chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain
Clinical narrative: Please include ?Pfizer-BioNTech COVID-19 Vaccine EUA? in the first line of box #18 of the report form.  Mild pain around injection site (dose #1 &  dose #2) and mild diarrhea approximately 14 hours after dose #2 injection only.  Diarrhea persisted approximately 30 hours.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Injection site warmth, Pain in extremity
Clinical narrative: My left arm developed a large hot red rash with a raised welt in the middle of the the injection site. My arm is extremely sore and I feel very tired. I have the same symptoms I had the first  3 days after the injection. I am wondering if I should get the 2nd shot??
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: My left arm developed a large hot red rash with a raised welt in the middle of the the injection site. My arm is extremely sore and I feel very tired. I have the same symptoms I had the first  3 days after the injection. I am wondering if I should get the 2nd shot??
Age: 51.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Tinnitus
Clinical narrative: tinnitus  ringing in ears daily
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: arm swell and itch
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Dizziness, Dysphagia, Feeling abnormal
Clinical narrative: 10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?.  1st Pfizer vaccine received @9:55a in Left Deltoid.  BP 100/50, HR 76 and regular.  Pt reports this BP being ?a little low for her?.  Pt ate breakfast and then had a snack before coming to clinic.  She has a distant history of ?getting very sick with the flu vaccine?.  Within a few hours of the dose 15 years ago or so, she developed a fever of 103 and had flu symptoms of aching everywhere.  The next year they gave her a pediatric dose and she had a similar response and has not had another flu shot since then.  She has received allergy shots for more than 10 years and takes OTC allergy meds daily.  She took her Zyrtec this am. She spoke with her allergist and received the recommendation to get the Covid vaccine.  Her next allergy shots are due next week.   She reports feeling fine before and during the injection and then the light-headedness started 5-6 minutes after sitting in the obs area.  Site director and pharmacist aware of events. 10:22a Pt drinking water and reports ?feeling strange with swallowing and jaw feels tight?. Pharmacist to pt side and decision made to give 12.5mg of liquid Benadryl.  Pt states, ?I wonder how much of this is me being anxious?.  8 oz water consumed and tolerated well. Pt reports ?tongue feels thick? with drinking Benadryl  10:24 pt reports legs feel less weak.  10:29 HR 76, BP 110/70.  Husband arrived.  Pt reports still feeling the same level of dizzy and throat feeling ?less tight?.   10:38 No change is s/s.  Consult with pharmacist-advised giving additional 12.5 mg oral Benadryl.   10:41 Benadryl given and tolerated well.  ?I don?t feel great?.  Finished second 8 oz bottle of water and third given.  Pt reports still feeling the same level of dizzy but has some increased thickness in throat.  Improves with drinking cold water.   10:46 Pt reports although throat feels better with water, that her airway still ?feels smaller?. When describing her throat and airway, ?it?s not 100% normal, but better?.   10:50 HR 64, BP 104/64. Pt reports ?dizziness unchanged throughout, legs still feel weak, jaw and tongue feel back to normal, but back of throat still feels tight, but cold water helps but when swallowing, it still feels harder to do?.   Reviewed case with pharmacist and site director, recommendation to take pt to ER for further obs.  Pt agrees to go.   10:59 Pt transferred safely to wheelchair and escorted to ER.  ER RN given report after pt checked in with husband beside her.  Recommended to pt that she notify her PCP and Allergist of today?s event and recommended they get a recommendation for receiving the second dose.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Limb discomfort, Muscle tightness, Muscular weakness, Tongue disorder
Clinical narrative: 10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?.  1st Pfizer vaccine received @9:55a in Left Deltoid.  BP 100/50, HR 76 and regular.  Pt reports this BP being ?a little low for her?.  Pt ate breakfast and then had a snack before coming to clinic.  She has a distant history of ?getting very sick with the flu vaccine?.  Within a few hours of the dose 15 years ago or so, she developed a fever of 103 and had flu symptoms of aching everywhere.  The next year they gave her a pediatric dose and she had a similar response and has not had another flu shot since then.  She has received allergy shots for more than 10 years and takes OTC allergy meds daily.  She took her Zyrtec this am. She spoke with her allergist and received the recommendation to get the Covid vaccine.  Her next allergy shots are due next week.   She reports feeling fine before and during the injection and then the light-headedness started 5-6 minutes after sitting in the obs area.  Site director and pharmacist aware of events. 10:22a Pt drinking water and reports ?feeling strange with swallowing and jaw feels tight?. Pharmacist to pt side and decision made to give 12.5mg of liquid Benadryl.  Pt states, ?I wonder how much of this is me being anxious?.  8 oz water consumed and tolerated well. Pt reports ?tongue feels thick? with drinking Benadryl  10:24 pt reports legs feel less weak.  10:29 HR 76, BP 110/70.  Husband arrived.  Pt reports still feeling the same level of dizzy and throat feeling ?less tight?.   10:38 No change is s/s.  Consult with pharmacist-advised giving additional 12.5 mg oral Benadryl.   10:41 Benadryl given and tolerated well.  ?I don?t feel great?.  Finished second 8 oz bottle of water and third given.  Pt reports still feeling the same level of dizzy but has some increased thickness in throat.  Improves with drinking cold water.   10:46 Pt reports although throat feels better with water, that her airway still ?feels smaller?. When describing her throat and airway, ?it?s not 100% normal, but better?.   10:50 HR 64, BP 104/64. Pt reports ?dizziness unchanged throughout, legs still feel weak, jaw and tongue feel back to normal, but back of throat still feels tight, but cold water helps but when swallowing, it still feels harder to do?.   Reviewed case with pharmacist and site director, recommendation to take pt to ER for further obs.  Pt agrees to go.   10:59 Pt transferred safely to wheelchair and escorted to ER.  ER RN given report after pt checked in with husband beside her.  Recommended to pt that she notify her PCP and Allergist of today?s event and recommended they get a recommendation for receiving the second dose.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Immediate post-injection reaction
Clinical narrative: Patient got a Covid19 (Moderna) vaccine and about 5 minutes after waiting in the wait area he felt dizzy. He attempted to get up and and fell to the floor. He was awake, alert and spoke intelligently while EMT team was being expected. After about 10 minutes he sat up on the floor and was doing just fine. He stated that he believed his reaction to the vaccine was because he had not eaten prior to getting it. The EMT arrived after about 25 minutes from when incident started, took his blood pressure and measured his sugar levels and both were fine. Patient declined an emergency room offer from the EMT, ate a chesse burger meal and left the store. Pharmacy has followed with 3 phone calls, but patient is yet to respond.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Urticaria
Clinical narrative: hives on my left side back. soreness under left armpit
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Muscular weakness
Clinical narrative: Ongoing leg weakness, dizziness and general fatigue. No treatment yet.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Dizziness, Dysstasia, Nausea, Syncope
Clinical narrative: After approximately 5 min after receiving the shot i started to feel a strong feeling of dizziness along with nausea, i could not stand and fainted, they carried me to a private area where i was picked up by the ambulance, my vital signs were not ok.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: After approximately 5 min after receiving the shot i started to feel a strong feeling of dizziness along with nausea, i could not stand and fainted, they carried me to a private area where i was picked up by the ambulance, my vital signs were not ok.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness, Malaise, Nausea, Pain
Clinical narrative: After approximately 5 min after receiving the shot i started to feel a strong feeling of dizziness along with nausea, i could not stand and fainted, they carried me to a private area where i was picked up by the ambulance, my vital signs were not ok.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Dizziness, Dysstasia, Nausea, Syncope
Clinical narrative: PATIENT STATED SHE DID NOT FEEL WELL AFTER VACCINE WITH DIZZINESS AND NAUSEA, NO VOMITING. THEN, "EVERYTHING WENT FOGGY." PATIENT PASSED OUT BRIEFLY, HAD LEFT SIDED PAINS. TRANSPORTED TO HOSPITAL BY RESCUE SQUAD.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: PATIENT STATED SHE DID NOT FEEL WELL AFTER VACCINE WITH DIZZINESS AND NAUSEA, NO VOMITING. THEN, "EVERYTHING WENT FOGGY." PATIENT PASSED OUT BRIEFLY, HAD LEFT SIDED PAINS. TRANSPORTED TO HOSPITAL BY RESCUE SQUAD.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness, Malaise, Nausea, Pain
Clinical narrative: PATIENT STATED SHE DID NOT FEEL WELL AFTER VACCINE WITH DIZZINESS AND NAUSEA, NO VOMITING. THEN, "EVERYTHING WENT FOGGY." PATIENT PASSED OUT BRIEFLY, HAD LEFT SIDED PAINS. TRANSPORTED TO HOSPITAL BY RESCUE SQUAD.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache, very tired
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Erythema, Flushing, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Approximately 15 minutes after receiving the Janssen vaccine, the patient complained of numbness and tingling around her mouth and fingertips, felt flush/warmness on her face with noticeable redness, and became hoarse while speaking. The patient was given 25 mg of diphenhydramine at the vaccination event and her hoarseness improved but returned a few minutes later.  She was taken to the Emergency Department for further observation.  In the ED, she was given famotidine, dexamethasone, and 1L of fluids, and her symptoms improved.  She was observed for 2 hours and discharged home with diphenhydramine and cetirizine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Skin warm
Clinical narrative: Approximately 15 minutes after receiving the Janssen vaccine, the patient complained of numbness and tingling around her mouth and fingertips, felt flush/warmness on her face with noticeable redness, and became hoarse while speaking. The patient was given 25 mg of diphenhydramine at the vaccination event and her hoarseness improved but returned a few minutes later.  She was taken to the Emergency Department for further observation.  In the ED, she was given famotidine, dexamethasone, and 1L of fluids, and her symptoms improved.  She was observed for 2 hours and discharged home with diphenhydramine and cetirizine.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Injection site rash, Lymphadenopathy, Migraine
Clinical narrative: Delayed reaction of 6 days. Strong headaches bordering migraine, swollen lymph nodes within left side of neck/throat, body aches mostly located at the hips, flu like symptoms. 8 days after injection the injection site got a small rash but disappeared 2 days after it appeared. 11 days after heart palpitations seemed to have started with no other side effects.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations
Clinical narrative: Delayed reaction of 6 days. Strong headaches bordering migraine, swollen lymph nodes within left side of neck/throat, body aches mostly located at the hips, flu like symptoms. 8 days after injection the injection site got a small rash but disappeared 2 days after it appeared. 11 days after heart palpitations seemed to have started with no other side effects.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Condition aggravated, Pruritus, Urticaria
Clinical narrative: Client received 1st dose of Moderna vaccine on 3/17/21. Client began experiencing itchy hives on his stomach and right side near his belt line on Friday 3/19/21. On 3/22/21 client is still experiencing these hives. Client reports the hives have remained the same. He has not had any worsening or spread of the hives. Client denies any shortness of breath or difficulty breathing. Client also reports experiencing an increase in his arthritis symptoms, but reports he missed his Celebrex dose on 3/20/21 which may also contribute to these symptoms.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Lightheaded , diaphoretic  states this always happen when I get shots. Patient did not want treatment or transport
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: 1 week later large red spot around injection site and rash and then 9 days after injection full body rash
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Tremor
Clinical narrative: severe shaking/fever 102 degrees 6 hours after shot. Next day fever 103 degrees, head ache, body ache, took acetaminophen. Two days after felt better still taking acetaminophen. Three days later almost back to normal. Will the second dose be worse????
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Patient reported having a "severe reaction" 5-6 days post injection of 1st dose of Moderna vaccine, consisting of severe headache and irretractable vomiting.  This lasted for 24 hours.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Ear congestion, Exposure to SARS-CoV-2, Headache, Myalgia
Clinical narrative: Patient completed second COVID-19 vaccine in January 2021 (unknown which manufacturer). Patient was at a family gathering and had close contact with a relative who later tested positive for Sars-cov-2. Patient subsequently started symptoms (sore throat, headache, nasal and ear congestion associated with myalgias) and presented to clinic where we had a positive rapid COVID-19 test. He was then sent to ED where he again tested positive for Sars-cov-2 on RVP PCR.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: Patient completed second COVID-19 vaccine in January 2021 (unknown which manufacturer). Patient was at a family gathering and had close contact with a relative who later tested positive for Sars-cov-2. Patient subsequently started symptoms (sore throat, headache, nasal and ear congestion associated with myalgias) and presented to clinic where we had a positive rapid COVID-19 test. He was then sent to ED where he again tested positive for Sars-cov-2 on RVP PCR.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site rash, Injection site warmth
Clinical narrative: 6-24 hours after injection: Extreme fatigue, chills, body aches, head aches and nausea. 24-72 hours after injection: Extreme fatigue. 72-5 days after injection: lots of energy, difficulty falling asleep. Day 6: return of extreme fatigue, nausea, head ache.  Day 7: Fatigue. After the first dose there was soreness in arm. A week after first injection there was heat and a rash at the injection site but it went away after that.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain, Pain in extremity
Clinical narrative: 6-24 hours after injection: Extreme fatigue, chills, body aches, head aches and nausea. 24-72 hours after injection: Extreme fatigue. 72-5 days after injection: lots of energy, difficulty falling asleep. Day 6: return of extreme fatigue, nausea, head ache.  Day 7: Fatigue. After the first dose there was soreness in arm. A week after first injection there was heat and a rash at the injection site but it went away after that.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain, Pain in extremity, Sleep disorder
Clinical narrative: really bad arm pain for 4 days, couldn't move my arm, couldn't sleep on my left side arm, mild body aches
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hot flush, Pruritus, SARS-CoV-2 test negative, Throat irritation
Clinical narrative: The Chief Complaint is: 40 y/o F with history of allergic rhinitis including systemic reaction to skin testing years ago presents for COVID vaccination.  She and I discussed getting vaccinated with her history a few weeks ago and I recommended vaccination.  She reports that today she is in previous good health but 15 minutes after vaccination she started to feel itching all over her body which was rapidly followed by throat itching and difficulty swallowing.  She was taken to the treatment area of the vaccination center and evaluated. - Pruritis, flushing, sclerae injection after COVID vaccination with PFizer vaccine.  May be allergic or due to complement release.    Treatment course -  took patient back to the treatment area and administered 0.3mg epinephrine with rapid improvement in symptoms and signs and minimal side effects. Follow up BP lower, flushing improved, sclerae improved and throat symptoms improved. Called 911 for EMS response to observe her in the ED will complete VAERS and contact patient by phone for follow up
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, Presyncope
Clinical narrative: Near syncopal event with Bradycardia
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac pacemaker insertion, Heart rate decreased
Clinical narrative: Near syncopal event with Bradycardia
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Feeling abnormal, Injection site pain, Memory impairment
Clinical narrative: Initially just soreness around the injection site. On 3/21 around 5pm EST. Severe pain began around left side collarbone, Pain "catches" when I inhale. Chills, fatigue, brainfog (I forget little things I just did and it takes me longer than usual to recall)
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Painful respiration
Clinical narrative: Initially just soreness around the injection site. On 3/21 around 5pm EST. Severe pain began around left side collarbone, Pain "catches" when I inhale. Chills, fatigue, brainfog (I forget little things I just did and it takes me longer than usual to recall)
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever. Chills. Nauseous, joint pain, headache Until approx  10 pm sunday night Ok on 3/22/21
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: 15 minutes after vaccination, patient began to experience pruritus all over body
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site scar, Injection site swelling
Clinical narrative: On day 7 injection site began to turn red, swell and itch. Days 8-9 it worsened (grew in side and swelling) but began to resolve on day 10. There is a circular scar where the affected area was on day 12 and slight redness.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Muscle spasms, Myalgia
Clinical narrative: Severe muscle pain and aches beginning 7-8 hours after vaccinated, muscle pain/charlie horse feelings all over body, low grade fever, chills, headache, very weak to get up off couch or bed  Tylenol taken every 5 hours - only helped for 2 hours after taken each time  Est. Delivery Date: August 1, 2021
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe muscle pain and aches beginning 7-8 hours after vaccinated, muscle pain/charlie horse feelings all over body, low grade fever, chills, headache, very weak to get up off couch or bed  Tylenol taken every 5 hours - only helped for 2 hours after taken each time  Est. Delivery Date: August 1, 2021
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills, muscle aches, headache, fever
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Fever 103 Chills Sweats Shaking Headache Full body aches
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Fever 103 Chills Sweats Shaking Headache Full body aches
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Decreased appetite, Disturbance in attention, Dizziness, Dyspnoea
Clinical narrative: Day 0:Within a few hours, I felt extremely dizzy and had numbness in my extremities. I had trouble concentrating. By the evening, i felt like I had a mastiff sitting on my chest and was having trouble filling my lungs. I took a benadryl and tylenol before bed.  Day 1: In the morning, I felt somewhat better, feeling like I had a 20lb dog on my chest.  Severe fatigue (slept for 5 hours in the afternoon/evening). Headache. Day 2: Continued pressure in chest. Feeling of something stuck in esophagus. More severe fatigue (slept another 5 hours in the afternoon). Injection site still tender. Cough began at bedtime and continued through morning. Day 3 (today): continued pressure in chest and feeling of something stuck in esophagus. Loss of appetite. Severe fatigue. Ache down injection arm to wrist.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Injection site pain, Pain
Clinical narrative: Day 0:Within a few hours, I felt extremely dizzy and had numbness in my extremities. I had trouble concentrating. By the evening, i felt like I had a mastiff sitting on my chest and was having trouble filling my lungs. I took a benadryl and tylenol before bed.  Day 1: In the morning, I felt somewhat better, feeling like I had a 20lb dog on my chest.  Severe fatigue (slept for 5 hours in the afternoon/evening). Headache. Day 2: Continued pressure in chest. Feeling of something stuck in esophagus. More severe fatigue (slept another 5 hours in the afternoon). Injection site still tender. Cough began at bedtime and continued through morning. Day 3 (today): continued pressure in chest and feeling of something stuck in esophagus. Loss of appetite. Severe fatigue. Ache down injection arm to wrist.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Day 0:Within a few hours, I felt extremely dizzy and had numbness in my extremities. I had trouble concentrating. By the evening, i felt like I had a mastiff sitting on my chest and was having trouble filling my lungs. I took a benadryl and tylenol before bed.  Day 1: In the morning, I felt somewhat better, feeling like I had a 20lb dog on my chest.  Severe fatigue (slept for 5 hours in the afternoon/evening). Headache. Day 2: Continued pressure in chest. Feeling of something stuck in esophagus. More severe fatigue (slept another 5 hours in the afternoon). Injection site still tender. Cough began at bedtime and continued through morning. Day 3 (today): continued pressure in chest and feeling of something stuck in esophagus. Loss of appetite. Severe fatigue. Ache down injection arm to wrist.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Seizure
Clinical narrative: received shot at 1130 am on 2/19.  client developed chills/ fever that evening on 2/19. on 2/20, woke up feeling well, was getting dressed to go out to lunch at 12 when he had a seizure, as per his wife, it lasted for about 5 sec. then he recovered and states had lunch and took a nap. no other issues after that.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Pruritus, Wheezing
Clinical narrative: swelling, redness and hive reaction about 5 by 4 cm at vaccination site, new  systemic pruritis, itching, wheezing sensation without asthma
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Flushing, Pruritus, Swollen tongue
Clinical narrative: Patient received Pfizer vaccine @ 1045AM. She begin to c/o itching and flushed feeling all over @ approx 11:00am. She was escorted to triage area where she begin to c/o increased itching and tongue swelling. Epi pen and Benadryl was  administered. Patient then begin to c/o difficulty swallowing and breathing. She remained alert and oriented to self, time, place and situation.  She was taken to Regional per EMT's.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient reported rash, itching, and feeling hot around the injection site. It has faded today (3/22, 2 days after the reported event). Patient felt better after applying cold compress and hydrocortisone
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: vomiting, dizziness, headache,
Age: 54.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Pain
Clinical narrative: Body aches and joints
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Flushing, Heart rate increased
Clinical narrative: Reported that approximately 15 mins after taking the vaccine she started to have have facial flushing t, rapid heart rate, redness on upper chest, and difficulty swallowing,  She was taken to the ED and observed and given benreayl whoch releved the symptoms after 1 1/2 hours.
Sex: F
Vaccine: FLUX, IPV, MMR, PPV, TTOX, VARZOS
Symptoms: Pain in extremity
Clinical narrative: without any problems, other than a sore arm; This spontaneous report was received from a 61 years old White female patient who referring to herself. Concurrent condition, historical condition and concomitant therapy were not reported.   On unknown dates, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23); zoster vaccine live(ZOSTAVAX); poliovirus vaccine inactivated (unspecified)); influenza virus vaccine (unspecified) and tetanus toxoid (dose, unit, route, lot# and expiration date were not reported).      The patient stated that without any problems, other than a sore arm. The outcome was not reported. Action taken was not applicable.   The causality between the event and suspect therapies was not reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: Nurse stated here were no additional AE's.; Nurse stated that the PNEUMOVAX 23 (prefilled syringes) had been administered to 2 patients since undergoing the temperature excursion.; This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.     On 02-MAR-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (strength, dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number reported as T031820, has been verified to be a valid lot number, expiration date reported and established as 10-MAY-2022) as prophylaxis (product storage error).  The administered dose of the vaccine was stored in a temperature between 2 degrees Celsius (C) to 8 degrees C (9.3 degrees C) for 4 hours, 40 minutes and 0 seconds, and then at -1.6 degrees C for 1 hour, 20 minutes and 0 seconds. There was no previous temperature excursion reported and no digital data logger was involved. No adverse events were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T031820; expirationdate: 10-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001865:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Some of her friends said it was painful and hurt the arm; Some of her friends said it was painful and hurt the arm; some of her friends said it was painful and hurt the arm; This spontaneous report was received from a consumer referring to an unspecified number of patients of unknown age and gender. The patients' pertinent concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patients were vaccinated with zoster vaccine live (manufacturer unknown) as prophylaxis (concentration, dosage, vaccination scheme frequency, route of administration, anatomical location, lot number and expiration date were not reported).   On an unknown date, some of the reporter's friends stated that when they received the zoster vaccine live (manufacturer unknown) it was painful and hurt the arm (pain, vaccination complication, pain in extremity).   At the time of this report, the outcome of the events was not reported.  As the reporter stated that the vaccination it was painful, the events pain and vaccination complication were considered related to zoster vaccine live (manufacturer unknown), and the causality assessment between the event pain in extremity and the suspect vaccine was not reported.   This is a non-valid case due to lack of patients' identifiers.; Sender's Comments:  US-009507513-2103USA003063:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Loss of consciousness, Nausea, Pallor
Clinical narrative: Lost consciousness (passed out) for several seconds; Went pale; Started seeing stars; Remained weak for several hours; Nauseous; Chills; Fever; A spontaneous report was received from a consumer concerning a female patient of an unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced lost consciousness (passed out) for several seconds, fever, chills, nauseous, went pale, started seeing stars and remained weak for several hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received the first of two planned doses of mRNA-1273 (Batch number not provided) on an unspecified date. On 05 Feb 2021, approximately few hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection.  On 05 Feb 2021 Friday night, the patient had chills and fever. On 06 Feb 2021, patient gradually became nauseous, went pale, started seeing stars and then lost consciousness (passed out) for several seconds (medically significant event). The patient remained weak for several hours but gradually recovered and was back to normal at the time of this report.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, chills, fever, lost consciousness (passed out) for several seconds, nauseous, went pale, started seeing stars and remained weak for several hour was recovered on an unspecified date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, Pyrexia
Clinical narrative: Lost consciousness (passed out) for several seconds; Went pale; Started seeing stars; Remained weak for several hours; Nauseous; Chills; Fever; A spontaneous report was received from a consumer concerning a female patient of an unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced lost consciousness (passed out) for several seconds, fever, chills, nauseous, went pale, started seeing stars and remained weak for several hours.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received the first of two planned doses of mRNA-1273 (Batch number not provided) on an unspecified date. On 05 Feb 2021, approximately few hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection.  On 05 Feb 2021 Friday night, the patient had chills and fever. On 06 Feb 2021, patient gradually became nauseous, went pale, started seeing stars and then lost consciousness (passed out) for several seconds (medically significant event). The patient remained weak for several hours but gradually recovered and was back to normal at the time of this report.   Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, chills, fever, lost consciousness (passed out) for several seconds, nauseous, went pale, started seeing stars and remained weak for several hour was recovered on an unspecified date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Diabetic ketoacidosis
Clinical narrative: Stroke; Diabetic Ketoacidosis; A spontaneous report was received from a consumer concerning a 77-years old, male patient who experienced the events cerebrovascular accident and diabetic ketoacidosis.   The patient's medical history included hypertension.  Concomitant product use was not provided by the reporter.  On 06 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly  for prophylaxis of COVID-19 infection.    On an unknown date, the patient experienced stroke and diabetic ketoacidosis. which caused hospitalization.  On 13 Feb 2021, the patient was admitted to the hospital. On 04 Mar 2021, the patient was discharged.  Treatment details was not provided.  Action taken with mRNA-1273 in response to the events was not unknown.  The outcome of the events cerebrovascular accident and diabetic ketoacidosis was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. However, the patient's advance age, diabetes, Hypertension, may remain contributing factor for this event.Further information has been requested
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Illness
Clinical narrative: illness and very very sick; Death; A spontaneous report was received from a lawyer concerning a 70 or 71-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who died following illness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unspecified date. On an unknown date, approximately 24 hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection.  Within 24 hours, of vaccination the patient got very ill and sick and on the 4th day patient went to have a shower and found dead by patient's husband. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event, illness and very sick was unknown. The patient died on 13 Mar 2021. The cause of death was unknown.  Plans for an autopsy were denied due to COVID-19 relation and are reporting to Moderna.  Autopsy was not performed.; Reporter's Comments: This is a case of death in an 70/71-year-old male subject with unknown medical history,  who was sick from day 1 and died on  day 4 after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: Tongue swelling not occluding airway; Fevers of 102-103F; Chills; Sweats; Fatigue; This is a spontaneous report from a contactable nurse (patient). This non-pregnant 37-year-old female patient received the second dose of BNT162B2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the left arm on 13Feb2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included postpartum 9 months c-section from an unknown date and unknown if ongoing. The patient had no allergies to medications, foods or other products and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included sunflower lecithin, fish oil and postnatal vitamin, all from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number EL9261) in the left arm on 23Jan2021 at 12:00 (at the age of 37-years-old) for COVID-19 immunisation. The patient reported that she experienced tongue swelling not occluding her airway starting 6 hours post second injection on 13Feb2021. She took diphenhydramine hydrochloride (BENADRYL) 25 mg and famotidine (PEPCID) 20 mg orally which resolved the symptoms after 1 hour. She also reported fevers of 102-103Fahrenheit (F) with chills, sweats, and fatigue for 36 hours. The events were reported as non-serious and did not require hospitalization. The clinical outcome of tongue swelling not occluding airway was recovered on 13Feb2021 at 17:00; the clinical outcomes of fevers of 102-103F, chills, sweats and fatigue were recovered on 15-FEB-2021 at 04:00. It was also reported the patient had not been tested for COVID-19 since vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Tongue swelling not occluding airway; Fevers of 102-103F; Chills; Sweats; Fatigue; This is a spontaneous report from a contactable nurse (patient). This non-pregnant 37-year-old female patient received the second dose of BNT162B2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the left arm on 13Feb2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included postpartum 9 months c-section from an unknown date and unknown if ongoing. The patient had no allergies to medications, foods or other products and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included sunflower lecithin, fish oil and postnatal vitamin, all from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number EL9261) in the left arm on 23Jan2021 at 12:00 (at the age of 37-years-old) for COVID-19 immunisation. The patient reported that she experienced tongue swelling not occluding her airway starting 6 hours post second injection on 13Feb2021. She took diphenhydramine hydrochloride (BENADRYL) 25 mg and famotidine (PEPCID) 20 mg orally which resolved the symptoms after 1 hour. She also reported fevers of 102-103Fahrenheit (F) with chills, sweats, and fatigue for 36 hours. The events were reported as non-serious and did not require hospitalization. The clinical outcome of tongue swelling not occluding airway was recovered on 13Feb2021 at 17:00; the clinical outcomes of fevers of 102-103F, chills, sweats and fatigue were recovered on 15-FEB-2021 at 04:00. It was also reported the patient had not been tested for COVID-19 since vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Has UTI; This is a spontaneous report from a contactable consumer. This 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number unknown at unspecified route on unspecified date in Feb2021 as single dose (at the age of 66 years) or COVID-19 immunisation.  On Feb2021 the patient experienced UTI (urinary tract infection) and was started on Cefuroxime Axetilas treatment.  Outcome of UTI is unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with covid; diagnosed with covid; This is a spontaneous report from a contactable nurse.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient was diagnosed with covid on an unspecified date after the first dose was administered. This was described as diagnosed 18 days out.  The patient underwent lab tests and procedures which included positive Covid-19 on  an unspecified date.  The outcome of diagnosed with covid was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: I had itching on my neck at the base of my hairline and then behind my ears; hives on torso that spread to my wrist, then inner elbow, inner thigh and eyelids; This is a spontaneous report from a contactable consumer reporting for herself. A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EM9810/expiration date: not provided), via an unspecified route of administration, on 13Feb2021 at 13:00 (at the age of 35 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: FL3246/expiration date: not provided), via an unspecified route of administration, on 23Jan2021 at 13:00 (at the age of 35 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was not reported. It was unknown if the patient had any allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021 at 12:45, the patient experienced itching and hives. The clinical course was as follows: "I had itching on my neck at the base of my hairline and then behind my ears and then noticed hives on torso that spread to my wrist, then inner elbow, inner thigh and eyelid". It was reported whether treatment was received for the events was unknown. The outcome of the events itching and hives was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid heart rate; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9266), via an unspecified route of administration in the right arm on 17Feb2021 12:00 (at the age of 69-years-old), as a single dose for COVID-19 immunization. The patient's medical history included: past history of breast cancer. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient had no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021 13:30, the patient experienced rapid heart rate. The clinical course was as follows: About 1.5 hours after having the vaccine (17Feb2021 13:30), the patient's heart was pounding rapidly. It went from around 94-110 BPM (beats per minute) to 138-140 BPM. This continued for about an hour, fluctuating up and down, and finally lowered. She did not know if this was anything to worry about, since she couldn't get a hold of a doctor. Since it lowered, she guessed it might have been just a basic side effect. She didn't have any other adverse effects. No treatment was received for the event. The clinical outcome of rapid heart rate recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral
Clinical narrative: patient's tongue started to feel a strange numbness; metallic taste; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 19:30 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation.  Medical history included allergies to Band-aide adhesive. The patient received dose 1 of the vaccine on 27Jan2021 07:30 PM, lot number: EN5318, Left arm. The patient is not pregnant at the time of vaccination.  Th patient did not have COVID-19 prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, triamterene (DYAZIDE) taken for an unspecified indication, start and stop date were not reported; ezetimibe (ZETIA) taken for an unspecified indication, start and stop date were not reported; celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.  On 17Feb2021 19:50, within 20 minutes of vaccine shot the patient's tongue started to feel a strange numbness from the tip to approximately an 3/4 of an inch. Then the patient developed a metallic taste. Thee outcome of the event was not recovered. The patient was not tested for COVID post vaccination. No treatment was received for the medication.