chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: threw up; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was recovered/resolved.   It was unknown if the reporter considered the vomiting to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's Comment: The reporter was the mother of the patient. The reporter reported that the patient received fist dose of Shingrix and on same day patient threw up and this had been resolved. The reporter did not indicate if the HCP was the same for her as was for her daughter. She only provided the HCP information for herself. The reporter did not consent to follow up. Additional supportive information: This case was linked with case US2022133812 reported by same reporter.; Sender's Comments:  US-GSK-US2022133812:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 27Nov2019, 2nd never received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27th November 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: The reporter reported that the patient never received second dose. The patient stated that she plans to receive second dose as soon as possible. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received second dose after six months; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received 1st dose of shingrix in February 2022.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's comment: The Pharmacist reported a patient who received the second dose of Shingrix after six months. Second dose was given few weeks after 6 months deadline. Pharmacist did not provide lot number and expiration date of any of the two doses already administered to the patient since these doses were given at different facilities. The reporter did not consent to follow-up. Additional Supportive information: The patient received second dose was given few weeks after 6 months deadline, which lead to lengthening of vaccination schedule. This case is linked to the case US2022134472, reported by the same reporter.; Sender's Comments:  US-GSK-US2022134472:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: STROKE; BLOOD CLOTS; This spontaneous report received from a consumer via a social media and by a company representative concerned a male of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient had blood clots and stroke. The reporter described that the patient was nearly killed with covid vaccine. It was reported that "You all nearly killed my grandpa with COVID vaccine. He had blood clots and a stroke from it. All you fake pandemic pushers deserve to go to jail for fraud and crimes against humanity". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220942760-Covid-19 vaccine ad26.cov2.s-stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.   20220942760-covid-19 vaccine ad26.cov2.s-blood clot . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PYREXIA (Fever). In March 2021, PYREXIA (Fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-620836, MOD-2022-623622 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Significant live follow up (Patient demographics, event information, reporter opinion of causality, suspect drug information, concomitant drug information, laboratory/diagnostic procedures and narrativedescription updated)
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Myalgia, Neurological symptom, Paraesthesia
Clinical narrative: neurologic reaction; weakness; numbness; paresthesia; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (neurologic reaction), ASTHENIA (weakness), HYPOAESTHESIA (numbness), PARAESTHESIA (paresthesia) and MYALGIA (muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (neurologic reaction), ASTHENIA (weakness), HYPOAESTHESIA (numbness), PARAESTHESIA (paresthesia) and MYALGIA (muscle pain). At the time of the report, NEUROLOGICAL SYMPTOM (neurologic reaction), ASTHENIA (weakness), HYPOAESTHESIA (numbness), PARAESTHESIA (paresthesia) and MYALGIA (muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Myalgia, Pain in extremity
Clinical narrative: Several side effects including diarrhea, side pain, and leg pain; Several side effects including diarrhea, side pain, and leg pain; Several side effects including diarrhea, side pain, and leg pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Several side effects including diarrhea, side pain, and leg pain), MYALGIA (Several side effects including diarrhea, side pain, and leg pain) and PAIN IN EXTREMITY (Several side effects including diarrhea, side pain, and leg pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose and TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Several side effects including diarrhea, side pain, and leg pain), MYALGIA (Several side effects including diarrhea, side pain, and leg pain) and PAIN IN EXTREMITY (Several side effects including diarrhea, side pain, and leg pain). At the time of the report, DIARRHOEA (Several side effects including diarrhea, side pain, and leg pain), MYALGIA (Several side effects including diarrhea, side pain, and leg pain) and PAIN IN EXTREMITY (Several side effects including diarrhea, side pain, and leg pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication information was reported.  It was unsure when the Moderna vaccine was taken and mentioned as 01 Mar 2021 or 04 Mar 20221.  It was reported that  a venous test was performed to rule out clot however result was not reported.  No treatment medication was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore after first COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore after first COVID vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Non-smoker, Abstains from alcohol and Plaque psoriasis.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2021, the patient experienced PAIN IN EXTREMITY (Arm was sore after first COVID vaccine). In 2021, PAIN IN EXTREMITY (Arm was sore after first COVID vaccine) had resolved.    mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. It was unknown if the patient was enrolled in covid-19 vaccine trials. No concomitant product reported by reporter.  The reporter's causality for the event(s) of outbreaks/psoriasis patient experiencing bad breakthrough/broke out with humira 40mg/0.4ml(adalimumab) was a reasonable possibility. No treatment medication reported by reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in. This case was linked to MOD-2021-623323 (Patient Link).
Sex: F
Vaccine: COVID19-2, FLUX, COVID19-2
Symptoms: Feeling abnormal, Influenza like illness, Joint range of motion decreased, Myalgia, Sluggishness
Clinical narrative: patient had a loss in range of motion in right arm; The muscle in my right arm is still hurting; sluggish; flu-like symptoms; Pateint was feeling blah; This spontaneous case was reported by an other health care professional and describes the occurrence of JOINT RANGE OF MOTION DECREASED (patient had a loss in range of motion in right arm), SLUGGISHNESS (sluggish), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (Pateint was feeling blah) and MYALGIA (The muscle in my right arm is still hurting) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Flu vaccination.    Patient did not have COVID positive test or diagnosis.    On 09-Sep-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 and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced SLUGGISHNESS (sluggish), INFLUENZA LIKE ILLNESS (flu-like symptoms) and FEELING ABNORMAL (Pateint was feeling blah). On 22-Sep-2022, the patient experienced JOINT RANGE OF MOTION DECREASED (patient had a loss in range of motion in right arm) and MYALGIA (The muscle in my right arm is still hurting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, JOINT RANGE OF MOTION DECREASED (patient had a loss in range of motion in right arm) and MYALGIA (The muscle in my right arm is still hurting) had not resolved and SLUGGISHNESS (sluggish), INFLUENZA LIKE ILLNESS (flu-like symptoms) and FEELING ABNORMAL (Pateint was feeling blah) 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 medications details were not reported by the reporter.  On 04-JAN-2021, patient received First dose of Moderna COVID-19 Vaccine with batch number 039K20A. On 02-FEB-2021, patient received Second dose of Moderna COVID-19 Vaccine with batch number 028L20A. On 23-AUG-2021, patient received First booster dose of Moderna COVID-19 Vaccine with batch number 053E21A. On 30-MAR-2022, Patient received Second booster dose  Moderna COVID-19 Vaccine with batch number 066K21A.  It was reported that Advil works better than the Tylenol.
Sex: F
Vaccine: COVID19-2, FLUX, COVID19-2
Symptoms: Cold sweat, Mobility decreased, Pain
Clinical narrative: patient had a loss in range of motion in right arm; The muscle in my right arm is still hurting; sluggish; flu-like symptoms; Pateint was feeling blah; This spontaneous case was reported by an other health care professional and describes the occurrence of JOINT RANGE OF MOTION DECREASED (patient had a loss in range of motion in right arm), SLUGGISHNESS (sluggish), INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (Pateint was feeling blah) and MYALGIA (The muscle in my right arm is still hurting) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for Flu vaccination.    Patient did not have COVID positive test or diagnosis.    On 09-Sep-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 and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced SLUGGISHNESS (sluggish), INFLUENZA LIKE ILLNESS (flu-like symptoms) and FEELING ABNORMAL (Pateint was feeling blah). On 22-Sep-2022, the patient experienced JOINT RANGE OF MOTION DECREASED (patient had a loss in range of motion in right arm) and MYALGIA (The muscle in my right arm is still hurting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, JOINT RANGE OF MOTION DECREASED (patient had a loss in range of motion in right arm) and MYALGIA (The muscle in my right arm is still hurting) had not resolved and SLUGGISHNESS (sluggish), INFLUENZA LIKE ILLNESS (flu-like symptoms) and FEELING ABNORMAL (Pateint was feeling blah) 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 medications details were not reported by the reporter.  On 04-JAN-2021, patient received First dose of Moderna COVID-19 Vaccine with batch number 039K20A. On 02-FEB-2021, patient received Second dose of Moderna COVID-19 Vaccine with batch number 028L20A. On 23-AUG-2021, patient received First booster dose of Moderna COVID-19 Vaccine with batch number 053E21A. On 30-MAR-2022, Patient received Second booster dose  Moderna COVID-19 Vaccine with batch number 066K21A.  It was reported that Advil works better than the Tylenol.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She has had a sore arm with all 4 doses of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (She has had a sore arm with all 4 doses of the vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 002A21A and 013L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third 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 (She has had a sore arm with all 4 doses of the vaccine). At the time of the report, PAIN IN EXTREMITY (She has had a sore arm with all 4 doses of the vaccine) outcome was unknown.            No concomitant information were reported by the reporter. No treatment information were reported by the reporter.   This case was linked to MOD-2022-649160 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster).    No concomitant medication was reported.    The reporter stated that she has a situation. She found out that they could not give the Moderna as a booster starting 31-Aug-2022, but she administered 15 monovalent doses as boosters. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) 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)) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster 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 ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter.  Nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults.  Patient received under dose of 0.25 ml of Moderna Bivalent Booster.  It was reported that CDC had recommended to re-vaccinate the patient with a full dose of 0.5mL.  No adverse events were reported.  No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) 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 ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml).    No concomitant medications were reported.   Physician reported that, the nurses had no standing order other than what they had for the second booster and assumed the same dose as the second booster (administered 0.25 milliliter instead of 0.5 ml to uncompromised adults). The patient did not experience any adverse events. It was reported that, recommended to revaccinate the patient with full dose of 0.5 mL. No treatment details were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site swelling
Clinical narrative: Red swollen area on upper left arm with pain and soreness.  Also tingling and intermittent sharp pains.  Swollen area appears the same after 36 hours and does not appear to be easing off.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Pain, Pyrexia, Rash
Clinical narrative: 24 hours later fever, chills, body aches, fatigue 39 hours later rash that has spread all over abdomen, bilateral legs, face, and bilateral arms
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Nurse reporting an AE for VAQTA that was administered to a 2 month old.; No additional AE/PQC.; This spontaneous report was received from a nurse and refers to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 14-SEP-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5ml, lot #U026792, expiration date: 28-OCT-2022 (strength, dosing schedule and route of administration were not provided) administered for prophylaxis (product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Aspartate aminotransferase, Asthenia, Gait disturbance, Muscle twitching, Paraesthesia
Clinical narrative: FELT WEAK; FELT LIMPED ON BOTH OF HER UPPER ARMS; TWITCHING ON BOTH LEGS THAT WAS SWITCHING TO CALVES WHICH MADE; WORSENED TREMORS ON BOTH THE LEGS; ELECTRICAL IMPULSE/TINGLING SENSATION; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (FELT WEAK), GAIT DISTURBANCE (FELT LIMPED ON BOTH OF HER UPPER ARMS), MUSCLE TWITCHING (TWITCHING ON BOTH LEGS THAT WAS SWITCHING TO CALVES WHICH MADE), TREMOR (WORSENED TREMORS ON BOTH THE LEGS) and PARAESTHESIA (ELECTRICAL IMPULSE/TINGLING SENSATION) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001EZ1A and 038B21A) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    The patient's past medical history included Ex-smoker from 1976 to 2010, Anemia in 2021, Nervousness and Phlebotomy in December 2020. Previously administered products included for Product used for unknown indication: DILAUDID and ORENCIA. Past adverse reactions to the above products included No adverse event with DILAUDID and ORENCIA. Concurrent medical conditions included Penicillin allergy (Manifested by dry heaves, super sick to stomach but could not vomit) and Drug allergy (Manifested by hives on her back and itchy). Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. In May 2021, the patient experienced ASTHENIA (FELT WEAK), GAIT DISTURBANCE (FELT LIMPED ON BOTH OF HER UPPER ARMS), MUSCLE TWITCHING (TWITCHING ON BOTH LEGS THAT WAS SWITCHING TO CALVES WHICH MADE), TREMOR (WORSENED TREMORS ON BOTH THE LEGS) and PARAESTHESIA (ELECTRICAL IMPULSE/TINGLING SENSATION). At the time of the report, ASTHENIA (FELT WEAK), GAIT DISTURBANCE (FELT LIMPED ON BOTH OF HER UPPER ARMS), MUSCLE TWITCHING (TWITCHING ON BOTH LEGS THAT WAS SWITCHING TO CALVES WHICH MADE), TREMOR (WORSENED TREMORS ON BOTH THE LEGS) and PARAESTHESIA (ELECTRICAL IMPULSE/TINGLING SENSATION) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Aspartate aminotransferase (9-32): 230 U/L. On 10-May-2021, Serum ferritin: showed high iron with unspecified level..         No treatment medication was reported. The patient had received shingles vaccination on 11May2021.  This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation # QE  019993
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Serum ferritin, Tremor
Clinical narrative: FELT WEAK; FELT LIMPED ON BOTH OF HER UPPER ARMS; TWITCHING ON BOTH LEGS THAT WAS SWITCHING TO CALVES WHICH MADE; WORSENED TREMORS ON BOTH THE LEGS; ELECTRICAL IMPULSE/TINGLING SENSATION; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (FELT WEAK), GAIT DISTURBANCE (FELT LIMPED ON BOTH OF HER UPPER ARMS), MUSCLE TWITCHING (TWITCHING ON BOTH LEGS THAT WAS SWITCHING TO CALVES WHICH MADE), TREMOR (WORSENED TREMORS ON BOTH THE LEGS) and PARAESTHESIA (ELECTRICAL IMPULSE/TINGLING SENSATION) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001EZ1A and 038B21A) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    The patient's past medical history included Ex-smoker from 1976 to 2010, Anemia in 2021, Nervousness and Phlebotomy in December 2020. Previously administered products included for Product used for unknown indication: DILAUDID and ORENCIA. Past adverse reactions to the above products included No adverse event with DILAUDID and ORENCIA. Concurrent medical conditions included Penicillin allergy (Manifested by dry heaves, super sick to stomach but could not vomit) and Drug allergy (Manifested by hives on her back and itchy). Concomitant products included LEVOTHYROXINE for Thyroid disorder.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. In May 2021, the patient experienced ASTHENIA (FELT WEAK), GAIT DISTURBANCE (FELT LIMPED ON BOTH OF HER UPPER ARMS), MUSCLE TWITCHING (TWITCHING ON BOTH LEGS THAT WAS SWITCHING TO CALVES WHICH MADE), TREMOR (WORSENED TREMORS ON BOTH THE LEGS) and PARAESTHESIA (ELECTRICAL IMPULSE/TINGLING SENSATION). At the time of the report, ASTHENIA (FELT WEAK), GAIT DISTURBANCE (FELT LIMPED ON BOTH OF HER UPPER ARMS), MUSCLE TWITCHING (TWITCHING ON BOTH LEGS THAT WAS SWITCHING TO CALVES WHICH MADE), TREMOR (WORSENED TREMORS ON BOTH THE LEGS) and PARAESTHESIA (ELECTRICAL IMPULSE/TINGLING SENSATION) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Aspartate aminotransferase (9-32): 230 U/L. On 10-May-2021, Serum ferritin: showed high iron with unspecified level..         No treatment medication was reported. The patient had received shingles vaccination on 11May2021.  This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation # QE  019993
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included (shingles on her face 45 to 50 days after starting RINVOQ therapy). Previously administered products included for Shingles: acyclovir (was on acyclovir for ten days); for Rheumatoid arthritis: RINVOQ. Past adverse reactions to the above products included No adverse reaction with acyclovir; and Shingles with RINVOQ. Concomitant products included VARICELLA ZOSTER VACCINE (SHINGRIX) for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced (Fever). At the time of the report,(Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 degrees Celsius.         Patient reported that 90 days after having shingles she got the first dose of the Shingrix vaccine along with her third Moderna COVID-19 vaccine and had a temperature of 103 degrees. She was not on RINVOQ at that time. She spoke with a physician that told her the fever was due to the COVID-19 vaccine.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for the event pyrexia was not provided with RINVOQ(  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Headache, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Loss of appetite; Inappropriate schedule of vaccine administered; Had a rash 10 days later; Fever; Headache; Dizziness; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizziness), RASH (Had a rash 10 days later), PYREXIA (Fever) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 038B21A and 036A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient does not have any allergies to any food or medications.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Had a rash 10 days later). On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizziness), PYREXIA (Fever), HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizziness), PYREXIA (Fever) and HEADACHE (Headache) had resolved and RASH (Had a rash 10 days later) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medications were reported.  Patient had a whole roster of symptoms that seem like the coronavirus. It took a long time.   This case was linked to MOD-2022-648669 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2022: Follow-up received include information regarding vaccination date and expiry date for dose 1 and dose 2.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Loss of appetite; Inappropriate schedule of vaccine administered; Had a rash 10 days later; Fever; Headache; Dizziness; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizziness), RASH (Had a rash 10 days later), PYREXIA (Fever) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 038B21A and 036A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient does not have any allergies to any food or medications.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Had a rash 10 days later). On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizziness), PYREXIA (Fever), HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizziness), PYREXIA (Fever) and HEADACHE (Headache) had resolved and RASH (Had a rash 10 days later) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medications were reported.  Patient had a whole roster of symptoms that seem like the coronavirus. It took a long time.   This case was linked to MOD-2022-648669 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2022: Follow-up received include information regarding vaccination date and expiry date for dose 1 and dose 2.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain
Clinical narrative: Breaking out in bumpsthat looked like gangling cysts; Hurt; This spontaneous case was reported by a patient and describes the occurrence of MASS (Breaking out in bumpsthat looked like gangling cysts) and PAIN (Hurt) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006b21a and 011a21a) for COVID-19 vaccination.     Patient had no allergies.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MASS (Breaking out in bumpsthat looked like gangling cysts) and PAIN (Hurt). At the time of the report, MASS (Breaking out in bumpsthat looked like gangling cysts) and PAIN (Hurt) had not resolved.            Patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient does not experienced a similar event in the past. The AE caused patient to seek medical care by office visit. The symptoms were getting worse. The patient had refused to receive any booster. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product label confusion, Product packaging confusion, Wrong product administered
Clinical narrative: No Adverse Event; Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster; Vial caps and labels for Monovalent and Bivalent look too similar; Vial caps and labels for Monovalent and Bivalent look too similar; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar), PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Received  booster (supposedly Bivalent) from a Monovalent vial  6M-5Y/Received 0.5ml of Monovalent vaccine 6M-5Y  instead of the Bivalent Booster), PRODUCT LABEL CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar) and PRODUCT PACKAGING CONFUSION (Vial caps and labels for Monovalent and Bivalent look too similar).    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2022: Live follow-up contains non-significant follow up -QE ID added.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) 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 ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml).    No concomitant medications were reported.   Physician reported that, the nurses had no standing order other than what they had for the second booster and assumed the same dose as the second booster (administered 0.25 milliliter instead of 0.5 ml to uncompromised adults). The patient did not experience any adverse events.  It was reported that, the national public health agency recommended to revaccinate the patient with full dose of 0.5 mL.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Monovalent vaccine given as booster; Inappropriate age at vaccine administration; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and NO ADVERSE EVENT (No adverse event) in an adolescent female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Monovalent vaccine given as booster) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration).    No concomitant medications were reported.  It was reported that the caller was the office manager. She had a situation. She found out that they could not give the Moderna as a booster starting 31-Aug-2022, but she administered 15 monovalent doses as boosters. She called public health, who said there was no harm in it. She was also told to call VAERS. She was told that the booster that they received did not cover omicron, so they would need to be revaccinated with the bivalent later.  No treatment medications were reported.