chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: fever; 4 month old was administered Kinrix; This case was reported by a nurse via call center representative and described the occurrence of fever in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, less than 4 months after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced fever and inappropriate age at vaccine administration. On an unknown date, the outcome of the fever and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the fever to be related to Kinrix and Kinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-Oct-2022 Reporter's comment:  The registered nurse reported a 4 month old was administered a dose of Kinrix in error. The patient developed a fever.  The vaccine administration facility was the same as primary reporter. The registered nurse did not ask about follow up but address, email and phone are above in healthcare professional details. The healthcare professional stated they had reported to VAERS already. Additional Supportive Information: 4 month old patient was administered a dose of Kinrix in error, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Herpes zoster, Injection site pain, Musculoskeletal chest pain, Product administered at inappropriate site
Clinical narrative: Shoulder Pain, sore shoulder; sharp pain on right side of rib cage; 2-dose series in 2018, in 2022 shingles/suspected vaccination failure; Shingles/diagnosed with shingles; Vacine given way too high in the shoulder area; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine  (received Shingles vaccine prior to Shingrix vaccine).   In October 2018, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In October 2018, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 12th October 2022, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced shoulder pain and rib pain. On an unknown date, the outcome of the vaccination failure, rib pain and vaccine administered at inappropriate site were unknown and the outcome of the shingles and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, shoulder pain and rib pain to be related to Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2022AMR148225   Additional Information: GSK receipt date: 13-Oct-2022 Reporter's comment: The patient's wife reported that the patient had the 2-dose series of Shingrix vaccine in 2018.  The second dose was injected in the right arm.  The reporter stated that the injection was administered way too high in the shoulder area and this caused pain and soreness on the shoulder area. The reporter stated that still this day the patient had pain in the shoulder.  The reporter stated that they did not knew if this was related to the vaccine.  The patient had a sharp pain on the right side of his rib cage and was diagnosed with Shingles. The patient was prescribed 1 gram of Valacyclovir stat, then three times a day for 7 days.   No additional information was provided. Not all information was available.   Lot and expiration date was unknown. Consented to follow up with healthcare professional was provided. The case was linked with case US2022AMR148225, reported by same reporter for different product for same patient. Additional supportive information: The injection was administered way too high in the shoulder area and this caused pain and soreness on the shoulder area, which led to vaccine administered at inappropriate site. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2022AMR148225:different product, same patient, same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Shoulder Pain, sore shoulder; sharp pain on right side of rib cage; 2-dose series in 2018, in 2022 shingles/suspected vaccination failure; Shingles/diagnosed with shingles; Vacine given way too high in the shoulder area; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine  (received Shingles vaccine prior to Shingrix vaccine).   In October 2018, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In October 2018, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 12th October 2022, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced shoulder pain and rib pain. On an unknown date, the outcome of the vaccination failure, rib pain and vaccine administered at inappropriate site were unknown and the outcome of the shingles and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, shoulder pain and rib pain to be related to Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2022AMR148225   Additional Information: GSK receipt date: 13-Oct-2022 Reporter's comment: The patient's wife reported that the patient had the 2-dose series of Shingrix vaccine in 2018.  The second dose was injected in the right arm.  The reporter stated that the injection was administered way too high in the shoulder area and this caused pain and soreness on the shoulder area. The reporter stated that still this day the patient had pain in the shoulder.  The reporter stated that they did not knew if this was related to the vaccine.  The patient had a sharp pain on the right side of his rib cage and was diagnosed with Shingles. The patient was prescribed 1 gram of Valacyclovir stat, then three times a day for 7 days.   No additional information was provided. Not all information was available.   Lot and expiration date was unknown. Consented to follow up with healthcare professional was provided. The case was linked with case US2022AMR148225, reported by same reporter for different product for same patient. Additional supportive information: The injection was administered way too high in the shoulder area and this caused pain and soreness on the shoulder area, which led to vaccine administered at inappropriate site. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2022AMR148225:different product, same patient, same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2019, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received the 1st dose of Shingrix in 2019).   On an unknown date, the patient received 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: 13-OCT-2022. Reporter's Comments: The reporter stated that a patient received the 1st dose of Shingrix in 2019 and was late for the 2nd dose. The reporter gave consent to follow up. Additional Supportive Information: The patient did not received 2nd dose which leads to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Sep 2021, 2nd 13Oct2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose (0.5ml) received in September 2019 intramuscularly into unknown arm).   On 13th October 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th October 2022, 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: 14-OCT-2022 Reporter's comment: The patient self-reported this case. The patient received her second Shingrix vaccine into unknown arm on 13th October 2022 (inappropriate schedule of vaccine).  The reporter did not consent to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix vaccine later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 252JX, expiry date 14th September 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th February 2022 with batch number 3AA9T and expiry date 20th April 2023) and Shingrix (2nd dose received on 1st May 2022 with batch number DC434 and expiry date 3rd June 2023).   On 14th October 2022, the patient received the 3rd dose of Shingrix. On 14th October 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's comment: Pharmacist reported that the patient inadvertently received a third dose of Shingrix today(day of reporting). The reporter consented to follow-up. Additional Supportive Information: The patient inadvertently received a third dose of Shingrix, which led to Extra dose administered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: received expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: The reporter was medical assistant. The reporter called to report that, a patient received an expired Kinrix vaccine at the time of reporting. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received an expired Kinrix vaccine, which led to expired vaccine used.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: sleep apnea, overweight, nicotine user, and allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A221A expiry: UNKNOWN) dose was not reported, administered on 21-APR-2021 15:45 for covid-19 prophylaxis. No concomitant medications were reported. On 04-OCT-2022, Laboratory data included: COVID-19 virus test Negative (No covid effects). On 05-OCT-2022, Laboratory data included: COVID-19 virus test Negative (No covid effects). On 06-OCT-2022, Laboratory data included: COVID-19 virus test Negative (No covid effects). On 07-OCT-2022, Laboratory data included: COVID-19 virus test Positive (at home). On an unspecified date, the patient experienced covid-19 test positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 test positive. This report was non-serious. This report was associated with a product quality complaint: 90000255691.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Seborrhoeic dermatitis
Clinical narrative: SEBORRHEIC DERMATITIS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1822811 expiry: UNKNOWN) dose was not reported, administered on 12-OCT-2021 for covid-19 prophylaxis. No concomitant medications were reported. On DEC-2021, the patient experienced seborrheic dermatitis. On SEP-2022, Laboratory data included: Biopsy seborrheic dermatitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from seborrheic dermatitis. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness
Clinical narrative: Experienced dizziness; clamminess shortly after receiving their dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Experienced dizziness) and COLD SWEAT (clamminess shortly after receiving their dose) in a 62-year-old female patient 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) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Experienced dizziness) and COLD SWEAT (clamminess shortly after receiving their dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Experienced dizziness) and COLD SWEAT (clamminess shortly after receiving their dose) outcome was unknown.            No concomitant medications were reported. The patient received the Moderna Bivalent Covid Vaccine.  After experiencing symptoms, patient had to lie down and was put on oxygen.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL COLD & FLU) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2022, SARS-CoV-2 test: (Positive) patient took a home Covid test which was positive.         No concomitant medications were reported.  On Jan-2021, the patient received first dose of Moderna vaccine. On 17-Feb-2021, the patient received second dose of Moderna vaccine. On Feb-2022, the patient received third dose of Moderna vaccine.  One week after receiving the most recent dose, the patient became sick with tiredness and cold like symptoms. She called the physician who recommended Tylenol cold and flu and advised the patient to remain quarantined for 5 days.   Reporter did not allow further contact
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adeverse event; patient was administered a dose of the Moderna COVID-19 monovalent vaccine instead of the Moderna bivalent vaccine as his booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 monovalent vaccine instead of the Moderna bivalent vaccine as his booster dose) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 monovalent vaccine instead of the Moderna bivalent vaccine as his booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient was administered a dose of the Moderna COVID-19 monovalent vaccine instead of the Moderna bivalent vaccine as his booster dose) 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 was administered a dose of the Moderna COVID-19 monovalent vaccine instead of the Moderna bivalent vaccine as his booster dose).    No concomitant medications were provided.  A patient was administered a dose of the Moderna COVID-19 monovalent vaccine instead of the Moderna bivalent vaccine as his booster dose. He received the correct dosage of 0.5 mL, but an incorrect product. Patient has not reported any adverse reactions at this time. No treatment information provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Adult patient received a Bivalent dose as a first primary dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Adult patient received a Bivalent dose as a first primary dose of the Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Adult patient received a Bivalent dose as a first primary dose of the Moderna COVID19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Adult patient received a Bivalent dose as a first primary dose of the Moderna COVID19 vaccine) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Adult patient received a Bivalent dose as a first primary dose of the Moderna COVID19 vaccine).    No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: given 0.25 ml of the bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (given 0.25 ml of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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 (given 0.25 ml of the bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (given 0.25 ml of the 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 ACCIDENTAL UNDERDOSE (given 0.25 ml of the bivalent booster).    Concomitant medication was not provided.  Treatment information was not provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; given a 0.25mL dose of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 14-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine).    No concomitant medications were reported. No symptoms were reported. No additional doses given were reported. Patient did not receive any treatment.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sore arm; COVID-19; Slight fever for a couple of days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), COVID-19 (COVID-19) and PYREXIA (Slight fever for a couple of days) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 027AC1A and 630620A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Diabetes and Drug allergy (Codeine). Concomitant products included LISINOPRIL for Blood pressure management, METFORMIN for Diabetes, GABAPENTIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-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 (Sore arm), COVID-19 (COVID-19) and PYREXIA (Slight fever for a couple of days). At the time of the report, PAIN IN EXTREMITY (Sore arm) and COVID-19 (COVID-19) outcome was unknown and PYREXIA (Slight fever for a couple of days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Patient had no medical history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. On 12-Nov-2021, received third dose as booster dose of Moderna COVID-19 Vaccine. It was reported that patient had normal problems with the first three doses that she received: sore arm, slight fever for a couple of days, just normal reactions.  No treatment drug was reported.   This case was linked to MOD-2022-659170, MOD-2022-659178 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm; COVID-19; Slight fever for a couple of days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), COVID-19 (COVID-19) and PYREXIA (Slight fever for a couple of days) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 027AC1A and 630620A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Diabetes and Drug allergy (Codeine). Concomitant products included LISINOPRIL for Blood pressure management, METFORMIN for Diabetes, GABAPENTIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-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 (Sore arm), COVID-19 (COVID-19) and PYREXIA (Slight fever for a couple of days). At the time of the report, PAIN IN EXTREMITY (Sore arm) and COVID-19 (COVID-19) outcome was unknown and PYREXIA (Slight fever for a couple of days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Patient had no medical history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. On 12-Nov-2021, received third dose as booster dose of Moderna COVID-19 Vaccine. It was reported that patient had normal problems with the first three doses that she received: sore arm, slight fever for a couple of days, just normal reactions.  No treatment drug was reported.   This case was linked to MOD-2022-659170, MOD-2022-659178 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: sore arm; slight fever for a couple of days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (slight fever for a couple of days) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027AC1A and 630620A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Codeine), Diabetes and Blood pressure abnormal. Concomitant products included LISINOPRIL for Blood pressure abnormal, METFORMIN for Diabetes, GABAPENTIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second 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) and PYREXIA (slight fever for a couple of days). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (slight fever for a couple of days) had resolved.            Patient had no medical history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. It was reported that patient had normal problems with the first three doses that she received: sore arm, slight fever for a couple of days, just normal reactions. No treatment drug was reported.   This case was linked to MOD-2022-659170, MOD-2022-659173 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; slight fever for a couple of days; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (slight fever for a couple of days) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027AC1A and 630620A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Codeine), Diabetes and Blood pressure abnormal. Concomitant products included LISINOPRIL for Blood pressure abnormal, METFORMIN for Diabetes, GABAPENTIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second 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) and PYREXIA (slight fever for a couple of days). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (slight fever for a couple of days) had resolved.            Patient had no medical history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. It was reported that patient had normal problems with the first three doses that she received: sore arm, slight fever for a couple of days, just normal reactions. No treatment drug was reported.   This case was linked to MOD-2022-659170, MOD-2022-659173 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; given a 0.25mL dose of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 14-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine).    No concomitant medications were reported.  No symptoms were reported.  No additional doses, medications, or treatments were given.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: given a 0.25mL dose of the bivalent vaccine; given a 0.25mL dose of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) and NO ADVERSE EVENT (given a 0.25mL dose of the bivalent vaccine) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 14-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (given a 0.25mL dose of the bivalent vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) and NO ADVERSE EVENT (given a 0.25mL dose of the bivalent vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (given a 0.25mL dose of the bivalent vaccine) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine).    The concomitant and treatment medication was not reported. On 14-Oct-2022, the four people over the age of 18 were given 0.25 ml dose of the bivalent vaccine by intramuscular injection. The patient had no reported symptoms, no additional doses, medications and treatments.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; given a 0.25mL dose of the bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 14-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (given a 0.25mL dose of the bivalent vaccine).    No concomitant medication was reported.  On 14-Oct-2022, the four people over the age of 18 were given 0.25 ml dose of the bivalent vaccine. No symptoms were reported.  No additional doses, medications or treatment was received.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient also did not get some side effects that patient got after previous doses; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient also did not get some side effects that patient got after previous doses) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient also did not get some side effects that patient got after previous doses). At the time of the report, IMMUNISATION REACTION (Patient also did not get some side effects that patient got after previous doses) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-659177 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: In bed for 10 days; Arm got very hot; Fever; Bad swelling in the left arm, Arm swell up; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (In bed for 10 days), VACCINATION SITE WARMTH (Arm got very hot), PYREXIA (Fever) and VACCINATION SITE SWELLING (Bad swelling in the left arm, Arm swell up) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 006M20A and QFA2036) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy (she is taking allergy pills). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (In bed for 10 days), VACCINATION SITE WARMTH (Arm got very hot), PYREXIA (Fever) and VACCINATION SITE SWELLING (Bad swelling in the left arm, Arm swell up). At the time of the report, ILLNESS (In bed for 10 days), VACCINATION SITE WARMTH (Arm got very hot), PYREXIA (Fever) and VACCINATION SITE SWELLING (Bad swelling in the left arm, Arm swell up) had resolved.            Patient is not taking other medication except for allergy pills and aspirin once in a while. No Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  Patient had no Allergies with medications, food and other products.  The doctor gave the patient antibiotic. The emergency clinic gave her another one and a shot in the hip.   This case was linked to MOD-2022-659373 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bacterial infection, Cellulitis, Illness, Pyrexia, Vaccination site swelling
Clinical narrative: In bed for 10 days; Arm got very hot; Fever; Bad swelling in the left arm, Arm swell up; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (In bed for 10 days), VACCINATION SITE WARMTH (Arm got very hot), PYREXIA (Fever) and VACCINATION SITE SWELLING (Bad swelling in the left arm, Arm swell up) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 006M20A and QFA2036) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy (she is taking allergy pills). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (In bed for 10 days), VACCINATION SITE WARMTH (Arm got very hot), PYREXIA (Fever) and VACCINATION SITE SWELLING (Bad swelling in the left arm, Arm swell up). At the time of the report, ILLNESS (In bed for 10 days), VACCINATION SITE WARMTH (Arm got very hot), PYREXIA (Fever) and VACCINATION SITE SWELLING (Bad swelling in the left arm, Arm swell up) had resolved.            Patient is not taking other medication except for allergy pills and aspirin once in a while. No Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  Patient had no Allergies with medications, food and other products.  The doctor gave the patient antibiotic. The emergency clinic gave her another one and a shot in the hip.   This case was linked to MOD-2022-659373 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: In bed for 10 days; Arm got very hot; Fever; Bad swelling in the left arm, Arm swell up; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (In bed for 10 days), VACCINATION SITE WARMTH (Arm got very hot), PYREXIA (Fever) and VACCINATION SITE SWELLING (Bad swelling in the left arm, Arm swell up) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 006M20A and QFA2036) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy (she is taking allergy pills). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (In bed for 10 days), VACCINATION SITE WARMTH (Arm got very hot), PYREXIA (Fever) and VACCINATION SITE SWELLING (Bad swelling in the left arm, Arm swell up). At the time of the report, ILLNESS (In bed for 10 days), VACCINATION SITE WARMTH (Arm got very hot), PYREXIA (Fever) and VACCINATION SITE SWELLING (Bad swelling in the left arm, Arm swell up) had resolved.            Patient is not taking other medication except for allergy pills and aspirin once in a while. No Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  Patient had no Allergies with medications, food and other products.  The doctor gave the patient antibiotic. The emergency clinic gave her another one and a shot in the hip.   This case was linked to MOD-2022-659373 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pain in hands after vaccination; Swollen hands after vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Pain in hands after vaccination) and PERIPHERAL SWELLING (Swollen hands after vaccination) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (Patient went through chemo and radiation. The cancer went away.) in 2020, Chemotherapy and Radiation therapy.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Pain in hands after vaccination) and PERIPHERAL SWELLING (Swollen hands after vaccination). At the time of the report, PAIN IN EXTREMITY (Pain in hands after vaccination) and PERIPHERAL SWELLING (Swollen hands after vaccination) outcome was unknown.            No concomitant medication information was provided.  Patient took 2 Moderna vaccine shots and then booster.  Ever since vaccination, patient started having pain in hands and swollen hands.  Treatment included pain medication.   This case was linked to MOD-2022-659356 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2022: Live Follow-up appended contains non significant information. On 14-Oct-2022: Live Follow-up appended contains non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: still feel a little bad; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (still feel a little bad) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In September 2022, the patient experienced FEELING ABNORMAL (still feel a little bad). The patient was treated with PARACETAMOL for Feeling bad, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (still feel a little bad) had not resolved.    The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.  No concomitant medications were reported. It was reported that patient was recently got vaccinated and mentioned that 15 days had passed and patient was still feeling a little bad. Patient had gone to health center and the only thing they prescribed was paracetamol.