chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This event was an administration error. The patient is 14 years of age and below the EUA approved age of 16 years. This individual was vaccinating in the presence of 3 other family members who also were vaccinated on March 3rd and March 24th. The family members who were also vaccinated were the child?s parents and 16 year old brother. The vaccine clinic staff who registered (intake) did not catch that the child was 14 years of age. The father is the one who registered the entire family including his two children (16 and 14 year olds) via our online scheduling system which does have a disclaimer stating the vaccine is only approved for use in those 16 years and older as we are a Pfizer site.  The parents did not disclose the age of the child when registering in our POD.  This administration error has been reported to  Dr., DOH Medical Director.  Our Vaccination POD has implemented processes to confirm age prior to administering the COVID Pfizer Vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia, Vaccination site inflammation
Clinical narrative: Guillain-barre syndrome; Inflammation at the injection site; Tingling and numbness now spread to her finger tips; Tingling and numbness now spread to her finger tips; This spontaneous report  was reported by a physician concerning a 49-years-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) and experienced Guillain-Barre syndrome, inflammation at the injection site and tingling and numbness now spread to her finger tips.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 18 Mar 2021, prior to onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch number: unknown) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient experienced inflammation at the injection site, tingling and numbness now spread to her fingertips and might be developing medically significant event of Guillain-Barre syndrome. On 19 Mar 2021, increasing severity of tingling and numbness. Treatment for the events included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Guillain-Barre syndrome, inflammation at the injection site and tingling and numbness now spread to her finger tips was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction
Clinical narrative: Patient had near syncopal episode post vaccine. Evaluated by EMS, BP taken.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: (3 days after): Pain in hand/wrist, body aches, nausea (2 days after):  Fever,  Pain at the injection site (that radiates into hand and wrist), nausea, body aches, chills, extreme exhaustion. (1 day after): Stinging sensation of left ear and scalp, headache, lethargy, exhaustion. (Day of Vaccine): spaced-out feeling (like everything was in slow motion).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Nausea, Pain, Pain in extremity
Clinical narrative: (3 days after): Pain in hand/wrist, body aches, nausea (2 days after):  Fever,  Pain at the injection site (that radiates into hand and wrist), nausea, body aches, chills, extreme exhaustion. (1 day after): Stinging sensation of left ear and scalp, headache, lethargy, exhaustion. (Day of Vaccine): spaced-out feeling (like everything was in slow motion).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: (3 days after): Pain in hand/wrist, body aches, nausea (2 days after):  Fever,  Pain at the injection site (that radiates into hand and wrist), nausea, body aches, chills, extreme exhaustion. (1 day after): Stinging sensation of left ear and scalp, headache, lethargy, exhaustion. (Day of Vaccine): spaced-out feeling (like everything was in slow motion).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hypersomnia, Pyrexia
Clinical narrative: Fever, chills, severe joint pain, severe fatigue causing me to sleep 32 hours in a 36 hour period
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Frequent bowel movements, Headache, Myalgia, Nausea
Clinical narrative: headache, fever of 99.8,  nausea, vomiting, increased bowel movement but not diarrhea, lightheaded, muscle aches and very sore arm self treating. ( it's only 6 hours since sx began)
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: headache, fever of 99.8,  nausea, vomiting, increased bowel movement but not diarrhea, lightheaded, muscle aches and very sore arm self treating. ( it's only 6 hours since sx began)
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Fatigue, Gait disturbance, Loss of personal independence in daily activities
Clinical narrative: Very [paonful hip and knee and joint problems. Could not walk without a walker.  Waling is ver painful and there is always an aching. Leg muscle aches. Right leg only.  Cannot move in turning motion. not circular movement.  just gives out . Shooting pains in lleg. , Some fatigue but not a problem. Cannot drive, grocerey cart cannot be use. Must use electric cart.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Very [paonful hip and knee and joint problems. Could not walk without a walker.  Waling is ver painful and there is always an aching. Leg muscle aches. Right leg only.  Cannot move in turning motion. not circular movement.  just gives out . Shooting pains in lleg. , Some fatigue but not a problem. Cannot drive, grocerey cart cannot be use. Must use electric cart.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gingival erythema, Gingival pain, Hypersensitivity, Noninfective gingivitis
Clinical narrative: gums red and extremely inflamed,  painful, dentist said my gums looked like an allergic reaction, dentist gave me RX for Periogard on April 11, 2021, Periogard hasn't helped the inflammation, I am to see him for recheck on April 5, 2021.  I am to see my regular doctor on March 31, 2021. My dentist sent my doctor a report on my gum condition.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, Chills, Body Aches, Headache
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate increased, Incomplete course of vaccination, Laboratory test
Clinical narrative: Fast heart rate/ atial Fib went to the emergency on 3/8/2021 at 8pm
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Fatigue, Hypoaesthesia, Multiple sclerosis relapse
Clinical narrative: Multiple Sclerosis flared up; Burning sensation in bilateral upper and lower extremities; Numbness in upper and lower extremities; tingling sensations in upper and lower extremities; Feel extremely weak; Fatigued; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced  events multiple Sclerosis flared up (multiple sclerosis relapse), fatigued (fatigue), feel extremely weak (asthenia), burning sensation in bilateral upper and lower extremities (burning sensation), numbness in upper and lower extremities (hypoaesthesia), and tingling sensations in upper and lower extremities (paraesthesia).  The patient's current conditions included multiple sclerosis. Concomitant medication includes gabapentin and albumin human, glucose, interferon beta injection.  On 05Mar2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch/Lot number: 030A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06Mar2021, the patient started feeling extremely weak and fatigued. The patient's multiple sclerosis flared up after receiving vaccine. The same day, patient experienced burning sensations in bilateral upper and lower extremities along with numbness and tingling sensations. The patient paid a visit to her neurologist. Treatment medications included; multiple sclerosis medications as prescribed with no significant improvements. The event multiple Sclerosis flared up was considered as medically significant.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, multiple Sclerosis flared up was not recovered at the time of this report. The outcome for the events, fatigued, feel extremely weak, burning sensation in bilateral upper and lower extremities, numbness in upper and lower extremities, and tingling sensations in upper and lower extremities was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Multiple Sclerosis flared up; Burning sensation in bilateral upper and lower extremities; Numbness in upper and lower extremities; tingling sensations in upper and lower extremities; Feel extremely weak; Fatigued; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced  events multiple Sclerosis flared up (multiple sclerosis relapse), fatigued (fatigue), feel extremely weak (asthenia), burning sensation in bilateral upper and lower extremities (burning sensation), numbness in upper and lower extremities (hypoaesthesia), and tingling sensations in upper and lower extremities (paraesthesia).  The patient's current conditions included multiple sclerosis. Concomitant medication includes gabapentin and albumin human, glucose, interferon beta injection.  On 05Mar2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch/Lot number: 030A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06Mar2021, the patient started feeling extremely weak and fatigued. The patient's multiple sclerosis flared up after receiving vaccine. The same day, patient experienced burning sensations in bilateral upper and lower extremities along with numbness and tingling sensations. The patient paid a visit to her neurologist. Treatment medications included; multiple sclerosis medications as prescribed with no significant improvements. The event multiple Sclerosis flared up was considered as medically significant.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, multiple Sclerosis flared up was not recovered at the time of this report. The outcome for the events, fatigued, feel extremely weak, burning sensation in bilateral upper and lower extremities, numbness in upper and lower extremities, and tingling sensations in upper and lower extremities was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Pain in extremity, Pyrexia, Rheumatoid arthritis
Clinical narrative: I am submitting this because I know there has been limited data on the effect of the vaccine on people with autoimmune issues.  I was diagnosed with rheumatoid arthritis March 2020.  Dietary changes have kept my rheumatoid arthritis in check -- not requiring any medication, even ibuprofen -- since May or June 2020.  Within 24 hours of receiving the J&J vaccine, my knees, ankles, hands, wrists, and feet began to hurt.  (I also had a 100 degree fever for 24 hours.)  Unfortunately, 2.5 weeks later, the joint pain persists.  The vaccine clearly triggered a flare up, but I hope that within another 2 weeks, the vaccine will have finishing tweaking my immune system for COVID response and the pain will abate.  I do not know yet if that will be the case.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Neuropathy peripheral
Clinical narrative: Extreme bout of peripheral neuropathy that lasted 4 days - still occurring Brain fog  that lasted 3 days
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site swelling, Nausea, Pain, Pallor
Clinical narrative: She got the vaccine, she was fine, no problems.  She woke up, Down's syndrome, and her sister-in-law saw that she was white faced, and looked like she was going to throw up, but said that she was achy and nauseous.  She has swelling to the injection site, a small dot.  She feels a little warm, but no fever, 97.9.  Has not taken anything for her symptoms.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: She got the vaccine, she was fine, no problems.  She woke up, Down's syndrome, and her sister-in-law saw that she was white faced, and looked like she was going to throw up, but said that she was achy and nauseous.  She has swelling to the injection site, a small dot.  She feels a little warm, but no fever, 97.9.  Has not taken anything for her symptoms.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Hyperhidrosis, Night sweats
Clinical narrative: This was my second dose, which was on my right arm. My first dose was injected on my left arm, and I experienced moderate to severe arm pain (it felt like I tore my shoulder). The  night after my second dose, I had cold/night sweats and completely drenched the bed. This occurred three nights in a row. The morning after the shot I also woke up with a 102.5 degree fever, but the fever went away shortly after I woke up. Additionally, I also experienced severe headaches and exhaustion for about two to three days after the injection. On the fourth day, all the adverse side effects dissipated and eventually went away completely.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This was my second dose, which was on my right arm. My first dose was injected on my left arm, and I experienced moderate to severe arm pain (it felt like I tore my shoulder). The  night after my second dose, I had cold/night sweats and completely drenched the bed. This occurred three nights in a row. The morning after the shot I also woke up with a 102.5 degree fever, but the fever went away shortly after I woke up. Additionally, I also experienced severe headaches and exhaustion for about two to three days after the injection. On the fourth day, all the adverse side effects dissipated and eventually went away completely.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: pt stated that she had 3 days of headache after taking the vax.  On the 11th day she had developed a 1 1/2 X 2 " red rash on the left arm at the injection site that was warm and itchy that lasted 5 days.  Pt used cortisone cream to help w/ the itching.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: With the first dose about 12 hours later I experienced some numbness of my face.  The next day I had a  measles-like rash which went away in a few hours. Pain in my arm went away in 2 days.  With the second dose on the third day after the injection I developed severe itching and noticed a red spreading rash in the area of the injection, just a little below the injection site.  This is very red, sore and feels somewhat warm to the touch.  The area is about 5 inches in size and is still painful.  I have also noticed some shortness of breath but minor.   Some numbness and itching around my face.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth, Pruritus, Rash erythematous
Clinical narrative: With the first dose about 12 hours later I experienced some numbness of my face.  The next day I had a  measles-like rash which went away in a few hours. Pain in my arm went away in 2 days.  With the second dose on the third day after the injection I developed severe itching and noticed a red spreading rash in the area of the injection, just a little below the injection site.  This is very red, sore and feels somewhat warm to the touch.  The area is about 5 inches in size and is still painful.  I have also noticed some shortness of breath but minor.   Some numbness and itching around my face.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: Patient felt dizzy, found t be hypertensive. Stated she missed a dose of vertigo medication.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: bruising at site and then on other areas of upper arm
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Fatigue, Malaise, Musculoskeletal stiffness
Clinical narrative: not feeling; Patient was found deceased; Stiffness in neck; Extreme fatigue; A Spontaneous report  was received from a consumer concerning a 65-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stiffness in neck/ musculoskeletal stiffness, extreme fatigue and patient was found deceased/Death.  The patient's current condition included obesity and diabetes. Concomitant medication was not reported.  On an unknown date, the patient received his first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 14 Mar 2021, prior to the event, the patient received his second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Mar 2021, after receiving the second dose of the vaccination the patient began to complain of not Feeling. On 16 Mar 2021, the patient began to complain of stiffness in neck and extreme fatigue. On Wednesday 17 Mar 2021, the patient was found deceased in their home. The event deceased was reported as serious. The family member states they would hate to link the Moderna vaccination to their uncle's death but the vaccination was the only alteration of the patient normal diet and medications. Treatment medication was not reported. The patient died on 17 Mar 2021. It was unknown if autopsy was performed.  Action taken with the drug in response to the events was not applicable.  The outcome of the event patient was found deceased was fatal whereas outcome of other events stiffness in neck, extreme fatigue was unknown.; Reporter's Comments: This is a case of sudden death in a 65-year-old male subject with a hx of obesity and diabetes  who died 3 days after receiving the second dose of vaccine. Very limited information has been provided at this time." Further information is requested.; Reported Cause(s) of Death: Death
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Tachycardia, Throat irritation, Tremor
Clinical narrative: Shortly after vaccine administration, pt c/o numbness to tongue, "difficulty" to back of throat, and shakiness. Dr.  evaluates and finds no SOB, clear lung sounds, maintained 99-100% O2 sat on room air, and intermittent tachycardia. Benadryl and zyrtec administered, pt advised to eat as he reports he hasn't had much today. Dr.  advises to go to ED if anything changes.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, body aches, dizziness , extreme fatigue, sensitivity when inhaling
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Pruritus
Clinical narrative: Approximately 3 days after receiving her 2nd dose of the moderna vaccine patient reported still having soreness around the injection site and having 2 circular rashes below the injection site. She stated the 2 rashes are distinctly separate. The rashes have provided little discomfort to this point, but have itched periodically.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Anion gap, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Full blood count
Clinical narrative: Patient reported 12 hours post vaccine administration he had tea colored urine with sediment. Patient had worked out, but nothing exceptionally strenuous/outside of his normal exercise plan. Patient noted some mild body aches, 2/10 pain. No other symptoms or concerns.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin urine, Metabolic function test, Monocyte count increased, Monocyte percentage increased, Pain
Clinical narrative: Patient reported 12 hours post vaccine administration he had tea colored urine with sediment. Patient had worked out, but nothing exceptionally strenuous/outside of his normal exercise plan. Patient noted some mild body aches, 2/10 pain. No other symptoms or concerns.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Protein urine, Urine analysis abnormal
Clinical narrative: Patient reported 12 hours post vaccine administration he had tea colored urine with sediment. Patient had worked out, but nothing exceptionally strenuous/outside of his normal exercise plan. Patient noted some mild body aches, 2/10 pain. No other symptoms or concerns.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Lacrimation increased, Sinus congestion, Vaccine positive rechallenge, Vision blurred
Clinical narrative: For BOTH initial (022621) and booster (032621) of Moderna, pt had moderate/severe eye reaction. Overnight about 3 days after first injection and 4 days after second injection.  Initial injection: pt went to bed on the 3rd night after vaccine having taken no medications and noted mild eye irritation. He woke up a few hours later (~midnight) to severe eye watering and blurriness which required him to keep his eyes closed with mild sinus congestion. No difficulty breathing noted. Pt had trouble getting it to stop despite taking loratadine 10mg and rinsing eyes with water. Pt seriously considered going to ER due to risk of blindness. Pt eventually fell asleep a few hours later and woke up with very sensitive eyes (irritated, very red) that took about 36h to fully recover.   Second injection: pt was on scheduled loratadine 10mg daily. Noted a similar eye irritation (this time four days after injection not three) when going to bed and took 50mg diphenhydramine (about 14h after loratadine dose). Woke up a few hours later to more minor but still debilitating eye watering with proportionally more sinus involvement. No difficulty breathing noted. Pt took an extended release pseudoephedrine, rinsed eyes with water  and waited for it to resolve about an hour or two later. Pt awoke the next morning to much less sensitive eyes than first time.   Note: due to first experience. From time of administration of second dose, pt was on scheduled naproxen (440mg loading dose followed by 220mg q12h), loratadine 10mg q24h,  and pseudoephedrine (120mg ER q24h). Pt took these scheduled days 1-3 and at time of second eye episode was only on scheduled loratadine still. Pt also had 50mg diphenhydramine on hand in case of episode.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: Tachycardia >100 bpm; This is a spontaneous report from a contactable consumer, who reported for himself. A 81-years-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EN6203), via an unspecified route of administration, on 22Feb2021 09:00 AM (at the age of 81-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Relevant medical history and concomitant medications were not reported. On 24Feb2021, the patient had Tachycardia >100 bpm. The patient went to see a doctor or other healthcare professional office/clinic visit. Treatment was not received.The clinical outcome of the events Tachycardia >100 bpm was recovered Feb2021. It was reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Diarrhoea, Flushing
Clinical narrative: Patient reports that she received her first dose of the Pfizer Covid vaccine and within an hour developed flushing and diarrhea and states that her blood pressure was elevated 160/100. She states that flushing resolved after 24 hours but diarrhea has persisted to some degree.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient sated "feel lightheaded".  B/P stable  130/80; Resolved past 10 minutes.  Advised passenger to drive patient home.   Patient waited > 30 minutes before leaving the site.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Hyperhidrosis, Hypotension
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Additional Details: Pt was sitting for observation and suddenly fell to lateral side. Staff RN and technician responded immediately.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Additional Details: Pt was sitting for observation and suddenly fell to lateral side. Staff RN and technician responded immediately.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pfizer-BioTech COVID-19 Vaccine  Site of shot is red, swollen, warm, itchy It is better but still there
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Sinus congestion
Clinical narrative: First day :headache/dizziness Second day :headache/chills/sweats (no temp) Third day :headache/chills/sweats (no temp) Fourth day to now :headache, sinus pressure/congestion
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: LOW GRADE FEVER 100.1 DF, HEADACHE, BODY ACHE
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Sleep disorder, Tension
Clinical narrative: Pt reported to the health unit today that she received the vaccine on 3/25/2021 at 12 PM.  She reports that ~5 minutes later her palms became diaphoretic and she started to feel "on edge."  She waited for 30 minutes before checking out with the nurse.  She reports that since the vaccination she has constantly been on the verge of a panic attack and is having difficulty sleeping because she is being "jolted" awake.  However, she admits she has not actually had a panic attack since vaccination, but she believes the vaccination is responsible for her current symptoms since they have not completely resolved. Pt does report an intermittent history of panic attacks dating back to 1997.  She reports her panic attacks started after she started taking mefloquine.  She has had panic attacks as recently as 2017, 2018 and 2020, usually secondary to external stressors.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 7 days after shot the injection site became swollen, very sore, the red circle around injection got more pronounced and the site because very itchy. This lasted for about 48 hours. There is still a red mark today, but swelling, pain and itchyness have all gone away.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Blood test, COVID-19, Chills, Chromaturia
Clinical narrative: Chief Complaint: CRAMPS, STOMACH ACHES, INDIGESTION, CHILLS & WEAK1ST COVID SHOT 1/182ND = 2/18.  Onset of symptoms: JAN 18TH. Additional information: HAD BOTTOM TEETH REMOVED - JANUARY 5 & COULDN'T EAT SOLIDS UNTIL LAST WEEK, LOST LOTS OF WEIGHT(WEIGHT TODAY INCLUDES HEAVY BOOTS)DARK YELLOW URINE ON 'BAD DAYS'. History of Present Illness -- Patient is seen today, really has not felt well for a while.  This is been especially the last month or more.  Has had several things going on this winter, actually contracted COVID-19 illness in December.  Says this was pretty much like having the flu but I think at the time felt.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Diarrhoea, Dyspepsia, Feeling abnormal, Muscle spasms
Clinical narrative: Chief Complaint: CRAMPS, STOMACH ACHES, INDIGESTION, CHILLS & WEAK1ST COVID SHOT 1/182ND = 2/18.  Onset of symptoms: JAN 18TH. Additional information: HAD BOTTOM TEETH REMOVED - JANUARY 5 & COULDN'T EAT SOLIDS UNTIL LAST WEEK, LOST LOTS OF WEIGHT(WEIGHT TODAY INCLUDES HEAVY BOOTS)DARK YELLOW URINE ON 'BAD DAYS'. History of Present Illness -- Patient is seen today, really has not felt well for a while.  This is been especially the last month or more.  Has had several things going on this winter, actually contracted COVID-19 illness in December.  Says this was pretty much like having the flu but I think at the time felt.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prostatic specific antigen increased, SARS-CoV-2 test positive, Vitamin B12 decreased, Weight decreased
Clinical narrative: Chief Complaint: CRAMPS, STOMACH ACHES, INDIGESTION, CHILLS & WEAK1ST COVID SHOT 1/182ND = 2/18.  Onset of symptoms: JAN 18TH. Additional information: HAD BOTTOM TEETH REMOVED - JANUARY 5 & COULDN'T EAT SOLIDS UNTIL LAST WEEK, LOST LOTS OF WEIGHT(WEIGHT TODAY INCLUDES HEAVY BOOTS)DARK YELLOW URINE ON 'BAD DAYS'. History of Present Illness -- Patient is seen today, really has not felt well for a while.  This is been especially the last month or more.  Has had several things going on this winter, actually contracted COVID-19 illness in December.  Says this was pretty much like having the flu but I think at the time felt.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Client received vaccination and then became dizzy and lightheaded. Passed out was sent to ER via EMS
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Erythema, Swelling
Clinical narrative: Raised red bump Sore back
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Influenza like illness, Nausea, Pain in extremity
Clinical narrative: Received vaccine on 3/16. Arm became incredibly sore/unusable for 2 days, followed by one day (3/18) of flu-like symptoms. I then started to experience occasional, mild tinnitus, which is still persisting.  On 3/22 I woke up with significant pain in my armpit that extended from my left breast through my elbow. This pain is still persisting, though less severe. On 3/26 I experienced an extreme episode of vertigo, lasting about 30 minutes, followed by an hour of vomiting. I have never had vertigo before. I continued to experience dizziness and nausea for the next 48 hours, and I'm still experiencing issues with blurred vision.  On the afternoon of 3/26, I had a televisit with a primary care physician to discuss the vertigo episode. She advised I take meclizine for the nausea and said she  could not diagnose anything conclusively unless another episode occurs.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo, Vision blurred, Vomiting
Clinical narrative: Received vaccine on 3/16. Arm became incredibly sore/unusable for 2 days, followed by one day (3/18) of flu-like symptoms. I then started to experience occasional, mild tinnitus, which is still persisting.  On 3/22 I woke up with significant pain in my armpit that extended from my left breast through my elbow. This pain is still persisting, though less severe. On 3/26 I experienced an extreme episode of vertigo, lasting about 30 minutes, followed by an hour of vomiting. I have never had vertigo before. I continued to experience dizziness and nausea for the next 48 hours, and I'm still experiencing issues with blurred vision.  On the afternoon of 3/26, I had a televisit with a primary care physician to discuss the vertigo episode. She advised I take meclizine for the nausea and said she  could not diagnose anything conclusively unless another episode occurs.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Oral discomfort, Paraesthesia oral, Swollen tongue
Clinical narrative: About 30 minutes after receiving her first dose of Moderna Vaccine, she started to feel burning in her mouth, swollen tongue, and taste of metal.  In the weeks to follow, it progressed to burning/tingling lips.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain
Clinical narrative: Body aches pains extreme nausea and chills 8-12 hours took some Aleve
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Fall, Muscle strain
Clinical narrative: Felt fine after injection; waited 15 minutes felt fine. Got up at 4 am to assist my mom in using the bathroom and everything was spinning in the room. I sat down on floor for about a minute and thought it passed, stood up and took two steps, and from what I?m told I went flat down on the ground without trying to even break my fall. I was out cold. Taken to hospital where I had four ct scans, numerous xrays done; all okay minus pulled muscles/ligaments and possibly some fractures in my foot. I had surgery on it in January and they couldn?t tell if it was old or new fractures.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, Vertigo, X-ray
Clinical narrative: Felt fine after injection; waited 15 minutes felt fine. Got up at 4 am to assist my mom in using the bathroom and everything was spinning in the room. I sat down on floor for about a minute and thought it passed, stood up and took two steps, and from what I?m told I went flat down on the ground without trying to even break my fall. I was out cold. Taken to hospital where I had four ct scans, numerous xrays done; all okay minus pulled muscles/ligaments and possibly some fractures in my foot. I had surgery on it in January and they couldn?t tell if it was old or new fractures.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram, Computerised tomogram head, Computerised tomogram neck, Dehydration
Clinical narrative: Felt fine after injection; waited 15 minutes felt fine. Got up at 4 am to assist my mom in using the bathroom and everything was spinning in the room. I sat down on floor for about a minute and thought it passed, stood up and took two steps, and from what I?m told I went flat down on the ground without trying to even break my fall. I was out cold. Taken to hospital where I had four ct scans, numerous xrays done; all okay minus pulled muscles/ligaments and possibly some fractures in my foot. I had surgery on it in January and they couldn?t tell if it was old or new fractures.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Fall, Fatigue, Full blood count, Loss of consciousness
Clinical narrative: Felt fine after injection; waited 15 minutes felt fine. Got up at 4 am to assist my mom in using the bathroom and everything was spinning in the room. I sat down on floor for about a minute and thought it passed, stood up and took two steps, and from what I?m told I went flat down on the ground without trying to even break my fall. I was out cold. Taken to hospital where I had four ct scans, numerous xrays done; all okay minus pulled muscles/ligaments and possibly some fractures in my foot. I had surgery on it in January and they couldn?t tell if it was old or new fractures.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Troponin, X-ray
Clinical narrative: Felt fine after injection; waited 15 minutes felt fine. Got up at 4 am to assist my mom in using the bathroom and everything was spinning in the room. I sat down on floor for about a minute and thought it passed, stood up and took two steps, and from what I?m told I went flat down on the ground without trying to even break my fall. I was out cold. Taken to hospital where I had four ct scans, numerous xrays done; all okay minus pulled muscles/ligaments and possibly some fractures in my foot. I had surgery on it in January and they couldn?t tell if it was old or new fractures.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Influenza like illness, Injection site nodule, Injection site pain
Clinical narrative: My symptoms started on March 23, 2021, a day after my first shot.  Around 11:00am I experience very bad chills, body aching, weak, left arm very sore swollen at the site and a knot.  I was so I weak I couldn't get out the bed.  Almost like having the flu.  On 3/24/2021 around 8:00am the symptoms were gone.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Mobility decreased, Pain
Clinical narrative: My symptoms started on March 23, 2021, a day after my first shot.  Around 11:00am I experience very bad chills, body aching, weak, left arm very sore swollen at the site and a knot.  I was so I weak I couldn't get out the bed.  Almost like having the flu.  On 3/24/2021 around 8:00am the symptoms were gone.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Fatigue, Headache, Malaise
Clinical narrative: 6 hours post shot: arm swelling  24 hours post shot: very tired, weak, unable to eat solids. Arm pain. Swollen arm. 48 hours: arm pain  8 days post shot: small rash The rash grew 3x the size within 24 hours. In a lot of pain. Felt weak and tired. Have had a headache since 3/27/21  3/29/21 semi lost taste. everything tastes bland. still have headache. overall not feeling the best.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: 6 hours post shot: arm swelling  24 hours post shot: very tired, weak, unable to eat solids. Arm pain. Swollen arm. 48 hours: arm pain  8 days post shot: small rash The rash grew 3x the size within 24 hours. In a lot of pain. Felt weak and tired. Have had a headache since 3/27/21  3/29/21 semi lost taste. everything tastes bland. still have headache. overall not feeling the best.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Inappropriate schedule of product administration, Off label use
Clinical narrative: first dose of BNT162B2:19Dec2020 ; second dose of BNT162B2: 05Jan2021; first dose of BNT162B2:19Dec2020 ; second dose of BNT162B2: 05Jan2021; hearing loss; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686), via unspecified route of administration on 05Jan2021 (at the age of 57 years) at a single dose in the left arm for COVID-19 immunization. Medical history included 'hypothyroid'. Concomitant medication included levothyroxine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) on 19Dec2020 at 11:00 AM (age: 57-years) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not pregnant at the time of vaccination. On 06Jan2021 at 16:00, the patient had hearing loss. The event resulted to physician office visit. The patient received steroids as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Vertigo
Clinical narrative: I was very tired the night of 2nd vaccine, aside from that absolutely no side effects, hardly any arm pain, so all well.  I actually felt great for about 9 days.  Then on 3/22/21  I was suddenly awaken by an intense, and peculiar, bout of vertigo.  I am familiar with vertigo from ear infections in the past (last one about 15 years ago and the one prior about 22 years ago).  For me vertigo is a generally mild sensation that stays with me until it clears up.  This was, and is, much different, it ebbs and increases during the day, if I concentrate on a physical task it sort of diminishes, then comes back, at times it goes away completely for an hour or two then comes back strong.  At same time that this started my thoughts and mental acuity started to suffer kind of a "brain fog" is the best explanation I can give.  I also have a slight headache at the back of my head wrapping around to the temples, I don't know if I can link the headache to the brain fog since my neck often gives me trouble.  I have ruled out ear infection by purposefully spinning myself around to see if I would lose balance, did not affect my balance.  I can also walk a relatively straight line of about 20' with my eyes closed without stumbling.  It feels like a kind of vertigo, but much different than any I have experienced in past and much longer lasting.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Gait disturbance, Pain in extremity
Clinical narrative: Moderna COVID-19 Vaccine EUA  2 pm day of first injection chills for 4 hours 4 days later- pain behind left knee when bent. As the time went on, about a week later, both legs started to be sore from the knee down. It felt like i worked out when i did not. The soreness did not prevent me from doing anything until Saturday 3/27/21. I walked 9 holes on the golf course when all of a sudden, my legs hurt very badly and they felt weak. I could no long walk the remaining 9 holes. I could still stand but it hurt at a rate of 9 on a scale of 1-10. Today they are still sore but at a 2. I did experience light light headedness 3/29 in the evening. I thought it was my glasses
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Discomfort, Groin pain, Supraventricular tachycardia
Clinical narrative: Moderna COVID-10 Vaccine EUA The evening after I received the shot, I had pain in my left groin area, same side as the injection. This has continued off and on in varying levels of pain/discomfort for 5 days. I also had an episode of SVT (heart rate reaching 218 beats/minute) 3 days after the vaccine (3/28). I have no known history of this nor family history of heart complications. An ambulance was called and they were able to bring down my heart rate by having me do the vagal nerve stimulation technique. I have a follow-up appointment with a cardiologist.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Had violent vomiting and diahrea, chills, high fever, headache, nausea, no energy, arm hurting.  day 3 still nauseaus and very tired.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Had violent vomiting and diahrea, chills, high fever, headache, nausea, no energy, arm hurting.  day 3 still nauseaus and very tired.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Blood test normal, Lymphadenopathy, Swelling, Ultrasound scan
Clinical narrative: shot occurred on 1 MAR.  swollen lymph nodes in the right armpit began to be noticeable around 3 MAR.  Pain and inflammation in left arm pit did occur off and over the next two weeks.  Blood work and revealed no significant issues.  Follow on ultrasound 23 MAR still showed some inflammation and sensitivity.  by today, 30 Mar the majority of the swelling is gone and pain has dissipated.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Full body rash
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Hypoaesthesia, Paraesthesia, Rash, Rash erythematous
Clinical narrative: 12 minutes after receiving dose, numbness and tingling in face and nose 15 minutes after receiving dose,  red rash evident on face and  patient highly agitated 75 -90 minutes all symptoms increased in intensity and rash spread to cover face and nose
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chest X-ray, Dysstasia, Gait inability
Clinical narrative: Unable to stand or walk; Unable to stand or walk; Pulmonary edema weakness; Temp. 101.7; Vomiting; weakness; This is a spontaneous report received from a contactable consumer (daughter of the patient) reported for in response to HCP follow-up letter sent in cross reference case. A 87-year-old male patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, second dose on 03feb2021 (formulation: Solution for injection, lot number: EIV6202) via intramuscular route of administration at single dose for covid 19 immunisation. The patient's medical history and concomitant medications was not reported. Historical vaccine of BNT162B2 for COVID Immunity on 06Jan2021. On 04Feb2021, the patient was unable to stand or walk. It was reported that the patient had to call all could not get off couch, no strength in his legs. All came could not stand or walk. On an unspecified date, patient had temp. 101.7, vomiting, SOB, chest X-ray showed pulmonary edema weakness. The patient received IV Lasix, one dose IV Antibiotics, physical therapy consult. On 05Feb2021 he could stand again on his own and able to walk on 06Feb2021. Discharged home on 07Feb2021. The outcome of event pulmonary edema was unknown and rest of the events was recovered on 11Feb2021. The reporter assessed the events are related to drug.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary oedema, Pyrexia, Vomiting
Clinical narrative: Unable to stand or walk; Unable to stand or walk; Pulmonary edema weakness; Temp. 101.7; Vomiting; weakness; This is a spontaneous report received from a contactable consumer (daughter of the patient) reported for in response to HCP follow-up letter sent in cross reference case. A 87-year-old male patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, second dose on 03feb2021 (formulation: Solution for injection, lot number: EIV6202) via intramuscular route of administration at single dose for covid 19 immunisation. The patient's medical history and concomitant medications was not reported. Historical vaccine of BNT162B2 for COVID Immunity on 06Jan2021. On 04Feb2021, the patient was unable to stand or walk. It was reported that the patient had to call all could not get off couch, no strength in his legs. All came could not stand or walk. On an unspecified date, patient had temp. 101.7, vomiting, SOB, chest X-ray showed pulmonary edema weakness. The patient received IV Lasix, one dose IV Antibiotics, physical therapy consult. On 05Feb2021 he could stand again on his own and able to walk on 06Feb2021. Discharged home on 07Feb2021. The outcome of event pulmonary edema was unknown and rest of the events was recovered on 11Feb2021. The reporter assessed the events are related to drug.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis bullous, Paraesthesia oral, Rash, Urticaria
Clinical narrative: 3/13 my entire scalp, neck and chest broke out in hives,welts. Treated with Benadryl with minimal relief. 3/14 symptoms worsened and spread, in the evening my tongue tingled. Went to ER and was treated as an allergic reaction. 3/16 went to an allergist as symptoms returned. Was told it was an immune reaction. Treated with Zyrtec, prednisone and as needed Benadryl. 3/30 symptoms still occur sporadically even while medicated.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High