chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: This spontaneous case, initially received on 28-Sep-2016, was reported by a health professional and concerns a 33-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 27-SEP-2016 to 27-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: WT55407. Site: Left deltoid. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown day in Sep-2016 following vaccination, the patient experienced an AFLURIA injection site reaction of a whelp that measures 60 mm by 50 mm. The reaction is red, warm, and raised. The injection site is on left deltoid. Ice was recommended. Outcome for all events: not reported. Reporter comments: The reporter considered all events as non-serious.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product deposit
Clinical narrative: This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a(n) 80-year-old female patient. Weight: Not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Sex: M
Vaccine: FLU4, MMR
Symptoms: Amylase increased, Blood culture negative, Blood sodium decreased, Computerised tomogram abnormal, Computerised tomogram head abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a 82-year-old male patient who received Influenza vaccine Quadrivalent. Co-suspect products included M-M-R. The patient's past medical history included paroxysmal atrial fibrillation and aortic valve stenosis (severe calcific aortic valve stenosis status post replacement with a tissue valve). Concurrent medical conditions included hypertension. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose and M-M-R at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), influenza A virus infection (serious criteria hospitalization), parotitis (serious criteria hospitalization), soft tissue inflammation (serious criteria hospitalization), cough (serious criteria hospitalization), myalgia (serious criteria hospitalization), sore throat (serious criteria hospitalization), swollen mouth (serious criteria hospitalization), fever (serious criteria hospitalization), parotid gland enlargement (serious criteria hospitalization) and hyperemia (serious criteria hospitalization). The patient was treated with azithromycin and Amoxicillin + Clavulanic Acid. On an unknown date, the outcome of the vaccination failure, influenza A virus infection, soft tissue inflammation, cough, myalgia, sore throat and fever were unknown and the outcome of the parotitis, swollen mouth, parotid gland enlargement and hyperemia were recovered/resolved. The reporter considered the vaccination failure, influenza A virus infection, cough, myalgia, sore throat and fever to be related to Influenza vaccine Quadrivalent. The reporter considered the parotitis, soft tissue inflammation, swollen mouth, parotid gland enlargement and hyperemia to be possibly related to Influenza vaccine Quadrivalent.
Sex: M
Vaccine: FLU4, MMR
Symptoms: Cough, Hyperaemia, Influenza, Influenza A virus test positive, Influenza B virus test
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a 82-year-old male patient who received Influenza vaccine Quadrivalent. Co-suspect products included M-M-R. The patient's past medical history included paroxysmal atrial fibrillation and aortic valve stenosis (severe calcific aortic valve stenosis status post replacement with a tissue valve). Concurrent medical conditions included hypertension. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose and M-M-R at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), influenza A virus infection (serious criteria hospitalization), parotitis (serious criteria hospitalization), soft tissue inflammation (serious criteria hospitalization), cough (serious criteria hospitalization), myalgia (serious criteria hospitalization), sore throat (serious criteria hospitalization), swollen mouth (serious criteria hospitalization), fever (serious criteria hospitalization), parotid gland enlargement (serious criteria hospitalization) and hyperemia (serious criteria hospitalization). The patient was treated with azithromycin and Amoxicillin + Clavulanic Acid. On an unknown date, the outcome of the vaccination failure, influenza A virus infection, soft tissue inflammation, cough, myalgia, sore throat and fever were unknown and the outcome of the parotitis, swollen mouth, parotid gland enlargement and hyperemia were recovered/resolved. The reporter considered the vaccination failure, influenza A virus infection, cough, myalgia, sore throat and fever to be related to Influenza vaccine Quadrivalent. The reporter considered the parotitis, soft tissue inflammation, swollen mouth, parotid gland enlargement and hyperemia to be possibly related to Influenza vaccine Quadrivalent.
Sex: M
Vaccine: FLU4, MMR
Symptoms: Influenza virus test negative, Mouth swelling, Myalgia, Oropharyngeal pain, Parotid gland enlargement
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a 82-year-old male patient who received Influenza vaccine Quadrivalent. Co-suspect products included M-M-R. The patient's past medical history included paroxysmal atrial fibrillation and aortic valve stenosis (severe calcific aortic valve stenosis status post replacement with a tissue valve). Concurrent medical conditions included hypertension. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose and M-M-R at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), influenza A virus infection (serious criteria hospitalization), parotitis (serious criteria hospitalization), soft tissue inflammation (serious criteria hospitalization), cough (serious criteria hospitalization), myalgia (serious criteria hospitalization), sore throat (serious criteria hospitalization), swollen mouth (serious criteria hospitalization), fever (serious criteria hospitalization), parotid gland enlargement (serious criteria hospitalization) and hyperemia (serious criteria hospitalization). The patient was treated with azithromycin and Amoxicillin + Clavulanic Acid. On an unknown date, the outcome of the vaccination failure, influenza A virus infection, soft tissue inflammation, cough, myalgia, sore throat and fever were unknown and the outcome of the parotitis, swollen mouth, parotid gland enlargement and hyperemia were recovered/resolved. The reporter considered the vaccination failure, influenza A virus infection, cough, myalgia, sore throat and fever to be related to Influenza vaccine Quadrivalent. The reporter considered the parotitis, soft tissue inflammation, swollen mouth, parotid gland enlargement and hyperemia to be possibly related to Influenza vaccine Quadrivalent.
Sex: M
Vaccine: FLU4, MMR
Symptoms: Parotitis, Pyrexia, Respiratory syncytial virus test negative, Soft tissue inflammation, Vaccination failure
Clinical narrative: This case was reported in a literature article and described the occurrence of vaccination failure in a 82-year-old male patient who received Influenza vaccine Quadrivalent. Co-suspect products included M-M-R. The patient's past medical history included paroxysmal atrial fibrillation and aortic valve stenosis (severe calcific aortic valve stenosis status post replacement with a tissue valve). Concurrent medical conditions included hypertension. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose and M-M-R at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), influenza A virus infection (serious criteria hospitalization), parotitis (serious criteria hospitalization), soft tissue inflammation (serious criteria hospitalization), cough (serious criteria hospitalization), myalgia (serious criteria hospitalization), sore throat (serious criteria hospitalization), swollen mouth (serious criteria hospitalization), fever (serious criteria hospitalization), parotid gland enlargement (serious criteria hospitalization) and hyperemia (serious criteria hospitalization). The patient was treated with azithromycin and Amoxicillin + Clavulanic Acid. On an unknown date, the outcome of the vaccination failure, influenza A virus infection, soft tissue inflammation, cough, myalgia, sore throat and fever were unknown and the outcome of the parotitis, swollen mouth, parotid gland enlargement and hyperemia were recovered/resolved. The reporter considered the vaccination failure, influenza A virus infection, cough, myalgia, sore throat and fever to be related to Influenza vaccine Quadrivalent. The reporter considered the parotitis, soft tissue inflammation, swollen mouth, parotid gland enlargement and hyperemia to be possibly related to Influenza vaccine Quadrivalent.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash
Clinical narrative: Rash on entire leg of administration.
Age: 28.0
Sex: F
Vaccine: ANTH, JEV1, SMALL, ANTH, JEV1, SMALL
Symptoms: Rash
Clinical narrative: Rash on right side of face for several days.
Age: 28.0
Sex: F
Vaccine: ANTH, JEV1, SMALL, ANTH, JEV1, SMALL
Symptoms: Erythema, Eyelid oedema, Skin exfoliation, Skin irritation
Clinical narrative: Rash on right side of face for several days.
Age: 18.0
Sex: F
Vaccine: ANTH, JEV1, SMALL, ANTH, JEV1, SMALL
Symptoms: Rash
Clinical narrative: On 01 Apr 17 received typhoid, and AVA and JE #1. One week later both eyelids were swollen from lid to brow. The area became red, irritated and skin was flaking. She went to a MD and was given both ZYRTEC and BENADRYL. Area stated to improve but was not completely better when she received AVA and JE # 2 on 06 May 17. Approx 3 days later she had the return of swelling to eyelids and to the right side of her face and neck is currently clear, but her eyes are still a little flakey. She states that when she misses a dose of BENADRYL the swelling returns. She denies any new creams, lotions, or foods. Never had anything like this before and denied problems with previous immunizations. Rash and oth nonspec skin eruption.
Age: 18.0
Sex: F
Vaccine: ANTH, JEV1, SMALL, ANTH, JEV1, SMALL
Symptoms: Erythema, Eyelid oedema, Skin exfoliation, Skin irritation
Clinical narrative: On 01 Apr 17 received typhoid, and AVA and JE #1. One week later both eyelids were swollen from lid to brow. The area became red, irritated and skin was flaking. She went to a MD and was given both ZYRTEC and BENADRYL. Area stated to improve but was not completely better when she received AVA and JE # 2 on 06 May 17. Approx 3 days later she had the return of swelling to eyelids and to the right side of her face and neck is currently clear, but her eyes are still a little flakey. She states that when she misses a dose of BENADRYL the swelling returns. She denies any new creams, lotions, or foods. Never had anything like this before and denied problems with previous immunizations. Rash and oth nonspec skin eruption.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain
Clinical narrative: Patient had a flu shot on Nov 12, 2016. He stated that he has been having pain from the injection and is getting treatment for it. We filled his medications and counseled him on their proper use. He needed more information about the flu shot he got and we provided it for him also.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: FEVER, CHILLS, BODY ACHES, RED, WARM RASH AT INJECTION SITE, CELLULITIS OF R ARM.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER, CHILLS, BODY ACHES, RED, WARM RASH AT INJECTION SITE, CELLULITIS OF R ARM.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Injection site bruising, Injection site erythema, Pain, Pyrexia
Clinical narrative: Bruise at injection site, 2 red dots on either side of injection site, fever and achiness.
Age: 77.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Asthenia, Fatigue, Injection site pain, Loss of personal independence in daily activities, Middle insomnia
Clinical narrative: Continuing pain in shoulder where shot was given. No redness or swelling, but deep bone and muscle ache and pain in rotating and moving arm/shoulder, prompting me to call clinic after 4 weeks. Was advised it was a common side effect, to take ibuprofen or Tylenol if continued. Also if continued to check with a doctor. I went to clinic in  where I was examined by a physician and 3 x-rays were taken. No abnormality was found and was advised to continue with the pain medication. It has now been 7 months and the pain continues, waking me up at night if I lay on the arm, and limiting my use of it. Normal activities such as reaching cause pain. The pain is like a deep-seated toothache, sometimes sharper than others. I do not like to take pain medication and only take it I can't sleep or if activities have over-stressed my shoulder. There is no external indication that anything is wrong. The x-rays showed nothing. And still this is affecting my activities. I do feel fatigue and loss of energy to do normal amount of work. I've had to change the way I put on my shirt or jacket, pull cover over my shoulder at night and so on. I am a healthy person otherwise, active and trying not to let this be a major factor in my life as many have it worse. However, it is bothersome.
Age: 77.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: X-ray normal
Clinical narrative: Continuing pain in shoulder where shot was given. No redness or swelling, but deep bone and muscle ache and pain in rotating and moving arm/shoulder, prompting me to call clinic after 4 weeks. Was advised it was a common side effect, to take ibuprofen or Tylenol if continued. Also if continued to check with a doctor. I went to clinic in  where I was examined by a physician and 3 x-rays were taken. No abnormality was found and was advised to continue with the pain medication. It has now been 7 months and the pain continues, waking me up at night if I lay on the arm, and limiting my use of it. Normal activities such as reaching cause pain. The pain is like a deep-seated toothache, sometimes sharper than others. I do not like to take pain medication and only take it I can't sleep or if activities have over-stressed my shoulder. There is no external indication that anything is wrong. The x-rays showed nothing. And still this is affecting my activities. I do feel fatigue and loss of energy to do normal amount of work. I've had to change the way I put on my shirt or jacket, pull cover over my shoulder at night and so on. I am a healthy person otherwise, active and trying not to let this be a major factor in my life as many have it worse. However, it is bothersome.
Age: 2.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Crying, Hypophagia, Intensive care, Laboratory test, Lethargy
Clinical narrative: Mom previously presented to ED on 5/23 concern of vomiting sent home. Triage call to RN on 524/17 mom concerns of vomiting, swollen hands and feet, not eating or drinking, lethargic. Disposition patient to present ASAP. Patient presented to clinic the afternoon of 5/24/17 sleeping in moms arms in the lobby. Nurse brought patient back to exam room. Patient awake and alert, crying during height and weight. Mom holding child in lap, child began lip smacking and black stare at ceiling. Patient unresponsive to stimulation, provider was contacted to come into room and code was called. Patient transferred on oxygen to ICU for seizure management. Patient currently still admitted on 5/25/2017.
Age: 2.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Peripheral swelling, Seizure, Staring, Tardive dyskinesia, Unresponsive to stimuli
Clinical narrative: Mom previously presented to ED on 5/23 concern of vomiting sent home. Triage call to RN on 524/17 mom concerns of vomiting, swollen hands and feet, not eating or drinking, lethargic. Disposition patient to present ASAP. Patient presented to clinic the afternoon of 5/24/17 sleeping in moms arms in the lobby. Nurse brought patient back to exam room. Patient awake and alert, crying during height and weight. Mom holding child in lap, child began lip smacking and black stare at ceiling. Patient unresponsive to stimulation, provider was contacted to come into room and code was called. Patient transferred on oxygen to ICU for seizure management. Patient currently still admitted on 5/25/2017.
Age: 2.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Vomiting
Clinical narrative: Mom previously presented to ED on 5/23 concern of vomiting sent home. Triage call to RN on 524/17 mom concerns of vomiting, swollen hands and feet, not eating or drinking, lethargic. Disposition patient to present ASAP. Patient presented to clinic the afternoon of 5/24/17 sleeping in moms arms in the lobby. Nurse brought patient back to exam room. Patient awake and alert, crying during height and weight. Mom holding child in lap, child began lip smacking and black stare at ceiling. Patient unresponsive to stimulation, provider was contacted to come into room and code was called. Patient transferred on oxygen to ICU for seizure management. Patient currently still admitted on 5/25/2017.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Pain, Skin irritation, Skin warm
Clinical narrative: Pt experienced large local reaction in the left triceps region of the arm. Pt went to the ER the following night of administration and c/o intense pain, hot to the touch and irritation. pt was given steroid and iced the area.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Induration, Pain, Pruritus, Swelling
Clinical narrative: Redness, hard induration/swelling, pain, itching. Did not require treatment.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling.
Age: 25.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Pain, Rash erythematous
Clinical narrative: Soreness, 5cm diameter red rash.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling, Swelling
Clinical narrative: This spontaneous report was received from a female consumer of "just over 50 years old", via company representative, referring to herself. The patient's medical history included varicella. The patient's concurrent condition, drug and allergy history was not reported. On 14-APR-2017 the patient was vaccinated with ZOSTAVAX (dose, strength, route of administration, lot number and expiration date were not reported) for prophylaxis. The patient's concomitant medication was not reported. The reporter stated that, on 15-APR-2017, the day after receiving the vaccine the patient experienced redness and swelling in the arm, lymph nodes under the arm, and into the breast area. In addition it was reported that the physician/employer looked at the patient's arm and "offered no treatment, but directed the patient that she would be all right". The outcome of the events were reported as resolved, on an unspecified date in 2017. The causality assessment between ZOSTAVAX and the adverse events was unknown at the time of reporting. Additional information is not expected, because physician refused additional contact.
Sex: F
Vaccine: HPV9
Symptoms: Chills, Headache, Nausea, Pain of skin, Vomiting
Clinical narrative: Information was received on 10-MAY-2017 from a physician via a company representative regarding a unspecified number of female patients. Medical history, concurrent conditions and concomitant medications were not reported. On 08-MAY-2017 and 09-MAY-2017 the patients received their first dose of GARDASIL 9 ( lot numbers and dose not specified) for the indication of age appropriate HPV prophylaxis. Per the physician, the patients "had the same callback complaints today (10-MAY-2017): headache, nausea, vomiting, chills, and complained their skin was hurting." As of the report, the patients status was reported as not recovered. No further information was provided. The physician did not rate the causal relationship. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative, referring to an 11 years old male patient. The patient's medical history, concurrent condition, drug and allergy history was not reported. There were not concomitant medications reported. On an unknown date, the patient was vaccinated intramuscularly with GARDASIL 9, solution for injection (dose, frequency, lot number and the expiration date were not reported), for vaccination (prophylaxis). Other suspect non-Merck therapies included, MENACTRA and DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE) (dose, frequency, administration route, lot number, expiration date and indication were not reported). On an unspecified date (reported as very recent), the patient experienced syncopal episode immediately following the administration of GARDASIL 9. In addition, it was reported that an orange juice was given to the patient after the episode. The reporter was not certain which of the vaccines caused the adverse event. The patient's outcome was reported as recovered. The causality assessment between GARDASIL 9 and syncope was unknown at the time of reporting. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a registered nurse concerning to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unspecified date, the patients were vaccinated with one dose of M-M-R II diluted in sterile diluent for prophylaxis (the lot #, expiration date, route, frequency, strength, and dose were not provided). On an unspecified date, due to a local measles outbreak, the patients had a titers test which was negative. At the time of this report, the patients had not received the second vaccine dose yet. The outcome of the event and the causal relationship between the event and the vaccine were unknown. This is one of two reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008462.
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information had been received on 22-MAY-2017 from a medical assistant who reported that a male patient (age unknown) received an expired dose of PROQUAD (lot# L044055, expiration 02-MAY-2017) on 19-MAY-2017. No adverse effects were reported. No further details provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Swollen to the size of a baseball, red, sore,itchy, and hot to the touch.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Erythematous raised rash around injection site on Upper L thigh, non tender no warmths no edema.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS, SWELLING, PAIN AT THE INJECTION SITE.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: KINRIX was given to a 6mo old. No adverse reaction noted no treatment needed.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: PATIENT BEGAN TO BECOME SICK TO STOMACH AND BE VERY LIGHTHEADEDED. SYMPTOMS SUBSIDED THEN BEGAN TO COMPLAIN OF A HEADACHE WHICH IS GETTING WORSE IN A NATURE.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema
Clinical narrative: Mild erythema at site of injection in less than 10 min after injection. Benadryl given in office and Mother of child to re dose after 6 hours.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 5/24/17 pt states: -raised red bump at site of injection (about $ inches down arm) -"density at site of injection -not a lot of heat at touch but looks and feels bruised -slight pain/tender to the touch (feels like hard deep bruise) on 5/25/17 at phone follow up with pt. pt states: - trending better -faiding in redness and pain is better than yesterday -site of injection is less density and less swollen -reports no fever.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Pain, Tenderness
Clinical narrative: 5/23 dose given. 5/24 very sore/stiff..pt cont to exercise arm, later pain at touch. 5/25 no longer sore or stiff but redness starting about an inch below site and pooling/swelling in distal bicep area.  Pt reported to me today and will see dr tomorrow.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Significant red, mildly raised area, tender when pressure is applied on 05/23/2017 at 10PM and 05/24/2017 at 10AM. On 05/25/2017 at 9:30AM there redness and swelling spread. Pt stated it had gotten better the night before prior to worsening. She denied any systemic reactions. Pt was advised to take OTC Benadryl and Ibuprofen PRN.
Age: 43.0
Sex: M
Vaccine: HEPAB, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reported pain and redness at injection site of PNEUMOVAX 23.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling on most of the bicep near injection, redness, heat, no fever, no nausea, extremely painful.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Hyperhidrosis, Pharyngeal oedema, Throat irritation
Clinical narrative: Pt c/o new onset itchy throat and trouble breathing. Pt diaphoretic. BP 154/95. Per MD, patient had throat swelling. Pt treated with epinephrine 0.3mg IM @ 1206 and 1226, Benadryl 25mg IV @ 1210, racemic epi 0.5mL @ 1223, prednisone 60mg po @ 1415.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Allergy test, Crying, Diarrhoea, Diet refusal, Discomfort
Clinical narrative: After vaccine administration she was fussy and crying in her car seat for about an hour. When I got her out she was really hot, so I took her temperature. It was 103.4f acillary. I gave her Tylenol. Temp came down to 101f. She was fussy, crying, in distress, rapid breathing app afternoon. She also vomited. The only intake she had was direct breast milk. She had another dose of Tylenol at 4pm and it brought her temperature back down to 101.3. She was fussy and seemed to be feeling worse. Said "head hurt". I noticed her lip swelling around 5:30 or 6pm. Called the after hour nurse. Was directed to urgent care. They assessed her, gave her Motrin. I was dissatisfied w her care. That night she didn't sleep well, woke w fever and in a lot of discomfort. I monitored her breathing and gave her Tylenol through the night. She jolted awake and had very disturbed breathing and sleep patterns, but no respiratory distress. She seemed to be improved the next day (5/25), but still fussy, didn't want to eat or drink, and had a low grade fever. She was gassy and had diarrhea. Still has not slept well or been herself, but does seem to be improving.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Emotional distress, Flatulence, Headache, Hyperventilation, Irritability
Clinical narrative: After vaccine administration she was fussy and crying in her car seat for about an hour. When I got her out she was really hot, so I took her temperature. It was 103.4f acillary. I gave her Tylenol. Temp came down to 101f. She was fussy, crying, in distress, rapid breathing app afternoon. She also vomited. The only intake she had was direct breast milk. She had another dose of Tylenol at 4pm and it brought her temperature back down to 101.3. She was fussy and seemed to be feeling worse. Said "head hurt". I noticed her lip swelling around 5:30 or 6pm. Called the after hour nurse. Was directed to urgent care. They assessed her, gave her Motrin. I was dissatisfied w her care. That night she didn't sleep well, woke w fever and in a lot of discomfort. I monitored her breathing and gave her Tylenol through the night. She jolted awake and had very disturbed breathing and sleep patterns, but no respiratory distress. She seemed to be improved the next day (5/25), but still fussy, didn't want to eat or drink, and had a low grade fever. She was gassy and had diarrhea. Still has not slept well or been herself, but does seem to be improving.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Lip swelling, Poor quality sleep, Pyrexia, Respiratory rate increased, Skin warm
Clinical narrative: After vaccine administration she was fussy and crying in her car seat for about an hour. When I got her out she was really hot, so I took her temperature. It was 103.4f acillary. I gave her Tylenol. Temp came down to 101f. She was fussy, crying, in distress, rapid breathing app afternoon. She also vomited. The only intake she had was direct breast milk. She had another dose of Tylenol at 4pm and it brought her temperature back down to 101.3. She was fussy and seemed to be feeling worse. Said "head hurt". I noticed her lip swelling around 5:30 or 6pm. Called the after hour nurse. Was directed to urgent care. They assessed her, gave her Motrin. I was dissatisfied w her care. That night she didn't sleep well, woke w fever and in a lot of discomfort. I monitored her breathing and gave her Tylenol through the night. She jolted awake and had very disturbed breathing and sleep patterns, but no respiratory distress. She seemed to be improved the next day (5/25), but still fussy, didn't want to eat or drink, and had a low grade fever. She was gassy and had diarrhea. Still has not slept well or been herself, but does seem to be improving.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Sleep disorder, Vomiting
Clinical narrative: After vaccine administration she was fussy and crying in her car seat for about an hour. When I got her out she was really hot, so I took her temperature. It was 103.4f acillary. I gave her Tylenol. Temp came down to 101f. She was fussy, crying, in distress, rapid breathing app afternoon. She also vomited. The only intake she had was direct breast milk. She had another dose of Tylenol at 4pm and it brought her temperature back down to 101.3. She was fussy and seemed to be feeling worse. Said "head hurt". I noticed her lip swelling around 5:30 or 6pm. Called the after hour nurse. Was directed to urgent care. They assessed her, gave her Motrin. I was dissatisfied w her care. That night she didn't sleep well, woke w fever and in a lot of discomfort. I monitored her breathing and gave her Tylenol through the night. She jolted awake and had very disturbed breathing and sleep patterns, but no respiratory distress. She seemed to be improved the next day (5/25), but still fussy, didn't want to eat or drink, and had a low grade fever. She was gassy and had diarrhea. Still has not slept well or been herself, but does seem to be improving.
Age: 1.75
Sex: M
Vaccine: MMR
Symptoms: Injection site reaction, Injection site warmth, Pyrexia, Rash erythematous
Clinical narrative: Pink, hot rash on thigh in which MMR booster was administered. Fever between 101-103.5.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose, Blood pressure increased, Dysarthria, Electrocardiogram, Heart rate decreased
Clinical narrative: Patient had MENACTRA vaccine. Within 5 min at admin had reaction of dilated pupils, slurred speech, decrease heart rate and oxygen,  increased blood pressure. EMS was called and was cleared. Blood sugar and EKG done in office.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Mydriasis, Oxygen saturation decreased
Clinical narrative: Patient had MENACTRA vaccine. Within 5 min at admin had reaction of dilated pupils, slurred speech, decrease heart rate and oxygen,  increased blood pressure. EMS was called and was cleared. Blood sugar and EKG done in office.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema
Clinical narrative: Redness over vaccines site.
Age: 1.42
Sex: F
Vaccine: HEPA, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Pt given ZOSTAVAX instead of VARIVAX.
Age: 1.08
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Diarrhoea, Injection site erythema, Pyrexia, Rash generalised
Clinical narrative: Shot given on 5/9/17. From 5/10/17 - 5/17/17 had diarrhea with a low grade fever. 5/19/17 injection site was very red and she started to break out in a rash on her back. By the next day 5/20/17 she was broke out head to toe with a rash and fever. (Injection site was Rt thigh).
Age: 49.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Skin discolouration, Skin warm
Clinical narrative: Localized redness and purplish streaks and feels hot. Dr. treated with cold pack and hydrocortisone. Redness measured 48mm ".
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Red, painful lump, swelling in (R) upper arm.
Age: 71.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus
Clinical narrative: No swelling FR (R) deltoid muscle today but swelling and redness has gone down to lower anterior arm. Swelling/induration around 10x12 cm, redness 12x15 cm. Pt also C/O itching. RX: KEFLEX x 7 days, Triamcinolone CR.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen - Red - sore left arm. Swelling past the elbow. Patient contacted her provider, who prescribed PREDNISONE 50 mg for 5 day plus ADVIL PM. Getting a bit better. Pt. contacted Pharmacy on 5-24-17 and said that she will verify with her provider. RPh called provider and patient on 5-25-17 to follow up.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Pt with swelling and moderate pain in area of vaccine administration, present on exam two weeks later.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Patient given ZOSTAVAX in place of VARIVAX.
Sex: F
Vaccine: FLUX
Symptoms: Death, Drug hypersensitivity, Non-small cell lung cancer
Clinical narrative: This spontaneous case, initially received on 23-Aug-2016, was reported by a health professional and concerns a female patient. Past medical history included COPD (chronic obstructive pulmonary disease), peripheral neuropathy, atrial fibrillation, abdominal aortic aneurysm and anxiety. Drug history included drug reactions/allergies to cefazolin and diphenhydramine. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced drug reactions/allergies (outcome: not reported). On an unspecified date in July 2015, the patient began therapy with KEYTRUDA injection for advanced non-small cell lung cancer 'refractory to all prior treatment' and died to progression of the disease. At the time of death on 11-Mar-2016, the patient was taking unspecified doses of the following medications: albuterol, alprazolam, DULCOLAX, SYMBICORT, DIPROLENE, vitamin B-12, COLACE, doxycycline, furosemide, gabapentin, MUCINEX, hydrocodone, DUONEB, lactobacillus, levothyroxine, magnesium chloride, metoprolol, morphine, multi-vitamin, prednisone, prochlorperazine and warfarin.
Age: 87.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 87 year old patient. Weight: not provided. Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 07-Sep-2016, the patient received AFLURIA for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 07-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Blood test, Blood thyroid stimulating hormone increased, Computerised tomogram abnormal
Clinical narrative: This spontaneous case, initially received on 31-Oct-2016, was reported by a non health professional and concerns a male patient. Weight: not provided; Height: not provided. Past medical history included low thyroid levels and pneumonia. Drug history includes carboplatin (reaction: pneumonia, low red blood cells, low white blood cells) and ABRAXANE (reaction: pneumonia, low red blood cells, low white blood cells). Concomitant medication: methylphenidate hydrochloride and salbutamol. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported, Batch number: Not reported. Non-company suspect drugs: On 18-Aug-2016, the patient received KEYTRUDA for non-small cell lung cancer. Dosage regimen: 100 mg once every three weeks. Route of administration: Intravenous. Batch number: Unknown. Next dose due 04-Nov-2016. Adverse reactions/events and outcomes: On an unknown date, the patient experienced being more tired, less active, joint pain in his knees and joint pain in his 3 fingers on right hand and a loss of appetite starting on an unspecified date. The patient states that when he comes home after receiving KEYTRUDA he goes right to bed and sleeps. The patient states that he does feel better the next morning because he is less tired and reports worsening neuropathy since starting KEYTRUDA. Outcome for all events: not recovered/not resolved. The patient sought medical attention by visiting a physician. Treatment was given for the adverse event. Lab diagnostic studies performed: blood tests. Additional information was received on 11-Jan-2017: On 09-Nov-2016, the patient received his third infusion of KEYTRUDA. He continued to feel tired since the starting of KEYTRUDA. The joint pain in his knees and joint pain in his three fingers on the right hand had improved. He continued to lose appetite but was not losing weight. His oncologist prescribed him with levothyroxine because his thyroid level was low and his TSH was high. He had a cough and had been coughing up phlegm since 'last week'. His oncologist also prescribed him Z-PAK for a lung infection and he was feeling better. His oncologist started him on an unspecified inhaler a, morphine and prednisone for cough and to ease the pain from coughing. He got over the cough after taking the unspecified inhaler, morphine and prednisone. On 21-Dec-2016, the patient received sixth infusion of KEYTRUDA. He continued to feel tired, nauseous and no appetite since starting KEYTRUDA. When he ate, he started feeling sick and was not hungry. His last CT scan showed that the tumors were shrinking. The thyroid medication had not helped with his tiredness. It was hard for him to breath and he wheezed. On 23-Nov-2016, he started taking prednisone 10 mg, daily as suggested by his oncologist, for the difficulty breathing. He reported that the more he rested, the less energy he had.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Decreased activity, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: This spontaneous case, initially received on 31-Oct-2016, was reported by a non health professional and concerns a male patient. Weight: not provided; Height: not provided. Past medical history included low thyroid levels and pneumonia. Drug history includes carboplatin (reaction: pneumonia, low red blood cells, low white blood cells) and ABRAXANE (reaction: pneumonia, low red blood cells, low white blood cells). Concomitant medication: methylphenidate hydrochloride and salbutamol. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported, Batch number: Not reported. Non-company suspect drugs: On 18-Aug-2016, the patient received KEYTRUDA for non-small cell lung cancer. Dosage regimen: 100 mg once every three weeks. Route of administration: Intravenous. Batch number: Unknown. Next dose due 04-Nov-2016. Adverse reactions/events and outcomes: On an unknown date, the patient experienced being more tired, less active, joint pain in his knees and joint pain in his 3 fingers on right hand and a loss of appetite starting on an unspecified date. The patient states that when he comes home after receiving KEYTRUDA he goes right to bed and sleeps. The patient states that he does feel better the next morning because he is less tired and reports worsening neuropathy since starting KEYTRUDA. Outcome for all events: not recovered/not resolved. The patient sought medical attention by visiting a physician. Treatment was given for the adverse event. Lab diagnostic studies performed: blood tests. Additional information was received on 11-Jan-2017: On 09-Nov-2016, the patient received his third infusion of KEYTRUDA. He continued to feel tired since the starting of KEYTRUDA. The joint pain in his knees and joint pain in his three fingers on the right hand had improved. He continued to lose appetite but was not losing weight. His oncologist prescribed him with levothyroxine because his thyroid level was low and his TSH was high. He had a cough and had been coughing up phlegm since 'last week'. His oncologist also prescribed him Z-PAK for a lung infection and he was feeling better. His oncologist started him on an unspecified inhaler a, morphine and prednisone for cough and to ease the pain from coughing. He got over the cough after taking the unspecified inhaler, morphine and prednisone. On 21-Dec-2016, the patient received sixth infusion of KEYTRUDA. He continued to feel tired, nauseous and no appetite since starting KEYTRUDA. When he ate, he started feeling sick and was not hungry. His last CT scan showed that the tumors were shrinking. The thyroid medication had not helped with his tiredness. It was hard for him to breath and he wheezed. On 23-Nov-2016, he started taking prednisone 10 mg, daily as suggested by his oncologist, for the difficulty breathing. He reported that the more he rested, the less energy he had.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Lung infection, Malaise, Nausea, Neuropathy peripheral, Non-small cell lung cancer
Clinical narrative: This spontaneous case, initially received on 31-Oct-2016, was reported by a non health professional and concerns a male patient. Weight: not provided; Height: not provided. Past medical history included low thyroid levels and pneumonia. Drug history includes carboplatin (reaction: pneumonia, low red blood cells, low white blood cells) and ABRAXANE (reaction: pneumonia, low red blood cells, low white blood cells). Concomitant medication: methylphenidate hydrochloride and salbutamol. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported, Batch number: Not reported. Non-company suspect drugs: On 18-Aug-2016, the patient received KEYTRUDA for non-small cell lung cancer. Dosage regimen: 100 mg once every three weeks. Route of administration: Intravenous. Batch number: Unknown. Next dose due 04-Nov-2016. Adverse reactions/events and outcomes: On an unknown date, the patient experienced being more tired, less active, joint pain in his knees and joint pain in his 3 fingers on right hand and a loss of appetite starting on an unspecified date. The patient states that when he comes home after receiving KEYTRUDA he goes right to bed and sleeps. The patient states that he does feel better the next morning because he is less tired and reports worsening neuropathy since starting KEYTRUDA. Outcome for all events: not recovered/not resolved. The patient sought medical attention by visiting a physician. Treatment was given for the adverse event. Lab diagnostic studies performed: blood tests. Additional information was received on 11-Jan-2017: On 09-Nov-2016, the patient received his third infusion of KEYTRUDA. He continued to feel tired since the starting of KEYTRUDA. The joint pain in his knees and joint pain in his three fingers on the right hand had improved. He continued to lose appetite but was not losing weight. His oncologist prescribed him with levothyroxine because his thyroid level was low and his TSH was high. He had a cough and had been coughing up phlegm since 'last week'. His oncologist also prescribed him Z-PAK for a lung infection and he was feeling better. His oncologist started him on an unspecified inhaler a, morphine and prednisone for cough and to ease the pain from coughing. He got over the cough after taking the unspecified inhaler, morphine and prednisone. On 21-Dec-2016, the patient received sixth infusion of KEYTRUDA. He continued to feel tired, nauseous and no appetite since starting KEYTRUDA. When he ate, he started feeling sick and was not hungry. His last CT scan showed that the tumors were shrinking. The thyroid medication had not helped with his tiredness. It was hard for him to breath and he wheezed. On 23-Nov-2016, he started taking prednisone 10 mg, daily as suggested by his oncologist, for the difficulty breathing. He reported that the more he rested, the less energy he had.