chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy, moved patient to open area, patient signed refusal.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral small vessel ischaemic disease, Cerebrovascular accident, Magnetic resonance imaging head abnormal
Clinical narrative: Patient returned to immunization clinic for 2nd dose of vaccine.   He reported that he had a stroke approximately 1 month after his COVID vaccine.  I advised nurse to not vaccinate today as this may be a vaccine adverse event.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Magnetic resonance imaging head abnormal, Plasminogen, Thalamic infarction
Clinical narrative: Patient returned to immunization clinic for 2nd dose of vaccine.   He reported that he had a stroke approximately 1 month after his COVID vaccine.  I advised nurse to not vaccinate today as this may be a vaccine adverse event.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Client received a first dose of COVID19 vaccine. This was missed by our vaccinator, who administered a dose of vaccine as a second dose. We understand that this counts as a valid second dose.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hot flush
Clinical narrative: client reported being hot b/p 120/84 SP02 100% pulse 68 Has hot flashes, monitored then walked to the door with staff and husband. Reported feeling fine except still warm.  Steady gate.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: She states on Saturday, 27th that she woke up having trouble breathing. She used VaporRub on her nose and throat and turned on her vaporizer. After about an hour, she started to feel better. But during that time, she felt like her throat was "closing" up. Her nose did not feel congested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Ear discomfort, Fatigue, Headache
Clinical narrative: She states on Saturday, 27th that she woke up having trouble breathing. She used VaporRub on her nose and throat and turned on her vaporizer. After about an hour, she started to feel better. But during that time, she felt like her throat was "closing" up. Her nose did not feel congested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Throat tightness
Clinical narrative: She states on Saturday, 27th that she woke up having trouble breathing. She used VaporRub on her nose and throat and turned on her vaporizer. After about an hour, she started to feel better. But during that time, she felt like her throat was "closing" up. Her nose did not feel congested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 38.0
Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Urticaria, Urticaria chronic
Clinical narrative: After the Moderna #1 I had a reoccurance of chronic urticaria and have had daily outbreaks since. Prior to vaccine I had 1+ years symptom free and managed with 100mgs of Dapsone. Since reoccurance of hives dapsone increased to 150mgs daily, still having daily outbreaks, but improved with dose increase.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: about 2" diameter area of swelling, redness, and mild irritation at injection site
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Migraine, Myalgia
Clinical narrative: joint pain, migraine, muscles aches, extreme fatigue
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Blood magnesium normal, Blood thyroid stimulating hormone, Cervical spinal stenosis, Chest X-ray normal
Clinical narrative: Sudden onset at rest of blurry vision and tingling paresthesias of trunk and limbs bilaterally.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Computerised tomogram neck, Electrocardiogram normal, Electroencephalogram normal, Full blood count normal
Clinical narrative: Sudden onset at rest of blurry vision and tingling paresthesias of trunk and limbs bilaterally.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Intervertebral disc degeneration, Low density lipoprotein, Magnetic resonance imaging head normal, Magnetic resonance imaging neck, Metabolic function test
Clinical narrative: Sudden onset at rest of blurry vision and tingling paresthesias of trunk and limbs bilaterally.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Prothrombin time, Stenosis, Thrombin time, Troponin normal
Clinical narrative: Sudden onset at rest of blurry vision and tingling paresthesias of trunk and limbs bilaterally.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis normal, Vision blurred
Clinical narrative: Sudden onset at rest of blurry vision and tingling paresthesias of trunk and limbs bilaterally.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Vaccine was administered at drive through event. During the waiting period, she developed wheezing and dyspnea.  She has a history of multiple allergies and self administered her own liquid benadryl 50mg and her own albuterol inhaler.  She was also given Depo Medrol 80mg IM.   Her symptoms resolved and she was monitored for an additional hour at the site.  She had an appointment already scheduled with her allergist later that day and plans to keep this appointment.  She had strict instructions to seek medical care immediately if other symptoms developed.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Gastrointestinal pain, Headache, Injection site pain
Clinical narrative: About 5 hours after the vaccination the injection site became extremely sore and is still sore on the third day after the vaccination.  On the first night after the vaccination I began to get body aches.  During day 2 the body aches became extreme, where getting out of bed or moving was painful.  The body aches were less severe on days 2 and 3, but are still continuing on day 4.  I was running  a fever all of day during days 2, 3, and 4.  I was throwing up on day 3.  I had GI pain and diarrhea on day 4.  I never have headaches, but have had a headache since day 2 and it is now day 5.  I have had lower back pain since day 2 and that also continues today (day 5).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: About 5 hours after the vaccination the injection site became extremely sore and is still sore on the third day after the vaccination.  On the first night after the vaccination I began to get body aches.  During day 2 the body aches became extreme, where getting out of bed or moving was painful.  The body aches were less severe on days 2 and 3, but are still continuing on day 4.  I was running  a fever all of day during days 2, 3, and 4.  I was throwing up on day 3.  I had GI pain and diarrhea on day 4.  I never have headaches, but have had a headache since day 2 and it is now day 5.  I have had lower back pain since day 2 and that also continues today (day 5).
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: PATEINT RECEIVED BOTH DOSES OF MODERNA AND GOT INFECTED WITH COVID-19 VIRUS MORE THAN 14 DAYS AFTER COMPLETING THE SERIES.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Muscle tightness, Myalgia
Clinical narrative: Nausea, joint aches, severe fatigue, headache, muscle tension and pain.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea, joint aches, severe fatigue, headache, muscle tension and pain.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain in extremity, Seizure
Clinical narrative: I started having normal side effects such as sore arm,  extreme tiredness and headache within 2 hours. By later that night I was in a dazelike state, had a lot of forgetfulness and lived life but as if I was sleepwalking and started having seizures over the next few days. A week later  I'm still having seizures, have no recollection of anything starting from the night of the day I got vaccinated
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Somnambulism
Clinical narrative: I started having normal side effects such as sore arm,  extreme tiredness and headache within 2 hours. By later that night I was in a dazelike state, had a lot of forgetfulness and lived life but as if I was sleepwalking and started having seizures over the next few days. A week later  I'm still having seizures, have no recollection of anything starting from the night of the day I got vaccinated
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Myalgia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: My father started showing symptoms of Covid such as low grade fever and muscle aches on 3/28 which was 11 days after receiving the first dose of moderna vaccine
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site pain
Clinical narrative: Headache, pain at site of injection, joint aches, chills
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Pain in extremity
Clinical narrative: pt states that later that night he had a very sore arm, headache and dizziness that lasted about 24 hours then went away.  About 10 later he developed diarrhea and this has lasted 3 days so far.  He took Pepto Bismol for 2 days but this did not seem to help.  He has an already scheduled appt w/ his Diabetic doctor and will discuss his symptoms with him to see what he suggest he should do about the diarrhea.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Tongue tingling and numb beginning within 2 hours of first dose
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Patient felt dizzy, diaphoretic post vaccine. Patient taken to ambulance for evaluation, patient signed refusal.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle aches and Fever. Fever details:  My normal temp is 98.1-98.2; this was my temp as of approx 8pm after 2pm vaccine By midnight: 99.8F 2 am: 99.9F 3am: 100.5F 6am: 99.6F 8am: 97.6F (fever gone)
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus, Skin warm
Clinical narrative: Patient called about 10 days after the shot and said she had a red circular rash on her arm where the shot was given to her. She said it was a little itchy and warm. She had it looked at to confirm nothing else was going on. I followed up with her today and she said that it has gone away.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Day of the vaccine developed soreness, swelling and redness at vaccine site. Overall aches and pains. Lasted 4 days, with fever on day two. On day two developed a "spongy" or paresthetic sensation of bottom of the feet that is still present 7 weeks later.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardioversion
Clinical narrative: ATRIAL FIBRILLATION.  SENT OT HOSPITAL ON 03/08 AND WAS CARDIOVERTED ON 03/10.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Obnoxious ringing in the ears, started approximately 1.5 days after the vaccine. Getting worse.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Pruritus, Skin warm
Clinical narrative: Large red welt around injection site, itchy, swollen and hot to touch. Upper arm muscle very achy and sore.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Large red welt around injection site, itchy, swollen and hot to touch. Upper arm muscle very achy and sore.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Nausea, Throat irritation
Clinical narrative: Symptoms experienced were: scratchy throat, nausea, numbness to hands and feet and difficulty breathing.   Patient was seen in ED where Epi Pen was given and a few other treatments.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Skin warm
Clinical narrative: SP02 99% heart rate 102  Feeling flushed and warm  b/p 128/90   Hx of asthma, no shortness of breath.   4:20 pm still feels flushed, no shortness of breath.  Only allergy is Keflex, no dizziness.  Offered to go the the ER but, declined. Told to monitor and call 911 if worsens. Daughter is with her.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain
Clinical narrative: body aches, headache, and swollen axillary lymph nodes  44 year old female (DOB: 11/08/1976) received the 2nd dose of the Pfizer COVID-19 vaccine at  Track on 03/26/2021 @ 13:30. Pt started experiencing body aches, headache, and swollen axillary lymph nodes on 03/26/2021 @ 21:00. Pt takes Diltiazem 120mg and Omega-3 supplement. Pt has microvascular dysfunction cornary vasospasm. Pt is allergic to Percocet, does not remember whether doctor specified the allergy was to oxycodone/opioid. Pt has not taken opioids since percocet reaction. Pt has taken Tylenol several times since percocet reaction, and has not experienced any side-effects or allergic type reactions. Pt prefers IBU because of the longer lasting effects. Allergy was likely related to opioid/oxycodone. Pt was advised to take Tylenol, monitor axillary lymph nodes, and if headache worsens, axillary lymph nodes swelling increases, or symptoms do not alleviate in 2 days to contact primary doctor for medical care.  was consulted and Dr.  was notified.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Immediate post-injection reaction, Musculoskeletal stiffness, Product administered at inappropriate site
Clinical narrative: Individual administering the vaccine shot placed it too high causing an instant stiff neck on the side of the injections and a slight headache. Later that day, I had a bruise and a stiff arm. Injections was administered in the Left Arm Joint and not in the Muscle, causing symptoms listed above.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Hypoaesthesia oral, Paraesthesia oral, Pharyngeal hypoaesthesia, Throat irritation
Clinical narrative: within 30 minutes of the injection, my mouth and tongue started tingling and feeling numb at the same time. It felt like there was swelling but I did not see swelling when looking in the mirror at the back of my throat, so the numbness may have just made it feel swollen, I'm not sure.  The best way to describe it is that my mouth, tongue, and throat felt like I had just received a numbing injection at the dentist or gargled with lidocaine. My throat also got very itchy and it was slightly difficult to swallow. I took 50 mg of Benadryl upon arriving home after the vaccination. The numbness and tingling lasted about 7 hours. I did not see a doctor, as my breathing was fine. The next morning, my throat is still itchy but numbness and tingling are gone.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Muscular weakness
Clinical narrative: PRESENTED TO ED WITH BILATERAL LEG WEAKNESS
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dysgeusia, Fatigue, Headache
Clinical narrative: Slight temporary dizziness right away, which could have been from blood pressure Mild headache within 15 mins - gone the next day Metal taste right away for two days and then intermittent for a couple of days Mild sore arm an hour or so after that lasted for about 4 days Moderate fatigue after about 3 hours - gone the next day Mild joint pain about 5 hours after - gone the next day
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slight temporary dizziness right away, which could have been from blood pressure Mild headache within 15 mins - gone the next day Metal taste right away for two days and then intermittent for a couple of days Mild sore arm an hour or so after that lasted for about 4 days Moderate fatigue after about 3 hours - gone the next day Mild joint pain about 5 hours after - gone the next day
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Nervousness
Clinical narrative: Vaccine was administered during a drive through vaccine clinic.  During the waiting period she had some facial flushing and felt nervous and dizzy.  She was given Benadryl 50mg po.  Symptoms resolved.  She was monitored for an extra period of time after resolution of symptoms.  She was dismissed to home with instructions to monitor carefully for any further symptoms and to seek medical attention should they occur.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myelitis transverse
Clinical narrative: Other severe and personal injuries; Transverse Myelitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient female patient of 60-year-old. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified). As a result of her receipt of zoster vaccine live (ZOSTAVAX), in 2008, the pt was caused to suffered transverse myelitis including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffered severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the pt was caused to suffered serious and dangerous side effects including Transverse myelitis, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and or medications. As a result of the foregoing acts and omission the pt required or will require more health care and services and did incur medical, health, incidental and related expenses. As a foreseeable, direct, and proximate consequence, the pt suffered transverse myelitis and other related health complications. In addition, the pt required and will continue to require healthcare and services. The pt had incurred and will continue to incur in medical and related expenses. The pt had suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, an other losses and damages. The pt direct medical losses and costs included physician care, monitoring, and treatment. The pt had incurred and will continue to incur mental and physical pain and suffering. The pt was informed and believed and further alleged that pt will in the future required to obtained further medical and hospital care, attention, and services.The outcome of the events was reported as not recovered. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX)  Upon internal review, the event Myelitis transverse was considered to be medically significant. Also, the lawyer considered  Myelitis transverse and ill-defined disorder to be disabling events.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Dizziness, Headache, Pain, Pain in extremity
Clinical narrative: Driving home from the vaccine I had double vision and a feeling like I was going up and down in an elevator. The next day I had the sore arm, aches and headache as expected. Sunday, started with carpal tunnel pain that extended from my left shoulder through my fingers as well as some vision issues where my eyes sort of had double vision again but I couldn?t blink it away for a minute. Monday morning I felt my right eye suddenly change vision where the one eye suddenly saw at a 45 degree angle.  My husband said my eye looked ok but I could clearly see 2 of him and couldn?t blink it away for a solid minute or so. Today my eyes are blurry and I?m dizzy. I reported this to my doctor yesterday to see if what was happening was vaccine related and she asked me to report it here.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Specialist consultation, Visual impairment
Clinical narrative: Driving home from the vaccine I had double vision and a feeling like I was going up and down in an elevator. The next day I had the sore arm, aches and headache as expected. Sunday, started with carpal tunnel pain that extended from my left shoulder through my fingers as well as some vision issues where my eyes sort of had double vision again but I couldn?t blink it away for a minute. Monday morning I felt my right eye suddenly change vision where the one eye suddenly saw at a 45 degree angle.  My husband said my eye looked ok but I could clearly see 2 of him and couldn?t blink it away for a solid minute or so. Today my eyes are blurry and I?m dizzy. I reported this to my doctor yesterday to see if what was happening was vaccine related and she asked me to report it here.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Malaise
Clinical narrative: Patient stated he didnt feel well, had no t eaten since 10AM
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: The patient felt dizzy after injection.  After the patient laid down and was given juice the issue was resolved.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus, Rash erythematous
Clinical narrative: On day 9 after receiving my first dose, I developed a large (approx. 2 inches long) red rash at the injection site, along with red rash marks from the band-aid.  Some itchiness occurred.
Sex: F
Vaccine: HPV9
Symptoms: Limb mass
Clinical narrative: mass on her arm; Information has been received from a physician via a sales representative, concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided.   On unspecified date, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), (dosage information was not provided) for prophylaxis.  It was reported that one month after the vaccination, the patient called to the physician informing about a mass in her arm. At the time of the report, the patient's outcome and the relatedness between the event and suspect therapy were not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dry mouth, Hyperhidrosis, Pyrexia, Rash macular
Clinical narrative: 3/27-right hip hurts, blotches, feverish/diaphoretic, mouth dry What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): Took ibuprofen and diphenhydramine Advised patient to seek medical attention for worsening symptoms; go to urgent care or contact PCP first thing on Monday morning. 3/29-Spoke with caller, states that she is back to her "old self", rash resolved, no longer diaphoretic, Took benadryl, ibuprofen and B12. Advised to contact us if she needs anything.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: He got his vaccine, had no issues immediately.  He went to bed and woke up with headache, aching muscles, dry mouth, sore throat, and now has fever of 100.8.  He took 2 baths to soak to get relief.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Pyrexia
Clinical narrative: Approximately 7 hours after receiving my second dose of the Pfizer/BioNtech COVID-19 vaccine, I developed soreness in my right arm near the injection site. Around two hours later, I noticed mild aching in my back and legs accompanied with a low grade fever of 99.0 degrees, compared to my normal temperature of 97.8 degrees.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Malaise
Clinical narrative: 3 weeks of fatigue, chills, night sweats, no fever, general malaise, sore throat, "odd" headache, loss of appetite
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Oropharyngeal pain
Clinical narrative: 3 weeks of fatigue, chills, night sweats, no fever, general malaise, sore throat, "odd" headache, loss of appetite
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Myelosuppression, Platelet count decreased, Platelet production decreased
Clinical narrative: bone marrow suppression; This spontaneous report as received from a consumer (patient's parent) regarding an 11-year-old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown by the reporter.  On an unspecified date in 2021, reported as Friday 12th, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (strength and route of administration were not provided; dose, frequency, lot number and expiration date were reported as unknown by the reporter) administered as prophylaxis.  On an unspecified date in 2021, medical attention was sought and by Tuesday (16th), they were flown to a hospital and the patient was admitted, as the vaccine had suppressed his bone marrow; therefore, he had stopped producing platelets and was a risk of bleeding out. It was unknown by the reporter if any treatment was received due to the event, if diagnostic labs or studies were performed. On an unspecified date the subject was discharged, but at the time of the report he had not recovered and had very little platelets.   Causal relationship between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was reported as related.   The reporter considered the event to be life threatening as the vaccine almost killed the patient.  Upon internal review, Bone marrow depression was considered as a medically significant event.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: My right arm started hurting a couple of hours after shot was given.  Had been moving my arm since getting the shot with no pain at first.  The pain is when I move my arm back to reach for anything or extend it to pick up something.  Hurts to touch area of the shot, but not as painful as when I use the arm   It is now 4 days later and the arm is still bothering me. I would say it is getting better.  I've been taking Ibuprofen every night to sleep.  Also been applying Icy Hot to the area when needed.  When pain is the worst I have applied a cold pack.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Tinnitus
Clinical narrative: My ears began ringing about 24 hours after I received the first dose of the Pfizer vaccination. It has been ongoing since and it's been a half hour now.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Lip swelling, Swelling face, Urticaria
Clinical narrative: Received 1st Pfizer vaccination on 3/24/21 at 2:50 PM in left arm at college campus where I am employed ( - ).  No pain or rash whatsoever. On Saturday 3/27,21, almost 4 days later, at about 1:00 PM, felt hives breaking out on my sides.  It traveled up to my lower armpits, but never went into my arm areas.  Later that day, it traveled down side of legs, but then dissipated.  I went to bed about 9:30 PM that night with only slight discomfort. At 1:30 AM on Sunday 3/28/21, I awoke with severely swollen lips and face.  My breathing began to get difficult, so I immediately headed to the ER at  (about 30 minutes away). They at first started to give me a dose of Benedryl, but I explained to them that I am allergic to it.  I then instead received some Prednisone and immediately the swelling subsided.  Dr.  prescribed 15 pills over a 5-day span to totally clear up the reaction.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Erythema, Fatigue, Headache, Injection site pain
Clinical narrative: Redness, heat, and tenderneas at injection site for 6 days, loss of voice, head ache, fatigue
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Redness, heat, and tenderneas at injection site for 6 days, loss of voice, head ache, fatigue
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Lethargy, Oropharyngeal pain
Clinical narrative: Day 1:  Fever, chills, headache, sore arm and lethargy.  Day 2:  Severe ear and throat on one side, headache.  Pain lasted 5 days.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Day 1:  Fever, chills, headache, sore arm and lethargy.  Day 2:  Severe ear and throat on one side, headache.  Pain lasted 5 days.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I got my vaccine and was ok (normal mild side effects). I went to bed and awoke around 2:20 a.m. with tinnitus. I have had it in the past but never more than a few hours. It's ongoing and I am concerned after reading prolonged tinnitus can cause hearing loss. I also found an online group of others having this issue (worse and louder than me) from all 3 Covid-19 vaccines). I have no pain, no itching, just the high pitched ringing and it seems to be "louder" or felt as louder in my right ear. All the mild symptoms are resolved and I'm left with this. My other concern is should I take the 2nd shot? Some on the group board skipped it.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness transitory
Clinical narrative: Cannot hear; A Spontaneous report  was received from a caregiver concerning a 84-year-old, female patient, who received dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced cannot hear (deafness transitory).  The patient's medical history included melanoma, anxiety, pain, edema and a non-specific heart/cardiac condition. Concomitant medications included medications for anxiety, pain, heart and edema.  No specific drug names/doses were reported.    On 01 MAR 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:022M20A) via unknown route for prophylaxis of Covid-19 infection.  On 01 Mar 2021, the patient cannot hear since she got vaccinated. It was reported that, it seems to come and go, hearing has been failing. The event, Deafness was medically significant.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, cannot hear (deafness transitory), was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous, Skin warm
Clinical narrative: Red circular rash at the injection site appeared 2 weeks post injection. There were no adverse reactions such as fever or sickness. The area was raised and hot , but it did not itch.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, fever, muscle aches, fatigue
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling cold
Clinical narrative: Patient felt lightheaded, cold post vaccine. Patient moved to open area. Refusal signed.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pain
Clinical narrative: Pt with shivering, body aches, loss of energy and feeling tired after dialysis treatment.  Patient sent to ER via EMS.  Patient went to hospital.  Patient was discharged form the ER.  No admission.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Condition aggravated, Headache, Nausea
Clinical narrative: 65 year old female (DOB: 06/30/1955) received the 2nd dose of the Moderna COVID-19 vaccine at County Fairgrounds on 03/09/2021 @ 11:00. Pt started experiencing body chills, body aches, fever, nausea, and headache on 03/25/2021 evening. Pt was scheduled for an elective surgery, bunion removal on left foot on 03/26/2021 @ 08:30. Pt was declined the elective surgery due to fever. Pt's fever peaked at 101.8F. Pt called primary doctor and doctor recommended pt go to ER. Pt was admitted to ER on 03/26/2021 @ 10:00 and discharged on 03/26/2021 @ 13:00. Pt tested (-) for COVID-19 and ER diagnosed pt with UTI and prescribed Cefalexin (Keflex) 500 mg for treatment. Pt is diagnosed with breast cancer and takes Anastrozole (Arimidex) 1 mg and multivitamins. Pt takes Tylenol for symptoms, but receives mild relief. Pt is still experiencing body chills, body aches, fever, nausea, and headache. Pt asked when should the elective surgery be scheduled. Pt was advised to talk to primary doctor and oncologist regarding the elective surgery and symptom management. SPI was consulted and Dr was notified.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: 65 year old female (DOB: 06/30/1955) received the 2nd dose of the Moderna COVID-19 vaccine at County Fairgrounds on 03/09/2021 @ 11:00. Pt started experiencing body chills, body aches, fever, nausea, and headache on 03/25/2021 evening. Pt was scheduled for an elective surgery, bunion removal on left foot on 03/26/2021 @ 08:30. Pt was declined the elective surgery due to fever. Pt's fever peaked at 101.8F. Pt called primary doctor and doctor recommended pt go to ER. Pt was admitted to ER on 03/26/2021 @ 10:00 and discharged on 03/26/2021 @ 13:00. Pt tested (-) for COVID-19 and ER diagnosed pt with UTI and prescribed Cefalexin (Keflex) 500 mg for treatment. Pt is diagnosed with breast cancer and takes Anastrozole (Arimidex) 1 mg and multivitamins. Pt takes Tylenol for symptoms, but receives mild relief. Pt is still experiencing body chills, body aches, fever, nausea, and headache. Pt asked when should the elective surgery be scheduled. Pt was advised to talk to primary doctor and oncologist regarding the elective surgery and symptom management. SPI was consulted and Dr was notified.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; A spontaneous report was received from a physician assistant, concerning a 54-year-old adult male patient who received Moderna's COVID-19 vaccine and experienced heart attack/myocardial infarction.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 25 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for COVID-19 infection prophylaxis.  On 07 Mar 2021, after first dose of vaccine, the patient had chest pain and shortness of breath. On 12 Mar 2021, patient had a heart attack and was airlifted to hospital. He was hospitalized from 13 Mar 2021 to 14 Mar 2021. Patient did not have history of heart condition nor was taking any medications prior to having the heart attack. During hospital stay, he had angiogram done, stents were placed.  Treatment also included cholesterol lowering medicine, blood pressure medicine and acetylsalicylic acid.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, heart attack was resolved on 14 Mar 2021.; 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 of myocardial infarction, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Vaccine was administered during a drive through event.  During the waiting period, she began to have facial flushing.  She was given benadryl 50mg po.  Symptoms resolved and she was monitored for an extra period of time at the site.  She was then dismissed to home with instructions to monitor carefully for additional symptoms and to seek medical attention immediately should these occur.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pain
Clinical narrative: Chills, achy, 101 temp, tired. Day and 1/2 felt these symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Left arm became swollen, tender and  hot in a 3  inch diameter around shot site.   The swelling and redness around shot lasted for 6 days and began to get smaller each day after day 3.  Around day 5 became itchy. The night of the shot and next day, I was fatigued, achy and slight headache.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Left arm became swollen, tender and  hot in a 3  inch diameter around shot site.   The swelling and redness around shot lasted for 6 days and began to get smaller each day after day 3.  Around day 5 became itchy. The night of the shot and next day, I was fatigued, achy and slight headache.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Throat tightness
Clinical narrative: I developed a sensation that my throat was tight and swollen. I never experienced difficulty breathing but the throat sensation was very pronounced and took several hours to resolve. I stayed on the vaccine administration site for an hour to ensure I did not experience an anaphylactic reaction.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Moderna COVID-19 Vaccine EUA Five days after vaccine in L arm, L axillary lymph node edema appeared - tenderness to area when palpating but no pain
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident
Clinical narrative: Stroke; not capable to understand or speak very well.; A spontaneous case was reported by a consumer  concerning herself and who received mRNA-1273 (Moderna COVID-19 Vaccine) for the prophylaxis of COVID-19 infection and experienced couple of stroke/ Cerebrovascular accident and not capable to understand or speak very well/aphasia.  The patients medical history was not reported. Concomitant medication details was not populated.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) 1 dosage form.  On unspecified date the patient experienced couple of stroke/ cerebrovascular accident and not capable to understand or speak very well/aphasia.  The events of  cerebrovascular accident and aphasia were considered to be serious (medically significant).   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was unknown.  The treatment medication was not reported.  The outcome of both the event was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: Arm swollen to half the diameter of a tennis ball, hot, red, tender and itched an entire week
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Asthenia, Bilevel positive airway pressure, COVID-19, Condition aggravated
Clinical narrative: Patient received 1st dose Pfizer COVID vaccine on 2/5/2021 and second dose on 2/26/21.  She had no adverse reaction to either dose.  Around 3/2/2021, she saw her physician complaining of pain in her arm, which was attributed to gout.  At the time, she also had a nonproductive cough, generalized weakness and one episode of loose stool.  She presented to the emergency room on 3/7/21 with significant hypoxia.  She tested positive for COVID 19 by both rapid test and PCR.  A quantitative test for COVID antibodies was sent out to a reference lab on 3/7/2021 and resulted on 3/11/2021 as >250 U/mL.  Pt. required CPAP, BiPAP, High Flow Oxygen and ultimately intubation.  Was not oxygen dependent before hospitalization. Pt. treated with dexamethasone, 2 doses of Remdesivir (then held due to acute kidney injury), tocilizumab X 1 dose, 1 unit COVID-19 convalescent plasma.  Pt. expired on 3/19/2021.  Sample sent for genome sequencing to check for variants of interest in joint effort between pathology and infectious disease.  Report not yet available.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Continuous positive airway pressure, Cough, Death, Diarrhoea, Endotracheal intubation
Clinical narrative: Patient received 1st dose Pfizer COVID vaccine on 2/5/2021 and second dose on 2/26/21.  She had no adverse reaction to either dose.  Around 3/2/2021, she saw her physician complaining of pain in her arm, which was attributed to gout.  At the time, she also had a nonproductive cough, generalized weakness and one episode of loose stool.  She presented to the emergency room on 3/7/21 with significant hypoxia.  She tested positive for COVID 19 by both rapid test and PCR.  A quantitative test for COVID antibodies was sent out to a reference lab on 3/7/2021 and resulted on 3/11/2021 as >250 U/mL.  Pt. required CPAP, BiPAP, High Flow Oxygen and ultimately intubation.  Was not oxygen dependent before hospitalization. Pt. treated with dexamethasone, 2 doses of Remdesivir (then held due to acute kidney injury), tocilizumab X 1 dose, 1 unit COVID-19 convalescent plasma.  Pt. expired on 3/19/2021.  Sample sent for genome sequencing to check for variants of interest in joint effort between pathology and infectious disease.  Report not yet available.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gout, Hypoxia, Pain in extremity, SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: Patient received 1st dose Pfizer COVID vaccine on 2/5/2021 and second dose on 2/26/21.  She had no adverse reaction to either dose.  Around 3/2/2021, she saw her physician complaining of pain in her arm, which was attributed to gout.  At the time, she also had a nonproductive cough, generalized weakness and one episode of loose stool.  She presented to the emergency room on 3/7/21 with significant hypoxia.  She tested positive for COVID 19 by both rapid test and PCR.  A quantitative test for COVID antibodies was sent out to a reference lab on 3/7/2021 and resulted on 3/11/2021 as >250 U/mL.  Pt. required CPAP, BiPAP, High Flow Oxygen and ultimately intubation.  Was not oxygen dependent before hospitalization. Pt. treated with dexamethasone, 2 doses of Remdesivir (then held due to acute kidney injury), tocilizumab X 1 dose, 1 unit COVID-19 convalescent plasma.  Pt. expired on 3/19/2021.  Sample sent for genome sequencing to check for variants of interest in joint effort between pathology and infectious disease.  Report not yet available.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Exposure during pregnancy, Hyperhidrosis, Nausea, Presyncope
Clinical narrative: Patient who is 7 months pregnant presented today for the first shot in the Moderna series. Patient presented with mild anxiety, appeared worried, mild sweating occurring during vaccination. Patient reported no contraindications to vaccine prior to administration. About 10 minutes after vaccinating, the patient informed the pharmacy staff that she was feeling lightheaded. The pharmacy had the patient sit down and notified the Nurse Practitioner who also practices in our building. The nurse had the patient lay on the ground with her feet up on a chair and kick her feet back and forth to get blood moving. The NP reported the patient was having a vasovagal reaction. The patient reported nausea and lightheadedness during this time. The patient was eventually able to sit up and drink water. The patient stayed for about 20 minutes after the incident, and made a full recovery to normal prior to leaving.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incomplete course of vaccination, Pruritus, Throat tightness, Urticaria
Clinical narrative: Client canceled second dose appointment.  Reported tight throat within 4 hours and "itchy body welts" the next day.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Throat tightness, Urticaria
Clinical narrative: Client canceled second dose appointment.  Reported tight throat within 4 hours and "itchy body welts" the next day.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Besides the pain are soreness at the injection area I suffered from severe headache, extreme tiredness and weakness for three days after first injection and for two days after second injection. Muscle ache in the upper abdominal area, both biceps and thighs on third day after second injection which only last 24 hours. I took Ibuprofen for the pain relief.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Besides the pain are soreness at the injection area I suffered from severe headache, extreme tiredness and weakness for three days after first injection and for two days after second injection. Muscle ache in the upper abdominal area, both biceps and thighs on third day after second injection which only last 24 hours. I took Ibuprofen for the pain relief.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Peripheral swelling
Clinical narrative: Brand and lot of vaccine:  Moderna 047 A  2119 or it could be ou7 A 2119 Adverse events experienced and are they still occurring now:  both legs swelling l significant  more swollen 2 inches above ankle bones   What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these):  elevate feet any sob or worsening symptoms seek medical advise.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Catheter directed thrombolysis, Deep vein thrombosis, Limb discomfort, Thrombectomy, Ultrasound Doppler
Clinical narrative: Pt received second dose of COVID vaccine at hospital on 2/19 (date given by pt).  Pt had been more sedentary than usual due to winter season.  As weather warmed and pt became more active, she began to experience symptoms of left lower extremity DVT on 3/15.  Pt evaluated at urgent care on 3/19 and was sent to medical center for follow up.  Lower extremity dopplers were negative for DVT.  Pt presented to orthopedic surgeon for follow up because symptoms not resolved and was placed on Medrol Dosepak for possible issues related to remote hip replacement.  When symptoms progressed, pt presented to hospital on 3/24.  3/24 lower extremity dopplers revealed thrombus in left leg that extended into saphenofemoral junction.  Patient was then transferred to hospital for L iliac venous EKOS catheter placement for catheter-directed thrombolysis with alteplase on 3/25.  Pt underwent second procedure on 3/26 where Angiojet thrombectomy and venoplasty of left external iliac, common femoral and femoral vein was performed.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Venous angioplasty
Clinical narrative: Pt received second dose of COVID vaccine at hospital on 2/19 (date given by pt).  Pt had been more sedentary than usual due to winter season.  As weather warmed and pt became more active, she began to experience symptoms of left lower extremity DVT on 3/15.  Pt evaluated at urgent care on 3/19 and was sent to medical center for follow up.  Lower extremity dopplers were negative for DVT.  Pt presented to orthopedic surgeon for follow up because symptoms not resolved and was placed on Medrol Dosepak for possible issues related to remote hip replacement.  When symptoms progressed, pt presented to hospital on 3/24.  3/24 lower extremity dopplers revealed thrombus in left leg that extended into saphenofemoral junction.  Patient was then transferred to hospital for L iliac venous EKOS catheter placement for catheter-directed thrombolysis with alteplase on 3/25.  Pt underwent second procedure on 3/26 where Angiojet thrombectomy and venoplasty of left external iliac, common femoral and femoral vein was performed.