chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cardiac arrest, Computerised tomogram, Condition aggravated, Headache
Clinical narrative: cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion; On 21Feb he went to the ER after vomiting and passing out; On 21Feb he went to the ER after vomiting and passing out; On 19Feb, he began to feel ill again with a fever. He felt worse on 20Feb; On 19Feb, he began to feel ill again with a fever. He felt worse on 20Feb; fever; headache; stomach upset; This is a spontaneous report from a contactable consumer reporting for the father:  A 75-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EL3428) at single dose at left arm on 03Feb2021 for Covid-19 immunisation. Medical history included type 2 diabetes mellitus. No known allergies. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included amitriptyline hydrochloride (manufacturer unknown) 10 mg, atorvastatin (manufacturer unknown) 20 mg, dutasteride (manufacturer unknown) 0.5 mg, linaclotide (LINZESS) 290 mcg, gabapentin (manufacturer unknown) 300 mg, montelukast (manufacturer unknown) 10 mg, ramipril (manufacturer unknown) 5 mg, insulin degludec (TRESIBA) 100 unit/ml, liraglutide (VICTOZA) 18 mg/3ml solution. No other vaccine in 4 weeks. The patient experienced cardiac arrest due to pericardial effusion on 21Feb2021 14:15, fever on 13Feb2021, headache on 13Feb2021, stomach upset on 13Feb2021, on 19feb, he began to feel ill again with a fever, he felt worse on 20feb on 19Feb2021, on 21feb he went to the ER after vomiting and passing out on 21Feb2021.  Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of cardiac arrest due to pericardial effusion.  Course of events: In Feb2021, 10 days after his 1st injection, the patient developed fever, headache, and stomach upset. He went for a rapid Covid-19 test (nasal swab) and it was negative on 11Feb2021. The doctor told him he might be having a delayed reaction to the vaccination. After a couple of days, he improved. On 19Feb2021, he began to feel ill again with a fever. He felt worse on 20Feb2021. On 21Feb2021 he went to the ER after vomiting and passing out and received treatment: IV fluids, diagnostic testing at ER. Rapid Covid test (nasal swab) at ER came back negative again on 21Feb2021. His heart arrested suddenly and he could not be resuscitated. CT scan results, that came back after death, showed Covid like pneumonia and pericardial effusion. The patient died on 21Feb2021 14:15. Cause of death was cardiac arrest due to pericardial effusion. An autopsy was not performed. The outcome of cardiac arrest due to pericardial effusion was fatal, of fever, headache, stomach upset was recovering, of he began to feel ill again with a fever, he felt worse was not recovered, of he went to the ER after vomiting and passing out was unknown.; Reported Cause(s) of Death: cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise, Pericardial effusion, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion; On 21Feb he went to the ER after vomiting and passing out; On 21Feb he went to the ER after vomiting and passing out; On 19Feb, he began to feel ill again with a fever. He felt worse on 20Feb; On 19Feb, he began to feel ill again with a fever. He felt worse on 20Feb; fever; headache; stomach upset; This is a spontaneous report from a contactable consumer reporting for the father:  A 75-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EL3428) at single dose at left arm on 03Feb2021 for Covid-19 immunisation. Medical history included type 2 diabetes mellitus. No known allergies. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included amitriptyline hydrochloride (manufacturer unknown) 10 mg, atorvastatin (manufacturer unknown) 20 mg, dutasteride (manufacturer unknown) 0.5 mg, linaclotide (LINZESS) 290 mcg, gabapentin (manufacturer unknown) 300 mg, montelukast (manufacturer unknown) 10 mg, ramipril (manufacturer unknown) 5 mg, insulin degludec (TRESIBA) 100 unit/ml, liraglutide (VICTOZA) 18 mg/3ml solution. No other vaccine in 4 weeks. The patient experienced cardiac arrest due to pericardial effusion on 21Feb2021 14:15, fever on 13Feb2021, headache on 13Feb2021, stomach upset on 13Feb2021, on 19feb, he began to feel ill again with a fever, he felt worse on 20feb on 19Feb2021, on 21feb he went to the ER after vomiting and passing out on 21Feb2021.  Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of cardiac arrest due to pericardial effusion.  Course of events: In Feb2021, 10 days after his 1st injection, the patient developed fever, headache, and stomach upset. He went for a rapid Covid-19 test (nasal swab) and it was negative on 11Feb2021. The doctor told him he might be having a delayed reaction to the vaccination. After a couple of days, he improved. On 19Feb2021, he began to feel ill again with a fever. He felt worse on 20Feb2021. On 21Feb2021 he went to the ER after vomiting and passing out and received treatment: IV fluids, diagnostic testing at ER. Rapid Covid test (nasal swab) at ER came back negative again on 21Feb2021. His heart arrested suddenly and he could not be resuscitated. CT scan results, that came back after death, showed Covid like pneumonia and pericardial effusion. The patient died on 21Feb2021 14:15. Cause of death was cardiac arrest due to pericardial effusion. An autopsy was not performed. The outcome of cardiac arrest due to pericardial effusion was fatal, of fever, headache, stomach upset was recovering, of he began to feel ill again with a fever, he felt worse was not recovered, of he went to the ER after vomiting and passing out was unknown.; Reported Cause(s) of Death: cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion; On 21Feb he went to the ER after vomiting and passing out; On 21Feb he went to the ER after vomiting and passing out; On 19Feb, he began to feel ill again with a fever. He felt worse on 20Feb; On 19Feb, he began to feel ill again with a fever. He felt worse on 20Feb; fever; headache; stomach upset; This is a spontaneous report from a contactable consumer reporting for the father:  A 75-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EL3428) at single dose at left arm on 03Feb2021 for Covid-19 immunisation. Medical history included type 2 diabetes mellitus. No known allergies. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included amitriptyline hydrochloride (manufacturer unknown) 10 mg, atorvastatin (manufacturer unknown) 20 mg, dutasteride (manufacturer unknown) 0.5 mg, linaclotide (LINZESS) 290 mcg, gabapentin (manufacturer unknown) 300 mg, montelukast (manufacturer unknown) 10 mg, ramipril (manufacturer unknown) 5 mg, insulin degludec (TRESIBA) 100 unit/ml, liraglutide (VICTOZA) 18 mg/3ml solution. No other vaccine in 4 weeks. The patient experienced cardiac arrest due to pericardial effusion on 21Feb2021 14:15, fever on 13Feb2021, headache on 13Feb2021, stomach upset on 13Feb2021, on 19feb, he began to feel ill again with a fever, he felt worse on 20feb on 19Feb2021, on 21feb he went to the ER after vomiting and passing out on 21Feb2021.  Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of cardiac arrest due to pericardial effusion.  Course of events: In Feb2021, 10 days after his 1st injection, the patient developed fever, headache, and stomach upset. He went for a rapid Covid-19 test (nasal swab) and it was negative on 11Feb2021. The doctor told him he might be having a delayed reaction to the vaccination. After a couple of days, he improved. On 19Feb2021, he began to feel ill again with a fever. He felt worse on 20Feb2021. On 21Feb2021 he went to the ER after vomiting and passing out and received treatment: IV fluids, diagnostic testing at ER. Rapid Covid test (nasal swab) at ER came back negative again on 21Feb2021. His heart arrested suddenly and he could not be resuscitated. CT scan results, that came back after death, showed Covid like pneumonia and pericardial effusion. The patient died on 21Feb2021 14:15. Cause of death was cardiac arrest due to pericardial effusion. An autopsy was not performed. The outcome of cardiac arrest due to pericardial effusion was fatal, of fever, headache, stomach upset was recovering, of he began to feel ill again with a fever, he felt worse was not recovered, of he went to the ER after vomiting and passing out was unknown.; Reported Cause(s) of Death: cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Illness, Influenza immunisation
Clinical narrative: was sick as hell; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via media.  This case involves a patient (age and gender unspecified) who was sick (illness), when received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.   It was unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Product Name: Product name was not provided. Since this was a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Adacel was given to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health professional (nurse) via Agency (Reference number- 00481678) and transmitted to Sanofi on 18-Feb-2021 .  This case involved a 46 year old male patient who received 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number: C5566AA] via an unknown route at an unknown administration site for prophylactic vaccination which was expired on 13-Feb-2021 (expired product administered). (Latency: At the same time of vaccination)  Medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  It was a case of actual medication error due to expired vaccine used.   It was reported that, reporter was wanted to safety concerns if any.   At the time of reporting, the patient did not have any side effects also no treatment specified at the time of reporting.   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 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: 1.17
Sex: U
Vaccine: HEPA, HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect product storage; No additional adverse events reported; This spontaneous report was received from an administrator via a Nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and  concomitant medications were not provided.   On 29-JAN-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) which had a lot # T013204 with expiration date on 03-DEC-2021 (dose, frequency and route of administration were not reported) for prophylaxis. Other dose of hepatitis a vaccine, inactivated (VAQTA) with lot # T013204 and expiration date on 03-DEC-2021 was also improperly stored. However no adverse events were mentioned.   It was reported that the vaccines were exposed to temperature of -7.9 Centigrade range for a time frame of 52 minutes and -10.5 for 52 minutes The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE or PQCs; VARlVAX was reconstituted using the STERILE DILUENT that came with the MMR II and administered; This spontaneous report was received from a nurse practitioner, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 12-FEB-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 1 time dose (lot number T025946 which has been verified to be valid, expiration date reported and validated as 30-JUL-2022) (vaccination scheme, route of administration, and anatomical site of injection were not reported) as prophylaxis. The administered dose was reconstituted using the sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported) that came with the measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (product preparation issue). No additional adverse events were reported in the patient.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA007358:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No further AE; 6 month old patient inadvertently received a first dose of ROTATEQ; This spontaneous report was received from a registered nurse and refers to a 6-month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 24-FEB-2021 the patient was vaccinated, at inappropriate age, with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dosage form, orally (lot # and expiration date were unknown) for prophylaxis. The patient did not experienced any adverse events.
Age: 9.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE/PQC reported at the time of this call.; Nurse calls to report an expired dose of MMR II was given to a patient.; This spontaneous report was received from a registered nurse, referring to a 9-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 24-FEB-2021, the patient was vaccinated with an expired measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot number S004118 which has been verified to be valid, expiration date reported and validated as 11-FEB-2021) (dose, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported) as prophylaxis (expired product administered). No other adverse events were reported in the patient.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Unevaluable event
Clinical narrative: Caller is reporting that PROQUAD that underwent a temperature excursion was administered; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions and allergies were not provided.   On 17-FEB-2021, the patient was vaccinated with an improperly stored dose (product storage error) of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) valid lot number T027115, expiration date 07-FEB-2022 (dose, vaccination scheme, and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of -10 Celsius (°C ) to 8 °C  degrees for 22 hours. Data logger was involved. There was no previous excursions reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pertinent Medical History: "might have a low immune system"; Caller states she had shingles 3 times with the last occurrence in 2000.; Caller is unsure if she has already had the vaccine but remembers getting an injection after the second time she had it but the date is unknown.; This spontaneous report was received from a consumer, referring to herself as a female patient of unknown age. The patient's pertinent medical history and previous drug reactions or allergies were not reported. The patient stated the she the took blood pressure medication.   On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), to prevent shingles, the route of vaccination was reported as 'injection" (formulation, strength, dose, vaccination scheme frequency, anatomical site of vaccination, lot number and expiration date were not reported).  The patient stated, that she had shingles 3 times with the last occurrence in 2000 (herpes zoster) (conflicting information, also reported as "AE Onset Date: "about 6 years ago"). In addition, she also stated that she was unsure if she had already had the vaccine, but she remembered getting an injection after the second time (circumstance or information capable of leading to medication error).   She also reported that, she "might have a low immune system" (immune system disorder).  The patient did not sought medical attention, and she did not received treatment for the adverse events.   The outcome of herpes zoster and immune system disorder was reported as recovered. The causality assessment between zoster vaccine live (ZOSTAVAX) with the aforementioned events was not provided.
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Nausea, Vomiting
Clinical narrative: Vomiting; Nausea; Spontaneous report received on 14FEB2020.  A caregiver (consumer's mother) reported that her 23-year-old daughter had nausea (PT: Nausea) and vomiting (PT: Vomiting) while being on Vivotif for immunisation. On 07FEB2020, the consumer took first dose of Vivotif and felt nauseated on the same day. On 13FEB2020 at approximately 05:00 pm, she took the last dose of Vivotif and vomited at 11:00 pm approximately. Moreover, she had not vomited again. Action taken with Vivotif with respect to the reported event nausea was dose not changed while, with respect to the event vomiting was not applicable. She had recovered from the event vomiting while the outcome of the event nausea was unknown.  Past medications included meningitis vaccine (meningococcal vaccine), polio vaccine and yellow fever vaccine, which were received on 21JAN2020.  She was concomitantly taking medication for birth control.  Company Comment: A consumer felt nauseated (nausea) after taking first dose of Vivotif, and then she had vomiting within a few hours of taking last dose of Vivotif. Vomiting was resolved and the outcome of nausea was unknown. Considering the events occurred after taking Vivotif and the potential of Vivotif to cause both these events, the causality of nausea and vomiting is assessed as possible with Vivotif.; Sender's Comments: A consumer felt nauseated (nausea) after taking first dose of Vivotif, and then she had vomiting within a few hours of taking last dose of Vivotif. Vomiting was resolved and the outcome of nausea was unknown. Considering the events occurred after taking Vivotif and the potential of Vivotif to cause both these events, the causality of nausea and vomiting is assessed as possible with Vivotif.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feeling quite poorly; This case was reported by a consumer via interactive digital media and described the occurrence of feels poorly in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feels poorly. On an unknown date, the outcome of the feels poorly was not recovered/not resolved.   It was unknown if the reporter considered the feels poorly to be related to Shingrix.  Additional details were provided as follows: The patient was reporter's husband. The age at vaccination was not reported. The patient felt quite poorly.  The reporter asked if he can took Tylenol.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Had bout of shivering; Slight fever; This case was reported by a consumer and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced shivering and fever. On an unknown date, the outcome of the shivering and fever were unknown.   It was unknown if the reporter considered the shivering and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had overnight bout of shivering and slight fever.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: mild adverse reaction / mild fever; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The case was reported by the patient. The patient had received 1st doses of the Shingrix vaccine recently. Upon receiving the 1st dose, the patient had an adverse reaction that was mild fever in that evening. After doing some reading online, before receiving 2nd dose took some Aleve and Tylenol, wondering whether sabotaged the efficacy of the 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: First dose / on Dec 2020, then she got Shingles disease; This case was reported by a other health professional via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, 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 Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received vaccine and then had shingles disease. The patient was wondering how soon could she inject the 2nd dose or dose the whole schedule reset. No other information was provided. The information regarding consent to follow up was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Lump at the injection site; red knot; This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site lump and injection site erythema. On an unknown date, the outcome of the injection site lump and injection site erythema were not recovered/not resolved.   The reporter considered the injection site lump and injection site erythema to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported that after she received a Shingrix vaccine in December, she had a lump at the injection site. The reporter did not consent to follow-up. No other information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Inappropriate schedule of product administration, Injection site cellulitis, Pain, Pyrexia
Clinical narrative: cellulitis/ travelled down the arm / cellulitis at injection site; body aches; fever; she had dose 1 of Shingrix about 18 months ago, and received dose 2 about 2 months ago; This case was reported by a consumer via call center representative and described the occurrence of cellulitis of arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included skin cancer (had skin cancer). Previously administered products included Shingrix (1st dose received 18 months ago).   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced cellulitis of arm (serious criteria GSK medically significant), general body pain and fever. The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis of arm, general body pain and fever were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the cellulitis of arm, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient had no events reported with dose 1. The patient received 2nd dose 2 months ago and experienced fever, body aches, and cellulitis which began at the injection site, and travelled down the arm. The patient received dose 2 late than athe recommended schedule, which led to lengthening of vaccination schedule. The physician visit was required. The patient was put on unspecified antibiotics and recovered. The reporter did not consent to follow up. This case was linked with caase US2021048467, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021048467:same reporter - husband´s case
Sex: M
Vaccine: COVID19
Symptoms: Transient global amnesia
Clinical narrative: Transient Global Amnesia; A spontaneous report was received from a physician concerning himself,  a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Transient Global Amnesia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 07-Jan-2021, prior to the onset of the event, the patient received a dose of mRNA-1273 (Batch number: 011J20A) for prophylaxis of COVID-19 infection.  On 09-Jan-2021, the patient experienced the event Transient Global Amnesia(Medically Significant) which lasted for 8 hours.  Laboratory details provided were CAT scan, Echocardiogram and various other workups  Treatment for the event Transient Global Amnesia reported was evaluation at a hospital with a CAT scan, Echocardiogram and various other workups.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event Transient Global Amnesia was reported recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Urticaria
Clinical narrative: Hives; Nausea; A spontaneous report was received from a non HCP concerning a 45-Year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives and nausea.   The patient was reported with an history of Anaphylaxis in the past.   No relevant concomitant medications were reported.     On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 11 Jan 2021, The patient experienced Urticaria (Hives) and Nausea with seriousness criteria of Hospitalization.   Laboratory details are not  provided.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event is unknown.; Reporter's Comments: This case concerns a 45-year-old female, with medical history of anaphylaxis, was hospitalized with serious unexpected events of urticaria and nausea.  The events occurred the same day as the first dose of mRNA-1273. Treated with Benadryl. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; A spontaneous report was received from a consumer, concerning herself, a 87-year-old, male patient who Moderna's COVID-19 Vaccine (mRNA-1273) and developed pneumonia.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 24 JAN 2021, approximately 1 day prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number:0138) intramuscularly for prophylaxis of COVID-19 infection.   On 25 JAN 2021, approximately 1 day after receiving the vaccine, the patient went to the emergency room for pneumonia, fever, cough, where in patient could not stop coughing hence he was hospitalized on an unspecified date in 2021. The event pneumonia was also considered to be medically significant. Patient would like to know if he can receive the second vaccine shot scheduled for 20 FEB 2021 and if he can receive the shingles vaccine because he has not yet received it. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, pneumonia was considered unknown at the time of this report.; Reporter's Comments: This case concerns an 87 year old male patient, who experienced a serious unexpected event of Pneumonia, 1 day after receiving first dose mRNA- 1273 (Lot# 0138). Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac arrest, Death, Unresponsive to stimuli
Clinical narrative: No pulse and no heart beat; couldn't wake him up; passed away; A spontaneous report was received from a daughter concerning a 84-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced no pulse or heartbeat, couldn't wake him up and passed away.  The patient's medical history, as provided by the reporter, included high blood pressure and prostate cancer. No relevant concomitant medications were reported.   On 19 Jan 2021, the patient had a blood pressure reading of 133/84 at a cardiology visit.   On 13 Feb 2021, approximately 3 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number 031M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021 at 3:30 pm, the patient could not be woken up and was found with no pulse or heartbeat.   Action taken with the drug in response to the events was not applicable.  The outcome of the events, no pulse or heartbeat and couldn't wake him up, were not provided. The patient died on 13 Feb 2021. The cause of death was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.   The patient's medical history of high blood pressure and prostate cancer remains the risk factors. The cause of death was unknown. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Behaviour disorder, Belligerence, Delusion, Thinking abnormal
Clinical narrative: Belligerent; scatter-brained; Erratic; Delusional; A spontaneous report was received on 16FEB2021 from a caregiver concerning a 91-years-old, male patient who received second dose of Moderna's COVID-19 vaccine and became belligerent, delusional, erratic and scatter-brained.  The patient's medical history, as reported by the consumer, include Myasthenia gravis (MG). Relevant concomitant medications reported included prednisone 10 mg, nortriptyline HCL 10 mg caps QD, tamsulosin HCL 0.4 mg caps BID, lisinopril 5 mg QD, gabapentin 200 mg QD night, pyridostigmine 90 mg TID, xanax 25 mg as needed, lexapro 5mg QD, levothyroxine 50 mcg QD, amiodarone HCL 200mg QD, carvedilol 6.25 mg BID. He had been on prednisone 20 mg for 6 weeks and they dropped it to 10mg a week before he received his first vaccine. Patient was taking prednisone for Myasthenia Gravis.  On 06JAN2021, patient received their first of two planned doses of mRNA-1273(BATCH/LOT # 012L20A) injection intramuscularly for the prophylaxis of COVID-19 infection.  On 09FEB2021, patient received their second of two planned doses of mRNA-1273(BATCH/LOT # 007M208) intramuscularly for the prophylaxis of COVID-19 infection.  After receiving second dose of vaccine, patient became belligerent, erratic and scatter-brained. He has no history of dementia.   On 16FEB2021 at 3:30am, patient called 911 for a foot fungus and paramedics took him to the hospital. The caregiver stated that he was delusional. Treatment for the events were not provided.  The outcome of the events, belligerent, delusional, erratic and scatter-brained, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: COVID pneumonia; A spontaneous report was received from a 78-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced COVID pneumonia.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 032L20A) for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient developed COVID pneumonia. She was hospitalized from 22 Jan to 27 Jan 2021. The patient received antibiotic and steroid medications at the hospital.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, COVID pneumonia, was considered resolved on 27 Jan 2021.; Reporter's Comments: Based on the current available information, mRNA -1273 does not contain a virus.The onset of COVID-19 pneumonia on the same day the patient received the vaccine makes the assessment of the event unlikely related to mRNA-1273.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Blood pressure fluctuation, Dizziness, Erythema
Clinical narrative: Red streak on inner side of left arm; Felt was going to die; General malaise; Weakness; Slight dizziness; Nausea; Vomited; Blood pressure fluctuation; Hives on inner arms; A spontaneous report was received from a consumer and physician concerning a 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt was going to die, general malaise, red streak on inner side of left arm, hives on inner arms, weakness, dizziness, blood pressure fluctuating, nausea and vomited.   The patient's medical history included breast cancer, breast cancer surgery and hives. Concomitant product use was not provided.   On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot #: 039K20A) (route of administration not specified) in the right arm for prophylaxis of COVID-19 infection.   On 17 Jan 2021, 12 to 13 days after the vaccination, the patient developed hives on inner arms which would come and go, appearing in the morning and disappearing during daytime. Patient took Benadryl for it and applied cortisone cream.  On 26 Jan 2021, after taking a walk, the patient experienced weakness, slight dizziness, and nausea. Patient was taken to the emergency room (ER) and vomited. The patient was sent home the same day but the patient's blood pressure was noted to be fluctuating.  On 27 Jan 2021, the patient "felt that she was going to die" and had general malaise. The patient was brought to the ER of another hospital but again was sent home.  On 29 Jan 2021, with the symptoms still ongoing and a red streak noted on the inner side of the left arm, the patient was admitted for observation at the second hospital.  Laboratory details included Blood works and radiologic tests were done with normal results. The patient's blood pressure was stabilized but patient was still experiencing malaise and still had the on and off rash on both inner arms.    Treatment information included Benadryl and Cortisone Cream for the indication hives.   Action taken with mRNA-1273 in response to the events was not reported.  The event, blood pressure fluctuation, was considered resolved/recovered on 01 Feb 2021.  The outcome of the events, hives on inner arms, red streak on inner side of left arm, weakness, dizziness, nausea, vomited, felt was going to die and general malaise, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.  This case concerns an 83-year-old female hospitalized with serious unexpected malaise, erythema, anxiety, and NS unexpected urticaria, asthenia, dizziness, BP fluctuation and NS expected nausea, vomiting. Event onset 23 days after the first dose of mRNA-1273. BP changes resolved, other events unknown. As above, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Urticaria, Vomiting
Clinical narrative: Red streak on inner side of left arm; Felt was going to die; General malaise; Weakness; Slight dizziness; Nausea; Vomited; Blood pressure fluctuation; Hives on inner arms; A spontaneous report was received from a consumer and physician concerning a 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt was going to die, general malaise, red streak on inner side of left arm, hives on inner arms, weakness, dizziness, blood pressure fluctuating, nausea and vomited.   The patient's medical history included breast cancer, breast cancer surgery and hives. Concomitant product use was not provided.   On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot #: 039K20A) (route of administration not specified) in the right arm for prophylaxis of COVID-19 infection.   On 17 Jan 2021, 12 to 13 days after the vaccination, the patient developed hives on inner arms which would come and go, appearing in the morning and disappearing during daytime. Patient took Benadryl for it and applied cortisone cream.  On 26 Jan 2021, after taking a walk, the patient experienced weakness, slight dizziness, and nausea. Patient was taken to the emergency room (ER) and vomited. The patient was sent home the same day but the patient's blood pressure was noted to be fluctuating.  On 27 Jan 2021, the patient "felt that she was going to die" and had general malaise. The patient was brought to the ER of another hospital but again was sent home.  On 29 Jan 2021, with the symptoms still ongoing and a red streak noted on the inner side of the left arm, the patient was admitted for observation at the second hospital.  Laboratory details included Blood works and radiologic tests were done with normal results. The patient's blood pressure was stabilized but patient was still experiencing malaise and still had the on and off rash on both inner arms.    Treatment information included Benadryl and Cortisone Cream for the indication hives.   Action taken with mRNA-1273 in response to the events was not reported.  The event, blood pressure fluctuation, was considered resolved/recovered on 01 Feb 2021.  The outcome of the events, hives on inner arms, red streak on inner side of left arm, weakness, dizziness, nausea, vomited, felt was going to die and general malaise, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.  This case concerns an 83-year-old female hospitalized with serious unexpected malaise, erythema, anxiety, and NS unexpected urticaria, asthenia, dizziness, BP fluctuation and NS expected nausea, vomiting. Event onset 23 days after the first dose of mRNA-1273. BP changes resolved, other events unknown. As above, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old female who received her first dose of the Moderna COVID-19 vaccine by accident; A spontaneous report was received from a parent concerning their 17 years-old female daughter, who received Moderna's COVID-19 vaccine (mRNA-1273) which resulted in the event: 17 year old received first dose of the Moderna COVID-19 vaccine by accident/ Product administered to patient of inappropriate age.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the Moderna COVID vaccine was given to a 17- year old patient. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, 17 year old received first dose of the Moderna COVID-19 vaccine by accident, was recovered on 28 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Ear pain, Facial paralysis, Lacrimation increased
Clinical narrative: Bell's Palsy; Neck pain and rigidity; Neck pain and rigidity; Pain in the ear; Epiphora; Could not blink; Shoulder soreness; Chills; Fever; A spontaneous report was received from a Consumer and a healthcare professional concerning a  35 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial paralysis, arthralgia, chills, fever, neck pain, nuchal rigidity, ear pain, lacrimation increased and lagophthalmos.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12-Feb-2021, prior to the onset of the events, the patient received their second planned dose of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the same day, the patient experienced shoulder soreness, pain in the ear, chills, fever, neck pain and rigidity, epiphora, couldn't blink and face paralysis.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events was unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 vaccine cannot be excluded. The events of arthralgia, chills and fever are consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Lagophthalmos, Neck pain, Nuchal rigidity, Pyrexia
Clinical narrative: Bell's Palsy; Neck pain and rigidity; Neck pain and rigidity; Pain in the ear; Epiphora; Could not blink; Shoulder soreness; Chills; Fever; A spontaneous report was received from a Consumer and a healthcare professional concerning a  35 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial paralysis, arthralgia, chills, fever, neck pain, nuchal rigidity, ear pain, lacrimation increased and lagophthalmos.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12-Feb-2021, prior to the onset of the events, the patient received their second planned dose of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the same day, the patient experienced shoulder soreness, pain in the ear, chills, fever, neck pain and rigidity, epiphora, couldn't blink and face paralysis.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events was unknown.; Reporter's Comments: Based on the information provided which includes a strong temporal association, a causal association between the reported events and the administration of the mRNA-1273 vaccine cannot be excluded. The events of arthralgia, chills and fever are consistent with the known safety profile of the vaccine.