chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest discomfort, Cold sweat, Dizziness, Dyspnoea, Headache
Clinical narrative: On November 10, 2023 at approximately 1:50pm after receiving her COVID-19 Vaccine, Guest complained of Shortness of Breath, pain radiating from her left side of head down to her left arm, tightness in her left chest, dizziness and nausea.  Vital taken: BP 148/98, HR 92, Cool & Clamy to touch.  EMS was notified and responded.  Patient was checked by paramedics and refused transport to the nearest hospital for treatment.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: On November 10, 2023 at approximately 1:50pm after receiving her COVID-19 Vaccine, Guest complained of Shortness of Breath, pain radiating from her left side of head down to her left arm, tightness in her left chest, dizziness and nausea.  Vital taken: BP 148/98, HR 92, Cool & Clamy to touch.  EMS was notified and responded.  Patient was checked by paramedics and refused transport to the nearest hospital for treatment.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Myalgia
Clinical narrative: I had a sore throat, dry cough, very tired, muscle aches everywhere, headache. and did not have a fever. I tested positive at home for COVID-19. I called my doctor on 10/02/2022 because I figured since I am 68 that I should get PAXLOVID, which I was prescribed.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: I had a sore throat, dry cough, very tired, muscle aches everywhere, headache. and did not have a fever. I tested positive at home for COVID-19. I called my doctor on 10/02/2022 because I figured since I am 68 that I should get PAXLOVID, which I was prescribed.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: breakthrough Covid-19 infection 4 weeks after
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Haemorrhage, Immediate post-injection reaction
Clinical narrative: Patient reported to the pharmacist that she experienced a lot of bleeding immediately after vaccine administration and developed bruising the next day that lasted up to 3 weeks. Patient has never bled or bruised from previous vaccinations and was concerned this happened to her. Patient did not seek any treatment. Pharmacist explained to patient that this can be a normal reaction to a vaccine but she was adamant that this reaction was unusual for her. Pharmacist told her she would report it.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling of eyelid
Clinical narrative: Eyelid swelling, swelling treated with IV and oral corticosteroids and oral antihistamine about 24 hours after administration.
Age: 57.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash, Urticaria
Clinical narrative: PATIENT STATED HAD HIVES/RASH A FEW DAYS LATER  AFTER THE VACCINE, WHICH HE ANTICIPATED DUE TO HIS ALLERGY TO NEOMYCIN. HE TOOK BENADRYL AND HAD SOME RELIEF. RASH IS MORE UNBEARABLE ON 11/8/22 AND TODAY HE CALLED TO ASK FOR FURTHER SYMPTOMS ALLIEVATION, IN WHICH ORAL CORTICOSTEROIDS WAS RECOMMENDED.  PT ALSO USED TOPICAL STEROIDS THAT HELPED BUT TOO SHORT OF DURATION.  PREDNISONE WAS PRESCRIBED BY HIS DOCTOR AND PRESCRIPTION WAS PICKED UP THIS EVENING 11/10/22. PATIENT WAS RECOMMENDED TO START WITH OTHER HEPATITIS  B VACCINES, BUT AGAIN INSURANCE REQUESTED PRIOR AUTH FROM DOCTOR, HENCE PATIENT WAS RECOMMENDED TO GET SERIES AT DR OFFICE.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: misread vaccine vial fo MMRII
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient appeared with parent for flu vaccine appointment. Patient was checked in for appointment and was given vaccine. Afterwards, the father came forward and said they believed the child had already gotten a flu vaccine for this year. Upon review this indeed was the case and the patient has received 2 flu vaccines for the 2022-2023 season. No adverse events of harm was reported.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropathy, Chills, Electric shock sensation, Headache, Nausea
Clinical narrative: My symptoms started around 4 pm the day I got the vaccine.  The fever started first, then body chills.  My nausea was mild and happened mostly the next morning when I first woke up, then subsided. My headache started soon after the fever and lasted until around 2 pm the next day. The body zaps started in the evening of the day I got the vaccine, and the brain zaps happened 3 times while I was sleeping, waking me up each time.  I fell asleep at 9 pm and got up at 4:30 am.   fever (101 degrees) chills nausea - no vomiting headache brain zaps - it felt like short bursts of lightning in my head body zaps - every time I moved it felt like lightning was in my body/joints sleep problems - I woke up every hour for the first few hours, then I started waking up every 15 minutes for the last couple of hours of sleep around 2 am.   All my symptoms disappeared by evening, 6 pm, the day after the vaccine. So, just over 24 hours of duration.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: My symptoms started around 4 pm the day I got the vaccine.  The fever started first, then body chills.  My nausea was mild and happened mostly the next morning when I first woke up, then subsided. My headache started soon after the fever and lasted until around 2 pm the next day. The body zaps started in the evening of the day I got the vaccine, and the brain zaps happened 3 times while I was sleeping, waking me up each time.  I fell asleep at 9 pm and got up at 4:30 am.   fever (101 degrees) chills nausea - no vomiting headache brain zaps - it felt like short bursts of lightning in my head body zaps - every time I moved it felt like lightning was in my body/joints sleep problems - I woke up every hour for the first few hours, then I started waking up every 15 minutes for the last couple of hours of sleep around 2 am.   All my symptoms disappeared by evening, 6 pm, the day after the vaccine. So, just over 24 hours of duration.
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Parosmia
Clinical narrative: Approx 10 days after bivalent moderna vaccine I began getting smells of "burning cigarettes". I don't smoke and am not around any known smokers. I smell at home, at work, driving in the car. It has been approx a week since it began and has not stopped. Doesn't affect taste. Just smell of cigarette smoke, not necessarily constant but happens multiple times an hour. Usually just smell for a single inhale then not the next but it can happen again as soon as a few inhales later. Sometimes 100 times an hour sometimes just a few an hour. Very displeasing and hoping goes away.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient had no previous COVID vaccine doses and received COVID Bivalent Booster in error
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: According to the Lot Number recorded on record the vaccine was expired at time of administration. Patient has not reported any ADR in regard to the records.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Interchange of vaccine products
Clinical narrative: PATIENT REQUESTED PFIZER COVID19 BIVALENT AND RECEIVED MODERNA COVID BIVALENT
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Wrong product administered
Clinical narrative: PATIENT REQUESTED PFIZER COVID19 BIVALENT AND RECEIVED MODERNA COVID BIVALENT
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Swelling
Clinical narrative: Pt reported SOB and swelling.  Unable to locate any records at time of vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac monitoring normal, Echocardiogram normal, Ischaemic stroke
Clinical narrative: Patient received her first booster on Jan 10, 2022 and had a acute ischemic stroke on March 24, 2022. Patient Spent a couple of days at Hospital and was discharged.   No cause of the stroke was found. No blockage, no blood vessel problems,  Damage to brain noted Patient is now on three new maintenance prescriptions for standards of care for stoke patients.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syringe issue, Underdose
Clinical narrative: Syringe malfunctioned/exploded during vaccine administration and patient received less than or equal to half the dose. Per clinic MD, patient was given another half dose (0.25ml) of Moderna Bivalent Booster. Patient was informed and agreed to receive.
Age: 24.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: patient came in on 11/10/2022 at around 5pm showing her left arm and saying that it is swollen and not getting better, but not getting worst either. she is going to see a doctor.  left arm site of injection did look swallow and little circular blue spot, but not radiating, not swelling beyond site of injection. I asked if it's painful, she stated a little.  I recommended some Motrin or Tylenol  and follow-up with md.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired at time  of administration (short dated)
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: THE PATIENT WAS GIVEN EXPIRED VACCINE
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired at time of administration ( short dated vaccine)
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Anticonvulsant drug level, Laboratory test, Seizure
Clinical narrative: Experienced seizure on 10/18/2022 requiring emergency room visit
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Cartilage injury, Injection site pain, Magnetic resonance imaging abnormal, Musculoskeletal discomfort
Clinical narrative: I have experienced a sore left upper arm consistently since August 27 date of vaccine (it is now Nov. 10), sharp pain in left shoulder, burning discomfort below  left scapula.  I have taken ibuprofen, received massage therapy. I experience some relief from ibuprofen and somewhat from rolfing massage therapy
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rotator cuff syndrome, Tendonitis
Clinical narrative: I have experienced a sore left upper arm consistently since August 27 date of vaccine (it is now Nov. 10), sharp pain in left shoulder, burning discomfort below  left scapula.  I have taken ibuprofen, received massage therapy. I experience some relief from ibuprofen and somewhat from rolfing massage therapy
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site vesicles
Clinical narrative: Patient showed a blister like lesion on the spot where she got her vaccination. The skin looks like a blister but it is not painful or itchy. It looks like an oval shaped lesion (oval pea size) that is red/pinkish and is shiny (such as stretched skin/new skin that looks like is healing). Pt reports having the lesion for a year and does not go away. She made her doctor aware and asked her to monitor.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Pt this dose as third dose.  This shot is out of guideline, pt should have only had two shots. So far, he reports no problem.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations day one until current.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Pt received the pediatric dose of the vaccine instead of the adult dose of the vaccine.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient did not report any AEs to pharmacy.  Post-vaccine Lot# audit found this may have been administered after expiration date of 8/31/22. Pharmacist has reached out to the patient to determine if any AEs occurred.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Body temperature increased, Exercise tolerance decreased, Fall, Gait disturbance
Clinical narrative: Patient received both Pfizer COVID bivalent vaccine and flu shot together on 10/7.  PAtient without previous reaction to flu shot.   Had moderna for all previous shots. Had never had 2 vaccines at the same time.  Felt well prior to injections.  Immediate onset of vertigo, severe . Patient fell when she got home.  Vertigo has lasted for a month, but improved now to only with head position changes..  Also complained of severe arthralgias starting next morning. All body but worst in left knee.  Low grade temp to 99.5. Not able to work, walk, exercise for about 3 weeks, now very gradually improving.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immediate post-injection reaction, Impaired work ability, Vertigo
Clinical narrative: Patient received both Pfizer COVID bivalent vaccine and flu shot together on 10/7.  PAtient without previous reaction to flu shot.   Had moderna for all previous shots. Had never had 2 vaccines at the same time.  Felt well prior to injections.  Immediate onset of vertigo, severe . Patient fell when she got home.  Vertigo has lasted for a month, but improved now to only with head position changes..  Also complained of severe arthralgias starting next morning. All body but worst in left knee.  Low grade temp to 99.5. Not able to work, walk, exercise for about 3 weeks, now very gradually improving.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Contusion, Paraesthesia oral, Pruritus, Skin warm
Clinical narrative: Tingling of lips within hours of receiving shot, BP elevated to 185/92 for 24 hours receiving, bruising, itching and warm to touch.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, Incorrect product formulation administered
Clinical narrative: Healthcare worker given the Pfizer Bivalent vaccine per the consent.  Healthcare worker previously had received the Pfizer Bivalent vaccine about 2 months ago.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event reported. The vaccine had expired 9/30/2022 and administered 11/10/2022.
Age: 55.0
Sex: F
Vaccine: COVID19-2, TDAP
Symptoms: Dizziness, Flushing, Immediate post-injection reaction, Nausea
Clinical narrative: flushed, dizziness, nausea within minutes after vaccines. Patient reminded seated, removed sweater, fanned self. Started to feel better within 5-10 minutes. Waited in store 15-20 minutes to make sure well enough to leave. Felt much better, no longer flushed, dizzy, or nauseated when left. Was going to go home and take it easy/more slowly rest of day and monitor for symptom return and reach out to Dr. if needed or continued
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Blindness unilateral, Headache, Hypoaesthesia, Nausea, Visual impairment
Clinical narrative: Day 1 - Vision loss/change left eye, Left face numbness, Numbness through hands then through whole body, nausea, headache, vomiting.  Subsided after rest and ibuprofen Day 3 - Vision loss/change left eye, Headache left side and center back, nausea.
Age: 16.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: Day 1 - Vision loss/change left eye, Left face numbness, Numbness through hands then through whole body, nausea, headache, vomiting.  Subsided after rest and ibuprofen Day 3 - Vision loss/change left eye, Headache left side and center back, nausea.
Age: 23.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea
Clinical narrative: dizziness, nausea, sweating within minutes of vaccine administration - patient remained seated, visibly sweating, drank some water, started feeling better within 5 minutes. Remained in store 15-20 minutes and was feeling back to normal when left with family. Would contact Dr. if returned or continued.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Cerebral disorder, Computerised tomogram, Electroencephalogram, Lumbar puncture
Clinical narrative: Serologic adverse reaction Adverse reaction to the shot Affected his Neuro periphery  (Brain stability) Caused an imbalance and Seizure related affects
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Nervous system disorder, Seizure like phenomena
Clinical narrative: Serologic adverse reaction Adverse reaction to the shot Affected his Neuro periphery  (Brain stability) Caused an imbalance and Seizure related affects
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adenovirus test positive, Blood calcium decreased, Blood chloride increased, Blood culture negative, Blood phosphorus
Clinical narrative: Serologic adverse reaction Adverse reaction to the shot Affected his Neuro periphery  (Brain stability) Caused an imbalance and Seizure related affects
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, CSF cell count normal, CSF culture negative, CSF protein, CSF red blood cell count positive
Clinical narrative: Serologic adverse reaction Adverse reaction to the shot Affected his Neuro periphery  (Brain stability) Caused an imbalance and Seizure related affects
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral ventricle dilatation, Computerised tomogram, Endotracheal intubation, Extubation, Herpes simplex test negative
Clinical narrative: Serologic adverse reaction Adverse reaction to the shot Affected his Neuro periphery  (Brain stability) Caused an imbalance and Seizure related affects
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Human rhinovirus test positive, Intensive care, Magnetic resonance imaging head abnormal, Metabolic function test, Respiratory viral panel
Clinical narrative: Serologic adverse reaction Adverse reaction to the shot Affected his Neuro periphery  (Brain stability) Caused an imbalance and Seizure related affects
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure like phenomena, Somnolence, White matter lesion, X-ray
Clinical narrative: Serologic adverse reaction Adverse reaction to the shot Affected his Neuro periphery  (Brain stability) Caused an imbalance and Seizure related affects
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Headache, nausea, fatigue
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site mass, Injection site pain, Injection site pruritus, Pain
Clinical narrative: Extreme pain in upper left arm, could not move or lift arm without extraordinary pain.  Lasted for two weeks.  An itchy lump at sight has come and gone since injection.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Polymenorrhoea
Clinical narrative: Started my menstrual cycle 11 days early. This is not normal for me.
Age: 75.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient received a second flu shot in the 2022-2023 flu season. She was supposed to get the Moderna Bivalent booster. She previously received a flu shot in September 2022.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Blood test, Fatigue, Inflammation
Clinical narrative: Heart pain/inflammation within 24hrs after second injection. Extreme fatigue.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac function test normal, Electrocardiogram, Hypoaesthesia, Paraesthesia
Clinical narrative: Customer reported numbness and tingling in her left arm after receiving  the vaccine on 9/7/22.  The  numbness and tingling was more prominent after several weeks after receiving the Shingrix vaccine.  It has subsided but not completely gone.   Customer stated that she's afraid to get her second series of the vaccine.   She reported that her doctor has ruled out any heart issues based on tests.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Antiphospholipid antibodies, Antithrombin III, Blood creatinine, Blood homocysteine
Clinical narrative: DVT left leg, 4 veins involved running from below knee to above knee
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Deep vein thrombosis, Differential white blood cell count, Electrocardiogram, Full blood count
Clinical narrative: DVT left leg, 4 veins involved running from below knee to above knee
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Protein C, Protein S, Prothrombin time, Ultrasound Doppler abnormal
Clinical narrative: DVT left leg, 4 veins involved running from below knee to above knee
Age: 68.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Balance disorder, Dizziness, Syncope
Clinical narrative: Patient called to report that she felt unbalanced on 10/09/2022 morning (1 day after she got the shots). She didn't fall but she just felt dizzy and fainting. I advised her to drink a lot of fluids, have some rest & take Tylenol when needed. Checked o patient after few hours, she was doing better.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Feeling abnormal, Neurological symptom
Clinical narrative: Brain issues consisting of brain fog and concussion symptoms
Age: 32.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Injection site pruritus, Injection site rash, Paraesthesia
Clinical narrative: Patient stated having itching and rash and tingling in the right arm (flublok arm), patient is taking benadryl and calling pcp.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Wheezing
Clinical narrative: rash on arm - rash on chest - respiratory wheezing
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Fear, Headache, Impaired work ability, Nausea
Clinical narrative: Severe headache ad nausea . Trouble breathing and felt like my tongue was swollen, Came very close to calling 911.  Finally went to sleep sitting up. Did not go into work the next day. Was able to breath ok in the morning.. The trouble breathing was very scary. I get the flu shot every year and never had a problem. I will never get this shot again. Last year I was given the Flu ad 65+ Quad PF 0.55ml and no issue. This year Fluzone HD 65+ 0.7 ML too strong.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue
Clinical narrative: Severe headache ad nausea . Trouble breathing and felt like my tongue was swollen, Came very close to calling 911.  Finally went to sleep sitting up. Did not go into work the next day. Was able to breath ok in the morning.. The trouble breathing was very scary. I get the flu shot every year and never had a problem. I will never get this shot again. Last year I was given the Flu ad 65+ Quad PF 0.55ml and no issue. This year Fluzone HD 65+ 0.7 ML too strong.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: When I went to lie down to sleep I was suddenly very aware of experiencing tinnitus. The only other times I have experienced this is when taking 2 ibuprofen, aspirin or Tylenol pills. Usually the ringing abates but the tinnitus has continued to this day 19 days later and it has not lessened.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Herpes zoster, Hypoaesthesia, Pruritus
Clinical narrative: Right eye pain day before Shingles vaccine taken. Suspected dry eye but pain in eyeball and atop eyeball, severe Same day as injection, pangs in head,  Following day continued pangs in head, saw PA, who diagnosed Shingles based on small rash hidden beneath right eye brow, unilateral symptoms Following, rash above right eye and between corner of right eye and nose, forehead, numbness in forehead now extreme itch, burning pain in scalp and forehead, continue pangs right side of head, top and behind right ear Prescribed Valacyclovir 1Gm 3x/day for 7 days and Gabapentin 100mg 3 x/day Now taking Gabapentin 100mg 2x/day and 200mg at bedtime, Aceetaminiphen 500mg 4 x/day, Ibuprofen 200mg 4 x/day, aloe or Caladryl on rashes, Bio True approximately 1-2 drops/day in right eye for what may be dry eye or a symptom of Shingles, Salonpas roll on for pain behind right ear
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin burning sensation
Clinical narrative: Right eye pain day before Shingles vaccine taken. Suspected dry eye but pain in eyeball and atop eyeball, severe Same day as injection, pangs in head,  Following day continued pangs in head, saw PA, who diagnosed Shingles based on small rash hidden beneath right eye brow, unilateral symptoms Following, rash above right eye and between corner of right eye and nose, forehead, numbness in forehead now extreme itch, burning pain in scalp and forehead, continue pangs right side of head, top and behind right ear Prescribed Valacyclovir 1Gm 3x/day for 7 days and Gabapentin 100mg 3 x/day Now taking Gabapentin 100mg 2x/day and 200mg at bedtime, Aceetaminiphen 500mg 4 x/day, Ibuprofen 200mg 4 x/day, aloe or Caladryl on rashes, Bio True approximately 1-2 drops/day in right eye for what may be dry eye or a symptom of Shingles, Salonpas roll on for pain behind right ear
Age: 17.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: red raised area on arm about 4 x 4 inches sore to the touch, arm was itchy
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on & off 1 day after Covid 19 vaccination
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in lower extremities and bilateral arms and hands. Narrative:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia, Fever, chills Temperature up to 102 degrees F Narrative:  Chills and high fevers.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Headache, Fever, CHILLS Narrative:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Sedation
Clinical narrative: Headache, Sedation & Myalgia Narrative:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: NauseaVomiting Narrative:
Age: 80.0
Sex: M
Vaccine: FLUA4
Symptoms: Device connection issue, No adverse event, Syringe issue
Clinical narrative: Narrative: Product Issue: (1) Patient received Influenza, Quadrivalent, Adjuvanted (Fluad) vaccine (Lot 346389; Exp 6/21/2023) on 10/21/2022. During vaccine administration the vaccine liquid came out at the head of they syringe and not the needle. Top of the syringe reportedly spins freely. Staff confirmed that the needle was all the way on the prefilled syringe. Event required wasting of flu vaccine and 2nd stick of patient. (2) A similar incident occurred 11/3/2022 involving influenza vaccine administrating to an employee. This 2nd incident occurred on 11/3/2022 and involved Afluria Quad 2022-2023 influenza vaccine also manufactured by Sequirs. NDC 33332-322-03; Lot: AS3619B; Exp: 5/31/2023. The employee reported to employee health and the vaccine was prepared for administration by attaching the needle to the prefilled syringe using the luer-lock tip. Staff administered the injection into the left deltoid and pushed the vaccine into the arm using plunger. When preparing to remove the needle, the luer-lock tip and needle remained in the employee's arm. Special care by Employee Health staff  had been taken to ensure the needle had been securely  fastened to the syringe, as the Health Promotion Coordinator had notified staff that there were other nurses who had experienced this same type issues. Per reporter in system, this is the third incident of the luer-lock tip disconnecting from the flu vaccine syringe during medication administration. **neither the employee nor the patient suffered side effects, required treatment, or had negative outcomes*
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RV5, UNK, UNK
Symptoms: Product formulation issue
Clinical narrative: Nurse went to draw up pentacel vaccine, and mixed the pentacel powder with the covid vial. The vaccine was partially administered and withdrawn as soon as error was noticed.  Senior nurse noticed the extra fluid in teh syringe and stopped the administration of the vaccine. Mom was notifiedby Dr. Dr. recommened someimte between now and teh 4 month visit that we complete a blood screen to see how many antibodies the child has created of the pentacell, and also offered to see if the child created nay covid antibodies. we watched the child for 30 minutes after immunization and mom felt comfortbale leaving.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab -positive; Nasal Swab -positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6204), in left arm and on 24Mar2021 at 16:30 as dose 2, single (Lot number: EP7533) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Muscle Cramping" (unspecified if ongoing). Concomitant medication(s) included: TRAMADOL; AMBIEN; ASPIRIN [ACETYLSALICYLIC ACID]; POTASSIUM PHOSPHATES. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Nasal Swab -positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Dec2021) Positive.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Headache, Magnetic resonance imaging
Clinical narrative: Nasal Swab -positive; Nasal Swab -positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6204), in left arm and on 24Mar2021 at 16:30 as dose 2, single (Lot number: EP7533) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Muscle Cramping" (unspecified if ongoing). Concomitant medication(s) included: TRAMADOL; AMBIEN; ASPIRIN [ACETYLSALICYLIC ACID]; POTASSIUM PHOSPHATES. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Dec2021, outcome "unknown" and all described as "Nasal Swab -positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Dec2021) Positive.
Age: 50.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19, VARZOS
Symptoms: Ageusia, Off label use, Product use issue
Clinical narrative: Lost the ability to taste; This case was reported by a consumer via other manufacturer and described the occurrence of taste loss in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis.   Concurrent medical conditions included drug allergy. Concomitant products included INFLUENZA VACCINE.   On 28th October 2022, the patient received Shingles vaccine and the 4th dose of COVID-19 VACCINE PFIZER. On 30th October 2022, 2 days after receiving Shingles vaccine, the patient experienced taste loss. On an unknown date, the outcome of the taste loss was not recovered/not resolved.  It was unknown if the reporter considered the taste loss to be related to Shingles vaccine.     Additional Information: Receipt Date: 03-NOV-2022 Reporter's Comments: The reporter reported that injection for COVID-19 vaccine and Shingles vaccine received same date. Unable to located or read the details Facility where the most recent COVID-19 vaccine was administered. The patient lost some of her ability to taste. She could still taste some things, but it was all sort of muted.  But she seem to had lost the ability to taste things that have a more subtle flavor.  For instance, she could not taste the flavoring anymore, or the cinnamon in my cinnamon Life cereal. Prior to vaccination, the patient was not diagnosed with COVID-19. No Since the vaccination, the patient was not tested for COVID-19. The reporter consented to follow up. Additional supportive information: It was unknown if the reporter considered the taste loss to be related to COVID-19 VACCINE PFIZER.
Age: 50.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19, VARZOS
Symptoms: Ageusia
Clinical narrative: Lost the ability to taste; This case was reported by a consumer via other manufacturer and described the occurrence of taste loss in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis.   Concurrent medical conditions included drug allergy. Concomitant products included INFLUENZA VACCINE.   On 28th October 2022, the patient received Shingles vaccine and the 4th dose of COVID-19 VACCINE PFIZER. On 30th October 2022, 2 days after receiving Shingles vaccine, the patient experienced taste loss. On an unknown date, the outcome of the taste loss was not recovered/not resolved.  It was unknown if the reporter considered the taste loss to be related to Shingles vaccine.     Additional Information: Receipt Date: 03-NOV-2022 Reporter's Comments: The reporter reported that injection for COVID-19 vaccine and Shingles vaccine received same date. Unable to located or read the details Facility where the most recent COVID-19 vaccine was administered. The patient lost some of her ability to taste. She could still taste some things, but it was all sort of muted.  But she seem to had lost the ability to taste things that have a more subtle flavor.  For instance, she could not taste the flavoring anymore, or the cinnamon in my cinnamon Life cereal. Prior to vaccination, the patient was not diagnosed with COVID-19. No Since the vaccination, the patient was not tested for COVID-19. The reporter consented to follow up. Additional supportive information: It was unknown if the reporter considered the taste loss to be related to COVID-19 VACCINE PFIZER.
Age: 7.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient is 7 years old, but was administered an an adult dose of the Pfizer Covid booster.  This was a pharmacist error.  He has ad no adverse reaction thus far (it's been a week now).  However, we are concerned about any potential long term effects.
Age: 7.0
Sex: M
Vaccine: COVID19-2, COVID19-2, FLUC4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient is 7 years old, but was administered an an adult dose of the Pfizer Covid booster.  This was a pharmacist error.  He has ad no adverse reaction thus far (it's been a week now).  However, we are concerned about any potential long term effects.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Recently in hosp, Oct 6, 4 days, minor cardiac diagnosed.; Woke up this morning very depressed.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 14:30 as dose 4 (booster), single (Lot number: GH0937) at the age of 70 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "high cholesterol" (unspecified if ongoing), notes: Other medical history: high cholesterol. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose-1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose-2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose-3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: CARDIAC DISORDER (hospitalization) with onset 2022, outcome "unknown", described as "Recently in hosp, Oct 6, 4 days, minor cardiac diagnosed."; DEPRESSION (non-serious) with onset 2022, outcome "unknown", described as "Woke up this morning very depressed.". The patient was hospitalized for cardiac disorder (start date: 06Oct2022, discharge date: 09Oct2022, hospitalization duration: 4 day(s)). Therapeutic measures were taken as a result of depression.  Additional information: Recently in hosp, 06Oct, 4 Days, minor cardiac diagnosed. Came Home, went to sleep off and on at 3 am. Woke up this morning very depressed. I Then read Paxlovid could have negative Emotional response. Yes, I am on Medication for controlled depression. No, Never hospitalized, never serious reaction To meds. Paxlovid did NOT shorten COVID. My significant other did not take treatment And his symptoms decreased on its own Within 5days. Day 10 for me, cough, Fatigue, not feeling well.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder, Depression
Clinical narrative: Recently in hosp, Oct 6, 4 days, minor cardiac diagnosed.; Woke up this morning very depressed.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 at 14:30 as dose 4 (booster), single (Lot number: GH0937) at the age of 70 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Known allergies Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "high cholesterol" (unspecified if ongoing), notes: Other medical history: high cholesterol. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose-1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose-2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose-3, Manufacturer unknown), for Covid-19 immunization. The following information was reported: CARDIAC DISORDER (hospitalization) with onset 2022, outcome "unknown", described as "Recently in hosp, Oct 6, 4 days, minor cardiac diagnosed."; DEPRESSION (non-serious) with onset 2022, outcome "unknown", described as "Woke up this morning very depressed.". The patient was hospitalized for cardiac disorder (start date: 06Oct2022, discharge date: 09Oct2022, hospitalization duration: 4 day(s)). Therapeutic measures were taken as a result of depression.  Additional information: Recently in hosp, 06Oct, 4 Days, minor cardiac diagnosed. Came Home, went to sleep off and on at 3 am. Woke up this morning very depressed. I Then read Paxlovid could have negative Emotional response. Yes, I am on Medication for controlled depression. No, Never hospitalized, never serious reaction To meds. Paxlovid did NOT shorten COVID. My significant other did not take treatment And his symptoms decreased on its own Within 5days. Day 10 for me, cough, Fatigue, not feeling well.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthma, Cough, Malaise, Pain in extremity, Respiratory tract irritation
Clinical narrative: it could be that he has caught COVID; it could be that he has caught COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: GH9702) for COVID-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 29Oct2022, outcome "unknown" and all described as "it could be that he has caught COVID".  Additional information: the patient reports having a side effect but he is not sure if it is from the vaccine or maybe he caught COVID. Patient just wants to find out if this is a normal side effect or it could be that he has caught COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: it could be that he has caught COVID; it could be that he has caught COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: GH9702) for COVID-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 29Oct2022, outcome "unknown" and all described as "it could be that he has caught COVID".  Additional information: the patient reports having a side effect but he is not sure if it is from the vaccine or maybe he caught COVID. Patient just wants to find out if this is a normal side effect or it could be that he has caught COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: it could be that he has caught COVID; it could be that he has caught COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: GH9702) for COVID-19 immunization; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 29Oct2022, outcome "unknown" and all described as "it could be that he has caught COVID".  Additional information: the patient reports having a side effect but he is not sure if it is from the vaccine or maybe he caught COVID. Patient just wants to find out if this is a normal side effect or it could be that he has caught COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss after receiving the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss after receiving the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair loss after receiving the Moderna vaccine). At the time of the report, ALOPECIA (Hair loss after receiving the Moderna vaccine) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   No concomitant medication information was provided. No treatment medication were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-670176, US-MODERNATX, INC.-MOD-2022-670184 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-670184:Male case 1 US-MODERNATX, INC.-MOD-2022-670176:Female case 1
Sex: F
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Herpes simplex reactivation, Herpes zoster reactivation, Infectious mononucleosis, Sciatic nerve neuropathy, Therapeutic response unexpected
Clinical narrative: Sciatic nerve problems; Nerve damage in the injection arm; Mono; Herpes zoster reactivation; Herpes simplex reactivation; Immediately after receiving the vaccine I noticed a difference (IQ)/ As soon as I got the ZOSTAVAX vaccine my IQ shot back up to 159; This spontaneous report has been received from a consumer referring to herself as an adult female patient of unknown age. The patient's pertinent medical history included history of mono, chicken pox multiple times, and family history of Alzheimer. Patient's concomitant medication included levothyroxine, topiramate, and allergy pills. Patient's drug reactions or allergies included baby aspirin.  On an unknown date in 2018 (also reported as 4 years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, (dose, strength, frequency, site of vaccination, route of administration, expiration date, and lot number were not provided) administered for prophylaxis. On an unknown date, the patient was vaccinated with a COVID-19 vaccine (reported as Johnson and Johnson COVID 19 vaccine), and on December 10th of an unknown year, the patient vas vaccinated with elasomeran (MODERNA COVID-19 VACCINE).  The reporter stated that the zoster vaccine live (ZOSTAVAX), had a benefit she did not expect "I did not know at the time, but the zoster vaccine live (ZOSTAVAX) cured herpes type 1 and type 2". She stated that her intelligent quotient (IQ) was 159 and it tanked at 75 (before vaccine) and no one could figure out the reason; immediately after she received the vaccine, she noticed a difference. It was also reported that as soon as she got the zoster vaccine live (ZOSTAVAX), her IQ shot back up to 159 (unexpected therapeutic benefit). The reporter informed that at the time she received the zoster vaccine live (ZOSTAVAX), she did not realize she had herpes type 1. She also stated that, after she received the Johnson and Johnson COVID-19 vaccine, it reactivated all the viruses she previously suffered from (herpes zoster reactivation and herpes simplex reactivation). Additionally, she reported that after she received one of the COVID 19 vaccines, she experienced nerve damage in the injection arm (vaccination site nerve damage), mono (mononucleosis infectious), and sciatic nerve problems (sciatic nerve neuropathy). The causal relationship between pembrolizumab (KEYTRUDA) and the events were not provided.  The outcome of the events was not provided. The action taking regarding the suspect therapy and the events was not provided.