chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: has had all three doses / taste was beginning to go away / couldn't taste the food before taking Paxlovid; A little fussy headed sometimes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DEXAMETHASONE. Vaccination history included: Bnt162b2 (1st dose, Caller then states he has had all three doses), for Covid-19 immunization; Bnt162b2 (2nd dose, Caller then states he has had all three doses), for Covid-19 immunization. The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "has had all three doses / taste was beginning to go away / couldn't taste the food before taking Paxlovid"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "A little fussy headed sometimes". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller then states he has had all three doses and now he came back with a new variant of Covid, states his doctor put him on this stuff. Caller states he is also taking another pill with Paxlovid which is called Dexamethasone, 6mg. Caller states his taste was beginning to go away where he couldn't taste the food before taking Paxlovid and now his taste is beginning to come back normal. Caller states he noticed he is a little fussy headed sometimes, which is why he think he must have missed the afternoon dose yesterday.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Maternal exposure during pregnancy, Placental disorder, Stillbirth
Clinical narrative: Yes (24Dec2021: covid test result=Positive); Yes (24Dec2021: covid test result=Positive); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 09:00 (Lot number: EW0177) at the age of 29 years as dose 2, single and administered in arm left, administration date 27Jul2021 09:00 (Lot number: EW0185) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herpes 1" (unspecified if ongoing), notes: Herpes 1; "PCOS", start date: 2019 (unspecified if ongoing), notes: PCOS but hormones have been regulated since 2019. Date of last menstrual period: 24Oct2020. The patient was 42 weeks pregnant at the time of exposure to bnt162b2. The patient was 39 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 31Jul2021. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome "recovered" (26Dec2021) and all described as "Yes (24Dec2021: covid test result=Positive)". The event "yes (24dec2021: covid test result=positive)" and "yes (24dec2021: covid test result=positive)" was evaluated at the physician office visit and emergency room visit. The pregnancy resulted in still birth (31Jul2021). The fetal outcome is intrauterine death. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) positive, notes: Nasal Swab; (26Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.   Clinical course- Patient experienced stillbirth-child died and infection of the placenta but not in blood on 03Aug2021 09:00 which resulted in hospitalization for 1 day (life threatening illness). Patient recovered from the events stillbirth-child died and infection of the placenta but not in blood. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was list of Prenatal vitamins and acyclovir other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Yes (24Dec2021: covid test result=Positive); Yes (24Dec2021: covid test result=Positive); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 09:00 (Lot number: EW0177) at the age of 29 years as dose 2, single and administered in arm left, administration date 27Jul2021 09:00 (Lot number: EW0185) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herpes 1" (unspecified if ongoing), notes: Herpes 1; "PCOS", start date: 2019 (unspecified if ongoing), notes: PCOS but hormones have been regulated since 2019. Date of last menstrual period: 24Oct2020. The patient was 42 weeks pregnant at the time of exposure to bnt162b2. The patient was 39 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 31Jul2021. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome "recovered" (26Dec2021) and all described as "Yes (24Dec2021: covid test result=Positive)". The event "yes (24dec2021: covid test result=positive)" and "yes (24dec2021: covid test result=positive)" was evaluated at the physician office visit and emergency room visit. The pregnancy resulted in still birth (31Jul2021). The fetal outcome is intrauterine death. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) positive, notes: Nasal Swab; (26Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.   Clinical course- Patient experienced stillbirth-child died and infection of the placenta but not in blood on 03Aug2021 09:00 which resulted in hospitalization for 1 day (life threatening illness). Patient recovered from the events stillbirth-child died and infection of the placenta but not in blood. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was list of Prenatal vitamins and acyclovir other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Amniotic fluid volume, Exposure during pregnancy, Foetal death, Foetal heart rate abnormal, Foetal hypokinesia
Clinical narrative: Yes (24Dec2021: covid test result=Positive); Yes (24Dec2021: covid test result=Positive); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 09:00 (Lot number: EW0177) at the age of 29 years as dose 2, single and administered in arm left, administration date 27Jul2021 09:00 (Lot number: EW0185) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herpes 1" (unspecified if ongoing), notes: Herpes 1; "PCOS", start date: 2019 (unspecified if ongoing), notes: PCOS but hormones have been regulated since 2019. Date of last menstrual period: 24Oct2020. The patient was 42 weeks pregnant at the time of exposure to bnt162b2. The patient was 39 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 31Jul2021. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome "recovered" (26Dec2021) and all described as "Yes (24Dec2021: covid test result=Positive)". The event "yes (24dec2021: covid test result=positive)" and "yes (24dec2021: covid test result=positive)" was evaluated at the physician office visit and emergency room visit. The pregnancy resulted in still birth (31Jul2021). The fetal outcome is intrauterine death. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) positive, notes: Nasal Swab; (26Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.   Clinical course- Patient experienced stillbirth-child died and infection of the placenta but not in blood on 03Aug2021 09:00 which resulted in hospitalization for 1 day (life threatening illness). Patient recovered from the events stillbirth-child died and infection of the placenta but not in blood. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was list of Prenatal vitamins and acyclovir other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Stillbirth, Ultrasound foetal abnormal, Uterine contractions during pregnancy
Clinical narrative: Yes (24Dec2021: covid test result=Positive); Yes (24Dec2021: covid test result=Positive); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 09:00 (Lot number: EW0177) at the age of 29 years as dose 2, single and administered in arm left, administration date 27Jul2021 09:00 (Lot number: EW0185) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herpes 1" (unspecified if ongoing), notes: Herpes 1; "PCOS", start date: 2019 (unspecified if ongoing), notes: PCOS but hormones have been regulated since 2019. Date of last menstrual period: 24Oct2020. The patient was 42 weeks pregnant at the time of exposure to bnt162b2. The patient was 39 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 31Jul2021. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome "recovered" (26Dec2021) and all described as "Yes (24Dec2021: covid test result=Positive)". The event "yes (24dec2021: covid test result=positive)" and "yes (24dec2021: covid test result=positive)" was evaluated at the physician office visit and emergency room visit. The pregnancy resulted in still birth (31Jul2021). The fetal outcome is intrauterine death. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) positive, notes: Nasal Swab; (26Dec2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.   Clinical course- Patient experienced stillbirth-child died and infection of the placenta but not in blood on 03Aug2021 09:00 which resulted in hospitalization for 1 day (life threatening illness). Patient recovered from the events stillbirth-child died and infection of the placenta but not in blood. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was list of Prenatal vitamins and acyclovir other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: SHOULDER REPLACEMENT; WOKE UP IN MIDDLE OF THE NIGHT; CANNOT WALK; RIGHT HIP PAIN; RIGHT LEG PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection for 9 days. However, still feels sick after that. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, dose number in series was 1, 01 in total administered on 09-APR-2021 for prophylactic vaccination.  Following administration of covid-19 vaccine ad26.cov2.s, the patient woke up in the middle of the night with right leg pain that disappeared and came back with the first vaccine (dose number in series was 1). The patient thought she had a blood clot but it was never confirmed by a doctor.   The outcome of woke up in middle of the night and right leg pain was not reported (dose number in series was 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: unknown) dose was not reported, dose number in series was 2, 01 in total, administered on 06-JAN-2022 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient again woke up with same issues, which she had after first dose. The patient had a shoulder replacement and was feeling good initially but afterwards, she was unable to walk due to right leg and hip pain (dose number in series was 2). As per patient's doctor, did not correlate covid-19 vaccine with her decrease in walking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right hip pain, cannot walk, and right leg pain, and the outcome of woke up in middle of the night and shoulder replacement was not reported (dose number in series was 2). This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint number: 90000214807 This case, involving the same patient is linked to 20220213452.; Sender's Comments: V0: 20220200404-COVID-19 VACCINE AD26.COV2.S-shoulder replacement. 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: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait inability, Middle insomnia, Pain in extremity, Shoulder arthroplasty
Clinical narrative: SHOULDER REPLACEMENT; WOKE UP IN MIDDLE OF THE NIGHT; CANNOT WALK; RIGHT HIP PAIN; RIGHT LEG PAIN; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection for 9 days. However, still feels sick after that. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, dose number in series was 1, 01 in total administered on 09-APR-2021 for prophylactic vaccination.  Following administration of covid-19 vaccine ad26.cov2.s, the patient woke up in the middle of the night with right leg pain that disappeared and came back with the first vaccine (dose number in series was 1). The patient thought she had a blood clot but it was never confirmed by a doctor.   The outcome of woke up in middle of the night and right leg pain was not reported (dose number in series was 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: unknown) dose was not reported, dose number in series was 2, 01 in total, administered on 06-JAN-2022 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient again woke up with same issues, which she had after first dose. The patient had a shoulder replacement and was feeling good initially but afterwards, she was unable to walk due to right leg and hip pain (dose number in series was 2). As per patient's doctor, did not correlate covid-19 vaccine with her decrease in walking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right hip pain, cannot walk, and right leg pain, and the outcome of woke up in middle of the night and shoulder replacement was not reported (dose number in series was 2). This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint number: 90000214807 This case, involving the same patient is linked to 20220213452.; Sender's Comments: V0: 20220200404-COVID-19 VACCINE AD26.COV2.S-shoulder replacement. 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: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Poor quality sleep
Clinical narrative: Headache beginning roughly 8 hours post-injection. Tried to sleep off, woke up 4 hours later with chills. Headache still present, took some Ibuprofen. Headache broke around 2-3 hours later, felt fine after. Got hit with fatigue (likely due to poor sleep) around 1pm the next day. Slept it off, woke up feeling fine. Haven't had any follow-up effects in the nearly one year since. Mainly submitting my experience to better understand VAERS.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Fear, Gait disturbance, Headache
Clinical narrative: Right sided migraine started 6 hours after vaccine. Started at back of head and radiated up to too of head near forehead hairline. Then right side of face went numb for 30 minutes, forehead, cheek, chin, ear. I did neuro exam on myself, funny faces sticking tongue out and overhead arm raises, all normal. It was terrifying and concerned for a stroke despite being 36yo. Felt dizzy and could not turn my head bc room would spin. Worst headache of my life and first time ever having facial numbness. The numbness passed but severe dizzy could not move head for nearly 2 hours. Dizzy decreased and brushed teeth early and went to bed. Slept 12 hours, woke up and nearly crawled to bathroom and back bc dizzy, mild brief nausea, and residual headache. Slept for another 4 hours and woke up tired but no longer nauseated dizzy or headache. Felt tired until the next morning, then ok.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Migraine, Nausea, Vertigo
Clinical narrative: Right sided migraine started 6 hours after vaccine. Started at back of head and radiated up to too of head near forehead hairline. Then right side of face went numb for 30 minutes, forehead, cheek, chin, ear. I did neuro exam on myself, funny faces sticking tongue out and overhead arm raises, all normal. It was terrifying and concerned for a stroke despite being 36yo. Felt dizzy and could not turn my head bc room would spin. Worst headache of my life and first time ever having facial numbness. The numbness passed but severe dizzy could not move head for nearly 2 hours. Dizzy decreased and brushed teeth early and went to bed. Slept 12 hours, woke up and nearly crawled to bathroom and back bc dizzy, mild brief nausea, and residual headache. Slept for another 4 hours and woke up tired but no longer nauseated dizzy or headache. Felt tired until the next morning, then ok.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Myalgia, Neuralgia, Pyrexia
Clinical narrative: I had fever, chills, back ache, muscle aches, and nerve pain every since my second vaccine.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: admin error. vaccine not diluted
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Somnolence
Clinical narrative: This was much milder and easier to handle  than previous Pfizer vaccine 1&2. Mild dull headache within one hour of vaccine, mild nausea started 2 hours in manageable with ginger chews and ginger ale. Nausea increased and Intense nausea that night about 3-4 hours later crackers and ginger only helped for a few minutes then intense nausea wave back. Felt like I needed to vomit but never did.  I took 12.5 mg phenergan  about 5-6 hours in and then bed shortly after. Slept 12 hours, woke up, nausea was mild to moderate and still felt tired and slept another 4 hours. Up for about 2 hours, felt fatigued, body drained and sleepy, back to bed for 2 additional hours and would have probably kept sleeping but woken up by a phone call. Felt very fatigued and drained the rest of the day and the next day. Slept another 10hours that night, then mostly ok. Took a few days to shake off the fatigued drained feeling
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: I had a very regular menstrual cycle before receiving the shot and have not had one since and have no other reason to have stopped.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Affect lability, Anger, Condition aggravated, Confusional state, Hypomania
Clinical narrative: Shortly after the first dose I noticed that I was becoming hypomania  but thought it was normal. After the second dose it started getting worse. I started talking fast, confused, moody, anger, overreacting, excessive spending, unable to stick to task. I am extremely sensitive to steroids and the reaction was very similar.  I am bipolar type 2 and rarely struggle with managing hypomania. I've been under psychiatric care for 33 years and manage my condition very well. I've always been able to get hypomania under control within 2 weeks. This was something different.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mood altered
Clinical narrative: Shortly after the first dose I noticed that I was becoming hypomania  but thought it was normal. After the second dose it started getting worse. I started talking fast, confused, moody, anger, overreacting, excessive spending, unable to stick to task. I am extremely sensitive to steroids and the reaction was very similar.  I am bipolar type 2 and rarely struggle with managing hypomania. I've been under psychiatric care for 33 years and manage my condition very well. I've always been able to get hypomania under control within 2 weeks. This was something different.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Breast pain, Chest pain, Electrocardiogram ambulatory, Exercise electrocardiogram
Clinical narrative: 1. Chest Pain, PVC's and aFib events.  Saw my cardiologist in 2021 post vax. I had a full workup and the abnormal heart rhythms were noted. The aFib went on for 8 months very frequently and has tapered off but every once in awhile I get an episode. The chest pain was really intense in the first 2 weeks, on and off fo 1-5 minute episodes. Working out and resting. It softened in intensity after a couple of months  2. Menses  Cycle was a MESS. Lots of heavy bleeding for the first cycle after the vaccine, and I bled for 18 solid days. The next few cycles were heavy and long with LOTS of clotting. My cycles finally regulated again after 7 or 8. Since the age of 26, my cycles have been regulated with estrogen and progesterone due to an infertility issue and I take them to protect my bones. (Privacy) has seen me before ad recommended this in my late 20's. So the vaccine altered my cycles while taking my normal medication.  3. I had 3 months of achy sometimes intense breast pain. I followed up wit my OBGYN and they ordered a mammogram, which was normal. I also reported my abnormal bleeding to them in 2021. I regularly get a flu shot. In Oct of 2021 I received my flu vaccine. The breast pain returned on and off for 2 weeks post flue vaccine. In the almost 40 years of taking the flu vax, I have never experienced d this.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Laboratory test, Mammogram normal, Pain, Ventricular extrasystoles
Clinical narrative: 1. Chest Pain, PVC's and aFib events.  Saw my cardiologist in 2021 post vax. I had a full workup and the abnormal heart rhythms were noted. The aFib went on for 8 months very frequently and has tapered off but every once in awhile I get an episode. The chest pain was really intense in the first 2 weeks, on and off fo 1-5 minute episodes. Working out and resting. It softened in intensity after a couple of months  2. Menses  Cycle was a MESS. Lots of heavy bleeding for the first cycle after the vaccine, and I bled for 18 solid days. The next few cycles were heavy and long with LOTS of clotting. My cycles finally regulated again after 7 or 8. Since the age of 26, my cycles have been regulated with estrogen and progesterone due to an infertility issue and I take them to protect my bones. (Privacy) has seen me before ad recommended this in my late 20's. So the vaccine altered my cycles while taking my normal medication.  3. I had 3 months of achy sometimes intense breast pain. I followed up wit my OBGYN and they ordered a mammogram, which was normal. I also reported my abnormal bleeding to them in 2021. I regularly get a flu shot. In Oct of 2021 I received my flu vaccine. The breast pain returned on and off for 2 weeks post flue vaccine. In the almost 40 years of taking the flu vax, I have never experienced d this.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Herpes zoster, Muscle twitching, Rash
Clinical narrative: Booster shot Covid 19 with lot no: 330308D received 11/30/21 at employee clinic. On December 22,2021 started experience burning on left upper quadrant of tummy  just below the left breast. On Dec.26,2021 rashes appeared on the site. December 30,2021 seen by urgent care still with rashes on left side diagnosed with shingles. Started on Gabapentin, valcyclovir and amitriptylline. Jan29 right eye twitching and burning on right side of cheek, seen by PCP Dr. on Feb2,2022 at 5pm. Started on valcyclovir.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial flutter, Blood pressure increased, Cardiac stress test normal, Electrocardiogram normal
Clinical narrative: Patient Blood pressure Report  July 22, 2021  Urgent Care    PA-C   Yearly Physical??.All Athlete status?. All tests perfect, Blood pressure 120/60  August 16, 2021 (24 DAYS LATER)  Second Covid vaccine??Immediate atrial flutter one hour after vaccine.  My wife and myself, with increasing high blood pressure. PFIZER BATCH # 7/23/21 FA6780 AND FC3181 8/16/21  October 27th. 2021  Appt. PA-C   EKG negative report.  October 31 st. 2021  Hospital Emergency Room Blood pressure 163/106/144 Dr.   All test attached. Dr. stated that there were no findings all perfect.  10/31/21 to 1/4/2022 Blood pressure readings 3 times per day on file Dr., Hospital.  1/4/21 Referred to Dr. at Hospital   EKG, ZIO PATCH, NKG, STRESS TEST   Dr. stated all test perfect no issues.  1. PA-C, Dr., and other Dr. all stated there were no findings all is perfect. 2. If all is perfect why would my blood pressure sky rocket in 24 days from physical July 22 to August 16th.? 3. I asked you Dr. what would cause my blood pressure to rise so rapidly. Dr, stated ? Because you are now a senior citizen? What kind of a unprofessional answer is that. You could not give me one reason. By age I am 65, relative age 40. Surf everyday, ride a bike over 100 miles per week, yoga, and have my own work out room. So to blame it on being a Senior citizen is bogus. Dr. you didn?t even want to discuss the fact that the cause is the vaccine.  (common sense) THE VACCINE HAS CAUSED MY HIGH BLOOD PRESSURE, THERE IS ABSOLUTLY NO QUESTION. 4. No discussion of Dr. who developed RMDA who stated in his report that  ?THE COVID VACCINE CAUSES BLOOD PRESSURE TO RISE? WHICH IS CAUSED BY A PROTIEN SPIKE. I understand that Dr. would be vilified if he stated the side effect of the vaccine is high blood pressure.  In conclusion it is obvious that the vaccine has caused  blood pressure in my wife and myself to rise right after the second vaccine. As there are no other factors which relate to having high blood pressure.  If my wife didn?t have the same issues I would consider that the high blood pressure was another issue. However it?s not. I would say that the doctor missed something accept all three doctors stated all is well?
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Seizure
Clinical narrative: About 30 hours after receiving third dose of the Moderna vaccine I had a seizure. I had juvenile epilepsy when I was 17-21 and no seizures or any neurological events in 14 years and then had a violent seizure unlike any other that I previously had.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Crying, Rash, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: 1 hour after the injection, patient started complaining about severe pain only on her left arm even though both arms got shots. I noticed it was red and the other arm was not. The next morning, we woke up around 7:30am and her left arm was swollen, red, hard and warm to the touch. She also had bumps all over her bottom/butt, I noticed these around 10:00am. She was itching her hand and arm all day. She would itch around the redness, but not directly on it since it hurt so bad. She would cry at times because how bad it hurt. This is her 2nd reaction, both times the same things occurred.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 1 hour after the injection, patient started complaining about severe pain only on her left arm even though both arms got shots. I noticed it was red and the other arm was not. The next morning, we woke up around 7:30am and her left arm was swollen, red, hard and warm to the touch. She also had bumps all over her bottom/butt, I noticed these around 10:00am. She was itching her hand and arm all day. She would itch around the redness, but not directly on it since it hurt so bad. She would cry at times because how bad it hurt. This is her 2nd reaction, both times the same things occurred.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Supraventricular tachycardia
Clinical narrative: Developed SVT/ SVTNRT has to have ablation therapy
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Inflammation, Oedema peripheral, Pain
Clinical narrative: Pain and swelling in the left armpit to the left breast. I had pain and inflammation for almost 1 week and my doctor prescribed ibuprofen that helped me get better quickly.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heavy menstrual bleeding
Clinical narrative: I had my period start 2 days later and it was a normal cycle but my next cycle was not. On 12/24/2021, my menstrual bleeding was so heavy I was considering going to the ER. I did not because I did not want to be exposed to Covid. I was wearing double pads and going to the bathroom every 15 min. If I was later than that, I was bleeding through everything onto my clothing. I have never experienced blood clots anywhere near that size previously. At first I had was wearing a tampon and it pulled out a blood clot the size of a plum. The bleeding continued at this rate for 5 - 6 hours. My period continues to be heavy for 2 days. I was very weak and light headed for about 4 days afterwards.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Baseball sized swelling and injection site pain requiring use of alternating ibuprofen/acetaminophen use over two days.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Death, Pneumonia, Septic shock
Clinical narrative: Patient hospitalized with apparent septic shock due to pneumonia on the evening of his vaccination. He died the following day 2/3
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blepharospasm, Malaise, Photophobia, Pruritus
Clinical narrative: for continous 12 days severe muscle pains shooting through my body, neck spasms severe, very sore arm where vaccine got injected , feeling tired. pain was the worst ever in muscle pain affected, shoulder, hip, back. almost went to doctor. my body felt weird. 2nd shot felt weakness afyer 3 days, general not feeling good, tired and experienced muscle twitch in eye for months, experienced allover my body skin rashes and itchy skin a couple of times lasting a day every they occured, light sensitivity
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: for continous 12 days severe muscle pains shooting through my body, neck spasms severe, very sore arm where vaccine got injected , feeling tired. pain was the worst ever in muscle pain affected, shoulder, hip, back. almost went to doctor. my body felt weird. 2nd shot felt weakness afyer 3 days, general not feeling good, tired and experienced muscle twitch in eye for months, experienced allover my body skin rashes and itchy skin a couple of times lasting a day every they occured, light sensitivity
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysmenorrhoea, Heavy menstrual bleeding, Postpartum state, Pyrexia
Clinical narrative: Post Partum 2 months at time of shot. Pregnancy was complicated by placenta previa that resulted in a blood transfusion during child birth.  No period resumed  On day of vaccine. Had severe chills and fever night of shot. Painful period resumed with severe  cramps and heavy bleeding on early Saturday morning.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Dizziness postural, Headache, Musculoskeletal chest pain
Clinical narrative: Left arm soreness; sharp pain radiating from left armpit to bottom of back ribcage; persistent orthostatic hypotension; sitting to standing dizziness/vertigo; headache; chills; sore neck and soreness at right armpit radiating to fingertips.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Orthostatic hypertension, Pain, Pain in extremity, Vertigo
Clinical narrative: Left arm soreness; sharp pain radiating from left armpit to bottom of back ribcage; persistent orthostatic hypotension; sitting to standing dizziness/vertigo; headache; chills; sore neck and soreness at right armpit radiating to fingertips.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 19Apr2021 13:15 (Lot number: EW0162) at the age of 45 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, administration time:10:45 AM, lot number: ER8730, Anatomical Location: Arm Right), administration date: 27Mar2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 19Apr2021 17:00, outcome "not recovered", described as "Extreme tiredness"; SOMNOLENCE (non-serious) with onset 19Apr2021 17:00, outcome "not recovered", described as "very sleepy". Therapeutic measures were not taken as a result of fatigue, somnolence. Additional information: Patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. No treatment received for the adverse event. No allergies to medications, food, or other products. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion occurred on 11/22/21; This spontaneous report was received from a nurse and refers to patients of unknown age and gender.  The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported.  On unknown dates, the patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U010398 (determined to be valid), expiration date: 01-APR-2023, administered for prophylaxis (strength, and route of administration were not provided) (administration of 17 doses was reported).  The vaccine underwent temperature excursion on an unknown date (6 degrees of Fahrenheit (F) to 14F for 10 minutes; 14F to to 46F (23.9F) for 3 hours. There was no previous temperature excursion reported. No adverse event was reported.   Follow-up information has been received from a nurse on 28-JAN-2022.  The case concerned a 51 years old, male patient.  The nurse reported that a temperature excursion occurred on 22-NOV-2021 and on 21-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided), measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously in the right arm (lot T034389, expiration date 08-OCT-2022) (strength and dose were not provided) and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) intramuscularly (lot C5787AA, expiration date 01-OCT-2022) (strength, dose and anatomical location were not provided)  No adverse event.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: Patient had no known side effects.; lmproperly stored vaccine administered to a patient.; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 30-DEC-2021, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (exact dose, lot#, expiration#, route of administration were not reported).  Administered dose of vaccine has been stored in the temperature of 34.3 F for 4 hours and 23 minutes.There were no previous temperature excursions reported. Patient had no known side effects.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA006297:
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion occurred on 11/22/21; This spontaneous report was received from a nurse referring to a 35 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on 22-NOV-2021. On 10-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously in the right arm (lot T034389, expiration date 08-OCT-2022) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion occurred 11/22/21; This spontaneous report was received from a nurse referring to a 52 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on 22-NOV-2021. On 29-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the right arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion on 11/22/21; This spontaneous report was received from a nurse referring to a 49 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on 22-NOV-2021. On 21-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously in the right arm (lot T034389, expiration date 08-OCT-2022) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion occurred; This spontaneous report was received from a nurse referring to a 29 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on an unspecified date. On 03-DEC-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the right arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously in the left arm (lot T027914, expiration date 18-AUG-2022) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion occurred; This spontaneous report was received from a nurse referring to a 47 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on 22-NOV-2021. On 03-JAN-2022 (also reported as 03-JAN-2023), the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion occurred; This spontaneous report was received from a nurse referring to a 25 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on an unspecified date. On 30-NOV-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the right arm (lot U020244, expiration date 28-JUN-2023) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion reported 11/22/21; This spontaneous report was received from a nurse referring to a 25 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on 22-NOV-2021. On 30-NOV-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left arm (lot U020244, expiration date 28-JUN-2023) (strength and dose were not provided) and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) intramuscularly in the right arm (lot C5787AA, expiration date 01-OCT-2023) (strength and dose were not provided).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No addtional AE; Expired MMR II was administered to a patient; This spontaneous report was received from a other(office manager) referring to a patient of unreported age and gender. The patient's pertinent medical history, and drug reactions or allergies were not provided. Concomitant therapies included sterile diluent (STERILE DILUENT).  On 26-JAN-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 milliliter, (expired product administered) (lot number T001212, expiration date 12-JAN-2022; vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis. The vaccine did not have any prior temperature excursion.   No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.