chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nausea, Neck pain, Nervousness
Clinical narrative: shaky inside my body; Felt like passing out; ears feel clogged; had a hard time falling asleep; unsettled stomach ( a little queasy).; Felt pressure with slight headache; Felt pressure with slight headache/felt pressure in my head; Loud Ringing in both ears; dizzy/dizzy spell; nauseated/unsettled stomach ( a little queasy)/sick to my stomach; body felt uneasy like it was fighting something inside; pain at injection site and side of left neck; pain at injection site and side of left neck; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Mar2021 13:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included vitiligo and known allergies. The patient had no COVID prior to vaccination. There were no concomitant medications. The patient has no other vaccine in four weeks. The patient was not tested for COVID post vaccination. On 22Mar2021, the patient got the shot and later (at 18:00) had pain at injection site and side of left neck. On 23Mar2021 10:30, the patient experienced loud ringing in both ears, felt dizzy and nauseated, and body felt uneasy like it was fighting something inside. On 24Mar2021, the patient was still having ringing in both ears, feel nauseated on and of lasting at least 30 seconds or so. From 25Mar2021 to 29Mar2021, ringing in ears sometimes get louder than other times, he also felt pressure with slight headache. On 30Mar2021, ringing in ears intensified and had a hard time falling asleep. The patient felt pressure in her head. She also had slight headache and an unsettled stomach (a little queasy). On 31Mar2021, ringing seems lower today; ears feel clogged. She still has pressure in head with slight headache and had one episode of dizzy spell for a few seconds only. At night, ringing in ears intensified. On 01Apr2021, lower ringing in ears noted. On 02Apr2021, the patient had pressure in head, clogged ears, sick to her stomach, shaky inside her body, and felt like passing out. Ringing was intensified at night. On 03Apr2021, headache and pressure in head were noted. The events resulted in doctor or other healthcare professional office/clinic visit but were not treated. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Tinnitus, Vaccination site pain
Clinical narrative: shaky inside my body; Felt like passing out; ears feel clogged; had a hard time falling asleep; unsettled stomach ( a little queasy).; Felt pressure with slight headache; Felt pressure with slight headache/felt pressure in my head; Loud Ringing in both ears; dizzy/dizzy spell; nauseated/unsettled stomach ( a little queasy)/sick to my stomach; body felt uneasy like it was fighting something inside; pain at injection site and side of left neck; pain at injection site and side of left neck; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Mar2021 13:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included vitiligo and known allergies. The patient had no COVID prior to vaccination. There were no concomitant medications. The patient has no other vaccine in four weeks. The patient was not tested for COVID post vaccination. On 22Mar2021, the patient got the shot and later (at 18:00) had pain at injection site and side of left neck. On 23Mar2021 10:30, the patient experienced loud ringing in both ears, felt dizzy and nauseated, and body felt uneasy like it was fighting something inside. On 24Mar2021, the patient was still having ringing in both ears, feel nauseated on and of lasting at least 30 seconds or so. From 25Mar2021 to 29Mar2021, ringing in ears sometimes get louder than other times, he also felt pressure with slight headache. On 30Mar2021, ringing in ears intensified and had a hard time falling asleep. The patient felt pressure in her head. She also had slight headache and an unsettled stomach (a little queasy). On 31Mar2021, ringing seems lower today; ears feel clogged. She still has pressure in head with slight headache and had one episode of dizzy spell for a few seconds only. At night, ringing in ears intensified. On 01Apr2021, lower ringing in ears noted. On 02Apr2021, the patient had pressure in head, clogged ears, sick to her stomach, shaky inside her body, and felt like passing out. Ringing was intensified at night. On 03Apr2021, headache and pressure in head were noted. The events resulted in doctor or other healthcare professional office/clinic visit but were not treated. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hemiparesis
Clinical narrative: This is a spontaneous report received from a contactable pharmacist (other healthcare professional). A patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), as single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient experienced sudden one sided weakness with loss of strength that occurred 2 days after 2nd dose of vaccine and resolved one own. This resulted in a hospitalization. Outcome of the event was recovered.  Information on Lot/Batch number has been requested.; Sender's Comments: As there is limited information in the case provided for Hemiparesis the causal association between the event and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: M
Vaccine: COVID19
Symptoms: Fatigue, Haemorrhage, Pruritus, Rash, Scratch
Clinical narrative: tired; bleeding all over, over and over; He has a bad rash all over his arms, his body, his legs. He has been itching, scratching and bleeding; He has been itching; Scratching; This is a spontaneous report from a contactable consumer (the patient). An 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198; Expiration Date: 30Jun2021) via an unspecified route of administration in left arm on 26Feb2021 09:30 at single dose for COVID-19 immunisation. It was not administered at Military Facility. Medical history included diabetes, allergic to penicillin, and "Thyroid, he is not sure". No prior vaccinations within 4 weeks. No relevant family medical history relevant to AEs. Concomitant medications included metformin taken for diabetes from an unspecified start date and ongoing; simvastatin (Lot and Expiry: Did not really want to provide) taken for an unspecified indication from an unspecified date; glipizide (NDC, Lot and Expiry not reported since his medications were down stairs) taken for an unspecified indication from an unspecified start date and ongoing; metoprolol tartrate taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took Flu Vaccine (Vaccine name: Unknown) in Oct2020, route: Injection in left arm, 4 over the past 4 years, he has been getting them once a year for that long. No additional vaccines administered on same date of the Pfizer suspect. Lot and Expiry of metoprolol tartrate was not reported since his medications were down stairs and he did not want to go get them. Looked the patient was tired (onset date unknown) and then they moved on. The patient had a rash all over on his arms, body, legs. He has been itching, scratching and bleeding all over, over and over, he had bloody t-shirts, underwear, PJ's. It was nasty. He went to the (female) doctor twice already and next Monday, 05Apr2021, he has a follow-up from the last visit. This was for the rash all over and the scratching and bleeding. Caller reported he never had a bad rash this bad in his whole life. This was the worst experience he has had in his life. It also reported it had been difficult the last 2-3 weeks with this but it has improved but, still not clear. The events occurred on 05Mar2021 between 18:00 and 19:00. No relevant tests were taken. It also reported the patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207; Expiration Date: 31Jul2021) via an unspecified route of administration in left arm on 19Mar2021 at single dose for COVID-19 immunisation. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report received from a contactable physician.  A patient of unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on an unknown date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had COVID and a positive test recovered. Patient received Pfizer vaccine, first dose. Reporter enquired about the need of a second dose. Outcome of the events was recovered.  Information on lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. There was no vaccination timeline given relative to occurrence of event. Based solely on temporal relation, a causal relation between 'drug ineffective', 'Covid-19' and BNT162B2 vaccine cannot be totally excluded. This case will be re-assessed if relevant information is received.  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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back Pain; This is a spontaneous report received from a contactable consumer. A 41-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in Deltoid Left on 21Jan2021 10:00 (Batch/Lot Number: EL8982) as SINGLE DOSE for covid-19 immunization.  Medical history included ongoing allergies from 2000. Concomitant medication(s) included montelukast sodium (SINGULAIR) taken for allergies from 2005 and ongoing; levocetirizine dihydrochloride (XYZAL) taken for allergies from 2009 and ongoing.  The patient experienced back pain on 22Jan2021. No treatment received. The outcome was recovered. Seriousness criteria from reporter was not serious.   No follow up attempts are needed no further information is expected.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This is a spontaneous report received from a Pfizer sponsored program, via a contactable consumer. A 91-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Mar2021 at single dose (at 91-year-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Mar2021, patient tested positive to COVID-19 virus and experienced fever. 2nd dose would be on 10Apr2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: After she received the 1st dose, she tested positive with the virus; After she received the 1st dose, she tested positive with the virus; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via unspecified route of administration on 14Mar2021 at single dose for COVID-19 Immunization. Medical history and concomitant medications were not reported. Patient received the 1st dose of the vaccine last 14Mar2021 and she was scheduled to get the 2nd dose on 04Apr2021. After she received the 1st dose, she was tested positive with the virus. She was not sure if she should take the 2nd dose or she needs to wait. She tried to look around and she didn't find a specific answer. Patient also mentioned that she had fever for 2 days but it was gone at time of reporting. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patient tested positive for COVID-19 3 days after the first dose; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 20Jan2021 (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. On 23Jan2021, the patient tested positive for COVID-19 3 days after the first dose (medically significant). The clinical course was reported as follows: The patient's son reported that his mother had the first dose on 20Jan2021. The patient tested positive for COVID-19 on 23Jan2021, and received an antibody shot on 24Jan2021. The patient's son reported "that's why his mother was not able to get the second dose of the vaccine."  The patient underwent lab tests and procedures which included COVID-19 test: positive on 23Jan2021.  Therapeutic measures were taken as a result of the event. The clinical outcome of the event, COVID-19, was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, X-ray
Clinical narrative: started having pain in the right side of my chest when I inhaled/ pneumonia developing in my right lung; This is a spontaneous report received from a contactable consumer, the patient. This 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 14:15 (at the age of 30-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication received within 2 weeks of vaccination included birth control. On 30Mar2021, several hours later at 21:00, when she was laying down for bed, the patient started having pain in the right side of her chest when she inhaled. It got worse while laying down. It still hurt to inhale in the morning so she went to urgent care. They did an X-ray of her lungs and determined she had pneumonia developing in her right lung. The patient stated that she had not been sick prior and no fever or anything so was not sure why it came on so suddenly. The patient was treated for pneumonia with an antibiotic. The clinical outcome of pneumonia was unknown. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Pulmonary thrombosis, Thrombosis, Ultrasound Doppler
Clinical narrative: Blood clots after the 2nd dose; Blood clot split and some went into side of lung; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm, on 14Feb2021 at 15:45 (Lot Number: EL3247) (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, family history, or concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: E10142 (as reported)), in the right arm, on 24Jan2021 at 15:45 (at the age of 73-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced blood clots after the 2nd dose and blood clot split and some went into side of lung in Feb2021, which required hospitalization from 27Feb2021 to 28Feb2021. The clinical course was reported as follows: The patient stated he did not know what date the blood clots occurred and can't tell when that happened, but it was maybe a few weeks after the second dose of the vaccine. He stated that one blood clot is in the right leg near the calves and the blood clot broke and split some and went up into the side of his lung as it was detected in a doppler on 27Feb2021. The patient was hospitalized from 27Feb2021 to 28Feb2021. The doppler was performed as soon as he went into the emergency room and they went through a series of tests with unknown results on 27Feb2021 and 28Feb2021. The patient stated that the right leg is bigger than the other leg and they told him it might stay that size and may not go down. The patient is now on apixaban (ELIQUIS) 5 mg for the rest of his life. In the beginning, they gave him an unspecified shot in his stomach, then after that he began taking apixaban at two pills in the morning and two pills at night, then they cut him down to 1 pill in the morning and 1 pill in the evening, and he started it right when he went into the hospital immediately. Therapeutic measures were taken as a result of the event as aforementioned. The clinical outcome of blood clots after the 2nd dose and blood clot split and some went into side of lung was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature decreased, Chills, Dizziness
Clinical narrative: felt very faint and light headed/ felt dizzy; felt dizzy & weak; teeth chattering uncontrollably; 12 hrs after 2nd dose I woke with my teeth chattering uncontrollably; temp was 92 degrees; This is spontaneous report from a contactable Nurse. A 66-year-old female nurse reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN6201), via an unspecified route of administration, in  Left arm on 13Feb2021 at 12:00 (at the age of 66-years-old) at single dose for covid-19 immunisation.  the patient received the first dose of bnt162b2 (lot EL9263) on 23Jan2021 at 08:00 in the left arm. Medical history included arrhythmia, hypoglycaemia, osteopenia and breast cancer. Concomitant medications included magnesium citrate, vaginal estrogen and omega 3 fish oil. The patient had a history of allergy to bactrim.  Twelve hrs after 2nd dose she woke with her teeth chattering uncontrollably,  temp was 92 degrees, took acetaminophen 500mg oral, later that morning temp 99 F and no other fever reducing agent taken.  44 hours after time of vaccine administration she took a shower and felt very faint and light headed.  She removed herself from the shower and laid on the bed and called her partner who she instructed to lift her lower extremities above heart heart. She did not pass out but felt dizzy and weak. She asked him to provide her with oral juice to drink. She recovered within 1.5 hrs.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Eye discharge, Facial paralysis, Feeling hot, Swelling face
Clinical narrative: drooping of her face; swelling on her face; under her eyes it was sticky and hot/some areas on her face feel hot; under her eyes it was sticky and hot/some areas on her face feel hot; This is a spontaneous report from a non-contactable consumer. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 14:15 (at the age of 85years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 03Mar2021 in the left arm (unspecified route) for Covid-19 immunization. The patient's medical history was reported as none. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had the second dose on Wednesday (24Mar2021) and four days later (as reported) (on 28Mar2021) she has swelling on her face and drooping of her face on the left side. It was further reported that it seems to be getting better today (31Mar2021); the drooping is almost all gone but some areas on her face feel hot; under her eyes it was sticky and hot. The reported asked if it was normal, or should the patient see the doctor. The patient was given Tylenol and she seems better. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Fatigue, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: Could understand words but could not answer back; Her symptoms came out as if she was having a stroke.; Bad headache/migraine; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6207, expiry date: Jul2021), via an unspecified route of administration, administered in left arm on 19Mar2021 10:45 at single dose for COVID-19 immunization. The patient's medical history included diabetes from Jun2001 and ongoing. The patient's concomitant medication included metformin taken for diabetes from Jun2001 and ongoing. The patient previously received flu shot from immunization (she had the flu shot 20 years ago had bad reaction to). Facility where the most recent COVID-19 vaccine was administered was at the hospital. The vaccine was not administered at military facility. The patient received the vaccine on 19Mar2021 and she felt fine that Friday. On 20Mar2021 (Saturday), she started having a bad headache and took Aleve. She took Aleve 3 times 4 hours apart because she still had a bad headache. She started losing the ability to bring out words. She stated that her headache was gone. On 21Mar2021 (around 4 o clock), her husband was in the kitchen and asked her a question but could not understand her and asked again. She could not say the words but she could spell them. Her husband asked her another question, she tried to talk but she could not answer back. At that point her husband said they were going to the hospital. She was admitted for 3 days from 21Mar2021 to 23Mar2021. The doctor told her she was having a migraine because it had lasted for 2 days. She also spoke with her primary care provider, who looked it up and said this could be a side effect. She was told the migraine may take away the ability to talk. Her headache has been gone but continues to feel very tired (extremely tired since 19Mar2021). Her symptoms came out as if she was having a stroke on an unspecified date. The event 'could not understand words but could not answer back' required an emergency room visit.The patient underwent lab tests and procedures which included CAT scan, MRI, and contrast test, all with negative result on 22Mar2021. The outcome of the event 'could understand words but could not answer back' was recovered on 22Mar2021, the event 'bad headache/migraine' was recovered on 21Mar2021, not recovered for extremely tired, and unknown for the event 'stroke'.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Scan with contrast
Clinical narrative: Could understand words but could not answer back; Her symptoms came out as if she was having a stroke.; Bad headache/migraine; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6207, expiry date: Jul2021), via an unspecified route of administration, administered in left arm on 19Mar2021 10:45 at single dose for COVID-19 immunization. The patient's medical history included diabetes from Jun2001 and ongoing. The patient's concomitant medication included metformin taken for diabetes from Jun2001 and ongoing. The patient previously received flu shot from immunization (she had the flu shot 20 years ago had bad reaction to). Facility where the most recent COVID-19 vaccine was administered was at the hospital. The vaccine was not administered at military facility. The patient received the vaccine on 19Mar2021 and she felt fine that Friday. On 20Mar2021 (Saturday), she started having a bad headache and took Aleve. She took Aleve 3 times 4 hours apart because she still had a bad headache. She started losing the ability to bring out words. She stated that her headache was gone. On 21Mar2021 (around 4 o clock), her husband was in the kitchen and asked her a question but could not understand her and asked again. She could not say the words but she could spell them. Her husband asked her another question, she tried to talk but she could not answer back. At that point her husband said they were going to the hospital. She was admitted for 3 days from 21Mar2021 to 23Mar2021. The doctor told her she was having a migraine because it had lasted for 2 days. She also spoke with her primary care provider, who looked it up and said this could be a side effect. She was told the migraine may take away the ability to talk. Her headache has been gone but continues to feel very tired (extremely tired since 19Mar2021). Her symptoms came out as if she was having a stroke on an unspecified date. The event 'could not understand words but could not answer back' required an emergency room visit.The patient underwent lab tests and procedures which included CAT scan, MRI, and contrast test, all with negative result on 22Mar2021. The outcome of the event 'could understand words but could not answer back' was recovered on 22Mar2021, the event 'bad headache/migraine' was recovered on 21Mar2021, not recovered for extremely tired, and unknown for the event 'stroke'.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Bone pain, Chills, Malaise
Clinical narrative: All of the symptoms that you list from the injection site; Feeling ill; Pretty high fever; shivering so bad I couldn't even type and went home to bed; All of the pain all of the muscle and bones and all of the other in the back; All of the pain all of the muscle and bones and all of the other in the back; All of the pain all of the muscle and bones and all of the other in the back; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Mar2021 (Batch/Lot Number: EN6205) as single dose for covid-19 immunization. Medical history included blood pressure high, overweight, breast cancer and had breast cancer surgery in 2015 and went on the 5-year cancer pill (unspecified medication). Concomitant medication includes cancer pill (unspecified medication) for breast cancer. The patient stated that she had nearly all the symptoms that was listed from the injection site on Mar2021, other than that, she did not have nausea or swollen lymph nodes. About 26 hours after she took the vaccine (Mar2021), she started feeling ill and it just seem to climax to about 4 o'clock when she must say she had pretty high fever she was at work, shivering so bad she couldn't even type and went home to bed. She did take Tylenol and managed. She thinks the 4 next morning (Mar2021), she was breaking the fever but still was not able to go to work. She still felt, other than this fever was gone, she still had all of the pain, of the muscle and the bones and all of the other in the back. So, she had to stay home for two days, pretty much in the bed, the whole time. And she was looking forward to her second vaccine which was on the 24th (24Mar2021), that maybe it would not affect her or may be not too bad, but she ended up staying home again another two days. The outcome of the events muscle pain, back pain and bone pain was not recovered while the other events were unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site reaction
Clinical narrative: All of the symptoms that you list from the injection site; Feeling ill; Pretty high fever; shivering so bad I couldn't even type and went home to bed; All of the pain all of the muscle and bones and all of the other in the back; All of the pain all of the muscle and bones and all of the other in the back; All of the pain all of the muscle and bones and all of the other in the back; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Mar2021 (Batch/Lot Number: EN6205) as single dose for covid-19 immunization. Medical history included blood pressure high, overweight, breast cancer and had breast cancer surgery in 2015 and went on the 5-year cancer pill (unspecified medication). Concomitant medication includes cancer pill (unspecified medication) for breast cancer. The patient stated that she had nearly all the symptoms that was listed from the injection site on Mar2021, other than that, she did not have nausea or swollen lymph nodes. About 26 hours after she took the vaccine (Mar2021), she started feeling ill and it just seem to climax to about 4 o'clock when she must say she had pretty high fever she was at work, shivering so bad she couldn't even type and went home to bed. She did take Tylenol and managed. She thinks the 4 next morning (Mar2021), she was breaking the fever but still was not able to go to work. She still felt, other than this fever was gone, she still had all of the pain, of the muscle and the bones and all of the other in the back. So, she had to stay home for two days, pretty much in the bed, the whole time. And she was looking forward to her second vaccine which was on the 24th (24Mar2021), that maybe it would not affect her or may be not too bad, but she ended up staying home again another two days. The outcome of the events muscle pain, back pain and bone pain was not recovered while the other events were unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Pt reports feeling a little tired; This is a spontaneous report received from a spontaneous Program. A contactable other healthcare professional and a consumer (patient) reported that a 76-year-old female patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), dose 2 via an unspecified route of administration on 17Mar2021 (Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ), via an unspecified route of administration from 10Jan2021, at 5 mg tablet, cyclic for an unspecified indication. The patient previously received the first dose of COVID-19 vaccine on an unspecified date for covid-19 immunization. Patient reported a 1 week pause in tofacitinib citrate treatment as advised after her 2nd COVID vaccine on 17Mar2021. Patient reported feeling "a little tired", but could not be sure if from tofacitinib citrate or recent move back form winter home. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Drug ineffective, Pneumonia, SARS-CoV-2 test
Clinical narrative: second vaccine on 16Mar2021 and tested positive for covid on 21Mar2021.; Second vaccine on 16Mar2021 and tested positive for covid on 21Mar2021; pneumonia; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EN6200), and dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Batch/Lot Number: EN6202), both as a single dose for covid-19 immunization. The patient's medical history included blood pressure high and diabetes from an unknown date, and brain aneurysm from 2006. Patient has no family history. The patient's concomitant medications were not reported. On 21Mar2121, the patient experienced on the second vaccine on 16Mar2021 patient tested positive for covid on 21Mar2021. It was further reported that the patient took the 2 shots and the last shot was on 16Mar2021. In-between 16Mar2021 and 21Mar2021 the caller developed a cough (given Quercetin to take for it)  and went to the urgent care on 21Mar2021. From the urgent care the patient was sent to the hospital and admitted because she was covid positive. Patient was admitted in the hospital from 21Mar2021 to 23Mar2021. The patient underwent lab tests and procedures which included chest x-ray: pneumonia  on 21Mar2012 (pneumonia of left lower lobe due to infectious organisms). The outcome of the events was unknown
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Frequent bowel movements, Haematochezia, Haemorrhage, Pain in extremity, Therapeutic response unexpected
Clinical narrative: Bleeding; Blood in her stools; Volumes of regular stool/went to the bathroom 20 times; Did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool/there may be something in the vaccine that could help her Irritable Bowel Syndrome; Aching arm; This is a spontaneous report. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9267; Expiration date was not reported) on the left arm on 28Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the Health Department. Medical history included ongoing irritable bowel syndrome for over 50 years; high level of hormones; was losing hair; and had rectal bleeding from Jan2021 to an unspecified date. Concomitant medication included ongoing spironolactone from Jan2021. On 01Mar2021, the patient did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool, and mentioned that there may be something in the vaccine that helped her irritable bowel syndrome; and had aching arm. On 02Mar2021, the patient was bleeding; had blood in her stools; and had volumes of regular stool, and went to the bathroom 20 times. The patient did not receive any treatment for the reported events. The outcome of the events was unknown. The patient had received the second dose of vaccination on 28Mar2021.
Sex: F
Vaccine: PPV
Symptoms: Blood test normal, Coagulation test normal, Laboratory test normal, Pneumonia
Clinical narrative: pneumonia; pneumonia; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had a family history of pneumonia (her mom had reactions a lot). The patient's concomitant medications were not reported. The patient had received the pneumonia vaccine and afterwards got pneumonia on an unspecified date and was hospitalized for 4 weeks (28 days). She had no idea if it was related. The patient underwent lab tests and procedures which included blood works and blood clot and everything came back fine, both on an unspecified date. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, General physical condition
Clinical narrative: Mild anaphylaxis--tongue swelling as well as occlusion of airway; This is a spontaneous report received from a non-contactable other healthcare professional. A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot was unknown due to not available/provided to reporter at the time of report completion) via an unspecified route of administration on 19Mar2021 at age of 39-year-old at single dose for COVID-19 immunisation. Medical history included eczema, known allergies: Food sensitives including gluten and dairy. Rashes with prolonged skin contact with metals or adhesives. The patient's concomitant medications were not reported. No COVID prior vaccination. COVID was not tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced mild anaphylaxis-tongue swelling as well as occlusion of airway on 19Mar2021. Started about 2min after shot. Occlusion lasted for 7minutes. EMS said vitals were normal. Swollen tongue lasted 24 hours. Have never had an allergic response to any vaccine before. The events were non-serious. No treatment was received for the events. The outcome of anaphylaxis was recovered in 2021, of tongue swelling was recovered on 20Mar2021, of occlusion of airway was recovered on 19Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event anaphylaxis cannot be totally excluded.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Back pain, Chills, Fatigue, Orbital oedema
Clinical narrative: I looked in the mirror & saw my bottom right eye orbit swelled.; I had fatigue & chills the following day after i got my vaccine.; I had fatigue & chills the following day after i got my vaccine.; I took ibuprofen for the pain in my back & arm; I took ibuprofen for the pain in my back & arm; When I stared to rest, I felt pressure when opening & closing them; This is a spontaneous report from a contactable other hcp (Patient). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8737) via an unspecified route of administration at arm left on 30Mar2021 16:45 as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history was not reported. Concomitant medication included vitamin d nos (VITAMIN D NOS). On 31Mar2021 The patient experienced and had fatigue and chills the following day after she got vaccine and took ibuprofen for the pain in my back & arm and when stared to rest she felt pressure when opening & closing them and looked in the mirror & saw her bottom right eye orbit was swollen and was conserved if she was having a reaction to the vaccine and called a nurse & tell a doc. They advised me to do cold compressions & take benadryl. Therapeutic measures were taken. The outcome of the events was recovered.; Sender's Comments: The causal association between the event bottom right eye orbit was swollen and the usage of the vaccine BNT162B2 cannot be excluded based on strong temporal association. As there is limited information in the case provided, the case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I looked in the mirror & saw my bottom right eye orbit swelled.; I had fatigue & chills the following day after i got my vaccine.; I had fatigue & chills the following day after i got my vaccine.; I took ibuprofen for the pain in my back & arm; I took ibuprofen for the pain in my back & arm; When I stared to rest, I felt pressure when opening & closing them; This is a spontaneous report from a contactable other hcp (Patient). A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8737) via an unspecified route of administration at arm left on 30Mar2021 16:45 as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history was not reported. Concomitant medication included vitamin d nos (VITAMIN D NOS). On 31Mar2021 The patient experienced and had fatigue and chills the following day after she got vaccine and took ibuprofen for the pain in my back & arm and when stared to rest she felt pressure when opening & closing them and looked in the mirror & saw her bottom right eye orbit was swollen and was conserved if she was having a reaction to the vaccine and called a nurse & tell a doc. They advised me to do cold compressions & take benadryl. Therapeutic measures were taken. The outcome of the events was recovered.; Sender's Comments: The causal association between the event bottom right eye orbit was swollen and the usage of the vaccine BNT162B2 cannot be excluded based on strong temporal association. As there is limited information in the case provided, the case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased, Body mass index, Chills, Fatigue, Feeling cold
Clinical narrative: fever started. 4:30AM - fever so high I thought I could fry an egg on the tops of my thighs; chills began as I got into bed; quite cold and shaky; quite cold and shaky; Heart rate hit 100 just lying in bed; lethargy; headache; feeling slightly tired but functional; Sweaty all day; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EP7534, second dose) solution for injection intramuscular in the left arm on 20Mar2021 at 08:15 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history dyshidrotic eczema, rosacea, severe seasonal allergies (grass, tree pollen, etc), oral allergy syndrome ((raw tree-based foods, sensitive to nickel, sensitive to some nuts (almonds)), cholesterol tends to be high but is managed and sensitive to nickel. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), biotin, polycarbophil calcium (FIBER) and FLO PMS vitamin. Historical vaccine included BNT162B2 (first dose, lot EN6198, administration time 08:15AM, vaccination location: left arm) for COVID-19 vaccination on 27Feb2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Mar2021 at 23:30, the patient had fever started, chills began as got into bed, quite cold and shaky, heart rate hit 100 just lying in bed, lethargy, headache, feeling slightly tired but functional. On 20Mar2021, the patient was sweaty all day. At 4:30AM on 21Mar2021, the fever so high I thought I could fry an egg on the tops of my thighs. Lab tests included BMI of 32 at time of shot (2021). Cholesterol tends to be high but was managed on an unknown date. There was no treatment for the events fever, chills, coldness, shaky, heart rate increased, lethargy, headache, sweaty, and tiredness. The outcome of the events fever, chills, coldness, shaky, heart rate increased, lethargy, headache, sweaty, and tiredness was recovered on 23Mar2021. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up needed; further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Hyperhidrosis, Hyperpyrexia
Clinical narrative: fever started. 4:30AM - fever so high I thought I could fry an egg on the tops of my thighs; chills began as I got into bed; quite cold and shaky; quite cold and shaky; Heart rate hit 100 just lying in bed; lethargy; headache; feeling slightly tired but functional; Sweaty all day; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EP7534, second dose) solution for injection intramuscular in the left arm on 20Mar2021 at 08:15 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history dyshidrotic eczema, rosacea, severe seasonal allergies (grass, tree pollen, etc), oral allergy syndrome ((raw tree-based foods, sensitive to nickel, sensitive to some nuts (almonds)), cholesterol tends to be high but is managed and sensitive to nickel. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), biotin, polycarbophil calcium (FIBER) and FLO PMS vitamin. Historical vaccine included BNT162B2 (first dose, lot EN6198, administration time 08:15AM, vaccination location: left arm) for COVID-19 vaccination on 27Feb2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Mar2021 at 23:30, the patient had fever started, chills began as got into bed, quite cold and shaky, heart rate hit 100 just lying in bed, lethargy, headache, feeling slightly tired but functional. On 20Mar2021, the patient was sweaty all day. At 4:30AM on 21Mar2021, the fever so high I thought I could fry an egg on the tops of my thighs. Lab tests included BMI of 32 at time of shot (2021). Cholesterol tends to be high but was managed on an unknown date. There was no treatment for the events fever, chills, coldness, shaky, heart rate increased, lethargy, headache, sweaty, and tiredness. The outcome of the events fever, chills, coldness, shaky, heart rate increased, lethargy, headache, sweaty, and tiredness was recovered on 23Mar2021. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up needed; further information has been requested.