chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: A spontaneous report was received from a consumer concerning a consumer of unknown age and gender who received Moderna's COVID-19 vaccine and experienced extreme chills, headache, muscle pain, joint pain and fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Dec 2020, approximately 0 days 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 31 Dec 2020, the patient had extreme chills throughout the night, headaches, muscle and joint pain and fatigue. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events were 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.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: A report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a planned dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  The patient reported they were running a fever on an unknown date. No additional details were provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, fever, was unknown.; Reporter's Comments: This case concerns a female of unknown age who had a nonserious expected event of pyrexia.  Event onset occurred with unknown latency after a planned dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the pyrexia, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy and red again in her left arm; became hard as rock; Swelled and big red mark 2/3 cm diameters; Swelled and big red mark 2/3 cm diameters; A report was received from a consumer concerning a 58-year old, female patient who received Moderna's COVID-19 vaccine and developed swelled and big red mark 2/3 cm diameters and itchy and red again in her left arm..  The patient's medical history and concomitant medications were not provided.  On 30 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced injection site swelling and a big red mark, approximately 2/3 centimeter. They drew a line around it and the next day it had extended outside the line and was "hard as a rock".  On 02 Jan 2021, the swelling and redness subside. On 06 Jan 2021, the injection site becomes itchy and is red again. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, injection site swelling, was considered recovered/resolved.  The outcome of the events, injection site redness and itching, were considered not recovered/ not resolved.   Follow-up received on 06 Jan 2021 included updated reporter information, updated patient information, additional events, and updated event outcome.; 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: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Erythema on the injection site; Warm to touch; Arm soreness; Fatigue; A spontaneous report was received from a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness, fatigue, erythema on the injection site, and warm to touch.   The patient's medical history was not provided. No relevant concomitant medications were provided.   On 24 Dec 2020, the patient received his first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in left arm for prophylaxis of COVID-19.  On 26 Dec 2020, the patient experienced arm soreness and fatigue.  On 01 Jan 2021, the patient stated that she started having erythema on the injection site. She was not sure if it is a bug bite, but it is bigger than insect bites and warm to touch. No treatment information was provided.     Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the events, headache, arm soreness, fatigue, erythema on the injection site, and warm to touch, were 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Chills; injection site reaction; Fatigue; Nausea; Fever; Headache; leg/muscle pain; Vomiting; A spontaneous report was received from a 67-year-old, male health care professional, who was also the patient, who received Moderna's COVID-19 vaccine and experienced an injection site reaction, fatigue, nausea, fever, headache, leg/muscle pain, vomiting, and chills.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) in their left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced injection site reaction (left arm), fatigue, nausea, fever, hadache, leg/muscle pain and vomiting. On the morning of 31 Dec 2020, the patient felt worst, but the patient also had a low-grade fever with chills on 01 Jan 2021. The patient was feeling a bit better with the rest of their symptoms, but their leg still hurt. The patient also vomited once on the morning of 01 Jan 2021 and was still experiencing the side effects at the time of reporting. Treatment for the events included paracetamol.   Action taken with mRNA-1273 in response to the events was unknown.  The events injection site reaction, fatigue, nausea, fever, headache, leg/muscle pain, vomiting, and chills were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site reaction, Vomiting
Clinical narrative: Chills; injection site reaction; Fatigue; Nausea; Fever; Headache; leg/muscle pain; Vomiting; A spontaneous report was received from a 67-year-old, male health care professional, who was also the patient, who received Moderna's COVID-19 vaccine and experienced an injection site reaction, fatigue, nausea, fever, headache, leg/muscle pain, vomiting, and chills.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) in their left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced injection site reaction (left arm), fatigue, nausea, fever, hadache, leg/muscle pain and vomiting. On the morning of 31 Dec 2020, the patient felt worst, but the patient also had a low-grade fever with chills on 01 Jan 2021. The patient was feeling a bit better with the rest of their symptoms, but their leg still hurt. The patient also vomited once on the morning of 01 Jan 2021 and was still experiencing the side effects at the time of reporting. Treatment for the events included paracetamol.   Action taken with mRNA-1273 in response to the events was unknown.  The events injection site reaction, fatigue, nausea, fever, headache, leg/muscle pain, vomiting, and chills were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: redness at distal to the injection site; Tenderness to the injection site itself.; swelling to injection site; A spontaneous report was received from other health professional concerning a 28-year-old, female patient who experienced swelling to injection site and redness at distal to the injection site and Tenderness to the injection site itself.    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 lithium, zolpidem tartrate, lorazepam, esomeprazole magnesium, and norethisterone acetate.  On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number 039K20A) intramuscularly in the Left Deltoid arm for prophylaxis of COVID-19 infection.   The reporter stated that the patient had swelling to injection site (start 01-JAN-2021) and redness at distal to the injection site and down the arm (start 02-JAN-2021) as well as tenderness to the injection site (start 02-JAN-2021). Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported  The outcome of the events, swelling to injection site and down the arm and tenderness to injection site were unknown.; Reporter's Comments: This case concerns a 28-year-old female who experienced NS expected events of injection site pain, injection site swelling, injection site erythema.  Event onset occurred 9 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Red hot spot at the site of injection; warm to touch.; A spontaneous report was received from a nurse concerning herself, a 64-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a red hot spot in her left arm was warm to the touch.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient reported that on day 2 after receiving the first injection, 01-Jan-2021, she noticed at the site of the injection a red hot spot in her left arm that was warm to the touch. She put an ice pack on the arm because she noticed it was hot.   Treatment for the event included paracetamol and cold therapy.    Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, red hot spot in her left arm was warm to the touch, was considered unknown.; Reporter's Comments: This case concerns a 64-year-old female who had nonserious events of unexpected vaccination site warmth and expected vaccination site erythema.  Event onset occurred 3 days after the first dose of mRNA-1273. Treated with Tylenol. Based on current available information and temporal association between use of the product and the start date of the vaccination site warmth and vaccination site erythema, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of RASH (Raised itchy rash on hands) and RASH (Raised itchy rash on feet) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN and LISINOPRIL for an unknown indication. On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced RASH (Raised itchy rash on hands) and RASH (Raised itchy rash on feet). On 05-Jan-2021, RASH (Raised itchy rash on hands) and RASH (Raised itchy rash on feet) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had three negative Covid-19 tests after rash. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: IRD date, patient  height, weight, concomitant drugs and event outcomes were updated; Sender'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: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: Body ache; shaking; sore at injection site; Fever of 102; chills; A report was received from a consumer concerning a 58-year old, male patient who was participating in the mRNA-1273 and experienced sore at injection site, fever of 102, chills, shaking, and body ache.   The patient's medical history, as provided by the reporter, included COVID-19. No relevant concomitant medications were reported.   On 31 Dec 2020 at 1:30 pm, approximately 0 days prior to the onset of the events, sore at injection site, fever of 102, chills and 1 day prior to the onset of the events shaking and body ache, the patient received their first of two planned doses of mRNA-1273 (LOT number 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced soreness at the injection site, a fever of 102 degrees and chills later in the night. On 01 Jan 2021, he experienced shaking in the afternoon and body ache. The patient was concerned his symptoms were indicative of another COVID infection. Treatment for the event included Tylenol.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were 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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site reaction
Clinical narrative: diarrhea, excess bowel movement just like colonoscopy flush; reaction at site of injection on his arm; A spontaneous report was received from a non-health professional concerning a 79-year-old, male consumer who received Moderna's COVID-19 vaccine and developed diarrhea and a reaction at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Dec 2020 at 10:00 AM, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.     On 29 Dec 2020, twelve hours post vaccination, the patient began to experience excess bowel movement which was more like colonoscopy flush. The patient reported diarrhea was also interfering in his day to day activities. He also developed a reaction at site of injection on his arm. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome for the events, diarrhea and a reaction at the injection site 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 events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram abdomen, Computerised tomogram thorax, Hiccups, Liver function test increased
Clinical narrative: Diffuse adenopathy; Elevated LFTs; Intractable hiccups; Fever; Chills; A spontaneous report was received from a health care provider concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed fever and chills, elevated LFTs, diffuse adenopathy and intractable hiccups.   The patient's medical history was not provided. Concomitant product use was not provided.  On an undisclosed date the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   A health care provider reported a patient received the vaccine and 24 hours later experienced fevers (100 to 100.5) and chills. Elevated LFTs after 3 to 4 days of receiving the vaccine. Diffuse adenopathy of abdomen and chest on CT and intractable hiccups.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, fever and chills, elevated LFTs, diffuse adenopathy and intractable hiccups, were considered unknown.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious listed events of fever and chills and the non-serious unlisted events of diffuse adenopathy, elevated LFTs, and intractable hiccups. Very limited information regarding these events has been provided at this time.  Based on temporal association between vaccination and the onset of events starting one day later, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Diffuse adenopathy; Elevated LFTs; Intractable hiccups; Fever; Chills; A spontaneous report was received from a health care provider concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed fever and chills, elevated LFTs, diffuse adenopathy and intractable hiccups.   The patient's medical history was not provided. Concomitant product use was not provided.  On an undisclosed date the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   A health care provider reported a patient received the vaccine and 24 hours later experienced fevers (100 to 100.5) and chills. Elevated LFTs after 3 to 4 days of receiving the vaccine. Diffuse adenopathy of abdomen and chest on CT and intractable hiccups.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, fever and chills, elevated LFTs, diffuse adenopathy and intractable hiccups, were considered unknown.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious listed events of fever and chills and the non-serious unlisted events of diffuse adenopathy, elevated LFTs, and intractable hiccups. Very limited information regarding these events has been provided at this time.  Based on temporal association between vaccination and the onset of events starting one day later, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness on injection stie; Pain on injection site; Soreness on injection site; A report was received from a consumer concerning a 48-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a vaccine injection site with pain, soreness and redness.   The patient's medical history and relevant concomitant medications were not reported.   On 24-Dec-2020, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 25-Dec-2020 the patient experienced injection site soreness and pain.  On 01-Jan-2021, the patient experienced redness at the injection site.  The patient treated the events with ibuprofen every four hours  and a warm compress beginning on 01-Jan-2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events soreness at the injection site, pain at the injection site, and redness at the injection site were not reported.  Reporter causality for the events was not provided.; 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: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical event.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact; Reporter's Comments: This is a case of vaccine exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site pain, Pyrexia
Clinical narrative: Injection site pain; 100 degree fever down to 99 the folloiwng morning and broke by 24 hours; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain and fever.   The patient's medical history was not provided.  No concomitant medications were provided.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient experienced injection site pain and fever about 2 hours after receiving the vaccine.  Her temperature was initially 100°F and remained feverish, hitting 101°F at the highest point.   On 30 Dec 2020, the fever resolved.  The injection site pain went away after 1-2 days.  No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, fever, was considered recovered on 30 Dec 2020.  The outcome of the event, injection site pain, was considered recovered on an unknown date.; 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. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on face; A spontaneous report was received from a consumer, concerning himself, a male patient of unspecified age, who received Moderna's COVID-19 vaccine and developed a rash on face.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unspecified date, after vaccination, the patient experienced rash on his face. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, rash on face 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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vaccination site pain, Vaccination site swelling
Clinical narrative: throbbing pain; swollen arm, hardness at the site of injection; bad chills; constant headache; feeling very tired; A spontaneous report was received from a consumer concerning a 49-year-old, female patient who was participating in the mRNA-1273 Emergency Use Program and experienced hardness at the site of injection, swollen arm, throbbing pain, bad chills, constant headache and feeling very tired.   The patient's medical history included migraines. Products known to have been used by the patient, within two weeks prior to the event, included gabapentin.    On 31-Dec-2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 01-Jan-2021, she began to experience side effects including hardness at the site of injection, a swollen arm, throbbing pain, bad chills, a constant headache and she felt very tired.  She reported it was like a horrible flu.  She took ibuprofen to help her chills but stated that it did not work.  She also took two warm showers, neither of which provided any relief.  Patient stated that she mostly laid in bed all day unable to move.  She attempted to treat her constant headache with the gabapentin she normally takes for migraines, however, that did not work either.  Patient reported that she is unsure if she will get the second dose of the vaccine. Treatment for the event included gabapentin, ibuprofen and warm showers.   Action taken with mRNA-1273 in response to the events is not applicable.  The outcome of the events, hardness at the site of injection, swollen arm, throbbing pain, bad chills, constant headache and feeling very tired, were considered as 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: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Lower extremities pain; A spontaneous report was received from a other health care professional concerning a 44 year-old, male patient who received Moderna's COVID-19 vaccine and experienced lower extremities pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient began to experience pain in his lower extremities for 10 days (at the time of report). No treatment information was provided.   Action taken with mRNA-1273 in response to the event(s) was not reported.   The outcome of the event was unknown.; Reporter's Comments: Based on the information provide which includes a temporal association, a causal association between the reported event and the product use cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Pain in jaw
Clinical narrative: Dull jaw pain on the left side; left cheek was heavy without facial droop or swelling; A spontaneous report was received from a healthcare professional who was a female patient that experienced dull jaw pain on left side and her left cheek feeling heavy, without facial droop or swelling.    The patient's medical history included temporomandibular joint syndrome. Concomitant product use was not provided/unknown by the reporter.  On 04 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in the left shoulder for prophylaxis of COVID-19 infection.   The reporter stated that soon after receiving the Moderna Covid-19 vaccine, she felt some dull jaw pain on the left side, which was resolved after a massage. Within an hour of receiving the vaccine, she felt heaviness in her left cheek, with no facial droop or swelling. Treatment for the event included 500mg acetaminophen and diphenhydramine hydrochloride. She volunteered that she always takes diphenhydramine hydrochloride following intramuscular injections.    Action taken with mRNA-1273 in response to the events is nor appplicabe.   The event, dull jaw pain on the left side was considered resolved on 04 Jan 2021. The outcome of the event left cheek was heavy, without facial droop or swelling is unknown.   The reporter did not provide causality for the events dull jaw pain on left side and her left cheek feeling heavy, without facial droop or swelling.; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Musculoskeletal stiffness
Clinical narrative: Herpes simplex; Stiff neck left/First sign of cold sore was concurrent with stiff left side of neck; This spontaneous case was reported by a consumer and describes the occurrence of HERPES SIMPLEX (Herpes simplex) and MUSCULOSKELETAL STIFFNESS (Stiff neck left/First sign of cold sore was concurrent with stiff left side of neck) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Hypothyroidism in 1983 and Essential hypertension in 2018. Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) and AMLODIPINE for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, ZOLPIDEM TARTRATE (AMBIEN) for Insomnia, LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES SIMPLEX (Herpes simplex) and MUSCULOSKELETAL STIFFNESS (Stiff neck left/First sign of cold sore was concurrent with stiff left side of neck). On 02-Feb-2021, MUSCULOSKELETAL STIFFNESS (Stiff neck left/First sign of cold sore was concurrent with stiff left side of neck) had resolved. On 03-Feb-2021, HERPES SIMPLEX (Herpes simplex) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The reporter mentioned the first sign of cold sore was concurrent with stiff left side of neck.  Treatment information not provided by reporter.       Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up recived and reporter information updated, patient medical history and concomitant medications updated, vaccine information updated and event information updated.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: All the muscle aches and pains; Nausea; A spontaneous report was received from a 36-year-old female health care professional who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced all the muscle aches and pains, and nausea.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the patient reported having muscle aches and pains. She also reported nausea but denied experiencing vomiting, swollen lymph nodes and fever.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, all the muscle aches and pains, and nausea, were 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
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site movement impairment
Clinical narrative: Shoulder pain; Can't move arm; A spontaneous report was received from a consumer concerning herself, a female patient of an unknown age who received Moderna's (mRNA-1273) COVID-19 Vaccine and experienced shoulder pain and inability to move her arm after receiving the vaccine.    The patient's medical history was not provided. No concomitant medications were provided.   On an unspecified date, prior to the onset of the symptoms, the patient received their dose of mRNA-1273 (Lot/Batch number unknown) for prophylaxis of COVID-19 infection.   The patient received the vaccine and now was having shoulder pain and can't move her arm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events shoulder pain and inability to move her arm after receiving the vaccine was provided.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness at injection site; Swelling at injection site; Pain at the injection site; A spontaneous report was received from a consumer concerning a 70-year-old, male patient who was participating in the mRNA-1273 Emergency Use Program and who experienced redness/vaccination site erythema, welling at the injection site/vaccination site swelling, and pain at the injection site/vaccination site pain.  The patient's medical history was not provided.  Products known to have been used by the patient, withing two weeks prior to the event, included Vascepa, Tribenzor, Rosuvastatin Calcium, Levothyroxine Sodium, Allopurinol, Xigduo, Omeprazole and Multivitamin.    On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (LOT: 011J20A) intramuscularly in the left shoulder for prophylaxis of COVID -19 infection.      On 24 Dec 2020, the patient experienced persistent redness, swelling at the injection site and pain in the arm for last two weeks.    Treatment for the events included taking Naproxen, keeping the injection site very clean and application of antibiotic ointment.   Action taken with the mRNA-1272 in response to the events, redness, swelling at the injection site and pain in the arm was not provided.   The events redness, swelling at the injection site and pain in arm were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Nausea; A spontaneous report was received from a consumer concerning a female patient who experienced fever/: pyrexia, chills/: chills, and nausea/: nausea.   The patient's medical history and concomitant product use were not provided/unknown by the reporter.  On 29-Dec-2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, after the patient received her first dose of vaccine she developed a fever of almost 103 degrees, chills, and nausea.  At the time of the report the outcome for the events was unknown.   Action taken with mRNA-1273 in response to the events was not provided/unknown.  The outcome of the events was not reported.; 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. Further information has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site mass, Injection site pain, Pain in extremity
Clinical narrative: Knot at injection site; Arm felt warm to touch; Headache; Fever; Tenderness at the injection site; Sore arm; A spontaneous report was received from a 52 year old, female, health care professional who received Moderna's COVID-19 Vaccine, and experienced a headache, fever, knot at injection site, tenderness at injection site, sore arm and arm felt warm to touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced a headache, fever, knot at injection site, tenderness at injection site, a sore arm and her arm felt warm to touch. The patient took Tylenol (acetaminophen) but symptoms did not improve. Consent was given to follow up and HCP contact provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, headache, fever, knot at injection site, tenderness at injection site, sore arm and arm felt warm to touch, were not resolved at the time of the report.; Reporter's Comments: This case concerns a 52-year-old female who experienced NS events of unexpected injection site mass, injection site warmth and expected pyrexia, headache, injection site pain, pain in extremity.  Event onset occurred on day 2 after the first dose of mRNA-1273. Treated with Tylenol. Events ongoing. Based on 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site warmth
Clinical narrative: Knot at injection site; Arm felt warm to touch; Headache; Fever; Tenderness at the injection site; Sore arm; A spontaneous report was received from a 52 year old, female, health care professional who received Moderna's COVID-19 Vaccine, and experienced a headache, fever, knot at injection site, tenderness at injection site, sore arm and arm felt warm to touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, approximately one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced a headache, fever, knot at injection site, tenderness at injection site, a sore arm and her arm felt warm to touch. The patient took Tylenol (acetaminophen) but symptoms did not improve. Consent was given to follow up and HCP contact provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, headache, fever, knot at injection site, tenderness at injection site, sore arm and arm felt warm to touch, were not resolved at the time of the report.; Reporter's Comments: This case concerns a 52-year-old female who experienced NS events of unexpected injection site mass, injection site warmth and expected pyrexia, headache, injection site pain, pain in extremity.  Event onset occurred on day 2 after the first dose of mRNA-1273. Treated with Tylenol. Events ongoing. Based on 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: Body temperature, Headache, Malaise, Pyrexia
Clinical narrative: headache; fever; Did not feel good; A spontaneous report was received from a health care provider concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed headache, pyrexia and did not feel good.   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 (Lot #011L20A) on 04 Jan 2021 in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021 the patient didn't feel good and experienced headache and pyrexia. She took her temperature while at work and two separate readings,  104. 8 degrees and 102 degrees.   Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, headache and pyrexia, was considered unknown  The reporter did not provide an assessment of the event, headache and pyrexia.; 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: M
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: Heartburn; A spontaneous report was received from a echocardiographer concerning a patient who may have received the Moderna's Covid-19 vaccine (mRNA-1273) and developed heartburn.  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 (Lot # not provided) on (date of vaccine not provided) for prophylaxis of COVID-19 infection.   The echocardiographer reported hearing someone say they had heartburn and asking if anyone else had heartburn at the facility. The reporter was unsure if this patient did or did not receive the vaccine.  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, heartburn, was considered unknown.   The reporter did not provide an assessment of the event, heartburn.; Reporter's Comments: Very limited information regarding these event has been provided at this time.  Further information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Confusional state, Dysmenorrhoea, Fatigue, Feeling abnormal
Clinical narrative: 1. Soreness at injection site lasting approximately 72 hours 2. Malaise, fatigue, mental confusion (brain fog) lasting approximately 72 hours 3. Lower back pain and menstrual cramping at day 11 of 28 day cycle lasting approximately 48 hours, which is abnormal for patient who's menstrual cycles are consistently 28 days with ovulation occurring around day 14 and premenstrual symptoms occurring with 3 to 7 days prior to onset of menstruation. 5. Menstruation began on time at day 28 in a 28 day cycle, however, bleeding was unusually heavy from day 1 to 3.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Injection site pain, Malaise
Clinical narrative: 1. Soreness at injection site lasting approximately 72 hours 2. Malaise, fatigue, mental confusion (brain fog) lasting approximately 72 hours 3. Lower back pain and menstrual cramping at day 11 of 28 day cycle lasting approximately 48 hours, which is abnormal for patient who's menstrual cycles are consistently 28 days with ovulation occurring around day 14 and premenstrual symptoms occurring with 3 to 7 days prior to onset of menstruation. 5. Menstruation began on time at day 28 in a 28 day cycle, however, bleeding was unusually heavy from day 1 to 3.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor'S recommendation or ACIP guidance.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Patient started having tingling feelings in hands and legs a couple hours after vaccination and still is persistent as of today 8/9/21
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, Blood creatine phosphokinase normal, Blood magnesium normal, Blood phosphorus normal
Clinical narrative: Patient started having tingling feelings in hands and legs a couple hours after vaccination and still is persistent as of today 8/9/21
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone normal, C-reactive protein normal, Chlamydia test negative, Computerised tomogram head normal, Double stranded DNA antibody
Clinical narrative: Patient started having tingling feelings in hands and legs a couple hours after vaccination and still is persistent as of today 8/9/21
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Glycosylated haemoglobin, HIV test negative, Hepatitis B test negative, Laboratory test normal
Clinical narrative: Patient started having tingling feelings in hands and legs a couple hours after vaccination and still is persistent as of today 8/9/21
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lipase normal, Liver function test normal, Metabolic function test normal, Pain, Paraesthesia
Clinical narrative: Patient started having tingling feelings in hands and legs a couple hours after vaccination and still is persistent as of today 8/9/21
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Protein urine absent, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Sexually transmitted disease test, Treponema test negative
Clinical narrative: Patient started having tingling feelings in hands and legs a couple hours after vaccination and still is persistent as of today 8/9/21
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urine analysis normal, Vitamin B12 normal, Vitamin B6 normal, Vitamin D
Clinical narrative: Patient started having tingling feelings in hands and legs a couple hours after vaccination and still is persistent as of today 8/9/21
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pyrexia, Sensitive skin
Clinical narrative: For approximately 24 hours, full-body joint aches, sensitive skin/scalp, fever ranging from 99-104 degrees F.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urine odour abnormal
Clinical narrative: Unusual smelling urine
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymph nodes / tender to touch under left arm pit. Left arm pain.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: About 5 minutes after injection, patient complained of itching in throat and began coughing. No rash or reaction was visible at injection site. Patient used an albuterol nebulizer to help with breathing until EMS arrived. Patient was also given 50mg diphenhydramine po while waiting for EMS as she did not want Epinephrine injection.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT GOT VACCINE ON 8/5/21 AND CAME ON 8/9/2021 TO PICK UP ANTI BIOTIC AND HAD CONVERSATION THEN FIND OUT ABOUT HER REACTION. SHE HAD SMALL BRUISE ON HER LEFT ARM AT INJECTION SITE, HER AREA OF VACCINATION IS SWALLON, RED AND HOT. SHE STARTED FEVER NEXT DAY, SHE STATED THAT SHE DID TOOK TYLENOL 500MG EVERY 6 HOURS TO HELP, BUT IT WAS ON AND OFF. SHE FELT LIKE ALLERGIC REACTION ALL OVER HER BODY AND HAVING ITCH AT INJECTION SITE AND OTHER AREAS OF  BODY. SHE WENT TO PRIMARY CARE DOCTOR TODAY, AND SHE WAS TOLD TO FINISH BACTRIM DS FOR 10 DAYS, BENDRYL AND TYLENOL UNTIL SYMTOMPS GETS BETTER.