chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Joint noise, Magnetic resonance imaging neck, Muscle tightness, Neck pain, Pain
Clinical narrative: I had my vaccine (Pfizer covid booster) on February 5th.  On February 6th, my neck started clicking and was somewhat swollen and painful on the left side (my vaccination was in the right arm).    I have had a subsequent xray, ultrasound and mri of my neck, paying particular attention to that swollen area on the left where the clicking is.  All tests have been negative.  It is not a lymph node.    It is now June (4 months later) and my neck is still swollen, painful and clicking on the left side.  My muscles are extremely tight.  It is not clear to me what happened but perhaps some kind of inflammatory response.  It is somewhat better-- I can turn my head without so much pain now and I can turn it further.  But I've been undergoing both physical therapy and chiropractic treatment.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal X-ray normal, Swelling, Ultrasound Doppler
Clinical narrative: I had my vaccine (Pfizer covid booster) on February 5th.  On February 6th, my neck started clicking and was somewhat swollen and painful on the left side (my vaccination was in the right arm).    I have had a subsequent xray, ultrasound and mri of my neck, paying particular attention to that swollen area on the left where the clicking is.  All tests have been negative.  It is not a lymph node.    It is now June (4 months later) and my neck is still swollen, painful and clicking on the left side.  My muscles are extremely tight.  It is not clear to me what happened but perhaps some kind of inflammatory response.  It is somewhat better-- I can turn my head without so much pain now and I can turn it further.  But I've been undergoing both physical therapy and chiropractic treatment.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: no adverse reaction was noted, no treatment required, patient had positive outcome with no problems associated with the error.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test normal, Ear disorder, Lymphadenopathy, Magnetic resonance imaging
Clinical narrative: Initially (11/15/21) lymph nodes under left arm swelled for a few days.  On 11/19/21began experiencing what felt like ear issues that led to full onset of Bells Palsy (11/24/21).
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Local reaction, Rash
Clinical narrative: Localized reaction LUE, rash
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Blood test normal, Dyspepsia, Endoscopy upper gastrointestinal tract
Clinical narrative: I had my first covid 19 Pfizer vaccination on the afternoon of April 20th, 2021. That afternoon I had a sore arm and felt a little fatigued but other than that normal.   The following morning on the 21st Apri, I woke up with an extremely distended stomach. It was painful to touch. This lasted for around a week straight before it eased up. The bloating is now intermittent, but the pain remains to this day.   The pain I feel daily is essentially like my stomach is burning and eating itself on the inside, it is still painful to touch externally when I push in on my abdomen. This pain is especially bad in my upper abdomen. This stomach pain and intermittent bloating is accompanied by severe acid reflux. These symptoms appear to be unrelated to the consumption of food and drink, I often wake up with them in the morning on an empty stomach. I've had these symptoms every day for the past 1 year and 2 months, I have tried multiple medications and natural remedies, and none seem to work.   Prior to the vaccination I had none of the above symptoms. I'm 31, healthy, eat healthily, I'm not overweight and go to the gym most days. These symptoms all started the morning after I had the first Pfizer vaccination.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gastrooesophageal reflux disease, Pain in extremity, Parasite stool test positive, Sensory disturbance
Clinical narrative: I had my first covid 19 Pfizer vaccination on the afternoon of April 20th, 2021. That afternoon I had a sore arm and felt a little fatigued but other than that normal.   The following morning on the 21st Apri, I woke up with an extremely distended stomach. It was painful to touch. This lasted for around a week straight before it eased up. The bloating is now intermittent, but the pain remains to this day.   The pain I feel daily is essentially like my stomach is burning and eating itself on the inside, it is still painful to touch externally when I push in on my abdomen. This pain is especially bad in my upper abdomen. This stomach pain and intermittent bloating is accompanied by severe acid reflux. These symptoms appear to be unrelated to the consumption of food and drink, I often wake up with them in the morning on an empty stomach. I've had these symptoms every day for the past 1 year and 2 months, I have tried multiple medications and natural remedies, and none seem to work.   Prior to the vaccination I had none of the above symptoms. I'm 31, healthy, eat healthily, I'm not overweight and go to the gym most days. These symptoms all started the morning after I had the first Pfizer vaccination.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Confusional state, Hypoxia
Clinical narrative: direct admit, transferred to the emergency department for hypoxia.  Confused at baseline, worsening since COVID pneumonia.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Asthenia, COVID-19, COVID-19 pneumonia, Encephalopathy
Clinical narrative: He presented to the ED on 06/08/22 after a syncopal episode at home, likely due to dehydration and diarrhea.  He was found to be COVID-19 positive.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: He presented to the ED on 06/08/22 after a syncopal episode at home, likely due to dehydration and diarrhea.  He was found to be COVID-19 positive.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Dehydration, Diarrhoea, SARS-CoV-2 test positive, Syncope
Clinical narrative: He presented to the ED on 06/08/22 after a syncopal episode at home, likely due to dehydration and diarrhea.  He was found to be COVID-19 positive.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram, Electrocardiogram ambulatory, Fatigue, Palpitations
Clinical narrative: Never had heart condition ever in my life.  My Booster shot was given on 12/10/2021.  Just after receiving the booster a few weeks later I got Covid. Noticed heart issues pounding fast and some chest pain after in Early February.  Referred to a Cardiologist
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Anticoagulant therapy, Atrial fibrillation, Cardiac ablation, Cardiac disorder
Clinical narrative: Never had heart condition ever in my life.  My Booster shot was given on 12/10/2021.  Just after receiving the booster a few weeks later I got Covid. Noticed heart issues pounding fast and some chest pain after in Early February.  Referred to a Cardiologist
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac monitoring, Cardiac stress test, Electrocardiogram, Impaired work ability, Malaise
Clinical narrative: Never had heart condition ever in my life.  My Booster shot was given on 12/10/2021.  Just after receiving the booster a few weeks later I got Covid. Noticed heart issues pounding fast and some chest pain after in Early February.  Referred to a Cardiologist
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cardiac disorder, Chest pain, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Never had heart condition ever in my life.  My Booster shot was given on 12/10/2021.  Just after receiving the booster a few weeks later I got Covid. Noticed heart issues pounding fast and some chest pain after in Early February.  Referred to a Cardiologist
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Heart rate irregular, Magnetic resonance imaging abnormal, Right atrial enlargement, Supraventricular tachycardia
Clinical narrative: Never had heart condition ever in my life.  My Booster shot was given on 12/10/2021.  Just after receiving the booster a few weeks later I got Covid. Noticed heart issues pounding fast and some chest pain after in Early February.  Referred to a Cardiologist
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Never had heart condition ever in my life.  My Booster shot was given on 12/10/2021.  Just after receiving the booster a few weeks later I got Covid. Noticed heart issues pounding fast and some chest pain after in Early February.  Referred to a Cardiologist
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea
Clinical narrative: Developed tinnitus after first two rounds of COVID-19 vaccine and ENT prescribed lipo-flavonoid that seemed to be resolving issues. After receiving booster tinnitus increased in severity and is now in both ears. On May 12th I noticed a swollen lymph node. Went to urgent clinic. Urgent care doctor instructed me to monitor it. Urgent clinic doctor seemed certain that it was due to the vaccine.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Lymphadenopathy, Tinnitus
Clinical narrative: Developed tinnitus after first two rounds of COVID-19 vaccine and ENT prescribed lipo-flavonoid that seemed to be resolving issues. After receiving booster tinnitus increased in severity and is now in both ears. On May 12th I noticed a swollen lymph node. Went to urgent clinic. Urgent care doctor instructed me to monitor it. Urgent clinic doctor seemed certain that it was due to the vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Gallbladder disorder, Inflammation, Vomiting
Clinical narrative: I had developed upper back pain 2 days after flu shot which was 1 month earlier.  I took Naproxen Sodium to curb inflammation, but stopped it 7-10 days before the Covid booster shot.  Approximately 4 hours after Covid shot, my back muscles seized up severely as if someone was squeezing my ribs extremely tightly.  Pain was along my back where the bra line sits and radiated to the front ribs right under my breasts.  I began to vomit repeatedly and was breathing very hard to catch a breath from the pain.  I have had this same pain location maybe 5 other times, happen maybe once a month before the covid booster.  I imagine the shot caused a severe inflammatory response.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Dyspnoea, Muscle contracture, Musculoskeletal chest pain, Pain
Clinical narrative: I had developed upper back pain 2 days after flu shot which was 1 month earlier.  I took Naproxen Sodium to curb inflammation, but stopped it 7-10 days before the Covid booster shot.  Approximately 4 hours after Covid shot, my back muscles seized up severely as if someone was squeezing my ribs extremely tightly.  Pain was along my back where the bra line sits and radiated to the front ribs right under my breasts.  I began to vomit repeatedly and was breathing very hard to catch a breath from the pain.  I have had this same pain location maybe 5 other times, happen maybe once a month before the covid booster.  I imagine the shot caused a severe inflammatory response.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: I had developed upper back pain 2 days after flu shot which was 1 month earlier.  I took Naproxen Sodium to curb inflammation, but stopped it 7-10 days before the Covid booster shot.  Approximately 4 hours after Covid shot, my back muscles seized up severely as if someone was squeezing my ribs extremely tightly.  Pain was along my back where the bra line sits and radiated to the front ribs right under my breasts.  I began to vomit repeatedly and was breathing very hard to catch a breath from the pain.  I have had this same pain location maybe 5 other times, happen maybe once a month before the covid booster.  I imagine the shot caused a severe inflammatory response.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Patient presented to the practice on 5/9/22 for follow up due to left shoulder pain. It appears on 5/5/22, patient was administered the Moderna Covid vaccine (by practice LPN) during a nurse only visit, with soon after, patient reporting having developed left shoulder pain. 5/9/22 office visit noted the patient had decreased ROM and insomnia due pain. The patient had showed a picture of her left shoulder with the Band-Aid placed in the superior posterolateral edge of the deltoid muscle. A referral was placed for ortho to further evaluate the patient's shoulder.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Patient presented to the practice on 5/9/22 for follow up due to left shoulder pain. It appears on 5/5/22, patient was administered the Moderna Covid vaccine (by practice LPN) during a nurse only visit, with soon after, patient reporting having developed left shoulder pain. 5/9/22 office visit noted the patient had decreased ROM and insomnia due pain. The patient had showed a picture of her left shoulder with the Band-Aid placed in the superior posterolateral edge of the deltoid muscle. A referral was placed for ortho to further evaluate the patient's shoulder.
Age: 78.0
Sex: F
Vaccine: DF, COVID19
Symptoms: COVID-19, Dizziness, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: presents to the emergency room with increasing dyspnea, fatigue, and dizziness.  Testing was negative for influenza however positive for COVID-19.
Age: 78.0
Sex: F
Vaccine: DF, COVID19
Symptoms: COVID-19, Dizziness, Dyspnoea, Fatigue, Influenza virus test negative
Clinical narrative: presents to the emergency room with increasing dyspnea, fatigue, and dizziness.  Testing was negative for influenza however positive for COVID-19.
Age: 78.0
Sex: F
Vaccine: DF, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: presents to the emergency room with increasing dyspnea, fatigue, and dizziness.  Testing was negative for influenza however positive for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neuropathy peripheral, SARS-CoV-2 test
Clinical narrative: I received my COVID-19 Pfizer shot in February 2021. I then received the second dose and boosters in Aug 2021 and June 2022. I developed peripheral neuropathy after second dose with a worsening after booster in August and June
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: I received my COVID-19 Pfizer shot in February 2021. I then received the second dose and boosters in Aug 2021 and June 2022. I developed peripheral neuropathy after second dose with a worsening after booster in August and June
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE/no PQC.; an expired dose of VAQTA was given to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 18-MAY-2022, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (1 ml/once, lot #T034003, expiration date: 28-MAR-2022; strength, and route of administration were not provided), administered for prophylaxis (Expired product administered). Vaccine had no history of temperature excursions. Patient had no adverse effects or symptoms following administration (no adverse event). Dose was supported by post-expiry memo. No further information was provided. No other adverse event (AE) or product quality complaint (PQC) was reported.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Mom reports the patient had an anaphylactic reaction to MMR II due to gelatin allergy.; This spontaneous report was received from nurse practitioner and refers to a 5-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions included  allergy to gelatin, the patient had visits to an allergist. Concomitant therapies were not reported.  On 19-MAR-2013, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #0287AE, expiration date: 01-FEB-2014, administered for prophylaxis (strength, and route of administration were not provided); the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT).  On the same date, the patient experienced an anaphylactic reaction to MMR II due to gelatin allergy. At the time of reporting, the outcome of the event anaphylactic reaction was not known. It was unknown by the reporter if laboratory test were performed, or if the patient received treatment for the event.   The reporter considered the anaphylactic reaction to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and/or sterile diluent (MERCK STERILE DILUENT).  Upon internal review, the event anaphylactic reaction was determined to be medically significant.
Age: 1.17
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; a 14 month old was administered a vaccine that had been expired for 2 weeks; This spontaneous report was received from a medical assistant and referred to a 14-month-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 26-APR-2022, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection (0.5 milliliter, lot #T034828, expiration date: 11-APR-2022 (it was reported that the vaccine had expired for 2 weeks)) for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer 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 was pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2022, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On an unspecified date, the pregnancy resulted in an unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure during pregnancy was not reported. This report was non-serious. This case, from the same reporter is linked to 20220136407, 20220114730 and 20220137233.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dysarthria, Memory impairment
Clinical narrative: Patient's short-term memory became worse; started to have slurred speech; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MEMORY IMPAIRMENT (Patient's short-term memory became worse) and DYSARTHRIA (started to have slurred speech) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Short-term memory loss (For about 2 years.).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MEMORY IMPAIRMENT (Patient's short-term memory became worse) and DYSARTHRIA (started to have slurred speech). At the time of the report, MEMORY IMPAIRMENT (Patient's short-term memory became worse) and DYSARTHRIA (started to have slurred speech) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product was provided by the reporter. Treatment medication received include Memory medication . After the 1st dose, within 4 hours of receiving the shot, patient's short term memory became worse, and started having slurred speech.   This case was linked to MOD-2022-585082 (Patient Link).
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT STORAGE ERROR (Initially vaccine was stored in fridge on 07-Feb-2022and was administered on 08-APR-2022 after more than 30 days) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially vaccine was stored in fridge on 07-Feb-2022and was administered on 08-APR-2022 after more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT STORAGE ERROR (Initially vaccine was stored in fridge on 07-Feb-2022and was administered on 08-APR-2022 after more than 30 days) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. It was reported that, the patient received total 4 doses and this was second booster dose. On 07-Feb-2022, the vials were initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment information was not provided. This case was linked to MOD-2022-584673 (Patient Link).
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  No temperature excursion was reported.  No treatment medication was provided by the reporter.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: For lot 083J21A refrigeration was on 07-Feb-2022, and date of administration on 01-Apr-2022; Expired doses administered beyond the BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD) and PRODUCT STORAGE ERROR (For lot 083J21A refrigeration was on 07-Feb-2022, and date of administration on 01-Apr-2022) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (For lot 083J21A refrigeration was on 07-Feb-2022, and date of administration on 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered beyond the BUD) and PRODUCT STORAGE ERROR (For lot 083J21A refrigeration was on 07-Feb-2022, and date of administration on 01-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient took booster of Moderna and took total 3 doses. Lot number 083J21A was refrigerated on 7-Feb-2022. Vial did not undergo any temperature excursion.  No treatment information was reported .
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022; Expired doses of Moderna COVID-19 were administered beyond the beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient took total 4 doses. Took booster 2 dose of Moderna on 12-Apr-2022. Patient received vaccine on 07-Feb-2022., Lot number 083J21A was refrigerated on 7-Feb-2022. Vial did not undergo any temperature excursion.  Treatment information was not provided.   This case was linked to MOD-2022-584673, MOD-2022-584679 (Patient Link).
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022; Expired doses of Moderna COVID-19 were administered beyond the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter  Patient took 2nd booster dose of Moderna and took total 4 doses. Lot number 083J21A was refrigerated on 7-Feb-2022. Vial did not undergo any temperature excursion  No treatment medication was reported by reporter.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired doses administered; Vaccine put in the fridge on 07Feb2022 and doses were administered on 18Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT STORAGE ERROR (Vaccine put in the fridge on 07Feb2022 and doses were administered on 18Apr2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT STORAGE ERROR (Vaccine put in the fridge on 07Feb2022 and doses were administered on 18Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT STORAGE ERROR (Vaccine put in the fridge on 07Feb2022 and doses were administered on 18Apr2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   On 07-Feb-2022 this vial was put in refrigerator and was administered on 18-Apr-2022.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and GERD. Concomitant products included OMEPRAZOLE and FLUOXETINE for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2022, SARS-CoV-2 test: positive positive. In June 2022, SARS-CoV-2 test: negative Negative.         It was reported that rebound in symptoms after finishing Paxlovid treatment and testing negative on 3 different antigen self tests. Device date was reported as 05-Jun-2022.  Company Comment: This is a spontaneous case concerning  a  35-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on June 1, 2022. Patient received the third dose of mRNA-1273 COVID 19 Vaccine on December 1, 2021. Patient was treated with nirmatrelvir and ritonavir from 21-May-2022 to 26-May-2022 at an unspecified dose and frequency. Patient tested positive SARS-CoV-2 test on June 1, 2022. It was reported that patient had rebound symptoms after completion of course of nirmatrelvir and ritonavir (Paxlovid). The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.  Sender's Comments: This is a spontaneous case concerning  a  35-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on June 1, 2022. Patient received the third dose of mRNA-1273 COVID 19 Vaccine on December 1, 2021. Patient was treated with nirmatrelvir and ritonavir from 21-May-2022 to 26-May-2022 at an unspecified dose and frequency. Patient tested positive SARS-CoV-2 test on June 1, 2022. It was reported that patient had rebound symptoms after completion of course of nirmatrelvir and ritonavir (Paxlovid). The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Vial did not undergo temperature excursion. Total of 102 doses were given from LOT 026C21A. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live non significant follow up. No new clinically significant information received.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 24-Oct-2021. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant follow up received on 8 Jun 2022.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 26-May-2022 to 30-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.         No concomitant medications were reported.  The patient did not take any other medications/Products within 2 weeks of starting Covid-19 treatment.  Patient had previously received a covid-19 -Vaccine.  On 07-JUN-2022 Covid rebound occurred 8 days after symptoms disappeared and Tested Positive on antigen test and return of fever.  Device date: 07-JUN-2022  Company Comment: This is a spontaneous case concerning  a  57-year-old, male patient with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on unknown date of May 2022, after the fourth dose of mRNA-1273 COVID 19 Vaccine which was administered on April 26, 2022. Patient was treated with nirmatrelvir and ritonavir from from 26-May-2022 to 30-May-2022 at an unspecified dose and frequency. Patient re-developed symptoms of Covid-19 on 07-JUN-2022 and tested positive on antigen test. The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Sender's Comments: This is a spontaneous case concerning  a  57-year-old, male patient with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on unknown date of May 2022, after the fourth dose of mRNA-1273 COVID 19 Vaccine which was administered on April 26, 2022. Patient was treated with nirmatrelvir and ritonavir from from 26-May-2022 to 30-May-2022 at an unspecified dose and frequency. Patient re-developed symptoms of Covid-19 on 07-JUN-2022 and tested positive on antigen test. The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 09-Nov-2021 and administered on 11-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 11-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 11-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 11-Nov-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Vials did not undergone any temperature excursion.  No treatment medication was reported.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up was received with non-significant information of secondary reporter was added.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 09-Nov-2021. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow up received reporter address updated.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022/Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022/Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022/Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022/Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date the vial was initially stored in the refrigerator was reported as unknown. Number of doses/vials was reported as 173 doses.  The vial did not undergo any temperature excursions  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Followup received, additional reporter was added.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in an 84-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator reported as unknown and the vial did not undergo any temperature excursions. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant follow up received.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Total of 173 doses/vials were given for LOT  070H21A. The vial did not undergone to any temperature excursions. It was unknown when the vial was stored in refrigerator.  No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contains non significant information