chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Injection pain/tenderness at site, tiredness,  HEADACHE, muscle pain, chills, joint pain, fever, nausea, feeling body aches
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Injection pain/tenderness at site, tiredness,  HEADACHE, muscle pain, chills, joint pain, fever, nausea, feeling body aches
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Pruritus, Pyrexia, Urticaria
Clinical narrative: Developed fever and headache then later developed hives, itching, and bruising. Already taking Zyrtec daily. Began taking famotidine daily. Required Benadryl on 1/11/21 but still has hives as of 1/11/21.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: when patient sat up 15 minutes post vaccination she felt light headed. She sat for an additional 15 minutes with hydration and resolved
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Lightheadness for 30 mins felt better after resting-Medium; symptoms lasted 0 days
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Feeling cold, Frequent bowel movements, Headache, Nausea
Clinical narrative: Temp 101.6, chills, extreme body aches and HA, nausea, vomiting, hyperactive bowel movements, (7 soft formed in 9 hours) resolved about 30 hours from onset.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Temp 101.6, chills, extreme body aches and HA, nausea, vomiting, hyperactive bowel movements, (7 soft formed in 9 hours) resolved about 30 hours from onset.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Chills, Fatigue, left arm pain and fever of 100.3.  Treatment include Tylenol with no improvement at this time.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, SARS-CoV-2 test, Swelling
Clinical narrative: Swelling right side of neck, shoulder, upper trapezius and tracheal area Slight rash Soreness in the swollen areas
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate irregular, Pain, Pyrexia
Clinical narrative: fever, aches, head pain, elevated heartrate, fatigue for 24- 48 hrs, elevated hr still intermittent
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: fever, aches, head pain, elevated heartrate, fatigue for 24- 48 hrs, elevated hr still intermittent
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: Pt experienced 103.7 fever and muscle spasms. Hospitalized.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Pruritus, Urticaria
Clinical narrative: Rash/hives, itching  on face, neck and ears and chest
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Fine motor skill dysfunction, Headache
Clinical narrative: Severe headache in back of lower head/neck and frontal head, fever up to 101 degrees F, chills and rigors, muscle pain, extreme weakness and fatigue.  Affected my ability to function. Took Tylenol. Took almost 48 hours to recover.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Severe headache in back of lower head/neck and frontal head, fever up to 101 degrees F, chills and rigors, muscle pain, extreme weakness and fatigue.  Affected my ability to function. Took Tylenol. Took almost 48 hours to recover.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperventilation, Hypoaesthesia
Clinical narrative: Systemic: Chills-Severe, Systemic: Chills/numbness lead to hyperventilating, felt better after taking benadryl and is back to normal-Severe; symptoms lasted 0 days
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Severe itching and redness circle around the site and a little hard
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Patient complained of HA. Observed 30 mins and resolved by the time she left. No other symptoms
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Sleep disorder
Clinical narrative: At first I felt slightly light headed which lasted about 2 hours. At around 7 PM that night, the arm pain started. I had a very bad nights sleep due to this arm pain. I would rate this 8/10. The next day, I had significantly less arm pain, about 4/10. I felt light headed the whole day. After 36 hours, all of my side effects were gone.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test
Clinical narrative: Received COVID vaccine on 1/7/2021 on  1/10/2021 I had a sudden onset of right side facial numbness.  I was worked up in the ER for a possible stroke but all testing was negative. The numbness lasted 3 days and has now resolved.  My COVID shot was given in the right arm.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: Patient felt some numbness in throat post vaccination. Drank water and rested, feeling resolved.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: Headaches; body aches;  chills; fatigue;  joint pain, muscle stiffness; extreme left arm pain.  Ongoing itchiness/swelling in the palms and head. This lasted greater than 2 days
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Headaches; body aches;  chills; fatigue;  joint pain, muscle stiffness; extreme left arm pain.  Ongoing itchiness/swelling in the palms and head. This lasted greater than 2 days
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Feeling hot, Headache, Heart rate irregular
Clinical narrative: Systemic: Headache, Systemic: IRREGULAR HEARTBEAT (HAS HISTORY OF AFIB), COMPLAINED OF BEING HOT; symptoms lasted 0 days
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: right arm pain, fever of 100.9 and Achy.  Tylenol taken on 1/13/21 no improvement.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Audiogram, Deafness unilateral, Sudden hearing loss
Clinical narrative: SUDDEN UNILATERAL (RIGHT)  HEARING  LOSS
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site paraesthesia, Limb discomfort, Muscular weakness, Neck pain
Clinical narrative: Tingling, arm feels "heavy" and "weak", arm that was vaccinated. Patient called PHN over, described that arm where she received vaccine felt heavy and weak. Patient states she felt tingling in arm, down to hand immediately following vaccine administration. Patient states her arm feels sore, soreness radiating into neck. Patient states she is feeling a little better after fifteen minutes. Recommended to follow up with PCP and seek care if symptoms persist or worsen. Pt. discharged from clinic.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Tingling, arm feels "heavy" and "weak", arm that was vaccinated. Patient called PHN over, described that arm where she received vaccine felt heavy and weak. Patient states she felt tingling in arm, down to hand immediately following vaccine administration. Patient states her arm feels sore, soreness radiating into neck. Patient states she is feeling a little better after fifteen minutes. Recommended to follow up with PCP and seek care if symptoms persist or worsen. Pt. discharged from clinic.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: i have a Knot on injection site 10 days later after first moderna vaccine. Woke up in the middle of the night on 01/13/2021 with my arm hurting. when I woke up to come to work I went to feel for the pain and noticed the knot.  It is burning, itching, its red , it hurts and the area feels very warm today is 01/14/2021 and has not got any better. I spoke to a nurse yesterday and she said she would investigate and call me back. Later in the day she did and told me other people have had the issue and wanted me to call her the next morning. I did and she asked me to call because she didnt know how to help. they sent me here.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: FIVE DAYS OF SINTOMES,PAIN INJECTIN SITE, SWELLING INJECTION SITE, RASH  AND INCHING.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: A little more than 24hr after the vaccine patient developed a red 'rash' at the injection site that spread up and down the arm.  No pain, no itch, no vesicles, no pustules, no swelling.  Just red and warm to the touch.  Mom called the after-hours triage line for advice.  Mom applied hydrocortisone cream.  She reported the occurrence to our office the next day.  The redness was resolved in 2 or 3 days.  No medical care needed.  No other visits needed.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Lethargy, Migraine, Pain
Clinical narrative: severe migraines, body aches, chills, fever, lethargic, swelling of eyes and face
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face
Clinical narrative: severe migraines, body aches, chills, fever, lethargic, swelling of eyes and face
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling abnormal, Tinnitus
Clinical narrative: within one hour of vaccine developed difficulty concentrating, described as brain fog.  She also developed tinnitus. Both symptoms were transient and resolved without intervention
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: GI upset: combination of loose stools and diarrhea 3-4 times per day
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hyperhidrosis, Injection site pain, Malaise
Clinical narrative: 12 hrs after first and second vaccines: injection site pain, fever 100F, sweating, body aches, joint pain, headache, malaise. First vaccine side effects lasted 1-2 days. Just had second vaccine yesterday, symptoms have not resolved yet
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 12 hrs after first and second vaccines: injection site pain, fever 100F, sweating, body aches, joint pain, headache, malaise. First vaccine side effects lasted 1-2 days. Just had second vaccine yesterday, symptoms have not resolved yet
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever 103.2, severe muscle and joint pain, fatigue
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo, Vision blurred
Clinical narrative: Verbalize at 1:02 pm feeling light headache, blurred vision like vertigo.  He was evaluated by Fire Rescue and released home feeling better at 1:05 pm.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: I have a fever of 100.7 headache  body aches  fatigue
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Pruritus, Urticaria
Clinical narrative: Day one: extreme malaise, fatigue and muscle soreness onset 4-5hrs from injection and lasted for 2 days. Day three: at midnight started itching and I had just dismissed it. Woke up at 6am itching in sleep on more place. Currently (0900 day 4) moderate hives presenting bilaterally on knees, elbows, sides, back, ear and eyes. Most of the hives present are fairly bilaterally. Applied benadryl tropical cream to spots and fighting the urge to itch.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysphagia, Dyspnoea, Ear discomfort, Pain
Clinical narrative: About 10 to 12 minutes after the injection, I started feeling like my throat was constricted.  I felt pain in my temple and I also felt like my ears were clogged.  My tonugue was tingling and I had pain across my chest.   I had trouble swallowing and taking a deep breath.  The medical providers assessed me and since my heart was not racing and I did not have a rash all over my body, deemed I was okay.  When I went home, I noticed a rash on my chest from my collarbone to my sternum and alongside my ears on my neck.  My sister is an ER Doctor and I did a video conference with her. She had me take Benadryl.  I have never had any reaction to any vaccine nor have I ever had to take Benadryl.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash, Throat tightness
Clinical narrative: About 10 to 12 minutes after the injection, I started feeling like my throat was constricted.  I felt pain in my temple and I also felt like my ears were clogged.  My tonugue was tingling and I had pain across my chest.   I had trouble swallowing and taking a deep breath.  The medical providers assessed me and since my heart was not racing and I did not have a rash all over my body, deemed I was okay.  When I went home, I noticed a rash on my chest from my collarbone to my sternum and alongside my ears on my neck.  My sister is an ER Doctor and I did a video conference with her. She had me take Benadryl.  I have never had any reaction to any vaccine nor have I ever had to take Benadryl.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site rash, Lymphadenopathy, Nausea
Clinical narrative: severe chills, fever 102,1, felt like someone beat me all over, swollen lymph nodes, bright read rash  at injection site which i still have., headache, nausea
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: severe chills, fever 102,1, felt like someone beat me all over, swollen lymph nodes, bright read rash  at injection site which i still have., headache, nausea
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Migraine, Vomiting
Clinical narrative: I received my 2nd shot 1/12 @3:30pm. 1/13 @5:00 I started having severe stomach cramps, a migraine, and vomiting that is still occurring 1/14 @ 8:10 am.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Systemic: swelling on entire left side of body
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Roughly 24 hours after receiving the vaccination, the site of injection was red/purple in color and visibly raised. The region was about the size of an egg. It was mildly itchy, and painful to the touch. It was also warm to the touch. Swelling went down over time, fully reduced about 24 hours after it was noticed.  Area remained red for another 24 hours and was slightly warm and then it transitioned to looking more like a bruise.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: I received the Pfizef COVID-19 vaccine, second dose at 11:45am on Monday, 01/11/2021 and approximately 12 hours later I began to experience chills, fatigue, muscle aches, nausea, loss of appetite, as well as a headache that became worse with time. The fatigue, muscle aches and headache resolved after about 20 hours after I began taking 1000 mg of acetaminophen every 4 hours. All other symptoms resolved shortly thereafter as well.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: I received the Pfizef COVID-19 vaccine, second dose at 11:45am on Monday, 01/11/2021 and approximately 12 hours later I began to experience chills, fatigue, muscle aches, nausea, loss of appetite, as well as a headache that became worse with time. The fatigue, muscle aches and headache resolved after about 20 hours after I began taking 1000 mg of acetaminophen every 4 hours. All other symptoms resolved shortly thereafter as well.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Muscle spasms, Nausea, Pain
Clinical narrative: Systemic: Chills-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Joint Pain-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Seizure-Mild, Systemic: hand spasms-Mild; symptoms lasted 1 day
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Vomiting
Clinical narrative: Systemic: Chills-Mild, Systemic: Generalized Body Aches -Mild, Systemic: Joint Pain-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Seizure-Mild, Systemic: hand spasms-Mild; symptoms lasted 1 day
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: Received Covid Vaccine on Jan 13, 2021.  Woke up on January 14, 2021 with a temperature of 103
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymph node palpable, Lymphadenopathy
Clinical narrative: right side  between neck and clavicle appears to be swollen lymph node, tender to palpate, fatigue will monitor and report to PCP if needed
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: one week later I was sick; got a flu shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 26-Nov-2020.  This case involves a patient of unknown demographics who experienced got a flu shot (influenza) and one week later patient was sick (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got a flu shot (influenza) and one week later patient was sick (illness), (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: my daughter (a nurse) gets sick for 2-3 weeks every time she gets it; Initial information received on 27-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a female patient of unknown age who (a nurse) gets sick for 2-3 weeks every time she gets it (Illness), while she received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.   On an unknown date, the patient received influenza vaccine (Strength, formulation, dose, frequency, route, batch number and expiry date were unknown) for prophylactic vaccination.  On an unknown date (unknown latency), after started therapy with suspect vaccine, the patient gots sick for 2-3 weeks every time she got it (Illness).  Action taken with the suspect drug was not applicable.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: First flu shot I ever got like to killed me; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a patient of unknown demographics who reported he/she got first flu shot ever got like to killed me (feeling abnormal), while he/she received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.  On an unknown date in 1969, the patient received influenza vaccine (Strength, formulation, dose, frequency, route, batch number and expiry date were unknown) for prophylactic vaccination.  On an unknown date (unknown latency), after started therapy with suspect vaccine, the patient got first flu shot ever got like to killed him (feeling abnormal). The patient never had another flu shot since and never will.  Action taken with the suspect drug was not applicable.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick everyvtime; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer via Social media.  This case involves an unknown age female patient who experienced sick every time (illness), while she received INFLUENZA VACCINE [INFLUENZA VACCINE].  Medical history, medical treatment, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, after started vaccine, the patient reported that was false yes do get sick (illness) took it every year and sick it would protect her no way would   No laboratory data was provided.  Final diagnosis was illness.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for illness.
Sex: U
Vaccine: FLUX
Symptoms: No adverse event
Clinical narrative: Not Hasn't worked yet with no adverse event; Initial information received on 10-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involved a patient of an unknown age and gender for whom not hasn't worked yet with no adverse event (Drug ineffective) was reported, after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient reported that not hadn't worked yet (Drug ineffective).  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: patient got the flu shot once in whole life and patient got so deathly sick patient was laid out in bed for 3 days so not for patient; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient) via social media.  This case involves a patient of unknown age who got the flu shot (INFLUENZA VACCINE) once in whole life and got so deathly sick patient was laid out in bed for 3 days (illness).  Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown),  patient who got the flu shot once in whole life and got so deathly sick patient was laid out in bed for 3 days (illness).  No laboratory data was provided.   It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administration error
Clinical narrative: Pentacel was administered in error with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional and transmitted to Sanofi on 30-Nov-2020.  This case involved a 4 year old male patient for whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was administered in error (product administration error).   The patient's past vaccination(s) included ACTHIB.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and INFLUENZA VACCINE (INFLUENZA).  On 19-Nov-2020, the health care professional stated DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE (Lot number UJ189AAA expiration date: 06-Apr-2021) via an unknown route in the right arm was administered in error (product administration error). Only the liquid was administered.  It was reported that the child was behind on his immunizations and reporter did not have a complete record of what patient had received but knew patient was up to date with his ActHIB so even though he didn't get that part he didn't need it.  At the time of this report, 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.
Age: 1.42
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: administered ACTHIB to a patient but the diluent had expired 4 days prior/ no AE; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case received from the other health care professional (Medical assistant) via Medical Information (Reference number- 00378491).  This case involves a 17 months old male patient who received a 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] single-dose vial (lot: UJ175AAA, diluent expiry date: 26-Nov-2020, vaccine expiry date: 02-May-2021) via intramuscular route in the right outer thigh, on 30-Nov-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) and INFLUENZA VACCINE (FLU) for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).   Medical Assistant (MA) reports that they administered ACT-HIB on Monday to a patient but the diluent had expired 4 days prior. MA requests to know if there no contraindication or side effects. They discarded the expired diluent. Patient received a dose of ACT-HIB on 30 Nov 2020 for which the diluent had expired on 26-Nov-2020, although the ACT-HIB vial itself did not expire until 05 Feb 2021. MD name and dose number in series not available. Medical assistant did not have the lot number for the diluent vial. Product used: Used.  At the time of report 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.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: patient was given only the DTaP/IPV portion of the PENTACEL. so the patient was just given the liquid with no AE; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 3 months old male patient who received only the dtap/ipv portion of the pentacel, so the patient was just given the liquid (product preparation issue), of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included IMMUNOGLOBULIN ANTIHEPATITIS B (HEPATITIS B); and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 04-Dec-2020, the patient received 0.5 mL dose once a day via intramuscular route in the left thigh of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: U6395AA and expiry date unknown) for prophylactic vaccination.  This was an actual medication error due to inappropriate reconstitution technique (PT: Product preparation issue) (latency was same day).  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: she gave the Pentacel part of the vaccine and missed the HIB part for the child with no AE; Initial information received on 10-Dec-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves child patient of an unknown age who received part of the vaccine and missed the hib (Haemophilus b) part (product preparation issue), while the patient received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was reported.   On an unknown date, the patient received 0.5 mL of dose once a day of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date unknown) via unknown route for prophylactic vaccination.  This was an actual medication error due to inappropriate reconstitution technique (PT: product preparation issue) (latency unknown).  No laboratory data reported.  At the time of reporting, no adverse event was reported to the patient.  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.  There would be no information regarding batch number for the case.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: 9 month-old child was supposed to receive a Pentacel vaccine, but the CMA administered only the DTaP/IPV portion, without reconstituting the Hib with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a health care professional on 15-Dec-2020.  This case involves a 9 month-old child who was supposed to receive a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (PENTACEL) vaccine, but the CMA administered only the DTaP/IPV portion, without reconstituting the Hib (medication error).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7v (crm197) (Prevnar).  On an unknown date, the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at a dose of 0.5 mL daily via intramuscular route right thigh (lot number: UJ390AA; Expiration date: 10-Dec-2021) for prophylactic vaccination.  On an unknown date, it was reported that the 9 month-old child was supposed to receive a Pentacel vaccine, but the CMA administered only the DTaP/IPV portion, without reconstituting the Hib (medication error) (non-serious event) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  No laboratory tests were reported.  It was not reported if the patient received a corrective treatment. At the time of report, the outcome was not applicable for the event.  Disclaimer: 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.
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: who took the FLUZONE QUAD vaccination on Nov 18 2020. Patient is back in for 2nd dose of FLUZONE QUAD today on 12/15/2020 which is the 27 day instead of 28 days with no AE; Initial information received on 15-Dec-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 9 month old infant patient who was on QUADRIVALENT INFLUENZA VACCINE (INFLUENZA QUADRIVAL A-B VACCINE) (FLUZONE QUADRIVALENT) (lot number and expiry date: not reported) for which who took the FLUZONE QUAD vaccination on Nov 18 2020 and was back in for the 2nd dose of FLUZONE QUAD today on 12/15/2020 which was the 27 day instead of 28 and wanted to know if it was acceptable to vaccinate on the 27th day (inappropriate schedule of product administration).  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.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Medication error, No adverse event, Product preparation error
Clinical narrative: diluent was given today but not the medicine/no AE; This was dose was number two in the series for the patient,it should have been the third/no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (Reference number- 00397592) on 17-Dec-2020.  This case involves a 6-month-old patient of unknown gender who was given second dose of diluent part of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] but not the medicine 0.5 ml once (5 dosage packs vial) (Pentacel lot number UJ337AAA and expiry date 05-Jul-2021) (ActHIB Lot UJ337AA, ActHIB Expiry. date: 05-Jul-2021), (DTaP-IPV Lot U6842BA, expiry date 05-Jul-2021) via intramuscular route on left thigh for prophylactic vaccination. (Product preparation error) (Incorrect dose administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and INFLUENZA VACCINE.  It was an actual medication error case due to Active ingredient not added to diluent and Incorrect dose administered. (same day latency)   It was reported that the patient had got diluent which was given on 17-Dec-2020 (reported as today) but not the medicine.  It was asked if sterile water could be used as the diluent and they got one blue (DTaP-IPV component) and they thought that was the diluent so then another blue (DTaP-IPV component) mixed with the green (ActHIB component) was given and this was dose was number two in the series for the patient. It should have been the third.  At the time of reporting, 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: they only gave the liquid portion. She was referred to the Pentacel Reconstitution with no adverse event; Initial information regarding an unsolicited valid non-serious case received on 30-Dec-2020 from a other health professional.  This case involves a patient (unknown demographics) who received the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], while she was referred to the pentacel reconstitution (product preparation issue).  Medical history, medical treatment, vaccination, family history and concomitant medications were not provided.  On 29-Dec-2020 (reported as yesterday), the patient received a partial dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number, expiry date and other dosing details were not reported] via unknown route at an unknown administration site for prophylactic vaccination as advised by nurse.  It was reported that the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) was only one of the 2 vials that came in the pack was given and they only gave the liquid portion (Product preparation issue). They wanted to know if they should re-administered the vaccine with the correct dose.  At the time of report, 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.  There will be no information available on the batch number for this case.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Incorrect dose administered
Clinical narrative: IPOL and PEDIARIX were inadvertently administered to a 4 years old patient, with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Medical Information (Reference number- 00414740) and transmitted to Sanofi on 04-Jan-2021.   This case involves a 4 years old male patient who was inadvertently administered a 0.5 ml dose of IPV (VERO) [IPOL] Dosage form: multi dose vial lot R1F971M, expiration date: 03-OCT-2021 via intramuscular route in the left vastus lateralis and PEDIARIX not produced by Sanofi Pasteur lot number and expiration date not reported via unknown route in unknown administration site on 07-Dec-2020 for prophylactic vaccination.  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant vaccinations included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCINE) and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) for prophylactic vaccination.  This was an actual medication error case due to extra dose administered (latency same day).   Caller with question regarding safety/ adverse effects following administration of extra dose of POLIOMYELITIS VACCINE (INACTIVATED) (IPV).  Adverse event symptoms: None 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 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.  There will be no information on the lot number of suspect vaccine PEDIARIX.
Age: 11.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11 year old patient was given DAPTACEL instead of ADACEL,with no AE; 11 year old patient was given DAPTACEL,with no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00416895) and transmitted to Sanofi on 05-Jan-2021.   This case involves a 11 years old male patient who received a standard 0.5ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. (lot number C5624AA, expiry date: 10-Jun-2021) once via intramuscular route in unknown administration site for prophylactic vaccination (Product administered to patient of inappropriate age) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Wrong product administered) on 30-Dec-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included HPV VACCINE (HPV VACCINE) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  This was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).   Case detail: The reporter stated that a 11-year old male accidently received Daptacel and not the ordered Adacel. The reporter stated that the prescriber ordered the Adacel but the Medical Assistant in the office administered Daptacel and wanted to know if the patient was going to be ok.  At the time of reporting, 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 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.
Age: 68.0
Sex: U
Vaccine: FLUR4
Symptoms: Injection site erythema
Clinical narrative: the patient complained of redness at the injection site after receiving the Flublok; Initial information regarding an unsolicited valid non-serious case received from the other health professional via phone at call center (Reference Number: US-SANOFI-00418826) received on 06-Jan-2021.  This case involved a 68-year old patient complained of redness at the injection site (Injection site erythema) after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (FLUBLOK QIV).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 08-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE 0.5 mL (lot number: UJ455AA, expiry date: 17-Mar-2021) via an unknown route in the left deltoid for prophylactic vaccination.  On an unknown date, unknown latency, the patient complained of redness at the injection site after receiving the Flublok (Injection site erythema).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown for the event of injection site erythema.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash to chest and neck area started around 6pm  on 12/19/20 and it is current today 1/14/21 but fading
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: I had the vaccine on 1/11 at 11:30AM. I only had a sore right arm on Tuesday.  I noticed a full front and back body rash that afternoon. It started spreading up my neck and onto my forehead. No other symptoms. I took 25mg of Benadryl that evening. Woke up the next day with improving rash but still visible.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Had COVID vaccine and had reaction. Large welts at site of injection, warm to touch, very swollen and tender. Itchy around that area.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Blood test, Computerised tomogram head, Hypoaesthesia
Clinical narrative: Numbness tingling in feet, toes progressed to waist.  ER  Sunday hosp, pt was admitted inpatient, diagnosis transverse myelitis.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunology test, Lumbar puncture, Magnetic resonance imaging brain, Magnetic resonance imaging spinal, Myelitis transverse
Clinical narrative: Numbness tingling in feet, toes progressed to waist.  ER  Sunday hosp, pt was admitted inpatient, diagnosis transverse myelitis.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Numbness tingling in feet, toes progressed to waist.  ER  Sunday hosp, pt was admitted inpatient, diagnosis transverse myelitis.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiotensin converting enzyme, Blood immunoglobulin G, Blood immunoglobulin M, Borrelia test, Full blood count
Clinical narrative: Numbness tingling in feet, toes progressed to waist.  ER  Sunday hosp, pt was admitted inpatient, diagnosis transverse myelitis.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gene mutation identification test, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging, Metabolic function test
Clinical narrative: Numbness tingling in feet, toes progressed to waist.  ER  Sunday hosp, pt was admitted inpatient, diagnosis transverse myelitis.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Myelitis transverse, Paraesthesia
Clinical narrative: Numbness tingling in feet, toes progressed to waist.  ER  Sunday hosp, pt was admitted inpatient, diagnosis transverse myelitis.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache
Clinical narrative: Reported headache, chills, greater than 6 loose stools overnight. Symptoms have resolved.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hot flush
Clinical narrative: Chills started 5 hrs after injection.  Headache, chills followed by hot flashes continued for 9 1/2 hrs.  Light headed ness upon rising  most of the day following the shot.  Fatigue continued for 3 days.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: ,TIRED,HEADACHE,CHILLS,,NAUSIA,FEELING BAD,AND DIARREA.