chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Palpitations, Pericarditis, Viral infection
Clinical narrative: PERICARDITIS; MILD HEART PALPITATIONS (TINGES); VIRAL INFECTION; This spontaneous report received from a patient via a company representative via social media (J and J Corporate account) concerned a 59 year old of unspecified sex, race and ethnicity.   The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in perfect health and had never been in an ER (emergency room) before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. Age at time of vaccination 6 decade old. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced mild heart palpitations (tinges) every 20 minutes or so after the vaccine and within 2 months of getting the vaccine patient experienced pericarditis after a viral infection. It was reported as "I had had mild heart palpitations (tinges) every 20 minutes or so after I got the J and J. They subsided after 2 days and I then got Periocarditis after a virus within 2 months or getting the vaccine. I wound up in the emergency room (I was 59, in perfect health and had never been in an ER) thinking I was having a heart attack. I am totally convinced that the J&J caused these issues" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild heart palpitations (tinges), and the outcome of pericarditis and viral infection was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20221153030.; Sender's Comments: V0:20221151295-Pericarditis. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer via other company (Novavax) concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced headache for about three months after vaccination with the second dose (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified (middle) age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died. The cause of death was unknown. The date of death was not reported. It was unknown whether an autopsy was performed. Reporter stated that, "I knew healthy people, one middle aged who died shortly after the shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221152669, 20221152749 and 20221152742.; Sender's Comments: V0: 20221152816-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died. It was reported as "my wife died from the vaccine" On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221155633- Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Attention deficit hyperactivity disorder
Clinical narrative: ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) WORSE THAN EVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: attention deficit hyperactivity disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced attention deficit hyperactivity disorder (adhd) worse than ever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of attention deficit hyperactivity disorder (adhd) worse than ever was not reported. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder, Myocardial infarction, Off label use
Clinical narrative: HEART ATTACK; HIS IMMUNE SYSTEM ATTACKED HIS BODY; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a consumer by a company representative via social media (J and J Corporate) and concerned a 35 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total was administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient was previously received with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total was administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3)  (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported (01 total), start therapy date were not reported for covid-19 prophylaxis which was off label dosing frequency (dose number in series 3). Age at the time of vaccination 4 decade. The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug was associated with Off label use. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack (dose number in series 3). Patient was told that his body had a reaction, went into overdrive and his immune system attacked his body. The patient was hospitalized on an unspecified date for an unspecified number of days. (dose number in series 3).  The reporter reported that, "my 35 yr old had a heart attack after 2nd booster. Spent several days in the hospital. He was told his body had a reaction and went into overdrive. His immune system attacked his body. Still seeing a cardiologist." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack, his immune system attacked his body and off label dosing frequency was not reported. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0:20221156298- Heart attack, His immune system attacked his body. The event has unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SOME TERRIBLE REACTIONS FROM THE SHOT; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced some terrible reactions from the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of some terrible reactions from the shot was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Disturbance in attention, Feeling abnormal
Clinical narrative: DIED; TROUBLE IN FOCUSING AND CONCENTRATING; WAS FEELING WRONG IN HER WORDS; This spontaneous report received from a consumer via social media via company representative concerned a 61-year-old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose and start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. Age at time of vaccination 7 decade old. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 13 hours post vaccination, the patient died in her recliner. That night, at 08:00 pm, it was reported that the patient had trouble in focusing and concentrating and was feeling wrong in her words. Patient was told to take rest by family members, but patient could not talk the next day as she was found dead. On an unspecified date, the patient died from an unknown cause of death. It was unspecified if an autopsy was performed or not. The consumer reported as, "My 61-year-old cousin died in her recliner, approximately 13 hours after being bullied into receiving the shot by her doctor on a well visit. I, now, realize that while I was speaking with her at 8:00 pm, that night, she was having trouble focusing and concentrating and was feeling, ("Wrong", her words), so I told her to get some rest and we would talk, tomorrow. Tomorrow never came, for her." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of trouble in focusing and concentrating and was feeling wrong in her words was not reported. This report was serious (Death).; Sender's Comments: V0- 20221156409-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous report received from a patient and by a company representative concerned a 67 year old patient of unspecified age, sex, race and ethnicity. Initial information processed with additional information received from Complaint department on 28-NOV-2022. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose and start therapy date were not reported, 1 total, first dose administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, second dose administered on an unspecified date in NOV-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 7 decade old. No concomitant medications were reported. On 14-NOV-2022, the patient experienced covid (Covid-19) (Dose number in series: 2). It was reported as "Thank you I am 67 years young and had the J&J covid series. It has been a year since I took the 2nd shot. Today I am on day 11 of covid. I would not say it is been exactly easy but I did not have to go to the hospital. My 70 year old spouse is doing even better than I am. You delivered. We were alive and did not have to go to the hospital". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid. This report was non-serious. This report was associated with a product quality complaint: 90000260886. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a 67 year old male. The patient's weight, height, and medical history were not reported. The patient previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose and start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 7 decade old. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 infection (dose number in series 2). It was reported that, "Thank you I am 67 years young and had the J and J covid series. It has been a year since I took the 2nd shot. Today I am on day 11 of covid. I won't say it's been exactly easy but I did not have to go to the hospital. My 70 year old spouse is doing even better than I am. You delivered. We're alive and didn't have to go to the hospital." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint 90000260891.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; This spontaneous report received from a patient via a company representative via social media (J and J corporate) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had never been on blood thinners before the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced pulmonary embolism. It was reported as "I had the Johnson and Johnson vaccine. Afterwards I got a pulmonary embolism. I never had been on blood thinners before and now I will be forever" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20221161615- pulmonary embolism. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Felt a bit of sore arm; Headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Felt a bit of sore arm) and HEADACHE (Headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A217) for COVID-19 vaccination.     The patient's past medical history included HbA1C increased (a couple months ago, it was because of inactive insulin she was taking). Previously administered products included for Product used for unknown indication: flu vaccine (3 weeks ago). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Allergic reaction to analgesics (allergic to Paracetamol and Acetaminophen), Hypothyroidism (8 or 9 years ago) and Type 1 diabetes mellitus (8 or 9 years ago). Concomitant products included LEVOTHYROXINE for Hypothyroidism, INSULIN GLULISINE (APIDRA SOLOSTAR) and INSULIN DEGLUDEC (TRESIBA) for Type 1 diabetes mellitus, VITAMIN D NOS and IRON for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Felt a bit of sore arm) and HEADACHE (Headache). On 18-Mar-2021, PAIN IN EXTREMITY (Felt a bit of sore arm) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The year of birth of the patient was reported.  Patient did not receive any treatment.   This case was linked to MOD-2022-679416, MOD-2022-679419 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Myalgia
Clinical narrative: Whenever took any of the covid-19 vaccine, it rattled Crohn's disease; Muscles were sore and could not bend down like used to; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Whenever took any of the covid-19 vaccine, it rattled Crohn's disease) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient's past medical history included Crohn's disease.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, 40MG/0.4ML. On an unknown date, the patient experienced CROHN'S DISEASE (Whenever took any of the covid-19 vaccine, it rattled Crohn's disease) (seriousness criterion medically significant) and MYALGIA (Muscles were sore and could not bend down like used to). At the time of the report, CROHN'S DISEASE (Whenever took any of the covid-19 vaccine, it rattled Crohn's disease) had resolved and MYALGIA (Muscles were sore and could not bend down like used to) had not resolved.            No concomitant medication information provided. It was reported that patient had a booster dose. MPID: 4782590 It was unknown if patient was enrolled in COVID-19-Vaccine Trial. No treatment information provided.  Company comment: This spontaneous case concerns an elderly female patient of unknown age with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease an unknown time after the booster dose of mRNA-1273.222. The patient reported that she experienced a Crohn's disease flare up every time she took a COVID-19 vaccine. Crohn's disease can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-675618 (Patient Link).; Sender's Comments: This spontaneous case concerns an elderly female patient of unknown age with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease an unknown time after the booster dose of mRNA-1273.222. The patient reported that she experienced a Crohn's disease flare up every time she took a COVID-19 vaccine. Crohn's disease can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test, Weight
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for Autoimmune disorder NOS.     Concurrent medical conditions included Atrial fibrillation (A-fib), Lupus syndrome (Lupus) and Blood cholesterol abnormal (Cholesterol). Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation, ROSUVASTATIN for Cholesterol, HYDROXYCHLOROQUINE for Lupus syndrome.    On 28-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Nov-2022, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2022, SARS-CoV-2 test: Positive. On an unknown date, Weight: Increased.         Patient received 1st dose on 15Jan2021 with Lot: 012L20A; 2nd dose on 16Feb2021 with Lot: 010M20A; 3rd dose on 25Oct2021 with Lot: 032F21A and 4th dose on 18Apr2022 with Lot: 005M21A.  Patient was allergic to a lot of things, so she had to wait the 30 minutes after 1st dose, but she was fine.  Patient had all her injection and booster. Patient had not taken any of the Paxlovid at the time of this report. Her symptoms started Saturday but she thought she just had a cold because all she really had was a runny nose.  Patient was much thinner when COVID pandemic had started however being home all the time and not doing anything she had put on a lot of weight. Patient was in the hospital the previous weekend and she believed that's where she had picked up the COVID-19.  Patient was diagnosed with COVID-19 after receiving 5 doses of the Moderna Covid Vaccine. It was reported that the packaging was sealed and intact.  No treatment medications were reported.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: No adverse event; needle came apart while administering a bivalent dose so patient could not get the vaccine; needle came apart while administering a bivalent dose so patient could not get the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (needle came apart while administering a bivalent dose so patient could not get the vaccine), UNDERDOSE (needle came apart while administering a bivalent dose so patient could not get the vaccine) and NO ADVERSE EVENT (No adverse event) in a 6-decade-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 vaccination.     The patient's height was unknown. The patient had no allergies.  The information was unknown whether patient had ever tested positive for COVID-19 diagnosis. Specific product reported as yes, specific product known from provided information.     On 23-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Nov-2022, the patient experienced DEVICE CONNECTION ISSUE (needle came apart while administering a bivalent dose so patient could not get the vaccine) and UNDERDOSE (needle came apart while administering a bivalent dose so patient could not get the vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (needle came apart while administering a bivalent dose so patient could not get the vaccine), UNDERDOSE (needle came apart while administering a bivalent dose so patient could not get the vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (needle came apart while administering a bivalent dose so patient could not get the vaccine) and UNDERDOSE (needle came apart while administering a bivalent dose so patient could not get the vaccine).    The patient could not received the vaccine. The was adult and in 50's. The patient received the first and second dose on an unknown date.  No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Erythema, Pain
Clinical narrative: Redness; Pain; Chills; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Redness), PAIN (Pain) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Specific product reported as: No, product was inferred.  .  Previously administered products included for Product used for unknown indication: Pfizer vaccine, Pfizer vaccine, Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. Past adverse reactions to the above products included Chills with Pfizer vaccine; Headache with Pfizer vaccine; Lipoma with Pfizer vaccine; Mobility decreased with Pfizer vaccine; Skin red with Pfizer vaccine; and Vomiting with Pfizer vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), PAIN (Pain) and CHILLS (Chills). At the time of the report, ERYTHEMA (Redness), PAIN (Pain) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were reported.   Pfizer's vaccine sent patient into such a tailspin, thought would die. A huge lipoma on right arm, severe chills, clustered deep red spots on hand (all on the right and started within hours of injection), neck would not move after dozed off, headache but the worst was incredibly vicious vomiting, every 3-5 minutes for close to 9 hrs. All but the neck and hand occurred with both vaccinations. Doctor used Moderna for boosters and though had some redness, pain and chills, so far have not had to deal with the beastly parts either time.   No treatment information was provided.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: severe pain at the site of the vaccine; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (severe pain at the site of the vaccine) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Nov-2022 at 7:00 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Nov-2022, the patient experienced VACCINATION SITE PAIN (severe pain at the site of the vaccine). At the time of the report, VACCINATION SITE PAIN (severe pain at the site of the vaccine) had not resolved.            Concomitant medications were not reported.  Patient arm did not hurt as patient was receiving the vaccine or even shortly after. It hurt more than any other vaccine patient received and was still painful to the touch at 5:19 pm on 24Nov2022. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Sensitive skin
Clinical narrative: Skin was exceptionally sensitive; Skin itchy; This spontaneous case was reported by a patient and describes the occurrence of SENSITIVE SKIN (Skin was exceptionally sensitive) and PRURITUS (Skin itchy) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Sickness (Sick with 104.2 temperature.), Fever (104.2 temperature.) and Flu. Previously administered products included for Flu prophylaxis: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Diabetes.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SENSITIVE SKIN (Skin was exceptionally sensitive) and PRURITUS (Skin itchy). At the time of the report, SENSITIVE SKIN (Skin was exceptionally sensitive) and PRURITUS (Skin itchy) outcome was unknown.            No concomitant medications were reported. It was reported that patient got the Moderna for first immunization, that was two shots. No treatment medications were reported.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse event; A toddler received as a first dose a 0.25ml adult formula bivalent vaccine; A toddler received as a first dose a 0.25ml adult formula bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (A toddler received as a first dose a 0.25ml adult formula bivalent vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A toddler received as a first dose a 0.25ml adult formula bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 25-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (A toddler received as a first dose a 0.25ml adult formula bivalent vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A toddler received as a first dose a 0.25ml adult formula bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A toddler received as a first dose a 0.25ml adult formula bivalent vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A toddler received as a first dose a 0.25ml adult formula bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (A toddler received as a first dose a 0.25ml adult formula bivalent vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A toddler received as a first dose a 0.25ml adult formula bivalent vaccine).    No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Experiencing extreme pain from the vaccine site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Experiencing extreme pain from the vaccine site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Experiencing extreme pain from the vaccine site). At the time of the report, VACCINATION SITE PAIN (Experiencing extreme pain from the vaccine site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Patient was administered the moderna vaccine about 2 years ago.  Treatment information was not provided.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pain
Clinical narrative: Felt achy; felt blechy; Chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy), FEELING ABNORMAL (felt blechy), CHILLS (Chills) and FATIGUE (tired) in a 13-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Felt achy), FEELING ABNORMAL (felt blechy), CHILLS (Chills) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Felt achy), FEELING ABNORMAL (felt blechy), CHILLS (Chills) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.  It was reported that, the patient took Tylenol. The patient felt a little better next day but felt more achy thru out day. Event took place after use of the vaccine.
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: side effect; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (side effect) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (side effect). At the time of the report, IMMUNISATION REACTION (side effect) outcome was unknown.            No concomitant medications were reported. Patient had a side effect from the booster. No treatment medications were reported.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory syncytial virus infection
Clinical narrative: I got RSV; This spontaneous case was reported by a patient and describes the occurrence of RESPIRATORY SYNCYTIAL VIRUS INFECTION (I got RSV) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced RESPIRATORY SYNCYTIAL VIRUS INFECTION (I got RSV). At the time of the report, RESPIRATORY SYNCYTIAL VIRUS INFECTION (I got RSV) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Patient received booster dose in Oct-2022 and about 10 to 14 days later patient experienced with RSV. Patient son claims that RSV caused by booster dose. However, patient did not believe that booster dose caused for RSV. Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: uncontrollable shaking; chills; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (uncontrollable shaking) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 031L20A and 039K20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (uncontrollable shaking) and CHILLS (chills). At the time of the report, TREMOR (uncontrollable shaking) and CHILLS (chills) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that After each dose of the Covid vaccine patient was experienced an uncontrollable shaking and chills approximately 8-10 hrs after receiving the vaccine. This was resolved by the morning of the following day. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-676579 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-676579:Dose 4
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Headache, Insomnia, Myalgia, Pyrexia
Clinical narrative: could not sleep and could not get up from bed because of body aches; could not sleep and could not get up from bed because of body aches; A lot of body aches; A lot of headache; The night patient started feeling a little fever; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (could not sleep and could not get up from bed because of body aches), BEDRIDDEN (could not sleep and could not get up from bed because of body aches), MYALGIA (A lot of body aches), HEADACHE (A lot of headache) and PYREXIA (The night patient started feeling a little fever) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 620M72A) for COVID-19 vaccination.     The patient's past medical history included HbA1C increased (because of inactive insulin she was taking). Previously administered products included for Product used for unknown indication: flu vaccine (3 weeks ago). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Type 1 diabetes mellitus (8 or 9 years ago), Hypothyroidism (8 or 9 years ago) and Allergic reaction to analgesics. Concomitant products included LEVOTHYROXINE for Hypothyroidism, INSULIN DEGLUDEC (TRESIBA) and INSULIN GLULISINE (APIDRA SOLOSTAR) for Type 1 diabetes mellitus, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and IRON for an unknown indication.    On 20-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Nov-2022, the patient experienced INSOMNIA (could not sleep and could not get up from bed because of body aches), BEDRIDDEN (could not sleep and could not get up from bed because of body aches), MYALGIA (A lot of body aches), HEADACHE (A lot of headache) and PYREXIA (The night patient started feeling a little fever). At the time of the report, INSOMNIA (could not sleep and could not get up from bed because of body aches), BEDRIDDEN (could not sleep and could not get up from bed because of body aches) and HEADACHE (A lot of headache) had not resolved and MYALGIA (A lot of body aches) and PYREXIA (The night patient started feeling a little fever) was resolving.             Patient did not receive any treatment.   This case was linked to MOD-2022-675472, MOD-2022-679416 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm, Pituitary-dependent Cushing's syndrome
Clinical narrative: Cushing's disease; they found a tumor and took it out, but he's not better; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for COVID-19 immunization. The following information was reported: PITUITARY-DEPENDENT CUSHING'S SYNDROME (medically significant), outcome "unknown", described as "Cushing's disease"; NEOPLASM (medically significant), outcome "unknown", described as "they found a tumor and took it out, but he's not better". The events "cushing's disease" and "they found a tumor and took it out, but he's not better" required physician office visit. Therapeutic measures were taken as a result of neoplasm.  Additional information: It was reported that the reporter was calling in regards to the Covid-19 vaccine. The reporter had the vaccine in Feb2021 and the second one in Mar2021. Wound up with cushing's. Read that the vaccine could cause adrenal crisis. The reporter met the patient who got the vaccine around the same time, just a couple weeks apart, and they both have crushing's. The patient got Cushing's and so did the reporter. He looked worse than the reporter. His face was so swollen. The two of them both got Cushings and it was so rare, and they both got the vaccine around the same time. He went to the same Cushing's doctor as the reporter. They found a tumor and took it out, but he was not better. It was so weird that both the reporter and the patient would get Cushing's.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201317278 similar report from the same reporter;