chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Bexsero on 15Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXB38AA, expiry date 22nd July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th August 2022, unknown after receiving Bexsero and Bexsero 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: 15-AUG-2022 Reporter's comment: A pharmacist reported that a patient had received an expired dose of Bexsero on 15th August 2022 which was expired on 22nd July 2022.  The reporter had consented to follow up. The Healthcare Professional (HCP) did not had the patient info like gender, initials, date of birth. Additional supportive information: The patient had received an expired dose of Bexsero, which led to expired vaccine used.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA468A, expiry date 31st March 2022) for prophylaxis.   On 10th August 2022, the patient received Menveo. On 10th August 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comment: The reporter stated that the patient received an expired Menveo vaccine. The reporter asked how to proceed, patient should revaccinate. The reporter confirmed that the expired vaccine was administered in their facility. The reporter inquired how to proceed, and should they revaccinate the patient. The reporter consented to follow up. Additional supportive information: The patient received a Menveo which was already expired, which led to expired vaccine used.
Age: 67.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received a dose that expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 67-year-old male patient who received HAB (Twinrix) (batch number x239d, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 16th August 2022, unknown after receiving Twinrix and Twinrix 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: 16-AUG-2022 Reporter's Comments: The nurse reported that a patient received a dose of Twinrix that was expired on 7th Aug 2022. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Immunodeficiency, Product administered to patient of inappropriate age
Clinical narrative: Patient is younger than 50 yeras old; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes.   In April 2022, the patient received the 1st dose of Shingrix. In April 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's comments: The pharmacist stated that a patient who was younger than 50 years had received their 1st dose of Shingrix in April 2022. It was not known whether the patient was considered immunocompromised due to the patient's diabetes. Possible adverse event for younger than indicated age in immunocompetent patient. The reporter had declined to provide additional information. The reporter did not consent to follow-up. Additional supportive information: The patient who had received Shingrix was younger than 50 years which had led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received dose 2 yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th October 2021 (0.5 ml) at intramuscularly route).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments:  The patient had not received dose 2 till the time of reporting. The information of lot number and injection site was not provided. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 3rd dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received first dose on 10th December 2021) and Engerix B (received second dose on 13th January 2022 batch number:4EA77 expiry date:11-Sep-2022).   On an unknown date, the patient did not receive the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 17-Aug-2022 Reporter's Comments: A Pharmacist reported that a female patient received the first dose of Engerix B on 10th December 2021, and the second dose on 13th January 2022 and the 3rd dose had not been administered yet.  The reporter denied to follow-up. The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: Till the time of reporting, the patient had not received the 3rd dose of Engerix B, which led to incomplete course of vaccination.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report received from a patient concerned a 69 year old female of an unspecified ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: penicillin allergy (neomycin), allergy to cold temperature, and mold allergy. The patient had lot of allergies. The patient was previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: Unknown) dose was not reported, therapy start date was not reported, 1 total administered for covid-19 prophylaxis. No adverse events reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: unknown) dose was not reported, 1 total administered to the left arm on 16-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 69 years old. No concomitant medications were reported. It was reported that on 16-NOV-2021, a few minutes after getting the booster the patient started feeling tingling in tongue. It was also mentioned that they kept her for past 15 minutes, but as the patient did not have any breathing problems, they let her went. The tingling in tongue stayed for a few hours then it went away and patient mentioned that it was been like this since and it was on and off. It was more frequent the first week then it became less frequent. The patient went to the dentist and got an anesthetic injection and she said it came back worse after the injection wore off. It was again worse and more frequent and affected her lips and palate, the first week then less frequent. It was mentioned that it seems somewhat related to stress. The patient said she thought it was over a couple of time but it came back a month later so she was never really sure if it was gone for good. The patient also said that she consulted with her allergist at first and the allergist told it was not an allergy. She was recommended to see a neurologist and the neurologist told her it was paresthesia (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paresthesia. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Mental disorder, Panic attack
Clinical narrative: PANIC ATTACKS; DIZZINESS; SPIKING BLOOD PRESSURES FOR A WHILE; AFFECTING MENTAL HEALTH; RINGING OF THE EARS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have spiking blood pressure, dizziness and panic attacks in her life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On APR-2021, the patient experienced affecting mental health, and ringing of the ears. On an unspecified date, the patient experienced panic attacks, dizziness, and spiking blood pressures for a while. Laboratory data (dates unspecified) included: Blood pressure spiking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spiking blood pressures for a while, and ringing of the ears on JUN-2022, and the outcome of dizziness, panic attacks and affecting mental health was not reported. This report was non-serious. This case, from the same reporter is linked to 20220827357.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: PANIC ATTACKS; DIZZINESS; SPIKING BLOOD PRESSURES FOR A WHILE; AFFECTING MENTAL HEALTH; RINGING OF THE EARS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have spiking blood pressure, dizziness and panic attacks in her life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On APR-2021, the patient experienced affecting mental health, and ringing of the ears. On an unspecified date, the patient experienced panic attacks, dizziness, and spiking blood pressures for a while. Laboratory data (dates unspecified) included: Blood pressure spiking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spiking blood pressures for a while, and ringing of the ears on JUN-2022, and the outcome of dizziness, panic attacks and affecting mental health was not reported. This report was non-serious. This case, from the same reporter is linked to 20220827357.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION (REBOUND OF COVID); This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 40 year old male. Initial information was processed with additional information received on 19-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart disease, and sulfa drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on 03-AUG-2021 at 12:00 on left arm for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 39 years old. Concomitant medications included cold and flu (dextromethorphan hydrobromide/doxylamine succinate/guaifenesin/paracetamol/phenylephrine hydrochloride/pseudoephedrine hydrochloride). On 28-JUL-2022 at 23:45, the patient experienced fevers and headaches (confirmed covid-19 infection) which lead to confirmed clinical vaccination failure.  The patient received non-company co-suspect drug Paxlovid (form of administration, route of admin, batch number, and expiry date were not reported) dose was not reported, administered from 28-JUL-2022 to 01-AUG-2022 for treatment of COVID-19.  On unspecified date, patient experienced rebound of covid symptoms with fevers and headaches after initially getting better and tested positive for covid again. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and treatment with Paxlovid was withdrawn on 01-AUG-2022 . The outcome of the confirmed covid-19 infection(rebound of covid) and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000247202.; Sender's Comments: V0-20220837250-covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of BONE PAIN (bone aches from the waist down) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 prophylaxis. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced BONE PAIN (bone aches from the waist down). At the time of the report, BONE PAIN (bone aches from the waist down) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not reported. The patient reports no other adverse reactions or side effects after the first vaccine. Treatment medications were not reported. This case was linked to MOD-2022-630013 (Patient Link).
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses) and NO ADVERSE EVENT (no adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #AR9237B) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .15 milliliter. On 16-Aug-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses) 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 ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses). Concomitant products were not reported. The patient received lower than authorized doses and received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml dose. The reporter had an issue and they incorrectly drawled up the doses. Treatment medications were not reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Neck pain, Pain, Vaccination site movement impairment
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift it up she has to help the left hand with the right one), BACK PAIN (major pain that goes to the neck or back), NECK PAIN (major pain that goes to the neck or back), PAIN (pain of 10) and VACCINATION SITE REACTION (hole in left  hand) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient was not tested positive or diagnosed for COVID-19. Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Food allergy (seafoods). On 01-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift it up she has to help the left hand with the right one), BACK PAIN (major pain that goes to the neck or back), NECK PAIN (major pain that goes to the neck or back), PAIN (pain of 10), VACCINATION SITE REACTION (hole in left  hand), HYPOAESTHESIA (numbness in fingers) and VACCINATION SITE SWELLING (left hand swollen). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift it up she has to help the left hand with the right one), BACK PAIN (major pain that goes to the neck or back), NECK PAIN (major pain that goes to the neck or back), PAIN (pain of 10), VACCINATION SITE REACTION (hole in left  hand), HYPOAESTHESIA (numbness in fingers) and VACCINATION SITE SWELLING (left hand swollen) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. AE cause patient to seek urgent care and specialist. It was reported that all the symptoms got worsened.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift it up she has to help the left hand with the right one), BACK PAIN (major pain that goes to the neck or back), NECK PAIN (major pain that goes to the neck or back), PAIN (pain of 10) and VACCINATION SITE REACTION (hole in left  hand) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient was not tested positive or diagnosed for COVID-19. Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Food allergy (seafoods). On 01-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift it up she has to help the left hand with the right one), BACK PAIN (major pain that goes to the neck or back), NECK PAIN (major pain that goes to the neck or back), PAIN (pain of 10), VACCINATION SITE REACTION (hole in left  hand), HYPOAESTHESIA (numbness in fingers) and VACCINATION SITE SWELLING (left hand swollen). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (cannot lift it up she has to help the left hand with the right one), BACK PAIN (major pain that goes to the neck or back), NECK PAIN (major pain that goes to the neck or back), PAIN (pain of 10), VACCINATION SITE REACTION (hole in left  hand), HYPOAESTHESIA (numbness in fingers) and VACCINATION SITE SWELLING (left hand swollen) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. AE cause patient to seek urgent care and specialist. It was reported that all the symptoms got worsened.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (had a fever) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (had a fever) and NAUSEA (nausea). At the time of the report, PYREXIA (had a fever) and NAUSEA (nausea) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications was reported. It was unknown if the patient had allergy, but was taking allergy shots. It was also unknown if the patient was tested or diagnosed with COVID and unknown if the patient experienced a similar event in the past. It was unknown, if the patient was taking any other vaccines within 1 month of staring COVID-19 vaccine. No treatment drug details was reported. This case was linked to MOD-2022-630193 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Pain, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (REACTION TO COVID VACCINE), PAIN (NO RESPONSE YET/NO IMPROVEMENT IN PAIN) and RASH (RASH with RINVOQ (UPADACITINIB) and HUMIRA (ADALIMUMAB)) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Psoriatic arthritis and ADALIMUMAB (HUMIRA) solution for injection for an unknown indication. Concurrent medical conditions included Psoriatic arthritis. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form, UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (REACTION TO COVID VACCINE), PAIN (NO RESPONSE YET/NO IMPROVEMENT IN PAIN) and RASH (RASH with RINVOQ (UPADACITINIB) and HUMIRA (ADALIMUMAB)). At the time of the report, IMMUNISATION REACTION (REACTION TO COVID VACCINE) and RASH (RASH with RINVOQ (UPADACITINIB) and HUMIRA (ADALIMUMAB)) had resolved and PAIN (NO RESPONSE YET/NO IMPROVEMENT IN PAIN) had not resolved. No concomitant medications were reported. There was no reported medical history. The patient experienced reaction to Covid vaccine, no response yet/no improvement in pain from Rinvoq and rash with Rinvoq (Upadacitinib) and Humira (Adalimumab). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for the events of reaction to Covid vaccine, no response yet/no improvement in pain from Rinvoq and rash was not provided. The reporter's causality for the events of no response yet/no improvement in pain from Rinvoq with Rinvoq (Upadacitinib) was a reasonable possibility. The reporter's causality for the events of reaction to Covid vaccine, no response yet/no improvement in pain from Rinvoq and no response yet/no improvement in pain from Rinvoq was not provided. The reporter's causality for the events of Rash with Humira (Adalimumab) was a reasonable possibility. No treatment information was provided by the reporter.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in an 86-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In June 2022, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of COVID-19 was not reported for Humira. No treatment drug details was reported. Company comment: This spontaneous case concerns a 86 year old female with no reported medical history who experienced the unexpected non-serious adverse event of special interest COVID-19 which occurred at an unknown interval after receiving a dose of mRNA1273. Further details regarding the clinical course, hospital admission, other diagnostic or imaging test done, concomitant medications and treatment were not provided. Information regarding other COVID-19 vaccines were not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 86 year old female with no reported medical history who experienced the unexpected non-serious adverse event of special interest COVID-19 which occurred at an unknown interval after receiving a dose of mRNA1273. Further details regarding the clinical course, hospital admission, other diagnostic or imaging test done, concomitant medications and treatment were not provided. Information regarding other COVID-19 vaccines were not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Contracted psoriasis) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Contracted psoriasis). At the time of the report, PSORIASIS (Contracted psoriasis) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications were reported. The patient had Humira given as a solution for injection in pre-filled pen. The reporter did not have the lot number information, because the packaging was discarded. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter causality for an event of contracted psoriasis with adalimumab (Humira) was a reasonable possibility. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired dose) and NO ADVERSE EVENT (no adverse event) 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 17-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) 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 (receiving expired dose). Vaccine was expired on the 13 and was given on the 17 Aug 2022. The vial was not exposed to a previous temperature excursion. didn't have information about the lot number of the used vial or the date that the vial was initially stored in the fridge as they discarded the vial No concomitant medication were given. No treatment information were given.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (hand itch in both palms of hands/feet itch) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PRURITUS (hand itch in both palms of hands/feet itch). At the time of the report, PRURITUS (hand itch in both palms of hands/feet itch) outcome was unknown. No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported. The reporter's causality for the event of HAND ITCH IN BOTH PALMS OF HANDS/FEET ITCH was not reported with Humira.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25 ml instead of 0.5 ml  for the very first dose) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 16-Aug-2022, the patient experienced UNDERDOSE (Received 0.25 ml instead of 0.5 ml  for the very first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25 ml instead of 0.5 ml  for the very first dose) 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 UNDERDOSE (Received 0.25 ml instead of 0.5 ml  for the very first dose). No concomitant information were reported by the reporter. The patient was an adult patient of 18 plus age received first dose of Moderna COVID-19 vaccine. Patient received 0.25 ml instead of 0.5 ml. The reporter was not sure which vial was used, but guessed it was red cap vial. No treatment information were reported by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Oropharyngeal discomfort, Rash, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (Sinuses started to swell up), COUGH (Coughing), OROPHARYNGEAL DISCOMFORT (So much flowing down the back of her throat), DIZZINESS (Dizzy) and RASH (Rash across her chest) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Astra Zeneca (Dose Number: 1 (participant in study), Lot no: A03326-105174, Left arm) on 08-Dec-2020, Astra Zeneca (Dose Number: 2, Lot no: A03468-112807, Left arm) on 05-Jan-2021, Pfizer (Dose Number: 1st booster, Lot no: 30145BA and Left arm) on 28-Sep-2021. Past adverse reactions to the above products included No adverse event with Astra Zeneca, Astra Zeneca and Pfizer. Concurrent medical conditions included Controlled hypertension (Recent change in status: controlled on medication) since 2004 and Allergy NOS (Allergies a lot). On 11-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Aug-2022, the patient experienced DIZZINESS (Dizzy). In August 2022, the patient experienced SINUSITIS (Sinuses started to swell up), COUGH (Coughing), OROPHARYNGEAL DISCOMFORT (So much flowing down the back of her throat) and RASH (Rash across her chest). At the time of the report, SINUSITIS (Sinuses started to swell up), COUGH (Coughing), OROPHARYNGEAL DISCOMFORT (So much flowing down the back of her throat), DIZZINESS (Dizzy) and RASH (Rash across her chest) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative and (Negative) Negative. No concomitant product use was provided. The patient didn't have any side effects from any of the previous vaccines. The patient didn't experienced a similar event in the past. The patient doesn't had COVID positive test or diagnosis. The patient states she went home after getting the Moderna booster on 11-Aug-2022. She immediately started feeling dizzy. She had a rash across her chest. Her sinuses started to swell up. Pretty soon there was so much flowing down the back of her throat that she started coughing. She's been coughing for a week. She states it's not the active ingredients in the product. She states Moderna vaccine has PEG, which has known allergenic effects including anaphylactic shock. She had it previously for a colonoscopy that she got so sick, she couldn't have the procedure. It never occurred to her that Moderna would put this horrible PEG in the vaccine, it's the relative to car anti-freeze. The patient already had a sensitivity. The AE cause patient to seek medical care for doctor call 2 days ago. The symptoms were improving gradually. No treatment medication was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (Sinuses started to swell up), COUGH (Coughing), OROPHARYNGEAL DISCOMFORT (So much flowing down the back of her throat), DIZZINESS (Dizzy) and RASH (Rash across her chest) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Astra Zeneca (Dose Number: 1 (participant in study), Lot no: A03326-105174, Left arm) on 08-Dec-2020, Astra Zeneca (Dose Number: 2, Lot no: A03468-112807, Left arm) on 05-Jan-2021, Pfizer (Dose Number: 1st booster, Lot no: 30145BA and Left arm) on 28-Sep-2021. Past adverse reactions to the above products included No adverse event with Astra Zeneca, Astra Zeneca and Pfizer. Concurrent medical conditions included Controlled hypertension (Recent change in status: controlled on medication) since 2004 and Allergy NOS (Allergies a lot). On 11-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Aug-2022, the patient experienced DIZZINESS (Dizzy). In August 2022, the patient experienced SINUSITIS (Sinuses started to swell up), COUGH (Coughing), OROPHARYNGEAL DISCOMFORT (So much flowing down the back of her throat) and RASH (Rash across her chest). At the time of the report, SINUSITIS (Sinuses started to swell up), COUGH (Coughing), OROPHARYNGEAL DISCOMFORT (So much flowing down the back of her throat), DIZZINESS (Dizzy) and RASH (Rash across her chest) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative and (Negative) Negative. No concomitant product use was provided. The patient didn't have any side effects from any of the previous vaccines. The patient didn't experienced a similar event in the past. The patient doesn't had COVID positive test or diagnosis. The patient states she went home after getting the Moderna booster on 11-Aug-2022. She immediately started feeling dizzy. She had a rash across her chest. Her sinuses started to swell up. Pretty soon there was so much flowing down the back of her throat that she started coughing. She's been coughing for a week. She states it's not the active ingredients in the product. She states Moderna vaccine has PEG, which has known allergenic effects including anaphylactic shock. She had it previously for a colonoscopy that she got so sick, she couldn't have the procedure. It never occurred to her that Moderna would put this horrible PEG in the vaccine, it's the relative to car anti-freeze. The patient already had a sensitivity. The AE cause patient to seek medical care for doctor call 2 days ago. The symptoms were improving gradually. No treatment medication was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient has received 2 primary and 3 booster doses by intramuscular injection to the deltoid; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has received 2 primary and 3 booster doses by intramuscular injection to the deltoid) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A22-2A, 042J21A, 061E21A, 012L20A and 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has received 2 primary and 3 booster doses by intramuscular injection to the deltoid). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has received 2 primary and 3 booster doses by intramuscular injection to the deltoid) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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 (Patient has received 2 primary and 3 booster doses by intramuscular injection to the deltoid). Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Nausea
Clinical narrative: Feeling sick/ not well; Not pleasant lasted 5 days, more intense in the beginning; Nauseated; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feeling sick/ not well), FEELING ABNORMAL (Not pleasant lasted 5 days, more intense in the beginning) and NAUSEA (Nauseated) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 prophylaxis.     The patient's past medical history included Sickness, Eye colour change (Had pink eye), Chest pain and Difficulty breathing. Concurrent medical conditions included GERD (Reflux), Type 2 diabetes mellitus, Blood pressure high, Allergy to antibiotic (Erythromycin (throws up)), Allergy to antibiotic (Tetracycline), Contrast media allergy (was rigid) and Dust allergy. Concomitant products included METOPROLOL TARTRATE (LOPRESSOR) for Blood pressure high, FAMOTIDINE (PEPCID [FAMOTIDINE]) for GERD, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CANNABIDIOL (CBD OIL) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MALAISE (Feeling sick/ not well), FEELING ABNORMAL (Not pleasant lasted 5 days, more intense in the beginning) and NAUSEA (Nauseated). In 2021, MALAISE (Feeling sick/ not well), FEELING ABNORMAL (Not pleasant lasted 5 days, more intense in the beginning) and NAUSEA (Nauseated) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. After receiving 1st dose, patient reported feeling sick, nauseated, not well, not pleasant lasted 5 days, more intense in the beginning. Patient's symptoms were improved. The adverse event had caused patient to seek medical care. No treatment medications were reported.   This case was linked to MOD-2022-630474 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Patient was in a lot of pain/ Everything hurt; Leg hurt; Horrible headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Patient was in a lot of pain/ Everything hurt), PAIN IN EXTREMITY (Leg hurt) and HEADACHE (Horrible headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Peanut allergy.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-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 (Patient was in a lot of pain/ Everything hurt), PAIN IN EXTREMITY (Leg hurt) and HEADACHE (Horrible headache). At the time of the report, PAIN (Patient was in a lot of pain/ Everything hurt), PAIN IN EXTREMITY (Leg hurt) and HEADACHE (Horrible headache) outcome was unknown.            Patient had no medical history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination. Patient was taking other medication. No treatment medications were reported.   This case was linked to MOD-2022-630443 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Overdose
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of OVERDOSE (1 ml dose received for dose 2), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1- 28-Jan-2021 and Dose - 11-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 007M20A) for COVID-19 prophylaxis. Concurrent medical conditions included Drug allergy (Chloroquine allergy), Penicillin allergy, Hypertension, Anxiety, Eye disorder and Pain. Concomitant products included ALPRAZOLAM for Anxiety, CARVEDILOL for Hypertension, IBUPROFEN and ACETAMINOPHEN for Pain. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 milliliter. On 11-Mar-2021, the patient experienced OVERDOSE (1 ml dose received for dose 2). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1- 28-Jan-2021 and Dose - 11-Mar-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (1 ml dose received for dose 2), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1- 28-Jan-2021 and Dose - 11-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OVERDOSE (1 ml dose received for dose 2) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose 1- 28-Jan-2021 and Dose - 11-Mar-2021).  Patient concomitant medication included Vit C/Vit E Lutein Minerals with indication of eye health, oral, 1 capsule continuing. No treatment information reported. This case was linked to MOD-2022-630498, MOD-2022-628728 (Patient Link).