chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Superficial blood clot in the leg/area is sore to touch; A spontaneous report was received from a consumer (patient), concerning a 82-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced superficial blood clot in the leg/area is sore to touch (thrombosis).  No medical history was reported. No concomitant medications were reported.  On 19 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided),  on 15 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced a superficial blood clot in her leg (medically significant). She also reported that the area was sore to touch. The doctor prescribed medication to treat her problem, but they said to wait a week to see if it solved on its own before taking it. She was also applying ice pack on the affected area. No further information as reported.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The event of superficial blood clot in the leg/area is sore to touch (thrombosis) was unresolved.  The reporter did not provide assessment for the event of superficial blood clot in the leg/area is sore to touch (thrombosis).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Enzyme abnormality, Headache, Illness, Nausea
Clinical narrative: has some enzyme issue; woke up sick; Nausea; Chills; Headache; Vomiting; A spontaneous report was received from a consumer concerning about a 65 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced enzyme abnormality and other events included sickness/illness, nausea, chills, headache and vomiting.  The patient's medical history was reported as have rheumatoid arthritis. Concomitant medications were reported as having medication for rheumatoid arthritis.  On 11 Mar 2021, prior to the onset of the events, the patient received their first planned doses of mRNA-1273 (Batch number: 04A21A) via intramuscular in right arm for the prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient woke up sick and was experiencing nausea, chills, headache, and vomiting.  On 13 Mar 2021, the patient went to the hospital and lots of test were done including a blood test. The physician mentioned she had some enzyme issue. The patient was admitted to the hospital ln 12 Mar 2021 and discharged on 15 Mar 2021.  On 16Mar2021 she went to cardiologist because she mentioned she has some enzyme issue. Treatment included paracetamol.  Laboratory results were not provided.  Action taken with mRNA-1273 in response to the events are unknown.  The outcomes of the reported events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: has some enzyme issue; woke up sick; Nausea; Chills; Headache; Vomiting; A spontaneous report was received from a consumer concerning about a 65 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced enzyme abnormality and other events included sickness/illness, nausea, chills, headache and vomiting.  The patient's medical history was reported as have rheumatoid arthritis. Concomitant medications were reported as having medication for rheumatoid arthritis.  On 11 Mar 2021, prior to the onset of the events, the patient received their first planned doses of mRNA-1273 (Batch number: 04A21A) via intramuscular in right arm for the prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient woke up sick and was experiencing nausea, chills, headache, and vomiting.  On 13 Mar 2021, the patient went to the hospital and lots of test were done including a blood test. The physician mentioned she had some enzyme issue. The patient was admitted to the hospital ln 12 Mar 2021 and discharged on 15 Mar 2021.  On 16Mar2021 she went to cardiologist because she mentioned she has some enzyme issue. Treatment included paracetamol.  Laboratory results were not provided.  Action taken with mRNA-1273 in response to the events are unknown.  The outcomes of the reported events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Rash, Skin disorder, Skin weeping
Clinical narrative: Staph infection on the legs; Hot to the touch rash on both legs; Fluid leaking out of broken skin on legs; Broken skin on the legs; Legs swelled up; Rash on both legs, Arms and Upper Body; A spontaneous report was received from a 68 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced staphylococcal infection, peripheral swelling, hot feeling in feet, skin oozing, skin breakdown, rash on legs, arms and upper body.  The patient's medical history included swelling of legs, weak immune system and use of steroids medication stopped prior to vaccination. No concomitant medications were reported.   On 24-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 011A21A) intramuscularly on right arm for prophylaxis of COVID-19 infection.  On 27-Feb-2021,the patient's legs swelled up like never before, had a rash on both legs that was hot to the touch, the skin broke on the legs, and fluid leaked out of broken skin. After the doctor's visit and treatment, the rash moved to arms and upper body. No laboratory data was provided. Treatment included diphenhydramine and treatment for staph infection.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event staphylococcal infection was considered as resolved on an unknown date in MAR 2021. The outcomes of the events peripheral swelling, hot feeling in feet, skin oozing, and skin breakdown were considered as resolved on 10 Mar 2021. The outcome of the event rash was considered as recovering at the time of the report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Staphylococcal infection
Clinical narrative: Staph infection on the legs; Hot to the touch rash on both legs; Fluid leaking out of broken skin on legs; Broken skin on the legs; Legs swelled up; Rash on both legs, Arms and Upper Body; A spontaneous report was received from a 68 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced staphylococcal infection, peripheral swelling, hot feeling in feet, skin oozing, skin breakdown, rash on legs, arms and upper body.  The patient's medical history included swelling of legs, weak immune system and use of steroids medication stopped prior to vaccination. No concomitant medications were reported.   On 24-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch 011A21A) intramuscularly on right arm for prophylaxis of COVID-19 infection.  On 27-Feb-2021,the patient's legs swelled up like never before, had a rash on both legs that was hot to the touch, the skin broke on the legs, and fluid leaked out of broken skin. After the doctor's visit and treatment, the rash moved to arms and upper body. No laboratory data was provided. Treatment included diphenhydramine and treatment for staph infection.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event staphylococcal infection was considered as resolved on an unknown date in MAR 2021. The outcomes of the events peripheral swelling, hot feeling in feet, skin oozing, and skin breakdown were considered as resolved on 10 Mar 2021. The outcome of the event rash was considered as recovering at the time of the report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Product dose omission issue
Clinical narrative: stroke; past the 28 days; A spontaneous report  was received from a Pharmacist, concerning a Male patient of unspecified age who received Moderna COVID-19 vaccine and experienced Stroke and Missed dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 26 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection.   On an unspecified date, the patient had experienced stroke. He is now past the 28 days (Missed dose). They would like to know if he can still get his second dose. Treatment information was not provided. The adverse event of stroke was assessed as medically significant.  Action taken with mRNA -1273 in response to the events was not reported.  Outcome of the event of stroke was not recovered. Outcome of the event of missed dose was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Phlebitis, Thrombosis, Ultrasound scan
Clinical narrative: phlebitis in my Right leg; small blood clot; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 09Feb2021 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation. Medical history included many allergies. The patient has no COVID prior to vaccination. The patient had other medications in two weeks but no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9263) on 20Jan2021 at 10:00 administered in the right arm for Covid-19 immunization. On 20Feb2021 at 12:00 (also reported as "in February"), the patient had a phlebitis in her right leg, a week later (Feb2021) a vascular surgeon office did an ultrasound and found a small blood clot. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with Eliquis BID (twice a day) for 45 days. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered.; Sender's Comments: A causal relationship between BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the event thrombosis cannot be excluded based on 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 RAs, Ethics Committees, and Investigators, as appropriate .
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Gait disturbance, Hypoaesthesia
Clinical narrative: feel weak; dizzy; acute numbness in both legs running up my feet to my knees - all balance - could not stand without assistance.; acute numbness in both legs running up my feet to my knees - all balance - could not stand without assistance/partial numbness in the face; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration in the left arm on 19Feb2021 at 14:00 as a single dose for COVID-19 immunization. Medical history included bladder cancer. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 29Jan2021 at 14:00 for COVID-19 immunization. The patient had no other vaccine in four weeks. Exactly two weeks after the second dose was administered (on 05Mar2021), the patient started to feel weak and dizzy and experienced acute numbness in both legs running up to his feet to his knees - all balance - could not stand without assistance, with partial numbness in the face. These progressively got worse for several days until disappearing on 12Mar2021. The patient had no COVID prior to vaccination and had not tested post-vaccination. No treatment was administered for the events. The patient recovered from the events on 12Mar2021. The adverse events (AE) resulted in: disability or permanent damage.  Information on the batch/lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Blood test, Computerised tomogram, Intra-abdominal haematoma
Clinical narrative: Abdominal hematoma; I went to my doctor, he thought it was appendicitis; This is a spontaneous report from a contactable consumer (patient).   A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 (Batch/Lot Number: EN6203; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. The patient medical history included White blood cell count decreased and tiredness. Concomitant medications included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for white blood cell count decreased, start and stop date were not reported (taking it for 2-3 months) and folic acid (FOLIC ACID) taken for an unspecified indication, start and stop date were not reported.   The patient was hospitalized with abdominal hematoma on 03Mar2021; patient went to doctor, he thought it was appendicitis and should take its course. She was admitted in the hospital from Friday afternoon (03Mar2021) until Wednesday afternoon (05Mar2021). They did a CT scan (03Mar2021), no surgery, they want to see if it would work out, it was rather large, they did blood work, they were very perplexed, they can't understand what happened. They keep asking what she did, although there was no bruising. She did say that she just got her shot.  The patient underwent lab tests and procedures which included blood test with unknown result on an unspecified date and computerised tomogram showed abdominal hematoma on 03Mar2021.  The patient had a check up on 11Mar2021, hematoma was rather large but the doctors don't know why she got it, she didn't know if it had anything to do with the vaccine. The caller's doctors can't figure it out and she is not on aspirin or blood thinners. There is no reason for the patient to get the vaccine, she did not have trauma and isn't on blood thinners. The patient was told to take 3 vitamins when she left the hospital because she became anemic, she is taking folic acid, vitamin B1 and a multivitamin which she is to take for 10 days to a month. The patient was considered to be recovering from the event abdominal hematoma while outcome of the event appendicitis was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation; This is a spontaneous report from a contactable consumer (patient) via Medical information team. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if she can delay her second dose of the Pfizer COVID-19 vaccine. She was scheduled to take the second dose of the Pfizer COVID-19 vaccine today (12Mar2021) but she is reluctant to get it because of her reaction with the first dose of the vaccine. She was hospitalized for atrial fibrillation after taking the first dose. The outcome of the event was unknown.  Information on about lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Asthenia, Blood pressure increased, Blood pressure measurement, Disorientation
Clinical narrative: heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immediate overall body weakness; slurred speech; lips tingling; disoriented; lightheaded; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration, at the age of 54 years, on the left arm on 08Mar2021 15:00 at a single dose for COVID-19 immunisation. Medical history included fibromyalgia, musculoskeletal disorder, drug hypersensitivity to penicillin, other food sensitivities and gluten sensitivity; all from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); ascorbic acid (C 500 [ASCORBIC ACID]); colecalciferol (D3) and magnesium (MAGNESIUM); all taken for an unspecified indication, start and stop date were not reported. The patient previously took progesterone, NP thyroid and lactose and experienced hypersensitivity. On 08Mar2021, the patient immediately felt the medications moving throughout her body. She felt immediate overall body weakness, slurred speech, lips tingling, disoriented, lightheaded, and heart discomforted. The medical staff took her blood pressure 30 minutes after the injection and it was 184/124. She stated she was not hypertensive. The final read before leaving the site was 149/90. No treatment was received for the events. The outcome of the events was recovering.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysarthria, Paraesthesia oral
Clinical narrative: heart discomforted.; blood pressure 30 minutes after the injection, and it was 184/124; I felt immediate overall body weakness; slurred speech; lips tingling; disoriented; lightheaded; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), via an unspecified route of administration, at the age of 54 years, on the left arm on 08Mar2021 15:00 at a single dose for COVID-19 immunisation. Medical history included fibromyalgia, musculoskeletal disorder, drug hypersensitivity to penicillin, other food sensitivities and gluten sensitivity; all from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); ascorbic acid (C 500 [ASCORBIC ACID]); colecalciferol (D3) and magnesium (MAGNESIUM); all taken for an unspecified indication, start and stop date were not reported. The patient previously took progesterone, NP thyroid and lactose and experienced hypersensitivity. On 08Mar2021, the patient immediately felt the medications moving throughout her body. She felt immediate overall body weakness, slurred speech, lips tingling, disoriented, lightheaded, and heart discomforted. The medical staff took her blood pressure 30 minutes after the injection and it was 184/124. She stated she was not hypertensive. The final read before leaving the site was 149/90. No treatment was received for the events. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis
Clinical narrative: blood clots in couple of toes near nails; observed swollen; This is a spontaneous report from a non-contactable consumer.   A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 24Feb2021 15:15 as a single dose for covid-19 immunisation . The patent has no medical history. The patient has no known allergies. The patient's concomitant medications were not reported. In Mar2021, the patient was observed with swollen and blood clots in couple of toes near nails. The events was not treated. The outcome of the events was not recovered. The patient has not had covid prior to vaccination and was not testes for Covid post vaccination.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Computerised tomogram, Gastrointestinal haemorrhage, Ileus, Infection
Clinical narrative: infection; Caller was diagnosed with colitis and GI bleed; Rectal bleeding; Ileus; Colitis; This is a spontaneous report from a contactable nurse. A 74-year-old female patient received first dosr of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6198; Expiration Date: Jun2021),via an unspecified route of administration, administered on left arm on 24Feb2021 12:59 at the age of 74 years-old at single dose for COVID-19 immunisation.  Medical history included regurge, diverticulosis, haemochromatosis, gingivitis, eczema, asthma, allergy to latex, bone density, polyps and did have an ileus 12 or 13 years ago and this one is in the same place. Concomitant medications included methylcellulose (CITRUCEL) taken for polyps; aluminium hydroxide gel, dried, magnesium carbonate (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) taken for regurgitation; calcium carbonate, colecalciferol, vitamin k nos (CITRACAL [CALCIUM CARBONATE;COLECALCIFEROL;VITAMIN K NOS]) taken for bone density.  The states she received the first dose of the Pfizer COVID vaccine on 24Feb2021, 24 hours later she experienced a GI bleed. Caller states she couldn't go to the bathroom at first and had dry heaves for two hours and then it resolved when she passed bright red blood and laid down. She then went to the emergency room and they did a CAT scan and diagnosed her with an ileus and colitis. She was also given two antibiotics and she is scheduled for a colonoscopy. By 1500 she started to have rectal bleeding; she saw the blood because it burst. She went to the emergency room that evening and they did a CAT scan that showed the ileus was swollen from infection so they put her on antibiotics. One of the doctors said something in her gut was out of balance. She chose not to be admitted to the hospital. She was treated with Cipro and Flagyl. Today she is still tender but she is passing soft stool and everything seems to be normal and she is eating low residue diet. She is scheduled to received the next dose of the vaccine on 17Mar2021. She is asking if the ileus is an effect of the shot and mentioned she did have an ileus 12 or 13 years ago and this one is in the same place. The outcome of events was unknown.; Sender's Comments: Based on the information provided, and on plausible temporal association,  the Company  assessed that a reasonable possibility could not be completely excluded that the reported events were related to the  PFIZER-BIONTECH COVID-19 VACCINE. 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: infection; Caller was diagnosed with colitis and GI bleed; Rectal bleeding; Ileus; Colitis; This is a spontaneous report from a contactable nurse. A 74-year-old female patient received first dosr of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6198; Expiration Date: Jun2021),via an unspecified route of administration, administered on left arm on 24Feb2021 12:59 at the age of 74 years-old at single dose for COVID-19 immunisation.  Medical history included regurge, diverticulosis, haemochromatosis, gingivitis, eczema, asthma, allergy to latex, bone density, polyps and did have an ileus 12 or 13 years ago and this one is in the same place. Concomitant medications included methylcellulose (CITRUCEL) taken for polyps; aluminium hydroxide gel, dried, magnesium carbonate (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) taken for regurgitation; calcium carbonate, colecalciferol, vitamin k nos (CITRACAL [CALCIUM CARBONATE;COLECALCIFEROL;VITAMIN K NOS]) taken for bone density.  The states she received the first dose of the Pfizer COVID vaccine on 24Feb2021, 24 hours later she experienced a GI bleed. Caller states she couldn't go to the bathroom at first and had dry heaves for two hours and then it resolved when she passed bright red blood and laid down. She then went to the emergency room and they did a CAT scan and diagnosed her with an ileus and colitis. She was also given two antibiotics and she is scheduled for a colonoscopy. By 1500 she started to have rectal bleeding; she saw the blood because it burst. She went to the emergency room that evening and they did a CAT scan that showed the ileus was swollen from infection so they put her on antibiotics. One of the doctors said something in her gut was out of balance. She chose not to be admitted to the hospital. She was treated with Cipro and Flagyl. Today she is still tender but she is passing soft stool and everything seems to be normal and she is eating low residue diet. She is scheduled to received the next dose of the vaccine on 17Mar2021. She is asking if the ileus is an effect of the shot and mentioned she did have an ileus 12 or 13 years ago and this one is in the same place. The outcome of events was unknown.; Sender's Comments: Based on the information provided, and on plausible temporal association,  the Company  assessed that a reasonable possibility could not be completely excluded that the reported events were related to the  PFIZER-BIONTECH COVID-19 VACCINE. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Malaise, Night sweats
Clinical narrative: felt very weak; tired; couldn't keep food down, vomiting even after water; diarrhea; night sweats; runny nose; COVID-19 antibody test negative; lost 20 pounds; felt ill; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as "age: 69; unit: unknown") received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 12Feb2021 (batch/lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose on 12Feb2021 and felt ill for 3 weeks later (Mar2021). She felt very weak and tired on unspecified date. She couldn't keep food down, vomiting even after water. She had diarrhea, night sweats and had to change her clothes and sheets. She has lost 20 pounds and experienced a runny nose. She is finally getting some energy back. She went to receive her second dose of the vaccine, but the clinic told her to get an antibody test.  Her antibody test came back negative. The patient was recovering from being tired; outcome of the rest of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, Vomiting, Weight
Clinical narrative: felt very weak; tired; couldn't keep food down, vomiting even after water; diarrhea; night sweats; runny nose; COVID-19 antibody test negative; lost 20 pounds; felt ill; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as "age: 69; unit: unknown") received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 12Feb2021 (batch/lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose on 12Feb2021 and felt ill for 3 weeks later (Mar2021). She felt very weak and tired on unspecified date. She couldn't keep food down, vomiting even after water. She had diarrhea, night sweats and had to change her clothes and sheets. She has lost 20 pounds and experienced a runny nose. She is finally getting some energy back. She went to receive her second dose of the vaccine, but the clinic told her to get an antibody test.  Her antibody test came back negative. The patient was recovering from being tired; outcome of the rest of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: felt very weak; tired; couldn't keep food down, vomiting even after water; diarrhea; night sweats; runny nose; COVID-19 antibody test negative; lost 20 pounds; felt ill; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as "age: 69; unit: unknown") received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 12Feb2021 (batch/lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose on 12Feb2021 and felt ill for 3 weeks later (Mar2021). She felt very weak and tired on unspecified date. She couldn't keep food down, vomiting even after water. She had diarrhea, night sweats and had to change her clothes and sheets. She has lost 20 pounds and experienced a runny nose. She is finally getting some energy back. She went to receive her second dose of the vaccine, but the clinic told her to get an antibody test.  Her antibody test came back negative. The patient was recovering from being tired; outcome of the rest of the events was unknown.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, SARS-CoV-2 test
Clinical narrative: lost vision of half of right eye; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is the 1st of 2 reports.   A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 08Feb2021 at 10:40 (pending clarification) (at the age of 74years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 intramuscular (left arm) on 18Jan2021 10:00 (at the age of 74years) for Covid-19 immunization. Medical history included high pressure, high sugar, and liver disorder; all from an unknown date and unknown if ongoing; no known allergies. Concomitant medications included nadolol, lisinopril, and metformin; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021 at 11:00am, 20 minutes after getting the shot, the patient experienced "lost vision of half of right eye" that lasted a few minutes. There was no treatment received for the adverse event. The patient was tested for Covid post vaccination (nasal swab) on 02Mar2021 with negative result. The outcome of event was recovered with sequel (also reported as recovered with lasting effects).  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021291774 same reporter, drug and event, different patient.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysgeusia, Headache, Nausea
Clinical narrative: tunnel vision; Nausea; dizziness; feeling weak; headache; metallic taste in mouth; left arm/leg pain; left arm/leg pain; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 11Mar2021 11:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included premenstrual dysphoric disorder (Pmdd), major depression (mdd), anxiety, high cholesterol and allergies: Penicillin, all from an unknown date and unknown if ongoing. No COVID prior vaccination and not COVID tested post vaccination. The patient is vaccinated at a clinic. No other vaccine in four weeks. Other medications reported was yes, however unspecified. It was reported that the patient experienced Nausea, dizziness, tunnel vision, feeling weak, headache, metallic taste in mouth, left arm/leg pain all on 12Mar2021. The outcome of the events was not recovered. No treatment for the events.   Information on the lot/ batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tunnel vision
Clinical narrative: tunnel vision; Nausea; dizziness; feeling weak; headache; metallic taste in mouth; left arm/leg pain; left arm/leg pain; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 11Mar2021 11:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included premenstrual dysphoric disorder (Pmdd), major depression (mdd), anxiety, high cholesterol and allergies: Penicillin, all from an unknown date and unknown if ongoing. No COVID prior vaccination and not COVID tested post vaccination. The patient is vaccinated at a clinic. No other vaccine in four weeks. Other medications reported was yes, however unspecified. It was reported that the patient experienced Nausea, dizziness, tunnel vision, feeling weak, headache, metallic taste in mouth, left arm/leg pain all on 12Mar2021. The outcome of the events was not recovered. No treatment for the events.   Information on the lot/ batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Vaginal haemorrhage
Clinical narrative: Miscarriage; spotting; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at right deltoid on 04Feb2021 at single dose for COVID-19 immunization. Medical history was reported as none. She has no known allergies and has no COVID prior to vaccination. Concomitant medications included folic acid, iron (PRENATAL) and fluoxetine. The patient has no other vaccine in four weeks. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231) at the age of 31-years-old, intramuscular at right arm on 14Jan2021 at 12:30 at single dose for COVID-19 immunization. The vaccine was administered in a hospital. The patient was pregnant, her last menstrual period was on 19Dec2020. Her expected due date is on 25Sep2021 and gestational period was 7 weeks (also reported as 3). The patient experienced miscarriage and spotting on 09Feb2021 which resulted in doctor or other healthcare professional office/clinic visit. She was not tested for COVID post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of  miscarriage and vaginal hemorrhage  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Fatigue, Hypertension, SARS-CoV-2 test
Clinical narrative: Had one fainting episode; Very tired; low energy (it has been almost 3 weeks); problems with high blood pressure; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on 02Feb2021 16:00 as a single dose for covid-19 immunisation. Medical history included hypertension and PCN allergies (penicillin allergy). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive other vaccine in four weeks. Concomitant medication included unspecified medication. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on Jan2021 15:15 as a single dose for covid-19 immunization. On 25Feb2021 06:00 PM, the patient was very tired, low energy (it has been almost 3 weeks), had one fainting episode though the patient doesn't know if it was related, and problems with high blood pressure. The fainting episode is reported, the other problems have been ongoing since second shot. The events required emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood pressure was high on 25Feb2021 and nasal swab (sars-cov-2 test) was negative on 22Feb2021. The outcome of the events was recovering.   Information on the lot/batch number for first dose has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Had one fainting episode; Very tired; low energy (it has been almost 3 weeks); problems with high blood pressure; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on 02Feb2021 16:00 as a single dose for covid-19 immunisation. Medical history included hypertension and PCN allergies (penicillin allergy). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive other vaccine in four weeks. Concomitant medication included unspecified medication. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), at vaccination age of 73-year-old via an unspecified route of administration in the left arm on Jan2021 15:15 as a single dose for covid-19 immunization. On 25Feb2021 06:00 PM, the patient was very tired, low energy (it has been almost 3 weeks), had one fainting episode though the patient doesn't know if it was related, and problems with high blood pressure. The fainting episode is reported, the other problems have been ongoing since second shot. The events required emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood pressure was high on 25Feb2021 and nasal swab (sars-cov-2 test) was negative on 22Feb2021. The outcome of the events was recovering.   Information on the lot/batch number for first dose has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: I have lost some of my hearing in the same side that I got the vaccine; This is a spontaneous report received from a contactable consumer (patient herself). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 06Mar2021 16:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 07Mar2021, the patient reported that she lost some of her hearing in the same side that she got vaccinated. The patient reported that she visited the clinic due to the event. Treatment received was reported as yes. The outcome of the event was not resolved.  Information about lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Thrombosis
Clinical narrative: Blood clot; Unable to use arm at all; This is a spontaneous report from a contactable consumer (patient, self-reported). A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, in arm left, on 09Mar2021 02:15 AM, as single dose for COVID-19 immunization. Patient's medical history included Fibromyalgia. Concomitant medications were not reported. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Patient did not receive other vaccine in four weeks of vaccination. On an unknown date in Mar2021, patient had Blood clot and patient was unable to use arm at all. Patient resulted in Emergency room/department or urgent care, Disability or permanent damage in Mar2021. Patient did not receive treatment for adverse events. Seriousness of the events reported as hospitalization and disability. Outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Sedation, Tinnitus
Clinical narrative: hearing loss; Tinnitus in left ear/Crackling sound and ringing in ear; dullness; This is a spontaneous report from a contactable consumer (reporting for herself). A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204, expiration date: unknown), via an unspecified route of administration in left arm on 05Mar2021 at 14:00 as SINGLE DOSE for COVID-19 immunization. The patient's medical history included Crohn's Disease, anxiety, and penicillin allergy. Concomitant medication included amitriptyline and celecoxib (CELEXA), both for unspecified indication. On 07Mar2021, the patient experienced tinnitus in left ear, crackling sound and ringing in ear, dullness and some hearing loss. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: woke up with a blood clot lying in her mouth; This is a spontaneous report from a contactable consumer (patient's parent). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her first dose of the Pfizer COVID-19 vaccine yesterday (13Mar2021), and this morning (14Mar2021) she woke up with a blood clot lying in her mouth. The reporter wanted to know if this side effect had been reported or of this could be associated with the Pfizer COVID-19 vaccine. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Slight left side face and lip droop; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6199), via an unspecified route of administration in left arm on 05Mar2021 08:00 as single dose for COVID-19 immunization. Patient had COVID prior vaccination. The patient had no known allergies and no other medical history. The patient was not pregnant. There were no concomitant medications. There were no other vaccine in four weeks and no other medications in two weeks. The patient experienced slight left side face and lip droop on 05Mar2021 09:30. There was no treatment for the event. The patient was not COVID tested post vaccination. The outcome of the event was not recovered.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Vaginal bleeding/spotting in menopause; Vaginal bleeding/spotting in menopause; This is a spontaneous report from a contactable consumer (patient). A 50-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration administered in left arm on 03Mar2021 14:45 as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no COVID prior to vaccination. The patient previously took lavender creams and experienced allergy. On 06Mar2021 at 03:30 PM, the patient experienced vaginal bleeding/spotting in menopause. There was no treatment received for the events. The patient underwent lab tests and procedures which included COVID test (nasal swab) which was negative on 05Mar2021. On an unspecified date, the patient recovered from the event.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: Minor heart flutter; This is a spontaneous report from a contactable consumer.  A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 43-years-old via an unspecified route of administration, administered in arm left on 10Mar2021 19:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included allergies: sulpha drugs from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient experienced minor heart flutter on 10Mar2021 20:30. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 24Jan2021 (covid test type post vaccination Nasal Swab). The patient recovered from the event on an unspecified date in Mar2021.  Information on batch/lot number has been requested.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report from a contactable consumer. A 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE  (at age of 84 years old) for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced heart attack on an unspecified date within 15 minutes after taking the Pfizer COVID-19 vaccine. Outcome of the event heart attack was unknown.