chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: little bit fever and chills at night; little bit fever and chills at night; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for 3 patients. This is the 2nd of 3 reports. This female consumer reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced little bit fever and chills at night. The outcome of the events was reported as resolved on an unknown date.  Information about lot/batch number has been requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Pain, Rash, Swelling face
Clinical narrative: Her body, was the rash in her legs, by the knee and all joints is given a pain and she have it on the back, her back is all rash, her legs all rash and her face is just swollen.; The rash is stopped right away but her face is still swollen.; She loose 8 pounds within two weeks because of after, she fell sick.; The pain is just after the first vaccine and it gets worse, after the second one.; Her body, was the rash in her legs, by the knee and all joints is given a pain and she have it on the back, her back is all rash, her legs all rash and her face is just swollen.; She loose 8 pounds within two weeks because of after, she fell sick.; This is a spontaneous report received from a contactable consumer. This consumer (mother) reported for a 16-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0172) via an unspecified route of administration on 24Apr2021 (at the age of 16-year old) as dose 1, single for COVID-19 immunization. Relevant medical history was reported as none. The patient's concomitant medications were not reported. It was mentioned that patient did not receive other products and no investigation assessment was done. On an unknown date in Apr2021 the patient had a problem with vaccine, reporter just thought that this was because of the vaccine but after the second one it got worse. She had rash in her legs, by the knee and all joints had pain and she had it on the back, her back was all rash, her legs all rash and her face was just swollen. The rash had stopped right away but her face was still swollen. Reporter stated that she lost 8 pounds within two weeks after, she fell sick. Right after her first vaccine, about a week after patient start facing pain in her joints. The pain was just after the first vaccine and it got worse, after the second one. When probed for lab test: Reporter stated, she had not yet got them and was going to go tomorrow, because two weeks ago, the doctor said, it was allergy and was prescribed Zyrtec and Benadryl. It did not work so that was why they going to do blood work tomorrow because she took her again. It was mentioned that patient received Zyrtec one in the morning and Benadryl one in the night but she took like 3 days and it gave her headache (Further not clarify hence not captured as event) so she start taking it the other, she does not take it. The reported took her again and doctor took her blood to see what was wrong because they could not really tell, what could be better. The reporter mentioned that her daughter was a completely normal kid and after this vaccine just everything had become like another world.  The split case was identified after the call hence no further relevant information for the patients could be probed. Limited information was available over the call.  Follow-up attempts were completed. No further information was expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Her body, was the rash in her legs, by the knee and all joints is given a pain and she have it on the back, her back is all rash, her legs all rash and her face is just swollen.; The rash is stopped right away but her face is still swollen.; She loose 8 pounds within two weeks because of after, she fell sick.; The pain is just after the first vaccine and it gets worse, after the second one.; Her body, was the rash in her legs, by the knee and all joints is given a pain and she have it on the back, her back is all rash, her legs all rash and her face is just swollen.; She loose 8 pounds within two weeks because of after, she fell sick.; This is a spontaneous report received from a contactable consumer. This consumer (mother) reported for a 16-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0172) via an unspecified route of administration on 24Apr2021 (at the age of 16-year old) as dose 1, single for COVID-19 immunization. Relevant medical history was reported as none. The patient's concomitant medications were not reported. It was mentioned that patient did not receive other products and no investigation assessment was done. On an unknown date in Apr2021 the patient had a problem with vaccine, reporter just thought that this was because of the vaccine but after the second one it got worse. She had rash in her legs, by the knee and all joints had pain and she had it on the back, her back was all rash, her legs all rash and her face was just swollen. The rash had stopped right away but her face was still swollen. Reporter stated that she lost 8 pounds within two weeks after, she fell sick. Right after her first vaccine, about a week after patient start facing pain in her joints. The pain was just after the first vaccine and it got worse, after the second one. When probed for lab test: Reporter stated, she had not yet got them and was going to go tomorrow, because two weeks ago, the doctor said, it was allergy and was prescribed Zyrtec and Benadryl. It did not work so that was why they going to do blood work tomorrow because she took her again. It was mentioned that patient received Zyrtec one in the morning and Benadryl one in the night but she took like 3 days and it gave her headache (Further not clarify hence not captured as event) so she start taking it the other, she does not take it. The reported took her again and doctor took her blood to see what was wrong because they could not really tell, what could be better. The reporter mentioned that her daughter was a completely normal kid and after this vaccine just everything had become like another world.  The split case was identified after the call hence no further relevant information for the patients could be probed. Limited information was available over the call.  Follow-up attempts were completed. No further information was expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid Positive; Covid Positive; This is a spontaneous report from a contactable other hcp.   A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248), via intramuscular route, administered in left arm on 02Feb2021 15:30 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received other vaccine in four weeks. It was unknown if patient had covid prior vaccination. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE via intramuscular route, administered in left arm on 14Jan2021 15:30 as DOSE 1 single for covid-19. On 07Jul2021, the patient was covid positive. On 07Jul2021, the patient underwent sars-cov-2 nasal swab test which was positive. The outcome of the event was not recovered.; Sender's Comments: Based on the reported information, a causal association between the reported events of vaccination failure, covid-19 and suspect drug bnt162b2 cannot be excluded.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: The pain is just after the first vaccine and it gets worse, after the second one; 2-3 weeks before I took her to the doctor she didn't feel better; This is spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 16-year-old female patient that: A 16-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EW0168), via an unspecified route of administration on 15May2021 (at the age of 16-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EW0172), via an unspecified route of administration on 24Apr2021 (at the age of 16-year-old) as DOSE 1, SINGLE FOR COVID-19 immunisation and experienced the events the pain is just after the first vaccine, her body was the rash in her legs, by the knee and she have it on the back, her back was all rash, her legs all rash, knee and all joints was given a pain, she lose 8 pounds within two weeks, her face was just swollen and she fell sick. Patient's mother reported patient experienced pain was just after the first vaccine and it gets worse, after the second one and 2-3 weeks before I took her to the doctor, she did not feel better on unspecified date on 2021, so I took her again for blood work because I never had this. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a non-contactable consumer (patient) or other non HCP.  An adult non-pregnant female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on 26Mar2021 as dose 2, single for COVID-19 immunisation was in doctor's office/urgent care. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), administered on an unknown date as  dose 1 single for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. On 06Jul2021, the patient tested positive for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included nasal swab: positive on 06Jul2021.Therapeutic measures were taken as a result of tested positive for COVID-19. Outcome of the events was resolving.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID; diagnosed with COVID; This is a spontaneous report form a contactable consumer. This consumer reported for a 5-decade-old (mid 40's) patient of an unspecified gender, who received both doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection); dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single; and received dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single; both for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that reporter have a friend who has two patients, mid 40's, with no underlying health issues, fully vaccinated with the Pfizer product for over 2 months who have recently been diagnosed with COVID on an unspecified date. On a unknown date, after vaccination, patient experienced COVID and drug ineffective. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was reported as unknown.  Information on batch/Lot number was not received. Further information has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021873180 same drug/event/reporter, different patient
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: I had the second shot. I have been having heart problems; This is a spontaneous report from a Pfizer sponsored program . A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number was not provided) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took BNT162B2 for COVID-19 immunization and experienced no adverse event. It was reported that on an unspecified date patient had heart problems. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Loss of personal independence in daily activities
Clinical narrative: severe chills and fatigue; severe chills and fatigue; I was bed ridden unable to get up or eat for 5 days; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) for covid-19 immunization. On an unspecified date, the patient experienced severe chills and fatigue and i was bed ridden unable to get up or eat for 5 days. She wanted to thank for vaccine efforts and did not doubt it is saving lives. The patient stated that after receiving her 2nd shot, she experienced severe chills and fatigue and was bed ridden unable to get up or eat for 5 days. She experienced severe chills that lasted for 10 days and had moderate chills for 3 weeks. This is called a normal side effect. She further stated that you are obtaining approval for a 3rd round and she was seriously questioning her participation for a 3rd time. The clinical outcome of the events was unknown.  Information about Lot/Batch number is requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: 5 days & nights of 102.7 fever; Chills; Bursting headache; Muscle & joint pain; Muscle & joint pain; Patient lost all feeling in fingers and toes; Fatigue; Serious illness after traveling; This is a spontaneous report from a contactable consumer or non-health care professional (the patient). A patient with unspecified age and gender received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot number/Expiration date: not reported) via an unspecified route of administration on 27Apr2021 as second dose, single for COVID-19 immunisation. Patient medical history included pneumonia and unspecified viral or bacterial infection from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 on an unspecified date via unspecified route of administration as first dose, single for covid-19 immunization. After patient being fully vaccinated on 27Apr2021 as second dose, he experienced serious illness on an unspecified after traveling to attend his father-in laws memorial on 28May2021 with unmasked. 12 days later, on an unspecified date in Jun2021 patient was endured with 5 days & nights of 102.7 fever, chills, bursting headache and muscle & joint pains which exceeding any of his past viral or bacterial infection 4 days and patient had lost all feeling in his fingers and toes. The fatigue after was similar to double pneumonia that he had decades ago. Not mild symptoms. The patient underwent lab tests which included body temperature results 102.7 degrees. Outcome of the event's serious illness, chills, bursting headache, had lost all feeling in his fingers and toes and fatigue was unknown. Fever, joint and muscle pains was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Illness, Myalgia, Pyrexia
Clinical narrative: 5 days & nights of 102.7 fever; Chills; Bursting headache; Muscle & joint pain; Muscle & joint pain; Patient lost all feeling in fingers and toes; Fatigue; Serious illness after traveling; This is a spontaneous report from a contactable consumer or non-health care professional (the patient). A patient with unspecified age and gender received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot number/Expiration date: not reported) via an unspecified route of administration on 27Apr2021 as second dose, single for COVID-19 immunisation. Patient medical history included pneumonia and unspecified viral or bacterial infection from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 on an unspecified date via unspecified route of administration as first dose, single for covid-19 immunization. After patient being fully vaccinated on 27Apr2021 as second dose, he experienced serious illness on an unspecified after traveling to attend his father-in laws memorial on 28May2021 with unmasked. 12 days later, on an unspecified date in Jun2021 patient was endured with 5 days & nights of 102.7 fever, chills, bursting headache and muscle & joint pains which exceeding any of his past viral or bacterial infection 4 days and patient had lost all feeling in his fingers and toes. The fatigue after was similar to double pneumonia that he had decades ago. Not mild symptoms. The patient underwent lab tests which included body temperature results 102.7 degrees. Outcome of the event's serious illness, chills, bursting headache, had lost all feeling in his fingers and toes and fatigue was unknown. Fever, joint and muscle pains was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: wants to know if he can take Zyrtec for his allergies; This is a spontaneous report from a Pfizer-sponsored program via Contactable male consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 04Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient wanted to know if he can take Zyrtec for his allergies on an unspecified date. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Illness
Clinical narrative: Diagnosed with shingles; Hospitalized due to sickness; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer sponsored program. A female patient of an unknown age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0175) via an unspecified route of administration on 24Apr2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient was not able to get her second dose and missed her second dose because she was hospitalized due to sickness and diagnosed with shingles, was wondering to get her second dose. This term was highlighted by the reporter. The reporter seriousness for the adverse events was reported as hospitalization. The patient was hospitalized from an unspecified date to unspecified date (as reported). She received her first dose of Pfizer Covid-19 vaccine on last Month 24Apr2021 and she was scheduled for the second dose last 15May2021, but she missed. She was not able to get her second dose because she was hospitalized due to sickness and she had shingles until now. She took it on 24Apr2021 and was trying to get back her second dose vaccine but was sick and finally diagnosed with shingles and still had them. She was wondering that she should go ahead and get my second dose. The outcome of the events was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypersensitivity, Insomnia, Pruritus, Rash
Clinical narrative: Similar to allergic/immunity response; Intense and long term hives; rash; itching; burning on neck, back of neck (top of back), chest, arms, legs; Unable to sleep; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: 8727) via an unspecified route of administration on 29Mar2021 (at the age of 60 years old) as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Known allergies was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced similar to allergic/immunity response, intense and long term hives, rash, itching, burning on neck, back of neck (top of back), chest, arms, legs, unable to sleep on 08Apr2021. Event reported as intense and long term hives, rash, itching, burning on neck, back of neck (top of back), chest, arms, legs. Similar to allergic/immunity response. Nothing at injection site or on torso or face. Unable to sleep, work, leave house. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included prednisone, antihistamines, steroid oil, EpiCeram. Since the vaccination, the patient has not tested for COVID-19. Outcome of the events were not recovered.  Follow-up attempts are completed. No further information was expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Similar to allergic/immunity response; Intense and long term hives; rash; itching; burning on neck, back of neck (top of back), chest, arms, legs; Unable to sleep; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: 8727) via an unspecified route of administration on 29Mar2021 (at the age of 60 years old) as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Known allergies was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced similar to allergic/immunity response, intense and long term hives, rash, itching, burning on neck, back of neck (top of back), chest, arms, legs, unable to sleep on 08Apr2021. Event reported as intense and long term hives, rash, itching, burning on neck, back of neck (top of back), chest, arms, legs. Similar to allergic/immunity response. Nothing at injection site or on torso or face. Unable to sleep, work, leave house. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included prednisone, antihistamines, steroid oil, EpiCeram. Since the vaccination, the patient has not tested for COVID-19. Outcome of the events were not recovered.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Pain in extremity
Clinical narrative: pain in the other hand; under my left armpit there is like a fluid building up; It does not hurt at all; This is a spontaneous report from Pfizer- sponsored program  from a contactable consumer (patient). A 56-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EW0198), via an unspecified route of administration, administered in Arm Left on an unspecified date at 4:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Patient did not take any vaccine in four weeks prior to vaccination. Patient stated that she got her first dose of vaccine yesterday (Further not clarified) at 4 o'clock and she felt fine and stuff but she just noticed a little bit ago a pain in the other hand, she got shot on the left arm and under her left armpit there was like a fluid building up under her armpit, it did not hurt at all and she stated that fluid pocket in arm pit was 3-4 inches long and couple of inches wide. She did not know if it was from the vaccine, she did not think it was there before, she did not know, it's just, she just noticed it today. Therapeutic measures were not taken due to the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Eye irritation, Hepatic enzyme
Clinical narrative: Mouth was drooping; Swollen lymph nodes; Liver enzymes were abnormally elevated; Cold sores; Arms were numbing when sleeping; Eyes were burning; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0196) via an unspecified route of administration in left arm on 27Jun2021 at 13:00 (at the age of 45-years-old) as first dose, single for COVID-19 immunization. Medical history included anemic and iron deficiency. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jun2021, the patient experienced eyes were burning at night while sleeping they started burning a few days after the vaccine. On 05Jul2021, the patient experienced liver enzymes were abnormally elevated and cold sores. On 07Jul2021, the patient experienced swollen lymph nodes. On 08Jul2021, the patient experienced mouth was drooping. On an unspecified date in Jul2021, the patient experienced arms were numbing when she was sleeping started three or four days ago and last night did not feel the numbing in her arms, she thought it has recovered completely. Patient reported that when she saw her face she thought she had a stroke and rushed to ER. She confirmed that she was not admitted. Therapeutic measures were taken as a result of mouth was drooping (bell's palsy), treatment was received as steroid and an antiviral medication. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date in 2021, computerized tomogram: do not have stroke on an unspecified date 2021, hepatic enzyme: liver enzymes were still elevated on 05Jul2021, magnetic resonance imaging: do not have stroke on an unspecified date in 2021. Patient was told at ER that she did not have a stoke and probably had Bells Palsy. The outcome of events of eyes were burning was recovered on an unspecified date in 2021, arms were numbing when sleeping was recovered on an unspecified date in Jul2021 and the outcome of events mouth was drooping, cold sores was recovering while the outcome of events swollen lymph nodes, liver enzymes were abnormally elevated was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme abnormal, Hypoaesthesia, Lymphadenopathy, Magnetic resonance imaging, Oral herpes
Clinical narrative: Mouth was drooping; Swollen lymph nodes; Liver enzymes were abnormally elevated; Cold sores; Arms were numbing when sleeping; Eyes were burning; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0196) via an unspecified route of administration in left arm on 27Jun2021 at 13:00 (at the age of 45-years-old) as first dose, single for COVID-19 immunization. Medical history included anemic and iron deficiency. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jun2021, the patient experienced eyes were burning at night while sleeping they started burning a few days after the vaccine. On 05Jul2021, the patient experienced liver enzymes were abnormally elevated and cold sores. On 07Jul2021, the patient experienced swollen lymph nodes. On 08Jul2021, the patient experienced mouth was drooping. On an unspecified date in Jul2021, the patient experienced arms were numbing when she was sleeping started three or four days ago and last night did not feel the numbing in her arms, she thought it has recovered completely. Patient reported that when she saw her face she thought she had a stroke and rushed to ER. She confirmed that she was not admitted. Therapeutic measures were taken as a result of mouth was drooping (bell's palsy), treatment was received as steroid and an antiviral medication. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date in 2021, computerized tomogram: do not have stroke on an unspecified date 2021, hepatic enzyme: liver enzymes were still elevated on 05Jul2021, magnetic resonance imaging: do not have stroke on an unspecified date in 2021. Patient was told at ER that she did not have a stoke and probably had Bells Palsy. The outcome of events of eyes were burning was recovered on an unspecified date in 2021, arms were numbing when sleeping was recovered on an unspecified date in Jul2021 and the outcome of events mouth was drooping, cold sores was recovering while the outcome of events swollen lymph nodes, liver enzymes were abnormally elevated was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a contactable consumer reported for an unknown (patient). A 5-decade-old (mid 40 s) patient of an unspecified gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single and first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as positive on an unspecified date. The patient medical history and concomitant medications were not reported. Patient with no underlying health issues, fully vaccinated with the Pfizer product for over 2 months who had recently been diagnosed with COVID. This doc wants to know whether these patients might be eligible for a follow-on trial of some sort. Further, he was interested in whether there are trials ongoing for COVID long haulers. The clinical outcome of the events was unknown.  AE/PQC e-transmitted for lack of efficacy. Response: Proposed response: Please refer caller to Clinical Trials Contact Center at (withheld) per VR. Sent SR-Topic requires further discussion due to verbal only response. Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021869132 same drug/event/reporter, different patient
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Discomfort, Fatigue, Gastric disorder
Clinical narrative: Gastric problem; She felt fast heart beat; Felt hand pain; Hand soreness; Drowsiness; Slight body discomfort; Burning sensation in the chest area; Sleeplessness; Feeling that her hands are shaking sometimes; Tiredness; Weakness; This is a spontaneous report received from pfizer sponsered program Support. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 1 via an unspecified route of administration, administered in Deltoid Left on 25Jun2021(at the age of 39 years old) (Batch/Lot Number: EW0191) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications. On 26Jun2021 the patient experienced she felt burning sensation in the chest area and then, she had, the second day and then the third day after her dose, she also on 27Jun2021 felt hand pain, drowsiness and slight body discomfort. From the fourth day until the tenth day after her first dose there were no signs of any discomfort but on eleventh day after the first dose, she said, when she lay down on the bed, after sleeping, 15 to 20 minutes after, she felt fast heart beat for a few seconds and had trouble going back to sleep and then on the twelfth day until the day, she is still feeling tiredness and weakness and she thought that maybe it is because of gastric problem and due to sleeplessness (Gastric problem and sleeplessness captured as events as per verbatim since further clarification was unknown). Also, she is feeling that her hands are shaking sometimes. Consumer further stated, Is this only have information sharing Actually, I just wanted to know what is a further procedure like whether I have to go for second vaccination dose or before that what is my condition after taking first dose. So, all these details, I thought like to share but I don't know like only just I have given details, but I did not receive any kind of guidance from this. So, I don't know what are these number first or for what I have given these number, I don't understand because in the next week I have the second dose before that I would like to check whether I have to go for second dose because I am facing now, some weakness, tiredness and something like burning sensation kind of thing in my chest area. So, whether I have to go because only one week was left and I thought I would get some information on this, whom I have to contact or where I have to go to if any investigation required. Outcome of event chest pain not recovered, for pain in extremity, drowsiness, she felt fast heartbeat, tiredness, weakness, gastric problem, sleeplessness, feeling that her hands are shaking sometimes was unknown, slight body discomfort was recovered on unspecified date.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Pain in extremity, Somnolence, Tremor
Clinical narrative: Gastric problem; She felt fast heart beat; Felt hand pain; Hand soreness; Drowsiness; Slight body discomfort; Burning sensation in the chest area; Sleeplessness; Feeling that her hands are shaking sometimes; Tiredness; Weakness; This is a spontaneous report received from pfizer sponsered program Support. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 1 via an unspecified route of administration, administered in Deltoid Left on 25Jun2021(at the age of 39 years old) (Batch/Lot Number: EW0191) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications. On 26Jun2021 the patient experienced she felt burning sensation in the chest area and then, she had, the second day and then the third day after her dose, she also on 27Jun2021 felt hand pain, drowsiness and slight body discomfort. From the fourth day until the tenth day after her first dose there were no signs of any discomfort but on eleventh day after the first dose, she said, when she lay down on the bed, after sleeping, 15 to 20 minutes after, she felt fast heart beat for a few seconds and had trouble going back to sleep and then on the twelfth day until the day, she is still feeling tiredness and weakness and she thought that maybe it is because of gastric problem and due to sleeplessness (Gastric problem and sleeplessness captured as events as per verbatim since further clarification was unknown). Also, she is feeling that her hands are shaking sometimes. Consumer further stated, Is this only have information sharing Actually, I just wanted to know what is a further procedure like whether I have to go for second vaccination dose or before that what is my condition after taking first dose. So, all these details, I thought like to share but I don't know like only just I have given details, but I did not receive any kind of guidance from this. So, I don't know what are these number first or for what I have given these number, I don't understand because in the next week I have the second dose before that I would like to check whether I have to go for second dose because I am facing now, some weakness, tiredness and something like burning sensation kind of thing in my chest area. So, whether I have to go because only one week was left and I thought I would get some information on this, whom I have to contact or where I have to go to if any investigation required. Outcome of event chest pain not recovered, for pain in extremity, drowsiness, she felt fast heartbeat, tiredness, weakness, gastric problem, sleeplessness, feeling that her hands are shaking sometimes was unknown, slight body discomfort was recovered on unspecified date.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: come down with COVID; come down with COVID; This is a spontaneous report from a contactable consumer via a sales representative. This same consumer reported for 3 patients. This report is 1st of 3.  An elderly female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. No medical history and concomitant medications were reported. On an unspecified date, after use of Pfizer vaccine, the patient come down with COVID. Event took place after use of product. The event was serious (medically significant). The reporter who reported for 3 patients, stated that all of them took the Pfizer vaccine when it became available because they were over 75 years of age. Recently three out of the eight in the group had come down with COVID. Their strain was unknown. It was believed that all were over 75 years old with co morbidities, and female. One of them had lost their husband to COVID unknown if he had been vaccinated. The patient underwent lab test which included SARS-CoV-2 test: Positive on an unspecified date. The outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021873318 Different patients, Same reporter, vaccine, event.;US-PFIZER INC-2021873319 Different patients, Same reporter, vaccine, event.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report from a contactable consumer. This report was received via a sales representative.   An elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date, as dose number unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After use of Pfizer vaccine on an unknown date, the patient came down with COVID. All of them took the Pfizer vaccine when it became available because they were over 75 years of age. Recently 3 out of the 8 in the group have come down with COVID. Their strain was unknown. Reporter believes all were over 75 years old with co morbidities. The patient underwent lab tests and procedures which included COVID-19 test: positive. event took place after use of product. Outcome of the event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021873299 Different patients, Same reporter, vaccine, event.;US-PFIZER INC-2021873319 Different patients, Same reporter, vaccine, event.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 3 out of the 8 in the group have come down with COVID; 3 out of the 8 in the group have come down with COVID; This is a spontaneous report from a contactable consumer. This consumer (Daughter) reported for her mother. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number and expiration date were unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. All of them took the Pfizer vaccine when it became available because they were over 75 years of age. Recently 3 out of the 8 in the group have come down with COVID. Their strain was unknown. Reporter believes all were over 75 years old with co morbidities. Event took place after use of product. The outcome of event was unknown. Follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021873318 Different patients, Same reporter, vaccine, event.;US-PFIZER INC-2021873299 Different patients, Same reporter, vaccine, event.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Vaccination site erythema
Clinical narrative: I was just tired; body ache; Chills; arm was kind of hurting where the injection site is and where I got the shot; like a whip over top of it and its kind of like red; arm was kind of hurting where the injection site is and where I got the shot; like a whip over top of it and its kind of like red; arm was kind of hurting where the injection site is and where I got the shot; like a whip over top of it and its kind of like red; This is a spontaneous report from a Contactable consumer (patient).   A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in arm on an unspecified date, as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date, as a single dose for covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, a next day after received vaccine (a day prior to this report (yesterday "it was 08:30 in the morning and then today), the patient felt just tired/ body ache, chills but actually patient's arm was kind of hurting where the injection site was and where patient got the shot it was like a 'whip'(Not clear and not clarified), like a whip over it now whip over the top of it and its kind of like red, it has a whip and it was kind a red in arm." Out-come of the event was unknown, at the time of this report.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I was just tired; body ache; Chills; arm was kind of hurting where the injection site is and where I got the shot; like a whip over top of it and its kind of like red; arm was kind of hurting where the injection site is and where I got the shot; like a whip over top of it and its kind of like red; arm was kind of hurting where the injection site is and where I got the shot; like a whip over top of it and its kind of like red; This is a spontaneous report from a Contactable consumer (patient).   A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in arm on an unspecified date, as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date, as a single dose for covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, a next day after received vaccine (a day prior to this report (yesterday "it was 08:30 in the morning and then today), the patient felt just tired/ body ache, chills but actually patient's arm was kind of hurting where the injection site was and where patient got the shot it was like a 'whip'(Not clear and not clarified), like a whip over it now whip over the top of it and its kind of like red, it has a whip and it was kind a red in arm." Out-come of the event was unknown, at the time of this report.  Information on Lot/Batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Higher resting heart rate/ high 70s to 80s; feeling heart pounding against chest; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (patient).   A 29-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an un-specified route of administration on 09Jul2021 (at the age of 29-year-old) as single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 09Jul2021, the patient experienced higher resting heart rate, and feeling heart pounding against chest. her resting heart rate was usually around 50s to low 60s. After 2nd dose (Pfizer Vaccine) on the day of this report (reported as today), she kept having these symptoms. her resting heart rate is now in the high 70s to 80s. Heart rate was measured using a  Watch in the same settings (sitting down, at rest, no movement). Patient was not hospitalized for the events. The outcome for the event was reported as not resolved. Device Date was 09Jul2021.  No follow-up attempts were possible; information about lot/batch number could not be obtained.