chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Skin rash as of today I have no relief.; Black bubbles started to develop on my skin; This case was reported by a consumer and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 2nd dose of Shingrix 50 ug. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and blister. On an unknown date, the outcome of the rash and blister were not recovered/not resolved.   It was unknown if the reporter considered the rash and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: The patient self-reported this case. After the second dose, the patient got skin rash and black bubbles started to develop on his/her skin.  The patient under dermatologist treatment, however till the time of reporting the patient had no relief. The patient asked did anyone else reported this and was there any good cure for this, their response would be helpful in his/her future treatment.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: still break out with them/suspected vaccination failure; still break out with them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional Information: GSK Receipt Date: 26-Mar-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter stated, it did not matter if you get the two-part shot, the patient still broke out with shingles. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible, as no contact details were available. This case had been linked to US2022AMR056645, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR056645:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Incomplete course of vaccination, Nerve injury
Clinical narrative: axillary nerve damage; fatigue in left arm; vaccinated aroud Fall of 2020 , declined to get 2nd dose; This case was reported by a physician via sales rep and described the occurrence of nerve damage in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced nerve damage, fatigue and incomplete course of vaccination. On an unknown date, the outcome of the nerve damage and incomplete course of vaccination were unknown and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the nerve damage and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-MAR-2022 Reporter's Comment: The patient vaccinated with first dose of Shingrix around fall of 2020 and experienced fatigue in left arm and had not made a full recovering. The diagnosis was axillary nerve damage. The patient declined from receiving second dose. Additional supportive information:  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: RECEIVED 1ST DOSE 2019 BUT NEVER GOT 2ND DOSE; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's Comments: The reporter enquired if a patient received Shingrix 1st dose in 2019 but never got 2nd dose what should be done. Additional Supportive Information: The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEP
Symptoms: Product administered at inappropriate site
Clinical narrative: Engerix B on butt cheek; This case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a male patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included IMMUNOGLOBULIN ANTIHEPATITIS B (HEPATITIS B IMMUNE GLOBULIN).   On 24th March 2022, the patient received Engerix B. On 24th March 2022, unknown after receiving Engerix B, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site was unknown.   Additional Information: GSK Receipt Date: 25-MAR-2022 Reporter's Comments: The patient receiving on the same day Engerix B and the hepatitis b immunoglobulin injection on the same butt cheek, not the same spot but close.  The reporter consented to follow up. Additional Supportive Information:  The patient received Engerix B on butt cheek, which led to vaccine administered at inappropriate site.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Received 2 doses, experienced pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: The patient's daughter reported this case. The patient received dose of Shingrix vaccine between 4 to 5 years ago from reporting date and experienced arm pain that eventually resolved.   The reporter did not consent to follow-up. Additional supportive information: This case had been linked with case US2022056751 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022056751:Same reporter.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: the vaccine was administered reconstituted with normal saline.; the vaccine was administered reconstituted with normal saline.; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adolescent male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA689A, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-MAR-2022 Reporter's Comments: Medical assistant reported that the patient was administered the Menveo serogroup A lyophilized vaccine portion that had been reconstituted with normal saline. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via phone. Additional Supportive Information: The patient received Menveo which was reconstituted with normal saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the ASO1B adjuvant; Patient was administered only the ASO1B adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th March 2022, the patient received the 1st dose of Shingrix. On 30th March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-MAR-2022 Reporter's Comments:  The patient was administered only the ASO1B adjuvant component of the Shingrix vaccine. The reporter consented to follow up. Additional supportive information:  The patient received only adjuvant component of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 1st booster shot was 100 µg, not 50; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (1st booster shot was 100 µg, not 50) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (1st booster shot was 100 µg, not 50). At the time of the report, ACCIDENTAL OVERDOSE (1st booster shot was 100 µg, not 50) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 031M20A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included Surgery in February 2006. Concurrent medical conditions included Breast cancer (Breast cancer diagnosed in late 2005) and Emphysema. Concomitant products included LANSOPRAZOLE, THEOPHYLLINE, PRAVASTATIN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) had resolved.            Patient information: Height 5.3. No treatment medications were reported.   This case was linked to MOD-2022-528604, MOD-2022-528616, MOD-2022-528626 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Patient has a sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Patient has a sore left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Patient has a sore left arm). At the time of the report, VACCINATION SITE PAIN (Patient has a sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient was not immunocompromised. No concomitant drug was reported. The patient received the Moderna vaccine in her left arm shoulder deltoid muscle. The patient received second Moderna Covid-19 vaccine on 14-Feb-2021. No treatment drug was reported.   This case was linked to MOD-2022-529131 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Immunisation reaction
Clinical narrative: received a full dose instead of a half dose; had a reaction to every dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a reaction to every dose) and ACCIDENTAL OVERDOSE (received a full dose instead of a half dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 393906, 044921A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced VACCINATION COMPLICATION (had a reaction to every dose). On 28-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (received a full dose instead of a half dose). In August 2021, VACCINATION COMPLICATION (had a reaction to every dose) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (received a full dose instead of a half dose) outcome was unknown.            Concomitant medication included medication for High blood pressure and blood thinner.  Patient got booster at a market and was not officially approved then so received a full dose instead of a half dose. Patient had reaction to every dose when received and it went away in a day or two.  Patient did not take any medications for any reactions.   This case was linked to MOD-2021-307576, MOD-2021-307152 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Immunisation reaction
Clinical narrative: Had a reaction to every dose; Received a full dose instead of a half dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a reaction to every dose) and ACCIDENTAL OVERDOSE (Received a full dose instead of a half dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 393906, 044921A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic asthma (Asthma induced with allergies).   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Received a full dose instead of a half dose). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a reaction to every dose). At the time of the report, VACCINATION COMPLICATION (Had a reaction to every dose) had resolved and ACCIDENTAL OVERDOSE (Received a full dose instead of a half dose) outcome was unknown.            No concomitant medications were provided. The caller reported that they had a reaction to every dose when they got them and it went away in a day or two. They did not take any medications for any reactions. No treatment medications were reported.   This case was linked to MOD-2021-307233, MOD-2021-307462, MOD-2021-307152 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited after each dose; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomited after each dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomited after each dose). At the time of the report, VOMITING (Vomited after each dose) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment medications was reported.   This case was linked to MOD-2022-529320, MOD-2022-528692 (Patient Link).   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: got a half dose instead of a full dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (got a half dose instead of a full dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cardiovascular disease, unspecified and Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (got a half dose instead of a full dose). At the time of the report, ACCIDENTAL UNDERDOSE (got a half dose instead of a full dose) outcome was unknown.            No concomitant medication was reported.  Patient's doctor gave him a note stating that he needs a full third dose. When he went to get the vaccination he saw the card said "Moderna COVID-19 booster 0.25mL".  Consent for Safety to follow up was not obtained.  No treatment information was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired moderna vaccine booster dose administered to 1 patient/Dose administered greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine booster dose administered to 1 patient/Dose administered greater than 12 hours post puncture) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2022 at 8:24 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2022 at 8:24 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine booster dose administered to 1 patient/Dose administered greater than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine booster dose administered to 1 patient/Dose administered greater than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vail was first punctured on 8:06 am  28Mar2022.  No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: My husband sick in the bed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (My husband sick in the bed) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (My husband sick in the bed). At the time of the report, ILLNESS (My husband sick in the bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported by the provider.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus, Pyrexia, Rash, Vaccination site rash
Clinical narrative: Covid arm; Rash on vaccination site left arm, 48 hours after 2nd shot; Felt warm day after 2nd shot, Fever unmeasured day after 2nd shot; front right elbow has a rash, he has been breaking out in other spot; looked like something bit him; neck is itchy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (looked like something bit him), PRURITUS (neck is itchy), VACCINATION SITE REACTION (Covid arm), RASH (front right elbow has a rash, he has been breaking out in other spot) and VACCINATION SITE RASH (Rash on vaccination site left arm, 48 hours after 2nd shot) in a 39-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 048L21A and 027L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin rash.   On 26-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Mar-2022 at 4:00 PM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced FEELING ABNORMAL (looked like something bit him), PRURITUS (neck is itchy) and RASH (front right elbow has a rash, he has been breaking out in other spot). On 27-Mar-2022, the patient experienced PYREXIA (Felt warm day after 2nd shot, Fever unmeasured day after 2nd shot). On 28-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE RASH (Rash on vaccination site left arm, 48 hours after 2nd shot). On 28-Mar-2022, PYREXIA (Felt warm day after 2nd shot, Fever unmeasured day after 2nd shot) had resolved. At the time of the report, FEELING ABNORMAL (looked like something bit him), PRURITUS (neck is itchy), RASH (front right elbow has a rash, he has been breaking out in other spot) and VACCINATION SITE RASH (Rash on vaccination site left arm, 48 hours after 2nd shot) outcome was unknown and VACCINATION SITE REACTION (Covid arm) was resolving.            Patient reported that he is prone to skin rash and it has happened prior to vaccination several times, he usually applies a cream and it goes away. Patient did not experience any side effect from first dose.  He confirmed that he did not have a rash anywhere else on his body at that time and also stated on 31 MAR 2022, COVID arm was improving.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up received includes medical history, dose 1 details, event fever added.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm; Rash on vaccination site left arm, 48 hours after 2nd shot; Felt warm day after 2nd shot, Fever unmeasured day after 2nd shot; front right elbow has a rash, he has been breaking out in other spot; looked like something bit him; neck is itchy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (looked like something bit him), PRURITUS (neck is itchy), VACCINATION SITE REACTION (Covid arm), RASH (front right elbow has a rash, he has been breaking out in other spot) and VACCINATION SITE RASH (Rash on vaccination site left arm, 48 hours after 2nd shot) in a 39-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 048L21A and 027L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin rash.   On 26-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Mar-2022 at 4:00 PM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced FEELING ABNORMAL (looked like something bit him), PRURITUS (neck is itchy) and RASH (front right elbow has a rash, he has been breaking out in other spot). On 27-Mar-2022, the patient experienced PYREXIA (Felt warm day after 2nd shot, Fever unmeasured day after 2nd shot). On 28-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE RASH (Rash on vaccination site left arm, 48 hours after 2nd shot). On 28-Mar-2022, PYREXIA (Felt warm day after 2nd shot, Fever unmeasured day after 2nd shot) had resolved. At the time of the report, FEELING ABNORMAL (looked like something bit him), PRURITUS (neck is itchy), RASH (front right elbow has a rash, he has been breaking out in other spot) and VACCINATION SITE RASH (Rash on vaccination site left arm, 48 hours after 2nd shot) outcome was unknown and VACCINATION SITE REACTION (Covid arm) was resolving.            Patient reported that he is prone to skin rash and it has happened prior to vaccination several times, he usually applies a cream and it goes away. Patient did not experience any side effect from first dose.  He confirmed that he did not have a rash anywhere else on his body at that time and also stated on 31 MAR 2022, COVID arm was improving.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up received includes medical history, dose 1 details, event fever added.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received a "full" booster dose prior to FDA approval; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (received a "full" booster dose prior to FDA approval) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (received a "full" booster dose prior to FDA approval). At the time of the report, ACCIDENTAL OVERDOSE (received a "full" booster dose prior to FDA approval) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: FLUR4
Symptoms: Antinuclear antibody positive, Eye disorder, Thirst
Clinical narrative: problems with her eyes; constantly thirsty; ANA teether/pattern reflex test with results higher than the normal range; Initial information received on 28-Mar-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 67 years old female patient who had problems with her eyes, constantly thirsty and ana teether/pattern reflex test with results higher than the normal range after receiving vaccine influenza quadrivalent recombinant vaccine [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of influenza quadrivalent recombinant vaccine (Formulation, strength, dose, frequency, route, batch number, expiry date and anatomical location: Unknown) for prophylactic vaccination.  On an unknown date the patient had a non-serious events problems with her eyes (eye disorder) and thirsty (thirst) and ana teether/pattern reflex test with results higher than the normal range (antinuclear antibody positive) (unknown latency).  Relevant laboratory test results included: Antinuclear antibody - On an unknown date: results higher than the normal range  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for all the events.  Outcome: Unknown
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: wrong patient- with no reported adverse event; Initial information received on 29-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 7 days old female patient who experienced wrong patient- with no reported adverse event while receiving vaccine HIB (PRP/T) Vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine for Immunisation.  On 29-Mar-2022, the patient received 0.5 ml of 1 dose of suspect HIB (PRP/T) vaccine (batch lot : UJ569AD Expiry date :02-Oct-2022)(unknown :strength and formulation)cycle, series:1 via intramuscular route in the right thigh.  On 29-Mar-2022 (latency :same day)the patient developed a non-serious event of wrong patient- with no reported adverse event (wrong patient received product) following the administration of HIB (PRP/T) vaccine  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: DTAP-IPV liquid portion of the vaccine was already administered to the patient without mixing the Hib part with no reported adverse event; Initial information received on 29-Mar-2022 regarding an unsolicited valid non-serious case received by other health professional.  This case involves an 8 week old female patient to whom DTAP-IPV liquid portion of the vaccine was already administered without mixing the HIB part with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 28-Mar-2022, the patient received Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (form, strength: unknown; lot UJ593AAA) via intramuscular route in unknown administration site as Immunization.  On 28-Mar-2022 (latency: same day), the patient DTAP-IPV liquid portion of the vaccine was already administered to the patient without mixing the HIB part with no reported adverse event (product preparation issue).  Action taken: Not applicable.  Event outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: ACT-HIB vaccination that contained the appropriate Hib lyophilized powder portion but was reconstituted with sterile water from a Merck varicella vaccine instead of the diluent provided in the ACT-HIB box,with no Adverse Event; Initial information received on 30-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB] vaccination that contained the appropriate hib lyophilized powder portion but was reconstituted with sterile water from a merck varicella vaccine instead of the diluent provided in the act-hib box with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; rotavirus vaccine for Prophylactic vaccination; iodinated glycerol (IPOL [IODINATED GLYCEROL]); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DAPTACEL) for Prophylactic vaccination; and varicella zoster vaccine (VARICELLA VACCINE).  On 29-Mar-2022, the patient received 0.5ml dose of suspect HIB (PRP/T) VACCINE, once, (strength and formulation: unknown) (lot UJ589AAA, Expiration Date: 25-Oct-2025) via intramuscular route in the right thigh for prophylactic vaccination.  On 29-Mar-2022 the patient received act-hib vaccination that contained the appropriate hib lyophilized powder portion but was reconstituted with sterile water from a merck varicella vaccine instead of the diluent provided in the act-hib box with no adverse event (product preparation error). The caller asked that "if this would count as a valid dose and how soon the patient could be re-vaccinated".  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event act-hib vaccination that contained the appropriate hib lyophilized powder portion but was reconstituted with sterile water from a merck varicella vaccine instead of the diluent provided in the act-hib box,with no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: pericarditis
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: soreness began that day.  I stretched according to instructions.  Soreness persists 3 months later...severe soreness so that my range of motion in left arm is severely limited
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cerebrovascular accident, Laboratory test
Clinical narrative: Sudden increase in blood pressure culminating in Stroke on 9/15/21. No problems with blood pressure before this
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Injection site erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Redness at injection site, swollen armpit, sore jaw on left side, sore left shoulder, sore left breast, lower left arm soreness  Left arm and shoulder still aches, left breast still sore
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Redness at injection site, swollen armpit, sore jaw on left side, sore left shoulder, sore left breast, lower left arm soreness  Left arm and shoulder still aches, left breast still sore
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Chest pain, Diplopia, Disorientation, Dizziness
Clinical narrative: - Intermittent tachycardia and heart palpitations, gradually building to intense chest pains lasting for months and severe bouts of tachycardia (sudden resting heart rate of 140-150 BPM) lasting for several hours at a time, resulting in cardiology POTS diagnosis  - Blood pressure instability - Persistent dizziness, lightheadeness, spacial disorientation, and vertigo - Neuropathy (numbness and tingling in extremeties) - Blurry and double vision - Nausea and heartburn - Rapid drop in ferretin and sex hormone levels - Insomnia / jolting awake at night
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Female sex hormone level abnormal, Full blood count abnormal, Hormone level abnormal, Hypoaesthesia
Clinical narrative: - Intermittent tachycardia and heart palpitations, gradually building to intense chest pains lasting for months and severe bouts of tachycardia (sudden resting heart rate of 140-150 BPM) lasting for several hours at a time, resulting in cardiology POTS diagnosis  - Blood pressure instability - Persistent dizziness, lightheadeness, spacial disorientation, and vertigo - Neuropathy (numbness and tingling in extremeties) - Blurry and double vision - Nausea and heartburn - Rapid drop in ferretin and sex hormone levels - Insomnia / jolting awake at night
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lipids decreased, Metabolic function test abnormal, Nausea, Neuropathy peripheral
Clinical narrative: - Intermittent tachycardia and heart palpitations, gradually building to intense chest pains lasting for months and severe bouts of tachycardia (sudden resting heart rate of 140-150 BPM) lasting for several hours at a time, resulting in cardiology POTS diagnosis  - Blood pressure instability - Persistent dizziness, lightheadeness, spacial disorientation, and vertigo - Neuropathy (numbness and tingling in extremeties) - Blurry and double vision - Nausea and heartburn - Rapid drop in ferretin and sex hormone levels - Insomnia / jolting awake at night
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Postural orthostatic tachycardia syndrome, Red blood cell count decreased, Serum ferritin decreased
Clinical narrative: - Intermittent tachycardia and heart palpitations, gradually building to intense chest pains lasting for months and severe bouts of tachycardia (sudden resting heart rate of 140-150 BPM) lasting for several hours at a time, resulting in cardiology POTS diagnosis  - Blood pressure instability - Persistent dizziness, lightheadeness, spacial disorientation, and vertigo - Neuropathy (numbness and tingling in extremeties) - Blurry and double vision - Nausea and heartburn - Rapid drop in ferretin and sex hormone levels - Insomnia / jolting awake at night
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tachycardia, Vertigo, Vision blurred
Clinical narrative: - Intermittent tachycardia and heart palpitations, gradually building to intense chest pains lasting for months and severe bouts of tachycardia (sudden resting heart rate of 140-150 BPM) lasting for several hours at a time, resulting in cardiology POTS diagnosis  - Blood pressure instability - Persistent dizziness, lightheadeness, spacial disorientation, and vertigo - Neuropathy (numbness and tingling in extremeties) - Blurry and double vision - Nausea and heartburn - Rapid drop in ferretin and sex hormone levels - Insomnia / jolting awake at night
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain, Weight decreased
Clinical narrative: Weight lost-60 lbs, passed out twice, pain in body.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Parent gave the wrong birthdate for patient
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Nurse administered vaccine to male patient using only the liquid adjuvant portion of the vaccin; Nurse administered vaccine to male patient using only the liquid adjuvant portion of the vaccin; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 45L54, expiry date 18th May 2023) for prophylaxis.   On 28th March 2022, the patient received the 1st dose of Shingrix. On 28th March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's Comment: The nurse administered Shingrix vaccine to patient using only the liquid adjuvant portion of the vaccine, it was not reconstituted with the lyophilized powder portion and adjuvant was administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. At the time of reporting, the dose had not been repeated. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received a 2nd dose; This case was reported by a other health professional 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 (received 1st on an unknown date in 2020).   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: 29-Mar-2022 Reporter's Comments: Medical Assistant reported that a patient never received a 2nd dose.  The reporter did not consent to follow-up.  Health care professional (HCP) wanted to remain anonymous Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Upper respiratory tract infection
Clinical narrative: UPPER RESPIRATORY INFECTION; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis.  No concomitant medications were reported.  On an unspecified date, the patient experienced upper respiratory infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from upper respiratory infection. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Two patients received Moderna vaccines 15 days after expiration date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna vaccines 15 days after expiration date.) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2022 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna vaccines 15 days after expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Two patients received Moderna vaccines 15 days after expiration date.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided. The vial did not undergo any temperature excursions. Date the vial was initially stored in the refrigerator: Unknown The patient not experienced any physical adverse reaction and was notified regarding the expired vaccine and would came to clinic to get a repeat booster. The patient receives the booster as 0.25 of unknown unit. The patient had no known allergies. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2022: Significant follow up appended: Report type updated, Reporter information updated (city and postal code), Patient demographics updated, Dosage information updated and Product coding updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The patient's past medical history included Surgery in 2006. Concurrent medical conditions included Breast cancer (Breast cancer diagnosed in late 2005) since 2005 and Emphysema. Concomitant products included LANSOPRAZOLE, THEOPHYLLINE, PRAVASTATIN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Patient height mentioned as 5.3. No treatment information was provided by the reporter. This case was linked to MOD-2022-528616, MOD-2022-528619, MOD-2022-528626 (Patient Link).