chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Eye pain, Hypoaesthesia, Injection site haemorrhage, Magnetic resonance imaging head normal
Clinical narrative: Periodic chest pain/heaviness as well as occasional shortness of breathe; Periodic chest pain/heaviness as well as occasional shortness of breathe; periodic chest pain/heaviness as well as occasional shortness of breathe; Tingly sensations in my left arm; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 09:00 at the age of 39-years-old (Batch/Lot Number: EP7533) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history was None.  There were no concomitant medications.  The patient previously took cefalexin monohydrate (KEFLEXIN) and experienced allergies. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient did not get covid prior vaccination. covid was not tested post vaccination. The patient stated she began to have tingly sensations in her left arm like it was 'asleep' from 02Apr2021. The tingly sensations started to move to her other limbs, and she went to see her neurologist (Name). He ran some test, blood work and an MRI of the Brain and no issues were found. In the last two to three weeks, she had been having periodic chest pain/heaviness as well as occasional shortness of breath from 02Apr2021. She went to the local urgent care; they did some blood test and again no issues found.Today she went to her neurologist to report her symptoms and he had made her an urgent cardiologist appointment for 3Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood test: no issues were found, MRI Brain WO: no issues were found, nerve tests: unknown results, all on an unspecified date.  The outcome of the events was not resolved.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Pain in extremity, Palpitations, Paraesthesia, Ultrasound scan
Clinical narrative: Periodic chest pain/heaviness as well as occasional shortness of breathe; Periodic chest pain/heaviness as well as occasional shortness of breathe; periodic chest pain/heaviness as well as occasional shortness of breathe; Tingly sensations in my left arm; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 09:00 at the age of 39-years-old (Batch/Lot Number: EP7533) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history was None.  There were no concomitant medications.  The patient previously took cefalexin monohydrate (KEFLEXIN) and experienced allergies. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient did not get covid prior vaccination. covid was not tested post vaccination. The patient stated she began to have tingly sensations in her left arm like it was 'asleep' from 02Apr2021. The tingly sensations started to move to her other limbs, and she went to see her neurologist (Name). He ran some test, blood work and an MRI of the Brain and no issues were found. In the last two to three weeks, she had been having periodic chest pain/heaviness as well as occasional shortness of breath from 02Apr2021. She went to the local urgent care; they did some blood test and again no issues found.Today she went to her neurologist to report her symptoms and he had made her an urgent cardiologist appointment for 3Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood test: no issues were found, MRI Brain WO: no issues were found, nerve tests: unknown results, all on an unspecified date.  The outcome of the events was not resolved.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Dyspnoea, Magnetic resonance imaging head
Clinical narrative: At the time of injection the site bled for a few minutes.  For the next following week I had sharp pains down my arm which turned into numbness that affected the fingers on my left hand.  Over the course of the next month, the numbness/tingling went on to affect both of my hands and feet.  At this point, my calf muscles in both legs begin to spasm.  The pains are worse at night.  After a month of this, I began to feel my heart racing and shortness of breath.  Currently, I am experiencing additional abdominal pain and my eyes ache.  None of my symptoms have resolved to date.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological examination, Paraesthesia
Clinical narrative: At the time of injection the site bled for a few minutes.  For the next following week I had sharp pains down my arm which turned into numbness that affected the fingers on my left hand.  Over the course of the next month, the numbness/tingling went on to affect both of my hands and feet.  At this point, my calf muscles in both legs begin to spasm.  The pains are worse at night.  After a month of this, I began to feel my heart racing and shortness of breath.  Currently, I am experiencing additional abdominal pain and my eyes ache.  None of my symptoms have resolved to date.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood test normal, Cardiac monitoring, Chest X-ray, Dyspnoea
Clinical narrative: At the time of injection the site bled for a few minutes.  For the next following week I had sharp pains down my arm which turned into numbness that affected the fingers on my left hand.  Over the course of the next month, the numbness/tingling went on to affect both of my hands and feet.  At this point, my calf muscles in both legs begin to spasm.  The pains are worse at night.  After a month of this, I began to feel my heart racing and shortness of breath.  Currently, I am experiencing additional abdominal pain and my eyes ache.  None of my symptoms have resolved to date.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Eye pain, Hypoaesthesia, Injection site haemorrhage, Magnetic resonance imaging head normal
Clinical narrative: At the time of injection the site bled for a few minutes.  For the next following week I had sharp pains down my arm which turned into numbness that affected the fingers on my left hand.  Over the course of the next month, the numbness/tingling went on to affect both of my hands and feet.  At this point, my calf muscles in both legs begin to spasm.  The pains are worse at night.  After a month of this, I began to feel my heart racing and shortness of breath.  Currently, I am experiencing additional abdominal pain and my eyes ache.  None of my symptoms have resolved to date.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Pain in extremity, Palpitations, Paraesthesia, Ultrasound scan
Clinical narrative: At the time of injection the site bled for a few minutes.  For the next following week I had sharp pains down my arm which turned into numbness that affected the fingers on my left hand.  Over the course of the next month, the numbness/tingling went on to affect both of my hands and feet.  At this point, my calf muscles in both legs begin to spasm.  The pains are worse at night.  After a month of this, I began to feel my heart racing and shortness of breath.  Currently, I am experiencing additional abdominal pain and my eyes ache.  None of my symptoms have resolved to date.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Hypersensitivity, Hypoacusis, Near death experience
Clinical narrative: I have severe allergies now because from the shot I almost died; shot made my allergies like ten times worse; I have severe allergies now because from the shot I almost died; shot made my allergies like ten times worse; I can't hear you my allergies are horrible today; Light-headed; Cough; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at 1 O'clock on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergies from an unknown date. The patient reported I'm on five different pills, I don't have them right now I didn't take up from the pharmacy yet. The patient stated, "I had to go to emergency room last night and I had a reaction to the vaccine and I have severe allergies now because from the shot I almost died. I can't hear you my allergies are horrible today. I started now with a cough, I have severe allergies and this all I had to go to hospital. I'm still like light-headed and I'm coughing too much and I never done it until I got the COVID shot. The events started couple of days after the injection. The patient further stated, "I have severe allergies and they thought I have a blood clot in my lung and I still have nothing wrong with that, my lungs and heart are fine. It's this shot the shot made my allergies like ten times worse. Now I'm in like on five different pills now." The patient reported no treatment received for the events, only thing they did is they done a test in my lung and everything is fine, my heart is fine so I'm doing pretty good. The event Cough started on 02Jun2021; other events started on unspecified date. The patient was hospitalized for the severe allergies now because from the shot she almost died. The outcome of event Cough and Light-headed was not recovered, outcome of other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test
Clinical narrative: I have severe allergies now because from the shot I almost died; shot made my allergies like ten times worse; I have severe allergies now because from the shot I almost died; shot made my allergies like ten times worse; I can't hear you my allergies are horrible today; Light-headed; Cough; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at 1 O'clock on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergies from an unknown date. The patient reported I'm on five different pills, I don't have them right now I didn't take up from the pharmacy yet. The patient stated, "I had to go to emergency room last night and I had a reaction to the vaccine and I have severe allergies now because from the shot I almost died. I can't hear you my allergies are horrible today. I started now with a cough, I have severe allergies and this all I had to go to hospital. I'm still like light-headed and I'm coughing too much and I never done it until I got the COVID shot. The events started couple of days after the injection. The patient further stated, "I have severe allergies and they thought I have a blood clot in my lung and I still have nothing wrong with that, my lungs and heart are fine. It's this shot the shot made my allergies like ten times worse. Now I'm in like on five different pills now." The patient reported no treatment received for the events, only thing they did is they done a test in my lung and everything is fine, my heart is fine so I'm doing pretty good. The event Cough started on 02Jun2021; other events started on unspecified date. The patient was hospitalized for the severe allergies now because from the shot she almost died. The outcome of event Cough and Light-headed was not recovered, outcome of other events was unknown.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Malaise, Pain in extremity, SARS-CoV-2 test
Clinical narrative: patient experienced Covid-19; feeling ill; arm soreness; COVID-19; This is a solicited report from a Non-Clinical-Study (Facilitated Collect) based on information received by Pfizer from via AbbVie (manufacturer control number: 21K-163-3734456-00):  A contactable consumer reported that a 44-year-old female received bnt162b2 (BNT162B2, Solution for injection ) intramuscularly on an unspecified date as single dose for COVID-19 vaccination and adalimumab (HUMIRA, Solution for injection in pre-filled pen) subcutaneously citrate free for psoriatic arthritis and currently discontinued. Medical history reported and concomitant medications were not reported. On unknown dates, the patient experienced feeling ILL and arm soreness. On 14Jan2021, the patient experienced COVID 19. In 2021, the COVID 19 resolved. On an unspecified date patient underwent COVID-19 test with Positive result. The outcome of events COVID-19 was recovered and for remaining events its unknown. The reporters causality for the events of feeling ill, covid 19 and arm soreness with HUMIRA was no reasonable possibility and with BNT162B2 it was not reported.  No follow-up attempts possible. No further information expected. Information about lot/batch number has been requested.; Sender's Comments: Based on the known safety profile, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Covid-19
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Breast pain, Breast tenderness, Computerised tomogram, Haemorrhagic cyst
Clinical narrative: hemorrhagic cyst; Breast pain and tenderness began after 2nd shot; Breast pain and tenderness began after 2nd shot; uterine tract infection; abdominal pain; swelling; This is a spontaneous report from a contactable consumer (patient) reported  for herself. A 57-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (also reported as on 28Mar2021, pending confirm) (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 57 years old.  Patient was not pregnant. Medical history included Colon surgery in 2017, followed by colon cancer chemotherapy in 2017- 2018, follow up CT scans performed every 6 months. CT scan on 04Apr2021 showed no observation of cyst on ovary. Historical vaccine included first dose of  COVID 19 vaccine (Brand: Pfizer; Lot number: ER8733; Vaccine location: Left arm) on 28Mar2021 11:00 AM). Concomitant medications included cetirizine hcl (CETIRIZINE HCL) 10 mg taken for an unspecified indication, start and stop date were not reported.  The patient experienced hemorrhagic cyst (medically significant), breast pain and tenderness began after 2nd shot, uterine tract infection, abdominal pain, swelling, all on 19May2021 with outcome of not recovered.  The patient underwent lab tests which included CT scan: no observation of cyst on 04Apr2021, ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder, a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm on 25May2021.  Adverse event reported as: Breast pain and tenderness began after 2nd shot and lasted approximately 30 days. On 19May2021 had symptoms of uterine tract  infection, abdominal pain, swelling. On 25May2021, primary care doctor ordered an ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder and a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm, may represent a hemorrhagic cyst. Left ovary not visualized. Followup is planned with gynecology surgeon. AE resulted in: Doctor or other healthcaremprofessional office/clinic visit. The treatment received for events included: antibiotic to treat infection. Prior to vaccination,  the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Additional information is requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Ultrasound bladder, Ultrasound kidney, Ultrasound ovary, Ultrasound uterus
Clinical narrative: hemorrhagic cyst; Breast pain and tenderness began after 2nd shot; Breast pain and tenderness began after 2nd shot; uterine tract infection; abdominal pain; swelling; This is a spontaneous report from a contactable consumer (patient) reported  for herself. A 57-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (also reported as on 28Mar2021, pending confirm) (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 57 years old.  Patient was not pregnant. Medical history included Colon surgery in 2017, followed by colon cancer chemotherapy in 2017- 2018, follow up CT scans performed every 6 months. CT scan on 04Apr2021 showed no observation of cyst on ovary. Historical vaccine included first dose of  COVID 19 vaccine (Brand: Pfizer; Lot number: ER8733; Vaccine location: Left arm) on 28Mar2021 11:00 AM). Concomitant medications included cetirizine hcl (CETIRIZINE HCL) 10 mg taken for an unspecified indication, start and stop date were not reported.  The patient experienced hemorrhagic cyst (medically significant), breast pain and tenderness began after 2nd shot, uterine tract infection, abdominal pain, swelling, all on 19May2021 with outcome of not recovered.  The patient underwent lab tests which included CT scan: no observation of cyst on 04Apr2021, ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder, a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm on 25May2021.  Adverse event reported as: Breast pain and tenderness began after 2nd shot and lasted approximately 30 days. On 19May2021 had symptoms of uterine tract  infection, abdominal pain, swelling. On 25May2021, primary care doctor ordered an ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder and a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm, may represent a hemorrhagic cyst. Left ovary not visualized. Followup is planned with gynecology surgeon. AE resulted in: Doctor or other healthcaremprofessional office/clinic visit. The treatment received for events included: antibiotic to treat infection. Prior to vaccination,  the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Additional information is requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: hemorrhagic cyst; Breast pain and tenderness began after 2nd shot; Breast pain and tenderness began after 2nd shot; uterine tract infection; abdominal pain; swelling; This is a spontaneous report from a contactable consumer (patient) reported  for herself. A 57-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (also reported as on 28Mar2021, pending confirm) (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 57 years old.  Patient was not pregnant. Medical history included Colon surgery in 2017, followed by colon cancer chemotherapy in 2017- 2018, follow up CT scans performed every 6 months. CT scan on 04Apr2021 showed no observation of cyst on ovary. Historical vaccine included first dose of  COVID 19 vaccine (Brand: Pfizer; Lot number: ER8733; Vaccine location: Left arm) on 28Mar2021 11:00 AM). Concomitant medications included cetirizine hcl (CETIRIZINE HCL) 10 mg taken for an unspecified indication, start and stop date were not reported.  The patient experienced hemorrhagic cyst (medically significant), breast pain and tenderness began after 2nd shot, uterine tract infection, abdominal pain, swelling, all on 19May2021 with outcome of not recovered.  The patient underwent lab tests which included CT scan: no observation of cyst on 04Apr2021, ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder, a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm on 25May2021.  Adverse event reported as: Breast pain and tenderness began after 2nd shot and lasted approximately 30 days. On 19May2021 had symptoms of uterine tract  infection, abdominal pain, swelling. On 25May2021, primary care doctor ordered an ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder and a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm, may represent a hemorrhagic cyst. Left ovary not visualized. Followup is planned with gynecology surgeon. AE resulted in: Doctor or other healthcaremprofessional office/clinic visit. The treatment received for events included: antibiotic to treat infection. Prior to vaccination,  the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Additional information is requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pruritus, Rash
Clinical narrative: Heart palpitations; Rash on right arm; Itching; This is a spontaneous report received from a contactable consume(patient). A 65-year-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6200, Expiration date: UNKNOWN), via an unspecified route of administration in right arm on 20Feb2021 (at the age of 65-years-old) 1ST DOSE SINGLE DOSE as single dose for COVID-19 immunization. The patient medical history is reported as none. The concomitant medications were not reported. The family medical history relevant to AE(s) was not provided by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. It was reported that no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same Date of the Pfizer Suspect. The Historical vaccine taken was first dose of BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, Batch/Lot Number: PFR, EN5318, Expiration date: UNKNOWN), via an unspecified route of administration in right arm on 28Jan2021 between 10 am and 1pm, midday, during the day(at the age of 65-years-old), and experienced a breakout of a rash on the arm where she was given the injection, it then went away and getting scabs and lesions, within 24 to 48 hours, after the first vaccine. On an unspecified date after her second dose, the patient experienced Rash on right arm and Itching, right arm and she also experienced heart palpitations on an unspecified date. The reporter reported many details, which included that she works out, eats well and is in tune with her body she is aware of the palpitations, and attributes that to the vaccine states she had read documentation that heart arrhythmia is being noted as a side effect of people who have gotten the vaccination and stated that she is unsure of the exact date, but it was close to the time of the second vaccine on 20Feb2021 she thought it would go away over time, but she is still getting palpitations, the rash as it started with the first vaccine and then went through until after the second vaccine it went away, but stayed for a good month. She wants to clarify that the rash was all the way down her arm and states she still has a little bit of the rash left on her forearm, but it is very minimal and itching after first and second vaccine, stated as approximately early evening as it is very minimal on her right arm and as it was lingering. The AE(s) did not required the visit of Emergency Room or Physician Office. The relevant tests are reported as none. The outcome of all the events was reported as resolving.  Follow-up attempts are possible. Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: Arm that hurt; I can barely move my arm, I can barely lift it, it is like a dead arm/The pain is like un-bearable; Arm that hurt; I can barely move my arm, I can barely lift it, it is like a dead arm/The pain is like un-bearable; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 29May2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient stated, I have my vaccination my second dose on Saturday, you know I have an arm that hurt but since then apparently I don't know really what happened but I can barely move my arm, I can barely lift it, it is like a dead arm. I do go to the urgent care because the pain is like unbearable. The events occurred on 30May2021; outcome of events was unknown.  Information about batch/lot number has been requested
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Hyperhidrosis, Hypoaesthesia
Clinical narrative: violently ill; nausea; sick; very dizzy with flu symptoms; grogginess and extreme exhaustion; arm got numb; grogginess and extreme exhaustion; arms were getting  weaker and weaker; weak; sweat; dizzy, weak, sweats; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Apr2021 (at 51-year-old) (Batch/Lot number was not reported) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included ongoing chronic back pain (diagnosed for years), and ongoing type 1 diabetes mellitus. The patient's concomitant medication was not reported. After the first dose, date unknown, he got violently ill, stated literally he got ill at the center where he got the vaccine, he was weak, started to sweat, the medical people there were a little concerned they held him there for an additional amount of time for observation after the first vaccine. He was very dizzy. (event weak, sweat and dizzy onset 24Apr2021 03:00 as reported) He went home and he was very nausea and sick, at 23:00 he laid down and slept all day until the next day. He woke up on the third day very dizzy with flu symptoms, but was able to get up and get moving and was getting better, after about a week during the four weeks between the two doses started calling doctor telling them something was wrong, got over the first three days and then the grogginess came back extreme exhaustion, noticed every night in bed if he curled up in bed or brought arms up or like now if he has arm up to his ear on the phone his arm got numb immediately. Arms went within a minute. The doctor and nurse practitioner doubted this was lingering side effects, progressively his arms were getting weaker and weaker, he was getting weaker and weaker as a person. MRI and rheumatology (lymes, MS, lupus) showed negative. The outcome of the events violently ill and arm numb was not resolved; of events weak, sweat, dizzy, nausea, sickness, flu symptoms, exhaustion, groggy and weakness of arms was unknown. The events under second dose referred to case 2021648178.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza, Magnetic resonance imaging, Malaise, Muscular weakness
Clinical narrative: violently ill; nausea; sick; very dizzy with flu symptoms; grogginess and extreme exhaustion; arm got numb; grogginess and extreme exhaustion; arms were getting  weaker and weaker; weak; sweat; dizzy, weak, sweats; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Apr2021 (at 51-year-old) (Batch/Lot number was not reported) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included ongoing chronic back pain (diagnosed for years), and ongoing type 1 diabetes mellitus. The patient's concomitant medication was not reported. After the first dose, date unknown, he got violently ill, stated literally he got ill at the center where he got the vaccine, he was weak, started to sweat, the medical people there were a little concerned they held him there for an additional amount of time for observation after the first vaccine. He was very dizzy. (event weak, sweat and dizzy onset 24Apr2021 03:00 as reported) He went home and he was very nausea and sick, at 23:00 he laid down and slept all day until the next day. He woke up on the third day very dizzy with flu symptoms, but was able to get up and get moving and was getting better, after about a week during the four weeks between the two doses started calling doctor telling them something was wrong, got over the first three days and then the grogginess came back extreme exhaustion, noticed every night in bed if he curled up in bed or brought arms up or like now if he has arm up to his ear on the phone his arm got numb immediately. Arms went within a minute. The doctor and nurse practitioner doubted this was lingering side effects, progressively his arms were getting weaker and weaker, he was getting weaker and weaker as a person. MRI and rheumatology (lymes, MS, lupus) showed negative. The outcome of the events violently ill and arm numb was not resolved; of events weak, sweat, dizzy, nausea, sickness, flu symptoms, exhaustion, groggy and weakness of arms was unknown. The events under second dose referred to case 2021648178.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Rheumatological examination, Somnolence
Clinical narrative: violently ill; nausea; sick; very dizzy with flu symptoms; grogginess and extreme exhaustion; arm got numb; grogginess and extreme exhaustion; arms were getting  weaker and weaker; weak; sweat; dizzy, weak, sweats; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Apr2021 (at 51-year-old) (Batch/Lot number was not reported) as 1st dose, single in arm left for COVID-19 immunisation. Medical history included ongoing chronic back pain (diagnosed for years), and ongoing type 1 diabetes mellitus. The patient's concomitant medication was not reported. After the first dose, date unknown, he got violently ill, stated literally he got ill at the center where he got the vaccine, he was weak, started to sweat, the medical people there were a little concerned they held him there for an additional amount of time for observation after the first vaccine. He was very dizzy. (event weak, sweat and dizzy onset 24Apr2021 03:00 as reported) He went home and he was very nausea and sick, at 23:00 he laid down and slept all day until the next day. He woke up on the third day very dizzy with flu symptoms, but was able to get up and get moving and was getting better, after about a week during the four weeks between the two doses started calling doctor telling them something was wrong, got over the first three days and then the grogginess came back extreme exhaustion, noticed every night in bed if he curled up in bed or brought arms up or like now if he has arm up to his ear on the phone his arm got numb immediately. Arms went within a minute. The doctor and nurse practitioner doubted this was lingering side effects, progressively his arms were getting weaker and weaker, he was getting weaker and weaker as a person. MRI and rheumatology (lymes, MS, lupus) showed negative. The outcome of the events violently ill and arm numb was not resolved; of events weak, sweat, dizzy, nausea, sickness, flu symptoms, exhaustion, groggy and weakness of arms was unknown. The events under second dose referred to case 2021648178.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: having a problem since I got the vaccine with keeping my balance; I kept loosing my balance; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having a problem since I got the vaccine with keeping my balance; I kept loosing my balance. The patient had a problem since got the vaccine with keeping patient balance. It was reported that patient received second dose on 02Mar2021. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: area around the shot got very red and hot.; area around the shot got very red and hot; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced area around the shot got very red and hot area around the shot got very red and hot on an unspecified date. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: running a fever yesterday; This is a spontaneous report from a contactable consumer (reporting on herself). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration on 23May2021 as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Previously patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02May2021 for COVID-19 immunization. It was reported that a patient received first dose of Pfizer's COVID vaccine on 02May2021 and the second dose on 23May2021. She was running a fever yesterday (on 02Jun2021) and it is gone today (on 03Jun2021). Asking does she need to quarantine because she was out of town and does she need to test for COVID if she had the fever yesterday (on 02Jun2021). Patient asking if the vaccine was good for 6 months. What are the 6 months top line analysis results of the Pfizer-BioNTech COVID-19 Vaccine. The outcome of the event was recovered on 03Jun2021.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Polymenorrhoea, Premenstrual syndrome, Tinnitus
Clinical narrative: Migraine Headaches; Shortened Menstrual Cycle; PMS; Ear Ringing/Tinnitus; This is a spontaneous report from a non-contactable consumer (patient). A 33-years-old female patient received First dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: ER8734 and Expiration date: unknown) via an unknown route of administration, in left arm on 31Mar2021 at 15:45 as single dose, second dose via an unknown route of administration, in left arm on 22Apr2021 at 17:15 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. Medical history included Tear Duct Clog as a Child and had Surgery to unblock both tear ducts as at the age of 4 and Heightened Local reactions to Beestings and those alike. Concomitant medications included alprazolam (ALPRAZOLAM) and methylphenidate (METHYLPHENIDATE). Patient was not tested positive for covid prior vaccination. Patient has not received other vaccine in four weeks. On an unknown date in Apr2021, the patient experienced migraine headaches (never experienced previously) began as gradual, now debilitating. Onset same time each day, shortened menstrual cycle followed by extreme PMS symptoms: Hot flashes, mood swings, extreme fatigue, brain fog. Also ear ringing/tinnitus, consistent ringing in the ears throughout the day, gradually builds throughout the day. Subsides after sleeping. Patient was not tested covid positive post vaccination. No treatment was received for events. The Outcome of events Polymenorrhoea, Premenstrual syndrome and Tinnitus was not recovered wheareas outcome of event migraine was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Feeling hot, Hyperhidrosis, Insomnia
Clinical narrative: Feeling sick; He felt pressure in his hands; He also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time; He also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time; Lethargic; cant sleep night; sense of feeling of a warm oil running through his veins; He still feels terrible; This is a spontaneous report received from a contactable consumer (patient) (this is 1 of 3). A 64-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0177) intramuscularly in left deltoid on 14May2021 at 11:40 (at the of 64-years-old) as unknown, single dose for COVID-19 immunization. Medical history of the patient included COVID-19 in the first week of Sep2020. High blood pressure (after covid-19 it has been high as 200/130 and 180/120). Concomitant medication included Lisinopril (MANUFACTURER UNKNOWN), via an unspecified route of administration, from an unspecified date in Feb2021 and ongoing at unknown dose and frequency for blood pressure high. Patient had no prior Vaccinations (within 4 weeks) of COVID vaccine and had no AE(s) following prior vaccinations. On 14May2021, within an hour after vaccination, the events started, patient was not feeling well. He stayed at the pharmacy for a while to make sure there wasn't an immediate reaction. Once he got home, he wished he hadn't taken the shot. He felt pressure in his hands; he already felt comprised. Events were still ongoing but are at different times of the day, they were happening off and on throughout the day. Patient also gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time. After three weeks of vaccination patient was still feeling sick, lethargic, could not sleep at night, and has a sense of feeling of a warm oil running through his veins. Patient went to his medical doctor (physician office visit due to events) and he was basically sent on the way. Patient also went back to the Walmart where he got the shot and they told him there was nothing that could be done, it would just have to work through his body. Patient still feels terrible. Patient reported that it wouldn't be so bad or he wouldn't be so concerned if it wasn't already 3 weeks since having the shot. He was worried and so was his wife. The clinical outcome of the feeling sick, he felt pressure in his hands, he also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time, lethargic, cant sleep night, sense of feeling of a warm oil running through his veins, he still feels terrible were not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Nausea
Clinical narrative: Feeling sick; He felt pressure in his hands; He also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time; He also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time; Lethargic; cant sleep night; sense of feeling of a warm oil running through his veins; He still feels terrible; This is a spontaneous report received from a contactable consumer (patient) (this is 1 of 3). A 64-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0177) intramuscularly in left deltoid on 14May2021 at 11:40 (at the of 64-years-old) as unknown, single dose for COVID-19 immunization. Medical history of the patient included COVID-19 in the first week of Sep2020. High blood pressure (after covid-19 it has been high as 200/130 and 180/120). Concomitant medication included Lisinopril (MANUFACTURER UNKNOWN), via an unspecified route of administration, from an unspecified date in Feb2021 and ongoing at unknown dose and frequency for blood pressure high. Patient had no prior Vaccinations (within 4 weeks) of COVID vaccine and had no AE(s) following prior vaccinations. On 14May2021, within an hour after vaccination, the events started, patient was not feeling well. He stayed at the pharmacy for a while to make sure there wasn't an immediate reaction. Once he got home, he wished he hadn't taken the shot. He felt pressure in his hands; he already felt comprised. Events were still ongoing but are at different times of the day, they were happening off and on throughout the day. Patient also gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time. After three weeks of vaccination patient was still feeling sick, lethargic, could not sleep at night, and has a sense of feeling of a warm oil running through his veins. Patient went to his medical doctor (physician office visit due to events) and he was basically sent on the way. Patient also went back to the Walmart where he got the shot and they told him there was nothing that could be done, it would just have to work through his body. Patient still feels terrible. Patient reported that it wouldn't be so bad or he wouldn't be so concerned if it wasn't already 3 weeks since having the shot. He was worried and so was his wife. The clinical outcome of the feeling sick, he felt pressure in his hands, he also reports that he gets nauseated after eating anything, for about 20 minutes with a nauseated sweat at the same time, lethargic, cant sleep night, sense of feeling of a warm oil running through his veins, he still feels terrible were not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, HLA-B*27 positive, Headache, Joint swelling
Clinical narrative: Chronic and severe all over body ache; Muscle aches; Swollen and painful joints; Swollen and painful joints; Headache; Fatigue; Back spasms; swollen/painful lymph nodes under both armpits; swollen/painful lymph nodes under both armpits; This is a spontaneous report from a contactable consumer (patient). A 53-Year old Female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0150, on 16Mar2011 11:00 at single dose in right arm (at the age of 53-year-old) for COVID-19 immunization. Medical history included Depression, Attention deficit hyperactivity disorder (ADHD), Hashimoto's disease, Fibromyalgia, Rheumatoid disease, and known allergies Latex. Concomitant medication included unspecified medication. The patient did not receive other vaccine in four weeks. The patient received Other medications in two weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. On 17Mar2021 12:00, the patient experienced Chronic and severe all over body ache, muscle aches, swollen and painful joints, headache, fatigue, back spasms and swollen/painful lymph nodes under both armpits. She had appointment with PCP for referral to rheumatologist 09May2021. All events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for events. Lab data included HLA-B27 gene positive. The outcome of all events was not resolved.  Follow-up actions are needed. Further information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Muscle spasms, Myalgia, Pain
Clinical narrative: Chronic and severe all over body ache; Muscle aches; Swollen and painful joints; Swollen and painful joints; Headache; Fatigue; Back spasms; swollen/painful lymph nodes under both armpits; swollen/painful lymph nodes under both armpits; This is a spontaneous report from a contactable consumer (patient). A 53-Year old Female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0150, on 16Mar2011 11:00 at single dose in right arm (at the age of 53-year-old) for COVID-19 immunization. Medical history included Depression, Attention deficit hyperactivity disorder (ADHD), Hashimoto's disease, Fibromyalgia, Rheumatoid disease, and known allergies Latex. Concomitant medication included unspecified medication. The patient did not receive other vaccine in four weeks. The patient received Other medications in two weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. On 17Mar2021 12:00, the patient experienced Chronic and severe all over body ache, muscle aches, swollen and painful joints, headache, fatigue, back spasms and swollen/painful lymph nodes under both armpits. She had appointment with PCP for referral to rheumatologist 09May2021. All events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for events. Lab data included HLA-B27 gene positive. The outcome of all events was not resolved.  Follow-up actions are needed. Further information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Sleep disorder, Vaccination site erythema, Vaccination site pain
Clinical narrative: she had itching on her arm and she was rubbing it and then took the band aid off and she noticed a little rash.; she had itching on her arm and she was rubbing it and then took the band aid off and she noticed a little rash.; Caller states she was also tired and went to sleep.; Caller states she was also tired and went to sleep.; its swollen; There is a little red circle on the caller's arm.; states the pain and itching have resolved; Caller states she also got chills and she is usually cold due to being anemic and she gets chills anyway; This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 29May2021 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. Medical history included anaemia she also got chills and she was usually cold due to being anemic. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2), via an unspecified route of administration on 08May2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. On 29May2021, the patient experienced rash and itching on her arm. On an unspecified date in May2021, the patient experienced chills, was tired, went to sleep, there was a little red circle on the caller's arm and it was swollen. She stated that after the second dose they put a band aid on the site and then she had itching on her arm and was rubbing it and then took the band aid off and noticed a little rash. She also stated that she did not scratch it very hard. Caller stated the pain and itching have resolved. Caller also stated that she was also tired and went to sleep and concerned with the side effects after the second dose since she did not have side effects with the first dose like she had with the second dose. The patient also reported that she was on a blood thinner and had to sit a half hour after she received the vaccine. Outcome of the event tired, went to sleep, there was a little red circle on the caller's arm and it was swollen was unknown at the time of this report. The events chills, pain and itching was resolved on unspecified date in May2021.