chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Musculoskeletal discomfort, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable physician. A 29-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history was not reported. The reporter is not related to a study or program. Concomitant medications included unspecified medication (She does take other medications but does not know the significance). On 30Mar2021, the physician stated that, the patient developed immediate right-side neck pressure, skin and jaw tingling, and swollen lymph nodes. She did not have any trouble breathing and did not have any hives. These events were considered as medically significant. The pharmacist gave her 2 Benadryl and she stayed there for an hour. She said she does not think the Benadryl did anything for her. The physician stated that the patient went home and slept off the immediate reaction she experienced and had fatigue for 3 days. The patient had fatigue for 3 days and no other problems. The physician inquired on advisable information for the second dose. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tricuspid valve incompetence
Clinical narrative: the tv (tricuspid valve incompetence); This is a spontaneous report from a contactable physician. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 12Apr2021 at 13:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included Stroke, and seizure. The patient's concomitant medications were not reported. On 12Apr2021 at 13:15, the patient experienced the tv (tricuspid valve incompetence). The patient did not received treatment for the event. The outcome of the event was unknown. The patient did not had COVID prior to vaccination and not tested for COVID post vaccination.  Information about lot/batch has been requested.; Sender's Comments: Based on the information currently available, the event is considered most likely associated with intercurrent or underlying medical conditions, appears unrelated to the suspect drug.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: diagnosed with Cancer; This is a spontaneous report from a non-contactable pharmacist. A 72-year-old male patient received his first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 72-years-old, via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of COVID-19 vaccine on 08Feb2021 and was reported to have been diagnosed with cancer on an unspecified date in 2021. The second dose was paused and the pharmacist was asking if it was still okay to get the second this late (into the 9th week). The outcome of the event was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, the event is considered most likely associated with intercurrent or underlying medical conditions, appears unrelated to the suspect drug.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Pneumonia, SARS-CoV-2 test
Clinical narrative: I'm no longer symptomatic. Very recently, in the last 4 days, I had a COVID test that showed positive; Pneumonia; This is a spontaneous report from a contactable consumer (Patient) reported for self. This 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Lot: EN6203, Expiration date: unknown) via an unspecified route of administration in left arm on 24Mar2021 at 17:30 at single dose for Covid-19 immunization. Patient relevant medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021, (as reported) patient experienced lot of coughing, low energy, fever with sweating then would feel extremely cold, Loss of taste, Hot and intense chills and pneumonia on 02Apr2021. Patient underwent lab test to the hospital and got a CT scan. The patient received cough drops and cough suppressant medication for cough with outcome of recovered. Patient took the antibiotics (Advil) for a week or 5 days for Pneumonia till 09Apr2021 with outcome of recovered. Patient underwent lab test and procedure which included COVID test positive (symptomatic) on 02Apr2021.The outcome of event was recovered.  Follow-up (12Apr2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I started my period after not having a period since Oct2019.; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151), via an unspecified route of administration, administered on the right arm at the age of 50 years, on 09Apr2021 08:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma/COPD, stroke, avascular necrosis both hips; all from an unknown date and unknown if ongoing. Concomitant medications included gabapentin (GABAPENTIN); atorvastatin (ATORVASTATIN); pantoprazole (PANTOPRAZOLE) and colecalciferol (VITAMIN D [COLECALCIFEROL]); all taken for an unspecified indication, start and stop date were not reported. The patient previously took penicillin and experienced drug hypersensitivity. The patient stated, "I started my period after not having a period since oct2019" on 09Apr2021 12:15. No treatment was received for the event. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: vertigo; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for three patients. This is the first of three reports.  A 70-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 26Mar2021 10:15 (not pregnant patient), single dose for covid-19 immunization. Medical history included Multiple Myeloma, stem cell transplant on 02Feb. In remission, Known allergies: sulfa drugs, all from an unknown date. The patient had her first dose of BNT162B2 on 05Mar2021 10:15 on left arm for Covid-19 immunization. Concomitant medications included acyclovir [aciclovir]; folic acid; pravastatin, all taken for an unspecified indication, start and stop date were not reported. The patient experienced 8 days after receiving 2nd dose of the Pfizer vaccine (03Apr2021), a severe attack of vertigo and was hospitalized for 3 nights. The outcome of the event was recovering. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 03Apr2021. No other vaccine in four weeks.Treatment for the adverse event were CT scan, brain MRI, drugs. No covid prior vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021402492 same drug, different patient, similar AE;PFIZER INC-2021402493 same drug, different patient, similar AE
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis
Clinical narrative: I have been having some problems with kidney stones; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age (Age: 61; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient has been having some problems with kidney stones on an unspecified date. The event was assessed as serious (medically significant). The patient asked what happens if she can't get the second dose? Second dose was scheduled on 15Apr2021. The outcome of the event was unknown.  No follow-up attempts are completed; information about batch/lot cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Feeling hot, Insomnia, Nasopharyngitis
Clinical narrative: shortness of breath; productive cough; a lot of throat congestion; she felt like she woke up with a cold; felt hot; she couldn't sleep,; This is a spontaneous report from a contactable nurse (patient).  A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:  ER8737, expiration date: 30Jul2021, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left deltoid on 08Apr2021 10:30 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia. Patient stated she has had fibromyalgia for about 20 years. She said she had a fibromyalgia flare up with increased back pain, and had a Toradol 60mg intramuscular injection in her left hip on Tuesday, 06Apr2021. Concomitant medication included ketorolac tromethamine (TORADOL) for fibromyalgia from 06Apr2021. It was reported she had her first COVID-19 vaccine injection on Thursday 08Apr2021 at 10:30AM. She said that night (08Apr2021) she couldn't sleep and woke up at 3:00AM (09Apr2021) with shortness of breath, productive cough, and throat congestion. She said she had so much throat congestion, she could hardly talk. She clarified she felt like she woke up with a cold. She said she still had the productive cough, but her other symptoms went away by 8:30AM-9:00AM on 09Apr2021. She said she hadn't had a cold in 4 years. She said she read something on the internet that suggested her symptoms may be due to having the COVID-19 virus prior to getting the COVID-19 Vaccine. She said if she had the COVID-19 virus prior to getting her first COVID-19 Vaccine, she was totally asymptomatic. She said she wanted to know what she should do. Patient further reported she felt her shortness of breath was medically significant because she was mouth breathing. She clarified she felt hot during that time, and took her temperature, which was 97 degrees. She said she thought the fact she was hot was medically significant because she thought she may have a bad respiratory infection or something. The patient was not brought to the emergency room or physician's office in response to the events. The patient recovered from shortness of breath, felt hot, throat congestion on 09Apr2021; recovering from productive cough, and unknown outcome for the remaining events. The events were assessed as related with bnt162b2.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Productive cough
Clinical narrative: shortness of breath; productive cough; a lot of throat congestion; she felt like she woke up with a cold; felt hot; she couldn't sleep,; This is a spontaneous report from a contactable nurse (patient).  A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:  ER8737, expiration date: 30Jul2021, NDC number: 59267-1000-02), via an unspecified route of administration, administered in the left deltoid on 08Apr2021 10:30 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia. Patient stated she has had fibromyalgia for about 20 years. She said she had a fibromyalgia flare up with increased back pain, and had a Toradol 60mg intramuscular injection in her left hip on Tuesday, 06Apr2021. Concomitant medication included ketorolac tromethamine (TORADOL) for fibromyalgia from 06Apr2021. It was reported she had her first COVID-19 vaccine injection on Thursday 08Apr2021 at 10:30AM. She said that night (08Apr2021) she couldn't sleep and woke up at 3:00AM (09Apr2021) with shortness of breath, productive cough, and throat congestion. She said she had so much throat congestion, she could hardly talk. She clarified she felt like she woke up with a cold. She said she still had the productive cough, but her other symptoms went away by 8:30AM-9:00AM on 09Apr2021. She said she hadn't had a cold in 4 years. She said she read something on the internet that suggested her symptoms may be due to having the COVID-19 virus prior to getting the COVID-19 Vaccine. She said if she had the COVID-19 virus prior to getting her first COVID-19 Vaccine, she was totally asymptomatic. She said she wanted to know what she should do. Patient further reported she felt her shortness of breath was medically significant because she was mouth breathing. She clarified she felt hot during that time, and took her temperature, which was 97 degrees. She said she thought the fact she was hot was medically significant because she thought she may have a bad respiratory infection or something. The patient was not brought to the emergency room or physician's office in response to the events. The patient recovered from shortness of breath, felt hot, throat congestion on 09Apr2021; recovering from productive cough, and unknown outcome for the remaining events. The events were assessed as related with bnt162b2.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cold sweat, Contusion, Diarrhoea
Clinical narrative: hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pretty badly bruised / bruise has gone above her knee to her ankle; Weak and could not get out of bed; Sleeping a lot; Dizziness; Headache; Chills; Vomiting; Queasy; This is a spontaneous report from a contactable consumer reporting for herself.  A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:05 (Batch/Lot Number: EP7534; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation  .  Medical history included hypersensitivity , immune system disorder , respiratory disorder , cytogenetic abnormality  , endocrine disorder Endocrine abnormalities , diabetes mellitus , obesity  , anxiety, hypersensitivity. Concomitant medication(s) included alprazolam (XANAX) at 5 mg daily, taken for anxiety, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) at 60 mg daily taken for anxiety, start and stop date were not reported.  The patient experienced fall  on 05Apr2021 with outcome of recovered with sequelae , pretty badly bruised / bruise has gone above her knee to her ankle  on 05Apr2021 with outcome of unknown , headache on 16Mar2021 with outcome of recovering , chills on 16Mar2021 with outcome of not recovered , vomiting on 16Mar2021 with outcome of recovering , queasy  on 16Mar2021 with outcome of not recovered , diarrhea on an unspecified date with outcome of recovering , weak and could not get out of bed  on 17Mar2021 with outcome of recovering , dizziness  on 16Mar2021 with outcome of not recovered , sleeping a lot  on 17Mar2021 with outcome of not recovered , hot and cold  on an unspecified date with outcome of unknown , very ill  on an unspecified date with outcome of unknown , felt horrible  on an unspecified date with outcome of unknown , clammy  on an unspecified date with outcome of unknown , feeling odd, kind of wonky, woozy  on an unspecified date with outcome of unknown.  The events fall and contusion were considered Important Medical Events. The remaining events were non serious.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Feeling abnormal, Feeling of body temperature change, Headache
Clinical narrative: hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pretty badly bruised / bruise has gone above her knee to her ankle; Weak and could not get out of bed; Sleeping a lot; Dizziness; Headache; Chills; Vomiting; Queasy; This is a spontaneous report from a contactable consumer reporting for herself.  A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:05 (Batch/Lot Number: EP7534; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation  .  Medical history included hypersensitivity , immune system disorder , respiratory disorder , cytogenetic abnormality  , endocrine disorder Endocrine abnormalities , diabetes mellitus , obesity  , anxiety, hypersensitivity. Concomitant medication(s) included alprazolam (XANAX) at 5 mg daily, taken for anxiety, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) at 60 mg daily taken for anxiety, start and stop date were not reported.  The patient experienced fall  on 05Apr2021 with outcome of recovered with sequelae , pretty badly bruised / bruise has gone above her knee to her ankle  on 05Apr2021 with outcome of unknown , headache on 16Mar2021 with outcome of recovering , chills on 16Mar2021 with outcome of not recovered , vomiting on 16Mar2021 with outcome of recovering , queasy  on 16Mar2021 with outcome of not recovered , diarrhea on an unspecified date with outcome of recovering , weak and could not get out of bed  on 17Mar2021 with outcome of recovering , dizziness  on 16Mar2021 with outcome of not recovered , sleeping a lot  on 17Mar2021 with outcome of not recovered , hot and cold  on an unspecified date with outcome of unknown , very ill  on an unspecified date with outcome of unknown , felt horrible  on an unspecified date with outcome of unknown , clammy  on an unspecified date with outcome of unknown , feeling odd, kind of wonky, woozy  on an unspecified date with outcome of unknown.  The events fall and contusion were considered Important Medical Events. The remaining events were non serious.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Nausea, Somnolence, Vomiting
Clinical narrative: hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pretty badly bruised / bruise has gone above her knee to her ankle; Weak and could not get out of bed; Sleeping a lot; Dizziness; Headache; Chills; Vomiting; Queasy; This is a spontaneous report from a contactable consumer reporting for herself.  A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:05 (Batch/Lot Number: EP7534; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation  .  Medical history included hypersensitivity , immune system disorder , respiratory disorder , cytogenetic abnormality  , endocrine disorder Endocrine abnormalities , diabetes mellitus , obesity  , anxiety, hypersensitivity. Concomitant medication(s) included alprazolam (XANAX) at 5 mg daily, taken for anxiety, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) at 60 mg daily taken for anxiety, start and stop date were not reported.  The patient experienced fall  on 05Apr2021 with outcome of recovered with sequelae , pretty badly bruised / bruise has gone above her knee to her ankle  on 05Apr2021 with outcome of unknown , headache on 16Mar2021 with outcome of recovering , chills on 16Mar2021 with outcome of not recovered , vomiting on 16Mar2021 with outcome of recovering , queasy  on 16Mar2021 with outcome of not recovered , diarrhea on an unspecified date with outcome of recovering , weak and could not get out of bed  on 17Mar2021 with outcome of recovering , dizziness  on 16Mar2021 with outcome of not recovered , sleeping a lot  on 17Mar2021 with outcome of not recovered , hot and cold  on an unspecified date with outcome of unknown , very ill  on an unspecified date with outcome of unknown , felt horrible  on an unspecified date with outcome of unknown , clammy  on an unspecified date with outcome of unknown , feeling odd, kind of wonky, woozy  on an unspecified date with outcome of unknown.  The events fall and contusion were considered Important Medical Events. The remaining events were non serious.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Biopsy liver, Chills, Diarrhoea, Dysentery
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 63-year-old male patient received the first dose of bnt162b2 (BNT162B2 also reported as Covid-19 vaccine Pfizer, lot ER8737), via an unspecified route of administration in the left arm on 02Apr2021 14:15 as SINGLE DOSE for Covid-19 immunization. Medical history included sinus infection and ongoing sulfa allergy. He found out about this allergy probably 25 years ago. He was taking a big white tablet for a sinus infection. Says that he was hospitalized for his reaction; doctor told him he almost died. He was also out of work for 2 months after hospitalization. Caller stated he ended up in the hospital with a spiked fever, vomiting, got sweaty and large purple spots  and lost weight and was in the hospital for two weeks due to the sulfa reaction. There were no concomitant medications. On 03Apr2021, he felt extremely tired, like he had been drugged and washed out. He just felt awful on 04Apr2021. He got so sick and was not doing very well on 05Apr2021. On 08Apr2021, he had diarrhea and stated it was like dysentery, just water. He drank 2 bottles of Electrolyte replacements he got from a pharmacy and he was weak as a kitten. He had chills, vomiting, shaking, he could not stand or lift his head on 10Apr2021. The patient underwent procedure which included biopsy liver: unknown result on unspecified date. Therapeutic measures were taken as a result of got so sick/ not doing very well, chills ,vomiting, he could not stand or lift his head, he could not stand or lift his head. The outcome of events fatigue was recovered on 03Apr2021; for malaise was recovered on 05Apr2021; for chills, vomiting, tremor, dysstasia, head discomfort was recovered on 11Apr2021; for diarrhea was recovering; for asthenia was recovered on unspecified date; for other events was unknown.  Information on the batch number was already obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue, Feeling abnormal, Head discomfort, Malaise
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 63-year-old male patient received the first dose of bnt162b2 (BNT162B2 also reported as Covid-19 vaccine Pfizer, lot ER8737), via an unspecified route of administration in the left arm on 02Apr2021 14:15 as SINGLE DOSE for Covid-19 immunization. Medical history included sinus infection and ongoing sulfa allergy. He found out about this allergy probably 25 years ago. He was taking a big white tablet for a sinus infection. Says that he was hospitalized for his reaction; doctor told him he almost died. He was also out of work for 2 months after hospitalization. Caller stated he ended up in the hospital with a spiked fever, vomiting, got sweaty and large purple spots  and lost weight and was in the hospital for two weeks due to the sulfa reaction. There were no concomitant medications. On 03Apr2021, he felt extremely tired, like he had been drugged and washed out. He just felt awful on 04Apr2021. He got so sick and was not doing very well on 05Apr2021. On 08Apr2021, he had diarrhea and stated it was like dysentery, just water. He drank 2 bottles of Electrolyte replacements he got from a pharmacy and he was weak as a kitten. He had chills, vomiting, shaking, he could not stand or lift his head on 10Apr2021. The patient underwent procedure which included biopsy liver: unknown result on unspecified date. Therapeutic measures were taken as a result of got so sick/ not doing very well, chills ,vomiting, he could not stand or lift his head, he could not stand or lift his head. The outcome of events fatigue was recovered on 03Apr2021; for malaise was recovered on 05Apr2021; for chills, vomiting, tremor, dysstasia, head discomfort was recovered on 11Apr2021; for diarrhea was recovering; for asthenia was recovered on unspecified date; for other events was unknown.  Information on the batch number was already obtained.
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 63-year-old male patient received the first dose of bnt162b2 (BNT162B2 also reported as Covid-19 vaccine Pfizer, lot ER8737), via an unspecified route of administration in the left arm on 02Apr2021 14:15 as SINGLE DOSE for Covid-19 immunization. Medical history included sinus infection and ongoing sulfa allergy. He found out about this allergy probably 25 years ago. He was taking a big white tablet for a sinus infection. Says that he was hospitalized for his reaction; doctor told him he almost died. He was also out of work for 2 months after hospitalization. Caller stated he ended up in the hospital with a spiked fever, vomiting, got sweaty and large purple spots  and lost weight and was in the hospital for two weeks due to the sulfa reaction. There were no concomitant medications. On 03Apr2021, he felt extremely tired, like he had been drugged and washed out. He just felt awful on 04Apr2021. He got so sick and was not doing very well on 05Apr2021. On 08Apr2021, he had diarrhea and stated it was like dysentery, just water. He drank 2 bottles of Electrolyte replacements he got from a pharmacy and he was weak as a kitten. He had chills, vomiting, shaking, he could not stand or lift his head on 10Apr2021. The patient underwent procedure which included biopsy liver: unknown result on unspecified date. Therapeutic measures were taken as a result of got so sick/ not doing very well, chills ,vomiting, he could not stand or lift his head, he could not stand or lift his head. The outcome of events fatigue was recovered on 03Apr2021; for malaise was recovered on 05Apr2021; for chills, vomiting, tremor, dysstasia, head discomfort was recovered on 11Apr2021; for diarrhea was recovering; for asthenia was recovered on unspecified date; for other events was unknown.  Information on the batch number was already obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a contactable consumer. An adult female patient of unspecified age (reported as age: 62; Unit: unknown) received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on unknown date (Batch/Lot Number: not provided) as COVID-19 immunization. Then, the 2nd dose on unknown date. It was stated that the patient had a stroke following administration of second dose on unknown date. Outcome of the event was unknown.   No follow-up attempts are possible, information on batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Dysgeusia, Parosmia, SARS-CoV-2 test
Clinical narrative: Fainted; extreme dizziness and disorientation since; extreme dizziness and disorientation since; metallic taste in mouth; smell metal coming out of pores; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient (not pregnant, age at vaccination 39-year-old) received the second dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand=Pfizer, Batch/Lot number was not reported), via an unspecified route of administration in the left arm, on 12Mar2021 09:00 as SINGLE DOSE for Covid-19 immunisation. Medical history included allergy to contrast dyes. She reported of Covid prior vaccination. She had her first dose of bnt162b2, 09am (lot unknown), left arm on 19Feb2021. Concomitant medications was antibiotics (unspecified) in two weeks. On 12Mar2021 09:15, the patient experienced faint/fainted, extreme dizziness and disorientation, metallic taste in mouth and had a smell metal coming out of pores (no treatment for the events). She had a clinic visit and Emergency room/department visit. The patient was hospitalized for 2 days due to the events. The patient underwent laboratory test Sars-cov-2 test: negative on 01Apr2021. The outcome of events was recovering.  Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted; extreme dizziness and disorientation since; extreme dizziness and disorientation since; metallic taste in mouth; smell metal coming out of pores; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient (not pregnant, age at vaccination 39-year-old) received the second dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand=Pfizer, Batch/Lot number was not reported), via an unspecified route of administration in the left arm, on 12Mar2021 09:00 as SINGLE DOSE for Covid-19 immunisation. Medical history included allergy to contrast dyes. She reported of Covid prior vaccination. She had her first dose of bnt162b2, 09am (lot unknown), left arm on 19Feb2021. Concomitant medications was antibiotics (unspecified) in two weeks. On 12Mar2021 09:15, the patient experienced faint/fainted, extreme dizziness and disorientation, metallic taste in mouth and had a smell metal coming out of pores (no treatment for the events). She had a clinic visit and Emergency room/department visit. The patient was hospitalized for 2 days due to the events. The patient underwent laboratory test Sars-cov-2 test: negative on 01Apr2021. The outcome of events was recovering.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot number: Expiry date: Unknown), dose 1 via an unspecified route of administration on 24Mar2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid (drug ineffective) (medically significant), tested positive for covid (covid-19) (medically significant) on 31Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Mar2021. The outcome of the event was unknown.  information on about lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antibody test, Disease recurrence, Lung neoplasm malignant, SARS-CoV-2 antibody test negative, SARS-CoV-2 test
Clinical narrative: She also mentioned that 2 weeks ago she found out that her lung cancer is back.; She also mentioned that 2 weeks ago she found out that her lung cancer is back.; I was tested for antibodies. I am Negative; This is a spontaneous report from contactable consumers. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: "reported as EL0262 or EL9262" on 22Jan2021 18:30 and second dose (lot number: EN6201) on 19Feb2021, both via an unspecified route of administration, administered in left arm for Covid-19 immunisation; mycophenolate mofetil hydrochloride (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included interstitial lung coughing, (she states that she didn't have a transplant but has interstitial lung coughing), arm got red, arm hurt and lung cancer. There were no concomitant medications. On an unspecified date, the patient reported that she went for an antibody test, which came back completely negative. She also mentioned that 2 weeks ago (unspecified date), she found out that her lung cancer was back. The action taken in response to the events for mycophenolate mofetil hydrochloride was permanently withdrawn on an unspecified date. The outcome of the events was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Headache, Pain, Pain in extremity
Clinical narrative: chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness to my heart; She also had tenderness in muscle where site of vaccine was; headache; Left arm pain; This is a spontaneous report from a contactable consumer reporting for herself.  A 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 27Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation (Age at vaccination 74 years) .  Medical history included atrial fibrillation from 2019  (AFib was diagnosed a couple of months before Dec2019) , chronic obstructive pulmonary disease from Dec2019  , medical device implantation  (Watchman device inserted), anaemia  , oesophagogastroduodenoscopy  , oesophageal stenosis, obesity. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) from Jul2019 to an unspecified stop date; metoprolol (METOPROLOL) taken for heart rate irregular from Nov2019 to an unspecified stop date.  The patient previously took bnt162b2 for covid-19 immunisation on 06Jan2021. The patient also took aspirin (E.C.) and experienced haemorrhage.  The patient experienced feeling occasional pain and tightness to my heart  on 30Jan2021 with outcome of not recovered , chest pain  on an unspecified date with outcome of not recovered , she also had tenderness in muscle where site of vaccine was  on 28Jan2021 with outcome of recovering , headache  on 28Jan2021 with outcome of recovering , left arm pain  on 28Jan2021 with outcome of recovered.    No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: chest pain; feeling occasional pain and tightness to my heart; feeling occasional pain and tightness to my heart; She also had tenderness in muscle where site of vaccine was; headache; Left arm pain; This is a spontaneous report from a contactable consumer reporting for herself.  A 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 27Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation (Age at vaccination 74 years) .  Medical history included atrial fibrillation from 2019  (AFib was diagnosed a couple of months before Dec2019) , chronic obstructive pulmonary disease from Dec2019  , medical device implantation  (Watchman device inserted), anaemia  , oesophagogastroduodenoscopy  , oesophageal stenosis, obesity. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) from Jul2019 to an unspecified stop date; metoprolol (METOPROLOL) taken for heart rate irregular from Nov2019 to an unspecified stop date.  The patient previously took bnt162b2 for covid-19 immunisation on 06Jan2021. The patient also took aspirin (E.C.) and experienced haemorrhage.  The patient experienced feeling occasional pain and tightness to my heart  on 30Jan2021 with outcome of not recovered , chest pain  on an unspecified date with outcome of not recovered , she also had tenderness in muscle where site of vaccine was  on 28Jan2021 with outcome of recovering , headache  on 28Jan2021 with outcome of recovering , left arm pain  on 28Jan2021 with outcome of recovered.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac disorder, Haemorrhage, Influenza like illness, Oral disorder
Clinical narrative: heart felt heavy; fuzziness in her mouth; the joint where the thumb meets the wrist started hurting; She stated her legs felt like she ran a mile/arms felt like she lifted weights/couldn't use both hands to open doorknobs without hurting; aching going up the steps; almost like she had the flu; she received the injection she said she bled but they said oh we got muscle; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support, received from a contactable consumer (patient). A female patient of an unspecified age (reported as 63 no unit) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration in the left arm on 30Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Mar2021, when she received the injection she said she bled but they said "oh we got muscle". On 01Apr2021, 2 days after, the patient reported that she did not get any fever or chills, however, her heart felt heavy a little bit. She got the shot in her left arm and, oddly enough, the joint where the thumb meets the wrist started hurting. She had fuzziness in her mouth but no anaphylactic reaction. She thought maybe it was psychosomatic. Her joints and extremities ached moderately, not mildly. She stated her legs felt like she ran a mile and her arms felt like she lifted weights and she never did. She stated this progressed for 10 days. It went to her other hands. She is very active and this is unusual. She couldn't use both hands to open doorknobs without hurting. Both arms and both legs hurt. She stated she lives in a 4 story home and has 3 flights of stairs and can run them no problem usually but was aching going up the steps and it was kind of crazy almost like she had the flu, it just never exploded. Today (unspecified date), for the first day, she is almost feeling back to herself, she's getting better now. The caller asked if she should get her second dose of the vaccine after these symptoms. She asked if the second dose would make these symptoms worse? She stated she is unsure if it is related. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: heart felt heavy; fuzziness in her mouth; the joint where the thumb meets the wrist started hurting; She stated her legs felt like she ran a mile/arms felt like she lifted weights/couldn't use both hands to open doorknobs without hurting; aching going up the steps; almost like she had the flu; she received the injection she said she bled but they said oh we got muscle; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support, received from a contactable consumer (patient). A female patient of an unspecified age (reported as 63 no unit) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration in the left arm on 30Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Mar2021, when she received the injection she said she bled but they said "oh we got muscle". On 01Apr2021, 2 days after, the patient reported that she did not get any fever or chills, however, her heart felt heavy a little bit. She got the shot in her left arm and, oddly enough, the joint where the thumb meets the wrist started hurting. She had fuzziness in her mouth but no anaphylactic reaction. She thought maybe it was psychosomatic. Her joints and extremities ached moderately, not mildly. She stated her legs felt like she ran a mile and her arms felt like she lifted weights and she never did. She stated this progressed for 10 days. It went to her other hands. She is very active and this is unusual. She couldn't use both hands to open doorknobs without hurting. Both arms and both legs hurt. She stated she lives in a 4 story home and has 3 flights of stairs and can run them no problem usually but was aching going up the steps and it was kind of crazy almost like she had the flu, it just never exploded. Today (unspecified date), for the first day, she is almost feeling back to herself, she's getting better now. The caller asked if she should get her second dose of the vaccine after these symptoms. She asked if the second dose would make these symptoms worse? She stated she is unsure if it is related. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod sting, Erythema, Eyelids pruritus, Feeling abnormal, Haemorrhage
Clinical narrative: Blood was coming through; Slight bee stings all over and thigh; Scabs on me; my eyelids have been a little itchy too; that was the only way that I am able to get some sleep; was miserable; consumer was in pain; hives; the same day I started to itch, it was mild across my breast and my stomach but my thighs and my bottom legs were turning red, swelling; but my thighs and my bottom legs were turning red/Thighs/Legs turned red; but my thighs and my bottom legs were turning red, swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 71-year-old, via an unspecified route of administration on 10Apr2021 13:30 (Lot Number: EN6207) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included apixaban (ELIQUIS), tamsulosin, and iron. The patient got her first injection on Saturday, 10Apr2021 at 1:30 pm in the afternoon around 7 o'clock the same day she started to itch, it was mild across her breast and stomach but her thighs and bottom legs were turning red, swelling, hives there too, and she rubbed alcohol (treatment) on this to stop the itch, that seems to helped a little bit, but the swelling was not that bad today but the redness was still there. She has scabs on her, blood was coming through, and slight bee stings all over and thigh on an unspecified date, she used hydrocortisone cream (treatment), she was lucky she have some of that here because she keep that when going or here but she rubbed that on last night and that was the only way that she was able to get some sleep. The patient doesn't think that she was going to get the second shot, she doesn't want to experience that again. It feels like that today it was not that bad itching today but at 71 that was miserable yesterday so probably she would not get the second shot. She hopes that the first one can protect her to a point, but she cannot subject herself to that again, that would be senseless for her to experience that again and get a second shot. The patient also stated that her eyelids have been a little itchy too so hopefully you all understand it was 71 years old was suffering from that kind of misery second time. The patient was unable to probe the more question, patient was in pain and not willing to proceed. The outcome of the events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Peripheral swelling, Pruritus, Scab
Clinical narrative: Blood was coming through; Slight bee stings all over and thigh; Scabs on me; my eyelids have been a little itchy too; that was the only way that I am able to get some sleep; was miserable; consumer was in pain; hives; the same day I started to itch, it was mild across my breast and my stomach but my thighs and my bottom legs were turning red, swelling; but my thighs and my bottom legs were turning red/Thighs/Legs turned red; but my thighs and my bottom legs were turning red, swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 71-year-old, via an unspecified route of administration on 10Apr2021 13:30 (Lot Number: EN6207) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included apixaban (ELIQUIS), tamsulosin, and iron. The patient got her first injection on Saturday, 10Apr2021 at 1:30 pm in the afternoon around 7 o'clock the same day she started to itch, it was mild across her breast and stomach but her thighs and bottom legs were turning red, swelling, hives there too, and she rubbed alcohol (treatment) on this to stop the itch, that seems to helped a little bit, but the swelling was not that bad today but the redness was still there. She has scabs on her, blood was coming through, and slight bee stings all over and thigh on an unspecified date, she used hydrocortisone cream (treatment), she was lucky she have some of that here because she keep that when going or here but she rubbed that on last night and that was the only way that she was able to get some sleep. The patient doesn't think that she was going to get the second shot, she doesn't want to experience that again. It feels like that today it was not that bad itching today but at 71 that was miserable yesterday so probably she would not get the second shot. She hopes that the first one can protect her to a point, but she cannot subject herself to that again, that would be senseless for her to experience that again and get a second shot. The patient also stated that her eyelids have been a little itchy too so hopefully you all understand it was 71 years old was suffering from that kind of misery second time. The patient was unable to probe the more question, patient was in pain and not willing to proceed. The outcome of the events was unknown.