chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 17Jan2022 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I have immune compromised system and I take meds for it." (unspecified if ongoing), notes: I have immune compromised system and I take meds for it. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2023) Negative, notes: Took Paxlovid for the 5 days tested negative when all was taken; (25Jun2023) Positive, notes: 5 days later I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid (lot number: Gg2270) from 16Jun2023 to 21Jun2023, for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Jun2023, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 48-year-old male patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: el9263), in left arm, on 13Feb2021 as dose 2, single (Lot number: el7267), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: 30145ba) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "hay fever" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2023) negative, notes: Tested negative; (20Jun2023) negative, notes: Tested negative; (22Jun2023) positive, notes: tested and it was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took Paxlovid from 12Jun2023 to 17Jun2023 for the treatment of COVID-19.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 74 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL3247), on 19Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 18Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "diabetic neuropathy" (unspecified if ongoing); "restless leg syndrom" (unspecified if ongoing). Concomitant medication(s) included: INSULINA [INSULIN] taken for hypoglycaemia, start date: Apr1993; INSULIN N taken for hypoglycaemia, start date: Apr1993; METFORMIN, start date: Jan2003. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: out of breath/she is very short of breath; fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 27Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "Knee replacement" (unspecified if ongoing), notes: She had knee replacement years ago; "Covid" (unspecified if ongoing), notes: She got Covid before getting the Covid vaccine, She had Covid about a year and a half ago; "thyroid" (unspecified if ongoing), notes: pill for her thyroid; "UTI" (unspecified if ongoing), notes: UTI's were before the Covid vaccine. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Lot number and expiration date not provided.), administration date: 02Jul2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "She screamed when she got her Covid shot"; BNT162b2 (DOSE 2, SINGLE , Lot number and expiration date not provided.), administration date: 27Jul2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "feeling very fatigued all the time", "out of breath easily/ Shortness of breath", "she has shrunk", "She screamed when she got her Covid shot"; Flu vaccine (DOSE NUMBER UNKNOWN, SINGLE , Lot number and expiration date not provided., It was for flu and the one that makes you burn and itchy body), for immunisation, reaction(s): "burn and itchy body", "burn and itchy body". The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "out of breath/she is very short of breath"; FATIGUE (non-serious), outcome "unknown", described as "fatigued".  Additional Information: She had gotten a paper from Pfizer to fill out more information. She was not sure where it was. She would like another one sent. It was about her after effects from the Pfizer COVID 19 vaccine. It has been terrible. She was a very active person. Whenever she is moving around and doing stuff, she is out of breath a lot. Like if she goes down stairs to do laundry and comes back up when she gets back up there she is very short of breath. She is very fatigued. Her son got the Moderna COVID shot, and was refusing at first. He was 35. As soon as he got the Moderna vaccine, he got that motion in his face. It stretched out or something. Her Pfizer 19 COVID vaccine history: 3 doses of the Pfizer COVID vaccine 02Jul2021,  27Jul2021 27Jan2022 store. No lot numbers listed. Reference number: unknown  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: carried the herpes virus for over 30 years/The outbreaks came back prior to a booster shot of your vaccine and subsided after the booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 76-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "herpes virus" (unspecified if ongoing), notes: I've carried the herpes virus for over 30 years. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "carried the herpes virus for over 30 years/The outbreaks came back prior to a booster shot of your vaccine and subsided after the booster".  Additional information: Patient carried the herpes virus for over 30 years. Patient was now 76. After their COVID vaccine the outbreaks were virtually eliminated. The outbreaks came back prior to a booster shot of their vaccine and subsided after the booster. Patient was grateful for the protection the vaccine provided against COVID. Patient was grateful for the vaccine's extended suppression of the herpes outbreaks. Patient hope was that they would find this side effect of their vaccine worthy of further research.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertent administration of an expired product with no reported adverse event; Initial information was received on 26-Jun-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves 2 years old female patient for whom inadvertent administration of an expired product diphtheria-15/tetanus/5 AC pertussis vaccine [Aaptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 26-Jun-2023, the patient inadvertent received expired product 0.5 ml dose 4 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (strength: standard, lot number: C5893AA, expiration date: 21-Jun-2023) via intramuscular route in the right thigh for immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event inadvertent administration of an expired product with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired dose of Daptacel (expired on 21-Jun-2023) with no repported adverse event; Initial information was received on 26-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 years old and unknown gender patient who experienced administered an expired dose of daptacel (diphtheria-15/tetanus/5 ac pertussis vaccine) (expired on 21-jun-2023) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Jun-2023, the patient received a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (Suspension for injection) (lot C5893AA, expiry date : 21-Jun-2023) (strength unknown) via unknown route in unknown administration site for Immunization.  On 26-Jun-2023 the patient developed a non-serious event of administered an expired dose of daptacel (expired on 21-jun-2023) with no reported adverse event (expired product administered) (latency : same day) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken with DIPHTHERIA, TETANUS and acellular pertussis vaccine (Daptacel) was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired dose of daptacel (expired on 21-jun-2023) with no repported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient that received a tenivac vaccine that was two days past its expiration date with no reported adverse event; Initial information received on 26-Jun-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 65 years old female patient where she received diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine that was two days past its expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s) and family history were not provided.  No concomitant vaccines were administered.   On 26-Jun-2023, the patient received 0.5 mL (TOTAL) Booster dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection single-dose prefilled syringe (batch number- U7092AA and expiration date- 24-Jun-2023) via intramuscular route in the left deltoid (strength: not provided) for Immunization.  On 26-Jun-2023 the patient received a tenivac vaccine that was two days past its expiration date with no reported adverse event (expired product administered) (latency- same day) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Had an audit on 6/26/23 and was found during the audit that this pt was given a 1st dose of the 5-11 pfizer vaccine orange cap on 12/08/2021, no reaction to the first dose, pt then came in on 12/31/2021 for the 2nd dose, however was documented as being given a gray top 12 year old dose, unsure if this was the lot that was given at the time, however this is what is documented. pt did not come back with any side effects. Spoke to Pfizer on 6/28/23 and was advised that pt no longer needs another vaccine since they have received that higher dose that day. Was not aware of any effects from this pt after the vaccine was given in 2021
Age: 0.5
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna bivalent 10mcg dose given instead of bivalent 25 mcg dose
Age: 39.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 1st dose given incorrectly due to incorrect age
Age: 0.75
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Moderna bivalent 10mcg dose given instead of bivalent 25 mcg dose
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna bivalent 10mcg dose given instead of bivalent 25 mcg dose
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Delivery, Discomfort, Dizziness
Clinical narrative: On 8/16/2021, I got my first dose of Moderna COVID-19 vaccine. I was 25 weeks pregnant at the time. Within less than ten minutes after receiving the vaccine, I experienced heavy dizziness. The entire left side of my body also had a strange, rushed sort of heavy sensation. Something just didn't feel right. I went home and lay down. Within 25-30 minutes, I began having contractions that radiated from my lower back to the front of my belly. The pains would come in intervals of five to ten minutes, and they felt like early-stage labor pains. I then ended up going to the ER. When I got to the ER, I was sent directly to obstetrics, where my contractions were monitored. The contractions then became less frequent. I was released shortly thereafter and sent home. The contractions then gradually went away. I gave birth to my daughter in 11/2021, and she was 19.5 inches long and weighed 7 lbs., 2 oz.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Feeling abnormal, Pain, Uterine contractions during pregnancy
Clinical narrative: On 8/16/2021, I got my first dose of Moderna COVID-19 vaccine. I was 25 weeks pregnant at the time. Within less than ten minutes after receiving the vaccine, I experienced heavy dizziness. The entire left side of my body also had a strange, rushed sort of heavy sensation. Something just didn't feel right. I went home and lay down. Within 25-30 minutes, I began having contractions that radiated from my lower back to the front of my belly. The pains would come in intervals of five to ten minutes, and they felt like early-stage labor pains. I then ended up going to the ER. When I got to the ER, I was sent directly to obstetrics, where my contractions were monitored. The contractions then became less frequent. I was released shortly thereafter and sent home. The contractions then gradually went away. I gave birth to my daughter in 11/2021, and she was 19.5 inches long and weighed 7 lbs., 2 oz.
Age: 0.83
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Moderna bivalent 10mcg dose given instead of bivalent 25 mcg dose
Age: 21.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: SWOLLEN ARM, TENDERNESS AND 3 INCH BAND AROUND LEFT ARM IS STILL SWOLLEN FOR MORE THAN 4 WEEKS
Age: 0.58
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Moderna bivalent 10mcg dose given instead of bivalent 25 mcg dose
Age: 0.75
Sex: U
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Moderna bivalent 10mcg dose given instead of bivalent 25 mcg dose
Age: 0.58
Sex: U
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Moderna bivalent 10mcg dose given instead of bivalent 25 mcg dose
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Moderna bivalent 10mcg dose given instead of bivalent 25 mcg dose
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, MMRV
Symptoms: Extra dose administered, Product administration error, Vaccination error, Wrong product administered
Clinical narrative: MA accidentally administered both MMR and a Proquad vaccine.  The Proquad also contains the MMR components so pt received a double dose of the MMR.  RN's were notified at approximately 1:15pm when MA realized that there was a vaccine administration error. Immediately upon learning this information RN's notified the provider and our clinic manager.  Both the CDC and local DOH were contacted by clinic nurses to obtain information and guidance for this vaccination error.  Parents of the patient were notified of the error by the provider.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna bivalent 10mcg dose given instead of bivalent 25 mcg dose
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: Na
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Gait inability
Clinical narrative: Patient's mother states that patient was unable to walk after recieveing  vaccines but states it occured two weeks after vaccination. Patient recieved a consult with Dr. and was referred to a Neurologist, Urologist, and Physical Therapy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling increased over 2 day period . Warm and hard to touch and itching. Mom placed ice on the area. No medication given
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event
Clinical narrative: no adverse reaction
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: I roomed the patient for a Well Child Check, received report form nurse practitioner. to give the baby the vaccines. withdrew the wrong vaccines. ( pt. needed the pneumococcal 13 and gave them pneumococcal23). realized error after administration and nurse practitioner left. notified MA supervisor about the error. called patient to let them know about the error and the need for vaccination with  pneumococcal 13, left voice message.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Anaemia, Blood test, COVID-19
Clinical narrative: On 10/22/2021, I had abdominal, pelvic, and perineal pain. I went to the ER, and I was told that I was having Braxton-Hicks contractions. I was then sent home. On 11/12/2021, I had upper abdominal pain. Suddenly, the vision in both my eyes became blurry for a few seconds, and I felt faint. I decided to take my blood pressure, which was 160/100. I then went to the ER. At the ER, I underwent nine blood tests, a PCR test for COVID-19, and a urine test. I was diagnosed with chest pains, dizziness, and giddiness. I was also diagnosed with anemia with resulting complications to pregnancy and supervision elderly multigravida, third trimester. I was not given any medications on account of my pregnancy, and they told me they would monitor my blood pressure and overall situation. Prior to my pregnancy, I had never had high blood pressure. I was then sent home. On 11/15/2021, I noticed that I wasn't feeling my baby move as much as before, so I went to the ER. At the ER, I underwent a urinalysis, a fetal biophysical profile with non-stress testing, and a limited obstetrical ultrasound. I was told that the baby's vitals looked fine and that there were no anomalies. On 11/2021, I went to hospital, where labor was induced. I was tested for COVID-19, and the result was positive. I gave birth to my daughter, who was 19.5 inches long and weighed 7 lbs., 2 oz. After I had the baby, I experienced chest pains, and I was examined by both a cardiologist and a neurologist. The cardiologist thought that the pains may have been caused by the COVID-19. I underwent an MRI with contrast dye; the neurologist thought that they had spotted a possible aneurysm, but fortunately, that turned out not to be the case. During my labor, I was given an epidural. After the birth, I was given pain pills, such as Motrin. I was given no medication for the COVID-19, though. I was discharged on the morning of 11/25/2021. I was admitted to the hospital on 12/7/2021, because my blood pressure was 200/180. I was given magnesium to lower my blood pressure. I underwent an echocardiogram and an EKG. I was released on 12/10/2021. I was prescribed Labetalol (100 mg), which was instructed to take every morning. On 12/21/2021, I had another episode in which my blood pressure was dangerously high. I went back to the ER.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Complication of pregnancy, Delivery, Dizziness, Echocardiogram
Clinical narrative: On 10/22/2021, I had abdominal, pelvic, and perineal pain. I went to the ER, and I was told that I was having Braxton-Hicks contractions. I was then sent home. On 11/12/2021, I had upper abdominal pain. Suddenly, the vision in both my eyes became blurry for a few seconds, and I felt faint. I decided to take my blood pressure, which was 160/100. I then went to the ER. At the ER, I underwent nine blood tests, a PCR test for COVID-19, and a urine test. I was diagnosed with chest pains, dizziness, and giddiness. I was also diagnosed with anemia with resulting complications to pregnancy and supervision elderly multigravida, third trimester. I was not given any medications on account of my pregnancy, and they told me they would monitor my blood pressure and overall situation. Prior to my pregnancy, I had never had high blood pressure. I was then sent home. On 11/15/2021, I noticed that I wasn't feeling my baby move as much as before, so I went to the ER. At the ER, I underwent a urinalysis, a fetal biophysical profile with non-stress testing, and a limited obstetrical ultrasound. I was told that the baby's vitals looked fine and that there were no anomalies. On 11/2021, I went to hospital, where labor was induced. I was tested for COVID-19, and the result was positive. I gave birth to my daughter, who was 19.5 inches long and weighed 7 lbs., 2 oz. After I had the baby, I experienced chest pains, and I was examined by both a cardiologist and a neurologist. The cardiologist thought that the pains may have been caused by the COVID-19. I underwent an MRI with contrast dye; the neurologist thought that they had spotted a possible aneurysm, but fortunately, that turned out not to be the case. During my labor, I was given an epidural. After the birth, I was given pain pills, such as Motrin. I was given no medication for the COVID-19, though. I was discharged on the morning of 11/25/2021. I was admitted to the hospital on 12/7/2021, because my blood pressure was 200/180. I was given magnesium to lower my blood pressure. I underwent an echocardiogram and an EKG. I was released on 12/10/2021. I was prescribed Labetalol (100 mg), which was instructed to take every morning. On 12/21/2021, I had another episode in which my blood pressure was dangerously high. I went back to the ER.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Epidural injection, Foetal hypokinesia, Foetal non-stress test, Hypertension
Clinical narrative: On 10/22/2021, I had abdominal, pelvic, and perineal pain. I went to the ER, and I was told that I was having Braxton-Hicks contractions. I was then sent home. On 11/12/2021, I had upper abdominal pain. Suddenly, the vision in both my eyes became blurry for a few seconds, and I felt faint. I decided to take my blood pressure, which was 160/100. I then went to the ER. At the ER, I underwent nine blood tests, a PCR test for COVID-19, and a urine test. I was diagnosed with chest pains, dizziness, and giddiness. I was also diagnosed with anemia with resulting complications to pregnancy and supervision elderly multigravida, third trimester. I was not given any medications on account of my pregnancy, and they told me they would monitor my blood pressure and overall situation. Prior to my pregnancy, I had never had high blood pressure. I was then sent home. On 11/15/2021, I noticed that I wasn't feeling my baby move as much as before, so I went to the ER. At the ER, I underwent a urinalysis, a fetal biophysical profile with non-stress testing, and a limited obstetrical ultrasound. I was told that the baby's vitals looked fine and that there were no anomalies. On 11/2021, I went to hospital, where labor was induced. I was tested for COVID-19, and the result was positive. I gave birth to my daughter, who was 19.5 inches long and weighed 7 lbs., 2 oz. After I had the baby, I experienced chest pains, and I was examined by both a cardiologist and a neurologist. The cardiologist thought that the pains may have been caused by the COVID-19. I underwent an MRI with contrast dye; the neurologist thought that they had spotted a possible aneurysm, but fortunately, that turned out not to be the case. During my labor, I was given an epidural. After the birth, I was given pain pills, such as Motrin. I was given no medication for the COVID-19, though. I was discharged on the morning of 11/25/2021. I was admitted to the hospital on 12/7/2021, because my blood pressure was 200/180. I was given magnesium to lower my blood pressure. I underwent an echocardiogram and an EKG. I was released on 12/10/2021. I was prescribed Labetalol (100 mg), which was instructed to take every morning. On 12/21/2021, I had another episode in which my blood pressure was dangerously high. I went back to the ER.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Induced labour, Magnetic resonance imaging head normal, Maternal exposure during pregnancy, Multigravida, Pelvic pain
Clinical narrative: On 10/22/2021, I had abdominal, pelvic, and perineal pain. I went to the ER, and I was told that I was having Braxton-Hicks contractions. I was then sent home. On 11/12/2021, I had upper abdominal pain. Suddenly, the vision in both my eyes became blurry for a few seconds, and I felt faint. I decided to take my blood pressure, which was 160/100. I then went to the ER. At the ER, I underwent nine blood tests, a PCR test for COVID-19, and a urine test. I was diagnosed with chest pains, dizziness, and giddiness. I was also diagnosed with anemia with resulting complications to pregnancy and supervision elderly multigravida, third trimester. I was not given any medications on account of my pregnancy, and they told me they would monitor my blood pressure and overall situation. Prior to my pregnancy, I had never had high blood pressure. I was then sent home. On 11/15/2021, I noticed that I wasn't feeling my baby move as much as before, so I went to the ER. At the ER, I underwent a urinalysis, a fetal biophysical profile with non-stress testing, and a limited obstetrical ultrasound. I was told that the baby's vitals looked fine and that there were no anomalies. On 11/2021, I went to hospital, where labor was induced. I was tested for COVID-19, and the result was positive. I gave birth to my daughter, who was 19.5 inches long and weighed 7 lbs., 2 oz. After I had the baby, I experienced chest pains, and I was examined by both a cardiologist and a neurologist. The cardiologist thought that the pains may have been caused by the COVID-19. I underwent an MRI with contrast dye; the neurologist thought that they had spotted a possible aneurysm, but fortunately, that turned out not to be the case. During my labor, I was given an epidural. After the birth, I was given pain pills, such as Motrin. I was given no medication for the COVID-19, though. I was discharged on the morning of 11/25/2021. I was admitted to the hospital on 12/7/2021, because my blood pressure was 200/180. I was given magnesium to lower my blood pressure. I underwent an echocardiogram and an EKG. I was released on 12/10/2021. I was prescribed Labetalol (100 mg), which was instructed to take every morning. On 12/21/2021, I had another episode in which my blood pressure was dangerously high. I went back to the ER.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Perineal pain, SARS-CoV-2 test positive, Scan with contrast normal, Ultrasound foetal, Urine analysis
Clinical narrative: On 10/22/2021, I had abdominal, pelvic, and perineal pain. I went to the ER, and I was told that I was having Braxton-Hicks contractions. I was then sent home. On 11/12/2021, I had upper abdominal pain. Suddenly, the vision in both my eyes became blurry for a few seconds, and I felt faint. I decided to take my blood pressure, which was 160/100. I then went to the ER. At the ER, I underwent nine blood tests, a PCR test for COVID-19, and a urine test. I was diagnosed with chest pains, dizziness, and giddiness. I was also diagnosed with anemia with resulting complications to pregnancy and supervision elderly multigravida, third trimester. I was not given any medications on account of my pregnancy, and they told me they would monitor my blood pressure and overall situation. Prior to my pregnancy, I had never had high blood pressure. I was then sent home. On 11/15/2021, I noticed that I wasn't feeling my baby move as much as before, so I went to the ER. At the ER, I underwent a urinalysis, a fetal biophysical profile with non-stress testing, and a limited obstetrical ultrasound. I was told that the baby's vitals looked fine and that there were no anomalies. On 11/2021, I went to hospital, where labor was induced. I was tested for COVID-19, and the result was positive. I gave birth to my daughter, who was 19.5 inches long and weighed 7 lbs., 2 oz. After I had the baby, I experienced chest pains, and I was examined by both a cardiologist and a neurologist. The cardiologist thought that the pains may have been caused by the COVID-19. I underwent an MRI with contrast dye; the neurologist thought that they had spotted a possible aneurysm, but fortunately, that turned out not to be the case. During my labor, I was given an epidural. After the birth, I was given pain pills, such as Motrin. I was given no medication for the COVID-19, though. I was discharged on the morning of 11/25/2021. I was admitted to the hospital on 12/7/2021, because my blood pressure was 200/180. I was given magnesium to lower my blood pressure. I underwent an echocardiogram and an EKG. I was released on 12/10/2021. I was prescribed Labetalol (100 mg), which was instructed to take every morning. On 12/21/2021, I had another episode in which my blood pressure was dangerously high. I went back to the ER.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine contractions during pregnancy, Vision blurred
Clinical narrative: On 10/22/2021, I had abdominal, pelvic, and perineal pain. I went to the ER, and I was told that I was having Braxton-Hicks contractions. I was then sent home. On 11/12/2021, I had upper abdominal pain. Suddenly, the vision in both my eyes became blurry for a few seconds, and I felt faint. I decided to take my blood pressure, which was 160/100. I then went to the ER. At the ER, I underwent nine blood tests, a PCR test for COVID-19, and a urine test. I was diagnosed with chest pains, dizziness, and giddiness. I was also diagnosed with anemia with resulting complications to pregnancy and supervision elderly multigravida, third trimester. I was not given any medications on account of my pregnancy, and they told me they would monitor my blood pressure and overall situation. Prior to my pregnancy, I had never had high blood pressure. I was then sent home. On 11/15/2021, I noticed that I wasn't feeling my baby move as much as before, so I went to the ER. At the ER, I underwent a urinalysis, a fetal biophysical profile with non-stress testing, and a limited obstetrical ultrasound. I was told that the baby's vitals looked fine and that there were no anomalies. On 11/2021, I went to hospital, where labor was induced. I was tested for COVID-19, and the result was positive. I gave birth to my daughter, who was 19.5 inches long and weighed 7 lbs., 2 oz. After I had the baby, I experienced chest pains, and I was examined by both a cardiologist and a neurologist. The cardiologist thought that the pains may have been caused by the COVID-19. I underwent an MRI with contrast dye; the neurologist thought that they had spotted a possible aneurysm, but fortunately, that turned out not to be the case. During my labor, I was given an epidural. After the birth, I was given pain pills, such as Motrin. I was given no medication for the COVID-19, though. I was discharged on the morning of 11/25/2021. I was admitted to the hospital on 12/7/2021, because my blood pressure was 200/180. I was given magnesium to lower my blood pressure. I underwent an echocardiogram and an EKG. I was released on 12/10/2021. I was prescribed Labetalol (100 mg), which was instructed to take every morning. On 12/21/2021, I had another episode in which my blood pressure was dangerously high. I went back to the ER.
Age: 14.0
Sex: M
Vaccine: IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: Patient threw up after receiving the vaccinations (5 total). Mother stated that he "usually feels that way after receiving any vaccines." Patient stayed additional observation time for 30 minutes and felt better after observation period.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Pallor, Unresponsive to stimuli
Clinical narrative: 17 year old given two immunizations (COVID and MenQuadfi) in her left arm. After receiving HPV9 vaccine in right arm client went pale, became non-responsive, and lost consciousness. The nurses lowered her to the ground and put her feet on a chair above her heart. She quickly regained consciousness after that. Nurses took her blood pressure once she was sitting up again (98/60) gave her juice, water and a granola bar to eat. She walked out of the public health center under her own power.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea at about 5pm Slight dizziness at 6:52
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Malaise, Mobility decreased, Pain
Clinical narrative: Terrible body aches and inflammation.  Can spend entire days in bed from feeling so sick.
Age: 59.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever, whole left arm aches, bump and red at shot site - for four days.  Whole Left arm aches still and it?s been 7 days now.
Age: 19.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient is a 19 yo female who presented to clinic for Hep B vaccine series and Varicella series due to upcoming medical program. Patient was seen and given Engerix-B (Hep B) vaccine 1.0 mL in the left deltoid by APRN.  APRN did do typical safety checks including checking vaccine name, lot, and exp with patient. Pt tolerated immunizations well and left clinic after 10-15 min sit time. On 6/27/23 APRN was speaking with another provider about Hep B vaccine age and realized that a 1.0 mL dose was given when the vaccine guidance states that anyone 19 years and younger should receive 0.5 mL dose. This was reported immediately to direct supervisor. APRN called manufacturer and based on their guidelines clarified that there is no clinical evidence to suggested that this will result in harm. Patient should receive 0.5 mL dose at their 1 mo repeat, and 1.0 mL at their 6 months as they will be 20 years old at that time. Called patient 6/28/23 after clarifying schedule and guidance with manufacturer. Verified 2 identifiers and advised patient of error, guidelines, and new dosing schedule. Patient stated that ?I am not worried about this at all?.
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: Acne, Blister, Rash
Clinical narrative: Patient came by today to the pharmacy to pick up his regular monthly medications and informed that he developed some form of bumps / blisters on his arms and legs (like dry pimples/ acne) and he feels that he did not react well with this vaccine
Age: 23.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: Pt w/ arthralgias in hands/fingers/shoulders, knees. Swelling in hand
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, Red, itching, large bump on Right leg, warm to touch
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Computerised tomogram, Electrocardiogram, Electromyogram
Clinical narrative: Tingling, numbness, burning, weakness, inflammation of upper, lost of sensory and motor skills in extremities, difficulties walking and holding items and lower extremities. I was diagnosed Oct 1, 2021 with Guillian Barre Syndrome, admitted at hospital Oct 12, 2021 and provided with a full course of IViG infusion which also caused hemolytic anemia extending my hospitalization until Nov. 5, 2021. I also experience migraines as a result and needed to receive treatment. Unfortunately I needed to be admitted to the hospital on 3 different occassions as it relates to Guillian Barre Syndrome and neuropathy (hospitalized at 2 different Hospitals; both located in same place. I have been advised against receiving any additional vaccinations due to adverse reaction of the COVID-19 vaccine and GBS diagnosis.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Grip strength decreased, Guillain-Barre syndrome, Haemolytic anaemia, Hypoaesthesia
Clinical narrative: Tingling, numbness, burning, weakness, inflammation of upper, lost of sensory and motor skills in extremities, difficulties walking and holding items and lower extremities. I was diagnosed Oct 1, 2021 with Guillian Barre Syndrome, admitted at hospital Oct 12, 2021 and provided with a full course of IViG infusion which also caused hemolytic anemia extending my hospitalization until Nov. 5, 2021. I also experience migraines as a result and needed to receive treatment. Unfortunately I needed to be admitted to the hospital on 3 different occassions as it relates to Guillian Barre Syndrome and neuropathy (hospitalized at 2 different Hospitals; both located in same place. I have been advised against receiving any additional vaccinations due to adverse reaction of the COVID-19 vaccine and GBS diagnosis.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Immunoglobulin therapy, Inflammation, Magnetic resonance imaging, Migraine, Motor dysfunction
Clinical narrative: Tingling, numbness, burning, weakness, inflammation of upper, lost of sensory and motor skills in extremities, difficulties walking and holding items and lower extremities. I was diagnosed Oct 1, 2021 with Guillian Barre Syndrome, admitted at hospital Oct 12, 2021 and provided with a full course of IViG infusion which also caused hemolytic anemia extending my hospitalization until Nov. 5, 2021. I also experience migraines as a result and needed to receive treatment. Unfortunately I needed to be admitted to the hospital on 3 different occassions as it relates to Guillian Barre Syndrome and neuropathy (hospitalized at 2 different Hospitals; both located in same place. I have been advised against receiving any additional vaccinations due to adverse reaction of the COVID-19 vaccine and GBS diagnosis.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Neuropathy peripheral, Paraesthesia, Sensory loss, Ultrasound scan
Clinical narrative: Tingling, numbness, burning, weakness, inflammation of upper, lost of sensory and motor skills in extremities, difficulties walking and holding items and lower extremities. I was diagnosed Oct 1, 2021 with Guillian Barre Syndrome, admitted at hospital Oct 12, 2021 and provided with a full course of IViG infusion which also caused hemolytic anemia extending my hospitalization until Nov. 5, 2021. I also experience migraines as a result and needed to receive treatment. Unfortunately I needed to be admitted to the hospital on 3 different occassions as it relates to Guillian Barre Syndrome and neuropathy (hospitalized at 2 different Hospitals; both located in same place. I have been advised against receiving any additional vaccinations due to adverse reaction of the COVID-19 vaccine and GBS diagnosis.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Rash pruritic, SARS-CoV-2 test
Clinical narrative: full body rash (not my face)/pink bumps on my arms and spread all over/bubbled up, dried up; full body rash/INSANELY itchy; Swelling hands feet legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2021 at 11:00 as dose 1, single (Lot number: EW0176) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (medically significant) with onset 07May2021, outcome "not recovered", described as "Swelling hands feet legs"; RASH (medically significant) with onset 07May2021, outcome "not recovered", described as "full body rash (not my face)/pink bumps on my arms and spread all over/bubbled up, dried up"; RASH PRURITIC (medically significant) with onset 07May2021, outcome "not recovered", described as "full body rash/INSANELY itchy". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were not taken as a result of rash, rash pruritic, peripheral swelling.  Additional information: Five days after getting the vaccine, the patient broke out in a full body rash (not her face). It started as pink bumps on her arms and spread all over. It bubbled up, dried up. It was insanely itchy. There was swelling in hands, feet and legs. It lasted 3 weeks and subsided for approximately 3 weeks. Then it returned full blown approximately 3 weeks later. This went on for one and a half years.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 1/11/21 lot# 032H20A;  Moderna 2/8/21 lot# 032H20A
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired and vaccine was administered, patient had no symptoms or no signs of reaction
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired and patient had no symptoms or no sign of reaction
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Gait disturbance, Headache
Clinical narrative: Day after injection given, c/o not feeling well; pain, redness, swelling in muscle where vaccine given, headache, shivering, feeling tired, weak--could hardly walk at times, hands, fingers, toes and feet hurt was in bed most of day. Temp 98.3 pulse was irreg. Next day felt somewhat stronger, not as tired or as achy. Took Hydrocodone several times which helped for comfort some.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Muscle swelling, Pain, Pain in extremity
Clinical narrative: Day after injection given, c/o not feeling well; pain, redness, swelling in muscle where vaccine given, headache, shivering, feeling tired, weak--could hardly walk at times, hands, fingers, toes and feet hurt was in bed most of day. Temp 98.3 pulse was irreg. Next day felt somewhat stronger, not as tired or as achy. Took Hydrocodone several times which helped for comfort some.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired and was administerd to the patient. Patient had no symptoms or no reaction
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product preparation error
Clinical narrative: 61 year old male received undiluted COVID19 Pediatric Bivalent 5-11 year old vaccine