chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; A spontaneous report was received from a male patient of unspecified age concerning himself who received Modern's COVID-19 vaccine (mRNA-1273) and experienced sinus infection.  The patient's medical history provided was not provided. No relevant concomitant medications reported.  On 21 Jan 2021, 21 days prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route of administration in an unknown anatomical location for prophylaxis of COVID-19 infection.    On an unknown date in Feb 2021, the patient experienced sinus infection.  No treatment information provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of the report, the outcome of event sinus infection was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Discomfort, Fatigue, Pain in extremity, Palpitations
Clinical narrative: Palpitations; Panic attack; Could not function; Was not herself; Little fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PALPITATIONS (Palpitations), PANIC ATTACK (Panic attack), COGNITIVE DISORDER (Could not function) and DISCOMFORT (Was not herself) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z8L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Little fatigue). On 13-Feb-2021, the patient experienced PALPITATIONS (Palpitations), PANIC ATTACK (Panic attack), COGNITIVE DISORDER (Could not function) and DISCOMFORT (Was not herself). The patient was treated with METRONIDAZOLE from 11-Feb-2021 to 15-Feb-2021 for Infection, at an unspecified dose and frequency. On 11-Feb-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Little fatigue) had resolved. On 15-Feb-2021, PALPITATIONS (Palpitations), PANIC ATTACK (Panic attack), COGNITIVE DISORDER (Could not function) and DISCOMFORT (Was not herself) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: event outcome updated
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: Palpitations; Panic attack; Could not function; Was not herself; Little fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PALPITATIONS (Palpitations), PANIC ATTACK (Panic attack), COGNITIVE DISORDER (Could not function) and DISCOMFORT (Was not herself) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z8L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Little fatigue). On 13-Feb-2021, the patient experienced PALPITATIONS (Palpitations), PANIC ATTACK (Panic attack), COGNITIVE DISORDER (Could not function) and DISCOMFORT (Was not herself). The patient was treated with METRONIDAZOLE from 11-Feb-2021 to 15-Feb-2021 for Infection, at an unspecified dose and frequency. On 11-Feb-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Little fatigue) had resolved. On 15-Feb-2021, PALPITATIONS (Palpitations), PANIC ATTACK (Panic attack), COGNITIVE DISORDER (Could not function) and DISCOMFORT (Was not herself) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: event outcome updated
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site cyst
Clinical narrative: redness; knot underneath; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness, knot underneath there.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   Redness, Knot underneath there.  Treatment details included Ice.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), redness and knot underneath  was Not recovered/Not resolved .
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: 2 swollen lymph nodes; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (2 swollen lymph nodes) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (2 swollen lymph nodes). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (2 swollen lymph nodes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No relevant treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: pain to touch; (Injection site )Itching; Knot; Swollen at the injection; Redness about 2 inches; Hot to touch at injection site; Sore arm; Achy arm; Tired; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, swollen at the injection, (injection site )itching, redness about 2 inches, hot to touch at injection site, knot, painful to touch, achy arm, tired.  The patient's medical history was not provided.  concomitant medications included unspecified medications.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) sore arm . On 12 Feb 2021, the patient experienced the event(s) swollen at the injection. (injection site )itching, redness about 2 inches, hot to touch at injection site, knot, painful to touch, achy arm, tired.  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, swollen at the injection,(injection site )itching,redness about 2 inches,hot to touch at injection site,knot,painful to touch,achy arm,tired was Recovering/Resolving.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain, Pain in extremity
Clinical narrative: pain to touch; (Injection site )Itching; Knot; Swollen at the injection; Redness about 2 inches; Hot to touch at injection site; Sore arm; Achy arm; Tired; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, swollen at the injection, (injection site )itching, redness about 2 inches, hot to touch at injection site, knot, painful to touch, achy arm, tired.  The patient's medical history was not provided.  concomitant medications included unspecified medications.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) sore arm . On 12 Feb 2021, the patient experienced the event(s) swollen at the injection. (injection site )itching, redness about 2 inches, hot to touch at injection site, knot, painful to touch, achy arm, tired.  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, swollen at the injection,(injection site )itching,redness about 2 inches,hot to touch at injection site,knot,painful to touch,achy arm,tired was Recovering/Resolving.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) itching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), itching was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Red at injection site; injection site is raised; Sore arm; A spontaneous report was received from a consumer concerning a 57-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, injection site is raised, red at the injection site.  The patient's medical history included the patient is HIV positive and is ongoing. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient experienced the event(s) sore arm,On 11 Feb 2021, the patient experienced the event(s) injection site is raised, red 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 event(s), sore arm, injection site is raised, red at the injection site was unknown.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: fever; warmth; red spot; hardness left arm; A spontaneous report was received from a consumer concerning a herself, who is a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, red spot, hardness left arm, warmth.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 04 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient experienced the events fever, red spot, hardness left arm, warmth.  No treatment details were reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events fever, red spot, hardness left arm, warmth was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site reaction
Clinical narrative: lymph nodes of armpit where the vaccine was administered are really sore; Lymph nodes of armpit where the vaccine was administered are really sore; Mild symptoms; Felt dizzy after the administration; Had a little bit of every symptoms but mild; A spontaneous report was received from a consumer concerning herself, who is a 41-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild symptoms, felt dizzy after the administration, had a little bit of every symptoms but mild, lymph nodes of armpit where the vaccine was administered are really sore.  The patient's medical history was not provided. Concomitant medications reported were aderol for drug use for unknown indication.  On 06 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 06 Feb 2021, the patient experienced the events mild symptoms, felt dizzy after the administration, pretty much had a little bit of every symptoms but mild. What bothers her is that the lymph nodes of armpit where the vaccine was administered are really sore.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events mild symptoms, felt dizzy after the administration, had a little bit of every symptoms but mild, lymph nodes of armpit where the vaccine was administered are really sore was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache the whole day, nauseated, muscle ache,  The patient's medical history was not provided. Concomitant medications reported were Depakote, Prozac, Crestor, Welbutrin, Synthroid, Tramadol, Vit C, Calcium, Vit. D3 all  for drug use for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) headache the whole day. nauseated, muscle ache.  Treatment details included :no treatment taken.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache the whole day, nauseated,muscle ache,  was unknown.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Fear
Clinical narrative: So Afraid; just feel horrible; Fatigue; Headache; joint pain; muscle pain; Fever 99 degrees; Chills; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, headache, muscle pain/myalgia, joint pain/arthralgia, chills, fever 99 degrees, just feel horrible/feeling abnormal, so afraid/fear.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, at 7.00 pm approximately eight hours after receiving the vaccine the patient experienced the events fatigue, headache, muscle pain, joint pain, chills, fever 99 degrees, just feel horrible, so afraid.  Treatment details included paracetamol, naproxen, baby aspirin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events fatigue, headache, muscle pain, joint pain, chills, fever 99 degrees, just feel horrible, so afraid was unknown.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Pyrexia
Clinical narrative: So Afraid; just feel horrible; Fatigue; Headache; joint pain; muscle pain; Fever 99 degrees; Chills; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, headache, muscle pain/myalgia, joint pain/arthralgia, chills, fever 99 degrees, just feel horrible/feeling abnormal, so afraid/fear.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, at 7.00 pm approximately eight hours after receiving the vaccine the patient experienced the events fatigue, headache, muscle pain, joint pain, chills, fever 99 degrees, just feel horrible, so afraid.  Treatment details included paracetamol, naproxen, baby aspirin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events fatigue, headache, muscle pain, joint pain, chills, fever 99 degrees, just feel horrible, so afraid was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: swelling at the site of injection; redness at the site of injection; hardness at the site of injection; fever; soreness at the site of injection; A spontaneous report was received from a healthcare professional concerning a 64-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness, swelling, redness, hardness, fever at the site of injection.  The patient's medical history include past medical history of 3 cancers and lung issues, rheumatoid arthritis, and skin disorder due to her cancers and surgeries. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event soreness . On 11 Feb 2021, the patient experienced the events swelling, redness, hardness, fever at the site of injection. Treatment details included Ice, Tylenol, and Aleve.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events soreness, swelling, redness, hardness, fever at the site of injection was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Vertigo
Clinical narrative: vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after; vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after; vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after the first dose of the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: not provided) in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the events- vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after the first dose of the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(vertigo, dizziness, kind of low blood pressure sensation now and then for about three weeks after the first dose of the vaccine was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Reaction after second dose; A spontaneous report  was received from a consumer, concerning a group of patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced reaction after second dose/ adverse reaction.  The patients' medical history was not provided. Concomitant products use was not provided by the reporter.   On unspecific date, few hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: [unknown] not specified site for prophylaxis of COVID-19 infection.   On unknown date, after vaccine administration the patient experienced adverse reaction. Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events, reaction after second dose was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Injection site pain, Vaccination site swelling, Vomiting
Clinical narrative: Wooziness; Stomach Pain; Vomiting; Pain; swelling; A spontaneous report was received from a consumer concerning a 87-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain, swelling, wooziness, stomach pain, vomiting.  The patient's medical history was not provided. Concomitant medications reported were Loratadine, Thyroid Pill, Ocuvite, Lipitor, Vitamin D3, Calcium, Vitamin C for drug use for unknown indication.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the event(s) pain, swelling. On 10 Feb 2021, the patient experienced the event(s) wooziness, stomach pain, vomiting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain, swelling, wooziness, stomach pain, vomiting was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site mass, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: welt is larger and around the skin is pink; Underneath it feels like a lump; rash next to the injection site, it was swollen, itchy and hot to the touch.; rash next to the injection site, it was swollen, itchy and hot to the touch; a rash next to the injection site, it was swollen, itchy and hot to the touch.; rash next to the injection site, it was swollen, itchy and hot to the touch.; A spontaneous report was received from a consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash next to the injection site, it was swollen, itchy and hot to the touch and welt is larger and around the skin is pink, and underneath it feels like a lump.  The patient's medical history was not provided. Concomitant medications reported were vitaminas for drug use for unknown indication.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: not provided) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) rash next to the injection site, it was swollen, itchy and hot to the touch. a. On 11 Feb 2021, the patient experienced the event(s) welt is larger and around the skin is pink, and underneath it feels like a lump.  Treatment details were not provided. Patient gives consent for Safety to follow case.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash next to the injection site, it was swollen, itchy and hot to the touch and welt is larger and around the skin is pink, and underneath it feels like a lump was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: welt is larger and around the skin is pink; Underneath it feels like a lump; rash next to the injection site, it was swollen, itchy and hot to the touch.; rash next to the injection site, it was swollen, itchy and hot to the touch; a rash next to the injection site, it was swollen, itchy and hot to the touch.; rash next to the injection site, it was swollen, itchy and hot to the touch.; A spontaneous report was received from a consumer concerning a 55-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash next to the injection site, it was swollen, itchy and hot to the touch and welt is larger and around the skin is pink, and underneath it feels like a lump.  The patient's medical history was not provided. Concomitant medications reported were vitaminas for drug use for unknown indication.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: not provided) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) rash next to the injection site, it was swollen, itchy and hot to the touch. a. On 11 Feb 2021, the patient experienced the event(s) welt is larger and around the skin is pink, and underneath it feels like a lump.  Treatment details were not provided. Patient gives consent for Safety to follow case.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash next to the injection site, it was swollen, itchy and hot to the touch and welt is larger and around the skin is pink, and underneath it feels like a lump was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Influenza like illness, Intentional product use issue, Muscle tightness
Clinical narrative: Flu like symptoms; extreme muscle tightness that she was not able to get up or move on her own; Bedridden for 4 to 5 days; 2nd shot is not intended to; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCLE TIGHTNESS (extreme muscle tightness that she was not able to get up or move on her own), BEDRIDDEN (Bedridden for 4 to 5 days) and INTENTIONAL PRODUCT USE ISSUE (2nd shot is not intended to) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCLE TIGHTNESS (extreme muscle tightness that she was not able to get up or move on her own), BEDRIDDEN (Bedridden for 4 to 5 days) and INTENTIONAL PRODUCT USE ISSUE (2nd shot is not intended to). The patient was treated with Hospice care (in the emergency doctor treated her) for Influenza like illness and Hospice care (in the emergency doctor treated her) for Muscle tightness. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCLE TIGHTNESS (extreme muscle tightness that she was not able to get up or move on her own) and BEDRIDDEN (Bedridden for 4 to 5 days) was resolving and INTENTIONAL PRODUCT USE ISSUE (2nd shot is not intended to) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported. No treatment information was provided by the reporter for the events BEDRIDDEN and INTENTIONAL PRODUCT USE ISSUE.  Next day after taken to the emergency, the patient was sent home. The patient did not take the 2nd shot and was not intended to.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up received on 12-Jul-2021, events were added, patient demographics was updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: hive on her neck"; she feels so bad; significant muscle pain; stiffness; achiness, body aches and pains; chills; fatigue; just wants to get into bed"; significant nausea; headache; A spontaneous report () was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events significant nausea, headache, hive on her neck?, felt like it moved to her left eye, she feels so bad, significant muscle pain, stiffness, achiness, chills, body aches, pains, fatigue, just wants to get into bed.  The patient's medical history include Allergies include ibuprofen. PMH includes hypertension.  Concomitant medications reported were amlodipine, atorvastatin, D3, multi vitamins for drug use for unknown indication.  On 17 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) in the left arm for prophylaxis of COVID-19 infection. On 14 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) in the left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the events significant nausea and headache . On 15 Feb 2021, the patient experienced the events hive on her neck?, felt like it moved to her left eye, she feels so bad, significant muscle pain, stiffness, achiness, chills, body aches, pains, fatigue, just wants to get into bed.  Treatment details included Aleve.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, significant nausea, headache, hive on her neck?, felt like it moved to her left eye, she feels so bad, significant muscle pain, stiffness, achiness, chills, body aches, pains, fatigue, just wants to get into bed was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pain, Urticaria
Clinical narrative: hive on her neck"; she feels so bad; significant muscle pain; stiffness; achiness, body aches and pains; chills; fatigue; just wants to get into bed"; significant nausea; headache; A spontaneous report () was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events significant nausea, headache, hive on her neck?, felt like it moved to her left eye, she feels so bad, significant muscle pain, stiffness, achiness, chills, body aches, pains, fatigue, just wants to get into bed.  The patient's medical history include Allergies include ibuprofen. PMH includes hypertension.  Concomitant medications reported were amlodipine, atorvastatin, D3, multi vitamins for drug use for unknown indication.  On 17 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) in the left arm for prophylaxis of COVID-19 infection. On 14 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) in the left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the events significant nausea and headache . On 15 Feb 2021, the patient experienced the events hive on her neck?, felt like it moved to her left eye, she feels so bad, significant muscle pain, stiffness, achiness, chills, body aches, pains, fatigue, just wants to get into bed.  Treatment details included Aleve.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, significant nausea, headache, hive on her neck?, felt like it moved to her left eye, she feels so bad, significant muscle pain, stiffness, achiness, chills, body aches, pains, fatigue, just wants to get into bed was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site swelling, Pain
Clinical narrative: little bit swollen; pink; sore; A spontaneous report was received from a consumer concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site is a little bit swollen, pink, sore, not excruciating.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the events injection site is a little bit swollen, pink, sore, not excruciating. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events injection site is a little bit swollen, pink, sore, not excruciating was considered unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Pain in extremity, Skin warm, Vaccination site induration
Clinical narrative: A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm got very sore/pain in extremity, left arm was very tight/limb discomfort, left arm was red/erythema, left arm was hot to the touch/skin warm, there was a knot/vaccination site induration.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 043L20A) in the left arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event arm got very sore. On 5 Feb 2021, the patient experienced the event left arm was very tight, left arm was red, left arm was hot to the touch, there was a knot. On 12 Feb 2021, the patient mentioned the knot was still there. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events arm got very sore, left arm was very tight, left arm was red, left arm was hot to the touch, there was a knot, knot was still there was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Fatigue, Feeling hot, Headache, Pain in extremity
Clinical narrative: fatigue; sinus pressure; headache; post nasal drip; dry throat; hot arm feeling; arm soreness; A spontaneous report was received from a consumer concerning a 71-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm soreness, fatigue, sinus pressure, headache, post nasal drip, dry throat, hot arm feeling.  The patient's medical history include hypothyroidism, hyperlipidemia and acid reflux disease. Concomitant medications reported were Simvastatin for cholesterol, Levothyroxine for thyroid, Esomeprazole for acid reflux.  On 10 Feb 2021, prior to the onset of the events the patient received their last of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event arm soreness . On 11 Feb 2021, the patient experienced the events fatigue, sinus pressure, headache, post nasal drip, dry throat, hot arm feeling.   Treatment details included Took Tylenol XR 2 tabs.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event- arm soreness was considered resolved on 12 Feb 2021. The outcome of events fatigue, sinus pressure, headache, post nasal drip, dry throat, hot arm feeling  was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Rhinorrhoea
Clinical narrative: fatigue; sinus pressure; headache; post nasal drip; dry throat; hot arm feeling; arm soreness; A spontaneous report was received from a consumer concerning a 71-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm soreness, fatigue, sinus pressure, headache, post nasal drip, dry throat, hot arm feeling.  The patient's medical history include hypothyroidism, hyperlipidemia and acid reflux disease. Concomitant medications reported were Simvastatin for cholesterol, Levothyroxine for thyroid, Esomeprazole for acid reflux.  On 10 Feb 2021, prior to the onset of the events the patient received their last of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event arm soreness . On 11 Feb 2021, the patient experienced the events fatigue, sinus pressure, headache, post nasal drip, dry throat, hot arm feeling.   Treatment details included Took Tylenol XR 2 tabs.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of event- arm soreness was considered resolved on 12 Feb 2021. The outcome of events fatigue, sinus pressure, headache, post nasal drip, dry throat, hot arm feeling  was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at a dose of UNK, qid. At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: tches around injection site; Red spot developed around injection site about the size of an orange.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (tches around injection site) and VACCINATION SITE ERYTHEMA (Red spot developed around injection site about the size of an orange.) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included INSULIN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (tches around injection site) and VACCINATION SITE ERYTHEMA (Red spot developed around injection site about the size of an orange.). At the time of the report, VACCINATION SITE PRURITUS (tches around injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (Red spot developed around injection site about the size of an orange.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: Rash from head to toe; arm sore; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash from head to toe) and MYALGIA (arm sore) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced MYALGIA (arm sore). On 03-Feb-2021, the patient experienced RASH (Rash from head to toe). The patient was treated with PREDNISONE for Symptomatic treatment, at a dose of 8 days of prednisone. At the time of the report, RASH (Rash from head to toe) and MYALGIA (arm sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information also included a steroid injection.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction). At the time of the report, ADVERSE REACTION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Injection site is swollen; Lymph nodes tender on the same arm; Injection site is red; Fever; Body aches; vomiting; diarrhea; pain; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), DIARRHOEA (diarrhea), MYALGIA (pain), INJECTION SITE SWELLING (Injection site is swollen) and VACCINATION SITE LYMPHADENOPATHY (Lymph nodes tender on the same arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3000493) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia since 1980. Concomitant products included GABAPENTIN, AMITRIPTYLINE HYDROCHLORIDE (LAROXYL), PAROXETINE, CETIRIZINE and FENOFIBRATE for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VOMITING (vomiting), DIARRHOEA (diarrhea) and MYALGIA (pain). On 11-Feb-2021, the patient experienced INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes tender on the same arm), INJECTION SITE ERYTHEMA (Injection site is red), PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (DOLIPRANE) for Adverse event, at an unspecified dose and frequency. At the time of the report, VOMITING (vomiting), DIARRHOEA (diarrhea), MYALGIA (pain), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes tender on the same arm), INJECTION SITE ERYTHEMA (Injection site is red), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.            Antispasmodics were reported as treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information received on 14-JUL-2021 and contains significant information- date of vaccination, concomitant products updated and events are updated. On 14-Jul-2021: Translation received on 23 Jul 2021 contain  concomitants, treatment medication and events, medical history were added.; 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vomiting
Clinical narrative: Injection site is swollen; Lymph nodes tender on the same arm; Injection site is red; Fever; Body aches; vomiting; diarrhea; pain; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), DIARRHOEA (diarrhea), MYALGIA (pain), INJECTION SITE SWELLING (Injection site is swollen) and VACCINATION SITE LYMPHADENOPATHY (Lymph nodes tender on the same arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3000493) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia since 1980. Concomitant products included GABAPENTIN, AMITRIPTYLINE HYDROCHLORIDE (LAROXYL), PAROXETINE, CETIRIZINE and FENOFIBRATE for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VOMITING (vomiting), DIARRHOEA (diarrhea) and MYALGIA (pain). On 11-Feb-2021, the patient experienced INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes tender on the same arm), INJECTION SITE ERYTHEMA (Injection site is red), PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (DOLIPRANE) for Adverse event, at an unspecified dose and frequency. At the time of the report, VOMITING (vomiting), DIARRHOEA (diarrhea), MYALGIA (pain), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes tender on the same arm), INJECTION SITE ERYTHEMA (Injection site is red), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.            Antispasmodics were reported as treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information received on 14-JUL-2021 and contains significant information- date of vaccination, concomitant products updated and events are updated. On 14-Jul-2021: Translation received on 23 Jul 2021 contain  concomitants, treatment medication and events, medical history were added.; 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00063418 and 015L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.            No concomitants or treatment medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain
Clinical narrative: Diarrhea; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PAIN (Soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DIARRHOEA (Diarrhea) and PAIN (Soreness). At the time of the report, DIARRHOEA (Diarrhea) and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.