chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Hyperglycaemia, Incoherent, Mobility decreased, Off label use
Clinical narrative: Difficulty awakening; tingling to hands; difficulty standing up; difficulty with mobility; unable to answer questions; hyperglycemic; incoherent; vomiting; weakness; dizziness; increased white blood cells; increased lactate value; Concomitant medication included an unspecified vaccine given on 08Apr2021; Concomitant medication included an unspecified vaccine given on 08Apr2021; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 08Apr2021 13:45, as single dose, for COVID-19 immunization, at a hospital. Medical history included asplenic, diabetes, Ehlers-Danlos syndrome (EDS), and autism. The patient did not have COVID-19 prior to vaccination. The patient previously took gabapentin and lactose and experienced allergies. Concomitant medications included an unspecified vaccine (reported as "other vaccine") given on 08Jan2021; and other unspecified medications. On 08Apr2021 at 22:00, the patient experienced difficulty awakening, tingling to hands, difficulty standing up, difficulty with mobility, unable to answer questions, hyperglycemic, incoherent, vomiting, weakness, dizziness, increased white blood cells, and increased lactate value. These events resulted to physician's office and emergency room visits; and hospitalization for one day (unspecified date). Treatment for the events included IV fluid and IV antibiotics. The patient had COVID nasal swab on 09Apr2021 and tested negative. The patient recovered from the events on an unspecified date.  Information on batch/lot number was requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Product use issue, SARS-CoV-2 test, Somnolence, Vomiting
Clinical narrative: Difficulty awakening; tingling to hands; difficulty standing up; difficulty with mobility; unable to answer questions; hyperglycemic; incoherent; vomiting; weakness; dizziness; increased white blood cells; increased lactate value; Concomitant medication included an unspecified vaccine given on 08Apr2021; Concomitant medication included an unspecified vaccine given on 08Apr2021; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 08Apr2021 13:45, as single dose, for COVID-19 immunization, at a hospital. Medical history included asplenic, diabetes, Ehlers-Danlos syndrome (EDS), and autism. The patient did not have COVID-19 prior to vaccination. The patient previously took gabapentin and lactose and experienced allergies. Concomitant medications included an unspecified vaccine (reported as "other vaccine") given on 08Jan2021; and other unspecified medications. On 08Apr2021 at 22:00, the patient experienced difficulty awakening, tingling to hands, difficulty standing up, difficulty with mobility, unable to answer questions, hyperglycemic, incoherent, vomiting, weakness, dizziness, increased white blood cells, and increased lactate value. These events resulted to physician's office and emergency room visits; and hospitalization for one day (unspecified date). Treatment for the events included IV fluid and IV antibiotics. The patient had COVID nasal swab on 09Apr2021 and tested negative. The patient recovered from the events on an unspecified date.  Information on batch/lot number was requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: Difficulty awakening; tingling to hands; difficulty standing up; difficulty with mobility; unable to answer questions; hyperglycemic; incoherent; vomiting; weakness; dizziness; increased white blood cells; increased lactate value; Concomitant medication included an unspecified vaccine given on 08Apr2021; Concomitant medication included an unspecified vaccine given on 08Apr2021; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 08Apr2021 13:45, as single dose, for COVID-19 immunization, at a hospital. Medical history included asplenic, diabetes, Ehlers-Danlos syndrome (EDS), and autism. The patient did not have COVID-19 prior to vaccination. The patient previously took gabapentin and lactose and experienced allergies. Concomitant medications included an unspecified vaccine (reported as "other vaccine") given on 08Jan2021; and other unspecified medications. On 08Apr2021 at 22:00, the patient experienced difficulty awakening, tingling to hands, difficulty standing up, difficulty with mobility, unable to answer questions, hyperglycemic, incoherent, vomiting, weakness, dizziness, increased white blood cells, and increased lactate value. These events resulted to physician's office and emergency room visits; and hospitalization for one day (unspecified date). Treatment for the events included IV fluid and IV antibiotics. The patient had COVID nasal swab on 09Apr2021 and tested negative. The patient recovered from the events on an unspecified date.  Information on batch/lot number was requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain
Clinical narrative: Swollen lymph nodes; Internal neck pain both sides of lymph nodes; This is a spontaneous report from a contactable consumer (Patient). A 36-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201 and expiry dates were not provided), Intramuscularly administered, at arm right on 19Feb2021 11:00AM (at the time of vaccination 36-years-old), as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. The patient previously took first dose of BNT162B2 (lot number: EL9263) on 27Jan2021 05:30 PM (at the age of 36-years-old) in left arm for COVID-19 immunization. It was reported that the patient had experienced swollen lymph node on the side of her neck (one week after the 1st dose), Internal neck pain both sides of lymph nodes (2 weeks after the second dose). Patient did not receive the any treatment for both events. Outcome of the event swollen lymph node on the side of her neck was resolved with sequelae and for event Internal neck pain both sides of lymph nodes was not resolved.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: Little weak; Headache; Little bit dizzy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, Expiration date unknown), via an unspecified route of administration on 16Apr2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was also reported that she was allergic to ibuprofen. On an unknown date, the patient after getting the vaccine, had a headache, she was feeling a little bit dizzy but not too bad and a little weak. She wanted to confirm if she could take Tylenol or Ibuprofen to get relief.  The unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Pain, Pain in extremity
Clinical narrative: pain; could barely move her arm; could barely move her arm, it was very painful; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer who reported similar events for three patients. This is the first of three reports. The report is for herself.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient has pain. She could barely move her arm, it was very painful. She stated for her pain it was just for two days and the second day she was better. The outcome was unknown.    No follow-up attempts were needed. Information on Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021425740 Same reporter/drug, different patients, similar AEs;US-PFIZER INC-2021425734 Same reporter/drug, different patients, similar AEs
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock, Joint swelling, Pharyngeal swelling, Urticaria
Clinical narrative: Anaphylactic shock; Swelling of throat; hives all over back and arms; swelling of wrists; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 27Mar2021 10:15 (Batch/Lot Number: GR8732) as SINGLE DOSE for COVID-19 immunization at the workplace clinic.  Medical history included asthma allergies.  Concomitant medications were not reported.  On 27Mar2021 13:00, the patient experienced anaphylactic shock with swelling of throat, hives all over back and arms and swelling of wrists. The patient had no COVID-19 prior to vaccination and not tested post vaccination. The patient was treated with antihistamines/steroids and recovered in 2021.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: I have filler in my face and vaccine making it swelled; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient stated "I had the Pfizer, the first Pfizer vaccine. I have filler in my face and it's swelling with the filler one. It's not an Emergency." on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 07Apr2021 (at the age of 35-year-old) as single dose for COVID-19 immunization. Patient stated that she just had the date of the vaccine but not an expiration date. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient stated that she was calling to get some information and she was not sure exactly to who was she supposed to be calling. So, she took the Pfizer vaccine (Covid-19 Vaccine) on April 7 (not clarified) and on April 8, she started having side effects and I still have side effects. So, she just wanted to know, how long the side effect will last or is there anything that is given for healthcare professionals (further clarification unknown), is there anything given for side effects. On 08Apr2021 the patient experienced flu-like symptoms. Seriousness of event was not specified. NDC and UPC number was not provided. Further probing could not be initiated as consumer hung up the call abruptly. Hence, other details were unknown and limited information was available over the call. Patient declined to complete the report and stated she was at work. Reason of delay: Daily spike of incoming calls due to COVID19 vaccine. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Joint swelling, Lymphadenopathy, Swelling
Clinical narrative: Allergic reactions to lymph node, swollen around my lower part of the neck and my shoulder; Allergic reactions to lymph node, swollen around my lower part of the neck and my shoulder; Allergic reactions to lymph node, swollen around my lower part of the neck and my shoulder; Allergic reactions to lymph node, swollen around my lower part of the neck and my shoulder; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 57-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were unknown), via an unspecified route of administration, on 10Apr2021, as a single dose for COVID-19 immunization. Patient received first dose three weeks before second dose. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: ER8734 and expiry date was unknown), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization Patient's medical history and concomitant medications were not reported. The patient reported that on 12Apr2021 at night, the patient had one of the allergic reactions to lymph node. The patient had swollen around  lower part of the neck and shoulder and wanted to know how serious that was. The patient did not receive any treatment for the events. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal disorder
Clinical narrative: Problems with her nose; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is calling in regards to the COVID vaccine. Her daughter took her second shot the Monday before last. A week later, so this past Monday (2 days ago), she went to the ENT. She clarifies her daughter was having problems with her nose, but it had nothing to do with the vaccine. So, whatever is going on with her nose, her daughter's doctor put her on 60mg of Prednisone for 5 days. She wasn't there with her daughter, but her husband was, and she is pretty sure he did tell them she had the second vaccine 2 days ago, and she wasn't done with the 2 week period. Caller is wanting to know is it okay for her daughter to be taking a steroid? Will it lessen the effect of the COVID vaccine if she is taking a steroid? Treatment received as Prednisone. Outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: he had his arm swollen; This is a spontaneous report received from a Pfizer-sponsored program Support via a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical and concomitant medications were not reported. Few days after taking the 1st dose, his doctor prescribed him an antibiotic as he had his arm swollen. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Pain
Clinical narrative: Breathing was off, it was like it was raspy; Coughing; Chills; Pain throughout my body; This is a spontaneous report from a contactable consumer. This 51-year-old consumer (patient) reported that the patient has received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EW0150, Expiration date: 31Jul2021) through an unspecified route at left arm on 07Apr2021 as a single dose for COVID-19 immunization. The second dose was scheduled on 26Apr2021. The medical history included high blood pressure and asthma; concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient reported that the patient took the shot on Wednesday when patient woke up on Thursday (08Apr2021) morning breathing was off, it was like it was raspy, patient was coughing, had chills, and pain throughout body. The outcome of these events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Little bit of fever on and off; Headache; being tired comes on and off; This is a spontaneous report received from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient got the vaccine last Tuesday and still having a little bit of fever on and off, headache and being tired on an unspecified date. Mainly that was headache while fever and being tired comes on and off on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: aching in the arm for a week; Injecting the vaccine too high and it's like so much into the shoulder; Poor administration, too high up on the shoulder instead of down in the muscle; This is a spontaneous report from a contactable nurse via Pfizer-sponsored program named Pfizer. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Apr2021 (Lot Number: ER8734) as single dose for covid-19 immunisation  .  Medical history included hyperthyroidism and Pott's disease. Concomitant medication included carvedilol.  The patient experienced aching in the arm for a week, injecting the vaccine too high and it's like so much into the shoulder; it has to be do with poor administration too high up on the shoulder instead of down in the muscle. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: became positive for Covid; became positive for Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on 30Mar2021 at single dose for covid-19 immunization. Medical history was and concomitant medications were not reported. On an unspecified date, the patient was supposed to get his/her second dose of vaccine, but patient had it cancelled because patient had suspected positive last week (date not specified) and asked how long do he/she had to wait before he/she can get his/her second shot instead of fact that he/she became positive for Covid. Patient had been told 90 days. The outcome of the events was unknown.   Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feels very sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient felt very sick on Apr2021 with outcome of unknown. Patient stated that she took the vaccine and she felt very sick and could not move out of bed and asked whether this normal 4 days after receiving the vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Motion sickness
Clinical narrative: MDDS, or disembarkment syndrome; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in arm right on 06Mar2021 15:00 (at the age of 37 years old) (Lot Number: EN6206) as single dose for COVID-19 immunisation. Medical history included hay fever, depression and allergies to penicillin. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. No other vaccines were administered within four weeks. One week after (reported as 15Mar2021 12:00 AM) patient took the vaccine, she thought she had an ear infection. She went to the ear nose and throat doctor who diagnosed her with MDDS, or disembarkment syndrome, which includes constant dizziness and rocking. She has joined a support group as the symptoms have continued and worsened. She mentioned that there are a couple of other people in the group whose symptoms either started or worsened after their vaccine. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and the seriousness reported was disability or permanent damage. The patient was treated with antibiotics, steroids and physical therapy. The patient did not get tested for COVID post vaccination. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: My face is swelling a little bit of my mouth but not my throat is not swollen; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history included asthma. Concomitant medications were not reported. The patient stated "I just had the vaccine the Pfizer vaccine this morning at about 10:15 and I do have an EpiPen and I do have asthma (Intent: History) but I am now just started about 15 minutes ago having a reaction where my face is swelling a little bit of my mouth but not my throat is not swollen. Can I take like maybe a Benadryl for it or should I call 911 or what should I do?" The outcome of the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: itching; breaking out in red rash; This is a spontaneous report from a contactable consumer reported for herself. A 54-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Apr2021 (Batch/Lot Number: ER8732) as single dose for covid-19 immunisation. Patient received the first dose on unknown date. Medical history included gastrointestinal disorder, knee arthroplasty, facial paralysis, hypersensitivity, migraine. Concomitant medications included dicycloverine hydrochloride (BENTYL); duloxetine hydrochloride (CYMBALTA); pregabalin (LYRICA); sertraline hydrochloride (ZOLOFT); tamsulosin; tizanidine. The patient experienced breaking out and itching, breaking out in red rash on 12Apr2021. Outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient (babysitter), fully vaccinated since February with the Pfizer shot, was tested positive; Patient (babysitter), fully vaccinated since February with the Pfizer shot, was tested positive; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients. This is report second of two reports. This consumer reported for herself and for her babysitter. This case refers to babysitter.  A patient of an unspecified age and gender received two doses of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), both on an unspecified date, in Feb2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient had not experienced COVID-19 prior vaccination. It was reported that the 3 kids of the reporter were tested positive for COVID. The patient (babysitter), fully vaccinated since February with the Pfizer shot, was tested positive on an unspecified date, in Apr2021. Clinical outcome of the events was unknown at time of this report.   The information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021421956 same reporter/drug/event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat closed up; This is a spontaneous report from a contactable consumer(patient friend).  A female patient of an unspecified age received bnt162b2 (Pfizer Covid 19 Vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced throat closed up on her at night and she was told not to get her second vaccine on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Heart rate increased, Myalgia
Clinical narrative: I was extra tired; couldn't get out of bed; Achiness, muscle and joint pain; Achiness, muscle and joint pain; Achiness, muscle and joint pain; Light headedness; Feverish; Rapid heart rate if lifting some things, my body responded if it was very strenuous; This is a spontaneous report received from a contactable consumer (patient).  A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left shoulder on 10Apr2021 13:51 (Lot Number: EP7533) as single dose for COVID-19 immunisation.  Medical history included Allergy. Concomitant medication included levocetirizine dihydrochloride (XYZAL) taken for Allergy, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 20Mar2021 (at age of 63 year-old) for COVID-19 immunisation and experienced extra tired for few days. The patient  stated,  it was in the wee hour of Sunday (11Apr2021) morning, between 1 and 2 AM, The patient  had a lot of achiness, muscle and joint pain. The patient  was so tired and  just couldn't get out of bed taking a Tylenol or an Advil (treatment) but that's where started and the patient did have during Sunday  (11Apr2021) had light headedness. The patient stated maybe a little feverish occasionally but the main thing was the lightheadedness, the rapid heart rate if the patient  just did some basic lifting of things, her body responded as if it was very strenuous when it really wasn't, the main thing was achy joint and muscles and light headedness but the patient had no respiratory issues, no sore throat. When probed for any treatment for the event, The patient stated, "I took an Advil, I don't usually take Advil, but I did take Advil, Sunday morning and afternoon and just before going to bed which was like 11 o'clock but I had taken a 2 hour nap in the afternoon, so I took a few Advil now, today I am much improved, I mean I may have a little ache here or there but I at this moment do not feel the need for any more Advil or anything for that matter." Therapeutic measures were taken as a result of achiness, muscle and joint pain, achiness, light headedness, feverish. The outcome of events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: I was extra tired; couldn't get out of bed; Achiness, muscle and joint pain; Achiness, muscle and joint pain; Achiness, muscle and joint pain; Light headedness; Feverish; Rapid heart rate if lifting some things, my body responded if it was very strenuous; This is a spontaneous report received from a contactable consumer (patient).  A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left shoulder on 10Apr2021 13:51 (Lot Number: EP7533) as single dose for COVID-19 immunisation.  Medical history included Allergy. Concomitant medication included levocetirizine dihydrochloride (XYZAL) taken for Allergy, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 20Mar2021 (at age of 63 year-old) for COVID-19 immunisation and experienced extra tired for few days. The patient  stated,  it was in the wee hour of Sunday (11Apr2021) morning, between 1 and 2 AM, The patient  had a lot of achiness, muscle and joint pain. The patient  was so tired and  just couldn't get out of bed taking a Tylenol or an Advil (treatment) but that's where started and the patient did have during Sunday  (11Apr2021) had light headedness. The patient stated maybe a little feverish occasionally but the main thing was the lightheadedness, the rapid heart rate if the patient  just did some basic lifting of things, her body responded as if it was very strenuous when it really wasn't, the main thing was achy joint and muscles and light headedness but the patient had no respiratory issues, no sore throat. When probed for any treatment for the event, The patient stated, "I took an Advil, I don't usually take Advil, but I did take Advil, Sunday morning and afternoon and just before going to bed which was like 11 o'clock but I had taken a 2 hour nap in the afternoon, so I took a few Advil now, today I am much improved, I mean I may have a little ache here or there but I at this moment do not feel the need for any more Advil or anything for that matter." Therapeutic measures were taken as a result of achiness, muscle and joint pain, achiness, light headedness, feverish. The outcome of events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Malaise, Nasopharyngitis, Nausea
Clinical narrative: Headache; Bad body ache and stuff; Cold; upset stomach; nauseous; feel really sick / not feeling good; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 09Apr2021 (Lot Number: EW0162) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included unspecified medications. The patient experienced headache on 09Apr2021, bad body ache and stuff on 09Apr2021, cold on 09Apr2021, upset stomach in Apr2021, nauseous in Apr2021, felt really sick / not feeling good in Apr2021. Clinical course: Headache and bad body ache and stuff and cold (Like 3 days ago) and now on Friday night and the symptoms very long after now it was affecting her stomach. She felt really sick like nauseous, upset stomach and day 3 not feeling good. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache; Bad body ache and stuff; Cold; upset stomach; nauseous; feel really sick / not feeling good; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 09Apr2021 (Lot Number: EW0162) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included unspecified medications. The patient experienced headache on 09Apr2021, bad body ache and stuff on 09Apr2021, cold on 09Apr2021, upset stomach in Apr2021, nauseous in Apr2021, felt really sick / not feeling good in Apr2021. Clinical course: Headache and bad body ache and stuff and cold (Like 3 days ago) and now on Friday night and the symptoms very long after now it was affecting her stomach. She felt really sick like nauseous, upset stomach and day 3 not feeling good. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Tiredness; Fever; stomach pain; muscle aches; This is a spontaneous report received from a contactable consumer or other non hcp. A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration in Arm Right on 12Apr2021 10:30 as SINGLE DOSE for COVID-19 immunization. The patient's medical history included rheumatoid arthritis from an unknown date and unknown if ongoing , colitis microscopic from an unknown date and unknown if ongoing , alopecia from an unknown date and unknown if ongoing ,and had history of covid-19 before vaccine. No medication was taken prior to covid-19 vaccine. Historical vaccine taken was BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: E L3247) via an unspecified route of administration, in Arm Right on 22Mar2021 11:00 as SINGLE DOSE for covid-19 immunisation. Concomitant medications included tofacitinib citrate (XELJANZ) taken for an unspecified indication, start and stop date were not reported (two weeks prior to vaccination). On 13Apr2021 12:00, the patient experienced headache, tiredness, fever, stomach pain and muscle aches. Outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reaction of rash on both arms; This is a spontaneous report from a contactable Other HCP. A 30-year-old consumer (patient) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (at the age of 30 years old) as SINGLE DOSE for covid-19 immunization. The patient medical history was none. Prior Vaccinations (within 4 weeks) was none. The concomitant medications were not reported. The patient experienced reaction of rash on both arms. The onset of event was about 24 hours after patient was administered first dose. The patient did not have to be hospitalized. The patient experienced no other symptoms. The event did not require a visit to emergency room or physician office. The outcome was recovered. The relatedness from reporter of event reaction of rash on both arms was related to Pfizer-BioNTech Covid-19 Vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Blood test, Chills, Confusional state
Clinical narrative: felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself).  This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also  experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Diarrhoea, Fall, Feeling hot, Head injury
Clinical narrative: felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself).  This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also  experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Lip injury, Pain in extremity, Seizure, Syncope
Clinical narrative: felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself).  This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also  experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself).  This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also  experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Experiencing knee pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for COVID-19 immunization. Medical history included torn meniscus. Concomitant medications were not provided. Patient was currently experiencing knee pain from what seemed to be a pre-existing torn meniscus, and wanted to know if she can take pain medications before the 2nd dose on 18Apr2021. Clarified that no pain medications were taken. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: only symptom was that I was tired, extra tired for few days; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 20Mar2021 at age of 63-year-old at single dose for COVID-19 immunization. Medical history included hypersensitivity (allergy). Concomitant medication included levocetirizine dihydrochloride (XYZAL) taken for allergy, a tablet daily.  The patient got her first shot 20Mar2021 and her only symptom was that she was tired on an unspecified in 2021, extra tired for few days. The outcome of tiredness was resolved in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Rash
Clinical narrative: break out; had a flare up; my right hip was hurting; This is a spontaneous report received from a contactable consumer (patient, self-reported). A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number: EW0158 and expiry date was unknown), via an unspecified route of administration, on 08Apr2021, as a single dose for COVID-19 immunization. The patient also received  pain relieving patch (CAMPHOR, MENTHOL, METHYL SALICYLATE, TOCOPHERYL ACETATE, lot number and expiry date were unknown). Patient's medical history and concomitant medications were not reported. It was reported that the patient did not have any reaction until Sunday morning. At Sunday morning patient's right hip was hurting so patient put some pain patches on lower back and within 3 minutes patient was having a breakout. The patient had used those patches for years and never had break out before. The patient immediately took them off to rinse them in drill. Two of them back there because patient kept having flare up. On Monday, the patient had a flare up. The patient had not used any patches since then. The patient was just wondering if it was in relationship with COVID-19 shot. The patient was unwilling to share further information. Hence further probing could not be done. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Both arms hurting after the second dose of COVID vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Caller states that her daughter had the same experience with both arms hurting after the second dose of COVID vaccine. She says it was the same vaccine as she had. Outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.