chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Fatigue, Migraine, Nausea, Vertigo
Clinical narrative: Severe vestibular conditions, vertigo, migranes, depression, exhaustion, nausea.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Vestibular disorder
Clinical narrative: Severe vestibular conditions, vertigo, migranes, depression, exhaustion, nausea.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chest pain, Chills, Musculoskeletal chest pain
Clinical narrative: Chills during night and half of next day.  Strong shivering during 1st night.  Very sore chest and ribs for about 2 days.
Age: 78.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: patient came into the pharmacy on 10/14 to show me her arms. Both arms had a large red patch on the lower portion of her upper arms. Patient stated that she thought the vaccines were administered too low on each arm. She thinks it was about 2 inches off to where it should have been given. By 10/19, she stated that the red marks were improving and did not think they were infected. Offer was made to revaccinate with the influenza vaccine, if she believed it was administered subcutaneously. Patient has not yet come back in for revaccination.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Headache, Hypersomnia
Clinical narrative: Extreme Fatigue (slept approximately 17 hours); headache (several hours)
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Mono vs Bivalent admin
Age: 47.0
Sex: U
Vaccine: COVID19, FLUR4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: THE NEEDLE FALL OFF THE SYRINGE AS MODERNA BOOSTER WAS ADMINISTERED- THERE WAS NO ADVERSE RXN - PATIENT WAS FINE- (MORE THAN HALF OF THE MODERNA DOSE WAS ADMINISTERED)
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: Fever 101.5; Muscle and joint pain; Headache Symptoms lasted about 24 hours
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: Atrial fibrillation, Blood pressure decreased, Cold sweat
Clinical narrative: BP dropped 88/41 and A_fib.  Cold sweat
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received flu vaccine when she wanted shingrix. Did not have any adverse effects
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Head discomfort, Palpitations
Clinical narrative: About 20-30 minutes after vaccination, patient returned to the pharmacy and reported feeling dizzy/lightheaded and like her heart was racing. Upon checking her BP, it was 175/119 and pulse was 73. Patient stated she had not eaten anything all day before getting vaccination and she sometimes experiences dizziness and chills when she is about to have a migraine episode. Also noted a little bit of pressure in her head. Had patient sit so we could monitor her until EMS arrived.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, pain, and itchy at the injection site.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy ear abnormal, Computerised tomogram head abnormal, Conductive deafness, Squamous cell carcinoma, Tinnitus
Clinical narrative: After the second dose of the Moderna Vaccine, inside my left ear canal. This was shortly thereafter diagnosed as squamous cell carcinoma inside the left ear canal in stage T3N0. The was not due to sun exposure, since the area is not exposed to sunlight, nor this this run in my family. I am also a man of dark skin color.  The cancerous tumor was surgically removed on 10/27/2021. In the operation, it was necessary to permanently remove my ear drum, which left me with conductive hearing loss and tinnitus in my left ear.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Tumour excision, Tympanic membrane disorder
Clinical narrative: After the second dose of the Moderna Vaccine, inside my left ear canal. This was shortly thereafter diagnosed as squamous cell carcinoma inside the left ear canal in stage T3N0. The was not due to sun exposure, since the area is not exposed to sunlight, nor this this run in my family. I am also a man of dark skin color.  The cancerous tumor was surgically removed on 10/27/2021. In the operation, it was necessary to permanently remove my ear drum, which left me with conductive hearing loss and tinnitus in my left ear.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given to minor by mistake when vaccine is indicated for 18 years and older. Patient feels fine today 10/23 (24 hours later), but wanted reported in case of issues.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Amnesia, Angiogram cerebral, Arteriogram carotid, Computerised tomogram head, Computerised tomogram neck
Clinical narrative: Woke up lost, confused, no memory at 11:00 pm.  Went to Emergency Room, had Brain CT, Received TPA beginning at 1:57 am 10/20/22 with completion at 2:25 am.  Memory started to return at 2:25 am.  Transferred to Medical Center via Ambulance.  In Emergency Department from time of arrival early morning (~3:15 am on 10/20/22 until approx. 3:00 pm on 10/21/22).  Received CT/CTa, of head/neck/soft tissue, brain MRI, Vascular Ultrasound throughout course of the day on 10/20/22.  Repeat Brain CT scan on 10/20/22  at 10:00 pm.  Early morning 10/21/22 had an EEG done.  Echocardiogram ordered, but never done (we will be having done as an outpatient).  Current diagnosis:  Transient Ischemic Attack Vs. Transient Global Amnesia.  Discharged at 6:00 pm on Friday, 10/21/22, memory issues resolved and back to baseline, with the exception of tongue turning to the right and a slight left-sided facial droop.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Confusional state, Electroencephalogram, Facial paralysis, Laboratory test, Magnetic resonance imaging head
Clinical narrative: Woke up lost, confused, no memory at 11:00 pm.  Went to Emergency Room, had Brain CT, Received TPA beginning at 1:57 am 10/20/22 with completion at 2:25 am.  Memory started to return at 2:25 am.  Transferred to Medical Center via Ambulance.  In Emergency Department from time of arrival early morning (~3:15 am on 10/20/22 until approx. 3:00 pm on 10/21/22).  Received CT/CTa, of head/neck/soft tissue, brain MRI, Vascular Ultrasound throughout course of the day on 10/20/22.  Repeat Brain CT scan on 10/20/22  at 10:00 pm.  Early morning 10/21/22 had an EEG done.  Echocardiogram ordered, but never done (we will be having done as an outpatient).  Current diagnosis:  Transient Ischemic Attack Vs. Transient Global Amnesia.  Discharged at 6:00 pm on Friday, 10/21/22, memory issues resolved and back to baseline, with the exception of tongue turning to the right and a slight left-sided facial droop.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tongue movement disturbance, Transient global amnesia, Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: Woke up lost, confused, no memory at 11:00 pm.  Went to Emergency Room, had Brain CT, Received TPA beginning at 1:57 am 10/20/22 with completion at 2:25 am.  Memory started to return at 2:25 am.  Transferred to Medical Center via Ambulance.  In Emergency Department from time of arrival early morning (~3:15 am on 10/20/22 until approx. 3:00 pm on 10/21/22).  Received CT/CTa, of head/neck/soft tissue, brain MRI, Vascular Ultrasound throughout course of the day on 10/20/22.  Repeat Brain CT scan on 10/20/22  at 10:00 pm.  Early morning 10/21/22 had an EEG done.  Echocardiogram ordered, but never done (we will be having done as an outpatient).  Current diagnosis:  Transient Ischemic Attack Vs. Transient Global Amnesia.  Discharged at 6:00 pm on Friday, 10/21/22, memory issues resolved and back to baseline, with the exception of tongue turning to the right and a slight left-sided facial droop.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood glucose normal, Body temperature decreased, Cold sweat, Hyperhidrosis, Loss of consciousness
Clinical narrative: @15:42 patient received her 4th dose ( pfizer bivalent booster) on her left arm intramuscularly , @ 15:54 patient had a witnessed syncopal episode by rn ,  rn assisted the client , no injury noted , patient regained consciousness immediately , md , emt , safety officer were called , patient is aox4 , no shortness of breath , cold clammy skin upon touch with diaphoresis , blood sugar was taken @0404 bs of 96mg/dl , temp of 96.2f , hr of 68 and bp of  110/68 , snacks and 1 bottle of water  given , @0420 patient verbalized that she feels better , dr asked emt to do another set of vital signs , bp of 110/60 , hr of 63 , temp of 96.8 and blood sugar of 85mg/dl , 1 bottle of energy drink was given and patient finished drinking it . patient has no complaints at this time , denies sob and dizziness , aox4 , patient was discharge on a stable condition by dr @ 04:35 .
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syncope
Clinical narrative: @15:42 patient received her 4th dose ( pfizer bivalent booster) on her left arm intramuscularly , @ 15:54 patient had a witnessed syncopal episode by rn ,  rn assisted the client , no injury noted , patient regained consciousness immediately , md , emt , safety officer were called , patient is aox4 , no shortness of breath , cold clammy skin upon touch with diaphoresis , blood sugar was taken @0404 bs of 96mg/dl , temp of 96.2f , hr of 68 and bp of  110/68 , snacks and 1 bottle of water  given , @0420 patient verbalized that she feels better , dr asked emt to do another set of vital signs , bp of 110/60 , hr of 63 , temp of 96.8 and blood sugar of 85mg/dl , 1 bottle of energy drink was given and patient finished drinking it . patient has no complaints at this time , denies sob and dizziness , aox4 , patient was discharge on a stable condition by dr @ 04:35 .
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Loss of consciousness, Mobility decreased, Nausea, Vomiting
Clinical narrative: 12 hours after receiving the vaccine (historically when my vaccine side effects set in), I became lightheaded and nauseous, laid down in the floor and passed out. I came to and vomited. I was not able to get up off the floor for about 30 minutes.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: pt came by pharmacy on 10/23/22. just to inform us that he received a fluzone HD on 10/17/22 by RN. He states next am on 10/18/22 he was experiencing pain down his left arm where received injection, he said pain continued to worse. He went to ortho MD who told pt possilby d/t injection. Pt to start PT on Wednesday. Pain is intermittent sometime worse sometimes better. he pointed to back of arm where coming from.pt could not remember where band aid was located i was curious if too high or below armpit where nerve plexus would be. pt is not blaming nurse but wants us to know . pt is very concerned about long term pain. he just retired and concerned will not improve
Age: 75.0
Sex: M
Vaccine: HEPAB
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: diarrhea, infrequent sharp pain in left abdomen
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Burning sensation, Rash, Rash vesicular
Clinical narrative: Onset of vesicular painful rash and burning in left thigh on 10/21/22
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Our patient received a Pfizer monovalent COVID vaccine on 8/31 as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Food and Drug Administration (FDA) amended emergency use authorizations (EUAs) of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The FDA has removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on leg.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Our patient received a Pfizer monovalent COVID vaccine on 8/31 as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Food and Drug Administration (FDA) amended emergency use authorizations (EUAs) of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The FDA has removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
Age: 21.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Eye pain, Eyelid pain, Facial pain, Skin discolouration, Sleep disorder
Clinical narrative: Approximately 12 hours after receiving the vaccines, my right eye was in immense pain and woke me up in the middle of the night. It hurt to blink for the next 24 hours, ibuprofen and acetaminophen were unhelpful. the following night, 36 hours after receiving the vaccines, my right upper eyelid was enormously swollen and even more painful. each time I blink I felt a sharp pain across the right side of my face. 48 hours after the vaccines, my right upper eyelid is discolored and tender, swelling has decreased minorly, sharp pain when blinking remains.
Age: 21.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Swelling of eyelid, Tenderness
Clinical narrative: Approximately 12 hours after receiving the vaccines, my right eye was in immense pain and woke me up in the middle of the night. It hurt to blink for the next 24 hours, ibuprofen and acetaminophen were unhelpful. the following night, 36 hours after receiving the vaccines, my right upper eyelid was enormously swollen and even more painful. each time I blink I felt a sharp pain across the right side of my face. 48 hours after the vaccines, my right upper eyelid is discolored and tender, swelling has decreased minorly, sharp pain when blinking remains.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Began with low grade fever then headache then chills and muscle aches. Now temperature is 100.3.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Our patient received a Pfizer monovalent COVID vaccine on 8/31 as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Drug Administration amended emergency use authorizations (EUAs) of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The have removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient's father insisted on child receiving Pfizer COVID-19 monovalent 5-11 vaccine, although due for bivalent booster.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Our patient received a Pfizer monovalent COVID vaccine on 8/31 as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Food and Drug Administration (FDA) amended emergency use authorizations (EUAs) of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The FDA has removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
Age: 29.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Erythema, Flushing, Rash, Urticaria
Clinical narrative: Patient had a self reported rash/hives  break  about 5-10 minutes after vaccine administration, upon presentation patient was given 2 tablets of diphenhydramine 25mg.  Visual appearance was a flushing of the cheeks but no swelling or raised "hives" visibly noteable. At about the 45 minute mark the customer was still upright, conscious and talking to her family group. Patient rejected use of epi-pen or 911 involvement. At 1 hour from injection patient was still conscious and coherent, upon offering further treatment once more the patient declined and her mother drover her home. Patient had redness of cheeks at time of departure
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Our patient received a Pfizer monovalent COVID vaccine on 8/31 as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Food and Drug Administration (FDA) amended emergency use authorizations (EUAs) of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The FDA has removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
Age: 57.0
Sex: F
Vaccine: FLUC4, PNC15
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Right arm became limited movement (only move 45 degrees) two hours after injection with significant swelling front and back of the arm; hot to touch and red spotty areas.  She thought it would get better but did not contact pharmacy until October 21, 2022 because continuation of mild swelling, still warm to touch, but concern because the area remained red in different areas on the are.  Told  her to take Benadryl 50 mg every 6 - 8 hours and alternate hydrocortisone cream 1% with benadryl cream every 6 hours.  She reported on October 22nd that there was improvement; she can move are normally and continue regimen. She reported on October 23rd that area is much better and did not feel need to contact a doctor.  I did encourage to seek medical help if not resolving.  Patient had no other concerns.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Our patient received a Pfizer monovalent COVID vaccine on 8/31 as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Administration amended emergency use authorizations of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The Administration has removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Our patient received a Pfizer monovalent COVID vaccine on 9/3  as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Food and Drug Administration (FDA) amended emergency use authorizations (EUAs) of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The FDA has removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Our patient received a Pfizer monovalent COVID vaccine on 9/1 as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Food and Drug Administration (FDA) amended emergency use authorizations (EUAs) of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The FDA has removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Our patient received a Pfizer monovalent COVID vaccine on 9/6 as their booster dose. Patient had no adverse reaction. On August 31, 2022, the Food and Drug Administration (FDA) amended emergency use authorizations (EUAs) of the Pfizer and Moderna COVID-19 vaccines to authorize updated, bivalent formulations of the vaccines for use as a single booster dose.   The FDA has removed the authorization to use the original monovalent Moderna and Pfizer COVID-19 vaccines as boosters for adults and adolescents. This means, individuals 12 years and older can no longer be given booster doses with the original monovalent COVID-19 vaccines.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Axillary pain, Crying, Loss of consciousness, Memory impairment, Moaning
Clinical narrative: Passed out about 16 hours later / next morning after getting up from bed to (successfully) go to bathroom and get a drink. Not first time up that night although no problem other two times.  Maybe fainted just as finished drinking? Have no memory of it. Water bottle was capped and back on counter but there was liquid on the stool and floor. Cut gash in head on nearby door frame. Woke up writhing on refreshingly cold floor,  moaning, sobbing for maybe fifteen/twenty minutes before could get back to bed and phone. May have passed out once more briefly in that period after trying to sit up. Half hour at least before could breath more calmly and call another person who could pick me up and keep an eye on me. Then was okay enough to walk outside to meet them. Wanted to avoid going to walk-in clinic and decided gash was shallow enough that we could avoid going in for stitches. (For what it's worth, next day new symptom early morning started having tender left armpit all day and a little ongoing still.)
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin laceration
Clinical narrative: Passed out about 16 hours later / next morning after getting up from bed to (successfully) go to bathroom and get a drink. Not first time up that night although no problem other two times.  Maybe fainted just as finished drinking? Have no memory of it. Water bottle was capped and back on counter but there was liquid on the stool and floor. Cut gash in head on nearby door frame. Woke up writhing on refreshingly cold floor,  moaning, sobbing for maybe fifteen/twenty minutes before could get back to bed and phone. May have passed out once more briefly in that period after trying to sit up. Half hour at least before could breath more calmly and call another person who could pick me up and keep an eye on me. Then was okay enough to walk outside to meet them. Wanted to avoid going to walk-in clinic and decided gash was shallow enough that we could avoid going in for stitches. (For what it's worth, next day new symptom early morning started having tender left armpit all day and a little ongoing still.)
Age: 42.0
Sex: F
Vaccine: FLUA4
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia, Peripheral swelling
Clinical narrative: Left arm swelling numbness tingling burning
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Hypoaesthesia, Pain
Clinical narrative: day 1 - sore arm, red spit size of a quarter, chills, fever, fatigue day 2 - sore arm, red spot 2? round, fatigue, chills, arm numbness day 3-  sore arm, red spot 4? round, itchiness day 4 -  sore arm, red spot 4?, crazy itchy day 5 - soreness, red spot 4?, itchy, pain radiating day 6 - pain, red spot, very itchy,
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Pyrexia
Clinical narrative: day 1 - sore arm, red spit size of a quarter, chills, fever, fatigue day 2 - sore arm, red spot 2? round, fatigue, chills, arm numbness day 3-  sore arm, red spot 4? round, itchiness day 4 -  sore arm, red spot 4?, crazy itchy day 5 - soreness, red spot 4?, itchy, pain radiating day 6 - pain, red spot, very itchy,
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Erythema, Gait inability, Joint swelling, Pain
Clinical narrative: Pt first developed rash bilaterally to flank, abdomen and legs two days after covid vaccine administration. Then developed pain, marked swelling and redness to bilateral knees and elbows with difficulty ambulating and pain with movement. Pt had a low grade fever and skin was sensitive and hot to touch near knees and elbows.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Rash, Sensitive skin, Skin warm
Clinical narrative: Pt first developed rash bilaterally to flank, abdomen and legs two days after covid vaccine administration. Then developed pain, marked swelling and redness to bilateral knees and elbows with difficulty ambulating and pain with movement. Pt had a low grade fever and skin was sensitive and hot to touch near knees and elbows.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Epistaxis, Thrombosis
Clinical narrative: My sinuses bled for 5 days. I kept blowing out small clots of red coagulated blood every morning for 5 days. Then it stopped.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Hypoaesthesia, Pyrexia
Clinical narrative: Severe chills, fever, numbness in toes
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: 5 days after receiving my shot, I developed 2 large patches of hives (approx. 2 inches across), one at the injection site and another on my shoulder.  I also have hives on my the back of my neck and a small patch on my chest.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Extreme dizziness and nausea the day after the  vaccine
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Chills, Hyperhidrosis, Malaise
Clinical narrative: Approximately 6-7 hours after receiving the flu shot, I developed the sudden onset of severe chills, body aches and fever (102.1)  with paroxysmal sweating. I later developed joint and skin pain. It's difficult to describe.  I felt tremendous malaise and took 1g of acetaminophen and 1 12 hour Aleve. I felt a bit better after about 90 minutes. I went to sleep. However, I awoke at about 0300 on 10/22/2022 with drenching night sweats (drenching in the most literal sense, I soaked through my pajamas and sheets), severe chills and muscle pain. The chills were worse than before and were the most intense I have experienced in my life.  I had chills and fever the remainder of the  night. The following morning, I attempted to go about my usual routine (breakfast, workout) but could not due to muscle pain and fatigue. I took another dose of acetaminophen.  At approximately 6pm that day, >24 hours from receiving the flu shot, I again spiked a fever of 101.6 and had chills, muscle pain, back pain, and skin pain. I can describe it only as that anything touching the surface of my skin suddenly hurt it.  The sensation of clothing on my skin was painful. I was scheduled to work my first of 3 night shifts (I am a nurse) and was so sick I could barely make it to work. My fever did not abate until about midnight of 10/23/22. This was completely unacceptable. I have gotten the flu shot every year of my adult life since I was about 14 years old and have never had a negative reaction to any of them, let alone one as severe as this. I would never have consented if I had known.  I am concerned that an error was made in labeling and that this was not in fact an inactivated vaccine, or I was perhaps accidentally given a covid vaccine (the second dose of Pfizer covid vaccine did give me some of these symptoms, though not as severe). It is just impossible for me to believe that I could suddenly have had such a severe reaction to the seasonal flu shot.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Night sweats, Pain, Pain of skin, Pyrexia
Clinical narrative: Approximately 6-7 hours after receiving the flu shot, I developed the sudden onset of severe chills, body aches and fever (102.1)  with paroxysmal sweating. I later developed joint and skin pain. It's difficult to describe.  I felt tremendous malaise and took 1g of acetaminophen and 1 12 hour Aleve. I felt a bit better after about 90 minutes. I went to sleep. However, I awoke at about 0300 on 10/22/2022 with drenching night sweats (drenching in the most literal sense, I soaked through my pajamas and sheets), severe chills and muscle pain. The chills were worse than before and were the most intense I have experienced in my life.  I had chills and fever the remainder of the  night. The following morning, I attempted to go about my usual routine (breakfast, workout) but could not due to muscle pain and fatigue. I took another dose of acetaminophen.  At approximately 6pm that day, >24 hours from receiving the flu shot, I again spiked a fever of 101.6 and had chills, muscle pain, back pain, and skin pain. I can describe it only as that anything touching the surface of my skin suddenly hurt it.  The sensation of clothing on my skin was painful. I was scheduled to work my first of 3 night shifts (I am a nurse) and was so sick I could barely make it to work. My fever did not abate until about midnight of 10/23/22. This was completely unacceptable. I have gotten the flu shot every year of my adult life since I was about 14 years old and have never had a negative reaction to any of them, let alone one as severe as this. I would never have consented if I had known.  I am concerned that an error was made in labeling and that this was not in fact an inactivated vaccine, or I was perhaps accidentally given a covid vaccine (the second dose of Pfizer covid vaccine did give me some of these symptoms, though not as severe). It is just impossible for me to believe that I could suddenly have had such a severe reaction to the seasonal flu shot.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Approximately 6-7 hours after receiving the flu shot, I developed the sudden onset of severe chills, body aches and fever (102.1)  with paroxysmal sweating. I later developed joint and skin pain. It's difficult to describe.  I felt tremendous malaise and took 1g of acetaminophen and 1 12 hour Aleve. I felt a bit better after about 90 minutes. I went to sleep. However, I awoke at about 0300 on 10/22/2022 with drenching night sweats (drenching in the most literal sense, I soaked through my pajamas and sheets), severe chills and muscle pain. The chills were worse than before and were the most intense I have experienced in my life.  I had chills and fever the remainder of the  night. The following morning, I attempted to go about my usual routine (breakfast, workout) but could not due to muscle pain and fatigue. I took another dose of acetaminophen.  At approximately 6pm that day, >24 hours from receiving the flu shot, I again spiked a fever of 101.6 and had chills, muscle pain, back pain, and skin pain. I can describe it only as that anything touching the surface of my skin suddenly hurt it.  The sensation of clothing on my skin was painful. I was scheduled to work my first of 3 night shifts (I am a nurse) and was so sick I could barely make it to work. My fever did not abate until about midnight of 10/23/22. This was completely unacceptable. I have gotten the flu shot every year of my adult life since I was about 14 years old and have never had a negative reaction to any of them, let alone one as severe as this. I would never have consented if I had known.  I am concerned that an error was made in labeling and that this was not in fact an inactivated vaccine, or I was perhaps accidentally given a covid vaccine (the second dose of Pfizer covid vaccine did give me some of these symptoms, though not as severe). It is just impossible for me to believe that I could suddenly have had such a severe reaction to the seasonal flu shot.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Developed fever the next day of 101 degrees F  Then developed diffuse itching on hands (both) neck, face and legs. More that night. Started on Friday and it is Sunday now
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt came in for a Covid-Bivalent Vaccine and was given the Covid Vaccine
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt came in for Covid-Bivalant Booster was Given Regular Covid vaccine in  Error.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient came in for Covid-Bivalent Booster was given Regular Covid vaccine instead
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient came in for Covid-Bivalent Booster was given Regular Covid vaccine instead
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Magnetic resonance imaging head, Paraesthesia
Clinical narrative: Bells Palsy  Symptoms: PARESTHESIA OF SKIN.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Mobility decreased, Peripheral swelling, Skin reaction
Clinical narrative: index finger turned red; diarrhea; finger swelled up/twice the size for several days; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (finger swelled up/twice the size for several days), ERYTHEMA (index finger turned red) and DIARRHOEA (diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Booster dose) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    In June 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced PERIPHERAL SWELLING (finger swelled up/twice the size for several days). On an unknown date, the patient experienced ERYTHEMA (index finger turned red) and DIARRHOEA (diarrhea). At the time of the report, PERIPHERAL SWELLING (finger swelled up/twice the size for several days) had resolved and ERYTHEMA (index finger turned red) and DIARRHOEA (diarrhea) outcome was unknown.            No concomitant medications was reported.  The patient mentioned that right after the booster dose, her finger swelled up. It was twice the size for several days. It just blew up. It was back to normal at the time of reporting. Her finger turned red. It was her index finger. This happened after her fourth shot in June 2022.  No treatment medications was reported.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Erythema, Peripheral swelling
Clinical narrative: index finger turned red; diarrhea; finger swelled up/twice the size for several days; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (finger swelled up/twice the size for several days), ERYTHEMA (index finger turned red) and DIARRHOEA (diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Booster dose) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    In June 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced PERIPHERAL SWELLING (finger swelled up/twice the size for several days). On an unknown date, the patient experienced ERYTHEMA (index finger turned red) and DIARRHOEA (diarrhea). At the time of the report, PERIPHERAL SWELLING (finger swelled up/twice the size for several days) had resolved and ERYTHEMA (index finger turned red) and DIARRHOEA (diarrhea) outcome was unknown.            No concomitant medications was reported.  The patient mentioned that right after the booster dose, her finger swelled up. It was twice the size for several days. It just blew up. It was back to normal at the time of reporting. Her finger turned red. It was her index finger. This happened after her fourth shot in June 2022.  No treatment medications was reported.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines Moderna 2/18/21 Lot# 037K20A;  Moderna 10/24/21 Lot# 024C21A;  Moderna 5/5/22 Lot# 04m21a
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines Moderna 2/18/21 Lot# 037K20A;  Moderna 10/24/21 Lot# 024C21A;  Moderna 5/5/22 Lot# 04m21a
Age: 32.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Client was given Bivalent Pfizer vaccine at dose #1 visit instead of the Monovalent Pfizer vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Client was given Bivalent Pfizer vaccine at dose #1 visit instead of the Monovalent Pfizer vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Arthralgia
Clinical narrative: Patient experiencing ongoing muscle weakness and fatigue since receiving vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Fatigue, Muscular weakness
Clinical narrative: Patient experiencing ongoing muscle weakness and fatigue since receiving vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: given wrong dose. Was given 0.25cc when 0.5cc should have been given.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: given wrong dose. Was given 0.25cc when 0.5cc should have been given.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: was given the wrong dosage. Was given 0.25cc and it should have been 0.5cc.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Underdose
Clinical narrative: was given the wrong dosage. Was given 0.25cc and it should have been 0.5cc.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: given wrong dosage. was given 0.25cc and it should have been 0.50 cc
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Underdose
Clinical narrative: given wrong dosage. was given 0.25cc and it should have been 0.50 cc
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: was given wrong dosage. Was given 0.25cc when it should have been 0.50cc
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Underdose
Clinical narrative: was given wrong dosage. Was given 0.25cc when it should have been 0.50cc
Age: 29.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: given wrong dosage. Was given 0.25cc and it should have been 0.55cc
Age: 29.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: given wrong dosage. Was given 0.25cc and it should have been 0.55cc
Age: 42.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: given wrong dosage amount. was given 0.25cc when 0.5cc should have been given.
Age: 42.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: given wrong dosage amount. was given 0.25cc when 0.5cc should have been given.
Age: 35.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: given wrong dosage. Was given 0.25cc and was suppose to get 0.5xx
Age: 35.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Underdose
Clinical narrative: given wrong dosage. Was given 0.25cc and was suppose to get 0.5xx
Age: 1.58
Sex: F
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Product preparation issue
Clinical narrative: My daughter was vaccinated incorrectly, the nurse who gave her the vaccine made a mistake when vaccinating my 19-month-old daughter. The vaccine was not diluted before being applied to my daughter, I just want the person who made this mistake to be more aware of what they are doing because it can harm patients. I hope this mistake does not affect and does not bring consequences in my daughter's health in the future.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site pruritus
Clinical narrative: The caller stated there was localized induration that occurred  2.5-5.5cm with itching that occurred on 10/03/2022 at the injection site after the administration; itching that occurred on 10/03/2022 at the injection site after the administration; This spontaneous report has been received from a nurse prescriber (reported as health care professional) (HCP) concerning to a 26-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included allergy to previous aspirin. No other allergies or previous drug reactions were reported.Concomitant medications included norethisterone (NORETHINDRONE [NORETHISTERONE]).  On 24-SEP-2022(also reported as 02-SEP-2022,conflicting information)the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered subcutaneously (strength, dose, vaccination scheme frequency and anatomical location were not provided; lot number W005208, that was verified to be valid with an expiration date reported and established as 14-FEB-2024) for immunization against varicella; in combination with sterile diluent solution for injection/infusion(dose not reported)(lot number W003337, that was verified to be valid with an expiration date reported and established as 06-JAN-2023).  On 03-OCT-2022, the patient experienced a localized induration that occurred 2.5-5.5 centimeters (cm) (vaccination site induration) with itching at the injection site after the administration (vaccination site pruritus). By the reporting time the outcome of the events was reported as not recovered.  It was reported that the patient sought for medical attention, treatment was not received, and none laboratory diagnostic or studies were performed.  The action with varicella virus vaccine live (oka/merck) (VARIVAX) regarding the events, was reported as discontinued, however per internal guidelines, was assessed as not applicable.   The causality assessment between varicella virus vaccine live (oka/merck) (VARIVAX), and the events, was not provided.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose
Clinical narrative: No additional AEs were reported.  No further information provided.; Medical assistant reported that a 12 month old patient received both PROQUAD and VARIVAX on 10/12/2022.; This spontaneous report has been received from a medical assistant, concerning a 12-months-old female patient. The patient's medical history, other concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.  On 12-OCT-2022, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number w024552 has been verified to be valid; expiration date reported and established as 31-JAN-2024) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number w012164 has been verified to be valid; expiration date reported and established as 12-APR-024) (accidental overdose), as prophylaxis, diluted with sterile diluent (doses, vaccination scheme, and routes of administration were not provided).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 29-JUL-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliters (ml), once, as prophylaxis (lot number 1879870 has been verified to be valid; expiration date not reported but upon internal validation established as 16-OCT-2023) (strength, vaccination scheme, route of administration, and anatomical location were not provided). The administered dose of the vaccine was stored at a temperature of 34.5 degrees Fahrenheit (F), during a time frame of 1 hour 7 minutes and 0 seconds. There was a previous temperature excursion reported as 66.7 F for 13 hours 52 minutes and 0 seconds. There was no adverse effect reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005936: US-009507513-2210USA005937: US-009507513-2210USA005929: US-009507513-2210USA005979: US-009507513-2210USA005916: US-009507513-2210USA005624: US-009507513-2210USA005942: US-009507513-2210USA005994: US-009507513-2210USA005996: US-009507513-2210USA006007:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HBP called in and reported that the improperly stored vaccine was administered.; This spontaneous report was received from a office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies were not reported.   On 13-OCT-2022, the patient was vaccinated with a improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot number W011622 was verified to be a valid number, expiration date reported and established as 06-APR-2024) (dose, strength, route of administration, anatomical injection site and vaccination scheme were not reported), administered for prophylaxis, that underwent a temperature excursion of -14 Celsius degrees up to -10 Celsius degrees (-11.9 Celsius degrees) for 42 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported.; Sender's Comments:  US-009507513-2210USA005741: US-009507513-2210USA005648: US-009507513-2210USA005639:
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: Fever day 1 100, fever day 2 - 102.7 fever day 3 - 103,  nausea, diarrhea, massive headache
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Aphasia, Arthralgia, Balance disorder, Blister
Clinical narrative: I woke with three blisters on my left buttock. Impaired cognition, impaired word-finding ability, intermittent blurred vision, I have trouble focusing and short term memory loss, sometimes I will fall asleep in mid-sentence (somnolence) while my family is talking with me, marked sensitivity to light/sound/smell, insomnia/severe sleep deprivation, tremors, dizziness and disequilibrium, temperature instability, fever/night sweats/chills/shivering, flushing, nausea, loss of appetite, muscle/joint aches, extreme fatigue, heart palpitations, and blue dilated veins on back of hands and palms.