chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ADACEL was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Consumer/ Other Non Professional via Global Medical Information (Reference number- SANOFI) and transmitted to Sanofi on 11-Nov-2021.  This case involves a 11 years old female patient who received expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 11-Nov-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6518AA, expiry date 05-Nov-21 via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired product administered (latency same day).  It was reported "Caller is looking for information on possible adverse effects as well as if they need to revaccinate the patient."  At time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Lethargy, Rash, Swelling
Clinical narrative: Large amount of swelling, rash, SOB. lethargy
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The nurse sated that she reconstituted the 5-11 year old  Pfizer Covid-19 vaccine with 1.8 ml of 0.9% of normal saline instead of 1.3 ml.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The nurse sated that she reconstituted the 5-11 year old  Pfizer Covid-19 vaccine with 1.8 ml of 0.9% of normal saline instead of 1.3 ml.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: The nurse sated that she reconstituted the 5-11 year old  Pfizer Covid-19 vaccine with 1.8 ml of 0.9% of normal saline instead of 1.3 ml.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: The nurse sated that she reconstituted the 5-11 year old  Pfizer Covid-19 vaccine with 1.8 ml of 0.9% of normal saline instead of 1.3 ml.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: The nurse sated that she reconstituted the 5-11 year old  Pfizer Covid-19 vaccine with 1.8 ml of 0.9% of normal saline instead of 1.3 ml.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; Medical Assistant calling to report a limited adverse event on a dose of PROQUAD that was administered improperly stored during a temperature excursion found supported; This spontaneous report was received from a medical assistant and refers to a 4 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 05-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot # T034614, expiration date 10-APR-2021 for prophylaxis (anatomical location and route of administration were not reported).   The vaccine was stored at the temperature that was reported as from 6 degrees of Fahrenheit (F) to 14 degrees of F (8.5 degrees of F) for 18 minutes and at the temperature from 6 degrees of F to 14 degrees of F (11.9 degrees of F) for 1 hour. There was no previous temperature excursion reported.  No additional adverse events reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a medical assistant and refers to a 12 month old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 15-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T032317, expiration date 22-SEP-2022 for prophylaxis (dose, anatomical location and route of administration were not reported).     The vaccine was stored at the temperature that was reported as from 6 degrees of Fahrenheit (F) to 14 degrees of F (8.5 degrees of F) for 18 minutes and at the temperature from 6 degrees of F to 14 degrees of F (11.9 degrees of F) for 1 hour. There was no previous temperature excursion reported.  No additional adverse event details available.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Extra dose administered, Rash, Vaccine positive rechallenge
Clinical narrative: rash, feels like sandpaper; 3 shots (vaccine); This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of rash (1st dose received on an unknown date, refer case US2021AMR237256) and Shingles vaccine with an associated reaction of rash (2nd dose received on an unknown date, refer case US2021AMR237274).   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash and extra dose administered. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the rash and extra dose administered were unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received 3rd Shingles vaccine shot, which led to extra dose dministered and still got a rash.  The rash felt like sandpaper.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR237274:Same reporter US-GLAXOSMITHKLINE-US2021AMR237256:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: inadvertently receiving 3 doses of Shingrix; This case was reported by a pharmacist via sales rep and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date) and Shingrix with an associated reaction of no adverse event (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix .5 ml. 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 were provided as follows: The age at vaccination was not reported. The patient inadvertently received 3 doses of Shingrix, which led to extra dose administered.  Health care professional stated that patient did not had any problems with the injection and inquired about long-term effects.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the 1st dose of the Shingrix vaccine on and had arm pain. The reporter asked some questions regarding the side effects of the vaccine and when she could receive the Covid 19 booster (3rd dose) after receiving the 1st dose of Shingrix vaccine. The reporter did not want to give her contact information and declined to give consent to be contacted.
Sex: F
Vaccine: COVID19
Symptoms: Multi-organ disorder
Clinical narrative: GOING TO LOSE AT LEAST ONE ORGAN QUITE POSSIBLY 4; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age of unknown 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) 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 reporter stated that "hey your experimental jabbed landed my niece in the hospital no liability for you she will be lucky to survive Just trying to get her to stay alive at this point Going to lose at least one organ, quite possibly 4". The patient was hospitalized (unspecified date and days). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of going to lose at least one organ quite possibly 4 was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211139171 -covid-19 vaccine ad26.cov2.s- "Going to lose at least one organ, quite possibly 4". 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).
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: MASSIVE BRAIN BLEED; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: 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 and lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that "my mother had a massive brain bleed 2 weeks after the you know what". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of massive brain bleed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211139481 -covid-19 vaccine ad26.cov2.s- massive brain bleed. 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).
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: SORENESS IN ARM WHERE INJECTION WAS RECEIVED/TENDER TOUCH AT INJECTION SITE; REDNESS AT INJECTION SITE 2 INCHES  WIDE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no change in lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 213D21A expiry: 11-APR-2022) dose was not reported, administered on 12-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-NOV-2021, the patient experienced soreness in arm where injection was received/tender touch at injection site. On 13-NOV-2021, the patient experienced redness at injection site 2 inches wide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in arm where injection was received/tender touch at injection site, and redness at injection site 2 inches wide. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy salivary gland, Lip swelling, Mouth swelling, Myalgia, Salivary gland enlargement
Clinical narrative: Swelling of the mouth; Swelling of the salivary glands; Swelling of the lips; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (Swelling of the mouth), SALIVARY GLAND ENLARGEMENT (Swelling of the salivary glands), LIP SWELLING (Swelling of the lips) and MYALGIA (Body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Allergies with trees of unknown kind.), Allergy to plants (Allergy to citrus.) and Penicillin allergy. Concomitant products included IBANDRONATE SODIUM (IBANDRONATE) for Osteoporosis.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced MYALGIA (Body aches). On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MOUTH SWELLING (Swelling of the mouth), SALIVARY GLAND ENLARGEMENT (Swelling of the salivary glands) and LIP SWELLING (Swelling of the lips). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. On 03-Apr-2021, MYALGIA (Body aches) had resolved. At the time of the report, MOUTH SWELLING (Swelling of the mouth), SALIVARY GLAND ENLARGEMENT (Swelling of the salivary glands) and LIP SWELLING (Swelling of the lips) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy salivary gland: negative (Negative) Negative for Sjorgren's syndrome.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not reported.  Lab data included blood works and series of diagnostics. It was reported that patient did not experience any event after first dose of vaccination.   This case was linked to MOD-2021-385897 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Event added, reporter type updated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Excursion from the freezer/administered to 118 patients(01Nov2021- 53 given); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer/administered to 118 patients(01Nov2021- 53 given)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer/administered to 118 patients(01Nov2021- 53 given)). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer/administered to 118 patients(01Nov2021- 53 given)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given. There was an excursion from their freezer on 01Oct2021.   This case was linked to MOD-2021-383439 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received Added patient demography and vaccination information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site rash
Clinical narrative: had red spot  that hurts that look like a rush were the needle  was given,; has a red spot that hurts where the needle was given; had red spot  that hurts that look like a rush were the needle  was given,; Had a bump like little rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Had a bump like little rash), VACCINATION SITE ERYTHEMA (had red spot  that hurts that look like a rush were the needle  was given,), VACCINATION SITE PAIN (has a red spot that hurts where the needle was given) and VACCINATION SITE RASH (had red spot  that hurts that look like a rush were the needle  was given,) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21a, 031l20a and 025a21a) for COVID-19 vaccination.     No medication history was provided by the reporter.  Concomitant products included ATORVASTATIN for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE MASS (Had a bump like little rash). On 10-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (had red spot  that hurts that look like a rush were the needle  was given,), VACCINATION SITE PAIN (has a red spot that hurts where the needle was given) and VACCINATION SITE RASH (had red spot  that hurts that look like a rush were the needle  was given,). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Had a bump like little rash), VACCINATION SITE ERYTHEMA (had red spot  that hurts that look like a rush were the needle  was given,), VACCINATION SITE PAIN (has a red spot that hurts where the needle was given) and VACCINATION SITE RASH (had red spot  that hurts that look like a rush were the needle  was given,) outcome was unknown.            Patient stated the the events didn't happened with first and second dose.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Erythema, Metabolic function test, Pain in extremity, Peripheral swelling
Clinical narrative: unilateral foot swelling; unilateral foot redness; unilateral foot pain; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (unilateral foot swelling), ERYTHEMA (unilateral foot redness) and PAIN IN EXTREMITY (unilateral foot pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017fz1a) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FAMOTIDINE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced PERIPHERAL SWELLING (unilateral foot swelling), ERYTHEMA (unilateral foot redness) and PAIN IN EXTREMITY (unilateral foot pain). On 06-Nov-2021, PERIPHERAL SWELLING (unilateral foot swelling), ERYTHEMA (unilateral foot redness) and PAIN IN EXTREMITY (unilateral foot pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: normal (normal) normal. On an unknown date, Metabolic function test: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had  test whose result was Normal  Treatment information was not provided.  This case concerns a 40-year old, female subject with no relevant medical history, who experienced the non-serious unexpected events of Peripheral swelling, Erythema, and Pain in Extremity. The events occurred 4 days after the booster dose of mRNA 1273 VACCINE and lasted for 4 days. Diagnostic tests done (C-reactive protein, basic metabolic panel, foot x-ray) yielded normal results. At the time of the report, outcome of the event was Recovered/Resolved. Rechallenge is Not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.; Sender's Comments: This case concerns a 40-year old, female subject with no relevant medical history, who experienced the non-serious unexpected events of Peripheral swelling, Erythema, and Pain in Extremity. The events occurred 4 days after the booster dose of mRNA 1273 VACCINE and lasted for 4 days. Diagnostic tests done (C-reactive protein, basic metabolic panel, foot x-ray) yielded normal results. At the time of the report, outcome of the event was Recovered/Resolved. Rechallenge is  Not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: unilateral foot swelling; unilateral foot redness; unilateral foot pain; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (unilateral foot swelling), ERYTHEMA (unilateral foot redness) and PAIN IN EXTREMITY (unilateral foot pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017fz1a) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FAMOTIDINE and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced PERIPHERAL SWELLING (unilateral foot swelling), ERYTHEMA (unilateral foot redness) and PAIN IN EXTREMITY (unilateral foot pain). On 06-Nov-2021, PERIPHERAL SWELLING (unilateral foot swelling), ERYTHEMA (unilateral foot redness) and PAIN IN EXTREMITY (unilateral foot pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: normal (normal) normal. On an unknown date, Metabolic function test: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had  test whose result was Normal  Treatment information was not provided.  This case concerns a 40-year old, female subject with no relevant medical history, who experienced the non-serious unexpected events of Peripheral swelling, Erythema, and Pain in Extremity. The events occurred 4 days after the booster dose of mRNA 1273 VACCINE and lasted for 4 days. Diagnostic tests done (C-reactive protein, basic metabolic panel, foot x-ray) yielded normal results. At the time of the report, outcome of the event was Recovered/Resolved. Rechallenge is Not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.; Sender's Comments: This case concerns a 40-year old, female subject with no relevant medical history, who experienced the non-serious unexpected events of Peripheral swelling, Erythema, and Pain in Extremity. The events occurred 4 days after the booster dose of mRNA 1273 VACCINE and lasted for 4 days. Diagnostic tests done (C-reactive protein, basic metabolic panel, foot x-ray) yielded normal results. At the time of the report, outcome of the event was Recovered/Resolved. Rechallenge is  Not applicable as no additional dose is expected to be given. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Horrible pain in the left arm/Slight at first/Pain has continued and gotten worse/Pain is ridiculous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Horrible pain in the left arm/Slight at first/Pain has continued and gotten worse/Pain is ridiculous) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 028A21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Horrible pain in the left arm/Slight at first/Pain has continued and gotten worse/Pain is ridiculous). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and NAPROXEN (MOTRIN [NAPROXEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Horrible pain in the left arm/Slight at first/Pain has continued and gotten worse/Pain is ridiculous) had not resolved.            Concomitant medication include diabetic medication.   Patient started feeling pain that same night from the shot, but it was slight at first and thought it was normal. However, pain has continued and gotten worse. Patient went to see his doctor last Thursday and doctor pain is from the shot. Doctor told him to take Advil or Motrin, but "it absolutely does nothing". Patient said "Pain is ridiculous, she have it all the time". Patient tried putting ice and heat on his arm, and although it calms pain at first, then it starts again.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 027L20A and 015M20A) for COVID-19 vaccination. No Medical History information was reported.  On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Facility type is Doctors office. Concomitants and Treatment medications were not provided. Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: follow up received
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna COVID 19 vaccine administered to 12 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID 19 vaccine administered to 12 year old) in a 12-year-old patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID 19 vaccine administered to 12 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID 19 vaccine administered to 12 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.    Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Had tiredness; Arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Had tiredness) and VACCINATION SITE PAIN (Arm was sore at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A, 044B21A and 051F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FATIGUE (Had tiredness) and VACCINATION SITE PAIN (Arm was sore at the injection site). At the time of the report, FATIGUE (Had tiredness) and VACCINATION SITE PAIN (Arm was sore at the injection site) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-384074, MOD-2021-384392 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart rate) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia. Concomitant products included APIXABAN (ELIQUIS), VALSARTAN, AMLODIPINE, CHLORTALIDONE (CHLORTHALIDONE), DEXLANSOPRAZOLE (DEXILANT), ATORVASTATIN, ZINC and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced HEART RATE INCREASED (Rapid heart rate). At the time of the report, HEART RATE INCREASED (Rapid heart rate) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Heart rate: 145 (abnormal) 145, getting rapid heart beat..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported.  Patient had ECG device attached continuously but no cause was determined.   This case was linked to MOD-2021-385670 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered 24 hours post puncture; 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 (Dose administered 24 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post puncture). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided. This case concerns a patient of unknown age and gender with no details on relevant medical history, who experienced Expired product administration after mRNA- 1273 Moderna vaccine. The event was associated with the first dose of mRNA- 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report; Sender's Comments: This case concerns a patient of unknown age and gender with no details on relevant medical history, who experienced Expired product administration after mRNA- 1273 Moderna vaccine. The event was associated with the first dose of mRNA- 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes swelling; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes swelling) in a 46-year-old female patient 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 LYMPHADENOPATHY (lymph nodes swelling). At the time of the report, LYMPHADENOPATHY (lymph nodes swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-385641 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: swollen, warm large area in the site of injection; swollen, warm large area in the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (swollen, warm large area in the site of injection) and VACCINATION SITE SWELLING (swollen, warm large area in the site of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced VACCINATION SITE WARMTH (swollen, warm large area in the site of injection) and VACCINATION SITE SWELLING (swollen, warm large area in the site of injection). At the time of the report, VACCINATION SITE WARMTH (swollen, warm large area in the site of injection) and VACCINATION SITE SWELLING (swollen, warm large area in the site of injection) had not resolved.            No relevant concomitant medications were reported. Treatment includes cold in the area.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling hot, Head discomfort, Headache, Pyrexia
Clinical narrative: Hacking cough; Hot; I could feel the heat radiate off my forehead; Pretty good headache; Last night , fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Hacking cough), FEELING HOT (Hot), HEAD DISCOMFORT (I could feel the heat radiate off my forehead), HEADACHE (Pretty good headache) and PYREXIA (Last night , fever) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced PYREXIA (Last night , fever). On an unknown date, the patient experienced COUGH (Hacking cough), FEELING HOT (Hot), HEAD DISCOMFORT (I could feel the heat radiate off my forehead) and HEADACHE (Pretty good headache). On 11-Nov-2021, PYREXIA (Last night , fever) was resolving. At the time of the report, COUGH (Hacking cough), FEELING HOT (Hot), HEAD DISCOMFORT (I could feel the heat radiate off my forehead) and HEADACHE (Pretty good headache) outcome was unknown.     Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given a 12 day expired booster dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given a 12 day expired booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given a 12 day expired booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given a 12 day expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.   Treatment information was not provided.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Breast tenderness, Fatigue
Clinical narrative: Breast tenderness; Breasts are lumpy and prominent; A little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BREAST TENDERNESS (Breast tenderness), BREAST MASS (Breasts are lumpy and prominent) and FATIGUE (A little fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced BREAST TENDERNESS (Breast tenderness), BREAST MASS (Breasts are lumpy and prominent) and FATIGUE (A little fatigue). At the time of the report, BREAST TENDERNESS (Breast tenderness), BREAST MASS (Breasts are lumpy and prominent) and FATIGUE (A little fatigue) had not resolved.            No concomitant medications were reported. Treatment medication was not provided by the reporter.  Patient got the Moderna booster and was experiencing side effects. Patient had a little fatigue and breast tenderness, feels like patient was about to breastfeed. Patient's breasts were lumpy and prominent. It started about 3 days after the vaccine and was still happening now. The patient had zero side effects from the first two doses.  This case concerns a 42-year-old, female patient, with no known medical history, who experienced the non-serious, unexpected events of breast tenderness and breast mass and non-serious expected event of fatigue. The events occurred  three days after booster dose of mRNA 1273 vaccine. The patient felt fatigue, breast tenderness, and her breasts felt lumpy and is ongoing as of receipt of report. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 42-year-old, female patient, with no known medical history, who experienced the non-serious, unexpected events of breast tenderness and breast mass and non-serious expected event of fatigue. The events occurred  three days after booster dose of mRNA 1273 vaccine. The patient felt fatigue, breast tenderness, and her breasts felt lumpy and is ongoing as of receipt of report. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: pain in the left arm; lymph nodes swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the left arm) and LYMPHADENOPATHY (lymph nodes swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PAIN IN EXTREMITY (pain in the left arm) and LYMPHADENOPATHY (lymph nodes swelling). At the time of the report, PAIN IN EXTREMITY (pain in the left arm) and LYMPHADENOPATHY (lymph nodes swelling) was resolving.            Patient took first dose in February having Lot no. 023M20A and second dose(unknown date) lot no is 006B21A No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-385641 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pancreatic carcinoma
Clinical narrative: died of pancreatic cancer; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATIC CARCINOMA (died of pancreatic cancer) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PANCREATIC CARCINOMA (died of pancreatic cancer) (seriousness criteria death and medically significant). The reported cause of death was Pancreatic cancer. It is unknown if an autopsy was performed.            Reporter stated that the patient was fine beforehand and used to run marathons.  No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Pancreatic Cancer. The event occurred approximately 6 months after receiving an unknown dose number of mRNA-1273 Vaccine and had a fatal outcome, with death occurring around the same time. The reported cause of death was Pancreatic cancer. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history, who experienced the unexpected event of Pancreatic Cancer. The event occurred approximately 6 months after receiving an unknown dose number of mRNA-1273 Vaccine and had a fatal outcome, with death occurring around the same time. The reported cause of death was Pancreatic cancer. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reported Cause(s) of Death: pancreatic cancer
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: mild flu like symptoms; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (mild flu like symptoms) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Injury (Injury 11-12 years ago (maybe in 2006 or 2007)).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (mild flu like symptoms). In January 2021, INFLUENZA LIKE ILLNESS (mild flu like symptoms) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INFLUENZA LIKE ILLNESS (mild flu like symptoms) to be possibly related.    No Concomitant medications were reported.  No Treatment information was reported.  The events lasted for 48-72 hrs.   This case was linked to MOD-2021-385888, MOD-2021-385889 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: Malaise; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise) and MYALGIA (Body aches) in a 77-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, MALAISE (Malaise) and MYALGIA (Body aches) outcome was unknown.            No concomitant product use was provided by the reporter.   This case was linked to MOD-2021-258759 (Patient Link).