chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Schizophrenia
Clinical narrative: Covid Syndrome; Covid Syndrome; schizophrenic episode; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date Mar2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "Covid Syndrome"; SCHIZOPHRENIA (medically significant) with onset Mar2022, outcome "unknown", described as "schizophrenic episode". The events "covid syndrome", "covid syndrome" and "schizophrenic episode" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Mar2022) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19, schizophrenia.  Clinical course: Reporters wife informed me on 16Mar that the sister of her co-worker had a booster shot recently and experienced a schizophrenic episode. She reported it to her doctor who informed her that she had experienced covid syndrome. I was asked how she could report the event and I provided the link to Pfizer safety reporting website.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Swelling face, Swollen tongue
Clinical narrative: tongue swelling; She awoke with a big old jaw; swelling in another part of her face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (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: SWOLLEN TONGUE (non-serious) with onset 2021, outcome "unknown", described as "tongue swelling"; SWELLING FACE (non-serious) with onset 2021, outcome "unknown", described as "She awoke with a big old jaw"; SWELLING FACE (non-serious) with onset 2021, outcome "unknown", described as "swelling in another part of her face". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: first dose in Feb2021.  About 2 weeks after, she experienced her tongue swelling and every month since then, she has experienced swelling in another part of her face.  She was prescribed Prednisone by her Doctor and her other Doctor said it is not good for her to take Prednisone.  She doesn't know what she should do.  She is currently seeing an Allergy and Asthma Specialist, they have done tests, but all return negative results.  She completed another test, a hormonal test, she didn't even know what that was, but still, everything is coming back negative. She awoke with a big old jaw this morning. She does not know what she can do about her  jaw.  Caller asking what does Pfizer advise her to do?  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Back injury, Gait disturbance, Job dissatisfaction, Muscle spasms
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 17May2021 (Lot number: EW0182) at the age of 60 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose: 22Apr2021 Lot: EW0172), administration date: 22Apr2021, when the patient was 60 years old, for Covid-19 immunization. The following information was reported: JOB DISSATISFACTION (disability), outcome "not recovered", described as "he is on Short Term Disability and can't work"; MUSCLE SPASMS (disability), BACK INJURY (disability), outcome "not recovered" and all described as "disabling muscle spasms and his back hurts all of the time"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "can't hardly walk". Clinical Course: Reporter stated that was on short term disability and can't work. He can't hardly walk and he has been doctoring the entire time and his neurologist was stumped at this point and time. He basically went from being a half marathon runner to being disabled with a long laundry list situation that keeps getting worse and worse. Reporter stated he had disabling muscle spasms and his back hurts all of the time.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID PCR test: Positive; COVID PCR test: Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 14:00 (Lot number: EW 0172) at the age of 37 years as dose 2, single and administered in arm left, administration date 09Apr2021 14:00 (Lot number: FM 0698) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination =Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jan2022, outcome "unknown" and all described as "COVID PCR test: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Jan2022) positive.  Clinical Course: Reporter stated that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's adverse event result in visit Doctor or other healthcare professional office/clinic, prior to vaccination patient was diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. No any other vaccines prior 4 weeks. No any treatment received for adverse event. Device Date : 15Mar2022.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Chest pain, Contusion, Decreased appetite
Clinical narrative: COVID PCR test: Positive; COVID PCR test: Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 14:00 (Lot number: EW 0172) at the age of 37 years as dose 2, single and administered in arm left, administration date 09Apr2021 14:00 (Lot number: FM 0698) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination =Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jan2022, outcome "unknown" and all described as "COVID PCR test: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Jan2022) positive.  Clinical Course: Reporter stated that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's adverse event result in visit Doctor or other healthcare professional office/clinic, prior to vaccination patient was diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. No any other vaccines prior 4 weeks. No any treatment received for adverse event. Device Date : 15Mar2022.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Insomnia, Joint swelling, Lethargy, Menstrual disorder
Clinical narrative: COVID PCR test: Positive; COVID PCR test: Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 14:00 (Lot number: EW 0172) at the age of 37 years as dose 2, single and administered in arm left, administration date 09Apr2021 14:00 (Lot number: FM 0698) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination =Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jan2022, outcome "unknown" and all described as "COVID PCR test: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Jan2022) positive.  Clinical Course: Reporter stated that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's adverse event result in visit Doctor or other healthcare professional office/clinic, prior to vaccination patient was diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. No any other vaccines prior 4 weeks. No any treatment received for adverse event. Device Date : 15Mar2022.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Pain in extremity, SARS-CoV-2 test positive, Tinnitus
Clinical narrative: COVID PCR test: Positive; COVID PCR test: Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 14:00 (Lot number: EW 0172) at the age of 37 years as dose 2, single and administered in arm left, administration date 09Apr2021 14:00 (Lot number: FM 0698) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination =Yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jan2022, outcome "unknown" and all described as "COVID PCR test: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Jan2022) positive.  Clinical Course: Reporter stated that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's adverse event result in visit Doctor or other healthcare professional office/clinic, prior to vaccination patient was diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19. No any other vaccines prior 4 weeks. No any treatment received for adverse event. Device Date : 15Mar2022.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal, Burning sensation, Drug ineffective
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4316080-00 (RA). A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Feb2022 (Batch/Lot number: unknown) at the age of 55 years as dose 4, single, intramuscular, administration date 03Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular, administration date 24Jun2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 24May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1159243) till 07Mar2022 for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURNING SENSATION (hospitalization), outcome "unknown", described as "hands are burning again"; BLOOD GLUCOSE ABNORMAL (hospitalization), outcome "not recovered", described as "blood sugar over 400"; DRUG INEFFECTIVE (hospitalization), outcome "unknown", described as "Humira alone dose not work". The patient underwent the following laboratory tests and procedures: blood glucose: over 400. The action taken for adalimumab was dosage permanently withdrawn on 07Mar2022. The reporter did not stated any reasonable causal relationship between Humira and the following events: Lack of drug effect, Blood sugar abnormal and Burning sensation of upper limb. The manufacturer stated that there is no reasonable possibility of causal relationship between Humira and the following events: Blood sugar abnormal and Lack of drug effect. The reporter stated that there is a reasonable possibility of causal relationship between BNT162b2 and the following events: Lack of drug effect, Blood sugar abnormal and Burning sensation of upper limb. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the currently available information the possibility of causal association between the events Blood sugar abnormal, Burning sensation of upper limb and the suspect drug BNT162B2 cannot be ruled out. Lack of drug effect (Humira) is assessed possibly unrelated to suspect drug BNT162B2. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Her mother got Covid from her father who refused to quarantine. Caller included that her mother is triple vaccinated with the Pfizer Covid-19 vaccine, and the last booster was in Sep2021.; Her mother got Covid from her father who refused to quarantine. Caller included that her mother is triple vaccinated with the Pfizer Covid-19 vaccine, and the last booster was in Sep2021.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 87 years as dose 3 (booster), single, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing), notes: Was diagnosed decades ago. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Her mother got Covid from her father who refused to quarantine. Caller included that her mother is triple vaccinated with the Pfizer Covid-19 vaccine, and the last booster was in Sep2021." Clinical course: Caller does not have the product details for the Covid-19 Vaccines. The patient received and stated that she had the vaccination card. Caller was unable to provide the NDC, Lot, or expiration dates for the Covid-19 vaccines that patient received.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Patient informs that she is covid positive; Patient informs that she is covid positive; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 77-year-old elderly female received a dose (unknown dose number) of BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose via unspecified route on an unspecified date for COVID-19 immunization. There was no medical history or concomitant medications reported. The patient previously received treatment for an unspecified indication with palbociclib (IBRANCE) from 15Oct2020 which was on hold during this time. The patient reported that she is COVID positive and was told to hold palbociclib. Treatment details, if any, were not reported. The outcome of the event COVID positive was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: vaxine kill my Mother; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: DEATH (death, medically significant), outcome "fatal", described as "vaxine kill my Mother". The reporter stated as follow: I'm very sorry for this inconvenience but your vaxine kill my Mother and I'm holding you and your company responsible for her death there was absolutely nothing wrong with her until she had your jab and you can say now it's age or underlying conditions. Please if you have any queries feel free to contact me on my cell phone if not I'm taking it as a acknowledged of guilt on you behalf. The patient date of death was unknown. The reported cause of death was "vaxine kill my Mother". It was not reported if an autopsy was performed. The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: vaxine kill my Mother
Age: 27.0
Sex: M
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administered YF-VAX to a patient intramuscularly instead of subcutaneously, with no reported adverse event; Initial information received on 16-Mar-2022 regarding an unsolicited valid non-serious case received by a health care professional and physician.  This case involves a 27 years old male patient with incorrect route of product administration (administered yf-vax to a patient intramuscularly instead of subcutaneously, with no reported adverse event) while receiving vaccine Yellow Fever Vaccine - [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 16-Mar-2022, the patient received 0.5 mL dose of Yellow Fever Vaccine -  (form, strength: unknown; lot UJ409AA and expiry date: 22-Oct-2022) via intramuscular route in the left deltoid for Immunization  On 16-MAR-2022 (Latency: same day), they administered YF-VAX to the patient intramuscularly instead of subcutaneously, with no reported adverse event (incorrect route of product administration).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness postural, Drooling, Dyspnoea, Hypoaesthesia
Clinical narrative: coughing/coughs so much until he throws up; nose runs; while he is coughing he is drooling; he feels dizzy when standing; about to pass out; whole face gets numb; coughs so much until he throws up; breathing has been the pits / He has been getting worse shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing has been the pits / He has been getting worse shortness of breath), COUGH (coughing/coughs so much until he throws up), RHINORRHOEA (nose runs), DROOLING (while he is coughing he is drooling) and DIZZINESS POSTURAL (he feels dizzy when standing) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNOEA (breathing has been the pits / He has been getting worse shortness of breath). On an unknown date, the patient experienced COUGH (coughing/coughs so much until he throws up), RHINORRHOEA (nose runs), DROOLING (while he is coughing he is drooling), DIZZINESS POSTURAL (he feels dizzy when standing), PRESYNCOPE (about to pass out), HYPOAESTHESIA (whole face gets numb) and VOMITING (coughs so much until he throws up). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (breathing has been the pits / He has been getting worse shortness of breath), COUGH (coughing/coughs so much until he throws up), RHINORRHOEA (nose runs), DROOLING (while he is coughing he is drooling), DIZZINESS POSTURAL (he feels dizzy when standing), PRESYNCOPE (about to pass out), HYPOAESTHESIA (whole face gets numb) and VOMITING (coughs so much until he throws up) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication were reported. Since receiving the first dose of the Moderna vaccine, breathing "has been the pits. Patient had been getting worse shortness of breath since then. Patient also sometimes felts a sensation when coughing like and was about to pass out. The patient had been in and out of the emergency room and urgent care. Patent has been taking albuterol, "the pump," and breathing treatments with a machine which helps for about 30 minutes. The patient had put in a request for an oxygen machine, but had not received that yet.   This case was linked to MOD-2022-516667, MOD-2022-516898 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Rhinorrhoea, Vomiting
Clinical narrative: coughing/coughs so much until he throws up; nose runs; while he is coughing he is drooling; he feels dizzy when standing; about to pass out; whole face gets numb; coughs so much until he throws up; breathing has been the pits / He has been getting worse shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing has been the pits / He has been getting worse shortness of breath), COUGH (coughing/coughs so much until he throws up), RHINORRHOEA (nose runs), DROOLING (while he is coughing he is drooling) and DIZZINESS POSTURAL (he feels dizzy when standing) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DYSPNOEA (breathing has been the pits / He has been getting worse shortness of breath). On an unknown date, the patient experienced COUGH (coughing/coughs so much until he throws up), RHINORRHOEA (nose runs), DROOLING (while he is coughing he is drooling), DIZZINESS POSTURAL (he feels dizzy when standing), PRESYNCOPE (about to pass out), HYPOAESTHESIA (whole face gets numb) and VOMITING (coughs so much until he throws up). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (breathing has been the pits / He has been getting worse shortness of breath), COUGH (coughing/coughs so much until he throws up), RHINORRHOEA (nose runs), DROOLING (while he is coughing he is drooling), DIZZINESS POSTURAL (he feels dizzy when standing), PRESYNCOPE (about to pass out), HYPOAESTHESIA (whole face gets numb) and VOMITING (coughs so much until he throws up) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication were reported. Since receiving the first dose of the Moderna vaccine, breathing "has been the pits. Patient had been getting worse shortness of breath since then. Patient also sometimes felts a sensation when coughing like and was about to pass out. The patient had been in and out of the emergency room and urgent care. Patent has been taking albuterol, "the pump," and breathing treatments with a machine which helps for about 30 minutes. The patient had put in a request for an oxygen machine, but had not received that yet.   This case was linked to MOD-2022-516667, MOD-2022-516898 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised Patient- Received lower than authorize dosage for 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised Patient- Received lower than authorize dosage for 3rd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included 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 (Immunocompromised Patient- Received lower than authorize dosage for 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised Patient- Received lower than authorize dosage for 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment drug were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm is sore; 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.   Concomitant products included COVID-19 VACCINE.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details reported were as follows: This case was reported by the patient. The age at vaccination was not reported. Few days ago, from reporting date, the patient received Shingles vaccine and Covid vaccine. After vaccination, the patient's arm was sore. The patient mean that the Covid shot was nothing like this soreness and not.  The patient stated that then need to get back before six months and to get two more mixes in one shot. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: new born received Havrix; received Havrix instead of Engerix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a neonate patient who received HAV (Havrix) (batch number 95EG7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th March 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 18th March 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: The age at vaccination was not reported. Medical assistant reported that a new born patient came to the office and received Havrix instead of Engerix B, which led to inappropriate age at vaccine administration and wrong vaccine administered. The patient demographics were asked but the healthcare professional did not provide them.  The consent to follow up was given.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous report received from a consumer concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tired was not reported. This report was non-serious. This case, involving the same patient is linked to 20220341321.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: staff gave the Moderna COVID 19 vaccine to a patient after 30-day use by date. The vaccine was administered to the patient on day 31; The vaccine was administered to the patient on day 31; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (staff gave the Moderna COVID 19 vaccine to a patient after 30-day use by date. The vaccine was administered to the patient on day 31) and PRODUCT STORAGE ERROR (The vaccine was administered to the patient on day 31) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (staff gave the Moderna COVID 19 vaccine to a patient after 30-day use by date. The vaccine was administered to the patient on day 31) and PRODUCT STORAGE ERROR (The vaccine was administered to the patient on day 31). At the time of the report, EXPIRED PRODUCT ADMINISTERED (staff gave the Moderna COVID 19 vaccine to a patient after 30-day use by date. The vaccine was administered to the patient on day 31) and PRODUCT STORAGE ERROR (The vaccine was administered to the patient on day 31) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hordeolum, Rash
Clinical narrative: sty on his eye (unspecified); rashes on his face/rashes recurred; This spontaneous case was reported by an other health care professional and describes the occurrence of HORDEOLUM (sty on his eye (unspecified)) and RASH (rashes on his face/rashes recurred) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A.) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HORDEOLUM (sty on his eye (unspecified)) and RASH (rashes on his face/rashes recurred). The patient was treated with SULFADIAZINE SILVER (SILVADENE) for Stye, at an unspecified dose and frequency. At the time of the report, HORDEOLUM (sty on his eye (unspecified)) outcome was unknown and RASH (rashes on his face/rashes recurred) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment included Topical antibiotics for rashes on his face which failed. The patient was subsequently given oral steroids which resolved the condition but the rashes recurred when the steroids was stopped.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Nov-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.            Patient is on concomitant medication reported but not specified which ones.  No treatment drug reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 5 doses were given from a vial exposed to several temperature excursions; 5 doses were given from a vial exposed to several temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions) in an 87-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses were given from a vial exposed to several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (5 doses were given from a vial exposed to several temperature excursions) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drug information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Temperature Excursion in their freezer with the Moderna vaccine; Patient received expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion in their freezer with the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion in their freezer with the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion in their freezer with the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that, as per video footage, administrator explained that while one of their inventory employees was working in their freezer they took the thermometer alarm off and put it back on. administrator further stated that the thermometer was put on and off docking station and did not record while employee was working. They had only one report that showed that the freezer temperature went out of range and timeframes. other timeframes and durations were unknown.   Patient received the vaccine that was placed in the refrigerator.   Frozen storage condition at the time of the excursion.  On 07-FEB-2022, 17.8F maximum, at 9:25 pm and 12.6F maximum at 10:07 pm.  Excursion duration reported as 15-30 minutes but not sure.  Expiration date of vaccine reported as 31-Dec-2069.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Headache, Inappropriate schedule of product administration
Clinical narrative: Headache/different than the headaches before/headache on my temple; May have received full dose for booster dose; Dose-2 (17Mar2021) and Booster (16Aug2022); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache/different than the headaches before/headache on my temple), ACCIDENTAL OVERDOSE (May have received full dose for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-2 (17Mar2021) and Booster (16Aug2022)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A, 045A21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to contrast dye.). Concomitant products included ALIROCUMAB (PRALUENT) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (May have received full dose for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-2 (17Mar2021) and Booster (16Aug2022)). On 21-Mar-2022, the patient experienced HEADACHE (Headache/different than the headaches before/headache on my temple). The patient was treated with BUTALBITAL for Pain, at an unspecified dose and frequency; TRAMADOL for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache/different than the headaches before/headache on my temple), ACCIDENTAL OVERDOSE (May have received full dose for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-2 (17Mar2021) and Booster (16Aug2022)) outcome was unknown.            Concomitant medications also included bone density injection after every 6 months. Treatment also included Excedrin without aspirin for pain.   This case was linked to MOD-2022-516871 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: third dose may have been full dose instead of half; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (third dose may have been full dose instead of half) 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 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (third dose may have been full dose instead of half). At the time of the report, ACCIDENTAL OVERDOSE (third dose may have been full dose instead of half) outcome was unknown.            No concomitant and treatment drug information was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: Administered with the vaccine beyond the 30 day use by date; 1st dose 19-Nov-2021 and 2nd dose 07-Mar-2022; Administered with the vaccine beyond the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine beyond the 30 day use by date), PRODUCT STORAGE ERROR (Administered with the vaccine beyond the 30 day use by date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 19-Nov-2021 and 2nd dose 07-Mar-2022) in a 46-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 045L21A and 006F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Mar-2022 at 1:42 PM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2022 at 1:42 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine beyond the 30 day use by date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 19-Nov-2021 and 2nd dose 07-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered with the vaccine beyond the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine beyond the 30 day use by date), PRODUCT STORAGE ERROR (Administered with the vaccine beyond the 30 day use by date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 19-Nov-2021 and 2nd dose 07-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  The reporter stated that they received a Moderna COVID-19 vaccine vial on 31-Jan-2021 and it was placed it in the refrigerator on the same day (specific time unknown). The patient did not report any adverse events.  Treatment information was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Rash
Clinical narrative: myalgia; fatigue; rash; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (myalgia), FATIGUE (fatigue) and RASH (rash) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heartburn, Optic neuritis and Multiple sclerosis. Concurrent medical conditions included Allergy to antibiotic (Levaquin), Allergy to antibiotic (Bactrim Allergy), Allergy to antibiotic (Zithromax Allergy), Allergy to antibiotic (Ceclor Allergy) and Relapsing-remitting multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 12-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2020, the patient experienced MYALGIA (myalgia), FATIGUE (fatigue) and RASH (rash). At the time of the report, MYALGIA (myalgia), FATIGUE (fatigue) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 12-Dec-2020 and Aug-2021, it was reported that patient experienced myalgia and fatigue and rash.   No treatment drug details was reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Larger than normal swelling, almost "spider" web type spread.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Computerised tomogram head, Hypoaesthesia, Magnetic resonance imaging head normal
Clinical narrative: In one week -out of the blue, I started with tinitus, neuropathy, and anxiety.  I was perfectly healthy prior.  I ended up being admitted into the ER because the neuropthy worsened and my leg went numb so I thought I was having a stroke.  I have had scans and MRI's of my back and  brain and all have shown nothing. Two weeks later, I was at a hospital and fainted. This has been a nightmare.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging spinal normal, Neuropathy peripheral, Scan normal, Syncope, Tinnitus
Clinical narrative: In one week -out of the blue, I started with tinitus, neuropathy, and anxiety.  I was perfectly healthy prior.  I ended up being admitted into the ER because the neuropthy worsened and my leg went numb so I thought I was having a stroke.  I have had scans and MRI's of my back and  brain and all have shown nothing. Two weeks later, I was at a hospital and fainted. This has been a nightmare.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Embolism, Laboratory test
Clinical narrative: Narrative:  patient received vaccine at hospital, but treatment and documentation at ER (self presented). Per outside hospital ER, admitting diagnosis: embolism without acute cor pulmonale (8-27-21)
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Pruritus
Clinical narrative: Narrative: Pt seen the Vaccine Clinic. Pt states he receive two doses of Pfizer Covid-19 vaccine. Pt states after returning home he had itching and blisters appear on his arms. PT states this occurred after Series 1 and Series 2 of the Pfizer vaccine. PT has hx of CHF. Related reactions: fatigue, SOB. PT declined 3rd dose (booster) until he speaks with his Cardiologists.