chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Parosmia, Taste disorder, Visual impairment
Clinical narrative: I have experienced several odd olfactory odors or aromas from foods like peanut butter, cheddar cheese, bacon, tuna fish all seem to have the same rancid taste, smell or phantom aroma. I have the same slight head ache repeatedly. also my vision seems to have deteriorated somewhat. .
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: This incident occurred on 1/22/2022 at 12:30pm. An 11 year and 9 month old patient received the 12+ dose of Pfizer.  This was her 1st COVID vaccine.  Due to the nature of the clinic, we have our vaccinators check each screening form to assure that the proper vaccine is given.  We also screen and turn away kids 11 and under once patients meet the data team at the first checkpoint.  This patient however, somehow received paperwork and entered the clinic.  Our vaccinator did not notice the age 11 that was written on her screening form and proceeded to vaccinate her.  The patient responded normally to the injection, waited 15 minutes for observation and left the clinic.  The issue was later brought to the site manager?s attention by a data entry personnel during checkout.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Pruritus
Clinical narrative: Swollen eyes, swollen lip, itchy body
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives and Urticaria rashes 10 days after the booster shot taken on 3rd November 2021. It is still intense all over the body. Suffering from it badly.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives and Urticaria rashes 10 days after the booster shot taken on 3rd November 2021. It is still intense all over the body. Suffering from it badly.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This incident occurred on 1/20/2022 at 12:30pm at a local Medical Center .  At the HCF, an 11 year and 9 month old male patient received the 12+ dose of Pfizer.  This was his 1st COVID vaccine.  Due to the nature of the drive-in clinic, we have our vaccinators check each screening form to assure that the proper vaccine is given.  We also screen and turn away kids 11 and under once patients meet the data team at the first checkpoint.  This patient however, somehow received paperwork and entered the clinic.  Our vaccinator did not notice the age 11 that was written on the screening form and proceeded to vaccinate him.  The patient responded normally to the injection, waited 15 minutes for observation and left the clinic.  The issue was later brought to the site manager?s attention by a data entry personnel during checkout.    This is a 17-year-old and 3 months male, accompanied by his mother. Client has history of epilepsy, according to the mother, and takes Keppra 2000mg PO daily.  He apparently had a recent episode and dosage increased from 1500mg to 2000mg.  There are no other meds taken and no known drug allergies.  He had a bit of common cold 2 weeks ago and felt healthy today after receiving his first dose of the vaccine.  Apparently, mother chose Moderna for him over Pfizer.  However, mother was unaware of the age qualification.  M.A. injected the vaccine Moderna 0.5mL IM to the client?s left arm and was observed for 15 minutes in the treatment room.  Client did not manifest any symptoms and was discharged home.  Upon learning about the incident, mother informed and was given instructions to go to the nearest ED or call 911 if developed any untoward symptoms such as shortness of breath, rashes, swelling, high fever.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rashes and hives all over the body ten days after the booster shot (moderna). On going to this day, five weeks later. Taking once daily antihistamine over the counter helps a little bit.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspareunia, Gynaecological examination, Heavy menstrual bleeding, Muscle spasms, Pelvic pain
Clinical narrative: Pelvic pain during intercourse  that started about 6 weeks after receiving vaccine. Heavy  menstruation with much more painful cramps than usual even though I have been taking the birth control pill for months.  This was is very unusual while on the BC pill, periods are usually light and nearly cramp free.  I saw my Gynecologist on 1/19 and she performed an exam and ordered a pelvic ultrasound that showed no significant structural abnormalities. No other explanation  for the pain has been found.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound pelvis
Clinical narrative: Pelvic pain during intercourse  that started about 6 weeks after receiving vaccine. Heavy  menstruation with much more painful cramps than usual even though I have been taking the birth control pill for months.  This was is very unusual while on the BC pill, periods are usually light and nearly cramp free.  I saw my Gynecologist on 1/19 and she performed an exam and ordered a pelvic ultrasound that showed no significant structural abnormalities. No other explanation  for the pain has been found.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Dizziness, Impaired work ability, Influenza like illness
Clinical narrative: This spontaneous report received from a patient concerned a white and not Hispanic or Latino female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid condition, and Graves' disease. The patient has no known allergies. The patient received the flu shot before and never had a reaction before after receiving those several times. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced faint, upset stomach, felt like passing, flu like feeling, chest pain/heart, bad reaction, fever, vomiting and missed work, and was hospitalized on 10-APR-2021. The patient was hospitalized for two days. On an unspecified date, the patient missed work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from faint, upset stomach, felt like passing, flu like feeling, chest pain/heart, bad reaction, fever and vomiting and the outcome of missed work was not reported. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0: 20220150535-: Covid-19 Vaccine Ad26.Cov2.S -Faint, upset stomach, felt like passing, flu like feeling, chest pain/heart, bad reaction. 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). V0: 20220150535- COVID-19 VACCINE AD26.COV2.S- fever and vomiting. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Nonspecific reaction, Pyrexia, Syncope, Vomiting
Clinical narrative: This spontaneous report received from a patient concerned a white and not Hispanic or Latino female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid condition, and Graves' disease. The patient has no known allergies. The patient received the flu shot before and never had a reaction before after receiving those several times. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced faint, upset stomach, felt like passing, flu like feeling, chest pain/heart, bad reaction, fever, vomiting and missed work, and was hospitalized on 10-APR-2021. The patient was hospitalized for two days. On an unspecified date, the patient missed work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from faint, upset stomach, felt like passing, flu like feeling, chest pain/heart, bad reaction, fever and vomiting and the outcome of missed work was not reported. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0: 20220150535-: Covid-19 Vaccine Ad26.Cov2.S -Faint, upset stomach, felt like passing, flu like feeling, chest pain/heart, bad reaction. 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). V0: 20220150535- COVID-19 VACCINE AD26.COV2.S- fever and vomiting. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Aortic valve stenosis, COVID-19, Cardiac failure, Cardiac murmur, Cardiac valve disease
Clinical narrative: HEART FAILURE; ELEVATED CARDIAC ENZYMES; LOT OF FLUID; HEART MURMUR; 2 TRICUSPID VALVES FUSED TOGETHER TO TURN INTO BICUSPID VALVE; STENOSIS OF AORTIC VALVE; COVID-19 INFECTION; VIRAL INFECTION; This spontaneous report received from a patient of an unknown age, gender, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, myocardial infarction (MI), sleep apnea, and obese. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  The patient called to report that on an unknown date in OCT-2021, the patient was diagnosed with a viral infection, had elevated cardiac enzymes with lot of fluid and heart failure. The patient was hospitalized on an unknown date in OCT-2021. Upon admission, the patient was found to have heart murmur. The patient also underwent removal of 15 pounds of fluid. During hospitalization, the patient also had 2 tricuspid valves fused together to turn into bicuspid valve and stenosis of the aortic valve. The patient underwent a surgical procedure to replace the aortic valve on an unknown date. On 13-Jan-2022 (2 weeks ago), the patient was diagnosed with covid-19 infection. The duration of hospitalization and date of discharge was not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the events viral infection, elevated cardiac enzymes, heart failure, covid-19 infection, lot of fluid, heart murmur, 2 tricuspid valves fused together to turn into bicuspid valve and stenosis of aortic valve was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220151859-COVID-19 VACCCINE AD26.COV2.S-Heart failure,Elevated cardiac enzymes,Lot of fluid,Heart murmur,2 tricuspid valves fused together to turn into bicuspid valve,Stenosis of Aortic valve. 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).
Sex: U
Vaccine: COVID19
Symptoms: Fluid retention, Myocardial necrosis marker, Myocardial necrosis marker increased, Viral infection
Clinical narrative: HEART FAILURE; ELEVATED CARDIAC ENZYMES; LOT OF FLUID; HEART MURMUR; 2 TRICUSPID VALVES FUSED TOGETHER TO TURN INTO BICUSPID VALVE; STENOSIS OF AORTIC VALVE; COVID-19 INFECTION; VIRAL INFECTION; This spontaneous report received from a patient of an unknown age, gender, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, myocardial infarction (MI), sleep apnea, and obese. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  The patient called to report that on an unknown date in OCT-2021, the patient was diagnosed with a viral infection, had elevated cardiac enzymes with lot of fluid and heart failure. The patient was hospitalized on an unknown date in OCT-2021. Upon admission, the patient was found to have heart murmur. The patient also underwent removal of 15 pounds of fluid. During hospitalization, the patient also had 2 tricuspid valves fused together to turn into bicuspid valve and stenosis of the aortic valve. The patient underwent a surgical procedure to replace the aortic valve on an unknown date. On 13-Jan-2022 (2 weeks ago), the patient was diagnosed with covid-19 infection. The duration of hospitalization and date of discharge was not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the events viral infection, elevated cardiac enzymes, heart failure, covid-19 infection, lot of fluid, heart murmur, 2 tricuspid valves fused together to turn into bicuspid valve and stenosis of aortic valve was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220151859-COVID-19 VACCCINE AD26.COV2.S-Heart failure,Elevated cardiac enzymes,Lot of fluid,Heart murmur,2 tricuspid valves fused together to turn into bicuspid valve,Stenosis of Aortic valve. 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).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Caller states her doctor has COVID-19 and she knows he "had all the vaccine"; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller states her doctor has COVID-19 and she knows he "had all the vaccine") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caller states her doctor has COVID-19 and she knows he "had all the vaccine"). At the time of the report, COVID-19 (Caller states her doctor has COVID-19 and she knows he "had all the vaccine") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided. Patient received all the vaccine.  Company Comment: This case concerns a male patient of an unknown age, with no medical history reported, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a male patient of an unknown age, with no medical history reported, who experienced the unexpected AESI event of COVID-19. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired booster vaccine >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster vaccine >12 hours post puncture) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2022 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster vaccine >12 hours post puncture). On 27-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received expired booster vaccine >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment details were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: hot to the touch; swollen arm for 4 days; red arm for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot to the touch), PERIPHERAL SWELLING (swollen arm for 4 days) and ERYTHEMA (red arm for 4 days) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thyroid cancer. Concurrent medical conditions included Immunocompromised and AFib. Concomitant products included METOPROLOL, ATORVASTATIN and APIXABAN (ELIQUIS) for AFib, LEVOTHYROXINE SODIUM (SYNTHROID) from April 2021 to an unknown date for an unknown indication.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot to the touch), PERIPHERAL SWELLING (swollen arm for 4 days) and ERYTHEMA (red arm for 4 days). At the time of the report, FEELING HOT (hot to the touch) outcome was unknown and PERIPHERAL SWELLING (swollen arm for 4 days) and ERYTHEMA (red arm for 4 days) had resolved.            No treatment drugs were reported. Patient medical history contains thyroid cancer surgery 29 Apr 2021. Patient has been smelling cigarette smoke every day for the past 3 to 4 months. Dose 3 was taken in mid December.   This case was linked to MOD-2022-463116, MOD-2022-463070 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Taste disorder, Vomiting
Clinical narrative: I immediately tasted the vaccine , about an hour afterward, I began to vomit in a violent manner. I remained nauseated for about 3 more days.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, C-reactive protein, Chest X-ray, Chills
Clinical narrative: 1 am - woke up with tingling in neck and face, nausea, severe chills and shaking, weakness, full feeling in throat. No temp, heart rate:98 BPM, O2 sat: 97%, BP 110/70, temp: 97.5 degrees.  430 am - worsening symptoms, nausea caused need to vomit, passed out when walking into bathroom, becoming lodged between toilet and sink - loss of consciousness for greater than 1 minute. Carried into bedroom by parents before coming to, passed out again on bed, diaphoresis, woke up and vomited for next 5 minutes. Difficulty breathing: O2 sat - 93%, BP- 110/80, pulse: 148 BPM, temp: 97.2 degrees. Required max assist by both parents to sits edge of bed, no torso control and weakness in arms and legs. Squad called. Unable to speak clearly, slurred speech. Required parents to don clothing.  Squad delayed in coming due to volunteer staff, squad called and told not to come, parents carried to car and both parents transported to ER x 30 minute drive. Arrive at ER ~5:50 am. Required parents put in wheelchair and wheeled in, unable to walk.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram head, Culture, Dysarthria, Dyspnoea
Clinical narrative: 1 am - woke up with tingling in neck and face, nausea, severe chills and shaking, weakness, full feeling in throat. No temp, heart rate:98 BPM, O2 sat: 97%, BP 110/70, temp: 97.5 degrees.  430 am - worsening symptoms, nausea caused need to vomit, passed out when walking into bathroom, becoming lodged between toilet and sink - loss of consciousness for greater than 1 minute. Carried into bedroom by parents before coming to, passed out again on bed, diaphoresis, woke up and vomited for next 5 minutes. Difficulty breathing: O2 sat - 93%, BP- 110/80, pulse: 148 BPM, temp: 97.2 degrees. Required max assist by both parents to sits edge of bed, no torso control and weakness in arms and legs. Squad called. Unable to speak clearly, slurred speech. Required parents to don clothing.  Squad delayed in coming due to volunteer staff, squad called and told not to come, parents carried to car and both parents transported to ER x 30 minute drive. Arrive at ER ~5:50 am. Required parents put in wheelchair and wheeled in, unable to walk.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Full blood count, Gait inability, Heart rate increased, Hyperhidrosis
Clinical narrative: 1 am - woke up with tingling in neck and face, nausea, severe chills and shaking, weakness, full feeling in throat. No temp, heart rate:98 BPM, O2 sat: 97%, BP 110/70, temp: 97.5 degrees.  430 am - worsening symptoms, nausea caused need to vomit, passed out when walking into bathroom, becoming lodged between toilet and sink - loss of consciousness for greater than 1 minute. Carried into bedroom by parents before coming to, passed out again on bed, diaphoresis, woke up and vomited for next 5 minutes. Difficulty breathing: O2 sat - 93%, BP- 110/80, pulse: 148 BPM, temp: 97.2 degrees. Required max assist by both parents to sits edge of bed, no torso control and weakness in arms and legs. Squad called. Unable to speak clearly, slurred speech. Required parents to don clothing.  Squad delayed in coming due to volunteer staff, squad called and told not to come, parents carried to car and both parents transported to ER x 30 minute drive. Arrive at ER ~5:50 am. Required parents put in wheelchair and wheeled in, unable to walk.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Metabolic function test, Muscular weakness, Nausea, Oropharyngeal discomfort
Clinical narrative: 1 am - woke up with tingling in neck and face, nausea, severe chills and shaking, weakness, full feeling in throat. No temp, heart rate:98 BPM, O2 sat: 97%, BP 110/70, temp: 97.5 degrees.  430 am - worsening symptoms, nausea caused need to vomit, passed out when walking into bathroom, becoming lodged between toilet and sink - loss of consciousness for greater than 1 minute. Carried into bedroom by parents before coming to, passed out again on bed, diaphoresis, woke up and vomited for next 5 minutes. Difficulty breathing: O2 sat - 93%, BP- 110/80, pulse: 148 BPM, temp: 97.2 degrees. Required max assist by both parents to sits edge of bed, no torso control and weakness in arms and legs. Squad called. Unable to speak clearly, slurred speech. Required parents to don clothing.  Squad delayed in coming due to volunteer staff, squad called and told not to come, parents carried to car and both parents transported to ER x 30 minute drive. Arrive at ER ~5:50 am. Required parents put in wheelchair and wheeled in, unable to walk.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test, Speech disorder, Tremor, Troponin
Clinical narrative: 1 am - woke up with tingling in neck and face, nausea, severe chills and shaking, weakness, full feeling in throat. No temp, heart rate:98 BPM, O2 sat: 97%, BP 110/70, temp: 97.5 degrees.  430 am - worsening symptoms, nausea caused need to vomit, passed out when walking into bathroom, becoming lodged between toilet and sink - loss of consciousness for greater than 1 minute. Carried into bedroom by parents before coming to, passed out again on bed, diaphoresis, woke up and vomited for next 5 minutes. Difficulty breathing: O2 sat - 93%, BP- 110/80, pulse: 148 BPM, temp: 97.2 degrees. Required max assist by both parents to sits edge of bed, no torso control and weakness in arms and legs. Squad called. Unable to speak clearly, slurred speech. Required parents to don clothing.  Squad delayed in coming due to volunteer staff, squad called and told not to come, parents carried to car and both parents transported to ER x 30 minute drive. Arrive at ER ~5:50 am. Required parents put in wheelchair and wheeled in, unable to walk.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vomiting
Clinical narrative: 1 am - woke up with tingling in neck and face, nausea, severe chills and shaking, weakness, full feeling in throat. No temp, heart rate:98 BPM, O2 sat: 97%, BP 110/70, temp: 97.5 degrees.  430 am - worsening symptoms, nausea caused need to vomit, passed out when walking into bathroom, becoming lodged between toilet and sink - loss of consciousness for greater than 1 minute. Carried into bedroom by parents before coming to, passed out again on bed, diaphoresis, woke up and vomited for next 5 minutes. Difficulty breathing: O2 sat - 93%, BP- 110/80, pulse: 148 BPM, temp: 97.2 degrees. Required max assist by both parents to sits edge of bed, no torso control and weakness in arms and legs. Squad called. Unable to speak clearly, slurred speech. Required parents to don clothing.  Squad delayed in coming due to volunteer staff, squad called and told not to come, parents carried to car and both parents transported to ER x 30 minute drive. Arrive at ER ~5:50 am. Required parents put in wheelchair and wheeled in, unable to walk.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: Received the first dose 11/30/2021 and 12/8/2021 I started breaking out in hives all over my face happened a few times for a week and stopped. I received my second dose 1/3/2022 or 1/4/2022 and same thing a week later face starts breaking out in hives again and has been doing so on and off ever since.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Malaise, Menstrual disorder
Clinical narrative: Started menstruating, haven't had a period in 9 years. Also, major insomnia,, body wouldn't allow me to sleep, slept off and on since vaccination and it has never been more than 2 hours at a time, this is after I finally get exhausted enough that I feel sick. One night I never went to sleep at all, laid in bed for 5 hours.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Headache, Illness, Nausea, Pyrexia
Clinical narrative: Nausea; Headache; Fever; Felt sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (received 1st dose on an unknown date and felt sick (nausea/headache/fever)refer case US2022AMR013100).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, nausea, headache and fever. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the nausea, headache and fever were unknown.   It was unknown if the reporter considered the sickness, nausea, headache and fever to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR013100  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient had received a dose of Shingles vaccine and felt sick for a week, nausea/headache/fever. But the patient guessed it's better than getting shingles. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR013100:1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: itching; constant at the site had the blisters; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a 73-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced injection site itching and injection site blisters. On an unknown date, the outcome of the injection site itching and injection site blisters were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching and injection site blisters to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown. The patient couldn't remember which prescription he/she got, as it had been 2 years and he/she had a constant at the site had the blisters. The patient stated it wasn't the Covid vaccine, he/she believed it might had been the other vaccine for shingles. The patient enquired, after a year would the itching persist, as it really bothered him/her and would the itching persist after treatment. The patient wanted to know could the itching be a long term affect to the vaccines. The follow-up would not be possible as no contact details were available.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Insomnia, Lip swelling, Urticaria
Clinical narrative: the reporter is hesitant about getting the 2nd dose of his Shingrix vaccine after his reaction, the 6 month window for the second dose has passed.; Experience hives on his hands and torso; Swelling around his lips; Insomnia; This case was reported by a consumer via call center representative and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and prednisone for hives and lip swelling.   On 28th June 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On an unknown date, the patient received the 2nd dose of Shingrix. On 29th June 2021, the patient started prednisone at an unknown dose and frequency. In June 2021, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced hives, lip swelling and insomnia. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with benadryl (nos) (Benadryl). The action taken with prednisone was unknown. On an unknown date, the outcome of the hives, lip swelling and insomnia were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the hives, lip swelling and insomnia to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not applicable for 2nd dose of Shingrix. The patient received his first dose of Shingrix into his right arm at his pharmacy and within 12 hours of receiving the injection, he began to experience hives on his hands and torso, and swelling around his lips. The patient went to the urgent care the next day and his physician started him on prednisone.  After 3 days with no relief from hives while on prednisone and due to the insomnia the patient was now experiencing, the physician told him to take Benadryl.  On the fourth day after the injection and after taking the Benadryl, the hives and swelling resolved.  The patient was hesitant about getting the 2nd dose of his Shingrix vaccine after his reaction, the 6 month window for the second dose had passed. Till the time of reporting, the patients did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient did not had the lot or expiration date of the vaccine administered. The reporter consented to follow-up. It was unknown if the reporter considered the hives, lip swelling and insomnia to be related to Prednisone.
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis relapse, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION BREAKTHROUGH; MULTIPLE SCLEROSIS FLARE-UP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: MS (multiple sclerosis). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-JUN-2021, the patient experienced multiple sclerosis flare-up (shakiness, and dizziness). On 26-DEC-2021, the patient experienced suspected covid-19 infection (breakthrough) and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from multiple sclerosis flare-up(shakiness, and dizziness), suspected covid-19 infection(breakthrough) and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000213710.; Sender's Comments: V0: 20220141626-JANSSEN COVID-19 VACCINE Ad26.COV2.S- multiple sclerosis flare-up -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: MEDICAL HISTORY, UNDERLYING DISEASE   20220141626-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine 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
Symptoms: Brain operation, Cerebrovascular accident, Gait disturbance
Clinical narrative: 4 STROKES; 3 BRAIN SURGERIES; LEARNING TO WALK; This spontaneous report received from a consumer via a company representative concerned an 18 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 administration was not reported, and batch number: Unknown and expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had 4 strokes and 3 brain surgeries after vaccination. She was learning to walk and live independently again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from learning to walk, and the outcome of 4 strokes and 3 brain surgeries was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220150514-covid-19 vaccine ad26.cov2.s -4 Strokes, 3 Brain surgeries. 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).
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (headache) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.   Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Pt leg felt heavy as if it has gone to sleep for 3 days-Medium
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, PPV
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, PPV
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature increased, COVID-19, Chills
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, PPV
Symptoms: Heart rate, Heart rate increased, Illness, Limb discomfort, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, PPV
Symptoms: Pyrexia, Rash macular, Vaccination site pain, Vaccination site rash
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid monitoring documentation. PT admitted 1/17/22 documented to have positive covid. PT received Pfizer 1/23/21 Lot EL9261 for dose 1. Dose 2 was Pfizer given on 2/13/21 Lot EL9264. PT received Pfizer Booster on 10/16/21 Lot FF2590
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient experienced rash over large area of body several days after receiving booster. She did not experience any adverse events after her first 2 doses. Oral prednisone helped releive some symptoms but the rash came back, her doctor thinks it is booster related.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid monitoring documentation. PT admitted 1/18/22 documented to have positive covid. PT received Moderna 07/6/21 Lot 8077702739 for dose 1. Dose 2 was Moderna given on 08/4/21 Lot 036C21A.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid monitoring documentation. PT admitted 1/18/22 documented to have positive covid. PT received Moderna 03/16/21 Lot 006B21A for dose 1. Dose 2 was Moderna given on 4/13/21 Lot 036B21A.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid monitoring documentation. PT admitted 1/21/22 documented to have positive covid. PT received Moderna 03/17/21 Lot 006B21A for dose 1. Dose 2 was Moderna given on 4/14/21 Lot 036B21A.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Covid monitoring documentation. PT admitted 1/21/22 documented to have positive covid. PT received Moderna 03/17/21 Lot 006B21A for dose 1. Dose 2 was Moderna given on 4/14/21 Lot 036B21A.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid monitoring documentation. PT admitted 1/17/22 documented to have positive covid. PT received Pfizer 2/25/21 Lot EN6200 for dose 1. Dose 2 was Pfizer given on 3/18/21 Lot EN6204. PT received Pfizer Booster on 8/19/21 Lot FC3180.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Hypersensitivity, Rash, SARS-CoV-2 test negative, Swelling
Clinical narrative: Occassional rashes, raised hives, urticaria from the waist line to scalp.  No obvious trigger for allergic reaction excepting a new onset sensitivity to NSAIDs.  Before last vaccine Ibuprofen was used for occasional back pain.  Appr two weeks after initial rash and reaction (appr 4 weeks after third vaccination shot) ibuprofen was taken and within 45 min rash from waistline to scalp to include full torso was experienced.  Ibuprofen use discontinued after this and now appr 4 weeks later periodic rash appears along clavicle, across chest, upper arms and back of neck into scalp.  Rash and itching has been controlled by taking up to 50mg diphenhydramine orally.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Occassional rashes, raised hives, urticaria from the waist line to scalp.  No obvious trigger for allergic reaction excepting a new onset sensitivity to NSAIDs.  Before last vaccine Ibuprofen was used for occasional back pain.  Appr two weeks after initial rash and reaction (appr 4 weeks after third vaccination shot) ibuprofen was taken and within 45 min rash from waistline to scalp to include full torso was experienced.  Ibuprofen use discontinued after this and now appr 4 weeks later periodic rash appears along clavicle, across chest, upper arms and back of neck into scalp.  Rash and itching has been controlled by taking up to 50mg diphenhydramine orally.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid monitoring documentation. PT admitted 1/17/22 documented to have positive covid. PT received Pfizer 1/12/21 Lot EL0140 for dose 1. Dose 2 was Pfizer given on 02/02/21 Lot EL3302.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid monitoring documentation. PT admitted 1/17/22 documented to have positive covid. PT received Pfizer 4/23/21 Lot EW0158 for dose 1. Dose 2 was Pfizer given on 05/14/21 Lot ER8736.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid monitoring documentation. PT admitted 1/16/22 documented to have positive covid. PT received Moderna 04/14/21 Lot 037A21B for dose 1. Dose 2 was Moderna given on 5/12/21 Lot 016C21A.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cough, Dyspnoea, Fatigue
Clinical narrative: Patient was admitted with shortness of breath, fatigue, and generalized weakness. Cough progressed. Patient required oxygen requirements via nasal cannula at 4L.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Immunizations team administering Pfizer and Moderna vaccine boosters.  Patient presented with screening form and request for Pfizer booster. Patient was screened and approved for booster.  Patient was administered Moderna instead of Pfizer booster.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Given Enoxaparin &  Pepcid; no other covid studied medications at this time
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Death, Dyspnoea, Fall, Fatigue
Clinical narrative: Pateint received the booster on 12/27/21. At 3am that next morning, he developed a severe headache, nausea, severe fatigue, bruising, shortness of breath, high fever. This was ongoing for 24 hours. On the morning of 1/2/2022, his wife heard him fall. He was found deceased with no pulse. CPR was completed and she was unable to revive him.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pulse absent, Pyrexia, Resuscitation
Clinical narrative: Pateint received the booster on 12/27/21. At 3am that next morning, he developed a severe headache, nausea, severe fatigue, bruising, shortness of breath, high fever. This was ongoing for 24 hours. On the morning of 1/2/2022, his wife heard him fall. He was found deceased with no pulse. CPR was completed and she was unable to revive him.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: Patient admitted with shortness of breath. Patient required up to 4L of nasal cannula oxygen.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Death, Dyspnoea, Mental status changes
Clinical narrative: Patient admitted with shortness of breath. Patient required up to 4L of nasal cannula oxygen.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test abnormal, Catheterisation cardiac abnormal, Condition aggravated, Coronary artery disease, Echocardiogram
Clinical narrative: Several weeks after the Pfizer Covid-19 booster, which was my first Pfizer vaccine as previous shots were Moderna, I experienced two episodes of tingling sensations across my chest when riding my bike, upper back and shoulders. I went to my cardiologist Dr. as reported above, and he conducted a stress test and echo cardiogram. The stress test showed possible blockage so I had a cardio catheter done by Doctor and this was negative for blockage but showed some arterial disease and I was prescribed I rosuvastatin. I renewed riding my bike and these strange symptoms persisted. Review of possible causes points to Thoracic outlet syndrome and I am going to see a neurologist about this. In parallel, following the Pfizer vaccine my hypertension has worsened and my related meds have been elevated. It is possible this vaccine caused these problems!
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Hypertension, Paraesthesia
Clinical narrative: Several weeks after the Pfizer Covid-19 booster, which was my first Pfizer vaccine as previous shots were Moderna, I experienced two episodes of tingling sensations across my chest when riding my bike, upper back and shoulders. I went to my cardiologist Dr. as reported above, and he conducted a stress test and echo cardiogram. The stress test showed possible blockage so I had a cardio catheter done by Doctor and this was negative for blockage but showed some arterial disease and I was prescribed I rosuvastatin. I renewed riding my bike and these strange symptoms persisted. Review of possible causes points to Thoracic outlet syndrome and I am going to see a neurologist about this. In parallel, following the Pfizer vaccine my hypertension has worsened and my related meds have been elevated. It is possible this vaccine caused these problems!
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid monitoring documentation. PT admitted 1/15/22 documented to have positive covid. PT received Pfizer 2/28/21 Lot EN6198 for dose 1. Dose 2 was Pfizer given on 03/21/21 Lot EN6199.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Covid monitoring documentation. PT admitted 1/15/22 documented to have positive covid. PT received Pfizer 2/28/21 Lot EN6198 for dose 1. Dose 2 was Pfizer given on 03/21/21 Lot EN6199.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Coating in mouth, Oral lichen planus, Oral mucosal blistering, Oral mucosal erythema, Oral pain
Clinical narrative: Symptoms of oral blisters and sore, red areas with white striae  in buccal mucosa began approximately 2 weeks after Moderna Booster in Nov. 2021. Diagnosed with Oral Lichen Planus in Jan. 2022 by local ENT physician.  Treatment with topical Clobetasol Ointment is ongoing. If not resolved, plan is to treat with systemic steroids or Tacrolimus.