chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Two, Three front teeth, My upper lip and then, My whole nose went numb after, I got the shot yesterday.; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 Solution for injection, Lot Number: not reported), via an unspecified route of administration on 21Aug2021 as Dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. On unspecified date in Aug2021 patient experienced two, three front teeth, my upper lip and then, my whole nose went numb after, consumer got the shot yesterday. The outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.  FUP (PRD/SRD 02Sep2021): Follow-up activities closed. Batch/lot number not available.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: Low grade fever; 101.4 Centigrade; Feeling sick; This is a spontaneous report from a contactable consumer (patient).   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Aug2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 20Aug2021, the patient was feeling sick and on 21Aug2021, the patient experienced low grade fever, 101.4 Centigrade. Clinical outcome of the adverse events was unknown at time of this report.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder, Weight
Clinical narrative: His voice started go; His voice completely went out, You can barely understand him; This is a spontaneous report from a contactable consumer (patient's wife). A 63-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: ER8729, Expiry date: Unknown) via an unspecified route of administration on 21Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced his voice started go, his voice completely went out, you can barely understand him. Patient went to walk-in clinic and they gave him a 'z-pack' (not clarified). The patient underwent lab tests and procedures which included weight: about 209 lbs on an unspecified date. It was reported that patient didn't receive any treatment for the events. The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: I have a slight and running, Just a very slight temp not very much.; Little bit of chills, Off and on.; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 21Aug2021 10:00 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient had second Covid shot yesterday morning (21Aug2021) at 10 O'clock and was taking elderly mother to an appointment today (22Aug2021) and patient was having just a couple side-effects. It was nothing bad. Just need to know, if should be around other people. Had a slight and running, just a very slight temperature (slight fever) not very much and a little bit of chills, off and on, that was it on an unspecified date in Aug2021. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Decreased appetite, Depressed mood, Headache
Clinical narrative: Headache; I am feeling down always like I want to be sleeping everyday; I am not hungry; I had a temperature twice; I am feeling down; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 16Aug2021 as dose 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date in Aug2021, patient experienced headache, feeling down always like want to be sleeping everyday, not hungry and had a temperature twice. The patient got first vaccine last Monday and was good till Tuesday, like maybe, the patient would say 15, it was 12 hours after I put it on, the patient started having like headache, felt down and not hungry. The patient stated nothing like that, but the worst thing was got headache. The patient had a temperature twice, just a little bit, a 101 for like 2 hours and went away and never came back but right now felt a lot of headache and not hungry and feeling down always like wanted to be sleeping every day. The patient was wondering was that normal. On an unspecified date in Aug 2021, the patient underwent lab tests body temperature with results a 101 for like 2 hours. The outcome of the event body temperature increased was recovered on an unspecified date in Aug 2021. Outcome of the other events were unknown.  The lot number for the vaccine [bnt162b2] was not provided and would be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Headache; I am feeling down always like I want to be sleeping everyday; I am not hungry; I had a temperature twice; I am feeling down; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 16Aug2021 as dose 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date in Aug2021, patient experienced headache, feeling down always like want to be sleeping everyday, not hungry and had a temperature twice. The patient got first vaccine last Monday and was good till Tuesday, like maybe, the patient would say 15, it was 12 hours after I put it on, the patient started having like headache, felt down and not hungry. The patient stated nothing like that, but the worst thing was got headache. The patient had a temperature twice, just a little bit, a 101 for like 2 hours and went away and never came back but right now felt a lot of headache and not hungry and feeling down always like wanted to be sleeping every day. The patient was wondering was that normal. On an unspecified date in Aug 2021, the patient underwent lab tests body temperature with results a 101 for like 2 hours. The outcome of the event body temperature increased was recovered on an unspecified date in Aug 2021. Outcome of the other events were unknown.  The lot number for the vaccine [bnt162b2] was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chest discomfort, Dizziness, Dry mouth
Clinical narrative: felt fainting / lightheadedness; stiff neck; back pain; dry mouth; heart palpitation; weak; tingling of limbs; shortness of breath; chest tightness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (BNT162B2), first single dose via an unspecified route of administration, administered in arm left on 27Feb2021 at 15:45 (Batch/Lot Number: EN 6205) for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks were taken. The patient experienced stiff neck, back pain, felt fainting, weak, dry mouth, heart palpitation, tingling of limbs, shortness of breath, chest tightness, lightheadedness on 05Mar2021. The patient had covid tests PCR (Nasal Swab) in Apr2020, May2021 and 20Aug2021 were negative. No treatment received for the events. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Musculoskeletal stiffness, Palpitations, Paraesthesia, SARS-CoV-2 test
Clinical narrative: felt fainting / lightheadedness; stiff neck; back pain; dry mouth; heart palpitation; weak; tingling of limbs; shortness of breath; chest tightness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (BNT162B2), first single dose via an unspecified route of administration, administered in arm left on 27Feb2021 at 15:45 (Batch/Lot Number: EN 6205) for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks were taken. The patient experienced stiff neck, back pain, felt fainting, weak, dry mouth, heart palpitation, tingling of limbs, shortness of breath, chest tightness, lightheadedness on 05Mar2021. The patient had covid tests PCR (Nasal Swab) in Apr2020, May2021 and 20Aug2021 were negative. No treatment received for the events. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Nausea, Vomiting
Clinical narrative: My stomach is cramping; Throwing up; Nauseous; Light headedness/Dizzy; This is a spontaneous report from a contactable consumer or other non hcp(patient). A patient of unspecified age and gender received first dose of  bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE,solution for injection,Lot number-not reported), via an unspecified route of administration on 22Aug2021earlier at 1:30 as DOSE 1, SINGLE for covid-19 immunisation .The patient's medical history and concomitant medications were not reported.It was reported that the patient received the first dose of Covid-19 vaccine today 22Aug2021 earlier at 1:30.On 22Aug2021 the patient experienced stomach cramping, throwing up ,nauseous, Light headedness,dizzy after patient took first dose of Covid-19 vaccine.The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia, Arthralgia, Fatigue, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, 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 extreme fatigue, lost all sense of smell, muscle and joint pain. The outcome of the events: unknown. The patient stated as follows: "I was vaccinated two weeks ago yesterday with the Pfizer first dose. Within 7 days I started feeling (you know it seems to be normal side effect) fatigue, extreme fatigue. Then I started getting muscle and joint pain, which lasted most of the week until Thursday, this last Thursday, today Sunday. Friday it was still there. It got better yesterday and today I am feeling much better. One of the things I noticed was on Thursday I lost all sense of smell. " The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Top lip was little swollen; This is a spontaneous report from a contactable consumer.    An 89-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 18Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced top lip was little swollen on 22Aug2021 with outcome of unknown.    The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Lung disorder
Clinical narrative: my son (consumer) needs "new Heart and Lung"; my son (consumer) needs "new Heart and Lung"; This is a spontaneous report from a contactable consumer (mother) reported for a male patient that: A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiration date were 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. Reporter stated, "We both (mother and son) got our Pfizer (first dose) shots and we did really good but for my son (patient) needs "new Heart and Lung" (further not clarified) we had (first dose) received in the Hospital about 3 weeks ago (Covid vaccination). Now we just had Vaccine second dose yesterday. Asking if there anything you can tell me about any help (treatment)". The outcome of both the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: right hip was really sore; it's painful to walk; This a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, on an unspecified route of administration as dose number unknown, single for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On an unknown date, 2 days after receiving the bnt162b2 vaccine, she said that her "right hip was really sore, it's painful to walk". She added that she was never had hip problems before. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I am experiencing pain in my shoulder where I got the shot; This is a spontaneous report from a contactable consumer (the patient).   A 9-decade-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Aug2021 (Batch/Lot Number: EW0181) as single dose  for covid-19 immunisation  .  Medical history included anticoagulant therapy.  The patient's concomitant medications were not reported.  The patient experienced pain in my shoulder where i got the shot  (non-serious) on 19Aug2021 with outcome of unknown. The patient still has pain in the muscle three days after the shot.  Follow up information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use, Oropharyngeal pain
Clinical narrative: Third dose last Wednesday on 18Aug2021; sore throat; Third dose last Wednesday on 18Aug2021; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer Sponsored.   This female patient (age unknown) received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unknown route, on 18Aug2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient stated that she received her third dose last Wednesday on 18Aug2021 and has a sore throat. The patient had an appointment to get swabbed for COVID and wanted to know if this will affect the result of the COVID test because her Pharmacist explained that she may test positive because she just had the booster. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: Demyelination, Magnetic resonance imaging head, Multiple sclerosis
Clinical narrative: an MRI of her brain that shows extensive  demyelination; her doctor thinks she has Multiple Sclerosis; This is a spontaneous report from a contactable Nurse (patient).  A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. Family history included sarcoidosis from an unknown date and unknown if ongoing (daughter is 40 years old). The patient medical history and concomitant medications were not reported. Since the patient was vaccinated, she had an MRI of her brain that showed extensive demyelination and her doctor thinks she has multiple sclerosis. They don't know for sure if she has it, but they are pretty sure she does. They are doing extensive test work. The patient is scheduled for a spinal tap next week to confirm the Multiple Sclerosis (patient had no history of Multiple sclerosis). Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Palpitations, Pruritus
Clinical narrative: heart pounding very hard; it pounds more than it use to and she has a racing feeling; arm hurt; itching; not feeling well; This is a spontaneous report received from a contactable consumer. This 70-Year-old female consumer (patient) reported for herself that:  A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration, administered in Right arm on 09Aug2021 (around 2 o'clock) (70-years-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included only takes supplements. She is not on heart medicine. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient had not received prior vaccinations within 4 weeks. On 10Aug2021, heart pounding very hard, it pounds more than it use to and she has a racing feeling. On an unspecified date on 2021, the patient's arm was hurt, itching and not feeling well. Later that night, on 10Aug2021, around 2-3 am she felt her heart pounding very hard. That went away but her heart isn't the same. she reported that it pounds more than it use to and she has a racing feeling. She is due for her second dose of the vaccine on Monday 30AUG and wants to know if she should get the vaccine. She also reported that her arm hurt after the vaccine and a few days later she experienced some itching. The patient reported that if she feels this way when her second vaccine is due, she will probably not get the second dose. At first she do not realize what it was. She had it as bad since then. Her heart had not been the same since that night. It is pounding more than it used to. She is supposed to take the second dose next week. If she felt this same way then she do not want to take it. She was not feeling well. Should she take the next shot feeling this way. The reporter do not have a prescribing doctor. She did report with Vsafe a couple days afterwards did put her heart was slightly pounding after Wednesday (01Sep2021) when really pounding. The pounding was not as hard as it was that one night. She only takes supplements. She is not on heart medicine. Time the vaccination was given (24 hour clock)-around 2 o'clock. The clinical outcome of events heart pounding very hard, it pounds more than it use to and she has a racing feeling were recovering and other events were unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Large blood clot in right leg(DVT). Currently on blood thinners; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 11Aug2021 13:00 (Lot Number: FC3180) as single dose (at age of 58-year-old) for covid-19 immunisation. Medical history was reported as none. He had no known allergies. Concomitant medications were not reported. Facility type vaccine: pharmacy or drug store. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Aug2021 06:00 patient experienced large blood clot in right leg, deep vein thrombosis (DVT). Currently on blood thinners. Event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient was admitted for the event on unknown date. Patient was treated with Coumadin and Lovenox. Patient did not have COVID prior vaccination. No COVID tested post vaccination. Patient had not recovered, at the time of the report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, COVID-19, Drug ineffective, Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Covid test type post vaccination=Nasal Swab/covid test result=Positive; Covid test type post vaccination=Nasal Swab/covid test result=Positive; my breasts started to be sore; I got my period - a bit heavier and longer then it had been as it was waning with menopause; I got my period - a bit heavier and longer then it had been as it was waning with menopause; I had been in menopause for about 14 months. About 2 weeks after the first dose/ I got my period - a bit heavier and longer then it had been as it was waning with menopause; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;Lot Number: EW0185),via an unspecified route of administration in Left arm on 20May2021 (at 58 years) as single dose for covid-19 immunisation. The patient medical history included menopause from 2020. No known allergy. Concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported. No other vaccines given in four weeks. Patient was in menopause for about 14 months. About 2 weeks after the first dose (on 03Jun2021), her breasts started to be sore and a few days later (Jun2021), she got her period,  a bit heavier and longer then it had been as it was waning with menopause.No treatment given and patient recovered on an unknown date in 2021.Later, on 07Jun2021, the patient had nasal swab that resulted positive (Drug ineffective, COVID-19) with outcome unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, SARS-CoV-2 test
Clinical narrative: Covid test type post vaccination=Nasal Swab/covid test result=Positive; Covid test type post vaccination=Nasal Swab/covid test result=Positive; my breasts started to be sore; I got my period - a bit heavier and longer then it had been as it was waning with menopause; I got my period - a bit heavier and longer then it had been as it was waning with menopause; I had been in menopause for about 14 months. About 2 weeks after the first dose/ I got my period - a bit heavier and longer then it had been as it was waning with menopause; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;Lot Number: EW0185),via an unspecified route of administration in Left arm on 20May2021 (at 58 years) as single dose for covid-19 immunisation. The patient medical history included menopause from 2020. No known allergy. Concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported. No other vaccines given in four weeks. Patient was in menopause for about 14 months. About 2 weeks after the first dose (on 03Jun2021), her breasts started to be sore and a few days later (Jun2021), she got her period,  a bit heavier and longer then it had been as it was waning with menopause.No treatment given and patient recovered on an unknown date in 2021.Later, on 07Jun2021, the patient had nasal swab that resulted positive (Drug ineffective, COVID-19) with outcome unknown.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Illness, Vomiting
Clinical narrative: I have been sick.; Light-headed/ Dizzy; Vomiting; Diarrhea; I had a really bad headache,  Had it for 4 days.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated, got the Pfizer shot Sunday. Sunday was fine but ever since Monday, consumer have been sick. Went to the doctor and to urgent care and did not know what else to do. Consumer also stated, lightheaded, vomiting., diarrhea and had a really bad headache had it for 4 days. The outcome for the event headache was recovered on an unspecified date whereas outcome for the other events were unknown.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Chills, Fatigue, Feeding disorder
Clinical narrative: The injection site pain that hurt all day; It is really really hot from like my shoulder almost to my elbow; I was running a fever; Tiredness; Headache; I have muscle pain; Joint pain so bad; Chills; Nauseous; Pain in arm; I can't eat; I couldn't get out of my bed; This is a spontaneous report received from a contactable consumer(patient).   A 48-years-old female patient received bnt162b2 (BNT162B2) dose 1, via an unspecified route of administration on 21Aug2021 (Batch/Lot Number: FC3182; Expiration Date: 31Oct2021) as single dose  for covid-19 immunisation  .  Medical history included coagulopathy,  breast cancer , covid-19 on Nov2020. Concomitant medications included boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) taken for menopause, start and stop date were not reported.  The patient experienced  injection site pain that hurt all day  (non-serious) on Aug2021 with outcome of unknown , it is really really hot from like my shoulder almost to my elbow (non-serious) on Aug2021 with outcome of unknown , I was running a fever  (non-serious) on Aug2021 with outcome of unknown , tiredness  (non-serious) on Aug2021 with outcome of unknown , headache (non-serious) on Aug2021 with outcome of unknown , i have muscle pain  (non-serious) on Aug2021 with outcome of unknown , joint pain so bad (non-serious) on Aug2021 with outcome of unknown , chills (non-serious) on Aug2021 with outcome of unknown , nauseous  (non-serious) on Aug2021 with outcome of unknown , pain in arm  (non-serious) on Aug2021 with outcome of unknown , i can't eat  (non-serious) on Aug2021 with outcome of unknown , i couldn't get out of my bed  (non-serious) on Aug2021 with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive   on Nov2020  .   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: The injection site pain that hurt all day; It is really really hot from like my shoulder almost to my elbow; I was running a fever; Tiredness; Headache; I have muscle pain; Joint pain so bad; Chills; Nauseous; Pain in arm; I can't eat; I couldn't get out of my bed; This is a spontaneous report received from a contactable consumer(patient).   A 48-years-old female patient received bnt162b2 (BNT162B2) dose 1, via an unspecified route of administration on 21Aug2021 (Batch/Lot Number: FC3182; Expiration Date: 31Oct2021) as single dose  for covid-19 immunisation  .  Medical history included coagulopathy,  breast cancer , covid-19 on Nov2020. Concomitant medications included boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) taken for menopause, start and stop date were not reported.  The patient experienced  injection site pain that hurt all day  (non-serious) on Aug2021 with outcome of unknown , it is really really hot from like my shoulder almost to my elbow (non-serious) on Aug2021 with outcome of unknown , I was running a fever  (non-serious) on Aug2021 with outcome of unknown , tiredness  (non-serious) on Aug2021 with outcome of unknown , headache (non-serious) on Aug2021 with outcome of unknown , i have muscle pain  (non-serious) on Aug2021 with outcome of unknown , joint pain so bad (non-serious) on Aug2021 with outcome of unknown , chills (non-serious) on Aug2021 with outcome of unknown , nauseous  (non-serious) on Aug2021 with outcome of unknown , pain in arm  (non-serious) on Aug2021 with outcome of unknown , i can't eat  (non-serious) on Aug2021 with outcome of unknown , i couldn't get out of my bed  (non-serious) on Aug2021 with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive   on Nov2020  .   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain, Vaccination site warmth
Clinical narrative: The injection site pain that hurt all day; It is really really hot from like my shoulder almost to my elbow; I was running a fever; Tiredness; Headache; I have muscle pain; Joint pain so bad; Chills; Nauseous; Pain in arm; I can't eat; I couldn't get out of my bed; This is a spontaneous report received from a contactable consumer(patient).   A 48-years-old female patient received bnt162b2 (BNT162B2) dose 1, via an unspecified route of administration on 21Aug2021 (Batch/Lot Number: FC3182; Expiration Date: 31Oct2021) as single dose  for covid-19 immunisation  .  Medical history included coagulopathy,  breast cancer , covid-19 on Nov2020. Concomitant medications included boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) taken for menopause, start and stop date were not reported.  The patient experienced  injection site pain that hurt all day  (non-serious) on Aug2021 with outcome of unknown , it is really really hot from like my shoulder almost to my elbow (non-serious) on Aug2021 with outcome of unknown , I was running a fever  (non-serious) on Aug2021 with outcome of unknown , tiredness  (non-serious) on Aug2021 with outcome of unknown , headache (non-serious) on Aug2021 with outcome of unknown , i have muscle pain  (non-serious) on Aug2021 with outcome of unknown , joint pain so bad (non-serious) on Aug2021 with outcome of unknown , chills (non-serious) on Aug2021 with outcome of unknown , nauseous  (non-serious) on Aug2021 with outcome of unknown , pain in arm  (non-serious) on Aug2021 with outcome of unknown , i can't eat  (non-serious) on Aug2021 with outcome of unknown , i couldn't get out of my bed  (non-serious) on Aug2021 with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive   on Nov2020  .   Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis bullous, Erythema, Lip swelling, Peripheral swelling, Post inflammatory pigmentation change
Clinical narrative: erythematous reticular patches on the upper back bilaterally/spread to beneath breasts and upper chests and arms; hand and lip swelling; hand and lip swelling; Pruritus started; previous areas turned into post inflammatory hyperpigmentation; rash became bullous at the edges, which were very sensitive to touch; rash became bullous at the edges, which were very sensitive to touch; This is a spontaneous report from a contactable other healthcare professional. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, in the left arm, on 09May2021 (at the age of 17-years-old) at dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medication within 2 weeks of vaccination. The patient received the first dose of BNT162B2 via intramuscular route, in the left arm, on 18Apr2021 (at the age of 17-years-old) for COVID-19 immunisation. The events occurred over a period of 2 months since vaccination. Started on 16May2021, as erythematous reticular patches on the upper back bilaterally. It was not pruritic at this point. Spread to beneath breasts and upper chests and arms. At this point, in 2021, patient also developed hand and lip swelling. Pruritus started in 2021. Additionally, in 2021 rash became bullous at the edges, which were very sensitive to touch, and the previous areas turned into post-inflammatory hyperpigmentation. The events were reported as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prednisone was administered in response to the events. The patient was recovering from the events.    The lot number for BNT162b2 was not provided and will be requested during follow up; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sensitive skin
Clinical narrative: erythematous reticular patches on the upper back bilaterally/spread to beneath breasts and upper chests and arms; hand and lip swelling; hand and lip swelling; Pruritus started; previous areas turned into post inflammatory hyperpigmentation; rash became bullous at the edges, which were very sensitive to touch; rash became bullous at the edges, which were very sensitive to touch; This is a spontaneous report from a contactable other healthcare professional. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, in the left arm, on 09May2021 (at the age of 17-years-old) at dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medication within 2 weeks of vaccination. The patient received the first dose of BNT162B2 via intramuscular route, in the left arm, on 18Apr2021 (at the age of 17-years-old) for COVID-19 immunisation. The events occurred over a period of 2 months since vaccination. Started on 16May2021, as erythematous reticular patches on the upper back bilaterally. It was not pruritic at this point. Spread to beneath breasts and upper chests and arms. At this point, in 2021, patient also developed hand and lip swelling. Pruritus started in 2021. Additionally, in 2021 rash became bullous at the edges, which were very sensitive to touch, and the previous areas turned into post-inflammatory hyperpigmentation. The events were reported as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prednisone was administered in response to the events. The patient was recovering from the events.    The lot number for BNT162b2 was not provided and will be requested during follow up; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain, Rhinorrhoea
Clinical narrative: I never had this intense Runny nose in my whole life; that is not the common side effect of the vaccine and I feel so bad; it may be I have Covid; I feel so bad after my 2nd shot; Fatigue; Pain and body ache; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot/Batch No: KC3182, expiry date not provided), via an unknown route of administration, administered on 20Aug2021 12:00, as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, Dose 1 for covid-19 immunisation. On 20Aug2021 after the second shot of the vaccine beginning at night, the patient experienced like a common side effect of fatigue, pain/body ache. After 24 hours of second shot on 21Aug2021, the patient experienced intense runny nose. The patient reported that when the patient looked online, it said the runny nose that did not mean it might be covid because that was not the common side effect. The patient also felt so bad after second shot. The patient wanted to report about common side effect of the runny nose. The patient reported that it never had this intense runny nose in whole life. The outcome of the events was unknown.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Graft versus host disease
Clinical narrative: Graft vs. Host disease, after both vaccines; 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 VACCINE; Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included acute myeloid leukaemia (AML) and stem cell transplant. The patient's concomitant medications were not reported.  Previously on an unknown date, the patient received the first dose of the vaccine for covid-19 immunisation.The patient experienced Graft vs. Host disease, after both vaccines on an unspecified date with outcome of unknown.  The reporter stated was trying to get the patient Rapamune/Sirolimus, she would like to secure Sirolimus for a stem cell transplant patient.The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Excruciating pain in right knee; This is a spontaneous report from a contactable physician (neighbor). The contactable physician reported similar events for three patients (this is the third of three reports). This case is non-serious. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced excruciating pain in right knee on an unspecified date with outcome of unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101030082 Same reporter/drug, similar event, different patient;US-PFIZER INC-202101032200 Same reporter/drug, similar event, different patient
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Blood test, Burning sensation, Rhinalgia, Somnolence
Clinical narrative: my joints felt like, the same symptoms; feeling sleepy; my body was burning; my nostrils were hurting; This is a spontaneous report received from a contactable consumer (patient). A 25-year-old male received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EW0175) via unspecified route of administration, administered in left arm on 05Jan2021 (age at the time of vaccination was 25-year-old) as a single dose for COVID-19 immunization. Medical history included HIV since an unspecified date in Aug2021. I was recently diagnosed with HIV. So, that was why I got my first shot. Concomitant Medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration, in left arm on Dec2020 (age at the time of vaccination was 24-year-old) as a single dose for COVID-19 immunization experienced a little bit fever and was like sleepy. On an unspecified date, the patient experienced my joints felt like, the same symptoms, feeling sleepy, my body was burning, and my nostrils were hurting. It was reported that Consumer stated, The first shot, let me think about it. So, the first shot. It was in December and I started having, I remember being, I think the symptoms were kind of same. I take the vaccine; I was off for two days after and I was like sleepy and I have just a little bit of fever and stuff like that. It was like the same that I am having right now. But not bad. The second dose, three hours after I got it, I was feeling sleepy. I slept, I believe like 20 hours. But like symptoms were like I would sleep that much. But then I was like waking up. I normally play in a video game & I was feeling like that something was happening and also like my body was burning, my nostrils were hurting, my joints felt like, the same symptoms and I was like waking up, just drinking water and going to the bathroom. Drinking water going to the bathroom, drinking water going to the bathroom and then just like sleeping. At the same time sleeping water bathroom. The patient underwent lab test and medical procedure which included Blood test on an unspecified date, which result was unknown and Urine analysis which result was unknown on an unspecified date. The clinical outcome of all the events was unknown.  Information on the lot batch number has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: my joints felt like, the same symptoms; feeling sleepy; my body was burning; my nostrils were hurting; This is a spontaneous report received from a contactable consumer (patient). A 25-year-old male received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EW0175) via unspecified route of administration, administered in left arm on 05Jan2021 (age at the time of vaccination was 25-year-old) as a single dose for COVID-19 immunization. Medical history included HIV since an unspecified date in Aug2021. I was recently diagnosed with HIV. So, that was why I got my first shot. Concomitant Medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration, in left arm on Dec2020 (age at the time of vaccination was 24-year-old) as a single dose for COVID-19 immunization experienced a little bit fever and was like sleepy. On an unspecified date, the patient experienced my joints felt like, the same symptoms, feeling sleepy, my body was burning, and my nostrils were hurting. It was reported that Consumer stated, The first shot, let me think about it. So, the first shot. It was in December and I started having, I remember being, I think the symptoms were kind of same. I take the vaccine; I was off for two days after and I was like sleepy and I have just a little bit of fever and stuff like that. It was like the same that I am having right now. But not bad. The second dose, three hours after I got it, I was feeling sleepy. I slept, I believe like 20 hours. But like symptoms were like I would sleep that much. But then I was like waking up. I normally play in a video game & I was feeling like that something was happening and also like my body was burning, my nostrils were hurting, my joints felt like, the same symptoms and I was like waking up, just drinking water and going to the bathroom. Drinking water going to the bathroom, drinking water going to the bathroom and then just like sleeping. At the same time sleeping water bathroom. The patient underwent lab test and medical procedure which included Blood test on an unspecified date, which result was unknown and Urine analysis which result was unknown on an unspecified date. The clinical outcome of all the events was unknown.  Information on the lot batch number has been requested.