chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; tired; fever; arm hurts; nauseous; diarrhea; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable Female consumer (patient) reported  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of 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 previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced headache, tired, fever, arm hurts, nauseous, diarrhea. Patient stated that after 1st dose, she experienced 5 days symptoms and after 2nd dose she experienced headache, feeling very tired, felt like having a fever, arm hurts, nauseous, severe diarrhea. It was reported first dose, she experienced 5 days symptoms and after 2nd dose she experienced headache, feeling very tired, felt like having a fever, arm hurts, nauseous, severe diarrhea and she also mentioned that she took Advil. Therapeutic measures taken for events with Advil. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain in extremity, Pruritus, Rash, Rash macular
Clinical narrative: It started itching; I knew that my arm was going to be sore, it was sore to touch; On the same arm where the injection was given, there was a sore spot under my arm and on top of it, my throat is not necessarily sore but it sounds like agitated; There is some difference in my throat; On the same arm where the injection was given, there was a sore spot under my arm and on top of it, my throat is not necessarily sore but it sounds like agitated; There is some difference in my throat; Had a rash only on the side of my neck where I took the injection in my arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as FP6955, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 07Apr2021 (at the age of 50 years old) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as 2P7534, Expiry date was not reported) via an unspecified route of administration, administered in Arm Right on 17Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included heartburn, blood clots and pain from an unknown date and unknown if ongoing. Concomitant medication(s) included apixaban (ELIQUIS) taken for thrombosis, start and stop date were not reported; omeprazole (PROTONIX [OMEPRAZOLE]) taken for an unspecified indication, start and stop date were not reported. Consumer stated, she was just concerned, she got second Pfizer shot (Covid Vaccine) last week and I discovered that I had a rash only on the side of my neck where I took the injection in my arm (On 08Apr2021) it started itching. I knew that my arm was going to be sore, it was sore to touch (on unspecified date). So, on the same arm where the injection was given, there was a sore spot under my arm and on top of it, my throat is not necessarily sore but it sounds like agitated or I don't know how to explain it but there is some difference in my throat (on unspecified date). So, for my throat I am not so much concerned but the rash on my neck, is it contagious, will it spread. My question was the rash on the side of my neck where I got my second injection will it spread. Consumer stated, Eliquis was for blood clots, and she takes pain medicine as needed. For treatment the consumer stated that, she was not taking any medicines, but she was putting some medicine on the rash because it itches. The patient did not receive any treatment for other events. The outcome for the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as ER2613, Expiry date was reported as 31Jul2021) via an unspecified route of administration, administered on 23Mar2021 (at the age of 64 years old) as dose 1, single for covid-19 immunisation. The patient has also received the second of (bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was reported as EW0161, Expiry date was reported as 31Jul2021) via an unspecified route of administration, administered on 13Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter states that, first injection was on the 23rd of last month a little soreness in the shoulder next day (On 24Mar2021) till today it was just been feeling like an energized battery. A lot of energy. I bought this house that been vacant for 15 years and I have just been tearing walls down. Today the patient just got the second injection so far alright. I ask everyone about their experiences, and they all tell me the peeing in the be and all this negative stuff and when I tell them how it hit its blowing them away. The outcome for the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 32-years-old non pregnant female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0158), via an unspecified route, administered in arm left on 07Apr2021 (age at vaccination was 32 years) as DOSE 2, SINGLE for covid-19 immunization at school or student health clinic. No other vaccines were received in four weeks. Medical history was not reported. Known allergies included shrimp and sesame. Concomitant medications were not reported. The patient previously took Z-PAK and experienced allergies and bnt162b2 (Batch/Lot Number: ER2613), via an unspecified route, administered in arm left on 17Mar2021 at 02:00 PM (age at vaccination was 32 years) as DOSE 1, SINGLE for covid-19 immunization and experienced muscle aches, bad migraine and dizziness. On an unspecified date in Apr2021, the patient's neck lymph node was very swollen, only slightly on right which led to chest pain. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site mass
Clinical narrative: swelling of lymph nodes; surrounding tissue (big lump) on shoulder near collarbone only on the side of the injection; This is a spontaneous report from a contactable consumer (patient). A 39-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Ep7534, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 23Mar2021 05:00 AM (at the age of 39-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported and Birth control (Unspecified) both received in two weeks. No other vaccine received in four weeks. No Covid prior vaccination, no Covid tested post vaccination. On 14Apr2021 at 07:00, the patient experienced swelling of lymph nodes, surrounding tissue (big lump) on shoulder near collarbone only on the side of the injection. It was reported that event occurred with the first shot days later. No treatment was received for events. The outcomes of events were unknown.  No follow up attempts are possible. No further information is expected. .
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity, Swelling
Clinical narrative: Second shot the swelling happened much more quickly and larger; Second shot more arm soreness; Some movement limitation; This is a spontaneous report received from a contactable consumer (patient reported for herself). A 39-years-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: solution for injection, Batch/Lot number: ER8734), via an unspecified route of administration, administered in left arm on 13Apr2021 at 17:15 hours (at the age of 39-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications in 2 weeks included sertraline hydrochloride (ZOLOFT) and birth control medications. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Formulation: solution for injection, Batch/Lot number: EP7534), via an unspecified route of administration, administered in left arm on 23Mar2021 at 17:00 hours as (at the age of 38-years-old) dose 1, single for COVID-19 immunisation and experienced swelling of lymph nodes and surrounding tissue (big lump) on shoulder near collarbone only on the side of the injection. The patient received no other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. On 14Apr2021 at 07:00, the patient experienced second shot the swelling happened much more quickly and larger, second shot more arm soreness, and some movement limitation. The patient received no treatment for the adverse events. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Swelling, Swelling face, Urticaria
Clinical narrative: lots of pain felt like a balloon being blown up/Hurt to move; My face swelled first then my whole body swelled; hives; My face swelled first then my whole body swelled; Was very itchy; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732), via an unspecified route of administration, administered in arm left on 27Mar2021 at 15:00 (age at vaccination 42-year-old) as dose 1, single for covid-19 immunisation at Hospital. The patient had no known allergies. The patient medical history was reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications included antibiotics within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced hives, her face swelled first then her whole body swelled, lots of pain felt like a balloon being blown up/hurt to move and was very itchy on 30Mar2021 at 22:15. The events resulted in Doctor or other healthcare professional office/clinic visit. As a treatment steroid three a day for five days was taken for all the events. The events were recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Inappropriate schedule of product administration, Mass, Neck pain
Clinical narrative: swelling, redness, pain at injection site; swelling, redness, pain at injection site; swelling, redness, pain at injection site; Lump on upper left collarbone that is causing pain in upper left chest, left side of neck, and left side of head; Lump on upper left collarbone that is causing pain in upper left chest, left side of neck, and left side of head; Lump on upper left collarbone that is causing pain in upper left chest, left side of neck, and left side of head; Lump on upper left collarbone that is causing pain in upper left chest, left side of neck, and left side of head; Start Date/Time: 14Apr2021 10:00 AM; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205) via an unspecified route of administration in left arm on 14Apr2021 at 10:00 (at the age of 31-year-old) as single dose for COVID-19 immunization at Workplace clinic. Medical history included sleep apnea and shellfish allergy. Patient did not receive other medications in two weeks or any other vaccine in four weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205) via an unspecified route of administration in left arm on 06Jan2021 at 11:30 (at the age of 31-year-old) as single dose for COVID-19 immunization and experienced COVID-19. On 15Apr2021 at 19:00, patient experienced swelling, redness, pain at injection site. Lump on upper left collarbone that was causing pain in upper left chest, left side of neck, and left side of head. Adverse event resulted in emergency room/department or urgent care. Patient did not receive any treatment in response to the event. Outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling, redness, pain at injection site; swelling, redness, pain at injection site; swelling, redness, pain at injection site; Lump on upper left collarbone that is causing pain in upper left chest, left side of neck, and left side of head; Lump on upper left collarbone that is causing pain in upper left chest, left side of neck, and left side of head; Lump on upper left collarbone that is causing pain in upper left chest, left side of neck, and left side of head; Lump on upper left collarbone that is causing pain in upper left chest, left side of neck, and left side of head; Start Date/Time: 14Apr2021 10:00 AM; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205) via an unspecified route of administration in left arm on 14Apr2021 at 10:00 (at the age of 31-year-old) as single dose for COVID-19 immunization at Workplace clinic. Medical history included sleep apnea and shellfish allergy. Patient did not receive other medications in two weeks or any other vaccine in four weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205) via an unspecified route of administration in left arm on 06Jan2021 at 11:30 (at the age of 31-year-old) as single dose for COVID-19 immunization and experienced COVID-19. On 15Apr2021 at 19:00, patient experienced swelling, redness, pain at injection site. Lump on upper left collarbone that was causing pain in upper left chest, left side of neck, and left side of head. Adverse event resulted in emergency room/department or urgent care. Patient did not receive any treatment in response to the event. Outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Had rash on body. On neck, arm pits, side of back and groin area as a result of second dose.; This is a spontaneous report from a contactable consumer. This 43-year-old male consumer reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; brand=er8737, lot number=ER8737) via an unspecified route of administration on 07Apr2021 at 04:15 PM on left arm (at 43-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history, known allergies and other medications in two weeks were reported as none. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. The patient did not have covid prior to vaccination and was not tested for covid post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; brand=EP6955, lot number=er8737) via an unspecified route of administration on 17Mar2021 at 04:30 PM (at 43-year-old) on left arm, as dose 1, single for COVID-19 immunization and experienced odd cold sore like break out on checks next to his lip. This was about 5cm break out and lasted a few days. On 10Apr2021 on 06:00 PM he had rash on body. On neck, arm pits, side of back and groin area as a result of second dose. No treatment was received for event. On 11Apr2021 the patient recovered.  No follow-up attempts were possible. No further information was expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: I had odd cold sore like break out on cheeks next to my lip.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 17Mar2021 16:30 (at the age of 43-year-old) as dose 1, single for COVID-19 immunization at hospital. Medical history was none. There were no concomitant medications. Patient's known allergies was none. The patient did not receive any other vaccine with 4 weeks prior to the vaccination or other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that after the first dose, he had odd cold sore like break out on checks next to his lip. This about 5cm break out and lasted a few days on an unspecified date. The patient did not received any other treatment for the events. Outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: joint ache; heacache; This is a spontaneous report from a contactable consumer. This 72-year-old consumer reported in response to non-HCP letter sent which included that who received bnt162b2 (BNT162B2) solution for injection dose 1 (Batch/Lot Number: EL3249) via intramuscular route of administration in upper arm on 19Jan2021 05:30 Patient (at the age of 72-year-old) as dose 1 single for covid-19 immunisation. The patient medical history and concomitant medication was not reported. On an unspecified date the patient experienced Minor headache, Joint Ache. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: This is a spontaneous report from contactable consumer or other non-HCP. A patient, of unspecified age and gender, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient experienced headache, 102ºF fever and fatigue. The patient underwent lab tests and procedures, which included body temperature: 102ºF fever on an unspecified date. The outcome of the event: unknown (at the time of report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: some more swelling just not as much as the first time; This is a spontaneous report from a contactable consumer reported for himself that:  A 50-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8737), via an unspecified route of administration, administered in Arm Left on 10Apr2021 14:30 (At the age of 50 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration, administered in Arm Left on 20Mar2021 02:45 PM (At the age of 50 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma and hypertension from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Vitamin D, Motrin, Diphenhydramine and Tylenol sinus taken for an unspecified indication, start and stop date were not reported. My first shot: a day or two after the injection 21Mar2021 01:00 PM my left side of the face swelled (mostly in the sinus regions) and tooth pain from upper gum swelling under the nose so he just thought it was just a sinus issue so he took over the counter meds and didn't think anything of it but after the second injection he noticed some more swelling just not as much as the first time and as soon as he noticed it he took Diphenhydramine. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Caller has really bad allergies; This is a spontaneous report from a Pfizer-sponsored program. A Non-contactable Female consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced really bad allergies. She got it and her Brother and his wife got it. At the time of this report, the outcome of event 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: Chills, Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Nurse. A (Age-57, Units-Unknown) male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown) via unknown route of administration on an unknown date as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown) via unknown route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient developed fever, body aches, chills and a headache. Seemed to last about 24 to 34 hours after the vaccine. The outcome of the events were recovered. No follow-up attempts were possible, information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eczema, Mass
Clinical narrative: I have noticed dry spots sarted to appear on my skin ,which looks like eczema.And it continue to appear randomly; I have noticed dry spots sarted to appear on my skin ,which looks like eczema.And it continue to appear randomly; This is a spontaneous report from a contactable other healthcare professional. A 44 year old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Dec2020 16:45 (Batch/Lot Number: EH 9899) as DOSE 1, SINGLE for covid-19 immunisation. Also received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 06Jan2021 16:45 (Batch/Lot Number: EH 9899) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient experienced dry spots started to appear on her skin ,which looks like eczema.and it continue to appear randomly as mass on 03Feb2021 with outcome of not recovered.  No follow-up attempts are required. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: I have noticed dry spots sarted to appear on my skin ,which looks like eczema.And it continue to appear randomly; I have noticed dry spots sarted to appear on my skin ,which looks like eczema.And it continue to appear randomly; This is a spontaneous report from a contactable other healthcare professional. A 44 year old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Dec2020 16:45 (Batch/Lot Number: EH 9899) as DOSE 1, SINGLE for covid-19 immunisation. Also received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 06Jan2021 16:45 (Batch/Lot Number: EH 9899) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient experienced dry spots started to appear on her skin ,which looks like eczema.and it continue to appear randomly as mass on 03Feb2021 with outcome of not recovered.  No follow-up attempts are required. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Chills, Dysmenorrhoea, Heavy menstrual bleeding, Lethargy
Clinical narrative: leading to anemia; chills; lethargy; Lightly itchy skin; very heavy, painful period that appears never ending that feels as if it is getting worse; very heavy, painful period that appears never ending that feels as if it is getting worse; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732), via an unspecified route, administered in arm left on 31Mar2021 at 06:00 PM (age at vaccination was 48 years) as DOSE 2, SINGLE for covid-19 immunization at other facility. The patient was not pregnant at the time of vaccination. No other vaccines received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Medical history included hypothyroidism and known allergy to penicillin; both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (UNITHROID) taken in two weeks for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Batch/Lot Number: EN6206), via an unspecified route, administered in arm left on 10Mar2021 at 06:00 PM (age at vaccination was 48 years) as DOSE 1, SINGLE for covid-19 immunization. On 03Apr2021, the patient experienced chills, lethargy, lightly itchy skin for 2.5 weeks. The patient also had very heavy, painful period that appeared never ending that felt as if it was getting worse, currently in third week, leading to anemia. The adverse events resulted in visit to doctor or other healthcare professional office/clinic visit. Treatment received was reported as unknown. Outcome of the events was not recovered.  No Follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: leading to anemia; chills; lethargy; Lightly itchy skin; very heavy, painful period that appears never ending that feels as if it is getting worse; very heavy, painful period that appears never ending that feels as if it is getting worse; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732), via an unspecified route, administered in arm left on 31Mar2021 at 06:00 PM (age at vaccination was 48 years) as DOSE 2, SINGLE for covid-19 immunization at other facility. The patient was not pregnant at the time of vaccination. No other vaccines received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Medical history included hypothyroidism and known allergy to penicillin; both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (UNITHROID) taken in two weeks for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Batch/Lot Number: EN6206), via an unspecified route, administered in arm left on 10Mar2021 at 06:00 PM (age at vaccination was 48 years) as DOSE 1, SINGLE for covid-19 immunization. On 03Apr2021, the patient experienced chills, lethargy, lightly itchy skin for 2.5 weeks. The patient also had very heavy, painful period that appeared never ending that felt as if it was getting worse, currently in third week, leading to anemia. The adverse events resulted in visit to doctor or other healthcare professional office/clinic visit. Treatment received was reported as unknown. Outcome of the events was not recovered.  No Follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Mass, Product administered at inappropriate site
Clinical narrative: but I think the girl gave it in the wrong place in my arm; With the second shot I still have a bump on my arm; This is a spontaneous report from a contactable consumer. This consumer (patient) reported. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient still have a bump on his arm but he think the girl gave it in the wrong place in his arm. Outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diaphragmalgia, Dysphagia, Gastrooesophageal reflux disease, Lip blister, Oral mucosal blistering
Clinical narrative: blisters on her lip, mouth and back of throat; blisters on her lip, mouth and back of throat; blisters on her lip, mouth and back of throat; horrible reflux; severe pain in her diaphragm; felt like there was a lump in her throat; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2, via an unspecified route of administration, administered in left arm on 03Apr2021 01:45 (Batch/Lot Number: ER8733) at the age of 61 years old as dose 2, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergy. Concomitant medication(s) included Vitamin C [ascorbic acid] and Calcium;Vitamin D (nos) supplements; both taken for unspecified indications, start and stops date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19. Since the vaccination, she has not been tested for COVID-19. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EN6205), administered in left arm on 13Mar2021 12:00. On 04Apr2021 09:30 (also reported as approximately 20 hours after the vaccination), the patient experienced blisters on her lip, mouth and back of throat. Also on 04Apr2021 09:30 (also reported as about 24 hours after that), horrible reflux with severe pain in her diaphragm and felt like there was a lump in her throat with difficulty swallowing. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included diphenhydramine (BENADRYL), methylprednisolone (MEDROL Dose Pack) and famotidine (PEPCID). Outcome of events were recovering.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal blistering, Sensation of foreign body
Clinical narrative: blisters on her lip, mouth and back of throat; blisters on her lip, mouth and back of throat; blisters on her lip, mouth and back of throat; horrible reflux; severe pain in her diaphragm; felt like there was a lump in her throat; difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2, via an unspecified route of administration, administered in left arm on 03Apr2021 01:45 (Batch/Lot Number: ER8733) at the age of 61 years old as dose 2, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergy. Concomitant medication(s) included Vitamin C [ascorbic acid] and Calcium;Vitamin D (nos) supplements; both taken for unspecified indications, start and stops date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19. Since the vaccination, she has not been tested for COVID-19. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EN6205), administered in left arm on 13Mar2021 12:00. On 04Apr2021 09:30 (also reported as approximately 20 hours after the vaccination), the patient experienced blisters on her lip, mouth and back of throat. Also on 04Apr2021 09:30 (also reported as about 24 hours after that), horrible reflux with severe pain in her diaphragm and felt like there was a lump in her throat with difficulty swallowing. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included diphenhydramine (BENADRYL), methylprednisolone (MEDROL Dose Pack) and famotidine (PEPCID). Outcome of events were recovering.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Somnolence
Clinical narrative: headache; upset stomach; Extreme fatigue; Sleepiness; Sleepiness; This is a spontaneous report from a contactable consumer or other non HCP. This contactable consumer reported in response to non HCP letter sent which included.  A 56-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6206, Expiry date: unknown), via an unspecified route of administration, administered in Arm Right on 04Mar2021 (at the age of 56 years old) as dose 2, single for covid-19 immunisation at clinic and levothyroxine sodium (SYNTHROID, Batch/Lot number was not reported), via an unspecified route of administration from 1977 and ongoing. There is no relevant medical history. Concomitant medication(s) included sertraline hcl from 2010 and ongoing; omeprazole magnesium (PRILOSEC) from 2015 and ongoing. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3249, Expiry date: unknown), via an unspecified route of administration, administered in arm right on 06Feb2021 (at the age of 56 years old) as dose 1, single for covid-19 immunisation. No history of any previous immunization with the Pfizer vaccine considered as suspect. Adverse event did not require a visit to Emergency Room/Physician Office. No Adverse events following prior vaccinations. No relevant medical history (including any illness at time of vaccination). No relevant family medical history to adverse event. No relevant tests done. The patient experienced headache on 05Mar2021 08:00 & 06Mar2021, upset stomach on 05Mar2021 08:00, sleepiness day after vaccine on 05Mar2021, extreme fatigue on 05Mar2021 & 06Mar2021, sleepiness also on day 2 on 07Feb2021 08:00. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cardiac flutter, Diarrhoea, Dizziness, Eye irritation
Clinical narrative: fluttering in my chest; Debilitating headache; fatigue; stomach pains; diarrhea; eyes burning; rash; brain fog worsened; dizziness; nausea; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: Unknown) via unspecified route in the left arm on 20Apr2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included lower back injury, 2 times surgeries, on disability and worker's compensation, gastritis, COVID-19 and long COVID (1 year, 6 days). The patient's known allergies included moxifloxacin (AVELOX) and ciprofloxacin (CIPRO). Concomitant medications received within 2 weeks of vaccination included metoprolol succinate (TOPROL), escitalopram oxalate (LEXAPRO), famotidine (PEPCID), carisoprodol (SOMA), butalbital, caffeine, paracetamol (FIORCET), colestipol hcl (COLESTID 'MEL'). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Apr2021 at 01:00 AM, the patient experienced debilitating headache, fatigue, stomach pains, diarrhea, fluttering in chest, eyes burning, rash, brain fog worsened, dizziness, nausea. There was no treatment received. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Nausea, Rash
Clinical narrative: fluttering in my chest; Debilitating headache; fatigue; stomach pains; diarrhea; eyes burning; rash; brain fog worsened; dizziness; nausea; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: Unknown) via unspecified route in the left arm on 20Apr2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included lower back injury, 2 times surgeries, on disability and worker's compensation, gastritis, COVID-19 and long COVID (1 year, 6 days). The patient's known allergies included moxifloxacin (AVELOX) and ciprofloxacin (CIPRO). Concomitant medications received within 2 weeks of vaccination included metoprolol succinate (TOPROL), escitalopram oxalate (LEXAPRO), famotidine (PEPCID), carisoprodol (SOMA), butalbital, caffeine, paracetamol (FIORCET), colestipol hcl (COLESTID 'MEL'). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Apr2021 at 01:00 AM, the patient experienced debilitating headache, fatigue, stomach pains, diarrhea, fluttering in chest, eyes burning, rash, brain fog worsened, dizziness, nausea. There was no treatment received. The outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Pain, Pyrexia, Vaccination site mass
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 29-years-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: Er8736) via an unspecified route of administration, administered in arm left on 28Apr2021 at 15:45 (at the age of 29-years-old) as dose 2, single for covid-19 immunization. The patient was not pregnant at time of vaccination. Patient medical history included known allergies with sulfa medication from an unknown date and unknown if ongoing. Concomitant medications was not reported. Patient had not received any other vaccine in four weeks and other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical vaccine included received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: Ew0158), via an unspecified route of administration, administered in arm left on 07Apr2021 at 15:45 as dose 1, single for covid-19 immunization and experienced sore arm at injection site. On 29Apr2021, the patient experienced sore arm with small lump at injection site, full body ache as the day progressed, chills. On 29Apr2021, at 15:45, the patient experienced fever. The patient noticed when she woke up the next day, she developed fever, chills and full body ache as the day progressed. Fever broke at 15:45 (24 hours after getting vaccine). The patient did not receive any treatment for the events. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 29-years-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: Er8736) via an unspecified route of administration, administered in arm left on 28Apr2021 at 15:45 (at the age of 29-years-old) as dose 2, single for covid-19 immunization. The patient was not pregnant at time of vaccination. Patient medical history included known allergies with sulfa medication from an unknown date and unknown if ongoing. Concomitant medications was not reported. Patient had not received any other vaccine in four weeks and other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical vaccine included received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: Ew0158), via an unspecified route of administration, administered in arm left on 07Apr2021 at 15:45 as dose 1, single for covid-19 immunization and experienced sore arm at injection site. On 29Apr2021, the patient experienced sore arm with small lump at injection site, full body ache as the day progressed, chills. On 29Apr2021, at 15:45, the patient experienced fever. The patient noticed when she woke up the next day, she developed fever, chills and full body ache as the day progressed. Fever broke at 15:45 (24 hours after getting vaccine). The patient did not receive any treatment for the events. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache with first dose COVID-19 Vaccine; This is a spontaneous report from a contactable consumer and received from a Pfizer sponsored program with Regulatory Authority support. A contactable consumer reported for herself. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 04May2021 (Age at vaccination: 77-year-old) as DOSE 1, SINGLE for COVID-19 immunization (Reason for no lot number: of COVID-19 Vaccine: complainant did not have the product with them at the time of call) and budesonide (BUDESONIDE), route of administration, start and stop date, batch/lot number and dose were not reported for diarrhoea (continuous diarrhoea) (Reason for no lot number of Budesonide: Complainant does not have the product with them at the time of call). Medical history included diarrhoea (had diarrhea in the past) from an unknown date and unknown if ongoing. Patient clarified that the continuous diarrhea was experiencing now began prior to the first dose COVID-19 Vaccine. Took Budesonide for three months. Is having continuous diarrhea again. Patient had taken Budesonide in the past for diarrhea and it worked. Concomitant medication was not reported. Doctor heard, that when take Pfizer COVID vaccine should not be using Budesonide (budesonide) 2 weeks after the second dose. The patient experienced Headache with first dose COVID-19 Vaccine and patient had a headache last night, but it went away. Patient feels great today and recovered completely. Patient received the first dose of the vaccine yesterday and arm did not hurt, but Budesonide (budesonide) was prescribed to start it today for continuous diarrhea. Patient had taken it previously for 3 months for same reason. Patient wanted to know if its ok to take steroids with vaccine patient was supposed to start steroid treatment (today). Wanted to know if she should not take the Budesonide until after the second dose COVID-19 Vaccine was done. A person evidently spoke to doctor stating she thinks caller should not be taking the Budesonide with the first COVID-19 Vaccine and should wait two weeks after the second shot. This person who spoke with doctor. Doctor did not know and advised caller to reach out to the pharmacist. As of right now, patient had not taken Budesonide yet, but was supposed to start taking (today). Dose: will take 3 pills per day, believes each pill is 9mg each. Dosage was not written down on the notes provided by the doctor. Stated she does not have a bottle of Budesonide, but picking up the prescription from the pharmacy (today). The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.