chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 13th December 2021 from lot number P7N2H and expiry date 30th January 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-JUN-2023 The pharmacist reported that a female patient received first dose of Shingrix and never received the second dose. At the time of reporting, the second dose had not been administered. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The vaccine administration facility is the same as primary reporter for 1st dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Second vaccination with Shingrix has been delayed due to Covid; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: Second vaccination with Shingrix has been delayed due to Covid). The outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 13-JUN-2023 The patient self-reported this case. The patient reported that her second vaccination with Shingrix had been delayed due to Covid.  No further information was known. Consented to follow-up was not asked.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: solid part was mixed with one of Merck's diluents for varicella; incorrectly giving Menveo; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: solid part was mixed with one of Merck's diluents for varicella) and inappropriate dose of vaccine administered (Verbatim: incorrectly giving Menveo). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-JUN-2023 The physician reported that one of the staff members told that she recalls incorrectly giving Menveo where the solid part was mixed with one of Merck's diluents for varicella.  So the Menveo diluent was not used. Menveo reconstituted with one of Merck's diluents for varicella instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Neck pain
Clinical narrative: Headaches; Neck pain; This non-serious case was reported by a physician via call center representative and described the occurrence of headache in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number J52PN, expiry date 31-MAR-2024) for prophylaxis.   On 09-JUN-2023, the patient received Bexsero (left arm). On 09-JUN-2023, less than a day after receiving Bexsero, the patient experienced headache (Verbatim: Headaches) and neck pain (Verbatim: Neck pain). The outcome of the headache and neck pain were not resolved.   It was unknown if the reporter considered the headache and neck pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the headache and neck pain to be related to Bexsero and Bexsero 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: 14-JUN-2023 The patient received Bexsero at the medical office and experienced headaches and neck pain since the night of the same day. The reporter consented to follow up.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 year old male received a dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 07-OCT-2024) for prophylaxis.   On 31-MAY-2023, the patient received Boostrix. On 31-MAY-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 5 year old male received a dose of Boostrix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023. A medical assistant reported that a 5 year old male received a dose of Boostrix on 31 May 2023. No symptoms reported. The reporter consented to follow up. Healthcare professional consented to follow-up via email. A dose of Boostrix was administered to a 5 year old patient, which led to inappropriate age at vaccine administration.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: pain (left arm); This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-JUN-2023, the patient received Shingrix (left arm). On 14-JUN-2023, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: pain (left arm)). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date: 14-JUN-2023 A reporter reported about her self she received her first dose of SHINGRIX today on the day of reporting. The patient stated that her left arm hurts. The reporter did not consent to follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Illness, Pulmonary hypertension, Thrombosis
Clinical narrative: BLOOD CLOT; COPD; SICK; PULMONARY HYPERTENSION; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight was 184 pounds, and height was 64 inches. The patient's concurrent conditions included: sulfa drug allergy, egg allergy, tuberculosis test allergy, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. There was no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered at right arm on 02-JUN-2021 for covid-19 prophylaxis. Age at time of vaccination 73 years old. No concomitant medications were reported.  Patient had the shot and then started to get sick on an unspecified date in 2022 and was still having issues. On an unspecified date in 2022, the patient was diagnosed with pulmonary hypertension. Patient reported that she was in the hospital in 2022. On 09-MAY-2022, the patient went to the hospital and was diagnosed with blood clot. The date of hospitalization and number of days hospitalized were not reported. On MAR-2023, the patient experienced COPD (Chronic obstructive pulmonary disease). Patient also reported that she was on oxygen 24 hours a day so she had to retire and she had nothing but troubles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot, and sick, and the outcome of COPD and pulmonary hypertension was not reported. This report was serious (Hospitalization Caused / Prolonged). This case is a duplicate of 20230627259.; Sender's Comments: V0: 20230627296-blood clot. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration. 20230627296-pulmonary hypertension. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19 immunisation, Suspected COVID-19, Urticaria
Clinical narrative: SUSPECTED COVID-19 INFECTION; PAIN AND SORENESS IN HIS KNEES; HIVES AROUND HIS FRONT AND BACK TORSO; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other company (Novartis) concerned a 64 year old male of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. On an unspecified date, the patient previously received 2 doses of covid-19 vaccine from unspecified manufacturer (dose number in series 1) (form of admin, route of admin, batch number and expiry date were not reported), dose was not reported, administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following covid-19 vaccine from unspecified manufacturer (dose number in series 1). The patient received third dose with covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient got sick with suspected covid-19 infection, and also started to experience hives around his front and back torso and experiencing swelling in his hands, palms, fingers, and feet when there's excessive pressure or exertion (dose number in series 2). In the evenings his temperature was like he had the flu and felt a slight change in his breathing and also stated that he started to experience pain and soreness in his knees (dose number in series 2). Treatment medications (dates unspecified) included: cetirizine hydrochloride. Reporter stated that symptoms he was experiencing was not going away and with high dose he feel more irritable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, hives around his front and back torso, pain and soreness in his knees and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20230628322.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pt states that she has pain thinking due to vaccine.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) 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)) (batch no. AS7184B) 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 EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)).    Concomitant medication use information was not provided by reporter.  Vaccine expired on 08-Jun-2023 (30th day). (6 doses of Moderna Covid-19 bivalent were Administered.)  Treatment medication use information was not provided by reporter.  This case contains information for the second patient out of six patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729005 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729005:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) 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)) (batch no. AS7184B) 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 EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)).    This case contains information of 3rd out of 6th patient reported by reporter. Concomitant medication use information was not provided by reporter. Vaccine expired on 08 June 2023 (30th day). 6 doses of Moderna Covid-19 bivalent were administered. Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729005 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729005:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine used; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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)) (batch no. AS7184B) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medications were not reported.  Vaccine expired on 08 June 2023 (30th day). 6 doses of Moderna Covid-19 bivalent were Administered.  Treatment information was not reported.  This case contains information of 4th out of 6th patient reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729005 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729005:(Patient no-1 out of 6 )
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) 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)) (batch no. AS7184B) 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 EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)).    This case contains information of 5th out of 6th patient reported by reporter. Concomitant medication use information was not provided by reporter. Vaccine expired on 08 June 2023 (30th day). 6 doses of Moderna Covid-19 bivalent were Administered. Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-729005 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729005:Master case
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported arm was red, itchy, swollen, and warm 6 inches below site of vaccine injection. Patients arm is still red and swollen but has improved over the past week.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine expired June 8th 2023 but was not removed appropriately from pharmacy by pharmacy tech. Administered by RN (no expiry date on vial) 8 days past expiration by accident.  No patients reported difficulties.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine expired June 8th 2023 but was not removed appropriately from pharmacy by pharmacy tech. Administered by RN (no expiry date on vial) 8 days past expiration by accident.  No patients reported difficulties.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine expired June 8th 2023 but was not removed appropriately from pharmacy by pharmacy tech. Administered by RN (no expiry date on vial) 8 days past expiration by accident.  No patients reported difficulties.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Seizure, Syncope
Clinical narrative: Syncopal episode with seizure like activity concerning for myoclonic seizure activity
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Hair disorder
Clinical narrative: Redness, swelling, heat, pain, decreased range of motion, fever, chills, myalgia, fatigued, headache, nausea w/o emesis, "My hair hurts"
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Joint range of motion decreased, Myalgia, Nausea, Pyrexia
Clinical narrative: Redness, swelling, heat, pain, decreased range of motion, fever, chills, myalgia, fatigued, headache, nausea w/o emesis, "My hair hurts"
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Swelling, Vomiting
Clinical narrative: Redness, swelling, heat, pain, decreased range of motion, fever, chills, myalgia, fatigued, headache, nausea w/o emesis, "My hair hurts"
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine expired June 8th 2023 but was not removed appropriately from pharmacy by pharmacy tech. Administered by RN (no expiry date on vial) 8 days past expiration by accident.  No patients reported difficulties.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine expired June 8th 2023 but was not removed appropriately from pharmacy by pharmacy tech. Administered by RN (no expiry date on vial) 8 days past expiration by accident.  No patients reported difficulties.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Activated partial thromboplastin time normal, Contusion, International normalised ratio normal, Platelet count normal, Prothrombin time normal
Clinical narrative: significant bruising to left foot aprox 4 hours after vaccine
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine should have been discarded on 6/14/23 due to BUD but was administered on 6/15/23 anyway.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Mobility decreased, Muscle strain, Muscle tightness, Neck pain
Clinical narrative: Pt. had his meningitis injection 3/30/23 2 days later he had neck pain and left shoulder pain He lifted a drum and then he felt a pain like he pulled a muscle and then after that he could not move his neck. He used ice and switched out the pillows and it has not helped It got better and went away for a week and then it came back again. He has pain that is 3/10 right now.  He feels a tension that does not allow him to turn his neck.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Pain, X-ray
Clinical narrative: Pt. had his meningitis injection 3/30/23 2 days later he had neck pain and left shoulder pain He lifted a drum and then he felt a pain like he pulled a muscle and then after that he could not move his neck. He used ice and switched out the pillows and it has not helped It got better and went away for a week and then it came back again. He has pain that is 3/10 right now.  He feels a tension that does not allow him to turn his neck.
Age: 29.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness, swelling, bruising, redness around puncture area
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Chills, Condition aggravated, Cough, Dry eye, Dry mouth
Clinical narrative: After I received the bivalent booster on 4/22/23, I experienced the normal side effects I had gotten from the four previous Covid vaccines (low-grade fever, body aches, and chills for 48 hours). Then on day 3 following the vaccine, I experienced burning in my nose, congestion, coughing, sneezing until day 8. Those symptoms resolved on their own. But since receiving the bivalent vaccine, I have expeienced a worsening of my Sjogren's symptoms - my dry eyes have gotten much worse, and my mouth dryness has gotten much worse. It has continued over the past two months (to the present). I made an appointment with the rheumatologist and opthamologist. The rheumatologist had me complete blood work and urinalysis.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Laboratory test abnormal, Nasal discomfort, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: After I received the bivalent booster on 4/22/23, I experienced the normal side effects I had gotten from the four previous Covid vaccines (low-grade fever, body aches, and chills for 48 hours). Then on day 3 following the vaccine, I experienced burning in my nose, congestion, coughing, sneezing until day 8. Those symptoms resolved on their own. But since receiving the bivalent vaccine, I have expeienced a worsening of my Sjogren's symptoms - my dry eyes have gotten much worse, and my mouth dryness has gotten much worse. It has continued over the past two months (to the present). I made an appointment with the rheumatologist and opthamologist. The rheumatologist had me complete blood work and urinalysis.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Sjogren's syndrome, Sneezing, Urine analysis
Clinical narrative: After I received the bivalent booster on 4/22/23, I experienced the normal side effects I had gotten from the four previous Covid vaccines (low-grade fever, body aches, and chills for 48 hours). Then on day 3 following the vaccine, I experienced burning in my nose, congestion, coughing, sneezing until day 8. Those symptoms resolved on their own. But since receiving the bivalent vaccine, I have expeienced a worsening of my Sjogren's symptoms - my dry eyes have gotten much worse, and my mouth dryness has gotten much worse. It has continued over the past two months (to the present). I made an appointment with the rheumatologist and opthamologist. The rheumatologist had me complete blood work and urinalysis.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Osteoarthritis, Pain, Tendonitis, X-ray limb abnormal
Clinical narrative: Continual dull aching pain in right shoulder, even after initial soreness in arm went away.  The dull aching pain has continued for 6 weeks since the injection.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC15, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives developed on right leg within 10 minutes of administration of vaccines. Administered 4ml of benadryl (12.5ml/5ml) at 3:55 pm and patient was starting to develop hives on forehead, cheeks, scalp, with no signs of distressed breathing, vomiting, lip swelling. Upon leaving the clinic, child was comfortably asleep in Mom's arms without urticaria, although some erythema still present at the injection site. Lungs were clear to auscultation, RR was WNL, no reactions/cyanosis/grunting/wheezing, pulse ox was WNL. Parents sent with appropriate Benadryl dosing and told to call our 24/7 on-call service if anything changes or worsens in the coming hours. A referral to an allergy specialist was also given. Left at 4:25pm.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.); No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) 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)) (batch no. AS7184B) for COVID-19 prophylaxis.     No relevant medical history/conditions, allergy, concomitant diseases and risk factor were 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 EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (It expired on 08Jun2023 (30th day)/(6 doses of Moderna Covid-19 bivalent were Administered.)).    This case contains information for the 6 of 6 patients described by the reporter.  No concomitant medications were reported. It was reported that vaccine was expired on 08-Jun-2023 (30th day). and 6 doses of Moderna Covid-19 bivalent were administered. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-729005 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729005:Master case
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination site pain
Clinical narrative: experiencing pain in the left shoulder ever since, it does not hurt all the time, only when he touches the area.; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experiencing pain in the left shoulder ever since, it does not hurt all the time, only when he touches the area.) and COVID-19 (COVID-19) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 012F21A, 030M20A and 038A21A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: EMPAGLIFLOZIN (25 mg), ASCORBIC ACID 2-O-GLUCOSIDE (10 mg 4 tables a day) and ALOGLIPTIN (12.5 mg.). Past adverse reactions to the above products included No adverse event with ALOGLIPTIN, ASCORBIC ACID 2-O-GLUCOSIDE and EMPAGLIFLOZIN. Concurrent medical conditions included Type 2 diabetes mellitus.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (COVID-19). On 02-Jun-2022, the patient experienced VACCINATION SITE PAIN (experiencing pain in the left shoulder ever since, it does not hurt all the time, only when he touches the area.). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (experiencing pain in the left shoulder ever since, it does not hurt all the time, only when he touches the area.) had not resolved and COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.  On 27 Oct 2022, the patient took MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) with batch number 021H02N  as a dose 5 and did not experience any adverse event.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse reactions are reported; The patient received moderna Covid-19 vaccine in which the vial was punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received moderna Covid-19 vaccine in which the vial was punctured more than 12 hours ago) and NO ADVERSE EVENT (No other adverse reactions are reported) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received moderna Covid-19 vaccine in which the vial was punctured more than 12 hours ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No other adverse reactions are reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received moderna Covid-19 vaccine in which the vial was punctured more than 12 hours ago) and NO ADVERSE EVENT (No other adverse reactions are reported) had not resolved.        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 other adverse reactions are reported) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The patient received moderna Covid-19 vaccine in which the vial was punctured more than 12 hours ago).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant information was reported.  A dose of Moderna Bivalent Covid-19 vaccine that was taken out of the refrigerator at 10:30AM on 11 Jun 2023. The vaccine was punctured and given to 2 patients appropriately on 11 June 2023 however another dose of vaccine was administered to a patient on 12 Jun 2023 at 11:30AM.   The patient received his first dose of the Moderna Monovalent vaccine on 25 Feb 2021 lot number 014M20A expiration date 12 August 2021 injection site was not known, and no adverse reactions.  Second dose of the moderna Covid-19 vaccine on 26 Mar 2021 lot number 008B21A expiration date 10 Sept 2021, arm of administration was not known. No adverse reactions with it.   First dose of the Moderna Covid-19 vaccine on 3 Nov 2021, lot number 939903 expiry date 3 Nov 2022. Patient does not know arm of administration or of any adverse reactions.   Bivalent Moderna Covid-19 vaccine on 14 Oct 2023 Lot number was not reported. Expiration date and arm of administration are not known. No adverse reactions with it. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728905 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728905:(patient 2)
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired Monovalent 2nd primary shot of Moderna COVID-19 vaccine on14-MAR-2023 (Lot# 074B22A & Expiration Date: 11-MAR-2023); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 2nd primary shot of Moderna COVID-19 vaccine on14-MAR-2023 (Lot# 074B22A & Expiration Date: 11-MAR-2023)) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 2nd primary shot of Moderna COVID-19 vaccine on14-MAR-2023 (Lot# 074B22A & Expiration Date: 11-MAR-2023)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 2nd primary shot of Moderna COVID-19 vaccine on14-MAR-2023 (Lot# 074B22A & Expiration Date: 11-MAR-2023)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Monovalent 2nd primary shot of Moderna COVID-19 vaccine on14-MAR-2023 (Lot# 074B22A & Expiration Date: 11-MAR-2023)).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Concomitant medication details not reported by the reporter. NDC number was reported as 80777027310. Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin discolouration, Vaccination site discolouration, Vaccination site swelling
Clinical narrative: discolored; opposite arm swollen; opposite arm discolored; arm has been swollen; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCOLOURATION (discolored), PERIPHERAL SWELLING (opposite arm swollen), SKIN DISCOLOURATION (opposite arm discolored) and VACCINATION SITE SWELLING (arm has been swollen) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (discolored), PERIPHERAL SWELLING (opposite arm swollen), SKIN DISCOLOURATION (opposite arm discolored) and VACCINATION SITE SWELLING (arm has been swollen). At the time of the report, VACCINATION SITE DISCOLOURATION (discolored), PERIPHERAL SWELLING (opposite arm swollen), SKIN DISCOLOURATION (opposite arm discolored) and VACCINATION SITE SWELLING (arm has been swollen) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported. The reporter stated that the patient received his 4th shot of the Moderna covid 19 vaccine and the arm had been swollen and discolored. It had also traveled to the opposite arm. It was unknown if the patient experienced any additional symptoms/events.  No treatment medication information was reported.
Age: 22.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: no adverse event; Administered expired vaccine 29-May-2023; Patient received Bivalent vaccine as a First dose on 29-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 29-May-2023), WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as a First dose on 29-MAY-2023) and NO ADVERSE EVENT (no adverse event) in a 22-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-May-2023, 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 29-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 29-May-2023) and WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as a First dose on 29-MAY-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 29-May-2023), WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as a First dose on 29-MAY-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine 29-May-2023) and WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as a First dose on 29-MAY-2023).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored on 11-May-2023 and vaccine was administered on 13-Jun-2023.; No adverse event; Nurse is calling to report that a 71-year-old patient received expired booster (5th dose) of Moderna Bivalent COVID-19 vaccine on 13JUN2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 71-year-old patient received expired booster (5th dose) of Moderna Bivalent COVID-19 vaccine on 13JUN2023), PRODUCT STORAGE ERROR (Vial was initially stored on 11-May-2023 and vaccine was administered on 13-Jun-2023.) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 71-year-old patient received expired booster (5th dose) of Moderna Bivalent COVID-19 vaccine on 13JUN2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored on 11-May-2023 and vaccine was administered on 13-Jun-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 71-year-old patient received expired booster (5th dose) of Moderna Bivalent COVID-19 vaccine on 13JUN2023), PRODUCT STORAGE ERROR (Vial was initially stored on 11-May-2023 and vaccine was administered on 13-Jun-2023.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that a 71-year-old patient received expired booster (5th dose) of Moderna Bivalent COVID-19 vaccine on 13JUN2023) and PRODUCT STORAGE ERROR (Vial was initially stored on 11-May-2023 and vaccine was administered on 13-Jun-2023.).    Concomitant product use was not provided by the reporter.  Expiry date of suspect vaccine was reported as26-Sep-2023. Individual vials or intact cartons were in open carton. Vial size was reported as 2.5 ml. Expired lot was 3 days after the 30 days beyond use date. Vial did not undergo any temperature excursions.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Anxiety
Clinical narrative: when the Children tell their parents that they are severely sick" The doctor mentions it is anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (when the Children tell their parents that they are severely sick" The doctor mentions it is anxiety) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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 ANXIETY (when the Children tell their parents that they are severely sick" The doctor mentions it is anxiety). At the time of the report, ANXIETY (when the Children tell their parents that they are severely sick" The doctor mentions it is anxiety) outcome was unknown.        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.   This case was processed as cluster case as there were no identifiable patients.  No concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: received Moderna for two doses and received the Pfizer; This is a spontaneous report received from a contactable reporter (Nurse) from medical information team, Program ID: (RA).  A 2-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Jan2023 as dose 3 (maroon cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 18Jan2023, outcome "unknown", described as "received Moderna for two doses and received the Pfizer".  Follow-up attempts are completed. No further information is expected.