chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Breast pain, Chills, Dizziness, Hyperhidrosis
Clinical narrative: Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous,  stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Nausea, Speech disorder
Clinical narrative: Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous,  stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Insomnia, Pyrexia
Clinical narrative: Headache,  low grade fever, chills, body aches and insomnia.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Measles
Clinical narrative: the consumer developed a "measles-like reaction" following MMR-11 administration; This spontaneous report was received from a nurse practitioner referring to a 12 months old male patient. There were none concomitant medication, pertinent medical history and drug reactions and allergies.   On 04-FEB-2021, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: rHA) (strength was not provided, lot# was T001211 and expiration date was 20-NOV-2021), 0.5 ml with sterile diluent (manufacturer unknown) (strength, lot# and expiration date was not provided) 0.5 (unit not provided) subcutaneously for immunization.    On the same day, the patient developed a measles-like reaction following measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administration. Medical attention was sought. Ibuprofen was given as treatment.   The outcome of the event was not recovered. The causality between the event and both therapies was not provided.  Upon internal review, the event of measles was determined to be medically significant.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, Product dose omission issue
Clinical narrative: Did not take the fourth dose of Vivotif; Took third dose of Vivotif on day 4; Spontaneous report received on 06JAN2020.  A pharmacist reported that a consumer "took third dose of Vivotif on day 4" (PT: Inappropriate schedule of product administration) and "did not take the fourth dose of Vivotif" (PT: Incomplete course of vaccination) while being on Vivotif for immunisation. The consumer took first, second and third dose of Vivotif on 23DEC2019, 25DEC2019 and 26DEC2019 respectively. It was reported that the consumer did not take the fourth dose. Action taken with Vivotif with respect to the reported events was not applicable. The outcome of the reported events was unknown.  Company Comment: A consumer took third dose of Vivotif on day 4" (Inappropriate schedule of product administration) and also did not take the fourth dose of Vivotif (Incomplete course of vaccination). Considering the nature of the events, the causality of both the events is not applicable to Vivotif.; Sender's Comments: A consumer took third dose of Vivotif on day 4" (Inappropriate schedule of product administration) and also did not take the fourth dose of Vivotif (Incomplete course of vaccination). Considering the nature of the events, the causality of both the events is not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took her last dose of Vivotif a day early; Spontaneous report received on 07JAN2020.  A female consumer "took her last dose of Vivotif a day early" (PT: Inappropriate schedule of product administration) after staring Vivotif course for immunization. It was reported that the consumer took her last dose of Vivotif a day early. Action taken with Vivotif with respect to event was not applicable. The clinical outcome of the reported event was unknown.  Company Comment: A consumer took her last dose of Vivotif a day early (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not applicable.; Sender's Comments: A consumer took her last dose of Vivotif a day early (Inappropriate schedule of product administration). Considering the nature of the event, the causality of the event is assessed as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose of Vivotif; Spontaneous report received on 07JAN2020.  A male consumer reported he had "missed second dose of Vivotif" (PT: Product dose omission). He was receiving Vivotif for immunisation. The consumer took his first dose of Vivotif on 04JAN2020 and then missed second dose of Vivotif. 48 hours had passed after his second dose was due at the time of the report. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed taking second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is not applicable to Vivotif.; Sender's Comments: A consumer missed taking second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is not applicable to Vivotif.
Sex: F
Vaccine: TYP, UNK
Symptoms: Labelled drug-drug interaction medication error
Clinical narrative: Took one dose of Vivotif while taking minocycline daily; Spontaneous report received on 07JAN2020.  A nurse reported that an adult female (age in between 20-30 years) consumer "took one dose of Vivotif while taking minocycline daily" (PT: Labelled drug-drug interaction medication error). He was receiving Vivotif for immunisation and minocycline for acne. The consumer took first dose of Vivotif on 06JAN2020. She was also taking minocycline daily before starting Vivotif for acne. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer who was taking minocycline daily for acne took one dose of Vivotif (Labelled drug-drug interaction medication error). Vaccination with Vivotif should be postponed during and for at least three days before and after antibiotic treatment. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer who was taking minocycline daily for acne took one dose of Vivotif (Labelled drug-drug interaction medication error). Vaccination with Vivotif should be postponed during and for at least three days before and after antibiotic treatment. Considering the nature of the event, the causality of Labelled drug-drug interaction medication error is assessed as not applicable to Vivotif
Age: 64.0
Sex: U
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed last dose of Vivotif; Spontaneous report received on 13JAN2020.  A pharmacist reported that a 64-year-old consumer "missed last dose of Vivotif" (PT: Product dose omission). The consumer was receiving Vivotif for immunisation. The consumer started Vivotif on 06JAN2020 and took three doses as per schedule but forgot to take the last dose, which was due on 12JAN2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer forgot to take the last dose and missed last dose of Vivotif (missed dose). The causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer forgot to take the last dose and missed last dose of Vivotif (missed dose). The causality of missed dose is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif two days in a row; Spontaneous report received on 13JAN2020.  A pharmacist reported that a consumer "took Vivotif two days in a row" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. The consumer took first and second dose of Vivotif on 12JAN2020 and 13JAN2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first dose of Vivotif and the very next day, took the second dose (Inappropriate schedule of product administration). Vivotif doses should be taken every alternate day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif and the very next day, took the second dose (Inappropriate schedule of product administration). Vivotif doses should be taken every alternate day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took unrefrigerated Vivotif; Spontaneous report received on 14JAN2020.  A pharmacist reported that a 50-year-old consumer who "took unrefrigerated Vivotif" (PT: Product storage error). The consumer was receiving Vivotif for immunisation. The consumer completed the course of unrefrigerated Vivotif. The pharmacist assumed that the consumer had started Vivotif approximately 8 days ago. She could not confirm the lot number of Vivotif and stated that the vaccine was likely left unrefrigerated since 17DEC2019. Moreover, she confirmed that the consumer took Vivotif every other day. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took unrefrigerated Vivotif (Incorrect product storage). Considering the nature of the event, the causality of incorrect product storage is assessed as not applicable to Vivotf.; Sender's Comments: A consumer took unrefrigerated Vivotif (Incorrect product storage). Considering the nature of the event, the causality of incorrect product storage is assessed as not applicable to Vivotf.
Age: 28.0
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif incorrectly / took Vivotif two days in a row; Spontaneous report received on 13JAN2020.  A female consumer reported that she "took Vivotif incorrectly / took Vivotif two days in a row" (PT: Inappropriate schedule of product administration). She was receiving Vivotif for immunization. It was reported that the consumer took Vivotif incorrectly. She took Vivotif two days in a row. She took first dose of Vivotif on 12JAN2020 at 08:00 am, and took second dose on 13JAN2020 at 07:30 am. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first and second doses of Vivotif two days in a row instead of taking them on alternate days (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first and second doses of Vivotif  two days in a row instead of taking them on alternate days (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Forgot to take Vivotif dose at night and took it the following morning; Spontaneous report received on 15JAN2020.  A nurse reported that a consumer "forgot to take Vivotif dose at night and took it the following morning" (PT: Inappropriate schedule of product administration). The consumer was receiving Vivotif for immunisation. It was reported that one year ago, the consumer took a dose of Vivotif a day late. The dose was scheduled for night but the consumer forgot to take Vivotif dose at night and took it the following morning. The consumer stated that less than 8 hours had past when the missed dose was administered. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer forgot to take Vivotif dose at night and took it the following morning (Inappropriate schedule of product administration). Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer forgot to take Vivotif dose at night and took it the following morning (Inappropriate schedule of product administration). Considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Urinary tract infection
Clinical narrative: Took two doses of Vivotif and then diagnosed with an infection (urinary tract infection); Spontaneous report received on 15JAN2020. Additional information received on 16JAN2020.  A nurse reported that an adult female consumer "took two doses of Vivotif and then diagnosed with an infection (urinary tract infection) (UTI)"(PT: Urinary tract infection). She was receiving Vivotif for immunisation. The consumer took two doses of Vivotif on an unknown date and then diagnosed with UTI on an unknown date. Action taken with Vivotif with respect to the reported event was unknown. The outcome of the reported event was unknown.  Treatment medication included an antibiotic for UTI, which was a "sulfa drug" but she could not confirm the drug. She did not know the start date of the antibiotic but it was reported that she was still taking antibiotic which would be completed on 20JAN2020.  Company Comment: A consumer was diagnosed with urinary tract infection (UTI) after she took two doses of Vivotif. In response to the event, consumer started taking antibiotic course on an unknown date. Information on consumer's medical history and action taken with Vivotif after diagnosed with UTI is limited. Considering the infectious pathogenesis of UTI, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer was diagnosed with urinary tract infection (UTI) after she took two doses of Vivotif. In response to the event, consumer started taking antibiotic course on an unknown date. Information on consumer's medical history and action taken with Vivotif after diagnosed with UTI is limited. Considering the infectious pathogenesis of UTI, the causality of the event is assessed as not related to Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Was not able to take his last dose of Vivotif; Spontaneous report received on 16JAN2020.  Based on the information obtained from the nurse, two individual case safety reports PVX2020-120 (wife) and PVX2020-121 (husband) were created and cross-linked in the database.  In this case, a male consumer "was not able to take his last dose of Vivotif" (PT: Product dose omission). He was receiving Vivotif capsule for immunisation. On 15JAN2020, the consumer's wife took her fourth dose of Vivotif and then took her husband's fourth dose mistakenly right after her last dose. Thus, he was not able to take his last dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer was not able to take his last Vivotif dose (missed dose) as his wife mistakenly took his Vivotif dose. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer was not able to take his last Vivotif dose (missed dose) as his wife mistakenly took his Vivotif dose. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Forgot to take the second dose; Spontaneous report received on 17JAN2020.  A pharmacist reported that a consumer "forgot to take the second dose" (PT: Product dose omission) while being on Vivotif capsule for immunisation. The consumer took first dose of Vivotif on 13JAN2020 and then forgot to take the second dose, which was due on 15JAN2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer forgot to take second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer forgot to take second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took first dose of Vivotif and on the very next day took a second dose; Spontaneous report received on 20JAN2020.  A nurse reported that a female consumer "took first dose of Vivotif and on the very next day took a second dose" (PT: Inappropriate schedule of product administration). The consumer was taking Vivotif for immunisation. The consumer took first dose of Vivotif on an unknown date and on the very next day, she took a second dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first dose of Vivotif and on the very next day took a second dose (Inappropriate schedule of vaccine administered). Vivotif doses should be taken every alternate day, and the causality of the event is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif and on the very next day took a second dose (Inappropriate schedule of vaccine administered). Vivotif doses should be taken every alternate day, and the causality of the event is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose of Vivotif and did not take any other doses since then; Spontaneous report received on 21JAN2020.  A nurse reported that a female consumer "missed second dose of Vivotif and did not take any other doses since then" (PT: Product dose omission). She was receiving Vivotif for immunisation. The consumer took first dose of Vivotif on 14JAN2020 at 10:00 pm and had not taken any other dose since then. The nurse reported that she would initiate the process for the consumer to restart the regimen of Vivotif but, she did not specify dates. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed second dose of Vivotif and did not take any other doses since then (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer missed second dose of Vivotif and did not take any other doses since then (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Consumer took Vivotif on days 1, 4, 6, and 8; Spontaneous report received on 22JAN2020.  A pharmacist reported that a consumer (unknown age and gender) who "took the Vivotif on days 1, 4, 6, and 8" (PT: Inappropriate schedule of product administration) for immunization. The action taken with Vivotif with respect to reported event was not applicable. The clinical outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif doses on days 1,4,6, and 8 (Inappropriate schedule of product administration) instead of taking it on alternate days. The causality of the event is assessed as not applicable with Vivotif.; Sender's Comments: A consumer took Vivotif doses on days 1,4,6, and 8 (Inappropriate schedule of product administration) instead of taking it on alternate days. The causality of the event is assessed as not applicable with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Ill-defined disorder
Clinical narrative: She had fallen ill; Spontaneous report received on 22JAN2020.  A female consumer reported that "she had fallen ill" (PT: Ill-defined disorder), while being on Vivotif capsule for immunization. The consumer took only first dose of Vivotif a week and a day ago. She believes that she had fallen ill due to being close to other family members who were sick during that time. It was reported that she did not complete her Vivotif course. Action taken with Vivotif with respect to reported event was vaccine withdrawn. The outcome of the reported event was unknown.  Company Comment: A consumer had fallen ill (Ill-defined disorder) after taking first dose of vivotif. The consumer was being around her family members who were sick during the time when she took the first dose of Vivotif and the consumer might have fallen ill as well. The consumer stopped taking further doses of Vivotif. Information on the type of family member's sickness and signs and symptoms of consumer's illness is limited. Considering the case information, the causality of ill-defined disorder is assessed as unlikely with Vivotif.; Sender's Comments: A consumer had fallen ill (Ill-defined disorder) after taking first dose of vivotif. The consumer was being around her family members who were sick during the time when she took the first dose of Vivotif and the consumer might have fallen ill as well. The consumer stopped taking further doses of Vivotif. Information on the type of family member's sickness and signs and symptoms of consumer's illness is limited. Considering the case information, the causality of ill-defined disorder is assessed as unlikely with Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose of Vivotif; Spontaneous report received on 23JAN2020.  A pharmacist reported that a consumer (unknown age and gender) who "missed second dose of Vivotif" (PT: Product dose omission), while being on Vivotif for immunization. The consumer missed the second dose of Vivotif, which was due on 22JAN2020. Action taken with Vivotif with respect to reported event was not applicable. At the time of report, the outcome of the reported event was unknown.  Company Comment: A consumer missed second dose of Vivotif. Considering the nature of the event, the causality of missed dose is assessed as not applicable with Vivotif.; Sender's Comments: A consumer missed second dose of Vivotif. Considering the nature of the event, the causality of missed dose is assessed as not applicable with Vivotif.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Tired; Received another dose of the Moderna COVID-19 vaccine the next day; Sore arm; A spontaneous report was received from a consumer, concerning herself, a 76-year-old female patient, who accidently received first dose of Moderna's COVID-19 vaccine and experienced sore arm, received another dose of the Moderna COVID-19 vaccine the next day and was tired.  The patient's medical history included sleep deprivation, short term memory loss, hyperparathyroidism, plaque in the artery, heart burn, ocular hypertension, irregular heartbeat, osteopenia, hypertension, cardiac arrhythmia, mitral valve prolapsed, aortic valve prolapsed, DVT, diverticulosis, IBS, rosacea, dry eye, osteoarthritis. Products known to have been used by the patient, within two weeks prior to the event, included Amlodipine, red yeast rice, ezetimibe, latanoprost, propranolol, Irbesartan, Flonase, N-Acetyl-L-Cysteine (NAC), heartburn essential and several supplements.  The patient received their first of two planned doses of mRNA-1273 (Lot number:007M20A) intramuscularly in the left arm on 03 Feb 2021. On 04 Feb 2021 approximately 1 day prior to the onset of the events, patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient received first dose of mRNA-1273 vaccine on 03 Feb 2021 and was accidently administered second dose of mRNA-1273 vaccine on 04 Feb 2021 from the same facility. Patient called poison center and was told the side effects may be intensified other than that patient should be fine. Patient stated of reading all the side effects and only thing she had was sore arm. Patient was tired because she only got 4.5 hours sleep on 04 Feb 2021 night. She was scared by the event. No treatment information was provided. Consent to follow up was given by her.  Action taken with mRNA-1273 in response to the event sore arm was no change.  Action taken with mRNA-1273 in response to the events received another dose of the Moderna COVID-19 vaccine the next day and tired were not applicable.  The event received another dose of the Moderna COVID-19 vaccine the next day was considered resolved on 04-Feb-2021. The outcome of events, sore arm and tired were considered unknown at the time of this report.; Reporter's Comments: This case concerns a 76-year-old female patient who received their first and second of two planned doses of mRNA-1273 (Lot: 007M20A), reporting Inappropriate schedule of product administration and associated adverse events of vaccination site pain and fatigue. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: took both of my Moderna shots 14 days apart; A spontaneous report was received from a consumer concerning a 90-year-old, male patient who experienced took both of my Moderna shots 14 days apart.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On unknown date, approximately fourteen days prior to the first dose, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    On unknown date, the patient reported he took both Moderna shots 14 days apart and he never had any reaction. Treatment information was not provided.    The action taken with the drug in response to the event is not applicable.  The outcome of the event took both of my Moderna shots 14 days apart was unknown.; Reporter's Comments: The reporter refers to a case of inappropriate schedule of product administration for mRNA-1273 vaccine, batch number not provided, with no associated AEs. Causality of this event is not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Muscular weakness, Pain, Peripheral swelling
Clinical narrative: Lost strength in his limbs, could not walk; Could not walk on his own; Arms and legs got swollen; Pain escalated; A spontaneous report was received from patient's daughter regarding her father who is a 92-year-old, male who experienced lost strength in his limbs and escalated pain to his chest, legs, shoulder, ankles, and hips/ MedDRA PT: [ Lost Strength in Limbs]  The patient medical history included Hypertonic and Diabetes. Products known to have been used by the patient, within two weeks prior to the event, included Cephalexin 500 mg for skin infection.    On 01 FEB 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID- 19 infection.  Patient was hospitalized for two days at the Falmouth Hospital where he underwent a battery of test for Muscular Weakness, could not walk on his own, Arms and legs got swollen, escalated pain to his chest, legs, shoulder, ankles, and hips, not relieved with stronger pain relievers. Daughter stated that her father is getting better but very slowly.  Treatment information was not provided/ unknown.  Action taken with mRNA-1273 in response to the event was recovering.   The Outcome of the events was not reported/unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Incorrect dose administered
Clinical narrative: Caused some vaccine to end up on the patient's arm and an incorrectly administered dose; Caused some vaccine to end up on the patient's arm and an incorrectly administered dose; When vaccine was being administered, the needle disconnected from the syringe; A spontaneous report was received from a healthcare professional concerning a 43-year-old female, White, patient that received Moderna's COVID-19 vaccine (mRNA-1273) and when the vaccine was being administered, the needle disconnected from the syringe/device connection issue. This caused some vaccine to end up on the patient's arm and an incorrectly administered dose/incomplete dose administered/exposure via skin contact.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29 Jan 2021, the patient received their second dose of mRNA-1273 (Lot number: 029L20A) intramuscularly in left deltoid for prophylaxis of COVID-19 infection.  On 29 Jan 2021, when the vaccine was being administered, the needle disconnected from the syringe. This caused some vaccine to end up on the patient's arm and an incorrectly administered dose.   Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the events is not applicable.   The outcome for the events was considered resolved on 29 Jan 2021.; Reporter's Comments: This report refers to a case of Product administration error (Incorrect dose administered, Exposure via skin contact , Device connection issue) for mRNA-1273, lot # 029L20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Chills, Dizziness, Loss of consciousness, Nausea
Clinical narrative: Passed out; Blood pressure dropped; Neck ache; Body ache; Dizziness; Nausea; Vomiting; Severe chills; Injection site swelling; A spontaneous report was received from a consumer, concerning a 86-year-old, female patient, who received Moderna's COVID-19 vaccine and experienced passed out, blood pressure dropped, neck, body ache, dizziness, nausea, vomiting, severe chills and injection site swelling.  The patient's medical history was not provided. Concomitant product use was not provided.  On 05 Feb 2021 at 10:00 am, prior to the onset of the events, patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Feb 2021, initially patient had injection site swelling. Then 22 hours later on 06 Feb 2021, she passed out, her blood pressure dropped, had nausea, vomiting, severe chills, neck and body ache, and dizziness. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events, passed out, blood pressure dropped, neck, body ache, dizziness, nausea, vomiting, severe chills and injection site swelling were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Vaccination site swelling, Vomiting
Clinical narrative: Passed out; Blood pressure dropped; Neck ache; Body ache; Dizziness; Nausea; Vomiting; Severe chills; Injection site swelling; A spontaneous report was received from a consumer, concerning a 86-year-old, female patient, who received Moderna's COVID-19 vaccine and experienced passed out, blood pressure dropped, neck, body ache, dizziness, nausea, vomiting, severe chills and injection site swelling.  The patient's medical history was not provided. Concomitant product use was not provided.  On 05 Feb 2021 at 10:00 am, prior to the onset of the events, patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Feb 2021, initially patient had injection site swelling. Then 22 hours later on 06 Feb 2021, she passed out, her blood pressure dropped, had nausea, vomiting, severe chills, neck and body ache, and dizziness. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the events, passed out, blood pressure dropped, neck, body ache, dizziness, nausea, vomiting, severe chills and injection site swelling were unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fall, Flushing, Loss of consciousness, Vaccination site pain
Clinical narrative: Passed out; Felt like two sticks in her stomach; Feeling of a warm flush; Fell on head; Sore arm; A spontaneous report was received from a consumer concerning a 68-years-old, female patient who experienced feeling of a warm flush, sore arm, felt like two sticks in her stomach, passed out and fell on head.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 15 Jan 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 01ZC207] intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient felt like two sticks were in her stomach and then a feeling of a warm flush going through her body. She also had a sore arm. Patient felt like she was going to pass out and did pass out and fell on her head. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The events feeling of a warm flush, sore arm, felt like two sticks in her stomach, passed out and fell on head were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Death, Internal haemorrhage
Clinical narrative: Died; Internal bleeding and died; A spontaneous report was received from a nurse concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced internal bleeding and died.  The patient's medical history was not provided. No concomitant product use was reported.  On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, a nurse reported she read about a doctor who received the COVID-19 vaccine and died 3 days later. She stated she read that the doctor had internal bleeding. It started with bleeding in his hands and feet, then went to his brain and died 3 days later.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, internal bleeding and died, was considered fatal.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Reported Cause(s) of Death: Internal bleeding
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Influenza like illness, Pain in extremity, Pyrexia, Rash pruritic
Clinical narrative: Sore arm; Itchy rash on back; Swelling; Red blotches all over her arm; Fever; Worsening rheumatoid arthritis; Worsening fibromyalgia; Flu like symptoms; A spontaneous report (United States) was received from a consumer concerning herself, a 74-year-old, female patient who Moderna's COVID-19 Vaccine (mRNA-1273) and experienced worsening fibromyalgia, worsening rheumatoid arthritis, flu-like symptoms, sore arm, itchy rash on back, fever, swelling and red blotches all over her arm.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A). On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.    On 06 Jan 2021, after the first shot of vaccine, the patient experienced worsening fibromyalgia, worsening rheumatoid arthritis like her fingers were hurting so bad that she felt like they were going to fall off and flu like symptoms with fever. On 05 Feb 2021, after the second shot, patient experienced sore arm, swelling, red blotches all over her arm and itchy rash on her back. Treatment for event included acetaminophen and diphenhydramine which didn't seems to help events at all.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, worsening fibromyalgia, worsening rheumatoid arthritis, flu-like symptoms, sore arm, itchy rash on back, fever, swelling and red blotches all over her arm were considered unknown at the time of this report.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the onset of the reported events, and the known safety profile of mRNA-1273 a causal relationship cannot be excluded
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Vaccination site rash, Vaccination site swelling
Clinical narrative: Sore arm; Itchy rash on back; Swelling; Red blotches all over her arm; Fever; Worsening rheumatoid arthritis; Worsening fibromyalgia; Flu like symptoms; A spontaneous report (United States) was received from a consumer concerning herself, a 74-year-old, female patient who Moderna's COVID-19 Vaccine (mRNA-1273) and experienced worsening fibromyalgia, worsening rheumatoid arthritis, flu-like symptoms, sore arm, itchy rash on back, fever, swelling and red blotches all over her arm.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A). On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number:031L20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.    On 06 Jan 2021, after the first shot of vaccine, the patient experienced worsening fibromyalgia, worsening rheumatoid arthritis like her fingers were hurting so bad that she felt like they were going to fall off and flu like symptoms with fever. On 05 Feb 2021, after the second shot, patient experienced sore arm, swelling, red blotches all over her arm and itchy rash on her back. Treatment for event included acetaminophen and diphenhydramine which didn't seems to help events at all.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events, worsening fibromyalgia, worsening rheumatoid arthritis, flu-like symptoms, sore arm, itchy rash on back, fever, swelling and red blotches all over her arm were considered unknown at the time of this report.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the onset of the reported events, and the known safety profile of mRNA-1273 a causal relationship cannot be excluded
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Chills, Chromaturia, Disorientation, Headache
Clinical narrative: Finally urinated and it was dark in color; Induration of erythema about 3 inches; Acute renal failure; Felt so dry and realized I did not urinate; Disoriented; Sustained tachycardia for about 26 hours straight; Couldn't lay on left side; Induration of erythema about 3 inches; chills/rigors; Chills and sweats, back and forth; Severe tremor, rigors/Chills; Temperature was 104.1/ Fever persisted; Significant headache/Worst headache of her life; Body aches; Nausea; Vomiting; A spontaneous report was received from a consumer who is a physician's assistant) concerning 46 year old female patient.  Medical history included cystic fibrosis.  No relevant concomitant medication was reported.  On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown)  for prophylaxis of COVID-19 infection. On 04Feb2021, the patient received the second dose of mRNA-1273 (lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05Feb2021, the patient experienced severe tremor, rigors, temperature of 104.1, significant headache (described as worst headache in her life), persistent fever, body aches, nausea vomiting, chills and sweats back and forth.  The patient was in bad all day 04Feb2021 (Thursday) through Saturday until 2pm.  She felt dry and did not urinate, until after a bag of unspecified intravenous fluids, when she finally urinated in was dark in color (the patient considered herself to have acute renal failure). The patient also experienced sustained tachycardia for 26 hours, was disoriented, had induration of erythema about three inches at the vaccination site, and could not lay on her left side.  The patient treated herself with ibuprofen and Tylenol for fever and body aches.  The patient reported she was fine on 08Feb2021.   Action taken with the mRNA-1273 in response to the events was not reported.  The outcome of the events of acute kidney injury, urinary retention, tremor, pyrexia, headache, pain, nausea, vomiting, hyperhidrosis, chromaturia, tachycardia, disorientation, vaccination site induration, vaccination site erythema, hypokinesia, and chills was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events , a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypokinesia, Nausea, Pain, Pyrexia
Clinical narrative: Finally urinated and it was dark in color; Induration of erythema about 3 inches; Acute renal failure; Felt so dry and realized I did not urinate; Disoriented; Sustained tachycardia for about 26 hours straight; Couldn't lay on left side; Induration of erythema about 3 inches; chills/rigors; Chills and sweats, back and forth; Severe tremor, rigors/Chills; Temperature was 104.1/ Fever persisted; Significant headache/Worst headache of her life; Body aches; Nausea; Vomiting; A spontaneous report was received from a consumer who is a physician's assistant) concerning 46 year old female patient.  Medical history included cystic fibrosis.  No relevant concomitant medication was reported.  On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown)  for prophylaxis of COVID-19 infection. On 04Feb2021, the patient received the second dose of mRNA-1273 (lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05Feb2021, the patient experienced severe tremor, rigors, temperature of 104.1, significant headache (described as worst headache in her life), persistent fever, body aches, nausea vomiting, chills and sweats back and forth.  The patient was in bad all day 04Feb2021 (Thursday) through Saturday until 2pm.  She felt dry and did not urinate, until after a bag of unspecified intravenous fluids, when she finally urinated in was dark in color (the patient considered herself to have acute renal failure). The patient also experienced sustained tachycardia for 26 hours, was disoriented, had induration of erythema about three inches at the vaccination site, and could not lay on her left side.  The patient treated herself with ibuprofen and Tylenol for fever and body aches.  The patient reported she was fine on 08Feb2021.   Action taken with the mRNA-1273 in response to the events was not reported.  The outcome of the events of acute kidney injury, urinary retention, tremor, pyrexia, headache, pain, nausea, vomiting, hyperhidrosis, chromaturia, tachycardia, disorientation, vaccination site induration, vaccination site erythema, hypokinesia, and chills was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events , a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Tremor, Urinary retention, Vaccination site erythema, Vaccination site induration
Clinical narrative: Finally urinated and it was dark in color; Induration of erythema about 3 inches; Acute renal failure; Felt so dry and realized I did not urinate; Disoriented; Sustained tachycardia for about 26 hours straight; Couldn't lay on left side; Induration of erythema about 3 inches; chills/rigors; Chills and sweats, back and forth; Severe tremor, rigors/Chills; Temperature was 104.1/ Fever persisted; Significant headache/Worst headache of her life; Body aches; Nausea; Vomiting; A spontaneous report was received from a consumer who is a physician's assistant) concerning 46 year old female patient.  Medical history included cystic fibrosis.  No relevant concomitant medication was reported.  On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown)  for prophylaxis of COVID-19 infection. On 04Feb2021, the patient received the second dose of mRNA-1273 (lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05Feb2021, the patient experienced severe tremor, rigors, temperature of 104.1, significant headache (described as worst headache in her life), persistent fever, body aches, nausea vomiting, chills and sweats back and forth.  The patient was in bad all day 04Feb2021 (Thursday) through Saturday until 2pm.  She felt dry and did not urinate, until after a bag of unspecified intravenous fluids, when she finally urinated in was dark in color (the patient considered herself to have acute renal failure). The patient also experienced sustained tachycardia for 26 hours, was disoriented, had induration of erythema about three inches at the vaccination site, and could not lay on her left side.  The patient treated herself with ibuprofen and Tylenol for fever and body aches.  The patient reported she was fine on 08Feb2021.   Action taken with the mRNA-1273 in response to the events was not reported.  The outcome of the events of acute kidney injury, urinary retention, tremor, pyrexia, headache, pain, nausea, vomiting, hyperhidrosis, chromaturia, tachycardia, disorientation, vaccination site induration, vaccination site erythema, hypokinesia, and chills was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events , a causal relationship cannot be excluded.