chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site rash, Lip erythema, Myalgia, Pyrexia
Clinical narrative: Fever,  headache,  rash at injection site, muscle pain, red patch on upper lip 24hrs later
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given past beyond use date, no adverse event associated
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: 6 hours after booster, sore arm. Tylenol taken.  12 hours after booster, fever of 101.1. Tylenol taken.  18 hours after booster, fever of 101.5, heart palpitations, chest feeling "squeezed" Tylenol taken. 24 hours after booster, fever of 102.5, heart palpitations, difficulty breathing,  Tylenol taken 30 hours after booster, fever is broken, heart and chest is back to normal, hives across left arm, left side of chest and back.   I had no serious reactions to the first moderna shot, and while I had a strong immune reaction to the second shot, I had no concerning side effects like I did for my booster.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 6 hours after booster, sore arm. Tylenol taken.  12 hours after booster, fever of 101.1. Tylenol taken.  18 hours after booster, fever of 101.5, heart palpitations, chest feeling "squeezed" Tylenol taken. 24 hours after booster, fever of 102.5, heart palpitations, difficulty breathing,  Tylenol taken 30 hours after booster, fever is broken, heart and chest is back to normal, hives across left arm, left side of chest and back.   I had no serious reactions to the first moderna shot, and while I had a strong immune reaction to the second shot, I had no concerning side effects like I did for my booster.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Headache, Lethargy, Lymphadenopathy
Clinical narrative: Swollen and sore left armpit, center of chest is sore, mild headache, lethargic
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abnormal faeces, Biopsy, Blood cholesterol, Blood test
Clinical narrative: Severe watery diarrhea and abdominal pain occurring 3-5 days after vaccination. This continued at same level for 1-3 weeks. GI symptoms have progressed since with continuing abdominal pain, diarrhea, constipation, nausea, vomiting and heartburn. Abnormal stools, yellow and/or pale, diarrhea, loose stools and infrequent blood in stools.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, Colonoscopy, Computerised tomogram, Computerised tomogram abdomen
Clinical narrative: Severe watery diarrhea and abdominal pain occurring 3-5 days after vaccination. This continued at same level for 1-3 weeks. GI symptoms have progressed since with continuing abdominal pain, diarrhea, constipation, nausea, vomiting and heartburn. Abnormal stools, yellow and/or pale, diarrhea, loose stools and infrequent blood in stools.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Culture, Diarrhoea, Differential white blood cell count, Dyspepsia
Clinical narrative: Severe watery diarrhea and abdominal pain occurring 3-5 days after vaccination. This continued at same level for 1-3 weeks. GI symptoms have progressed since with continuing abdominal pain, diarrhea, constipation, nausea, vomiting and heartburn. Abnormal stools, yellow and/or pale, diarrhea, loose stools and infrequent blood in stools.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Haematochezia, Hepatobiliary scan, Laboratory test, Lipase decreased
Clinical narrative: Severe watery diarrhea and abdominal pain occurring 3-5 days after vaccination. This continued at same level for 1-3 weeks. GI symptoms have progressed since with continuing abdominal pain, diarrhea, constipation, nausea, vomiting and heartburn. Abnormal stools, yellow and/or pale, diarrhea, loose stools and infrequent blood in stools.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Nausea, Pallor, Ultrasound scan, Urine analysis
Clinical narrative: Severe watery diarrhea and abdominal pain occurring 3-5 days after vaccination. This continued at same level for 1-3 weeks. GI symptoms have progressed since with continuing abdominal pain, diarrhea, constipation, nausea, vomiting and heartburn. Abnormal stools, yellow and/or pale, diarrhea, loose stools and infrequent blood in stools.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe watery diarrhea and abdominal pain occurring 3-5 days after vaccination. This continued at same level for 1-3 weeks. GI symptoms have progressed since with continuing abdominal pain, diarrhea, constipation, nausea, vomiting and heartburn. Abnormal stools, yellow and/or pale, diarrhea, loose stools and infrequent blood in stools.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received first dose of bnt162b2 (BNT162B2, Batch/Lot number: Unknown) administration date 04Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 04Mar2021, outcome "unknown", described as "headache".  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Fatigue, Headache
Clinical narrative: extreme fatigue weakness diarrhea headache fever vomiting severe abdominal pain
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: extreme fatigue weakness diarrhea headache fever vomiting severe abdominal pain
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mobility decreased, Sleep disorder
Clinical narrative: About 30 hours after the shot, I had SUCH sore lymph nodes in my armpit that I could not even move my arm to pull down my pants to urinate. I could not sleep that night because I was too uncomfortable.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric Pfizer dose (10 microgram) was given to 12 year old child instead of adult dose (30 microgram dose). No other side effects are reported
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac abnormal, Chest pain, Condition aggravated, Vascular graft thrombosis
Clinical narrative: Patient had 4 vessel CABG on 12/3/2021. On the day of discharge (12/8/2021), patient was given Moderna booster. On 12/15/2021, he was admitted for severe chest pain and taken to cath lab. Found to have thrombosed one of the bypass grafts to the ramus medianus and obtuse marginal branch.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Pediatric dose (10 microgram) was given to 12 year old child (30 microgram) .No side effects are reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Acute sinusitis, Paranasal sinus discomfort, Sinus congestion, Skin discolouration
Clinical narrative: Initial symptom was a purple discoloration around both eyes that was identified on the afternoon of 11/27/2021. Then several days later on 12/1/2021 started having feeling of pressure/congestion of the sinuses.  Had a virtual doctor visit with my primary care physician, Dr. (PRIVACY) on 12/3/21, who diagnosed acute sinusitis and prescribed antibiotics (Amoxicillin-Pot Clavulanate) and a nasal spray (Fluticasone Propionate 50 MCG/ACT).  As of 12/16/21, have recovered from the sinusitis and symptoms are no longer present.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Pulmonary embolism, Ultrasound Doppler abnormal
Clinical narrative: Patient developed left lower extremity DVT and subsequent PE. He has no other risk factors for thrombosis. No recent surgeries or immobilizations. No chronic medical conditions. Of note, the patient also developed a Bell's Palsy after the first dose of his Moderna Vaccine which was given on 10/13/2021.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate decreased, Hypersensitivity, Pruritus
Clinical narrative: The next day upon applying lotion, patient experienced what she felt were allergy symptoms: itching and difficulty breathing. Husband took her to EMS. Heart rate also dropped very low.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body height
Clinical narrative: 2 days ago I had a pain in lower back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 83-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Feb2021 10:00 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (ongoing); "Arthritis" (unspecified if ongoing), notes: Caller states Her hands hurt because of arthritis, she goes on to mention she has salve she uses. Caller reports she Osteoporosis. The patient took concomitant medications. The following information was reported: BACK PAIN (non-serious) with onset 25Feb2021, outcome "recovering", described as "2 days ago I had a pain in lower back". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of back pain.  Additional information: The patient stated I had the vaccination a week ago, then 2 days ago I had a pain in lower back." Caller wants to know if she can take Advil. Caller wants to know if the back pain is related to arthritis or the vaccine. Caller states She only take vitamins.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue, Feeling abnormal, Hypersensitivity
Clinical narrative: Patient has had fatigue, depression, and chronic allergies since the first shot. Patient says, "Something happened, and I don't feel like myself."
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Supraclavicular lymph node enlarged
Age: 21.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Burning sensation, Injection site inflammation, Rash, Rash pruritic, Urticaria
Clinical narrative: Symptoms began with mild rash on torso on 12/12/21. Rash spread to face on 12/13/21 which was noticed after waking from a nap at 5:00 pm., the injection site was also inflamed. By 6 pm the rash was significantly worse on thighs, torso, arms, neck and the hives on her face intensified. By 7 pm her face was nearly fully covered with hives, rash had also intensified in all other areas of her body and the site of injection was more inflamed. Due to the rapid progression of the rash/hives across her body, I took her to the ER where she was given Prednisone and Benedryl. Two days later the hives have gone down a bit, but are still quite significant, along with the rash over her body. It's interesting that she has hives on her face, but the rest of the affected areas have a rash. All of the affected areas are itchy, painful and feel like they are on fire. She is four days in and has only experienced mild relief from the medicines provided and also from using cool washcloths to help reduce all her symptoms.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Energy increased, Pyrexia, Sleep disorder
Clinical narrative: 12 hours post Moderna booster, chills along with a fever lasting 24 hours. 48 hours later extreme energy (fatigue is normally an everyday MS symptom) accompanied by inability to fall asleep, which is never an issue for me. I've now been up 20 hours straight with no feeling of being tired. I also have not felt hunger since the booster shot. All the above follows exactly what I experienced after my 2nd dose of the COVID-19 vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given a booster dose (0.25mL) of Moderna instead of a full dose (0.5mL) as this was patient's 2nd dose. Patient was notified and returned to the clinic to receive another 0.25mL dose of Moderna. No reactions or adverse event from receiving 2 injections.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Syncope, Unresponsive to stimuli
Clinical narrative: Patient fell from a chair, he was found in prone position. Upon assessment patient did not respond to verbal commands, 911 was then called. After approximate five seconds patient was verbal and moving. He was coherent to person, place, time, and situation. Patients vitals post syncope episode were T. 98.2 R. 22 P. 96 B/P 131/71 spo2 96% on room air
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Faeces discoloured, Haematochezia, Haemorrhage subcutaneous, Injection site induration
Clinical narrative: Friday the 10th, a week after the Moderna booster shot, when I scratched my skin to relieve itching subcutaneous bleeding arose on the site of scratching, which usually never happens to me for any reason.  I've been applying anti-itch ointments since then to prevent further instances.  Also a subcutaneous bleed of an ancient surgical scare erupted in a place I didn't scratch, on that same day, which it also did almost a year ago when I came down with a bad cough from attending jury duty and caught whatever was floating around. (Early COVID? Don't know, but it was a hell of a bad cough with strong colored and sticky production from coughing).   Other than these two instances in this past year, the latest being in the past week, that scar never bleed subcutaneously in any manner since I had an aneurstic cyst removed there when I was about 7 or 8 years old.  It had  been utterly static for decades.    Today, the 15th, my mouth started bleeding from an oral surgery site that hasn't bleed, but had fully healed, by at least May 2021.  It was a small bleed I could stop with compression, but utterly unaccounted for by any act of eating or other pressure on the bleed site before it started bleeding.  I also am uncertain but suspect I had some blood in stool, brownish-red not fully to tar stage of black but not fully red for fresh blood either.    I had only minor hardness and soreness at the injection site which went away the day after the injection otherwise.  I cannot account for mysterious bleeding except for some response to the 3rd booster shot of Moderna.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Mouth haemorrhage, Pruritus, Scratch
Clinical narrative: Friday the 10th, a week after the Moderna booster shot, when I scratched my skin to relieve itching subcutaneous bleeding arose on the site of scratching, which usually never happens to me for any reason.  I've been applying anti-itch ointments since then to prevent further instances.  Also a subcutaneous bleed of an ancient surgical scare erupted in a place I didn't scratch, on that same day, which it also did almost a year ago when I came down with a bad cough from attending jury duty and caught whatever was floating around. (Early COVID? Don't know, but it was a hell of a bad cough with strong colored and sticky production from coughing).   Other than these two instances in this past year, the latest being in the past week, that scar never bleed subcutaneously in any manner since I had an aneurstic cyst removed there when I was about 7 or 8 years old.  It had  been utterly static for decades.    Today, the 15th, my mouth started bleeding from an oral surgery site that hasn't bleed, but had fully healed, by at least May 2021.  It was a small bleed I could stop with compression, but utterly unaccounted for by any act of eating or other pressure on the bleed site before it started bleeding.  I also am uncertain but suspect I had some blood in stool, brownish-red not fully to tar stage of black but not fully red for fresh blood either.    I had only minor hardness and soreness at the injection site which went away the day after the injection otherwise.  I cannot account for mysterious bleeding except for some response to the 3rd booster shot of Moderna.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse food reaction, Food allergy, Hypersensitivity, Vomiting
Clinical narrative: Developed several allergic reactions after 30 years of no allergies, developed wheat allergies, perfuse vomiting after any consumption of red sauces or tomato.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Urticaria
Clinical narrative: After booster shot, experienced hives everywhere. Also heartburn and allergy like symptoms
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 09:15 (Lot number: EL3247) at the age of 60 years as dose 1, single and administered in arm right (Lot number: EP6955) as dose 2, single for covid-19 immunization.   The patient's relevant medical history was not reported. Concomitant medication(s) included: atorvastatin.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Mar2021 17:00, outcome "recovering", described as "Soreness at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not have covid prior vaccination and was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Coagulation test, Computerised tomogram, Deafness unilateral
Clinical narrative: On October 20, 2021, I suffered acute sudden hearing loss in left ear (75 db loss and pressure test showing inability to moderate ear pressure in left ear).  After running a course of oral steroids at the direction of an ENT doctor, I finished the course of steroids on October 26, 2021.  On October 26, I suffered what appeared to be a stroke and was admitted to Community Hospital.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Sudden hearing loss
Clinical narrative: On October 20, 2021, I suffered acute sudden hearing loss in left ear (75 db loss and pressure test showing inability to moderate ear pressure in left ear).  After running a course of oral steroids at the direction of an ENT doctor, I finished the course of steroids on October 26, 2021.  On October 26, I suffered what appeared to be a stroke and was admitted to Community Hospital.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: The vial of the vaccine was wrongly diluted in 0.8 ml NS 0.9% instead of 1.8 ml NS 0.9%.  Patient received 0.3 ml from this dilution ( Vial in 0.8 ml NS 0.9%)
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Tiredness; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 03Mar2021 18:00, outcome "unknown", described as "Tiredness"; CHILLS (non-serious) with onset 03Mar2021 18:00, outcome "unknown", described as "Chills".  Additional information: Patient reported a week before she got the vaccine, she would take Emergen-C 1000 vitamin C drink which would usually give her energy and helps her immune system. She would like to know if she can take Emergen-C now after having her vaccine dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Vaccination site pain
Clinical narrative: Slightly elevated temperature - 99.2F; Pain at the injection site; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Mar2021 10:00 (Lot number: EL3247) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "penicillin" (unspecified if ongoing); "Arthritis" (ongoing), notes: Pertinent details: minor arthritis in hands and feet, age related.; "High Cholesterol", start date: Oct2020 (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol increased, start date: Oct2020 (ongoing). Vaccination history included: Bnt162b2 (First dose, Time; 10:00  Am, Date: 11Feb2021, Anatomical site of the injection: left arm, Parent route of administration: intramuscular, Lot/ batch number: EL3247), administration date: 11Feb2021, for COVID-19 Immunisation, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 04Mar2021 06:00, outcome "recovered" (2021), described as "Slightly elevated temperature - 99.2F"; VACCINATION SITE PAIN (non-serious) with onset 04Mar2021 06:00, outcome "recovered" (2021), described as "Pain at the injection site"; HEADACHE (non-serious) with onset 04Mar2021 06:00, outcome "recovered" (2021), described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of body temperature increased, vaccination site pain, headache.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient have not been tested for COVID-19. The patient received third dose of bnt162b2 (BNT162B2, Batch number: EW0217) via an Intramuscular route of administration on left arm on 14Oct2021 for COVID-19 immunization. She became aware (i.e., made connection between her symptoms and the vaccine received) in the evening of 4Mar2021. She filed her report on March 5, in the morning. At that time she realized that her symptoms started earlier the day before (she was not aware of it then, made no connection). She had a progressively worse reaction to the vaccinations practically none with the first dose slight fever/ injection site pain with the second. After third dose she had 38.2 c fever for two days in the morning of the second day she was not able to stand due to feeling dizzy (symptoms resolved by the evening). She had slight diarrhea for a day. The injection site was painful for year couple of days then become red and itchy. All symptoms got resolved. She was healthy and active 71 year old. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: About 12 hours after receiving the vaccine, I vomited.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). The reporter is the patient. A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 09:30 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "allergy". The following information was reported: VOMITING (non-serious) with onset 04Mar2021 21:00, outcome "recovered" (Mar2021), described as "About 12 hours after receiving the vaccine, I vomited.". Therapeutic measures were not taken as a result of vomiting. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient not diagnosed with COVID-19 and since the vaccination, the patient not been tested for COVID-19. This events were reported as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: uncontrollable shivering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 08:30 (Lot number: EL3247) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRAZODONE; GLUCOSAMINE; IBUPROFEN. Past drug history included: Vicodin, reaction(s): "drug allergy", notes: Known allergy: Vicodin. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical Location: Arm Right, lot number: EL3247, Time: 09:00 AM), administration date: 11Feb2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 04Mar2021 22:30, outcome "recovered" (Mar2021), described as "uncontrollable shivering". Therapeutic measures were not taken as a result of chills.  Additional information: Event Description: Approximately 14 hours after receiving second dose patient experienced chills and uncontrollable shivering. The symptoms lasted approximately 4 hour to 6 hours. The patient had no other vaccine within four weeks and other medications received within 2 weeks of vaccination included trazodone, glucosamine, multi vitamin, ibuprofen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: injection site pain; headache; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 09:45 (Lot number: EL3247) at the age of 41 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "headaches/migraine" (unspecified if ongoing); "headaches/migraine" (unspecified if ongoing); "Known allergy/ penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Mar2021, outcome "recovering", described as "injection site pain"; HEADACHE (non-serious) with onset 04Mar2021, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 04Mar2021, outcome "recovering", described as "tiredness". Therapeutic measures were taken as a result of vaccination site pain, headache, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received birth control medication within 2 weeks of vaccination. She received ibuprofen for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Anxiety, Chills, Fatigue, Myalgia
Clinical narrative: injection site pain; fatigue; chills; myalgia; abdominal cramps; anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-years-old male patient received first dose of bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 50 years as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "Hypertension" (unspecified if ongoing); "known allergies: AVELOX" (unspecified if ongoing), notes: AVELOX. Concomitant medication(s) included: ELIQUIS; LEXAPRO; LOSARTIN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Mar2021, outcome "not recovered", described as "injection site pain"; FATIGUE (non-serious) with onset 04Mar2021, outcome "not recovered", described as "fatigue"; CHILLS (non-serious) with onset 04Mar2021, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 04Mar2021, outcome "not recovered", described as "myalgia"; ABDOMINAL PAIN (non-serious) with onset 04Mar2021, outcome "not recovered", described as "abdominal cramps"; ANXIETY (non-serious) with onset 04Mar2021, outcome "not recovered", described as "anxiety". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills, myalgia, abdominal pain, anxiety.  Additional Information: The patient had no other vaccine within 4 weeks. Other medications in two Prior to vaccination: ELIQUIS, LEXAPRO, LOSARTIN. Prior to vaccination, the patient was diagnosed with COVID-19 and was not tested for COVID-19 since the vaccination. Allergies to medications, food, or other products: AVELOX. No treatment was received for the adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; fatigue; chills; myalgia; abdominal cramps; anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-years-old male patient received first dose of bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 50 years as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "Hypertension" (unspecified if ongoing); "known allergies: AVELOX" (unspecified if ongoing), notes: AVELOX. Concomitant medication(s) included: ELIQUIS; LEXAPRO; LOSARTIN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Mar2021, outcome "not recovered", described as "injection site pain"; FATIGUE (non-serious) with onset 04Mar2021, outcome "not recovered", described as "fatigue"; CHILLS (non-serious) with onset 04Mar2021, outcome "not recovered", described as "chills"; MYALGIA (non-serious) with onset 04Mar2021, outcome "not recovered", described as "myalgia"; ABDOMINAL PAIN (non-serious) with onset 04Mar2021, outcome "not recovered", described as "abdominal cramps"; ANXIETY (non-serious) with onset 04Mar2021, outcome "not recovered", described as "anxiety". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills, myalgia, abdominal pain, anxiety.  Additional Information: The patient had no other vaccine within 4 weeks. Other medications in two Prior to vaccination: ELIQUIS, LEXAPRO, LOSARTIN. Prior to vaccination, the patient was diagnosed with COVID-19 and was not tested for COVID-19 since the vaccination. Allergies to medications, food, or other products: AVELOX. No treatment was received for the adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Site injection soreness in arm; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via Regulatory Agency. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04Mar2021, outcome "recovering", described as "Site injection soreness in arm"; FATIGUE (non-serious) with onset 04Mar2021, outcome "recovering", described as "Tiredness". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  Additional information: No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient not diagnosed with COVID-19 and since the vaccination, the patient not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Myalgia, Vaccination site pain
Clinical narrative: I didn't feel great; My muscle in the area where I got the shot was aching; My body is not feeling well; My muscle in the area where I got the shot was aching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I didn't feel great"; MYALGIA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "My muscle in the area where I got the shot was aching"; MALAISE (non-serious), outcome "unknown", described as "My body is not feeling well". The event "i didn't feel great" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of feeling abnormal, myalgia, malaise, vaccination site pain.  Additional information: Date of vaccination: The patient stated that he received first dose on Tuesday and due date for second dose was on 23Mar2021. The patient reported that he had a first dose for Pfizer Covid-19 vaccine and after he got the shot in the morning, in the morning he was okay, but in the afternoon, he did not feel great and his muscle in the area where he got the shot was aching and his body was not feeling well. So, he took the Advil (treatment) in the evening and heard that the Advil would interfere with this creating an antibody and he should have taken Tylenol (further clarification unknown) and so, he wanted to ask about the effectiveness of vaccine after took the Advil. The patient concerned about the effectiveness after took the Advil, it was 200 mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site nodule
Clinical narrative: she had a nodule at the injection site; arm was so sore she couldn't touch it; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE NODULE (non-serious), outcome "unknown", described as "she had a nodule at the injection site"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was so sore she couldn't touch it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Bite, Dermatitis contact
Clinical narrative: Showing a couple of like mosquito bite on his neck and then on his shoulder it was like raised area; It was on the neck and the shoulder area and little bit on the back area like at top of your back; He was showing some little like I would say almost like when you get Poison ivy or something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 67-years-old male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: E19267) at the age of 67 years as unknown, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication(s) included: ATORVASTATIN; METFORMIN taken for diabetes mellitus. The following information was reported: BITE (non-serious), outcome "unknown", described as "Showing a couple of like mosquito bite on his neck and then on his shoulder it was like raised area; It was on the neck and the shoulder area and little bit on the back area like at top of your back"; DERMATITIS CONTACT (non-serious), outcome "unknown", described as "He was showing some little like I would say almost like when you get Poison ivy or something".  Additional Information: When probed for the concern, the reporter stated, she was actually calling for her husband (Consumer/Patient), he took the PFIZER COVID-19 vaccine on Monday (01Mar2021) but it looked like he got a little rash, like a mosquito and stuff kind of on his neck and may be on top of his shoulder, so she was trying to see if anything was alarmed about. When probed for weight, she stated, that about 250 pounds." (Further not clarified. Hence, not captured in the tab). About Lot Number: She stated E19267 (not clarified further, hence not captured in tab). About start date of events: She stated, she would say Tuesday (not clarified further). About outcome of events: She stated that it was still persisting (events not paraphrased and clarified further, hence persisting not checked in seriousness criteria). When probed for vaccine expiration date, reporter stated, no expiration date. When probed for any treatment for the problem, she stated that no, not really, he kind of rubbed like alcohol along it but no he did not take any medicine because he did not really knew what he was taking it for.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Chills, SARS-CoV-2 test, Vomiting
Clinical narrative: vomiting; chills; swollen stomach; Stomach cramps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Lot number: EL9264) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "low immune system" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: Received on 30Jan2021, lot EL9262, expiration 31May2021. Dosage 0.3 ml.), administration date: 30Jan2021, when the patient was 59 years old, for COVID-19 immunisation. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 22Feb2021, outcome "not recovered", described as "Stomach cramps"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; CHILLS (non-serious), outcome "unknown", described as "chills"; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "swollen stomach". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Results of tests on 01Mar2021, test: COVID-19 PCR test, result: negative.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: sores; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "heart stent" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "sores".  Additional information: The patient reported that patient just got my 2nd vaccine dose and patient is fine. Patient just got some sores but patient is ok. Patient have had a heart stint in the past. Do you have a trial for people with pre-existing conditions such as Heart conditions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Muscle discomfort, Musculoskeletal discomfort
Clinical narrative: after the second injection, feel I may have some longer lasting effects in my bicep muscle and shoulder joint; after the second injection, feel I may have some longer lasting effects in my bicep muscle and shoulder joint; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Feb2021 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st inj. 15Jan2021, Lot EL1283), administration date: 15Jan2021, for COVID-19 immunisation. The following information was reported: MUSCLE DISCOMFORT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown" and all described as "after the second injection, feel I may have some longer lasting effects in my bicep muscle and shoulder joint".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feel I may have some longer lasting effects in my bicep muscle and shoulder joint; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Jan2021 (Lot number: EL1283) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "feel I may have some longer lasting effects in my bicep muscle and shoulder joint".  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Experiencing a very sore arm and it is hard to lift it and  it is just sore, real sore/I can hardly raise my arm and it hurts; Experiencing a very sore arm and it is hard to lift it and  it is just sore, real sore/I can hardly raise my arm and it hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73-year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 11:20 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for Covid-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious) all with onset 03Mar2021, outcome "unknown" and all described as "Experiencing a very sore arm and it is hard to lift it and it is just sore, real sore/I can hardly raise my arm and it hurts". Therapeutic measures were not taken as a result of pain in extremity, mobility decreased.  Additional information: the patient wanted to know was it was a natural effect of the shot. She mentioned that the first one was fine and after the second one when she noticed it was sore. Consumer stated that she did not receive any treatment. She just hoped that it would go away. Comment: This case might be spilt since further clarifications about husband was unknown, hence split not made.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Weight
Clinical narrative: Experiencing a very sore arm and it is hard to lift it and it is just sore, real sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient's wife).  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 11:10 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for covid-19 immunization, reaction(s): "No problems". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Mar2021, outcome "unknown", described as "Experiencing a very sore arm and it is hard to lift it and it is just sore, real sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had the first COVID shot and was fine. And received the second COVID shot and experiencing Sore arm, can hardly raise arm and it hurts and it is sore. Got vaccine on 02Mar2021 and yesterday (03Mar2021) woke with the sore arm and also this morning (04Mar2021) with a sore arm. The patient got the vaccine at (hospital name). The reporter wanted to know if it is a natural affect of the shot, the vaccine or not. No Investigation Assessment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm".  Additional information: The patient wanted to know if she could take Tylenol for the pain in her arm but did not want to be transferred. She decided to call someone tomorrow to see if she can take Tylenol. Was not able to read ISI or IVR due to reporter hanging up. It was unknown if the reporter is a Healthcare Professional (HCP) or not and Is the reporter the prescribing HCP or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.