chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Arrhythmia, Condition aggravated
Clinical narrative: Initial information regarding an unsolicited valid serious case received on 26-Sep-2018 from a consumer. This case involves a 75 years old female patient who experienced recurrence of arrhythmia, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Arrhythmia. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 16-Sep-2018, the patient received a 0.5 first dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the right arm. On an unknown date, the patient developed a serious recurrence of arrhythmia (arrhythmia), one day (reported as next day) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. Other relevant tests included no lab data. Final diagnosis was recurrence of arrhythmia. It was not reported if the patient received a corrective treatment. The patient was not recovered from the event. List of documents held by sender: none.; Sender's Comments: This case involves a 75 years old patient with history of arrhythmia who developed recurrence of arrhythmia one-day post vaccination with FLUZONE HIGH DOSE. Time to onset is compatible. This could have multiple causes viz. other preexisting medical conditions, any other drug treatment, stress etc. Additional information including patient's medical history, condition at the time of vaccination, concomitant vaccinations and therapies, lab test ruling out other etiology is missing for further assessment of the case. Based on limited information reported assessment cannot be done.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Flu shot given too high in arm. Patient complained of tightness and pain shooting down arm.
Age: 5.0
Sex: M
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives all over his left leg and left arm almost 2 hours after the vaccine was given. Mom was instructed by Dr. to give him 5 ml (10 mg) of hydroxyzine (10mg/5 ml) every 6 hours until hives resolved. First dose of hydroxyzine was at 4:45 PM on 10/01/2018 and the hives resolved by 6:45. No further doses of hydroxyzine given. Instructions on treatment and patient's follow up was all done over the phone with Dr. and triage nurse. No follow up appt. needed in clinic.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Flu shot given too high in arm. Patient complaining of tightness and soreness in arm.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Skin rash, itchy, papulas to shoulder, then to left lower back and flank, left medial thigh started on 9/27/18, self treated with Benardyl. On 10/1/18 she noted a  rash  to right axilla and chest wall, to continue with Benadryl and if needed an over the counter steroid cream. Employee to follow up with her Dermatologist.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia
Clinical narrative: Patient states her hand has felt numb since the day after her vaccination.
Age: 28.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: Possible shoulder injury related to vaccine administration (SIRVA) after vaccinations on 9/13/18. Patient complained of shoulder pain bilateral that started 1 week after receiving Tdap booster and seasonal flu vaccine. Sharp right shoulder pain, 5 to 6/10, worsens when lifting arms and moderate left shoulder pain. Patient concerned that vaccines was injected too high on her arm (upper 1/3 deltoid). Patient denies fevers/chills, rashes, flu-like symptoms, polyarthralgia, myalgias. Patient is pregnant, EDD 11/13/18. Meds: prenatal vitamin. No known drug allergy. No other complicated or concerns noted by patient.
Age: 13.0
Sex: F
Vaccine: HEP, HEPA, HPV9, MNQ, VARCEL
Symptoms: Dizziness, Electroencephalogram, Fall, Headache, Loose tooth
Clinical narrative: 13 year old female patient was vaccinated with the above vaccines. Patient was seated for approximately 3-5 minutes post vaccination and then stood and walked approximately 5 feet and then walked back, during which time she was talking. She stood for approximately 2-3 minutes after walking back and then fainted, falling to the floor. Patient was placed in chair and ice was applied and pressure placed to cut to chin area. Cut measured approximately 1 inch. Patient also stated that felt right side lower back tooth (2nd to last) felt loose. Also stated she had a headache and felt dizzy. Patient was accompanied by Aunt (who is her guardian) to clinic and Aunt was encouraged to take patient to clinic or hospital for possible need of stitches and evaluation of possible concussion. Patient was helped into wheelchair and wheeled to Aunt's awaiting care at front of clinic. Patient left clinic accompanied by Aunt and Uncle. On October 1, 2018, two messages were left with no response. On October 2, I spoke with Aunt. Aunt states she immediately took patient to be evaluated. She states that an EEG was done and that she received stitches to her chin. She was also given medication for pain. She states patient returned to school today but continues with soreness to jaw and loose tooth. She states she will have the tooth evaluated after the patient's stitches are removed.
Age: 13.0
Sex: F
Vaccine: HEP, HEPA, HPV9, MNQ, VARCEL
Symptoms: Pain in jaw, Suture insertion, Syncope, Wheelchair user
Clinical narrative: 13 year old female patient was vaccinated with the above vaccines. Patient was seated for approximately 3-5 minutes post vaccination and then stood and walked approximately 5 feet and then walked back, during which time she was talking. She stood for approximately 2-3 minutes after walking back and then fainted, falling to the floor. Patient was placed in chair and ice was applied and pressure placed to cut to chin area. Cut measured approximately 1 inch. Patient also stated that felt right side lower back tooth (2nd to last) felt loose. Also stated she had a headache and felt dizzy. Patient was accompanied by Aunt (who is her guardian) to clinic and Aunt was encouraged to take patient to clinic or hospital for possible need of stitches and evaluation of possible concussion. Patient was helped into wheelchair and wheeled to Aunt's awaiting care at front of clinic. Patient left clinic accompanied by Aunt and Uncle. On October 1, 2018, two messages were left with no response. On October 2, I spoke with Aunt. Aunt states she immediately took patient to be evaluated. She states that an EEG was done and that she received stitches to her chin. She was also given medication for pain. She states patient returned to school today but continues with soreness to jaw and loose tooth. She states she will have the tooth evaluated after the patient's stitches are removed.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Symptom are significant upper arm pain like a strained muscle or bruised bone. Pain increases when moving arm. Upper arm has burning feeling in the middle of the night enough to wake me up and take pain relievers. It's been 7 days since the shot and the pain does not show signs of subsiding.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Patient experienced redness on site.
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Computerised tomogram, Erythema, Joint range of motion decreased, Pain in extremity, Papule
Clinical narrative: Left arm pain, decreased ROM, localized erythema and pus filled papule approximately 48-72 hours after injection provided. Treated with ice, ibuprofen. Resolved approximately 1 week later.
Age: 34.0
Sex: M
Vaccine: FLUC4
Symptoms: Purulent discharge
Clinical narrative: Left arm pain, decreased ROM, localized erythema and pus filled papule approximately 48-72 hours after injection provided. Treated with ice, ibuprofen. Resolved approximately 1 week later.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure decreased, Chills, Cold sweat, Dizziness, Dyspnoea
Clinical narrative: Description per patient's message: "I just wanted to let you know that I had a rather severe reaction to the shot. It was the High dose. I don't know if I've ever had high dose before. I have had mild reactions in past. This time, my reaction was not allergic and resolved w/in 36 hours. I had the shot on Thurs at 4pm. My arm was expectedly sore that evening. I woke up around 04:00 to pee and could barely get out of bed. I was achy, chilled, clammy, exhausted walking down the stairs with shortness of breath. Felt like the proverbial freight train had hit me. Went back to sleep and at 07:00 I experienced dizziness so I took my BP. Sitting was 90/60 (normal), standing  dropped to 78/36. My heart rate (normally a bit high) was 143. These acute sx resolved quickly. I felt better as day progressed, had some additional flu like sx that evening. Was fine by Sat. a.m.  Won't be doing the high dose again."
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Influenza like illness, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Description per patient's message: "I just wanted to let you know that I had a rather severe reaction to the shot. It was the High dose. I don't know if I've ever had high dose before. I have had mild reactions in past. This time, my reaction was not allergic and resolved w/in 36 hours. I had the shot on Thurs at 4pm. My arm was expectedly sore that evening. I woke up around 04:00 to pee and could barely get out of bed. I was achy, chilled, clammy, exhausted walking down the stairs with shortness of breath. Felt like the proverbial freight train had hit me. Went back to sleep and at 07:00 I experienced dizziness so I took my BP. Sitting was 90/60 (normal), standing  dropped to 78/36. My heart rate (normally a bit high) was 143. These acute sx resolved quickly. I felt better as day progressed, had some additional flu like sx that evening. Was fine by Sat. a.m.  Won't be doing the high dose again."
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Dizziness, Dyspnoea, Hypotension, Influenza like illness
Clinical narrative: Description per patient's message: "I just wanted to let you know that I had a rather severe reaction to the shot. It was the High dose. I don't know if I've ever had high dose before. I have had mild reactions in past. This time, my reaction was not allergic and resolved w/in 36 hours. I had the shot on Thurs at 4pm. My arm was expectedly sore that evening. I woke up around 04:00 to pee and could barely get out of bed. I was achy, chilled, clammy, exhausted walking down the stairs with shortness of breath. Felt like the proverbial freight train had hit me. Went back to sleep and at 07:00 I experienced dizziness so I took my BP. Sitting was 90/60 (normal), standing  dropped to 78/36. My heart rate (normally a bit high) was 143. These acute sx resolved quickly. I felt better as day progressed, had some additional flu like sx that evening. Was fine by Sat. a.m.  Won't be doing the high dose again."
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Description per patient's message: "I just wanted to let you know that I had a rather severe reaction to the shot. It was the High dose. I don't know if I've ever had high dose before. I have had mild reactions in past. This time, my reaction was not allergic and resolved w/in 36 hours. I had the shot on Thurs at 4pm. My arm was expectedly sore that evening. I woke up around 04:00 to pee and could barely get out of bed. I was achy, chilled, clammy, exhausted walking down the stairs with shortness of breath. Felt like the proverbial freight train had hit me. Went back to sleep and at 07:00 I experienced dizziness so I took my BP. Sitting was 90/60 (normal), standing  dropped to 78/36. My heart rate (normally a bit high) was 143. These acute sx resolved quickly. I felt better as day progressed, had some additional flu like sx that evening. Was fine by Sat. a.m.  Won't be doing the high dose again."
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure decreased, Chills, Cold sweat, Dizziness, Dyspnoea
Clinical narrative: ARM ACHE; 12 HOURS AFTER RECEIVING VACCINE, FLU-LIKE SMPTOMS (CANNOT GET OUT OF BED), CHILLS, BODY ACHES, SHORTNESS OF BREATH; 15 HOURS AFTER, DIZZINESS, LOB BP (90/60); GOT BETTER AFTER 36 HOURS.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Influenza like illness, Mobility decreased, Pain, Pain in extremity
Clinical narrative: ARM ACHE; 12 HOURS AFTER RECEIVING VACCINE, FLU-LIKE SMPTOMS (CANNOT GET OUT OF BED), CHILLS, BODY ACHES, SHORTNESS OF BREATH; 15 HOURS AFTER, DIZZINESS, LOB BP (90/60); GOT BETTER AFTER 36 HOURS.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Dizziness, Dyspnoea, Hypotension, Influenza like illness
Clinical narrative: ARM ACHE; 12 HOURS AFTER RECEIVING VACCINE, FLU-LIKE SMPTOMS (CANNOT GET OUT OF BED), CHILLS, BODY ACHES, SHORTNESS OF BREATH; 15 HOURS AFTER, DIZZINESS, LOB BP (90/60); GOT BETTER AFTER 36 HOURS.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: ARM ACHE; 12 HOURS AFTER RECEIVING VACCINE, FLU-LIKE SMPTOMS (CANNOT GET OUT OF BED), CHILLS, BODY ACHES, SHORTNESS OF BREATH; 15 HOURS AFTER, DIZZINESS, LOB BP (90/60); GOT BETTER AFTER 36 HOURS.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness around vaccinated area measuring 4 cm. with warm to touch, with itching sensation.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Fatigue, Headache, Nausea, Sensation of foreign body
Clinical narrative: Patient called on 10/02/2018 @ 12:30 pm and told us she had a reaction from the Flu shots that she took yesterday. Patient said she felt feeling tired and felt something in her throat in about 25 to 30 minutes after the shots. She went home felt headache, nausea  and latter vomited. She call the 911 in later that afternoon she told me her blood pressure drops and went to hospital and given IV fluid and released were told to follow up with her primary care.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient called on 10/02/2018 @ 12:30 pm and told us she had a reaction from the Flu shots that she took yesterday. Patient said she felt feeling tired and felt something in her throat in about 25 to 30 minutes after the shots. She went home felt headache, nausea  and latter vomited. She call the 911 in later that afternoon she told me her blood pressure drops and went to hospital and given IV fluid and released were told to follow up with her primary care.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2 and 1/2 inch diameter warm red swollen mark around injection site. Noticed it about 2 hours after shot was administered. Still there the next morning and gave ADVIL. Went to the school nurse and she applied ice.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: About 2 hours after receiving the 2nd of 2 SHINGRIX shots, the patient experienced excruciating, debilitating pain at the injection site, radiating down the entire arm. The 2nd shot was given 60 days after the first shot. Patient declined medical treatment. Patient's daughter, a nurse, gave the patient 800mg of ibuprofen. Another 800mg dose was given 8 hours later. The pharmacy was notified the next day. Pharmacist was told that the patient was sleeping. Pharmacist strongly suggested that patient's spouse call their PCP. Upon followup several hours later, pharmacist was notified that patient was doing much better and was awaiting a callback from the PCP.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Discomfort, Fatigue, Injection site rash, Lymphadenopathy
Clinical narrative: On day 4 when initial symptoms, sore arm, tired, rash on left upper arm, went away. The rash came back for 2 weeks, loss of appetite for 1 week. My WBC is around 100 with lymphocytes in 80's at this point in my disease. Axillary nodes that the oncologist could feel but I couldn't. Left Axillary node went to a size between walnut and lemon and very uncomfortable. Went to see oncologist day 13-14. I'm a RN so I waited to see if symptoms would go away. After history and exam, we both agreed that it was probably the vaccine not my leukemia. I opted not to have labs done. Now 4 1/2 weeks nodes finally down to pre injection size. It was only the nodes on the side of the injection
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphocyte count decreased, Pain in extremity, White blood cell count decreased
Clinical narrative: On day 4 when initial symptoms, sore arm, tired, rash on left upper arm, went away. The rash came back for 2 weeks, loss of appetite for 1 week. My WBC is around 100 with lymphocytes in 80's at this point in my disease. Axillary nodes that the oncologist could feel but I couldn't. Left Axillary node went to a size between walnut and lemon and very uncomfortable. Went to see oncologist day 13-14. I'm a RN so I waited to see if symptoms would go away. After history and exam, we both agreed that it was probably the vaccine not my leukemia. I opted not to have labs done. Now 4 1/2 weeks nodes finally down to pre injection size. It was only the nodes on the side of the injection
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Fatigue, Hyperhidrosis, Influenza like illness
Clinical narrative: Flu like symptoms - achy joints. tired, listless, chills and sweats. My wife and I experienced similar symptoms for about 24 hours after getting the flu shot.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Listless
Clinical narrative: Flu like symptoms - achy joints. tired, listless, chills and sweats. My wife and I experienced similar symptoms for about 24 hours after getting the flu shot.
Age: 49.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Chills, Diarrhoea, Myalgia
Clinical narrative: Diarrhea, abdominal cramping, myalgia and chills.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness on right thigh, no fever, warm to touch, mother administered TYLENOL night of reaction. No other symptoms. Mother was advised to administer BENADRYL every 6 hours for 1-2 days, Ibuprofen tid for 1-2 days. Signs of alarm given (high fever, increased redness, induration).
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Confusional state, Lethargy, Miosis, Ocular hyperaemia
Clinical narrative: Recieved flu vaccination around 1500 on 9/26/18. Approximately 1630, patient appeared to be slightly confused with noticeable miosis of both pupils. Eyes appeared red. Patient became lethargic and stated that he was sleepy but could not close his eyes. Axillary temperature at this time was 102.6 degrees Fahrenheit, heart rate 140. Continued to monitor patient. Approximately 1830 axillary temperature reached 103.6. On call physician called. Was directed to monitor patient and administer MOTRIN if patient became uncomfortable. Heart rate at this time 150. MOTRIN administered at 1900. Patient reassessed hourly, at 2130, axillary temperature reached 104 degrees. TYLENOL given at this time. Patient continued to remain febrile until 0200. At 0200 patient temperature 98.6 degrees axillary. Patient reassessed at 0730 am. Patient stated he was excissevely thirsty with no other symptoms.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Somnolence, Thirst
Clinical narrative: Recieved flu vaccination around 1500 on 9/26/18. Approximately 1630, patient appeared to be slightly confused with noticeable miosis of both pupils. Eyes appeared red. Patient became lethargic and stated that he was sleepy but could not close his eyes. Axillary temperature at this time was 102.6 degrees Fahrenheit, heart rate 140. Continued to monitor patient. Approximately 1830 axillary temperature reached 103.6. On call physician called. Was directed to monitor patient and administer MOTRIN if patient became uncomfortable. Heart rate at this time 150. MOTRIN administered at 1900. Patient reassessed hourly, at 2130, axillary temperature reached 104 degrees. TYLENOL given at this time. Patient continued to remain febrile until 0200. At 0200 patient temperature 98.6 degrees axillary. Patient reassessed at 0730 am. Patient stated he was excissevely thirsty with no other symptoms.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Blood test, Herpes zoster
Clinical narrative: No issues reported until today (10/2/18) patient reported having shingles. Got case of shingles on right side of body from stomach area up to under breast area---first showed up on Sun 9/30--went to doctor's today and they confirmed it and also did bloodwork---gave rx for VALTREX and sample of LYRICA and was told to stay home from work (at school until next week).
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: No issues reported until today (10/2/18) patient reported having shingles. Got case of shingles on right side of body from stomach area up to under breast area---first showed up on Sun 9/30--went to doctor's today and they confirmed it and also did bloodwork---gave rx for VALTREX and sample of LYRICA and was told to stay home from work (at school until next week).
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report was received from the patient's mother an refers to a 4 -year-old male patient with possible asthma and allergy to penicillin. On an unknown date in approximately 2015 (reported as "about 3 years"), the patient was vaccinated with the first dose of M-M-R II injection (dose, route of administration, lot number and expiration date were not reported) and had experienced no adverse events thereafter. On 12-SEP-2018, the patient was vaccinated with the second dose of M-M-R II injection, intramuscularly, lot # N032752 with expiration date on 20-NOV-2019. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. On 12-SEP-2018, the patient experienced rash on his arm and and fever. At the time of the report, the patient was recovering form the events. The relatedness between the events and M-M-R II was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, allergies and concomitant therapies were not reported. The reporter stated that a few unspecified patient received improper stored doses of GARDASIL 9 on multiple unspecified dates since 12-SEP-2018, for prophylaxis (lot # # N032956, expiration date: 13-JUL-2020) (dose, frequency, route of administration were not reported). There were no adverse effects reported. The doses of the vaccines were exposed to a temperature of 47 degrees Fahrenheit (F) to 77 degrees (F) for a time frame of 20 hours. A previous temperature excursion (below 32 degrees (F) (30.9 degrees (F)) was reported with a time frame of 1 hour. A digital data logger was involved. Furthermore, No product quality complaint (PQC) was involved. This report was considered to be non-valid due to lack of patient identifiers.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a Registered Nurse (RN) referring to a 34 year old tobacco user, non pregnant female patient with hypothyroidism, and drug reaction/allergy to codeine. On 26-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R009408, expiring on 07-MAR-2020, intramuscularly, in the right deltoid for prophylaxis (dosage schedule was not reported). Concomitant therapies included levothyroxine sodium, CHANTIX and ORTHO-CYCLEN. On 26-SEP-2018, at the evening, the patient developed pain and swelling at the area of the injection site. The RN stated that the symptoms became worse over the next couple of days and the swelling and pain spread from the injection site down to the elbow. On 27-SEP-2018, the patient experienced a low grade fever. On 28-SEP-2018, the patient was seen in the RN's office. No treatment was given for the adverse events.  No lab diagnostic tests were performed. The outcome of the aforementioned events was reported as recovering. The reporter did not assess the causal relationship between therapy with PNEUMOVAX 23 and the events.
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Muscle tightness
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, Patient Testimonial Recruitment. A contactable consumer reported for himself, a male patient of an unspecified age who received PREVNAR 13; (lot number and expiration date unknown), via an unspecified route of administration on 23Sep2018 at a single dose for pneumonia shot. The patient's medical history and concomitant medications were not reported. The patient just got a pneumonia shot and he thought they were supposed to do it in the shoulder, but it was done a little lower toward where his muscle was. It was pretty tight and swollen. It was also pretty painful. The patient asked if this was an allergic reaction and would like to know if this was a side effect or infected. The patient stated that it has been one day and he was pretty worried about this. He normally would not get these shots but his doctor insisted. The outcome of the events was unknown. No follow-up attempts are possible, information on the batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Erythema, Injection site rash, Injection site reaction, Pallor
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 65-year-old female patient received first dose of PREVNAR 13 (lot: W09943), intramuscular on 01Aug2018 at 0.5 ml, single as routine vaccine. The patient's medical history and concomitant medications were not reported. In Aug2018, the patient had site reaction and redness. On 01Aug2018, shortly after administration, the patient became dizzy and pale. She developed a rash at the site on 06Aug2018. Therapeutic measures were taken as a result of rash at the site which included BENADRYL. Outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. An infant female patient received PREVNAR 13, 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. On an unspecified date, it was reported that the patient swelled and turned red in seconds/ redness. It was also reported that the patient experienced 'hot and heat' (pending clarification). The patient was told to go home and put ice in the leg which later in the day was reported fine just leaving the area red. The outcome of the event 'turned red in seconds/ redness' was unknown; all other events was recovered on unspecified date. Information on the batch number has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited non-valid non-serious case received from a non-health care professional (pharmacy other). This case is linked with 2018SA271680 and 2018SA271669. This case involves a female patient (unknown age) who was exposed to vaccine FLUZONE HIGH DOSE in context of FLUZONE HD inadvertently given to several pregnant patients, increase rate of injection site reaction. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported FLUZONE HD inadvertently given to 3 pregnant patients, increase rate of injection site reaction and FLUZONE HD inadvertently given to several pregnant patients occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route while she was pregnant. Other relevant tests included no lab test. Final diagnosis was FLUZONE HD inadvertently given to pregnant patient. It was not reported if the patient received a corrective treatment. Additionally, at time of reporting, the outcome of the pregnancy is unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Follow-up information regarding an unsolicited valid case received from a health care professional (pharmacy other) on 25-Sep-2018. Event and reporter updated. List of documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site extravasation
Clinical narrative: Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an 23-years female patient who experienced injection site leaking, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history was not provided. No concomitant medication was received. On 24-Sep-2018, the patient received a 0.5 ml single first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI980AB in the right arm. On an unknown date, following the administration of INFLUENZA QUADRIVAL A-B VACCINE, the injection site was leaking clear fluid (injection site extravasation). The injection site was not swollen, red or anything. She couldnt even see where she got the shot. The patient stated that there was slight seepage at the site. The injection site was not infected. Her patients got panicked over getting these vaccines. Pharmacist believed that this was just normal 'body function. (Other relevant tests included no lab data.) Final diagnosis was injection site leaking. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for injection site leaking.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 82 years old male patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UJ004AA via intramuscular route in the left deltoid (expiry date not reported) on 25 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to vaccine underdose. It was also a case of syringe issue. It was reported that giving the vaccine to a patient and liquid leaked out the compartment between the needle and the part of the syringe where the vaccine is. They believe that patient received the majority of it but need to know if he should be vaccinated again. It was unknown whether patient experienced any adverse reaction after the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a female child (8 days before the child's 6 month) vaccination with 0.25 ml first dose of FLUZONE QUADRIVALENT (batch number UT6259LA, expiry date 30 June 2019, route of administration was not reported) in the left thigh on 21 Sep 2018. Patient concomitant vaccinations included PENTACEL and HEPATITIS B VACCINE, PREVENAR and ROTATEQ (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Patient medical history and concomitant medication were not reported. It was a also a case of actual medication error as Inappropriate age at vaccine administration as patient was administered she administered to a female child; MC, event occurred on 21Sep2018, which was 8 days before the child's 6 month birthdate. It was unknown whether any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 70 years old patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot: UJ022AB; expiry date: 18-Apr-2019) via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines administered. It was a case of actual medication error due to exposure via skin contact and vaccine underdose since the vaccine ran down the patient's arm and probably did not get much of the vaccine. The bulk leaked out while nurse pulled the needle from the patient's skin. It was reported that the leak was around hub where the needle was attached to syringe and from the patient's arm when it was pulled out. It was also a case of syringe issue. It was not reported whether the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 7.0
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a seven years old patient (unknown gender) who was vaccinated with a 0.5ml dose of QUADRACEL (Batch number: C5248AA, expiration date: 21-Aug-2019, route: intramuscular and site of administration: right deltoid) on 22-May-2018 instead of ADACEL (Batch number, expiration date and dose were not reported). Concomitant medications included was MMR and VARICELLA VACCINE (Batch number, expiration date, dose, route and site of administration was not reported). The patients medical history were not reported. It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received from a nurse on 26-Sep-2018. This case involves a 45 years old female patient who was vaccinated with 0.25ml FLUZONE QUADRIVALENT (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and family history were not reported. The patient did not receive any concomitant medications. It was an actual medication error due to vaccine underdose. It was reported that adult patient received a pediatric dose of FLUZONE QUADRIVALENT. The patient did not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive  and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from nurse. This case involves a 71 years old female patient received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. The patient did not receive any concomitant vaccines. On 18-Sep-2018, the patient received a 0.5ml single dose of suspect Influenza Quadrival A-B Vaccine, lot UI986AA, expiry date 30 Jun 2020 via unknown route in the right deltoid. It was an actual medication error due to incorrect product storage. It was reported that patient received FLUZONE QUAD that was exposed to 31.5F for 1 hour and 40 minutes. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 49 years old male patient who received a 0.5 ml dose of vaccines FLUZONE HIGH DOSE (lot UJ023AA) via intramuscular route in the left deltoid instead of FLUZONE QUADRIVALENT on 26-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a 68 years old female patient and reports that patient received a second FLUZONE HIGH-DOSE vaccine injection approximately 30 minutes from the first injection, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Dementia. The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 26-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: U1985AB) (expiry date, dose in series was not reported) via intramuscular route in the left deltoid. On 26-Sep-2018 she also received a 0.5 ml dose of the same vaccine (lot number: U1985AB) via intramuscular route in the right deltoid. It was a case of actual medication error due to extra dose administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves 6 months old female patient who was vaccinated with a 0.5 ml instead of 0.25 ml dose of FLUZONE QUADRIVALENT (batch number UI975AC and expiration date 30-JUN-2019) via unknown route in the left thigh On 24-Sep-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to 6-months old child have been given 0.5 ml FLUZONE QIV. It was reported that the patient did not have any reaction last night, no fever or side effects, did not go to the ER or seek treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.58
Sex: F
Vaccine: HEPA, HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 months old female patient who received 0.5 mL dose of vaccines ACT-HIB (lot UI917AA via unknown route in the left thigh expiry date: 30-NOV-2019) with sterile water from Merck lot M041689, Expiration date: 29-Jun-2019 on 21-SEP-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation. It was an actual medication error due to wrong solution used in drug reconstitution. It was reported that a female patient age 19 months received 0.5 ml of the ACTHIB with sterile water from Merck, not using the 0.4 sodium chloride as they should of. It was reported that She did not have any side effects or problems. Had not gone to the ER or to seek emergency treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 8.0
Sex: U
Vaccine: DTAP, IPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an eight-year old child patient who received 0.5 ml fifth dose of DAPTACEL (batch number, expiry date was not reported) intramuscularly in left deltoid instead of 0.5 ml ADACEL on 25 Sep 2018. Concomitant medication involved IPOL (lot details C5171AA, expiry date 23 Mar 2019) in right deltoid. It was a case of actual medication error as wrong vaccine administered and inappropriate age at vaccine administration. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.