chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: I had the two shot shingrix vaccine as reccomended by my doctor.   The first dose in Pharmacy was no eventful.  The second vaccine at the Pharmacy has caused sever side effects.  Started with immediate swelling in my right arm followed by soreness in my right shoulder and neck.   The arm pain and shoulder pain are gone but my neck pain continues.   Plus i have a tingling sensation up my neck and into my ear five or six times a day.  Also I seem to be very fatigued all day which is affecting my ability to do normal things like playing golf, which I do 3 or 4 times a week.   I have never had a reaction to a shot at all.  In my opinion the side affects of this vaccine outway the benifit.  Do you know what I can do to help?  Thanks,
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray, Computerised tomogram head, Dysphagia, Electrocardiogram, Electromyogram
Clinical narrative: Multiple events of legs collapsing and falling down. Numbness. Tingling, No control of legs. Went to ER on 12/4, held in ER for testing and admitted to hospital on 12/5. Diagnosed with Guillain-Barre Syndrome (GBS). Moved to ICU due to respiratory distress and swallowing issues. Numbness in arms and hands. 5 Courses of IVIG administered.  Moved to Hospital on 12/18/19 for Inpatient Acute Rehabilitation. Discharged on 12/27/19. Currently homebound, had in home PT eval, and starting  outpatient PT.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fall, Guillain-Barre syndrome, Haematology test, Housebound, Hypoaesthesia
Clinical narrative: Multiple events of legs collapsing and falling down. Numbness. Tingling, No control of legs. Went to ER on 12/4, held in ER for testing and admitted to hospital on 12/5. Diagnosed with Guillain-Barre Syndrome (GBS). Moved to ICU due to respiratory distress and swallowing issues. Numbness in arms and hands. 5 Courses of IVIG administered.  Moved to Hospital on 12/18/19 for Inpatient Acute Rehabilitation. Discharged on 12/27/19. Currently homebound, had in home PT eval, and starting  outpatient PT.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immunoglobulin therapy, Intensive care, Laboratory test, Loss of control of legs, Lumbar puncture
Clinical narrative: Multiple events of legs collapsing and falling down. Numbness. Tingling, No control of legs. Went to ER on 12/4, held in ER for testing and admitted to hospital on 12/5. Diagnosed with Guillain-Barre Syndrome (GBS). Moved to ICU due to respiratory distress and swallowing issues. Numbness in arms and hands. 5 Courses of IVIG administered.  Moved to Hospital on 12/18/19 for Inpatient Acute Rehabilitation. Discharged on 12/27/19. Currently homebound, had in home PT eval, and starting  outpatient PT.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging brain, Magnetic resonance imaging spinal, Muscular weakness, Paraesthesia, Respiratory distress
Clinical narrative: Multiple events of legs collapsing and falling down. Numbness. Tingling, No control of legs. Went to ER on 12/4, held in ER for testing and admitted to hospital on 12/5. Diagnosed with Guillain-Barre Syndrome (GBS). Moved to ICU due to respiratory distress and swallowing issues. Numbness in arms and hands. 5 Courses of IVIG administered.  Moved to Hospital on 12/18/19 for Inpatient Acute Rehabilitation. Discharged on 12/27/19. Currently homebound, had in home PT eval, and starting  outpatient PT.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dyspnoea, Gait inability
Clinical narrative: Multiple events of legs collapsing and falling down. Numbness. Tingling, No control of legs. Went to ER on 12/4, held in ER for testing and admitted to hospital on 12/5. Diagnosed with Guillain-Barre Syndrome (GBS). Moved to ICU due to respiratory distress and swallowing issues. Numbness in arms and hands. 5 Courses of IVIG administered.  Moved to Hospital on 12/18/19 for Inpatient Acute Rehabilitation. Discharged on 12/27/19. Currently homebound, had in home PT eval, and starting  outpatient PT.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain, Injection site warmth, Pain, Pyrexia
Clinical narrative: 1/3/2020, 8pm: 101 degree fever. Large (4"dia), painful, hot lump at injection site. Body aches. Took Tylenol. Fever gradually came down overnight. 1/4/2020, 1pm: 100.3 degrees. Lump on arm has spread out, gone down,  and is not as painful. Still taking Tylenol.
Age: 54.0
Sex: F
Vaccine: TYP
Symptoms: Wrong product administered
Clinical narrative: Patient received Typhoid vaccine when she was not in fact due for it. Patient was due for Tdap instead. Clinic provider, Dr., notified of incident and patient/staff reviewed. Patient was then administered correct dose of Tdap in right arm.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Skin discolouration, Swelling
Clinical narrative: About 7 to 10 days after receiving the vaccination the patient noticed a pink raised bump the size of a pimple with a scabed point. It does not hurt and is not tender unless pulled by clothing. No change in appearance or size over a 2 week period. Patient saught care from PCP on 1/3/19 and was prescribed mupirocin 2% ointment and referred to a dermatologist.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: experienced a shingles outbreak under nose above lip that lasted 4 weeks in duration. Claims to have never had a shingles outbreak before. Patient contacted their PCP and who denied a valcyclovir prescription and instead directed patient to purchase Abreeva OTC. Outbreak resolved in 4 weeks.
Age: 34.0
Sex: F
Vaccine: FLUR4
Symptoms: Diarrhoea, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Fatigue, Severe naseus (treated with Zofran), Body Aches, Fever (treated with Ibuprofen), Explosive Diarrhoea (treated with pedialyte pops)
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus, Throat irritation, Urticaria
Clinical narrative: 1/4/2020 3pm: Patient called this afternoon stating that he had developed itching and hives, including itching in his throat somewhat relieved by benadryl. Patient was not having trouble breathing. Patient was instructed to continue benadryl and consult with urgent care. Patient received first dose of shingrix vaccine in right arm and had received flu vaccine in left arm on 1/3/2020. Hives were not worse at either of these vaccinations sites/ no indication of which vaccine reaction could have been from. I spoke with urgent care Dr. at 5:45 pm who said patient was experiencing an allergic reaction, however, she could not confirm that it was from vaccines but was treating as so with steroids. Patient was instructed to follow up with primary care Dr. on Monday to discuss how to proceed. Patient had received flu vaccines in the past without issue. As part of counseling, I told patient he would need a prescription from his PCP if they decide they wanted him to get the second dose of Shingrix in 2 months.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Presented with Hives, diminish with Benadryl, worsen with Heat, Upset Emotions, etc.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Muscular weakness, Pain
Clinical narrative: Guillan Barre syndrome with bilateral lower extremity weakness, ~ 8 days after receiving vaccine, started with diffuse body pain with development of lower extremity weakness on January 1/2
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: -Fever for 24 hours called Dr. and was told it was probable a side effect of the vaccine
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Headache, Myalgia
Clinical narrative: Headache,shivering, body aches, muscle's sore all over, nausea and upset stomach with stomach pain.  If not better by Monday 01/06/2020, I'll be contacting my Dr.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Headache,shivering, body aches, muscle's sore all over, nausea and upset stomach with stomach pain.  If not better by Monday 01/06/2020, I'll be contacting my Dr.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Back pain, Chest pain, Pain
Clinical narrative: chest pain  on left side of chest  & pain was radiating around to left side of his back
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Diarrhoea, Headache, Insomnia, Pain
Clinical narrative: diarrhea, vomiting, headache, body ache, insomnia, dehydration for which went to ER for
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: diarrhea, vomiting, headache, body ache, insomnia, dehydration for which went to ER for
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Low grade fever (100) starting the morning after being given the shot and lasting for about 48 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site inflammation, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Low grade fever (100) starting the morning after being given the shot and lasting for about 48 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Morning after receiving the shot had a fever of 101 which lasted at least 48 hours.  Also the injection site became inflamed and swollen and that swelling and itchiness lasted over one week.  I had a low grade fever after receiving the first shot, but thought I would have developed antibodies and not have a reaction to the second, but instead the reaction to the 2nd shot was worse.  I have never had a reaction to any other immunizations.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site inflammation, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Morning after receiving the shot had a fever of 101 which lasted at least 48 hours.  Also the injection site became inflamed and swollen and that swelling and itchiness lasted over one week.  I had a low grade fever after receiving the first shot, but thought I would have developed antibodies and not have a reaction to the second, but instead the reaction to the 2nd shot was worse.  I have never had a reaction to any other immunizations.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Epilepsy, Seizure
Clinical narrative: Adverse event - seizures Treatment- keppra meds Diagnosis - epilepsy
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Influenza like illness, Injected limb mobility decreased, Pain
Clinical narrative: Hit by a truck.  Base of skull hurt so badly, I didn't want to move.  Flu-like symptoms:  chills and achy.  I do not know if I had a fever.  I could barely move my left arm.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Pain at site of injection (upper left arm) was severe for two weeks, then mild for a month
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Blister, Erythema, Hypoaesthesia, Swelling
Clinical narrative: Patient experienced redness around the area and this started to swell up after several hours of the vaccination administration. Patient stated this was very painful and seemed to enlarge through the night. Patient put ice on to help the pain. Patient came to notify pharmacist the next day right away at 9am. Blistering had formed around the area. Patient mentioned experiencing numbness in the arm with the Prevnar13 which lasted for several months after vaccination in 2018. Patient is going to speak with primary care physician on reaction.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Muscle Aches, Chills, Teeth Chattering, Fever, Headache, Extreme Fatigue, Soreness at the site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Muscle Aches, Chills, Teeth Chattering, Fever, Headache, Extreme Fatigue, Soreness at the site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Mild pain in upper arm and shoulder when arm at rest, extreme pain in upper arm and shoulder when raising arm to do normal activities such as getting dressed, driving, washing hair, reaching for items on shelves.    Self care has consisted of ibuprofen, rest, "Ben Gay" cream. After waiting  approximately 6 weeks for  condition to improve with self care ( it has not ), doctor has recommended physical therapy, which I have not yet begun.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Micturition urgency, Mobility decreased, Pain
Clinical narrative: 3 hours after receiving the vaccine, the patient had radiating pain from the injection site down to her hand and up to her head causing a headache. She was in bed for 2 days after receiving the vaccine, unable to get up to do anything other than go to the bathroom. She felt like she had an increased urge to urinate, going about every 2 hours. When she woke up on the third day after receiving the vaccine, she was feeling much better.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: 3 hours after receiving the vaccine, the patient had radiating pain from the injection site down to her hand and up to her head causing a headache. She was in bed for 2 days after receiving the vaccine, unable to get up to do anything other than go to the bathroom. She felt like she had an increased urge to urinate, going about every 2 hours. When she woke up on the third day after receiving the vaccine, she was feeling much better.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Hot flush, Nausea, Presyncope
Clinical narrative: cold shivers & hot flashes almost fainted several times nausea  All lasted a few hours, then following sleep and rest, all disappeared the following day
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Blood test normal, Magnetic resonance imaging brain normal
Clinical narrative: On Oct. 9 (the next day after receiving vaccine) I experienced loss of taste. I still have no sense of taste.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia
Clinical narrative: On Oct. 9 (the next day after receiving vaccine) I experienced loss of taste. I still have no sense of taste.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: The day after immunization (January 4, 2020) pain and redness  developed at injection site (size of quarter), 2 days later (January 5, 2020) injection site redness increased (size  of softball)
Age: 0.33
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Headache, Injection site erythema
Clinical narrative: Nausea, vomiting, dry heaves, excruciating pain radiating from head to toes on right side, huge red circular mark around site of injection, swollen and warm, severe headaches, severe weakness, dizziness, chills and fever.  Lasting five days.
Age: 0.33
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, vomiting, dry heaves, excruciating pain radiating from head to toes on right side, huge red circular mark around site of injection, swollen and warm, severe headaches, severe weakness, dizziness, chills and fever.  Lasting five days.
Age: 0.33
Sex: F
Vaccine: VARZOS
Symptoms: Retching, Vomiting
Clinical narrative: Nausea, vomiting, dry heaves, excruciating pain radiating from head to toes on right side, huge red circular mark around site of injection, swollen and warm, severe headaches, severe weakness, dizziness, chills and fever.  Lasting five days.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Pruritus, Throat irritation, Tongue disorder
Clinical narrative: Within two minutes of getting the shot, my throat and tongue started to feel like an allergic reaction.  I immediately took a benedryl melt (child's dose).  I sucked on it all the home. The feeling persisted and had progressed to include itchy ear canals. I immediately took a full dose of liquid benedryl and decided if it didn't help I would go to an ER.  After 10 min the symptoms subsided.  They returned when  the benedryl wore off and I have been taking a dose every four hours since.  My doctor's office is closed on weekends, so I will call him first thing mon am to see if I should continue with benedryl .
Age: 70.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Immediate post-injection reaction, Injection site pain, Nerve injury, Pain, Product administered at inappropriate site
Clinical narrative: Pharmacist injected into the incorrect part of the upper left arm. Patient identifies posterior aspect of left upper arm as site of injection.  Patient claims that the moment the needle went into the posterior upper area of the arm, the nerve was hit and immediately felt pain above typical IM injection pain.  It had progressed in intensity causing her to seek medical attention numerous times.  The pain (continuous burning and stabbing) intensity has come down in two months, but is still persistent.  The patient came in to the pharmacy on 1.4.2020 to report it to me because she wanted to confront the pharmacist who gave her the vaccine.  The pharmacist was a floater and does not work steadily at this location.  She did not want to get the pharmacist in trouble was her rationale for not reporting it sooner.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Deafness, Dizziness, Feeling cold, Headache
Clinical narrative: patient got dizzy/lost her hearing/anxiety.  she requested glucose (liquid) and that brought some of her color back.  She was placed on floor with ice pack.  She said she had headache all over from that and removed it.  She was also very cold and put a blanket/coat on her.  ambulance came and she left premises.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Pallor
Clinical narrative: patient got dizzy/lost her hearing/anxiety.  she requested glucose (liquid) and that brought some of her color back.  She was placed on floor with ice pack.  She said she had headache all over from that and removed it.  She was also very cold and put a blanket/coat on her.  ambulance came and she left premises.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Blindness unilateral, Blood test, Magnetic resonance imaging brain, Ophthalmological examination
Clinical narrative: Six days after I got this vaccine my right optic nerve hemorrhaged and I am now legally blind in my right eye.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Optic nerve sheath haemorrhage
Clinical narrative: Six days after I got this vaccine my right optic nerve hemorrhaged and I am now legally blind in my right eye.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Malaise
Clinical narrative: Felt unwell (lethargic) all day. Felt fine the next day.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity, Injection site erythema
Clinical narrative: patient experienced signs and sxs of allergic rxn. redness at injection site. trouble breathing went to emergency room after consulting the pharmacy rxn happened within 2 hours of injection patient was treated in ER with IV fluids and prescribed prednisone and hydroxyzine once discharged
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Electrocardiogram, Malaise, Syncope
Clinical narrative: Did not feel well next day - fainted about 1 PM - taken to emergency room by family member - treated in emergency room & spent night in hospital for observation
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Pain, Swelling
Clinical narrative: Swelling, redness, pain, and nausea two days after injection. Patient experienced no adverse effects from first dose. Advised her to take Tylenol and use a cold compress for the pain and Benadryl for the swelling.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Seizure
Clinical narrative: My son had a seizure (something he have never had before) two weeks after getting these vaccines. He's never been prone to seizures, doesn't run in our family history.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Drooling, Eye movement disorder, Fall, Seizure
Clinical narrative: My son had a seizure (something he have never had before) two weeks after getting these vaccines. He's never been prone to seizures, doesn't run in our family history.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: PATIENT COMPLAINED OF SWELLING, REDNESS AROUND INJECTION SIGHT AND FEELING NAUSEATED. SAID ARM HAD SWELLED UP TO ABOUT SIZE OF 2 GOLF BALLS WITHIN COUPLE DAYS OF VACCINATION. SHE NOTICED IT IN MORNING AFTER SHOT AND IT CONTINUED TO GET WORSE. PAINFUL ONLY IF TOUCHED.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: On the evening of the vaccine, I had chills that became more severe, but not really a major issue. Went to bed at usual time. Approx., 2 AM is was sweating profusely and nauseous. Got up from bed and into the bathroom. Horrible sweating. Did not vomit (if I remember correctly).  Had to throw off my nightshirt as it was drenched with sweat and I was too hot to wear anything. Left toilet and was dizzy. Stood up and walked to sink to wash. Felt very hot and sick. Next time I recall anything it was laying on the bathroom tile floor calling out for my husband. I had passed out though no clue for how long I was laying there. When I awoke, I actually thought I was in bed and had no clue I was on the floor.  That was very frightening and dangerous.  I worry for others, especially those getting vaccinated and living alone.  I was somewhat out of it the next day (mild headache).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Malaise, Nausea
Clinical narrative: On the evening of the vaccine, I had chills that became more severe, but not really a major issue. Went to bed at usual time. Approx., 2 AM is was sweating profusely and nauseous. Got up from bed and into the bathroom. Horrible sweating. Did not vomit (if I remember correctly).  Had to throw off my nightshirt as it was drenched with sweat and I was too hot to wear anything. Left toilet and was dizzy. Stood up and walked to sink to wash. Felt very hot and sick. Next time I recall anything it was laying on the bathroom tile floor calling out for my husband. I had passed out though no clue for how long I was laying there. When I awoke, I actually thought I was in bed and had no clue I was on the floor.  That was very frightening and dangerous.  I worry for others, especially those getting vaccinated and living alone.  I was somewhat out of it the next day (mild headache).
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dysphagia, Erythema, Lymphadenopathy, Palpitations, Peripheral swelling
Clinical narrative: -HEART RACING...FRIDAY NIGHT AFTER VACCINE...LASTED 5 HOURS UNTIL PATIENT WENT TO SLEEP- NOT TREATED -SWELLING OF ARM AND REDNESS /WARM TO TOUCH/TENDERNESS...EXPECTED--USE ICE PACK, TOOK ONE 200MG TABLET ADVIL -SWOLLEN GLANDS UNDER NECK REGION--NOT TREATED, , SEEN 2 DAYS AFTER SHOTS -DIFFICULTY SWALLOWING - NOTICED TODAY , 2 DAYS AFTER SHOT-NOT TREATED -DID NOT REPORT ANY SWELLING OF TONGUE OR SOB OR DIFFICULTY BREATHING
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: -HEART RACING...FRIDAY NIGHT AFTER VACCINE...LASTED 5 HOURS UNTIL PATIENT WENT TO SLEEP- NOT TREATED -SWELLING OF ARM AND REDNESS /WARM TO TOUCH/TENDERNESS...EXPECTED--USE ICE PACK, TOOK ONE 200MG TABLET ADVIL -SWOLLEN GLANDS UNDER NECK REGION--NOT TREATED, , SEEN 2 DAYS AFTER SHOTS -DIFFICULTY SWALLOWING - NOTICED TODAY , 2 DAYS AFTER SHOT-NOT TREATED -DID NOT REPORT ANY SWELLING OF TONGUE OR SOB OR DIFFICULTY BREATHING
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PT REPORTED PAIN/ SORENESS IN LEFT ARM, ENOUGH THAT A NUMBER OF DAYS LATER SHE WENT TO MD AND RECEIVED FLEXIRIL, DICLOFENAC AND A MEDROL DOSE PACK
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, Foetal disorder, Premature delivery, Ultrasound antenatal screen
Clinical narrative: I was pregnant when I received my flu shot from work. Had no issue when I would get my check ups. Then I had my flu shot the end of September. That's when my baby stopped growing normally. She was delivered early the next month. She was only 3 lbs 14 oz on Oct 27 2016. She was my first pregnancy.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort, Dyspnoea, Urticaria
Clinical narrative: I began to have hives that covered my face, neck, and arms. My upper and lower airways began to constrict and I experienced difficulty breathing and shortness of breath.  I took oral antihistamines over the course of one day and that resolved the hives. My airway compromise lasted over the course of a week. I went to urgent care and was given an albuterol aerosol treatment and I was given immediate relief of the tightness in my chest an lungs. The Nurse Practitioner also sent me home with oral prednisone and an inhaler and my upper airway symptoms began to subside over the course of a week.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: patient experiencing arm pain since recieving the vaccine, pt to follow up with doctor this month
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Pain
Clinical narrative: Achiness, tiredness, upset stomach
Age: 90.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Laboratory test, Muscular weakness, Pain
Clinical narrative: Symptoms developed of body aches, progressive muscle weakness developing into Gillian-barre syndrome diagnosed by Drs at hospitals and clinics.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site pain
Clinical narrative: Extra dose; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 1st March 2019 in left deltoid and experienced arm pain for 2 days which resolved, refer case US2019AMR221733) and Shingrix with an associated reaction of pain in extremity (2nd dose received on 23rd August 2019, in left deltoid of the arm and experienced arm pain till the elbow which subsequently resolved, refer case US2019AMR221727). Concomitant products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX 23).   On 3rd December 2019, the patient received the 3rd dose of Shingrix. On 3rd December 2019, unknown after receiving Shingrix, the patient experienced extra dose administered. In December 2019, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and extra dose administered were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient received dose of Pneumovax 23 in the right arm. The reporter stated that, after vaccination, the patient had injection site pain. On 3rd December 2019, the patient received 3rd dose of Shingrix vaccine, which led to extra dose administered. The reporter consented to follow up. This case has been linked with case US2019AMR221727 and US2019AMR221733, reported by same reporter for same patient.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Seizure
Clinical narrative: Mom states that 2 weeks after vaccines were given child had a seizure at home- fell out of chair, eyes rolled back and reports he was drooling- episode witnessed by her boyfriend and lasted about 4 minutes.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Drooling, Eye movement disorder, Fall, Seizure
Clinical narrative: Mom states that 2 weeks after vaccines were given child had a seizure at home- fell out of chair, eyes rolled back and reports he was drooling- episode witnessed by her boyfriend and lasted about 4 minutes.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Pruritus
Clinical narrative: When I arrived home I was very hot.  I didn't any way to take my temperature.  About three hours after the shot, I started itching all over my body.  The itching lasted all night and all the next day.  I took diphenhydramine (2 tablets 25 mg. each).  It helped for a while, but now that 4 hours have gone by, I am itching all over again (face, arms, buttocks, legs).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster related conditions (the dosage regimen information was not reported). Subsequently, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 18-year-old patient was administered a dose of PROQUAD; This spontaneous report was received from a medical assistance concerning a 18-year-old patient of unknown gender.  The patient's pertinent medical history, concomitant medications, concurrent conditions, and drug allergies or reactions were not reported.  On 19-DEC-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product administered to patient of inappropriate age)  dose 1, lot number S021620 and expiration date 09-JAN-2021, for prophylaxis.
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 6 year old male patient who received one dose each of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 11-Nov-2019, the patient received a one dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, [Lot number and other dosing details are not reported] via unknown route in unknown administration site.  It was a case of actual medication error due to extra dose administered.  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 month-old female received 0.25ml Fluzone Quadrivalent / no AE; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who received 0.25 ml INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UJ255AA (Expiry date 30-Jun-2020) via intramuscular route in the left vastus lateralis on 06-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that 4 month-old female received 0.25ml Fluzone Quadrivalent.  At the time of reporting no adverse reaction 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: FLU4
Symptoms: Chills, Fatigue
Clinical narrative: chills; fatigue; Initial information received on 11-Dec-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 38 years old male patient who experienced chills (chills) and fatigue (fatigue), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5 ml) lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious chills (chills) and fatigue (fatigue) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests were not reported. Final diagnosis was fatigue and chills.  It was not reported if the patient received a corrective treatment.  The outcome was reported as recovered (lasted for 3 days).
Sex: U
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: popped and a lot of liquid went out of the syringe. More of the vaccine got on her arm and her face / no AE; popped and a lot of liquid went out of the syringe. More of the vaccine got on her arm and her face; cracked syringe; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves unknown demography patient who had an incomplete vaccination of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] lot UJ273AB (Expiry date unknown) via intramuscular route in unknown administration site.  It was an actual medication error case due to vaccine underdose.  It was also a case of syringe leak and Exposure via skin contact.  At the time of reporting no adverse reaction 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: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: little pain (on day three); Initial information received on 17-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a female patient who experienced little pain (on day three) (Pain), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Fibromyalgia.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious little pain (on day three) (pain) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests were not reported.  Final diagnosis was little pain (on day three).  It was not reported if the patient received a corrective treatment.  The outcome was reported as unknown for little pain (on day three).
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: multi-dose vials of Fluzone and has been giving more than the 10 doses of either .25 or .5 mL doses of flu to their patients.; Initial information received on 18-Dec-2019 regarding an unsolicited non-valid non-serious case received from a nurse.  This was a Non-valid case as number of patients are not identified.  This case involves patients with unknown demographics who were vaccinated with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] which was given more than 10 doses of either 0.25 or 0.5 ml doses of flu (wrong technique in product usage process).  Medical history, medical treatments, vaccinations and family history were not provided.     On an unknown date, the patients received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [lot number and other dosing details were not reported] via unknown route in unknown administration site.  It was reported that provider was not aware of the rule with multi-dose vials of Fluzone and has been has given more than 10 doses to unknown number of patients.  It was a case of actual medication error due to wrong technique in product usage process.  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.  Information on the batch number was requested.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was administered on 18 Dec 2019 a Pentacel vaccine that was delayed in transit due to bad weather/no AE; if it is needed re vaccinate someone who received 1 dose of Pentacel that went through a temperature excursion after being in transit too long/ no AE; Initial information received on 19-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  It was reported that 2 months old female patient was vaccinated with pentacel vaccine on 18 Dec 2019  that was delayed in transit due to bad weather/no AE (poor quality product administered) and if it is needed re vaccinate of Pentacel that went through a temperature excursion after being in transit too long/ no AE (product storage error).of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 18-Dec-2019, the patient received a 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ198ABA via unknown route in unknown administration site.  It was a case of actual medication error due poor quality vaccine administered.  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 holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site inflammation, Vaccination site mass
Clinical narrative: hard at the vaccination site; red lump at the vaccination site; lump at the vaccination site; red at the vaccination site; Initial information received on 24-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a female patient (age unknown) who experienced hard red lump at the vaccination site (vaccination site induration), (vaccination site inflammation), (vaccination site swelling) and (vaccination site erythema), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious hard red lump at the vaccination site (vaccination site induration), (vaccination site inflammation), (vaccination site swelling) and (vaccination site erythema) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was vaccination site induration, vaccination site inflammation, vaccination site swelling and vaccination site erythema.   It was not reported if the patient received a corrective treatment.  The event outcome was not reported for the events.  Information on the batch number was requested.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Pt. was given Dtap instead of Hep. B
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product quality issue
Clinical narrative: 7 ROTATEQS with defective spikes. 7 in carton of 10 with cracked caps; Patients were administered with defective Rotateq; No adverse events reported; This spontaneous report as received from a nurse via a company representative refers to unspecified patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant medications were not reported.       On unspecified dates, the patients were vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # R016791, expiry date : 16-APR-2020) for prophylaxis. The nurse reported that "7 ROTATEQS with defective spikes. 7 in carton of 10 with cracked caps" were used to administer to unspecified patients (product quality issue and poor quality product administered). No additional adverse effects were reported.  This case was considered to be non-valid due to lack of patient identifiers.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: acute hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. In or around 26-MAY-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose #, lot #, expiration date and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Less than two months after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered and was diagnosed with acute hearing loss. As a direct and proximate result, the zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries, suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, acute hearing loss was determined to be medically significant and disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: muscle soreness; stiffness at the injection site; tender arm; have trouble with certain movements. such as reaching; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site muscle pain, stiffness, pain in arm and activities of daily living impaired. On an unknown date, the outcome of the injection site muscle pain, stiffness, pain in arm and activities of daily living impaired were unknown.   It was unknown if the reporter considered the injection site muscle pain, stiffness, pain in arm and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, still had muscle soreness and stiffness at the injection site after vaccination with dose of Shingrix. The patient reported that, after vaccination, the patient's upper arm was very tender and had trouble with certain movements, such as reaching.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: muscle soreness; stiffness at the injection site; tender arm; have trouble with certain movements. such as reaching; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site muscle pain, stiffness, pain in arm and activities of daily living impaired. On an unknown date, the outcome of the injection site muscle pain, stiffness, pain in arm and activities of daily living impaired were unknown.   It was unknown if the reporter considered the injection site muscle pain, stiffness, pain in arm and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, still had muscle soreness and stiffness at the injection site after vaccination with dose of Shingrix. The patient reported that, after vaccination, the patient's upper arm was very tender and had trouble with certain movements, such as reaching.