chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Malaise, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume normal
Clinical narrative: 2 days after administration had local pain, malaise, 3 days after injection fevers, local swelling down to elbow and redness with induration. 7 days after administration mother noticed a large knot, redness, swelling and very painful. ER visit, treated with clindamycin tabs, not tolerated, used after that Keflex. 3rd visit to ER and others to urgent care, an ultrasound is performed, pocket of 2.4 ml with fluid noticed. Draine, obtained about 12-14 ml of purulent discharge. Culture negative. Treated with IV Ancef, then completed orally Keflex. 10 days. Assessed again 5.10.24 still 5 cm induration, redness, tender and still serosanguineous discharge. Started Clindamycin. Pain control.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Metamyelocyte count, Monocyte count, Monocyte percentage, Myelocyte count, Neutrophil count
Clinical narrative: 2 days after administration had local pain, malaise, 3 days after injection fevers, local swelling down to elbow and redness with induration. 7 days after administration mother noticed a large knot, redness, swelling and very painful. ER visit, treated with clindamycin tabs, not tolerated, used after that Keflex. 3rd visit to ER and others to urgent care, an ultrasound is performed, pocket of 2.4 ml with fluid noticed. Draine, obtained about 12-14 ml of purulent discharge. Culture negative. Treated with IV Ancef, then completed orally Keflex. 10 days. Assessed again 5.10.24 still 5 cm induration, redness, tender and still serosanguineous discharge. Started Clindamycin. Pain control.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Neutrophil percentage decreased, Nodule, Pain, Peripheral swelling, Platelet count increased
Clinical narrative: 2 days after administration had local pain, malaise, 3 days after injection fevers, local swelling down to elbow and redness with induration. 7 days after administration mother noticed a large knot, redness, swelling and very painful. ER visit, treated with clindamycin tabs, not tolerated, used after that Keflex. 3rd visit to ER and others to urgent care, an ultrasound is performed, pocket of 2.4 ml with fluid noticed. Draine, obtained about 12-14 ml of purulent discharge. Culture negative. Treated with IV Ancef, then completed orally Keflex. 10 days. Assessed again 5.10.24 still 5 cm induration, redness, tender and still serosanguineous discharge. Started Clindamycin. Pain control.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Promyelocyte count, Purulent discharge, Pyrexia, Red blood cell count normal, Red blood cell nucleated morphology
Clinical narrative: 2 days after administration had local pain, malaise, 3 days after injection fevers, local swelling down to elbow and redness with induration. 7 days after administration mother noticed a large knot, redness, swelling and very painful. ER visit, treated with clindamycin tabs, not tolerated, used after that Keflex. 3rd visit to ER and others to urgent care, an ultrasound is performed, pocket of 2.4 ml with fluid noticed. Draine, obtained about 12-14 ml of purulent discharge. Culture negative. Treated with IV Ancef, then completed orally Keflex. 10 days. Assessed again 5.10.24 still 5 cm induration, redness, tender and still serosanguineous discharge. Started Clindamycin. Pain control.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Red cell distribution width normal, Staphylococcus test negative, Swelling, Tenderness, Ultrasound scan abnormal
Clinical narrative: 2 days after administration had local pain, malaise, 3 days after injection fevers, local swelling down to elbow and redness with induration. 7 days after administration mother noticed a large knot, redness, swelling and very painful. ER visit, treated with clindamycin tabs, not tolerated, used after that Keflex. 3rd visit to ER and others to urgent care, an ultrasound is performed, pocket of 2.4 ml with fluid noticed. Draine, obtained about 12-14 ml of purulent discharge. Culture negative. Treated with IV Ancef, then completed orally Keflex. 10 days. Assessed again 5.10.24 still 5 cm induration, redness, tender and still serosanguineous discharge. Started Clindamycin. Pain control.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: White blood cell count normal
Clinical narrative: 2 days after administration had local pain, malaise, 3 days after injection fevers, local swelling down to elbow and redness with induration. 7 days after administration mother noticed a large knot, redness, swelling and very painful. ER visit, treated with clindamycin tabs, not tolerated, used after that Keflex. 3rd visit to ER and others to urgent care, an ultrasound is performed, pocket of 2.4 ml with fluid noticed. Draine, obtained about 12-14 ml of purulent discharge. Culture negative. Treated with IV Ancef, then completed orally Keflex. 10 days. Assessed again 5.10.24 still 5 cm induration, redness, tender and still serosanguineous discharge. Started Clindamycin. Pain control.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphoria
Clinical narrative: dysphoria; dizziness; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Apr2023 as dose number unknown (booster), single (Lot number: GJ3268) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DYSPHORIA (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown".  Additional information: Caller said he just received the Pfizer covid vaccine bivalent booster and experienced side effects (dizziness and dysphoria). Caller also stated he was part of the clinical study department for the Pfizer RSV and wanted to know if he was part of either the placebo or group since he is trying to find out if the side effects he experienced was due only to the Pfizer covid vaccine he got, or was it because of the RSV.
Age: 66.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Incorrect dose administered, Product preparation error, Underdose
Clinical narrative: No additional adverse event; Patient received the pediatric dose of VAQTA (also reported as Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) conflicting information) instead of adult dose; Patient received the pediatric dose of VAQTA  (also reported as Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB)  instead of adult dose; This spontaneous report was received from a nurse and refers to a 66-year-old female patient. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.    On 04-APR-2023, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated(VAQTA) (also reported as Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) conflicting information), intramuscularly, in the right deltoid, lot # W028555, expiration date 10-JUL-2024,  for prophylaxis; instead of adult dose (incorrect dose administered and underdose). This error occurred during preparation and administration of vaccine. No additional adverse events and nor product quality complain were reported.  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2305USA000680:
Sex: M
Vaccine: PPV
Symptoms: Back pain, Fatigue, Myalgia, Neck pain, Pyrexia
Clinical narrative: BACK ACHE; neck pain; 99F and is feeling feverish; feels fatigued; myalgia; This spontaneous report was received from a physician via Pfizer, and referred to himself, a male of unknown age. The patient's concurrent conditions and concomitant therapies were not reported. He received pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) years ago (as reported).  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  3 or 4 days after the vaccination, he started to experience an ache in his back and neck and it had continued for 8 days. He normally had a body temperature of 97F, however after the vaccination he had ran a 99F and was feeling feverish. He also felt fatigued and had myalgia that did not go away until he took ibuprofen (ADVIL). The outcome of all the events was not reported.  The causal relationship between all the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No side effects or symptoms reported; Patient received his 3rd dose of GARDASIL 9 four weeks after second dose; This spontaneous report was received from a Licensed Practical Nurse (L. P. N.) concerning to a 16-year-old male patient.  The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On an unknown date in August 2022, at the age of 15-year-old, the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiry date, anatomical location and route of administration were not provided). On approximately 03-APR-2023 (also reported as "March 2022", conflicting information), the patient received the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiry date, anatomical location and route of administration were not provided). Then, on 01-MAY-2023 (also reported as "yesterday" and "four weeks after second dose"), he was vaccinated with the 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiry date, anatomical location and route of administration were not provided), which was administered at incorrect dosing interval, four weeks after second dose instead of the recommended 12-week interval (inappropriate schedule of product administration). Al three vaccine doses were administered as prophylaxis.   No side effects or symptoms were reported (no adverse event).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 65-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Leukopenia.    In August 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Oct-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-Oct-2022 to 29-Oct-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  The patient's date of birth was reported as Sep-1957.  It was reported that the patient's initial symptom was running nose, that progressed to significant phlegm, minor sore throat, difficult sleep due to congestion when supine and lack of mental clarity for detailed/complex activities.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown 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.     No Medical History information was reported.    In April 2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.) 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 (Patient received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.).    No concomitant medications were reported.  Doses were administered on 21-Apr-2023 and 28-Apr-2023.  Patients ranged from 10m-5y old.  No treatment medications were reported.  This case contains information for the 2nd of 4th child patients described by the reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-723264 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723264:Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown 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.     No Medical History information was reported.    In April 2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.) 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 (Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.).    No concomitant medications was reported. Suspect product dosage text was reported as unknown. It was reported that 4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation. Doses were administered on 21-APR-2023 and 28-APR-2023. Each was administered as a second dose in the series. Patients ranged from 10m-5y old.  No treatment drug details was reported. This case contains information of 4th out of 4 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723264 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723264:Patient 1
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Meniscus injury
Clinical narrative: She continued to have swelling in her knees due to this tear; In OCT2022, she tore her meniscus while exercising; This spontaneous case was reported by a consumer and describes the occurrence of MENISCUS INJURY (In OCT2022, she tore her meniscus while exercising) and JOINT SWELLING (She continued to have swelling in her knees due to this tear) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 939905, 037A21B and 042L20A) for COVID-19 prophylaxis.     Patient did not have previous diagnosis of COVID-19.  Concurrent medical conditions included Allergic sinusitis.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2022, the patient experienced MENISCUS INJURY (In OCT2022, she tore her meniscus while exercising). On an unknown date, the patient experienced JOINT SWELLING (She continued to have swelling in her knees due to this tear). On 06-May-2023, JOINT SWELLING (She continued to have swelling in her knees due to this tear) had resolved. At the time of the report, MENISCUS INJURY (In OCT2022, she tore her meniscus while exercising) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  In OCT2022, patient tore her meniscus while exercising. Patient did not have to get surgery for it but continued to swelling in her knees due to this tear.  However, patient noticed on Saturday morning (6MAY2023), that her knee was no longer feeling uncomfortable and there was no swelling anymore.   Treatment Medication use information was not provided by reporter.   This case was linked to MOD-2023-723494 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; HCP states that a 9 month old patient received the Moderna COVID-19 bivalent vaccine from the incorrect vial for his 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP states that a 9 month old patient received the Moderna COVID-19 bivalent vaccine from the incorrect vial for his 2nd dose) and NO ADVERSE EVENT (No adverse event) in an infant male patient 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 COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1 Monovalent (6month-5years) and batch/lot number: Unkown) on 28-Mar-2023. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine.    On 28-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 28-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP states that a 9 month old patient received the Moderna COVID-19 bivalent vaccine from the incorrect vial for his 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP states that a 9 month old patient received the Moderna COVID-19 bivalent vaccine from the incorrect vial for his 2nd dose) 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 (HCP states that a 9 month old patient received the Moderna COVID-19 bivalent vaccine from the incorrect vial for his 2nd dose).    No concomitant medications were reported. The patient received Moderna COVID-19 bivalent vaccine (for 6months-5years) from the incorrect vial as a  2nd dose, resulting in a lower than authorized dose. Reporter wants to get guidance on how to proceed with this patient. The patient was not reported any adverse reactions at this time. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2023: Live non significant follow up received
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Caller is stating that they found a 69-year-old patient who received expired Bivalent booster; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Caller is stating that they found a 69-year-old patient who received expired Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2023 at 8:30 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-May-2023 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Caller is stating that they found a 69-year-old patient who received expired Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Caller is stating that they found a 69-year-old patient who received expired Bivalent booster) 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 (Caller is stating that they found a 69-year-old patient who received expired Bivalent booster).    Concomitant medication was not reported.  Patient received expired Bivalent additional booster beyond 12 hours after first puncture. Patient received dose form 2.5 ml Blue Cap Date the vial was initially stored in the refrigerator on 01-May-2023. Vial was first punctured on 04-May-2023 12:45 PM. Vial did not undergone any temperature excursion. Vial exposed to room temperature for less than 24hrs. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2023: Live significant follow-up received. Patient details, dose details and events and narrative was updated.
Age: 0.58
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the pink cap instead of Blue cap for 2nd dose; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the pink cap instead of Blue cap for 2nd dose) and NO ADVERSE EVENT (No adverse event) in a 7-month-old patient of an unknown 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.     No Medical History information was reported.    On 05-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 05-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the pink cap instead of Blue cap for 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the pink cap instead of Blue cap for 2nd dose) 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 (Patient received the pink cap instead of Blue cap for 2nd dose).    No concomitant medications were provided. Patient received first monovalent Moderna COVID-19 vaccine dose on 7-Apr-2023 with unknown lot number and expiration date. No treatment medication was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: no adverse event; HCP advised the her office could not clarify if her pharmacy has administer correct vaccine vials to her patients in August of 2022 / HCP is unsure of if vaccine dose that were administered were bivalent booster of monovalent boosters; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP advised the her office could not clarify if her pharmacy has administer correct vaccine vials to her patients in August of 2022 / HCP is unsure of if vaccine dose that were administered were bivalent booster of monovalent boosters) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In August 2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP advised the her office could not clarify if her pharmacy has administer correct vaccine vials to her patients in August of 2022 / HCP is unsure of if vaccine dose that were administered were bivalent booster of monovalent boosters). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP advised the her office could not clarify if her pharmacy has administer correct vaccine vials to her patients in August of 2022 / HCP is unsure of if vaccine dose that were administered were bivalent booster of monovalent boosters) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (HCP advised the her office could not clarify if her pharmacy has administer correct vaccine vials to her patients in August of 2022 / HCP is unsure of if vaccine dose that were administered were bivalent booster of monovalent boosters).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist calling to report patient received a vaccine pass 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report patient received a vaccine pass 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     It was unknown if patient had any diseases and had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 08-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 08-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report patient received a vaccine pass 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist calling to report patient received a vaccine pass 12 hours post puncture) 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 (Pharmacist calling to report patient received a vaccine pass 12 hours post puncture).    No concomitant information was reported. Suspect product dosage text was reported as additional booster. It was reported that the vaccine was punctured around 12:15 pm yesterday (07-May-2023) and was administered to 2 patients at 9:58 am and 10:02 am the following day (08-May-2023). This case is reported for patient 2 out of 2 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723413 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723413:Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: They had a mild case of Covid in Apr2023; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (They had a mild case of Covid in Apr2023) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) and Moderna COVID-19 Vaccine (Dose 2); for Product used for unknown indication: JANSSEN COVID-19 VACCINE (Dose 2, Batch Number unknown), JANSSEN COVID-19 VACCINE (Dose 1 and Batch Number unknown). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE, JANSSEN COVID-19 VACCINE, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   In September 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 an unknown date, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In April 2023, the patient experienced COVID-19 (They had a mild case of Covid in Apr2023). At the time of the report, COVID-19 (They had a mild case of Covid in Apr2023) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported. Treatment medication not reported.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: COVID-19; She got exposed to COVID-19 and started having symptoms on 30-APR-2023; This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE TO SARS-COV-2 (She got exposed to COVID-19 and started having symptoms on 30-APR-2023) and COVID-19 (COVID-19) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose) in March 2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose) in April 2021, PFIZER BIONTECH COVID-19 VACCINE (1 st booster) in October 2021 and PFIZER BIONTECH COVID-19 VACCINE (2 nd booster). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.   In September 2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Apr-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPOSURE TO SARS-COV-2 (She got exposed to COVID-19 and started having symptoms on 30-APR-2023). On 01-May-2023, the patient experienced COVID-19 (COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (She got exposed to COVID-19 and started having symptoms on 30-APR-2023) and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as additional booster. It was reported that patient did not had any adverse event after second bivalent shot but on 27-APR-2023 was got exposed to COVID-19 and started having symptoms on 30-APR-2023,symptoms that were experienced were fatigue, chills coughing, sneezing, nasal drip, partial loss of taste and smell, patient was recovering but was still blowing nose on 08-MAY-2023. No treatment information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Trigger finger
Clinical narrative: he started experiencing trigger thumb again; extreme fatigue; sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), TRIGGER FINGER (he started experiencing trigger thumb again) and FATIGUE (extreme fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 030A21A, 017F21A and 042J21A) for COVID-19 prophylaxis.     Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Shingrix vaccine on 07-Apr-2023. Past adverse reactions to the above products included No adverse event with Shingrix vaccine. Concurrent medical conditions included Hypertension (well controlled with medication), Lipids abnormal and Allergy to antibiotic (Erythromycin).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), TRIGGER FINGER (he started experiencing trigger thumb again) and FATIGUE (extreme fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (extreme fatigue) had resolved and TRIGGER FINGER (he started experiencing trigger thumb again) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2023-720918 (Patient Link).   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic lymphocytic leukaemia, Inappropriate schedule of product administration
Clinical narrative: CLL; 2nd dose: 18Mar2022, 3rd dose: 08Apr2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 63-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Depression" (ongoing); "Weakened immune system" (unspecified if ongoing). Concomitant medication(s) included: QUETIAPINE oral taken for depression (ongoing); VENLAFAXINE oral taken for depression (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Route of administration: Intramuscular), administration date: 24Nov2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Route of administration: Intramuscular), administration date: 18Mar2022, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Apr2022, described as "2nd dose: 18Mar2022, 3rd dose: 08Apr2022"; CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant) with onset Jul2022, described as "CLL". Therapeutic measures were taken as a result of chronic lymphocytic leukaemia which included intravenous Obinutuzumab from 08Sep2022 to 09Feb2023 and oral Venetoclax from 29Sep2022 and ongoing.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (04May2023): This is a spontaneous follow-up report received from a contactable Other HCP reported in response to the HCP letter sent via follow up letter. Updated information: case was upgraded to serious (medically significant), suspect drug coding, reaction data (description of event Inappropriate schedule of product administration and new event of CLL), and further clinical details  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, a causal relationship between suspect drug BNT162B2 and event chronic lymphocytic leukemia cannot be excluded. 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-PV202300059072 same patient, different vaccine dose/event;US-PFIZER INC-202300079837 same patient, different vaccine dose/event;
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Incorrect route of product administration, Malaise
Clinical narrative: feeling unwell; route: subcutaneously; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation; pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "feeling unwell"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "route: subcutaneously".  Additional information: He also mentioned feeling unwell for a day or two after being vaccinated.  The information on the batch/lot number for BNT162b2, pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s): US-PFIZER INC-202300180962 Same reporter/ drug/ event for different patients. US-PFIZER INC-PV202300080379 Same reporter/patient, different drug/AE; US-PFIZER INC-202300180835 Same reporter/ drug different event for same patients.
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Blister, Feeling hot, Peripheral swelling, Rash, Vitamin B12 decreased
Clinical narrative: rash break out on her right arm; rash break out on her right arm and issues like blisters and they got hot and swollen; rash break out on her right arm and issues like blisters and they got hot and swollen; she has Low B12; rash break out on her right arm and issues like blisters and they got hot and swollen; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 79-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 27Apr2023 as dose number unknown, 0.5 ml single (Lot number: SJ2607, Expiration Date: Aug2023) at the age of 79 years intramuscular, in right arm for immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Sleep" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal as 10 mg, daily (one every day); ATORVASTATIN taken for blood cholesterol as 10 mg; LISINOPRIL taken for blood pressure abnormal as 20 mg; TRAZODONE taken for sleep disorder as 100 mg. The following information was reported: RASH (non-serious) with onset 27Apr2023, outcome "recovered" (2023), described as "rash break out on her right arm"; BLISTER (non-serious) with onset 27Apr2023, outcome "recovering", PERIPHERAL SWELLING (non-serious), FEELING HOT (non-serious) all with onset 27Apr2023, outcome "recovered" (2023) and all described as "rash break out on her right arm and issues like blisters and they got hot and swollen"; VITAMIN B12 DECREASED (non-serious) with onset 27Apr2023, outcome "recovering", described as "she has Low B12". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: NDC number: 0005200010. It was reported that when the patient came back on 04May2023 for a different injection, she stated that when she was vaccinated on 27Apr2023, she had a reaction with Prevnar 20 vaccine. It was like a rash break out on her right arm and issues like blisters and got hot and swollen. The patient looked fine today. No more swelling, but still had couple of blisters left. Everything was normal on the patient's lab tests but she has low vitamin b12.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 12Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: 33030BD) for covid-19 immunisation. The patient's relevant medical history included: "low thyroid" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for hypothyroidism (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 25Apr2023 to 29Apr2023.
Sex: F
Vaccine: PNC20
Symptoms: Guillain-Barre syndrome, Mechanical ventilation
Clinical narrative: ended up with Guillain Barre and ended up on the ventilator; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization), outcome "unknown", described as "ended up with Guillain Barre and ended up on the ventilator". Therapeutic measures were taken as a result of guillain-barre syndrome. The patient is fine at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXAPRO. 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: It was reported that patient was treated with Paxlovid from 22Apr2023 to 26Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300181554 same patient, different drug and different event.;