chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Illness, Pruritus, Rash, Syncope
Clinical narrative: Dehydrated; Itchy; Long 4-inch rash, it was itchy; Fainted; sick, like she had a high fever; A spontaneous report was received from a consumer , who was a 73-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting (syncope), sick like had a high fever (illness), long 4-inch rash (rash), itchy (pruritis), and dehydrated (dehydration).    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29 Jan 2021, the patient received her first of the two planned vaccine doses of mRNA-1273 (Batch number: 012M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 26 Feb 202, the patient received her second of the two planned vaccine doses of mRNA-1273 (Batch number: 014M20A), intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 27 Feb 2021 the patient was sick, like she had a high fever..  Reportedly, her temperature was not taken.  She was unable to eat or drink and she fainted. It was reported that she was not aware that she fainted until the next day when her husband told her. The following Monday, she was informed by the doctor that she was dehydrated.   On 28 Feb 2021, the patient developed a long 4-inch rash, that was itchy, but resolved in a week. It was reported that this reoccurs every now and then and feels itchy. Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, fainting, sick like had a high fever, long 4-inch rash, itchy, and dehydrated, were not reported.; 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Blood Clot in Leg; A spontaneous report was received from consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in leg.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient included blood thinners for blood clot.   On 21-Jan-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 013L20A) through intramuscular route on left upper arm for prophylaxis of COVID-19 infection.  On 18-Feb-2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013M20A) through intramuscular route at right upper arm for prophylaxis of COVID-19 infection.  On 23-Jan-2021, after the first dose patient developed leg pain. The patient reported of having the leg pain linger for about 2 weeks before seeing a healthcare professional. The healthcare professional had later found that the leg pain was related to the development of a blood clot.   Relevant Treatment  for the event was with blood thinner.   The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of event, blood clot in leg was unknown.; 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Had a stroke; A spontaneous report was received from a healthcare professional concerning a 57-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a stroke.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10-Mar-2021, at 13:30, the patient received first of two planned doses of mRNA-1273 (batch: not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 10-Mar-2021, at 15:30, the patient had a stroke and was admitted.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event had a stroke was considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Mild symptom of Bell's palsy; A spontaneous report was received from a nurse concerning an 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild symptoms of Bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On 01 Mar 2021, prior to the onset of the event, the patient received their second of the two planned doses of mRNA-1273 (lot/batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Mar 2021, the patient developed mild symptoms of medically significant of Bell's palsy. Treatment for the event included steroids.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the events was not applicable.  The outcome of the event mild symptoms of Bell's palsy was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Disorientation, Dizziness, Fall
Clinical narrative: fainted and collapsed for few seconds; husband mentions she was wide awake as ghost and unconscious at the same time; dizzy; fainted and collapsed for few seconds; disoriented; weak; intense chills; felt overwhelmingly nauseous; went to bed with throbbing injection site pain; stiff and sore arm; A spontaneous report was received from a consumer concerning a 49-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stiff and sore arm (musculoskeletal stiffness), went to bed with throbbing injection site pain (vaccination site pain), nauseous (nausea), disoriented, dizzy and weak (asthenia), then fainted (loss of consciousness) and collapsed (fall)for few seconds, and having intense chills (chills).   The patient's medical history, was not provided. No Concomitant medications were reported . On 11 Mar 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 003A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11 Mar 2021, the patient felt stiff and sore arm, went to bed with throbbing injection site pain,.  On 12 mar 2021, she had awakened around 1 AM and experienced overwhelmingly nauseous, disoriented, dizzy and weak. She then fainted, collapsed for few seconds, during that that time her husband mentioned that she was wide awake as ghost and unconscious at the same time.  The patient also mentioned that she had intense chills.  She also reported that she had no history of fainting and or reactions from  any vaccine in the past.   Treatment for the events included Ibuprofen.Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the  events, experienced stiff and sore arm (musculoskeletal stiffness), went to bed with throbbing injection site pain (vaccination site pain), nauseous (nausea), disoriented, dizzy and weak (asthenia), then fainted (loss of consciousness) and collapsed (fall)for few seconds, and having intense chills (chills). were reported as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Nausea, Syncope, Vaccination site pain
Clinical narrative: fainted and collapsed for few seconds; husband mentions she was wide awake as ghost and unconscious at the same time; dizzy; fainted and collapsed for few seconds; disoriented; weak; intense chills; felt overwhelmingly nauseous; went to bed with throbbing injection site pain; stiff and sore arm; A spontaneous report was received from a consumer concerning a 49-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stiff and sore arm (musculoskeletal stiffness), went to bed with throbbing injection site pain (vaccination site pain), nauseous (nausea), disoriented, dizzy and weak (asthenia), then fainted (loss of consciousness) and collapsed (fall)for few seconds, and having intense chills (chills).   The patient's medical history, was not provided. No Concomitant medications were reported . On 11 Mar 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 003A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11 Mar 2021, the patient felt stiff and sore arm, went to bed with throbbing injection site pain,.  On 12 mar 2021, she had awakened around 1 AM and experienced overwhelmingly nauseous, disoriented, dizzy and weak. She then fainted, collapsed for few seconds, during that that time her husband mentioned that she was wide awake as ghost and unconscious at the same time.  The patient also mentioned that she had intense chills.  She also reported that she had no history of fainting and or reactions from  any vaccine in the past.   Treatment for the events included Ibuprofen.Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the  events, experienced stiff and sore arm (musculoskeletal stiffness), went to bed with throbbing injection site pain (vaccination site pain), nauseous (nausea), disoriented, dizzy and weak (asthenia), then fainted (loss of consciousness) and collapsed (fall)for few seconds, and having intense chills (chills). were reported as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Almost fainted; A spontaneous report was received from a Consumer  concerning a 73-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced almost fainted.  The patient's medical history, was not provided by the reporter. Concomitant use of the Products was not Provided by the reporter.  On 16-Mar-2021 at 10:10 am, approximately eight hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16-Mar-2021, after first dose of vaccine.  At 6:00 pm, the patient almost fainted while having shower and was referred to HCP.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, almost fainted  was unknown.  The Causality between the event and the m-RNA-1273 Vaccine was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic response; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction.  The patient's medical history was not provided. Concomitant medications were not provided.  On 16 Mar 2021, a few moments prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.   On 16 Mar 2021, the patient had an anaphylactic reaction and had to be hospitalized. She was still in the hospital as of 17 Mar 2021. Treatment information mentions 4 epinephrine pens and diphenhydramine.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, anaphylactic reaction, was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Volvulus
Clinical narrative: surgery for twisted intestine; issue with their throat, was not being able to swallow; A spontaneous report was received from a Consumer concerning an 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Volvulus and Dysphagia.    The patient's medical history was not provided. No relevant concomitant medications were e reported.    On 13-FEB-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 015M20A) in the Anatomical location unspecified for prophylaxis of COVID-19 infection.  On 27-Feb-2021, the patient experienced the events Volvulus and Swallowing impaired and the patient was hospitalized for 12 days. The patient underwent surgery for twisted intestine. The patient had an issue with their throat that has not been settled and was not being able to swallow. It was not related to the vaccine at all. The patient was discharged on 11-Mar-2021. The second dose was scheduled on 13-Mar-2021. As they could not drive and take their second dose. it will be re-scheduled.   Laboratory details were not provided.  Treatment details were included sodium chloride 1 gm 3 tablets by mouth three times a day with meals and potassium chloride 2 tablets by mouth everyday for 5 doses.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Volvulus  and Swallowing impaired was unknown.  The reporter did not provide the causality between the events Volvulus  and Swallowing impaired and the study drug.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient found dead two days after vaccination; A spontaneous report was received from a healthcare provider concerning 48-year-old, male patient who received Moderna's COVID-19 vaccine (mrna-1273) and died.  The patient's medical history includes bipolar disorder, colon polyps, hypertension, benign tremors & other Comorbidities. Concomitant product like iron sulfate, Fluticasone, Gabapentin, Lamotrigine, Methocarbamol, Propranolol hydrochloride was reported by the reporter .  On 11 mar 2021, approximately 2 days prior to the event, the patient received their first dose of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 13 Mar 2021, the patient died. No other details were reported. Treatment information was unknown.   The patient died on 13 Mar 2021. The cause of death was not provided. Plans for an autopsy were unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Developed cancer in right earlobe after first dose; A spontaneous report was received from a consumer concerning himself, a 68 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cancer in right earlobe/neoplasm malignant.  The patient's medical history was not provided by the reporter. Products known to have been used by the patient, within two weeks prior to the event include tacrolimus, metoprolol, losartan, apixaban and vitamins.  On 16 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 16M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.   On an unspecified date after receiving mRNA-1273, the patient developed cancer in his right earlobe. The patient mentioned that he is on immunosuppresants.   Action taken with mRNA -1273 in response to the event was not reported.  Outcome of the event, cancer in the right earlobe was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Muscle tightness, Rash pruritic, Skin texture abnormal, Vaccination site pain
Clinical narrative: A spontaneous report was sent by non health professional concerning a female patient of unknown age who received Modern's COVID-19 vaccine (mRNA-1273) and experienced tenderness at the injection site, itchy rash, redness, feeling hot, muscle tightness and diagnosed cellulitis and She also stated that her outsides edges were a brighter red than in the center.  The patient's medical history was unknown. The Concomitant medication was unknown.  03 Mar 2021, prior to the onset of the events, the patient received the first dose of mRNA-1273 (Lot number: 014M20A) via unknown route in right arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021 she felt only tenderness at the injection site,   On 13 Mar 2021, 10 days later she developed a rash the size of her fist, it went from her shoulder to about a quarter away from her elbow, it itched like crazy. She did not have temperature but her arm was hot to touch, muscle was tight and was diagnosed as cellulitis.   The patient still feel a difference in texture of the skin. She also stated that her outsides edges were brighter red than in the center.  Treatment was unknown. No laboratory details are provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of vaccination site pain was resolved on same day, itchy rash was resolved till 19 mar 2021, redness, muscle tightness and feeling hot was resolved on 17 Mar 2021 and unknown for cellulitis.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: A spontaneous report was sent by non health professional concerning a female patient of unknown age who received Modern's COVID-19 vaccine (mRNA-1273) and experienced tenderness at the injection site, itchy rash, redness, feeling hot, muscle tightness and diagnosed cellulitis and She also stated that her outsides edges were a brighter red than in the center.  The patient's medical history was unknown. The Concomitant medication was unknown.  03 Mar 2021, prior to the onset of the events, the patient received the first dose of mRNA-1273 (Lot number: 014M20A) via unknown route in right arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021 she felt only tenderness at the injection site,   On 13 Mar 2021, 10 days later she developed a rash the size of her fist, it went from her shoulder to about a quarter away from her elbow, it itched like crazy. She did not have temperature but her arm was hot to touch, muscle was tight and was diagnosed as cellulitis.   The patient still feel a difference in texture of the skin. She also stated that her outsides edges were brighter red than in the center.  Treatment was unknown. No laboratory details are provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of vaccination site pain was resolved on same day, itchy rash was resolved till 19 mar 2021, redness, muscle tightness and feeling hot was resolved on 17 Mar 2021 and unknown for cellulitis.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient
Clinical narrative: Temporary blindness for 10 minutes in only one eye; A spontaneous report was received from a nurse concerning a 85-year-old, elderly male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temporary blindness for 10 minutes in only one eye/blindness transient .  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 01 Mar 2021, approximately 2 days prior to the event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 022M20A) intramuscularly in left non dominant arm  for prophylaxis of COVID-19 infection prophylaxis.   On 03 Mar 2021, after first dose of vaccine, the patient experienced temporary blindness for 10 minutes in only one eye. The event temporary blindness for 10 minutes in only one eye was considered as medically significant. He visited doctor and after the investigation, it was confirmed that patient was fine. Treatment medication for the event included Clopidogrel bisulfate.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, temporary blindness for 10 minutes in only one eye was resolved on 03 Mar 2021.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature increased, Heart rate, Injection site cellulitis, Oxygen saturation
Clinical narrative: Cellulitis around the injection site; red spot the size of a quarter, sore, it was a lump, and warm at the injection site; red spot the size of a quarter, sore, it was a lump, and warm at the injection site; red spot the size of a quarter, sore, it was a lump, and warm at the injection site; came back bigger redder/darker; red spot the size of a quarter, sore, it was a lump, and warm at the injection site; A spontaneous/solicited report was received from a consumer who is 67 year female who experienced a reaction to the vaccine, developed cellulitis around the injection site, with a red spot the size of a quarter that was sore, warm and had a lump which became bigger, redder, and darker (rash macular).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly in an unspecified arm for prophylaxis of COVID-19 infection.     On 02-MAR2-021, the patient initially reported her AE, see previous report MOD21-043017/MOD-2021-032495. She stated that it began to fade between 02-MAR-MAR-2021 through 05-MAR-2021. On 06-MAR-2021 patient states "it came back bigger and redder/darker". She went to a walk in clinic at pharmacy because it was bothering her. She was diagnosed with cellulitis and was told it was either an allergic reaction to the needle or something in vaccine. She stated that when she went to the clinic it wasn't quite 3 inches in diameter. She was prescribed antibiotics, and told to put an ice pack on the injection site as well as take acetaminophen(Tylenol).  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events, reaction to the vaccine, developed cellulitis around the injection site, with a red spot the size of a quarter that was sore, warm and had a lump which became bigger, redder, and darker (rash macular) is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: Cellulitis around the injection site; red spot the size of a quarter, sore, it was a lump, and warm at the injection site; red spot the size of a quarter, sore, it was a lump, and warm at the injection site; red spot the size of a quarter, sore, it was a lump, and warm at the injection site; came back bigger redder/darker; red spot the size of a quarter, sore, it was a lump, and warm at the injection site; A spontaneous/solicited report was received from a consumer who is 67 year female who experienced a reaction to the vaccine, developed cellulitis around the injection site, with a red spot the size of a quarter that was sore, warm and had a lump which became bigger, redder, and darker (rash macular).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 28-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly in an unspecified arm for prophylaxis of COVID-19 infection.     On 02-MAR2-021, the patient initially reported her AE, see previous report MOD21-043017/MOD-2021-032495. She stated that it began to fade between 02-MAR-MAR-2021 through 05-MAR-2021. On 06-MAR-2021 patient states "it came back bigger and redder/darker". She went to a walk in clinic at pharmacy because it was bothering her. She was diagnosed with cellulitis and was told it was either an allergic reaction to the needle or something in vaccine. She stated that when she went to the clinic it wasn't quite 3 inches in diameter. She was prescribed antibiotics, and told to put an ice pack on the injection site as well as take acetaminophen(Tylenol).  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events, reaction to the vaccine, developed cellulitis around the injection site, with a red spot the size of a quarter that was sore, warm and had a lump which became bigger, redder, and darker (rash macular) is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Gait disturbance
Clinical narrative: muscle pain; joint pain; I could barely walk; Temperature increased slightly; sweating; soreness in the arm; Headache; Tiredness; chills; This is a spontaneous report from a contactable consumer. A 55-year-old female patient (non-pregnant) received first dose of BNT162B2 (lot number El9267), via an unspecified route of administration on left arm on 14Feb2021 at 13:00 at the age of 55 year old at a single dose for COVID-19 immunisation at hospital. Medical history included thyroid problems and hypertension. No Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (LEVOXYL) and lisinopril. The patient received other medications within 2 weeks of vaccination. On 07Feb2021 at 16:00, the patient experienced soreness in the arm, headache, tiredness, chills, on 08Feb2021, the next morning with severe soreness in the arm, very severe muscle and joint pain and could barely walk. On 08Feb2021, temperature increased slightly. Chills and sweating. It felt worse than the flu! This morning feeling better, still weak but better. Patient did take Alene to help with the muscle pain, soreness and could barely walk. Seriousness of all the events was reported as non-serious. No treatment was received in response to the adverse events temperature increased slightly, headache, tiredness, chills, joint pain and sweating. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from all the events.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Myalgia, Pain in extremity
Clinical narrative: muscle pain; joint pain; I could barely walk; Temperature increased slightly; sweating; soreness in the arm; Headache; Tiredness; chills; This is a spontaneous report from a contactable consumer. A 55-year-old female patient (non-pregnant) received first dose of BNT162B2 (lot number El9267), via an unspecified route of administration on left arm on 14Feb2021 at 13:00 at the age of 55 year old at a single dose for COVID-19 immunisation at hospital. Medical history included thyroid problems and hypertension. No Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (LEVOXYL) and lisinopril. The patient received other medications within 2 weeks of vaccination. On 07Feb2021 at 16:00, the patient experienced soreness in the arm, headache, tiredness, chills, on 08Feb2021, the next morning with severe soreness in the arm, very severe muscle and joint pain and could barely walk. On 08Feb2021, temperature increased slightly. Chills and sweating. It felt worse than the flu! This morning feeling better, still weak but better. Patient did take Alene to help with the muscle pain, soreness and could barely walk. Seriousness of all the events was reported as non-serious. No treatment was received in response to the adverse events temperature increased slightly, headache, tiredness, chills, joint pain and sweating. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from all the events.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Respiratory distress, Speech disorder, Wheezing
Clinical narrative: acute resp distress; Dyspnea; unable to talk in complete sentences; diffuse wheezing; This is a spontaneous report from a contactable Physician. A 60-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in the left arm on an unspecified date (at 04:00 PM) at single dose in left arm for covid-19 immunization. Medical history included PCN (Penicillin allergy). The patient was not pregnant at the time of vaccination. Concomitant medications included PPI, Thiazide Diuretic, ARB, Muscle relaxant in two weeks. The patient had no other vaccine in four weeks. The patient previously received Metformin and Neomycin, both experiencing drug allergy. The patient reported dyspnea in the post vaccination observation area. Noted to be in acute resp distress (no angioedema noted) unable to talk in complete sentences, diffuse wheezing on auscultation with poor air entry noted." All events started from Feb2021 04:00 PM. AE resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment was received for events, including EPI x 1, IM Steroids, PO Antihistamines, PO Steroids tapered dose. No covid tested post vaccination. Outcome of the events was recovered.   Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject drug BNT162B2 cannot be excluded for the reported events acute resp distress and Dyspnea in this 60 year old female patient. 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nail discolouration, Raynaud's phenomenon, SARS-CoV-2 test
Clinical narrative: finger nails and tips turn blue; Raynaud's disease; This is a spontaneous report from a contactable consumer (patient).    A 37-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left on 28Jan2021 12:00 PM (Lot Number: EL8982) as single dose for COVID-19 immunisation. Medical history included anxiety and penicillin allergy. The patient was not pregnant. The patient did not have COVID prior vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergy. The patient did not receive other vaccine in four weeks. The patient received the first dose on 28Jan2021. On 09Feb2021 10:00 AM, both of her fingers near her finger nails and tips turned blue. (This had never happened to be before). Today, she was diagnosed with Raynaud's disease. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included Amlodipine. The patient had Covid test post vaccination (type: Nasal Swab, name: COVID-19 Ag CARD) on 11Feb2021 with the result: negative. The patient received second dose of bnt162b2 (PFIZER COVID 19 VACCINE, lot number: EM9809) in left arm on 17Feb2021. The outcome of the events was recovered with lasting effects (sequelae).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Inappropriate schedule of product administration, Loss of consciousness, Off label use
Clinical narrative: first dose of BNT162B2 on 27Jan2021 14:00  and second dose on 10Feb2021(range 15 days); first dose of BNT162B2 on 27Jan2021 14:00  and second dose on 10Feb2021(range 15 days); dizziness followed by blackout; dizziness followed by blackout; This is a spontaneous report from a contactable consumer(patient himself).  A 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm left on 10Feb2021 14:00 (at age of 69-year-old)  (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included Penicillin allergy. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 27Jan2021 14:00 (at age of 69-year-old)  in left arm for COVID-19 immunisation. The patient experienced dizziness followed by blackout on 10Feb2021 15:00. There was no treatment received for the events. There was no Covid prior vaccination or Covid tested post vaccination. The outcome of events dizziness followed by blackout  was resolved on unknown date.  Information on the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electrocardiogram, Erythema, Hypertension
Clinical narrative: It got to 217/99; I got really red; This is a spontaneous report received from a contactable consumer (Patient). A 79-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 09Feb2021 at single dose for COVID-19 immunization. Patient's medical history included Cancer, asthma. Concomitant medications included letrozole taken for neoplasm malignant, gabapentin, montelukast taken for asthma. Patient received the first dose after half an hour the patient had such subjective symptoms as red, blood pressure had gotten very high after half an hour of Vaccination. It got to 217/99 having somewhat high blood pressure but not that high. Patient went to the emergency room at a hospital they put me on EKG machine to monitor my heart and took some blood samples. Benadryl was given as treatment. The outcome of the events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Gastrointestinal disorder, Pain in extremity
Clinical narrative: Tiredness; sore arm; stomach and intestinal issues; Diarrhea; very unsettled stomach; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 12Feb2021 at 13:45 (at the age of 68-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included breast and colon cancer, thyroid surgery, controlled blood pressure (BP), and diabetic. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications included trastuzumab (HERCEPTIN) infusions every 3 weeks from an unspecified date for cancer, pertuzumab (PERJETA) from an unknown date for cancer, anastrozole from an unknown date for cancer, levothyroxine sodium (SYNTHROID) from an unknown date for thyroid surgery, nadolol from an unknown date for controlled blood pressure, linagliptin (TRAJENTA) from an unknown date for diabetic, pantoprazole (PROTONIX) from an unknown date for an unknown indication, cetirizine (ZYRTEC) from an unknown date for an unknown indication, and "vita" from an unknown date for an unknown indication. The patient previously received penicillin, aspirin, and medications from yew pine tree from unspecified dates for unspecified indications and experienced allergy. On 06Feb2021 (as reported) the patient experienced tiredness. On "day 2" the patient experienced sore arm, stomach and intestinal issue, diarrhea and very unsettled stomach. The event were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of tiredness and sore arm were recovered on an unspecified date. The outcomes of stomach and intestinal issues, diarrhea and very unsettled stomach were recovered on "day 5". It was also reported that since the vaccine, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Pain, Pyrexia
Clinical narrative: Body aches; fever; headache; chills; lethargy; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received dose 2 of BNT162B2 via an unspecified route of administration on 22Feb2021 at 12:00 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. The patient did not receive any other vaccines within 4 weeks of the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not take any concomitant medications. The patient did not have allergies to medications, food, or other products. The patient previously receive dose 1 of BNT162B2 on 02Feb2021 as a single dose in the left arm for COVID-19 immunization. After dose 2 of BNT162B2, on 23Feb2021 at 00:00 the patient experienced body aches, fever, headache, chills, and lethargy. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of body aches, fever, headache, chills, and lethargy were recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Fatigue, Gallbladder disorder
Clinical narrative: Chills; fatigue; Severe abdominal cramping; Gallbladder attack; This is a spontaneous report from a contactable consumer, patient.   A 73-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) intramuscularly in the left arm on 26Jan2021 at 03:30 AM (at the age of 73-years-old) as a single dose (Batch/Lot Number: EI9262), and received the second dose intramuscularly, in the left arm on 16Feb2021 (at the age of 73-years-old) as a single dose (Batch/Lot Number: EN6201), for COVID-19 immunisation .  Medical history included Penicillin allergy from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included hydrochlorothiazide/ramipril (RAMIPRIL HCTZ).  About a week after both Covid-19 vaccine injections, the patient experienced chills, fatigue, severe abdominal cramping, and gallbladder attack. The patient stated that the chills and fatigue, were expected, but she had severe abdominal cramping and what appeared to be a gallbladder attack. The patient did not have a sore arm or fever. No treatment was received for the events. The patient recovered from the events, chills, fatigue, severe abdominal cramping, and gallbladder attack.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Intraocular pressure increased
Clinical narrative: Slight head and eyes pressure; slight head and eyes pressure, light a cloud in his head; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 1 via an unspecified route of administration, administered in arm right on 23Feb2021 08:15 as single dose for covid-19 immunisation. Medical history included Heart issues, 10 attacks, 11 stents. The patient's concomitant medications were not reported. No covid prior vaccination. No covid tested post vaccination. The patient previously took metoprolol and experienced allergies. The patient experienced slight head and eyes pressure, light a cloud in his head on 23Feb2021 08:15. No treatment received. Gone by the time he got home 1/2 hour later. The outcome of events was recovered.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Dizziness, Heart rate, Heart rate increased, Heart rate irregular
Clinical narrative: dizziness/ light headedness; rapid heart rate at 130; irregular heartbeat; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Feb2021 11:00 (Batch/Lot Number: EL9265) as single dose for covid-19 immunisation. The patient was not pregnant. Medical history included irregular heart beat, controlled hypertension, high chloresterol. Known allergies included sertraline hydrochloride (ZOLOFT). There was no covid prior vaccination. No covid tested post vaccination. There was no other vaccine in four weeks. Other medications in two weeks included ezetimibe taken for an unspecified indication, start and stop date were not reported; duloxetine taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported and cholesterol medications. The patient had light headedness, dizziness, rapid heart rate at 130, irregular heartbeat; on 20Feb2021 11:30 AM. The patient went to hospital on the 2nd day after vaccine. Events resulted in Emergency room/department or urgent care. Treatment received for the events included fluids and meclizine 25 mg. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received her first Pfizer vaccine on 10Feb2021.  She has tested positive today; received her first Pfizer vaccine on 10Feb2021. She has tested positive today; This is an initial spontaneous report from a contactable pharmacist. A 66-years-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 10Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced drug ineffective, covid-19 on 23Feb2021. Clinical course reported as Pharmacist calling from (Pharmacy name) asking for guidance on a patient, female, aged 66 who received her first Pfizer vaccine on 10Feb2021. She has tested positive today, she wants to know if she can still receive her second dose on 10Mar2021? Caller refused transfer. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown.  No follow-up attempts are possible. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Covid-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over; This is a spontaneous report from a contactable consumer.   A 71-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 10Feb2021, at 09:45 as single dose for covid-19 immunization.  The patient medical history was not reported.   There were unspecified concomitant medications.   On 18Feb2021, at 08:00 patient experienced rash all over ( this occurred eight days the vaccine was given) and described as terrible rash all over her body.  Therapeutic measures were taken as a result of rash all over in the form of prednisone cream. The patient did not have COVID prior to vaccination, and no COVID test post vaccination. The outcome of  rash all over  was not recovered.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Disorientation, Headache, Nausea, Pain
Clinical narrative: nausea; headache; body ache "all over"; chills; very drowsy; disoriented; This is a spontaneous report from a contactable health professional, the patient. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On Feb2021, the patient experienced nausea, headache, body ache "all over", chills and was very drowsy and disoriented. The patient questioned the efficacy of the vaccine after the first dose. The clinical outcome of nausea, headache, body ache "all over", chills, very drowsy and disoriented was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: nausea; headache; body ache "all over"; chills; very drowsy; disoriented; This is a spontaneous report from a contactable health professional, the patient. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On Feb2021, the patient experienced nausea, headache, body ache "all over", chills and was very drowsy and disoriented. The patient questioned the efficacy of the vaccine after the first dose. The clinical outcome of nausea, headache, body ache "all over", chills, very drowsy and disoriented was unknown.  Information on the lot/batch number has been requested.