chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Abortion spontaneous, Arthralgia, Discomfort, Exposure during pregnancy, Feeling abnormal
Clinical narrative: On 10Dec, I had a miscarriage.; felt terrible all night; body aches; joint paint; received my booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 15:00 (Lot number: FJ8757) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing). Date of last menstrual period: 02Oct2021. The patient was 9 weeks pregnant at the time of exposure to bnt162b2. The patient was 9 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 09Jul2022. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. Vaccination history included: Bnt162b2 (Dose 2, lot number: EW0162, administration time: 09:00 AM, vaccine location: Left arm), administration date: 14Apr2021, for covid 19 immunization; Bnt162b2 (Dose 1, Lot number: ER8730, Administration time: 09:00 AM, Vaccine location: Left arm), administration date: 03Mar2021, for covid 19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 06Dec2021, outcome "unknown", described as "received my booster shot"; ABORTION SPONTANEOUS (medically significant) with onset 10Dec2021, outcome "recovered with sequelae", described as "On 10Dec, I had a miscarriage."; FEELING ABNORMAL (non-serious) with onset 09Dec2021, outcome "recovered with sequelae", described as "felt terrible all night"; PAIN (non-serious) with onset 09Dec2021, outcome "recovered with sequelae", described as "body aches"; ARTHRALGIA (non-serious) with onset 09Dec2021, outcome "recovered with sequelae", described as "joint paint". The events "on 10dec, i had a miscarriage.", "felt terrible all night", "body aches" and "joint paint" were evaluated at the physician office visit and emergency room visit. The pregnancy resulted in spontaneous abortion. No known allergies. No covid prior vaccination. Covid was not tested post vaccination. No other vaccine in four weeks. Other medications in two weeks included Prenatal Vitamin - Mama Bird Prenatal, Multi+ Iodin. Patient received her booster shot on 06Dec2021, felt terrible all night with body aches and joint paint. On 10Dec2021, patient had a miscarriage. Therapeutic measures were taken as a result of abortion spontaneous, feeling abnormal, pain, arthralgia included IV, Tylenol and medical watch. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Myalgia, Ultrasound scan vagina abnormal
Clinical narrative: On 10Dec, I had a miscarriage.; felt terrible all night; body aches; joint paint; received my booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 15:00 (Lot number: FJ8757) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing). Date of last menstrual period: 02Oct2021. The patient was 9 weeks pregnant at the time of exposure to bnt162b2. The patient was 9 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 09Jul2022. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. Vaccination history included: Bnt162b2 (Dose 2, lot number: EW0162, administration time: 09:00 AM, vaccine location: Left arm), administration date: 14Apr2021, for covid 19 immunization; Bnt162b2 (Dose 1, Lot number: ER8730, Administration time: 09:00 AM, Vaccine location: Left arm), administration date: 03Mar2021, for covid 19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 06Dec2021, outcome "unknown", described as "received my booster shot"; ABORTION SPONTANEOUS (medically significant) with onset 10Dec2021, outcome "recovered with sequelae", described as "On 10Dec, I had a miscarriage."; FEELING ABNORMAL (non-serious) with onset 09Dec2021, outcome "recovered with sequelae", described as "felt terrible all night"; PAIN (non-serious) with onset 09Dec2021, outcome "recovered with sequelae", described as "body aches"; ARTHRALGIA (non-serious) with onset 09Dec2021, outcome "recovered with sequelae", described as "joint paint". The events "on 10dec, i had a miscarriage.", "felt terrible all night", "body aches" and "joint paint" were evaluated at the physician office visit and emergency room visit. The pregnancy resulted in spontaneous abortion. No known allergies. No covid prior vaccination. Covid was not tested post vaccination. No other vaccine in four weeks. Other medications in two weeks included Prenatal Vitamin - Mama Bird Prenatal, Multi+ Iodin. Patient received her booster shot on 06Dec2021, felt terrible all night with body aches and joint paint. On 10Dec2021, patient had a miscarriage. Therapeutic measures were taken as a result of abortion spontaneous, feeling abnormal, pain, arthralgia included IV, Tylenol and medical watch. No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Abortion spontaneous, Arthralgia, Feeling abnormal, Immunisation, Pain
Clinical narrative: On 10Dec, I had a miscarriage.; felt terrible all night; body aches; joint paint; received my booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 15:00 (Lot number: FJ8757) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing). Date of last menstrual period: 02Oct2021. The patient was 9 weeks pregnant at the time of exposure to bnt162b2. The patient was 9 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 09Jul2022. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. Vaccination history included: Bnt162b2 (Dose 2, lot number: EW0162, administration time: 09:00 AM, vaccine location: Left arm), administration date: 14Apr2021, for covid 19 immunization; Bnt162b2 (Dose 1, Lot number: ER8730, Administration time: 09:00 AM, Vaccine location: Left arm), administration date: 03Mar2021, for covid 19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 06Dec2021, outcome "unknown", described as "received my booster shot"; ABORTION SPONTANEOUS (medically significant) with onset 10Dec2021, outcome "recovered with sequelae", described as "On 10Dec, I had a miscarriage."; FEELING ABNORMAL (non-serious) with onset 09Dec2021, outcome "recovered with sequelae", described as "felt terrible all night"; PAIN (non-serious) with onset 09Dec2021, outcome "recovered with sequelae", described as "body aches"; ARTHRALGIA (non-serious) with onset 09Dec2021, outcome "recovered with sequelae", described as "joint paint". The events "on 10dec, i had a miscarriage.", "felt terrible all night", "body aches" and "joint paint" were evaluated at the physician office visit and emergency room visit. The pregnancy resulted in spontaneous abortion. No known allergies. No covid prior vaccination. Covid was not tested post vaccination. No other vaccine in four weeks. Other medications in two weeks included Prenatal Vitamin - Mama Bird Prenatal, Multi+ Iodin. Patient received her booster shot on 06Dec2021, felt terrible all night with body aches and joint paint. On 10Dec2021, patient had a miscarriage. Therapeutic measures were taken as a result of abortion spontaneous, feeling abnormal, pain, arthralgia included IV, Tylenol and medical watch. No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Diarrhoea, Nausea, Vomiting
Clinical narrative: severe abdominal cramps; nausea; vomiting; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 08:00 (Lot number: EN6206) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 15Mar2021 16:00, outcome "recovered", described as "severe abdominal cramps"; NAUSEA (non-serious) with onset 15Mar2021 16:00, outcome "recovered", described as "nausea"; VOMITING (non-serious) with onset 15Mar2021 16:00, outcome "recovered", described as "vomiting"; DIARRHOEA (non-serious) with onset 15Mar2021 16:00, outcome "recovered", described as "diarrhea". The events "severe abdominal cramps", "nausea", "vomiting" and "diarrhea" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of abdominal pain, nausea, vomiting, diarrhoea. Additional information: No other vaccine in four weeks. No other medications in two weeks. Adverse event resulted in emergency room/department or urgent care. Event treatment included Zofran. No covid prior vaccination. Did not get covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Immunisation, Limb discomfort, Malaise
Clinical narrative: I have had numbness, tingling, and weakness in my left arm and hand for four weeks after my COVID booster. It feels like there is a band constricting around my deltoid and is cutting off circulation to my arm and hand but there is no visible damage. I have been prescribed Gabapentin 200mg tid and this has numbed the pain but hasn't solved the problem. My insurance has denied both a ct-scan and an MRI. I have no diagnosis or treatment plan.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Neck pain, Paraesthesia, Vaccination site pain
Clinical narrative: I have had numbness, tingling, and weakness in my left arm and hand for four weeks after my COVID booster. It feels like there is a band constricting around my deltoid and is cutting off circulation to my arm and hand but there is no visible damage. I have been prescribed Gabapentin 200mg tid and this has numbed the pain but hasn't solved the problem. My insurance has denied both a ct-scan and an MRI. I have no diagnosis or treatment plan.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Pain, Paraesthesia, Poor peripheral circulation
Clinical narrative: I have had numbness, tingling, and weakness in my left arm and hand for four weeks after my COVID booster. It feels like there is a band constricting around my deltoid and is cutting off circulation to my arm and hand but there is no visible damage. I have been prescribed Gabapentin 200mg tid and this has numbed the pain but hasn't solved the problem. My insurance has denied both a ct-scan and an MRI. I have no diagnosis or treatment plan.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray normal
Clinical narrative: I have had numbness, tingling, and weakness in my left arm and hand for four weeks after my COVID booster. It feels like there is a band constricting around my deltoid and is cutting off circulation to my arm and hand but there is no visible damage. I have been prescribed Gabapentin 200mg tid and this has numbed the pain but hasn't solved the problem. My insurance has denied both a ct-scan and an MRI. I have no diagnosis or treatment plan.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Hormone level abnormal, Raynaud's phenomenon, Rheumatoid arthritis
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 18:00 (Lot number: EW0187) at the age of 50 years as dose 2, single and administered in arm left, administration date 17May2021 18:00 (Lot number: EW0187) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy; "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 08Jan2022, outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: Nasal Swab.  Clinical Source: Prior to vaccination patient was diagnosed with COVID-19 and since the vaccination, patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hot flush, Raynaud's phenomenon, Rheumatoid arthritis, SARS-CoV-2 test
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 18:00 (Lot number: EW0187) at the age of 50 years as dose 2, single and administered in arm left, administration date 17May2021 18:00 (Lot number: EW0187) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy; "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 08Jan2022, outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: Nasal Swab.  Clinical Source: Prior to vaccination patient was diagnosed with COVID-19 and since the vaccination, patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 18:00 (Lot number: EW0187) at the age of 50 years as dose 2, single and administered in arm left, administration date 17May2021 18:00 (Lot number: EW0187) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy; "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 08Jan2022, outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: Nasal Swab.  Clinical Source: Prior to vaccination patient was diagnosed with COVID-19 and since the vaccination, patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Impaired driving ability, Muscle spasms
Clinical narrative: I was told that I had to go to a hospital instead of a vaccine site because I had a history of shellfish allergy. So I went to hospital and had the shot. I was fine for the wait time at the hospital. As I was driving home, about 15 miles away, I had to stop in route because of debilitating charley horses and muscle cramps.  Those cramps continued for the entire 3 weeks that I had to wait for the second shot. I told the nurse giving the shot and she said it was just a coincidence.  I received the 2nd shot and they started all over again with high intensity.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Hypoaesthesia oral, Nausea, Paraesthesia
Clinical narrative: Pt Pfizer dose 0.3cc was given by healthcare professional @1718.  Pt c/o that the room was swaying and numbness/tingling around mouth @ 1735.  Vitals:  BP 140/92 pulse 96 resp.20.  Pt was given water and instructed to hydrate.  Pt was then transfered to an area with nurse and placed supine with legs elevated on chair.  Vitals @ 1745 160/110 pulse112 resp. 20.  Vitals @1750 140/100 pulse 100 and resp 18.  Pt then c/o of nausea and therefore was helped to a sitting position with a waste basket nearby.  Pt @ 1805 c/o chills with continued nausea and emesis of  water and food particles.  Pt's numbness and tingling was now bilaterally at the level of her cheeks.  Vitals 37.1 Bp 140/120 pulse 112 resp 18. At 1810, after consulting with nurse made the decision to have employee to call 911.  Vitals @ 1820 180/130 pulse 112 and resp 18.  Paramedics arrived @1824.  Assessment was made by parametics and pt. agreed to be transferred to ER for further evaluation.  Pt's sister accompanied patient to the ER via ambulance.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Vertigo, Vomiting
Clinical narrative: Pt Pfizer dose 0.3cc was given by healthcare professional @1718.  Pt c/o that the room was swaying and numbness/tingling around mouth @ 1735.  Vitals:  BP 140/92 pulse 96 resp.20.  Pt was given water and instructed to hydrate.  Pt was then transfered to an area with nurse and placed supine with legs elevated on chair.  Vitals @ 1745 160/110 pulse112 resp. 20.  Vitals @1750 140/100 pulse 100 and resp 18.  Pt then c/o of nausea and therefore was helped to a sitting position with a waste basket nearby.  Pt @ 1805 c/o chills with continued nausea and emesis of  water and food particles.  Pt's numbness and tingling was now bilaterally at the level of her cheeks.  Vitals 37.1 Bp 140/120 pulse 112 resp 18. At 1810, after consulting with nurse made the decision to have employee to call 911.  Vitals @ 1820 180/130 pulse 112 and resp 18.  Paramedics arrived @1824.  Assessment was made by parametics and pt. agreed to be transferred to ER for further evaluation.  Pt's sister accompanied patient to the ER via ambulance.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Paraesthesia, Stress
Clinical narrative: Extreme fatigue for about 6 months after vaccination which slowly improved over time. Pins and needles pain. Low stress tolerance. Lightheadedness. Weakness.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Currently no adverse event is reported,however,an undiluted vaccine was given.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Tinnitus, Tremor
Clinical narrative: Vaccine 5:15 pm 2/1; 103.3 fever with uncontrollable body shakes, severe headache and severe muscle aches at approximately 3:00am 2/2. Fever continued until 2/4. Fluctuating from 100 to 102 while piggy backing Tylenol and advil. Residual tinnitus in rt ear since headache
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site discolouration, Injection site warmth, Peripheral swelling, Pruritus
Clinical narrative: Arm swelling and redness. I now have a 4 inch purple hot spot at injection site. The redness and swelling has changed daily since my shot. It?s 4 days after and my arm is swollen red and hot past my elbow and it?s itchy.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Arm swelling and redness. I now have a 4 inch purple hot spot at injection site. The redness and swelling has changed daily since my shot. It?s 4 days after and my arm is swollen red and hot past my elbow and it?s itchy.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No reported adverse event, however, undiluted vaccine was given resulting in administration error. The patient is informed of the incident and advised.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Urticaria
Clinical narrative: Chronic spontaneous urticaria diagnosed by dermatologist. Symptoms began about a week after booster was received. 8 weeks later I am still experiencing symptoms. I take a daily regimen of Allegra to manage but as soon as I come off the medicine the hives return. They break out all over my body from head to toe. I have no history of prior allergies other than small swelling reactions to ant bites.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Breast pain, Breast swelling, Lymphadenopathy
Clinical narrative: 2 days after the 3rd booster dose I developed significant swelling of the right axillary lymph nodes extending out to the lateral breast.  I had Moderna dose 1 & 2 in the Right Arm as well and had right axillary lymphadenopathy as well. The swelling and pain persisted for ~2 weeks. I took ibuprofen and warm compress for my axilla and breast. The swelling went down significantly after two weeks. Then 3 days later I started my menstrual cycle and the same particular area on the right lateral breast swelled and became painful again, it was warm and formed a significant lump. I contacted my physicians office who advised waiting two weeks to see if the pain/swelling/lump would go away. The pain and swelling has gone away but a lump remains in that breast. I had an office visit today for an evaluation and an ultrasound was ordered.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Disturbance in attention, Dyspnoea
Clinical narrative: Less than 10 hours after getting the shot on 12/14 I got my period, even though my last period had ended 12/5--only 9 days prior. It lasted for 6 days, which was longer than usual, though it wasn't as heavy as normal. My regular cycle is about 35 days, yet I got my next period on January 4th--a week earlier than I should've gotten it if I hadn't gotten an extra period and and over 2 weeks earlier when I take the extra period into account. I also experienced a terrible fever, chills, muscular aching from my neck to the arches of my feet, chronic joint pains, brain fog and concentration issues, and gastrointestinal pains including nausea and diarrhea starting about 12 hours after 12/14 and lasting through the night. The aches, fever, and brain fog/concentration issues lasted for a few days; by day three my joints and muscles were still in awful condition and I was unable to catch my breath on a short routine walk. In high school, I was a 3 sport athlete, and throughout college I was heavily involved with my school's marching band. Breath support has never been a problem for me.  All told, I didn't feel back to normal until about 12/20, and even then I was a bit easily worn out. Immediately before the vaccine I had not gotten Covid, and on that day, I took an at-home Covid test and got a negative result.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gastrointestinal pain, Menstruation irregular, Myalgia, Nausea
Clinical narrative: Less than 10 hours after getting the shot on 12/14 I got my period, even though my last period had ended 12/5--only 9 days prior. It lasted for 6 days, which was longer than usual, though it wasn't as heavy as normal. My regular cycle is about 35 days, yet I got my next period on January 4th--a week earlier than I should've gotten it if I hadn't gotten an extra period and and over 2 weeks earlier when I take the extra period into account. I also experienced a terrible fever, chills, muscular aching from my neck to the arches of my feet, chronic joint pains, brain fog and concentration issues, and gastrointestinal pains including nausea and diarrhea starting about 12 hours after 12/14 and lasting through the night. The aches, fever, and brain fog/concentration issues lasted for a few days; by day three my joints and muscles were still in awful condition and I was unable to catch my breath on a short routine walk. In high school, I was a 3 sport athlete, and throughout college I was heavily involved with my school's marching band. Breath support has never been a problem for me.  All told, I didn't feel back to normal until about 12/20, and even then I was a bit easily worn out. Immediately before the vaccine I had not gotten Covid, and on that day, I took an at-home Covid test and got a negative result.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Less than 10 hours after getting the shot on 12/14 I got my period, even though my last period had ended 12/5--only 9 days prior. It lasted for 6 days, which was longer than usual, though it wasn't as heavy as normal. My regular cycle is about 35 days, yet I got my next period on January 4th--a week earlier than I should've gotten it if I hadn't gotten an extra period and and over 2 weeks earlier when I take the extra period into account. I also experienced a terrible fever, chills, muscular aching from my neck to the arches of my feet, chronic joint pains, brain fog and concentration issues, and gastrointestinal pains including nausea and diarrhea starting about 12 hours after 12/14 and lasting through the night. The aches, fever, and brain fog/concentration issues lasted for a few days; by day three my joints and muscles were still in awful condition and I was unable to catch my breath on a short routine walk. In high school, I was a 3 sport athlete, and throughout college I was heavily involved with my school's marching band. Breath support has never been a problem for me.  All told, I didn't feel back to normal until about 12/20, and even then I was a bit easily worn out. Immediately before the vaccine I had not gotten Covid, and on that day, I took an at-home Covid test and got a negative result.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Headache, Pruritus, Rash, Urticaria
Clinical narrative: Hives all over the body. Itchiness. Rash. Headaches. Sever breast pain before the period (usually no pain).  Claritin and corticosteroid topical help to reduce itchiness and rash. Advil does not help with headaches.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over legs when out walking 24hours later. Spread to feet. Has happened again with vigorous activity since the booster.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear infection, Tinnitus
Clinical narrative: Ear infection hearing loss 60%
Age: 50.0
Sex: M
Vaccine: FLU4, HEP, UNK
Symptoms: Incorrect route of product administration, Injection site pain, Magnetic resonance imaging abnormal, Muscle spasms, Tendon injury
Clinical narrative: The 3rd shot was given in the same arm as the other two, and much higher, not in my deltoid muscle, but higher in my shoulder.  I immediately felt a sharp pain in my shoulder during the injection, as well as a muscle spasm.  When I arrived home immediately after the vaccination I began to feel a dull pain in my shoulder and upper arm, eventually seeking a medical evaluation on 12/23/2021.  I was  prescribed a pain medication, and told to return in 3 weeks.  I returned on 1/19/2022 and was sent for an MRI which took place on 1/21/2022.  I have been prescribed pain killers and muscle relaxers since my 1/19/2022 appointment, and have a referral for an orthopedic surgeon and pain management physician.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, COVID-19, Foetal heart rate abnormal, Pregnancy test positive, Ultrasound scan vagina
Clinical narrative: Received vaccine on 8/29/2021. Pregnancy detected on 12/24/2021. COVID + on  1/18/2022. Started bleeding vaginally on 1/21/2022. Confirmed pregnancy on 1/21/2022 to be 6 weeks 6 days with no fetal heartbeat. Vaginal bleeding continued. On 1/24/2022, complete miscarriage confirmed. Continued bleeding for 9 days.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Received vaccine on 8/29/2021. Pregnancy detected on 12/24/2021. COVID + on  1/18/2022. Started bleeding vaginally on 1/21/2022. Confirmed pregnancy on 1/21/2022 to be 6 weeks 6 days with no fetal heartbeat. Vaginal bleeding continued. On 1/24/2022, complete miscarriage confirmed. Continued bleeding for 9 days.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Regulatory Authority (manufacturer control number: PR-AMGEN-PRISL2021060593). A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 53 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. The following information was reported: ABDOMINAL PAIN (non-serious), outcome "unknown", described as "After she got the vaccine she had abdominal pain, like when she used to get her periods". Therapeutic measures were not taken as a result of abdominal pain. Additional information: The patient began Enbrel, Reusable Autoinjector on an unknown date. The patient missed one dose of Enbrel after her vaccine of COVID. After she got the vaccine she had abdominal pain, like when she used to get her periods. This happened twice already. The patient would check if it happens again and she would let the doctor know at the time of appointment. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the event abdominal pain. The causal relationship between the event abdominal pain and Enbrel with Reusable Autoinjector was not provided by the consumer. The reporter could not read/could not find lot number. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; PROQUAD was improperly stored on 15-DEC-2021 and administered to a patient; This non-valid spontaneous report was received from a nurse and referred 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 an unknown date the patient was vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), (unspecified dose, frequency, route of administration, lot # T032149 has been verified to be a valid lot number, expiration date was reported and established as 20-MAR-2022, lot # U024508 has been verified to be a valid lot number, expiration date was reported and established as 02-FEB-2023, lot # U009261 has been verified to be a valid lot number, expiration date was reported and established as 19-SEP-2022, lot # U026794, expiration date: 26-FEB-2023, vaccination site was not provided) for prophylaxis.   It was reported that one dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD), was improperly stored on 15-DEC-2021 and was administered to a patient. on an unknown date (product storage error). The vaccine was stored at a temperature of -8.1 Celsius (C) for a time frame of 8 hours and 35 minutes with no previous temperature excursion.   No product quality complaint (PQC) and no additional adverse event (AEs) was reported.   This case was considered non-valid due the lack of patient identifiers.   Follow-up information was received  from the nurse on 01-FEB-2022.  Demographics of the patient were provided. The case concerned a female patient of 2 years and 4 months old.   Concomitant vaccines administered were diphtheria vaccine toxoid, hib vaccine conj (TET TOX), pertussis vaccine acellular 5-component, polio vaccine inact 3v (MRC 5), tetanus vaccine toxoid (PENTACEL) and influenza vaccine (FLUZONE.)  On 23-DEC-2021, the patient was vaccinated with first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous route lot number U024508 (rHA) expiration date 02-FEB-2023 as prophylaxis.   The nurse reported that the freezer was found out to be out of range due to a digital data logger. The problem was corrected, however, the vaccine was administered before the problem was reported.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Patient had no known side effects; Vaccine Coordinator reported a temperature excursion for VAQTA which was supported; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided.  On 03-JAN-2022, the patient was vaccinated with incorrectly stored hepatitis a vaccine, inactivated (VAQTA) lot # U024505, expiration date 15-OCT-2022 (formulation, dose, route of administration, anatomical location were not reported) for prophylaxis (product storage error). The patient had no known side effects (no adverse event).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA005595: US-009507513-2201USA005673: US-009507513-2201USA005751: US-009507513-2201USA005901: US-009507513-2201USA006295: US-009507513-2201USA006305: US-009507513-2201USA006322: US-009507513-2201USA006342: US-009507513-2201USA006419: US-009507513-2201USA006445: US-009507513-2201USA006536:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Patient had no known side effects; Vaccine Coordinator reported a temperature excursion for VAQTA which was supported. Caller reported that 1 dose of VAQTA was administered to a patient.; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant therapy provided.  On 04-JAN-2022, the patient was vaccinated with improperly stored 1 dose hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, lot # U024505, expiration date 15-OCT-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). It was reported that a temperature excursion for hepatitis a vaccine, inactivated (VAQTA) was supported. No details provided. The patient had no known side effects (no adverse event).
Age: 33.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE reported; a 33 year old consumer was inadvertently administered PROQUAD rather than MMR-II; a 33 year old consumer was inadvertently administered PROQUAD rather than MMR-II; This spontaneous report as received from a nurse refers to a 33-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided.  On 24-JAN-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD), lot # T028298, expiry date 16-FEB-2022 (dose, route and site of administration were not reported) for prophylaxis, rather than with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered, product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse events; a dose of VARlVAX was administered to a patient today via intramuscular route versus subcutaneous route; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 26-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot number U022732, expiration date 20-JUL-2023, intramuscular instead of subcutaneous (incorrect route of product administration) for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: No additional adverse events reported; an extra dose of VARlVAX was administered to a patient (third dose); This spontaneous report has been received from a nurse, referring to a 16-year-old patient of unknown gender. The patient's pertinent historical vaccines included measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The patient's drugs reactions or allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), then on 23-MAR-2011, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) both were received as prophylaxis (strengths, doses, exact frequencies, routes of administration, anatomical injection sites, lot numbers and expiration dates were not reported).  On 31-JAN-2022, the patient was vaccinated with the third dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) at the dose of 0.5 milliliter (strength, route of administration, anatomical injection site, lot number and expiration date were not reported) as prophylaxis (extra dose administered). These was outside the recommendations of the prescribing information. It was reported that the patient received three dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) because when they entered the administration date into their electronic health record, they noticed the other two doses of this vaccine, previously they only noted the historical vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). No other information given. No additional adverse events reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse reporting a dose of improperly stored VARIVAX; No additional adverse events reported; This spontaneous information was received from a registered nurse concerning a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 31-JAN-2022, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml for prophylaxis, lot number: U020238 with expiration date on 28-JUN-2023 (strength, frequency, route of administration and anatomical location were not provided) (incorrect product storage).  The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at a temperature range of 6 degrees Fahrenheit (F) up to 14 degrees Fahrenheit (13.8F) for the time frame of 1 hour and 45 minutes and 0 seconds, and for the temperature range of 14F up to 46F (14.4F) for 0 hours 25 minutes and 0 seconds. There was no previous temperature excursion.  No additional adverse events reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: no other issues or concerns noted; a patient was administered an expired dose of ROTATEQ on 01-FEB-2022; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 01-FEB-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) as prophylaxis (strength, dose, frequency, and route of administration were not reported; lot number T028131 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent with expiration date on 31-JAN-2022) (expired product administered). No other issues or concerns noted.; Sender's Comments:  US-009507513-2202USA000490:
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; Information has been received regarding a case in litigation from a lawyer and referred to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around December 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered Bell's palsy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event Bell's palsy was considered as not recovered. The causality assessment between the event and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    The lawyer considered the event Bell's palsy to be disability. Upon internal review, Bell's palsy was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unidentified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that patients get a sore arm following a dose of Shingrix. The reporter did not agree to follow up. The case has been linked to US2022AMR016132,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR016132:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 29th January 2022, the patient received the 2nd dose of Shingles vaccine. In January 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that he/she was going to get on and complain a little about the pain he/she experienced after the second shot a day before reporting. The reporter stated the pain other consumers had was much greater than his/her. This case has been linked to US2022AMR017852, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR017852:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Eye disorder
Clinical narrative: reaction in eyes; This case was reported by a consumer via interactive digital media and described the occurrence of eye disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced eye disorder. On an unknown date, the outcome of the eye disorder was unknown.   The reporter considered the eye disorder to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient had a reaction from the first shot in his/her eyes. The patient did not get the second one. The followup could not be possible as no contact details were available.