chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Cough, Headache, Malaise, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Congestion, cough, sore throat, nasal drip, malaise, headache. Pt is planning to see his MD.
Age: 70.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Upper-airway cough syndrome
Clinical narrative: Congestion, cough, sore throat, nasal drip, malaise, headache. Pt is planning to see his MD.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: This spontaneous report was received from a physician via a company representative regarding a patient of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On an unspecified date in 2003, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, strength, anatomical location or route of administration were not provided), for prophylaxis. Other suspect therapy included PREVNAR 13 (dose, frequency, strength, indication, anatomical location or route of administration were not provided). On an unknown date, the patient experienced fever and muscle aches. At the reporting time, it was unknown if the patient recovered from the aforementioned events. The causality assessment between the fever and muscle aches with the suspect vaccines was not provided.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Heart rate increased, Hyperhidrosis, Insomnia, Mobility decreased, Musculoskeletal pain
Clinical narrative: Arm muscle all the way to elbow became sore and unusable for 3 days. Neck shoulder and shoulder blade also very sore and painful when moved. Patient was sweaty. Heartbeat and breathing were rapid. Sleep was difficult. Nausea set in for three nights with vomiting on October 3. Stayed in bed mostly until Oct. 4. Arm still sore on Oct. 4 but improving.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Arm muscle all the way to elbow became sore and unusable for 3 days. Neck shoulder and shoulder blade also very sore and painful when moved. Patient was sweaty. Heartbeat and breathing were rapid. Sleep was difficult. Nausea set in for three nights with vomiting on October 3. Stayed in bed mostly until Oct. 4. Arm still sore on Oct. 4 but improving.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Respiratory rate increased, Vomiting
Clinical narrative: Arm muscle all the way to elbow became sore and unusable for 3 days. Neck shoulder and shoulder blade also very sore and painful when moved. Patient was sweaty. Heartbeat and breathing were rapid. Sleep was difficult. Nausea set in for three nights with vomiting on October 3. Stayed in bed mostly until Oct. 4. Arm still sore on Oct. 4 but improving.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray, Electrocardiogram, Full blood count, Herpes zoster, Metabolic function test
Clinical narrative: Patient developed Shingles 4 days after receiving the vaccine on the left side of her chest, prescribed gabapentin, lidoderm patches.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: Redness and inflammation around injection site, Sweating and fever on 10/01/18. Patient went to Dr and was prescribed Amoxil 500mg.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Discomfort, Dizziness, Malaise, Pain, Skin abrasion
Clinical narrative: 'Light-headed' ...'heavy' arm (cannot lift to the side at all); 'warm to the touch;' achiness; general malaise.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Vertigo
Clinical narrative: Vertigo type Sx when on my feet. OK when seated. Tried eating, BP was 92/70 which is normal for me. Just the feeling like I was going to fall if I ambulated. Sitting again was OK. Lasted 24 hours, and was noticeable to 10% the next half day. No treatment. Not classic vertigo, just felt unstable.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The patient repeorts that after recieving her flu vaccine, she is still cannot move her arm due to the pain in her arm 10 days later.
Age: 35.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash wrapping around arm, painful.... has been taking motrin otc and icing. Symptoms improving.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea, Pain
Clinical narrative: Patient explained that later that day after the vaccination had trouble breathing and had pain everywhere. Went to hospital to be treated.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient presented to the pharmacy on 10/1/2018 with swelling from the lower triceps head to her elbow. The area was warm but not painful. The area presented similar to an insect bite.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pharyngeal oedema, Swelling face
Clinical narrative: Patient began having redness and swelling at injection site the night of her vaccine, 10/2/18, She then had facial swelling and redness the next day which continues to get worse. Her throat also has visible swelling. She was taken to the ED for treatment.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Abnormal behaviour, Crying, Hallucination, visual, Inappropriate affect
Clinical narrative: Patient returned to clinic laughing, crying, acting unusual with visual hallucinations.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Dyspnoea, Nausea, Throat irritation, Wheezing
Clinical narrative: Patient received the noted vaccines, and left our office. His dad took him to the hospital cafeteria to purchase a snack and drink when he noticed that patient was coughing and seemed to be having trouble breathing. He did not eat any snack or drink, but it is not known whether he came into contact with any allergens in the cafeteria. He did develop nausea and said his throat was itchy. Upon exam, he was noted to have expiratory wheezing (which was not present at his check up a few minutes prior). We immediately gave him oral diphenhydramine and 2 albuterol nebulizer treatments. His wheezing improved but did not fully resolve. He was started on ORAPRED, and will follow up in our office tomorrow for a recheck. We discussed the use of injectable epinephrine, ER visit, and 911 call if symptoms worsen.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Eye pruritus, Oral pruritus, Urticaria
Clinical narrative: Employee reported having itchy eyes and mouth approximately 30 minutes after receiving the Flu vaccine. She felt like her face was swollen but this was not visible when she looked in the mirror. She did have red hives on her face. She had Benadryl 25mg on her person, she proceeded to take to tablets with relief. 10/4/18 she states have no further symptoms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Feeling abnormal, Inflammation, Pain in extremity, Pruritus
Clinical narrative: Patient states that she had an inflammation, itching, and pain from elbow up to her neck. Felt her skin was extremely stretched out. Also complained aboout difficulty breathing. Went to the hospital and states she felt she was going to die.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Skin tightness
Clinical narrative: Patient states that she had an inflammation, itching, and pain from elbow up to her neck. Felt her skin was extremely stretched out. Also complained aboout difficulty breathing. Went to the hospital and states she felt she was going to die.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to Employee Health at 1 hour post injection. Her right arm was red, swollen and itching from her shoulder to her hand. She was shaking. The injection site was HOT to the touch. No SOB at the time. She was taken to the ED for evaluation and treatment.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Pruritus, Tremor
Clinical narrative: Patient came to Employee Health at 1 hour post injection. Her right arm was red, swollen and itching from her shoulder to her hand. She was shaking. The injection site was HOT to the touch. No SOB at the time. She was taken to the ED for evaluation and treatment.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pain, Peripheral swelling
Clinical narrative: Client states the next day her arm was swollen, red and very sore. Around 10/2/18 it became itchy and she did itch it. The area around the vaccine became very red. Today it is light pink and just slightly itchy.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pruritus
Clinical narrative: Client states the next day her arm was swollen, red and very sore. Around 10/2/18 it became itchy and she did itch it. The area around the vaccine became very red. Today it is light pink and just slightly itchy.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient complaining of upper arm swollen and red. When she presented to us the severity was hard to notice but she says it was worse yesterday.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Pt felt sick that afternoon. Had a Fever of 104 degrees for 1½ days.
Age: 39.0
Sex: F
Vaccine: FLUR4
Symptoms: Limb discomfort, Muscular weakness, Nausea, Paraesthesia, Urticaria
Clinical narrative: Hives on face, left arm heavy weak and fingers tingling, nauseated.
Age: 41.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Paraesthesia oral, Pruritus, Rash generalised
Clinical narrative: Client waited 15 approximately 15 minutes after vaccination before she left. When she left, she had no signs of adverse reaction. Client states that at about 4:10 PM she developed a full body rash and itching. She also stated her lips were tingling but denied difficulty breathing. I instructed client to seek immediate medical attention. Client took Benadryl and went to her PCP. Her PCP prescribed a medication (not sure what medication). Today client states she feels better. States the rash is gone but she still has some itching.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Redness and swelling from right shoulder to halfway between R shoulder and R elbow. Area warm to touch. Child trying to scratch it. No fevers. Small blister 1 cm X 1 cm (from Band Aid- Mom left Band Aid on overnight). Dr. also examine child and site of immunization. Treatment: cetirizine PO. Epinephrine 1 mg/ 1 ml SC ordered by Dr.- to give 0.1 ml just below the reaction site right arm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received PNEUMOVAX twice in the same year. The first one was given on 2/4/2014 and the second one was given on 09/17/2014 but the patient never reported adverse reactions on those vaccines.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: 12 hours after vaccination developed chills, severe muscle pain, shivering, headache, nausea without vomiting. Symptoms persisted for 24 hours.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus generalised
Clinical narrative: Pt stated she was itchy all over, no rash, no shortness of breath, no injection site reaction.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site nodule, Injection site pain
Clinical narrative: Redness, inflammation, pain, knot below injection site.
Age: 84.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced swollen/tender with heat but no pain at the injection site.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: NAUSEA/VOMITING, GENERAL FEELING OF BEING UNWELL STARTING 8 HOURS AFTER INJECTION. STARTED TO RESOLVE BE EARLY AFTERNOON.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Erythema, pruritus, about 10 cm in diameter.
Age: 9.0
Sex: M
Vaccine: FLU4, HPV9, PPV
Symptoms: Erythema, Pain in extremity, Pruritus, Rash macular, Skin warm
Clinical narrative: PT REC'D PPV23 AND HPV IN RT AM IM, 1 DAY AFTER INJECTED PT C/O PAIN AND ITCHINESS IN THAT ARM. CAME TO CLINIC. ARM APPEARED READ AND SPLOTCHY AND WARM TO TOUCH. PT WAS TOLD TO GIVE IBUPROFEN AND BENADRYL.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received her SHINGRIX on Saturday. She felt fine on Saturday but on Sunday was fatigued, ran a low grade fever, & her arm was slightly swollen & sore. She was not concerned about these symptoms being that the VIS states them as possible adverse events. But then on Wednesday evening, she developed slight redness & itching around the injection site. She came into the pharmacy on Thursday to inquire about it. The patient states that the itching is a 1-2 on a scale of 10 & the redness spread out about an inch or two from injection site. I ( the pharmacist) plan to follow up with her to see if the rash resolves but even though it was a mild reaction I  thought it best to report rather than not.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient received her SHINGRIX on Saturday. She felt fine on Saturday but on Sunday was fatigued, ran a low grade fever, & her arm was slightly swollen & sore. She was not concerned about these symptoms being that the VIS states them as possible adverse events. But then on Wednesday evening, she developed slight redness & itching around the injection site. She came into the pharmacy on Thursday to inquire about it. The patient states that the itching is a 1-2 on a scale of 10 & the redness spread out about an inch or two from injection site. I ( the pharmacist) plan to follow up with her to see if the rash resolves but even though it was a mild reaction I  thought it best to report rather than not.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving vaccination.
Age: 0.92
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 11 month old patient of unknown gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 20-JUL-2018, the patient was vaccinated with M-M-R II lot # reported as R002932 with expiration date 29-JUL-2018, per intramuscular route (incorrect route of drug administration) (dose, strength, dose, and anatomical location were not reported) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received on 01-OCT-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age and a female consumer. The male patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 24-DEC-2015, the patient received the ZOSTAVAX (lot number and expiration unknown) unknown route for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a Shingles outbreak, in addition to chronic pain, rash and lesions to his ear and side of his face. The patient did not have a Shingles outbreak until 19-JAN-2017. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient 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. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Shingles outbreak/lesions to his ear and Shingles outbreak were considered to be disabling. Shingles outbreak/lesions to his ear was considered to be medically significant. Additional information has been received.
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Facial paralysis
Clinical narrative: Information has been received on 02-OCT-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On 08-OCT-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy for routine health maintenance and for the prevention of shingles. Shortly after receiving ZOSTAVAX, the patient was admitted to a hospital due to a sudden and severe right-sided facial paralysis and was diagnosed with Bell's palsy and later diagnosed with hearing loss. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Hearing loss and Bell's palsy were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 07-MAY-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # N006321 with expiration date of 08-NOV-2019, for prophylaxis (route was not reported), and was also vaccinated, on 04-AUG-2018, with an improperly stored dose of ROTATEQ orally, lot # N034401 with expiration date of 09-MAY-2019, for prophylaxis. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion below 0°C (degrees Celsius) (-0.26 °C) for 30 minutes; no previous temperature excursion was performed. The call was because of a "data logger".
Sex: F
Vaccine: PNC13
Symptoms: Drug ineffective
Clinical narrative: This is a spontaneous report from a contactable consumer (parent). A 9-month-old female patient received 2 doses of pneumococcal PREVNAR 13, lot number and expiration date unknown) both via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the pneumococcal PREVNAR 13 injections that were issued in June and July (unspecified date) had a problem with them and that they are ineffective. It was recommended that her daughter be revaccinated. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked with 2018SA267442 and 2018SA271680. This case involves a female patient (unknown age) who was exposed to a vaccine FLUZONE HIGH DOSE on an unspecified age (lot number, exp date, dosing details, route and site of administration not reported). It was a case of vaccine exposure during pregnancy. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is a pregnancy case reported that the patient had FLUZONE HD inadvertently given to 3 pregnant patients, increase rate of injection site reaction (no study in pregnancy) and FLUZONE HD inadvertently given to several pregnant patients occurred at unknown gestation period. It was not reported if any adverse event occurred (reported as no knowledge or information about the event whatsoever). Pregnancy outcome was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Vaccination complication, Wrong drug administered
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked with 2018SA267442 and 2018SA271669. This case involves a female patient (unknown age) who was exposed to a vaccine FLUZONE HIGH DOSE on an unspecified age. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is a pregnancy case reported that the patient had FLUZONE HD inadvertently given to 3 pregnant patients, increase rate of injection site reaction and FLUZONE HD inadvertently given to several pregnant patients occurred at unknown gestation period. Pregnancy outcome was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Lip swelling, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves Elderly male patient who experienced severe allergic reaction, while he received 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 FLUZONE HIGH DOSE lot UJ000AA. On an unspecified date, post vaccination patient developed a non-serious severe allergic reaction throat and lip swelling, throat and lip swelling, non-serious blood shot eyes. Patient went to local emergency room. Lab data not reported. Final diagnosis was severe allergic reaction. An unknown corrective treatment was received. The patient outcome was reported as Unknown for severe allergic reaction, as Unknown for throat and lip swelling, as Unknown for throat and lip swelling and as Unknown for blood shot eyes.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Furuncle, Peripheral swelling
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA272107 (Same reporter). This case involves a 74 years old female patient who experienced "very swollen arm", very red, it appeared a was boil coming from the side of swell and had been dizzy since the injection, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MECOBALAMIN (B12 RAPID SHOT) for Immunisation on an unknown date. On 25-Sep-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ023AA and expiry date: 25-Apr-2019) (dose in series and route of administration were not reported) in the left arm. On an unknown date, the patient developed a non-serious "very swollen arm" (peripheral swelling) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious very red (erythema) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious it appeared a was boil coming from the side of swell (furuncle) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious had been dizzy since the injection (dizziness) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that on 27-Sep-2018, patient was appointed to visit to the HCP. No Lab data was reported. Final diagnosis was had been dizzy since the injection, it appeared a was boil coming from the side of swell, very red and "very swollen arm". It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for very red, as Unknown for "very swollen arm", as Unknown for it appeared a was boil coming from the side of swell and as Unknown for had been dizzy since the injection.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Gait inability
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA272102 (same reporter). This case involves a 54 years old female patient who experienced she was "dizzy", had shortness of breath, she couldn't walk from the dizziness and just did not feel good, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Cardiac disorder on an unknown date. The patient's past medical treatment(s), vaccination(s) and family history were not provided. No concomitants. On 24-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UI998AE and expiry date: 30-Jun-2019) in the left deltoid (dose in series and route of administration were not reported). On an unknown date, the patient developed a non-serious she was "dizzy" following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious had shortness of breath following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious she couldn't walk from the dizziness following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious just did not feel good following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No Lab data was reported. Final diagnosis was just did not feel good, she couldn't walk from the dizziness, had shortness of breath and she was "dizzy". It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for she was "dizzy", as Unknown for had shortness of breath, as Unknown for she couldn't walk from the dizziness and as Unknown for just did not feel good. List of documents held by the sender: none.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure decreased, Dizziness, Pallor, Syncope
Clinical narrative: Patient was given flu shot. He was talking fine as his mom and sister received theirs. Then he stated he felt dizzy and then fainted. His blood was taken and given water and woke up right away after falling to ground. He was able to speak to mom asking for watering but stayed lying down for about 10 minutes until color came back to his face and BP went up. He was able to leave clinic on his own and speak.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain
Clinical narrative: Vaccine given below deltoid and patient's left arm is bruised from below deltoid to below elbow. Patient takes warfarin so bleeds more than usual. She reports she had pain the day of the vaccination.
Age: 22.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd Hepatitis A was given too early.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Rash, fever, consistent with Varicella.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever of 102, tired, achy for 2 days. Sore arm for 4 days (woke up if rolled over on it at night).  Patient said all back to normal after 4 days. Patient took ADVIL.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Vaccination site swelling
Clinical narrative: Swelling and redness in area of vaccination -  about 4" around, pain in arm.
Age: 76.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient reported the morning after injection, that her right arm had a red itchy circle around the injection site. She said the circle was about the size of a half dollar. She was instructed to put some hydrocortisone on the area or to take BENADRYL to help with the reaction. She reported improvement throughout the day. Upon recheck on 10/04/18, she reported recovery.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Large area of celulitus on arm.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Noticed symptoms of numbness and tingling in my left arm and partial spots of my left face from my mouth all the way up to around my left eye. Later in the day, noticed numbness and tingling in my left foot. Took 1 tablet of ZYRTEC around 11:00 AM. Symptoms resided the next morning.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Erythema, Pain in extremity, Pyrexia
Clinical narrative: Chills and fever started about 12 hours after shot, also stomach upset; Fever, chills, and upset stomach lasted for about 24 hours. Pain in arm and redness started about 2 hours after shot. It lasted about 3 days. I took acetaminophen for chills and fever.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Loss of consciousness, Syncope
Clinical narrative: About 10 min after vaccine was given patient fainted next to brother on the chair. Lost consciousness about 1-2 seconds and patient came back. Laid him on the floor and elevated his feet for 10-15 minutes until we helped patient walk to the exam room next door and laid down and elevate his legs again. After 20-25 minutes patient return to normal vitals and color and was discharged.
Age: 0.25
Sex: M
Vaccine: UNK
Symptoms: Decreased appetite, Lethargy, Pyrexia
Clinical narrative: Fever, lethargy and loss of appetite.
Age: 33.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site rash, Pruritus
Clinical narrative: PATIENT PRESENTED 2 DAYS AFTER VACCINATION WITH REDNESS AND RASH NOTED ON UPPER R DELTOID REGION AND C/O OF AREA BEING VERY ITCHY OVER LAST 2 DAYS.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: PATIENT FELT LIGHT HEADED AND FAINT APPROX 10 MINUTES AFTER RECEIVING THE VACCINE. WE CALLED 911 AND THE PARAMEDICS WERE SUMMONED AND THE PATIENT WAS TAKEN TO THE HOSPITAL.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient has 4 in X 3 in dark pink patch at injection site. Arm is very painful from shoulder to elbow. Patient used ice packs and BENADRYL still monitoring symptoms.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Bursa disorder, Injection site movement impairment, Injection site pain, Joint noise
Clinical narrative: Pt described a popping sound and pain at site after vaccine administration- limited mobility followed shortly after. Pain/ mobility had not improved after a few weeks so pt scheduled visit with his PCP where he was diagnosed with bursa. Pt was given NSAID therapy and a variety of light muscle workouts to be started this month.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site nodule, Injection site swelling
Clinical narrative: Blood drops from left deltoid with a small bump with swelling. Ice applied.
Age: 48.0
Sex: F
Vaccine: FLUR4
Symptoms: Dysphagia
Clinical narrative: Difficulty swallowing.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt said her arm was red and swollen around the injection site.
Age: 89.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Blood culture, Chest X-ray, Laboratory test, Pyrexia
Clinical narrative: Fevers, severe weakness requiring hospital admission.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity, Rash
Clinical narrative: Patient had pain and by 6 pm could not lift her arm. She also had a rash of at least 4 inches in diameter that circled her arm. The pain and rash lasted several days. There was no "heat" with the rash.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Dyskinesia, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, loss of control of limbs.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Headache, Lip swelling, Pyrexia
Clinical narrative: Patient recieved flu shot at approximately 6pm Wed night, Thursday morning around 6 am she awoke with a headache, fever >103 and swollen lips and eyes. Mom gave her 200mg ibuprofen and 25mg diphenhydramine, patient fell back asleep and when she awoke 4 hours later her eyes and lips were not swollen, her headache was tolerable and fever was going down. Mom was going to continue ibuprofen every 6 hours and make sure she stays well hydrated and will follow up with her physician if the situation worsens or does not improve.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait inability, Rash pruritic, Vomiting
Clinical narrative: Vomited day following the vaccine, couldn't walk until the afternoon on the day following the vaccine.  Developed spots on ankles, writs, arms, breast, and stomach that itch. Patient contacted pharmacy and it was recommended to be evaluated by the doctor to rule out shingles. Dr has evaluated and said not shingles, however triamcinolone cream was ordered for topical use on the spots. Everything else has resolved except itchy spots.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Area below injection site on the arm, is red, swollen, and warm to touch.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Head discomfort, Injection site induration, Nausea, Pyrexia
Clinical narrative: FEVER (103.5F). SITE IS HARD, SIZE OF GRAPEFRUIT. NAUSEA. PRESSURE IN THE HEAD.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Insomnia, Rash erythematous, Skin warm
Clinical narrative: Patient reports difficulty sleeping that night due to discomfort. Friday afternoon the patient showed her husband the rash which was red and warm to the touch. Friday evening the patient sought medical care at urgent care and was prescribed an antibiotic and MEDROL dose pack. Upon presenting to the pharmacy, the patient showed the pharmacist her upper arm which had a 4-5 inch diameter red, rashy area.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Swelling, Tenderness
Clinical narrative: Patient stated that she had chills, fatigue and a swollen red area that was the size of a baseball that was sensitive to the touch.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient experienced headache, fever, and a "feeling of being out of sorts" the day after but the reason she came in was because around the injection site was red, swollen, hard, and painful to the touch.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Patient experienced headache, fever, and a "feeling of being out of sorts" the day after but the reason she came in was because around the injection site was red, swollen, hard, and painful to the touch.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Erythema, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Left arm was red and swollen and a rash was present. Patient indicated that pain and swelling continued down the arm since 10/1/2018. She also had diarrhea on 10/3/2018. All of arm was tender. RPh advised for pt to see Dr to evaluate.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Left arm was red and swollen and a rash was present. Patient indicated that pain and swelling continued down the arm since 10/1/2018. She also had diarrhea on 10/3/2018. All of arm was tender. RPh advised for pt to see Dr to evaluate.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site induration
Clinical narrative: Hardening of the site and bruising, used a cold ice pack.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Patient's husband reported that the patient experienced "extreme" pain in the left shoulder and that it hurt to move. The husband also reported that the patient had difficulty in performing normal activities for two days. Then reported that "She's fine now" indicating unknown duration for recovery from pain after immunization.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Cold sweat, Dizziness, Hyperhidrosis, Hypoacusis
Clinical narrative: Patient wrote out descriptions: Symptoms of "blurred vision, muffled hearing, dizziness, tingling sensation in arms, sweating/ feeling clammy; "After receiving flu shot, I started feeling all of the symptoms previously described. They began within the first 5 minutes after getting the shot. I went back to the pharmacy and they had me sit down and monitor me. They gave me a juice box and sweets, should the problem have been my blood sugar." "The feelings began to subside a few minutes after sitting down, and were gone a half hour later. This has never happened before." Pharmacist: I had the patient sit, have a snack, put a wet washcloth on her neck, and talked. She was clearly not having an allergic reaction. I felt like she needed to be calmed down, since she was becoming anxious. I let her leave about 30-45 minutes later when she looked better and expressed that she was better. I spoke to her several hours later and she was back to normal.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: Patient wrote out descriptions: Symptoms of "blurred vision, muffled hearing, dizziness, tingling sensation in arms, sweating/ feeling clammy; "After receiving flu shot, I started feeling all of the symptoms previously described. They began within the first 5 minutes after getting the shot. I went back to the pharmacy and they had me sit down and monitor me. They gave me a juice box and sweets, should the problem have been my blood sugar." "The feelings began to subside a few minutes after sitting down, and were gone a half hour later. This has never happened before." Pharmacist: I had the patient sit, have a snack, put a wet washcloth on her neck, and talked. She was clearly not having an allergic reaction. I felt like she needed to be calmed down, since she was becoming anxious. I let her leave about 30-45 minutes later when she looked better and expressed that she was better. I spoke to her several hours later and she was back to normal.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: PER PHONE CONVERSATION FROM PATIENT ON 10/2/18 AT 3:22PM PATIENT REPORTED SWELLING NEAR HER LEFT ELBOW. SHE SAID SWELLING AND PAIN STARTED NEAR INJECTION SITE 9/30/18 (NEXT DAY AFTER SHE GOT THE SHOT) SWELLING TRAVELED TOWARD ELBOW EACH DAY. BY THE TIME OF REPORT SHE SAID SWELLING SIGNIFICANTLY GOT BETTER AND NOT PAINFUL.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Laboratory test, Muscle spasms, Pain
Clinical narrative: Patient complained of shock approximately 25 mins after receiving vaccine with muscle spasm and pain that started in the upper part of her body and radiated throughout her entire body. She does not believe it was the vaccines she received since she's had vaccines in the past without issues.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Bed rest, Chills, Fatigue, Pyrexia
Clinical narrative: Patient called and stated at 1 am he woke up with chills all over his body, then broke out in a fever which lasted about an hour. When fever broke he was extremely tired. He was in bed the next day because he was exhausted.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Inflammation of the left arm and pain.
Age: 25.0
Sex: M
Vaccine: FLUC4
Symptoms: Lethargy, Loss of consciousness, Syncope
Clinical narrative: Patient received the flu shot in the past, with no issue. In doctor's office a few months ago, experienced light dizziness/nausea when receiving PPD shot, patient alerted doctor to reaction. When patient received flu shot on 10/01/2018 at approximately 7:00pm, he was fine. After 5 minutes, the patient experienced syncope and lost consciousness for a few minutes while seated with girlfriend. He did not fall or experience any trauma; slumped in seat, but awoke after a few minutes. Patient then felt very lethargic after waking, but remained seated for approximately 15 minutes (alert). Patient then felt better and left the pharmacy. Did not have to perform CPR or give Epi-pen to patient. Counseled patient to receive future vaccines in doctor's office and to follow-up with PCP.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Day of the flu shot my 9 year old was fine. The next day and for the next five days the injection site turned red, was hot, itched extremely, and ending in being the size of half his upper arm.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING, REDNESS, FEVER UPPER LEFT ARM. HER DR RECOMMENDED TYLENOL AND MADE HER APPT FOR 10/5/18 AT 1:30 PM.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Patient's left arm was red and swollen. Area was about 5 inches in diameter. Patient took some TYLENOL for the pain. Area has improved a little bit from 10/3/18 to 10/4/18, but it was still red.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient comes in after 10 days with a rash to the right side of his body. Rash is light no itching or pain.
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, Skin warm
Clinical narrative: Patient stated having major pain in her right arm. Was warm to tough and unable to life arm. Patient had achy feeling since the night on the third.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient called and stated that the site was warm to touch and some swelling. At location of shot there was a red dot.
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Loss of consciousness, Nausea
Clinical narrative: Patient received flu vaccination, stated that it hurt upon injection, he waited while father got vaccination and then passed out 1-2 minutes after father received vaccination. Father stated son was nervous prior to injection, has had flu shot previously without incidence and has passed out once previously (not medication related). Patient felt nauseous when he regained consciousness, sat in chair, applied cold compresses, took blood pressure twice. First reading-117/82, second reading 10 minutes later-122/79. Patient remained seated for 5 more minutes, felt better.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose normal, Electrocardiogram normal, Generalised tonic-clonic seizure
Clinical narrative: Patient had a generalized tonic clonic seizure about 40 minutes after the vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient got the FLUZONE HD vaccine on 10/1/18. She reported to her Dr. on 10/4/18 with a large area of her left arm red and with swelling. Her Dr. diagnosed the area as cellulitis and gave her a prescription for cephalexin. He informed the patient that if she did not notice the area getting better, she should report to the hospital ER in the next couple of days.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bone pain, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Large red welt below injection site. Severe pain in both arm and leg bones and in joints. Pain lasted all night. Large red welt still there. Sore and itchy.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Pain in extremity
Clinical narrative: Large red welt below injection site. Severe pain in both arm and leg bones and in joints. Pain lasted all night. Large red welt still there. Sore and itchy.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Body temperature increased, Headache, Mood altered, Nausea
Clinical narrative: Severe body aches, joints pain, slight increase in body temperature, mood changes, nervousness, severe headache, toothache and nausea, it has been almost 4 weeks since I received the vaccine and I am still suffering from these symptoms.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Nervousness, Pain, Toothache
Clinical narrative: Severe body aches, joints pain, slight increase in body temperature, mood changes, nervousness, severe headache, toothache and nausea, it has been almost 4 weeks since I received the vaccine and I am still suffering from these symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chest discomfort, Dyspnoea, Fatigue, Feeling cold
Clinical narrative: Received the SHINGRIX vaccine from my PCP and by 8 pm I was so tired and had to go to bed. Throughout the night I had major night sweats and then moments of freezing. At 3:30 am, I got up as I was super thirsty and my head was pounding. I took 1-Extra Strength TYLENOL and went back to bed where I continue to have both freezing and night sweats again. I finally dragged myself out of bed and was soaked. Around 11 am on 9/29/2018, my husband said I was breathing pretty hard and looked bad, felt my head and I was hot. Took my temperature and it was 102 F. I was now having a heaviness on my chest, severe headache and fever. Went to the local hospital where they first ruled out flu and pneumonia is but I remained with temperatures of both 102 and then 103F. HR greater than 120 and B/P greater than my normal 110/70's, stayed above 140/85 for hours. After review of testing they admitted to hospital for overnight to determine what other source could be causing all of the symptoms, fluids given along with TYLENOL and monitored until discharged on 10/1/2018. My first shingle shot back in April 2018 I only had a sore arm but none of the severe side effects this last time.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Night sweats, Pyrexia, Skin warm
Clinical narrative: Received the SHINGRIX vaccine from my PCP and by 8 pm I was so tired and had to go to bed. Throughout the night I had major night sweats and then moments of freezing. At 3:30 am, I got up as I was super thirsty and my head was pounding. I took 1-Extra Strength TYLENOL and went back to bed where I continue to have both freezing and night sweats again. I finally dragged myself out of bed and was soaked. Around 11 am on 9/29/2018, my husband said I was breathing pretty hard and looked bad, felt my head and I was hot. Took my temperature and it was 102 F. I was now having a heaviness on my chest, severe headache and fever. Went to the local hospital where they first ruled out flu and pneumonia is but I remained with temperatures of both 102 and then 103F. HR greater than 120 and B/P greater than my normal 110/70's, stayed above 140/85 for hours. After review of testing they admitted to hospital for overnight to determine what other source could be causing all of the symptoms, fluids given along with TYLENOL and monitored until discharged on 10/1/2018. My first shingle shot back in April 2018 I only had a sore arm but none of the severe side effects this last time.