chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Periorbital swelling
Clinical narrative: eye felt irritated and burned; eye puffed up and was red; eye was red; felt a little cruddy; arm hurts; headache; A spontaneous report was received from a consumer concerning a 69-years-old male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, arm hurts, felt a little cruddy, normal side effects, puffed up and was red.  The patient's medical history was not provided. Concomitant medications reported were  for drug use for unknown indication.  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.  On 9 Feb 2021, the patient experienced the event(s) headache. arm hurts, felt a little cruddy, normal side effects. On 11 Feb 2021, the patient experienced the events, eye puffed up and was red.  Treatment details included Didn't take anything.  Action taken with mRNA-1273 in response to the events were not applicable. The outcome of event,felt a little cruddy was considered resolved on 9 Feb 2021.The outcome of events ,normal side effects was considered resolved on 11 Feb 2021.The outcome of events,puffed up eye  was considered resolved on 11 Feb 2021. The outcome of events, headache, arm hurts, eye felt irritated and burned and red eyes were unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint swelling, Pain
Clinical narrative: A spontaneous report was received from a consumer concerning a 65-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, aches, knee swelled up.  The patient's medical history was not provided. Concomitant medications reported were synvisc-one injection for drug use for unknown indication.  On 15 Jan 2021, 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. On 6 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 6 Feb 2021, the patient experienced the event(s) headache. aches. On 9 Feb 2021, the patient experienced the event(s) knee swelled up.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable. The outcome of event(s) headache was considered resolved on 7 Feb 2021.The outcome of event(s) aches was considered resolved on 7 Feb 2021. The outcome of event(s), knee swelled up,  was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Gait disturbance, Hypersomnia, Palpitations
Clinical narrative: diarrhea; She woke up this morning and fell asleep for more 4 hours; her heart was palpitating; staggering all over the house; getting really dizzy while lying down; A spontaneous report was received from a consumer concerning a 62-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events getting really dizzy while lying down, had a lot of diarrhea, staggering all over the house, her heart was palpitating, she woke up this morning and fell asleep for more 4 hours.  The patient's medical history was not provided. Concomitant medications reported were Progesterone, estradiol patch, gabapentin 400mg, ibuprofen, vitamin D 500mg or 1000mg for drug use for unknown indication.  On 12 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 12 Feb 2021, the patient experienced the event(s) getting really dizzy while lying down. had a lot of diarrhea, staggering all over the house, her heart was palpitating, she woke up this morning and fell asleep for more 4 hours.  Treatment details included None.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), getting really dizzy while lying down, had a lot of diarrhea,staggering all over the house,her heart was palpitating,she woke up this morning and fell asleep for more 4 hours was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Decreased appetite, Exploding head syndrome, Eye pain, Fatigue
Clinical narrative: head is about to explode; every bone in my body hurts; my eyelids hurt; my nail beds hurt; i have no appetite; sharp pain woke patient out of sleep; low grade fever; im tired and sleepy; A spontaneous report was received from a healthcare professional concerning a 57-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events head is about to explode, low grade fever, sharp pain woke patient out of sleep, every bone in my body hurts, my eyelids hurt, my nail beds hurt, im tired and sleepy, i have no appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   head is about to explode, low grade fever, sharp pain woke patient out of sleep, every bone in my body hurts, my eyelids hurt, my nail beds hurt, im tired and sleepy, i have no appetite.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), head is about to explode, low grade fever,sharp pain woke patient out of sleep,every bone in my body hurts,my eyelids hurt,my nail beds hurt,im tired and sleepy,i have no appetite was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Onychalgia, Pain, Pyrexia
Clinical narrative: head is about to explode; every bone in my body hurts; my eyelids hurt; my nail beds hurt; i have no appetite; sharp pain woke patient out of sleep; low grade fever; im tired and sleepy; A spontaneous report was received from a healthcare professional concerning a 57-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events head is about to explode, low grade fever, sharp pain woke patient out of sleep, every bone in my body hurts, my eyelids hurt, my nail beds hurt, im tired and sleepy, i have no appetite.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   head is about to explode, low grade fever, sharp pain woke patient out of sleep, every bone in my body hurts, my eyelids hurt, my nail beds hurt, im tired and sleepy, i have no appetite.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), head is about to explode, low grade fever,sharp pain woke patient out of sleep,every bone in my body hurts,my eyelids hurt,my nail beds hurt,im tired and sleepy,i have no appetite was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain
Clinical narrative: insomnia; a little achy; a little nauseous; A spontaneous report  was received from a healthcare professional concerning a 64-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a little nauseous, a little achy, insomnia.  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 their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  on an unknown date, she experienced events include a little nauseous, a little achy, insomnia.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.   The outcome of event(s), a little nauseous, a little achy,insomnia was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: A spontaneous report was received from a consumer concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe pain on the injection site, fever, chills, severe headache.  The patient's medical history was not provided. Concomitant medications reported were Steroid Shot for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) severe pain on the injection site . On 13 Feb 2021, the patient experienced the event(s) fever. chills, severe headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), severe pain on the injection site, fever,chills,severe headache was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: lot of itching; I develop small rash about a size of tennis ball; A spontaneous report was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events i develop small rash about a size of tennis ball, lot of itching.  The patient's medical history was not provided. Concomitant medications reported were High Blood Pressure Medication for drug use for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the event(s) i develop small rash about a size of tennis ball. lot of itching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), i develop small rash about a size of tennis ball, lot of itching was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pruritus, Pain in extremity, Skin swelling
Clinical narrative: arm at the injection site is puffy; big rash on her arm at the injection site; arm at the injection site is red; arm at the injection site is itchy; headache that lasted for 5 day; sore arm that lasted for 4 days; A spontaneous report was received from a consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm that lasted for 4 days, headache that lasted for 5 day, big rash on her arm at the injection site, arm at the injection site is puffy, arm at the injection site is red, arm at the injection site is itchy.  The patient's medical history was not provided. Concomitant medications reported were Lipitor for drug use for unknown indication.  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: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the events sore arm that lasted for 4 days. headache that lasted for 5 day.  On 12 Feb 2021, the patient experienced the event(s) big rash on her arm at the injection site. arm at the injection site is puffy, arm at the injection site is red, arm at the injection site is itchy.  Treatment details included Said that she put Neosporin cream and it relieved the itching..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sore arm that lasted for 4 days, headache that lasted for 5 day was resolved and big rash on her arm at the injection site,arm at the injection site is puffy,arm at the injection site is red,arm at the injection site is itchy was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: arm at the injection site is puffy; big rash on her arm at the injection site; arm at the injection site is red; arm at the injection site is itchy; headache that lasted for 5 day; sore arm that lasted for 4 days; A spontaneous report was received from a consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm that lasted for 4 days, headache that lasted for 5 day, big rash on her arm at the injection site, arm at the injection site is puffy, arm at the injection site is red, arm at the injection site is itchy.  The patient's medical history was not provided. Concomitant medications reported were Lipitor for drug use for unknown indication.  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: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the events sore arm that lasted for 4 days. headache that lasted for 5 day.  On 12 Feb 2021, the patient experienced the event(s) big rash on her arm at the injection site. arm at the injection site is puffy, arm at the injection site is red, arm at the injection site is itchy.  Treatment details included Said that she put Neosporin cream and it relieved the itching..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sore arm that lasted for 4 days, headache that lasted for 5 day was resolved and big rash on her arm at the injection site,arm at the injection site is puffy,arm at the injection site is red,arm at the injection site is itchy was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Flushing, Nasopharyngitis, Throat irritation
Clinical narrative: bad taste/bitter taste in her mouth; her cheeks was flushed; sinuses were opening; scratchy feeling in her throat like she has a cold; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events bad taste bitter taste in her mouth, her cheeks was flushed, sinuses were opening, scratchy feeling in her throat like she has a cold,  The patient's medical history was not provided. Concomitant medications reported were Metformin 500MG, Actose 15mg, Aspirin 81, Hydrochlorozide, Bystolic 2.5mg, Folic acid, Vitamin D3 5000IU for drug use for unknown indication.  On 12 Feb 2021, 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.  On 12 Feb 2021, the patient experienced the event(s) bad taste bitter taste in her mouth. her cheeks was flushed, sinuses were opening, scratchy feeling in her throat like she has a cold.  Treatment was not taken.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, bad taste bitter taste in her mouth, her cheeks was flushed,sinuses were opening,scratchy feeling in her throat like she has a cold,  was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Iron deficiency
Clinical narrative: Iron low; A spontaneous report was received from a healthcare professional concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events iron low.  The patient's medical history was not provided. Concomitant medications reported were periodic iron infussion for drug use for unknown indication.  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, before the second dose of vaccine, the patient showed Iron low.  Treatment details was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event iron low,  was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site soreness; A spontaneous report was received from a consumer concerning a 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a little bit of soreness at the injection site.  The patient's medical history was not provided. Concomitant medications were not reported.  On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown)via unknown route to the left arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) a little bit of soreness 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), a little bit of soreness at the injection site was unknown..
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: itches , hives , and redness at the left arm; itches , hives , and redness at the left arm; itches , hives , and redness at the left arm; A spontaneous report was received from a consumer concerning a 72-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itches at the injection arm/pruritis, hives at the injection arm/Urticaria, redness at the injection arm/Erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) itches, hives and redness at the left arm/pruritis . On 12 Feb 2021, the patient experienced the event(s) itches, hives and redness at the left arm/Urticaria . On 12 Feb 2021, the patient experienced the event(s) itches, hives and redness at the left arm/Erythema. .  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), itches at the injection arm was unknown.The outcome of event(s), hives at the injection arm was unknown.The outcome of event(s), redness at the injection arm was unknown..
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash erythematous
Clinical narrative: arm was swollen; red rash; arm was sore for a week; A spontaneous report was received from a consumer concerning a 64-years-old female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was swollen, red rash, arm was sore for a week.  The patient's medical history was not provided. No relevant concomitant medications were reported.  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: 012L20A) in right dominant arm for prophylaxis of COVID-19 infection. On 04 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M20A) in right dominant arm for prophylaxis of COVID-19 infection.  On an unspecified date after vaccine administration the patient experienced arm was swollen, there was red rash, arm was sore for a week.  Treatment reported included Benadryl.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, arm was swollen, red rash, arm was sore for a week was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: Ear felt plugged up; A spontaneous report was received from a consumer concerning a unknown age of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events ear plugged up.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.and experienced Ear plugged up.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), ear plugged up was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Illness, Pyrexia
Clinical narrative: very sick; 104 fever; pretty severe reactions; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (pretty severe reactions), ILLNESS (very sick) and PYREXIA (104 fever) 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) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced ADVERSE REACTION (pretty severe reactions). On an unknown date, the patient experienced ILLNESS (very sick) and PYREXIA (104 fever). At the time of the report, ADVERSE REACTION (pretty severe reactions), ILLNESS (very sick) and PYREXIA (104 fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021089752 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Consumer declined to provide email and declined further follow upAR onset date and other events added; Sender's Comments:  MOD-2021089752:Crosslinked, Father's case
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Influenza, Injection site nodule, Musculoskeletal stiffness, Pain
Clinical narrative: Arm is red; Nod at arm; Sitff; Achy; Flu; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Sitff), PAIN (Achy), INFLUENZA (Flu), ERYTHEMA (Arm is red) and INJECTION SITE NODULE (Nod at arm) in a 75-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 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Sitff), PAIN (Achy) and INFLUENZA (Flu). On 13-Feb-2021, the patient experienced ERYTHEMA (Arm is red) and INJECTION SITE NODULE (Nod at arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (Sitff), PAIN (Achy) and INFLUENZA (Flu) had resolved and ERYTHEMA (Arm is red) and INJECTION SITE NODULE (Nod at arm) had not resolved.            Treatment information included just drank plenty of water.  Concomitant medications included Prescription Eye drop.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Ocular hyperaemia, Tooth discolouration
Clinical narrative: There is also one tooth in the back that is particularly darkened; Canker sores; Whites of her eyes have been veiny and red; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Whites of her eyes have been veiny and red), APHTHOUS ULCER (Canker sores) and TOOTH DISCOLOURATION (There is also one tooth in the back that is particularly darkened) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Canker sores oral (history of canker sores when she is aggravated or tired). Concurrent medical conditions included Hypercholesterolemia and Hair thinning. Concomitant products included BIOTIN for Hair thinning, SIMVASTATIN (SIMVASTIN) for Hypercholesterolemia, VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced OCULAR HYPERAEMIA (Whites of her eyes have been veiny and red). On 04-Feb-2021, the patient experienced APHTHOUS ULCER (Canker sores). On 08-Feb-2021, the patient experienced TOOTH DISCOLOURATION (There is also one tooth in the back that is particularly darkened). At the time of the report, OCULAR HYPERAEMIA (Whites of her eyes have been veiny and red), APHTHOUS ULCER (Canker sores) and TOOTH DISCOLOURATION (There is also one tooth in the back that is particularly darkened) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included dry eye medication and children's cold sore medication.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up information received included patient demographic details, relevant history details and concomitant medication details. On 09-Jul-2021: Follow up received included no new information.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Migraine
Clinical narrative: A spontaneous report was received from a consumer concerning a 24-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events horrible migraine, out of work for 3 weeks, contracted covid the night after receiving the vaccination.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   horrible migraine, out of work for 3 weeks, contracted covid the night after receiving the vaccination.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), horrible migraine was unknown.The outcome of event(s), out of work for 3 weeks was unknown.The outcome of event(s), contracted covid the night after receiving the vaccination was unknown..
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Intermittent fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Intermittent fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Stem cell transplant (had the procedure years ago). Concurrent medical conditions included Multiple myeloma.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PYREXIA (Intermittent fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (Intermittent fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: tingling in right hand; injection site pain; A spontaneous report was received from a consumer concerning a 94-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain soreness at the injection site, tingling in his right hand.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received  first of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) pain soreness at the injection site. tingling in his right hand.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain soreness at the injection site, tingling in his right hand was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: Pain in back of neck; Pain in shoulders; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in back of neck) and ARTHRALGIA (Pain in shoulders) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced NECK PAIN (Pain in back of neck) and ARTHRALGIA (Pain in shoulders). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Pain in back of neck) and ARTHRALGIA (Pain in shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pruritus
Clinical narrative: Itchy torso; Right hand numbness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy torso) and HYPOAESTHESIA (Right hand numbness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Colitis, Migraine, Irritable bowel syndrome, Psoriasis and Allergy (The patient is allergic to ACE inhibitors.). Concomitant products included LEVONORGESTREL (MIRENA) for Intrauterine contraception, MONTELUKAST SODIUM (SINGULAIR), TRAZODONE HYDROCHLORIDE, RIMEGEPANT SULFATE, ONDANSETRON (ZOFRAN MELT) and BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PRURITUS (Itchy torso) and HYPOAESTHESIA (Right hand numbness). At the time of the report, PRURITUS (Itchy torso) and HYPOAESTHESIA (Right hand numbness) outcome was unknown.        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.   Treatment information was not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Lymphadenopathy, Vaccination site discharge, Vaccination site erythema
Clinical narrative: itchy; it felt like blisters; redness head spread from his deltoid down to his elbow; oozing from the injection site; arm felt tight; warm to the touch; red; 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 oozing from the injection site, arm felt tight, warm to the touch, red, itchy, redness head spread from his deltoid down to his elbow, it felt like blisters.  The patient's medical history was not provided. Concomitant medications reported were lantus, Janumet, Glimepiride, Protonix, Atorvastatin, Telmisartan for drug use for unknown indication.  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: 007M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) oozing from the injection site. arm felt tight, warm to the touch, red, itchy. On 12 Feb 2021, the patient experienced the event(s) redness head spread from his deltoid down to his elbow. it felt like blisters.  Treatment details included Benadryl and Benadryl cream.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), oozing from the injection site, arm felt tight, warm to the touch, red, itchy, redness head spread from his deltoid down to his elbow,   it felt like blisters was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: itchy; it felt like blisters; redness head spread from his deltoid down to his elbow; oozing from the injection site; arm felt tight; warm to the touch; red; 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 oozing from the injection site, arm felt tight, warm to the touch, red, itchy, redness head spread from his deltoid down to his elbow, it felt like blisters.  The patient's medical history was not provided. Concomitant medications reported were lantus, Janumet, Glimepiride, Protonix, Atorvastatin, Telmisartan for drug use for unknown indication.  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: 007M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) oozing from the injection site. arm felt tight, warm to the touch, red, itchy. On 12 Feb 2021, the patient experienced the event(s) redness head spread from his deltoid down to his elbow. it felt like blisters.  Treatment details included Benadryl and Benadryl cream.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), oozing from the injection site, arm felt tight, warm to the touch, red, itchy, redness head spread from his deltoid down to his elbow,   it felt like blisters was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dyspnoea
Clinical narrative: "burning sensation that lasted on & off about 2 weeks"; "trouble breathing for a day"; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION ("burning sensation that lasted on & off about 2 weeks") and DYSPNOEA ("trouble breathing for a day") in a female 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION ("burning sensation that lasted on & off about 2 weeks") and DYSPNOEA ("trouble breathing for a day"). At the time of the report, BURNING SENSATION ("burning sensation that lasted on & off about 2 weeks") and DYSPNOEA ("trouble breathing for a day") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications reported was not provided.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 diagnose after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 diagnose after vaccination) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure fluctuation. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN D NOS for an unknown indication, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP).   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (COVID-19 diagnose after vaccination). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 diagnose after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.         Treatment includes Apure.   Reporter did not allow further contact
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: bright red hives all over her body; itching; burning; A spontaneous report was received from a consumer concerning a 86-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events bright red hives all over her body, itching, burning.  The patient's medical history was eczema. She has applying a cream it seems to be helpful.  On 9 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) bright red hives all over her body. itching, burning.  Treatment details included She has been applying a cream and it seems to be helping..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), bright red hives all over her body, itching,burning was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Side effects post vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects post vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   In February 2021, the patient experienced ADVERSE EVENT (Side effects post vaccination). At the time of the report, ADVERSE EVENT (Side effects post vaccination) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information was not provided. Concomitant medication was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Vaccination site cellulitis, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Vaccine related skin reaction/allergic reaction; Spreading and cellulitis-like near vaccination site upper L arm; Bump on injection site; Redness; Itching sometimes/itchiness/scratching injection site; This spontaneous case was reported by a health care professional and describes the occurrence of DERMATITIS ALLERGIC (Vaccine related skin reaction/allergic reaction), VACCINATION SITE CELLULITIS (Spreading and cellulitis-like near vaccination site upper L arm), VACCINATION SITE PRURITUS (Itching sometimes/itchiness/scratching injection site), VACCINATION SITE SWELLING (Bump on injection site) and VACCINATION SITE ERYTHEMA (Redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Blepharitis and Cataract. Concurrent medical conditions included Allergy (Allergy to cefaclor, sulfamethoxazole trimethoprim). Concomitant products included DINOPROSTONE, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and VITAMIN B COMPLEX for an unknown indication, FISH OIL, OENOTHERA BIENNIS OIL, TOCOPHERYL ACETATE (OMEGA 3 & 6).   On 29-Jan-2021 at 3:19 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching sometimes/itchiness/scratching injection site). On an unknown date, the patient experienced DERMATITIS ALLERGIC (Vaccine related skin reaction/allergic reaction), VACCINATION SITE CELLULITIS (Spreading and cellulitis-like near vaccination site upper L arm), VACCINATION SITE SWELLING (Bump on injection site) and VACCINATION SITE ERYTHEMA (Redness). The patient was treated with LORATADINE at a dose of 10 mg. At the time of the report, DERMATITIS ALLERGIC (Vaccine related skin reaction/allergic reaction), VACCINATION SITE CELLULITIS (Spreading and cellulitis-like near vaccination site upper L arm), VACCINATION SITE PRURITUS (Itching sometimes/itchiness/scratching injection site), VACCINATION SITE SWELLING (Bump on injection site) and VACCINATION SITE ERYTHEMA (Redness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment also includes Azithromycin and sulfamethoxazole trimethoprim.  lab test also includes CBC w/diff, CMP, CRP drawn on 02/09/2021.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure abnormal, Blood pressure measurement, Hyperhidrosis, Pain
Clinical narrative: tingle in arm; pain from her collar bone to the tip of her fingers; shoulder blade was painful and if felt like arthritis; sweat on her forehead; felt feverish; blood pressure was 135/90; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingle in arm), PAIN (pain from her collar bone to the tip of her fingers), ARTHRALGIA (shoulder blade was painful and if felt like arthritis), HYPERHIDROSIS (sweat on her forehead) and PYREXIA (felt feverish) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 12 HOUR) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PARAESTHESIA (tingle in arm), PAIN (pain from her collar bone to the tip of her fingers), ARTHRALGIA (shoulder blade was painful and if felt like arthritis), HYPERHIDROSIS (sweat on her forehead), PYREXIA (felt feverish) and BLOOD PRESSURE ABNORMAL (blood pressure was 135/90). At the time of the report, PARAESTHESIA (tingle in arm), PAIN (pain from her collar bone to the tip of her fingers), ARTHRALGIA (shoulder blade was painful and if felt like arthritis), HYPERHIDROSIS (sweat on her forehead), PYREXIA (felt feverish) and BLOOD PRESSURE ABNORMAL (blood pressure was 135/90) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 135/90 135/90  Patient states he blood pressure is usually low..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used a heating pad to help alleviate the pain.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: tingle in arm; pain from her collar bone to the tip of her fingers; shoulder blade was painful and if felt like arthritis; sweat on her forehead; felt feverish; blood pressure was 135/90; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingle in arm), PAIN (pain from her collar bone to the tip of her fingers), ARTHRALGIA (shoulder blade was painful and if felt like arthritis), HYPERHIDROSIS (sweat on her forehead) and PYREXIA (felt feverish) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 12 HOUR) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PARAESTHESIA (tingle in arm), PAIN (pain from her collar bone to the tip of her fingers), ARTHRALGIA (shoulder blade was painful and if felt like arthritis), HYPERHIDROSIS (sweat on her forehead), PYREXIA (felt feverish) and BLOOD PRESSURE ABNORMAL (blood pressure was 135/90). At the time of the report, PARAESTHESIA (tingle in arm), PAIN (pain from her collar bone to the tip of her fingers), ARTHRALGIA (shoulder blade was painful and if felt like arthritis), HYPERHIDROSIS (sweat on her forehead), PYREXIA (felt feverish) and BLOOD PRESSURE ABNORMAL (blood pressure was 135/90) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 135/90 135/90  Patient states he blood pressure is usually low..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used a heating pad to help alleviate the pain.