chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable pharmacist reported similar events for three patients. This is the third of the three reports. A patient of unspecified age and gender received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Jan2021, for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. On an unspecified date in 2021, after the first vaccination, the patient had COVID-19 confirmed by positive COVID-19 test and was put on isolation. The outcome of the event was unknown. The reporting pharmacist was wondering if there was a need to hold off the second dose of vaccination or if it could be administered on 07Feb2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity after the first vaccine dose.,Linked Report(s) : US-PFIZER INC-2021148508 same drug and event, different patient;US-PFIZER INC-2021148568 same drug and event, different patient
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Oedema, Pain in extremity, Pruritus, Rash
Clinical narrative: Flu like symptoms; Full body rash with itching; Full body rash with itching; localized arm pain with ancillary edema x 5 days; localized arm pain with ancillary edema x 5 days; This is a spontaneous report from a contactable nurse (patient). The nurse reported 2 reports for same patient, same product. This is the second report. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ3246), intramuscular in the right arm on 12Jan2021 08:30 AM at single dose for covid-19 immunisation. Known allergies included Tramadol and Lexapro. No other medical history. Concomitant medication (Other medications in two weeks) included VITAMIN B complex (B COMPLEX), collagen marine, methylsulfonylmethane (MARINE COLLAGEN PEPTIDES WITH MSM), saw palmetto [serenoa repens] and zinc. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685, administrator route=Intramuscular, vaccine location=Left arm) on 22Dec2020 at age of 39-year-old for covid-19 immunisation and experienced general malaise with nausea and diarrhea, localized pain 3-4/10 after first dose x 5 days. The patient experienced full body rash with itching, localized arm pain with ancillary edema x 5 days. Flu like symptoms. After second dose in 2021. Treatment for events included Antihistamine. No Covid prior vaccination. The outcome of events was recovering. Unknown if Covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021123153 same patient, same product (first dose), different events.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Glycosylated haemoglobin, Pruritus, Skin depigmentation, Urticaria
Clinical narrative: I have broken out in welts all over my body and I am itching like absolute crazy; I have broken out in welts all over my body and I am itching like absolute crazy; My face is red as a bee and I even got it on my legs and my arm; all for my feet and legs are covered with white, itch spots; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) at the age of 84-years-old, via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure, diabetes, and allergies. Concomitant medications included unspecified medications. The patient got the COVID vaccine on 18Jan2021 and she has been okay until last week. The patient has broken out in welts all over her body and was itching like absolute crazy on Jan2021. She went to her doctor on Friday but couldn't see him because he had too many people, but she asked a PA (as reported) to tell the doctor to see him. The doctor wanted to know what she has done. She mentioned that she has been at her house ever since last March because of the virus. She hasn't even been to a grocery store or anywhere. She was given ZYRTEC, PEPCID, and something to put on, it's Triamcinolone to put on twice a day. She mentioned that Triamcinolone has been helping her since Friday, but now it's not doing a thing. She was just scratching. Her face was red as a bee and she even got it on her legs and arm. It started on her hands and now, it was going up her arms. This started a week ago (Jan2021). She was suffering from the symptoms, all her feet and legs were covered with white, itch spots and they all go together. She mentioned that she was going to see another doctor tomorrow or go to the hospital or somewhere again. She couldn't stand this and added that you don't understand how serious this is. She was supposed to get the second shot tomorrow and mentioned that she was afraid to get it. The patient underwent lab test and procedure which included A1C with an unknown result on an unspecified date. The outcome of the events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasal congestion
Clinical narrative: chills; congestion; tiredness; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. Medical history included diabetes, sleep apnea, post-traumatic stress disorder (PTSD), anxiety, herpes, vitamin d deficiency, environmental allergies, asthma, allergies to possible latex. Concomitant medications included unspecified medications in two weeks. No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 on 16Jan2021 08:00 in left arm for COVID-19 immunization and experienced sore arm, slept for 17 straight hours, chills, upset stomach, upper body flushing for up to 4 days later. The patient experienced chills, congestion, tiredness, all on 06Feb2021. So far not near as bad as 1st time, but took 25mg benadryl and 1000mg of Tylenol, and a dose of pepcid just before she got the shot under advise of physician and nurse practitioner due to previous side effects. No Covid test post vaccination. The outcome of the events was recovered in Feb2021.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in jaw
Clinical narrative: Worsened sharp headaches; jaw pain; This is a spontaneous report from a contactable healthcare professional (patient). A 32 years old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3246) intramuscular, in left arm, on 15Jan2021 at 09:30, for COVID-19 immunisation. The first dose of vaccine was given on 23Dec2020 at 17:30, intramuscular, in left arm (lot EJ1685), at the age of 31 years, experiencing right ear infection and right sided headaches 2 weeks after this first dose. No other vaccine was given in four weeks. Medical history included asthma, known allergies: a yellow mushroom from overwatering house plants, PCOS, eczema. The patient had no COVID prior vaccination and had not been tested for COVID post vaccination. Concomitant medication included topical triamcinolone acetonide 0.1% cream. On an unspecified date in 2021 the patient experienced worsened sharp headaches with jaw pain. Headaches became mild and jaw pain relieved when she removed ear wax. The final events outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: fatigue; achy body; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history included ongoing psoriatic arthritis. The patient's concomitant medications were not reported. The patient experienced fatigue and achy body on an unspecified date. The outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Energy increased, Therapeutic response unexpected
Clinical narrative: felt less tired/ increase of energy; felt less tired/ increase of energy; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  Medical history included COVID-19 (last spring with severe symptoms) from an unknown date to an unknown date. The patient reported that: "I still was very tired from COVID-19.  I felt less tired/ increase of energy after first Pfizer vaccine. " on an unspecified date. The patient outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache; body aches; Fever; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received bnt162b2 (BNT162B2) , via an unspecified route of administration from an unspecified date, as a single dose for COVID-19 immunization. Medical history included had Covid last spring with severe symptoms. Concomitant medications were not reported.  The patient reported that  "I still was very tired from COVID. I felt less tired after first Pfizer vaccine. I had headache fever and body aches after second one and now have even more energy. The outcome of the events was unknown.  Information regarding lot number has been request.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: mild headache; mild bodyache; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (Solution for injection, Batch/Lot: unknown) via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications was not reported. Patient did not had Covid prior vaccination. Patient was not tested for Covid tested post vaccination. The patient experienced mild headache, mild body ache on 03Feb2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Slight Fever (100.4 F); Fatigue; Chills; Moderate pain at Injection Site; This is a spontaneous report received from a contactable consumer. A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on 03Feb2021 15:30 to Left arm at single dose for COVID-19 immunization. Medical history included Shellfish, Tree Nuts (Migraine Trigger). Concomitant medications were not reported. Past drug included BNT162B2 (dose number:1). It was reported as on 04Feb2021 06:30 patient experienced with Slight Fever (100.4 F), Headache, Fatigue, Chills and Moderate pain at Injection Site. Treatment was not received for events. Outcome of events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected. Information regarding Lot/Batch No. cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; Slight Fever (100.4 F); Fatigue; Chills; Moderate pain at Injection Site; This is a spontaneous report received from a contactable consumer. A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration on 03Feb2021 15:30 to Left arm at single dose for COVID-19 immunization. Medical history included Shellfish, Tree Nuts (Migraine Trigger). Concomitant medications were not reported. Past drug included BNT162B2 (dose number:1). It was reported as on 04Feb2021 06:30 patient experienced with Slight Fever (100.4 F), Headache, Fatigue, Chills and Moderate pain at Injection Site. Treatment was not received for events. Outcome of events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected. Information regarding Lot/Batch No. cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Nightmare
Clinical narrative: 5 nights having nightmares; waking with rapid heart rate; This is a spontaneous report from a non-contactable consumer (patient). A70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the left arm on 30Jan2021, at 14:30 (age at vaccination: 70 years) as a single dose for COVID-19 immunisation. The patient medical history included IgA blood deficiency, hypothyroidism and allergy to horse serum. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication included levothyroxine sodium (LEVOTHYROXIN) at 88ug daily, monascus purpureus (RED YEAST RICE), glucosamine hcl + msm (glucosamine hydrochloride;methylsulfonylmethane), calcium, fish oil, loratadine (CLARITIN), minerals nos, vitamins nos (ONE A DAY). The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that during the 2 weeks after the first dose, the patient experienced 5 nights having nightmares and waking with rapid heart rate on 05Feb2021. The patient did not receive any treatment for the events. The events were reported as non-serious by the reporter. The outcome of the events 5 nights having nightmares and waking with rapid heart rate was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site induration, Vaccination site rash
Clinical narrative: Rash at injection site and Induration; Rash at injection site and Induration; headache; This is a spontaneous report from a non-contactable consumer or other non hcp. A 34-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EH9899), on Left arm via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot no: EL3246) on Left arm on 06Jan2021 for covid-19 immunisation and experienced 12hours after injection felt like cold, malaise, bigger rash than first dose, 1 inch induration, felt better after 48 hours with Tylenol. It was reported on 16Dec2020 due to first dose patient experienced rash at injection site and Induration, headache that lasted until day 2 after taking Tylenol. There was no COVID prior vaccination and no COVID tested post vaccination. Patient was not pregnant while vaccination. There was no known allergies. Outcome of the events was recovered on unspecified date.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Induration, Malaise, Rash
Clinical narrative: 12hours after injection felt like cold; malaise; bigger rash than first dose; 1 inch induration; This is a spontaneous report from a non-contactable consumer or other non hcp. A 34-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no:EL3246), on Left arm via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot no: EH9899) on Left arm on16Dec2020 for covid-19 immunisation and experienced Rash at injection site, Induration and headache. It was reported that 12hours after injection (Jan2021) of second dose felt like cold, malaise, bigger rash than first dose, 1 inch induration, felt better after 48 hours with Tylenol. There was no COVID prior vaccination and no COVID tested post vaccination. Patient was not pregnant while vaccination. There was no known allergies. Outcome of the events was recovering.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Palpitations, Vaccination site pain
Clinical narrative: Heart palpitations; sore injection site; body aches in the back; headache; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 58-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: 013L20A) via an unspecified route of administration on 05Feb2021 08:45 in left arm at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There was no other vaccine in four weeks. The patient had heart palpitations after vaccine - only lasting a few seconds, sore injection site and body aches in the back - both of which were relieved with naproxen sodium (ALEVE), small headache - went away shortly after getting out of bed. Event onset date reported as 05Feb2021 12:30. Treatment received for the events. The outcome of the event heart palpitations was recovered on 05Feb2021, of other remain events was recovered in Feb2021.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Fatigue, Pain, Productive cough
Clinical narrative: excess phlem; Exhaustion; Body aches; fever; chills; cold sweat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3247), via an unspecified route of administration on right arm on 04Feb2021 10:00 (at age of 48 years old) at single dose for COVID-19 immunization. Medical history included spinal stenosis, liver hemangiomas, uterine fibroids, parapelvic and renal cysts, complex left ovarian cysts, PTSD (Post-traumatic stress disorder), pap smear atypical cells of undetermined significance, endometrial cells, bacterial vaginosis, HPV (Human papilloma virus infection), osteopenia, anemia, patellar tendenitis, right hip impingement, left shoulder impingement syndrome, microscopic hematuria, hiatal hernia, cricopharyngeal spasms and allergies to contrast die. Concomitant medication included pregabalin (LYRICA), sertraline hydrochloride (ZOLOFT), colecalciferol (VIT.D3) and glutathione. The patient previously received first dose of BNT162B2 (Lot number=EL3247) on 15Jan2021 at 10:45 AM on right arm for COVID-19 immunization. The patient experienced excess phlem, exhaustion, body aches, fever, chills, cold sweat on 04Feb2021 17:00. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment from events. The outcome of events was recovered in Feb2021.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: excess phlem; Exhaustion; Body aches; fever; chills; cold sweat; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3247), via an unspecified route of administration on right arm on 04Feb2021 10:00 (at age of 48 years old) at single dose for COVID-19 immunization. Medical history included spinal stenosis, liver hemangiomas, uterine fibroids, parapelvic and renal cysts, complex left ovarian cysts, PTSD (Post-traumatic stress disorder), pap smear atypical cells of undetermined significance, endometrial cells, bacterial vaginosis, HPV (Human papilloma virus infection), osteopenia, anemia, patellar tendenitis, right hip impingement, left shoulder impingement syndrome, microscopic hematuria, hiatal hernia, cricopharyngeal spasms and allergies to contrast die. Concomitant medication included pregabalin (LYRICA), sertraline hydrochloride (ZOLOFT), colecalciferol (VIT.D3) and glutathione. The patient previously received first dose of BNT162B2 (Lot number=EL3247) on 15Jan2021 at 10:45 AM on right arm for COVID-19 immunization. The patient experienced excess phlem, exhaustion, body aches, fever, chills, cold sweat on 04Feb2021 17:00. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment from events. The outcome of events was recovered in Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: he felt bad, so he took two Percocet; This is a spontaneous report from a contactable consumer. A male patient of 94(unit unknown) received the first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, on 05Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient (the reporter's friend) who is 94 (not clarified) and the patient had his first yesterday(05Feb2021). Then the patient went into the yard and started gardening for 5 or 6 or 7 hours. And the patient felt bad in Feb2021, so he took two Percocet. And the reporter brother-in-law is a pharmacy doctor and he, through the reporter's sister told the reporter not to take any. So, the reporter was a little worried about the patient and does it have any effect on the efficacy of the COVID-19 Vaccine. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: When I swallow or when I gulp like a whole glass of water or half a glass of orange juice or something like that, my gland on the side of my neck hurts, it hurts me, it is sore; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, on 18Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. The patient had her first Pfizer shot and it will be three weeks, it was on 18Jan and on Monday (02Feb2021) she developed when she swallow or when gulp like a whole glass of water or half a glass of orange juice or something like that, her gland on the side of neck hurt, it hurt her, it was sore. She did not know if that was the part of the side effects. That was it and she was going to get the second shot on Monday. It happened on Monday when it started hurting. She thought it would go away. It started going away with hot, when I drink something like hot tea but it was still there, when she swallow. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness postural, Malaise
Clinical narrative: Dizzy spells/When paraphrased, consumer stated that when he/she stand up, right; not feeling good; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had had the first shot and that was vaccination and she/he was due to have the second vaccination and she/he was having dizzy spells now (on an unspecified date), just last couple of days. She/he wanted to know if dizzy spells be coming on with His/her second vaccination and if it would that have any effect on the second vaccination at all. When paraphrased, consumer stated that when he/she stand up, right. Consumer further stated, you know he/she was not feeling good. She/he was just going to ask you if it is a serious thing or anything. The patient was just experiencing dizzy spells because she/he was going to be getting the second shot. That was all the patient wanted to know. If it is okay, that is all. The patient did not want to answer anything. The outcome of the events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; chills; fever; muscle aches; This is a spontaneous report from a contactable consumer. A 50-years-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318), via an unspecified route of administration at arm right on 04Feb2021 11:30 at age of 50-years-old at single dose for COVID-19 immunization. The patient medical history was not reported, no known allergies. The concomitant medications in two weeks included vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included 1st dose of BNT162B2 on 15Jan2021 at age of 50-years-old for COVID-19 immunization. The patient experienced headache, chills, fever, muscle aches started at 05Feb2021 20:00 and resolved within 24 hours. Reported now feeling fine on 06Feb2021, symptoms resolved. No treatment was received for the adverse events. The events outcome was recovered on 06Feb2021. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Nausea, Pain, Pyrexia
Clinical narrative: fever, chills, nausea, aches, joint pain; fever, chills, nausea, aches, joint pain; fever, chills, nausea, aches, joint pain; fever, chills, nausea, aches, joint pain; fever, chills, nausea, aches, joint pain; This is a spontaneous report from a contactable consumer reporting for self. A 65-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included covid-19. Concomitant medication included celecoxib. The patient experienced fever, chills, nausea, aches, joint pain on 08Jan2021. Outcome of events was recovered.   Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Headache, Lip swelling
Clinical narrative: Fever greater than 102; Swollen lips; red welt a injection site; pain at injection site; swollen injection site; chills; body aches; headache; chest pressure and tightness; This is a spontaneous report from a contactable other HCP (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL8982), intramuscular on 29Jan2021 15:00 at single dose for covid-19 immunization. Vaccine location was right arm and it was the second dose. Patient is not pregnant. The facility type vaccine was School or Student Health Clinic. Patient intramuscularly received the first dose of vaccine on 08Jan2021 04:15PM (also at age of 24 years old) at right arm with lot number EL8982 for covid-19 immunization. Medical history included chronic sinusitis from an unknown date, allergies to sulfa medications. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient experienced Fever greater than 102, Swollen lips, large red welt a injection site, pain at injection site, swollen injection site, chills, body aches, headache, chest pressure and tightness on 30Jan2021 03:00 AM. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in 2021.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Fever greater than 102; Swollen lips; red welt a injection site; pain at injection site; swollen injection site; chills; body aches; headache; chest pressure and tightness; This is a spontaneous report from a contactable other HCP (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL8982), intramuscular on 29Jan2021 15:00 at single dose for covid-19 immunization. Vaccine location was right arm and it was the second dose. Patient is not pregnant. The facility type vaccine was School or Student Health Clinic. Patient intramuscularly received the first dose of vaccine on 08Jan2021 04:15PM (also at age of 24 years old) at right arm with lot number EL8982 for covid-19 immunization. Medical history included chronic sinusitis from an unknown date, allergies to sulfa medications. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient experienced Fever greater than 102, Swollen lips, large red welt a injection site, pain at injection site, swollen injection site, chills, body aches, headache, chest pressure and tightness on 30Jan2021 03:00 AM. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in 2021.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Had swelling to the right side of the neck lasting x ~6 hrs most likely the result of a swollen right lymph node.; This is a spontaneous report from a contactable Other HCP (patient).  A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3248, on 12Jan2021 20:30 at single dose in left arm for COVID-19 immunization. Medical history included Known allergies to Pumpkin seeds and Codine. Concomitant medication was none. The patient previously received first dose of BNT162B2 (Lot number EH9899) on 22Dec2020 19:30 in left arm. The patient had no other vaccine in four weeks. covid tested post vaccination. The patient had swelling to the right side of the neck lasting x ~6 hrs most likely the result of a swollen right lymph node on 14Jan2021 21:00. No treatment was received for the event. The outcome of the event was resolved on 15Jan2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Shortly after receiving second dose had a slight metallic taste in my mouth.   Today it's 6 days later and I still have it off and on.; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient (no pregnant) received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283) , via an unspecified route of administration on 01Feb2021 09:30 at single dose at left arm for covid-19 immunisation. The patient previously took the first dose bnt162b2 on 11Jan2021 for covid-19 immunization. The patient medical history was not reported. Concomitant medication included sertraline.  The patient experienced shortly after receiving second dose had a slight metallic taste in mouth on 01Feb2021 10:00. On 06Feb2021, it's 6 days later and patient still have it off and on.  No treatment for event. The outcome of event was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Body aches; Fatigue; headache; Chills; This is a Spontaneous report from a Contactable Consumer (patient). A 47-years-old male patient received bnt162b2 (BNT162B2; lot unknown=True, lot unknown reason=Not available/provided to reporter at the time of report completion) second dose, via an unspecified route of administration on 04Feb2021 15:00 at SINGLE DOSE for covid-19 immunization, vaccine location was Left arm. The patient's medical history and concomitant medications were not reported. No covid prior vaccination. No covid tested post vaccination. Patient had no Known allergies. Historical vaccine included first dose of BNT162B2 for covid-19 immunization on 14Jan2021. The patient experienced body aches, fatigue, headache and chills, all on 04Feb2021 20:00 with outcome of recovered. No treatment was received.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Chills; achy; low grade fever; tired; Arm sore at injection site; all the patient did was sleep.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EM9809) via an unspecified route of administration on 04Feb2021 16:00 in the left arm at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, COVID (prior vaccination).  There was no other vaccine in four weeks. The patient received other medications in two weeks (unspecified). The patient has no COVID tested post vaccination. The patient experienced chills, achy, low grade fever, tired, arm sore at injection site, and all the patient did was sleep. Event onset date reported as 05Feb2021 06:00. Following day, feel much better. Body temperature showed low grade fever on 05Feb2021 06:00. No treatment received for the events. The outcome of the events was recovered in Feb2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: Chills; achy; low grade fever; tired; Arm sore at injection site; all the patient did was sleep.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EM9809) via an unspecified route of administration on 04Feb2021 16:00 in the left arm at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, COVID (prior vaccination).  There was no other vaccine in four weeks. The patient received other medications in two weeks (unspecified). The patient has no COVID tested post vaccination. The patient experienced chills, achy, low grade fever, tired, arm sore at injection site, and all the patient did was sleep. Event onset date reported as 05Feb2021 06:00. Following day, feel much better. Body temperature showed low grade fever on 05Feb2021 06:00. No treatment received for the events. The outcome of the events was recovered in Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Shoulder was a little sore; arm soreness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age (reported for himself) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number reported as "ELI283 or EL1283"), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he heard that the second dose can cause more side effects and he stated he and his wife both experienced arm soreness after the first dose on an unspecified date. Consumer stated, first of all thank you guys for making this vaccine. He and his wife received the vaccine (unspecified vaccine) their first dose last Saturday, a week ago yesterday and had no reaction to it at all, their shoulder was a little sore but that's it. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021130328 same reporter and drug, similar events, different patient
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Vomiting
Clinical narrative: Throwing up; Dizzy; Weakness; Headache; This is a spontaneous report from a contactable Other-HCP (patient). A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3248, on 05Feb2021 15:30 in left arm for COVID 19. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number EL1284) on 22Jan2021 13:30 in left arm. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient experienced Throwing up, dizzy, weakness, headache on 06Feb2021 04:00. No treatment was received for all events. The outcome of the events was not resolved.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Within 4 hours a rash between my inner thighs appeared.; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration in the left arm on 04Feb2021 at 14:15 (02:15 PM) at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a hospital. The patient had no other vaccine in four weeks. The patient's medical history included diabetes, and the patient had Covid prior to vaccination. The patient had no known allergies. Concomitant medication included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), semaglutide (OZEMPIC), and prenatal vitamin. Within 4 hours (on 04Feb2021 at 06:30 PM) a rash between her inner thighs appeared. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included steroid cream and diphenhyramin HCl (BENADRYL). The patient has not been tested for Covid post vaccination. The outcome of the event was not recovered.   Information on the batch/lot number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Hyperhidrosis, SARS-CoV-2 test, Urticaria
Clinical narrative: Positive COVID-19 test with symptoms; Elbows and hands broke out in hives; Urticaria and flu like symptoms were getting worse each day; Patient woke up in sweat puddles but no fever; This is a spontaneous report from a contactable consumer (patient).   A 24-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL09265) in the left arm, at single dose, on 03Feb2021 at 10:00 AM, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. Past drug event included hives due to ondansetron hydrochloride (ZOFRAN). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine and she had not received any other medications within 2 weeks prior to the BNT162B2. On 04Feb2021, at 06:00, the patient experienced flu like symptoms, a lot of mucus in cough, she woke up in sweat puddles but no fever. Chills, body aches and elbows and hands broke out in hives. Urticaria and flu like symptoms were getting worse each day. Emergency Room Visit / Physician Office Visit required. Treatment was received. Post the vaccination, the patient has been tested for COVID-19 (Nasal Swab, POCT rapid screening) and resulted positive on 06Feb2021. Clinical outcome of COVID-19 was unknown, while the patient did not recover from the other events.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Vaccination site pain
Clinical narrative: Insomnia; headache; fatigue; pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in the left arm, on 06Feb2021 at 17:45, at single dose, for COVID-19 immunisation. Medical history included asthma. Patient did not experience COVID-19 prior to vaccination. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC) and loratadine (CLARITINE ALLERGY). The patient experienced insomnia (non-serious) on 06Feb2021 at 20:00 with outcome of recovering, headache (non-serious) on 06Feb2021 at 20:00 with outcome of recovering, fatigue (non-serious) on 06Feb2021 at 20:00 with outcome of recovering, pain at injection site (non-serious) on 06Feb2021 at 20:00 with outcome of recovering. No therapeutic measures were taken as a result of the events. Patient did not tested for COVID-19 post vaccination.  The information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: I just kept having bowel movements and I already had one this morning, I mean it was just liquid/ diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unknown), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I had the vaccine (COVID 19 vaccine by Pfizer) on the Thursday (04Feb2021), but Friday I had a bowel movement which is normal for me, but then yesterday (06Feb2021) I don't know what was wrong I just kept having bowel movements. And I already had one this morning, I mean it was just liquid. I don't know if it had anything to do with it or not. So I am trying to find out if that shot has been doing with the person having diarrhea?" Consumer confirmed the vaccine name as Pfizer COVID 19 vaccine and stated, "Yes, I had that shot on Thursday." Consumer stated, "What question, okay it's fine, I will just call them and find out. I just wanted to know if that or may be something I ate it, I got to figure out what it is." The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Periorbital swelling, Tenderness
Clinical narrative: This morning I woke up swollen under my eyes right where I had filler done; The swelling and tenderness is the exact same swelling and tenderness experienced right after the filler was done; achy and tired; achy and tired; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration in the left arm on 05Feb2021 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunization.  Medical history included Celiac disease, allergy to gluten, filler under eyes in Jul2020, and the patient is prone to inflammation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included GUARANA [PAULLINIA CUPANA] and a multivitamin, both from an unknown date for an unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unknown date for COVID-19 immunization and experienced fatigue and feeling achy. The patient stated she did not have any kind of reaction to her first dose other than fatigue and feeling achy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021 the patient experienced feeling achy and tired, the patient had no other initial reactions after the injection. On 07Feb2021 at 06:30, the second day after the second immunization, the patient woke up swollen under her eyes right where she previously had filler done (last Jul2020, so per the patient, it wasn't recent). The patient stated the swelling and tenderness was the exact same swelling and tenderness that the patient experienced right after she had the filler done. The patient stated she should also note that she does have Celiac disease, which is an autoimmune disease and she is prone to inflammation, however the patient was not on immunosuppressant drugs and was otherwise very healthy. The patient did not receive any treatment for the events feeling achy and tired, swelling and tenderness under her eyes. The clinical outcome of the feeling achy and tired, swelling and tenderness was not recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 05Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was noticing a side effect from the vaccine and one of them was the swollen lymph node and the reason why the patient was calling was because "last night I went to the bathroom and I had a swollen lymph node up on my upper thigh close to the groin area." When asked for any question regarding the concern, consumer stated "Yes, it is. I want, this cause is rare in swollen lymph node and I want to ask you does it stay like that, does it go down? Do I need to go to a doctor? What?" Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Night sweats, SARS-CoV-2 antibody test
Clinical narrative: We were very tired; We had very hot sweaty night; I felt cold; she was chillier than I was during Friday; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunization. Medical history included believed they had a mild case of COVID in Jul (unspecified year; it was prior to COVID Vaccine, in Sep (unspecified year), both him and his wife tested positive for the antibodies for COVID). The patient's concomitant medications were not reported. The patient reported that had a couple of side effects that the paper they were given asked them to report it. The patient reported the vaccination was on 04Feb2021. On 05Feb2021 morning, his wife had chills most out of that day. The patient felt cold but not uncomfortable (in Feb2021). That night (in Feb2021), they were very tired and then they went to bed at that night they had very hot sweaty night and they assumed that was the reaction to the vaccination. The patient confirmed that they both had reaction and stated, "Yes, she was chillier than I was during Friday" (in Feb2021). They were wondering if the reaction to the vaccination was because they had antibodies in their system already. The outcome of the events was unknown.  Information on the lot/batch number has been requested.