chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Urine analysis abnormal
Clinical narrative: BODY ACHES; FEVER; NASTY TASTE; dark urine; backache; heartburn; fatigue; This is a spontaneous report received from a contactable consumer(patient).  A 75-years-old female received second dose of BNT162B2 (BNT162B2, formulation: solution for injection, lot no: EL9267), via an unspecified route of administration in Arm Right as SINGLE DOSE for covid-19 immunisation on 12-FEB-2021. Medical history included Diabetes mellitus from an unknown date in 2002 and unknown if ongoing, gastroesophageal reflux disease from 2010 and unknown if ongoing, Gall bladder reflux surgery and blood cholesterol from 2014. Concomitant medication included farxiga (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) 10mg from 2018, esomeprazole sodium (ESOMEPRAZOLE SODIUM) 40 mg, Januvia (SITAGLIPTIN) 100 mg, montelukast (MONTELUKAST)-10 mg, atorvastatin calcium (ATORVASTATIN CALCIUM) 80 mg, hydrochlorothiazide(HYDROCHLOROTHIAZIDE) 12.5 mg. All the drugs are ongoing.On 13Feb2021, patient experienced body aches, fever, nasty taste, dark urine, backache, heartburn, fatigue. There was no treatment due to events. The  outcome of events were recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Back pain, Drug level, Ear pain, Headache
Clinical narrative: her left side was very weak; her left arm was sore for a while which radiated to shoulder; her left arm was sore for a while which radiated to shoulder; back pains; her ears hurt on left side; hearing ringing and a loud noise which hurts the brain; hearing ringing and a loud noise which hurts the brain; hearing ringing and a loud noise which hurts the brain; heavy sweating around the neck; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 30Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included thyroid (disorder), had 2 bad strokes a few years ago, heart attack on the left side, chronic pain, bone issues, leukemia in the bone, TIA, and miniature strokes. Concomitant medication included warfarin sodium (COUMADIN). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 for COVID-19 immunization in her right arm and it hurt a little bit. The patient also experienced coumadin level increased; she takes coumadin regularly and measured her coumadin level to be at 1.6 after getting the 1st dose. 2 weeks after, she mentioned that her level was 3 point something which was too high. The patient received her 2nd dose of the Pfizer COVID19 vaccine on 30Mar2021 on her left arm. She mentioned that her left arm was sore for a while which radiated to shoulder on 2021. It was hurting real the first night, but she mentioned that she was going to be fine and take Tylenol. She mentioned that her left arm was her dominant arm. She also had some back pains and that her ears hurt on left side and she has been hearing ringing and a loud noise which hurts the brain on 2021. She also mentioned that her left side was very weak on 2021. She takes coumadin regularly and measured her coumadin level to be at 1.6 after getting the 1st dose. 2 weeks after, she mentioned that her level was 3 point something which was too high. Upon receiving her 2nd dose, it went down to 2.4. She specifically mentioned that she did not bleed from the injection site. She also had heavy sweating around the neck last night (2021) to the point that she woke up to "a pool of her own sweat". She mentioned that she had the sweating in the winter times too and maybe associated with her thyroid. She is asking if these have been reported with the vaccine and if coumadin or blood thinners may interact with it. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hemiparesis, Hyperacusis, Hyperhidrosis, Pain in extremity, Tinnitus
Clinical narrative: her left side was very weak; her left arm was sore for a while which radiated to shoulder; her left arm was sore for a while which radiated to shoulder; back pains; her ears hurt on left side; hearing ringing and a loud noise which hurts the brain; hearing ringing and a loud noise which hurts the brain; hearing ringing and a loud noise which hurts the brain; heavy sweating around the neck; This is a spontaneous report from a contactable consumer (patient) from Pfizer-sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 30Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included thyroid (disorder), had 2 bad strokes a few years ago, heart attack on the left side, chronic pain, bone issues, leukemia in the bone, TIA, and miniature strokes. Concomitant medication included warfarin sodium (COUMADIN). The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 for COVID-19 immunization in her right arm and it hurt a little bit. The patient also experienced coumadin level increased; she takes coumadin regularly and measured her coumadin level to be at 1.6 after getting the 1st dose. 2 weeks after, she mentioned that her level was 3 point something which was too high. The patient received her 2nd dose of the Pfizer COVID19 vaccine on 30Mar2021 on her left arm. She mentioned that her left arm was sore for a while which radiated to shoulder on 2021. It was hurting real the first night, but she mentioned that she was going to be fine and take Tylenol. She mentioned that her left arm was her dominant arm. She also had some back pains and that her ears hurt on left side and she has been hearing ringing and a loud noise which hurts the brain on 2021. She also mentioned that her left side was very weak on 2021. She takes coumadin regularly and measured her coumadin level to be at 1.6 after getting the 1st dose. 2 weeks after, she mentioned that her level was 3 point something which was too high. Upon receiving her 2nd dose, it went down to 2.4. She specifically mentioned that she did not bleed from the injection site. She also had heavy sweating around the neck last night (2021) to the point that she woke up to "a pool of her own sweat". She mentioned that she had the sweating in the winter times too and maybe associated with her thyroid. She is asking if these have been reported with the vaccine and if coumadin or blood thinners may interact with it. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Idiopathic intracranial hypertension, Intracranial pressure increased, Postural orthostatic tachycardia syndrome
Clinical narrative: increased intracranial pressure; Pseudotumor Cerebri; Transverse sinus stenosis; left sided pulsatile tinnitus; severe headache; Postural Orthostatic Tachycardia Syndrome; dizzy and light headed; Then I developed a red circle around the injection site a week after the injection; This is a spontaneous report received from contactable consumer (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 18Mar2021 12:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. No known drug allergies. The patient received other concomitant medications within 2 weeks of vaccination (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event started on 18Mar2021 13:15. The patient became dizzy and light headed within 30 minutes of receiving the first dose. The patient believed this was related to her postural orthostatic tachycardia syndrome (POTS).  The symptoms lasted for approximately 12 hours. She also developed symptoms of increased intracranial pressure the morning after she received the first dose.  The patient believed this was related to her pseudotumor cerebri (PTC) and transverse sinus stenosis (TSS).  The symptoms included left sided pulsatile tinnitus and a severe headache. These symptoms lasted for approximately one week.  Then she developed a red circle around the injection site a week after the injection. The patient contacted her neurologist as a result of all of symptoms. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Transverse sinus stenosis, Vaccination site erythema
Clinical narrative: increased intracranial pressure; Pseudotumor Cerebri; Transverse sinus stenosis; left sided pulsatile tinnitus; severe headache; Postural Orthostatic Tachycardia Syndrome; dizzy and light headed; Then I developed a red circle around the injection site a week after the injection; This is a spontaneous report received from contactable consumer (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 18Mar2021 12:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. No known drug allergies. The patient received other concomitant medications within 2 weeks of vaccination (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event started on 18Mar2021 13:15. The patient became dizzy and light headed within 30 minutes of receiving the first dose. The patient believed this was related to her postural orthostatic tachycardia syndrome (POTS).  The symptoms lasted for approximately 12 hours. She also developed symptoms of increased intracranial pressure the morning after she received the first dose.  The patient believed this was related to her pseudotumor cerebri (PTC) and transverse sinus stenosis (TSS).  The symptoms included left sided pulsatile tinnitus and a severe headache. These symptoms lasted for approximately one week.  Then she developed a red circle around the injection site a week after the injection. The patient contacted her neurologist as a result of all of symptoms. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Illness, Loss of consciousness
Clinical narrative: eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy and tingly; my left leg was achy and tingly; headache; nauseated; weak; fever; just didn't feel good; sick; became rigid; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer-BioNTech, lot unknown=true, lot unknown reason=unable to locate or read the details) via an unspecified route of administration in right arm on 26Mar2021 11:45 (62-year-old at vaccination date) at a single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM), a bruit, ventricularomegaly, gastrointestinal (GI) issues, many female issues (before she got a hysterectomy), cancer activity, hepatitis C (Hep C), COVID-19 since 18Mar2021 (diagnosed as extremely positive, remained sick until 25Mar2021), and allergies to medications, food, or other products included Motion sickness meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as yes but unspecified. About 25 minutes after the vaccine, her throat area under her jaw line started to hurt, her left leg was achy and tingly, and she was started to get a bad headache. She became nauseated and weak. She made it home, took paracetamol (TYLENOL), and got in bed. Saturday her headache was on steroids, she had fever, and just didn't feel good. Later that day, she was so sick she went to the bathroom and she guessed she passed out. Basically, her husband said he found her on the floor after he heard a thump. He asked me what was his name. He said she responded correctly, but then her eyes rolled back, she became rigid, and he called 911. she knew 2 sets of paramedics arrived w/ambulances. They monitored her vitals and stayed until she was normal. They were willing to take her to the hospital, but offered other options for her husband and she to consider. They suggested she see her Primary care doctor (she did on 29Mar2021). Her doctor believed she should not take the 2nd dose of the vaccine. Adverse event start date was 26Mar2021 at 12:30 pm. AE resulted in doctor or other healthcare professional office/clinic visit. It was reported no treatment received for the adverse event. The outcome of event was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle rigidity, Nausea, Oropharyngeal pain, Pain in extremity, Paraesthesia
Clinical narrative: eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy and tingly; my left leg was achy and tingly; headache; nauseated; weak; fever; just didn't feel good; sick; became rigid; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer-BioNTech, lot unknown=true, lot unknown reason=unable to locate or read the details) via an unspecified route of administration in right arm on 26Mar2021 11:45 (62-year-old at vaccination date) at a single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM), a bruit, ventricularomegaly, gastrointestinal (GI) issues, many female issues (before she got a hysterectomy), cancer activity, hepatitis C (Hep C), COVID-19 since 18Mar2021 (diagnosed as extremely positive, remained sick until 25Mar2021), and allergies to medications, food, or other products included Motion sickness meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as yes but unspecified. About 25 minutes after the vaccine, her throat area under her jaw line started to hurt, her left leg was achy and tingly, and she was started to get a bad headache. She became nauseated and weak. She made it home, took paracetamol (TYLENOL), and got in bed. Saturday her headache was on steroids, she had fever, and just didn't feel good. Later that day, she was so sick she went to the bathroom and she guessed she passed out. Basically, her husband said he found her on the floor after he heard a thump. He asked me what was his name. He said she responded correctly, but then her eyes rolled back, she became rigid, and he called 911. she knew 2 sets of paramedics arrived w/ambulances. They monitored her vitals and stayed until she was normal. They were willing to take her to the hospital, but offered other options for her husband and she to consider. They suggested she see her Primary care doctor (she did on 29Mar2021). Her doctor believed she should not take the 2nd dose of the vaccine. Adverse event start date was 26Mar2021 at 12:30 pm. AE resulted in doctor or other healthcare professional office/clinic visit. It was reported no treatment received for the adverse event. The outcome of event was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: eyes rolled back/passed out; my throat area under my jaw line started to hurt; my left leg was achy and tingly; my left leg was achy and tingly; headache; nauseated; weak; fever; just didn't feel good; sick; became rigid; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer-BioNTech, lot unknown=true, lot unknown reason=unable to locate or read the details) via an unspecified route of administration in right arm on 26Mar2021 11:45 (62-year-old at vaccination date) at a single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy (HCM), a bruit, ventricularomegaly, gastrointestinal (GI) issues, many female issues (before she got a hysterectomy), cancer activity, hepatitis C (Hep C), COVID-19 since 18Mar2021 (diagnosed as extremely positive, remained sick until 25Mar2021), and allergies to medications, food, or other products included Motion sickness meds. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was reported as yes but unspecified. About 25 minutes after the vaccine, her throat area under her jaw line started to hurt, her left leg was achy and tingly, and she was started to get a bad headache. She became nauseated and weak. She made it home, took paracetamol (TYLENOL), and got in bed. Saturday her headache was on steroids, she had fever, and just didn't feel good. Later that day, she was so sick she went to the bathroom and she guessed she passed out. Basically, her husband said he found her on the floor after he heard a thump. He asked me what was his name. He said she responded correctly, but then her eyes rolled back, she became rigid, and he called 911. she knew 2 sets of paramedics arrived w/ambulances. They monitored her vitals and stayed until she was normal. They were willing to take her to the hospital, but offered other options for her husband and she to consider. They suggested she see her Primary care doctor (she did on 29Mar2021). Her doctor believed she should not take the 2nd dose of the vaccine. Adverse event start date was 26Mar2021 at 12:30 pm. AE resulted in doctor or other healthcare professional office/clinic visit. It was reported no treatment received for the adverse event. The outcome of event was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Already missed 2nd dose.; This is a Follow-up spontaneous report from a Pfizer-Sponsored Program Support. A contactable female consumer (patient) of an unspecified age reported for herself that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 07Mar2021 (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 already missed 2nd dose. (product dose omission issue) on an unspecified date. Caller (name withheld) and husband (name withheld) called in because they received the 1st dose last 07MAR2021 and don't receive notification yet and don't have a schedule for their 2nd dose. Already missed 2nd dose. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was reported as unknown.   Information about lot/batch number cannot be obtained.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: a sore arm; This is a spontaneous report received from a contactable consumer. This 75-year-old male contactable consumer (patient) reported for himself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration, administered in Arm Left on 03Feb2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included chronic lymphocytic leukaemia Stage 0 No active treatment from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. On 03Mar2021 12:00, he stated the only reaction he had was a sore arm. His wife has had an antibody test which came back positive and he has had two antibody tests which came back negative. He has CLL, a type of Chronic Leukemia, that effects his immune system. He wants more information on antibody testing after receiving the Pfizer COVID-19 vaccine and whether or not he was protected. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (patient). This male patient (Age: 61 Unit: Unspecified) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Mar2021 as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. On 10Mar2021 the patient got bell's palsy. The doctors put him on prednisone and an antiviral. They told him it was ok to take ibuprofen (ADVIL) which he did and the second vaccine was scheduled for 26Mar2021. The patient took ibuprofen up until the morning before his second vaccine. He then heard can't take ibuprofen because it reduced the efficacy of the vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. Information on the lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I found out I was positive with covid/tested positive with the Covid-19 virus; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable female consumer (patient, self-reported).   A female patient of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via unspecified route of administration on 19Mar2021, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It sated that, the patient received a 1st dose of the vaccine on 19Mar2021 and tested positive with the Covid-19 virus on 30Mar2021. She wants to know if she still needs to take the 2nd dose on the scheduled date on 02Apr2021. Her husband was also scheduled for the 2nd dose on 02Apr2021 and will take the test scheduled on 31Mar2021. Also reported that she received first dose and was supposed to get the 2nd dose today, On Sunday she became ill, Monday she went for test and on Tuesday 30Mar2021, she found out she was positive with covid. Her doctor told to wait for 30 days from the time she was diagnosed. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Blood test, Computerised tomogram, Constipation
Clinical narrative: Approximately 4 days after my first Covid shot, I developed constipation.; This is a spontaneous report from a contactable consumer (patient). The consumer reported similar event for himself in different dosage. This is the first of two reports. This 53-year-old male patient received the first dose of BNT162B2, via an unspecified route of administration administered in right arm on 01Mar2021 18:45 (Batch/Lot Number: EL9264) as single dose for covid-19 immunisation. Medical history included autoimmune autonomic disorder , Sjogren's disease, Crohn's (in remission 3 decades), covid prior vaccination. The patient had known allergies: ototoxic reaction to clarithromycin (BIAXIN), also skin rash to levofloxacin (LEVAQUIN) and ciprofloxacin (CIPRO). Concomitant medication included doxycycline. The patient did not receive other vaccine in four weeks. Approximately 4 days after his first COVID shot, on 05Mar2021, he developed constipation. Constipation resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. The constipation initially partially responded to laxatives between the first and second vaccinations. The patient had abdominal CT, blood tests, hearing test with unknown results. The patient did not had covid tested post vaccination. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021364170 same patient/drug, different events in different dosage
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Myalgia
Clinical narrative: Pain in joints, muscles, knees, back and shoulders; Pain in joints, muscles, knees, back and shoulders; Pain in joints, muscles, knees, back and shoulders; This is a spontaneous report from a contactable other-HCP dentist (patient). An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP7534 and expiration date were not reported) via unknown route in left arm on 17Mar2021 13:30 at SINGLE DOSE for covid-19 immunization. The report is not related to a study or programme. Medical history included high blood pressure unspecified time and was ongoing and hypothyroidism from unspecified time to unspecified time. Patient reported that he does have severe arthritis and that it could be that. There was no relevant family medical history. Concomitantly patient had been taking levothyroxine sodium (LEVOXYL) at a dose of 175mcg tablet once a day in morning for hypothyroid since about 15 years, lisinopril at a dose of 30mg tablet for high blood pressure since about 2-3 years, buspirone as antidepressant at a dose of 15mg tablet twice a day since about 2 years, escitalopram oxalate (LEXAPRO) at a dose of 20mg tablet once a day as antidepressant since about 3 years and trazadone at an unknown dose of for sleep since about an year. Reportedly, all the concomitant medications were ongoing at the time of report. Patient stated that he takes a cataract medicine does not know the name of it, states that it is a large pill and is brown colored. There was no investigation assessment and relevant tests. On Mar2021 (2 days after the injection), patient had pain in joints, muscles, knees, back and shoulders. Patient took Tylenol as treatment for event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no history of previous vaccinations. There were no other vaccinations administered on same day. Vaccination facility type was pharmacy, it was not administered in military facility. Patient reported that he had vaccination on 17Mar2021 and today is 30Mar2021 and he was still having pain. The event did not require any visit to physician or emergency room. Patient wanted to know why this is happening and if this can happen. Patient was scheduled for second dose on 07Apr2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis
Clinical narrative: She received the Pfizer COVID vaccine and became infected by COVID a few weeks later; She received the Pfizer COVID vaccine and became infected by COVID a few weeks later; Head cold; This is spontaneous report from a contactable consumer. A contactable Female reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number, expiration date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. on an unspecified date patient received the COVID vaccine and infected by COVID a few weeks later. On 30Mar2021, patient also had consistent symptoms with a head cold. The outcome for the events was unknown.  Information about lot/batch number is requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Postmenopausal haemorrhage
Clinical narrative: Very sore arm, tiredness, sudden vaginal bleeding during menopause; Very sore arm, tiredness, sudden vaginal bleeding during menopause; Very sore arm, tiredness, sudden vaginal bleeding during menopause; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 (Lot Number: EW 0150) at single dose for covid-19 immunization. Medical history included chronic pain from old injury. No known allergies. The patient didn't have Covid prior vaccination. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; hydromorphone 2 mg taken for an unspecified indication, start and stop date were not reported; tramadol ER 200 mg taken for an unspecified indication, start and stop date were not reported. No other vaccines in four weeks. The patient previously received the first dose of bnt162b2 (Lot number: EN6207) in left arm on 12Mar2021 at 55 years old for covid-19 immunization. The patient experienced very sore arm, tiredness, sudden vaginal bleeding during menopause on 01Apr2021 05:00 PM. No treatment was received for the events. Covid was not tested post vaccination. The outcome of the events was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Intense headache
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Tic, Tourette's disorder
Clinical narrative: After receiving the vaccine. My daughter developed Tourettes and Tics.  Vocal noises and shaking of arms. She has never had anything happen to her after any injection.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Differential white blood cell count normal, Full blood count normal, Rash, SARS-CoV-2 test negative
Clinical narrative: Bruise like rash broke out on back and arms with spots with several dozen spots up to 1 inch in diameter.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site rash, Injection site swelling, Myalgia
Clinical narrative: Fever, headache, sore throat, muscle ache, chills, rash and swelling at injection site
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, headache, sore throat, muscle ache, chills, rash and swelling at injection site
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Pyrexia, Vomiting
Clinical narrative: I started with shivers, then a few hours later I had a fever and a bad headache. I took one Tylenol but that did not help after several hours. I took another and that still didn't help. I started feeling sick to my stomach, then I vomited several times. After emptying my stomach, I started feeling better. After 24 hours after the shot, I felt fine.  Then, again, 12 days after the shot, I got another bout of similar symptoms. I had a headache, stomach ache, then vomited. After a few hours of rest, I felt fine again.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia oral, Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia
Clinical narrative: Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; She felt panicky, because it felt like her throat was "closing"; very odd, uncomfortable feeling; This is a spontaneous report from a non-contactable consumer reported for herself. This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 in left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021, the patient experienced mouth & throat felt numb & tingly. She felt panicky, because it felt like her throat was "closing". It was a very odd, uncomfortable feeling that lasted roughly 1.5-2 hours. It scared her.  No treatment received for events. Patient did not have COVID prior vaccination, and did not test COVID post vaccination.  The outcome of events was recovered on unspecified date.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; Mouth & throat felt numb & tingly; She felt panicky, because it felt like her throat was "closing"; very odd, uncomfortable feeling; This is a spontaneous report from a non-contactable consumer reported for herself. This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 in left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021, the patient experienced mouth & throat felt numb & tingly. She felt panicky, because it felt like her throat was "closing". It was a very odd, uncomfortable feeling that lasted roughly 1.5-2 hours. It scared her.  No treatment received for events. Patient did not have COVID prior vaccination, and did not test COVID post vaccination.  The outcome of events was recovered on unspecified date.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Conjunctival oedema, Eye pain, Eye pruritus
Clinical narrative: Day after vaccine normal chills and fatigue.  Sore eyes and sore arm where vaccine was administered.  Subsequent day woke up with extremely itchy eye (right only) and growing lump in eye which grew throughout day.  Called health facility for university and on-call nurse said to go to ER.  ER said some allergic reaction possibly due to season (patient has not experienced any allergic reactions to her knowledge prior).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Mass, Pain in extremity
Clinical narrative: Day after vaccine normal chills and fatigue.  Sore eyes and sore arm where vaccine was administered.  Subsequent day woke up with extremely itchy eye (right only) and growing lump in eye which grew throughout day.  Called health facility for university and on-call nurse said to go to ER.  ER said some allergic reaction possibly due to season (patient has not experienced any allergic reactions to her knowledge prior).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain
Clinical narrative: bruising and strong pain that has persisted 38 hours so far
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Gait disturbance, Osteoarthritis, Walking aid user
Clinical narrative: Extreme worsening of osteoarthritis in right knee, almost cannot walk the pain is so bad, started the morning after the second dose. It gets a little better the more I walk on it, but if I sit for more than a few minutes and then try to walk it's so bad I need a cane. I never ever used a cane before.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleed, it's adverse because I have never had one
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Investigation
Clinical narrative: angioedema; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included anaphylaxis to NSIADs. The patient's concomitant medications were not reported. The patient experienced angioedema after 1st dose of vaccine and an epinephrine (EPIPEN) was administered. She subsequently was tested for a Miralax allergy which was negative. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of angioedema cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. 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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Mild to moderate soreness at site of injection. Lasted 24 hrs +
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Drug resistance, Endocrine test normal, Headache, Laboratory test normal
Clinical narrative: I began to get unexplained headaches. I initially thought it was puberty however I've had hormones checked and entire neurological workups as an adult and medications are ineffective to relieve any pain.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Lumbar puncture, Magnetic resonance imaging normal, Neurological examination normal
Clinical narrative: I began to get unexplained headaches. I initially thought it was puberty however I've had hormones checked and entire neurological workups as an adult and medications are ineffective to relieve any pain.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: fever 102 F, chills, mild nausea, mild headache
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disorientation, Feeling abnormal, Hallucination, Headache
Clinical narrative: Nausea vomiting debilitating headache and muscle pain brain fog fever chills insomnia hallucinations disorientation extremely hot and swollen at injection site becoming encircled in a black ?ring/band? and is very painful and itchy. This is the current remaining issue on day 4.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Nausea vomiting debilitating headache and muscle pain brain fog fever chills insomnia hallucinations disorientation extremely hot and swollen at injection site becoming encircled in a black ?ring/band? and is very painful and itchy. This is the current remaining issue on day 4.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea vomiting debilitating headache and muscle pain brain fog fever chills insomnia hallucinations disorientation extremely hot and swollen at injection site becoming encircled in a black ?ring/band? and is very painful and itchy. This is the current remaining issue on day 4.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Achenbach syndrome, Spontaneous haemorrhage
Clinical narrative: Spontaneous bleeding, Achenbach Syndrome
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Feeling cold, Headache
Clinical narrative: Headache in back of head, stomach bloated, diarrhea today, chills
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Full blood count, Haemoglobin, Hemiparesis
Clinical narrative: Day 8 woke up to leg pain and severe leg weakness on right side. Day 9 really bad smtummy pain and diarrhea.  That was before the news hit that the shot had been places on paused. Leg still hurt.. other symptoms too. I am on hormones replacement therapy and have a blood disorder.  Have nor felt well. Son is not well either. We got ours on same day.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Muscular weakness, Pain in extremity
Clinical narrative: Day 8 woke up to leg pain and severe leg weakness on right side. Day 9 really bad smtummy pain and diarrhea.  That was before the news hit that the shot had been places on paused. Leg still hurt.. other symptoms too. I am on hormones replacement therapy and have a blood disorder.  Have nor felt well. Son is not well either. We got ours on same day.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Headache, Pain in extremity, Peripheral swelling, Platelet count
Clinical narrative: Day 8 woke up to leg pain and severe leg weakness on right side. Day 9 really bad smtummy pain and diarrhea.  That was before the news hit that the shot had been places on paused. Leg still hurt.. other symptoms too. I am on hormones replacement therapy and have a blood disorder.  Have nor felt well. Son is not well either. We got ours on same day.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Ultrasound scan
Clinical narrative: Day 8 woke up to leg pain and severe leg weakness on right side. Day 9 really bad smtummy pain and diarrhea.  That was before the news hit that the shot had been places on paused. Leg still hurt.. other symptoms too. I am on hormones replacement therapy and have a blood disorder.  Have nor felt well. Son is not well either. We got ours on same day.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Rash erythematous
Clinical narrative: A week after vaccine, I vaccination site turned red and was warm to the touch. At 2 weeks after vaccination, the area has a red ring around it and has grown in size.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive of Covid-19 virus; became positive with covid between doses; This is a spontaneous report received from a contactable consumer (Patients wife) via contactable consumer reported similar events for 2 patients. This report is for 2nd of 2 patients. A male patient with unspecified units of age 49 received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received first dose of BNT162B2. On last Wednesday (24Mar2021), the patient tested positive of COVID-19 virus. The patient became positive with COVID between doses of the Pfizer vaccine. The second dose of BNT162B2 is scheduled for 01Apr2021(coming Thursday); hence, the reporter wanted to know whether the second dose of BNT162B2 could be rescheduled. The outcome of the events was unknown.  Information on the lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021350996 same reporter/drug/event, different patient
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joints were sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN9581), via an unspecified route of administration, administered in Arm Left on 22Feb2021 09:15 (at 77-year-old) as single dose for COVID-19 immunization. Medical history included ongoing AFib (She has had this condition for a about 6 years), ongoing getting anemic real easy (She says she has had this for the last 20 years), Glaucoma from 1998 (She says that in 1998 she had both eyes operated on and in 2016 she was operated on again), Cataracts from 2018, Pacemaker insertion (cardiac) (She states she has a pacemaker that controls her heart so the pulse does not drop below 65. She says that pacemaker was implanted, she thinks, 2014 maybe), Concomitant medications included metoprolol tartrate (METOPROLOL TARTRAS) taken for atrial fibrillation, blood pressure measurement from an unspecified start date and ongoing; warfarin (WARFARIN) taken for prophylaxis from an unspecified start date and ongoing; duloxetine (DULOXETINE) taken for anxiety from an unspecified start date and ongoing; montelukast (MONTELUKAST) taken for asthma from an unspecified start date and ongoing; folic acid (FOLIC ACID) taken for prophylaxis from 2015 and ongoing; ferrous sulfate (FERROUS SULFATE) taken for anaemia from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for diuretic therapy from an unspecified start date and ongoing; baclofen (BACLOFEN) taken for muscle spasms from an unspecified start date and ongoing; hydrocodone bitartrate, paracetamol (NORCO) taken for arthritis from an unspecified start date and ongoing; calcium (CALCIUM) taken for arthritis from an unspecified start date and ongoing; ergocalciferol (VITAMIN D) taken for anaemia from an unspecified start date and ongoing; ongoing adult vitamins since her body doesn't absorb what she eats.  The patient previously took BNT162B2 (Batch/lot number EL3246, Dosage text left arm) first dose on 04Feb2021 for COVID-19 immunization and experienced heart attack; must have passed out; the muscle that goes around her heart, it was having like a charley horse; heart rate, 102, 103, it went up to 200 in the ambulance; chest pain; Nausea; hard to breath; she didn't remember all the tests; sharp pain underneath her left rib cage/pain was number10/still had pain off and on, periodically; broke out in sweat, real bad, number 10, she broke out in a clammy sweat.  The patient said she has to leave in 20 minutes to a doctor's appointment. She says her second shot was on 22Feb2021 and the only reaction was it felt like a truck hit her, all her joints were sore (unspecified date), it lasted 2 days then went away, she feels good. Patient was hospitalized. She says she got the second dose to make sure she gets all the doses so she doesn't get sick. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: tested positive with covid-19 virus; tested positive with covid-19 virus; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: unknown), via an unspecified route of administration on 10Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, patient tested positive with COVID-19 virus. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on unspecified date in Mar2021. Her 2nd dose appointment was on 31Mar2021 and she was asking if she can still get the 2nd dose. She was in contact with some relatives and she got, she tested positive for COVID. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.