chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain of skin, Peripheral swelling
Clinical narrative: Swollen arm; skin hot to touch; mimics effects of bee sting; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (non-pregnant) received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), dose 2 via an unspecified route of administration, administered in Arm Left on 21Feb2021 16:00 (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included atorvastatin, metformin. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), dose 1 via an unspecified route of administration, administered in Arm Left on 31Jan2021 (37-year-old) 16:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have covid prior vaccination and no covid tested post vaccination. The patient had no known allergies. On 22Feb2021 09:00 the patient experienced swollen arm, skin hot to touch, mimics effects of bee sting. The patient did not receive any treatment for events. AE resulted in Doctor or other healthcare professional office/clinic visit.  The outcome of the events was unknown. Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain in my arm; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 12:00 (at the age of 24-year-old) as dose 1, single for COVID-19 immunization. Medical history reported as no. The patient concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines in 4 weeks prior to the COVID vaccine. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021 the patient experienced muscle pain in arm. The clinical outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: she lost her taste and smell and it stayed gone up until that first shot and then everything began to come back; she lost her taste and smell and it stayed gone up until that first shot and then everything began to come back; she lost her taste and smell; she lost her taste and smell; This is a spontaneous report from a contactable consumer (patient) and physician. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: EL9262, Expiry Date: Not Reported), via an unspecified route of administration on 28Jan2021 (at the age of 68-year-old) as dose 1, single for COVID-19 immunisation. There was no medical history, no concomitant medications, and no investigation assessment. The patient had taken a COVID test many times. It was last year she had gone to the store; she wore her mask, but her niece did not. She told her doctor she lost her taste and smell and it stayed gone up until that first shot and then everything began to come back, and she was happy. Everyone was saying how do you feel some, she knows some of her friends and family had problems, but she got her taste and smell back. She clarifies she has not been tested for COVID since it the taste and smell came back, she will see at her doctors appointment next month, what was going on. Outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm still sore, but that also happened after first shot; This is a spontaneous report from a contactable consumer (patient). An elderly non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in left arm on 31Jan2021 15:30 (Lot Number: EI9262) as dose 1, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included unspecified known allergies to Penicillin and Demerol. Concomitant medications included ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin B12 NOS, vitamin D NOS, vitamin E NOS, zinc (CENTRUM MULTIGUMMIES); calcium and Vitamin C [ascorbic acid] form unknown date and unknown if ongoing. No other vaccine administered in four weeks. On an unspecified date, the patient stated arm still sore, but that also happened after first shot. Patient had no COVID prior vaccination and not tested for COVID post vaccination. Outcome of the event was unknown at the time of reporting.   No follow up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Illness, Insomnia, Pain
Clinical narrative: achiness; getting sick; Could not even sleep because of the achiness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received second dose, bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number: not reported), via an unspecified route of administration on 16Feb2021 (at the ag of 73 years-old) as dose 2, single for COVID-19 immunisation. Medical history included Diabetes and cholesterol from an unknown date and unknown if ongoing. Concomitant medication(s) included janumet for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection) on 16Jan2021 as single dose for covid19 immunisation. The patient experienced achiness, getting sick, could not even sleep because of the achiness on an unspecified date. Patient stated that she was kind of just wondering, she already got her second shot, and she got it last Tuesday and this week, it was not until now that she was feeling, thinks she was not sure, if that was side effect from the shot. Like towards the evening, she felt achy, it's like she was got sick, but then she wake up in the morning okay. Would she still be getting side effects from second shot, well, last night, after the second one. But the first one, she started getting sick the next day. The patient underwent lab tests and procedures which included blood work: everything was good on an unspecified date. Tylenol were taken as a result of achiness. The outcome of events was unknown.  No follow-up attempts are needed. Information about lot/ batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: experienced pain in his arm; tired; This is a spontaneous report from a contactable consumer or other non health care professional. This female (daughter) consumer reported for a 60-year-old male patient (father).  A 60-year-old male patient (father) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6202, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that reporter father has experienced pain in his arm this morning and feeling tired. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Vaccination site pain
Clinical narrative: Caller states she thinks the person giving the injection put the darn thing through her bone.; Caller reports that with the first shot she got a really sore arm.; This is a spontaneous report from a contactable nurse (patient herself). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL8982), via an unspecified route of administration, administered in arm on an unspecified date (age at vaccination was 80 years) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced patient states, she thinks the person giving the injection put the darn thing through her bone and she reports that with the first shot she got a really sore arm. She thought it was to be expected but it feels like the person who administered the vaccine was a poor shot giver. The outcome of events were unknown.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This is a spontaneous report from a contactable consumer (herself). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was EL3247) dose 1 via an unspecified route of administration, administered on Arm Right on 01Mar2021 10:45, as DOSE 1, SINGLE for COVID-19 immunization (at the age 54 years). Medical history included breast cancer from Sep2018 to an unknown date (2018 diagnosis), drug hypersensitivity with Sulfa drugs from an unknown date and unknown if ongoing, ligament sprain from an unknown date and unknown if ongoing. Concomitant medications included tamoxifen; paracetamol (TYLENOL); atorvastatin (LIPITOR [ATORVASTATIN]); celecoxib (CELEBREX) and Multi-Vit medications received within 2 weeks. The patient previously took Levaquin and experienced drug hypersensitivity, flu vaccine vii for immunisation and experienced Sore arm at injection site, like when i get a flu shot. The patient was not pregnant at time of vaccination. The patient did not received 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, the patient has not been tested for COVID-19. The patient experienced sore arm at injection site on 02Mar2021 12:00 AM. Sore arm at injection site, like when she got a flu shot. Realized it when she rolled over onto the arm during the night. Had the shot in her non-dominant arm. No therapeutic measures taken as a result of event. The clinical outcome of the event was recovering.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report from a contactable consumer (patient). This consumer reported for 3 patients (Reporter self, Mother and Husband). This is for Reporter self. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient stated she and her husband also received the Pfizer covid vaccine and experienced tiredness but no major side effects. Patient and her husband got theirs almost 3 weeks ago and are due for the second one next week. The only thing they felt was tired but no major aches and pains. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of unspecified age had received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: Not reported) via an unspecified route of administration on unspecified date as Dose 1, Single for Covid-19 immunization. The patient's medical history and concomitant were not reported. On an unspecified date, the reporter stated that her husband had experienced tired/ tiredness but no major side effects such as aches and pains. The reporter stated that the patient was due for the second one next week. The reporter confirmed product as COVID 19 Vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site joint pain, Vaccination site pain
Clinical narrative: Second shot arm soreness on the arm of the injection mostly in the joint for about 48 hours; Second shot arm soreness on the arm of the injection mostly in the joint for about 48 hours; drowsiness. I slept for about four hours after I got home.; This is a spontaneous report from a contactable consumer. This 66-Year-old male consumer reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 17Feb2021 in right arm (at 66-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history included heart from an unknown date and unknown if ongoing, digestive from an unknown date and unknown if ongoing, knee injuries from an unknown date and unknown if ongoing, post-traumatic stress disorder from an unknown date and unknown if ongoing ptsd and several others. The allergies were reported as none. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. The patient received other medications in two weeks. The patient did not have Covid prior 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; Lot number: EN5318) via an unspecified route of administration on 27Jan2021 (at 66-year-old) on right arm as dose 1, single for COVID-19 immunization and experienced soreness to the injection site for like 5 hours, metallic taste in my mouth for a few minutes and metallic taste in my mouth for a few minutes. On 17Feb2021 after receiving the second shot the patient experienced soreness on the arm of the injection mostly in the joint for about 48 hours and drowsiness. He slept for about four hours after I got home. No treatment was received for events. On an unknown date in Feb2021 the patient recovered.  Information on Lot/Batch number has been requested  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021228004 same patient/drug, different dose/event
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Pain at injection site; Sore arm; This is a spontaneous report from a contactable consumer or other non-health care professional.  A 55-year-old male received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6198) via unspecified route of administration, administered in arm left on 28Feb2021 at 14:45 (age at the time of vaccination was 55-year-old) as a dose 1, single dose for COVID-19 immunization. The patient's relevant medical history included high blood pressure, high cholesterol, seasonal allergies and transient ischemic attack (13 years ago) from an unspecified date. The patient's concomitant medications include Folic Acid 1 mg, Aspirin 81 (ACETYLSALICYLIC ACID), Vitamin D3, Hydrochlorothiazide 25 mg, Levocetirizine Dihydrochloride 5mg, Fenofibrate 145 mg and Vitamin C (ASCORBIC ACID) and Zinc Chloride taken for an unspecified indication. On 28Feb2021 (at 08:00), the patient experienced Pain at injection site and Sore arm. The patient received Acetaminophen as treatment medication for adverse events. The patient was made aware in the late evening of Sunday, 28Feb2021 and had a personal situation on Monday, 01Mar2021, so was not able to report on 01Mar2021. He reported as soon as was able to on Tuesday, 02Mar2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The clinical outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: feeling achy all over; This is a spontaneous report from a Pfizer sponsored program COVAX US Support reported via non-contactable consumer or other non hcp(patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced feeling achy all over (pain). The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable consumer (patient).   A 54-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL 3247, Expiry date: not reported), via an unspecified route of administration in left arm on 01Mar2021 10:30 (at age of 54-years-old) as dose 1, single for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included depression, Adult ADHD (attention deficit hyperactivity disorder). The patient previously took erythromycin, amoxicillin, avelox, zithromycin, Inderal and experienced drug hypersensitivity. Concomitant medication(s) included bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; liraglutide (SAXENDA) taken for an unspecified indication, start and stop date were not reported; methylphenidate (METHYLPHENIDATE) taken for an unspecified indication, start and stop date were not reported; eletriptan (ELETRIPTAN) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 01Mar2021 22:00, the patient experienced soreness at injection site. No therapeutic measures were taken in response to the event. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Paraesthesia
Clinical narrative: My arm a little sore; I was a little bit sore.; I kind feel little nausea at my stomach and I have never had that; Tingling; I was a little bit sore.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN5202) via an unspecified route of administration on 24Feb2021 (at the age of 58-year-old) at dose 1, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. On an unspecified date in2021 the patient experienced my arm a little sore; i was a little bit sore, i kind feel little nausea at my stomach and i have never had that, tingling. Additional Context: When probed for the concern, reporter stated, I went out yesterday and I took the Pfizer, I took the shot yesterday and it just made my arm a little sore after the shot and that was fine and then this morning I was a little bit sore so I continued to do my normal exercise that I do in the morning and like about 10 or 11 O'clock I started getting nausea and stomach nausea and so I haven't eaten my dinner but I went back to sleep couple of hours ago and I just woke up. So, I read my paper and it said to contact you guys if I had any nausea or, I haven't had any headache just kind of tingling so I am thinking that, since that's my first one it might be working or it is just new to my body so I am trying to giving it a little time. I am fixing to put something in my stomach I hadn't ate dinner yet but I kind feel little nausea at my stomach and I have never had that. I don't have stomach problems or nothing like that, I didn't have until I took the shot so I am just kind of taking a step ahead to give it today and if it continues then least I have made the call so. When confirmed the vaccine as Pfizer's Covid 19 vaccine, consumer stated: Yes. LOT, consumer stated, Okay hold on 1 minute. It is Pfizer EN5202, looks like. Patient did not receive treatment for the adverse events. Outcome of the events was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: had some diarrhea; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm on 13Feb2021 (at the age of 84 years old) as dose 2, single for COVID-19 immunisation. Medical history included high blood pressure. The patient's concomitant medications were not reported. On 22Feb2021, the patient had some diarrhea in the last two days. The patient could not remember if treatment was taken for the event. The patient was recovering from diarrhea.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a little bit of arm sore.; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) from a Pfizer sponsored program. A female patient of an unspecified age received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 22Feb2021 as dose 2, single for COVID-19 immunization. Medical history included ongoing back pain for 12 years. The concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route as dose 1, single for COVID-19 immunization. On an unspecified date in Feb2021, the patient had a little bit of arm sore. It was reported that patient inquired if she could take Celebrex for her ongoing back pain, she already had for 12 years and this pain. The outcome of event was unknown.  No follow-up attempts are needed; information about batch/ lot number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Supraclavicular swelling began from day 2 (2/23/2021).; This is a spontaneous report from a contactable consumer (patient). A 45-Year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9266) via an unspecified route, administered left arm on 23Feb2021 at 17:30 (at the age of 45 years) as dose 2, single for covid-19 immunization at public health department. The patient's medical history was not reported. The patient's concomitant medications (other medications in two weeks) included vitamin D (VIATMIN D NOS). No other vaccine in four weeks. The patient took previously first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9265) via an unspecified route, administered left arm on 02Feb2021at 19:00 (at the age of 45 years) as dose 1, single for covid-19 immunization. There were no other vaccine in four weeks. No covid prior vaccination. The patient experienced supraclavicular swelling began from day two on 23Feb2021. The patient did not receive treatment for adverse event. No covid tested post vaccination. The outcome of event was unknown.  Follow-up attempts were completed. No further information was expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle aches; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 64-years-old female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date (at the age of 64 years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported, and concomitant medications was none. Patient historical vaccine was flu vaccine. The patient experienced muscle aches. States she wanted to throw in she usually gets muscle aches like after the flu vaccine last year and after her 1st dose. States after the 1st time it lasted 6 days. The outcome of muscle aches was unknown.  No follow-up attempts are Possible. Information on lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Vaccination site pain
Clinical narrative: lump on the left arm pit; pain in the administration site; This is a spontaneous report from a contactable consumer or other non hcp who reported for himself.  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: en6203) via an unspecified route of administration, administered in left arm on 27Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had a lump on the left arm pit and vaccination site pain. Patient reported that he received the vaccine on 27Feb, yesterday he found out he has a lump on the left arm pit where he received the vaccine, the lump hurts today. Patient had received the vaccination at medical center. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: This is a spontaneous report from a noncontactable consumer or other non-HCP. A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient had a head cold on an unspecified date. Verbatim and Event Description: No patient identifiers provided but the reporter has firsthand knowledge of the patient and reporting on a specific patient. Mother-in-law got first vaccine. She is scheduled for her second dose. She got a head cold just recently. She is inquiring if mother-in-law can take second vaccine while sick. The event outcome reported unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if prior to vaccination, the patient was diagnosed with covid-19. Since the vaccination, it was unknown if the patient had been tested for covid-19. On 01Mar2021 in late evening, patient experienced chills. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Poor quality product administered, Vaccination site reaction
Clinical narrative: believe, very strongly that it was administered SQ instead of IM no doubt in her mind she was administered the second dose subcutaneously instead of intramuscularly; she believes her second dose was dosed incorrectly (SubQ) and she believes it to be invalid; bubble under the skin; This is a spontaneous report from a contactable other healthcare professional (patient) via Medical Information Team.   A 70-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6198; Expiration Date: Jun2021), via subcutaneous route, administered in Arm Left on 01Mar2021 at 16:00 (age at the time of vaccination was 70 years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included chronic lung disease from 2017 and ongoing. There were no concomitant medications reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramusculary, administered in Arm Left on 06Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. prior Vaccinations (within 4 weeks) and Relevant Tests were reported as no. Reportedly, history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations) were not available. On 01Mar2021 at 16:00, the patient experienced believe, very strongly that it was administered sq instead of intramuscularly no doubt in her mind she was administered the second dose subcutaneously instead of intramuscularly and she believes her second dose was dosed incorrectly (subq) and she believes it to be invalid. On 01Mar2021, the patient experienced bubble under the skin. It was reported that, the reporter was a retired medical assistant who received her second dose of Pfizer-Biontech Covid19 vaccine yesterday and believed that the dose was given subcutaneously instead of IM. the patient also reported a bubble under the skin. She asked what should be done next and asked does she need another dose. The patient asked, what was the efficacy data for 1st dose, since she believed her second dose was dosed incorrectly (SubQ) and she believed it to be invalid. She mentioned strong data coming out of Israel as well. There was no doubt in her mind she was administered subcutaneously instead of intramuscularly and she doesn't know what to do about that. The outcome of the event bubble under the skin was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: fatigue; chills; achy; This is a spontaneous report from a contactable consumer. A 48-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation:Solution of injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 28Feb2021 12:15 (at the age of 48-year-old) as Dose Number Unknown, Single for COVID-19 immunization.The patient medical history and concomitant medications were not reported.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient received other medications within 2 weeks of vaccination, but list is unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient is not having any Allergies to medications, food, or other products. On 28Feb2021, the patient experienced fatigue, chills, achy. The patient did not receive any treatment for the adverse event. The outcome of the events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild pain at the injection site; This is a spontaneous report from a contactable consumer (Patient). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: Et 3247), via an unspecified route of administration, administered in left arm on 01Mar2021 at 10:00 AM (at the age of 34-years-old) as dose 1, single for COVID-19 immunisation at Workplace Clinic. The patient medical history and concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the Covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 01Mar2021 at 05:00 PM, the patient experienced mild pain at the injection site. The patient not received treatment for the event. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 23Mar2021 at 02:30 PM as dose 2, single for COVID-19 immunisation. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (husband).   A 69-year-old male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9266; Expiration Date: May2021) via an unspecified route of administration on 24Feb2021 (at the age of 69 years old) as dose 1, single for COVID-19 immunisation.  Medical history included asthma and concomitant medications were not reported. On Feb2021, the patient experienced sore arm with outcome of unknown without treatment received.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: Left arm soreness at the injection site; foggy feeling; This is a spontaneous report from a contactable consumer. This 47-year-old consumer (patient) reported for herself. A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 14:45 (at the age of 47-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) within 2 weeks of vaccination included spironolactone; iron; multivitamins. The patient did not have any allergies. The patient had no other vaccine within four 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. The patient experienced left arm soreness at the injection site, foggy feeling on 01Mar2021 16:45. The patient did not receive any treatment. Outcome of the event was recovered, at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: trouble with muscle soreness especially in her thighs.; worst pains in her thighs like cramping; Lethargic; She says her arm still hurts from the shots; headaches; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 84-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration on 22Feb2021 (at the age of 84-year-old) as single dose for COVID-19 immunization. The patient medical history reported as none and concomitant medications were not reported. The next day on 23Feb2021 the patient felt lethargic all the day, on an unspecified date in 2021 she had headaches, She thinks she had a headache when she woke up in morning. She probably had one yesterday. She says it was hard to say when the headaches began but she would go along with yesterday. On 24Feb2021 she had trouble with muscle soreness especially in her thighs, felt the worst pains in her thighs like cramping. The patient stated her arm still hurts from the shots on 22Feb2021. She knows these are probably all effects from the shot. She thought she would be getting better. She says she will do whatever was necessary to help. Outcome of the events trouble with muscle soreness especially in her thighs, felt the worst pains in her thighs like cramping, arm still hurts from the shots were not resolved. Outcome of rest all events were unknown.  Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in right arm at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 56-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL3247) via an unspecified route of administration in arm right on 24Feb2021 (age at the time of the vaccination 56 year) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included VITAMIN D, in two weeks. No other vaccine in four weeks. The historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL3247) via an unspecified route of administration in arm left on 03Feb2021 age at the time of the vaccination 56 year as dose 1, single for COVID-19 immunization. On 24Feb2021, the patient experienced soreness in right arm at injection site. Did not require admission due to the event and no treatment was received for adverse event. The outcome of the event recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood glucose, Blood glucose decreased, Dizziness, Eating disorder symptom
Clinical narrative: Little discomfort in the ribs; Sore ribs; Dizziness; Blood sugar going down; I am feeling like reluctant to put food in my mouth and because it does not seem to be agreeing with me; I got horribly sick to my stomach and it cause me to throw up; I got horribly sick to my stomach and it cause me to throw up; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 71-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration on 23Feb2021 (at the age of 71-year-old) as dose 2, single for covid-19 immunization. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications patient stated as yes, she took a lot of medication, well there was awful lot of them.".Historical vaccine included BNT162B2 (solution for injection) via an unspecified route of administration, administered on 02Feb2021 as dose 1 single for COVID-19 immunization. On 24Feb2021 the patient got horribly sick to her stomach and it cause her to throw up, on an unspecified date she experienced little discomfort in the ribs; sore ribs, dizziness, blood sugar going down, she felt like reluctant to put food in her mouth and because it does not seem to be agreeing with her. The patient underwent lab tests and procedures which included blood glucose: going down on an unspecified date. No treatment received for blood sugar as the patient stated her blood sugar was fine. Outcome of the events Little discomfort in the ribs; Sore ribs, Felt like reluctant to put food in her mouth and because it does not seem to be agreeing with her were not resolved, outcome of the event Blood sugar going down was resolving and Outcome of rest of all the events were unknown.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Vomiting
Clinical narrative: Little discomfort in the ribs; Sore ribs; Dizziness; Blood sugar going down; I am feeling like reluctant to put food in my mouth and because it does not seem to be agreeing with me; I got horribly sick to my stomach and it cause me to throw up; I got horribly sick to my stomach and it cause me to throw up; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 71-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration on 23Feb2021 (at the age of 71-year-old) as dose 2, single for covid-19 immunization. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications patient stated as yes, she took a lot of medication, well there was awful lot of them.".Historical vaccine included BNT162B2 (solution for injection) via an unspecified route of administration, administered on 02Feb2021 as dose 1 single for COVID-19 immunization. On 24Feb2021 the patient got horribly sick to her stomach and it cause her to throw up, on an unspecified date she experienced little discomfort in the ribs; sore ribs, dizziness, blood sugar going down, she felt like reluctant to put food in her mouth and because it does not seem to be agreeing with her. The patient underwent lab tests and procedures which included blood glucose: going down on an unspecified date. No treatment received for blood sugar as the patient stated her blood sugar was fine. Outcome of the events Little discomfort in the ribs; Sore ribs, Felt like reluctant to put food in her mouth and because it does not seem to be agreeing with her were not resolved, outcome of the event Blood sugar going down was resolving and Outcome of rest of all the events were unknown.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Chills
Clinical narrative: Chills; she had a temperature; This is a spontaneous report from a contactable consumer or other non hcp (patient) and physician. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration on 24Feb2021 (at the age of 67-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Feb2021, the patient experienced chills, she had a temperature. This consumer was administered her second dose of Pfizer COVID-19 Vaccine 24Feb2021. She was doing good the whole entire evening until late evening; she started to feel chills around 20:00-21:00. Through the night she had a temperature, so she took 2 Tylenol. She has no pain in her arm where the Pfizer COVID-19 Vaccine was given; but she has a temperature. She does not know what to take, she asked if she should take Tylenol or something else for her temperature. The patient received Tylenol as treatment for the events. The patient underwent lab tests and procedures which included had a temperature on 24Feb2021. The outcome for the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Musculoskeletal stiffness
Clinical narrative: stiff neck; a sore left arm pit; a swollen bump in the middle of her left arm pit; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (wife). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiry date were not reported), dose 1 via an unspecified route of administration, administered in left arm on 20Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient got first Pfizer COVID-19 Vaccine shot last Saturday on 20Feb2021 and clarified that the patient was scheduled to get their second COVID-19 Vaccine on 18Mar2021. The reporter stated that the patient woke up in morning of 25Feb2021, 5 days after getting the COVID-19 Vaccine, with a stiff neck, a sore left arm pit, and a swollen bump in the middle of her left arm pit. He clarified his wife received her COVID-19 Vaccine in her left arm, and she still has the swollen bump in the middle of her left arm pit. The patient declined to complete a report over the phone because the patient had to go to work. The clinical outcome of the events stiff neck and a sore left arm pit was unknown. Outcome for the event a swollen bump in the middle of her left arm pit was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills; Muscle ache; This is a spontaneous report from a Pfizer Sponsored Program via contactable pharmacist. A 38-year-old female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date, NDC and UPC number was unknown) via an unspecified route of administration on 04Feb2021 as dose 1, single (at the age of 38-years-old) for COVID-19 immunisation. Patient had no medical history and received no concomitant medications. On Feb2021, after the first dose, patient had a reaction included chills and muscle ache. Therapeutic measures were taken as a result of the events and treatment included took some Tylenol. On 25Feb2021 (today), patient was scheduled for her second vaccine and questioned that if she should receive that second vaccine because of the reaction she had with the first one. The outcome of the events was unknown.  Pharmacist stated there was a definite causality of BNT162b2 with the events.  Follow-up attempts completed. No further information expected.