chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Feeling hot, Headache
Clinical narrative: felt really bad/ in general he still has a feeling like he has never had before. It is like things are off; tiredness; headache; muscle aches; chills; nausea; feverish; felt warm; feeling unwell; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration in left arm (also reported as left shoulder) on 28Jan2021 at 10:40 (at the age of 81-years-old) at dose 1, single for COVID-19 immunisation. Medical history included having a pacemaker (three-wire pacemaker), different issues with his eyes such as glaucoma, and he had a seizure once a while back and was now on KEPPRA for seizures; all of which were ongoing. He also had prostate cancer, but he was free of it now. Concomitant medication included levetiracetam (KEPPRA) tablet for seizures. There were no additional vaccines administered on the same date as BNT162B2. Prior vaccinations within 4 weeks was reported as none. He has never had a vaccination before this one. Vaccination facility type was reported as hospital. The patient received first dose of the vaccine on 28Jan2021 and is scheduled for second dose on 18Feb2021. When he first received the vaccine, everything was fine. He had no issues at all until last Monday, 15Feb2021 at 06:00. He felt really bad and started to experience tiredness, headache, muscle aches, chills, nausea, and he was feverish. The patient felt like he had a fever, but he did not have it. He felt warm but did not actually check his temperature. He had an overall feeling of being unwell. The chills come and go. He had some first thing in the morning, but then they went away. An hour ago (at the time of reporting), he also had chills, but now they're gone. The feverish feeling, feeling warm, like he had a fever stopped on Tuesday, 16Feb2021. When probed if the events recovered completely or recovered with lasting effects, he stated that in general, he still has a feeling like he has never had before, it was like things were off. He would like to know if he should get the second dose if he was experiencing these symptoms. The outcome of the events "feverish" and "felt warm" was recovered on 16Feb2021 and not recovered for all other events.   No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: felt really bad/ in general he still has a feeling like he has never had before. It is like things are off; tiredness; headache; muscle aches; chills; nausea; feverish; felt warm; feeling unwell; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration in left arm (also reported as left shoulder) on 28Jan2021 at 10:40 (at the age of 81-years-old) at dose 1, single for COVID-19 immunisation. Medical history included having a pacemaker (three-wire pacemaker), different issues with his eyes such as glaucoma, and he had a seizure once a while back and was now on KEPPRA for seizures; all of which were ongoing. He also had prostate cancer, but he was free of it now. Concomitant medication included levetiracetam (KEPPRA) tablet for seizures. There were no additional vaccines administered on the same date as BNT162B2. Prior vaccinations within 4 weeks was reported as none. He has never had a vaccination before this one. Vaccination facility type was reported as hospital. The patient received first dose of the vaccine on 28Jan2021 and is scheduled for second dose on 18Feb2021. When he first received the vaccine, everything was fine. He had no issues at all until last Monday, 15Feb2021 at 06:00. He felt really bad and started to experience tiredness, headache, muscle aches, chills, nausea, and he was feverish. The patient felt like he had a fever, but he did not have it. He felt warm but did not actually check his temperature. He had an overall feeling of being unwell. The chills come and go. He had some first thing in the morning, but then they went away. An hour ago (at the time of reporting), he also had chills, but now they're gone. The feverish feeling, feeling warm, like he had a fever stopped on Tuesday, 16Feb2021. When probed if the events recovered completely or recovered with lasting effects, he stated that in general, he still has a feeling like he has never had before, it was like things were off. He would like to know if he should get the second dose if he was experiencing these symptoms. The outcome of the events "feverish" and "felt warm" was recovered on 16Feb2021 and not recovered for all other events.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulder pain; This is a spontaneous report from a Pfizer-sponsored program COVAX US SUPPORT. A contactable male consumer (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.   Patient received second dose of Pfizer COVID vaccine this morning. He has shoulder pain and he had shoulder pain and issues with his shoulder prior to receiving the vaccine. Patient would like to know if he can use Aspercreme with Lidocaine on his shoulder. He had shoulder pain before taking the 2nd dose this morning, asked if he can rub a cream on his shoulder. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity, Pulmonary pain, Sneezing
Clinical narrative: had a pain on her left side lung that "hit her like a knife."/sharp pain in left lung where histoplasmosis is; head cold and sneezing; head cold and sneezing; arm a little sore; This is a spontaneous report from a contactable nurse (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9809), via an unspecified route of administration, administered in left arm on 12Feb2021 10:30 as single dose for COVID-19 immunisation. The patient's medical history included histoplasmosis in left lung, diagnosed 15-20 years ago, asthma in the past and has taken before Advair or Ventolin but has not had to take that in over a year. The patient's concomitant medications were not reported. The patient previously took articaine and had a reaction. The patient also previously received a Tetanus shot in the past, got a hot arm and a little fever. She got the Pfizer vaccine on 12Feb2021, and stated that day her arm was a little bit sore. On Sunday morning (14Feb2021) when she woke up, she had a head cold and sneezing lots of tickling in her nose. She stated that she had no sore throat, no fever, and stated that lasted until this morning. The patient reported that last night she went to bed and had a pain on her left side lung that hit her like a knife on 16Feb2021. The pain continued throughout the night and it really hurt, really shocked her. She couldn't lay on that side. She had a sharp pain in left lung where histoplasmosis is. The vaccination facility type was clinic. Vaccine was not administered in military facility. The patient is scheduled to receive the second dose on 06Mar2021. The outcome of the event had a pain on her left side lung that "hit her like a knife"/sharp pain in left lung where histoplasmosis is was recovering; the outcome of the events head cold and sneezing was recovered on 17Feb2021; and the outcome of the event arm a little sore was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Influenza, Migraine
Clinical narrative: Migraine; headache; flu symptoms; vomiting; feverish; tired; he was really sick for about 6 hours; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age (Age: 69, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included went through Chemo in 2005 and 2006 for Hepatitis C (liver was at a stage 3). The patient's concomitant medications were not reported.  The patient reported that that he received first dose of vaccine on Monday. The patient has since experienced the following symptoms: Headache, flu symptoms, vomiting, feverish, tired from unspecified dates. The patient further reported he felt just about everything except the rash. The patient reports that he was really sick for about 6 hours on an unspecified date. The patient reported that he gets severe migraines and takes shots for his migraines and would like to know if he can take his sumatriptan injection prescribed for his migraines. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Migraine; headache; flu symptoms; vomiting; feverish; tired; he was really sick for about 6 hours; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age (Age: 69, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included went through Chemo in 2005 and 2006 for Hepatitis C (liver was at a stage 3). The patient's concomitant medications were not reported.  The patient reported that that he received first dose of vaccine on Monday. The patient has since experienced the following symptoms: Headache, flu symptoms, vomiting, feverish, tired from unspecified dates. The patient further reported he felt just about everything except the rash. The patient reports that he was really sick for about 6 hours on an unspecified date. The patient reported that he gets severe migraines and takes shots for his migraines and would like to know if he can take his sumatriptan injection prescribed for his migraines. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pruritus
Clinical narrative: dizziness; extreme itchy skin; headache; fatigue; This is a spontaneous report from a contactable other-healthcare professional reported for herself. A 48-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL9262), via an unspecified route in the left arm on 19Jan2021 at 14:30 (age at vaccination: 48-year-old), as a single dose for covid-19 immunization. Medical history included asthma and Known allergies: Sulfa Drugs. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 19Jan2021 at 15:30, after first shot patient experienced dizziness and extreme itchy skin 1 hour after shot for approx. 2 hours before it ended, then headache and fatigue for 1-2 days. However, after 48 hours all effects from the 1st shot were gone. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered in Jan2021.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rosacea
Clinical narrative: rosacea; This is a spontaneous report from a Pfizer-sponsored program via Regulatory Authority Support. This is a spontaneous report from a contactable other HCP (patient)/nurse. A 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 10Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rosacea on an unspecified date. Therapeutic measures were taken as a result of rosacea and doxycyline was used as a treatment drug. Outcome of the event was unknown.  Follow-up (12Feb2021): The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 12Feb2021, this case now contains all required information to be considered valid.  Follow-up (23Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Vaccination site pain
Clinical narrative: experiencing back ache; sore at the injection site.; This is a spontaneous report from a contactable consumer or other non hcp.    A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection(Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 as dose 1, single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. It was Reported that, both of them took the 1st dose last 10Feb2021. The wife called in and would like to know if she can take Tylenol or Naproxen. Both of them experienced sore at the injection site, the patient experienced back ache, sore at the injection site on Feb2021 with outcome of unknown.   Follow-up (11Feb2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program.    Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program COVAX US SUPPORT. A contactable consumer (patient's wife) reported for a male patient (husband). A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 10Feb2021 as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient experienced sore at the injection site on an unspecified date. The reporter would like to know if she can take Tylenol or Naproxen. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3247) via an unspecified route of administration (age at the time of vaccination was 38 years and non-pregnant at the time of vaccination) on 17Feb2021 09: 15 AM in left arm as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history was none. Concomitant medication was not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3247), via an unspecified route of administration (age at the time of vaccination was 38 years and non-pregnant at the time of vaccination) on 27Jan2021 09: 00 AM in left arm as DOSE 1, SINGLE for COVID-19 immunisation. There were no other vaccine in four weeks. There were no other medications in two weeks. There was no covid prior vaccination. Not tested for COVID post vaccination. There were no known allergies. On 17Feb2021 at 08:00 PM, the patient had chills, fever, body aches, headaches and soreness of arm. The patient did not receive any treatment for the events. The outcome of the events was reported as recovering. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: doesn't believe vaccine was given in muscle; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, Caller was a nurse and noticed that the injection doesn't look like it was given in the muscle. She stated nothing indicates she got a shot, no muscle soreness and wants to know what Pfizer recommends. She stated this is her 2nd dose. Provided number and cold transferred for AE due to wait times, since caller doesn't believe vaccine was given in muscle the patient experienced doesn't believe vaccine was given in muscle on an unspecified date with outcome of unknown.    Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 70-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: was not reported), via an unspecified route of administration, on an unspecified date (age at the time of vaccination 70-years-old) as a single dose for COVID-19 immunization. Patient previously received first dose of BNT162b2 vaccine, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache and body aches. The outcome for all the events was unknown. Information of Lot/ Batch number have been requested.Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: Bladder infection; This is a spontaneous report from a Pfizer-sponsored program. A 77-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient reported that she took the COVID 19 vaccine and came down with a bladder infection. The doctor put her on a different medicine because the tumor has grown. It is on her liver now. She said to go on the 22nd for a PET scan and will see what was going on. The Ibrance didn't work. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Arm soreness; fever of 101; chills; headache; This is a spontaneous report from a Non-contactable consumer. A 30-years-old non-Pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL3247), via an unspecified route of administration on 17Feb2021 at 13:45 administered in Arm Left as a single dose for COVID-19 immunization at Workplace clinic. The patient had received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; batch/Lot Number not provided), via an unspecified route of administration on 27Jan2021 at 13:45 administered in Arm Left as a single dose for COVID-19 immunization at Workplace clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies. On 18Feb2021 at 12:15 AM, the patient experienced Arm soreness, fever of 101, chills and headache. Therapeutic measures were taken as a result of arm soreness (pain in extremity), fever of 101 (pyrexia), chills (chills), headache (headache) and treatment included Ibuprofen.The outcome of the events was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: body aches; had a fever of 102.2F; severe in the legs; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: 5318) via an unspecified route of administration in Arm Right on 18Feb2021 14:30 (age at vaccination: 46 Years) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient didn't have covid prior to vaccination. The patient medical history and patient's concomitant medications were not reported. patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: 5318) via unspecified route of administration in Arm right on 27Jan2021 14:30(age at vaccination:46 years) as DOSE 1, SINGLE for covid-19 immunisation. On 18Feb2021 12:00 the patient experienced body aches, had a fever of 102.2f, severe in the legs. The patient underwent lab tests and procedures which included pyrexia: 102.2 fahrenheit on 18Feb2021. Therapeutic measures were taken as a result of body aches, had a fever of 102.2f, severe in the legs was Tylenol. Patient was not tested with covid to post vaccination. The outcome of the events pain, pyrexia, pain in extremity was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Pruritus, Tongue discomfort
Clinical narrative: my tongue felt furry after 3 hours, i felt itchy and very sore arm plus light headed; my tongue felt furry after 3 hours, i felt itchy and very sore arm plus light headed; my tongue felt furry after 3 hours, i felt itchy and very sore arm plus light headed; my tongue felt furry after 3 hours, i felt itchy and very sore arm plus light headed; This is a spontaneous report from a contactable other HCP. This 56-Years-Old non pregnant female other HCP received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 11:00 as DOSE 1, SINGLE for covid-19 immunisation (Age at vaccination 56 years). Medical history included, drug hypersensitivity. Concomitant medication(s) included acetaminophen (ACETAMINOPHEN); ubidecarenone (COQ-10); biotin (BIOTIN); angelica archangelica root, beta vulgaris root, betula pendula leaf, centaurea benedicta herb, cimicifuga racemosa root, equisetum arvense, gentiana lutea root, matricaria recutita flower, petroselinum crispum leaf, rumex crispus root, solidago virgaurea herb, taraxacum officinale root (LIVER CLEANSE [ANGELICA ARCHANGELICA ROOT;BETA VULGARIS ROOT;BETULA PENDULA LEAF;CENTAUREA BENEDICTA HERB;CIMICIFUGA RACEMOSA ROOT;EQUISETUM ARVENSE;GENTIANA LUTEA ROOT;MATRICARIA RECUTITA FLOWER;PETROSELINUM CRISPUM LEAF;RUMEX CRISPUS ROOT;SOLIDAGO) super liver cleanse. The patient previously took iodine and experienced drug hypersensitivity, penicillin, adverse reactions to steroids. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 04Feb2021 patient experienced my tongue felt furry after 3 hours, i felt itchy and very sore arm plus lightheaded. Therapeutic measures were taken as a result of all events includes took Benadryl (2) 9 days later arm still sore went to see physician and he prescript loratadine 10mg and naproxen 500 mg. The outcome for all events was recovering.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Headache; Nausea; fever; Chills; This is a spontaneous report from a contactable consumer (patient himself). A 65-yers-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, formulation: solution for injection, lot number: EN6201, expiry date: unknown) via un-specified route of administration, in left arm on 16Feb2021 11:30 (age at vaccination: 65-years) as dose 2, single for Covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3302, expiry date: unknown) via unspecified route of administration, in left arm on 27Jan2021 (age at vaccination: 65-years) as dose 1, single for Covid-19 immunisation. Facility type vaccine was hospital. Patients medical history and concomitant medications were not reported. Patient had no known allergies. No other vaccines in four weeks was administered to patient. On 16Feb2021 11: 30 PM, patient experienced headache, nausea, fever, and chills. No treatment was given as a result of the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of events was recovered on an unspecified date in 2021.   Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Malaise
Clinical narrative: felt badly; tired; malaise; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced felt badly, tired, malaise after second vaccine of COVID-19. Outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rubella, SARS-CoV-2 antibody test, Varicella
Clinical narrative: It looks like varicella virus on my arms and legs; German measles on my back and stomach; This is a spontaneous report from a contactable other health care professional (nurse) reported for herself. A 59-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), intramuscular, administered in right arm on 07Jan2021 at 14:30 (at the age of 59-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included food allergy (known allergies: Shellfish) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) and vitamin taken for an unspecified indication, start and stop date were not reported medications received in two weeks. The patient previously took iodine (Known allergies: Iodine) and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination. Facility type Vaccine at workplace clinic. On 13Jan2021, the patient experienced it looks like varicella virus on arms and legs and german measles on back and stomach. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: negative (Nasal Swab). Adverse event resulted in Doctor or other health care professional office/clinic visit. Treatment include Hydrocortisone cream. The outcome of the events were not recovered.  Information on lot number/batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Cough, Headache, Muscular weakness
Clinical narrative: nausea; headache; calf-muscle pain under the knee; chills; cough; She is worried about the duration of this side effects.; muscle weakness; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age 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 13Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included abdominal discomfort; she said that even before the vaccine she was feeling sick of the stomach from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that, she received the first dose of the COVID vaccine on 13Feb2021 and still seven days later of this on 20Feb2021 she was having nausea, headache, calf-muscle pain under the knee, chills and cough. Nausea was still there along with muscle weakness. She was calling to get recommendations on what to do or what to take for this symptoms. She was worried about the duration of this side effects. Additionally to this, caller has scheduled her second dose on 05Mar2021 and according to the count that would be 20 days from her first dose. The outcome nausea and muscle weakness was not resolved while outcome of other events was unknown.  Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: nausea; headache; calf-muscle pain under the knee; chills; cough; She is worried about the duration of this side effects.; muscle weakness; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age 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 13Feb2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included abdominal discomfort; she said that even before the vaccine she was feeling sick of the stomach from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that, she received the first dose of the COVID vaccine on 13Feb2021 and still seven days later of this on 20Feb2021 she was having nausea, headache, calf-muscle pain under the knee, chills and cough. Nausea was still there along with muscle weakness. She was calling to get recommendations on what to do or what to take for this symptoms. She was worried about the duration of this side effects. Additionally to this, caller has scheduled her second dose on 05Mar2021 and according to the count that would be 20 days from her first dose. The outcome nausea and muscle weakness was not resolved while outcome of other events was unknown.  Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dyspnoea, Fatigue, Pain in extremity
Clinical narrative: arm got more sore; fatigued; First 5 min.: Elevated blood pressure; Slight difference in breathing; This is a spontaneous report from a contactable consumer (patient) reporting for self. A 71-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL 9262), via an unspecified route of administration, administered in Left arm on 01Feb2021 18:00 at the age of 71-years-old as dose 1, single for covid-19 immunisation. Medical history included known allergies: Asthma seasonal from unspecified date, Mild afib from unspecified date. Concomitant medications included vitamins nos (VITAMINS NOS) taken for an unspecified indication, start and stop date were not reported, metoprolol (METOPROLOL), 25 taken for an unspecified indication, start and stop date were not reported, diazepam (DIAZEPAM), 2 mg taken for an unspecified indication, start and stop date were not reported, albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported received in two weeks of vaccination. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 01Feb2021 at 18:00, the patient experienced for first 5 min.: Elevated blood pressure and slight difference in breathing. Both returned to normal in less than 15 min. Day 2 nothing much. Day 3, on 03Feb2021, arm got more sore than previous vaccinations I'm used to manually. For about 4-5 days. Seemed a bit fatigued on day 3 on 03Feb2021. But can't attribute that to Vac.1. No treatment was received for adverse events. AE resulted in none of the above. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 01Feb2021. The outcome of events, Elevated blood pressure, slight difference in breathing were recovered on 01Feb2021 in less than 15 min. while other events recovered on an unspecified date in 2021.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Muscle spasms, Pain in extremity
Clinical narrative: Joint pains/ Moderate pains Knee, elbow, shoulder, hips.; Sore arm; Leg cramps in the back of calves and knees; On the day of the vaccination, after 4 to 5 hours had 3 to 4 dizzy spells.; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration, in the left arm on 09Feb2021 at 09:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included high bp, diabetes, asthma and hypothyroid. Concomitant medication and medications in two weeks included vitamin b complex (VITAMIN B), colecalciferol (VITAMIN D) and levothyroxine sodium (LEVOTHYROXIN) 25 mcg. No other vaccine in four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. 09Feb2021, (on the day of the vaccination, after 4 to 5 hours), patient had 3 to 4 dizzy spells and did not pass out. On 13Feb2021 at 12:00 (after 3 days of vaccination), patient had sore arm for 24 hours. Joint pains started 4 started after vaccination. Still persists after 10 days. Moderate pains knee, elbow, shoulder, hips. Leg cramps in the back of calves and knees. Needed pain killer on 1 day. No treatment was received. The outcome of events was resolving.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare, Rash
Clinical narrative: experienced the development of new rashes on my hands, arms, wrist and on my stomach; that I recognized as Granuloma Annulare; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9267), via an unspecified route of administration in arm left on 16Feb2021 at 13:30 (at the age of 74-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included pre-diabetes, controlled High Blood Pressure and Asthma. The known allergies of the patient were reported as yes. The Other mediation in two weeks were reported as yes. The patient previously received first dose of BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9263), via an unspecified route of administration in arm left on 26Jan2021 at 13:30 (at the age of 74-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient was not pregnant at the time of vaccination. The patient reported that she had a skin condition for years called Granuloma Annulare it has been under control for months. On Wednesday 17Feb at 17:45, one day after receiving 2nd Cvid Vaccine she experienced the development of new rashes on her hands, arms, wrist and on her stomach that she recognized as Granuloma Annulare. Therapeutic measures were not taken as a result of events. The outcome of the events was reported as not resolved.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Injection site swelling 24 hours later; This is a spontaneous report from a non-contactable consumer (patient). An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 18Feb2021 09:00 as dose number unknown, single for COVID-19 immunisation at hospital. The patient medical history and concomitant medications were not reported. The patient previously took codeine and experienced drug allergy, prednisone for inflammation (prednisone 5mg). Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced injection site swelling 24 hours later on 19Feb2021 09:00. No treatment was given for the adverse event. Patient did not tested for COVID post vaccination. Outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Lip swelling, Rash, Swollen tongue
Clinical narrative: Mild rash mid back.; Slight metallic taste; Slight swelling of tongue; Slight full/swollen/numb feeling on lips.; Slight full/swollen/numb feeling on lips.; This is a spontaneous report from a contactable other Health Care Professional. A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:30 as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. Medical history included thyroid cancer, scoliosis, gastroesophageal reflux disease, irritable bowel syndrome, urinary tract infection, major depression, generalized anxiety disorder, post-traumatic stress disorder, multiple allergies, sjogren's syndrome from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (TIROSINT), hydroxychloroquine sulfate (PLAQUENIL S), gabapentin, budesonide (NASOCORT) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. On 19Feb2021 12:45 the patient experienced mild rash mid back, slight metallic taste, slight swelling of tongue, slight full/swollen/numb feeling on lips. The outcome of event was not recovered.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood cholesterol, Blood cholesterol increased, Blood pressure increased, Blood pressure measurement
Clinical narrative: elevated blood pressure and cholesterol level's; elevated blood pressure and cholesterol level's; Chills; Headaches; Joint pain; myalgia; fatigue; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EJ1686) (age at the time of vaccination was 78 years) via an unspecified route of administration on 11Feb2021 at 02:00 PM in left arm as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included COPD and asthma. Concomitant medications included lisinopril, amlodipine, simvastatin, and aspirin low. The patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN5318) (age at the time of vaccination was 78 years) via an unspecified route of administration on 23Jan2021 at 02:30 AM in left arm as DOSE 1, SINGLE for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. Not tested for COVID post vaccination. On 17Feb2021, the patient experienced chills, headaches, joint pain, myalgia, fatigue and elevated blood pressure and cholesterol levels and not feeling well. No treatment was received for the events. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.  Follow-up attempts were completed. No further information was expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: elevated blood pressure and cholesterol level's; elevated blood pressure and cholesterol level's; Chills; Headaches; Joint pain; myalgia; fatigue; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EJ1686) (age at the time of vaccination was 78 years) via an unspecified route of administration on 11Feb2021 at 02:00 PM in left arm as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included COPD and asthma. Concomitant medications included lisinopril, amlodipine, simvastatin, and aspirin low. The patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN5318) (age at the time of vaccination was 78 years) via an unspecified route of administration on 23Jan2021 at 02:30 AM in left arm as DOSE 1, SINGLE for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. Not tested for COVID post vaccination. On 17Feb2021, the patient experienced chills, headaches, joint pain, myalgia, fatigue and elevated blood pressure and cholesterol levels and not feeling well. No treatment was received for the events. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.  Follow-up attempts were completed. No further information was expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: chills; dizziness; fatigue; headache; nausea; fever 100° F; This is a spontaneous case from a contactable consumer. This 72-years-old female consumer (patient) reported for herself. A 72-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EL9265) via an unspecified route of administration in arm left on 08Feb2021 15:30 as dose 2, single (age at vaccination: 72 years) for COVID-19 immunisation. Medical history included sjogren's, hashimoto's thyroiditis, CAD, osteoporosis, high MCV, MTHFR, known allergies: iodine dye, reglan, motrin high dose, all from an unknown date and unknown if ongoing. Concomitant medications included clonazepam (KLONOPIN); amlodipine besilate (NORVASC); asa (ASA), multiple vitamins all taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number was not reported) via an unspecified route of administration in arm left on 17Jan2021 03:45 PM as dose 1, single for COVID-19 immunisation. No covid prior vaccination and did not tested covid post vaccination. On 19Feb2021 03:30 PM, the patient experienced symptoms of chills, fever 100 degree fahrenheit, nausea, dizziness, fatigue, headache occurs 10-11 days after 2nd dose. No treatment was received. The patient underwent lab test and procedure which included fever resulted as 100 degree fahrenheit on 19Feb2021. The clinical outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: chills; dizziness; fatigue; headache; nausea; fever 100° F; This is a spontaneous case from a contactable consumer. This 72-years-old female consumer (patient) reported for herself. A 72-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number: EL9265) via an unspecified route of administration in arm left on 08Feb2021 15:30 as dose 2, single (age at vaccination: 72 years) for COVID-19 immunisation. Medical history included sjogren's, hashimoto's thyroiditis, CAD, osteoporosis, high MCV, MTHFR, known allergies: iodine dye, reglan, motrin high dose, all from an unknown date and unknown if ongoing. Concomitant medications included clonazepam (KLONOPIN); amlodipine besilate (NORVASC); asa (ASA), multiple vitamins all taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot Number was not reported) via an unspecified route of administration in arm left on 17Jan2021 03:45 PM as dose 1, single for COVID-19 immunisation. No covid prior vaccination and did not tested covid post vaccination. On 19Feb2021 03:30 PM, the patient experienced symptoms of chills, fever 100 degree fahrenheit, nausea, dizziness, fatigue, headache occurs 10-11 days after 2nd dose. No treatment was received. The patient underwent lab test and procedure which included fever resulted as 100 degree fahrenheit on 19Feb2021. The clinical outcome of the events was not resolved.  Follow-up attempts completed. No further information expected.