chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID: A 3-year-old male patient received BNT162b2 (BNT162B2), on 02Aug2022 as dose 2 (maroon cap), single (Lot number: FT9142, Expiration Date: 01Sep2022) at the age of 3 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Batch/Lot#: FT9142, Anatomical Site of Injection: Left deltoid), administration date: 12Jul2022, for COVID-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 02Aug2022, outcome "unknown" and all described as "The dose was not diluted"; PAIN IN EXTREMITY (non-serious) with onset 02Aug2022, outcome "recovered" (2022), described as "arm sore the evening of the overdose"; PYREXIA (non-serious) with onset 03Aug2022, outcome "recovered" (2022), described as "had fever last night (temperature not provided)". Additional information: It was reported by RN about a three-year-old male patient who received his second dose of the maroon cap. Warm transfer from [withheld] with Support, CEP: 159558 with a health care provider/vaccine provider on the line to report adverse event where they had a patient who was administered the Pfizer COVID-19 vaccine maroon cap without a diluent. They have a medical information question, want to ask for some guidance to notify the family of the patient. She clarified that she was a nurse, provided by inbound transfer agent only as healthcare provider/vaccine provider. She clarified that this patient was administered a dose without diluent of Pfizer COVID-19 vaccine, maroon cap formulation. She clarified that their medical director will probably want to know a little more, so she wanted to get guidance regarding this event to provide to the medical director. She reported there has been no testing, treatment or medical intervention relative to this event that she was aware of. Upon follow-up on 04Aug2022, she spoke with the mom this morning who reported that the patient's arm sore the evening of the overdose and he also had fever last night (temperature not provided). Mom said he was fine today, so the reporter considered the events resolved.  No follow-up attempts are possible. No further information is expected. Follow-up (04Aug2022): New information received from a contactable Nurse. This Nurse reported in response to HCP telephonic follow-up activity which included. Updated information included: New reporter slider added. New historical vaccine (none) and historical vaccine notes. Vaccine Facility Information, new events added (Pain in arm and Fever) were added. No follow-up attempts are possible. No further information is expected.
Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team, Program ID: A 3-year-old male patient received BNT162b2 (BNT162B2), on 02Aug2022 as dose 2 (maroon cap), single (Lot number: FT9142, Expiration Date: 01Sep2022) at the age of 3 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Batch/Lot#: FT9142, Anatomical Site of Injection: Left deltoid), administration date: 12Jul2022, for COVID-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 02Aug2022, outcome "unknown" and all described as "The dose was not diluted"; PAIN IN EXTREMITY (non-serious) with onset 02Aug2022, outcome "recovered" (2022), described as "arm sore the evening of the overdose"; PYREXIA (non-serious) with onset 03Aug2022, outcome "recovered" (2022), described as "had fever last night (temperature not provided)". Additional information: It was reported by RN about a three-year-old male patient who received his second dose of the maroon cap. Warm transfer from [withheld] with Support, CEP: 159558 with a health care provider/vaccine provider on the line to report adverse event where they had a patient who was administered the Pfizer COVID-19 vaccine maroon cap without a diluent. They have a medical information question, want to ask for some guidance to notify the family of the patient. She clarified that she was a nurse, provided by inbound transfer agent only as healthcare provider/vaccine provider. She clarified that this patient was administered a dose without diluent of Pfizer COVID-19 vaccine, maroon cap formulation. She clarified that their medical director will probably want to know a little more, so she wanted to get guidance regarding this event to provide to the medical director. She reported there has been no testing, treatment or medical intervention relative to this event that she was aware of. Upon follow-up on 04Aug2022, she spoke with the mom this morning who reported that the patient's arm sore the evening of the overdose and he also had fever last night (temperature not provided). Mom said he was fine today, so the reporter considered the events resolved.  No follow-up attempts are possible. No further information is expected. Follow-up (04Aug2022): New information received from a contactable Nurse. This Nurse reported in response to HCP telephonic follow-up activity which included. Updated information included: New reporter slider added. New historical vaccine (none) and historical vaccine notes. Vaccine Facility Information, new events added (Pain in arm and Fever) were added. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  On 04-Jun-2022 the vials were initially stored in the refrigerator.  Vial did not undergone any temperature excursions.  No treatment information was provided.
Age: 61.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 09-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  On 04-Jun-2022 the vials were initially stored in the refrigerator.  Vial did not undergone any temperature excursions.  No treatment information was provided.
Age: 51.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Product use issue
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022).    No concomitant product use was reported.  Reportedly, Patient received half dose.  Date the vial was initially stored in the refrigerator was 04-Jun-2022.    Vial did not undergone any temperature excursions.  No treatment information was provided.
Age: 51.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022).    No concomitant product use was reported.  Reportedly, Patient received half dose.  Date the vial was initially stored in the refrigerator was 04-Jun-2022.    Vial did not undergone any temperature excursions.  No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: sore arm; She is coughing up a lot of stuff and blowing out stuff; congested; hoarse; having a hard time talking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2022 at 12:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "impaired immune system" (unspecified if ongoing), notes: Medical conditions: impaired immune system. The patient's concomitant medications were not reported. Vaccination history included: moderna (Dose 1, Manufacturer: Moderna , Date: 26Jan2021, LOT: 030L20A, EXP: 16Jul2021, Dose and Route: Unknown dose; route is left arm , Time: Believes 20:00), administration date: 26Jan2021, when the patient was 60-year-old, for Covid-19 immunization; moderna (Dose 2, Manufacturer: Moderna , Date: 23Feb2021, LOT: 013M20A, EXP: 31Jul2021, Dose and Route: Unknown dose; route is left arm , Time: About 18:30-18:45), administration date: 23Feb2021, when the patient was 60-year-old, for Covid-19 immunization; BNT162b2 (Dose 3, Manufacturer: Pfizer , Date: 18Nov2021, LOT: FH8030, Dose and Route: Unknown dose; given in left arm, Dose and Route: Unknown dose; given in left arm), administration date: 18Nov2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "sore arm", "She is coughing up a lot of stuff and blowing out stuff", "congested", "hoarse", "having a hard time talking"; Flu vaccine (Previous Fall had to get flu); Pneumonia vaccine (Second pneumonia). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; COUGH (non-serious), outcome "unknown", described as "She is coughing up a lot of stuff and blowing out stuff"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congested"; DYSPHONIA (non-serious), outcome "unknown", described as "hoarse"; SPEECH DISORDER (non-serious), outcome "unknown", described as "having a hard time talking". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed, No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphonia, Nasal congestion, Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; She is coughing up a lot of stuff and blowing out stuff; congested; hoarse; having a hard time talking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2022 at 12:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "impaired immune system" (unspecified if ongoing), notes: Medical conditions: impaired immune system. The patient's concomitant medications were not reported. Vaccination history included: moderna (Dose 1, Manufacturer: Moderna , Date: 26Jan2021, LOT: 030L20A, EXP: 16Jul2021, Dose and Route: Unknown dose; route is left arm , Time: Believes 20:00), administration date: 26Jan2021, when the patient was 60-year-old, for Covid-19 immunization; moderna (Dose 2, Manufacturer: Moderna , Date: 23Feb2021, LOT: 013M20A, EXP: 31Jul2021, Dose and Route: Unknown dose; route is left arm , Time: About 18:30-18:45), administration date: 23Feb2021, when the patient was 60-year-old, for Covid-19 immunization; BNT162b2 (Dose 3, Manufacturer: Pfizer , Date: 18Nov2021, LOT: FH8030, Dose and Route: Unknown dose; given in left arm, Dose and Route: Unknown dose; given in left arm), administration date: 18Nov2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "sore arm", "She is coughing up a lot of stuff and blowing out stuff", "congested", "hoarse", "having a hard time talking"; Flu vaccine (Previous Fall had to get flu); Pneumonia vaccine (Second pneumonia). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; COUGH (non-serious), outcome "unknown", described as "She is coughing up a lot of stuff and blowing out stuff"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congested"; DYSPHONIA (non-serious), outcome "unknown", described as "hoarse"; SPEECH DISORDER (non-serious), outcome "unknown", described as "having a hard time talking". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed, No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder
Clinical narrative: sore arm; She is coughing up a lot of stuff and blowing out stuff; congested; hoarse; having a hard time talking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2022 at 12:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "impaired immune system" (unspecified if ongoing), notes: Medical conditions: impaired immune system. The patient's concomitant medications were not reported. Vaccination history included: moderna (Dose 1, Manufacturer: Moderna , Date: 26Jan2021, LOT: 030L20A, EXP: 16Jul2021, Dose and Route: Unknown dose; route is left arm , Time: Believes 20:00), administration date: 26Jan2021, when the patient was 60-year-old, for Covid-19 immunization; moderna (Dose 2, Manufacturer: Moderna , Date: 23Feb2021, LOT: 013M20A, EXP: 31Jul2021, Dose and Route: Unknown dose; route is left arm , Time: About 18:30-18:45), administration date: 23Feb2021, when the patient was 60-year-old, for Covid-19 immunization; BNT162b2 (Dose 3, Manufacturer: Pfizer , Date: 18Nov2021, LOT: FH8030, Dose and Route: Unknown dose; given in left arm, Dose and Route: Unknown dose; given in left arm), administration date: 18Nov2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "sore arm", "She is coughing up a lot of stuff and blowing out stuff", "congested", "hoarse", "having a hard time talking"; Flu vaccine (Previous Fall had to get flu); Pneumonia vaccine (Second pneumonia). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; COUGH (non-serious), outcome "unknown", described as "She is coughing up a lot of stuff and blowing out stuff"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congested"; DYSPHONIA (non-serious), outcome "unknown", described as "hoarse"; SPEECH DISORDER (non-serious), outcome "unknown", described as "having a hard time talking". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed, No further information expected.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, MENB, MNQ
Symptoms: Blood glucose, Blood pressure measurement, Heart rate, Presyncope
Clinical narrative: PT WAS GIVEN COVID INJECTION ON RIGHT ARM THEN MENVEO AND MEN B ON LEFT ARM. AFTER ALL INJECTIONS PATIENT HAD VASOVAGUL SYNCOPE AND LOST CONSCIOUSNESS FOR 3-5 SECONDS. PATIENT WAS LAID DOWN, GIVEN ICE, SNACKS AND VITALS OBTAINED. PT WAS ALERT AND ORIENTED X3 AFTER COMING BACK TO. EVALUATED BY DR. AT BEDISIDE AND PATIENT STATED SHE WAS FINE AND FELT FINE AFTER RESTING.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, MENB, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: PT WAS GIVEN COVID INJECTION ON RIGHT ARM THEN MENVEO AND MEN B ON LEFT ARM. AFTER ALL INJECTIONS PATIENT HAD VASOVAGUL SYNCOPE AND LOST CONSCIOUSNESS FOR 3-5 SECONDS. PATIENT WAS LAID DOWN, GIVEN ICE, SNACKS AND VITALS OBTAINED. PT WAS ALERT AND ORIENTED X3 AFTER COMING BACK TO. EVALUATED BY DR. AT BEDISIDE AND PATIENT STATED SHE WAS FINE AND FELT FINE AFTER RESTING.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna as a Booster dose while not being eligible to receive a Moderna booster for her age group and was administered a vaccine that was past the beyond use date.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the beyond use date.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the beyond use date.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after the beyond use date.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was given after the beyond use date
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after the beyond use date.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given past the beyond use date.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after the beyond use date.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after the beyond use date
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after the beyond use date.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Crying, Gait inability, Hypoaesthesia
Clinical narrative: Low back pain with numbness in left leg. Now spasticity in both feet/legs. Cannot walk without a walker. Need help with bathroom/shower; cannot drive. Taking pain medication, nerve control medication and muscle relaxant. Nothing helps. Did 3 MRIs and need to do 2 more next week. Saw multiple doctors. No one can diagnose what I have. I will have to lose my job because of these vaccines. It destroyed my life. My son is 12 and sees me crying all the time.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Impaired work ability, Loss of personal independence in daily activities, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: Low back pain with numbness in left leg. Now spasticity in both feet/legs. Cannot walk without a walker. Need help with bathroom/shower; cannot drive. Taking pain medication, nerve control medication and muscle relaxant. Nothing helps. Did 3 MRIs and need to do 2 more next week. Saw multiple doctors. No one can diagnose what I have. I will have to lose my job because of these vaccines. It destroyed my life. My son is 12 and sees me crying all the time.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasticity, Walking aid user
Clinical narrative: Low back pain with numbness in left leg. Now spasticity in both feet/legs. Cannot walk without a walker. Need help with bathroom/shower; cannot drive. Taking pain medication, nerve control medication and muscle relaxant. Nothing helps. Did 3 MRIs and need to do 2 more next week. Saw multiple doctors. No one can diagnose what I have. I will have to lose my job because of these vaccines. It destroyed my life. My son is 12 and sees me crying all the time.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after the beyond use date.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was given after the beyond use date.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Dermatitis, Skin swelling
Clinical narrative: With each COVID-19 vaccination my skin had became a little itchy (pin prickly) and inflamed, getting worse with each vaccination. After this 4th dose, my skin became swollen and inflamed. I went to Urgent Care and was diagnosed with Cellulitis. I was prescribed Cephalexin 2000mg X 10 days.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Patient that was administered an expired dose of MMR II on 09JUL2022; This spontaneous report was received from a pharmacy intern and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-JUL-2022, the patient was administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), subcutaneous injection, lot # T020655, expiration date: 16-JUN-2022, administered for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered). No additional adverse events (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additonal AE's; an improperly stored MMR II vaccine was administered to a patient.; This spontaneous report was received from a medical assistant and referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On 13-JUL-2022, the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) subcutaneous injection, lot #U022175, expiration date: 14-JUL-2023 (strength, dose, and route of administration were not provided), used as directed to prevent measles, mumps and rubella infection. The vaccines underwent the temperature excursion of 10 degree Celsius (C) for 57 hours (Product storage error). There was no previous temperature excursions. There was no additional adverse event.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No adverse event; Patient was administered expired GARDASIL 9 on 07/12/2022; This spontaneous report was received from a nurse referring to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 12-JUL-2022, the patient was vaccinated with expired vaccine of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #1637648, expiration date: 19-JUN-2022) for prophylaxis (dose, strength, anatomical location and route of administration were not provided) (expired product administered). There was no temperature excursion reported for affected product as confirmed by reporter at current call time. No adverse event was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no AE; MMRII with a labeled expiry of 5/29/2022 was administered to 6 patients on various dates; This spontaneous report was received from an office manager via employee, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, and concomitant therapies were not reported.  On 09-JUN-2022, the patient was vaccinated with one dose (quality: 1) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin (rHA)) subcutaneous injection, 0.5 milliliter, lot #T018669, expiration date: 29-MAY-2022 (strength, route of administration and anatomical location were not provided) administered for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).  This is the one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007188: US-009507513-2207USA007049: US-009507513-2207USA007041: US-009507513-2207USA007043: US-009507513-2207USA007052:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient had no adverse effects or other symptoms as a result of administration; Vaccine was administered following multiple temperature excursions; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, previous drug reactions or allergies were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 22-JUN-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-Merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) 0.5ml once, lot number W006583, expiration date 23-AUG-2023 (strength, route of administration, and anatomical location were not provided) administered as prophylaxis.  The measles, mumps, rubella and varicella (oka-Merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) vaccine experienced multiple temperature excursions: on 11-MAY-2022 was stored at a temperature of 5.7 degrees Fahrenheit (F) for 7 minutes, 27-MAY-2022 5.7 F for 5 minutes, 06-JUN-2022 5.9 F for 6 minutes, 09-JUN-2022 5.4 F for 4 minutes, 14-JUN-2022 5.7 F for 7 minutes, 17-JUN-2022 29.1 F for 39 minutes, 20-JUN-2022 7.2 F for 10 minutes, and 22-JUN-2022 8.4 F for 15 minutes. Total excursion time was 96 minutes. No temperature excursion occurred prior to 11-MAY-2022.  No additional adverse events were reported  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007867: US-009507513-2207USA007847: US-009507513-2207USA007985: US-009507513-2207USA007729: US-009507513-2207USA007826: US-009507513-2207USA008018: US-009507513-2207USA007975: US-009507513-2207USA008097: US-009507513-2207USA007928: US-009507513-2207USA007847:
Sex: U
Vaccine: MMRV, UNK
Symptoms: Product storage error
Clinical narrative: No other adverse event reported; the patient received this vaccine following the excursions; This spontaneous report has been received from an office manager, referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was not provided.  Between 11-MAY-2022 and 28-JUN-2022, there were reported temperature excursions registered for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) total excursion time was 96 minutes. On 11-MAY-2022, a temperature of 5.7 Fahrenheit degrees (F) for 7 minutes, on 27-MAY-2022 a temperature of 5.7 F for 5 minutes, on 06-JUN-2022, a temperature of 5.9  F for 6 minutes, on 09-JUN-2022 a temperature of 5.4  F for 4 minutes, on 14-JUN-2022  a temperature of 5.7  F for 7 minutes, on 17-JUN-2022 a temperature of 29.1 F for 39 minutes, on 20-JUN-2022  a temperature of 7.2 F for 10 minutes, on 22-JUN-2022 a temperature of 8.4 F for 15 minutes, and on 28-JUN-2022 a temperature of 5.2 F for 3 minutes.   On 20-JUL-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) at a dose of 0.5ml once, lot number W006583, expiration date: 23-AUG-2023 (route of administration, and anatomical location were not provided) administered for prophylaxis following a temperature excursion for total time of 96 minutes (product storage error). Additionally, the patient was administered sterile diluent, solution for injection/infusion, (strength, dose, lot #, expiry date, route of administration, and indication were not provided). The patient had no adverse effect or other symptoms as a result of the vaccine administration (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2207USA007832: US-009507513-2207USA007867: US-009507513-2207USA007985: US-009507513-2207USA007729: US-009507513-2207USA007826: US-009507513-2207USA008018: US-009507513-2207USA008097: US-009507513-2207USA007975: US-009507513-2207USA007928: US-009507513-2207USA007867:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Patient administered vaccine after a temperature excursion.; This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 27-JUL-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot # U025789 confirmed to be valid with an expiration date 19-AUG-2023 (exact dose, route of administration, anatomical location were not reported) for prophylaxis. The vaccine underwent a temperature excursion of - 13.994 degrees Celsius (C) for 1 hour and 20 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event, Social problem
Clinical narrative: she received her first dose of GARDASIL 9 in February of 2020 and due to COVID-19 never completed the series; No additional AE; This spontaneous report was received from a female patient of unspecified age, reporting on herself. Her medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in February 2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis.  On an unknown date, the patient called to report that she was at the pharmacy store trying to restart series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) which due to coronavirus disease-19 (COVID-19) never completed the vaccination schedule, and for that was requesting to restart the series (Inappropriate schedule of product administration). No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called to report administration of ROTATEQ after unreported temperature excursion; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender.  The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  On approximately 18-JUL-2022 (also reported as "the week of 18-JUL-2022"), 2 vials, 2 ml 3 doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a temperature excursion for an unspecified amount of time and temperature.  On an unspecified date in July 2022, the patients were vaccinated with doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dosage regimen, route of administration, lot #, and expiry date were not provided) as prophylaxis (improper storage of product in use). There were no adverse events reported.  This is a non-valid case due to lack of patients' identifiers.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs/; the patient received ROTATEQ at 6 months.; the patient received ROTATEQ at 6 months; This spontaneous report was received from a physician, referring to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Approximately in July 2022, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), orally (dose, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration, product administered to patient of inappropriate age). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs/no PQCs.; HCP called in to report a temperature excursion and also reported that the vaccine, MMR- II was administered.; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 01-AUG-2022, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) lot #: U022175, expiration date: 14-JUL-2023 (exact dose, formulation, strength, site and route of administration were not provided) for prophylaxis. There was no additional adverse event reported.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AEs; temperature excursion and also reported that the vaccine, VAQTA was administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 01-AUG-2022, the patient was vaccinated with a dose of improperly stored Hepatitis A Vaccine, Inactivated (VAQTA) lot # U033212, expiration date 07-NOV-2022 (dose and exact anatomical locations were not reported). Administered dose of vaccine experienced an unspecified temperature excursion (product storage error). No additional adverse events were reported.
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site swelling, Wound secretion
Clinical narrative: Reddish swollen area all around place of vaccination, its oozing a little bit; Reddish swollen area all around place of vaccination, its oozing a little bit; Reddish swollen area all around place of vaccination, its oozing a little bit; A spontaneous report was received from a patient on 24JUN2022.  An adult male developed "reddish swollen area all around place of vaccination, its oozing a little bit" (PT: Injection site erythema, PT: Injection site swelling, and PT: Wound secretion) following immunisation with ACAM2000 (smallpox vaccine, live) (lot number: unknown). It was reported that the patient got ACAM2000 last Thursday (16JUN2022) at 7 o'clock. It was reported that on 23JUN2022 he had a check-up, and he was informed that everything looked fine. While today (at the time of reporting), when the patient was going to take a shower, he noticed that there was a reddish swollen area all around the place of vaccination which was oozing a little bit. The patient had not recovered from the reported events at the time of this report.  The patient also confirmed that he had been vaccinated as a child.  Action taken with ACAM2000 with respect to the reported events was not applicable.  No additional information was reported.  Company comment: A consumer received ACAM2000 and after about 7 days developed reddish swollen area all around place of vaccination, and it's oozing a little bit (injection site erythema, injection site swelling, and wound secretion). Considering the case information, the causality of injection site erythema, injection site swelling, and wound secretion is assessed as possible with ACAM2000 (its role cannot be ruled out).; Sender's Comments: A consumer received ACAM2000 and after about 7 days developed reddish swollen area all around place of vaccination, and it's oozing a little bit (injection site erythema, injection site swelling, and wound secretion). Considering the case information, the causality of injection site erythema, injection site swelling, and wound secretion is assessed as possible with ACAM2000 (its role cannot be ruled out).
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: Terrible stomach pain; A spontaneous report was received from the patient on 25JUN2022. It described a 60-year-old female patient (height: 165.1 cm/65 inches, weight: 66.678 kgs/147 pounds) who experienced "terrible stomach pain" (PT: Abdominal pain upper) following administration of oral Vivotif (Typhoid vaccine live oral Ty21A) (lot number: unknown) for travel. It was reported that on 24JUN2022 (Friday), the patient took the first dose of Vivotif and it was in total 4 tablets (one every other day). Reportedly, as soon as the patient took the first dose of Vivotif, she experienced terrible stomach ache so, she asked "should she discontinue taking it or continue". The patient had not recovered from the reported event at the time of this report.   Furthermore, it was reported that she would take the second tablet on Sunday (26JUN2022).  Medical history included acid reflux. The patient had no allergies.   The patient took Ibuprofen (600 mg) for ache, which was prescribed to her a long time ago and for in case she was tired (as needed), and Prilosec (omeprazole; as needed) for acid reflux.  Action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a consumer experienced terrible stomach pain (abdominal pain upper) as soon as she took the first dose of Vivotif. Considering the case information, the causality of abdominal pain upper is assessed as possible with Vivotif (its role cannot be ruled out).; Sender's Comments: It was reported that a consumer experienced terrible stomach pain (abdominal pain upper) as soon as she took the first dose of Vivotif. Considering the case information, the causality of abdominal pain upper is assessed as possible with Vivotif (its role cannot be ruled out).
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Wrong technique in product usage process
Clinical narrative: Completed only 3 out of the 4 Vivotif doses as he accidentally bit into the fourth capsule/ he won't be taking it; Accidentally bit into the fourth capsule; A spontaneous report was received from a nurse on 29JUN2022. It described a male patient (unknown age) who "completed only 3 out of the 4 Vivotif doses as he accidentally bit into the fourth capsule/ he won't be taking it" (PT: Incomplete course of vaccination and PT: Wrong technique in product usage process). The patient took the Vivotif capsule (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took only 3 out of the 4 Vivotif doses as he accidentally bit into the fourth capsule, and it cracked. Reportedly, he would not take that fourth dose of Vivotif. The outcome of the reported events was unknown.  Action taken with Vivotif with respect to the reported events was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer had completed only 3 out of the 4 Vivotif doses (incomplete course of vaccination) as he accidentally bit into the fourth capsule (wrong technique in product usage process). Considering the case information, the causality of incomplete course of vaccination and wrong technique in product usage process is assessed as not applicable with Vivotif considering the nature of the events.; Sender's Comments: It was reported that a consumer had completed only 3 out of the 4 Vivotif doses (incomplete course of vaccination) as he accidentally bit into the fourth capsule (wrong technique in product usage process). Considering the case information, the causality of incomplete course of vaccination and wrong technique in product usage process is assessed as not applicable with Vivotif considering the nature of the events.