chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 24th of 24 patients described by the reporter.  Concomitant Medication use information was not provided.  Patient age was between 6 months to 5-years.  Clinic received incorrect guidance from the DOH, who instructed to order and give the pink top. This resulted in patient being under vaccinated. Patient was contacted and revaccinated with the correct dose. RCA being performed and DOH notified of their mistake  They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.  Treatment Medication use information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 14th of 24 patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  Patient age was between 6 months to 5 years.  Clinic received incorrect guidance from the DOH, who instructed to order and give the pink top. This resulted in patient being under vaccinated. Patient was contacted and revaccinated with the correct dose. RCA being performed and DOH notified of their mistake  They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 15th of 24 patients described by the reporter.  Patient age was between 6 months to 5 years.  Concomitant Medication use information was not provided by reporter.  Clinic received incorrect guidance from the DOH, who instructed to order and give the pink top. This resulted in patient being under vaccinated. Patient was contacted and revaccinated with the correct dose. RCA being performed and DOH notified of their mistake.  They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 16th patient out of 24 patients as described by the reporter.  Concomitant medications were not reported.  The vaccination clinic received incorrect guidance from the DOH in regards to the vaccination, who instructed to order and administer the vials with pink top to patients.  It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were aged between 6 months to 5 years. The patients were being contacted and revaccinated with the correct dose.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 4th patient of 24 patients as described by the reporter.  Concomitant medications were not reported.  The vaccination clinic received incorrect guidance from the DOH in regards to the vaccination, who instructed to order and administer the vials with pink top to patients. This resulted in 24 patients being undervaccinated.  It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were aged between 6 months to 5 years. The patients were being contacted and revaccinated with the correct dose.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 ( Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    Concomitant medication was not provided.  The administration of under dose bivalent vaccine to patient for either their 1st or 2nd doses. The patient was between 6 months to 5 years. They received incorrect guidance and gave the pink top. This resulted in 24 patients being under vaccinated.  Patient was under vaccinated when the switch from monovalent to bivalent. Patient received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.   Treatment information was not provided.  This case contains information for the 6th of 24 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial).    Patient age was between 6 months to 5-years. Concomitant medication was not reported.  Clinic received incorrect guidance from the DOH, who instructed to order and give the pink top. This resulted in patient being under vaccinated. Patient was contacted and revaccinated with the correct dose. RCA being performed and DOH notified of their mistake.   Treatment medication was not reported.  This case contains information for the 24th of 24 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction; Patient was given an extra covid vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient was given an extra covid vaccine) and NO ADVERSE EVENT (No adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1 at 04:58 PM, intramuscular, on left thigh, batch/lot number: FT9142) on 19-Aug-2022, Pfizer (Dose 2 at 11:36 AM, intramuscular, on Right thigh, batch/lot number: FT9142) on 23-Sep-2022, Pfizer (Dose 3 at 07:56 AM, intramuscular,  on right thigh and batch/lot number: FT9142) on 02-Dec-2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 09-Mar-2023 at 9:36 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 09-Mar-2023 at 9:36 AM, the patient experienced EXTRA DOSE ADMINISTERED (Patient was given an extra covid vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXTRA DOSE ADMINISTERED (Patient was given an extra covid vaccine) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient was given an extra covid vaccine).    No concomitant medications were reported. It was reported that patient received product of moderna bivalent (6m-5y). It was reported that the error was not noticed and intercepted before the product was supplied to the patient. It was reported that inadvertent human error was the factor responsible for the medication error. It was reported that the dose should have not been given to the patient. It was reported that for Pfizer product the dose has their expiry date of 09-Jan-2023 which was 10 weeks after it was placed in the refrigerator. The patient didn't provide information regarding the reported adverse event with the use of product.    No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; states she inadvertently gave a patient an expired Moderna COVID19 Vaccine, Bivalent; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (states she inadvertently gave a patient an expired Moderna COVID19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 03-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.   On 04-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-May-2023, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 24-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (states she inadvertently gave a patient an expired Moderna COVID19 Vaccine, Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (states she inadvertently gave a patient an expired Moderna COVID19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (states she inadvertently gave a patient an expired Moderna COVID19 Vaccine, Bivalent).    Concomitant medication details not reported by the reporter. Patient did not  received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial size was reported as 2.5 ml. Vial was initially stored in refrigerator on 23-MAY-2023. Vial did not undergo temperature excursion. Treatment details was not reported by the reporter.   This case was linked to MOD-2023-726230 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Biopsy liver, Hepatic enzyme, Hepatitis
Clinical narrative: Autoimmune Hepatitis Flare; This is a literature report.  A 67-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing), notes: elevated liver enzymes associated with fatigue.; "autoimmune hepatitis was controlled" (unspecified if ongoing), notes: on a regimen of prednisone and MMF for, six months. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunization. The following information was reported: HEPATITIS (medically significant), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "Autoimmune Hepatitis Flare". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 105, notes: significant increase from normal the month; 87; Aspartate aminotransferase: 99, notes: significant increase from normal the month; 73, notes: within two months; Biopsy liver: autoimmune hepatitis; Hepatic enzyme: elevated; lab work-up: autoimmune hepatitis. Therapeutic measures were taken as a result of hepatitis.  Clinical course:A 67-year-old female with a past medical history of hypothyroidism was found to have elevated liver enzymes associated with fatigue. Further lab work-up and liver biopsy revealed autoimmune hepatitis. This patient's autoimmune hepatitis was controlled on a regimen of prednisone and MMF for six months. However, three weeks after receiving the third COVID Pfizer vaccine, this patient's labs exhibited AST: 99 and ALT: 105. These values were a significant increase from normal the month before. Her immunosuppressants were up-titrated with an increase in MMF and the addition of cyclosporine. Her labs improved to AST: 73 and ALT: 87 within two months. <br/>Discussion(s): These cases demonstrate that COVID vaccination may play a role in autoimmune hepatitis flares.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event (HEPATITIS) and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300091486 Same article/ drug/event and different patient;US-PFIZER INC-202300199135 Same article/ drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test
Clinical narrative: Autoimmune Hepatitis Flare; This is a literature report.  A 67-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing), notes: elevated liver enzymes associated with fatigue.; "autoimmune hepatitis was controlled" (unspecified if ongoing), notes: on a regimen of prednisone and MMF for, six months. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunization. The following information was reported: HEPATITIS (medically significant), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "Autoimmune Hepatitis Flare". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 105, notes: significant increase from normal the month; 87; Aspartate aminotransferase: 99, notes: significant increase from normal the month; 73, notes: within two months; Biopsy liver: autoimmune hepatitis; Hepatic enzyme: elevated; lab work-up: autoimmune hepatitis. Therapeutic measures were taken as a result of hepatitis.  Clinical course:A 67-year-old female with a past medical history of hypothyroidism was found to have elevated liver enzymes associated with fatigue. Further lab work-up and liver biopsy revealed autoimmune hepatitis. This patient's autoimmune hepatitis was controlled on a regimen of prednisone and MMF for six months. However, three weeks after receiving the third COVID Pfizer vaccine, this patient's labs exhibited AST: 99 and ALT: 105. These values were a significant increase from normal the month before. Her immunosuppressants were up-titrated with an increase in MMF and the addition of cyclosporine. Her labs improved to AST: 73 and ALT: 87 within two months. <br/>Discussion(s): These cases demonstrate that COVID vaccination may play a role in autoimmune hepatitis flares.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event (HEPATITIS) and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300091486 Same article/ drug/event and different patient;US-PFIZER INC-202300199135 Same article/ drug/event and different patient;
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Blood pressure measurement, Fatigue, Hypotension
Clinical narrative: low blood pressure; tired every time afterwards, "I feel so crappy; low blood sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOTENSION (non-serious), outcome "unknown", described as "low blood pressure"; FATIGUE (non-serious), outcome "unknown", described as "tired every time afterwards, "I feel so crappy"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "low blood sugar". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that when the patient gets the vaccine she had low blood pressure and wants to know how to limit and if she should take another dose. Caller said she has had 5 shots so far and was debating about getting the next dose. Caller said she was tired every time afterwards, "she feel so crappy". Caller also said that it may be low blood sugar causing her to feel poorly after the vaccine dose. Caller asked if there was a way to manage the low blood pressure effects from the vaccine. Caller asked if there was any information on low blood sugar after vaccine dosing?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Blood pressure measurement, Fatigue, Hypotension
Clinical narrative: tired every time afterwards, "I feel so crappy; low blood sugar; low blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "low blood sugar", "tired every time afterwards, "I feel so crappy"", "low blood pressure". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired every time afterwards, "I feel so crappy"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "low blood sugar"; HYPOTENSION (non-serious), outcome "unknown", described as "low blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Blood glucose, Blood glucose decreased, Fatigue
Clinical narrative: blood pressure gets really low; seasonal Asthma; low blood sugar; felt "really weak, like I have the flu"; tired every time afterwards, "I feel so crappy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EL9262), for COVID-19 immunization, reaction(s): "lowblood sugar", "tired every time afterwards, "I feel so crappy", "lowblood pressure"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "low blood sugar", "tired every time afterwards, "I feel so crappy", "low blood pressure"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "difficulty, generalized weakness for several days", "chills", "Low blood pressure", "body aches"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "low blood sugar", "tired/feel so crappy", "low blood pressure", "really weak, like I have the flu". The following information was reported: HYPOTENSION (non-serious), outcome "unknown", described as "blood pressure gets really low"; ASTHMA (non-serious), outcome "unknown", described as "seasonal Asthma"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "low blood sugar"; ASTHENIA (non-serious), outcome "unknown", described as "felt "really weak, like I have the flu""; FATIGUE (non-serious), outcome "unknown", described as "tired every time afterwards, "I feel so crappy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that she has low blood pressure and wants to know how to limit and if she should take another dose. she is tired every time afterwards, "I feel so crappy". Caller said specifically after the last bivalent booster she felt "really weak, like I have the flu".  when she get the Vaccine she really had a very rough four days it does something to my blood pressure and my blood pressure gets really low and stated that when she get the Vaccine, she really had a very rough four days it does something to my blood pressure and my blood pressure gets really low. she have not had COVID, but she have Asthma and seasonal Asthma. This report is not related to a study or program.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: blood pressure gets really low; seasonal Asthma; low blood sugar; felt "really weak, like I have the flu"; tired every time afterwards, "I feel so crappy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EL9262), for COVID-19 immunization, reaction(s): "lowblood sugar", "tired every time afterwards, "I feel so crappy", "lowblood pressure"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "low blood sugar", "tired every time afterwards, "I feel so crappy", "low blood pressure"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "difficulty, generalized weakness for several days", "chills", "Low blood pressure", "body aches"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "low blood sugar", "tired/feel so crappy", "low blood pressure", "really weak, like I have the flu". The following information was reported: HYPOTENSION (non-serious), outcome "unknown", described as "blood pressure gets really low"; ASTHMA (non-serious), outcome "unknown", described as "seasonal Asthma"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "low blood sugar"; ASTHENIA (non-serious), outcome "unknown", described as "felt "really weak, like I have the flu""; FATIGUE (non-serious), outcome "unknown", described as "tired every time afterwards, "I feel so crappy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that she has low blood pressure and wants to know how to limit and if she should take another dose. she is tired every time afterwards, "I feel so crappy". Caller said specifically after the last bivalent booster she felt "really weak, like I have the flu".  when she get the Vaccine she really had a very rough four days it does something to my blood pressure and my blood pressure gets really low and stated that when she get the Vaccine, she really had a very rough four days it does something to my blood pressure and my blood pressure gets really low. she have not had COVID, but she have Asthma and seasonal Asthma. This report is not related to a study or program.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM, start date: Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid/Pfizer from 23May2023 (lot number: 2707499) for Treatment of COVID-19. No known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and covid-19 cannot be ruled out.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Lot number: EL0142), in left arm, on 01Feb2021 as dose 2, single (Lot number: EL3248), in left arm and on 03Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Apr2022 as dose 4 (booster), single (Lot number: 045L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Apr2022, outcome "not recovered"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Negative, notes: After three consecutive negative antigen tests, the last 48 hrs ago; (May2023) Negative, notes: After three consecutive negative antigen tests, the last 48 hrs ago; (May2023) Negative, notes: After three consecutive negative antigen tests, the last 48 hrs ago; (24May2023) Positive, notes: Antigen test this morning is positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 13May2023, treatment stop date: 18May2023. Known allergies: no.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE), Interchange of vaccine products and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300200887 same patient, different drug, different event;
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: The day following immunization administration, the patient developed cellulitis to bilateral thighs at injections sites.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lactation insufficiency
Clinical narrative: Prior to vaccination able to over produce breast milk, once vaccination was received a few weeks later noticed an extreme drop in breast milk supply. Able to fill 3 - 8oz bottles with breast milk in one pumping session, once vaccinated unable to create more than 4 ounces of breast milk in 2 pumping sessions.  Eventually needed to supplement with powdered formula, breast milk supply did not increase, and powdered formula was used to replace breast milk completely.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Pt.given a child dose of HepA vaccine.No adverse effects noted at the time of administration. Pt denies any difficulty.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Rash, Rash erythematous, Vaccination site reaction
Clinical narrative: Patient states left feeling okay, but about 1-2 days later they noticed they had a rash that appeared adjacent to the vaccination site. It became very painful, red, and rash filled. Patient stated a level of pain they had to take one of their pain medications and they cannot lift up there arm for simple task like put on deodorant, which really concerned the patient. They have had no other treatment or anything on that arm by the site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Headache, Vomiting
Clinical narrative: Severe headache, vomiting and diarrhea, weakness, not eating
Age: 65.0
Sex: F
Vaccine: PNC15
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: About a week after the injection, there was noticeable swelling around my nose, and lower left side of my face in the evening. The next  morning the injection site swelled enormously (about the size of a baseball) was red, hot, painful and sensitive to the touch.  A descending dosage for a week of Prednisone was prescribed, and remedied the reaction.
Age: 65.0
Sex: F
Vaccine: PNC15
Symptoms: Swelling face
Clinical narrative: About a week after the injection, there was noticeable swelling around my nose, and lower left side of my face in the evening. The next  morning the injection site swelled enormously (about the size of a baseball) was red, hot, painful and sensitive to the touch.  A descending dosage for a week of Prednisone was prescribed, and remedied the reaction.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site mass
Clinical narrative: lump at injection site, started after vaccine and is still continuing. Patient reports it is about marble sized, does not move, not red, not painful, staying the same size. No interventions done. Just wondering if it's normal.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Nodule, Peripheral swelling
Clinical narrative: Patient presented to the pharmacy with complaints of erythema and tenderness at the injection site. Patient's arm has a swollen nodule about 1-2 inches in diameter that she says has gotten worse from day 1. She has tried to scratch at the site due to some itching but then feels pain. She confirmed that she had not taken any medication to help relieve her symptoms since receiving her vaccination.  She also confirmed she has not had any symptoms of hives/rash, difficulty breathing, swelling in the face or throat, or immobility of her arm.
Age: 0.5
Sex: M
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: patient recieved pneumo 20, instead of pneumo 13- the wrong vaccine was given- this is the adverse event- no signs or symptoms were reported or observed - patient is 6 months old- notified mother- notified Immunization Coordinator for internal review
Age: 22.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Hyperhidrosis, Panic attack
Clinical narrative: Patient has fear of needles/vaccines. Anxiousness prior to injection. Patient felt faint after vaccine and was very sweaty. Says he had a panic attack. Pt was given water and put his feet up. Patient fully recovered.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site nodule, Pain, Pain in extremity
Clinical narrative: Patient felt pain immediately after injection radiating toward elbow.  He has developed a knot at the injection site.  He had soreness moving the arm and sleeping on that side for several months afterwards, but only has mild soreness now.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: Patient felt pain immediately after injection radiating toward elbow.  He has developed a knot at the injection site.  He had soreness moving the arm and sleeping on that side for several months afterwards, but only has mild soreness now.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Rash beginning afternoon of 5/25/23. Rash described as urticaria only, no respiratory distress/vomiting/syncope/fever/lip swelling.  Rash started on thighs , then by next morning was on upper arms, chest.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired pfizer bivalent vaccine was given due to mislabeling.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired pfizer bivalent vaccine was given to the patient due to mislabeling.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: all described  as standard but lasted approximately 24   All times are Approximate Time of injection Onset of symptoms Redness and rash still present.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC15, VARCEL
Symptoms: Injection site erythema
Clinical narrative: L Thigh injection with Prevnar & Varicella     3 1/2 x2 inch red area    dissipated with time approx 30 min. R Thigh with MMR/Hib/Hep A on Right red area 2 1/2 by 2inch - faded after 30 min
Age: 3.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Tdap was administered instead of DTAP
Sex: U
Vaccine: PNC15
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE or PQC reported; HCP reported a patient only received a partial dose of VAXNEUVANCE due to moving their leg during the administration.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 23-MAY-2023, the patient only received a partial dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) due to moving the leg (unspecified laterality) during the administration, (lot # W027250, has been verified to be a valid lot number for pneumococcal 15v conj vaccine [crm197] [VAXNEUVANCE], expiration date reported and upon internal validation established as 09-JUL-2024) (dose, and route of administration were not reported). The vaccine was administered for prophylaxis. The reporter was unsure of the exact amount of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) that was administered (Incorrect dose administered).  No additional adverse event reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported.; Caller reports that improperly stored vaccines were administered.; This spontaneous report has been received form an administrator, concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant therapies was not reported.  On 30-MAR-2023, the patient was vaccinated with an improperly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 1 time dose, lot #U031056, expiration date: 16-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided).  The administered dose underwent a temperature excursion of -40 degrees Fahrenheit (F), for 70 hours and 5 minutes. No previous temperature excursion was reported. No additional adverse event was reported.