chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Allergy test, Allergy to vaccine, Hypersensitivity, Obstructive airways disorder
Clinical narrative: Patient received his first Gardisil shot when he was 30 years of age. The exact date of his shot was July 3, 2019, and within 9 days (precisely July 12, 2020), patient was rushed to a nearby Urgent Care facility and injected with a steroid to stop the closing of his airways due to a severe allergic reaction. For the next several months patient suffered multiple allergic reactions to foods he had no prior issue eating before the Gardisil shot. Patient was later referred to an allergy specialist by his PCP which concluded that patient would need to carry an Epinipherine-pen in his pocket at all times due to the severity of his allergies.  In addition, patient began feeling emotional and psychological changes, which became noticeable to his peers since patient is considered an outgoing, fun-loving, down to earth individual who gets along with anybody. As a high achieving individual, who prior to graduating from University and an individual who at work would be responsible for traveling alone to foreign countries on assignment, patient's demeanor and energy began to decline. Patient began developing a fear of driving which led to panic attacks and agoraphobia. Not wanting to leave his apartment and feeling helpless and frustrated due to not understanding the cause of his decline in health, patient had to step away from work and devote himself to a full recovery while losing his independence and moving back to his parent's home in a nearby state.   During his yearlong journey in recovery and seeking answers, patient met with multiple specialists from Neuro-Optometrists, Neurologists, Psychologists, and Naturopathic doctors to find answers, just to name a few. One of patient's doctor's connected the dots and recommended patient seek legal counsel, for according to their suspicion, the timeline and symptoms pre and post the Gardisil vaccine made it clear to them there was a connection.
Age: 30.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Abnormal behaviour, Agoraphobia, Allergy test, Asthenia, Emotional disorder
Clinical narrative: Patient received his first Gardisil shot when he was 30 years of age. The exact date of his shot was July 3, 2019, and within 9 days (precisely July 12, 2020), patient was rushed to a nearby Urgent Care facility and injected with a steroid to stop the closing of his airways due to a severe allergic reaction. For the next several months patient suffered multiple allergic reactions to foods he had no prior issue eating before the Gardisil shot. Patient was later referred to an allergy specialist by his PCP which concluded that patient would need to carry an Epinipherine-pen in his pocket at all times due to the severity of his allergies.  In addition, patient began feeling emotional and psychological changes, which became noticeable to his peers since patient is considered an outgoing, fun-loving, down to earth individual who gets along with anybody. As a high achieving individual, who prior to graduating from University and an individual who at work would be responsible for traveling alone to foreign countries on assignment, patient's demeanor and energy began to decline. Patient began developing a fear of driving which led to panic attacks and agoraphobia. Not wanting to leave his apartment and feeling helpless and frustrated due to not understanding the cause of his decline in health, patient had to step away from work and devote himself to a full recovery while losing his independence and moving back to his parent's home in a nearby state.   During his yearlong journey in recovery and seeking answers, patient met with multiple specialists from Neuro-Optometrists, Neurologists, Psychologists, and Naturopathic doctors to find answers, just to name a few. One of patient's doctor's connected the dots and recommended patient seek legal counsel, for according to their suspicion, the timeline and symptoms pre and post the Gardisil vaccine made it clear to them there was a connection.
Age: 30.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Fear-related avoidance of activities, Food allergy, Frustration tolerance decreased, Helplessness, Hypersensitivity
Clinical narrative: Patient received his first Gardisil shot when he was 30 years of age. The exact date of his shot was July 3, 2019, and within 9 days (precisely July 12, 2020), patient was rushed to a nearby Urgent Care facility and injected with a steroid to stop the closing of his airways due to a severe allergic reaction. For the next several months patient suffered multiple allergic reactions to foods he had no prior issue eating before the Gardisil shot. Patient was later referred to an allergy specialist by his PCP which concluded that patient would need to carry an Epinipherine-pen in his pocket at all times due to the severity of his allergies.  In addition, patient began feeling emotional and psychological changes, which became noticeable to his peers since patient is considered an outgoing, fun-loving, down to earth individual who gets along with anybody. As a high achieving individual, who prior to graduating from University and an individual who at work would be responsible for traveling alone to foreign countries on assignment, patient's demeanor and energy began to decline. Patient began developing a fear of driving which led to panic attacks and agoraphobia. Not wanting to leave his apartment and feeling helpless and frustrated due to not understanding the cause of his decline in health, patient had to step away from work and devote himself to a full recovery while losing his independence and moving back to his parent's home in a nearby state.   During his yearlong journey in recovery and seeking answers, patient met with multiple specialists from Neuro-Optometrists, Neurologists, Psychologists, and Naturopathic doctors to find answers, just to name a few. One of patient's doctor's connected the dots and recommended patient seek legal counsel, for according to their suspicion, the timeline and symptoms pre and post the Gardisil vaccine made it clear to them there was a connection.
Age: 30.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Mental disorder, Obstructive airways disorder, Panic attack
Clinical narrative: Patient received his first Gardisil shot when he was 30 years of age. The exact date of his shot was July 3, 2019, and within 9 days (precisely July 12, 2020), patient was rushed to a nearby Urgent Care facility and injected with a steroid to stop the closing of his airways due to a severe allergic reaction. For the next several months patient suffered multiple allergic reactions to foods he had no prior issue eating before the Gardisil shot. Patient was later referred to an allergy specialist by his PCP which concluded that patient would need to carry an Epinipherine-pen in his pocket at all times due to the severity of his allergies.  In addition, patient began feeling emotional and psychological changes, which became noticeable to his peers since patient is considered an outgoing, fun-loving, down to earth individual who gets along with anybody. As a high achieving individual, who prior to graduating from University and an individual who at work would be responsible for traveling alone to foreign countries on assignment, patient's demeanor and energy began to decline. Patient began developing a fear of driving which led to panic attacks and agoraphobia. Not wanting to leave his apartment and feeling helpless and frustrated due to not understanding the cause of his decline in health, patient had to step away from work and devote himself to a full recovery while losing his independence and moving back to his parent's home in a nearby state.   During his yearlong journey in recovery and seeking answers, patient met with multiple specialists from Neuro-Optometrists, Neurologists, Psychologists, and Naturopathic doctors to find answers, just to name a few. One of patient's doctor's connected the dots and recommended patient seek legal counsel, for according to their suspicion, the timeline and symptoms pre and post the Gardisil vaccine made it clear to them there was a connection.
Age: 54.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: red raised and hot to the touch
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Product administered at inappropriate site, Tendonitis
Clinical narrative: A patient was seen on 09/18/2020 by a nurse in the immunization clinic and received a PCV 13 vaccine. She called on 10/26/2020 to report that she believes that the nurse that administered the vaccine may have administered it to high up on her arm. She states that she has been in so much pain that she had to go to her primary care physician (PCP)  to get an MRI which she claims shows that she has tendinitis in her left arm that she claims her PCP states was caused by an injection to her rotator cuff. She called again this morning and stated that she is taking two pain medications because of this (Methyltrdnisol and Diclofenac).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; VARIVAX had a temperature excursion on 10 OCT 2020 and was administered; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.       On 19-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T012548), for prophylaxis  (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No additional adverse events (AE) were reported.  The vaccine had a temperature excursion on 10-OCT-2020, being stored in temperature ranges of -14 degree Celsius (°C) to -10°C (-14.3°C) for 1 hour and 15 minutes and -9°C to -8°C (-9.3°C) for 32 minutes as recorded by a data logger. There was no previous temperature excursion reported.   Lot No. T012548 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as 09-APR-2022 but upon internal validation established as 10-APR-2022.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: back pain; This case was reported by a consumer via call center representative and described the occurrence of back pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced back pain. On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient experienced back pain after 1st dose of shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: not received the 2nd dose of Shingrix on time due to the pandemic/ dose on November 2019 / not received the 2nd one yet.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of shingrix, due to social problem. The reporter did not consent to follow up. This case has been linked with US2020216280, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020216280:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pain, Pyrexia
Clinical narrative: fever; chills; ACHY; lethargic 6-36 hours after injection; This case was reported by a consumer via sales rep and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 18 hrs after receiving Shingrix, the patient experienced fever, chills, pain and lethargy. On an unknown date, the outcome of the fever, chills, pain and lethargy were recovered/resolved.   The reporter considered the fever, chills, pain and lethargy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with 2nd dose of Shingrix. The patient had chills, achy and lethargic 6-36 hours after vaccination. The patient also developed fever at approximately 18 hours post vaccination. All symptoms were resolved within 48 hours. The patient did not felt the need to follow-up with physician. The reporter felt that symptoms were definitely related to the injection. The reporter consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient came in on 10/30/20 and asked if arm should still be sore after getting the shingles shot on 10/1/20. Was using diclofenac gel on her own. Referred patient to her doctor if continues. Area of concern was within the shot range of immunization administration when asked where arm pain is located.
Age: 76.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Joint noise, Pain in extremity
Clinical narrative: patient said he has had arm pain/ talked to someone about it but they said it was normal after receiving the shot, today he came in and talked to a pharmacist (myself) and he said he is hearing clicking in his arm, and having shoulder/arm pain still and wanted to let us know. I told him to call his primary care dr
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging abnormal, Oedema, Pain in extremity, Periarthritis
Clinical narrative: Severe left arm pain. MRI was performed which showed edema and suggested adhesive capsuilits.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis
Clinical narrative: Pt presented with cellulitis
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever of 102.4 documented in ED.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Hypersomnia
Clinical narrative: Prevanar in the left arm-no sensation.  Fluzone vaccination-immediately felt soreness. Experienced fatigue after making it home. Felt feverish an hour later. Pain increased in right arm.  Slept for hours. Fever was 101. Experienced nausea. Within 45 minutes to an hour, she experienced vomiting and diarrhea. Intense stomach cramps. Vomiting and diarrhea subsided around 3 am. Also experienced chills. Around 5 or 6 am, the nausea subsided. The fatigue and the pain in right arm lasted for 3 days. Also developed rash around the midsection, below the breast. A little itchiness.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Immediate post-injection reaction, Nausea, Pain, Pain in extremity, Pruritus
Clinical narrative: Prevanar in the left arm-no sensation.  Fluzone vaccination-immediately felt soreness. Experienced fatigue after making it home. Felt feverish an hour later. Pain increased in right arm.  Slept for hours. Fever was 101. Experienced nausea. Within 45 minutes to an hour, she experienced vomiting and diarrhea. Intense stomach cramps. Vomiting and diarrhea subsided around 3 am. Also experienced chills. Around 5 or 6 am, the nausea subsided. The fatigue and the pain in right arm lasted for 3 days. Also developed rash around the midsection, below the breast. A little itchiness.
Age: 69.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Prevanar in the left arm-no sensation.  Fluzone vaccination-immediately felt soreness. Experienced fatigue after making it home. Felt feverish an hour later. Pain increased in right arm.  Slept for hours. Fever was 101. Experienced nausea. Within 45 minutes to an hour, she experienced vomiting and diarrhea. Intense stomach cramps. Vomiting and diarrhea subsided around 3 am. Also experienced chills. Around 5 or 6 am, the nausea subsided. The fatigue and the pain in right arm lasted for 3 days. Also developed rash around the midsection, below the breast. A little itchiness.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site swelling, Pain
Clinical narrative: Patient started adverse events on 11/1/20 body aches,chills and swelling where the vaccination was administered on 11/2/20.
Age: 55.0
Sex: F
Vaccine: FLUR4, TDAP
Symptoms: Erythema, Furuncle, Localised infection, Peripheral swelling, Pustule
Clinical narrative: Patient came to pharmacy on 11/3/20. She stated she had developed an infection in her arm from her flu shot. She showed me a round scaled spot with a slightly bleeding center to it. I took her name/dob and looked her up. She had flublok and adacel on that day. She states the flu was in the left arm but our records indicate the adacel was in the left arm. The vaccines were given on 10/17/20. I asked patient if she had seen her provider. She stated no but that she had been trying to. Patient stated that her arm became red a swollen shortly after receiving the vaccine then it developed and pussy /boil type area that popped and drained. I highly advised patient to see a physician. She said she would try to do a walk in appointment today.
Age: 55.0
Sex: F
Vaccine: FLUR4, TDAP
Symptoms: Secretion discharge, Skin exfoliation, Skin haemorrhage
Clinical narrative: Patient came to pharmacy on 11/3/20. She stated she had developed an infection in her arm from her flu shot. She showed me a round scaled spot with a slightly bleeding center to it. I took her name/dob and looked her up. She had flublok and adacel on that day. She states the flu was in the left arm but our records indicate the adacel was in the left arm. The vaccines were given on 10/17/20. I asked patient if she had seen her provider. She stated no but that she had been trying to. Patient stated that her arm became red a swollen shortly after receiving the vaccine then it developed and pussy /boil type area that popped and drained. I highly advised patient to see a physician. She said she would try to do a walk in appointment today.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Local reaction
Clinical narrative: Patient presented with a large red area around the injection site on right arm.   "Rash at site of influenza vaccine: Consistent with large local reaction.  Area essentially nontender so cellulitis unlikely.  Dose of benadryl given in clinic.  No systematic symptoms.  Family to give ibuprofen and benedryl for the next few days.  Ink line drawn around the erythema to better track increase/decrease in size."
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature fluctuation, Chills, Fatigue, Influenza like illness, Injection site erythema
Clinical narrative: Injection site reaction- red swelling in a thick circular pattern about 3 in long and 2 in wide, with small bumps surrounding.  Pain in arm.  Chills, body temp changing from hot to cold, flu-like symptoms, fatigue, etc (stated she has all the general symptoms except fever). Reported roughly 48 hours after immunization
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: Injection site reaction- red swelling in a thick circular pattern about 3 in long and 2 in wide, with small bumps surrounding.  Pain in arm.  Chills, body temp changing from hot to cold, flu-like symptoms, fatigue, etc (stated she has all the general symptoms except fever). Reported roughly 48 hours after immunization
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Diarrhoea, Dizziness, Feeling hot, Loss of consciousness
Clinical narrative: started with very sore arm muscle, felt achy and woke up every hour all night, felt hot and dizzy and had diarrhea on waking, passed out and woke up in a cold sweat at 6:30am, continued to have fever for an hour and gradually started feeling better as the day is wearing on.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Sleep disorder
Clinical narrative: started with very sore arm muscle, felt achy and woke up every hour all night, felt hot and dizzy and had diarrhea on waking, passed out and woke up in a cold sweat at 6:30am, continued to have fever for an hour and gradually started feeling better as the day is wearing on.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac arrest, Death, Decreased appetite, Fatigue, Myalgia
Clinical narrative: Received Shingrix vaccine (first of two) on 10/26/2020 Developed fatigue, loss of appetite and myalgias on 10/29-30. On 10/31/2020, in AM, went to walk up steps and had cardiac arrest and died Family declined Autopsy
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities, Muscle spasms, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: It's listed in the notes that are attached. I had tetanus vaccine 01August 2020 and had an adverse reaction. Patient had a HA August 1, 2020 at clinic. I had a tetanus vaccine shot that was due and had in injected on my left arm that day. As far as I remember, I've never had a reaction like I did this vaccine. The next day my arm was little sore and I expected it to be. I did have tingling sensations a couple of days after the shot and didn't think much of it. At times it felt like it was falling asleep. My arm felt a little stiff but nothing I couldn't handle. The week went by and my arm persisted. It wasn't until August 8 on a Saturday that my lower back on the right side began to cramp and tighten up. I had difficulty touching my toes and putting on my socks and shoes. The next three days got worse. I had trouble getting out of bed. It would take me a few minutes to get warmed up in order to put my clothes, shoes, and move around. I had trouble squatting. I would get cramps on my lower right back and couldn't squat all the way down. I almost went to the doctor, but I was going to see if it would get better by Wednesday August 12. On August 13 I was going to participate in a exercise that was on August 14 and 15. My back got a little better and I was able to walk and put on my shoes with some pain. At the exercise, I met a healthcare worker. She was in the medical center where I participated earlier that month. I told her about my incident, and she told me that I need to document this and see a doctor. I asked her if it had to be a specific doctor and she said no. I could use my doctor in my hometown. So, Monday August 24, 2020, I went to the healthcare clinic and saw Dr. I told him about my issue and that I need to be examined and have documentation in case this tetanus had given me bad side effects. He examined me and took blood and urine samples. He also suggested to be checked from the COVID 19 virus. The samples and tests were done. The results were given to me Friday August 20, 2020. I was tested negative on the COVID 19 virus and the rest of the blood and urine samples seemed normal. My back has almost zero stiffness and my arm has slight tingles now and then. I'm documenting this so that it can in the medical record in case I may have re-occurring effects in the future. I will be at work until December 31, 2020 with the COVID 19 mission. I'm ready to get back into exercising like before and teaching. I will keep physically fit as much as I can. This was a very unusual experience because this has never happened to me before where I cannot move or do any form of hard exercise unless I'm very hurt or very sick.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash maculo-papular, Rash pruritic, Urticaria
Clinical narrative: a little more than 24hr after getting the vaccine pt had two areas of skin rash 1. hives on right hip above ASIC area about 6cm2 2. 3 maculopapular lesions left side at left axillary line, each papule <1mm pt describes as intensely pruritic
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Rash
Clinical narrative: rash/ Rash, spread from site of injection all the way to the face; rash/ Rash, spread from site of injection all the way to the face; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a 5-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number 7P5BE, expiry date 30th June 2021) for prophylaxis.   On 27th October 2020, the patient received the 1st dose of Fluarix Quadrivalent 2020-2021 season (intramuscular). On 27th October 2020, 1 hr after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced injection site rash and rash. On an unknown date, the outcome of the injection site rash and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash and rash to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported but it could be 4 years or 5 years. The reporter called to request information on the presence of milk protein in the Fluarix vaccine since a patient developed a rash after being given the Fluarix vaccine.  The vaccine was given on 27th October 2020 in right thigh and rash started same day. It went from the site of injection all the way to the face, worsening by day of report 28th October 2020. The reporter confirmed that there was no fever or runny nose, no other symptom aside from the rash. The reporter consented to follow up.
Age: 5.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 5 year old male patient was given Flublok inadvertently/ No AE; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a consumer.  This case is linked to case 2020SA273273.  This case involves a 5 year old male patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA2005, expiry date: 21-May-2021), via an unknown route and administration site inadvertently, on 25-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications were unknown.  It was a case of an actual medication error due to the inappropriate age at vaccine administration (latency on same day).  At the time of reporting, the patient had no 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 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: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 44 years old female patient was administered an expired dose of Fluzone Quadrivalent, No AE; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 44 years old female patient who was vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  No concomitant medications or vaccination given to the patient.   On 28-Sep-2020, the patient received a 0.5 mL (drug interval dosage : once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot U6655AA and expiry date: 30-Jun-2020) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency on same day).  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.
Age: 11.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent was accidentally administered to an 11 year old patient with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from pharmacist on 04-Oct-2020.  This case involved a 11-year-old male patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] accidently (Product administered to patient of inappropriate age) .  The patient's medical history, medical treatments, vaccinations and family history were not provided.   No concomitant vaccine was given.  On 01-Oct-2020, the patient received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- UJ448AB, expiration date- 22-Mar-2021) via intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to Inappropriate age at vaccine administration (Latency: same day).  At the time of reporting, the patient was doing well and had no reaction .  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: 10.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 10-year-old patient received a dose of Flublok vaccine in error/ no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist via Agency (reference number 00317321) and transmitted to Sanofi on 15-Oct-2020.  This case involved a 10 years old patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2040, Expiration date- 30-Jun-2021, Prefilled Syringe) via intramuscular route in the left arm (Product administered to patient of inappropriate age) for prophylactic vaccination on 13-Oct-2020.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.  It was a case of actual medication error due to Inappropriate age at vaccine administration (Latency: 1 day). Reporter wanted to know about re-dosing and if any harmful adverse reactions to look out for.  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.
Age: 15.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: gave FLUBLOK to 15 years old patient/ No AE; Initial information received on 16-Oct-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 15 years old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiry date: not reported) via an unknown route and site on unknown date for prophylactic vaccination (product administered to patient of inappropriate age).   The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration (latency: same day at the time of vaccination).  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.  There will be no information on the lot number for this case.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered with an expired Menactra/no adverse event; Initial information regarding an unsolicited valid serious case was received from an other health professional via Global Medical Information (GMI) (Reference number- 00329737) and transmitted to Sanofi on 23-Oct-2020.  This case involves patient with an unknown demographics who was given 0.5 mL once dose of expired suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot u6346aa and expiration date: 03-Aug-2020) on an unknown date via unknown route at an unknown administration site for prophylactic vaccination. (expired product administered)  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day)  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: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Gait disturbance, Hypoaesthesia, Magnetic resonance imaging, Muscular weakness
Clinical narrative: weak in arms and legs; tingling (pins and needles) in left leg which spread to face and right side; numbness; difficult to walk; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via The Agency (Reference number- 00334283) and transmitted to Sanofi on 27-Oct-2020.  This case involves a 29 year old female patient who had numbness (hypoaesthesia), difficulty to walk (gait disturbance), weakness in arms and legs (muscular weakness) and tingling (pins and needles) in left leg which spreaded to face and right side (paraesthesia) while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  She received no other medications or vaccination at that time.  On 09-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UT7058KA, expiry date: 30-Jun-2021) once via unknown route in the left arm for prophylactic vaccination.  On 22-Oct-2020, the patient developed a non-serious numbness (hypoaesthesia), difficulty to walk (gait disturbance), weakness in arms and legs (muscular weakness) and tingling (pins and needles) in left leg which spreaded to face and right side (paraesthesia)13 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  She stated that she's been to the emergency room (ER) several times and seen a neurologist.  On an unknown date, the patient developed a non-serious weakness in arms and legs (muscular weakness) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included: Computerized tomogram and magnetic resonance imaging (results awaited)  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from paraesthesia, hypoaesthesia and gait disturbance.  At the time of report, the outcome of muscular weakness was unknown.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: weak in arms and legs; tingling (pins and needles) in left leg which spread to face and right side; numbness; difficult to walk; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via The Agency (Reference number- 00334283) and transmitted to Sanofi on 27-Oct-2020.  This case involves a 29 year old female patient who had numbness (hypoaesthesia), difficulty to walk (gait disturbance), weakness in arms and legs (muscular weakness) and tingling (pins and needles) in left leg which spreaded to face and right side (paraesthesia) while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  She received no other medications or vaccination at that time.  On 09-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UT7058KA, expiry date: 30-Jun-2021) once via unknown route in the left arm for prophylactic vaccination.  On 22-Oct-2020, the patient developed a non-serious numbness (hypoaesthesia), difficulty to walk (gait disturbance), weakness in arms and legs (muscular weakness) and tingling (pins and needles) in left leg which spreaded to face and right side (paraesthesia)13 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  She stated that she's been to the emergency room (ER) several times and seen a neurologist.  On an unknown date, the patient developed a non-serious weakness in arms and legs (muscular weakness) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included: Computerized tomogram and magnetic resonance imaging (results awaited)  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from paraesthesia, hypoaesthesia and gait disturbance.  At the time of report, the outcome of muscular weakness was unknown.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: Patient developed erythematous rash at injection site over 1 month later. Says that rash was tender and warm. Resolved in 5-7 days. Did not seek medical attention. Notified my office 2 months after injection.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Tremor
Clinical narrative: Patient stated swelling and pain at the injection site for 2 days post vaccine. After 2 days until present patient complains of inability to life her arm above her head. Patient states a tremor has developed gradually in her left arm in addition to continued tenderness at the injection site
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Rash, Skin warm, Swelling
Clinical narrative: Erythematous large (4 inch by 5.5 inch vertical oval) rash with swelling and warmth to touch. No associated pain.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Body temperature increased, Fall, Syncope, Tremor
Clinical narrative: Patient fainted and fell on the floor a couple of minutes after receiving the vaccine. Her Dad said she was shaking while on the floor. Ambulance was called and everything was normal except they noted her temp to be  100 degrees (temp was 98.2 at time of immunization). No treatment was performed and her parents took her home. Called to check on her and Mom said she is feeling better.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: LEFT ARM/DELTOID MUSCLE TENDERNESS AND SWELLING 4 HOURS POST VACCINATION AND PERSISTENT UNTIL TODAY 11/3/2020
Age: 9.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: Vasovagal syncope
Age: 50.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: started with a fever of 104 without medication, today is day 4 and I still have a fever of 101 while alternating Motrin and Tylenol.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Arthritis, Blood test normal, Ear pain, Fatigue
Clinical narrative: 10/13/20-shot administered, early evening pain in left hand between thumb and index finger( lower area), a bit later exact pain in the exact place on right hand, left arm was sore due to injection, pain in left elbow, neck and spine felt achy and my right knee ached,  at one point my right TMJ joint hurt ( my inner right ear ached but it went away quickly). I felt extremely tired. Next morning left thumb feeling better but right was worse, spine still achy as well as my neck, arm still sore. I took Tylenol ( extra strength) as advised. Sent message to dr. but didn't go through, again on 10/21/20' right thumb pain seemed to be worse than left but I felt perhaps better and now it is a week later. 10/23/20' my wrists
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain in extremity, Spinal pain, Temporomandibular joint syndrome
Clinical narrative: 10/13/20-shot administered, early evening pain in left hand between thumb and index finger( lower area), a bit later exact pain in the exact place on right hand, left arm was sore due to injection, pain in left elbow, neck and spine felt achy and my right knee ached,  at one point my right TMJ joint hurt ( my inner right ear ached but it went away quickly). I felt extremely tired. Next morning left thumb feeling better but right was worse, spine still achy as well as my neck, arm still sore. I took Tylenol ( extra strength) as advised. Sent message to dr. but didn't go through, again on 10/21/20' right thumb pain seemed to be worse than left but I felt perhaps better and now it is a week later. 10/23/20' my wrists
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Around 5 pm started having Muscle pain, extremely tired for about 30-40 hours, had chills throughout the night  and upset stomach lasting about 30-48 hour. Also had 104.0 fever . Rec flu vax for 60+ with 1st dose of shingrix vax. Thought she had COVID so called MD.   Called into MD and nurse stated the symptoms were possible reactions to vax.   With 2nd dose of  vax  (recieved 10/27/20 2:00) around 11pm had 101 fever. chills shivers, upset stomach, flu like symptoms throughout the night. Lasting about 30-48 hours. .
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Around 5 pm started having Muscle pain, extremely tired for about 30-40 hours, had chills throughout the night  and upset stomach lasting about 30-48 hour. Also had 104.0 fever . Rec flu vax for 60+ with 1st dose of shingrix vax. Thought she had COVID so called MD.   Called into MD and nurse stated the symptoms were possible reactions to vax.   With 2nd dose of  vax  (recieved 10/27/20 2:00) around 11pm had 101 fever. chills shivers, upset stomach, flu like symptoms throughout the night. Lasting about 30-48 hours. .
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Fever, chills, headache (not relieved by OTC med), muscle aches, dizziness,  swelling in arm and lymph nodes under arm (armpit), wheezing
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Wheezing
Clinical narrative: Fever, chills, headache (not relieved by OTC med), muscle aches, dizziness,  swelling in arm and lymph nodes under arm (armpit), wheezing
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Mobility decreased, Syncope
Clinical narrative: 10 minutes after vaccination. Patient fainted while in the doctor's office and was unable to get up. She continued to feel light headed for approximately 1 hour.
Age: 19.0
Sex: F
Vaccine: FLU4, FLU4, MENB, MENB, PPV, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: reports rt arm was the worse reaction, the left arm had some redness and swelling too but not as bad had fever for 72 hours, resolved day after admission on antibiotic doing better now chart reviewed, received trumemba rt arm, pneumovax and flu shot to the left arm
Age: 86.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: PATIENT SAID THAT SHE HAD REDNESS/SORENESS  IN BOTH ARMS SHORTLY AFTER IMMUNIZATIONS ON 9/17/2020.  SHE CALLED US TODAY (11/3/2020)  AND SAID THAT SHE WAS STILL HAVING SORENESS IN BOTH ARMS, AND IT HAD TURNED FROM SORENESS TO PAIN AND HAD MOVED TO THE BACK OF THE ARM ALSO.  SHE HAD TRIED EVERYTHING I WOULD HAVE RECOMMENDED FOR HER TO TRY.  I RECOMMENDED THAT SHE GIVE HER DR'S OFFICE A CALL, SINCE SHE HAD TRIED EVERYTHING I COULD RECOMMEND FOR HER TO TRY AND IT HAD BEEN 6 WEEKS.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: PATIENT DEVELOPED LOW GRADE FEVER (100.5) FOLLOWING MORNING .
Age: 63.0
Sex: F
Vaccine: FLUR4
Symptoms: Swelling
Clinical narrative: Pt went to emergency room with swelling in neck and stated she "felt like golf balls" in neck.
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Chest X-ray, Echocardiogram, Pain in extremity, Skin tightness
Clinical narrative: A week after flu shot increased urination started, very painful leg pain, swelling, tightness   Was seen at the ER 10/27/20 and they sent her home. Also spoke to MD and he told her to take a diuretic.
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Urine output increased
Clinical narrative: A week after flu shot increased urination started, very painful leg pain, swelling, tightness   Was seen at the ER 10/27/20 and they sent her home. Also spoke to MD and he told her to take a diuretic.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Emergency room 10/23/2019 with shingles, but misdiagnosed
Age: 66.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Pruritus, Skin warm, Somnolence
Clinical narrative: Within an hour of the injection my face started getting hot & red and very itchy. I took 50 mg of Benedryl a little after 11:00. I went home at 1:00 due to drowsiness. Saturday morning my face was still hot, red & itchy so i took the Benedryl through out the day. The symptoms were much better on Sunday.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Listless, Pain
Clinical narrative: chills, headache, body aches, listlessness