chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Computerised tomogram, Gait inability, Muscle spasms, Pain in extremity
Clinical narrative: UNABLE TO WALK; UNKNOWN DIAGNOSIS SIGNS OF SYMPTOMS OF STROKE; PAIN IN THE LEGS; BAD CRAMPS THAT RUN IN THE BACK OF THE LEG; SWELLING OF BOTH LEGS; This spontaneous report received from a patient concerned a 60 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 26-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-APR-2021, after 1 month of receiving the vaccine the patient experienced swelling of left leg and she felt it would burst, the right leg was almost swollen by then. She had visited the doctor and she gave her Lasix and Augmentin. Couple of weeks later the swelling had gone down but in MAY-2021 the swelling in both legs had come back. She was then prescribed with Augmentin (amoxicillin/clavulanic acid) and Lasix again along with potassium (furosemide/potassium chloride). Treatment medications included: Lasix with potassium and Augmentin for swelling of legs. On an unspecified date, the patient experienced very bad cramps that had run in the back of her legs. On NOV-2021, the patient experienced pain in the legs. On 15-NOV-2021, the patient was able to bend over and tie her shoe but three weeks later that was, on 06-DEC-2021, the patient was unable to walk and she was hospitalized. On an unspecified date, she had undergone CT (Computerized Tomography). The patient reported that there was an unknown diagnosis- signs and symptoms of stroke but the CT had not showed it at all. The patient was hospitalized for 1 month and then transferred to a nursing home rehab hospital. She was in a wheelchair seemed like Guillain-Barre syndrome (GBS) syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of both legs, bad cramps that run in the back of the leg, pain in the legs, unable to walk, and unknown diagnosis signs of symptoms of stroke. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0-20220236867-covid-19 vaccine ad26.cov2.s-Unable to walk, Pain in the legs, Unknown diagnosis signs of symptoms of stroke. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: UNABLE TO WALK; UNKNOWN DIAGNOSIS SIGNS OF SYMPTOMS OF STROKE; PAIN IN THE LEGS; BAD CRAMPS THAT RUN IN THE BACK OF THE LEG; SWELLING OF BOTH LEGS; This spontaneous report received from a patient concerned a 60 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 26-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-APR-2021, after 1 month of receiving the vaccine the patient experienced swelling of left leg and she felt it would burst, the right leg was almost swollen by then. She had visited the doctor and she gave her Lasix and Augmentin. Couple of weeks later the swelling had gone down but in MAY-2021 the swelling in both legs had come back. She was then prescribed with Augmentin (amoxicillin/clavulanic acid) and Lasix again along with potassium (furosemide/potassium chloride). Treatment medications included: Lasix with potassium and Augmentin for swelling of legs. On an unspecified date, the patient experienced very bad cramps that had run in the back of her legs. On NOV-2021, the patient experienced pain in the legs. On 15-NOV-2021, the patient was able to bend over and tie her shoe but three weeks later that was, on 06-DEC-2021, the patient was unable to walk and she was hospitalized. On an unspecified date, she had undergone CT (Computerized Tomography). The patient reported that there was an unknown diagnosis- signs and symptoms of stroke but the CT had not showed it at all. The patient was hospitalized for 1 month and then transferred to a nursing home rehab hospital. She was in a wheelchair seemed like Guillain-Barre syndrome (GBS) syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of both legs, bad cramps that run in the back of the leg, pain in the legs, unable to walk, and unknown diagnosis signs of symptoms of stroke. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0-20220236867-covid-19 vaccine ad26.cov2.s-Unable to walk, Pain in the legs, Unknown diagnosis signs of symptoms of stroke. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Neck pain
Clinical narrative: SORE FACE; SORE NECK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sore face, and sore neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore face and sore neck was not reported. This report was non-serious. This case, involving the same patient is linked to 20220238109.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Investigation, Platelet factor 4, Thrombosis with thrombocytopenia syndrome
Clinical narrative: VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; This spontaneous report was received from literature. This report concerned 4 multiple patients of unspecified sex, age, race and ethnicity. The objective of this study was to characterize anti-PF4 antibodies in VITT. (Janssen Johnson & Johnson) vaccines against COVID-19 have been associated with thrombotic thrombocytopenic reactions referred to as vaccine-induced immune thrombotic thrombocytopenia (VITT) characterized by the presence of platelet-activating, anti-PF4 antibodies. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, Expiry: Unknown) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced vaccine induced immune thrombotic thrombocytopenia. Laboratory data included: Reactivity of VITT anti-PF4 antibodies to un complexed PF4, PF4-Polyvinyl sulfonate (PVS), and PF4-heparin targets was evaluated, and the platelet-activating ability of these antibodies was examined in the PF4-dependent P-selectin Expression assay (PEA). Anti-PF4 antibodies were isolated from patient blood samples using PF4-treated heparin sepharose beads, and isolated antibodies were subject to mass spectrometric evaluation (Liquid Chromatography Electrospray Ionization Quadrupole time-of- ight mass spectrometry [LC-ESI-QTOF MS]) were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine induced immune thrombotic thrombocytopenia was not reported. The authors emphasized that development of platelet-activating anti-PF4 antibodies and the thrombotic thrombocytopenia syndrome seen after Ad26.COV2.S vaccination resembles HIT, these findings demonstrate that clonally restricted anti-PF4 antibodies mediate VITT while polyclonal anti-PF4 antibodies mediate HIT. It is also likely that high levels of monoclonal/oligoclonal anti-PF4 antibodies cause the severe thrombotic phenotypes seen in VITT and Spontaneous HIT. The high mortality rate and reports of disease refractoriness therapy in VITT may warrant consideration of additional therapeutic modalities like rituximab and therapeutic plasma exchange in select cases. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220238408 - covid-19 vaccine ad26.cov2.s- Vaccine induced immune thrombotic thrombocytopenia. This event(s) is labeled per Agency and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Intracardiac thrombus
Clinical narrative: BLOOD CLOT IN HEART; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered  for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The reporter stated that " Don't trust them they made the vaccine and people still get the virus and a friend who got the vaccine died of a blood clot in her heart". On an unspecified date, the patient died from blood clot in heart. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220241243-COVID-19 VACCINE AD26.COV2.S- blood clot in heart. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT IN HEART
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus, Weight fluctuation
Clinical narrative: DIABETES (SUGAR); WEIGHT FLUCTUATIONS (GAINS WEIGHT, THEN LOSES AGAIN); This spontaneous report received from a consumer concerned a 58 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had nothing like that before receiving vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on APR-2021 (maybe 2 years ago, but reporter was not sure) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, shortly after received the vaccine patient started losing weight and was treated for sugar diabetes. Still had weight fluctuations (gains weight, then loses again) and being treated for diabetes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diabetes (sugar) and weight fluctuations (gains weight, then loses again). This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220242399-COVID-19 VACCINE AD26.COV2.S- Diabetes (sugar) ,Weight fluctuations (gains weight, then loses again).. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Feeling hot, Headache
Clinical narrative: BLOOD PRESSURE ELEVATED/FELT BLOOD PRESSURE IN THE LEFT SIDE OF THE HEAD; DIZZINESS; HOT FLASHES; NAUSEA; LOW GRADE HEADACHE; TINGLING SENSATION; SHOOTING WEIRD PAINS IN BODY; SENSATION FELT ACHY; SENSATION FELT HOT; FELT LIKE ARM SWOLLEN; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, drug allergy, hypothyroidism, and venous malformation in left temporal lobe. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 05-DEC-2021 for prophylactic vaccination. Concomitant medications included lisinopril for hypertension, and levothyroxine for hypothyroidism. On DEC-2021, the patient experienced felt like arm swollen. On 05-DEC-2021, the patient experienced sensation felt hot, shooting weird pains in body, sensation felt achy, and tingling sensation. On 06-DEC-2021, the patient experienced low grade headache. On 14-FEB-2022, Laboratory data included: Blood pressure (NR: not provided) 160/100. On an unspecified date, the patient experienced blood pressure elevated/felt blood pressure in the left side of the head, dizziness, hot flashes, and nausea. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 140/90 elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shooting weird pains in body, and tingling sensation on DEC-2021, had not recovered from low grade headache, and the outcome of sensation felt hot, felt like arm swollen, blood pressure elevated/felt blood pressure in the left side of the head, nausea, dizziness, hot flashes and sensation felt achy was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Nausea, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: BLOOD PRESSURE ELEVATED/FELT BLOOD PRESSURE IN THE LEFT SIDE OF THE HEAD; DIZZINESS; HOT FLASHES; NAUSEA; LOW GRADE HEADACHE; TINGLING SENSATION; SHOOTING WEIRD PAINS IN BODY; SENSATION FELT ACHY; SENSATION FELT HOT; FELT LIKE ARM SWOLLEN; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, drug allergy, hypothyroidism, and venous malformation in left temporal lobe. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: UNKNOWN) dose was not reported, administered on 05-DEC-2021 for prophylactic vaccination. Concomitant medications included lisinopril for hypertension, and levothyroxine for hypothyroidism. On DEC-2021, the patient experienced felt like arm swollen. On 05-DEC-2021, the patient experienced sensation felt hot, shooting weird pains in body, sensation felt achy, and tingling sensation. On 06-DEC-2021, the patient experienced low grade headache. On 14-FEB-2022, Laboratory data included: Blood pressure (NR: not provided) 160/100. On an unspecified date, the patient experienced blood pressure elevated/felt blood pressure in the left side of the head, dizziness, hot flashes, and nausea. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 140/90 elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shooting weird pains in body, and tingling sensation on DEC-2021, had not recovered from low grade headache, and the outcome of sensation felt hot, felt like arm swollen, blood pressure elevated/felt blood pressure in the left side of the head, nausea, dizziness, hot flashes and sensation felt achy was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Infection, Scar
Clinical narrative: DIVOT ON SKIN LIKE A HOLE; INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced divot on skin like a hole, and infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the divot on skin like a hole and infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder
Clinical narrative: PROBLEMS WITH HANDS AND FEET; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced problems with hands and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of problems with hands and feet was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rosacea
Clinical narrative: Rosacea
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, Hypothyroidism, Swelling
Clinical narrative: Lower neck swelling and hypothyroidism both of which started soon after the shot and has not subsided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lethargy, Paraesthesia, Pruritus
Clinical narrative: 5 MIN AFTER RECEIVING COVID-19 PFIZER VACCINE, PATIENT EXPERIENCED LEATHARGY, ITCHINESS TO BACK OF HER HEAD, AND TINGLING AND NUMBNESS SENSATION TO RIGHT SHOULDER THAT RADIATES DOWN TO RIGHT HAND.  PATIENT WAS MONITORED FOR 30 MIN AND SYMPTOMS SUBSIDED WITH MEDICATION IMPLEMENTATION
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram, Dysarthria, Full blood count, Magnetic resonance imaging
Clinical narrative: Acute cerebral venous sinus thrombosis with Dysarthria and migraines
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Migraine
Clinical narrative: Acute cerebral venous sinus thrombosis with Dysarthria and migraines
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Neurological symptom, Rash, Skin burning sensation
Clinical narrative: By the night came she had the chills very bad. Her skin felt like it was burning all over and she had a rash for three days.  A month after taking the booster she started experiencing some neurological issues.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Middle ear effusion
Clinical narrative: Continued fluid in ears, not responding to treatment as allergies, nor as ear infection. Pain is severe and unrelenting. First 2 days of Prednisone titration (50/40mg) helped however nothing has since. Pseudoephedrine takes edge off pain. No fever. No runny nose. No congestion. Ear pain is the only true symptom.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Chills, Cough, Diarrhoea, Night sweats
Clinical narrative: On January 2nd I woke up with a fever, chills, bad cough, body aches, night sweats, diarrhea, and vomiting. On January 7th I got a X RAY and they confirmed that I had pneumonia and they provided a z pack(antibiotics). After two to three days later I started to fell better and back to my normal self.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pneumonia, Pyrexia, Vomiting
Clinical narrative: On January 2nd I woke up with a fever, chills, bad cough, body aches, night sweats, diarrhea, and vomiting. On January 7th I got a X RAY and they confirmed that I had pneumonia and they provided a z pack(antibiotics). After two to three days later I started to fell better and back to my normal self.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Loss of personal independence in daily activities, Pain, Sleep disorder
Clinical narrative: Acute burning knee pain, never experienced prior to vaccine.  Pain was severe enough to awaken me when asleep and interrupt ADL's. Went to PCP after 2 weeks who prescribed Meloxicam with excellent results.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Electroencephalogram, Loss of consciousness
Clinical narrative: Had seizure. unconscious for 8.5 hours
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Had seizure. unconscious for 8.5 hours
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Skin discolouration
Clinical narrative: Slight outbreak on face, purple ring finger on right hand.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Micturition urgency, Myalgia, Rash
Clinical narrative: After 01/05/2022 in the morning I had a bad headache, painful joints and muscles, fever of 102. Urgency of going to the bathroom. I had rash all over my body. I took Advil for 3 days. Friday morning I started feeling better.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Received ½ dose of vaccine I/O full dose.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Pfizer BioNTech vaccine for 5-11  formulation (orange cap) was given to a patient age 12 years old resulting in a lower than authorized dose
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Development of Shingles in right groin/low back the morning following her second dose of shingrx #2.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: I got the shot on 2/17/2021. I felt fine when I came home and felt fine. About 24 hours after I started to feel chills and my arm was a little sore. I got the under the covers and drank some hot tea. I also took two pain medications 650 mg each. Next morning I felt fine. I felt normal.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was stored in freezer too long resulting in a temperature excursion.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Hypertension, Laboratory test, Oedema peripheral, Palpitations
Clinical narrative: Unexplained unilateral, left lower extremity edema, hypertension, heart palpitations, PVCs
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pulse abnormal, Ultrasound Doppler, Ventricular extrasystoles
Clinical narrative: Unexplained unilateral, left lower extremity edema, hypertension, heart palpitations, PVCs
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Chest tightness and some pain.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy abnormal, Culture stool, Diarrhoea, Haemorrhoids, Laboratory test abnormal
Clinical narrative: I received the vaccine in February and in June I had severe diarrhea for two days and then it went down to once a week. I had a colonoscopy done and it showed hemorrhoids. I then had blood work done from the doctor. I have lost 25 pounds and the doctors cant find anything wrong. It has sense lessened to two times max a month.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: I received the vaccine in February and in June I had severe diarrhea for two days and then it went down to once a week. I had a colonoscopy done and it showed hemorrhoids. I then had blood work done from the doctor. I have lost 25 pounds and the doctors cant find anything wrong. It has sense lessened to two times max a month.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Rash, Rash erythematous
Clinical narrative: The day after patient received the Pfizer COVID-19 vaccine, her mother stated she developed bilateral redness on her arms and across her chest. The mother denied having any raised bumps noted on her daughter's skin. Patient stated the red areas were a little itchy. On the third day after  the vaccination, she also developed a similar red rash on her legs. Her mother stated the symptoms resolved the afternoon of the third day after receiving the Pfizer COVID-19 vaccine. The patient and her mother denied experiencing any dizziness, shortness of breath, symptoms of anaphylaxis or other signs. No treatment administered for the rash. The patient's mother gave her  Tylenol for arm pain. No follow-up with any physicians. The patient has no chronic medical conditions, medications or known allergies.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient admitted on 1/8/22 after being diagnosed with COVID on 12/27/21. Patient received two doses of Pfizer on 2/84/21 and 3/4/21, however was not boosted. Patient was transferred from hospital to another hospital for higher level of care on 1/12/22. Patient requested to be transferred to comfort care on 1/17/22.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 2nd dose of COVID-19; administered 0.2mL without reconstitution.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Dysgeusia
Clinical narrative: metallic taste, auto immune disease
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 2nd dose of COVID administered. 0.2mL dosing administered without reconstitution
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, Palpitations
Clinical narrative: vaccine given 10:25am 2-21-22.            patient felt heart racing and irritable bowel starting approximately 3:30pm 2-21-22.  she came to the pharmacy to ask about it, as she works here at the store.   blood pressure at that time 142/100mmhg which is normal  for her.   heart rate was 81 bpm.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 1st dose of COVID administered. 0.2mL dosing administered without reconstitution
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Balance disorder, C-reactive protein increased, Ear discomfort, Feeling abnormal
Clinical narrative: On 09/10/2021, I was driving  late at night and I experienced this light sensitivity to headlights. Later, I experienced sharp pain to the center of my forehead, flashing lights in the left eye, headaches, ringing & fullness in the ears loss of balance, and had a feeling of impending doom. I felt foggy headed and I felt like I wasn't thinking clearly. There was pain and pressure in the base of my skull as well. I was prescribed migraine medication that was not effective. I've seen an ophthalmologist and an ENT. I have an appointment with a neurologist soon to do an MRI.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Photophobia, Photopsia, Thinking abnormal
Clinical narrative: On 09/10/2021, I was driving  late at night and I experienced this light sensitivity to headlights. Later, I experienced sharp pain to the center of my forehead, flashing lights in the left eye, headaches, ringing & fullness in the ears loss of balance, and had a feeling of impending doom. I felt foggy headed and I felt like I wasn't thinking clearly. There was pain and pressure in the base of my skull as well. I was prescribed migraine medication that was not effective. I've seen an ophthalmologist and an ENT. I have an appointment with a neurologist soon to do an MRI.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, White blood cell count increased
Clinical narrative: On 09/10/2021, I was driving  late at night and I experienced this light sensitivity to headlights. Later, I experienced sharp pain to the center of my forehead, flashing lights in the left eye, headaches, ringing & fullness in the ears loss of balance, and had a feeling of impending doom. I felt foggy headed and I felt like I wasn't thinking clearly. There was pain and pressure in the base of my skull as well. I was prescribed migraine medication that was not effective. I've seen an ophthalmologist and an ENT. I have an appointment with a neurologist soon to do an MRI.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation, COVID-19, COVID-19 pneumonia, Death
Clinical narrative: Morderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 7/28/21 and 8/25/21. Admitted 1/24/22 for acute hypoxemic respiratory failure 2/2 Covid PNA. Transferred to ICU 1/27 w/renal failure requiring dialysis, a-fib with variable ventricular response, severe septic shock on multiple pressors, severe hypercapnic and hypoxemic respiratory failure that required proning. Continued to decompensate with worsening shock and respiratory acidosis despite maximal ventilator settings. Transitioned to comfort care. Treated with remdesivir and decadron. Expired 02/08/22.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dialysis, Intensive care, Mechanical ventilation, Renal failure, Respiratory acidosis
Clinical narrative: Morderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 7/28/21 and 8/25/21. Admitted 1/24/22 for acute hypoxemic respiratory failure 2/2 Covid PNA. Transferred to ICU 1/27 w/renal failure requiring dialysis, a-fib with variable ventricular response, severe septic shock on multiple pressors, severe hypercapnic and hypoxemic respiratory failure that required proning. Continued to decompensate with worsening shock and respiratory acidosis despite maximal ventilator settings. Transitioned to comfort care. Treated with remdesivir and decadron. Expired 02/08/22.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory failure, Septic shock, Viral test
Clinical narrative: Morderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 7/28/21 and 8/25/21. Admitted 1/24/22 for acute hypoxemic respiratory failure 2/2 Covid PNA. Transferred to ICU 1/27 w/renal failure requiring dialysis, a-fib with variable ventricular response, severe septic shock on multiple pressors, severe hypercapnic and hypoxemic respiratory failure that required proning. Continued to decompensate with worsening shock and respiratory acidosis despite maximal ventilator settings. Transitioned to comfort care. Treated with remdesivir and decadron. Expired 02/08/22.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Feeding disorder, Hypertension
Clinical narrative: I woke up the day after my shot with chills and fever. I had shortness of breath, felt weak and couldn't do my normal daily activities. I was sick for about 36 hours and couldn't eat and my blood pressure was high. I  took fluids and tydonol for three days and eventually started to feel better.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: I woke up the day after my shot with chills and fever. I had shortness of breath, felt weak and couldn't do my normal daily activities. I was sick for about 36 hours and couldn't eat and my blood pressure was high. I  took fluids and tydonol for three days and eventually started to feel better.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Cough, Dyspnoea, Fatigue, Spirometry
Clinical narrative: Persistent cough and fatigue so I went to Allergist and he prescribed Flovent. I still have shortage of breath with intense exercising. I was informed this may solve itself in time so I will be monitored.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: 10 days after my booster shot, I woke up itchy.  By that evening I was itching over my whole body and there were large welts all over my body from where I itched.  From research I have found what my body is experiencing is dermatographia or skin writing.  The first 6 days were completely miserable, but after getting on Zyrtec my symptoms are manageable.  However it has now been over 8 weeks and the dermatographia has still not gone away.  I am on Zyrtec daily.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Heart rate irregular, Tachycardia
Clinical narrative: Irregular heartbeat which after had EKG and Holter monitor was diagnosed to be Tachycardia.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: I had terrible red bump hives on my arm; I contacted my doctor on 04/18/2021 who administered and prescribed me triamcinolone acetonide cream to help reduce the itchiness and spread of the hives from progressing. After using the cream twice a day for about 2 weeks, the hives and itchiness went away on its own and hasn't returned since.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adnexa uteri pain, Anorectal discomfort, Back pain, Haemorrhagic ovarian cyst, Ovarian cyst ruptured
Clinical narrative: Extreme right ovary pain, 2 hours after shot was given. Pain lasts for 20 minutes to a hour at a time, goes away for 10-30 minutes and repeats. Worst at night when trying to sleep. Pain level 9 out of 10 sometimes higher. Also pressure with pain in my vaginal opening and anus. I have a sharp pain on the left side of my anus going up inside my colon. All of this happens at the same time. I also have low back pain and pelvic pain on the right side. The last covid 19 shot I received in May the next day I had all of these symptoms but slightly worse. I ended up in the er. I found out an ovarian cyst ruptured and had blead into my abdomen. That cyst was 3.9 centimeters in size. I didn't report it because I didn't know where to report it.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pelvic pain, Proctalgia, Vulvovaginal discomfort, Vulvovaginal pain
Clinical narrative: Extreme right ovary pain, 2 hours after shot was given. Pain lasts for 20 minutes to a hour at a time, goes away for 10-30 minutes and repeats. Worst at night when trying to sleep. Pain level 9 out of 10 sometimes higher. Also pressure with pain in my vaginal opening and anus. I have a sharp pain on the left side of my anus going up inside my colon. All of this happens at the same time. I also have low back pain and pelvic pain on the right side. The last covid 19 shot I received in May the next day I had all of these symptoms but slightly worse. I ended up in the er. I found out an ovarian cyst ruptured and had blead into my abdomen. That cyst was 3.9 centimeters in size. I didn't report it because I didn't know where to report it.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ovarian cyst
Clinical narrative: Extreme right ovary pain, 2 hours after shot was given. Pain lasts for 20 minutes to a hour at a time, goes away for 10-30 minutes and repeats. Worst at night when trying to sleep. Pain level 9 out of 10 sometimes higher. Also pressure with pain in my vaginal opening and anus. I have a sharp pain on the left side of my anus going up inside my colon. All of this happens at the same time. I also have low back pain and pelvic pain on the right side. The last covid 19 shot I received in May the next day I had all of these symptoms but slightly worse. I ended up in the er. I found out an ovarian cyst ruptured and had blead into my abdomen. That cyst was 3.9 centimeters in size. I didn't report it because I didn't know where to report it.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram, Cough, Death, Dyspnoea
Clinical narrative: Patient treated several times since 12/13/21 for unresolving pneumonia, cough and SOB.  Patient subsequently found to have a malignant neoplasm of the lung. Patient passed away 1/24/2022.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Lung neoplasm malignant, Pneumonia
Clinical narrative: Patient treated several times since 12/13/21 for unresolving pneumonia, cough and SOB.  Patient subsequently found to have a malignant neoplasm of the lung. Patient passed away 1/24/2022.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching on my upper back/shoulder, thighs and arms. Called pharmacist and they recommended Benadryl.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was stored in freezer too long resulting in a temperature excursion.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Arthralgia, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Immediately after vaccination - profuse sweating, dizziness, and nausea. Resolved in 15 minutes with water Day after vaccination - headache  2 days after - intense body aches and pain through shoulders. Heart pain. Soreness in legs
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Nausea, Pain, Pain in extremity
Clinical narrative: Immediately after vaccination - profuse sweating, dizziness, and nausea. Resolved in 15 minutes with water Day after vaccination - headache  2 days after - intense body aches and pain through shoulders. Heart pain. Soreness in legs
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Ultrasound scan normal
Clinical narrative: I got the vaccine and have been post menopaused for four years but eight months after the vaccine I got my period again and it was a normal period as when I was younger.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vaccine dosage incorrect. Patient received 0.3mL instead of 0.2mL.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was stored in freezer too long resulting in a temperature excursion.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea exertional, SARS-CoV-2 test negative, Upper respiratory tract infection, Wheezing
Clinical narrative: Dx: Dyspnea upon exertion. This was a new onset. I have never had dyspnea before with or without a cold. I have no prior history of asthma or other breathing problems.  Treatment: Albuterol inhaler 2 puff(s) Inhalation Every 6 hours as needed as needed for wheezing and/or chest tightness. Please dispense with a spacer.. Refills: 0.  Outcome: Dyspnea resolved after 1 week on albuterol inhaler when URI resolved.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: No adverse event
Clinical narrative: Mother reports no adverse reaction, re-administration of Varicella not recommended by manufacturer
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea
Clinical narrative: 02/10/2022 Started with Diarrhea and it lasted for longer than expected for what I initially blamed it on lasts nights dinner. As it stands, I put myself on a soft diet and starting on (2/15) take two of major loperamide hydrochloride tablets for each BM after trying a solid meal. 02/18 Went to my PCP office where they blood test and was advised to call my GI doc if it last for more than a week.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Mar2021 12:00 (Lot number: EN6206) at the age of 58 years as dose 1, single and intramuscular, administered in arm left, administration date 13Apr2021 11:30 (Lot number: EW0161) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; FENOFIBRATE; VITAMIN E AND VITAMIN C; VITAMIN D3; ASPRIN; COQ 10; GARLIC & PARSLEY [ALLIUM SATIVUM OIL;PETROSELINUM CRISPUM OIL]. The following information was reported: NAUSEA (non-serious) with onset 24Mar2021 04:00, outcome "recovered" (2021), described as "Nausea". Therapeutic measures were not taken as a result of nausea. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. The patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Feeling abnormal, Impaired work ability, Vaginal haemorrhage
Clinical narrative: Bleeding like a period; Swelling  of the eyes; Felt uncomfortable; Cant work; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Bleeding like a period), EYE SWELLING (Swelling  of the eyes), FEELING ABNORMAL (Felt uncomfortable) and IMPAIRED WORK ABILITY (Cant work) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (Bleeding like a period), EYE SWELLING (Swelling  of the eyes), FEELING ABNORMAL (Felt uncomfortable) and IMPAIRED WORK ABILITY (Cant work). At the time of the report, VAGINAL HAEMORRHAGE (Bleeding like a period), EYE SWELLING (Swelling  of the eyes), FEELING ABNORMAL (Felt uncomfortable) and IMPAIRED WORK ABILITY (Cant work) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was hospitalized because patient thought she might be pregnant or mensuration.Doctor told patient it was a reaction to a medication.  No relevant concomitant medications were reported. No treatment information was provided.  This is a spontaneous case concerning  a  28-year-old, female patient with no reported medical history, who experienced the unexpected non-serious events of Vaginal haemorrhage, Eye swelling, Feeling abnormal and Impaired work inability. The events occurred on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. No treatment information was provided. The events were reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-483642 (Patient Link).; Reporter's Comments: MOD-2022-483642; Sender's Comments: This is a spontaneous case concerning  a  28-year-old, female patient with no reported medical history, who experienced the unexpected non-serious events of Vaginal haemorrhage, Eye swelling, Feeling abnormal and Impaired work inability. The events occurred on an unknown day after the unknown dose of mRNA-1273 COVID 19 Vaccine. No treatment information was provided. The events were reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: booster given instead of second dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (booster given instead of second dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A and 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 12-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (booster given instead of second dose). On 12-Feb-2022, ACCIDENTAL UNDERDOSE (booster given instead of second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Someone gave expired dose of Moderna vaccine to a patient 2 days after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Someone gave expired dose of Moderna vaccine to a patient 2 days after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Someone gave expired dose of Moderna vaccine to a patient 2 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Someone gave expired dose of Moderna vaccine to a patient 2 days after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.