chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Nervousness, Stress cardiomyopathy, Troponin increased
Clinical narrative: Trouble swallowing and shakey 20 minutes after receiving vaccine, called EMS, transported to emergency department for evaluation of possible allergic reaction to vaccine. In ED, given Benadryl, ran multiple blood tests, found out my troponin was elevated indicating possible cardiac issue. Had multiple EKGs, chest CT scan. Started on aspirin and blood thinner. My troponin level continued to rise. I was directly admitted to hospital via ambulance. Spent 2 nights in hospital for cardiac monitoring. Continued to receive blood thinner and aspirin. Had multiple blood tests, echocardiogram, and cardiac catheterization procedure. Cardiac catheterization showed no blockages or clots. Diagnosed with stress cardiomyopathy congestive heart disease, which my doctor thinks the RSV vaccine may have triggered this diagnoses. Discharged after 2 nights. Prescribed  carvedilol 3.125mg twice a day, cardiac rehab 12 week program, blood pressure monitoring, and cardiology follow up in 2-3 weeks.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: chills, fatigue, muscle ache
Age: 85.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Patient was feeling heat and swelling at injection site for more than 5 days- pain became unbearable on 10/05 so she visited the clinic on 10/05 and was prescribed an antibiotic for possible Cellulitis
Age: 72.0
Sex: M
Vaccine: FLUA4
Symptoms: Discomfort, Injected limb mobility decreased, Injection site joint pain, Sleep disorder
Clinical narrative: PATIENT IS COMPLAINING OF PAIN IN HIS RIGHT SHOULDER JOINT.  HE IS UNABLE TO RAISE HIS ARM ABOVE HIS SHOULDERS.  HE IS HAVING TROUBLE SLEEPING DUE TO THE PAIN IN HIS SHOULDER JOINT.  HE IS TAKING TYLENOL AND SOMETIMES ALEVE FOR THE DISCOMFORT.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram head, Laboratory test, Syncope
Clinical narrative: Syncopal episode immediately after vaccination.  Known history of vasovagal syncope.  Seen in ED, negative work-up.  Neurology pending.  Has had flu shots annually for 23 years without incident.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder, Disability, Frontotemporal dementia, Impaired driving ability, Loss of employment
Clinical narrative: Rapid Cognitive Decline.  Sleep apnea testing, magnesium infusions, lumbar puncture, MRI of the brain, neuropsych testing and a  PET scan on 10/24/2023 Loss of Job, no longer driving, qualified for disability based on cognitive ability  He has been diagnosed with Frontal Temporal Dementia 10/1/2023
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging head, Neuropsychological test, Positron emission tomogram, Sleep study
Clinical narrative: Rapid Cognitive Decline.  Sleep apnea testing, magnesium infusions, lumbar puncture, MRI of the brain, neuropsych testing and a  PET scan on 10/24/2023 Loss of Job, no longer driving, qualified for disability based on cognitive ability  He has been diagnosed with Frontal Temporal Dementia 10/1/2023
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Underdose
Clinical narrative: pediatric dose given to adult patient, no symptoms reported
Age: 65.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient recieved the COVID vaccine when they wanted the flu shot. Patient called on Wednesday (10/4) and scheduled the appointment over the phone. Patient states that they requested a flu shot but the person putting in the appointment scheduled them for the COVID19 shot. Patient came for the vaccine appointment and it wasn't until after the vaccination was complete was it noticed the wrong vaccine was scheduled.  No reactions to the vaccine as of yet but patient did not wish to receive the vaccine.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Balance disorder, Dizziness, Heart rate decreased, Hyperhidrosis
Clinical narrative: Server low blood pressure and heart rate readings. Also, dizzy,sweating,weakness, and blance issures.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: Server low blood pressure and heart rate readings. Also, dizzy,sweating,weakness, and blance issures.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Atrial fibrillation, Computerised tomogram thorax, Echocardiogram, Electrocardiogram, Pericarditis
Clinical narrative: Atrial Fib with tachycardia, pericarditis  Treated with ibuprofen, colchicine, prednisone and metoprolol - oral medications  Went to the Emergency Department on 10-3-2023 and admitted to hospital.  Was discharged on 10-5-2023.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Scan with contrast, Tachycardia, Troponin increased, X-ray
Clinical narrative: Atrial Fib with tachycardia, pericarditis  Treated with ibuprofen, colchicine, prednisone and metoprolol - oral medications  Went to the Emergency Department on 10-3-2023 and admitted to hospital.  Was discharged on 10-5-2023.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy to animal, Dyspnoea
Clinical narrative: Projectile vomiting 20 mins after vaccine.  Then again 30 mins after.that.  Patient stable after second episode.  Able to take fluids PO,   Patient sent home to rest, with instructions to call 911 if any Shortness of breath,or his symptoms get worse he can go to the Emergency room.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia, Pain in extremity, Paraesthesia
Clinical narrative: She got her vaccine, and had the typical ache in the arm.  It wasn't until the 17th that she noticed that she had tingling in which it may have triggered peripheral artery disease which she may have.  Then she thought to herself is it possible that her hair doing what it is doing, (hair shedding), started receding and not growing back.  When she got the tingling in her arms and things, she thought and was wondering after hearing complaining about the vaccines was from that.  She then thought that maybe her reactions were from the vaccines.    She is having hair loss on the skin of the forehead where the hair beings, receding about 1/2", at the temples, and on top of her head, crown area portion has thinned out quite a bit.  It seems to be concentrated there.  There is shedding elsewhere, but these are the areas that are mostly offended by whatever this vaccine may be doing.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: adult given pediatric dose, no adverse rxn reported
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dizziness, Dysgeusia, Fatigue, Injected limb mobility decreased
Clinical narrative: after an hour had metallic taste in my mouth, felt faint.  as fast as it came it disappeared as fast.  Eyesight reading letters were blurry, an memory for spelling not good.  Then got tired my usual reaction to preservatives, took a couple of naps most of the afternoon.   Whole body started to ache.  Around 8pm  site started to hurt, got swollen and red.  Now today the only problem is the site is warm and red and hard to raise my arm.  Otherwise seem ok.   Was concerned as i have A fib with a pacemaker.  Cardiologist said they could not see any a fib episodes for yesterday and this morning.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: after an hour had metallic taste in my mouth, felt faint.  as fast as it came it disappeared as fast.  Eyesight reading letters were blurry, an memory for spelling not good.  Then got tired my usual reaction to preservatives, took a couple of naps most of the afternoon.   Whole body started to ache.  Around 8pm  site started to hurt, got swollen and red.  Now today the only problem is the site is warm and red and hard to raise my arm.  Otherwise seem ok.   Was concerned as i have A fib with a pacemaker.  Cardiologist said they could not see any a fib episodes for yesterday and this morning.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: after an hour had metallic taste in my mouth, felt faint.  as fast as it came it disappeared as fast.  Eyesight reading letters were blurry, an memory for spelling not good.  Then got tired my usual reaction to preservatives, took a couple of naps most of the afternoon.   Whole body started to ache.  Around 8pm  site started to hurt, got swollen and red.  Now today the only problem is the site is warm and red and hard to raise my arm.  Otherwise seem ok.   Was concerned as i have A fib with a pacemaker.  Cardiologist said they could not see any a fib episodes for yesterday and this morning.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Husband and wife came into pharmacy to get COVID and RSV vaccines at the same time and wife was mistakenly given husband's COVID shot instead of her RSV so she got two doses of COVID (one in left arm and the other in right arm). Counseled her on what to expect and if worsening of side effects or life threatening to go to the hospital. Pharmacy will be in contact with patient over the next several days checking on her.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Migraine, Nausea, Photophobia, Tinnitus
Clinical narrative: 5 days of severe migraine headache, photophobia, nausea tinnitus and fatigue.  Vaginal bleeding also began within several hours of receiving vaccine.  I am on Mirena and usually do  not get a period.  These symptoms have happened every single time after all of my vaccines, but thought it was coincidental.  Now that pattern emerged, pretty certain it's related to vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccine positive rechallenge, Vaginal haemorrhage
Clinical narrative: 5 days of severe migraine headache, photophobia, nausea tinnitus and fatigue.  Vaginal bleeding also began within several hours of receiving vaccine.  I am on Mirena and usually do  not get a period.  These symptoms have happened every single time after all of my vaccines, but thought it was coincidental.  Now that pattern emerged, pretty certain it's related to vaccine.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: arm pain, itching
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Agitation, Irritability
Clinical narrative: During the evening, overnight and the following day until Noon, I was hyper-agitated and hyper-irritable. It started abruptly and ended abruptly. Nothing in my routine had changed or was non-typical except for the booster shot. It felt very intense during that 12 hour period.
Age: 62.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site bruising, Injection site pain, Injection site paraesthesia, Injection site warmth, Pain
Clinical narrative: patient states location of vaccine hurt right away. Vaccine site was hot to touch and tingling. patient came back to pharmacy 6 days later on 10/5/23 to complain of bruising and pain. Injection site had black/blue bruising. Patient could lift arm but stated it was sore.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: Vocational Nurse students performing vaccination under the supervision of staff. The student did not ask the patient about pregnancy and was given flu vaccine from multidose vial
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Blepharospasm
Clinical narrative: Approximately two hours after administration, uncontrolled twitching in left eyelid lasting for approximately 30 minutes.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration, Vitiligo
Clinical narrative: Vitiligo - patient began losing color in skin / vitiligo spots on hands 2 weeks after receiving COVID booster. Since then, vitiligo has extended up hands and arms. Reviewed treatment options with dermatologist and declined.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Atrial fibrillation, Blister, C-reactive protein, Condition aggravated
Clinical narrative: She got her vaccine, had no problems, the next day she went into atrial fibrillation on the 17th she had a rash on the back and front of her legs with swelling of fluid, she had swelling in her wrist, left more than the right.  On the 19th the left wrist and right side of her neck were hurting.  Then on the 20th the left wrist was still hurting, but the right one was better.  Then on the 23rd, the left hand was hurting on the top.  On the 24th she went back into A-fib for one day which has a history of this but has been under control.  She went in the sun on her sunporch, then the next day she broke out into a rash all over.  On the 30th she could not sleep at all as she was itching so bad.  On teh 31st she had a bi big blister on her right big toe, which went away after a few days.  She had never had this before.  Then on 9/3/23 she went out to water the flowers, had been in teh sun 10-15 minutes and then the rash came back from head to toes.  If she takes a hot shower then she is itching all night.  She went on a Medrol dosepack.  With this the swelling went down in her wrist, but she still had the rash.  Once teh A-fib was under control she lost 3# in one day.  The next day she was so tired that she did not do anything but lie away.  She went to the doctor on the 7th and he did blood work that day.  It showed tha ther RA was really high, they did 3 separate tests for that.    SHe has an appointment to see a rheumatologist on 10/17/23 to see what is going on.  She also has a cardiologist.  Her RA factor was 42 and it supposed to be below 12.  The CRP was 5.81, high normal being 0 - 3.28, Sed rate was 64.  She has been in remission and the vaccine seems to have kicked it all off again.    She can still the rash on her body and still has some itching of her body.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Neck pain, Pain in extremity, Pruritus, Rash
Clinical narrative: She got her vaccine, had no problems, the next day she went into atrial fibrillation on the 17th she had a rash on the back and front of her legs with swelling of fluid, she had swelling in her wrist, left more than the right.  On the 19th the left wrist and right side of her neck were hurting.  Then on the 20th the left wrist was still hurting, but the right one was better.  Then on the 23rd, the left hand was hurting on the top.  On the 24th she went back into A-fib for one day which has a history of this but has been under control.  She went in the sun on her sunporch, then the next day she broke out into a rash all over.  On the 30th she could not sleep at all as she was itching so bad.  On teh 31st she had a bi big blister on her right big toe, which went away after a few days.  She had never had this before.  Then on 9/3/23 she went out to water the flowers, had been in teh sun 10-15 minutes and then the rash came back from head to toes.  If she takes a hot shower then she is itching all night.  She went on a Medrol dosepack.  With this the swelling went down in her wrist, but she still had the rash.  Once teh A-fib was under control she lost 3# in one day.  The next day she was so tired that she did not do anything but lie away.  She went to the doctor on the 7th and he did blood work that day.  It showed tha ther RA was really high, they did 3 separate tests for that.    SHe has an appointment to see a rheumatologist on 10/17/23 to see what is going on.  She also has a cardiologist.  Her RA factor was 42 and it supposed to be below 12.  The CRP was 5.81, high normal being 0 - 3.28, Sed rate was 64.  She has been in remission and the vaccine seems to have kicked it all off again.    She can still the rash on her body and still has some itching of her body.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor increased, Sleep disorder
Clinical narrative: She got her vaccine, had no problems, the next day she went into atrial fibrillation on the 17th she had a rash on the back and front of her legs with swelling of fluid, she had swelling in her wrist, left more than the right.  On the 19th the left wrist and right side of her neck were hurting.  Then on the 20th the left wrist was still hurting, but the right one was better.  Then on the 23rd, the left hand was hurting on the top.  On the 24th she went back into A-fib for one day which has a history of this but has been under control.  She went in the sun on her sunporch, then the next day she broke out into a rash all over.  On the 30th she could not sleep at all as she was itching so bad.  On teh 31st she had a bi big blister on her right big toe, which went away after a few days.  She had never had this before.  Then on 9/3/23 she went out to water the flowers, had been in teh sun 10-15 minutes and then the rash came back from head to toes.  If she takes a hot shower then she is itching all night.  She went on a Medrol dosepack.  With this the swelling went down in her wrist, but she still had the rash.  Once teh A-fib was under control she lost 3# in one day.  The next day she was so tired that she did not do anything but lie away.  She went to the doctor on the 7th and he did blood work that day.  It showed tha ther RA was really high, they did 3 separate tests for that.    SHe has an appointment to see a rheumatologist on 10/17/23 to see what is going on.  She also has a cardiologist.  Her RA factor was 42 and it supposed to be below 12.  The CRP was 5.81, high normal being 0 - 3.28, Sed rate was 64.  She has been in remission and the vaccine seems to have kicked it all off again.    She can still the rash on her body and still has some itching of her body.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Cough, Fatigue
Clinical narrative: FATIGUE, WEAKNESS, COUGH
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; The patients are all adults the patients have not reported other side effects; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects). At the time of the report, PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze).    No relevant concomitant medications were reported. No treatment medication reported.     This case was for the 4th patient out of 10 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
Sex: U
Vaccine: UNK
Symptoms: Immunisation reaction
Clinical narrative: Side effects post reception of latest Moderna Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effects post reception of latest Moderna Covid vaccine) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects post reception of latest Moderna Covid vaccine). At the time of the report, IMMUNISATION REACTION (Side effects post reception of latest Moderna Covid vaccine) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2023: Live Non-significant Follow-up received contains reference number added.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Mobility decreased, Somnolence
Clinical narrative: sleepy; exhausted; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), FATIGUE (exhausted), CHILLS (chills) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes, Blood pressure high and Hypothyroidism. Concomitant products included LOSARTAN for Blood pressure high, TIRZEPATIDE (MOUNJARO) and INSULIN for Diabetes, THYROID (ARMOUR THYROID) for Hypothyroidism.    On 01-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Oct-2023, the patient experienced SOMNOLENCE (sleepy), FATIGUE (exhausted), CHILLS (chills) and HEADACHE (headache). At the time of the report, SOMNOLENCE (sleepy), FATIGUE (exhausted), CHILLS (chills) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient had a total of 3 Moderna COVID-19 vaccine so far. The previous vaccine was administered about a year ago, but patient could not be sure. Patient did not find her vaccination card. On 02Oct2023 patient started having chills and spent 2 days in bed. Patient did not even get up to eat. Patient still felt very sleepy, slight headache and exhausted. Patient did not have other vaccines within the last 4 months.  Treatment medications were not reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash at injection site; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (swelling at injection site) 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 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (swelling at injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (swelling at injection site) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient last previous booster was 6 months ago, Each time, patient gotten rash and swelling at injection site, to treat these issues, (She used hydrocortisone).   This case was linked to US-MODERNATX, INC.-MOD-2023-742904 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742904:Monovalent case
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Bacterial infection, COVID-19 pneumonia, Incentive spirometry
Clinical narrative: COVID-19 Acute viral pneumonia Duonebs q.6 hours  Short acting bronchodilator: Albuterol prn IV azithromycin and ceftriaxone for empiric coverage of secondary bacterial infection. Supplemental Oxygen therapy p.r.n. Incentive spirometer Antitussive therapy Patient to bring Paxilovid to the hospital for administration. Not hypoxic at this time, not meeting indication for dexamethasone IV or remdesivir.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia, Pneumonia, Pyrexia, Sepsis, Tachycardia
Clinical narrative: Sepsis (fever, tachycardia, acute viral pneumonia) secondary to acute COVID-19 viral pneumonia:   -supportive care   -IV fluid hydration with normal saline 75 cc/hour  -antipyretic therapy ordered p.r.n.  -empiric coverage with ceftriaxone
Age: 67.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Pt. received 3 doses Menquadfi: 1/12/23, 4/6/23,10/5/23
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Asthenia, COVID-19, Gait inability, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for COVID-19 last week.  States he feels so weak he is unable to walk.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received initial influenza vaccine on 9/7/2023. Duplicate influenza administered in error on 9/28/2023. Patient, physician, and manufacturer made aware at time of event. No adverse events.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: no symtoms or signs
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Nausea
Clinical narrative: I have had 3 Pfizer vaccines and had self-limiting GI upset (nausea and diarrhea) within 6 hours of each injection, lasting about 12 hours. Dose # 2 was received on 1/18/2021 (lot # EL 1284), also as Hospital. Dose #3 was received on 1/8/2022, (Lot # FL3197), given to me at an immunization site.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AS UNAPPROVED STORAGE UNIT
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia
Clinical narrative: 2 minutes after vaccine was administer, pt complaint of metallic taste in her mouth and some tingling on her gums- pt stayed in the pharmacy waiting area for 1 hour to make sure that her symptoms didn't worsen-- after 1 hour, she reported that she s feeling fine, "no more metallic and tingling sensation  in her mouth". she was advised to  get to ER immediately if she doesn' t feel well at home.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Injection site discolouration, Injection site haemorrhage, Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: After injection a single drop of blood dripped from injection site. After approximately 15 minutes swelling began and progressed to about 2 inches in diameter and was raised about 1/2 and inch. The swelling was very lightly purple in color. Pt reported some tingling in hand.   Patient stated after vaccination when swelling started that she remembered she should not have had an injection in that arm - due to recent hx of breast cancer removal surgery.    I recommended patient be seen in ER or I could call physician immediately. Pt opted to call "navigator" - a nurse assigned to assist her post surgical care.  Pt called back after speaking to nurse later upon our request. She was recommended to ice and observe over several days. Over those few hours she reported the swelling had gone down by 4.  Followup 2 days later the patient had pain in the arm next day (often common with that vaccine). Otherwise she was feeling much improved. She mentioned her nurse said that may consider a compression sleeve if pain or swelling persists.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Dyspnoea, Nausea, Pyrexia, Tachycardia
Clinical narrative: Within 36 hours of receiving the RSV vaccine the patient experienced a gradual escalation severe fever, chills, and difficulty breathing, tachycardia, shaking, nausea to the point that the patient considered calling an ambulance. These symptoms continued for 3 hours.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Tremor
Clinical narrative: Within 36 hours of receiving the RSV vaccine the patient experienced a gradual escalation severe fever, chills, and difficulty breathing, tachycardia, shaking, nausea to the point that the patient considered calling an ambulance. These symptoms continued for 3 hours.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Burning sensation, Chills, Fatigue, Headache
Clinical narrative: Severe shivering 2 hours/ headache, nausea, severe arthralgia and myalgia for 18 hours/burning hands, freezing feet 2 hours. Severe fatigue for 7 days. Moderate fatigue and nausea  through the 2nd week as well as general malaise.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Myalgia, Nausea, Peripheral coldness
Clinical narrative: Severe shivering 2 hours/ headache, nausea, severe arthralgia and myalgia for 18 hours/burning hands, freezing feet 2 hours. Severe fatigue for 7 days. Moderate fatigue and nausea  through the 2nd week as well as general malaise.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Diarrhoea, Fatigue, Myalgia
Clinical narrative: Substantial muscular soreness lasting several days. Diarrhea lasting 7 days. Fatigue lasting 5 days.
Sex: F
Vaccine: UNK
Symptoms: Chills
Clinical narrative: chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHILLS (chills) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  The patient had chills as a result of the vaccine.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Flank pain, Headache, Oropharyngeal pain
Clinical narrative: Temperature of 100.5; she had a reaction; chills; had extreme joint pain; shooting pains on side/body aches; sore throat; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), ARTHRALGIA (had extreme joint pain), PAIN (shooting pains on side/body aches), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 29-Sep-2023, the patient experienced CHILLS (chills), ARTHRALGIA (had extreme joint pain), PAIN (shooting pains on side/body aches), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache). On an unknown date, the patient experienced PYREXIA (Temperature of 100.5) and VACCINATION SITE REACTION (she had a reaction). At the time of the report, CHILLS (chills), ARTHRALGIA (had extreme joint pain), PAIN (shooting pains on side/body aches), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) had not resolved and PYREXIA (Temperature of 100.5) and VACCINATION SITE REACTION (she had a reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  The patient woke up this morning and had chills, had extreme joint pain and shooting pains on side, body aches, chills, sore throat, bad headache and the temperature was 100.5. She stated she called because she had a reaction..   This case was linked to US-MODERNATX, INC.-MOD-2023-743076 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2023: 02-Oct-2023: Live follow up contains new event.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743076:Same patient, Bivalent  moderna vaccine
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia, Vaccination site reaction
Clinical narrative: Temperature of 100.5; she had a reaction; chills; had extreme joint pain; shooting pains on side/body aches; sore throat; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), ARTHRALGIA (had extreme joint pain), PAIN (shooting pains on side/body aches), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 29-Sep-2023, the patient experienced CHILLS (chills), ARTHRALGIA (had extreme joint pain), PAIN (shooting pains on side/body aches), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache). On an unknown date, the patient experienced PYREXIA (Temperature of 100.5) and VACCINATION SITE REACTION (she had a reaction). At the time of the report, CHILLS (chills), ARTHRALGIA (had extreme joint pain), PAIN (shooting pains on side/body aches), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache) had not resolved and PYREXIA (Temperature of 100.5) and VACCINATION SITE REACTION (she had a reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   Treatment medication not reported.  The patient woke up this morning and had chills, had extreme joint pain and shooting pains on side, body aches, chills, sore throat, bad headache and the temperature was 100.5. She stated she called because she had a reaction..   This case was linked to US-MODERNATX, INC.-MOD-2023-743076 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2023: 02-Oct-2023: Live follow up contains new event.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743076:Same patient, Bivalent  moderna vaccine
Sex: F
Vaccine: UNK
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: drug exposure during pregnancy; No adverse event; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Company comment This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected, non-serious, event of maternal exposure during pregnancy and no adverse event was reported. The patient received a dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS). The event onset date was not provided, thus, exact latency between vaccination and onset of the events could not be assessed. Last menstrual period and estimated date of delivery were not provided. No further clinical information was provided. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: chills; sore throat; weak butt muscle; Pain and weakness at injection; diarrhea; shooting pin headache; Pain and weakness at injection; nausea; extremely fatigued; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MUSCULAR WEAKNESS (weak butt muscle), ASTHENIA (Pain and weakness at injection), DIARRHOEA (diarrhea) and HEADACHE (shooting pin headache) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Flu vaccination.    No Medical History information was reported.   In September 2023, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 19-Sep-2023 at 7:00 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 21-Sep-2023, the patient experienced OROPHARYNGEAL PAIN (sore throat), MUSCULAR WEAKNESS (weak butt muscle), ASTHENIA (Pain and weakness at injection), DIARRHOEA (diarrhea), HEADACHE (shooting pin headache), VACCINATION SITE PAIN (Pain and weakness at injection), NAUSEA (nausea) and FATIGUE (extremely fatigued). On 24-Sep-2023, the patient experienced CHILLS (chills). The patient was treated with CALCIUM CARBONATE (TUMS EX) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) on 30-Sep-2023 at an unspecified dose and frequency. On 01-Oct-2023, OROPHARYNGEAL PAIN (sore throat), MUSCULAR WEAKNESS (weak butt muscle), ASTHENIA (Pain and weakness at injection), DIARRHOEA (diarrhea), HEADACHE (shooting pin headache), VACCINATION SITE PAIN (Pain and weakness at injection), NAUSEA (nausea), FATIGUE (extremely fatigued) and CHILLS (chills) had resolved.            On Sunday morning (24-Sep-2023), patient had minor chills. Patient took probiotic capsules and Tums EX frequently which did not help and then finally on 30-Sep-2023, patient took Pepto Bismol (ginger and chamomile). Patient also ate rice porridge mixed with mushroom soup or rice porridge with Chicken Flavored Better than Bullion. Patient drank plenty of water and for last 2 days slept on and off all day before recovering and feeling much better after awakening at 5:30 PM on 02-Oct-2023. Causality of the events with FLU vaccine was not reported by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Injection site reaction, Muscular weakness, Nausea, Oropharyngeal pain
Clinical narrative: chills; sore throat; weak butt muscle; Pain and weakness at injection; diarrhea; shooting pin headache; Pain and weakness at injection; nausea; extremely fatigued; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), MUSCULAR WEAKNESS (weak butt muscle), ASTHENIA (Pain and weakness at injection), DIARRHOEA (diarrhea) and HEADACHE (shooting pin headache) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Flu vaccination.    No Medical History information was reported.   In September 2023, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 19-Sep-2023 at 7:00 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 21-Sep-2023, the patient experienced OROPHARYNGEAL PAIN (sore throat), MUSCULAR WEAKNESS (weak butt muscle), ASTHENIA (Pain and weakness at injection), DIARRHOEA (diarrhea), HEADACHE (shooting pin headache), VACCINATION SITE PAIN (Pain and weakness at injection), NAUSEA (nausea) and FATIGUE (extremely fatigued). On 24-Sep-2023, the patient experienced CHILLS (chills). The patient was treated with CALCIUM CARBONATE (TUMS EX) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) on 30-Sep-2023 at an unspecified dose and frequency. On 01-Oct-2023, OROPHARYNGEAL PAIN (sore throat), MUSCULAR WEAKNESS (weak butt muscle), ASTHENIA (Pain and weakness at injection), DIARRHOEA (diarrhea), HEADACHE (shooting pin headache), VACCINATION SITE PAIN (Pain and weakness at injection), NAUSEA (nausea), FATIGUE (extremely fatigued) and CHILLS (chills) had resolved.            On Sunday morning (24-Sep-2023), patient had minor chills. Patient took probiotic capsules and Tums EX frequently which did not help and then finally on 30-Sep-2023, patient took Pepto Bismol (ginger and chamomile). Patient also ate rice porridge mixed with mushroom soup or rice porridge with Chicken Flavored Better than Bullion. Patient drank plenty of water and for last 2 days slept on and off all day before recovering and feeling much better after awakening at 5:30 PM on 02-Oct-2023. Causality of the events with FLU vaccine was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Skin reaction
Clinical narrative: delayed skin reaction; covid 19; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (delayed skin reaction) and COVID-19 (covid 19) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (delayed skin reaction) and COVID-19 (covid 19). At the time of the report, SKIN REACTION (delayed skin reaction) and COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient stated he been taking Moderna vaccine since January 2021. Patient had the first 3 full doses and then he got a delayed skin reaction. Patient was fine with the half dose booster and had no reaction.  Treatment information was not reported.
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Exposure to SARS-CoV-2
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The reporter reports that her friend came to visit her and that he had all of his Covid-19 shots, but he also had Covid-19 and infected the patient with Covid-19.  The reporter said, lots of patients got COVID-19 after they received their COVID-19 shots.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743339 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2023: Live follow-up information received included updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743339:Case for Patient
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: had some stiffness and soreness; had some stiffness and soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (had some stiffness and soreness) and PAIN (had some stiffness and soreness) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Oct-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (had some stiffness and soreness) and PAIN (had some stiffness and soreness). On 02-Oct-2023, MUSCULOSKELETAL STIFFNESS (had some stiffness and soreness) and PAIN (had some stiffness and soreness) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient had some stiffness and soreness, and she was not able to play on Sunday but on Monday, 02-Oct-2023, she was okay. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743553 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743553:Wife patient case