chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MEN
Symptoms: Chills, Diarrhoea, Dysstasia, Fatigue, Pain
Clinical narrative: Could barely stand up; so tired; Had chills; Her whole body hurt for days; Diraheaa; This case was reported by a consumer via interactive digital media and described the occurrence of difficulty in standing in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced difficulty in standing, tiredness, chills, generalized aching and diarrhea. On an unknown date, the outcome of the difficulty in standing, tiredness, chills, generalized aching and diarrhea were unknown.   It was unknown if the reporter considered the difficulty in standing, tiredness, chills, generalized aching and diarrhea to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient could barely stand up and was so tired, chills and her whole body hurt for days after taking this shot.  No further information was provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Loss of personal independence in daily activities, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever; Myalgia; Not feeling very sick/sick; Needed someone to help her to the commode and take care of her; sick; . This case was reported by a physician and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number JC55P, expiry date unknown) for prophylaxis.   On 18th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever, myalgia, feeling unwell, walking difficulty and sickness. On an unknown date, the outcome of the fever, myalgia, feeling unwell, walking difficulty and sickness were recovered/resolved.   It was unknown if the reporter considered the fever, myalgia, feeling unwell, walking difficulty and sickness to be related to Shingrix.  Additional details were reported as follows: The reported batch number GC55P for Shingrix did not exist and was updated to JC55P as per the sales database. The the patient did not had immediate reactions but later told the doctor that she had experienced fever, myalgia and not feeling very sick for 3 days after the vaccine was administered.  She was so sick that she needed someone to help her to the commode and take care of her. Consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Felt tired; This case was reported by a consumer and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (years before reporting). Previously administered products included Zostavax (negative history for immunization with Zostavax (she never got the live shingles vaccine)).   In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   The reporter considered the tiredness to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient stated that she didn't feel much with the first shot. She said she felt tired but it resolved within 24 hours.  The reporter did not want to answer any further questions. For tolerance of 2nd dose, refer case US2020AMR249357.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR249357:Same reporter
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Middle insomnia, Sleep disorder
Clinical narrative: sometimes wakes her up at night; Localized Muscle Pain at her injection site; This case was reported by a other health professional and described the occurrence of injection site muscle pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 5DK5E, expiry date 31st March 2022) for prophylaxis.   On 23rd September 2020, the patient received Shingrix (intramuscular). On 23rd September 2020, less than a day after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the patient experienced middle insomnia. On an unknown date, the outcome of the injection site muscle pain and middle insomnia were unknown.   It was unknown if the reporter considered the injection site muscle pain and middle insomnia to be related to Shingrix.  Additional details were reported as follows: The patient received dose of Shingrix and experienced localized muscle pain at her injection site. The patient felt pain when she does a pushup and it sometimes wakes up at night. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Immediate post-injection reaction, Mobility decreased, Pain, Pain in extremity
Clinical narrative: right arm weakness; right arm pain /  increased pain with swimming / arm pain escalated to sharp shooting pain; arm pain and weakness has left her unable to swim; This case was reported by a nurse via call center representative and described the occurrence of weakness of arms in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB09AZ, expiry date 31st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th December 2020, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 15th December 2020, immediately after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm and activities of daily living impaired. On 16th December 2020, the patient experienced weakness of arms. The patient was treated with ibuprofen. On an unknown date, the outcome of the weakness of arms, pain in arm and activities of daily living impaired were not recovered/not resolved.   It was unknown if the reporter considered the weakness of arms, pain in arm and activities of daily living impaired to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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 received her first dose of Bexsero in the right deltoid. Immediately following the injection the patient complained of right arm pain. On 16th December 2020, the patient began to experience right arm weakness.  The patient was a competive swimmer and the arm pain and weakness had left her unable to swim due to the increased pain with swimming. The right arm pain escalated to sharp shooting pain.  The patient self treated with ice, rest and ibuprofen.  The reporter consented to follow up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administered a vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 36-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered a vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered a vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of medication error for mRNA-1273 (Lot: 025J20-2A), where refrozen vaccine was administered. There were no reported AEs associated with this case of out of specification product use.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysphagia, Erythema, Face oedema, Fatigue
Clinical narrative: face was still red; swollen; feeling weak; Tired; Severe allergic reaction; Difficulty swallowing; A spontaneous report was received from a healthcare professional concerning herself, a 28 year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a severe allergic reaction,  difficulty swallowing, face was still red, swollen, felt  week and tired.  The patient's medical history included anxiety and allergy to latex. Concomitant product use was not provided by the reporter.   On 12-Jan-2021, 15 minutes prior to the onset of the symptoms, the patient received one of two planned doses of mRNA-1273 (026L20A) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   12-Jan-2021, after receiving the vaccine, the patient experienced a severe allergic reaction which made her face puffy, red, and covered with hives.  She took 50 mg of diphenhydramine.  She was also having trouble pronouncing words because her tongue was swelling and she couldn't swallow water, so she used epinephrine  and go to the emergency room.  On 14 Jan 2021 she felt weak and tired.   On 13 Jan 2021follow up information was received and per source document/call -  In addition one day later, on 13Jan2021 around 5:30 pm, patient reported that she went to the bathroom and noticed that her "face was still red" and "swollen" and had a "little bit of difficulty swallowing" and took another unknown dose of Benadryl and felt better.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events,severe allergic reaction, difficulty swallowing, face was still red, swollen and felt weak and tired was not reported.; Reporter's Comments: This case concerns a 28 year old female with medical history of anxiety and allergy to latex who experienced serious medically significant unlisted event of severe allergic reaction described as her face puffy, red, covered with hives, tongue swelling and difficulty swallowing within 15 minutes after the first dose of the study medication administration (LOT:026L20A). Patient also experienced additional reported events of non-serious listed events of "face was still red" and "feeling tired" and non-serious unlisted events of "face swollen", had a "little bit of difficulty swallowing", and "feeling weak". Patient was treated for the severe allergic reaction with initially Benadryl 50 mg and then with epinephrine pen and was sent to ER. Based on the temporal association between the use of the product and the start date of the events within 15 minutes of receiving the vaccine, a causal relationship cannot be excluded and the event of severe allergic reaction is possibly related to vaccine. Additional reported events of non-serious listed events of "face was still red" and "feeling tired" and non-serious unlisted events of "face swollen", had a "little bit of difficulty swallowing" and "feeling weak" are possibly related to vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: face was still red; swollen; feeling weak; Tired; Severe allergic reaction; Difficulty swallowing; A spontaneous report was received from a healthcare professional concerning herself, a 28 year old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a severe allergic reaction,  difficulty swallowing, face was still red, swollen, felt  week and tired.  The patient's medical history included anxiety and allergy to latex. Concomitant product use was not provided by the reporter.   On 12-Jan-2021, 15 minutes prior to the onset of the symptoms, the patient received one of two planned doses of mRNA-1273 (026L20A) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   12-Jan-2021, after receiving the vaccine, the patient experienced a severe allergic reaction which made her face puffy, red, and covered with hives.  She took 50 mg of diphenhydramine.  She was also having trouble pronouncing words because her tongue was swelling and she couldn't swallow water, so she used epinephrine  and go to the emergency room.  On 14 Jan 2021 she felt weak and tired.   On 13 Jan 2021follow up information was received and per source document/call -  In addition one day later, on 13Jan2021 around 5:30 pm, patient reported that she went to the bathroom and noticed that her "face was still red" and "swollen" and had a "little bit of difficulty swallowing" and took another unknown dose of Benadryl and felt better.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events,severe allergic reaction, difficulty swallowing, face was still red, swollen and felt weak and tired was not reported.; Reporter's Comments: This case concerns a 28 year old female with medical history of anxiety and allergy to latex who experienced serious medically significant unlisted event of severe allergic reaction described as her face puffy, red, covered with hives, tongue swelling and difficulty swallowing within 15 minutes after the first dose of the study medication administration (LOT:026L20A). Patient also experienced additional reported events of non-serious listed events of "face was still red" and "feeling tired" and non-serious unlisted events of "face swollen", had a "little bit of difficulty swallowing", and "feeling weak". Patient was treated for the severe allergic reaction with initially Benadryl 50 mg and then with epinephrine pen and was sent to ER. Based on the temporal association between the use of the product and the start date of the events within 15 minutes of receiving the vaccine, a causal relationship cannot be excluded and the event of severe allergic reaction is possibly related to vaccine. Additional reported events of non-serious listed events of "face was still red" and "feeling tired" and non-serious unlisted events of "face swollen", had a "little bit of difficulty swallowing" and "feeling weak" are possibly related to vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Incomplete dose; Something happened with the syringe; A spontaneous report was received from a healthcare facility staff member concerning an unspecified patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incomplete dose and something happened with the syringe.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient was administered an incomplete dose of vaccine due to something happening with the syringe. No additional details were provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, incomplete dose and something happened with the syringe, were considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of a patient who experienced non-serious events of incomplete dose, something happened with the syringe (Incomplete dose administered, Syringe issue) for mRNA-1273, lot # unknown), Exp date-unknown. There were no reported AEs associated with the events of incomplete dose, something happened with the syringe.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Accidentally given 1 mL instead of the 0.5mL dose; A spontaneous report was received from a physician concerning themselves, a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced receiving double the normal dose (1 mL instead of 0.5 mL) [Accidental overdose].    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29-Dec-2020,  the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in an unknown injection site for prophylaxis of COVID-19 infection.   The patient was reported to be one of four individuals who were accidentally given 1 mL of the vaccine instead of the recommended 0.5 mL dose. The patient did not experience any adverse effects.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was considered resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who accidentally received double the normal dose of mRNA-1273 vaccine during administration of their first dose.; Sender's Comments:  :Master case - linked case numbers pending
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Not sure how much dose the patient got; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was not sure how much of the dose the patient got (Incorrect dose administered).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 13 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (LOT 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, a healthcare professional was unsure of exactly how much of the vaccine the patient received as the luer-lock came off of the syringe during administration.  The reporter wanted to know what the next step was in order to make sure the patient was protected.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.    The event, not sure how much dose the patient got, was considered resolved on 13 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced a non-serious unexpected event of Incorrect dose administered during their first injection of mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: nurse administered it, it leaked down her arm; A spontaneous report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced nurse administered it, it leaked down her arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 12-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The reporter stated that the nurse had issues withdrawing the medication from the vial. She also stated that when the nurse administered the vaccine, it leaked down her arm. After that she was made to wait two hours while it was determined whether or not she could receive the second dose of vaccine.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.    The event, nurse administered it, it leaked down her arm, was considered resolved.   The reporter did not provide a causality assessment of the event nurse administered it, it leaked down her arm.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Some of the product leaked from where the needle was attached to the syringe; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the product leaked from where the needle was attached to the syringe, patient did not receive full dose.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on (date of vaccination not provided) for prophylaxis of COVID-19 infection.   A nurse called to report a vaccinator was pulling a dose to give to this patient and noticed some of the product leaked from where the needle was attached to the syringe. The nurse reported, patient did not receive a full dose.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, some of the product leaked from where the needle was attached to the syringe, patient did not receive full dose, was considered resolved.  The reporter did not provide an assessment of the events, some of the product leaked from where the needle was attached to the syringe, patient did not receive full dose.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Vaccine was given cloudy, the vial was still frozen or not thawed properly; A spontaneous report was received from a consumer concerning a 58-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that the vaccine given was cloudy, still frozen and not properly thawed at the time of the administration.  The patient's medical history was not provided. Concomitant medications were not reported.  On 13 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 13 JAN 2021, the patient received first dose of vaccine and reported that the vaccine given was cloudy, still frozen and not properly thawed at the time of the administration. The patient also stated that the pharmacist warmed up the new vial in his hands for couple of minutes.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, the vaccine given was cloudy, still frozen and not properly thawed at the time of the administration, were considered recovered.; Reporter's Comments: This report refers to a case of Product preparation issue for mRNA-1273, lot # 028L20A. There were no reported AEs associated with this case of Product preparation issue.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: The needle fell off and some of the vaccine spilled on nurse and on the patient's pants; The needle fell off and some of the vaccine spilled on nurse and on the patient's pants; A spontaneous report was received from a pharmacist, concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine and while receiving vaccine the needle fell off and some of the vaccine spilled on nurse and the patient's pants.   No relevant medical history and concomitant medications were reported.   On 11-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 11-Jan-2021, while nurse was giving a patient his 1st dose of the Moderna vaccine, she had to change the needle as he was a larger man. When nurse was administering the vaccine, the needle fell off and some of the vaccine spilled on her and on patient's pants. The patient became irate that he couldn't get a replacement dose.   Action taken with the first dose of mRNA-1273 in response to the event was not reported.   The outcome for the event the needle fell off and some of the vaccine spilled on nurse and the patient's pants was considered to be resolved on 11-Jan-2021.; Reporter's Comments: This report refers to a case of a male patient who experienced non-serious event of the needle fell off and some vaccine spilled on nurse and the patient's pants (Incomplete dose of vaccine administered, needle issue)  for mRNA-1273 (lot # 025L20A, Exp date-unknown). There were no reported AEs associated with the event of  the needle fell off and some vaccine spilled.
Sex: F
Vaccine: COVID19
Symptoms: Horner's syndrome
Clinical narrative: Horner's Syndrome; A spontaneous report was received from a physician who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Horner's syndrome.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, two days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 30 Dec 2020 the patient developed Horner's syndrome. The specific presenting signs and symptoms experienced by the patient were not provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, Horner's syndrome, was not reported.; Reporter's Comments: This spontaneous report refers to a female patient who experienced unexpected Horner's syndrome on day 3 after administration of the first dose of mRNA-1273, lot # unknown, Exp date-unknown. There is limited information to assess this case as the exact symptoms and confirmatory diagnostic test results were not provided. However, based on temporal information provided a causal association cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Pain, Pyrexia
Clinical narrative: Aching; Fatigue; Fever; Headache; Pulse was 135; A spontaneous report was received from a nurse who was also a 34-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fatigue, aching, fever, headache, and pulse was 135.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 13 Jan 2021, approximately 12 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm at 09:00 for prophylaxis of COVID-19 infection.  On 13 Jan 2021, around 21:00, the patient experienced fatigue, aching, fever, and headache. On 14 Jan 2021, the patient was taken to the emergency room because his pulse was 135. He hadn't been able to bring it down since 13 Jan 2021. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, fatigue, aching, fever, headache, and pulse was 135, were unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected events of heart race increased, a non-serious unexpected event of pain, and a non-serious expected event of fatigue, pyrexia and headache. The event of fatigue, pyrexia, pain and headache occurred 4 hours after mRNA-1273 (lot # unknown) administration. The event of heart rate increased occurred on an unknown date after mRNA-1273 (lot # unknown) administration. Treatment details were not provided. Very limited information regarding the events have been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: Wrong needle size used; A spontaneous report was received from a pharmacist concerning 31-year-old, male patient who who received Moderna's COVID-19 vaccine (mRNA-1273) and the wrong needle size was used [Product administration error].   The patient's medical history was not provided. Concomitant medication use was not provided by the reporter.   On 13-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   The pharmacist reported that the nurse made an administration error today by using the wrong size of needle.   Treatment for the event was not provided.    Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event were resolved.; Reporter's Comments: This report refers to a case of a 31-year-old male patient who experienced non-serious event of the wrong needle size was used (Wrong technique in device usage process ) for administration of  mRNA-1273 (lot # unknown, Exp date-unknown). There were no reported AEs associated with the event of the wrong needle size was used.
Sex: F
Vaccine: COVID19
Symptoms: Meningitis
Clinical narrative: Meningitis; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious event of meningitis.  The patient's medical history was not provided. No concomitant medications were reported.  On 03 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient experienced meningitis like symptoms. She was hospitalized for meningitis. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the event, meningitis was unknown.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of meningitis. The event of meningitis occurred 3 days after mRNA-1273 (lot # unknown) administration. Treatment details were not provided. Very limited information regarding the events have been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Hypertension, Troponin, Troponin increased
Clinical narrative: Severe difficulty breathing; Blood pressure shot up to 200; Troponin level jumped up; A spontaneous report was received from a non-health professional concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe difficulty breathing and that his troponin level and blood pressure (BP) had shot up.  The patient's medical history included chronic obstructive pulmonary disease (COPD). Concomitant product use was not provided by the reporter.  On 09 Jan 2021, at approximately 14:42, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 09 Jan 2021 at 20:30, the patient experienced severe difficulty breathing and his BP shot up to 200. The patient went to the hospital and they found his troponin levels had jumped up. The patient reported no known heart issues. On 12 Jan 2021, he went to see his primary care physician (PCP).  No treatment information for the event was provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, severe difficulty breathing and  troponin level and blood pressure (BP) had shot up, were unknown.; Reporter's Comments: This case concerns a 77-year-old, male patient, with medical history of chronic obstructive pulmonary disease (COPD), who experienced a serious, unexpected event of dyspnoea, hypertension and raised troponin level. The event occurred 5 hours 48 min after the first dose of mRNA-1273 (Lot number: 039K20A).  Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Nausea, Syncope
Clinical narrative: Fainted to the floor; Dizzy; Too dizzy, hot and sweaty; Nausea; A  little vomit; sweaty; A spontaneous report was received from a non-health professional who was a 40-years-old, female patient who received Moderna's COVID-19 vaccine and fainted, was dizzy, felt hot, had nausea and vomiting, and sweaty.  The patient's medical history included a propensity for fainting and low blood pressure. Concomitant product use was not provided by the reporter.  On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 12 Jan 2021, after receiving the vaccine, the patient got dizzy, had nausea, a little vomit, and fainted to the floor. She reported feeling dizzy, hot and sweaty.  Patient did not take medication to treat her symptoms.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, fainted, dizziness, felt hot, nausea and vomiting, and sweaty were unknown.; Reporter's Comments: This case concerns a 40-year-old female patient with medical history of propensity for fainting and low blood pressure who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the unlisted event of Syncope which was considered medically significant. Additionally, the patient experienced the non-serious listed events of Nausea and Vomiting, and the non-serious unlisted events of Feeling Hot, Dizziness and Hyperhidrosis. Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. We would note that the patient's history of propensity for fainting and low blood pressure could be also contributory.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fainted to the floor; Dizzy; Too dizzy, hot and sweaty; Nausea; A  little vomit; sweaty; A spontaneous report was received from a non-health professional who was a 40-years-old, female patient who received Moderna's COVID-19 vaccine and fainted, was dizzy, felt hot, had nausea and vomiting, and sweaty.  The patient's medical history included a propensity for fainting and low blood pressure. Concomitant product use was not provided by the reporter.  On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 12 Jan 2021, after receiving the vaccine, the patient got dizzy, had nausea, a little vomit, and fainted to the floor. She reported feeling dizzy, hot and sweaty.  Patient did not take medication to treat her symptoms.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, fainted, dizziness, felt hot, nausea and vomiting, and sweaty were unknown.; Reporter's Comments: This case concerns a 40-year-old female patient with medical history of propensity for fainting and low blood pressure who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the unlisted event of Syncope which was considered medically significant. Additionally, the patient experienced the non-serious listed events of Nausea and Vomiting, and the non-serious unlisted events of Feeling Hot, Dizziness and Hyperhidrosis. Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. We would note that the patient's history of propensity for fainting and low blood pressure could be also contributory.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Loss of consciousness, Pain in extremity
Clinical narrative: Fainted; unconscious for 1-2 minutes; Felt dizzy; sweating; shaking; brain feels foggy; didn't sleep well; left arm started hurting from shoulder to elbow; A spontaneous report was received from a consumer who was an 51-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events of left arm started hurting from shoulder to elbow, didn't sleep well, felt dizzy, fainted, unconscious for 1-2 minutes, sweating, shaking, and brain feels foggy.   The patient's medical history included asthma, hypoglycemia allergy to penicillin and tuberculin (TB) test. No concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On the same day, the patient experienced left arm started hurting from shoulder to elbow.  On 14 Jan 2021, the patient reported that she didn't sleep well, felt dizzy, and fainted. The patient was unconscious for 1-2 minutes before the ambulance arrived. It was noted that the patient's vitals were normal, so she declined to go to the hospital. The patient also experienced sweating, shaking, and brain feels foggy like she has a hangover. The patient stated that the Moderna vaccine gave her the same reaction except with penicillin and TB test she went unconscious immediately. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The events, fainted and unconscious for 1-2 minutes, was considered resolved on 14 Jan 2021.  The outcome for the events, felt dizzy and brain feels foggy, was not resolved.  The outcome for the events, left arm started hurting from shoulder to elbow, sweating, shaking and didn't sleep well, was unknown.; Reporter's Comments: This spontaneous report refers to a 51-year-old female patient with medical history of asthma who experienced unexpected serious events of fainted and loss of consciousness (1-2 minutes), and non-serious events of dizziness, sweating, shaking, brain feels foggy, didn't sleep well and  left arm started hurting from shoulder to elbow) the next day after administration of the first dose of mRNA-1273, lot # : 012L20A, Exp date-unknown. Based on temporal information provided and with no other etiological factors, a causal association cannot be excluded. The event of left arm started hurting from shoulder to elbow is consistent with the known safety profile of the study medication.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Syncope, Tremor
Clinical narrative: Fainted; unconscious for 1-2 minutes; Felt dizzy; sweating; shaking; brain feels foggy; didn't sleep well; left arm started hurting from shoulder to elbow; A spontaneous report was received from a consumer who was an 51-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events of left arm started hurting from shoulder to elbow, didn't sleep well, felt dizzy, fainted, unconscious for 1-2 minutes, sweating, shaking, and brain feels foggy.   The patient's medical history included asthma, hypoglycemia allergy to penicillin and tuberculin (TB) test. No concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On the same day, the patient experienced left arm started hurting from shoulder to elbow.  On 14 Jan 2021, the patient reported that she didn't sleep well, felt dizzy, and fainted. The patient was unconscious for 1-2 minutes before the ambulance arrived. It was noted that the patient's vitals were normal, so she declined to go to the hospital. The patient also experienced sweating, shaking, and brain feels foggy like she has a hangover. The patient stated that the Moderna vaccine gave her the same reaction except with penicillin and TB test she went unconscious immediately. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The events, fainted and unconscious for 1-2 minutes, was considered resolved on 14 Jan 2021.  The outcome for the events, felt dizzy and brain feels foggy, was not resolved.  The outcome for the events, left arm started hurting from shoulder to elbow, sweating, shaking and didn't sleep well, was unknown.; Reporter's Comments: This spontaneous report refers to a 51-year-old female patient with medical history of asthma who experienced unexpected serious events of fainted and loss of consciousness (1-2 minutes), and non-serious events of dizziness, sweating, shaking, brain feels foggy, didn't sleep well and  left arm started hurting from shoulder to elbow) the next day after administration of the first dose of mRNA-1273, lot # : 012L20A, Exp date-unknown. Based on temporal information provided and with no other etiological factors, a causal association cannot be excluded. The event of left arm started hurting from shoulder to elbow is consistent with the known safety profile of the study medication.
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Dyspnoea, Genital swelling, Pain in extremity, Pyrexia
Clinical narrative: went deaf for a while; Trouble breathing; Swollen genitals; Injection site arm in severe pain; fever; A spontaneous report was received from a consumer who was also a male patient who received Moderna's COVID-19 Vaccine, and who developed trouble breathing, swollen genitals, injection site arm in severe pain, fever, and went deaf for a while.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 13 Jan 2021, approximately one hour prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, approximately one hour after receiving the injection, he developed trouble breathing, swollen genitals and severe pain at the injection site.  He had a fever, and he went deaf for a while.    On 14 Jan 2021, the pain became so overwhelming that he went to the emergency department.  No diagnostic information was provided.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, trouble breathing, swollen genitals, injection site arm in severe pain, fever, and went deaf for a while, was not provided.  The event, went deaf for a while, was considered recovered/resolved on an undisclosed date.  The outcome of the events, trouble breathing, swollen genitals, injection site arm in severe pain and fever, was not reported.; Reporter's Comments: This spontaneous report refers to a male patient who experienced unexpected events of trouble breathing, swollen genitals, severe pain at the injection site, fever and went deaf for a while one hour after administration of the first dose of mRNA-1273, lot # unknown, Exp date-unknown.  Based on temporal information provided and in the absence of any other etiological factors, a causal association cannot be excluded. Pain and fever are consistent with the known safety profile of the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Refroze the vaccines after receiving them and administered them to patients; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) with product storage error.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on (date not provided) for prophylaxis of COVID-19 infection.   A pharmacist called to report the vaccines were refrozen after receiving them. He stated he thought that they were frozen, but they were shipped refrigerated. He reported that he administered 108 patients with the refrozen vaccine.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, product storage error, was considered resolved.; Reporter's Comments: This report refers to a case of Product storage error for mRNA, where refrozen vaccine was administered. There were no reported AEs associated with this case of out of specification product use.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactoid reaction
Clinical narrative: Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a 45-year-old,  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms.  The patient's medical history included hypertension. The patient had no history of allergies or prior vaccine reactions. No concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 45-year-old patient with medical history of hypertension, who experienced a serious, unexpected event of Anaphylactoid reaction. The event occurred the day  the patient received the first dose of mRNA-1273 (Lot number: 041L20A), at an unspecified time. 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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Cough, Pain in extremity, Rhinorrhoea
Clinical narrative: Arm tenderness; Runny nose; Cough; Anaphylactic reaction; A spontaneous report was received from a 63-year-old male who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, arm tenderness, runny nose and cough.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:011(J/5)20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021, patient started to experienced cough which got progressively worse, runny nose and his heart started racing. He could not swallow water, his airway was shutting down, and he stated that it was an anaphylactic reaction. Patient also felt exhausted with arm tenderness and pronounced discomfort. Treatment for the events were not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, anaphylactic reaction, arm tenderness, runny nose and cough was unknown.; Reporter's Comments: This case concerns a 63-year-old, male patient, who experienced a serious unexpected event of anaphylactic reaction, and non-serious unexpected event of cough, and rhinorrhea, and a non-serious expected event of pain in extremity. The events occurred 1 day (same day) after first dose of mRNA-1273, lot # 011(J/5)20A. No treatment was administered. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.