chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Productive cough, Sensory disturbance, Sputum discoloured
Clinical narrative: 28 hours after vaxinations, a severe cough ensued. The cough was productive but only after at least 3-gut-based-extreme coughs each time. the cough was usually productive only on 3rd or 4th cough ans the phlem was dense and light beige in color. My temperature elevated to 101 to 102 on a consistent basis. The cough continued, initiated by what I'd descrobe as alightening bolt across the upper chest then 3 or 4 deep gut coughs to expel the phlem. This continued for 4 days, and the body temp briefly rose to 107.1 beofre measures were taken to reduce. My wife insisted I then visit and Emergency Room. Chest x-ray was clear and daiphram intact. no identifiable symptoms. The business where these were administered was a local grocery chain. The vaccination card had no information on FLU identifiers.  I am so very angry that the CDC recommendation was it was acceptable to have both of these vaccinations concurrently injected. It is obviously quite negative in my bodie's response, with long-lasting symptoms with sevete pain and duration including a very high fever. Today as I write this 13 days later I still have a productive cough about 10 to 12 times a day. The resulting phlem is still light beige in color. I am not a smoker for 40 years now. My guts still ache from very frequent coughing that by body was using to try and rid itself of what seemed to be an overall coating of this phlem throughout my entire lungs.  It saddens me to think other people could be forced to endure these symptoms. I think you should seriously re-consider ok'in, recommending, or allowing for any 2 vaccinations on the same day.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eczema, Headache, Malaise, Pruritus, Rash
Clinical narrative: eczema; Rash of skin on stomach, back, and legs down to his knees; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (eczema) and RASH (Rash of skin on stomach, back, and legs down to his knees) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (eczema) and RASH (Rash of skin on stomach, back, and legs down to his knees). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ECZEMA (eczema) and RASH (Rash of skin on stomach, back, and legs down to his knees) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient had 2 vaccines and 2 boosters. Following these injections he developed eczema from it. The dermatologists did not know what to do and how to treat this. He did not know what to do. Rash of skin on stomach, back, and legs down to his knees. He had tried multiple medications, or creams. He was taking Benadryl. Talked to 2 dermatologists. He could not go outside without a shirt.   This case was linked to MOD-2021-280030 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash morbilliform
Clinical narrative: eczema; Rash of skin on stomach, back, and legs down to his knees; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (eczema) and RASH (Rash of skin on stomach, back, and legs down to his knees) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (eczema) and RASH (Rash of skin on stomach, back, and legs down to his knees). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ECZEMA (eczema) and RASH (Rash of skin on stomach, back, and legs down to his knees) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient had 2 vaccines and 2 boosters. Following these injections he developed eczema from it. The dermatologists did not know what to do and how to treat this. He did not know what to do. Rash of skin on stomach, back, and legs down to his knees. He had tried multiple medications, or creams. He was taking Benadryl. Talked to 2 dermatologists. He could not go outside without a shirt.   This case was linked to MOD-2021-280030 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eczema, Rash
Clinical narrative: eczema; Rash of skin on stomach, back, and legs down to his knees; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (eczema) and RASH (Rash of skin on stomach, back, and legs down to his knees) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (eczema) and RASH (Rash of skin on stomach, back, and legs down to his knees). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ECZEMA (eczema) and RASH (Rash of skin on stomach, back, and legs down to his knees) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient had 2 vaccines and 2 boosters. Following these injections he developed eczema from it. The dermatologists did not know what to do and how to treat this. He did not know what to do. Rash of skin on stomach, back, and legs down to his knees. He had tried multiple medications, or creams. He was taking Benadryl. Talked to 2 dermatologists. He could not go outside without a shirt.   This case was linked to MOD-2021-280030 (Patient Link).   Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: PPV, PNC20, PNC15, PPV
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: It was swollen quite a bit, just the upper part of the arm. About 6 inches above the arm. Down from the shoulder, it didnt get into the shoulder. Swelling and pain, and I still have the pain. This was the left arm.
Age: 83.0
Sex: F
Vaccine: PPV, PNC20, PNC15, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: It was swollen quite a bit, just the upper part of the arm. About 6 inches above the arm. Down from the shoulder, it didnt get into the shoulder. Swelling and pain, and I still have the pain. This was the left arm.
Age: 83.0
Sex: F
Vaccine: PPV, PNC20, PNC15, PPV
Symptoms: Amnesia, Injected limb mobility decreased, Vaccination site pain, Vaccination site swelling
Clinical narrative: It was swollen quite a bit, just the upper part of the arm. About 6 inches above the arm. Down from the shoulder, it didnt get into the shoulder. Swelling and pain, and I still have the pain. This was the left arm.
Age: 9.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Asthenia, Fatigue, Headache, Nausea, Product administered to patient of inappropriate age
Clinical narrative: Daughter was given 12+ Pfizer Bivalent Shot (gray cap) when it was supposed to be pediatrics dose (orange cap)
Age: 9.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Pyrexia, Wrong product administered
Clinical narrative: Daughter was given 12+ Pfizer Bivalent Shot (gray cap) when it was supposed to be pediatrics dose (orange cap)
Age: 9.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Daughter was given 12+ Pfizer Bivalent Shot (gray cap) when it was supposed to be pediatrics dose (orange cap)
Age: 24.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Angina pectoris, Chest pain, Dizziness, Dyspnoea, Nausea
Clinical narrative: Severe chest pain around heart; difficulty exhaling; dizziness; nauseous; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 13:00 as dose 4 (booster), single (Lot number: GH970Z) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gastroparesis" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: BUPROPION HCL, Birth control. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (first booster), for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant) with onset 20Oct2022 at 19:00, outcome "recovering", described as "Severe chest pain around heart"; DYSPNOEA (non-serious) with onset 20Oct2022 at 19:00, outcome "recovering", described as "difficulty exhaling"; DIZZINESS (non-serious) with onset 20Oct2022 at 19:00, outcome "recovering"; NAUSEA (non-serious) with onset 20Oct2022 at 19:00, outcome "recovering", described as "nauseous". The events "severe chest pain around heart", "difficulty exhaling", "dizziness" and "nauseous" required emergency room visit. Therapeutic measures were taken as a result of angina pectoris, dyspnoea, dizziness, nausea included muscle relaxer .
Age: 24.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Angina pectoris, Dizziness, Dyspnoea, Nausea
Clinical narrative: Severe chest pain around heart; difficulty exhaling; dizziness; nauseous; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 13:00 as dose 4 (booster), single (Lot number: GH970Z) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gastroparesis" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: BUPROPION HCL, Birth control. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (first booster), for COVID-19 immunization. The following information was reported: ANGINA PECTORIS (medically significant) with onset 20Oct2022 at 19:00, outcome "recovering", described as "Severe chest pain around heart"; DYSPNOEA (non-serious) with onset 20Oct2022 at 19:00, outcome "recovering", described as "difficulty exhaling"; DIZZINESS (non-serious) with onset 20Oct2022 at 19:00, outcome "recovering"; NAUSEA (non-serious) with onset 20Oct2022 at 19:00, outcome "recovering", described as "nauseous". The events "severe chest pain around heart", "difficulty exhaling", "dizziness" and "nauseous" required emergency room visit. Therapeutic measures were taken as a result of angina pectoris, dyspnoea, dizziness, nausea included muscle relaxer .
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: Blood pressure dropped very low; felt like fainting; pain and redness on the injection site; pain and redness on the injection site; This spontaneous case was reported by a patient and describes the occurrence of HYPOTENSION (Blood pressure dropped very low), DIZZINESS (felt like fainting), VACCINATION SITE PAIN (pain and redness on the injection site) and VACCINATION SITE ERYTHEMA (pain and redness on the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 042L20A and 011J20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced HYPOTENSION (Blood pressure dropped very low), DIZZINESS (felt like fainting), VACCINATION SITE PAIN (pain and redness on the injection site) and VACCINATION SITE ERYTHEMA (pain and redness on the injection site). At the time of the report, HYPOTENSION (Blood pressure dropped very low), DIZZINESS (felt like fainting), VACCINATION SITE PAIN (pain and redness on the injection site) and VACCINATION SITE ERYTHEMA (pain and redness on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Blood pressure measurement: dropped very low. On an unknown date, Antibody test: >150.         No relevant concomitant medications were reported. After the 2nd primary shot and after the First Moderna Booster and after Pfizer Booster, within 24 hours after the shot, her Blood pressure dropped very low and she felt like fainting. The patient had pain and redness on the injection site. No treatment information was provided.     This case was linked to MOD-2021-023445, MOD-2021-662209 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Blood pressure measurement, Dizziness, Hypotension, Vaccination site erythema
Clinical narrative: Blood pressure dropped very low; felt like fainting; pain and redness on the injection site; pain and redness on the injection site; This spontaneous case was reported by a patient and describes the occurrence of HYPOTENSION (Blood pressure dropped very low), DIZZINESS (felt like fainting), VACCINATION SITE PAIN (pain and redness on the injection site) and VACCINATION SITE ERYTHEMA (pain and redness on the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 042L20A and 011J20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced HYPOTENSION (Blood pressure dropped very low), DIZZINESS (felt like fainting), VACCINATION SITE PAIN (pain and redness on the injection site) and VACCINATION SITE ERYTHEMA (pain and redness on the injection site). At the time of the report, HYPOTENSION (Blood pressure dropped very low), DIZZINESS (felt like fainting), VACCINATION SITE PAIN (pain and redness on the injection site) and VACCINATION SITE ERYTHEMA (pain and redness on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Blood pressure measurement: dropped very low. On an unknown date, Antibody test: >150.         No relevant concomitant medications were reported. After the 2nd primary shot and after the First Moderna Booster and after Pfizer Booster, within 24 hours after the shot, her Blood pressure dropped very low and she felt like fainting. The patient had pain and redness on the injection site. No treatment information was provided.     This case was linked to MOD-2021-023445, MOD-2021-662209 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Blood pressure dropped very low; felt like fainting; pain and redness on the injection site; pain and redness on the injection site; This spontaneous case was reported by a patient and describes the occurrence of HYPOTENSION (Blood pressure dropped very low), DIZZINESS (felt like fainting), VACCINATION SITE PAIN (pain and redness on the injection site) and VACCINATION SITE ERYTHEMA (pain and redness on the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 042L20A and 011J20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced HYPOTENSION (Blood pressure dropped very low), DIZZINESS (felt like fainting), VACCINATION SITE PAIN (pain and redness on the injection site) and VACCINATION SITE ERYTHEMA (pain and redness on the injection site). At the time of the report, HYPOTENSION (Blood pressure dropped very low), DIZZINESS (felt like fainting), VACCINATION SITE PAIN (pain and redness on the injection site) and VACCINATION SITE ERYTHEMA (pain and redness on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Blood pressure measurement: dropped very low. On an unknown date, Antibody test: >150.         No relevant concomitant medications were reported. After the 2nd primary shot and after the First Moderna Booster and after Pfizer Booster, within 24 hours after the shot, her Blood pressure dropped very low and she felt like fainting. The patient had pain and redness on the injection site. No treatment information was provided.     This case was linked to MOD-2021-023445, MOD-2021-662209 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Breast pain, Groin pain, Lymphadenopathy, Rash
Clinical narrative: Lymph Node Swollen and leaking in groin
Age: 69.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Discharge, Lymphadenopathy
Clinical narrative: Lymph Node Swollen and leaking in groin
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Loss of vision; Cataract; That arm would be severely painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; OMEPRAZOLE. Vaccination history included: coviD-19 vaccine (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 30Mar2021, when the patient was 50-year-old, for COVID-19 immunization, reaction(s): "COVID test result=Positive". The following information was reported: CATARACT (medically significant) with onset 28Apr2021 at 06:00, outcome "recovered" (2022); BLINDNESS (medically significant) with onset 28Apr2021 at 06:00, outcome "recovered" (2022), described as "Loss of vision"; PAIN IN EXTREMITY (non-serious) with onset 28Apr2021 at 06:00, outcome "recovered" (2022), described as "That arm would be severely painful". The events "loss of vision", "cataract" and "that arm would be severely painful" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of blindness, cataract, pain in extremity.  Additional information: No other vaccine given in four weeks. Other medications in two weeks include multivitamin. Patient slowly lost use of injection arm and using that arm would be severely painful. Also a rare fast developing clear type cataract in both eyes causing loss of vision. AE resulted in [Doctor or other healthcare professional office/clinic visit]. AE treatment Medication & Surgery. No COVID prior vaccination and COVID was tested post vaccination. Other medical history: none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Cataract, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Loss of vision; Cataract; That arm would be severely painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2021 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN; OMEPRAZOLE. Vaccination history included: coviD-19 vaccine (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 30Mar2021, when the patient was 50-year-old, for COVID-19 immunization, reaction(s): "COVID test result=Positive". The following information was reported: CATARACT (medically significant) with onset 28Apr2021 at 06:00, outcome "recovered" (2022); BLINDNESS (medically significant) with onset 28Apr2021 at 06:00, outcome "recovered" (2022), described as "Loss of vision"; PAIN IN EXTREMITY (non-serious) with onset 28Apr2021 at 06:00, outcome "recovered" (2022), described as "That arm would be severely painful". The events "loss of vision", "cataract" and "that arm would be severely painful" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of blindness, cataract, pain in extremity.  Additional information: No other vaccine given in four weeks. Other medications in two weeks include multivitamin. Patient slowly lost use of injection arm and using that arm would be severely painful. Also a rare fast developing clear type cataract in both eyes causing loss of vision. AE resulted in [Doctor or other healthcare professional office/clinic visit]. AE treatment Medication & Surgery. No COVID prior vaccination and COVID was tested post vaccination. Other medical history: none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Wrong product administered
Clinical narrative: Patient filled out consent form for influenza vaccine. It was verified to patient by RN 3 times that patient was receiving flu vaccination. She received flu vaccine and then stated she wanted a covid booster and had already received a flu vaccine on 9/19/22.
Age: 68.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient filled out consent form for influenza vaccine. It was verified to patient by RN 3 times that patient was receiving flu vaccination. She received flu vaccine and then stated she wanted a covid booster and had already received a flu vaccine on 9/19/22.
Age: 64.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19-2, FLUA4
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Hypopnoea
Clinical narrative: body aches, fever, chills, rapid heart rate, fatigue, sweats, headaches
Age: 64.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19-2, FLUA4
Symptoms: Palpitations, Pyrexia
Clinical narrative: body aches, fever, chills, rapid heart rate, fatigue, sweats, headaches
Age: 64.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19-2, FLUA4
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: body aches, fever, chills, rapid heart rate, fatigue, sweats, headaches
Age: 64.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19-2, FLUA4
Symptoms: Pain, Pyrexia
Clinical narrative: body aches, fever, chills, rapid heart rate, fatigue, sweats, headaches
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Ten-week Calculation of the expiration of the vaccine from the date of receipt to the pharmacy was greater than the manufacturers expiration date, 10/21/2022, if I recall correctly, and was the date labeled on the vaccine upon receipt. Vaccine was provided with the understanding that the expiration date of the vaccine was 10/21/2022
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Ten-week Calculation of the expiration of the vaccine from the date of receipt to the pharmacy was greater than the manufacturers expiration date, 10/21/2022, if I recall correctly, and was the date labeled on the vaccine upon receipt. Vaccine was provided with the understanding that the expiration date of the vaccine was 10/21/2022
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Headache, Impaired work ability, Lip disorder, Nausea
Clinical narrative: 2 HOURS AFTER INJECTION I COULD WALK.  I LAID ON THE COUCH TOOK A NAP., WHEN I WOKE UP HAD A HEADACHE AND.  STILL COULDN'T WALK. I ROLLED AROUND ON THE FLOOR AND FINALLY HAD MY KIDS HELP ME UP.  FELT NAUSEOUS THROUGH UP ANY BREAKFAST, WENT BACK TO SLEEP.  TOOK THE NEXT DAY OFF FROM WORK, STILL COULDNT WALK.  THAT NIGHT THE BOTTOM OF MY LAGS AND FEET WERE STINGING AND THROBING AND HAVE CONTINUED TO HURT EVER SINCE .  EVERY NIGHT MY LEGS HURT AND FEET STING.  ALSO ABOUT 3 WEEKS LATER MY UPPER LIP WAS DEAD.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: 2 HOURS AFTER INJECTION I COULD WALK.  I LAID ON THE COUCH TOOK A NAP., WHEN I WOKE UP HAD A HEADACHE AND.  STILL COULDN'T WALK. I ROLLED AROUND ON THE FLOOR AND FINALLY HAD MY KIDS HELP ME UP.  FELT NAUSEOUS THROUGH UP ANY BREAKFAST, WENT BACK TO SLEEP.  TOOK THE NEXT DAY OFF FROM WORK, STILL COULDNT WALK.  THAT NIGHT THE BOTTOM OF MY LAGS AND FEET WERE STINGING AND THROBING AND HAVE CONTINUED TO HURT EVER SINCE .  EVERY NIGHT MY LEGS HURT AND FEET STING.  ALSO ABOUT 3 WEEKS LATER MY UPPER LIP WAS DEAD.
Age: 8.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Dizziness, Face injury, Fall, Loss of consciousness
Clinical narrative: VACCINES ADMINISTERED BY NURSE, RN. HER REPORT WAS AS FOLLOWS: PT PASSED OUT SHORTLY AFTER VACCINE ADMINISTRATION, APPROXIMATELY 2 MINUTES AFTER. SCRAPED CHIN WHEN SHE FELL. PLACED PT ON GROUND AND ELEVATED FEET ON CHAIR. CAME TO AFTER ABOUT 5 SECONDS. ENCOURAGED FLUIDS, REST. NO C/O DIZZINESS & NORMAL HR WHEN LEAVING. PATIENT SAID SHE FELT DIZZY RIGHT BEFORE PASSING OUT. MOM IS A PHARMACIST, TALKED WITH HER ABOUT WHEN TO CALL DOC IF CONCERNED ABOUT PATIENT.
Age: 20.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain, Chest pain, Fatigue, Gastrointestinal pain, Headache
Clinical narrative: I did not seek treatment for the reactions but I had a fever, fatigue, chest pains, severe abdominal pain, pain in my lower intestine, headache, aches, and nausea.
Age: 20.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: I did not seek treatment for the reactions but I had a fever, fatigue, chest pains, severe abdominal pain, pain in my lower intestine, headache, aches, and nausea.
Age: 31.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Chest X-ray normal, Chest pain, Dizziness, Electrocardiogram normal, Nausea
Clinical narrative: At 2 am I was awaken by sudden chest pain, a dull ache in the center of my chest, heart palpitations, dizzy, nausea, light headedness, pain in left arm and chest pain that got worse when laying down.  I went to the hospital because I thought it was a heart attack. EKG and chest x-Ray showed no obvious signs and I was discharged and told to take ibuprofen for pain and follow up with my primary care doctor.
Age: 31.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Pain in extremity, Palpitations
Clinical narrative: At 2 am I was awaken by sudden chest pain, a dull ache in the center of my chest, heart palpitations, dizzy, nausea, light headedness, pain in left arm and chest pain that got worse when laying down.  I went to the hospital because I thought it was a heart attack. EKG and chest x-Ray showed no obvious signs and I was discharged and told to take ibuprofen for pain and follow up with my primary care doctor.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Acute kidney injury, Agitation, Alanine aminotransferase normal, Aspartate aminotransferase increased, Blood albumin decreased
Clinical narrative: The patient developed delirium, worsening falls with fever.  She was admitted and underwent LP with elevated protein.  She was discharged and returned on October 25, 2022 and admitted to ICU with worsening agitated delirium, acute renal injury, and lactic acidosis.  ICU service consulted this evening to assist with her complexity and agitated delirium.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blood alkaline phosphatase increased, Blood bilirubin increased, Blood creatinine increased, Blood magnesium, Blood phosphorus normal
Clinical narrative: The patient developed delirium, worsening falls with fever.  She was admitted and underwent LP with elevated protein.  She was discharged and returned on October 25, 2022 and admitted to ICU with worsening agitated delirium, acute renal injury, and lactic acidosis.  ICU service consulted this evening to assist with her complexity and agitated delirium.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blood potassium increased, Blood sodium decreased, Blood urea increased, CSF protein increased, Carbon dioxide decreased
Clinical narrative: The patient developed delirium, worsening falls with fever.  She was admitted and underwent LP with elevated protein.  She was discharged and returned on October 25, 2022 and admitted to ICU with worsening agitated delirium, acute renal injury, and lactic acidosis.  ICU service consulted this evening to assist with her complexity and agitated delirium.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Cardiomegaly, Cholelithiasis, Computerised tomogram abdomen abnormal, Delirium, Faecal volume increased
Clinical narrative: The patient developed delirium, worsening falls with fever.  She was admitted and underwent LP with elevated protein.  She was discharged and returned on October 25, 2022 and admitted to ICU with worsening agitated delirium, acute renal injury, and lactic acidosis.  ICU service consulted this evening to assist with her complexity and agitated delirium.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Fall, Gallbladder disorder, Haemoglobin decreased, Hepatic cirrhosis, Intensive care
Clinical narrative: The patient developed delirium, worsening falls with fever.  She was admitted and underwent LP with elevated protein.  She was discharged and returned on October 25, 2022 and admitted to ICU with worsening agitated delirium, acute renal injury, and lactic acidosis.  ICU service consulted this evening to assist with her complexity and agitated delirium.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: International normalised ratio increased, Laboratory test, Lactic acidosis, Lumbar puncture abnormal, Platelet count normal
Clinical narrative: The patient developed delirium, worsening falls with fever.  She was admitted and underwent LP with elevated protein.  She was discharged and returned on October 25, 2022 and admitted to ICU with worsening agitated delirium, acute renal injury, and lactic acidosis.  ICU service consulted this evening to assist with her complexity and agitated delirium.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Pleural effusion, Pleural thickening, Portal hypertension, Pyrexia, Splenomegaly
Clinical narrative: The patient developed delirium, worsening falls with fever.  She was admitted and underwent LP with elevated protein.  She was discharged and returned on October 25, 2022 and admitted to ICU with worsening agitated delirium, acute renal injury, and lactic acidosis.  ICU service consulted this evening to assist with her complexity and agitated delirium.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: White blood cell count normal
Clinical narrative: The patient developed delirium, worsening falls with fever.  She was admitted and underwent LP with elevated protein.  She was discharged and returned on October 25, 2022 and admitted to ICU with worsening agitated delirium, acute renal injury, and lactic acidosis.  ICU service consulted this evening to assist with her complexity and agitated delirium.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Computerised tomogram abnormal, Nephrolithiasis, Pain
Clinical narrative: Right side abdominal pain started night of 10/19/2022, improved the next day, then started again at night and was worse, again improved the next day, then started again morning of 10/22/2022, went to emergency room, diagnosed by CT with 2 mm kidney stone on right side nearing bladder. Given oxycodone for pain and FloMax to flush urinary system. Pain on and off since 10/22/2022. Will follow up with urologist on 10/31/2022.
Age: 65.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Body temperature increased, Breast pain, Cardiac disorder, Electric shock sensation, Hypoaesthesia
Clinical narrative: Right leg: Lightening strikes down back side of the leg. Mid-thigh to mid-calf. Electrical shock beginning at thigh and ending at calf. Jolting, shocking, irritating jolts. 6 or 8 of them. Occurred over 5-10 minutes while seated at a computer. Never felt before or since. Edema in both feet/ankles for 2 years. Numb big toes.  Separately at a later time sitting on toilet: deep breath, lung expands and touches a needle poking in my left breast near the nipple. (there is no needle). Surprised recoil. Cautious deep breath: again, needle sharp pain like a needle piecing a balloon. Scared to walk, maybe a heart attach? But no pain in arms, no shortness of breath, no other symptoms. Walked to other room to get cell phone to be ready to call 911. Then it's gone and never returned. No pain. Hugh breaths and no problem. Another time: heart feels like it's going to begin atrial fibrillation / tachycardia, but it doesn't happen. Heart feels very labored and tired. I've had tachycardia for 50 years, so I know what it feels like. This one was tachycardia without the fast heartbeat (135). Although heartbeat did go to 122 at one point. Went away after a half hour or so. Temp to 100.6. No cough's, no runny nose, no other symptoms. All symptoms occurred during the 3 days. Heartbeat went to 122, down to 57 and then back up to 100 again. Recovered without aid or medication.
Age: 65.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Oedema peripheral
Clinical narrative: Right leg: Lightening strikes down back side of the leg. Mid-thigh to mid-calf. Electrical shock beginning at thigh and ending at calf. Jolting, shocking, irritating jolts. 6 or 8 of them. Occurred over 5-10 minutes while seated at a computer. Never felt before or since. Edema in both feet/ankles for 2 years. Numb big toes.  Separately at a later time sitting on toilet: deep breath, lung expands and touches a needle poking in my left breast near the nipple. (there is no needle). Surprised recoil. Cautious deep breath: again, needle sharp pain like a needle piecing a balloon. Scared to walk, maybe a heart attach? But no pain in arms, no shortness of breath, no other symptoms. Walked to other room to get cell phone to be ready to call 911. Then it's gone and never returned. No pain. Hugh breaths and no problem. Another time: heart feels like it's going to begin atrial fibrillation / tachycardia, but it doesn't happen. Heart feels very labored and tired. I've had tachycardia for 50 years, so I know what it feels like. This one was tachycardia without the fast heartbeat (135). Although heartbeat did go to 122 at one point. Went away after a half hour or so. Temp to 100.6. No cough's, no runny nose, no other symptoms. All symptoms occurred during the 3 days. Heartbeat went to 122, down to 57 and then back up to 100 again. Recovered without aid or medication.
Age: 20.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Fatigue, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Low grade fever (99 degrees), fatigue, sore arm, sore throat
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; An improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.    On 06-JUL-2022, the patient was vaccinated with an improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter, lot number 1879870 with expiration date 16-OCT-2023, administered orally for prophylaxis (strength and vaccination scheme were not provided) (product storage error).   The administered vaccine experienced a temperature excursion at 34.5 fahrenheit (F) for 1 hour 7 minutes 0 seconds. Also, was reported a previous temperature excursion of 66.7 fahrenheit (F) for 13 hours 52 minutes 0 seconds. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005936: US-009507513-2210USA005917: US-009507513-2210USA005916: US-009507513-2210USA005624: US-009507513-2210USA005916: US-009507513-2210USA005979: US-009507513-2210USA005942: US-009507513-2210USA005994: US-009507513-2210USA005996: US-009507513-2210USA006007:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE.; An improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.    On 19-JUL-2022, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milliliter, lot number W007371 with expiration date 13-JUL-2023, administered for prophylaxis (strength, vaccination scheme, route of administration and anatomical site of application were not provided)  The administered vaccine experienced a temperature excursion at 34.5 fahrenheit (F) for 1 hour 7 minutes 0 seconds. Also, was reported a previous temperature excursion of 66.7 fahrenheit (F) for 13 hours 52 minutes 0 seconds. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005917:MSD US-009507513-2210USA005937: US-009507513-2210USA005929: US-009507513-2210USA005979: US-009507513-2210USA005936: US-009507513-2210USA005916: US-009507513-2210USA005994: US-009507513-2210USA005996: US-009507513-2210USA006007: US-009507513-2210USA005624:
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE informantion reported; Nurse requesting information on stability of MMRII dose that was administered after expiration date to a 20 year old female. She confirmed that the vaccine had not undergone any temperature excursions. She did not have the lot number at the time of t; MMRII dose that was administered after expiration date to a 20 year old female.; This spontaneous report has been received from a nurse and refers to a 20-year-old female patient. The patient's medical history, concurrent conditions, previous drug allergies or reactions, and concomitant therapies were not reported.  On 14-OCT-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 ml, lot  number T034392, expiration date reported and internal validated as 08-OCT-2022, administered for prophylaxis (strength, anatomical site of administration, and route of administration were not provided) (expired product administered). The patient was 20-year-old at the time of vaccination (product administered to patient of inappropriate age). No additional adverse event reported.
Age: 49.0
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse events were reported; Patient who was already immune received a dose of RECOMBIVAX on 10/4/2022.; This spontaneous report has been received from a nurse prescriber referring a 49-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 04-OCT-2022, the patient was already immune and was vaccinated with 1 dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (lot number K9H5S with reported expiration date 03-OCT-2024 is not valid for hepatitis b vaccine (recombinant) (RECOMBIVAX HB)), (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (extra dose administered). No additional adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a second dose of PNEUMOVAX 23 to a patient 4 years and 5 months after the 1st dose; no adverse event; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies details were not reported.  On an unknown date, the patient was vaccinated with a first dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unknown date, reported as after 4 years and 5 months, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (inappropriate schedule of vaccine administration). No further information was provided. No additional adverse event or product quality complaint was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional adverse event; VARIAX was inadvertently administered after being improperly stored and expired.; VARIAX was inadvertently administered after being improperly stored and expired.; This spontaneous report has been received from a pharmacist referring a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. Concurrent conditions and medical history and were not reported.  On 19-OCT-2022, the patient was vaccinated with an expired and improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number T002843 with expiration date 23-JAN-2022, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (product storage error and expired product administered).   The vaccine administered experienced a temperature excursion of 5 celsius (C), for 336 hours. There was no previous temperature excursion. No additional adverse event reported.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: pain during the injection, described by him as a 6 on a scale from 1-10 (10 being th worst); This spontaneous report was received from a patient's mother who is a company representative and refers to a 12-year-old male patient. His medical history, concurrent conditions and concomitant therapies details were not reported.  On 20-OCT-2022, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On the same date, the patient experienced pain during the injection, described by him as a 6 on a scale from 1-10 (10 being the worst), which resolved 5 minutes post injection.   The causal relationship between the event and suspected vaccine was not reported.
Age: 0.75
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; 9 Month Old Patient was administered expired VAQTA on 10/18/2022; This spontaneous report has been received from a nurse, concerning 9-months-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 18-10-2022, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (valid lot number U024505 [expiration date 15-OCT-2022]) for prophylaxis (expired product administered). No previous temperature excursion was reported.   No additional adverse events (AE) were reported.