chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling, Injection site warmth, Somnolence
Clinical narrative: Vx given subcutaneous instead of intramuscular; Sleepy; Redness at injection site; Swelling at injection site; Heat at injection site; This case was reported by a physician via call center representative and described the occurrence of sleepiness in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 18th October 2021, the patient received Menveo (subcutaneous). In October 2021, less than a week after receiving Menveo, the patient experienced sleepiness, injection site erythema, injection site swelling and injection site warmth. On 18th October 2021, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the sleepiness was recovered/resolved and the outcome of the injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the sleepiness, injection site erythema, injection site swelling and injection site warmth to be related to Menveo.  Additional details were provided as follows: The patient received dose of Menveo vaccine in the right arm. The reporter stated that, the medical assistant in the office inadvertently gave Menveo vaccine to the patient subcutaneously instead of intramuscular, which led to intramuscular formulation administered by other route.
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received HAB (Twinrix) (batch number unknown, expiry date 28th November 2020) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 20th October 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was inadvertently administered an expired dose of Twinrix, which led to expired vaccine used. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal cord insertion, Fatigue, Injection site pain, Maternal exposure during pregnancy, Ultrasound scan
Clinical narrative: MARGINAL CORD INSERTION; MATERNAL EXPOSURE DURING PREGNANCY; SORE ARM (SORE UPPER ARM AT INJECTION SITE); FATIGUE; This solicited pregnancy report received from a patient concerned a 34 year old white female. The patient was enrolled in a non-company sponsored study. The patient's weight was 76.19 kilograms, and height was not reported. The patient's concurrent conditions included: attention deficit hyperactivity disorder, body mass index increased, asthma, and non alcohol user, and other pre-existing medical conditions included: The study participant had no obstetrical history and no history of tobacco and recreational drug use. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 for covid-19 immunisation. Concomitant medications included cetirizine hydrochloride, famotidine, fluticasone propionate, iron, minerals nos/vitamins nos, and paracetamol.  On 06-APR-2021, the patient experienced maternal exposure during pregnancy, sore arm (sore upper arm at injection site) and fatigue.  On 21-JUL-2021, the patient experienced marginal cord insertion. Laboratory data included: Ultrasound scan (NR: not provided) Unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm (sore upper arm at injection site) on 08-APR-2021, and fatigue on 07-APR-2021, and the outcome of marginal cord insertion and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and marginal cord insertion, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and sore arm (sore upper arm at injection site), and fatigue was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211055909-COVID-19 VACCINE AD26.COV2.S-Marginal cord insertion. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. 20211055909-COVID-19 VACCINE AD26.COV2.S-Maternal exposure during pregnancy. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 25 PATIENTS GIVEN THE JANSSEN  COVID-19 VACCINE PAST THE  EXPIRATION DATE; This spontaneous report received from a health care professional concerned multiple patients. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced 25 subjects given the janssen covid-19 vaccine past the expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 25 patients given the janssen covid-19 vaccine past the expiration date was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Vaccination complication
Clinical narrative: After taking Moderna Booster shot the injection site is terribly  aching and throbbing in the muscle.  No relief.  I tried cold hot compresses exercises, message etc More specific information to relieve Covid Arm should be available to public .  This pain is horrible!    I am planning to go to my Doctor if this horrible pain continues. We need more information on side effects and how to treat them.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Lymphadenopathy, Sleep disorder
Clinical narrative: Mild daily headaches, swollen neck lymph nodes, and moderate chest pain mostly on the right side of the chest. Unable to sleep as the lymph nodes cause me to wake up and feel as though I am unable to breath. Have been hesitant to go in to doctor just because this should be keeping me out of the hospital.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Itching around waistline 30 minutes following vaccine which developed into a full, splotches red, itchy body rash by 2pm- neck, chest, backs and front of hands, abdomen, fronts and backs if thighs, forearms, face, chin, neck. No rash near vaccine site
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient called inquiring about booster dose of Pfizer vaccine and it was determined patient had been given Moderna Dose 1 and Dose 2  was given 21 days after first dose instead of 28 days.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Cerebrovascular accident, Magnetic resonance imaging head abnormal, Motor dysfunction
Clinical narrative: stroke ,  speech arm , weakness , unable to speak , grasp idem ,  urgent care , MRI confirmed , doctors appointments , primary Doctors , seeing neurology , Doctor   said no more vaccination  or boosters , what so ever , My mom is being followed up closely This stroke has made it so sad for her , and us .  She has had  covid 19 ammonia   and I did her daughter in May and by grace of god  we lived . Ninety days latter  my mom has vaccination and has stroke so sad . God bless all of you who have to  read sad news .  written by pts daughter ,
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: pain at site day after injection, itching day afterat site, unusual swelling day after at injection site
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Received both shots and has covid; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Received both shots and has covid) and DRUG INEFFECTIVE (lack of drug effect) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced COVID-19 (Received both shots and has covid) and DRUG INEFFECTIVE (lack of drug effect). On 30-Jul-2021, DRUG INEFFECTIVE (lack of drug effect) had resolved. At the time of the report, COVID-19 (Received both shots and has covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, COVID-19: positive (Positive) positive.         No treatment medication were reported This case concerns a 62-year-old male patient with no previous relevant medical history, who experienced the non serious unexpected event of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, Drug Ineffective was captured. The event occurred approximately 5 months and 24 days after the second dose of Spikevax. Clinical course included oropharyngeal pain and fatigue. The rechallenge is not applicable, since the only reported event if COVID-19. The benefit-risk relationship of Spikevax vaccine is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow-up received :Lab data added. Event outcome updated unknown.; Sender's Comments: This case concerns a 62-year-old male patient with no previous relevant medical history, who experienced the non serious unexpected event of COVID-19 after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). Additionally, Drug Ineffective was captured. The event occurred approximately 5 months and 24 days after the second dose of Spikevax. Clinical course included oropharyngeal pain and fatigue. The rechallenge is not applicable, since the only reported event if COVID-19. The benefit-risk relationship of Spikevax vaccine is not affected by this report
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Completed suicide
Clinical narrative: Nobody was listening to her.She couldn't take it anymore and she took her life; Woman that had the shot the moderna shot had the same symptoms that I had.; This spontaneous case was reported by a consumer and describes the occurrence of COMPLETED SUICIDE (Nobody was listening to her.She couldn't take it anymore and she took her life) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 COMPLETED SUICIDE (Nobody was listening to her.She couldn't take it anymore and she took her life) (seriousness criteria death and medically significant) and ADVERSE EVENT (Woman that had the shot the moderna shot had the same symptoms that I had.). The patient died on an unknown date. The reported cause of death was nobody was listening to her.she couldn't take it anymore and she took her life. It is unknown if an autopsy was performed. At the time of death, ADVERSE EVENT (Woman that had the shot the moderna shot had the same symptoms that I had.) outcome was unknown.            The caller stated that he was talking to his cousin and they had family friends that the woman that had the shot the Moderna shot had the same symptoms he had and nobody was listening to her. She couldn't take it anymore and she took her life.  No concomitant product use was provided by the reporter.    No treatment medications were reported.  Company Comment: This case concerns a female patient of an unknown age who with no reported medical history, who experienced unexpected event of completed suicide as a result of unknown adverse event stated as  nobody was listening to her, she couldn't take it anymore and she took her life. The event occurred following an unspecified period after an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as dosing order details was not disclosed.  Causality for the event with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age who with no reported medical history, who experienced unexpected event of completed suicide as a result of unknown adverse event stated as  nobody was listening to her, she couldn't take it anymore and she took her life.  The event occurred following an unspecified period after an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as dosing order details was not disclosed.  Causality for the event with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Reported Cause(s) of Death: Nobody was listening to her.She couldn't take it anymore and she took her life
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: I am pregnant and received my two doses of the Moderna covid vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and received my two doses of the Moderna covid vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and received my two doses of the Moderna covid vaccine). On 23-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (I am pregnant and received my two doses of the Moderna covid vaccine) had resolved. Not Provided          No concomitant medications were provided No treatment medications were provided  COMPANY COMMENT: This case concerns a 30-year-old, female patient with no medical history disclosed, who experienced vaccine exposure during pregnancy with no other adverse events. The patient received the first and second dose of Spikevax (Moderna COVID-19 vaccine) on unknown gestation period. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 30-year-old, female patient with no medical history disclosed, who experienced vaccine exposure during pregnancy with no other adverse events. The patient received the first and second dose of Spikevax (Moderna COVID-19 vaccine) on unknown gestation period. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Influenza like illness
Clinical narrative: One patient developed the regular mild flu-like symptoms; Patient received vaccine that may not have an extended expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date) and INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received and contains significant information - Event(Flu like symptoms )was updated
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to 6 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 6 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 6 patients). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 6 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that they had a Moderna vial expired on that day at 6 AM but they have it administered to 6 patients until 11 AM. The vaccine was removed from the freezer at 20-Oct-2021 at 6 AM, and was out for more than 24 hours. Lot no: 050C21A and expiration date: 06-Nov-2021.  No concomitant medications or treatment details were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Feeling abnormal, Influenza
Clinical narrative: Felt like hit by a truck; Extremely bad flu; Trouble getting out of bed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (Extremely bad flu) and BEDRIDDEN (Trouble getting out of bed) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer since 2009 and Lung cancer (Patient reported hardly having any lungs. Never had chemo/radiation) since 2012. Concomitant products included DENOSUMAB (PROLIA) and OMEPRAZOLE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (Extremely bad flu) and BEDRIDDEN (Trouble getting out of bed). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (Extremely bad flu) and BEDRIDDEN (Trouble getting out of bed) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-359508 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was used on 16 October for doses after expired date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was used on 16 October for doses after expired date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was used on 16 October for doses after expired date). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was used on 16 October for doses after expired date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Dose administered after 30-day Use By Date or after manufacturer date of expiry. The vial was initially stored in the refrigerator on 10 September 2021.The temperature range of the refrigerator was from 33-38 degrees Fahrenheit. As per pharmacist the vial didn't undergo any temperature excursions.   This case was linked to MOD-2021-359827, MOD-2021-359782 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Feeling abnormal, Influenza, Malaise
Clinical narrative: Felt really bad after the third one; adverse reaction; Felt like hit by a truck; extremely bad flu; trouble getting out of bed; 99.8 fever - running a low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt really bad after the third one), VACCINATION COMPLICATION (adverse reaction), FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (extremely bad flu) and BEDRIDDEN (trouble getting out of bed) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A., 029K20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung cancer (Patient reported she has hardly any lungs.Never had chemo, no radiation.) in 2009 and Lung cancer (Patient reported she has hardly any lungs. Never had chemo, no radiation.) in 2012. Concomitant products included DENOSUMAB (PROLIA) and OMEPRAZOLE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-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 MALAISE (Felt really bad after the third one), VACCINATION COMPLICATION (adverse reaction), FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (extremely bad flu), BEDRIDDEN (trouble getting out of bed) and PYREXIA (99.8 fever - running a low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Felt really bad after the third one), VACCINATION COMPLICATION (adverse reaction), FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (extremely bad flu), BEDRIDDEN (trouble getting out of bed) and PYREXIA (99.8 fever - running a low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 (High) 99.8 fever.         It was reported that patient did not take antibody test before third shot.  The adverse reaction that she had in her my mind was because  she had antibodies and it was fighting it.   This case was linked to MOD-2021-359456 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Felt really bad after the third one; adverse reaction; Felt like hit by a truck; extremely bad flu; trouble getting out of bed; 99.8 fever - running a low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt really bad after the third one), VACCINATION COMPLICATION (adverse reaction), FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (extremely bad flu) and BEDRIDDEN (trouble getting out of bed) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A., 029K20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung cancer (Patient reported she has hardly any lungs.Never had chemo, no radiation.) in 2009 and Lung cancer (Patient reported she has hardly any lungs. Never had chemo, no radiation.) in 2012. Concomitant products included DENOSUMAB (PROLIA) and OMEPRAZOLE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-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 MALAISE (Felt really bad after the third one), VACCINATION COMPLICATION (adverse reaction), FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (extremely bad flu), BEDRIDDEN (trouble getting out of bed) and PYREXIA (99.8 fever - running a low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Felt really bad after the third one), VACCINATION COMPLICATION (adverse reaction), FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (extremely bad flu), BEDRIDDEN (trouble getting out of bed) and PYREXIA (99.8 fever - running a low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 (High) 99.8 fever.         It was reported that patient did not take antibody test before third shot.  The adverse reaction that she had in her my mind was because  she had antibodies and it was fighting it.   This case was linked to MOD-2021-359456 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Feel weak due to chemotherapy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feel weak due to chemotherapy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Feel weak due to chemotherapy). At the time of the report, ASTHENIA (Feel weak due to chemotherapy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain in extremity
Clinical narrative: Arm hurt really bad; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt really bad) and ILLNESS (felt sick) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 061E21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizure, Hypertension and High cholesterol.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Arm hurt really bad) and ILLNESS (felt sick). In 2021, ILLNESS (felt sick) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitants and Treatment medication were reported.   This case was linked to MOD-2021-360000 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered  past the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-359738 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: shortness of breath/difficulty breathing; a fast heart rate; chest pain; chills; vomiting; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/difficulty breathing), HEART RATE INCREASED (a fast heart rate), CHEST PAIN (chest pain), CHILLS (chills) and VOMITING (vomiting) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath/difficulty breathing), HEART RATE INCREASED (a fast heart rate), CHEST PAIN (chest pain), CHILLS (chills), VOMITING (vomiting), FATIGUE (fatigue) and PYREXIA (fever). At the time of the report, DYSPNOEA (shortness of breath/difficulty breathing), HEART RATE INCREASED (a fast heart rate), CHEST PAIN (chest pain), CHILLS (chills), VOMITING (vomiting), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: abnormal (Inconclusive) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Cardiac related signs and symptoms: shortness of breath, difficulty breathing, chest pain, fast heart rate, fatigue  No concomitant drug was reported.  No Treatment drug was not reported.   This case was linked to MOD-2021-360066 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia, Vomiting
Clinical narrative: shortness of breath/difficulty breathing; a fast heart rate; chest pain; chills; vomiting; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/difficulty breathing), HEART RATE INCREASED (a fast heart rate), CHEST PAIN (chest pain), CHILLS (chills) and VOMITING (vomiting) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath/difficulty breathing), HEART RATE INCREASED (a fast heart rate), CHEST PAIN (chest pain), CHILLS (chills), VOMITING (vomiting), FATIGUE (fatigue) and PYREXIA (fever). At the time of the report, DYSPNOEA (shortness of breath/difficulty breathing), HEART RATE INCREASED (a fast heart rate), CHEST PAIN (chest pain), CHILLS (chills), VOMITING (vomiting), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: abnormal (Inconclusive) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Cardiac related signs and symptoms: shortness of breath, difficulty breathing, chest pain, fast heart rate, fatigue  No concomitant drug was reported.  No Treatment drug was not reported.   This case was linked to MOD-2021-360066 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: one full dose of the Moderna vaccine (0.5 ml)/received J&J's vaccine on 12MAR2021; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (one full dose of the Moderna vaccine (0.5 ml)/received J&J's vaccine on 12MAR2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: J&J on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J.    On 21-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 21-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (one full dose of the Moderna vaccine (0.5 ml)/received J&J's vaccine on 12MAR2021). On 21-Oct-2021, ACCIDENTAL OVERDOSE (one full dose of the Moderna vaccine (0.5 ml)/received J&J's vaccine on 12MAR2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received contains Non-significant information
Sex: U
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: Ended up in the hospital; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Ended up in the hospital) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Ended up in the hospital) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Ended up in the hospital) outcome was unknown.            The reporter stated she was not at liberty to provide information regarding her friend and stated her friend was receiving treatment.  No concomitant medications were reported   No treatment information was provided  Company Comment: This case concerns an unknown age female patient with no relevant medical history, who experienced the unexpected serious event of hospitalisation. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event occured after the second dose and no additional dosing will be given. The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This case concerns an unknown age female patient with no relevant medical history, who experienced the unexpected serious event of hospitalisation. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event occured after the second dose and no additional dosing will be given. The benefit-risk relationship of drug is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: My arm was achy; Tired for day, or so; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was achy) and FATIGUE (Tired for day, or so) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (My arm was achy) and FATIGUE (Tired for day, or so). At the time of the report, PAIN IN EXTREMITY (My arm was achy) and FATIGUE (Tired for day, or so) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-360547 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: sick; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) and PYREXIA (low grade fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Splenectomy (splenectomy) and Appendectomy (appendix taken out.). Concurrent medical conditions included Immune system disorder (weak immune system), Liver damage (liver disease), Hypertension (hypertension) and Diabetic (diabetic).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick) and PYREXIA (low grade fever). At the time of the report, ILLNESS (sick) and PYREXIA (low grade fever) had resolved.            Patient stated that Four weeks ago patient had a flu shot. He mentioned other ailments he had which make him at risk of severe COVID. It's been over 8 months and he was worried for his protection against COVID. He contacted hi local health department and all they have is Pfizer.  No concomitant medications were provided. Patient took sports drink for his adverse event.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site pain, Vaccination site swelling, Vertigo
Clinical narrative: It (arm) was also warm; Tenderness (at injection site); swelling at injection site; Pain (at injection site); Vertigo started to getting worse; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo started to getting worse), FEELING HOT (It (arm) was also warm), VACCINATION SITE PAIN (Tenderness (at injection site)), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PAIN (Pain (at the injection site)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 025A21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced VERTIGO (Vertigo started to getting worse). On an unknown date, the patient experienced FEELING HOT (It (arm) was also warm), VACCINATION SITE PAIN (Tenderness (at injection site)), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PAIN (Pain (at the injection site)). The patient was treated with MECLIZINE HCL ongoing since an unknown date for Vertigo, at a dose of 12.5 milligram three times a day. At the time of the report, VERTIGO (Vertigo started to getting worse) had not resolved and FEELING HOT (It (arm) was also warm), VACCINATION SITE PAIN (Tenderness (at injection site)), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE PAIN (Pain (at the injection site)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The caller also notes that about 4 months ago she did get a scooter to help her move around without falling.  No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-360746 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Hypertension, Vaccination site pain
Clinical narrative: Chest pressure; High blood pressure; Sore arm at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest pressure), HYPERTENSION (High blood pressure), VACCINATION SITE PAIN (Sore arm at the injection site) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced CHEST DISCOMFORT (Chest pressure), HYPERTENSION (High blood pressure), VACCINATION SITE PAIN (Sore arm at the injection site) and HEADACHE (Headache). At the time of the report, CHEST DISCOMFORT (Chest pressure), HYPERTENSION (High blood pressure), VACCINATION SITE PAIN (Sore arm at the injection site) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported. Patient not consulted cardiologist for the chest pain no lab work and cardiac tests have been done .
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Slight side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Slight side effects) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Due to underlying muscle disease.) and Muscle disorder NOS.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Slight side effects). At the time of the report, VACCINATION COMPLICATION (Slight side effects) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-361351, MOD-2021-361341 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) 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. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered). In October 2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.