chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Chills, Dizziness, Fluid intake reduced
Clinical narrative: flu symptoms; splitting headache; neck pain; back pain; chills; total body myalgia; weakness to the point of barely being able to make it to the bathroom, unable to move; dizziness; nausea; can not eat or drink; sick on stomach; near fainting spells; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 66-year-old female patient (nurse) who could not eat or drink (eating disorder) and experienced near fainting (presyncope), sick on stomach (abdominal discomfort), dizziness, nausea and flu symptoms (influenza) with splitting headache (headache), neck pain, back pain, chills, total body myalgia (myalgia), weakness to the point of barely being able to make it to the bathroom, unable to move (asthenia) , after she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination included flu vaccine which she received every year and she never had any symptoms but short of mild myalgia. The patient's past medical treatment(s), family history and concomitant medication were not provided.   On 30-Sep-2020 at 13:00, the patient received a 0.7 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (prefilled syringe, batch number and expiry date not reported) via intramuscular route at an unknown administration site for prophylactic vaccination.  On 30-Sep-2020 at 19:00, the patient could not eat or drink (eating disorder) and developed near fainting (presyncope), sick on stomach (abdominal discomfort), dizziness, nausea and flu symptoms (influenza) with splitting headache (headache), neck pain, back pain, chills, total body myalgia (myalgia), weakness to the point of barely being able to make it to the bathroom, unable to move (asthenia) , 6 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Patient stated that the symptoms all together hit at once. Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient had not recovered from headache and could not eat or drink and outcome was not reported for other events.   There will be no information available on the batch number for this case.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypophagia, Influenza, Myalgia, Nausea
Clinical narrative: flu symptoms; splitting headache; neck pain; back pain; chills; total body myalgia; weakness to the point of barely being able to make it to the bathroom, unable to move; dizziness; nausea; can not eat or drink; sick on stomach; near fainting spells; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 66-year-old female patient (nurse) who could not eat or drink (eating disorder) and experienced near fainting (presyncope), sick on stomach (abdominal discomfort), dizziness, nausea and flu symptoms (influenza) with splitting headache (headache), neck pain, back pain, chills, total body myalgia (myalgia), weakness to the point of barely being able to make it to the bathroom, unable to move (asthenia) , after she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination included flu vaccine which she received every year and she never had any symptoms but short of mild myalgia. The patient's past medical treatment(s), family history and concomitant medication were not provided.   On 30-Sep-2020 at 13:00, the patient received a 0.7 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (prefilled syringe, batch number and expiry date not reported) via intramuscular route at an unknown administration site for prophylactic vaccination.  On 30-Sep-2020 at 19:00, the patient could not eat or drink (eating disorder) and developed near fainting (presyncope), sick on stomach (abdominal discomfort), dizziness, nausea and flu symptoms (influenza) with splitting headache (headache), neck pain, back pain, chills, total body myalgia (myalgia), weakness to the point of barely being able to make it to the bathroom, unable to move (asthenia) , 6 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Patient stated that the symptoms all together hit at once. Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient had not recovered from headache and could not eat or drink and outcome was not reported for other events.   There will be no information available on the batch number for this case.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Presyncope
Clinical narrative: flu symptoms; splitting headache; neck pain; back pain; chills; total body myalgia; weakness to the point of barely being able to make it to the bathroom, unable to move; dizziness; nausea; can not eat or drink; sick on stomach; near fainting spells; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 66-year-old female patient (nurse) who could not eat or drink (eating disorder) and experienced near fainting (presyncope), sick on stomach (abdominal discomfort), dizziness, nausea and flu symptoms (influenza) with splitting headache (headache), neck pain, back pain, chills, total body myalgia (myalgia), weakness to the point of barely being able to make it to the bathroom, unable to move (asthenia) , after she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past vaccination included flu vaccine which she received every year and she never had any symptoms but short of mild myalgia. The patient's past medical treatment(s), family history and concomitant medication were not provided.   On 30-Sep-2020 at 13:00, the patient received a 0.7 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (prefilled syringe, batch number and expiry date not reported) via intramuscular route at an unknown administration site for prophylactic vaccination.  On 30-Sep-2020 at 19:00, the patient could not eat or drink (eating disorder) and developed near fainting (presyncope), sick on stomach (abdominal discomfort), dizziness, nausea and flu symptoms (influenza) with splitting headache (headache), neck pain, back pain, chills, total body myalgia (myalgia), weakness to the point of barely being able to make it to the bathroom, unable to move (asthenia) , 6 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Patient stated that the symptoms all together hit at once. Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient had not recovered from headache and could not eat or drink and outcome was not reported for other events.   There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient received an expired doe of FLUZONE QUADRIVALENT/ No AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via agency (Reference number- 00315880) and transmitted to Sanofi on 14-Oct-2020.  This case involves female patient (age unspecified) who received an expired dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (Fluzone quadrivalent) [lot number and expiry date not reported] via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error due to expired vaccine used. (Latency: at the time of vaccination)  It was reported that, reporter wanted to know how long before patient had to wait before they could administer the correct vaccine.   At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on buttocks
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: SWELLING OF CHIN AND LIPS HIVES & WELTS DEVELOP ALL OVER THE BODY, INCLUDING HIS NASAL MEMBRANE
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Cyst
Clinical narrative: Injection resulted in cyst 2inx3inx1in, will require surgical intervention
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Headache
Clinical narrative: headache and weakness
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: Patient called the office stating she wasn't supposed to receive the MMR vaccine because it's a live virus and she gives herself Dupixent injections. She stated she did not have any reactions to the vaccination and was encouraged to call the office if symptoms did develop.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Nerve conduction studies abnormal
Clinical narrative: Guillain Barre Syndrome
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reports that she has had redness and pain at the injection sight for over 1 week. Patient returned to the clinic to have arm assessed. No redness noted and no swelling at injection sight. Patient did say injection sight was tender to  touch.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: PATIENT STATED SHE GOT CELLULITIS AND WAS IN THE HOSPITAL FOR 3 DAYS.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Patient reports fever, chills, and fatigue the evening following vaccination and for a day thereafter. Patient reports peak temperature of 104 degrees
Age: 63.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Loss of personal independence in daily activities, Sleep disorder
Clinical narrative: After approximately 24 hours, developed redness and severe soreness at injection site of Shingrix vaccine.  Pain was severe and lasted 3-4 days, responding only slightly to Ibuprofen (recommended by pharmacy where injection was administered).  Daily activities, including sleeping were disrupted due to the pain. No other adverse affects, other than tiredness due to lack of sleep.  Note, second Shingrix dose was administered on 11/13/2020 (2 months later) with no adverse affects.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient is experiencing severe arm and shoulder pain.  Medication was likely given too high, just below the acromium process.  At this time the primary care physician's office is to treat conservatively, refer to physical therapy and hope it resolves in a few weeks.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Ageusia, Bedridden, Fatigue, Headache, Myalgia
Clinical narrative: Chronology:  ============================================== Muscle sore immediately (Sunday afternoon to Wednesday morning).  Fever over 100 degree Fahrenheit (deg F) the next 1 days (Mon),  Headache. Taking  Naproxen Sodium. Bedridden. Tired.  99+ deg F next day (Tuesday), Headache. Taking  Naproxen Sodium. Not bedridden. Resume activities. 98.7 deg F (normal for me, Wednesday).  Some nausea and loss of taste. Taking  Naproxen Sodium.  No redness or swelling at injection site, or any other site as far as I could tell.   I hope that this data helps, I thought that you should know, even though I have no persistent concern at this time.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Chronology:  ============================================== Muscle sore immediately (Sunday afternoon to Wednesday morning).  Fever over 100 degree Fahrenheit (deg F) the next 1 days (Mon),  Headache. Taking  Naproxen Sodium. Bedridden. Tired.  99+ deg F next day (Tuesday), Headache. Taking  Naproxen Sodium. Not bedridden. Resume activities. 98.7 deg F (normal for me, Wednesday).  Some nausea and loss of taste. Taking  Naproxen Sodium.  No redness or swelling at injection site, or any other site as far as I could tell.   I hope that this data helps, I thought that you should know, even though I have no persistent concern at this time.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Nerve compression, Pain in extremity
Clinical narrative: Pt states she jumped when receiving the shot and arm has been in constant pain since receiving. Claims "pinched nerve" but multiple trips to her MD have not revealed the root cause of the problem.
Age: 5.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Decreased appetite, Dysstasia, Eye movement disorder, Headache, Moaning
Clinical narrative: Around 6 p.m. Pt. developed 105 fever that lasted all night despite Tylenol. The following day still warm. Still in bed with moaning and headache. Refuse to get out of bed. Could not stand. No appetite. Possible loss of conscious. Eyes rolled back in head.
Age: 5.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Pyrexia, Skin warm
Clinical narrative: Around 6 p.m. Pt. developed 105 fever that lasted all night despite Tylenol. The following day still warm. Still in bed with moaning and headache. Refuse to get out of bed. Could not stand. No appetite. Possible loss of conscious. Eyes rolled back in head.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: 11:30am (Mon. Sept 14) received vaccines for shingles and flu.  Felt fine most of the day, minor arm discomfort. 7:30pm slight headache began 10:00pm feeling nauseous, worsening headache, chills (particularly my feet were cold) Between midnight and 3am vomited once; nausea briefly abated then returned Second day (Tuesday Sept 15) still had a headache and arm is sore to the touch but mildly.  Not much interest in eating. 1:00pm took Tylenol.  Tired and low energy the rest of the day; eating small dry bites only. Third day (Wed. Sept 16) felt nearly back to normal.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Limb discomfort, Nausea, Peripheral coldness, Tenderness, Vomiting
Clinical narrative: 11:30am (Mon. Sept 14) received vaccines for shingles and flu.  Felt fine most of the day, minor arm discomfort. 7:30pm slight headache began 10:00pm feeling nauseous, worsening headache, chills (particularly my feet were cold) Between midnight and 3am vomited once; nausea briefly abated then returned Second day (Tuesday Sept 15) still had a headache and arm is sore to the touch but mildly.  Not much interest in eating. 1:00pm took Tylenol.  Tired and low energy the rest of the day; eating small dry bites only. Third day (Wed. Sept 16) felt nearly back to normal.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pain in extremity, Pyrexia, Skin warm, Vaccination site swelling
Clinical narrative: Patient came in for catch vaccination of DTaP (Left Arm) and Hep B (Right Arm) yesterday on 11/17/2020.  Both vaccines given without any immediate adverse reaction noted.    The  guardian called and stated she stated she gave Tylenol last night because she complained her left arm was a little sore.  She was sent home for school today, 11/18/2020,  when the nurse assessed her and  she had a low grade temp of 99, redness and swelling that traveled up her arm to her shoulder and it is warm to touch.  I explained she was more tense when I vaccinated the left  arm first and was lot less tense with the 2nd vaccine on the right arm.   She has given her Tylenol since she has been back home and has a cold compress on her arm as well.   I informed her as mentioned in the VIS form that DTaP is known to cause swelling to the site and tend to not after the 4th or 5th dose.  This was her 3rd dose and first episode.  I advised her on the severe allergic reactions and to get her to the ER if those symptoms occurs.  I asked her to please call me at the location on Friday with an update or sooner if anything else arises.
Age: 8.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, IPV, MMRV
Symptoms: Arthralgia, Headache, Pain in extremity, Pyrexia
Clinical narrative: SIGNIFICANT JOINT PAIN, HIGH FEVERS X 4 DAYS (BETWEEN 101-103F), SEVERE HEADACHE, LEFT ARM PAIN
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Poor quality sleep
Clinical narrative: Patient reported significant fatigue starting 5 to 6 hours after receiving vaccination and resolving about 24 hours after receiving vaccination. Patient reported no other symptoms. Did not sleep well the night after receiving vaccination.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia, Pain
Clinical narrative: Patient experiencing throbbing shoulder arm pain.  Has little improvement with over the counter ibuprofen and ice.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Nausea, Vomiting
Clinical narrative: received the vaccine at 10:30am Monday Nov. 16.  Felt fine that day until evening... about 9pm began feeing nauseous and cold, with a slight headache. 11:30pm vomited; nausea briefly abated then returned 1:15am vomited again Second day (Tuesday Nov. 17) still had a headache so took one dose of Tylenol which cleared the headache and it did not return. Feeling slightly better this day and virtually no arm pain at all.  A bit tired. Third day (Wed. Nov. 18) feel fine and back to normal.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Topical reaction lasting 4 days. Fever, burning sensation, pain in the injection area and on the body.  The area turned red.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Bronchitis, Chest pain, Chills, Cough, Fatigue
Clinical narrative: Two hours after injection developed a "relentless" slightly productive cough and burning in her chest "like a bronchitis".    She used her Airduo inhaler and at first the cough worsened, but then it subsided. She also felt "punky, chilled, and lethargic".  No fever. Temp was 99.0
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Lethargy
Clinical narrative: Two hours after injection developed a "relentless" slightly productive cough and burning in her chest "like a bronchitis".    She used her Airduo inhaler and at first the cough worsened, but then it subsided. She also felt "punky, chilled, and lethargic".  No fever. Temp was 99.0
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Decreased appetite, Headache, Migraine, Nausea
Clinical narrative: Cough, Runny nose followed by nausea, headache which lead to migraine lasting 2 days, 4 days of appetite changes and weight loss.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea, Weight decreased
Clinical narrative: Cough, Runny nose followed by nausea, headache which lead to migraine lasting 2 days, 4 days of appetite changes and weight loss.
Age: 14.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Dose administered to minor in error. Family notified of incident. No adverse reactions as of 11/18/2020.
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Dose administer to minor in error.  Family notified.  No adverse reaction as on 11/18/2020.
Age: 0.25
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site urticaria
Clinical narrative: Pt's mother reports Edema, Erythema, and Urticaria on (L) Leg going outward from injection site. Symptoms started 24hrs after injection. Provider recommended stopping Hib series going forward.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lethargy, Nausea, Pyrexia
Clinical narrative: FEVER, HORRIBLE HEADACHE, NAUSEA, AND EXTREME LETHARGIC. NO TREATMENT
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity, Poor quality sleep
Clinical narrative: Severe upper arm pain.  So severe i couldnt sleep the first night.  As the days have past the ache and occasional shooting pain  gradually reduced, and is now is just  located in the shoulder joint.  Joint pain has shut down the ability to raise my arm.  Its the 5th day after the shot and my sense is it will take another 5 to return to normal.  Arm pain can spike during sleep, waking me and i am awake for hours.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, redness and swelling the size approximately of her hand
Age: 74.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated that he has had swelling, redness, and heat at the injection site for 3 days after vaccination.  I instructed patient to alert PCP if area became worse, did not start getting better, and/or if seeing red streaks, or affected area grows.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Differential white blood cell count, Full blood count, Injection site pain, Metabolic function test
Clinical narrative: Pt received pneumovax (PVX) at Pharmacy 11/17/20.  Pt states she developed severe pain at the injection site left upper arm deltoid region, left axilla, left neck.  She took 2 aleve and 2 tylenol for this.  She states her urine was butterscotch color.  She was seen in the office 11/18/20, physical exam pt afebrile, BP 145/107  P 107, she was not in acute distress.  No erythema, fluctuance, or induration of left deltoid region, left axilla, and left neck but there was tenderness to palpation  in those regions.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Tenderness, Urine analysis
Clinical narrative: Pt received pneumovax (PVX) at Pharmacy 11/17/20.  Pt states she developed severe pain at the injection site left upper arm deltoid region, left axilla, left neck.  She took 2 aleve and 2 tylenol for this.  She states her urine was butterscotch color.  She was seen in the office 11/18/20, physical exam pt afebrile, BP 145/107  P 107, she was not in acute distress.  No erythema, fluctuance, or induration of left deltoid region, left axilla, and left neck but there was tenderness to palpation  in those regions.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Upper Right arm has redness, swelling, and blisters at injection site.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood glucose increased, Dizziness, Headache, Nausea
Clinical narrative: Patient reported feeling a headache within an hour of getting flu vaccine on 11/12. The day after (11/13) patient stared feeling dizzy and on 11/ 14 started feeling nauseous. She reports headaches are now resolved, but she was still having some dizziness and nausea when she called the clinic on 11/17. She has a history of diabetes and reports her glucose level was over 500 in the past few days. She denies stroke-like symptoms. Clinic's MD spoke with her on 11/17 and advised her to go to the nearest ED to further testing and evaluation given elevated glucose reading. RN called patient on 11/18 to follow up.
Age: 12.0
Sex: F
Vaccine: MMRV, TDAP
Symptoms: Pyrexia, Rash, Swelling face
Clinical narrative: 48 hrs after shots she had fever between 99.7-100.7 that lasted 8 days (off and on) She had rash break out on neck, chest, belly and back on day 8. Day 10 she had "facial swelling".  She has had previous Tdap with no rxn and Varicella with no rxn.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, White blood cell count normal
Clinical narrative: large local reaction; swelling, redness w/o pain upper arm to the elbow
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: no current
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Caused arm Pain and inflammation in Bursa of Shoulder
Age: 8.0
Sex: M
Vaccine: MNQ
Symptoms: Rash, Rash pruritic
Clinical narrative: ITCHY RASH ON ARMS/LEGS
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dyskinesia, Loss of consciousness, Skin warm, Tremor
Clinical narrative: The patient returned to the pharmacy area a few minutes after receiving her vaccine saying that she felt like she was going to pass out. Her mother caught her as she lost consciousness in a chair, saying she did not hit her head. She regained consciousness as I entered the area to care for her and said she felt warm and like "she was dreaming." She lost consciousness a second time and was having involuntary muscular contractions in her body and clenching her hands. I was holding her so she didn't fall out of her chair and it felt like she was also shaking. She regained consciousness after a minute or so and said again she felt warm and like "she was dreaming". We gave her water, orange juice, and hard candy and monitored her until paramedics arrived. They examined her and said she declined to go to the hospital. She walked out of the store about 15-20 minutes after her initial episode.
Age: 82.0
Sex: M
Vaccine: FLUA3
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Patient Called pharmacy on 11/18/2020. to report that he had been diagnosed with Guillain Barre Syndrome. He received the Fluad vaccination on 11/6 and started to experience symptoms on the 14 of November.  A spinal tap ordered by a neurologist confirmed the diagnosis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: patient called reporting that she had a hard lump in the left deltoid. her arm was painful to lift. no fever, no redness, no warmth at injection site. she was advised to consult on-call md for assessment who referred her to ED for assessment. we have not been able to contact patient to confirm outcome.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, Product administered at inappropriate site, Tendonitis
Clinical narrative: Patient came to pharmacy 11/18/20 stating that the flu shot given was too high on the arm and developed tendonitis.  About 4 to 5 days after receiving the flu shot she experienced arm pain and had difficulty lifting her arm.  She went to the doctor and was diagnosed with tendonitis.  She was given meloxicam to treat the tendonitis.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Eyelid rash, Headache, Nasal congestion
Clinical narrative: Rash on left eyelid the evening after the vaccine - severe headache and congestion 3 days after vaccine
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Patient stated she has felt faint when receiving certain vaccines in the past.  Patient stayed at the pharmacy after receiving her first dose of Shingrix today for monitoring.  Shortly after receiving the vaccination she stated she felt overheated and after about 20 minutes she laid down on the bench due to feeling dizzy.  Temperature was normal with infrared thermometer to forehead and initial blood pressure (BP) reading was 106/80, patient stated she felt hot and sweaty.  A cool, wet compress was applied to the back of her neck and changed frequently and the patient sipped on ice water.  After about 10 minutes her BP was 107/81 and temperature was normal.  She did not feel sweaty any longer but still felt dizzy.  Patient felt like sitting up after another 10 minutes and drank some more ice water, BP was 112/81, she still felt a dizzy but not as much.  Upon recheck of BP of 112/81 she decided to walk, using a shopping cart for support and a staff member nearby, to the restroom.  Upon successful return she felt much better and a neighbor came to bring her home.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient received Fluzone HD on 10/23/2020 in left arm. One week later patient had pain in arm and could not lift arm.  She has been taking Tylenol.  She will be going to the physician.
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Fall, Loss of consciousness, Nausea, Restlessness
Clinical narrative: The patient had recieved the vaccine after the mother had to calm her down for a few mintus leading up to the shot. The patient finally calmed down and I administered the shot in the left deltoid muscle. After just a minute or two had passed at most, the patient felt dizzy and started to fall over. The mother was holding the child as the child began to collapse. She held on to her as she fell to the floor. We immediately called the paramedics and she came to after just a brief 3-5 seconds of unconsciousness. She was a little drowsy and nausous for a minute but that wore off quick and the paramedics arrived very quickly. She was checked out by the paramedics and seemed ok to return to normal condition of day
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Somnolence
Clinical narrative: The patient had recieved the vaccine after the mother had to calm her down for a few mintus leading up to the shot. The patient finally calmed down and I administered the shot in the left deltoid muscle. After just a minute or two had passed at most, the patient felt dizzy and started to fall over. The mother was holding the child as the child began to collapse. She held on to her as she fell to the floor. We immediately called the paramedics and she came to after just a brief 3-5 seconds of unconsciousness. She was a little drowsy and nausous for a minute but that wore off quick and the paramedics arrived very quickly. She was checked out by the paramedics and seemed ok to return to normal condition of day
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Sleep disorder, Tremor
Clinical narrative: 14 hours after the shot, I got a chill to end all chills. I shook uncontrollably for 45 minutes, My arms shook violently. My entire body shook. I was in bed at the time and added an extra blanket and put on a sweatshirt. They provided some relief but it didn't seem like anything could stop the shakes. Finally, after about 45 minutes, the chills and shakes stopped. I did not sleep well after that. I woke up every hour, but was able to get back to sleep without trouble. I think at the end of the night I may have taken some acetaminophen (2 tablets 500mg each), perhaps around 4 or 5 AM. I slept better after that.  I slept a half hour longer than normal (I turned the alarm off and went back to sleep) and felt reasonably good when I got out of bed. There were no reoccurrence of the chills and shakes all day. I feel much better now, about 24 hours after the onset of the chills.
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Peripheral swelling, Tremor, Vision blurred
Clinical narrative: Patient was experiencing swelling from neck to elbow, shaky hands, dizziness, blurred vision. Was seen at an clinic where she was prescribed prednisone to be taken once if needed.
Age: 25.0
Sex: F
Vaccine: HEPA, HPV9, JEV1
Symptoms: Dizziness, Syncope
Clinical narrative: Pt verbalized she has become lightheaded with previous vaccinations. Pt received three separate injections at time of visit. After final vaccine, pt fainted but roused approximately 5 seconds later. Pt was seated in chair and did not fall. No injuries noted. Pt advised to lay down on treatment table and elevate feet. After several minutes, pt stated she felt better. Pt assisted to seated position. Pt escorted to waiting room after no report of dizziness and advised to remain for additional 15-20 minutes.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Rash pruritic
Clinical narrative: PATIENT COMPLAINED THAT THE DAY AFTER THE VACCINATION, HER ARM HAD AN ITCHY, STINGING RASH AND FELT CHILLS, WHICH ALL RESOLVED THE FOLLOWING DAY.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Faeces soft, Feeling cold, Myalgia
Clinical narrative: Sleepiness that afternoon.  Restless sleep to 3 am developed stomach pain then bowel movement.  restless sleep until 6 am.  Got up for work felt groggy so coffee!  Felt achy in all my muscles.  Had another bowel movement.  Soft but not diahrea.  Then after lunch felt very cold; shivers and thermostat reads 74F inside.  Hands and fingers especially cold.  I sat in sun for 30 min. at 1pm but when inside got cold again.  Fell asleep immediately after work at 3:30 pm and woke up at 6pm  Worried I had Covid, but read the form the facility gave me and realized probably reaction to Shingles vaccine 2nd dose.  8pm now 18 Nov. and feel tired but better after Chicken soup!
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Poor quality sleep, Somnolence
Clinical narrative: Sleepiness that afternoon.  Restless sleep to 3 am developed stomach pain then bowel movement.  restless sleep until 6 am.  Got up for work felt groggy so coffee!  Felt achy in all my muscles.  Had another bowel movement.  Soft but not diahrea.  Then after lunch felt very cold; shivers and thermostat reads 74F inside.  Hands and fingers especially cold.  I sat in sun for 30 min. at 1pm but when inside got cold again.  Fell asleep immediately after work at 3:30 pm and woke up at 6pm  Worried I had Covid, but read the form the facility gave me and realized probably reaction to Shingles vaccine 2nd dose.  8pm now 18 Nov. and feel tired but better after Chicken soup!
Age: 8.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Headache, Retching, Vomiting
Clinical narrative: Woke up at appx 7:00 a.m. with headache. Began vomiting at 8:00 a.m. Vomiting/dry heaving and headache continued until approximately 9:30 a.m. when she fell asleep. Woke up around 10:30 a.m. feeling a little better. She was then able to sip pedialyte and eventually eat saltiness crackers. Headache continued until her stomach felt well enough to tolerate children's Tylenol.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Febrile convulsion, Full blood count normal, Pyrexia
Clinical narrative: Patient developed a fever 12-14 hours after the initial vaccines were given. She was given the DTaP and IPV vaccines.  She had a febrile seizure due to a fever that was reported at 103 in the hospital.
Age: 71.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site pain
Clinical narrative: Patient reports that they have had pain at the injection site starting the day after the vaccination but that the pain continues to persist as of 11-18-2020 despite attempts to treat it with OTC Tylenol, Ibuprofen as well as icing the area.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash maculo-papular
Clinical narrative: Maculopapular rash spreading across left anterior shoulder, left upper trunk  and right anterior shoulder then behind ears. Mild pruritus, self-limited to rash without airway involvement
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fall, Feeling abnormal, Muscular weakness
Clinical narrative: At 11:00 pt attempted to walk down stairs and legs gave out an fall down several stairs. Also that day brain "fog" started - still experiencing. On 11/5 - was showering - saw white light almost passed out. -Still experiencing
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: RAsh At injectioN site
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: patient developed a rash approximately 3 days after getting the vaccine -the rash moved down his arm approximately 8 inches and is itchy distally to injection site
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site nodule, Pain, Pain in extremity
Clinical narrative: Arm pain, Knot at injection site; pt states it hurts to raise her arm. Has been going on since injection given on 10-3-2020.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Nodule
Clinical narrative: pharmacist said pt had nodule, requested vax higher, pharmacist did higher
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria, Vaccination complication
Clinical narrative: the patient broke out in rash; she had a reaction to one and broke out in hives; Initial information regarding this unsolicited valid non-serious case via Information (reference number: 00302650) was received from a patient and transmitted to Sanofi 06-Oct-2020.  This case involved a 72 years old female patient who broke out in rash and she had a reaction to one and hives (urticaria), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  Concurrent condition included severely allergic to penicillin, neomycin and streptomycin.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date) not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient broke out in non-serious rash (rash) and hives (urticaria) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that she received a pneumonia vaccine less than a year ago and had no problems. Her doctor kept her in the office for 20 minutes after vaccination, to monitor for such.  Relevant laboratory test was not reported.  Final diagnosis was she had a reaction to one and broke out in hives and the patient broke out in rash.   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient had recovered from the reported events.  There will be no information available on batch number for this case.
Age: 89.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blister, Burning sensation, Erythema, Rash erythematous, Rash macular
Clinical narrative: a rash all over his body up to his neck that started the day after he received the vaccine; Initial information received on 12-Oct-2019 regarding an unsolicited valid non-serious case (inquiry number: 00311305) received from a consumer.  This case involves 89 year old male patient who experienced rash all over his body (rash), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On 11-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot 2J501AB and expiry date is 30-June-2021] via intramuscular route in the right arm for prophylactic vaccination.  On 12-Oct-2020, the patient developed a non-serious rash all over his body (rash) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  The patient was treated with Loratadine (Claritin).  It was not reported if the patient received any corrective treatment.   At the time of reporting, the event outcome was not recovered.
Age: 89.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Rash pruritic
Clinical narrative: a rash all over his body up to his neck that started the day after he received the vaccine; Initial information received on 12-Oct-2019 regarding an unsolicited valid non-serious case (inquiry number: 00311305) received from a consumer.  This case involves 89 year old male patient who experienced rash all over his body (rash), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On 11-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot 2J501AB and expiry date is 30-June-2021] via intramuscular route in the right arm for prophylactic vaccination.  On 12-Oct-2020, the patient developed a non-serious rash all over his body (rash) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  The patient was treated with Loratadine (Claritin).  It was not reported if the patient received any corrective treatment.   At the time of reporting, the event outcome was not recovered.
Age: 89.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Rash
Clinical narrative: a rash all over his body up to his neck that started the day after he received the vaccine; Initial information received on 12-Oct-2019 regarding an unsolicited valid non-serious case (inquiry number: 00311305) received from a consumer.  This case involves 89 year old male patient who experienced rash all over his body (rash), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On 11-Oct-2020, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot 2J501AB and expiry date is 30-June-2021] via intramuscular route in the right arm for prophylactic vaccination.  On 12-Oct-2020, the patient developed a non-serious rash all over his body (rash) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  The patient was treated with Loratadine (Claritin).  It was not reported if the patient received any corrective treatment.   At the time of reporting, the event outcome was not recovered.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Chills
Clinical narrative: Received 2nd dose of Shingrix vaccine at pharmacy by pharmacist. 5 hours later experienced severe chills, shivering at night in bed, got up at 9:30 am and immediately noticed hissing in both ears, face flushed and red, feverish feeling, had difficulty concentrating as if had a brain fog, the next day had a bad headache, still had chills and hissing noise in both ears. Did not have this ear noise prior to getting vaccine. 4 days later still had hissing in ears and feeling unwell, went to Urgent Care and they said immune system did not like something in the vaccine, inflammatory reaction, prescribed 5 day course of prednisone which improved symptoms but after finishing course the hissing in ears returned. Went to family doctor who said he was not aware of this reaction from anyone after a shingles vaccine but he did not give them..he did blood work and said if ear noise continued go to an ENT doctor. He did not prescribe anything for me for this.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Chills, Confusional state, Dissociation, Disturbance in attention
Clinical narrative: Received 2nd dose of Shingrix vaccine at pharmacy by pharmacist. 5 hours later experienced severe chills, shivering at night in bed, got up at 9:30 am and immediately noticed hissing in both ears, face flushed and red, feverish feeling, had difficulty concentrating as if had a brain fog, the next day had a bad headache, still had chills and hissing noise in both ears. Did not have this ear noise prior to getting vaccine. 4 days later still had hissing in ears and feeling unwell, went to Urgent Care and they said immune system did not like something in the vaccine, inflammatory reaction, prescribed 5 day course of prednisone which improved symptoms but after finishing course the hissing in ears returned. Went to family doctor who said he was not aware of this reaction from anyone after a shingles vaccine but he did not give them..he did blood work and said if ear noise continued go to an ENT doctor. He did not prescribe anything for me for this.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dry mouth, Erythema, Feeling abnormal, Feeling hot, Flushing
Clinical narrative: Received 2nd dose of Shingrix vaccine at pharmacy by pharmacist. 5 hours later experienced severe chills, shivering at night in bed, got up at 9:30 am and immediately noticed hissing in both ears, face flushed and red, feverish feeling, had difficulty concentrating as if had a brain fog, the next day had a bad headache, still had chills and hissing noise in both ears. Did not have this ear noise prior to getting vaccine. 4 days later still had hissing in ears and feeling unwell, went to Urgent Care and they said immune system did not like something in the vaccine, inflammatory reaction, prescribed 5 day course of prednisone which improved symptoms but after finishing course the hissing in ears returned. Went to family doctor who said he was not aware of this reaction from anyone after a shingles vaccine but he did not give them..he did blood work and said if ear noise continued go to an ENT doctor. He did not prescribe anything for me for this.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Hot flush, Inappropriate schedule of product administration, Initial insomnia, Insomnia
Clinical narrative: Received 2nd dose of Shingrix vaccine at pharmacy by pharmacist. 5 hours later experienced severe chills, shivering at night in bed, got up at 9:30 am and immediately noticed hissing in both ears, face flushed and red, feverish feeling, had difficulty concentrating as if had a brain fog, the next day had a bad headache, still had chills and hissing noise in both ears. Did not have this ear noise prior to getting vaccine. 4 days later still had hissing in ears and feeling unwell, went to Urgent Care and they said immune system did not like something in the vaccine, inflammatory reaction, prescribed 5 day course of prednisone which improved symptoms but after finishing course the hissing in ears returned. Went to family doctor who said he was not aware of this reaction from anyone after a shingles vaccine but he did not give them..he did blood work and said if ear noise continued go to an ENT doctor. He did not prescribe anything for me for this.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Malaise, Nervous system disorder, Panic reaction, Pyrexia, Tinnitus
Clinical narrative: Received 2nd dose of Shingrix vaccine at pharmacy by pharmacist. 5 hours later experienced severe chills, shivering at night in bed, got up at 9:30 am and immediately noticed hissing in both ears, face flushed and red, feverish feeling, had difficulty concentrating as if had a brain fog, the next day had a bad headache, still had chills and hissing noise in both ears. Did not have this ear noise prior to getting vaccine. 4 days later still had hissing in ears and feeling unwell, went to Urgent Care and they said immune system did not like something in the vaccine, inflammatory reaction, prescribed 5 day course of prednisone which improved symptoms but after finishing course the hissing in ears returned. Went to family doctor who said he was not aware of this reaction from anyone after a shingles vaccine but he did not give them..he did blood work and said if ear noise continued go to an ENT doctor. He did not prescribe anything for me for this.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Disturbance in attention, Erythema, Flushing, Headache
Clinical narrative: Received 2nd dose of Shingrix vaccine at pharmacy by pharmacist. 5 hours later experienced severe chills, shivering at night in bed, got up at 9:30 am and immediately noticed hissing in both ears, face flushed and red, feverish feeling, had difficulty concentrating as if had a brain fog, the next day had a bad headache, still had chills and hissing noise in both ears. Did not have this ear noise prior to getting vaccine. 4 days later still had hissing in ears and feeling unwell, went to Urgent Care and they said immune system did not like something in the vaccine, inflammatory reaction, prescribed 5 day course of prednisone which improved symptoms but after finishing course the hissing in ears returned. Went to family doctor who said he was not aware of this reaction from anyone after a shingles vaccine but he did not give them..he did blood work and said if ear noise continued go to an ENT doctor. He did not prescribe anything for me for this.