chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site inflammation, Pain
Clinical narrative: Shot in upper left arms, very soar that night, 2 days after noticed red/pink blotch 2 inches wide near injection site with additional inflammation surrounding.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient came in for first dose of Covid 19 vaccine.  Pfizer given, she was given 0.1 mL VS 0.3mL dose. No adverse effects noted.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: RN drew up Pfizer 0.1 mL Correct dose 0.3 mL Patient recieved less than correct dose of covid vaccine during am clinic. No adverse event noted.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient recieved first dose of covid 19 vaccine (Pfizer) He recieved 0.1 mL dose vs 0.3 mL correct dose.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient came in for second dose, of Pfizer covid 19. He recieved 0.1 mL dose vs 0.3 mL dose. No adverse event noted.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: No treatment - office visit.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient came in for second Covid vaccine Pfizer. Patient recieved 0.1ml vs 0.3mL IM. No adverse event noted.
Age: 11.0
Sex: F
Vaccine: DTAP, HPV9, MNQ
Symptoms: Peripheral swelling
Clinical narrative: We could not get in touch with the patient mother via phone . letter mailed out to the home. Pt c mild swelling to her R arm.  Mom thought Regular reaction.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Mom reports pt got siblings vaccines MA (Medical Assistant) does not feel so. 1 yr old due for MMR, varicella, hep A. 2 yo due for Hep A. ? Vaccines switched. Offered mom 1yr to get MMR + Varicella again. Did on 8/30/21.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 1 hr after shot, chest rash
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: R arm swollen, warm to touch area with rash 3cm surrounding injection site with tenderness
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Worsening left hip pain after Moderna vaccine given 8/18/2021
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Congestive cardiomyopathy, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Without any history of heart Disease I was Diagnosed with Dilated Cardiomyopathy with frequent PVCs on May 24, 2021. Tests showed two incidents of myocarditis
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging, Myocarditis, Scan, Ventricular extrasystoles
Clinical narrative: Without any history of heart Disease I was Diagnosed with Dilated Cardiomyopathy with frequent PVCs on May 24, 2021. Tests showed two incidents of myocarditis
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: None. Just Developed Positive Covid Test (Rapid)
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: Pt came in with her mother and her mother's boyfriend. All three were on Our Covid Vaccine schedule. Someone put her on the schedule and she shouldn't have been. She should have received Pfizer someone else.
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Full blood count, Metabolic function test, Myalgia, Red blood cell sedimentation rate
Clinical narrative: Generalized Hives Facial swelling Myalgias started approx 4-5 hours after vaccine, intermittent for 4 weeks with hives/myalgias
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Generalized Hives Facial swelling Myalgias started approx 4-5 hours after vaccine, intermittent for 4 weeks with hives/myalgias
Age: 35.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Rph  found  that   the  given  Vaccine  has  expired a week  before  the  administration.  Pt Contacted, and  confirmed  no  adverse  event  occured.
Age: 74.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Wrong product administered
Clinical narrative: Pt wanted a flu shot and we accidentally gave a covid shot. He already had 2 Moderna shots, the last on 4/10. We gave the flu shot after realizing mistake.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient recieved first dose of covid 19 Pfizer. The dose given was 0.1ml vs 0.3mL IM. No adverse effect noted.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient had first Dose of Pfizer Covid 19, She recieved 0.1mL VS 0.3mL IM. No adverse reactioN noted
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient recieved 0.1ml of Pfizer covid vaccine us correct dose of 0.3mL IM. No adverse effects noted.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient received second Pfizer vaccine. She received, 0.1ML IM US 0.3 ML IM. No adverse event noted.
Age: 17.0
Sex: U
Vaccine: MENB, MNQ
Symptoms: Dizziness, Dysstasia, Orthostatic hypotension, Presyncope
Clinical narrative: patient had near syncopal episode  after vaccines. patient  had orthostatic hypotension.  patient did not eat before vaccines, found to have accu-check 78.  Felt better after poptart. Patient  went with EMS  since was not able  to stand  without feeling  symptomatic & dizzy.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: No reaction on previous exposure to drug, Underdose
Clinical narrative: Patient recieved second dose of covid 19 Pfizer. He recieved 0.1ml vs 0.3mL dose. No adverse reaction noted  First dose on 8-4-21
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: for Dose 1 of the COVID-19 vaccine. We called 911 & gave her 50mg Benadryl
Sex: U
Vaccine: COVID19
Symptoms: Blood test, General physical health deterioration
Clinical narrative: I got the Pfizer vaccine and I had complications with my health
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Differential white blood cell count normal, Electrocardiogram abnormal, Full blood count normal, Headache
Clinical narrative: MODERNA COVID-19 Vaccine use for COVID-19 under Emergency Use Authorization (EUA): Chest palpitations, headache. Patient received first Moderna vaccine 8/25/21 at 1645. Pre-screen negative. Reported feeling well, received vaccine to left deltoid. Observed for 25 min, pulse taken 2x, 15 min apart: 74, and 72. Patient went to emergency room at 2300 for headache and chest palpitations that were preventing her from falling asleep. Received adenosine IV. Continued with chest palpitations until morning; headache resolved. Advised to follow with PCP for any further management.
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test normal, Palpitations, Sinus rhythm, Sleep disorder, Supraventricular tachycardia
Clinical narrative: MODERNA COVID-19 Vaccine use for COVID-19 under Emergency Use Authorization (EUA): Chest palpitations, headache. Patient received first Moderna vaccine 8/25/21 at 1645. Pre-screen negative. Reported feeling well, received vaccine to left deltoid. Observed for 25 min, pulse taken 2x, 15 min apart: 74, and 72. Patient went to emergency room at 2300 for headache and chest palpitations that were preventing her from falling asleep. Received adenosine IV. Continued with chest palpitations until morning; headache resolved. Advised to follow with PCP for any further management.
Sex: U
Vaccine: HEPA, MMR, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored administered MMR II, VAQTA and ROTATEQ; No additional AE reported; This spontaneous report was received from a nurse referring to unknown number of patient with unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided. Concomitant medication included sterile diluent(STERILE DILUENT) (lot# reported as T018895).   On unknown dates, the patients were vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(rHA)(M-M-R II) (lot # T001214, expiration date 12-JAN-2022, 1 dose, dose number and route of administration were not reported), or hepatitis a vaccine, inactivated(VAQTA) (lot#T023914, expiration date 31-MAR-2022,1 dose, dose number and route of administration were not reported), or rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot# reported as 1741416, expiration date 21-MAR-2022, 1 dose, dose number and route of administration were not reported) for prophylaxis.   The vaccines were stored improperly in the temperature of 9 degree Celsius for the time frame of 12 minutes. There was no previous temperature excursion. Digital Data Logger was involved. No adverse event was reported.  This is an amended report. This is a non-valid case due to no patient identifiers. The case was sent to Distribution in error, therefore, it is being sent to Distribution for the last time to notify all recipients. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.  manufactureraddress: manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: T023914; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupcorrection :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal mass, Biopsy, Contusion, Eczema, Morphoea
Clinical narrative: Shortly after my second COVID vaccine, I started to develop a bruise on my abdomen which later went away. I started to have generalized itching that produced some eczema over all over. The bruise at this point started to feel like a mass. I went the MD and they did an ultrasound which came back negative, but the itching and eczema were getting worse. I went to see a dermatologist about the itching and eczema and mentioned the bruise/mass has turned white. They did a biopsy and found that I had Morphea. I have no predisposition to any auto immune disorder or any explication of why I was itching and developed eczema. It was decided they I was possibly having a systemic reaction to the COVID vaccine. I reported to Pfizer, but they have yet to contact me about my case.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Ultrasound scan
Clinical narrative: Shortly after my second COVID vaccine, I started to develop a bruise on my abdomen which later went away. I started to have generalized itching that produced some eczema over all over. The bruise at this point started to feel like a mass. I went the MD and they did an ultrasound which came back negative, but the itching and eczema were getting worse. I went to see a dermatologist about the itching and eczema and mentioned the bruise/mass has turned white. They did a biopsy and found that I had Morphea. I have no predisposition to any auto immune disorder or any explication of why I was itching and developed eczema. It was decided they I was possibly having a systemic reaction to the COVID vaccine. I reported to Pfizer, but they have yet to contact me about my case.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal mass, Biopsy abdominal wall abnormal, Contusion, Eczema, Morphoea
Clinical narrative: Shortly after my second COVID vaccine, I started to develop a bruise on my abdomen which later went away. I started to have generalized itching that produced some eczema over all over. The bruise at this point started to feel like a mass. I went the MD and they did an ultrasound which came back negative, but the itching and eczema were getting worse. I went to see a dermatologist about the itching and eczema and mentioned the bruise/mass has turned white. They did a biopsy and found that I had Morphea. I have no predisposition to any auto immune disorder or any explication of why I was itching and developed eczema. It was decided they I was possibly having a systemic reaction to the COVID vaccine. I reported to Pfizer, but they have yet to contact me about my case.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Shortly after my second COVID vaccine, I started to develop a bruise on my abdomen which later went away. I started to have generalized itching that produced some eczema over all over. The bruise at this point started to feel like a mass. I went the MD and they did an ultrasound which came back negative, but the itching and eczema were getting worse. I went to see a dermatologist about the itching and eczema and mentioned the bruise/mass has turned white. They did a biopsy and found that I had Morphea. I have no predisposition to any auto immune disorder or any explication of why I was itching and developed eczema. It was decided they I was possibly having a systemic reaction to the COVID vaccine. I reported to Pfizer, but they have yet to contact me about my case.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dysarthria, Erythema, Fatigue, Peripheral swelling
Clinical narrative: 5 days after vaccine I was rushed to hospital via ambulance because my blood pressure was 70/40. I was not lucid. Passed out in kitchen. Slurred speak and loss of word choice.  Went to neurologist who told me I have neurological damage in left injection site arm. PCP sent me to allergist. Rheumatologist is checking for immune disease which came out negative. Have lost 40lbs. Fatigue, loss of words, foggy thinking, pain in joints. Red swollen hands which ache and burn. Intolerance to heat. No strength in left arm and hand. Cannot use left hand. Weakness in right arm and hand. Loss of balance. Memory loss.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face, Syncope
Clinical narrative: 5 days after vaccine I was rushed to hospital via ambulance because my blood pressure was 70/40. I was not lucid. Passed out in kitchen. Slurred speak and loss of word choice.  Went to neurologist who told me I have neurological damage in left injection site arm. PCP sent me to allergist. Rheumatologist is checking for immune disease which came out negative. Have lost 40lbs. Fatigue, loss of words, foggy thinking, pain in joints. Red swollen hands which ache and burn. Intolerance to heat. No strength in left arm and hand. Cannot use left hand. Weakness in right arm and hand. Loss of balance. Memory loss.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Anxiety, Aphasia, Arthralgia, Asthenia
Clinical narrative: 5 days after vaccine I was rushed to hospital via ambulance because my blood pressure was 70/40. I was not lucid. Passed out in kitchen. Slurred speak and loss of word choice.  Went to neurologist who told me I have neurological damage in left injection site arm. PCP sent me to allergist. Rheumatologist is checking for immune disease which came out negative. Have lost 40lbs. Fatigue, loss of words, foggy thinking, pain in joints. Red swollen hands which ache and burn. Intolerance to heat. No strength in left arm and hand. Cannot use left hand. Weakness in right arm and hand. Loss of balance. Memory loss.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood test normal, Botulinum toxin injection, Burning sensation, Computerised tomogram normal
Clinical narrative: 5 days after vaccine I was rushed to hospital via ambulance because my blood pressure was 70/40. I was not lucid. Passed out in kitchen. Slurred speak and loss of word choice.  Went to neurologist who told me I have neurological damage in left injection site arm. PCP sent me to allergist. Rheumatologist is checking for immune disease which came out negative. Have lost 40lbs. Fatigue, loss of words, foggy thinking, pain in joints. Red swollen hands which ache and burn. Intolerance to heat. No strength in left arm and hand. Cannot use left hand. Weakness in right arm and hand. Loss of balance. Memory loss.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depression, Dysarthria, Erythema, Fatigue, Feeling abnormal
Clinical narrative: 5 days after vaccine I was rushed to hospital via ambulance because my blood pressure was 70/40. I was not lucid. Passed out in kitchen. Slurred speak and loss of word choice.  Went to neurologist who told me I have neurological damage in left injection site arm. PCP sent me to allergist. Rheumatologist is checking for immune disease which came out negative. Have lost 40lbs. Fatigue, loss of words, foggy thinking, pain in joints. Red swollen hands which ache and burn. Intolerance to heat. No strength in left arm and hand. Cannot use left hand. Weakness in right arm and hand. Loss of balance. Memory loss.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Immunology test normal, Injection site injury, Loss of consciousness, Magnetic resonance imaging head normal
Clinical narrative: 5 days after vaccine I was rushed to hospital via ambulance because my blood pressure was 70/40. I was not lucid. Passed out in kitchen. Slurred speak and loss of word choice.  Went to neurologist who told me I have neurological damage in left injection site arm. PCP sent me to allergist. Rheumatologist is checking for immune disease which came out negative. Have lost 40lbs. Fatigue, loss of words, foggy thinking, pain in joints. Red swollen hands which ache and burn. Intolerance to heat. No strength in left arm and hand. Cannot use left hand. Weakness in right arm and hand. Loss of balance. Memory loss.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Muscular weakness, Neurological symptom, Peripheral swelling, Sleep disorder
Clinical narrative: 5 days after vaccine I was rushed to hospital via ambulance because my blood pressure was 70/40. I was not lucid. Passed out in kitchen. Slurred speak and loss of word choice.  Went to neurologist who told me I have neurological damage in left injection site arm. PCP sent me to allergist. Rheumatologist is checking for immune disease which came out negative. Have lost 40lbs. Fatigue, loss of words, foggy thinking, pain in joints. Red swollen hands which ache and burn. Intolerance to heat. No strength in left arm and hand. Cannot use left hand. Weakness in right arm and hand. Loss of balance. Memory loss.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Temperature intolerance, Weight decreased
Clinical narrative: 5 days after vaccine I was rushed to hospital via ambulance because my blood pressure was 70/40. I was not lucid. Passed out in kitchen. Slurred speak and loss of word choice.  Went to neurologist who told me I have neurological damage in left injection site arm. PCP sent me to allergist. Rheumatologist is checking for immune disease which came out negative. Have lost 40lbs. Fatigue, loss of words, foggy thinking, pain in joints. Red swollen hands which ache and burn. Intolerance to heat. No strength in left arm and hand. Cannot use left hand. Weakness in right arm and hand. Loss of balance. Memory loss.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Hypertension, Injection site pruritus
Clinical narrative: Severe Itching  Throat Swelling High Blood Pressure High Pulse Chest Pain Jaw Pain Headache Leg Swelling Mouth Inflamation
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash, Throat tightness
Clinical narrative: Severe Itching  Throat Swelling High Blood Pressure High Pulse Chest Pain Jaw Pain Headache Leg Swelling Mouth Inflamation
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Dehydration, Heart rate, Heart rate increased
Clinical narrative: Severe Itching  Throat Swelling High Blood Pressure High Pulse Chest Pain Jaw Pain Headache Leg Swelling Mouth Inflamation
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension
Clinical narrative: Severe Itching  Throat Swelling High Blood Pressure High Pulse Chest Pain Jaw Pain Headache Leg Swelling Mouth Inflamation
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Cardiac stress test, Chest X-ray, Chest pain, Dehydration
Clinical narrative: Severe Itching  Throat Swelling High Blood Pressure High Pulse Chest Pain Jaw Pain Headache Leg Swelling Mouth Inflamation
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Headache, Heart rate increased, Hypertension
Clinical narrative: Severe Itching  Throat Swelling High Blood Pressure High Pulse Chest Pain Jaw Pain Headache Leg Swelling Mouth Inflamation
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in jaw, Peripheral swelling, Pharyngeal swelling, Pruritus, Stomatitis
Clinical narrative: Severe Itching  Throat Swelling High Blood Pressure High Pulse Chest Pain Jaw Pain Headache Leg Swelling Mouth Inflamation
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac monitoring, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: Lack of air/Short breaths; Stabbing pain in the chest. Chest pain.; This is a spontaneous report from a contactable consumer (patient).    A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 17Jun2021 at 10:00 (lot number: Ew0187; expiry date: unknown) at the age of 17-years-old, as dose 1, single, for COVID-19 immunization. Medical history included COVID-19 (prior vaccination). The patient's concomitant medications were not reported. The patient had no relevant past drug history. The vaccine was administered in a Public Health Clinic. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient was not diagnosed with COVID prior vaccination. The patient has not been tested for COVID-19 since vaccination. On 19Jun2021, the patient experienced stabbing pain in the chest, chest pain, lack of air, and short breaths. The events resulted to Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. Outcome of the events was not recovered.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Paraesthesia
Clinical narrative: Lack of air/Short breaths; Stabbing pain in the chest. Chest pain.; This is a spontaneous report from a contactable consumer (patient).    A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 17Jun2021 at 10:00 (lot number: Ew0187; expiry date: unknown) at the age of 17-years-old, as dose 1, single, for COVID-19 immunization. Medical history included COVID-19 (prior vaccination). The patient's concomitant medications were not reported. The patient had no relevant past drug history. The vaccine was administered in a Public Health Clinic. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient was not diagnosed with COVID prior vaccination. The patient has not been tested for COVID-19 since vaccination. On 19Jun2021, the patient experienced stabbing pain in the chest, chest pain, lack of air, and short breaths. The events resulted to Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. Outcome of the events was not recovered.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Lack of air/Short breaths; Stabbing pain in the chest. Chest pain.; This is a spontaneous report from a contactable consumer (patient).    A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 17Jun2021 at 10:00 (lot number: Ew0187; expiry date: unknown) at the age of 17-years-old, as dose 1, single, for COVID-19 immunization. Medical history included COVID-19 (prior vaccination). The patient's concomitant medications were not reported. The patient had no relevant past drug history. The vaccine was administered in a Public Health Clinic. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient was not diagnosed with COVID prior vaccination. The patient has not been tested for COVID-19 since vaccination. On 19Jun2021, the patient experienced stabbing pain in the chest, chest pain, lack of air, and short breaths. The events resulted to Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. Outcome of the events was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 47 year and 9 months old white male, ethnicity unknown. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: Unknown) 0.5 ml, frequency 1 total, administered on 20-MAY-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that on an unspecified date the patient experienced fever, headache and diarrhea. On 16-Aug-2021, SARS-CoV-2 PCR test was performed, and result was positive (confirmed clinical vaccination failure and confirmed covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846649.; Sender's Comments: V0-20210858816-Covid-19 Vaccine AD26.COV2.s-Confirmed Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 47 year and 9 months old white male, ethnicity unknown. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: Unknown) 0.5 ml, frequency 1 total, administered on 20-MAY-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that on an unspecified date the patient experienced fever, headache and diarrhea. On 16-Aug-2021, SARS-CoV-2 PCR test was performed, and result was positive (confirmed clinical vaccination failure and confirmed covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846649.; Sender's Comments: V0-20210858816-Covid-19 Vaccine AD26.COV2.s-Confirmed Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a health care professional concerned a 4 decade old female with unknown ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was pregnant at the time of vaccination. The pregnancy was gravida 1, para 0. Patient was not admitted to hospital. Patient had six more weeks to go for delivery. Patient was not currently breastfeeding. Patient had no any other suspected causes including co-administered vaccine(s) or risk factors.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: UNKNOWN) 0.5 ml, 1 total administered in left arm on 20-MAY-2021 for prophylactic vaccination. There was no any issue during administration of vaccine (e.g. syringe leak, needle disconnect). No concomitant medications were reported.  On 20-MAY-2021, the patient experienced vaccine exposure during pregnancy. On an unspecified date patient experienced fever, headache, nasal congestion and diarrhoea. On 02-AUG-2021, COVID-19 PCR test was performed. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive (confirmed clinical vaccination failure and confirmed covid-19 infection). The date of the patient's last menstrual period and expected delivery date were not reported. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on AUG-2021, and the outcome of confirmed clinical vaccination failure and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210858816.; Sender's Comments: V0- 20210860658- covid-19 vaccine ad26.cov2.s - Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Exposure during pregnancy, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a health care professional concerned a 4 decade old female with unknown ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was pregnant at the time of vaccination. The pregnancy was gravida 1, para 0. Patient was not admitted to hospital. Patient had six more weeks to go for delivery. Patient was not currently breastfeeding. Patient had no any other suspected causes including co-administered vaccine(s) or risk factors.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: UNKNOWN) 0.5 ml, 1 total administered in left arm on 20-MAY-2021 for prophylactic vaccination. There was no any issue during administration of vaccine (e.g. syringe leak, needle disconnect). No concomitant medications were reported.  On 20-MAY-2021, the patient experienced vaccine exposure during pregnancy. On an unspecified date patient experienced fever, headache, nasal congestion and diarrhoea. On 02-AUG-2021, COVID-19 PCR test was performed. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive (confirmed clinical vaccination failure and confirmed covid-19 infection). The date of the patient's last menstrual period and expected delivery date were not reported. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on AUG-2021, and the outcome of confirmed clinical vaccination failure and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210858816.; Sender's Comments: V0- 20210860658- covid-19 vaccine ad26.cov2.s - Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Exposure during pregnancy, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a health care professional concerned a 4 decade old female with unknown ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was pregnant at the time of vaccination. The pregnancy was gravida 1, para 0. Patient was not admitted to hospital. Patient had six more weeks to go for delivery. Patient was not currently breastfeeding. Patient had no any other suspected causes including co-administered vaccine(s) or risk factors.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: UNKNOWN) 0.5 ml, 1 total administered in left arm on 20-MAY-2021 for prophylactic vaccination. There was no any issue during administration of vaccine (e.g. syringe leak, needle disconnect). No concomitant medications were reported.  On 20-MAY-2021, the patient experienced vaccine exposure during pregnancy. On an unspecified date patient experienced fever, headache, nasal congestion and diarrhoea. On 02-AUG-2021, COVID-19 PCR test was performed. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive (confirmed clinical vaccination failure and confirmed covid-19 infection). The date of the patient's last menstrual period and expected delivery date were not reported. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on AUG-2021, and the outcome of confirmed clinical vaccination failure and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210858816.; Sender's Comments: V0- 20210860658- covid-19 vaccine ad26.cov2.s - Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Appendicectomy, Appendicitis, Blood test
Clinical narrative: Parent of patient concerned that she developed symptoms and then was found to have appendicitis within 3-4 days of getting 1st COVID vaccine
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Parent of patient concerned that she developed symptoms and then was found to have appendicitis within 3-4 days of getting 1st COVID vaccine
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound abdomen, Urine analysis
Clinical narrative: Parent of patient concerned that she developed symptoms and then was found to have appendicitis within 3-4 days of getting 1st COVID vaccine
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appendicitis, General symptom
Clinical narrative: Parent of patient concerned that she developed symptoms and then was found to have appendicitis within 3-4 days of getting 1st COVID vaccine
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Dysarthria, Hemiparesis, Ischaemic stroke, Magnetic resonance imaging head abnormal
Clinical narrative: I am assuming that he received Pfizer but I cannot confirm that.  The patient arrived to our emergency department with the following symptoms:  Dysarthria, Facial Droop, Right Upper Extremity Weakness, Headache, Elevated Troponin.  Patient was transferred to Hospital for further eval and treatment.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: I am assuming that he received Pfizer but I cannot confirm that.  The patient arrived to our emergency department with the following symptoms:  Dysarthria, Facial Droop, Right Upper Extremity Weakness, Headache, Elevated Troponin.  Patient was transferred to Hospital for further eval and treatment.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Facial paralysis, Headache, Muscular weakness, Troponin increased
Clinical narrative: I am assuming that he received Pfizer but I cannot confirm that.  The patient arrived to our emergency department with the following symptoms:  Dysarthria, Facial Droop, Right Upper Extremity Weakness, Headache, Elevated Troponin.  Patient was transferred to Hospital for further eval and treatment.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Pain, Sleep disorder
Clinical narrative: PATIENT STATES HE HAS A SORE ARM BUT IT HAS GOTTEN BETTER OVER THE PAST WEEK. HE IS NOT SURE IF ITS FROM THE VACCINE BUT IT HAPPENED AFTER THE SHOT.  HE HAS NOT SEEN THE DR AND IS NOT INTERESTED TO SO.  I SUGGESTED TO PATIENT TO APPLY COMPRESS OR TAKING MOTRIN AND HE SAID THAT ITS GETTING BETTER. HE DID REPORT IT TO VAERS.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: PATIENT STATES HE HAS A SORE ARM BUT IT HAS GOTTEN BETTER OVER THE PAST WEEK. HE IS NOT SURE IF ITS FROM THE VACCINE BUT IT HAPPENED AFTER THE SHOT.  HE HAS NOT SEEN THE DR AND IS NOT INTERESTED TO SO.  I SUGGESTED TO PATIENT TO APPLY COMPRESS OR TAKING MOTRIN AND HE SAID THAT ITS GETTING BETTER. HE DID REPORT IT TO VAERS.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Angiogram pulmonary abnormal, Anion gap, Aspartate aminotransferase increased, Bilevel positive airway pressure
Clinical narrative: Acute respiratory failure with hypoxia and hypercapnia (HCC), Pneumonia due to COVID-19
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal, Blood chloride normal
Clinical narrative: Acute respiratory failure with hypoxia and hypercapnia (HCC), Pneumonia due to COVID-19
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea increased
Clinical narrative: Acute respiratory failure with hypoxia and hypercapnia (HCC), Pneumonia due to COVID-19
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Cough, Death, Dyspnoea
Clinical narrative: Acute respiratory failure with hypoxia and hypercapnia (HCC), Pneumonia due to COVID-19
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Glomerular filtration rate normal, Haematocrit normal, Haemoglobin normal, Hypoxia, Lung opacity
Clinical narrative: Acute respiratory failure with hypoxia and hypercapnia (HCC), Pneumonia due to COVID-19
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mean cell volume normal, N-terminal prohormone brain natriuretic peptide increased, Neutrophil count increased, Platelet count normal, Pleural effusion
Clinical narrative: Acute respiratory failure with hypoxia and hypercapnia (HCC), Pneumonia due to COVID-19
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pneumonia, Procalcitonin, Protein total decreased, Red blood cell count decreased, SARS-CoV-2 test positive
Clinical narrative: Acute respiratory failure with hypoxia and hypercapnia (HCC), Pneumonia due to COVID-19
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachycardia, White blood cell count increased
Clinical narrative: Acute respiratory failure with hypoxia and hypercapnia (HCC), Pneumonia due to COVID-19
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Hypercapnia
Clinical narrative: Acute respiratory failure with hypoxia and hypercapnia (HCC), Pneumonia due to COVID-19
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Chest discomfort, Echocardiogram, Ejection fraction decreased, Electrocardiogram ST segment elevation
Clinical narrative: Myocarditis Patient was started on prednisone  daily with a 6 week taper Avoid rigorous physical activity for 6 months.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intensive care, Magnetic resonance imaging heart, Myocarditis, Nausea, Troponin
Clinical narrative: Myocarditis Patient was started on prednisone  daily with a 6 week taper Avoid rigorous physical activity for 6 months.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Echocardiogram, Myocarditis, Troponin increased
Clinical narrative: Myocarditis Patient was started on prednisone  daily with a 6 week taper Avoid rigorous physical activity for 6 months.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Condition aggravated, Fibromyalgia, Joint swelling, Pain in extremity
Clinical narrative: STARTED TO GET THE SAME FEELING IN LEFT FOOT TOO; SEVERAL BLOOD CLOTS BEHIND THE CALF AND BEHIND THE KNEE; AFFECTED HEART; AFFECTED ARM; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 290 pounds, and height was 66 inches. The patient's concurrent conditions included: fibromyalgia. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total administered on 15-AUG-2021 in afternoon for prophylactic vaccination on left deltoid (arm). No concomitant medications were reported.  On an unspecified date in AUG-2021, it was reported vaccine affected heart, and arm. For arms effect lasted for 3-4 days and for heart 2 days. At the time of reporting, it was completely resolved. On 20-AUG-2021, the patient experienced several blood clots behind the calf and behind the knee. It started out with lot of pain on the right side of patient's foot. Patient took a picture of it on 20-AUG-2021. Patient saw a physician on 24-AUG-2021 as the ankle was bumpy, the physician sent patient for the ultrasound and on 25-AUG-2021 patient went for ultrasound. Laboratory data included: Diagnostic ultrasound (NR: not provided) Blood clots. Patient contacted her physician but was not available, so another physician had prescribed her to start blood thinner as soon as possible. Treatment medications included: apixaban. On 27-AUG-2021 patient saw healthcare professional and was told there was several blood clots behind the calf and behind the knee. On 29-AUG-2021 patient took picture of the leg because inside of the right leg had more bumps and was swollen. Patient woke up on 30-AUG-2021 morning and 6 inches pass right knee patient was getting pain in that area. Patient started to get the same feeling in left foot too. Pain comes and goes but most of the pain was above the knee. Patient had to worry about dying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from affected heart, and affected arm, and had not recovered from several blood clots behind the calf and behind the knee, and started to get the same feeling in left foot too. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210860050-covid-19 vaccine ad26.cov2.s-several blood clots behind the calf and behind the knee. This event(s) is considered unassessable. 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).
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: STARTED TO GET THE SAME FEELING IN LEFT FOOT TOO; SEVERAL BLOOD CLOTS BEHIND THE CALF AND BEHIND THE KNEE; AFFECTED HEART; AFFECTED ARM; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 290 pounds, and height was 66 inches. The patient's concurrent conditions included: fibromyalgia. Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total administered on 15-AUG-2021 in afternoon for prophylactic vaccination on left deltoid (arm). No concomitant medications were reported.  On an unspecified date in AUG-2021, it was reported vaccine affected heart, and arm. For arms effect lasted for 3-4 days and for heart 2 days. At the time of reporting, it was completely resolved. On 20-AUG-2021, the patient experienced several blood clots behind the calf and behind the knee. It started out with lot of pain on the right side of patient's foot. Patient took a picture of it on 20-AUG-2021. Patient saw a physician on 24-AUG-2021 as the ankle was bumpy, the physician sent patient for the ultrasound and on 25-AUG-2021 patient went for ultrasound. Laboratory data included: Diagnostic ultrasound (NR: not provided) Blood clots. Patient contacted her physician but was not available, so another physician had prescribed her to start blood thinner as soon as possible. Treatment medications included: apixaban. On 27-AUG-2021 patient saw healthcare professional and was told there was several blood clots behind the calf and behind the knee. On 29-AUG-2021 patient took picture of the leg because inside of the right leg had more bumps and was swollen. Patient woke up on 30-AUG-2021 morning and 6 inches pass right knee patient was getting pain in that area. Patient started to get the same feeling in left foot too. Pain comes and goes but most of the pain was above the knee. Patient had to worry about dying. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from affected heart, and affected arm, and had not recovered from several blood clots behind the calf and behind the knee, and started to get the same feeling in left foot too. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210860050-covid-19 vaccine ad26.cov2.s-several blood clots behind the calf and behind the knee. This event(s) is considered unassessable. 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).