chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: About 10 minutes after the second dose, I noticed the hives and irritation come on my throat, neck and my arm. I talked to the people who were monitoring and they gave me 50 mg of Benadryl and they kept me for 45- one hour. They Benadryl took about 20-30 minutes to for having the hives and irritation go away. After that happened, I went home and I started to get body aches and feeling very fatigued; a little bit nauseous.  I did have some soreness and swelling on my arm after vaccine that lasted two or three days. The fatigue and body aches lasted for one day. The hives and irritation on my throat and neck and arm didn't come back after the dose of Benadryl.  I had a doctor appt on Feb 8 about the side affects of the vaccine - he told me if hives came back to take Benadryl.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Urticaria
Clinical narrative: About 10 minutes after the second dose, I noticed the hives and irritation come on my throat, neck and my arm. I talked to the people who were monitoring and they gave me 50 mg of Benadryl and they kept me for 45- one hour. They Benadryl took about 20-30 minutes to for having the hives and irritation go away. After that happened, I went home and I started to get body aches and feeling very fatigued; a little bit nauseous.  I did have some soreness and swelling on my arm after vaccine that lasted two or three days. The fatigue and body aches lasted for one day. The hives and irritation on my throat and neck and arm didn't come back after the dose of Benadryl.  I had a doctor appt on Feb 8 about the side affects of the vaccine - he told me if hives came back to take Benadryl.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Interchange of vaccine products
Clinical narrative: No additional adverse event or product quality complaint were reported; Inadvertently gave an employee a dose of  PROQUAD instead of MMRII; Inadvertently gave an employee a dose of  PROQUAD instead of MMRII at the age of 56 years old; This spontaneous report was received from a License practical nurse referring to a 56-year-old patient.  The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 04-FEB-2021, the patient received the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, anatomical location, route of administration, lot #, and expiration date were not reported) for prophylaxis.     On 05-MAR-2021, the patient was vaccinated inadvertently vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live(PROQUAD) at a dose of 0.5 milliliters, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (wrong product administered).  The second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) had been not administered yet.   No additional adverse events or product quality complaints were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle and joint aches
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vomiting
Clinical narrative: Vomit headache exhaustion
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: thrombocytopenia
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Immune thrombocytopenia, Immunoglobulin therapy, Intensive care, Platelet count decreased
Clinical narrative: thrombocytopenia
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet transfusion, Rash, Rash erythematous
Clinical narrative: thrombocytopenia
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Ultrasound liver normal
Clinical narrative: Marked elevation in AST and ALT noted on routine screening.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Fatigue, Hyperhidrosis, Hypotension, Lip blister
Clinical narrative: Patient's lips blistered; hands, lips, nose and vagina became swollen. Patient had hives on arms, lower extremities were extremely tender, patient felt poking sensations over the body (felt like needles). Nose and throat became dry and patient felt out of breath and extreme fatigue. Patient had low blood pressure and extreme sweating. Patient went to urgent care and was given a steroid injection to reduce swelling and was diagnosed with bronchial spasms. Patient received a butanol treatment.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal dryness, Paraesthesia, Peripheral swelling, Respiration abnormal, Swelling
Clinical narrative: Patient's lips blistered; hands, lips, nose and vagina became swollen. Patient had hives on arms, lower extremities were extremely tender, patient felt poking sensations over the body (felt like needles). Nose and throat became dry and patient felt out of breath and extreme fatigue. Patient had low blood pressure and extreme sweating. Patient went to urgent care and was given a steroid injection to reduce swelling and was diagnosed with bronchial spasms. Patient received a butanol treatment.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Urticaria, Vulvovaginal swelling
Clinical narrative: Patient's lips blistered; hands, lips, nose and vagina became swollen. Patient had hives on arms, lower extremities were extremely tender, patient felt poking sensations over the body (felt like needles). Nose and throat became dry and patient felt out of breath and extreme fatigue. Patient had low blood pressure and extreme sweating. Patient went to urgent care and was given a steroid injection to reduce swelling and was diagnosed with bronchial spasms. Patient received a butanol treatment.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Fever, chills, diarrhea, nausea, headache
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: Breaking out / Splotches all of her body/ Red splotches; Painful splotches; This case was reported by a physician and described the occurrence of red blotches in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced red blotches and painful rash. On an unknown date, the outcome of the red blotches and painful rash were unknown.   The reporter considered the red blotches and painful rash to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix about a year ago. After the Shingrix dose, the patient started breaking out in red painful splotches all of her body. The reporter thought it could be related to her Shingrix. The reporter consented to follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Client was given her second dose before reviewing her vaccine card on her previous dose. She received her dose 3 days earlier than the earliest it should have been given. She did receive the appropriate second dose but to soon.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Lymphadenopathy
Clinical narrative: Achiness through upper torso plus a lump in arm pit of  left arm.   Rubbed self down with arnicare for achiness the day following shot, cleared up that situation within.  Iced the lump at the same time but still tender on 2nd day continue to ice off and on.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Tinnitus/ hearing loss
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Patient complained of lips and tongue tingling; denied any shortness of breath; Benadryl (5cc) administered.  Advised to go home and go to bed.    After reaction started, she admitted that she has this happen after any type of vaccine received.  Did not advise of this when completing questionnaire - only acknowledged allergy to statin.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site rash, Pain in extremity
Clinical narrative: 3/23/21 pt developed red circular rash the size rash the size of a grapefruit around the injection site on the right arm. 3/25/2021 pt  developed a red circular rash the size the size of a grapefruit on his right bicep. 3/26/2021 pt went to PCP where he was told he thought he had dermatitis and was told to take cortisone cream. Pt still has some pain redness in the arm.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Ultrasound scan normal
Clinical narrative: Small node on left clavicle appeared on second day after vaccine. Noticed after 54 hours after receiving Covid 19 Vaccine
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Hospitalization within 6 weeks after receiving vaccine
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Cold sweat, Dizziness, Nausea
Clinical narrative: Two minutes after receiving his vaccine he started to get lightheaded and dizzy, cold sweats, nausea, and he was bradycardic. Ammonia was used while he was in the POD.  He was removed from the cell and brought to the medical observation area. His blood pressure on arrival  was 119/68, heart rate 71, pulse ox on room air was 99%. Patient was placed in trendelenberg  for about 10 minutes. His follow up blood pressure was 113/68 @ 2:49. About 5 minutes later hw as placed in a semi fowlers position with his follow up blood pressure was 127/62, HR 72. , subsequent in a sitting position was 113/68 HR 74, and in a standing position 125/64. Patient reported his symptoms have resolved.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: Bad rash all over my body. Tiny bumps/hives
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contraindicated product administered
Clinical narrative: PT. RECEIVED JANSSEN COVID VACCINE AFTER RECEIVING FIRST AND SECOND DOSE OF MODERNA VACCINE
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no adverse events. patient was not 18 by 3 months and i was told this need to be reported
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness. Began within 20 minutes after injection, continued for 3 days. Treated with ibuprofen, which helped reduce soreness.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Needle issue
Clinical narrative: During vaccine administration, needle became separated from syringe and remained in patient's arm. Needle was gently removed with harm to the patient.  Full dose was given.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Influenza like illness, Loss of consciousness, Malaise
Clinical narrative: Extreme Flu-like symptoms. Massive headache, nausea, muscle aches. Coincidently, happened to have a previously scheduled blood draw for the next day at my doctor, listed previously. I got extremely nauseous, began sweating profusely and passed out right after the draw (have never had a blood draw reaction). 56 hrs since my shot and I still feel poorly, but better.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Extreme Flu-like symptoms. Massive headache, nausea, muscle aches. Coincidently, happened to have a previously scheduled blood draw for the next day at my doctor, listed previously. I got extremely nauseous, began sweating profusely and passed out right after the draw (have never had a blood draw reaction). 56 hrs since my shot and I still feel poorly, but better.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Moderna COVID-19 Vaccine EUA.   30 hours of aches, extreme tiredness, and fever.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Neck pain, Pain
Clinical narrative: Bells palsy; Soreness; Neck pain; A spontaneous report was received from a consumer concerning a 44-years-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness/ pain, bells palsy/ facial paralysis and neck pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 8 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch Number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced soreness, bells palsy , and neck pain. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events, soreness, bells palsy, and neck pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Cough, Lacrimation increased, Obstruction gastric, Pulmonary congestion
Clinical narrative: Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for Covid-19 vaccine, Dose #1.  She developed itching in there throat within 30 minute waiting period.    She was taken to Rapid Response Room.   Symptoms progressed from itchy throat, to congestion in throat/upper chest, clearing her throat, watery eyes.  Then dry cough.    No nausea, no vomiting, no light headed feeling.  No facial swelling  No hives.    OBJECTIVE: Vitals -  154/97, 105, 100%RA Neck -  Supraclavicular mild retractions, end inspiratory stridor CV: tachy, regular, no murmur pulm - diminished breathe sounds throughout, no wheezing.  Speaking full sentences.    Assessment/ Plan:   Anaphylaxis to Covid-19 Vaccine: -  emergency responders - epi 0.3 mg IM administered to L mid outer thigh at 9:35 am by me - epi 0.3 mg IM administered to R mid outer thigh at 9:41 am because symptoms not subsiding by me -benadryl 50 mg IM x 1 L deltoid by RN 9:45 am - Itching in throat subsided but still retracting and clearing throat so albuterol 3 puffs given at 9:50 am   Vitals stable entire time (see midas report)   EMS arrived to transport to local hospital.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Stridor, Tachycardia
Clinical narrative: Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for Covid-19 vaccine, Dose #1.  She developed itching in there throat within 30 minute waiting period.    She was taken to Rapid Response Room.   Symptoms progressed from itchy throat, to congestion in throat/upper chest, clearing her throat, watery eyes.  Then dry cough.    No nausea, no vomiting, no light headed feeling.  No facial swelling  No hives.    OBJECTIVE: Vitals -  154/97, 105, 100%RA Neck -  Supraclavicular mild retractions, end inspiratory stridor CV: tachy, regular, no murmur pulm - diminished breathe sounds throughout, no wheezing.  Speaking full sentences.    Assessment/ Plan:   Anaphylaxis to Covid-19 Vaccine: -  emergency responders - epi 0.3 mg IM administered to L mid outer thigh at 9:35 am by me - epi 0.3 mg IM administered to R mid outer thigh at 9:41 am because symptoms not subsiding by me -benadryl 50 mg IM x 1 L deltoid by RN 9:45 am - Itching in throat subsided but still retracting and clearing throat so albuterol 3 puffs given at 9:50 am   Vitals stable entire time (see midas report)   EMS arrived to transport to local hospital.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site swelling, Rash macular
Clinical narrative: Arm red and swollen from injection site to elbow. Red patches on arm Headache over 48 hours Flu like symptoms
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Got his vaccine,  stayed 30 minutes, had no problems.  He went to bed, woke up and has mild persistent headache, mild persistent fever, achiness, body aches all over, flu-like symptoms, not much appetite.   He did take Ibuprofen for the symptoms and is starting to feel a little better.  The headache is gone, the arm is less sore.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dysuria, Headache, Pain, Pyrexia
Clinical narrative: low grade fever, headache, multiple body aches including neck, back, abdomen, hips and legs,mild diarrhea, frequent and painful urination and worsening of asthma.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncope lasting 2 minutes
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Diagnosed with Bells Palsy after first dose of vaccine; A spontaneous report was received from a physician concerning, a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and diagnosed with Bell's Palsy after first dose of vaccine.  The patient's medical history and concomitant medication was not provided.  On an unknown date, approximately 3 weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 22 Jan 2021, approximately 3 weeks after receiving mRNA-1273, patient was diagnosed with Bell's palsy by an emergency room physician. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the event, diagnosed with Bell's palsy, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Candida infection, Chills
Clinical narrative: Severe headaches, 5 days, fever, chills, on and off for first 3 days, nausea, 5-6 days, weakness, fatigue, 5-6 days, brain fog, 6-7 days, joint aches,6-7 days, dizziness and loss of balance, still have but not as severe , full body thrush, day 2-5.  Extreme soreness at injection for 4-5 days
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Injection site pain
Clinical narrative: Severe headaches, 5 days, fever, chills, on and off for first 3 days, nausea, 5-6 days, weakness, fatigue, 5-6 days, brain fog, 6-7 days, joint aches,6-7 days, dizziness and loss of balance, still have but not as severe , full body thrush, day 2-5.  Extreme soreness at injection for 4-5 days
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Severe headaches, 5 days, fever, chills, on and off for first 3 days, nausea, 5-6 days, weakness, fatigue, 5-6 days, brain fog, 6-7 days, joint aches,6-7 days, dizziness and loss of balance, still have but not as severe , full body thrush, day 2-5.  Extreme soreness at injection for 4-5 days
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Classical Bell's Palsy symptoms, right side of the face. Treatment began with valtrex and prednisone on 03/23/2021. No decrease (or increase) in symptoms so far.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Ataxia, Gait inability, Hypotonia, Motor dysfunction
Clinical narrative: stroke like symptoms: severe ataxia, left side flaccid, could not walk, could not understand spoken word, fever 100.2F, hands contracted, could only speak 2 or 3 words. symptoms lasted about 4-5 hours intensely, not recovered until next day.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Peripheral swelling, Pyrexia, Rash, Skin induration
Clinical narrative: mild fever, chills - 12-24 hours after shot, lasting 24 hours hard, sore, swollen arm - 2 hours after shot. lasting 4 days patchy rash on chest - 12-24 hours after shot. 14 days and still active
Age: 41.0
Sex: U
Vaccine: UNK, COVID19
Symptoms: Dysgeusia, Fatigue, Flushing, Headache, Pain in extremity
Clinical narrative: flushed face, metallic taste, very sore arm, extreme fatigue, headache
Age: 41.0
Sex: U
Vaccine: UNK, COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Limb discomfort, Nausea
Clinical narrative: flushed face, metallic taste, very sore arm, extreme fatigue, headache
Age: 41.0
Sex: U
Vaccine: UNK, COVID19
Symptoms: Vaccination site pain
Clinical narrative: flushed face, metallic taste, very sore arm, extreme fatigue, headache
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Laboratory test, Migraine, Nausea
Clinical narrative: I had a mild headache for about 6 days. On day 7, I had a temporary vision cut for 43 min and then it returned in full, but I had a severe migraine and nausea. They did CT imaging and labs. Everything was clear. I was medicated with IV pain meds and anti-nausea meds. I continued to have a mild headache for a few days, but it eventually resolved.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: I had a mild headache for about 6 days. On day 7, I had a temporary vision cut for 43 min and then it returned in full, but I had a severe migraine and nausea. They did CT imaging and labs. Everything was clear. I was medicated with IV pain meds and anti-nausea meds. I continued to have a mild headache for a few days, but it eventually resolved.
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Hospitalization within 6 weeks after receiving vaccine
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Hospitalization within 6 weeks after receiving vaccine
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of consciousness, Memory impairment, Pruritus
Clinical narrative: Passed out for around one minute and did not remember anything for that one minute; Her arm was very itchy; Passed out for around one minute and did not remember anything for that one minute; Feeling tired after vaccination; A spontaneous report was received from a consumer on 22 Feb 2021, with additional information received on 15 Mar 2021, concerning about a female patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an adverse reaction including passed out for around one minute and did not remember anything for that one minute, Her arm was very itchy, and Feeling tired after vaccination.  The patient's medical history was reported as the patient have allergy towards nuts, cats, dogs, dust and trees. Concomitant medications were not reported.  On an unknown date in Feb 2021, prior to the onset of the events, the patient received their planned doses of mRNA-1273 (Batch number: unknown) via unknown route for the prophylaxis of COVID-19 infection.  The patient experienced an adverse reaction including passed out for around one minute and did not remember anything for that one minute, Her arm was very itchy, and Feeling tired after vaccination. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not provided.  The outcomes of the reported events remain unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Dyspnoea, Hypoaesthesia, Paraesthesia oral, Pruritus
Clinical narrative: 9:20 am Patient was kept under observation for 30 min after the administration of the vaccine.  9:45 am Patient notifies the nurse in charge of the area that he feels itchy forearm, she proceeds to notify the staff, vitals are measured B / P 159/88, P. 68, T. 36.1, R. 21, S. 97 %, Dextrox 91mg / dl. Patient is channeled with .9NS. Starts with rash on both arms and back Dr. of the clinic orders to administer Benadryl 50 mg IV. Patient verbalizes having a heavy tongue and numb left arm and indicates that he cannot breathe.  Benadryl discontinued  O2 cannula is placed. Indicates feeling better. Solumedol IV 125 mg was placed, after the administration began with involuntary movements in the arms and legs. The drug is discontinued. Involuntary movements decreased. She is transported by ambulance by calling 911 to the nearest hospital.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 9:20 am Patient was kept under observation for 30 min after the administration of the vaccine.  9:45 am Patient notifies the nurse in charge of the area that he feels itchy forearm, she proceeds to notify the staff, vitals are measured B / P 159/88, P. 68, T. 36.1, R. 21, S. 97 %, Dextrox 91mg / dl. Patient is channeled with .9NS. Starts with rash on both arms and back Dr. of the clinic orders to administer Benadryl 50 mg IV. Patient verbalizes having a heavy tongue and numb left arm and indicates that he cannot breathe.  Benadryl discontinued  O2 cannula is placed. Indicates feeling better. Solumedol IV 125 mg was placed, after the administration began with involuntary movements in the arms and legs. The drug is discontinued. Involuntary movements decreased. She is transported by ambulance by calling 911 to the nearest hospital.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain in extremity, Sleep disorder
Clinical narrative: Same day as vaccine administered 3/15/2021 Headache. Tiredness. During the early morning hours  on 3/16 Big Toe throbbing woke me up.  Throbbing stopped in big toe and then moved to right wrist, then stopped at wrist and went to left leg.  Throughout the next 24 hours their would be sharp pains in right ankle.  Left arm at injection sight very painful. Pains would occur in different body parts next 24 hours.  Extreme tiredness to the point of ongoing sleep well passed the 6 hours of regular sleep for me.  It took 4 days for me to start to feel I was returning to normal function,  the fifth day I felt normal.  I thought this was a long time to recover from shot in comparison to what I did hear.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Local reaction
Clinical narrative: pt develped delayed local reaction at the site of injection measuring 6 cm by 9cm.  Erythematous and pruritic as well as tender.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: pt develped delayed local reaction at the site of injection measuring 6 cm by 9cm.  Erythematous and pruritic as well as tender.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Oropharyngeal pain, Pain, Pyrexia, Vomiting
Clinical narrative: Sore throat, migraine, body aches, vomiting, fever
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Retching
Clinical narrative: After vaccine pt showed signs of severe nausea, dry heaving, and dizziness. Pt laid down for 30min. Patient revealed of symptoms, vitals are stable.  Patient escorted by dad home.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Dyspnoea, Muscle spasms, Pruritus
Clinical narrative: Anaphylaxis: Shortness of breath, chest tightness, itching, muscle spasm
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Blood test, Burning sensation, Chest X-ray, Electrocardiogram abnormal
Clinical narrative: Anaphylaxis: Shortness of breath, chest tightness, itching, muscle spasm
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye irritation, Feeling abnormal, Muscle spasms, Seizure, Skin burning sensation
Clinical narrative: Anaphylaxis: Shortness of breath, chest tightness, itching, muscle spasm
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Throat tightness
Clinical narrative: Anaphylaxis: Shortness of breath, chest tightness, itching, muscle spasm
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Angioedema; A spontaneous report was received from a physician assistant concerning a 63 year old female patient who experienced angioedema.  Medical history included dermal filler injections (Botox, Voluma, and Restylane).  Concomitant product use was unknown.   On 03 Feb 2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 031L20A) for prophylaxis of COVID-19 infection.   On 03 Feb 2021, the patient developed angioedema. She went to emergency room within 24 hours and was given IV treatment with prednisone, Benadryl (diphenhydramine) and Pepcid (famotidine).   The action taken with mRNA-1273 in response to the event angioedema was unknown.   The event of angioedema was considered as resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Condition aggravated, Diarrhoea, Fatigue, Headache
Clinical narrative: Patient describes fatigue starting 1 hour after receiving vaccination. Patient now calls COVID19 hotline 3 days after initial symptoms and states fatigue is more moderate. Patient experiencing loose stool. Patient has hx of IBS however symptoms are worse than baseline.  Patient describes mild headache and increase in agitation/moodiness. Hx of bipolar disorder.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal septum deviation
Clinical narrative: Patient describes fatigue starting 1 hour after receiving vaccination. Patient now calls COVID19 hotline 3 days after initial symptoms and states fatigue is more moderate. Patient experiencing loose stool. Patient has hx of IBS however symptoms are worse than baseline.  Patient describes mild headache and increase in agitation/moodiness. Hx of bipolar disorder.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache, chills, body aches
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: 10 minutes after receiving vaccine began to feel dizzy and nausea. Began to feel better after 5 minutes
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Nausea, Swollen tongue, Throat tightness
Clinical narrative: Swollen tongue, tight throat and chest, dizziness, light headedness, and nausea.  Given epinephrine, Benadryl and Zofram
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Pt was waiting in observation area after receiving her covid vaccine. PT began feeling dizzy and lightheaded. Pt fainted briefly and EMS responded immediately. Fire/Rescue immediately responded shortly after. Pt regained consciousness and was evaluated by EMS and Fire/Rescue. Pt stated she has this kind of medical episode every so often. Last episode was 3 months ago. Pt and EMS do not believe this was directly related to the Covid vaccine. Pts vital were stable and exited premises on her own. Pt had family waiting for her in the the parking lot.
Age: 91.0
Sex: F
Vaccine: TYP
Symptoms: Fatigue, Headache, Nausea, Sleep disorder
Clinical narrative: I was tired, then I got an awful headache, couldn't sleep.  Tired, nauseous when I moved,  No arm soreness.  It comes and goes.   I am a very healthy person and this is not like me.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Developed raised, red, itchy  rash at injection site. Lasted for about 8 days.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: 3/22  Arm soreness 3/26 Body Aches, chills, headache, sore throat
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Pain, Pain in extremity
Clinical narrative: slight fever, soreness of arm, slivering, chills, headache, aches, stomach pain
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: slight fever, soreness of arm, slivering, chills, headache, aches, stomach pain
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, White blood cell count increased
Clinical narrative: High white blood cells; Pressure on eyes; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high white blood cells/white blood cell count increased, pressure on eyes/ocular discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, four weeks after receiving the vaccine dose the patient experienced the event high white blood cells. The patient was hospitalized and was still in the hospital with 3 weeks because of high white blood cells. On unknown date the patient experienced the event pressure on eyes. The patient also had tested negative for COVID on unknown date.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event high white blood cells, pressure on eyes was unknown.; Reporter's Comments: This case concerns a 74-year-old female hospitalized with serious unexpected events of white blood cell count increased and ocular discomfort. SARS-CoV-2 test negative. Event onset occurred 4 weeks after the first dose of mRNA-1273. Treatment not reported. Event outcome resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Very  very bad headache  and dizzy for 2 days now.. The headache is very bad! :(
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Body temperature, Head discomfort, Headache
Clinical narrative: severe headache pressure hour after my vaccine injection taking Tylenol every 8 hours.  Extreme HIVES all over my body with intense itching.  Took Benadryl and went to the ER.  received an IV with steroids and med to take at him.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: severe headache pressure hour after my vaccine injection taking Tylenol every 8 hours.  Extreme HIVES all over my body with intense itching.  Took Benadryl and went to the ER.  received an IV with steroids and med to take at him.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Red rash, hard spot, itchy, hot skin all at injection site
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Patient noticed swelling of her tongue. No SOB or other symptoms. VSS.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Pain
Clinical narrative: 3/3/2021--called to report an adverse reaction to her 2nd dose of Pfizer COVID-19 Vaccine received on 2/25/2021. She reports she had extreme pain and achiness on her whole L side (arm she received vaccine in) from her head to her toes. The next morning her daughter called and she had temporary dysphasia (she lives alone and had not tried to speak at all until then). Daughter took her to the Instacare and then the hospital - she stayed at the hospital through the day and received IV fluids and the dysphasia occurred again while there but has not happened again since. LSW, RN.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Mania
Clinical narrative: I would get the detailed vaccine information, but I am too tired to get my card. I have experienced severe fatigue.  I have been struggling with the onset of a manic episode due to Bipolar 1.  The fatigue due to the vaccine has exacerbated the problem and increased mania.  Had I known the extremely high prevalence of fatigue, I would have delayed vaccination.  I did consult with my psychiatrist prior to vaccination.  He did not seem aware of the high prevalence of fatigue.  If he did, he would have told me to delay vaccination.    Now I have mania problem that's getting worse.  A 25% incidence of fatigue needs to be disclosed for safety.    In addition, I am 37 years old.  I understand there is an age difference in adverse reactions.  COVID impacts 30 year-olds very differently than 50 year-olds.  However, the information available through the CDC reports data from 16-55 or something like that.  I need more detailed data.
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Rash
Clinical narrative: Fatigue-treatment frequent naps Rash on toes legs stomach arms back treatment hydrocortisone  Headache treatment Tylenol
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dyspnoea, Laboratory test, Oxygen saturation decreased, Pyrexia
Clinical narrative: febrile, shortness of breath, tachyacardic, low oxygen saturations, mental confusion
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: febrile, shortness of breath, tachyacardic, low oxygen saturations, mental confusion
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pharyngeal swelling
Clinical narrative: Pt. C/O swelling in her throat and nausea. On assessment she was verbal, A$O x4. V/s - BP 134/87, RR 16, HR 85, Temp. 97.6, Psox 99% RA. Pt. offered 500 mls of water and 125 mls of apple juice and she finished all.  No S/S of respiratory distress notde and pt denied  any pain. Further observation was initiated until pt. said she felt  better and ready to leave. She left the observation hall at 2:55p m to her home.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Pallor, Seizure
Clinical narrative: 20-year-old male with a past medical history of vasovagal episodes, cerebral palsy, dorsal rhizotomy and VP shunt followed by neurology, taking no medications presents to the ED for evaluation of a first-time seizure which occurred 1 hour ago 10 minutes after receiving a Covid vaccine.  Mother states that the patient receive the Covid vaccine around 11:15 AM and 10 minutes later he became very pale the e-stim to left lower and patient he had generalized body convulsions lasting less than 1 minute and turned very pale/cyanotic.  When he stopped seizing mother states that he was slightly confused as to what had happened and continued to be pale.  Patient is completely at baseline at this time answering questions appropriately, however he still complains of having dizziness with sitting up or standing. Patient is answering all questions appropriately.  He denies any numbness or tingling.  He states he generally feels slightly weak but there is no focal weakness. No headache, nausea, vomiting, diarrhea, recent head trauma, abdominal pain, chest pain or palpitations.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Vaccinator pushed needle into patient's right deltoid. Vaccinator pushed plunger and vaccine solution came out around the base of the needle. Needle was a vanish point that could not be tightened or loosened. Unable to determine amount given to patient; another dose was given in the opposite deltoid without incident.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Loss of consciousness, Nausea, Somnolence
Clinical narrative: felt groggy; sick to the stomach; passed out; felt very weak; cold sweat; shaky; A spontaneous report was received from a consumer  who was also an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed out/loss of consciousness, felt very weak/asthenia, sick to the stomach/ nausea, cold sweat, shaky/ tremor, could not see straight/ blurred vision and felt groggy/ somnolence.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium, calcium, tramadol and vitamin B complex.   The patient received their first of two planned doses of mRNA-1273 (Batch number:02AL20A) on 29 Jan 2021.  On 01 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 003A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 01 Mar 2021, 10 hours after getting the 2nd dose, the patient felt very weak, sick to the stomach, cold sweat, shaky, could not see straight and she passed out. On 02 Mar 2021, the patient felt groggy. The patient stated that she did not take any medications for her symptoms.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, passed out, felt very weak, sick to the stomach, cold sweat, shaky and could not see straight, were considered resolved on 02 Mar 2021. The event felt groggy was considered resolved on 03 Mar 2021.; 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: felt groggy; sick to the stomach; passed out; felt very weak; cold sweat; shaky; A spontaneous report was received from a consumer  who was also an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed out/loss of consciousness, felt very weak/asthenia, sick to the stomach/ nausea, cold sweat, shaky/ tremor, could not see straight/ blurred vision and felt groggy/ somnolence.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium, calcium, tramadol and vitamin B complex.   The patient received their first of two planned doses of mRNA-1273 (Batch number:02AL20A) on 29 Jan 2021.  On 01 Mar 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 003A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 01 Mar 2021, 10 hours after getting the 2nd dose, the patient felt very weak, sick to the stomach, cold sweat, shaky, could not see straight and she passed out. On 02 Mar 2021, the patient felt groggy. The patient stated that she did not take any medications for her symptoms.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, passed out, felt very weak, sick to the stomach, cold sweat, shaky and could not see straight, were considered resolved on 02 Mar 2021. The event felt groggy was considered resolved on 03 Mar 2021.; 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: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Hyperhidrosis, Paraesthesia
Clinical narrative: Sweaty  Warm Anxious Parasthesia
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Dizziness, Magnetic resonance imaging normal, Sleep disorder, Vision blurred
Clinical narrative: Started having blurry vision/trouble focusing eyes/feeling dizzy on Monday. By Wednesday, this was very difficult to handle and I went to see a practicioner at my primary care office and I could not sleep at all on Wednesday night; went to the ER on Thursday morning out of major concern.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 1 hour after 2nd shot developed hives on neck, shoulder and back.  Last approx 6 hours. No hives were experienced after the 1st shot.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Electrocardiogram normal, Fatigue
Clinical narrative: chills, headache, fatigue, shortness of breath, heaviness on chest for 2-3 days and shortness of breath and heaviness on chest is ongoing
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: chills, headache, fatigue, shortness of breath, heaviness on chest for 2-3 days and shortness of breath and heaviness on chest is ongoing
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Pyrexia
Clinical narrative: Fever, chills, light cough, heavy fatigue starting 03/26 AM. Continuing into AM. Took fever reducer/pain relivever.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Patient experienced lip tingling, throat tingling, and chest tightness.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Urticaria
Clinical narrative: Diarrhea..... ongoing Hives on injected arm....ongoing Nausea....first 4 days after injection No treatment done as of yet
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Joint injury, Loss of consciousness
Clinical narrative: lost consciousness and fell to floor striking left elbow. provided juice and crackers, declined ems
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dysgeusia, Feeling hot, Nightmare, Pain in extremity
Clinical narrative: Diarrhea; Injection site is sore; Felt hot; Pain from my arm radiated into my armpit; The most intense, crazy, scary nightmare that I've had in my entire life; Iodine flavor in his mouth; A spontaneous report was received from a consumer concerning for himself a 41-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events most intense, crazy, scary nightmare that i've had in my entire life/nightmare, iodine flavor in his mouth/dysgeusia, diarrhea, pain from my arm radiated into my armpit/pain in extremities, felt hot, Injection site is sore/ Vaccination site pain.  The patient's Current Condition included TMJ. Concomitant medications reported were hydrocodone, Carisoprodol both used for TMJ.  On 13Mar2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 13Mar2021, the patient experienced the event iodine flavor in his mouth. On 15Mar2021, the patient experienced the event most intense, crazy, scary nightmare that he had in his entire life and the same day he visited Emergency room. On an unknown date, the patient experienced the events diarrhea, pain from my arm radiated into my armpit, felt hot and injection site was sore. The event pain from his arm radiated to armpit was reported medically significant.  Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of events, most intense, crazy, scary nightmare that he had in his entire life, iodine flavor in his mouth, diarrhea, pain from arm radiated into his armpit, felt hot, injection site was sore was unknown, at the time of this report.; Reporter's Comments: This case concerns a 41 Y/O M with a serious unexpected event of pain in extremity and nonserious unexpected diarrhea, dysgeusia, feeling hot, nightmare, and expected vaccination site pain. Event onset the same day as first dose mRNA-1273. Treated with hydrocodone and Soma. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.