chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Investigation
Clinical narrative: urinated blood; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, for COVID-19 immunisation. It was reported that, 2 days after receiving his second dose of the Pfier BioNTech COVID-19 vaccine, he urinated blood. It was just one incident and after that it disappeared. The patient followed up with his doctor who told him everything was fine. The patient wanted to know if there were other people who experienced this after the vaccine. The outcome for the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: lost her taste; lost her taste and sense of smell; This is a spontaneous report from a contactable other nurse (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 09Jan2021 (Batch/Lot Number: EK5730; at the age of 69 years old) as dose 2, single for COVID-19 immunisation. Medical history included asthmatic bronchitis. The patient was not pregnant at the time of report. She has no known allergies and she did not receive any other vaccines in four weeks before the COVID vaccine. The patient was not tested for COVID-19 prior to vaccination. Concomitant medications included vitamins and royal jelly. She previously received first dose of BNT162B2, intramuscular, administered in the left arm on 19Dec2020, at 16:30 (Batch/Lot Number: EK5730; at the age of 69 years old) for COVID-19 immunisation. On 11Jan2021, at 00:00, the patient lost her taste and sense of smell for about five days, and then returned. They disappeared again almost immediately after the second dose. After almost two months since her last dose, some of her taste has returned, but her sense of smell was still not back. The patient underwent lab tests and procedures which included nasal swab: negative and rapid COVID 19: negative both on 28Jan2021. No treatment was received for the events. The patient has not recovered from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Tinnitus
Clinical narrative: A little warmer but no fever; Ringing in the ear; Pain on knee; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on 25Feb2021 as dose 1, single for COVID- 19 Immunisation. Relevant medical history included thyroid, cholesterol, anxiety/depression, and asthma, sciatica, received lumbar injection last Friday on 24Feb2021. Concomitant medications were not reported. The patient received Flu shot in 2021. On an unknown date in Feb2021, the patient was feeling quite not okay, a little warmer but no fever. The patient experienced ringing in the ear and pain on knee and applied Biofreeze on her knee. The patient was also taking Tylenol every 6 hours. The patient was scheduled to get the second dose on 19Mar2021, which was more than 21 days after the first dose. Caller wants to know if it was because of the vaccine or does the vaccine affect her sciatica. Therapeutic measures were taken with Biofreeze and Tylenol as a result of the all adverse events. The 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.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Tinnitus
Clinical narrative: ringing in the ear; pain on the knee; This is a spontaneous report from a contactable consumer or other non hcp.  A male patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on  an unspecified date dose unknown, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced ringing in the ear and pain on the knee on an unspecified date. The event outcome was reported as unknown  No follow-up attempts are possible: Information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Fatigue, Headache, Lip swelling
Clinical narrative: Facial rash/Rash; lip and eye swelling; lip and eye swelling; hives; itching arms stomach and hand palms; headache; chills; fatigue; arm pain at injection site; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN8200), dose 2 via an unspecified route of administration, administered in Arm Left on 14Feb2021(Age at vaccination: 66 years) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included Osteoporosis, elevated cholesterol, panic attacks. Patient had known allergies of Environmental, barley, rye, prescribed narcotic medicine.  Concomitant medications included Alendronate Sodium 70 mg; vitamin b complex (VITAMIN B); Zinc; colecalciferol (VITAMIN D [COLECALCIFEROL]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); Calcium. Historical vaccine included bnt162b2 (COMIRNATY) 0.3 ml as dose 1 received on 24Feb2021 at 9AM in left arm with lot number EL3247 for covid-19 immunisation. Patient did not receive other vaccines in 4 weeks. The patient experienced facial rash/ rash, lip and eye swelling, hives, itching arms stomach and hand palms, headache, chills, fatigue, arm pain at injection site on 26Feb2021. Facial rash/rash, lip and eye swelling/hives/itching arms, stomach and hand palms. All occurred approximately 2 weeks after the second dose and was currently ongoing. Other reactions were headache, chills, fatigue, arm pain at injection site which went away within 48 hours after the injection. Took over the counter allergy medicine Benedryl. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination.  The outcome of the events headache, chills, fatigue, arm pain at injection site was recovered on 28Feb2021. The outcome of the rest of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination site pain
Clinical narrative: Facial rash/Rash; lip and eye swelling; lip and eye swelling; hives; itching arms stomach and hand palms; headache; chills; fatigue; arm pain at injection site; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN8200), dose 2 via an unspecified route of administration, administered in Arm Left on 14Feb2021(Age at vaccination: 66 years) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included Osteoporosis, elevated cholesterol, panic attacks. Patient had known allergies of Environmental, barley, rye, prescribed narcotic medicine.  Concomitant medications included Alendronate Sodium 70 mg; vitamin b complex (VITAMIN B); Zinc; colecalciferol (VITAMIN D [COLECALCIFEROL]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); Calcium. Historical vaccine included bnt162b2 (COMIRNATY) 0.3 ml as dose 1 received on 24Feb2021 at 9AM in left arm with lot number EL3247 for covid-19 immunisation. Patient did not receive other vaccines in 4 weeks. The patient experienced facial rash/ rash, lip and eye swelling, hives, itching arms stomach and hand palms, headache, chills, fatigue, arm pain at injection site on 26Feb2021. Facial rash/rash, lip and eye swelling/hives/itching arms, stomach and hand palms. All occurred approximately 2 weeks after the second dose and was currently ongoing. Other reactions were headache, chills, fatigue, arm pain at injection site which went away within 48 hours after the injection. Took over the counter allergy medicine Benedryl. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination.  The outcome of the events headache, chills, fatigue, arm pain at injection site was recovered on 28Feb2021. The outcome of the rest of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain, Vaccination site erythema
Clinical narrative: I experience sore arm (injection arm); redness near the injection site; tired; minor chills; body ache; joint pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 02Mar2021, patient experienced I experience sore arm (injection arm), redness near the injection site, tired, minor chills, body ache, joint pain. Patient reported that I experienced more severe adverse event for about a day started the day after injection. I became really tired on Tuesday afternoon, and started to have minor chills, body ache and joint pain. There was no fever. All the adverse event except a little arm pain have resolved on Wednesday. The clinical outcome of event vaccination site pain was not recovered, and other events was recovered on 03Mar2021.  No follow-up possible are possible, Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I experience sore arm (injection arm); redness near the injection site; tired; minor chills; body ache; joint pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 02Mar2021, patient experienced I experience sore arm (injection arm), redness near the injection site, tired, minor chills, body ache, joint pain. Patient reported that I experienced more severe adverse event for about a day started the day after injection. I became really tired on Tuesday afternoon, and started to have minor chills, body ache and joint pain. There was no fever. All the adverse event except a little arm pain have resolved on Wednesday. The clinical outcome of event vaccination site pain was not recovered, and other events was recovered on 03Mar2021.  No follow-up possible are possible, Information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eyelid pain, Lymphadenopathy, Myalgia, Pain
Clinical narrative: different skin patches on lower legs showed up day 5 after injection; Bad muscle aches.; pain; fever; chills; swollen lymph nodes; achy eye lids; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Right arm on 05Feb2021 13:00 (at the age of 52 year old) as dose 2, single for COVID-19 immunisation. Medical history included Sjogren's, and factor V-Leiden deficient from an unknown date. Patient has known allergies to sulpha medications. Concomitant medications included apixaban (ELIQUIS); zinc; vitamin d3 and other multivitamins. The patient was not pregnant at the time of vaccination. Prior vaccination, patient was not diagnosed with COVID and did not receive any other vaccines within 4 weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration in left arm, on 11Jan2021 15:00 (at the age of 52 year old), as single dose for COVID-19 immunization. After vaccination, within 16 hours of administration, that is on 06Feb2021, 05:00, patient laid flat with bad muscle aches/pain, fever/chills, swollen lymph nodes in right armpit area, achy eye lids. These lasted for 40 hours. On 10- 11th day, repetition of events occurred, almost exactly same only slightly less. On 10Feb2021 (after 5 days of injection), showed up different skin patches on lower legs. Skin patches were investigated and blood was drawn. Since the vaccination, patient had not been tested for COVID. Treatment was received for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin discolouration, Skin test
Clinical narrative: different skin patches on lower legs showed up day 5 after injection; Bad muscle aches.; pain; fever; chills; swollen lymph nodes; achy eye lids; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Right arm on 05Feb2021 13:00 (at the age of 52 year old) as dose 2, single for COVID-19 immunisation. Medical history included Sjogren's, and factor V-Leiden deficient from an unknown date. Patient has known allergies to sulpha medications. Concomitant medications included apixaban (ELIQUIS); zinc; vitamin d3 and other multivitamins. The patient was not pregnant at the time of vaccination. Prior vaccination, patient was not diagnosed with COVID and did not receive any other vaccines within 4 weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration in left arm, on 11Jan2021 15:00 (at the age of 52 year old), as single dose for COVID-19 immunization. After vaccination, within 16 hours of administration, that is on 06Feb2021, 05:00, patient laid flat with bad muscle aches/pain, fever/chills, swollen lymph nodes in right armpit area, achy eye lids. These lasted for 40 hours. On 10- 11th day, repetition of events occurred, almost exactly same only slightly less. On 10Feb2021 (after 5 days of injection), showed up different skin patches on lower legs. Skin patches were investigated and blood was drawn. Since the vaccination, patient had not been tested for COVID. Treatment was received for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Gingival pain, Gingival swelling, Oral pain, Rash
Clinical narrative: swollen gums at teeth; Sore in teeth; Sore inner cheeks; Canker sores; Lower back rash; This is a spontaneous report from a contactable consumer or other non hcp.   A 66-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3246, expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 02Feb2021 15:15 (at the age of 66 years) as dose 1, single for covid-19 immunisation.  Medical history included hypertension allergy to Penicillin. Patient did not receive any other vaccine within 4 weeks. Patient neither diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 after the vaccination. Concomitant medications included Lisinopril 10 mg. on 05Feb2021, the patient experienced swollen gums at teeth, Sore inner cheeks, Sore gums at cheek line, Canker sores and Lower back rash. At the time of report, patient was recovering from all the events.  No follow-up attempts were possible; information about lot/batch number could not been obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Myalgia, Pain, Vaccination site pain
Clinical narrative: Chest feels slightly tight; Pain from shot site all the way down arm; Really tired; muscle aches; pains; This is a spontaneous report from a contactable consumer (patient). A non pregnant 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; lot number was EN6205 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 04Mar2021 15:30(at the age of 24-years-old) at dose 1, single for covid-19 immunization. Patient had known allergies to Sulfa, tree nuts, coconut, blueberries, etc. The patient's concomitant medications were not reported. The most recent covid-19 vaccine was administered at Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced pain from shot site all the way down arm  and was really tired with muscle aches and pains; chest felt slightly tight on 04Mar2021 15:45. No treatment was given for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Dyspnoea, Fatigue, SARS-CoV-2 test
Clinical narrative: flared up joint pain; flared up joint pain; Breathing difficulties; heavy fatigue; This is a spontaneous report from a non-contactable other HCP. A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via an unspecified route of administration, administered in Left Arm on 12Feb2021 as DOSE 2, SINGLE (at the age of: 28-year-old) for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution injection, Lot number: Unknown) on 12Feb2021 for covid-19 immunization. Medical history included lyme disease. The patient's concomitant medications were not reported. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid. No known allergies reported for the patient. On 13Feb2021, the patient experienced flared up joint pain, flared up joint pain, breathing difficulties and heavy fatigue. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of all events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Arthralgia, Cough, Pain in extremity, Peripheral swelling
Clinical narrative: Snoty nose; cough; sore arm that swelled to size of base ball; loss of smell; heaviness in joints; sore arm that swelled to size of baseball; This is a spontaneous report from a contactable other HCP (patient).   A 26-years-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration, administered at right arm on 24Feb2021 at 12:15 PM (at the age of 26-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history included TBI, epilepsy, non epileptic seizures, post-traumatic stress disorder and ADHD (from an unknown date and unknown if ongoing for all medical history). The patient had known allergies with sulfa mild allergy. The patient's concomitant medications included lamotrigine (LAMICTAL) for an unspecified indication from an unknown date (in two weeks of vaccination) and unknown if ongoing and venlafaxine for an unspecified indication from an unknown date (in two weeks of vaccination) and unknown if ongoing. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. On 27Feb2021 at 17:00, the patient experienced snoty nose, cough, sore arm that swelled to size of baseball, loss of smell, heaviness in joints. The patient received no treatment for adverse event. The patient did not receive other vaccines prior to the COVID vaccine. The patient had not Covid tested post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Snoty nose; cough; sore arm that swelled to size of base ball; loss of smell; heaviness in joints; sore arm that swelled to size of baseball; This is a spontaneous report from a contactable other HCP (patient).   A 26-years-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration, administered at right arm on 24Feb2021 at 12:15 PM (at the age of 26-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history included TBI, epilepsy, non epileptic seizures, post-traumatic stress disorder and ADHD (from an unknown date and unknown if ongoing for all medical history). The patient had known allergies with sulfa mild allergy. The patient's concomitant medications included lamotrigine (LAMICTAL) for an unspecified indication from an unknown date (in two weeks of vaccination) and unknown if ongoing and venlafaxine for an unspecified indication from an unknown date (in two weeks of vaccination) and unknown if ongoing. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. On 27Feb2021 at 17:00, the patient experienced snoty nose, cough, sore arm that swelled to size of baseball, loss of smell, heaviness in joints. The patient received no treatment for adverse event. The patient did not receive other vaccines prior to the COVID vaccine. The patient had not Covid tested post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Jaw disorder, Nasal oedema, Pain of skin, Skin warm
Clinical narrative: Nose got swollen; Bridge of nose was very red; Glands on the bottom of his jaw got swollen and sensitive; Whole skin was very tender and warm; Whole skin was very tender and warm; This is a spontaneous report from a contactable consumer. This male contactable consumer (patient) reported for himself that: A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number were not reported, NDC number and Expiry Date: Not Provided), via unspecified route administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number were not reported, NDC number and Expiry Date: Not Provided), via unspecified route administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date after the second dose of vaccination, the patient experienced nose got swollen, bridge of nose was very red, glands on the bottom of his jaw got swollen and sensitive and whole skin was very tender and warm. It was reported that, patient reported he was administered the second dose of Pfizer COVID-19 Vaccine injection on Friday. Starting last night his nose got swollen; the bridge of his nose was very red; and the whole skin was very tender and warm; the glands on the bottom of his jaw got swollen and sensitive. Patient called to ask if he should worry about these events or if he should take some medication for them. Patient: Sex: Patient referred to as male during this report, but sex not verified with caller who was unwilling to complete report. The outcome of events was reported as unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Gingival pain, Nausea, Pain in extremity
Clinical narrative: Pain on site, up his right arm; pain in his gum; Pain on site, up his right arm; pain in his gum; Pain on site, up his right arm; pain in his gum; Swelling on the face on his right side, neck, his lymph glands, his gum; Sensitivity when he eats or drinks anything hot, cold or otherwise doesn't matter the temperature; Sensitivity when he eats or drinks anything hot, cold or otherwise doesn't matter the temperature; Pain in his shoulder; Nausea; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on 23Feb2021 09:00 as dose 1, single for coivd-19 immunisation. Patients medical history and concomitant medications were not reported.  On an unspecified date, patient experienced pain on site up his right arm, swelling on the face on his right side, neck, his lymph glands, his gum, he had sensitivity when he eats or drinks anything hot, cold or otherwise doesn't matter the temperature. He wears dentures, so there are no teeth where he was having pain in his gum. So pain in his shoulder, neck, gums, swelling on right side of his face, he was having nausea. Called  wanted to know will the second vaccination cause any side effect worse or otherwise. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Temperature intolerance, Vaccination site pain
Clinical narrative: Pain on site, up his right arm; pain in his gum; Pain on site, up his right arm; pain in his gum; Pain on site, up his right arm; pain in his gum; Swelling on the face on his right side, neck, his lymph glands, his gum; Sensitivity when he eats or drinks anything hot, cold or otherwise doesn't matter the temperature; Sensitivity when he eats or drinks anything hot, cold or otherwise doesn't matter the temperature; Pain in his shoulder; Nausea; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on 23Feb2021 09:00 as dose 1, single for coivd-19 immunisation. Patients medical history and concomitant medications were not reported.  On an unspecified date, patient experienced pain on site up his right arm, swelling on the face on his right side, neck, his lymph glands, his gum, he had sensitivity when he eats or drinks anything hot, cold or otherwise doesn't matter the temperature. He wears dentures, so there are no teeth where he was having pain in his gum. So pain in his shoulder, neck, gums, swelling on right side of his face, he was having nausea. Called  wanted to know will the second vaccination cause any side effect worse or otherwise. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fatigue; Joint aches; Headaches; Fever that advanced in severity; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Jan2021 (Lot Number: EL3248) (at the age of 54-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive other vaccine within four weeks of vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 07Jan2021 at 11:00 AM (Lot Number: EL0142) (at the age of 54-years-old) as dose 1, single for covid-19 immunisation. The patient did not have covid-19 prior vaccination. The patient fatigue, joint aches, headaches, fever that advanced in severity on 27Jan2021 09:00 AM. The patient did not receive any treatment for the events. The patient was tested for covid-19 post vaccination on 02Feb2021 by nasal swab and the result was negative. The outcome of the events was recovered in 2021.  No follow up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Headache, Pain
Clinical narrative: Stomach pain; body aches; chills; fever; headache; joint pain; This is a spontaneous report from a contactable healthcare professional (patient). A 58-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6203) administered in left arm via an unknown route of administration (at the age of 58 years old) on 25Feb2021 at 14:15 pm as dose 1, single for covid-19 immunisation. Medical history included chronic sinusitis (event verbatim-Chronic sinusitis, pneumonia). Other concomitant medications in two weeks included allergy injections. The patient had known allergies to Penicillin and other antibiotics. It was reported that the patient did not have covid prior vaccination. The patient did not tested covid post vaccination. On 26Feb2021 at 14:00pm, the patient experienced stomach pain, body aches, chills, fever, headache and joint pain.  No treatment was received for all the events. The outcome of all the events was reported as recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Stomach pain; body aches; chills; fever; headache; joint pain; This is a spontaneous report from a contactable healthcare professional (patient). A 58-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6203) administered in left arm via an unknown route of administration (at the age of 58 years old) on 25Feb2021 at 14:15 pm as dose 1, single for covid-19 immunisation. Medical history included chronic sinusitis (event verbatim-Chronic sinusitis, pneumonia). Other concomitant medications in two weeks included allergy injections. The patient had known allergies to Penicillin and other antibiotics. It was reported that the patient did not have covid prior vaccination. The patient did not tested covid post vaccination. On 26Feb2021 at 14:00pm, the patient experienced stomach pain, body aches, chills, fever, headache and joint pain.  No treatment was received for all the events. The outcome of all the events was reported as recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling cold, Headache, Hyperacusis
Clinical narrative: Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic; Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic; Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic; headache; hypersensitivity to noise and physical contact; muscle aches; joint aches; malaise/ fatigue; malaise/ fatigue; excessive thirst; mild tinnitus; feeling cold; random shooting pains; hypersensitivity to noise and physical contact; This is a spontaneous report from a contactable consumer (patient).  A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and Expiration date was not reported) via an unspecified route of administration, in right leg on 24Feb2021 11:00 AM (at the age of 48-years-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included transient ischaemic attack, found to be heterozygous for factor V Leiden, and diagnosed PFO (repaired) from an unknown date and unknown if ongoing. Patient was allergic to azithromycin, penicillin. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247 and Expiration date was not reported) via an unspecified route of administration, in right leg on 03Feb2021 09:30 AM as dose 1, single for COVID-19 immunization and experienced First injection site was erythematous, not swollen or painful, covering ~10cm x 10cm; began to itch after 8-10 days; now appears as a large diffuse, blotchy bruise surrounded by erythema. Patient was sure as she can be that this was administered into fat (ie.not IM). The patient concomitant medication included aspirin (81 mg), one-a-day vitamin (received within two weeks of vaccination). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021, the patient had experienced Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic. On an unspecified date feb2021, the patient had experienced pronounced side effects 1 and 2 days post-injection: headache, hypersensitivity to noise and physical contact, muscle aches, joint aches, malaise/ fatigue, excessive thirst, mild tinnitus, feeling cold (no fever), random shooting pains! Stayed home from work that day. Should not have gone to work 28Feb due to recurrence of these mid-morning left work early. Reporter stated that first awareness of initial sign for 1st vaccine was 04Feb2021, and for 2nd vaccine was 25Feb2021. Patient had not received any treatment for the events reported. The outcome of the events was recovered with sequel on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Malaise, Myalgia, Pain, Thirst
Clinical narrative: Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic; Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic; Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic; headache; hypersensitivity to noise and physical contact; muscle aches; joint aches; malaise/ fatigue; malaise/ fatigue; excessive thirst; mild tinnitus; feeling cold; random shooting pains; hypersensitivity to noise and physical contact; This is a spontaneous report from a contactable consumer (patient).  A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and Expiration date was not reported) via an unspecified route of administration, in right leg on 24Feb2021 11:00 AM (at the age of 48-years-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included transient ischaemic attack, found to be heterozygous for factor V Leiden, and diagnosed PFO (repaired) from an unknown date and unknown if ongoing. Patient was allergic to azithromycin, penicillin. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247 and Expiration date was not reported) via an unspecified route of administration, in right leg on 03Feb2021 09:30 AM as dose 1, single for COVID-19 immunization and experienced First injection site was erythematous, not swollen or painful, covering ~10cm x 10cm; began to itch after 8-10 days; now appears as a large diffuse, blotchy bruise surrounded by erythema. Patient was sure as she can be that this was administered into fat (ie.not IM). The patient concomitant medication included aspirin (81 mg), one-a-day vitamin (received within two weeks of vaccination). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021, the patient had experienced Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic. On an unspecified date feb2021, the patient had experienced pronounced side effects 1 and 2 days post-injection: headache, hypersensitivity to noise and physical contact, muscle aches, joint aches, malaise/ fatigue, excessive thirst, mild tinnitus, feeling cold (no fever), random shooting pains! Stayed home from work that day. Should not have gone to work 28Feb due to recurrence of these mid-morning left work early. Reporter stated that first awareness of initial sign for 1st vaccine was 04Feb2021, and for 2nd vaccine was 25Feb2021. Patient had not received any treatment for the events reported. The outcome of the events was recovered with sequel on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic; Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic; Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic; headache; hypersensitivity to noise and physical contact; muscle aches; joint aches; malaise/ fatigue; malaise/ fatigue; excessive thirst; mild tinnitus; feeling cold; random shooting pains; hypersensitivity to noise and physical contact; This is a spontaneous report from a contactable consumer (patient).  A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and Expiration date was not reported) via an unspecified route of administration, in right leg on 24Feb2021 11:00 AM (at the age of 48-years-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included transient ischaemic attack, found to be heterozygous for factor V Leiden, and diagnosed PFO (repaired) from an unknown date and unknown if ongoing. Patient was allergic to azithromycin, penicillin. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247 and Expiration date was not reported) via an unspecified route of administration, in right leg on 03Feb2021 09:30 AM as dose 1, single for COVID-19 immunization and experienced First injection site was erythematous, not swollen or painful, covering ~10cm x 10cm; began to itch after 8-10 days; now appears as a large diffuse, blotchy bruise surrounded by erythema. Patient was sure as she can be that this was administered into fat (ie.not IM). The patient concomitant medication included aspirin (81 mg), one-a-day vitamin (received within two weeks of vaccination). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021, the patient had experienced Second injection site is currently ~6cm x 7cm, diffuse erythema, mildly firm, and has been mildly pruritic. On an unspecified date feb2021, the patient had experienced pronounced side effects 1 and 2 days post-injection: headache, hypersensitivity to noise and physical contact, muscle aches, joint aches, malaise/ fatigue, excessive thirst, mild tinnitus, feeling cold (no fever), random shooting pains! Stayed home from work that day. Should not have gone to work 28Feb due to recurrence of these mid-morning left work early. Reporter stated that first awareness of initial sign for 1st vaccine was 04Feb2021, and for 2nd vaccine was 25Feb2021. Patient had not received any treatment for the events reported. The outcome of the events was recovered with sequel on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Fatigue
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever - for 2 days 101-102 degrees; injection site swelling; nausea; feeling unwell; dry cough; This is a spontaneous report from a contactable Consumer. This 67-year-old Female Consumer reported for herself that:  A 67-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Not available/provided to reporter at the time of report completion) via an unspecified route of administration in arm left on 25Feb2021 11:00 as single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing if covid prior vaccination Yes. Concomitant medications included levocetirizine (LEVOCETIRIZINE), metoprolol succinate (TOPROL), pantoprazole (PANTOPRAZOLE) all taken for an unspecified indication, start and stop date were not reported and have other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 26Feb2021 at 12:00 patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever - for 2 days 101-102 degrees, dry cough, injection site swelling, nausea, feeling unwell. Patient didn't received treatment for adverse event. The clinical outcome of the event was recovering.    No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever - for 2 days 101-102 degrees; injection site swelling; nausea; feeling unwell; dry cough; This is a spontaneous report from a contactable Consumer. This 67-year-old Female Consumer reported for herself that:  A 67-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Not available/provided to reporter at the time of report completion) via an unspecified route of administration in arm left on 25Feb2021 11:00 as single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing if covid prior vaccination Yes. Concomitant medications included levocetirizine (LEVOCETIRIZINE), metoprolol succinate (TOPROL), pantoprazole (PANTOPRAZOLE) all taken for an unspecified indication, start and stop date were not reported and have other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 26Feb2021 at 12:00 patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever - for 2 days 101-102 degrees, dry cough, injection site swelling, nausea, feeling unwell. Patient didn't received treatment for adverse event. The clinical outcome of the event was recovering.    No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever - for 2 days 101-102 degrees; injection site swelling; nausea; feeling unwell; dry cough; This is a spontaneous report from a contactable Consumer. This 67-year-old Female Consumer reported for herself that:  A 67-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Not available/provided to reporter at the time of report completion) via an unspecified route of administration in arm left on 25Feb2021 11:00 as single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing if covid prior vaccination Yes. Concomitant medications included levocetirizine (LEVOCETIRIZINE), metoprolol succinate (TOPROL), pantoprazole (PANTOPRAZOLE) all taken for an unspecified indication, start and stop date were not reported and have other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 26Feb2021 at 12:00 patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever - for 2 days 101-102 degrees, dry cough, injection site swelling, nausea, feeling unwell. Patient didn't received treatment for adverse event. The clinical outcome of the event was recovering.    No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Headache, Nervousness
Clinical narrative: Dizzy; Joint pain; Weak; Shaky; Fever; Headache; This is a spontaneous report from a non-contactable other hcp. A 66-year-old female non pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, age at vaccination 66-year-old) via an unspecified route of administration on unspecified date in Jan2021 (Lot Number and expiry date was not reported) as single dose for COVID-19 immunisation. Medical history included keratitis and known allergies to Plaster, Sanitizer from an unknown date and unknown if ongoing. Concomitant medications included fish oil; probiotics; calcium; colecalciferol (VITAMIN D) taken for an unspecified indication start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration on unspecified date in Jan2021 (Lot Number and expiry date was not reported) as single dose for COVID-19 immunization. No COVID prior to vaccination. On 26Jan2021, the patient was dizzy, weak, shaky and had joint pain, fever, headache. The patient experienced dizzy symptoms a month after taking it, never got dizzy. She still had joint pain over a month after taking it. She was weak, shaky, fever, headache, and joint pain the night after taking second dose and latest three days. The patient underwent lab tests and procedures which included sars-cov-2 test via nasal swab as negative post vaccination on 26Feb2021. She did not receive treatment for adverse event. The outcome of all the events was recovering.  No follow-up attempts are possible. No further information is expected.