chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP, HEPA, HEPA, HIBV, HPV9, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA003717: US-009507513-2103USA005236: US-009507513-2103USA005237: US-009507513-2103USA005238: US-009507513-2103USA005239: US-009507513-2103USA005241: US-009507513-2103USA005234: US-009507513-2103USA005233: US-009507513-2103USA005235:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles, including any and all of its sequelae/the patient had been caused to suffered severe personal injuries; Shingles, including any and all of its sequelae; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a 62-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 04-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). In 2014, as a result of her received zoster vaccine live (ZOSTAVAX), the patient was caused to suffered shingles, included any an all of its sequelae. As a result of her received zoster vaccine live (ZOSTAVAX), the patient had been caused to suffered severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. This action was also brought on her spouse and who suffered loss of consortium damages. The outcome of shingles and ill-defined disorder were not recovered. The reporter considered shingles and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; shingles, including any and all of its sequelae; This spontaneous report was received from a lawyer and a 63 year old female patient regarding a case in litigation on 18-MAR-2021. The patient's concurrent conditions, concomitant medications, medical history, drug reactions or allergies were not reported. On 14-NOV-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) as prophylaxis. On 09-APR-2017, as a result of her receipt of zoster vaccine live (ZOSTAVAX), plaintiff was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress. At the reporting time, the outcome of shingles, including any and all of its sequelae was considered as not recovered. The reporters considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered shingles, including any and all of its sequelae to be disabling.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy including any and all of its sequelae; Bell's Palsy; This spontaneous report was received from a lawyer and a 65 year old female patient regarding a case in litigation on 18-MAR-2021. The patient's concurrent conditions, concomitant medications, medical history, drug reactions or allergies were not reported. On 27-SEP-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) as prophylaxis. On 30-SEP-2013, as a result of her receipt of zoster vaccine live (ZOSTAVAX), plaintiff was caused to suffer Bell's Palsy, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress. At the reporting time, the outcome of Bell's Palsy, including any and all of its sequelae was considered as not recovered. The reporters considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered the event of Bell's Palsy, including any and all of its sequelae to be disabling. Upon internal review, Bell's Palsy was determined to be medically significant.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; shingles, including any and all of its sequelae; This spontaneous report was received from a lawyer and an approximately 63 year old female patient regarding a case in litigation on 18-MAR-2021. The patient's concurrent conditions, concomitant medications, medical history, drug reactions or allergies were not reported. On 04-FEB-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) as prophylaxis. On an unspecified date in October 2013, as a result of her receipt of zoster vaccine live (ZOSTAVAX), plaintiff was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress. At the reporting time, the outcome of shingles, including any and all of its sequelae was considered as not recovered. The reporters considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered the events of shingles, including any and all of its sequelae to be disabling.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Ill-defined disorder
Clinical narrative: allergic reaction, included any and all of its sequelae; allergic reaction, included any and all of its sequelae/ as well as other severe and personal injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a 64-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 14-NOV-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On 17-NOV-2011, as a result of zoster vaccine live (ZOSTAVAX) administration, , foregoing act and omissions, the patient was caused to suffered serious and dangerous side effects included: allergic reaction, included any and all of its sequelae; as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, included diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of vaccine, the patient had been caused to suffered severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. It was reported that defects in zoster vaccine live (ZOSTAVAX) were substantial in caused patient's injuries. As a result of the foregoing acts and omissions the patient required and/or would require more health care and services and did incur medical, health, he would in the future be required to obtain further medical and/or hospital care, attention, and services. In addition, the patient required and would continue to require healthcare and services. The patient had incurred and would continue to incur medical and related expenses. Also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravated of preexisted conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs included physical care, monitoring and treatment. The patient had incurred and would continue to incur mental and physical pain and suffering. The outcome of hypersensitivity and ill-defined disorder were not recovered. The reporter considered of hypersensitivity and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX).  Hypersensitivity and ill-defined disorder were considered to be disable events.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster meningoencephalitis, Ill-defined disorder
Clinical narrative: Varicella Encephalitis; shingles, included any an all of its sequelae/ as well as other severe and personal injuries; shingles, included any an all of its sequelae; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a 70-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported) (it was reported the patient was 60 year old at time of vaccine, conflicted information). On 25-DEC-2015, as a result of zoster vaccine live (ZOSTAVAX) administration, foregoing act and omissions, the patient was caused to suffered serious and dangerous side effects included: varicella encephalitis and shingles, included any and all of its sequelae, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, included diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of vaccination, the patient had been caused to suffered severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. Negligence was the proximate caused of injuries, harm and economic loss which the patient suffered and/or would continue to suffer. As a result of the foregoing acts and omissions the patient required and/or would require more health care and services and did incur medical, health, incidental and related expenses. The patient was informed and believed and further alleged that the patient would in the future be required to obtained further and/or hospital care, attention and services. The outcome of herpes zoster meningoencephalitis, shingles and ill-defined disorder were not recovered. The reporter considered herpes zoster meningoencephalitis, shingles and ill-defined disorder to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, herpes zoster meningoencephalitis was determined to be medically significant events. Herpes zoster meningoencephalitis, shingles and ill-defined disorder were considered to be disable events.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: no adverse events reported; he received his first dose of GARDASIL 9 in June of 2020 and received his second dose 05MAR2021; he is unsure of the valency of Fall 2019 HPV vaccination; This spontaneous report has been received from a 28 year old male patient, reporting on himself. The patient was not sexually active so he considered himself as human papillomavirus (HPV) naive. No other information regarding the patient's concurrent conditions, concomitant medications or medical history were not reported.   In fall 2019, the patient was vaccinate with his first dose of an unknown valency of human papillomavirus (HPV) (manufacturer unknown) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The patient "recently" graduated from medical school and had decided to become sexually active. In June 2020, the patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported) and on 05-MAR-2021, received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis  (dose, route of administration, lot number and expiration date were not reported). Due to the interruption in schedule the patient wanted to know if he should restart the series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No adverse event was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Illness, Influenza like illness, Injection site erythema
Clinical narrative: warm to touch; Red cheeks; almost flu like symptoms; sick; knocked out; Fever of 102 F; delayed cutaneous hypersensitive arm; sore; itching; covid arm; red at injection site; A spontaneous report was received from a consumer concerning 71year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed redness/erythema , warm to touch/feeling hot, cutaneous hypersensitive arm/cutaneous sympoms, injection site was red/ vaccination site erythema, hot, sore/pain and itching/pruritus, like COVID arm/vaccination site reaction. After the second shot of vaccine she got sick/sickness, fever of 102 F/pyrexia, flu like symptoms/influenza like illness and was knocked out/loss of consciousness.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) on 19 Jan 2021. On 21 Feb 2021, approximately on the same day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Consumer had reported that 12 days after receiving the first dose, patient experienced delayed cutaneous hypersensitive arm. Arm was red at injection site, which later spread to whole upper arm. The injection site was re, hot, sore, itchy like COVID arm. Which was resolved later, and she had taken diphenhydramine for it. After receiving her second dose of vaccine she got sick, fever of 102 F, knocked out, almost flu like symptoms. which lasted for couple of days and was resolved on 23 Feb 2021. For which she had taken acetaminophen for it. Also, she had red cheeks, warm to touch for last few days, almost 2 weeks after her 2nd dose of vaccine.    Treatment for the event included diphenhydramine and acetaminophen.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the  events, redness, warm to touch, cutaneous hypersensitive arm, injection site was red, hot, sore and itchy like COVID arm were considered resolved and for she got sick, fever of 102 F, knocked out and flu like symptoms was unknown.; 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain, Pruritus, Pyrexia, Sensitive skin
Clinical narrative: warm to touch; Red cheeks; almost flu like symptoms; sick; knocked out; Fever of 102 F; delayed cutaneous hypersensitive arm; sore; itching; covid arm; red at injection site; A spontaneous report was received from a consumer concerning 71year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed redness/erythema , warm to touch/feeling hot, cutaneous hypersensitive arm/cutaneous sympoms, injection site was red/ vaccination site erythema, hot, sore/pain and itching/pruritus, like COVID arm/vaccination site reaction. After the second shot of vaccine she got sick/sickness, fever of 102 F/pyrexia, flu like symptoms/influenza like illness and was knocked out/loss of consciousness.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) on 19 Jan 2021. On 21 Feb 2021, approximately on the same day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Consumer had reported that 12 days after receiving the first dose, patient experienced delayed cutaneous hypersensitive arm. Arm was red at injection site, which later spread to whole upper arm. The injection site was re, hot, sore, itchy like COVID arm. Which was resolved later, and she had taken diphenhydramine for it. After receiving her second dose of vaccine she got sick, fever of 102 F, knocked out, almost flu like symptoms. which lasted for couple of days and was resolved on 23 Feb 2021. For which she had taken acetaminophen for it. Also, she had red cheeks, warm to touch for last few days, almost 2 weeks after her 2nd dose of vaccine.    Treatment for the event included diphenhydramine and acetaminophen.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the  events, redness, warm to touch, cutaneous hypersensitive arm, injection site was red, hot, sore and itchy like COVID arm were considered resolved and for she got sick, fever of 102 F, knocked out and flu like symptoms was unknown.; 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: warm to touch; Red cheeks; almost flu like symptoms; sick; knocked out; Fever of 102 F; delayed cutaneous hypersensitive arm; sore; itching; covid arm; red at injection site; A spontaneous report was received from a consumer concerning 71year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed redness/erythema , warm to touch/feeling hot, cutaneous hypersensitive arm/cutaneous sympoms, injection site was red/ vaccination site erythema, hot, sore/pain and itching/pruritus, like COVID arm/vaccination site reaction. After the second shot of vaccine she got sick/sickness, fever of 102 F/pyrexia, flu like symptoms/influenza like illness and was knocked out/loss of consciousness.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) on 19 Jan 2021. On 21 Feb 2021, approximately on the same day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Consumer had reported that 12 days after receiving the first dose, patient experienced delayed cutaneous hypersensitive arm. Arm was red at injection site, which later spread to whole upper arm. The injection site was re, hot, sore, itchy like COVID arm. Which was resolved later, and she had taken diphenhydramine for it. After receiving her second dose of vaccine she got sick, fever of 102 F, knocked out, almost flu like symptoms. which lasted for couple of days and was resolved on 23 Feb 2021. For which she had taken acetaminophen for it. Also, she had red cheeks, warm to touch for last few days, almost 2 weeks after her 2nd dose of vaccine.    Treatment for the event included diphenhydramine and acetaminophen.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the  events, redness, warm to touch, cutaneous hypersensitive arm, injection site was red, hot, sore and itchy like COVID arm were considered resolved and for she got sick, fever of 102 F, knocked out and flu like symptoms was unknown.; 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Headache, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Cellulitis; Arm found to be warm; Arm was itchy; Arm was little red; Little headache; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Modena's COVID-19 vaccine and experienced cellulitis, little headache, arm was itchy and red and arm found it to be a warm.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 04 Mar 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number 011A21A) intramuscularly in the left non dominant arm for prophylaxis of COVID-19 infection.   On 04 Mar 2021, the patient had little headache for a day and arm was itchy and little red. 6-7 days later, the patient found it to be warm and very red. On 13 Mar she went to ER (emergency room), doctor said that it could be medically significant event of cellulitis. Treatment for the event included cephalexin.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event little headache was not reported. The outcome of the events cellulitis and arm was itchy and red and arm found it to be a warm was not reported.; Reporter's Comments: This case concerns a 74 Y/O F with a serious unexpected event of Cellulitis and nonserious unexpected vaccination site warmth, and expected vaccination site erythema, vaccination site pruritus, and headache.  Event onset 10 days after first dose mRNA-1273. Treated with cephalexin. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Insomnia, Myalgia
Clinical narrative: can't sleep; muscle aches ("I can't walk , I can't sleep, it hurts so bad"); crippling; A spontaneous report  was received from a 79-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle aches (i can't walk , i can't sleep, it hurts so bad), insomnia, and crippling.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the consumer received first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Feb 2021, ten days after the vaccination, the patient experienced the events muscle aches (i can't walk , i can't sleep, it hurts so bad) and crippling.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, muscle aches (i can't walk, i can't sleep, it hurts so bad), insomnia, and crippling was not recovered / not 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Erythema, Nausea, Palpitations
Clinical narrative: Heart is racing on and off this morning; Face is swollen; Diarrhea; Rash; Temperature of 99; Nausea; Had a full blown lupus flare; Face is beet red; A spontaneous report was received from a consumer (patient) concerning a 54-years-old, female patient was who received Moderna's COVID-19 Vaccine (mRNA-1273) and had a full blown lupus flare (condition aggravated), face is beet red (erythema), temperature of 99 (pyrexia), face is swollen (swelling face), heart is racing on and off this morning (palpitations), really really sick (sickness), rash, nausea, diarrhea.  Medical history included abnormal blood pressure and lupus. The concomitant medications included pantoprazole, hydroxychloroquine and blood pressure medications.  On 12 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: not provided), intramuscularly for the prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient had a full blown lupus flare (medically significant). The patient went to the emergency room. Her face was beet red and swollen and had temperature of 99. The patient stated that she had nausea and diarrhea and a rash.  On 16 Mar 2021, the stated that her heart was racing now on and off. She was really really sick now.  The treatment information included prednisone and epinephrine.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The outcome of the events of had a full blown lupus flare (condition aggravated), face is beet red (erythema), temperature of 99 (pyrexia), face is swollen (swelling face), nausea, diarrhea, rash, really really sick (sickness), heart is racing on and off this morning (palpitations) was unknown.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Swelling face, Systemic lupus erythematosus
Clinical narrative: Heart is racing on and off this morning; Face is swollen; Diarrhea; Rash; Temperature of 99; Nausea; Had a full blown lupus flare; Face is beet red; A spontaneous report was received from a consumer (patient) concerning a 54-years-old, female patient was who received Moderna's COVID-19 Vaccine (mRNA-1273) and had a full blown lupus flare (condition aggravated), face is beet red (erythema), temperature of 99 (pyrexia), face is swollen (swelling face), heart is racing on and off this morning (palpitations), really really sick (sickness), rash, nausea, diarrhea.  Medical history included abnormal blood pressure and lupus. The concomitant medications included pantoprazole, hydroxychloroquine and blood pressure medications.  On 12 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: not provided), intramuscularly for the prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient had a full blown lupus flare (medically significant). The patient went to the emergency room. Her face was beet red and swollen and had temperature of 99. The patient stated that she had nausea and diarrhea and a rash.  On 16 Mar 2021, the stated that her heart was racing now on and off. She was really really sick now.  The treatment information included prednisone and epinephrine.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The outcome of the events of had a full blown lupus flare (condition aggravated), face is beet red (erythema), temperature of 99 (pyrexia), face is swollen (swelling face), nausea, diarrhea, rash, really really sick (sickness), heart is racing on and off this morning (palpitations) was unknown.; 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: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fracture
Clinical narrative: Fall; fracture; A spontaneous report  was received from a pharmacist concerning a 93-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a fall and a fracture.    The patient's medical history was not provided. Concomitant product use was not provided.  On 03 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (batch no. 012M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.    On an unknown date after the first vaccination, the patient experienced a fall and sustained a fracture and was hospitalized.  The pharmacist stated that the patient has crossed 42 days to received the second injection due to hospitalization (the day of this report was day 42).  The patient was in a nursing home at the time of this report.    The action taken with mRNA-1273 COVID-19 Vaccine) was unknown.  The outcomes of the events of fall and fracture were unknown.   The reporter did not provide causality assessment.; 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.; Sender's Comments:  MOD21-056578:Cross linked case for patient 2
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis in leg; A spontaneous report was received from a consumer concerning 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis in leg/cellulitis.    The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Levothyroxine for thyroid medication, eye drops for glaucoma and baby aspirin for general health.  On 19 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   On 19 Feb 2021, after first dose of vaccination, the patient experienced leg pain and a hot sensation in the leg. The patient reported that she went to an Urgent Care and was diagnosed with developing cellulitis in leg.  Treatment for the event included Bactrim, Doxycycline and Cipro.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, cellulitis in leg, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of leg cellulitis, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Fatigue, Loss of consciousness, Magnetic resonance imaging
Clinical narrative: Stroke; Blood clot on the brain; I Just sort of zoned out on them; Arm soreness; I Just kept getting tireder; A spontaneous report  was received from a consumer, concerning a 69-years old male patient, who received Moderna's COVID-19 vaccine and experienced stroke, blood clot on brain, arm soreness without redness and swelling, he just kept getting tireder, he just sort of zoned out on them.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 05 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 037K20A) via unknown route for COVID-19 infection prophylaxis. On 05-FEB-2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (lot number 032L20A) via unknown route for COVID-19 infection prophylaxis.  On 05 Feb 2021, after the second dose of vaccine, the patient experienced arm soreness and fatigue, He did not get any medication or treatments for his arm soreness without redness and swelling and and just kept getting tireder events. On10-MAR-2021 patient experienced just sort of zoned out of them, stroke, blood clot on brain. An ambulance was called for him and he was taken to the hospital where he received MRIs, and CT scans. He states they think it was a stroke. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events (arm soreness without redness and swelling and he was just kept getting tireder) was recovered but the events (stroke, blood clot on brain, he just sort of zoned out on them) not resolved 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 events, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: Stroke; Blood clot on the brain; I Just sort of zoned out on them; Arm soreness; I Just kept getting tireder; A spontaneous report  was received from a consumer, concerning a 69-years old male patient, who received Moderna's COVID-19 vaccine and experienced stroke, blood clot on brain, arm soreness without redness and swelling, he just kept getting tireder, he just sort of zoned out on them.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 05 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 037K20A) via unknown route for COVID-19 infection prophylaxis. On 05-FEB-2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (lot number 032L20A) via unknown route for COVID-19 infection prophylaxis.  On 05 Feb 2021, after the second dose of vaccine, the patient experienced arm soreness and fatigue, He did not get any medication or treatments for his arm soreness without redness and swelling and and just kept getting tireder events. On10-MAR-2021 patient experienced just sort of zoned out of them, stroke, blood clot on brain. An ambulance was called for him and he was taken to the hospital where he received MRIs, and CT scans. He states they think it was a stroke. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events (arm soreness without redness and swelling and he was just kept getting tireder) was recovered but the events (stroke, blood clot on brain, he just sort of zoned out on them) not resolved 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 events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Endocarditis
Clinical narrative: Two cases of endocarditis after the vaccine; A spontaneous report  was received from a consumer concerning two unspecified patients who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event endocarditis after the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patients experienced the event endocarditis after the vaccine. The event endocarditis, was considered medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, endocarditis after the vaccine was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Overdose, Product preparation error
Clinical narrative: an entire undiluted vial was administered to one patient; an entire undiluted vial was administered to one patient; Flu like symptoms; This is a spontaneous report from a contactable pharmacist. A 33-year-old patient of unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, Expiration Date: Mar2021), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that an entire undiluted vial was administered to one patient on 09Jan2021. The pharmacist asked for recommendations with regards to this concern. The patient had moderate to severe flu like symptoms for 3-4 days in Jan2021 after the vaccine overdose. The day of the overdose, when they realized what they had administered, the patient was admitted to the emergency department for observation for a couple hours. The patient didn't have a reaction and was given an Epi-Pen to take home just in case. The patient had not reported any further adverse reactions after the flu like symptoms resolved. The outcome of the event flu like symptoms was resolved in 2021.  Follow-up (20Jan2021): New information reported from the same contactable pharmacist included: reporter information.  Information on the lot/batch number has been requested.  Follow-up (12Mar2021 and 12Mar2021): New information received from a contactable pharmacist included reporter information, patient data (age), suspect vaccine data (start date/stop date, lot number and expiration date), new event (Flu like symptoms), onset date of events, outcome of event, stop date of event and clinical event course.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Gait disturbance, Palpitations, Vomiting
Clinical narrative: I have had difficulty walking, vomiting, bloody nose, and severe heart palpations
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears (Tinnitus) Ongoing since I got the shot and wont go away.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: 03/20/21 - Patient was scheduled to receive 2nd dose of Moderna COVID vaccine.  EHR was working very slow (at times it was down completely), and MA was unable to fully review patient?s chart prior to vaccine administration. All patients scheduled that morning were scheduled to receive 2nd Moderna dose, which is why the MA felt comfortable administering vaccine after patient verbalized that she was coming in for the second dose of the COVID vaccine. After vaccine was administered, MA asked the patient for the COVID vaccine card to update the information. It was then that he noticed that the first vaccine administered on 02/20/21 was Pfizer, not Moderna. Provider was notified right away and Dr. went into room to speak with patient, explain situation, and offer reassurance. Upon chart review, it was determined that on 02/20/21, Pfizer vaccine had been administered.  Per CDC website "Interchangeability of COVID-19 vaccine products" ?In exceptional situations in which the vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series.? The situation that occurred is not what is described above, but it is helpful to know as it is the same outcome ? two different products used, although not ideal, not necessarily harmful. This was discussed with Medical Directors for medical input. All agreed that there is nothing else to do medically for patient as long as she is doing well. She has completed COVID vaccine series, no need to restart series or get a 2nd Pfizer vaccine. 03/26/21 ? Dr. was updated with information above.  03/29/21 -  Writer spoke to patient and updated her on situation. She denied having any adverse effects to COVID vaccines. Patient was grateful for the follow up phone call and relieved to learn that the COVID vaccines are valid. Questions and concerns were addressed to patient?s satisfaction. MAs involved are being followed up with by Nurse Educator.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Heart rate increased
Clinical narrative: c/o of increased HR and seems anxious.  P=124; O2=98.  resolved.  P=89
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pruritus, Rash erythematous
Clinical narrative: Moderna COVID-19 Vaccine EUA body aches, headache red rash, tough skin with itching
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: Increase in frequency but not severity/quality of hot flashes.  Starting the day following the shot, and for about a week, I was having frequent (estimating 5 to 8) hot flashes each day.  In the last couple of days it has declined to 2 or 3 per day.  My typical frequency prior to the shot was about once every two days.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Injection site pain, Sinus headache
Clinical narrative: Severe pain where shot was administered for 3 day.  Very Bad Sinus Headache for 4 days.  I still have this symptom not as severe but  every time I cough I get the pain in the center of my forehead or if I bend to get something from the floor. I never had this before till I received the first shot.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Fatigue, Headache, Insomnia
Clinical narrative: aching joints, extreme fatigue, head ache, fever of 100.9 all night, muscle cramps in left foot, not able to sleep much because of headache, .
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: aching joints, extreme fatigue, head ache, fever of 100.9 all night, muscle cramps in left foot, not able to sleep much because of headache, .
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Patient reports swollen around injection site and upper arm  after first shot and starting day 8 experienced swelling and discomfort in the armpit. Also large area of redness around injection site.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Drug eruption, Mechanical urticaria
Clinical narrative: The patient had a fixed drug eruption on volar surface left wrist.  She also had a bit of dermatographism on volar surface left wrist.  Patient has a history of dermatographism, though.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Rash, Swollen tongue, Urticaria
Clinical narrative: immediately felt itching and nausea. 3 days after vaccine, itching, nausea continued and she also developed rash/hives around her nexk, axilla, groin, and back, tongue started to swell
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Paraesthesia
Clinical narrative: tingling, chest tightness, shortness of breath
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: 3/31/21 To er for eval of dizziness. States she was at the hairdresser when she became very dizzy and had to lay  In the floor, was nauseated but no vomiting. Incident happened approximately 10am.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Impaired work ability
Clinical narrative: After 1st Dose (2/26/21, 3:50pm)- Pain in left arm appeared about 8 hours after injected and lasted for about 1-2 days. After 2nd Dose (3/22/21, 3:35pm)- Pain in left arm, fever (100.6 F), chills, headache, nausea, body aches (Severe pain in lower back and hips. Knees and elbows ached too. I assume the aches were associated with the fever b/c this often happens to me with fevers). All of these symptoms started around 3:30am 3/23/21 and lasted through 4-5 pm on 3/23/21. Only treatment was Acetaminophen Extra Strength, 2 pills taken around 2:30 pm on 3/23/21. Symptoms started improving 20 minutes after taking medication.  I stayed home from work on 3/23/21, but was able to return to work on 3/24/21. Felt great on 3/24/21. No symptoms.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: After 1st Dose (2/26/21, 3:50pm)- Pain in left arm appeared about 8 hours after injected and lasted for about 1-2 days. After 2nd Dose (3/22/21, 3:35pm)- Pain in left arm, fever (100.6 F), chills, headache, nausea, body aches (Severe pain in lower back and hips. Knees and elbows ached too. I assume the aches were associated with the fever b/c this often happens to me with fevers). All of these symptoms started around 3:30am 3/23/21 and lasted through 4-5 pm on 3/23/21. Only treatment was Acetaminophen Extra Strength, 2 pills taken around 2:30 pm on 3/23/21. Symptoms started improving 20 minutes after taking medication.  I stayed home from work on 3/23/21, but was able to return to work on 3/24/21. Felt great on 3/24/21. No symptoms.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Clumsiness, Computerised tomogram abnormal, Dysarthria, Dysphagia
Clinical narrative: On 3/15/2021 pt was trying to use her computer when she started having problems with her vision.  She noticed her left hand was clumsy and awkward.  Her left leg would not operate properly.  She could not swallow pills with water and her speech was slowed and slurred.  She went to the Hospital ER.  They did MRI, CT, blood test that showed she had a small stroke.  She was released to go home to do physical therapy and speech therapies.  She has both of these scheduled and will follow up w/ PCP on 4/23/2021.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Laboratory test abnormal, Magnetic resonance imaging abnormal, Slow speech, Visual impairment
Clinical narrative: On 3/15/2021 pt was trying to use her computer when she started having problems with her vision.  She noticed her left hand was clumsy and awkward.  Her left leg would not operate properly.  She could not swallow pills with water and her speech was slowed and slurred.  She went to the Hospital ER.  They did MRI, CT, blood test that showed she had a small stroke.  She was released to go home to do physical therapy and speech therapies.  She has both of these scheduled and will follow up w/ PCP on 4/23/2021.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My calves lower legs (both) was really sore lasted overnight. I called my doctor and next day I felt better.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: About 4 days after the vaccine, I noticed a high pitched ringing in my ear. It was not gradual it was right away. I had a health visit and was advised to monitor it. If it didn't get better, I would be referred to and ENT.  I have not seen an ENT at this time.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Fever, body aches, chills, headache, nausea, fatigue.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, body aches, chills, headache, nausea, fatigue.