chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: he tested positive for covid on 30Dec2021 & his wife tested positive a couple of days prior; he tested positive for covid on 30Dec2021 & his wife tested positive a couple of days prior; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 28Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 07Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "he tested positive for covid on 30Dec2021 & his wife tested positive a couple of days prior". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) negative; (Dec2021) positive.  Clinical Course: he and his wife received the first Pfizer Covid 19 Vaccine on 07Feb2021. The second Pfizer Covid 19 Vaccine was received on 28Feb2021. Per caller he tested positive for covid on 30Dec2021 & his wife tested positive a couple of days prior roughly 10 days ago in Dec. Caller reports they both tested negative on 08Jan2022. They are scheduled to receive the Pfizer Covid 19 Booster on 12Jan2021. Caller asking if that will be to soon. Caller is a 79 year old male and his wife is an 80 year old female.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200036785 same reporter/drug/event, different patient.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia
Clinical narrative: myalgia; fatigue; dizz/dizziness; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 14 year-old female patient received bnt162b2 (COMIRNATY), administration date 09Jan2022 15:30 (Batch/Lot number: unknown) at the age of 14 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 09Jan2022 21:00, outcome "unknown", described as "dizz/dizziness"; MYALGIA (non-serious) with onset 10Jan2022 07:00, outcome "unknown", described as "myalgia"; FATIGUE (non-serious) with onset 10Jan2022 07:00, outcome "unknown", described as "fatigue". Additional information Description of Event: 14 year old healthy female. Received costed at 03:30pm on 09Jan.  Felt dizzy by 9pm. Awoke at 7am 10Jan with myalgia, fatigue, dizziness Optional Information: NKDA. No significant PMH. No medications  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid breakthrough infection; Covid breakthrough infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid breakthrough infection". The patient is a healthy immunocompetent female.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: after the vaccine, he basically had fever since then so, since Friday and up to 103.7; his temperature it is up and down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 07Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "periodic fever syndrome" (unspecified if ongoing), notes: usually he get fever once a month on a cycle. no more than one day, . The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First Dose, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "after the vaccine, he basically had fever since then so, since Friday and up to 103.7; his temperature it is up and down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional information Reporter stated, "So, my son got the second dose of the vaccine (COVID-19 vaccine) on this 07Dec2021 (further not clarified) and he also have something called periodic fever syndrome (intent medical history). I do not know, if it is something you are familiar with but usually he get fever once a month on a cycle. So, he is actually and usually he gets it for not more than one day, well and he is actually, he had not had once for over a month (further clarification unknown) and then now after the vaccine he does, he basically had fever since then so, since Friday and up to 103.7 (further clarification unknown) and the Tylenol does not seems to bring it down. So, I keep, basically right now I have one and he is 'under' (further clarification unknown) with an ice pack over his head and I like, constantly taking his temperature it is up and down, crazy."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pneumonia, SARS-CoV-2 test
Clinical narrative: I had symptoms for Covid with Pneumonia.; BOOSTER; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm right, administration date 27Oct2021 08:30 (Lot number: EW0217) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillian" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; PROTONIX [OMEPRAZOLE]; TIZANIDINE; AMITRIPTYLINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 08:15 AM), administration date: 15Feb2021, when the patient was 45 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 08:30 AM), administration date: 25Jan2021, when the patient was 45 years old, for COVID-19 Immunization. The patient did not receive other vaccines within four weeks of the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 27Oct2021 08:30, outcome "unknown", described as "BOOSTER"; PNEUMONIA (medically significant) with onset 28Dec2021, outcome "recovering", described as "I had symptoms for Covid with Pneumonia". The event "i had symptoms for covid with pneumonia" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pneumonia which included antibiotics. Clinical course: Patient reported he had symptoms for COVID with pneumonia which began on 28Dec2021. Emergency Room visit was on 03Jan2022 for treatment. Patient stated that although he tested negative, he was told he still had COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Immunisation
Clinical narrative: The day following my booster shot, I got a very tender sometimes painful swollen lump under my right arm. Located where the chest and axilla meet.; The day following my booster shot, I got a very tender sometimes painful swollen lump under my right arm. Located where the chest and axilla meet.; Dose number 3; This is a spontaneous report received from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.   An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 05Jan2022 at 16:00 (Lot number: FL3209) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EM9809, Route of Administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: ER2613, Route of Administration: unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 at 16:00, outcome "unknown", described as "Dose number 3"; AXILLARY MASS (non-serious), AXILLARY PAIN (non-serious) all with onset 06Jan2022, outcome "recovered" (10Jan2022), and all described as "The day following my booster shot, I got a very tender sometimes painful swollen lump under my right arm. Located where the chest and axilla meet". Therapeutic measures were not taken as a result of axillary mass and axillary pain.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the tender swelling remained for 4 days. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: breakthrough covid-19 infection; breakthrough covid-19 infection; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Dec2021 12:30 (Lot number: FE3590) at the age of 64 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 01Apr2021 13:00 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 11Mar2021 13:15 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "afib" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Allergies: environmental and food allergies" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE; ROSUVASTATIN; METFORMIN; ASPIRIN [ACETYLSALICYLIC ACID]. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 04Dec2021 12:30, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovered" and all described as "breakthrough covid-19 infection". The event "breakthrough covid-19 infection" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Nasal Swab. Therapeutic measures taken as a result of the event included doxycycline hyclate 100mg.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: Off label use; Booster; Breakthrough COVID-19 infection; Breakthrough COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 43 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "recovered" (Jan2022) and all described as "Breakthrough COVID-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive, notes: Nasal Swab.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The contributory role of the suspect product to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: patient received a third dose of BNT162b2; patient was positive for COVID-19 on an unknown date and had received all three Pfizer vaccines; patient was positive for COVID-19 on an unknown date and had received all three Pfizer vaccines; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received three doses of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Numbers: UNKNOWN) as single doses for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: the patient experienced drug ineffective and COVID-19. The patient was positive for COVID-19 on an unknown date and had received all three Pfizer vaccines. The clinical outcomes of drug ineffective and COVID-19 were unknown.   The lot numbers for bnt162b2 were not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to amend previous information: amended patient data, relevant medical history, suspect vaccine, event description and narrative information.  Follow-up (12Jan2022): This is a follow-up report to notify that the case 202101873835 and case 202200055538  are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202200055538.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Covid 19, Drug Ineffective, and immunisation and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: FLUX
Symptoms: Cardiac fibrillation, Exercise tolerance decreased, Loss of personal independence in daily activities, Near death experience, Palpitations
Clinical narrative: nearly killed me; could not run which I do often for more than 20 yards without heart jumping out of chest; My heart went into defibrillation for more than ten seconds at a time; Initial information received on 04-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced nearly killed me, could not run which I do often for more than 20 yards without heart jumping out of chest and my heart went into defibrillation for more than ten seconds at a time while receiving vaccine INFLUENZA VACCINE.  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 suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, form, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  The patient reported that this shot nearly killed me (near death experience (onset date and latency: unknown). This event was assessed as medically significant. His/her heart went into defibrillation for more than ten seconds at a time this happened for more that three days in a row (unevaluable event, onset date and unknown latency). The patient  could not run, which he do often, for more than 20 yards without his/her heart jumping out of his/her chest (losss of personal independence in daily activities, onset date and unknown latency, seriousness: disability). He/she had yet to test it again.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (My heart went into defibrillation for more than ten seconds at a time, nearly killed me).  At time of reporting, the outcome was Unknown for the event my heart went into defibrillation for more than ten seconds at a time, was unknown for could not run which I do often for more than 20 yards without heart jumping out of chest and was Unknown for the event nearly killed me.; Sender's Comments: Sanofi Company Comment dated 04-Jan-2022:  This case involves a patient of unspecified demographics who experienced "nearly killed me"  and "My heart went into defibrillation for more than ten seconds at a time." Further information regarding previous vaccination, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed
Sex: U
Vaccine: FLUX
Symptoms: Near death experience
Clinical narrative: almost died; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced almost died while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2011, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, form, dosage, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious almost died (near death experience) (unknown latency) following the administration of INFLUENZA VACCINE. The patient reported that the only time the patient actually almost died was after he/she got a flu shot in 2011. This event was assessed as medically significant and life-threatening.  Final diagnosis was (life-threatening) almost died.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (almost died).  At time of reporting, the outcome was Unknown for the event almost died.; Sender's Comments: Sanofi Company Comment dated 06-Jan-2022:  This case involves a patient of unspecified demographics and it was reported that the patient almost died after receiving the influenza shot. Further information regarding previous vaccination, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: pneumonia; Flu; Initial information received on 06-Jan-2022 regarding an unsolicited valid Social Media serious case received from a patient.  This case involves an unknown age and unknown gender patient who experienced pneumonia and flu while receiving Influenza vaccine.  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 suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, route, lot number, expiry date unknown) in unknown administration site as prophylactic vaccination.  On an unknown date the patient had pneumonia (unknown latency). This event was assessed as medically significant. The patient was hospitalized for this event.  On an unknown date the patient had flu (influenza) (unknown latency).  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: Unknown for both the events; Sender's Comments: Sanofi Company Comment dated 13-Jan-2022. This case involves an unknown age and unknown gender patient who experienced pneumonia and flu while receiving Influenza vaccine. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Sex: U
Vaccine: FLUX
Symptoms: Critical illness
Clinical narrative: deathly ill for a week both times; Initial information received on 07-Jan-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp via social media.  This case involves an unknown age and gender patient who experienced deathly ill for a week both times, while receiving vaccine Influenza vaccine.   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 suspect Influenza Vaccine  produced by unknown manufacturer (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient reported I had two and was deathly ill for a week both times (critical illness) (unknown latency)  and never again. Patient further ask  could you use your covid vaccine as a suppository. This event was assessed as medically significant.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event (deathly ill for a week both times).  At time of reporting, the outcome was Unknown for the event deathly ill for a week both times.; Sender's Comments: Sanofi company comment date 13-Jan-2022:This case concerns a patient  of unknown age and gender who had critical illness, while receiving Influenza Vaccine. The time to onset is compatible with the role of the vaccine. Patient's the lack of information regarding past drugs, relevant medical history, concurrent conditions, psychiatric history, personal history, therapy details, latency and concomitant medications preclude a comprehensive assessment of this case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date, for tolerance refer case US2022AMR004592).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. Rechallenge with Shingles vaccine was positive. 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 Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR004592  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had a sore arm for a day or two with each of the two shots. The follow-up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR004601:same reporter - other patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain
Clinical narrative: mild case; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR004619  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had a mild shingles case between the first and second injection of Shingles vaccine. The patient had the Covid vaccine two weeks after the second Covid shot and had shingles, it was painful, and the nerve pain was unbearable. The patient stated that the shingles vaccine did not prevent. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR004619:same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: low grade fever; body aches; soreness at the site; Second dose delayed because Covid; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19 (patient was diagnosed with Covid on 30th June 2020). Previously administered products included Shingrix with an associated reaction of chest pain (1st dose received on 31st January 2020 and developed fever and swelling in arm, for tolerance refer case US2022004276).   On 3rd September 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced low grade fever, general body pain, injection site pain and social problem. On an unknown date, the outcome of the low grade fever, general body pain and injection site pain were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the low grade fever, general body pain and injection site pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022004276  Additional details were reported as follows: The patient received second dose of Shingrix late due to Covid 19 infection. Also, after receiving second dose, the patient experienced low grade fever, body aches and soreness at site of injection, all events were later resolved. Consent to follow up was denied.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022004276:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: get shingles of the eye; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that he/she got shingles of eye 3 months after his/her 2nd dose of Shingrix. The patient asked that what he/she did the wrong. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Gait inability, Pyrexia
Clinical narrative: Fever; Dizziness; Inability to Walk; This case was reported by a consumer via call center representative and described the occurrence of fever in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 30th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 30th August 2021, less than a day after receiving Shingrix, the patient experienced fever, dizziness and unable to walk. The patient was treated with paracetamol (Tylenol). On 1st September 2021, the outcome of the fever, dizziness and unable to walk were recovered/resolved.   It was unknown if the reporter considered the fever, dizziness and unable to walk to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received first dose of Shingrix vaccine in left deltoid muscle.   For the 24 hours following vaccine patient stated she had high fever, dizziness, and inability to walk.   The patient stated she then took Tylenol and was fine.   The patient had been advised by her health care provider she should not receive second dose. The reporter consented to follow up. The patient gave permission to contact pharmacy for follow up information.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 43 year old white female of unspecified ethnicity. Initial information was processed along with the additional information received on 11-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On 09-APR-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-NOV-2021, the patient received booster dose of non-company suspect vaccine mrna 1273 (Moderna) (dose number in series: 2) (form of admin, route of admin not reported, batch number: 071F21A expiry: UNKNOWN) dose was not reported, administered for prophylactic vaccination. On 30-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced symptoms of congestion, runny nose, and sneezing (suspected covid-19 infection) and reported her illness is a mild case. On 04-JAN-2022, the patient experienced suspected clinical vaccination failure. Laboratory data included: COVID-19 antigen test (Home kit test) (NR: not provided) Positive (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s, and mrna 1273 (Moderna) was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition) This report was associated with product quality complaint number: 90000210214. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220105417-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure . This event(s) is considered not related. 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
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 45 year old female of and unknown ethnicity. Initial information was processed along with the additional information received on 12-JAN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: no alcohol use, and non-smoker. The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol, and metronidazole.  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, route of admin not reported, batch number: 1820095, expiry: 02-OCT-2021) dose was not reported, administered 1 in total at the right arm on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JAN-2022, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection (Dose number in series was 1).  The patient experienced symptoms like bad headache, cough, congestion, feeling cold and hot, pain, fatigue and loss of appetite (subsumed under suspected covid-19 infection). The Symptoms started on 02-JAN-2022, patient experienced different symptoms daily.  On 02-JAN-2022, She had cough and migraine that won't go away, sore throat, then chills, pain in different parts of her body, lost her apatite then she has fatigue.  The patient visited urgent Care on 02-JAN-2022 and took a rapid antigen test (via nasal swab) and results came back positive within 15 minutes. The patient was told to quarantine for 10 days. Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220116910 (booster dose series 2 case). This report was associated with product quality complaint: 90000211426; Sender's Comments: V0: 20220107394-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. 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
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported.  Reporter stated 56 doses were given after the 30-day use by date limit but the total amount of doses that were given was currently unknown to the HCP. On 06-Dec-2021, the vial was initially stored in the refrigerator. Everyday,that lot number was distributed numerous times. The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-449565, MOD-2022-449456, MOD-2022-449634, MOD-2022-449491, MOD-2022-449651, MOD-2022-449729, MOD-2022-449588, MOD-2022-449524, MOD-2022-449610, MOD-2022-449544 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: Follow up received contains significant information, case became valid, patient demographics added, drug start date, dose details, event start and stop date were updated.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: rash on chest and back; headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on chest and back) and HEADACHE (headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 10-Jan-2022, the patient experienced RASH (rash on chest and back). At the time of the report, RASH (rash on chest and back) and HEADACHE (headache) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported. Rash on chest and back  started  around noon.   This case was linked to MOD-2022-447768, MOD-2022-449895, MOD-2022-449902 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Sore arm; A little weakness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ASTHENIA (A little weakness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and ASTHENIA (A little weakness). At the time of the report, PAIN IN EXTREMITY (Sore arm) and ASTHENIA (A little weakness) 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.   Concomitant information was not provided.  It was reported that after the first two doses of the vaccine she had a sore arm and a little weakness that went away quickly  Treatment information was not provided.   This case was linked to MOD-2022-448411, MOD-2022-448414 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 11 Doses administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  It was reported that vaccine was put out of the freezer on 01 Dec 2021and placed in the refrigerator, so it was not supposed to be used beyond 31-Dec-2021 but 11 doses were administered on 05-Jan-2022. Vial did not underwent any temperature excursions.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 11 Doses administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Moderna vaccine put out of the freezer on 01-Dec-2021 and placed in the refrigerator, so it was not supposed to be used beyond 31-Dec-2021.  No concomitant medications were provided.  No treatment medications were provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. The vials were placed in refrigerator on 6-Dec-2021. The vaccine was used past 30-day use by date. It was reported that patient took booster dose.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  On 06-Dec-2021,Lot 012H21B vials were placed in refrigerator.     This case was linked to MOD-2022-448109 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Under arm swollen after booster; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (Under arm swollen after booster) 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) 1 dosage form. On an unknown date, the patient experienced SWELLING (Under arm swollen after booster). At the time of the report, SWELLING (Under arm swollen after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.   Reporter did not allow further contact
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.No treatment medications were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product were reported No treatment medication was provided