chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Dizziness, Dry skin, Hot flush, Palpitations
Clinical narrative: pt felt ringing in ears after vaccine, feels heart pounding 1056 AM BP 160/97 HR 68 "similar to hot flash 1058 AM BP 145/96 HR 69 talking, alert, oriented, skin warm and dry, denies feeling dizzy 1102 AM 143/96 HR 69 sipping water, skin warm & dry 1104 AM 137/93 HR 74 talking with nurse 1108 AM 139/94 HR 72 skin warm & dry 1112 142/89 HR 74 feeling better, no ringing in ears, skin warm & dry, states husband at home to be w/her
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Tinnitus
Clinical narrative: pt felt ringing in ears after vaccine, feels heart pounding 1056 AM BP 160/97 HR 68 "similar to hot flash 1058 AM BP 145/96 HR 69 talking, alert, oriented, skin warm and dry, denies feeling dizzy 1102 AM 143/96 HR 69 sipping water, skin warm & dry 1104 AM 137/93 HR 74 talking with nurse 1108 AM 139/94 HR 72 skin warm & dry 1112 142/89 HR 74 feeling better, no ringing in ears, skin warm & dry, states husband at home to be w/her
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong patient received product
Clinical narrative: "Casirivimab (part of Regeneron mAbs) under Emergency Use Authorization (EUA)" On 12-30-2020 at 17:01, Dr. was notified by medical personnel that 42 people who went to the vaccination site for those 80 years and above, inadvertently received 0.5 mL Regeneron antibody instead of Moderna vaccine by the nurse vaccinator. During the call, determined that it was the REGN10933 component which is casirivimab 300 mg/2.5 single-dose vials were in a box instead of Moderna vaccine. Mistake was noticed when the pharmacist vaccinators at three other vaccination locations that evening called the center to report they received incorrect vials. Upon notification, alerts went to other sites receiving vaccine and the error was identified. At the original storage site, vials of casirivimab and vials of Moderna vaccine were stored side by side in the refrigerator as both require refrigeration. It should be notified that the box of casirivimab was shipped separately from the rest of the Regenerol mAbs product without notification; therefore, arrival of this box was not anticipated. When the people came to pick up the vaccine, vials of both drugs were taken for re-distribution to vaccination site locations. It should be noted that the shipping boxes used for both drugs are identical on the outside; the packing list inside the box identifies box contents. The boxes for the vaccine inside the shipping boxes are marked. The labels for both of the Regeneron mAbs drugs (casirivimab and imdevirmab) are poorly label for identification having letters and numbers instead of the drug name on the vials: vials do say 2.5 mL. The Moderna vial does not list total volume of contents but rather (10 doses of 0.5 mL per dose). Both drug vials have a red top.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Myalgia
Clinical narrative: I was diagnosed with COVID-19 on 12/7/2020. My course of symptoms lasted 16 days, meaning I started feeling healthy again on 12/23/20. I am a pharmacist with a healthcare system and they have been offering the Pfizer/Biontech COVID-19 vaccine for essential associates. I received by first dose of vaccine on 12/31/20. On 1/1/20 I woke up with very noticeable muscle aches and fairly profound lethargy, which last 18-20 hours. I was not able to do much on 1/1/21 because of the way I was feeling. I'm not sure if this reaction is normal for patients who receive their COVID-19 vaccine close to their illness/infection with COVID-19, which is why I'm reporting this to the FDA.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Patient reported a mild headache after receiving the Moderna COVID vaccine in the Right Deltoid. patient's vitals stable.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: Upon receiving Moderna COVID vaccine, patient became light headed and hypertensive ( BP 200/100).
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bell's palsy, Chest discomfort, Dyspnoea, Ear pain
Clinical narrative: [pfizer covid 19 vaccine] treatment under Emergency Use Authorization(EUA):pfizer covid 19 vaccine administration  12/28/2020 0830 left deltoid. At 1200 (within 4 hrs) began experiencing L sided facial and Left foot numbness/tingling and left hand. At 1600- palpitations, chest tightness.  1900-chills, myalgia, cold sensation of b/l feet. 12/20-+fatigue, SOB, left sided low back pain - severe 12/30-headache, left ear pain, left face pain/continued numbness tingling 12/31-mild facial weakness left forehead, left cheek/smile asymmetry. Reported to health care provider, began steroid for early onset bell's palsy. Today is 1/8/2021 continue to have paresthesia of my left face, left hand, left foot, headache, mild left facial weakness/altered sensation Use Authorization(EUA):
Sex: F
Vaccine: COVID19
Symptoms: Facial asymmetry, Facial pain, Facial paresis, Fatigue, Headache
Clinical narrative: [pfizer covid 19 vaccine] treatment under Emergency Use Authorization(EUA):pfizer covid 19 vaccine administration  12/28/2020 0830 left deltoid. At 1200 (within 4 hrs) began experiencing L sided facial and Left foot numbness/tingling and left hand. At 1600- palpitations, chest tightness.  1900-chills, myalgia, cold sensation of b/l feet. 12/20-+fatigue, SOB, left sided low back pain - severe 12/30-headache, left ear pain, left face pain/continued numbness tingling 12/31-mild facial weakness left forehead, left cheek/smile asymmetry. Reported to health care provider, began steroid for early onset bell's palsy. Today is 1/8/2021 continue to have paresthesia of my left face, left hand, left foot, headache, mild left facial weakness/altered sensation Use Authorization(EUA):
Sex: F
Vaccine: COVID19
Symptoms: Hemiplegia, Hypoaesthesia, Myalgia, Palpitations, Paraesthesia
Clinical narrative: [pfizer covid 19 vaccine] treatment under Emergency Use Authorization(EUA):pfizer covid 19 vaccine administration  12/28/2020 0830 left deltoid. At 1200 (within 4 hrs) began experiencing L sided facial and Left foot numbness/tingling and left hand. At 1600- palpitations, chest tightness.  1900-chills, myalgia, cold sensation of b/l feet. 12/20-+fatigue, SOB, left sided low back pain - severe 12/30-headache, left ear pain, left face pain/continued numbness tingling 12/31-mild facial weakness left forehead, left cheek/smile asymmetry. Reported to health care provider, began steroid for early onset bell's palsy. Today is 1/8/2021 continue to have paresthesia of my left face, left hand, left foot, headache, mild left facial weakness/altered sensation Use Authorization(EUA):
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: [pfizer covid 19 vaccine] treatment under Emergency Use Authorization(EUA):pfizer covid 19 vaccine administration  12/28/2020 0830 left deltoid. At 1200 (within 4 hrs) began experiencing L sided facial and Left foot numbness/tingling and left hand. At 1600- palpitations, chest tightness.  1900-chills, myalgia, cold sensation of b/l feet. 12/20-+fatigue, SOB, left sided low back pain - severe 12/30-headache, left ear pain, left face pain/continued numbness tingling 12/31-mild facial weakness left forehead, left cheek/smile asymmetry. Reported to health care provider, began steroid for early onset bell's palsy. Today is 1/8/2021 continue to have paresthesia of my left face, left hand, left foot, headache, mild left facial weakness/altered sensation Use Authorization(EUA):
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain in extremity, SARS-CoV-2 test, Swelling
Clinical narrative: I received the Pfizer vaccine on 12/21/20 without adverse events other than soreness in deltoid. On 12/31/20 I began to notice pain, redness and swelling in second toe on R foot from base of toe to base of nail. I initially thought it was gout and self medicated with ibuprofen 400 mg BID x 1 day on 01/01/21 with some improvement. I did not take anything on 01/02/21 and woke up on 01/03/21 with return of swelling, redness and pain. I took another 400 mg of ibuprofen and it felt better but after examining the toe, I questioned whether I had developed pernio (COVID toe).
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Five (5) vials of Moderna COVID vaccine (NDC:80777-0273-99 (5010700] Lot#011J20A) that was supposed to contain (10) doses per vial contained only (9) doses. Facility received 250, 5ML (10) dose vials in a shipment received 12/22/2020. At onset of vaccinations, the Immunization Clinic noted five of the vials did not contain the appropriate amount of vaccine as stated per the manufacturer. No adverse impact. No mission degradation. Quality Report is submitted to address this discrepancy on current and future vaccine shipments.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling/redness/itchiness at injection site 1week after dose #1 of Moderna vaccine
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Migraine
Clinical narrative: Emergency Use Authorization (EUA): injection Hard red swelling painful at injection site and migraine headache
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Fluid retention, Gait disturbance, Joint swelling
Clinical narrative: Received Moderna COVID vaccine 12/31/20, 3 days later noticed generalized joint pain all over. Day 4 noticed both knees were red and tender and could palpate pockets of fluid. Had bilateral ankle and foot pain, right ankle swollen. Overnight 1/5-1/6/21 was in severe pain and unable to sleep, very difficult to walk on ankles and feet, stairs were very painful. Motrin relieved symptoms to where able to walk more comfortably but generalized achiness and tenderness to ankles and knees remain.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pain, Pain in extremity, Sleep disorder, Tenderness
Clinical narrative: Received Moderna COVID vaccine 12/31/20, 3 days later noticed generalized joint pain all over. Day 4 noticed both knees were red and tender and could palpate pockets of fluid. Had bilateral ankle and foot pain, right ankle swollen. Overnight 1/5-1/6/21 was in severe pain and unable to sleep, very difficult to walk on ankles and feet, stairs were very painful. Motrin relieved symptoms to where able to walk more comfortably but generalized achiness and tenderness to ankles and knees remain.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: This is a report about me. I received my Covid vaccine on Sunday after my hospital shift (it was first dose of the Pfizer vaccine). Other than some muscle soreness, which I expected, I started experiencing numbness and tingling in the arm that received the shot (my left arm). It is now 4 days later, and the numbness/ tingling is not any better. I don't know if this is a frequent side effect that will go away in time, but it is very concerning to me.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis after Covid 19 vaccine #1. Pfizer Lot # EH9899
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Magnetic resonance imaging abnormal, Product administered at inappropriate site, Soft tissue disorder
Clinical narrative: I was given the Fluzone Quad vaccine in left arm on 10 19 2020. This injection is suppose to be given intramuscularly. It was given in errant location and as a result a permanent 2.5in diameter and 0.5in deep soft tissue defect resulted by the 4th post-injection day and remains unchanged.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: I experienced a significant reaction after receiving the pneumoooooal polysaccharide 23 vaccine on Wednesday, January 6. The right upper arm was the site of the injection. I experienced redness, swelling and the area was very warm. The redness spread down into the foreaarm and encircled my upper arm the next day. My arm became very swollen. It looked like hives. I could not lift my arm or extend my arm without great pain. I went to the urgent care center or Friday and they diagnosed this as cellulitis and prescribed antibiotics. My practicioner did not let me know there were any side effects or provide me with paperwork. I realize now, via articles in NH that there can be allergic reactions. My doctor an the physician assistant both saw this as cellulitis and not allergic reaction. Today, on Sunday my arm is still painful to touch and lift.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Tenderness, Urticaria
Clinical narrative: I experienced a significant reaction after receiving the pneumoooooal polysaccharide 23 vaccine on Wednesday, January 6. The right upper arm was the site of the injection. I experienced redness, swelling and the area was very warm. The redness spread down into the foreaarm and encircled my upper arm the next day. My arm became very swollen. It looked like hives. I could not lift my arm or extend my arm without great pain. I went to the urgent care center or Friday and they diagnosed this as cellulitis and prescribed antibiotics. My practicioner did not let me know there were any side effects or provide me with paperwork. I realize now, via articles in NH that there can be allergic reactions. My doctor an the physician assistant both saw this as cellulitis and not allergic reaction. Today, on Sunday my arm is still painful to touch and lift.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Received 2nd shingrix vaccination 1/8/21. On 1/9/21 my arm was sore but I had sever generalised body aches lasting 24 hours. Treated with ibuprofen and Tylenol. 2months earlier after the first vaccine I just had fatigue and a sore arm
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Headache, Injection site erythema
Clinical narrative: Second Shingrix shot. Arm swollen and red. Shivering during the night. Severe headache. Upset stomach and diarrhea.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Second Shingrix shot. Arm swollen and red. Shivering during the night. Severe headache. Upset stomach and diarrhea.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Dizziness, Injection site rash, Rash
Clinical narrative: Person received final shot of Covid vaccine by Moderna today at 11:05am, then experienced dizziness 5 minutes after. Her blood pressure was 191/92 with HR of 94 at 11:20 am, then retaken at 11:40AM with values of BP=163/77 and HR of 95. SHe also experienced rash at injection site and in chest/breasts.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Paraesthesia
Clinical narrative: I received the Covid vaccine. The injection itself was without any issues. However, 6-7 hours later, my entire upper arm began aching-pain from my trapezius down to my elbow. This continued throughout the weekend and then Monday, my index and middle finger began tingling (as if asleep). This symptom has never subsided. I am noting pain in each of the major joints of my arm-shoulder, elbow and wrist. I have tired trigger injections in my trapezius, ibuprofen, muscle relaxers, heat, exercises, a steroid burst-all without relief of symptoms. I am able to move my arm and I do have strength in the extremity. I have seen a specialist in physical medicine and rehabilitation. What I believe may have triggered this reaction is that in October I had a radial and ulnar tunnel release in the same extremity. I wonder whether the medication has affected the nerves that had been manipulated during surgery. I am wondering if anyone participating gin the trial had recent surgery was well? if so, did they note any complication after receiving the vaccine. Any help you can give would be appreciated. Thanks you for your time.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Throat irritation
Clinical narrative: After administration of Moderna COVID vaccine to left arm, patient reported itchy throat and tingling from left arm to back of neck.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Rash
Clinical narrative: Pneumovax 23. Rash away from injection site. Unusual intense pain above injection site, specifically at shoulder joint.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: After injection , c/o itchlness to site.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: 6 hours after receiving 2nd dose of Pfizer COVID-19 vaccine I began experiencing palpitations. Using mobile device it appears to be PACS. Sustained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Rash
Clinical narrative: pt said he had a rash that developed under her breasts an hour after receiving the vaccine. pt took Benadryl and went to sleep. Rash was there still when she woke up and she also had flu-like symptoms
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pain
Clinical narrative: The patient received the vaccine on 12/28/2020 around 2:45pm. She reported a headache the next morning which turned into body aches and a cough. She was sent home and advised to call occupation health.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: This is a report about me. I received my Covid vaccine on Sunday after my hospital shift (if was first dose of the Pfizer vaccine). Other than some muscle soreness, which I expected, I started experiencing numbness and tingling in the arm that received the shot (my left arm). It is now 4 days later, and the numbness/tingling is not any better. I don't know if this is a frequent side effect that will go away in time, but it is very concerning to me.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pain
Clinical narrative: The patient received the vaccine on 12/28/2020 around 2:45pm. She reported a headache the next morning which turned into body aches and a cough. She was sent home and advised to call occupational health.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphoedema, Oedema, Weight increased
Clinical narrative: [Pfizer COVID Vaccine] treatment under Emergency Use Authorization(EUA): Pfizer Covid Vaccine- substantial lymphedema under armpit of injected arm. Dose of vaccine #2 on 1/12/2021. armpit sore to touch and patient experienced 6 lb weight gain from edema
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: Standard side effect, it seems, just reporting for tracking. EXTREME tiredness/lethargy 36-72 hours after Pfizer Bion Tech vaccine dose 2. No other side effects, did not require any medical treatment, self-resolved with time.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Fatigue, Headache, Impaired work ability
Clinical narrative: I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such as headache and fatigue and dizziness. That night I awoke with severe stabbing abdominal pain. I couldn't sleep much of the night due to pain. The pain continued until the following day. I had to take the day off work due to fatigue and pain. I have a couple of autoimmune diseases and I surmised this is why the vaccine affected me in this way.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such as headache and fatigue and dizziness. That night I awoke with severe stabbing abdominal pain. I couldn't sleep much of the night due to pain. The pain continued until the following day. I had to take the day off work due to fatigue and pain. I have a couple of autoimmune diseases and I surmised this is why the vaccine affected me in this way.
Sex: M
Vaccine: FLU4
Symptoms: Aphasia, Biopsy brain abnormal, Central nervous system lesion, Coma, Dysarthria
Clinical narrative: Pt rec'd flu vaccine (lot # 2202: UJ535AB) at a pharmacy on 11/16/2020. The next day he developed right hemifacial spasm and palatal myoclonus. 11/17/2020 BRAIN MRI showed a small left frontal non-enhancing lesion, initially thought to possibly be a subacute stroke. However, he worsened and developed anarthria, aphagia, right arm wkns, and aspiration pneumonia necessitating intubation. Repeat BRAIN MRI 11/24/2020 was worse. He had the 1st of 2 brain biopsies 11/28/2020, which pathology was resulted as "reactive changes" but was non-diagnostic. He had add'l BRAIN MRIs that showed continued worsening of the left hemisphere lesion and subsequent involvement of the right hemisphere. A 2nd brain brain biopsy was done 12/16/2020, which pathology was also resulted as "reactive changes" but was also non-diagnostic. The pt has a h/o "low-grade" T-cell lymphoma, but neither biopsy samples had evidence of lymphoma in CNS or of obvious features to suggest other neoplasm, vasculitis, granulomatous disease, infection, or demyelination. This is a very odd / challenging case. Initially despite the timing I did not consider the flu vaccine to be relevant / causative. However, there is no other obvious possible etiology. Hence I would consider the flu vaccine probably related to his CNS problem and a serious adverse reaction. He eventually started having seizures. He remains in a coma on life support. His family is going to withdraw care 1/8/2020.
Sex: M
Vaccine: FLU4
Symptoms: Dysphagia, Endotracheal intubation, Facial spasm, Life support, Magnetic resonance imaging brain abnormal
Clinical narrative: Pt rec'd flu vaccine (lot # 2202: UJ535AB) at a pharmacy on 11/16/2020. The next day he developed right hemifacial spasm and palatal myoclonus. 11/17/2020 BRAIN MRI showed a small left frontal non-enhancing lesion, initially thought to possibly be a subacute stroke. However, he worsened and developed anarthria, aphagia, right arm wkns, and aspiration pneumonia necessitating intubation. Repeat BRAIN MRI 11/24/2020 was worse. He had the 1st of 2 brain biopsies 11/28/2020, which pathology was resulted as "reactive changes" but was non-diagnostic. He had add'l BRAIN MRIs that showed continued worsening of the left hemisphere lesion and subsequent involvement of the right hemisphere. A 2nd brain brain biopsy was done 12/16/2020, which pathology was also resulted as "reactive changes" but was also non-diagnostic. The pt has a h/o "low-grade" T-cell lymphoma, but neither biopsy samples had evidence of lymphoma in CNS or of obvious features to suggest other neoplasm, vasculitis, granulomatous disease, infection, or demyelination. This is a very odd / challenging case. Initially despite the timing I did not consider the flu vaccine to be relevant / causative. However, there is no other obvious possible etiology. Hence I would consider the flu vaccine probably related to his CNS problem and a serious adverse reaction. He eventually started having seizures. He remains in a coma on life support. His family is going to withdraw care 1/8/2020.
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Myoclonus, Pneumonia aspiration, Seizure
Clinical narrative: Pt rec'd flu vaccine (lot # 2202: UJ535AB) at a pharmacy on 11/16/2020. The next day he developed right hemifacial spasm and palatal myoclonus. 11/17/2020 BRAIN MRI showed a small left frontal non-enhancing lesion, initially thought to possibly be a subacute stroke. However, he worsened and developed anarthria, aphagia, right arm wkns, and aspiration pneumonia necessitating intubation. Repeat BRAIN MRI 11/24/2020 was worse. He had the 1st of 2 brain biopsies 11/28/2020, which pathology was resulted as "reactive changes" but was non-diagnostic. He had add'l BRAIN MRIs that showed continued worsening of the left hemisphere lesion and subsequent involvement of the right hemisphere. A 2nd brain brain biopsy was done 12/16/2020, which pathology was also resulted as "reactive changes" but was also non-diagnostic. The pt has a h/o "low-grade" T-cell lymphoma, but neither biopsy samples had evidence of lymphoma in CNS or of obvious features to suggest other neoplasm, vasculitis, granulomatous disease, infection, or demyelination. This is a very odd / challenging case. Initially despite the timing I did not consider the flu vaccine to be relevant / causative. However, there is no other obvious possible etiology. Hence I would consider the flu vaccine probably related to his CNS problem and a serious adverse reaction. He eventually started having seizures. He remains in a coma on life support. His family is going to withdraw care 1/8/2020.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: mRNA-1273 treatment under Emergency Use Authorization(EUA): Patient received first dose of Moderna Covid vaccine at about 10:30 on 1/4/21. Experienced body aches and low grade fever throughout the night of 1/4/21 and continued with body aches most of day on 1/5/21. Felt fine again morning of 1/6/21.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Oral herpes
Clinical narrative: Reaction to 1st Shingrix vaccine; within 24 hours, lasted for 4 days; pain at injection site, headache, neusea, vomitting, shivering, new cold sore.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Reaction to 1st Shingrix vaccine; within 24 hours, lasted for 4 days; pain at injection site, headache, neusea, vomitting, shivering, new cold sore.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Migraine, Nausea
Clinical narrative: First dose of the Moderna Vaccine: I got an optic nerve meningioma this summer and I've had a horrible migraine with accompanying nausea since I got the vaccine. It is not the 13th and I feel horrible. Moderna Batch 039K20A
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: mRNA-1273 treatment under Emergency Use Authorization(EUA): After getting the Covid vaccine 1/4, I developed a tingling, skin of numb area on my left upper lip 1/5 and it continues today, 1/6. Also had some diarrhea and left sided abd pain for 2 days but seems to be resolving today.
Sex: U
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Covid vaccination, Clinic: The involved Nurse was attempting to dilute vial of Pfizer vaccine with needle and syringe, some amount of saline went into vial, the rest squirted out of syringe outside of vial.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cerebral haemorrhage, Computerised tomogram, Gait disturbance, Magnetic resonance imaging
Clinical narrative: Received Shingrix vaccine 9/16/2020. Later that day noted dragging right leg when walking. By following day had weakness in right leg and right arm. Presented to ED 9/22/2020 and found to have left frontal intraparenchymal hemorrhage measuring 2.7 x 2.2 x 2.6 cm. Subsequent imaging showed 7 x 10 mm left centrum semiovale cavernoma. Patient has had good recovery without residual weakness and did not require intervention during 6 days of hospitalization.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain
Clinical narrative: I received my 2nd shingles shot I was told of body aches, fatigue etc. 36 hours after shot and feeling sore head to toe, I discovered an enlarged lymph gland on my collar bone, same side as shot. I notified my physician who said swollen glands can happen after a vaccine. it was not one of the symptoms on the patient reaction page so it alarmed me
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Sleep disorder
Clinical narrative: Woke up to severe itching at injection site almost exactly a week after the injection for the moderna covid 19 vaccine. THe itching kept me awake for an hour and has cause pain and itching throughout today with need for benadryl Lot H02SJ20-2A. Dose was administered on 1/5/2021. I put in random expiration date because I did not have access to that information
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Underdose
Clinical narrative: Plunger stopped 3/4 of way during administration of Prevnar13 injection  Patient came into the office for Prevnar13 injection. During the injection process  the plunger stopped about 3/4 of the way through the administration and would not release the remaining medication.  Patient did not receive full dose of vaccination.   Office staff spoke with RN from the manufacturer Drug Safety department who gathered information on the situation and placed an active form on file.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Magnetic resonance imaging abnormal, Product administered at inappropriate site, Soft tissue disorder
Clinical narrative: I was given the Fluzone Quad vaccine in left arm on 10 19 2020. This injection is suppose to be given intramuscularly. It was given in errant location and as a result a permanent 2.5in diameter and 0.5in deep soft tissue defect resulted by the 4th post-injection day and remains unchanged.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Severe pain deep in left buttocks hip area. Began 01/14/21 am and continuing Now. Taking Aleve every 12 hours for some relief Pfizer COVID Vaccination on 01/13/21 at 7:27 am at medical center. Vaccination in right arm. I am 77.5 years old. Is there a drug interaction between Valtrex and the COVID vaccine?? I take Valtrex daily. Help
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Stress
Clinical narrative: Severe pain deep in left buttocks hip area. Began 01/14/21 am and continuing Now. Taking Aleve every 12 hours for some relief Pfizer COVID Vaccination on 01/13/21 at 7:27 am at medical center. Vaccination in right arm. I am 77.5 years old. Is there a drug interaction between Valtrex and the COVID vaccine?? I take Valtrex daily. Help
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: After injection , c/o itchiness to site.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: [BioNTech COVID-19] treatment under Emergency Use Authorization(EUA):BioNTech Pfizer COVID-19 Vaccination. Two vaccinations given. Mild arm tenderness associated with 1st dose. Second dose administered 20 days after 1st dose resulted in adverse effects (AE) approximately 40-43 hours after 2nd dose was administered. AEs involved nausea, malaise, flu-like symptoms, mild fever, chills, body aches, gastritis and diarrhea. AEs lasted approximately 4-5 hours. Fatigue lingered for approx. 12 hours. Patient felt normal upon awakening next morning with no additional or lingering AEs to report since experiencing AEs from 2nd dose of BioNTech vaccine. 650mg acetaminophen was taken during 2nd dose experience with AEs. Acetaminophen did alleviate severity of symptoms slightly. Patient had loss of appetite due to AEs experienced. Patient was able to consume water without complications. No mental effects only tiredness from symptoms were experienced.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Gastritis, Inappropriate schedule of product administration, Influenza like illness, Malaise, Nausea
Clinical narrative: [BioNTech COVID-19] treatment under Emergency Use Authorization(EUA):BioNTech Pfizer COVID-19 Vaccination. Two vaccinations given. Mild arm tenderness associated with 1st dose. Second dose administered 20 days after 1st dose resulted in adverse effects (AE) approximately 40-43 hours after 2nd dose was administered. AEs involved nausea, malaise, flu-like symptoms, mild fever, chills, body aches, gastritis and diarrhea. AEs lasted approximately 4-5 hours. Fatigue lingered for approx. 12 hours. Patient felt normal upon awakening next morning with no additional or lingering AEs to report since experiencing AEs from 2nd dose of BioNTech vaccine. 650mg acetaminophen was taken during 2nd dose experience with AEs. Acetaminophen did alleviate severity of symptoms slightly. Patient had loss of appetite due to AEs experienced. Patient was able to consume water without complications. No mental effects only tiredness from symptoms were experienced.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: [BioNTech COVID-19] treatment under Emergency Use Authorization(EUA):BioNTech Pfizer COVID-19 Vaccination. Two vaccinations given. Mild arm tenderness associated with 1st dose. Second dose administered 20 days after 1st dose resulted in adverse effects (AE) approximately 40-43 hours after 2nd dose was administered. AEs involved nausea, malaise, flu-like symptoms, mild fever, chills, body aches, gastritis and diarrhea. AEs lasted approximately 4-5 hours. Fatigue lingered for approx. 12 hours. Patient felt normal upon awakening next morning with no additional or lingering AEs to report since experiencing AEs from 2nd dose of BioNTech vaccine. 650mg acetaminophen was taken during 2nd dose experience with AEs. Acetaminophen did alleviate severity of symptoms slightly. Patient had loss of appetite due to AEs experienced. Patient was able to consume water without complications. No mental effects only tiredness from symptoms were experienced.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site rash, Rash
Clinical narrative: Person received first shot of COVID vaccine by Moderna today at 11:05am, then experienced dizziness 5 minutes after. Her blood pressure was at 191/92 with HR of 94 at 11:20am, then retaken at 11:40AM with values of BP=163/77 and HR of 95. SHe also experienced rash at injection site and in chest/breasts.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pain
Clinical narrative: I received my 2nd shingles shot I was told of body aches, fatigue etc. 36 hours after shot feeling sore head to toe, I discovered an enlarged lymph gland on my collar bone, same side as shot. I notified my physician who said swollen glands can happen after a vaccine. it was not one of the symptoms on the patient reaction page so it alarmed me
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Electrocardiogram normal
Clinical narrative: Experienced mild chest pressure within minutes of second dose of Pfizer-BioNTech Covid-19 vaccine I am still experiencing mild (2/10) chest pressure over 12 hours after vaccine (from 8:30 am - 10:40 pm). No other symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Rash
Clinical narrative: pt said she had a rash that developed under her breasts an hour after receiving the vaccine. pt took Benadryl and went to sleep. Rash was there still when she woke up and she also had flu-like symptoms
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Nausea, Pain
Clinical narrative: Covid vx Pfizer Swollen lymph nodes under arm on the same side as injection site. Fatigue, nausea, chills, body aches, fever
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Covid vx Pfizer Swollen lymph nodes under arm on the same side as injection site. Fatigue, nausea, chills, body aches, fever
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardioversion, Immediate post-injection reaction, Muscle contractions involuntary, Pulse absent, Resuscitation
Clinical narrative: Patient was vaccinated in right arm. Within 5 to 10 seconds after vaccination, patient started clinching his hands tightly and became unresponsive. Patient was lowered to the floor and did not exhibit a pulse.  CPR was initiated and 911 was called.  An AED was used and healthcare professionals onsite continued compressions until the paramedics arrived.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient was vaccinated in right arm. Within 5 to 10 seconds after vaccination, patient started clinching his hands tightly and became unresponsive. Patient was lowered to the floor and did not exhibit a pulse.  CPR was initiated and 911 was called.  An AED was used and healthcare professionals onsite continued compressions until the paramedics arrived.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Immediate post-injection reaction, Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient was vaccinated in right arm. Within 5 to 10 seconds after vaccination, patient started clinching his hands tightly and became unresponsive. Patient was lowered to the floor and did not exhibit a pulse.  CPR was initiated and 911 was called.  An AED was used and healthcare professionals onsite continued compressions until the paramedics arrived.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Migraine
Clinical narrative: Emergency Use Authorization (EUA): Injection Hard red swelling painful at injection site and migraine headache
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Palpitations
Clinical narrative: COVID-19 Vaccine treatment under Emergency Use Authorization(EUA): Dizziness, Palpitations, Fatigue, Cold like Symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Nasal congestion, Pain
Clinical narrative: Pfizer name] treatment under Emergency Use Authorization(EUA): Second dose receive 1/8/21 at 9 am - by 11 pm severe chills and am 1/9 substantial headache and body aches. Feel like I was hit by bus. Significant nasal congestion noted/
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea, Oral herpes
Clinical narrative: Reaction to 1st Shingrix vaccine; began within 24 hours, lasted for 4 days: pain at injection site, headache, nausea, vomiting, shivering, new cold sore.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Reaction to 1st Shingrix vaccine; began within 24 hours, lasted for 4 days: pain at injection site, headache, nausea, vomiting, shivering, new cold sore.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Product label confusion, Product packaging confusion, Wrong product administered
Clinical narrative: FDA/CDER/OSE Follow-up for FAERS Case EUA Casirivimab given to 44 patients instead of intended COVID-19 vaccine. Follow up with reporter on 04Jan2021 revealed that 44 patients, ages 77 to 97 years received casirivimab 0.5 mL intramuscularly instead of the intended Moderna COVID-19 vaccine on December 30. Of the 44 patients, 38 were vaccinated on December 31. At 48-hour follow up on Jan 1, 31 reported no adverse events. Of the 13 patients reporting an adverse event, most (n=9) reported arm soreness. The contributing factors/cause Included: Wholesaler shipping boxes for the vaccine and monoclonal antibodies look identical. Hospital was supposed to receive 216 vials of casirivimab and 216 vials of imdevimab, but received a partial shipment of casirivimab. The wholesaler sent a 2nd shipping box of casirivimab that was not expected. Staffing shortages at the hospital. Vials stored next to each other in the refrigerator. Picked up the "red top" vials and delivered them to multiple vaccination sites. Four sites received both casirivimab and Moderna COVID-19 vaccine in the same delivery, of which one site inadvertently administered the casirivimab to 44 patients instead of the intended Moderna vaccine. The Regeneron EUA products "are poorly labeled for identification having letter and numbers instead of the drug name on the vials". "Both drug vials have a red top"
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up to FAERS 18694343: Patient received casirivimab instead of intended COVID vaccine. No AEs reported at 48-hr follow up Patient received for 3 weeks to get the COVID vaccine
Sex: U
Vaccine: COVID19
Symptoms: Product contamination physical
Clinical narrative: Moderna Vaccine while drawing up vaccinations black floater in the vial
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: My mom works for the Health Department in outpatient clinics. They have been administering the Pfizer vaccine at their clinics and local long term care facilities. The first day my mom was vaccinating, her boss told her to dilute vials with 1.9mL of diluent to get 6-7 vaccines from one vial (they vaccinated >250 people that day). The next day my mom was given a sheet with the correct instructions from Pfizer that say to dilute with 1.8mL to obtain 5 doses/vial. She told her boss that she would only do what the sheet says and dilute correctly but her boss was telling all the nurses to dilute with 1.9mL and get 6-7 doses/vial. My mom talked to me and I told her to report it. She let her boss's boss know and I guess the big boss decided what the boss was doing was an ok practice. Apparently they called around to other nearby places and they were all saying that even when they added 1.8mL they would frequently get 6 doses out of a vial. These are the places.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  At 48-hr follow up, patient reported arm soreness.  Patient received COVID vaccine on December 31
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up revealed patient experienced arm soreness. Patient received COVID vaccine on December 31
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Hypertension, Pain in extremity, Pyrexia, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  At 48-hr follow up, patient reported soreness to arm, fever of 99.9 and high blood pressure.  Wife thought he was anxious.  Follow up 2 hrs later and next morning, he reported he was "fine'.  Received COVID vaccine on December 31
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up revealed patient experienced little bit of arm soreness. Patient received COVID vaccine on December 31
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up didn't reveal any AEs. Patient received COVID vaccine on December 31
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. At 48-hr follow-up, patient reported arm soreness. Patient received COVID vaccine on December 31
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimeb instead of intended COVID vaccine. 48-hr follow up revealed arm soreness Patient received COVID vaccine December 31
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  At 48-hr follow up, patient reported runny nose.  Patient received COVID vaccine on December 31
Sex: M
Vaccine: COVID19
Symptoms: Headache, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  At 48-hr follow up revealed patient experienced Headache.  Patient received COVID vaccine on December 31
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  At 48-hr follow up, patient reported arm soreness.  Patient received COVID vaccine on December 31
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. At follow up on Jan 4, patient reported having shortness of breath and fast heart rate (has pacemaker). Will see provider this week. Not yet scheduled to receive COVID 19 vaccine
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up didn't identify AEs. Patient  Patient received COVID vaccine on December 31.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up didn't identify AEs. Patient received COVID vaccine on December 31.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up didn't identify AEs. Patient received COVID vaccine on December 31
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient  Patient received COVID vaccine on December 31
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine. 48-hr follow up didn't identify AEs. Patient Patient received COVID vaccine on December 31.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  At 48-hr follow up, patient reported arm soreness. Patient received COVID vaccine on December 31
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow revealed patient experienced little bit of arm soreness. Patient received COVID vaccine on December 31
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Follow up: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up didn't identify AEs. Patient received COVID vaccine on December 31
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine.  At 48-hr follow up. patient reported arm soreness.  Patient received COVID vaccine on December 31.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Patient received casirivimab instead of intended COVID vaccine.  48-hr follow up revealed arm soreness Patient received COVID vaccine on December 31