral test negative
Clinical narrative: Patient began having chest pain, mild shortness of breath on exertion, and general malaise several days after receiving vaccination. Initially seen in the ED at Medical Center on 03/29/2019, had normal EKG, normal labs including troponin, CBC, CMP, and was discharged home. Continued to have symptoms, and was sent to the ED again from his clinic on 04/02/2019 as he had reported a fever orally of 101F on the evening of 04/01/2019. EKG, CBC, CMP again unremarkable; however troponin was elevated at 1.87. Given concern for myocarditis, patient will be admitted to Medical Center for Echocardiogram and further evaluation by medicine and Cardiology services.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash macular, Skin warm
Clinical narrative: Pt reports arm feeling itchy, hot, pink, and blotchy. Symptoms presented about a week after vaccination on 4/1/2019.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Headache, fever and chills, sweating.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain
Clinical narrative: And chest pain.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Borrelia test positive, Dizziness, Headache, Immunology test, Lyme disease
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to a 14 year old female patient. It was unknown if the patient had concomitant medications, concurrent conditions, medical history, drug reaction or allergies. On 26-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided). On 12-DEC-2017, the patient went to the emergency department complaining of "being dizzy and light headed" (dizziness). On 27-DEC-2017, the patient was vaccinated with the second dose of GARDASIL 9 injection, for prophylaxis (strength, dose, frequency, route, lot number and expiration date were not provided) and continued to be dizzy. As a result, on an unspecified date in Januray 2018, the patient was screened for "Lymes disease and screened positive, but the western blot test came back negative". It was also stated that  "throughout the year of 2018, on unspecified dates, the patient had appointments with an unspecified cardiologist, neurologist, and otolaryngologists (ENT), and all unspecified findings were negative". Reporter stated that the patients "symptoms improved throughout the spring of 2018, however the patient went back to the Physician on unspecified date in December 2018 complaining of headache, and dizziness". As a result, the patient was tested again for "Lymes disease", and the "western blot for Lymes came back positive" (lyme disease) and was treated with "intravenous doxycycline twice on unspecified dates in 2018". The reporter stated that the "patient was still complaining of being dizzy currently". At the time of reporting, the outcome of lyme disease was reported as not resolved. The outcome of dizziness was recovered in March 2018. Causality assessment was not provided. Upon internal review, the event lyme disease was determined to be medically significant.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 68-year-old male patient who received SHINGRIX (batch number KB99G, expiry date 23rd February 2021) for prophylaxis. On 21st September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The patient experienced current episode of shingles after receiving SHINGRIX. The patient's date of birth is not encoded in the present case as the note in the classification keyword states that it is wrong.
Age: 51.0
Sex: M
Vaccine: TYP
Symptoms: Syringe issue
Clinical narrative: When assembling the injection, the cap on the syringe was not secured tightly enough to the end of the syringe. When attempting to attach the needle, the barrel section of the syringe slipped out of the cap. The cap assembly was not tightly secure. And cap assembly was not tightly secure.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Induration, Injection site warmth, Pruritus
Clinical narrative: Itching immediately after vaccine given on 3-13-19. Noted redness and induration on 3-14-19. Itching continues. Injection site warm to touch.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Myalgia, Neuropathy peripheral
Clinical narrative: Myalgia, Fever, Diarrhea, Tachycardia and neuropathy, chills, fatigue.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Myalgia, Fever, Diarrhea, Tachycardia and neuropathy, chills, fatigue.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Large reddened area at injection site. (Left vastus lateralis) increased in size from 3/26 - 3/27. Itchy, hard, warm. Prescribed CLEOCIN TID for 10 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Headache, Injection site pain, Nausea
Clinical narrative: Patient reported headache, nausea, and injection site pain with both doses in the series. With the second dose given on 3-25-19 she reported severe pain in her left arm pit area and reported this to her physician. Patient had been applying heat for 6 hours prior to reporting. Instructed to use ice and TYLENOL or ibuprofen for relief. Symptoms resolved after 3 days.
Age: 1.5
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Patient developed a bump at the injection site. Painful to the touch, bump is about 1-2 cm in size. Slight temperature in the am, that subsided through out the day. No other symptoms reported.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Infection, Pain, Scab
Clinical narrative: Pt reports expected soreness with some redness and swelling. Approximately 2.5 weeks after second SHINGRIX dose she experienced blistering on the shoulder near injection site. She ended up with 2 large blisters (lemon-sized) which broke open and scabbed. Blister sites have become infected and pt has been to her doctor and received an Rx for antibiotic cream.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Pt reports expected soreness with some redness and swelling. Approximately 2.5 weeks after second SHINGRIX dose she experienced blistering on the shoulder near injection site. She ended up with 2 large blisters (lemon-sized) which broke open and scabbed. Blister sites have become infected and pt has been to her doctor and received an Rx for antibiotic cream.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Influenza like illness, Myalgia
Clinical narrative: Elevated temperature, muscle aches. 26 hours later still 100 degree temp, muscle aches, feels like fuel symptoms. This is my second vaccination. My first was in August 2018 and this same reaction of being in bed for two days. I recovered before after 2 days and assume I will be improved tomorrow.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Influenza like illness, Injection site pain
Clinical narrative: Pt came to our office and received 1st dose of SHINGRIX vaccine at approx 11 AM on 3/30/19. Pt states that by the evennig on 3/30/19 she developed "shaking chills", severe headache, flu like body aches, injection site pain. Fever - took TYLENOL to relieve symptoms before taking temp. Highest temp she got on the thermometer was 99.0 F orally. Pt does have a history of asthma but did state that she had some issues with wheezing but did not have any issue before getting SHINGRIX vaccine. Pt states that the shaking chills and fever symptoms last 1.5 days. She is still having issues with injection site pain/weakness, headache, and muscle aches 4 days post vaccination. Pt reported concerns to RN Care Manager out of concern for meeting a new granddaughter and the length of the side effects. Information was called to PCP office manager to report to PCP.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Pt came to our office and received 1st dose of SHINGRIX vaccine at approx 11 AM on 3/30/19. Pt states that by the evennig on 3/30/19 she developed "shaking chills", severe headache, flu like body aches, injection site pain. Fever - took TYLENOL to relieve symptoms before taking temp. Highest temp she got on the thermometer was 99.0 F orally. Pt does have a history of asthma but did state that she had some issues with wheezing but did not have any issue before getting SHINGRIX vaccine. Pt states that the shaking chills and fever symptoms last 1.5 days. She is still having issues with injection site pain/weakness, headache, and muscle aches 4 days post vaccination. Pt reported concerns to RN Care Manager out of concern for meeting a new granddaughter and the length of the side effects. Information was called to PCP office manager to report to PCP.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Small localized swelling immediately after injection given at 1 pm. That evening patient noticed continued swelling at site of injection and right axillary lymph adenopathy. Swelling was itchy, red, and painful. Pt came back to our clinic following day and NP found 6" x 7" red induration at site of injection with lymphadenopathy in R axilla. Less than 24h after injection, NP determined to be a site localized reaction and recommended ice and antihistamines. Pt went to urgent care after work (a little after 24h after injection) and they diagnosed it as cellulitis and started antibiotics. Pt took antibiotics overnight but without improvement.  Pt went to ED where they also diagnosed as cellulitis and told him to continue antibiotics. Following day, lesion started improving in redness, swelling, and adenopathy reduced.  6 days after initial injection, patient is back to normal and asymptomatic.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Local reaction, Lymphadenopathy, Swelling
Clinical narrative: Small localized swelling immediately after injection given at 1 pm. That evening patient noticed continued swelling at site of injection and right axillary lymph adenopathy. Swelling was itchy, red, and painful. Pt came back to our clinic following day and NP found 6" x 7" red induration at site of injection with lymphadenopathy in R axilla. Less than 24h after injection, NP determined to be a site localized reaction and recommended ice and antihistamines. Pt went to urgent care after work (a little after 24h after injection) and they diagnosed it as cellulitis and started antibiotics. Pt took antibiotics overnight but without improvement.  Pt went to ED where they also diagnosed as cellulitis and told him to continue antibiotics. Following day, lesion started improving in redness, swelling, and adenopathy reduced.  6 days after initial injection, patient is back to normal and asymptomatic.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Fall, Syncope
Clinical narrative: Patient fainted and fell over on the bench she was sitting on and ammonia inhalant was used to arouse patient. She had no complaints of pain or dizziness after she woke up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Feeling abnormal, Mobility decreased, Syncope
Clinical narrative: On the morning following the injection, I awoke, feeling okay, went to the kitchen for my omeprazole, and then went into the shower (as usual). After a few minute, I began to feel odd, and thought I was going to faint. I got out of the shower, grabbed a towel, and sat on the closed toilet seat. Next thing I knew, I was on the floor -- don't remember falling or slipping. I felt I couldn't move, but after a few moments, I was able to get myself up, holding on to the counter nearby. I was breathing heavily. Got myself to my bed in the next room, and lay there until I felt able to get up  I don't know how long I was on the floor, because I guess I fainted. I took it easy,and was okay the rest of the day.
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Ear swelling, Eye swelling, Hypersensitivity, Inflammation, Peripheral swelling
Clinical narrative: The patient came to the pharmacy on 4/2/19 she said that she has an adverse reaction due a vaccine that she received in our pharmacy. On 3/27/19 two vaccines FLUARIX on right arm and PNEUMOVAX on left arm. On 3/29/19 she said that her left arm was swelling and hot but nothing further. On 3/30/19 the back of her ear was swelling then on Sunday 3/31/2019 the forehead was swelling and on Monday April 1, 2019 the area under the eyes start swelling she visit her primary physician on 4/2/19. Her primary physician sent a prescription of Methylprednisolone Dose pack.  Dr. (her primary physician) said that the patient apparently has an allergic reaction that her arm do not appear to has infection just a normal reaction at the site of the injection but her eyes are swelling he prescribe corticosteroids to relief the inflammation.