chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: SIRVA? Pain in both arms, sometimes in my bicep  muscles  and other times in my shoulders. It moves from one area to the other.  Sometimes it impacts my ability to concentrate (because it's all I can focus on) or my movement  (reaching for things) and other times not. It's not excruciating but enough for me to take Tylenol or Back and Body pills for the pain to go away.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Facility called the morning of 08/03/21 and spoke to staff member on the medical team at Pfizer who gave the same information. Staff member was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Skin tightness
Clinical narrative: About a week after receiving the first shot my arm was itchy. There was a red hot tight area at the injection site. The next day it was raised, still itchy, hot, red, and tight. It gradually resolved and lasted about a week.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, COVID-19, Dysuria, Headache
Clinical narrative: Patient fully vaccinated with Moderna (patient reports received 2nd dose 1/2021) contracts COVID, requiring admission to the hospital on 8/1/2021 (symptoms began 7/28). Chief complaint included weakness, headache, urinary symptoms, malaise. Required 2-3L O2 (no baseline oxygen requirements) - reported on hospital day 3.   Patient treated with dexamethasone 4 mg.  Required at least 4 days of hospitalization (reported hospital day 3).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Patient fully vaccinated with Moderna (patient reports received 2nd dose 1/2021) contracts COVID, requiring admission to the hospital on 8/1/2021 (symptoms began 7/28). Chief complaint included weakness, headache, urinary symptoms, malaise. Required 2-3L O2 (no baseline oxygen requirements) - reported on hospital day 3.   Patient treated with dexamethasone 4 mg.  Required at least 4 days of hospitalization (reported hospital day 3).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi-dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Called the morning of 8/3/21 and spoke to the medical team at Pfizer who gave the same information. Was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Hospital called the morning of 08/03/21 and spoke to the medical team at Pfizer who gave the same information. Was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline. No adverse events reported by patient.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Followed up with patient 3 days post-vaccination and patient reports feeling fine and experiencing no side effects.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Restless legs syndrome
Clinical narrative: Restless Leg Syndrome
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi-dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Called the morning of 8/3/21 and on the medical team at Pfizer who gave the same information. She was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Morning of 08/03/21 spoke to agent who gave the same information. Agent was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline. No adverse events have been reported by patient.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: The patient fainted after 5 min from administring; no BLS needed, woke up in less than 1 min no epinephrine needed
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi-dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store-level, they were not able to give any information on anything other than the single-use vials were studied. Called the morning of 8/3/21 and spoke to the medical team at Pfizer who gave the same information. The reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Agency called the morning of 08/03/21 and spoke to Representative on the medical team at Pfizer who gave the same information. Representative was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline. No adverse events have been reported by patient.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: about 5 mina fter receiving the vaccine the patient was sitting next to parent and fainted.  Mother caught him.  I went behind him to support him and it took about 5 min to fully recover
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy endometrium, Postmenopausal haemorrhage
Clinical narrative: I am menopausal for 4 years now. I had bleeding on July 27 2021 which lasted for 3 days.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Ongoing daily heart palpitations that did not take place prior to the second vaccination shot.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Loss of consciousness, Pallor
Clinical narrative: Client reported having a history of syncopal episodes during prescreening questionnaire. Vaccination was given in a zero gravity chair. Immediately following COVID vaccination client experienced a loss of consciousness lasting less than 10 seconds. A set of vitals were taken : BP 110/59, HR: 47, RR 30, A&Ox4, skins clammy, warm and pale. Client complained of a slight headache rated 2/10. Denied any other symptoms such as chest pain, shortness of breath, dizziness or numbness/tingling in mouth, face or throat. At 1050 a second set of vitals taken : BP 100/64, HR: 53, RR 18 skins normal for ethnicity, warm and dry, A&Ox4. At 1105 client stated her headache was resolved. She stated her vitals were normal for her due to her athleticism. A final set of vitals taken: BP 102/64, HR: 47, RR 12 skins normal for ethnicity, warm and dry. Client left observation site on her own accord with a steady gait at approximately 1105.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Pain in extremity
Clinical narrative: Right arm very sore starting that evening. Soreness into the nest day. Heart pain.  Today is only the second day abs his symptoms are bad enough to go to the doctor.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Injection site bruising
Clinical narrative: Arm bruised at injection site. Lingering cough.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in my mouth within 5 minutes of injection, which lasted for at least 12 hours.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient was diagnosed with Covid-19 on 6/30/2021, and subsequently died on 7/8/2021. Covid-19 was listed as a contributing factor on his death certificate.
Age: 25.0
Sex: F
Vaccine: IPV
Symptoms: Wrong product administered
Clinical narrative: Administered Polio instead of  Tubersol for a PPD placement
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Asthenia, Back pain, Chest pain, Depressed mood
Clinical narrative: Day 2 shaking nauseated dRymouth ha 3 swEating Lymph NodEs swollEn dizzy wEak 4 Low back bEiNg RippEd out feeliNg hollow 5 distEnded chest paiN coughing pRoductive wEak InsidE mouth fEEls Raw 6-13 bloatEd distended nauseatEd wEak
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Hyperhidrosis, Lymphadenopathy, Nausea
Clinical narrative: Day 2 shaking nauseated dRymouth ha 3 swEating Lymph NodEs swollEn dizzy wEak 4 Low back bEiNg RippEd out feeliNg hollow 5 distEnded chest paiN coughing pRoductive wEak InsidE mouth fEEls Raw 6-13 bloatEd distended nauseatEd wEak
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Stomatitis, Tremor
Clinical narrative: Day 2 shaking nauseated dRymouth ha 3 swEating Lymph NodEs swollEn dizzy wEak 4 Low back bEiNg RippEd out feeliNg hollow 5 distEnded chest paiN coughing pRoductive wEak InsidE mouth fEEls Raw 6-13 bloatEd distended nauseatEd wEak
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site swelling
Clinical narrative: Patient is experiencing swelling at vaccine site and tingling intermittently from vaccine site to lower arm
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patients mother called office & stated that his Left thigh was swollen & warm to touch. Dad brought him in for it to be checked out the next morning. Left thigh was still swollen and warm to touch. But was better than the picture they had from the night before. Dr. saw him in office.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypoaesthesia, Pyrexia, Swelling face
Clinical narrative: facial swelling, numbness x 5d low-grade fever x 100 degrees for 5d diarrhea x/wk sxs have been intermittent lasting 1-2d, not as severe
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death
Clinical narrative: Case was fully vaccinated against Covid19, and became infected with Covid-19 on 7/12/2021. She died on 7/15/2021 with Covid Pneumonia listed as a secondary diagnosis contributing to her death.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 RNA, SARS-CoV-2 test positive
Clinical narrative: Patient completed COvid-19 vaccination series on 2/10/2021, was diagnosed with Covid-19 on 6/30/2021, and died on 7/14/2021 with Covid listed as a condition contributing to his death.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMRV, TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered a 2nd dose of Tdap  3 months after a 1st one was given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Rash macular
Clinical narrative: Patient developed red splotchy areas to face and noted itching to those areas within 10 minutes of vaccine administration. Patient was observed for 30 minutes after vaccine administration and symptoms (redness and itching) significantly improved. Patient noted no other associated symptoms. No medications were given to relieve symptoms and provider plan is to have patient evaluated by allergist before future vaccines are given.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Oral pruritus, Pruritus, Urticaria
Clinical narrative: after initial vaccine Hives, Swelling, Fever, Chest pain, Seizure, and Anaphylaxis three days after severe chest pain, anaphylaxis, shortness of breath, htn
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest pain, Computerised tomogram thorax, Dyspnoea, Electrocardiogram
Clinical narrative: after initial vaccine Hives, Swelling, Fever, Chest pain, Seizure, and Anaphylaxis three days after severe chest pain, anaphylaxis, shortness of breath, htn
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Pyrexia, Seizure, Swelling, Troponin
Clinical narrative: after initial vaccine Hives, Swelling, Fever, Chest pain, Seizure, and Anaphylaxis three days after severe chest pain, anaphylaxis, shortness of breath, htn
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: after initial vaccine Hives, Swelling, Fever, Chest pain, Seizure, and Anaphylaxis three days after severe chest pain, anaphylaxis, shortness of breath, htn
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Appendicitis, Computerised tomogram abdomen, Laboratory test
Clinical narrative: pt currently has covid 19
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: pt currently has covid 19
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: I went to shock and started itching. I started breaking in hives all over. My face begin to become numb. My throat became swollen. Doctor began treating me with steroids and Benadryl.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electrocardiogram, Hypoaesthesia, Pharyngeal swelling, Pruritus
Clinical narrative: I went to shock and started itching. I started breaking in hives all over. My face begin to become numb. My throat became swollen. Doctor began treating me with steroids and Benadryl.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: I went to shock and started itching. I started breaking in hives all over. My face begin to become numb. My throat became swollen. Doctor began treating me with steroids and Benadryl.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Feeling cold, Heart rate decreased
Clinical narrative: At the 10 minute mark, extreme nausea, then high heart rate followed by drop in blood pressure, chills, dizziness
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Nausea, Pallor, Tremor
Clinical narrative: At the 10 minute mark, extreme nausea, then high heart rate followed by drop in blood pressure, chills, dizziness
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Chills, Dizziness, Heart rate increased, Investigation
Clinical narrative: At the 10 minute mark, extreme nausea, then high heart rate followed by drop in blood pressure, chills, dizziness
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: At the 10 minute mark, extreme nausea, then high heart rate followed by drop in blood pressure, chills, dizziness
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Severe vertigo; Dizziness; Nausea; Could not keep head upright; This is a spontaneous report from a contactable consumer. A 52-years-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration, administered in Arm Left on 17Mar2021 07:00 (at the age of 52-years-old) (Batch/Lot number : unknown) as SINGLE for covid-19 immunization administered was hospital. Medical history included multiple sclerosis and covid-19 from an unknown date and unknown if ongoing. Concomitant medications included dimethyl fumarate (TECFIDERA) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination the patient was diagnosed with COVID-19, Since the vaccination the patient had not been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At approximately 12:00AM on 20Mar2021 experiencing severe vertigo, dizziness and nausea. Could not keep head upright. As of this report, 8:20pm on the same day, 20Mar2021, the symptom has improved only very slightly. The patient received no treatment for the adverse event. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient underwent lab investigation which included covid test with positive result. At the time of reporting the outcome of events was recovering.  Lo/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Muscle disorder, Nausea, SARS-CoV-2 test, Vertigo
Clinical narrative: Severe vertigo; Dizziness; Nausea; Could not keep head upright; This is a spontaneous report from a contactable consumer. A 52-years-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration, administered in Arm Left on 17Mar2021 07:00 (at the age of 52-years-old) (Batch/Lot number : unknown) as SINGLE for covid-19 immunization administered was hospital. Medical history included multiple sclerosis and covid-19 from an unknown date and unknown if ongoing. Concomitant medications included dimethyl fumarate (TECFIDERA) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination the patient was diagnosed with COVID-19, Since the vaccination the patient had not been tested for COVID-19. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At approximately 12:00AM on 20Mar2021 experiencing severe vertigo, dizziness and nausea. Could not keep head upright. As of this report, 8:20pm on the same day, 20Mar2021, the symptom has improved only very slightly. The patient received no treatment for the adverse event. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient underwent lab investigation which included covid test with positive result. At the time of reporting the outcome of events was recovering.  Lo/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Logorrhoea, Throat tightness
Clinical narrative: I experienced an anaphylactic shock reaction; spasms in my throat; difficult to breathe; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 15:30 (at the age of 56-years-old) (Batch/Lot Number: ER7833) as single dose for COVID-19 immunization. Medical history included high blood pressure, known allergies. The patient had no covid prior vaccination. The patient received other medications (unspecified) in two weeks. The patient did not receive any other vaccine in four weeks. On 29Mar2021, 15.30 (as reported), within 3 minutes of getting the vaccine the patient experienced an anaphylactic shock reaction. At the site she was given Benadryl and was administered 3 EpiPen injections then was taken by ambulance to a hospital. Not sure what she was given in the ambulance. In the hospital not sure of all the medications she was given (would have to request her records) but she did know she was given 3 breathing treatments. Also experienced spasms in her throat which made it even more difficult to breathe. AE resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient received ER treatment, Benadryl, Epi-pen, Breathing treatment. The patient had tested covid post vaccination. The patient underwent lab tests and procedures which included Covid test post vaccination (Nasal Swab): negative on an unspecified date. Outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic shock, Dizziness
Clinical narrative: I experienced an anaphylactic shock reaction; spasms in my throat; difficult to breathe; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 15:30 (at the age of 56-years-old) (Batch/Lot Number: ER7833) as single dose for COVID-19 immunization. Medical history included high blood pressure, known allergies. The patient had no covid prior vaccination. The patient received other medications (unspecified) in two weeks. The patient did not receive any other vaccine in four weeks. On 29Mar2021, 15.30 (as reported), within 3 minutes of getting the vaccine the patient experienced an anaphylactic shock reaction. At the site she was given Benadryl and was administered 3 EpiPen injections then was taken by ambulance to a hospital. Not sure what she was given in the ambulance. In the hospital not sure of all the medications she was given (would have to request her records) but she did know she was given 3 breathing treatments. Also experienced spasms in her throat which made it even more difficult to breathe. AE resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient received ER treatment, Benadryl, Epi-pen, Breathing treatment. The patient had tested covid post vaccination. The patient underwent lab tests and procedures which included Covid test post vaccination (Nasal Swab): negative on an unspecified date. Outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic shock, Dyspnoea, Muscle spasms, SARS-CoV-2 test
Clinical narrative: I experienced an anaphylactic shock reaction; spasms in my throat; difficult to breathe; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 15:30 (at the age of 56-years-old) (Batch/Lot Number: ER7833) as single dose for COVID-19 immunization. Medical history included high blood pressure, known allergies. The patient had no covid prior vaccination. The patient received other medications (unspecified) in two weeks. The patient did not receive any other vaccine in four weeks. On 29Mar2021, 15.30 (as reported), within 3 minutes of getting the vaccine the patient experienced an anaphylactic shock reaction. At the site she was given Benadryl and was administered 3 EpiPen injections then was taken by ambulance to a hospital. Not sure what she was given in the ambulance. In the hospital not sure of all the medications she was given (would have to request her records) but she did know she was given 3 breathing treatments. Also experienced spasms in her throat which made it even more difficult to breathe. AE resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient received ER treatment, Benadryl, Epi-pen, Breathing treatment. The patient had tested covid post vaccination. The patient underwent lab tests and procedures which included Covid test post vaccination (Nasal Swab): negative on an unspecified date. Outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears few hours after 1st shot; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8727) via an unspecified route of administration in the right arm on 24Mar2021 at 14:15 (at the age of 58-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0171) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included seafood allergy. Concomitant medications included tamsulosin hydrochloride (FLOMAX) and ciclosporin (RESTASIS). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 18:00, the patient experienced ringing in ears (tinnitus) few hours after 1st shot. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event ringing in ears (tinnitus) few hours after 1st shot was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Anxiety, Disturbance in attention, Ear discomfort, Hypoacusis
Clinical narrative: Heavy pressure on both ears, seems as if there is heavy suction placed on both ears; Sound seems to be muffled; Extreme difficulty in sleeping; Right ear starts ringing; Difficulty with concentration; Difficulty with hearing; Rising stress; Rising stress and anxiety.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERB733) via an unspecified route of administration in the left arm on 29Mar2021 at 17:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to apple skins. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, Tuesday morning, the patient's right ear started ringing. It happened again in succession less than 10 minutes apart. Wednesday evening, right ear rings again, twice in succession less than 10 minutes apart. Thursday morning, after awaking, left ear started to ring, similar to the right ear the days prior. By Thursday night, on 01Apr2021, the patient experienced constant ringing inside head, extreme difficulty in sleeping and sound seemed to be muffled. By Friday, on 02Apr2021, the patient experienced heavy pressure on both ears, seemed as if there was heavy suction placed on both ears. On Saturday, 03Apr2021, the patient visited local Urgent Care Clinic and was diagnosed with tinnitus-bilateral. On 07Apr2021, the patient visited an ENT and was diagnosed/confirmed with tinnitus. On an unknown date in 2021, the patient experienced difficulty with concentration, hearing, rising stress and anxiety. The events had resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events right ear started ringing, extreme difficulty in sleeping, sound seems to be muffled, heavy pressure on both ears, seemed as if there is heavy suction placed on both ears, difficulty with concentration, hearing, rising stress and anxiety was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Stress, Tinnitus
Clinical narrative: Heavy pressure on both ears, seems as if there is heavy suction placed on both ears; Sound seems to be muffled; Extreme difficulty in sleeping; Right ear starts ringing; Difficulty with concentration; Difficulty with hearing; Rising stress; Rising stress and anxiety.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERB733) via an unspecified route of administration in the left arm on 29Mar2021 at 17:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to apple skins. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, Tuesday morning, the patient's right ear started ringing. It happened again in succession less than 10 minutes apart. Wednesday evening, right ear rings again, twice in succession less than 10 minutes apart. Thursday morning, after awaking, left ear started to ring, similar to the right ear the days prior. By Thursday night, on 01Apr2021, the patient experienced constant ringing inside head, extreme difficulty in sleeping and sound seemed to be muffled. By Friday, on 02Apr2021, the patient experienced heavy pressure on both ears, seemed as if there was heavy suction placed on both ears. On Saturday, 03Apr2021, the patient visited local Urgent Care Clinic and was diagnosed with tinnitus-bilateral. On 07Apr2021, the patient visited an ENT and was diagnosed/confirmed with tinnitus. On an unknown date in 2021, the patient experienced difficulty with concentration, hearing, rising stress and anxiety. The events had resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events right ear started ringing, extreme difficulty in sleeping, sound seems to be muffled, heavy pressure on both ears, seemed as if there is heavy suction placed on both ears, difficulty with concentration, hearing, rising stress and anxiety was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Disturbance in attention, Ear discomfort, Hypoacusis, Insomnia
Clinical narrative: Heavy pressure on both ears, seems as if there is heavy suction placed on both ears; Sound seems to be muffled; Extreme difficulty in sleeping; Right ear starts ringing; Difficulty with concentration; Difficulty with hearing; Rising stress; Rising stress and anxiety.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERB733) via an unspecified route of administration in the left arm on 29Mar2021 at 17:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to apple skins. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, Tuesday morning, the patient's right ear started ringing. It happened again in succession less than 10 minutes apart. Wednesday evening, right ear rings again, twice in succession less than 10 minutes apart. Thursday morning, after awaking, left ear started to ring, similar to the right ear the days prior. By Thursday night, on 01Apr2021, the patient experienced constant ringing inside head, extreme difficulty in sleeping and sound seemed to be muffled. By Friday, on 02Apr2021, the patient experienced heavy pressure on both ears, seemed as if there was heavy suction placed on both ears. On Saturday, 03Apr2021, the patient visited local Urgent Care Clinic and was diagnosed with tinnitus-bilateral. On 07Apr2021, the patient visited an ENT and was diagnosed/confirmed with tinnitus. On an unknown date in 2021, the patient experienced difficulty with concentration, hearing, rising stress and anxiety. The events had resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events right ear started ringing, extreme difficulty in sleeping, sound seems to be muffled, heavy pressure on both ears, seemed as if there is heavy suction placed on both ears, difficulty with concentration, hearing, rising stress and anxiety was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Stress, Tinnitus
Clinical narrative: Heavy pressure on both ears, seems as if there is heavy suction placed on both ears; Sound seems to be muffled; Extreme difficulty in sleeping; Right ear starts ringing; Difficulty with concentration; Difficulty with hearing; Rising stress; Rising stress and anxiety.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERB733) via an unspecified route of administration in the left arm on 29Mar2021 at 17:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to apple skins. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, Tuesday morning, the patient's right ear started ringing. It happened again in succession less than 10 minutes apart. Wednesday evening, right ear rings again, twice in succession less than 10 minutes apart. Thursday morning, after awaking, left ear started to ring, similar to the right ear the days prior. By Thursday night, on 01Apr2021, the patient experienced constant ringing inside head, extreme difficulty in sleeping and sound seemed to be muffled. By Friday, on 02Apr2021, the patient experienced heavy pressure on both ears, seemed as if there was heavy suction placed on both ears. On Saturday, 03Apr2021, the patient visited local Urgent Care Clinic and was diagnosed with tinnitus-bilateral. On 07Apr2021, the patient visited an ENT and was diagnosed/confirmed with tinnitus. On an unknown date in 2021, the patient experienced difficulty with concentration, hearing, rising stress and anxiety. The events had resulted in doctor or other healthcare professional office/clinic visit and emergency room/department visit or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events right ear started ringing, extreme difficulty in sleeping, sound seems to be muffled, heavy pressure on both ears, seemed as if there is heavy suction placed on both ears, difficulty with concentration, hearing, rising stress and anxiety was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased
Clinical narrative: Rapid Heartrate; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 07Apr2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included ascorbic acid; calcium; minerals nos; retinol; tocopheryl acetate; vitamin b nos; vitamins nos; zinc (CENTRUM SILVER) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 15:15, the patient experienced rapid Heartrate regular heartrate. About 10 times heartrate would return to normal for about 2 minutes then start the fast rate again. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event heart rate increased was recovered on 07Apr2021 at 1800.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Ligament rupture, Swelling face
Clinical narrative: 3 Days after vaccination ligament in my left shoulder tear during normal arm use.; Next day my face was swollen.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN7534) via an unspecified route of administration in the left arm on 24Mar2021 at 13:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) for an unknown indication, from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient's face was swollen. On 27Mar2021, 3 Days after vaccination the patient experienced ligament in his left shoulder tear during normal arm use. Therapeutic measures were taken as a result of both adverse events and included treatment with pain medications. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events face was swollen and  ligament in his left shoulder tear during normal arm use was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ligament rupture, Swelling face
Clinical narrative: 3 Days after vaccination ligament in my left shoulder tear during normal arm use.; Next day my face was swollen.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN7534) via an unspecified route of administration in the left arm on 24Mar2021 at 13:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) for an unknown indication, from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient's face was swollen. On 27Mar2021, 3 Days after vaccination the patient experienced ligament in his left shoulder tear during normal arm use. Therapeutic measures were taken as a result of both adverse events and included treatment with pain medications. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events face was swollen and  ligament in his left shoulder tear during normal arm use was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: There were no adverse events reported.   The patient should have received dose #2 of Moderna and instead, Pfizer was administered.   An incident report was filed at the pharmacy and Moderna was consulted.  Per Moderna, no additional dose was needed.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: There were no adverse events reported.   The patient should have received dose #2 of Moderna and instead, Pfizer was administered.   An incident report was filed at the pharmacy and Moderna was consulted.  Per Moderna, no additional dose was needed.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Acute coronary syndrome, Acute myocardial infarction, Blood creatinine increased, Catheterisation cardiac abnormal
Clinical narrative: same day at 10:00  arm sore, 12:00 upset stomach, 2:00 started vomiting, body cold, next day face color changed,
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray abnormal, Chest pain, Chills, Coronary arterial stent insertion, Coronary artery occlusion
Clinical narrative: same day at 10:00  arm sore, 12:00 upset stomach, 2:00 started vomiting, body cold, next day face color changed,
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, Echocardiogram, Echocardiogram abnormal, Ejection fraction
Clinical narrative: same day at 10:00  arm sore, 12:00 upset stomach, 2:00 started vomiting, body cold, next day face color changed,
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ejection fraction decreased, Endotracheal intubation, Intra-aortic balloon placement, Nausea, Pain in extremity
Clinical narrative: same day at 10:00  arm sore, 12:00 upset stomach, 2:00 started vomiting, body cold, next day face color changed,
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pallor, Percutaneous coronary intervention, Peripheral coldness, Pulmonary oedema, Respiratory failure
Clinical narrative: same day at 10:00  arm sore, 12:00 upset stomach, 2:00 started vomiting, body cold, next day face color changed,
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Restlessness, Vomiting
Clinical narrative: same day at 10:00  arm sore, 12:00 upset stomach, 2:00 started vomiting, body cold, next day face color changed,
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Cardiogenic shock, Coronary arterial stent insertion, Electrocardiogram abnormal, Endotracheal intubation
Clinical narrative: same day at 10:00  arm sore, 12:00 upset stomach, 2:00 started vomiting, body cold, next day face color changed,
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Troponin increased, Vomiting
Clinical narrative: same day at 10:00  arm sore, 12:00 upset stomach, 2:00 started vomiting, body cold, next day face color changed,
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Feeling cold, Pain in extremity, Skin discolouration, Thrombosis
Clinical narrative: same day at 10:00  arm sore, 12:00 upset stomach, 2:00 started vomiting, body cold, next day face color changed,
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: same day at 10:00  arm sore, 12:00 upset stomach, 2:00 started vomiting, body cold, next day face color changed,