chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Impaired driving ability, Vertigo positional, Visual impairment
Clinical narrative: Two days after receiving my shot, I began to experience mild dizziness. Four days after my vaccine, the dizziness began to intensify to the point where on day 5 (Sunday), I could not get out of bed.  I attempted to go to an urgent care facility, but none where open.  I called my PCP and talked to the covering doctor.  I was told that it might be BPPV and was given a prescription for meclazine.  On  day 6, I was a little better and tried to make an appointment with my PCP (I was unable to get one until this coming Friday), so I went to an urgent care.  They seemed to agree with the BPPV diagnosis and told me to look on T.V. for how to do the Epley maneuver.  It has now been 8 days since my vaccine and I am still experiencing dizziness, but am able to function with some limits (I haven't driven my car as of yet).  The Epley maneuver did not seem to help.  Besides the dizziness, my ears feel full and especially in the morning, I have a bit of a problem with my eyes focusing correctly.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Impaired work ability, Nausea
Clinical narrative: Became more exhausted throughout the night. Left work early since I was so tired I could barely see straight. Woke up the next day with trouble breathing and nausea, along with still feeling exhausted.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Body aches, chills
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient had filled out questionnaire stating he had not received a covid vaccine.  Pt received Jansen vaccine on 3/29 but after inputting his inoformation , we noticed he had already received the first dose of Moderna previously.  We followed up and patient states felt no side effects or adverse events. He then stated he had previously received Moderna.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: Swelling of lips and tongue began about 30 minutes after receiving vaccine. Took Benadryl; symptoms gradually improved and were gone within about 90 minutes after taking Benadryl
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. An ID requirement has been put in place to prevent this situation from occurring in the future.  Follow up to be done Physician or delegee will include specific description of next steps for obtaining dose 2. Initial education provided by MD from DOD.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal faeces, Blood iron normal, Blood thyroid stimulating hormone normal, Differential white blood cell count normal, Dysgeusia
Clinical narrative: Strong metallic taste in mouth, stool, gas all smell like metal.  Six weeks from first administration of vaccine and two weeks after second administration it is still present.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Lipase normal, Liver function test normal, Serum ferritin normal, Stool analysis normal
Clinical narrative: Strong metallic taste in mouth, stool, gas all smell like metal.  Six weeks from first administration of vaccine and two weeks after second administration it is still present.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vitamin B12 normal
Clinical narrative: Strong metallic taste in mouth, stool, gas all smell like metal.  Six weeks from first administration of vaccine and two weeks after second administration it is still present.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Asthenia, Memory impairment
Clinical narrative: HAIR LOSS; MEMORY AFFECTED; BODY WEAKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced hair loss, memory affected, and body weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hair loss, memory affected and body weakness was not reported. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient arrives to observation at 12:40 following feeling lightheaded and sweaty after receiving the vaccination.  BP 100/63 HR 75 oxygen sat 100% on room air.  She was given some gold fish crackers and water.  12:55 BP 105/75 HR 82 Pulse oxygen 100% on room air.   patient stated she feels better and was escorted to the exit in a wheelchair and was with her husband.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Injection site erythema, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pateint \"swooned\" when the observer was getting the timer.  He was responsive after 2 minutes.  sat upright after 5 minutes.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Injection site warmth
Clinical narrative: A few days (week maybe?) my arm got a rash that looks like hives near the injection point on my arm.  It's hot to the touch, but does not itch.  It is not sore at all, just very red.  No fever or anything either.  This was only my first vaccine shot.  It's been almost two weeks and it's still red and warm to the touch at injection point.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Intensive care, Magnetic resonance imaging
Clinical narrative: Stroke ~ 15 hours after 2d Pfizer injection.  911 Ambulance to the medical center
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Cerebellar haemorrhage, Cerebrovascular accident, Computerised tomogram, Dizziness
Clinical narrative: Stroke ~ 15 hours after 2d Pfizer injection.  911 Ambulance to the medical center
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate, Heart rate irregular, Infarction, Investigation, Magnetic resonance imaging
Clinical narrative: Stroke ~ 15 hours after 2d Pfizer injection.  911 Ambulance to the medical center
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site rash, Pruritus, Rash
Clinical narrative: Chronic Rash that started at the injection site(left deltoid IM) approximately 2 weeks after second Moderna vaccine up to present. Same rash appeared along collarbone bilaterally; 2 golf ball size spots along flanks bilaterally;  high pubic area and along testicles; low back localized in center of spine. The rash could be best described as flat "flaky" surface. Affected areas can be very itchy and uncomfortable when sweaty. Course of treatment to date has been Cortisone cream as needed and Benadyl  prior to bed.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted within 15 minutes of receiving vaccine. Patient was responsive and did not have trouble breathing. Gave patient supportive care (had patient continue to lie down, gave water, stayed with patient). Patient was able to get back up after a few minutes. Told patient to stay an additional 15 minutes as a precaution. Patient was able to leave safely afterwards.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: This was my 2nd shot of the Moderna COVID-19 Vaccine EUA.  The morning after day of shot I had a sore arm and felt tired through the day, I slept most of the day.  These symptoms went away quickly from the following day.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Headache, Oedema, Pain
Clinical narrative: swelling inflammation of extremeties, severe pain, headache, boneaches, weakness, edema,
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling inflammation of extremeties, severe pain, headache, boneaches, weakness, edema,
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: SYRINGES  LOOKED LIKE THEY ALREADY HAD SOMETHING IN THERE, AS IF THE PLUNGERS WERE DRAWN UP; PHYSICIAN BELIEVES 7 PEOPLE DID  NOT GET THE VACCINE (GOT EMPTY VACCINES); This spontaneous report received from a physician concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced syringes looked like they already had something in there, as if the plungers were drawn up. On 26-MAR-2021, the subject experienced physician believes 7 people did not get the vaccine (got empty vaccines). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the syringes looked like they already had something in there, as if the plungers were drawn up and physician believes 7 people did not get the vaccine (got empty vaccines) was not reported. This report was non-serious. This case is associated with product quality complaint, Product Quality number: 90000174637.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pruritus, Injection site rash
Clinical narrative: Rash and itch started 4/6 as well as what feels like a lump at the injection site.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Hyperhidrosis, Hypotension, Pallor
Clinical narrative: presents with a potential reaction to the COVID19 vaccine. The patient was evaluated in his vehicle. The patient's wife (passenger) reported that as he pulled into the monitoring area, he become disoriented and pale. Upon evaluation, the patient was found to be significantly diaphoretic, pale, and mildly disoriented. Initial vitals revealed a pulse of 45, SpO2 of 86%. No BP was obtained at the time, but the patient was clearly hypotensive. The patient was laid supine in his seat and given aggressive oral hydration.  After aggressive hydration and close monitoring, the patient rapidly improved and returned to baseline with normal vitals. He was returned home with his wife as drive.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: red raised palm size area in the evening after injection. Previous Palm area on arm is clear. Red tender when touch approximately 3 inches long 3 inches wide extends down arm under area where the palm size red was seen after injection on March 18th.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus, Skin warm, Swelling
Clinical narrative: large red circle/spot around the injection site on my arm.  It's warm to the touch, slightly swollen and slightly itchy but not too bothersome overall.  This occurred about 11 days after my dose 1 vaccination date.  No treatment, other than taking antihistimine (Zyrtec).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Decreased appetite, Fatigue, Pain, Paraesthesia
Clinical narrative: I've been tired, achy, no appetite, weird prickly sensation on skin. I have felt sick for over a week. I'm slightly better each day.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever, chills and back pain starting from 2:00am and all throughout the next day. Very tired with headache from noon 4/6/2021 til approx 6am  on 4/7/2021. To summarize adverse events included fever, chills, headache, and tiredness. The side effects lasted approximately 28 hours.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itch all over the body; rash
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Malaise, Pyrexia
Clinical narrative: FELT COLDER; FEEL SICK; FEVER; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced felt colder, feel sick, fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel sick, fever, tired and felt colder was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: NO adverse event. Nurse attempted to give client vaccine but almost all of the vaccine leaked out between the syringe and needle. Client was revaccinated as he did not receive a full dose of Moderna.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Lymph node pain, Lymphadenopathy, Night sweats
Clinical narrative: The lymph nodes in my left underarm became very enlarged and very sore and painful for 5-6 days. I also had flu like symptoms and severe night sweats while asleep.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: We administered the pfizer dose (ER8737) as a second dose instead of Moderna.   Patient has not complained of side effects, however the CDC guidelines say this has to be reported as an adverse event.  Moderna 1st dose 03-10-2021 (lot # 0404a21a) Pfizer 2nd dose 04-07-2021 (lot # ER8737)
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Mild, Additional Details: pt blood pressure dropped to 88/54 after vaccine and was lightheaded, paramedics were called but bP had recovered to 111/62 by their arrival, pt  was monitored but did not go with the paramedics, refused too, ultimately went home with friend driving her
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspnoea, Flushing, Heart rate increased, Rash
Clinical narrative: Patient reports of feeling flush. She reports she feels she has a rash on her hands. Reports of shortness of breath, Blood pressure elevated and elevated Heart rate. Duration: 30+ minutes.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue and lightheadedness 2 hrs after vaccination for two days Fever onset 8 hours after vaccination, peaking at 104F lasting 14 hours Chills onset 8 hours after vaccination lasting 18 hours Headache onset 24 hours after vaccination lasting one day
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Nausea, Pain, Pallor
Clinical narrative: On Day 5 after receiving the second dose of the Pfizer vaccine, I woke up with hot flashes. I have felt flu-like body aches and a fairly intense headache.  6 hours later I am feeling better but still a little nauseated and "pale" feeling.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Off label use
Clinical narrative: POSSIBLE WRONG ROUTE OF ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once a total dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 26-MAR-2021, the subject experienced possible wrong route of administration. On 26-MAR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible wrong route of administration and off label use was not reported. This report was non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Muscular pain, headache, vomiting, nausea, fever
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. An ID requirement has been put in place to prevent this situation from occurring in the future.  Follow up to be done by Physician or delegee will include specific description of next steps for obtaining dose 2. Initial education provided by MD.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101 degrees
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, COVID-19, Pruritus, Rash, SARS-CoV-2 test positive
Clinical narrative: Pt has a rash on her face that is swollen and itching. Pt has blister on both hands. Pt tested Positive for Covid-19 on12/23/2020.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Pt has a rash on her face that is swollen and itching. Pt has blister on both hands. Pt tested Positive for Covid-19 on12/23/2020.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Vision blurred, Visual impairment
Clinical narrative: patient started experiencing blurry vision, black spots, and next day loss of vision in that eye
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus
Clinical narrative: Large rash  (fist sized) appeared on arm at injection site 8 days post-injection, very itchy
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Muscle pain at shot point.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Respiratory disorder
Clinical narrative: UPPER RESPIRATORY ISSUE; INSOMNIA; FATIGUE; INTERMITTENT HEADACHE; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included morphine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25/MAY/2021) dose was not reported, administered on 12-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced insomnia. On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced intermittent headache. On 28-MAR-2021, the subject experienced upper respiratory problem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, upper respiratory problem, insomnia, and intermittent headache. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Joint swelling, Musculoskeletal chest pain, Peripheral swelling
Clinical narrative: I'm not sure if that is the correct lot number (it was hard to read).  Low fever of 99.1 (I'm always below 98.6) with some chills. My hands and joints swelled up so much and hurt and my rib cage was extremely painful.  These are common symptoms of RA when I am in a flare.  I felt better on April 3rd.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rheumatoid arthritis
Clinical narrative: I'm not sure if that is the correct lot number (it was hard to read).  Low fever of 99.1 (I'm always below 98.6) with some chills. My hands and joints swelled up so much and hurt and my rib cage was extremely painful.  These are common symptoms of RA when I am in a flare.  I felt better on April 3rd.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Dizziness, Fatigue, Hypoaesthesia, Injection site pain
Clinical narrative: Moderna COVID-19 Vaccine EUA  All of the reactions occurred roughly 20-30 minutes after receiving vaccine  Both arms numb from shoulder down. Lasted for about 6 hrs Neck muscle sore/strained feeling. Lasted for most of the day Slight loss of smell. This lasted about 36 hrs  Nose became numb. This lasted about 36 hrs as well Vertigo/dizziness. Lasted about 20 minutes Tiredness. I took a 2 hr nap and was not tired afterwards. FYI its not normal for me to take naps at all.  Arm at injection site very sore and weak for about 3 days after
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle strain, Muscular weakness, Myalgia, Vertigo
Clinical narrative: Moderna COVID-19 Vaccine EUA  All of the reactions occurred roughly 20-30 minutes after receiving vaccine  Both arms numb from shoulder down. Lasted for about 6 hrs Neck muscle sore/strained feeling. Lasted for most of the day Slight loss of smell. This lasted about 36 hrs  Nose became numb. This lasted about 36 hrs as well Vertigo/dizziness. Lasted about 20 minutes Tiredness. I took a 2 hr nap and was not tired afterwards. FYI its not normal for me to take naps at all.  Arm at injection site very sore and weak for about 3 days after
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Recipient underage at the time of vaccination.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Feeling cold, Joint swelling, Malaise
Clinical narrative: No soreness or pain at the injection site. About 12 hours after the vaccine, I started feeling very cold and had a sort of disturbed night. The next day I did not want to do anything, it felt like I had the flu. I felt fatigued, like I had some pressure on me. My next night was more or less normal and the next day I felt more or less normal.  I started probably before the second dose feeling my left knee swelling. I also felt like a nerve pain, in on the left knee. The right one did not bother me at all. It is not just a knee pain it is like a nerve pain the knee and the upper calf. My knee feels inflated like a bike tire. My left knee is now much less mobile than my right knee. I did not see my doctor, just called his office and said I was concerned about a DVT so he suggested the ultrasound and later one physical therapy.  The PT helped me  a lot  in the beginning but then stopped getting any better and still does not feel right.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Sleep disorder, Ultrasound scan
Clinical narrative: No soreness or pain at the injection site. About 12 hours after the vaccine, I started feeling very cold and had a sort of disturbed night. The next day I did not want to do anything, it felt like I had the flu. I felt fatigued, like I had some pressure on me. My next night was more or less normal and the next day I felt more or less normal.  I started probably before the second dose feeling my left knee swelling. I also felt like a nerve pain, in on the left knee. The right one did not bother me at all. It is not just a knee pain it is like a nerve pain the knee and the upper calf. My knee feels inflated like a bike tire. My left knee is now much less mobile than my right knee. I did not see my doctor, just called his office and said I was concerned about a DVT so he suggested the ultrasound and later one physical therapy.  The PT helped me  a lot  in the beginning but then stopped getting any better and still does not feel right.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Feeling abnormal, Nausea, Pruritus
Clinical narrative: Nausea,  vomiting,  diarrhea,  itching,  brain fog, speaking in tongs, dizziness. It has been one week since last vaccine and I am still having symptoms.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Vomiting
Clinical narrative: Nausea,  vomiting,  diarrhea,  itching,  brain fog, speaking in tongs, dizziness. It has been one week since last vaccine and I am still having symptoms.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. An ID requirement has been put in place to prevent this situation from occurring in the future.  Follow up to be done by  Physician or delegee will include specific description of next steps for obtaining dose 2. Initial education provided by MD from.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Piloerection
Clinical narrative: ACHY ALL OVER; GOOSEBUMPS; COLD SHAKES; FEVER; BAD HEADACHE; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On 26-MAR-2021, the subject experienced achy all over. On 26-MAR-2021, the subject experienced goosebumps. On 26-MAR-2021, the subject experienced cold shakes. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, cold shakes, bad headache, achy all over and goosebumps was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHY ALL OVER; GOOSEBUMPS; COLD SHAKES; FEVER; BAD HEADACHE; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. On 26-MAR-2021, the subject experienced achy all over. On 26-MAR-2021, the subject experienced goosebumps. On 26-MAR-2021, the subject experienced cold shakes. On 26-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced bad headache. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, cold shakes, bad headache, achy all over and goosebumps was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: The morning after I received the second vaccine I woke up with a large red oval at the site of the injection.  The area was raised, hot and painful to touch.  I also felt very tired and sleepy and had an achy body.  There was no fever or sore throat.  The tiredness and achy body feeling went away after 24 hours.  The area that was raised, hot to the touch and painful to touch went away in 7 days.  I did not report any of this to my doctor at the time it was occurring.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: The morning after I received the second vaccine I woke up with a large red oval at the site of the injection.  The area was raised, hot and painful to touch.  I also felt very tired and sleepy and had an achy body.  There was no fever or sore throat.  The tiredness and achy body feeling went away after 24 hours.  The area that was raised, hot to the touch and painful to touch went away in 7 days.  I did not report any of this to my doctor at the time it was occurring.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Generalised tonic-clonic seizure
Clinical narrative: Patient had a tonic-clonic seizure approximately five minutes after receiving the first dose of the Moderna covid-19 vaccination. Post seizure the patient reported feeling a fever leading up to seizure. Patient had no history of seizure but has experienced fainting in the past. 911 was called immediately and paramedics cared for her.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Nausea
Clinical narrative: Pt c/o nausea following vaccination.  Pt monitored by paramedics and medical provider for 30 mins and symptoms subsided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Pain in extremity, Pyrexia
Clinical narrative: Left arm became sore immediately. I took ibuprofen 20 minutes after the injection. At 11pm I developed chills and a fever of 102. The fever continued throughout the night and all the following day. I used tylonel and Advil to help reduce the fever. In a 24 hour period from when I started symptoms, I slept for about 22 hours. Finally started feeling better on Wednesday around noon. I have no other major health concerns. My asthma is in check. I eat healthy and workout regularly.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Injury associated with device
Clinical narrative: Grazed finger with unretracted needle immediately after covid vaccination
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Myalgia, Nausea
Clinical narrative: Very sore muscles especially in the injection arm. Lack of appetite. Very tired. Nausea began on evening of April 6th and persisted until medication was taken (ondansetron) to stop it.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphonia, Induration, Lymphadenopathy, Myalgia
Clinical narrative: 10 days after the second vaccine I developed a low grade fever, congestion, and a enlarged lymph node at the top of my neck. Additionally, my voice was horse and I experienced muscle aches and chills. These symptoms lasted approximately 7 days. I no longer feel sick; however,  the lymph node in my upper neck remains swollen and is hard to the touch.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: 10 days after the second vaccine I developed a low grade fever, congestion, and a enlarged lymph node at the top of my neck. Additionally, my voice was horse and I experienced muscle aches and chills. These symptoms lasted approximately 7 days. I no longer feel sick; however,  the lymph node in my upper neck remains swollen and is hard to the touch.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Hyperhidrosis, Pyrexia, Tremor
Clinical narrative: Body temperature increase to 102.5 degrees Fahrenheit. Shaking, fever, and severe fatigue and sweat all over body.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Headache, nauseous, body aches, fatigue
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Mild pain in bicep below shoulder at injection site starting 48 hours after the injection. Pain off and on until 3/16/2021 when pain began to increase. Severe pain starting the evening of 3/19/2021. Doctor visit 03/22/2021 04:10 PM. Received prescription for DICLOFENAC SODIUM 75 MG ORAL TABLET DELAYED RELEASE. No reduction in pain so contacted doctor. MEDROL 4 MG ORAL TABLET THERAPY PACK prescribed and started 3/25/2021. Finished dose pack, and pain decreased for a few days but started again.  Severe pain at times not connected with exercise of use of right arm.  Shoulder and arm examined by physical therapist for rotator cuff problem (none) and no problems with movement of shoulder after complete examination of shoulder 4/7/2021; no signs of compartment syndrome; progressive weakness in the right hand including mistakes while typing at keyboard.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: She arrived at vaccine clinic to receive her covid vaccine.  She reported this was her second vaccine and that she had forgotten to bring her vaccine card from first covid vaccine appointment.  When asked by check in staff what vaccine she was here for, she reported she was here to receive her second pfizer vaccine so new card was started at check in desk for pfizer.  She then arrived at vaccine station and reported to nurse that she was here for her second pfizer vaccine .  Once vaccine was given, it was noted in data base that she  had received moderna for her first vaccine.  This was reported to medical team lead and vax clinic manager.  Vax clinic manager spoke with patient and informed her of error.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Loss of consciousness, Oxygen saturation
Clinical narrative: Symptoms of Patient: Complaint of feeling light headedness and not being able to see. Patient then passed out. 14:55 P-126, SaO2 85 Treatment: Offered patient fluid prior to her passing out. Patient was able to take a few sips of water and was alert and oriented prior to passing out. Patient was lowered to the floor from chair. Patient head was protected as she was lowered to the floor. Patient legs were elevated. Patient Blood pressure checked B/P110/70, P-70, SaO2 99%. Cool gauze was placed on client forehead. Emergency services were called to assist in care of patient. Upon elevation of patients legs patient states, was able to see. Patient alert and oriented x 3. Per patient states, is able to get back in chair. Patient states no longer dizzy. Emergency services arrived. Pulse and oxygen saturation maintaining continuous until they arrived.  Patient   blood pressure, oxygen saturation pulse rechecked by Emergency services. Patient B/P 110/80, P-67, O2 sat-93%, per emergency services, paramedic services came and assess patient. Per paramedic patient did not need to be placed on monitor. Client was no taken by ambulance. Client signed document with Emergency services patient declined transfer. Per patient feeling better, Patient denies feeling lightheaded and dizzy as if she was going to passout. If repeated and severe side effects reviewed with patient. Patient escorted to car by staff and friend Patient left location at 15:30.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Symptoms of Patient: Complaint of feeling light headedness and not being able to see. Patient then passed out. 14:55 P-126, SaO2 85 Treatment: Offered patient fluid prior to her passing out. Patient was able to take a few sips of water and was alert and oriented prior to passing out. Patient was lowered to the floor from chair. Patient head was protected as she was lowered to the floor. Patient legs were elevated. Patient Blood pressure checked B/P110/70, P-70, SaO2 99%. Cool gauze was placed on client forehead. Emergency services were called to assist in care of patient. Upon elevation of patients legs patient states, was able to see. Patient alert and oriented x 3. Per patient states, is able to get back in chair. Patient states no longer dizzy. Emergency services arrived. Pulse and oxygen saturation maintaining continuous until they arrived.  Patient   blood pressure, oxygen saturation pulse rechecked by Emergency services. Patient B/P 110/80, P-67, O2 sat-93%, per emergency services, paramedic services came and assess patient. Per paramedic patient did not need to be placed on monitor. Client was no taken by ambulance. Client signed document with Emergency services patient declined transfer. Per patient feeling better, Patient denies feeling lightheaded and dizzy as if she was going to passout. If repeated and severe side effects reviewed with patient. Patient escorted to car by staff and friend Patient left location at 15:30.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Ageusia, Asthma, Chest pain, Decreased appetite
Clinical narrative: Patient reported developing symptoms 4/3/21: nausea, heartburn, loss of taste, sore belly, and "heat" around her chest. Also developed exacerbation of asthma on the morning of 4/7/21 which is when patient called the pharmacy. As of 4/7, the nausea persisted but had improved, taste had returned with diminished appetite, acid reflux/heartburn symptoms continued, and patient had difficulty breathing (though she had forgotten her inhalers the days before).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Dyspnoea, Nausea
Clinical narrative: Patient reported developing symptoms 4/3/21: nausea, heartburn, loss of taste, sore belly, and "heat" around her chest. Also developed exacerbation of asthma on the morning of 4/7/21 which is when patient called the pharmacy. As of 4/7, the nausea persisted but had improved, taste had returned with diminished appetite, acid reflux/heartburn symptoms continued, and patient had difficulty breathing (though she had forgotten her inhalers the days before).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever 102 degrees, headache
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm feels sore.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Fatigue, Oropharyngeal pain, Pain in extremity
Clinical narrative: LOW TEMPERATURE 97.2F; FATIGUE; SORE THROAT; SORE ARM; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included coronavirus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and  expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported. On 26-MAR-2021, the subject experienced sore arm. On 27-MAR-2021, the subject experienced sore throat. On 27-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced low temperature 97.2f. Laboratory data included: Body temperature (NR: not provided) 97.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore throat, sore arm, and fatigue, and had not recovered from low temperature 97.2f. This report was non-serious. This case, from the same reporter is linked to 20210356147.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: 10:45am patient became unconscious and was laid on the floor with legs elevated.  Heartrate 50 BP 76/60 10:50am BP systolic 90 HR 60 weakly responsive 10:52am BP systolic 92 10:55am More responsive, eyes open, speaking, HR 64, BP systolic 100. 10:58am EMS arrived, patient declined transport.
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Death, Dyspnoea, Logorrhoea, Mouth breathing
Clinical narrative: OBJECTIVE: Patient found deceased on March 26, 2021, less than one week post vaccination with Pfizer-BioNTech COVID19 vaccine dose #1. Found by daughter who is also RN and caregiver. Patient found with black tongue protruding slightly from open mouth. Three days post vaccine date and for three days patient found mouth-breathing heavily. When patient?s attention was called to his breathing he immediately resumed normal breathing. Also three days post vaccine date and for three days patient had loosened waist belt and offered complaint of feeling full. Also, Patient was more talkative during the week following vaccination. SUBJECTIVE: Perhaps related to anxiety. OBJECTIVE: Patient had eaten only one avocado per day for his remaining two days of life. Patient had history of stoicism and was known to downplay or deny deviations in physical well-being.
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Protrusion tongue, Tongue discolouration
Clinical narrative: OBJECTIVE: Patient found deceased on March 26, 2021, less than one week post vaccination with Pfizer-BioNTech COVID19 vaccine dose #1. Found by daughter who is also RN and caregiver. Patient found with black tongue protruding slightly from open mouth. Three days post vaccine date and for three days patient found mouth-breathing heavily. When patient?s attention was called to his breathing he immediately resumed normal breathing. Also three days post vaccine date and for three days patient had loosened waist belt and offered complaint of feeling full. Also, Patient was more talkative during the week following vaccination. SUBJECTIVE: Perhaps related to anxiety. OBJECTIVE: Patient had eaten only one avocado per day for his remaining two days of life. Patient had history of stoicism and was known to downplay or deny deviations in physical well-being.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Fatigue, Feeling abnormal, Pain
Clinical narrative: On Monday, the same day as the shot... Towards the evening left arm hurting: like someone punched me really hard in the arm (like it did after the first shot) Around 8 PM or so, I started to feel achy and sore, like I had been working outside all day moving heavy items.  My whole body was sore.  Woke up the next morning and felt off.  Took my temp. and it read 101.  I took Tylenol.  Pretty much stayed in bed the whole day.  I was tired and achy.  Fever went up to 103 at around 4 PM.  Took Tylenol.  By the evening I was feeling better.  Next morning I woke up.  Not achy but not 100percent.  Fever at 99, but now I'm dizzy. (This is written on 4-7-21 2:40 pm)
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: On Monday, the same day as the shot... Towards the evening left arm hurting: like someone punched me really hard in the arm (like it did after the first shot) Around 8 PM or so, I started to feel achy and sore, like I had been working outside all day moving heavy items.  My whole body was sore.  Woke up the next morning and felt off.  Took my temp. and it read 101.  I took Tylenol.  Pretty much stayed in bed the whole day.  I was tired and achy.  Fever went up to 103 at around 4 PM.  Took Tylenol.  By the evening I was feeling better.  Next morning I woke up.  Not achy but not 100percent.  Fever at 99, but now I'm dizzy. (This is written on 4-7-21 2:40 pm)
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Noted left upper arm red itchy rash, about 12-13 days from injection.  About 6" high by 4.5" across.  Not raised.  Lasted for about 4 days.  Was advised via online patient portal to get the second injection in the opposite arm.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pain, Pyrexia
Clinical narrative: ACHES, PAINS; HIGH FEVER; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-MAR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) between 100.8° and 102°. On 28-MAR-2021, the subject experienced aches, pains. On 28-MAR-2021, the subject experienced high fever. On 28-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, aches, pains and nausea was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Back injury, Body temperature increased, Chills, Computerised tomogram normal, Fall
Clinical narrative: I had the second dose of Moderna at 11:30 a.m.  on April 5, 2021.  By 8:30 p.m. on April 5, 2021, I was running a temperature and had chills for hours.  At around 2 am., I got up, fainted and fell.  Had a blow to my head.   Fainted a second time and fell.  Went to the ER with a 101 temperature.  I was admitted to ICU.  The CT scan didn't show any brain bleeding.  Hurt my lower back when I fell.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Syncope
Clinical narrative: I had the second dose of Moderna at 11:30 a.m.  on April 5, 2021.  By 8:30 p.m. on April 5, 2021, I was running a temperature and had chills for hours.  At around 2 am., I got up, fainted and fell.  Had a blow to my head.   Fainted a second time and fell.  Went to the ER with a 101 temperature.  I was admitted to ICU.  The CT scan didn't show any brain bleeding.  Hurt my lower back when I fell.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Headache, Photophobia
Clinical narrative: Extreme weakness, headache,  temperature of 101, chills, extreme light sensitivity
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Oropharyngeal pain
Clinical narrative: sudden onset sore throat, dizziness, and exhaustion 24 hours after injection
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Patient arrives to observation at 11:00 following feeling lightheaded and sweaty after receiving the vaccination.  She states she has a needle phobia and "just needs to lay down"  BP 140/79 HR 68 oxygen sat 98% on room air.  She was given some water, utilized slow breathing and relaxation techniques and gold fish crackers .  10:05 BP 132/74 HR 79 Pulse oxygen 100% on room air.   10:20 BP 129/89 HR 77 oxygen sat 100% on room air. patient stated she feels better and was escorted to the exit in a wheelchair at 10:20 am
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: The night of March 31 I had difficulty sleeping due to intense pain at injection site. Pain receded over the following few days until today, April 7. This morning I woke to itchiness at the injection site. The itchiness has intensified over the day, the injection site is now swollen, inflamed, warm to touch. I am also feeling very tired.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Insomnia
Clinical narrative: The night of March 31 I had difficulty sleeping due to intense pain at injection site. Pain receded over the following few days until today, April 7. This morning I woke to itchiness at the injection site. The itchiness has intensified over the day, the injection site is now swollen, inflamed, warm to touch. I am also feeling very tired.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Red arm at injection site 9 days later