chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort
Clinical narrative: patient came for COVID 19 vaccine today while in observation she got up to walk and felt dizzy. MD on site assessed patient, No SOB, speaking in full sentences, Complained of  heaviness in bilateral ears.  Patient rested, given crackers and water patient verbalized she did not eat breakfast.  Patient has BP machine at home and will monitor BP in morning and evening and bring those readings to onsite appointment on 03/23/21.  Nurse called patient also in the evening to check in. Patient reported all symptoms resolved and feeling back to normal with no concerns
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles infection; A spontaneous report  was received from a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shingles infection.   The patient's medical history was not provided. No Concomitant medications information was provided.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) in an unknown injection site for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced shingles infection (Herpes Zoster). No treatment information was provided.  The seriousness criterion for the event was medically significant .  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, shingles infection was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site rash
Clinical narrative: 10 days after vaccination, I noticed a slight rash and red round mark about 2 inches in diameter on my left upper arm where the injection site was.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperglycaemia
Clinical narrative: Patient reported hyperglycemia after the vaccine.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: It was discovered today that patient received a Pfizer vaccine at outside clinic on 03/05/2021. She received a Moderna vaccine from facility on 03/18/2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint swelling, Vaccination complication
Clinical narrative: 45 Min after shot given Covid Arm Developed 12 -13 Hours after Numbness developed in both arms and hands 17 hours after Joint swelling occurred ( Hands, Knee's )
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Red itchy rash and hives over legs, arms, torso
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test negative
Clinical narrative: developed a rash on his right elbow about 9 days after vaccine. It then appeared on his hands and left elbow. It has since started to clear up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash, Severe itching. Can not take Benedryl
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Mammogram, Ultrasound scan
Clinical narrative: Pain in left breast and under armpit
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Dyspnoea
Clinical narrative: ISOLATION-INFECTIOUS DISEASE WEAKNESS - GENERALIZED SHORTNESS OF BREATH Covid-19
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Hypersensitivity, Lip swelling, Pruritus
Clinical narrative: Really bad hurting in chest pain, swollen lips and a headache. Had to go to ER.  Forgot to mention the vaccine shot. They finally decided it was an allergic reaction. Gave a steroid shot and Benadryl. Sent home on steroids for 5 days. The next day had rash and itching. The next day it was worse looked like lace pattern rash over most of his body and really bad itching. Like this through the 20th then he took Claritin and put on anti -itch cream. The next  day the rash had mostly cleared but still a little itchy. Today the 22 I have had a really bad headache.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Really bad hurting in chest pain, swollen lips and a headache. Had to go to ER.  Forgot to mention the vaccine shot. They finally decided it was an allergic reaction. Gave a steroid shot and Benadryl. Sent home on steroids for 5 days. The next day had rash and itching. The next day it was worse looked like lace pattern rash over most of his body and really bad itching. Like this through the 20th then he took Claritin and put on anti -itch cream. The next  day the rash had mostly cleared but still a little itchy. Today the 22 I have had a really bad headache.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscular weakness, Nausea, Tinnitus
Clinical narrative: Intense ringing in left ear post vaccine Chronic nausea Fatigue muscle weakness low grade headache at times  Treatment: Tylenol, Excedrin migraine
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Progress Notes (Nurse Practitioner) ? ? Nurse Practitioner Cosigned by: MD at 3/18/2021  2:51 PM Expand AllCollapse All    3/18/2021    Subjective Patient is a 18 y.o. female who was seen at COVID Vaccine site today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience left arm numbness and tingly..  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting.   Complained of numbness and tingling in the left arm (shot arm) after shot.     ALLERGY REVIEW OF SYSTEMS:  All other systems negative   Patient complains of muscle aches   CONT negative HENT negative Eyes negative Respiratory negative Skin negative GI negative Neuro negative     Previous Reactions: None    Objective    Vitals Vitals:   03/18/21 1120 03/18/21 1140 BP: (!) 141/81 125/74 Pulse: 88 85 SpO2: 99% 99%          Physical Exam Constitutional:      Appearance: She is well-developed.  HENT:     Head: Normocephalic and atraumatic.     Right Ear: External ear normal.     Left Ear: External ear normal.     Nose: Nose normal.  Eyes:     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Abdominal:     General: Bowel sounds are normal.     Palpations: Abdomen is soft.  Musculoskeletal:        General: Tenderness present. Normal range of motion.     Cervical back: Normal range of motion and neck supple.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     Mental Status: She is alert and oriented to person, place, and time.     Comments: Numbness in left fingers        Assessment/Plan  Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Pt left at 12:06.  Numbness resolved in left hand       Electronically Signed 3/18/2021 12:07 PM
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Patient stated she had tingling in her face 10-15 minutes after receiving the vaccine.  She thought maybe it was just her mask, but wasn't sure. She stayed an additional 15 minutes for a total of 30 minutes and at that time said it was better but still existent. She went home with understanding to call 9-1-1 if any symptoms of anaphylaxis.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin discolouration, Skin warm
Clinical narrative: (3/19/2021) 1 day after first dose of vaccine, all fingers on both hands turned red from the knuckle to the tips. Fingers were very hot and itchy. Effect lasted 2-5 min.  (3/20/2021) 2 days after first does of vaccine, hands and legs turned red and itchy for 2 hours. Took Benadryl to calm itching.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Fatigue, Lip haemorrhage, Rhinorrhoea, Seizure
Clinical narrative: seizure / hospitalized for having seizure; trouble talking; biting her lips and as a result was bleeding all over.; feel sluggish.; Fatigue; runny nose; sneezing; A spontaneous report was received from a consumer concerning a 75-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced was Seizure, trouble talking, runny nose, sneezing, biting her lips and as a result was bleeding all over, Very upset / frustration, feel sluggish, and fatigue.  The patient's medical history was not provided by the reporter. Current history includes stroke. Concomitant medications were carvedilol 12.5 bid, losartan 100mg, rovastatin 20mg, ezetimibe 10mg, levothyroxine 75 mcg, aspirin 81mg  On 28-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the unknown location for prophylaxis of COVID-19 infection.   On 25-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26-Feb-2021, the patient experienced seizure which occurred less than 24 hours after receiving the 2nd dose of the Moderna vaccine.  At approximately 10:00 am, the patient wasn't able to formulate a sentence, similar to when she had a stroke. Husband drove her to the ER and she had a seizure in the car. CT Scan showed no stroke, showed a seizure. Patient was admitted, kept overnight, intubated and administered anti-seizure medicine. On 27-Feb-2021, the patient was discharged and developed flu-like symptoms (runny nose, sneezing, fatigue). Flu-like symptoms have cleared. The reporter feels the seizures are related to the prior stroke history.   On 10-Mar-2021, a follow-up was received. Patient feel huge disappointment and frustration on reporting serious adverse reaction. New information about the event include that on 26-Feb-2021, her husband noticed she was biting her lips and as a result was bleeding all over. Patient stated she has never had history of seizure but after this incident neurologists put her on high dose anti-seizure medications twice daily. These medications make her feel sluggish.   Treatment details provided was Keppra, anti -seizure medications.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event seizure, fatigue, runny nose, sneezing  were recovered on 27-Feb-2021 and 01-Mar-2021 respectively. The outcome of the events trouble talking, biting her lips, feeling upset and frustrated and feeling sluggish were unknown.; Reporter's Comments: Based on reporter's causality and the described prior history of stroke, the event is assessed as unlikely related to mRNA-1273.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Sneezing
Clinical narrative: seizure / hospitalized for having seizure; trouble talking; biting her lips and as a result was bleeding all over.; feel sluggish.; Fatigue; runny nose; sneezing; A spontaneous report was received from a consumer concerning a 75-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced was Seizure, trouble talking, runny nose, sneezing, biting her lips and as a result was bleeding all over, Very upset / frustration, feel sluggish, and fatigue.  The patient's medical history was not provided by the reporter. Current history includes stroke. Concomitant medications were carvedilol 12.5 bid, losartan 100mg, rovastatin 20mg, ezetimibe 10mg, levothyroxine 75 mcg, aspirin 81mg  On 28-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the unknown location for prophylaxis of COVID-19 infection.   On 25-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 014M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26-Feb-2021, the patient experienced seizure which occurred less than 24 hours after receiving the 2nd dose of the Moderna vaccine.  At approximately 10:00 am, the patient wasn't able to formulate a sentence, similar to when she had a stroke. Husband drove her to the ER and she had a seizure in the car. CT Scan showed no stroke, showed a seizure. Patient was admitted, kept overnight, intubated and administered anti-seizure medicine. On 27-Feb-2021, the patient was discharged and developed flu-like symptoms (runny nose, sneezing, fatigue). Flu-like symptoms have cleared. The reporter feels the seizures are related to the prior stroke history.   On 10-Mar-2021, a follow-up was received. Patient feel huge disappointment and frustration on reporting serious adverse reaction. New information about the event include that on 26-Feb-2021, her husband noticed she was biting her lips and as a result was bleeding all over. Patient stated she has never had history of seizure but after this incident neurologists put her on high dose anti-seizure medications twice daily. These medications make her feel sluggish.   Treatment details provided was Keppra, anti -seizure medications.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event seizure, fatigue, runny nose, sneezing  were recovered on 27-Feb-2021 and 01-Mar-2021 respectively. The outcome of the events trouble talking, biting her lips, feeling upset and frustrated and feeling sluggish were unknown.; Reporter's Comments: Based on reporter's causality and the described prior history of stroke, the event is assessed as unlikely related to mRNA-1273.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: HEADACHE, NAUSEA, CHILLS, BODY ACHE
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Diplopia, Dizziness, Magnetic resonance imaging, Nystagmus
Clinical narrative: On March 13, I developed double vision, dizziness and nystagmus.  I was transferred by ambulance to a hospital due to stroke symptoms.  Admitted overnight. Diagnosis:  Transient Ischemic Attack.  This occurred one month after second Covid injection.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast, Transient ischaemic attack
Clinical narrative: On March 13, I developed double vision, dizziness and nystagmus.  I was transferred by ambulance to a hospital due to stroke symptoms.  Admitted overnight. Diagnosis:  Transient Ischemic Attack.  This occurred one month after second Covid injection.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Eye disorder, Facial paralysis, Ocular discomfort
Clinical narrative: Started afternoon of March 20. Drooping mouth first, then difficulty closing left eye. Treated in emergency room.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus
Clinical narrative: Injection site redness and discomfort for 72 hours, managed with cold compress. Was fine for a few days. On the 7th day the injection site became VERY red and somewhat itchy. The site was over 3 inches in diameter. Treated with topical cortisone cream and cold compress. Today is day 10 and there is still a wide area of redness.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: Patient started leaning over in chair 5-10 minutes after receiving shot. She was with her spouse who was helping her sit up straight.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis
Clinical narrative: Chills Sweating temperature
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: After receiving referral from  Family Medicine ,I called and spoke to patient regarding monoclonal antibody infusion. He became symptomatic on 3/16, was tested on 3/19, and tested positive on 3/21 at  Family Medicine  (PCR). He is a candidate based on his BMI> 35, DM. I reviewed EUA for Casirivimab/Imdevimab and reviewed risks vs benefits with the patient. Discussed need to wait 90 days from infusion to get COVID vaccine. Also discussed the newness of medication and inability to know all possible side effects. They would like to proceed with the infusion. We discussed coming in via the side door at the 6th and Folks office for appt tomorrow, March 23rd at 9 am. Call  when they arrive. Discussed time frame for infusion. All questions and concerns were addressed. Patient agreeable and will arrive at above stated date and time.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient had no reactions to first vaccine post dialysis.  The morning after the patient received the vaccine, patient expired at home. Police stated that the death was vaccine related.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Cough, Fatigue, Feeling abnormal, Nasal congestion
Clinical narrative: Experiencing similar symptoms of those of heart failure; Feeling bad; Congestion; Coughing a lot; Tired alot; A spontaneous report was received from a consumer concerning an 82-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced feeling bad/feeling abnormal, had similar symptoms of those of heart failure/cardiac failure, coughing a lot/cough ,congestion/nasal congestion and tired a lot/fatigue.  The patient's medical history included heart failure and hypothyroidism. Concomitant medications reported included medication for heart failure and hypothyroidism.  On 19-JAN-2021, approximately three weeks prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10-FEB-2021, the patient reported that three weeks after receiving the vaccine she started feeling bad, had similar symptoms of those of heart failure (which he has had), cough/coughing a lot, congestion and tired a lot. The event similar symptoms of those of heart failure is considered as medically significant. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events feeling bad, similar symptoms of those of heart failure, cough (coughing a lot),congestion and tired a lot, were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Pt developed numbness on left side of her body (face, arm, leg) after receiving vaccine in left arm,  Pt was sent to ER to be further evaluated
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Within 24 hours developed "temporal" headache and has headaches off and on since vaccination...Relates temporal area is tender to touch and he has never had this type of headache before Relates he did call his physician but did not go in for a visit Relates he has had to take some otc for relief of headache twice since the headaches started He does not plan to take second dose at this time
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eustachian tube disorder, Immediate post-injection reaction, Pharyngeal swelling, Pruritus, Swollen tongue
Clinical narrative: Within a minute of receiving the vaccination, my throat and tongue began to swell.  After about 10-15 minutes, my face and head began itching and my Eustacian tubes began to close (as if flying in an airplane and unable to "pop" my ears).  I took a 25 mg benadryl right after receiving the vaccination and remained at the pharmacy for an hour observation.  When I arrived home, about 1 hour and 15 minutes after receiving the vaccination, I took another benadryl and slept for about 6 hours.  Upon waking, all symptoms were gone.  The reaction to the second vaccination was more intense than the reaction to the first Covid-19 vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Computerised tomogram, Dizziness, Magnetic resonance imaging heart, Magnetic resonance imaging neck
Clinical narrative: Within 36 hours, extreme dizziness, vomiting, cold sweat. Could not move. Taken by ambulance to hospital. Admitted for three days with severe vertigo.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Ultrasound Doppler, Vertigo, Vomiting
Clinical narrative: Within 36 hours, extreme dizziness, vomiting, cold sweat. Could not move. Taken by ambulance to hospital. Admitted for three days with severe vertigo.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Red, itchy knot area larger than half dollar that appeared on arm 8 days after vaccination. Encouraged to watch for other s/s, call 911 if needed, watch for red streaking and fever. Encouraged to call doctor to report reaction as well.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Fatigue, Headache, Pyrexia
Clinical narrative: About 12 hours after receiving the vaccine I had a headache, fever (99-101 degrees), sore eyes, fatigue and some chills all day until I went to bed around 11 pm.   I found relief with 500 mg of tylenol throughout the day.  Upon waking up on March 11, all side effects had subsided and I felt just fine.  No side effects since. (today is 13 days after receiving the vaccine)
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Received COVID 19 vaccine second dose on 3/4/21. Says started having redness, swelling and pain at the site of injection on 3/6. Associated with some diarrhea, but this resolved in 2 days. But left arm pain and swelling was worsening and so came to E.R on 3/8 and was d/ced home with oral Keflex. Says, since started using Keflex, started having nausea and vomiting and so came back to E.R last night
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Received COVID 19 vaccine second dose on 3/4/21. Says started having redness, swelling and pain at the site of injection on 3/6. Associated with some diarrhea, but this resolved in 2 days. But left arm pain and swelling was worsening and so came to E.R on 3/8 and was d/ced home with oral Keflex. Says, since started using Keflex, started having nausea and vomiting and so came back to E.R last night
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - ongoing, 11 days
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Hallucination, Restlessness
Clinical narrative: hallucination; restlessness; sleepiness during the day; trembling; mumbling words in his sleep; weak; tiredness; chills; A spontaneous report was received from a male patient (unspecified age) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucination, tiredness, restlessness, chills, not feeling good, sleepiness in the morning, trembling, mumbling words in his sleep and weak.  The patient's medical history included drug allergy to versed anesthesia during cataract surgery. No relevant concomitant medications were reported.  On 26 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 23 Feb 2021, prior to the onset of the events the patient received the second of two planned doses of mRNA-1273 (lot/batch: 022M20A) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, after receiving the second dose the patient experienced restlessness, chills, tiredness, hallucination, not feeling good, sleepiness during the day, trembling, mumbling words in his sleep and weak. The patient had been to the emergency room and they could not find anything wrong. The patient reported that he thought as he was allergic to Versed (midazolam) anesthesia which he took some years back during cataract surgery similarly now he had reaction to vaccine.  Treatment information was not reported.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, hallucination, tiredness, restlessness, chills, not feeling good, sleepiness in the morning, trembling, mumbling words in his sleep and weak was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Sleep talking, Somnolence, Tremor
Clinical narrative: hallucination; restlessness; sleepiness during the day; trembling; mumbling words in his sleep; weak; tiredness; chills; A spontaneous report was received from a male patient (unspecified age) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucination, tiredness, restlessness, chills, not feeling good, sleepiness in the morning, trembling, mumbling words in his sleep and weak.  The patient's medical history included drug allergy to versed anesthesia during cataract surgery. No relevant concomitant medications were reported.  On 26 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On 23 Feb 2021, prior to the onset of the events the patient received the second of two planned doses of mRNA-1273 (lot/batch: 022M20A) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, after receiving the second dose the patient experienced restlessness, chills, tiredness, hallucination, not feeling good, sleepiness during the day, trembling, mumbling words in his sleep and weak. The patient had been to the emergency room and they could not find anything wrong. The patient reported that he thought as he was allergic to Versed (midazolam) anesthesia which he took some years back during cataract surgery similarly now he had reaction to vaccine.  Treatment information was not reported.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, hallucination, tiredness, restlessness, chills, not feeling good, sleepiness in the morning, trembling, mumbling words in his sleep and weak was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Corticotropin-releasing hormone stimulation test, Differential white blood cell count, Fatigue, Full blood count, Hypotension
Clinical narrative: Patient received Moderna vaccine ~2pm, by the evening, had developed fatigue, with low blood pressure. Patient required admission to the ICU with vasopressor support, which was able to discontinue after ~3 days. Patient reports no other symptoms. Fatigue persisted until mid-March.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Leukocytosis, Metabolic function test abnormal
Clinical narrative: Patient received Moderna vaccine ~2pm, by the evening, had developed fatigue, with low blood pressure. Patient required admission to the ICU with vasopressor support, which was able to discontinue after ~3 days. Patient reports no other symptoms. Fatigue persisted until mid-March.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient complaining of bodyaches, fever, and chills.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Initially Fever Body aches and pains --all symptoms lasted for 12-14 hours
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold
Clinical narrative: Chilled, Hard to stay warm, Tired
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain, Productive cough
Clinical narrative: Sore throat lasting at least 2 days now Sticky build up of flem in back of throat lasting 2 days now Sharp and strong muscle ache intermittently about 8 hours on Sunday Low grade headache 6 hours on Sunday
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Musculoskeletal stiffness, Oropharyngeal pain, Pain
Clinical narrative: FEVER, ACHES, SORE THROAT, SWOLLEN GLANDS, HEADACHE, STIFF NECK...SO FAR GOING ON TWO DAYS
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER, ACHES, SORE THROAT, SWOLLEN GLANDS, HEADACHE, STIFF NECK...SO FAR GOING ON TWO DAYS
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity, Paraesthesia, Periarthritis
Clinical narrative: Severe pain in my arm from the time I received the shot. Could not use my entire left arm at all for a month. Tingling down to my fingertips. Required multiple trips to an orthopedic specialist. Multiple courses of medication.  First diagnose' was SIRVA, followed by frozen shoulder.  Still having pain and issues to this day. Limited use of my left shoulder. Injection site was too high.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Severe pain in my arm from the time I received the shot. Could not use my entire left arm at all for a month. Tingling down to my fingertips. Required multiple trips to an orthopedic specialist. Multiple courses of medication.  First diagnose' was SIRVA, followed by frozen shoulder.  Still having pain and issues to this day. Limited use of my left shoulder. Injection site was too high.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 1 week after vaccination, developed 2 lumps under arm in lymph nodes in arm pit the same arm as vaccine.  Was seen by doctor and having follow up visit
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Delusional disorder, unspecified type, Erythema, Eye swelling, Hallucination, Illness
Clinical narrative: hallucinating; Delusional; Eyes are swollen; Night terrors; She was really really sick; her is red red; her body hurts; fever 102; A spontaneous report was received from an consumer concerning a 46 years old, female patient who experienced hallucination, delusional, swollen eyes, night terrors (sleep terror), was really sick (illness), her is red (erythema), body hurts (myalgia) and fever 102 (pyrexia)    The patient's medical history included COVID-19. Concomitant product use was not provided by the reporter.   On 05 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 036A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    The patient experienced the events she was really sick, fever 102, her body hurts, her is red, hallucinating, she was delusional, she had night terrors, like on drugs and her eyes are like swollen, like little bag under her eyes all since an unknown date in Mar 2021. The event hallucination was considered medically significant. Treatment for the event included Tylenol.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events hallucination, delusional, swollen eyes, night terrors, was really sick, her is red, body hurts and fever 102 were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Sleep terror
Clinical narrative: hallucinating; Delusional; Eyes are swollen; Night terrors; She was really really sick; her is red red; her body hurts; fever 102; A spontaneous report was received from an consumer concerning a 46 years old, female patient who experienced hallucination, delusional, swollen eyes, night terrors (sleep terror), was really sick (illness), her is red (erythema), body hurts (myalgia) and fever 102 (pyrexia)    The patient's medical history included COVID-19. Concomitant product use was not provided by the reporter.   On 05 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 036A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    The patient experienced the events she was really sick, fever 102, her body hurts, her is red, hallucinating, she was delusional, she had night terrors, like on drugs and her eyes are like swollen, like little bag under her eyes all since an unknown date in Mar 2021. The event hallucination was considered medically significant. Treatment for the event included Tylenol.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events hallucination, delusional, swollen eyes, night terrors, was really sick, her is red, body hurts and fever 102 were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reports "I was extremely weak, fatigued, high fever, swollen lymph nodes in my left arm pit and elbow.  my right arm (injection site) is red, swollen, tender and warm to touch"
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Joint swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Pt reports "I was extremely weak, fatigued, high fever, swollen lymph nodes in my left arm pit and elbow.  my right arm (injection site) is red, swollen, tender and warm to touch"
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: No treatment needed other than ice and otc analgesic/antipyretic
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient reports a very sore/painful arm, which radiated up her neck and across to her back. After 3 days of rest, the pain has completely resolved.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Enlarged uvula, Feeling hot, Panic reaction, Swelling face, Tearfulness
Clinical narrative: Client has previous allergies to cows milk and aloe.  Reported her face was hot and swelling after vaccine.  Family member in car with client confirmed her face was swollen as not visible initially. Client tearful  and panicked.  Reclined in car seat and Dr and Epi Pen called for.  Dr spoke with client and examined the swelling, stating her Uvula was swollen.  He administered an epi pen to left thigh muscle.  0.3ml  .  Blood pressure was 135/75 with pulse of 82 RR22 and oxygen saturation of 100%.  EMS on site.  Epi pen was administered on 12.10 pm.  Client responded quickly and stated the she felt much better.  second vital signs in 5 minutes were blood pressure 133/77 pulse 78 RR 18 and oxygen saturation of 97%.  Transported by EMR to hospital.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: WHEN SHOT WAS BEING ADMINISTERED I FELT IT TRICKLING DOWN MY ARM. WHEN I LET THE NURSE KNOW AND SHE LOOKED AT IT AND PULLED IT OUT NEEDLE CAME OFF THE SYRINGE AND FELL TO THE FLOOR. I AM NOT SURE IF ANY OF THE VACCINE GOT ADMINISTERED. THIS HAS CAUSED ME TO LOSE MY PEACE OF MIND. THEY SAID THEY CANNOT GIVE ME ANOTHER DOSE BECAUSE THERE WAS NO WAY TO TELL HOW MUCH ACTUALLY WENT IN AND AN OVERDOSE CAN BE HARMFUL. I WAS TOLD TO JUST COME FOR MY SECOND DOSE AS SCHEDULED AND I WOULD BE ALRIGHT. I NEED SOMEONE MORE KNOWLEDGABLE TO ASSURE ME OF THIS.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash on right breast and lower right scapular area. Prescribed prednisone and valtrex
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Neutrophil count decreased, Pulmonary pain
Clinical narrative: #2 shot Feb 28th - March 2 headaches,pain in lungs, extreme fatigue-went to bed for a few days then I was able to walk around but chills,fatigue for 3 weeks
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; A spontaneous report was received from a consumer concerning her husband, a 75 years old, male patient who received Moderna (mRNA-1273) vaccine and experienced Stroke (Cerebrovascular accident).  The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included: prefervifion.  On 14-Feb-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031M20A)intramuscularly for prophylaxis of COVID-19 infection.   On 1-Mar-2021, the patient had a stroke and was hospitalized on the same day. The patient is still hospitalized. No laboratory details were provided.  On 14 Mar 2021, the patient has their second shot scheduled.  Treatment information provided by the reporter included: Aspirin, prolix, cleft, lovenox.  Action taken with mRNA-1273 in response to the event was unknown  The outcome of the event, Stroke was considered Not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Dyspnoea
Clinical narrative: Weakness Shortness of breath Covid-19
Age: 34.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: Pt coughing/SOB. Pt hx of asthma that became symptomatic after vaccination. Pt triaged and assessed by MD. No audible wheezing. MD decided to escalate to ER for further evaluation.
Age: 34.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Pt coughing/SOB. Pt hx of asthma that became symptomatic after vaccination. Pt triaged and assessed by MD. No audible wheezing. MD decided to escalate to ER for further evaluation.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle twitching
Clinical narrative: I developed a non stop under eye twitch on my left eye 2 days post vaccine.  Today is 6 days later and it's still twitching.  I also feel extra fatigue.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: General Message: Patient left voicemail regarding his COVID-19 positive status after being fully vaccinated. He had spoke with physician over the weekend who said another physician might be interested in testing him for variants.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dose give outside of the recommended age range.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye irritation, Fatigue, Malaise, Pain
Clinical narrative: Around noon the following day I started feeling achy and tired.  My eyes burn and I have chills.  Just feel like I'm coming down with something.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Gallbladder disorder
Clinical narrative: Emergency room for gallbladder; Could not get out of bed; A spontaneous report was received from a 85-year-old female patient who had to go to Emergency room for gall bladder/ gallbladder disorder NOS and could not get out of bed/bedridden after receiving Moderna's COVID-19 vaccine (mRNA-1273).  Medical history or concomitant product use was not reported.  On 30 Jan 2021, the patient received first of two planned dose of mRNA-1273 (batch number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 24 Feb 2021, the patient went to the emergency room for gallbladder and was admitted same day. On 26 Feb 2021, the patient had a procedure done and had a bag for drainage. On 01 Mar 2021, the patient was admitted to rehabilitation facility and remained there as of 10 Mar 2021. The patient was planned to receive the second dose of mRNA-1273 on 27 Feb 2021.  Since the patient was in the rehab facility, the pharmacy provided the vaccine on 04 Mar 2021 but the patient could not get out of bed to go to the pharmacy.  Action taken with mRNA-1273 in the response to the events Emergency room for gall bladder and could not get out of bed was not reported.  The outcome of the events Emergency room for gall bladder and could not get out of bed was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Chills, Loss of consciousness, Pyrexia, Urinary incontinence
Clinical narrative: The night of the vaccine she developed fever and chills. 3/17 she had bowel and urine incontinence and her daughter told her to rest and then she insisted on getting into the shower because she was upset about the incontinence 9:15 am she had gotten in the shower and her other daughter was close by when she had bowel and urine incontinence again and then lost consciousness and then she came to and had bowel and urine incontinence for a 3rd time. The bowel movements were massive diarrhea. Reporter believes she had a TIA event (Mini stroke). She was cared for at home by her daughter who is a nurse. In the past, when she has high fever and chills she tends to have TIA events.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Palpitations
Clinical narrative: Diarrhea, racing heartbeat, heart palpitations, headache, nausea all started at 1.5 hours post injection.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation, Injection site rash, Injection site warmth
Clinical narrative: approx 6" area around injection spot on arm was pink in color/irritated/warm to touch for a couple of days (which began over a week after injection); a Google search identified all these symptoms as "Covid arm" which matched it perfectly...after 3-4 days symptoms went away no issues since then; my second shot scheduled for 3/31/21
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: Bump and rash on left arm one week after shot.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Electrocardiogram, Tremor, Vertigo
Clinical narrative: Vertigo. Tremors.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Night sweats, Pyrexia
Clinical narrative: Chills @ 5 am till 6 am Lightheadedness @ 5:30am Vomit @ 5:45 am Fever & night sweats from 6 am till 1pm
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: External rash.  Treated with antihistamines
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Patients husband called to report incident. Patient developed Bells Palsy on 3/16/21, which was 8 days following the 1st dose of Moderna Covid-19 vaccine. She was treated by PCP and also by a specialist.  Ongoing tests and follow-up were scheduled.  She was started on several medications that the husband reporting did not know at the time.  The incident was reported to the pharmacy several days after incident.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Multiple sclerosis, Pyrexia
Clinical narrative: exacerbated multiple sclerosis; weakness; fatigue; chills; fever; A spontaneous report was received from a consumer, who is a 74-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness/ asthenia, fatigue, chills, fever/ pyrexia and exacerbated multiple sclerosis (MS)/ multiple sclerosis relapse.  The patient's medication history included multiple sclerosis and COVID infection on 27 Dec 2020. No relevant concomitant medications were reported.  On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in left arm for prophylaxis of COVID-19 infection. On an unspecified date, after receiving vaccine, the patient experienced weakness, fatigue, chills, fever and exacerbated multiple sclerosis (medically significant).  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was unknown. The second dose of the vaccine was scheduled on 25 Feb 2021.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Pneumonia
Clinical narrative: Pneumonia  Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC)  COVID-19 virus infection
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Had a syncope episode right after vaccine lasting a few seconds.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Using V Safe I reported mild symptoms of soreness & swelling at the injection site which abated by day 5. V Safe stopped communicating by Friday, 3/19. I'm trying to make the CDC aware that they are missing reportable adverse react because of limited follow-up. I developed itching at the injection site on 3/20 in the a.m. I note approximately a 15 cm area of erythema around the injection site. On 3/20, after a 5 mile walk I felt similar symptoms that I had in the first couple of days after the injection of lightheadedness and felt poorly enough to have to rest the remainder of the day. I am better today and was able to function, but not ready to resume exercise. How many others have had a delayed reaction that is being missed because V Safe stops the follow-up when initial signs & symptoms disappear?
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Using V Safe I reported mild symptoms of soreness & swelling at the injection site which abated by day 5. V Safe stopped communicating by Friday, 3/19. I'm trying to make the CDC aware that they are missing reportable adverse react because of limited follow-up. I developed itching at the injection site on 3/20 in the a.m. I note approximately a 15 cm area of erythema around the injection site. On 3/20, after a 5 mile walk I felt similar symptoms that I had in the first couple of days after the injection of lightheadedness and felt poorly enough to have to rest the remainder of the day. I am better today and was able to function, but not ready to resume exercise. How many others have had a delayed reaction that is being missed because V Safe stops the follow-up when initial signs & symptoms disappear?
Age: 26.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Wrong product administered
Clinical narrative: Vaccine error. The patient received Dose 1 Moderna 2/24/2021 (lot 012A21A) and received the second dose of Pfizer  3/22/2021 (lot EN6206) in error. The dose should have been Moderna. The event occurred at a large vaccine site administered jointly. This event is being reported as a vaccine error to assist in data collection and process improvement. CDC recommendations are that no further action is needed at this time. Patient was counseled by a doctor .
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Feeling hot, Irregular breathing, Speech disorder, Urinary incontinence
Clinical narrative: Patient started breathing heavily a few minutes after receiving the vaccine, was able to say words not full sentences. said he was feeling hot. he lost muscle control and uncontrollably urinated. EMR was contacted; patient retained muscle control and got back to normal in about 2 minutes after the start of the adverse events. and was able to walk with the EMR outside to get medical check.