chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Paralytic lagophthalmos, Synkinesis, Tinnitus
Clinical narrative: Bilateral Sensorinerural Hearing Loss; Ramsey Hunt Syndrome; Paralytic Lagophthalmos; Exposure Keratopathy; Severe Ocular synkinesis; tinnitus; herpes zoster; This spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 10-AUG-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around 23-AUG-2010, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient suffered left sided facial paralysis, blisters, ringing in her ears, and vision problems and was diagnosed with herpes zoster, bilateral sensorineural hearing loss, tinnitus, ramsey hunt syndrome, paralytic lagophthalmos, severe ocular synkinesis, and exposure keratopathy. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient symptoms had resulted in physical limitations not presented prior to using Zoster Vaccine Live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events deafness neurosensory, herpes zoster oticus, and paralytic lagophthalmos were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Bilateral Sensorinerural Hearing Loss; Ramsey Hunt Syndrome; Paralytic Lagophthalmos; Exposure Keratopathy; Severe Ocular synkinesis; tinnitus; herpes zoster; This spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 10-AUG-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around 23-AUG-2010, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient suffered left sided facial paralysis, blisters, ringing in her ears, and vision problems and was diagnosed with herpes zoster, bilateral sensorineural hearing loss, tinnitus, ramsey hunt syndrome, paralytic lagophthalmos, severe ocular synkinesis, and exposure keratopathy. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, the patient symptoms had resulted in physical limitations not presented prior to using Zoster Vaccine Live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events deafness neurosensory, herpes zoster oticus, and paralytic lagophthalmos were considered to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; PROQUAD underwent a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On 12-AUG-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # U002538, expiration date 24-JUL-2022, 0.5 milliliter) for prophylaxis (product storage error). Temperature excursion was 5.7 Fahrenheit degree for 10 minutes. There was no previous temperature excursion. No additional AE was reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pruritus, Rash, Vaccination site pruritus
Clinical narrative: Injection site pruritus; Fatigue; Dizziness; Pruritus; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizziness), PRURITUS (Pruritus), VACCINATION SITE PRURITUS (Injection site pruritus), RASH (Rash) and FATIGUE (Fatigue) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Allergy to antibiotic. Concomitant products included METFORMIN, CARVEDILOL, GLIMEPIRIDE, SIMVASTATIN and LISINOPRIL for an unknown indication.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced PRURITUS (Pruritus) and RASH (Rash). On 12-Jan-2021 at 8:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness). On 12-Jan-2021 at 8:15 AM, the patient experienced FATIGUE (Fatigue). On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site pruritus). At the time of the report, DIZZINESS (Dizziness), PRURITUS (Pruritus), VACCINATION SITE PRURITUS (Injection site pruritus), RASH (Rash) and FATIGUE (Fatigue) 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.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up information received on 16 Jul 2021 contains non-significant information.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Injection site pain
Clinical narrative: Heavy menstrual period; Injection site pain; This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy menstrual period) and INJECTION SITE PAIN (Injection site pain) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Overweight, Respiratory infection and Constipation. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and MAGNESIUM (MARINE MAGNESIUM) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy menstrual period). 04-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy menstrual period) and INJECTION SITE PAIN (Injection site pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received included: details on additional event, concomitant medication and other concurrent conditions.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Received Heplisav-B then Two Doses of Engerix; Initial Report Received on 22-Jul-2021  A licensed practical nurse (LPN) reported that a 27 year-old male (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and 2 subsequent doses of Engerix.   No relevant medical history was reported.  No relevant concomitant medications were reported.  On 18-May-2020, dose 1 of HEPLISAV-B (Lot #, expiration date, NDC #, and serial number all unknown).   On 30-Oct-2020, 166 days after having received dose 1 of HEPLISAV-B, dose 1 of Engerix (hepatitis B vaccine) was administered.  On 02-Apr-2021, 320 days after having received dose 1 of HEPLISAV-B, dose 2 of Engerix (hepatitis B vaccine) was administered.    No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: I was given a third Shingrix.; This case was reported by a consumer via media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details provided were as follows: Age at vaccination was not reported. The case was reported by patient for himself/herself. The patient received the 3rd dose of Shingrix, which led to extra dose administered. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Pain, Poor quality sleep, Sensitive skin
Clinical narrative: felt achy; low energy; headaches; poor sleep; skin feels sensitive; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced pain, energy decreased, headache, poor sleep and sensitive skin. On an unknown date, the outcome of the pain, energy decreased, headache, poor sleep and sensitive skin were unknown.   It was unknown if the reporter considered the pain, energy decreased, headache, poor sleep and sensitive skin to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingrix vaccine, 2 weeks ago of reporting date and felt achy, low energy, headaches, poor sleep and skin felt sensitive. The patient wanted to know, if this normal. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd / shot by mistake; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on October 2019) and Shingrix (2nd dose received on February 2020).   In August 2021, the patient received the 3rd dose of Shingrix. In August 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details provided were as follows: Age at vaccination was not reported. The case was reported by the patient himself/herself. The patient received the 3rd dose of Shingrix by mistake which led to extra dose administered. No further details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Chest pain, Cough, Throat irritation
Clinical narrative: I still have a bad cough; Raw throat feeling; Cough hurts me in my chest; This case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cough, raw throat and chest pain. On an unknown date, the outcome of the cough, raw throat and chest pain were not recovered/not resolved.   It was unknown if the reporter considered the cough, raw throat and chest pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported his/her symptoms dissipated after second vaccine shot, the patient still had a bad cough and raw throat feeling. The cough hurt in chest as well and reporter wanted help
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / on 8/30/2018 and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th August 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provide are as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received the 2nd dose, which led to incomplete course of vaccination. The reporter preferred not to disclose any information regarding the patients but clarified that there were two patients involved. The reporter had no further information but agreed to contacted for follow-up. The reporter consented to follow-up. This is one of two cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170563:Same reporter
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received a dose / that had expired on 07-06/2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-year-old female patient who received HAV (Havrix) (batch number PA99T, expiry date 7th June 2021) for prophylaxis.   On 11th August 2021, the patient received Havrix. On 11th August 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provide are as follows: The case was reported by Medical assistant. The patient received a dose of Havrix after expiration date, which led to expired vaccine used. The reporter consented to follow-up via fax.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / 2 years ago / has not yet received the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago, on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The pharmacist reported this case on behalf of the physician (MD). The age at vaccination was not applicable. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist did not have any patient demographics to provide, as the physician (MD) did not provide patient's demographics. The reporter did not consent to follow-up.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only the liquid meningococcal CWY-135 portion; Inappropriate preparation of medication; This case was reported by a nurse via call center representative and described the occurrence of incorrect dose administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA521A, expiry date 31st October 2022) for prophylaxis.   On 12th August 2021, the patient received Menveo. On 12th August 2021, unknown after receiving Menveo, the patient experienced incorrect dose administered and inappropriate preparation of medication. On an unknown date, the outcome of the incorrect dose administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The registered nurse reported that, a medical assistant administered Menveo vaccine to the patient without reconstituting vaccine with meningoccocal A lyophilized portion prior to administration, which led to inappropriate preparation of medication The patient received only the liquid meningococcal CWY-135 portion of the vaccine, which led to incorrect dose administered. The reporter provided permission for follow up.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: used sterile water / when reconstituting with / lyophilized conjugate vaccine component; used sterile water / when reconstituting with / lyophilized conjugate vaccine component; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA521A, expiry date 30th April 2022) and (batch number AMXA521A, expiry date 31st October 2022) for prophylaxis.   On 12th August 2021, the patient received Menveo (intramuscular). On 12th August 2021, the dose was an unknown dose. On 12th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that she used sterile water instead of the liquid conjugate vaccine component (Vial 1) when reconstituting with MenA lyophilized conjugate vaccine component (Vial 2) of Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The patient received the vaccine in left arm. The reporter would like more information on what signs to look for in case of a reaction. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 17 YO / was administered / adult vaccine instead of the / pediatric vaccine; 17 YO / was administered / adult vaccine instead of the / pediatric vaccine; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 17-year-old male patient who received HAV (Havrix adult) for prophylaxis.   On 26th July 2021, the patient received the 2nd dose of Havrix adult. On 26th July 2021, unknown after receiving Havrix adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.  Additional details were provided as follows: The nurse reported that the 17 year old patient received Havrix adult, which led to accidental overdose and adult product administered to child. The reporter consented to follow up.
Age: 14.0
Sex: M
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year old / received / Twinrix; 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 14-year-old male patient who received HAB (Twinrix) (batch number 3Y7NL, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th August 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 6th August 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: A14 year old patient received a dose of Twinrix, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up.
Age: 96.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose / on April-26-2021 / 2nd dose / (Aug-13-2021); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 96-year-old female patient who received HAB (Twinrix) (batch number 57E3G, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 26th April 2021).   On 13th August 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 13th August 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pharmacist reported that, the patient received 2nd dose of Twinrix later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: receiving first dose / in September of 2019 / has not yet received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of vaccine, which led to incomplete course of vaccination. No patient demographics were provided. The reporter did consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Aches; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches) and PYREXIA (Fever). At the time of the report, PAIN (Aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No treatment information provided.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: Swelling itchy eye after vaccine; itchy eye after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swelling itchy eye after vaccine) and EYE PRURITUS (itchy eye after vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Swelling itchy eye after vaccine) and EYE PRURITUS (itchy eye after vaccine). At the time of the report, EYE SWELLING (Swelling itchy eye after vaccine) and EYE PRURITUS (itchy eye after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine (39 days post thawing in the refrigerator) administered to 50 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine (39 days post thawing in the refrigerator) administered to 50 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine (39 days post thawing in the refrigerator) administered to 50 patients). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine (39 days post thawing in the refrigerator) administered to 50 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Malaise, Pyrexia, Tremor
Clinical narrative: Not feel right; Body tremors; Sick all day yesterday; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feel right), TREMOR (Body tremors), MALAISE (Sick all day yesterday), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2021.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced MALAISE (Sick all day yesterday), PYREXIA (Fever) and CHILLS (Chills). On 28-Jun-2021, the patient experienced FEELING ABNORMAL (Not feel right) and TREMOR (Body tremors). At the time of the report, FEELING ABNORMAL (Not feel right), TREMOR (Body tremors), MALAISE (Sick all day yesterday), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Lung neoplasm malignant, Pain in extremity, Pneumonia
Clinical narrative: Inaccurately diagnosed with pneumonia; lung cancer in right lung that has spread; legs hurt; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Inaccurately diagnosed with pneumonia) and LUNG NEOPLASM MALIGNANT (lung cancer in right lung that has spread) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESILATE (AMLODIPINE BESYLATE), MELOXICAM, DEXAMETHASONE, CLONIDINE, FOLIC ACID, METOPROLOL, CETIRIZINE HYDROCHLORIDE (CETRIZINE), ROSUVASTATIN CALCIUM and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Inaccurately diagnosed with pneumonia) (seriousness criterion medically significant), LUNG NEOPLASM MALIGNANT (lung cancer in right lung that has spread) (seriousness criterion medically significant) and PAIN IN EXTREMITY (legs hurt). At the time of the report, PNEUMONIA (Inaccurately diagnosed with pneumonia), LUNG NEOPLASM MALIGNANT (lung cancer in right lung that has spread) and PAIN IN EXTREMITY (legs hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included Flonase.  Treatment medication included three antibiotics.  Laboratory details was mentioned as on an unknown date patient done scan which showed patent had lung cancer in right lung and it was now spreading.  Company Comment: 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.; Sender'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: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism reaction to Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism reaction to Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism reaction to Moderna vaccine) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism reaction to Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided by the reporter.  No treatment information was provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-AUG-2021, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: suspected immunological vaccine failure; This spontaneous report received from a consumer concerned a male of unspecified age. Initial information was processed with the additional information received on 16-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number 1808978) dose were not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had an antibody test coming back negative after vaccination (suspected immunological vaccine failure).  Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189367. The suspected product quality complaint has been confirmed to be disposition type: undetermined. The reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210822782-covid-19 vaccine-suspected immunological vaccine failure . This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JUL-2021, laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. Patient had suspected clinical vaccine failure and suspected covid 19 infection. The action taken with covid-19 vaccine was not applicable. The outcome of the suspected clinical vaccine failure and suspected covid 19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189372.; Sender's Comments: V0;20210822908- covid-19 vaccinesuspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age. 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 administration not reported, batch number: Unknown and expiry; Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient felt very sick with Corona virus (Covid-19), (suspected clinical vaccination failure, and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189626. This case, from the same reporter is linked to 20210824869 and 20210821314.; Sender's Comments: V0: 20210824895-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex. 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 not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-JUL-2021, patient had a positive covid-19 test (suspected covid-19 infection and suspected clinical vaccination failure). The patient also mentioned was sick while reporting.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid 19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189454.; Sender's Comments: V0 20210826210- COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced chills and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Nasal odour, Nausea
Clinical narrative: BACKACHE FROM LAYING DOWN FOR TOO LONG; ODD SMELLING SNOT; ARM TOO SORE TO LIFT; HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 30-JUL-2021, the patient experienced backache from laying down for too long. On 30-JUL-2021, the patient experienced odd smelling snot. On 30-JUL-2021, the patient experienced arm too sore to lift. On 30-JUL-2021, the patient experienced headache. On 30-JUL-2021, the patient experienced nausea. On 30-JUL-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, fatigue, backache from laying down for too long, odd smelling snot, and arm too sore to lift. This report was non-serious. This case, from the same reporter is linked to 20210826549.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: BACKACHE FROM LAYING DOWN FOR TOO LONG; ODD SMELLING SNOT; ARM TOO SORE TO LIFT; HEADACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 30-JUL-2021, the patient experienced backache from laying down for too long. On 30-JUL-2021, the patient experienced odd smelling snot. On 30-JUL-2021, the patient experienced arm too sore to lift. On 30-JUL-2021, the patient experienced headache. On 30-JUL-2021, the patient experienced nausea. On 30-JUL-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, fatigue, backache from laying down for too long, odd smelling snot, and arm too sore to lift. This report was non-serious. This case, from the same reporter is linked to 20210826549.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Underlying condition. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose not reported, frequency one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was admitted to Intensive case unit as she was diagnosed with covid-19 infection after she had received the Janssen Covid 19 vaccine. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The outcome of the Suspected Covid-19 infection and Suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210827058- covid-19 vaccine - Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210827058 - covid-19 vaccine-Suspected Covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).