chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Administered vaccine more than 6 hours after vial was punctured; A spontaneous report was received from a nurse concerning a 41-year-old, male, patient who received Moderna's COVID-19 vaccine and experienced the event, administered vaccine more than 6 hours after vial was punctured.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the mRNA-1273 vaccine vial had been punctured at 08:30 AM and then the vaccine was administered to the patient eight hours later at 4:30 PM.  The patient experienced no symptoms in regards to the event. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, administered vaccine more than 6 hours after vial was punctured, was considered resolved on 07 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of out of specification product use.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: extremely itchy, swelling at the injection site; my skin around the injection site was shiny; extremely itchy, swelling at the injection site; Red at the injection site; Drawn out skin reaction and could be cellulitis; left side lymph nodes around the clavicle were inflamed and large; pain at the injection site; A spontaneous report was received from a healthcare professional who was also a 22-years old female patient who received Moderna's COVID-19 (mRNA-1273) developed pain, itching, swelling, redness and discoloration at the injection site, swollen lymph nodes, and possible cellulitis.     The patient's medical history and relevant concomitant medications were not reported.   On 31 Dec 2020, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection and experienced injection site pain.  On undisclosed dates over the next week, the patient experienced swollen lymph nodes and itching, swelling, and redness at the injection site. She also experienced shiny skin at the injection site.  On 06 Jan 2021, her lymph nodes became inflamed and she went to Urgent Care, who sent her to the emergency room with symptoms of a possible aneurysm.  She was not admitted to the hospital and on 07 Jan 2021 she returned to Urgent Care where a physician diagnosed possible cellulitis and prescribed antibiotics.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events pain, itching, swelling, redness and discoloration at the injection site, swollen lymph nodes, and possible cellulitis were not reported.; Reporter's Comments: This case concerns a 22-year old, female patient, who is a healthcare professional.  The patient's medical history and relevant concomitant medications were not reported. The patient experienced event of injection site pain, swelling, erythema, pruritis, lymphadenopathy,  injection site skin discoloration and cellulitis. The event started on undisclosed date after receiving the first dose of mRNA-1273 on 31 Dec 2020.The event of lymphadenopathy occurred 7 days after first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: extremely itchy, swelling at the injection site; my skin around the injection site was shiny; extremely itchy, swelling at the injection site; Red at the injection site; Drawn out skin reaction and could be cellulitis; left side lymph nodes around the clavicle were inflamed and large; pain at the injection site; A spontaneous report was received from a healthcare professional who was also a 22-years old female patient who received Moderna's COVID-19 (mRNA-1273) developed pain, itching, swelling, redness and discoloration at the injection site, swollen lymph nodes, and possible cellulitis.     The patient's medical history and relevant concomitant medications were not reported.   On 31 Dec 2020, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection and experienced injection site pain.  On undisclosed dates over the next week, the patient experienced swollen lymph nodes and itching, swelling, and redness at the injection site. She also experienced shiny skin at the injection site.  On 06 Jan 2021, her lymph nodes became inflamed and she went to Urgent Care, who sent her to the emergency room with symptoms of a possible aneurysm.  She was not admitted to the hospital and on 07 Jan 2021 she returned to Urgent Care where a physician diagnosed possible cellulitis and prescribed antibiotics.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events pain, itching, swelling, redness and discoloration at the injection site, swollen lymph nodes, and possible cellulitis were not reported.; Reporter's Comments: This case concerns a 22-year old, female patient, who is a healthcare professional.  The patient's medical history and relevant concomitant medications were not reported. The patient experienced event of injection site pain, swelling, erythema, pruritis, lymphadenopathy,  injection site skin discoloration and cellulitis. The event started on undisclosed date after receiving the first dose of mRNA-1273 on 31 Dec 2020.The event of lymphadenopathy occurred 7 days after first dose of mRNA-1273. 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: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Some of the vaccine leaked; Revaccinated in right arm with a partial dose; A spontaneous report was received from a consumer who was a 31-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dose leakage and possible overdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, 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 06 Jan 2021, during administration, some of the vaccine leaked (original site of injection was his left arm). In other to make up for the dose that leaked out, he was revaccinated in his right arm with a partial dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, dose leakage and possible overdose, was considered resolved on 06 Jan 2021.; Reporter's Comments: The case concerns 31-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine leak after the first dose. In other to make up for the dose that leaked out, he was revaccinated in his other arm with a partial dose. There were no reported AEs associated with this case and the case is unlisted and causality was assessed as not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate decreased, Loss of consciousness
Clinical narrative: Passed out; Feeling funny, that his insides were cold; Heart rate low; A spontaneous report was received from a 32-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported felt funny, his insides were cold, low heart rate, and passed out.  The patient's medical history was not provided. Concomitant medications were not reported.  The patient received their first of two planned doses of mRNA-1273 on an undisclosed date.  On 08 Jan 2021, prior to the onset of events, the patient received their second dose of mRNA-1273 (Batch number: unknown) intramuscularly in his left arm for prophylaxis of COVID-19 infection. Afterwards, he felt funny, his insides were cold, and he passed out. His smartwatch reported that his heart rate was low. He said now he was feeling better.  No treatment information was provided.  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, felt funny, his insides were cold, low heart rate, and passed out, were recovered on 08 Jan 2021.; Reporter's Comments: This case concerns a 32 year old male patient who experienced serious events of Loss of consciousness and Chills and a non-serious event of Heart rate decreased following their second dose of mRNA-1273 (Batch number: unknown). Very limited information regarding the events has been provided at this time.  Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction.  The patient's medical history was not provided. Concomitant product use was not reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, after vaccine administration, the patient had an anaphylactic reaction. The patient reported he was "all smooth" now, and would not be receiving the second dose. Treatment for the event included epinephrine.  The second dose of mRNA-1273 was discontinued in response to the event.  The event, anaphylactic reaction, was considered resolved.; Reporter's Comments: This case concerns a male patient who experienced a serious unexpected event of anaphylaxis. The event occurred on an unspecified date after first dose mRNA-1273 (Lot# unknown) administration. The subject's concomitant medication was not provided. The event was treated with epinephrine. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave vaccine to a 16 year old; A spontaneous report was received from a pharmacist concerning a 16-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event,  gave vaccine to a 16-year-old.  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 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, a pharmacist gave the mRNA-1273 vaccine to a 16-year-old patient. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event, gave vaccine to a 16-year-old was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age specification product use for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Cellulitis; Intense itching; Redness; Swelling; Arm soreness; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of arm soreness, intense itching, redness, swelling and cellulitis.  The patient's medical history included allergy to several drug allergies. No concomitant medications were reported.  On an unknown date of Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced arm soreness.   On an unknown date of Jan 2021, the patient experienced intense itching, redness and swelling. The patient reported that she went to her doctor and was diagnosed with cellulitis. The treatment information for the events included clindamycin.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, arm soreness, intense itching, redness, swelling and cellulitis was unknown.; Reporter's Comments: This case concerns a female patient with medical history of several drug allergies, who experienced events of arm  soreness, intense itching, redness, swelling and cellulitis.  The events of arm soreness, intense itching, redness, swelling  occurred on the same day after the first and last dose of mRNA-1273 vaccine administration. The event of cellulitis was reported approximately 10 days after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis around injection site; A spontaneous report was received from a healthcare professional, who is a 30-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis around injection site.  The patient's medical history was not provided. Concomitant medications were not reported.  On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A), intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, a couple of hours after vaccination, the patient experienced cellulitis around the injection site. Her arm was hot and so painful that even when her clothes lightly touched or slid down on the injection site, she felt excruciating pain. She visited five different urgent cares but was rejected because the event was not considered high risk. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, cellulitis around injection site, was unknown.; Reporter's Comments: This case concerns a 30 year old, female who experienced a serious unexpected event of cellulitis. The event occurred same day after first dose of mRNA-1273 (Lot# 011J20A) administration. The subject concomitant and treatment medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Swelling in the face; Rashes all over body; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling in the face and rashes all over his body.  The patient's medical history was not provided. No concomitant medications were reported.  On 04 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 07 Jan 2021, the patient was hospitalized due to swelling in the face and rashes all over his body. Treatment for the events included epinephrine.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, swelling in the face and rashes all over his body, was unknown.; Reporter's Comments: This case concerns a male patient (unknown age), who experienced events of swelling in the face and rashes all over his body.  The events occurred 4 days after the first and only dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: cellulitis, infection under the skin; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the serious event of cellulitis.   The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to the onset of the events, 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 experienced cellulitis, infection under the skin. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the event, cellulitis was unknown.; Reporter's Comments: This case concerns a female patient with who experienced a serious unexpected event of Cellulitis.  The event occurred at an unspecified time after first dose of mRNA-1273.  Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Cough, Nasal congestion, Pneumonia
Clinical narrative: Feels like onset of pneumonia; Congested; Coughing; Chest is heavy; Increased BP 161/97; A spontaneous report was received from a consumer who was a 56-year-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced feels like onset of pneumonia, congested, coughing, chest is heavy and increased BP 161/97.   The patient's medical history included post-traumatic stress disorder, depression and asthma.  Concomitant product use was not provided by the reporter.   On 07-Jan-2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 07-Jan-2021 the patient received the Moderna vaccine. On an unknown date, he reported that he felt as if pneumonia was setting in.  He stated that he was congested, coughing and had chest heaviness.  Additionally, he stated that his blood pressure was elevated to 161/97.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, feels like onset of pneumonia, congested, coughing, chest is heavy and increased BP 161/97, was not provided.   The outcome of the events, feels like onset of pneumonia, congested, coughing, chest is heavy and increased BP 161/97, was unknown.; Reporter's Comments: This spontaneous report refers to a case of a 56-year-old female patient with medical history of post-traumatic stress disorder, depression and asthma, who experienced events of feels like onset of pneumonia, congested, coughing, heavy chest and increased BP 161/97 after the administration of the first and only dose of mRNA-127 (Lot number unknown, Exp date-unknown). Based on temporal the information provided and the absence of any other etiology factors a causal association between the events and vaccine administration cannot be excluded. However, the patient has history of asthma and post-traumatic stress disorder which are confounding factors.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Pain, Seizure, Tongue spasm
Clinical narrative: Seizure x 10 with pain internally; Shaking uncontrollably from head to toe; Joint pain; Body aches/Crying in pain; Tongue started having spasms like crazy jumping like heartbeat; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced body aches, tongue spasms, joint pains, seizures, and tremors.  The patient's medical history was not provided. Concomitant medications were not reported.  On 04 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient experienced body aches and tongue started having spasms that was explained as like crazy jumping like heartbeat. On 06 Jan 2021, she experienced joint pain. On 07 Jan 2021 at 8:00 AM, she experienced seizure times 10 with pain internally and convulsion, and she shook uncontrollably from head to toe and cried in pain. Her husband reported that her seizure-like symptoms were lessened during sleep. He took his wife to emergency room where blood test and urinalysis were performed but no significant findings were found. The patient was transferred to a different hospital's emergency room and was given lorazepam in the ambulance. At the hospital, the same tests were repeated with the same results. The patient was notified that there were no findings from the blood test, and no viruses were evident. The patient was given diphenhydramine at the hospital. The patient was advised to see a neurologist.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, body aches, tongue spasms, joint pains, seizures, and tremors, were not recovered.; Reporter's Comments: This case concerns a female patient who experienced serious unexpected events of Seizure, Pain, and Tremor, a non-serious unexpected event of Tongue spasm, and a non-serious expected event of Arthralgia. The events of Pain and Tongue spasm occurred on the same day when the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown). The event of Arthralgia occurred 3 days after the administration of mRNA-1273. The events of Seizure and Tremor occurred 4 days after the administration of mRNA-1273. Very limited information regarding the events has been provided at this time.  Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Urine analysis
Clinical narrative: Seizure x 10 with pain internally; Shaking uncontrollably from head to toe; Joint pain; Body aches/Crying in pain; Tongue started having spasms like crazy jumping like heartbeat; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced body aches, tongue spasms, joint pains, seizures, and tremors.  The patient's medical history was not provided. Concomitant medications were not reported.  On 04 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient experienced body aches and tongue started having spasms that was explained as like crazy jumping like heartbeat. On 06 Jan 2021, she experienced joint pain. On 07 Jan 2021 at 8:00 AM, she experienced seizure times 10 with pain internally and convulsion, and she shook uncontrollably from head to toe and cried in pain. Her husband reported that her seizure-like symptoms were lessened during sleep. He took his wife to emergency room where blood test and urinalysis were performed but no significant findings were found. The patient was transferred to a different hospital's emergency room and was given lorazepam in the ambulance. At the hospital, the same tests were repeated with the same results. The patient was notified that there were no findings from the blood test, and no viruses were evident. The patient was given diphenhydramine at the hospital. The patient was advised to see a neurologist.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, body aches, tongue spasms, joint pains, seizures, and tremors, were not recovered.; Reporter's Comments: This case concerns a female patient who experienced serious unexpected events of Seizure, Pain, and Tremor, a non-serious unexpected event of Tongue spasm, and a non-serious expected event of Arthralgia. The events of Pain and Tongue spasm occurred on the same day when the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown). The event of Arthralgia occurred 3 days after the administration of mRNA-1273. The events of Seizure and Tremor occurred 4 days after the administration of mRNA-1273. Very limited information regarding the events has been provided at this time.  Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administration error
Clinical narrative: Vaccine dose was less than 0.5ml; Vaccine dose as it was given to a patient squirted out from the needle; A spontaneous report was received from a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine dose was less than 0.5ml and vaccine dose as it was given to a patient squirted out from the needle.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the vaccine was being administered to the patient, the vaccine squirted out from the needle and the patient only received the left over dose from the needle. The patient received less than 0.5 ml of the Moderna Covid-19 vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, vaccine dose was less than 0.5ml and vaccine dose as it was given to a patient squirted out from the needle , were considered resolved on unknown date.; Reporter's Comments: This case concerns a patient of unknow age and gender, who experienced an unexpected event of inappropriate dose administered (less than 0.5ml was given) and vaccine squirted out of needle. The event occurred on an unknown date during the administration of the first dose of mRNA-1273(Lot number: 025J20A). This report refers to a case of Product administration error and inappropriate dose administered for mRNA-1273(Lot number: 025J20A).
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site pruritus, Injection site swelling
Clinical narrative: Itching at site; Swelling at the site; Had some leak; A spontaneous report was received from a female consumer consume who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine leak and then developed some itching and swelling at the site.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, patient experienced some of the vaccine leaked. On 8 Jan 2021, the patient developed some itching and swelling at vaccine site. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, experienced vaccine leak was considered resolved on 31 Dec 2020. The outcome of the events, then developed some itching and swelling at the site, were unknown.; Reporter's Comments: a)~The case concerns female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine leak after the first dose. Additionally, eight days after the first dose patient experienced non serious, related events of itching and swelling at injection site. Swelling at injection site is listed, however itching is unlisted. 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.  Causality assessment for vaccine leak was assessed as not applicable.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Ocular discomfort
Clinical narrative: Lightheaded; Dizzy in both eyes; Pressure surrounding left eye; Blood pressure went really high; A spontaneous report was received from a 48-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, lightheaded, dizzy in both eyes, pressure surrounding left eye, and blood pressure went really high.  The patient's medical history was not provided. Concomitant medications were not reported.  On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 07 Jan 2021, minutes after vaccination, the patient felt lightheaded, dizzy in both eyes, a pressure surrounding her left eye, and her blood pressure went really high. She was then sent to the emergency room and was advised to see a cardiologist. The patient was discharged from the hospital without any medication. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, lightheaded, dizzy in both eyes, pressure surrounding left eye, and blood pressure went really high, was not reported.; Reporter's Comments: This case concerns a 48 year old, female who experienced a serious unexpected event of dizziness, dizzy, ocular discomfort and blood pressure increased. The event occurred same day after first dose of mRNA-1273 (Lot# unknown) administration. The subject concomitant and treatment medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Injection site joint pain, Injection site pain, Product administered at inappropriate site
Clinical narrative: Think it was not administered properly; Arm pain in the injection site; Joint pain in the injection site; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced arm and joint pain at the injection site and doesn't think vaccine was administered properly.   The patient's medical history was not provided. No relevant concomitant medications were reported  On 09 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient reported that he received the Moderna Covid-19 vaccine on 09 Jan 2021. Per the patient, the vaccine was administered 2 inches higher than the usual intramuscular injection site. He reported that 16 hours later he was having arm pain and joint pain at the injection site. He did not believe that it was administered properly and that it is not injected into the muscle, but in the versa space. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The out come of the event, vaccine not administered properly is considered resolved on 09 Jan 2021. The outcome of the events arm and joint pain at the injection is considered unknown.; Reporter's Comments: This case concerns a male patient, who experienced a non-serious expected event of injection site pain, injection site joint pain and a non-serious unexpected event of product administered at inappropriate site. There were no reported AEs associated with product administered at inappropriate site. The events of injection site pain, injection site joint pain occurred same day after first dose of mRNA-1273, lot # unknown. No treatment was administered for the events. The event of product administered at inappropriate site was assessed as not-applicable. Based on the current available information and temporal association between the use of the product and onset of the events- injection site pain and injection site joint pain, a causal relationship cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle aches
Sex: F
Vaccine: COVID19
Symptoms: Blister, Body temperature increased, Cellulitis, Chills, Fatigue
Clinical narrative: Cellulitis of the left arm; Blisters; Left deltoid was super itchy; Barely slept; Intermittent flushing; Horrible headache; Felt exhausted; Body aches; Chills; A spontaneous report was received from a nurse concerning a 46-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced cellulitis, chills, body aches, headache, flushing, exhaustion, itching at the injection site, trouble sleeping, and blisters.   The patient's medical history, as provided by the reporter, included shingles, hysterectomy, acid reflux, and allergies to penicillin and sulfonamides. Relevant concomitant medications included estrogen patch.   On 31 Dec 2020, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   The patient developed pain in her left arm on 31 Dec 2020, which she treated with ice.  On 01 Jan 2021 she had chills, temperature of 100 degrees Fahrenheit (F), body aches, headache, and intermittent flushing.  She felt exhausted and her left deltoid became itchy, red, and there was a knot at the injection site.  On 07 Jan 2021 the injection site became more red, hot, painful, and itchy and she had a temperature of 99.4 F.  On 07 Jan 2021 at approximately 8:00 PM she presented to the emergency room where she was prescribed cefalexin.  On 08 Jan 2021 she applied ice and elevated the affected area.  On 09 Jan 2021 she developed bumps around the injection site that developed into blisters that began to weep.  On 11 Jan 2021 her temperature was 99.4 F.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events cellulitis, chills, exhaustion, itching at the injection site, had trouble sleeping, and blisters were not reported. The outcome for the event, headache, was considered recovered/resolved on 03 Jan 2021. The outcome for the event, body aches, was considered recovered/resolved on 04 Jan 2021. The outcome for the event, flushing, was considered recovered/resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a 46-year-old female subject with medical history of shingles, hysterectomy, acid reflux, and allergies to penicillin and sulfonamides, who experienced a serious, unexpected event of cellulitis, and nonseries events of flushing, injection site pruritus and blister, insomnia, headache, fatigue, myalgia and chills. These events occurred within 1 week after the first dose of the mRNA-1273 study medication administration. Treatment for these events included cefalexin, with no reported outcome for the events of cellulitis, chills, exhaustion, itching at the injection site, insomnia, and blisters. The outcome of the events headaches, body aches, and flushing are reported as recovered/resolved. 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: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Injection site pruritus, Insomnia, Myalgia
Clinical narrative: Cellulitis of the left arm; Blisters; Left deltoid was super itchy; Barely slept; Intermittent flushing; Horrible headache; Felt exhausted; Body aches; Chills; A spontaneous report was received from a nurse concerning a 46-years old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced cellulitis, chills, body aches, headache, flushing, exhaustion, itching at the injection site, trouble sleeping, and blisters.   The patient's medical history, as provided by the reporter, included shingles, hysterectomy, acid reflux, and allergies to penicillin and sulfonamides. Relevant concomitant medications included estrogen patch.   On 31 Dec 2020, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   The patient developed pain in her left arm on 31 Dec 2020, which she treated with ice.  On 01 Jan 2021 she had chills, temperature of 100 degrees Fahrenheit (F), body aches, headache, and intermittent flushing.  She felt exhausted and her left deltoid became itchy, red, and there was a knot at the injection site.  On 07 Jan 2021 the injection site became more red, hot, painful, and itchy and she had a temperature of 99.4 F.  On 07 Jan 2021 at approximately 8:00 PM she presented to the emergency room where she was prescribed cefalexin.  On 08 Jan 2021 she applied ice and elevated the affected area.  On 09 Jan 2021 she developed bumps around the injection site that developed into blisters that began to weep.  On 11 Jan 2021 her temperature was 99.4 F.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events cellulitis, chills, exhaustion, itching at the injection site, had trouble sleeping, and blisters were not reported. The outcome for the event, headache, was considered recovered/resolved on 03 Jan 2021. The outcome for the event, body aches, was considered recovered/resolved on 04 Jan 2021. The outcome for the event, flushing, was considered recovered/resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a 46-year-old female subject with medical history of shingles, hysterectomy, acid reflux, and allergies to penicillin and sulfonamides, who experienced a serious, unexpected event of cellulitis, and nonseries events of flushing, injection site pruritus and blister, insomnia, headache, fatigue, myalgia and chills. These events occurred within 1 week after the first dose of the mRNA-1273 study medication administration. Treatment for these events included cefalexin, with no reported outcome for the events of cellulitis, chills, exhaustion, itching at the injection site, insomnia, and blisters. The outcome of the events headaches, body aches, and flushing are reported as recovered/resolved. 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: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years and a half got the first shot; A spontaneous report was received from a pharmacist concerning a 17-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and 17 years and a half got the first shot.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, 17 years and a half got the first shot, was considered resolved on 07 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 025J20A), reporting Product administered to patient of inappropriate age without any associated adverse events.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Tachycardia
Clinical narrative: 10 minutes after vaccination, I was waiting in my car per instructions and began to feel extremely light headed and dizzy/faint.  I began to sweat a little and have minor tachycardia.  I never went back into the clinic but instead leaned the seat of my car back and those symptoms went away after about 30 minutes.  I never experienced any symptoms after that.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Headache, Pain in extremity
Clinical narrative: Mild cellulitis; Headache; Sore arm; A spontaneous report was received from a nurse, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm, headache, and mild cellulitis.   The patient's medical history was not provided. Concomitant medications reported included calcium and memantine hydrochloride.   On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 28 Dec 2020, after receiving the vaccine, the patient had a sore arm for 2-3 days. She was worried that she would get a headache so she took ibuprofen.   On 03 Jan 2021, the patient had a low-grade headache but it was not a migraine. She took acetaminophen and ibuprofen but it did not help.   On 04 Jan 2021, the patient's arm was a bit sore.   On 05 Jan 2021, the patient's headache went away but she felt she had mild cellulitis. Her arm felt a little bit warm at the injection site, it was also swollen and red. These symptoms persisted for about 2 days and then began to get better. Treatment for the events included ibuprofen, acetaminophen and icing.  Action taken with mRNA-1273 in response to the events was not reported.   The event, mild cellulitis, was considered resolving. The event, headache, was resolved on 05 Jan 2021. The outcome of the event, sore arm, was not reported.; Reporter's Comments: This case concerns a 67year old, female patient who experienced a serious unexpected event of cellulitis, and non-serious expected event of pain in extremity and headache. The event of pain in extremity occurred same day after first dose mRNA-1273 (Lot# 026L20A) administration. The event of headache occurred after 7 days and cellulitis occurred 9 days after mRNA-1273 (Lot# 026L20A) administration. The subject's concomitant medication included calcium and Biomentin. The treatment medications were included Tylenol, Advil and icing. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cellulitis, Fatigue, Myalgia
Clinical narrative: Cellulitis; Upset stomach; Mild muscle aches; Fatigue; A spontaneous report was received from a consumer concerning a male patient, who was also the patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced mild muscle aches, fatigue, cellulitis, and upset stomach.  The patient's medical history was not provided.  Concomitant medications were not reported.  On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for the prophylaxis of COVID-19 infection.  On 27 Dec 2020, the patient experienced mild muscle aches felt fatigued for a few days.  One week later, the injection site was red, swollen, hot to the touch and looked like cellulitis.  The redness grew significantly, and he also had an upset stomach.  The symptoms resolved.  Treatment information was not provided.  Action taken for the event was not reported.  The events, mild muscle aches, fatigue, cellulitis, and upset stomach, were considered recovered/resolved on an unknown date.; Reporter's Comments: This case concerns a male patient, who experienced the serious unexpected events of cellulitis, a non-serious unexpected event of abdominal discomfort and non-serious expected event of myalgia and fatigue. The event of myalgia and fatigue occurred after 2 days after the first dose of mRNA-1273 (Lot# unknown). The date of onset for cellulitis and abdominal discomfort was not provided. The treatment details were not provided. Very limited information regarding this event has 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: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site pain
Clinical narrative: A spontaneous report was received from a consumer who was a 59-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced the serious adverse event of cellulite at the injection site and local pain at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 31 Dec 2021, approximately one week 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 deltoid for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient had local pain at the site of the injection.   On 08 Jan 2021, she visited a healthcare provided who diagnosed cellulite at the injection site. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, cellulite at the injection site and injection site pain, was not reported.; Reporter's Comments: This spontaneous report refers to a case of a 59-year-old female patient who experienced events of local pain at the site of the injection and event of cellulite at the injection site  8 days after the administration of the first and only dose of mRNA-127 (Lot number 039K20A, Exp date-unknown). Based on temporal the information provided and the absence of any other etiology factors, a causal association between both events and vaccine administration cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Fever over 100, chills, body aches, extreme sleepiness,  headache, sore arm, joint pain
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Fever over 100, chills, body aches, extreme sleepiness,  headache, sore arm, joint pain
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: muscle aches, headache, fever 100.4, fatigue
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Lethargy, Nausea, Neck pain
Clinical narrative: Left hand numbness and tingling within a couple of hours of vaccine. About 8 hours after vaccine severe shoulder/neck pain on left side. Both symptoms resolved within 24 hours. Otherwise felt lethargic and nauseous for about 48 hours. All side effects disappeared within 48 hours and were somewhat alleviated with acetaminophen. No medical treatment was needed.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Left hand numbness and tingling within a couple of hours of vaccine. About 8 hours after vaccine severe shoulder/neck pain on left side. Both symptoms resolved within 24 hours. Otherwise felt lethargic and nauseous for about 48 hours. All side effects disappeared within 48 hours and were somewhat alleviated with acetaminophen. No medical treatment was needed.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Nausea
Clinical narrative: approximately 5 minutes after vaccine administration, reported headache and nausea.  Brief chest discomfort.  No respiratory symptoms, REsolved after 30 minutes and discharged to home.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Headache, Peripheral swelling, Skin warm
Clinical narrative: Chronic dizziness, Chronic arm swelling, redness, and hot. Chronic headache frontal.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphthous ulcer, Arthralgia, Lymphadenopathy, Musculoskeletal stiffness, Myalgia
Clinical narrative: Swollen throat glands + sore throat, beginning January 1, 2021 through January  7, 2021. Stiff and sore right shoulder and neck (muscular and joint pain), mid-January through present. Multiple Canker Sores on lower lip, January 22 through present.