chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: head rush immediately after injection; extremely sore arm; This is a spontaneous report from a contactable consumer. This 65-year-old  female consumer (patient) reported that:  A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 10:00 as SINGLE DOSE for covid-19 immunisation. Medical history included, covid-19 covid prior vaccination: Yes. Concomitant medications included amlodipine taken for an unspecified indication, metformin hydrochloride taken for an unspecified indication, the patient previously took flagyl metronidazole and experienced drug hypersensitivity, ciprofloxacin, and experienced drug hypersensitivity.  The patient experienced head rush immediately after injection, extremely sore arm and the events were assessed as Non serious by health authority and outcome of the events recovering   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Flush face; This is a spontaneous report from a contactable consumer. This 73-years-old male consumer (patient) reported that he received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 01Mar2021 15:30 (Batch/Lot Number: EN6205) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfur and experienced drug hypersensitivity. The patient experienced flush face on 01Mar2021 15:45. Flush face about 20 mins after injection lasting less than an hour. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was reported as recovered.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Mild injection site pain; muscle and joint pain; muscle and joint pain; fatigue; severe diarrhea; This is a spontaneous report from a contactable consumer. A 55-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm Left on 26Feb2021 10:30 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, high blood Pressure ,neoplasm malignant and depression. Known allergies included shellfish. Concomitant medication included acarbose taken for an unspecified indication, glipizide taken for an unspecified indication, lisinopril taken for an unspecified indication, metformin taken for an unspecified indication, metoprolol taken for an unspecified indication. On 27Feb2021 12.00 am the patient experienced mild injection site pain, muscle and joint pain , muscle and joint pain, fatigue and severe diarrhea. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There was no treatment received for the adverse events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Have a lump in my arm; This is a spontaneous report from a contactable consumer. An unspecified age of female patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection), via unspecified route of administration on 29Jan2021 to 29Jan2021 at single dose for covid-19 immunization and received second dose of bnt162b2 (BNT162B2; Formulation: Solution for injection), via unspecified route of administration on 21Feb2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that I had my second vaccine on Sunday, and I noticed I have a lump in my arm, nothing I have not had anything, or like pain or anything it's just massive, is it normal on 21Feb2021. Consumer stated, "I just had Pfizer EL9264 that was the first shot, and it was 29Jan2021 and clinic was (clinic name), okay the second shot that number is EN6203, that Feb2021. Consumer stated, "Why do you need all this information". Consumer was informed about the role of Pfizer drug safety department. When probed if still experiencing the event, Consumer stated, "It did not hurt or anything it's just when I touch I know it is there, it does not hurt me." Consumer stated, "I took 2 Ibuprofen." And "Blood pressure medication." The outcome of event was "Unknown".
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: chills; low grade fever (100.5); joint pain; fatigue; This is a spontaneous report from a contactable consumer. This 54-year-old (at the time of vaccination) female consumer reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19, solution for injection, lot number; EL3247) via an unspecified route of administration on 10Feb2021 at 08:15 am at left arm at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Facility type vaccine was reported as hospital. Patient's medical history included known allergies; shrimp (unspecified dates). Past drug event included known allergies to tramadol and codeine (dates unspecified). Concomitant medications were not reported (if other vaccine in four weeks; no, other medications in two weeks- N/A). Patient experienced chills, low grade fever (100.5), joint pain, fatigue on 10Feb2021 at 08:00 pm. She felt like she had a "mini version" of COVID. Treatment for adverse event was not given. Patient had covid-19 prior to vaccination. Patient was not tested for covid-19 post vaccination. The outcome of events was recovered on an unknown date.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Pain, Pyrexia
Clinical narrative: diarrhea; Fever; Chills; Headache; Groggy; Body ache; This is a spontaneous report from a contactable other health care professional. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 21Feb2021 11:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included spinal stenosis, rhinitis, Intermittent asthma and allergies to almonds, peanuts, and hazelnuts. Concomitant medication included estradiol (ESTROGEN), ibuprofen and levocetirizine dihydrochloride (XYZAL). The patient experienced fever, chills, headache, groggy and body ache on 22Feb2021 at 15:00 and diarrhea on 23Feb2021. Outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: diarrhea; Fever; Chills; Headache; Groggy; Body ache; This is a spontaneous report from a contactable other health care professional. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 21Feb2021 11:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included spinal stenosis, rhinitis, Intermittent asthma and allergies to almonds, peanuts, and hazelnuts. Concomitant medication included estradiol (ESTROGEN), ibuprofen and levocetirizine dihydrochloride (XYZAL). The patient experienced fever, chills, headache, groggy and body ache on 22Feb2021 at 15:00 and diarrhea on 23Feb2021. Outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: experiencing muscle pain to my upper right arm and to my right groin region which then began generating a strong pain to my quadricep leg muscle and down to the back of my right knee; This is a spontaneous report from a contactable health care professional. A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 17Feb2021 15:30 (Batch/Lot Number: El 9266) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2, amoxicillin. The patient 24 Hours after having the 2nd vaccine I started experiencing muscle pain to my upper right arm and to my right groin region which then began generating a strong pain to my quadricep leg muscle and down to the back of my right knee. It is now 6 days after the vaccine, the arm pain has gone way, but the leg muscle pain persists. I have been limping from the pain and having difficulty stretching it out. The outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Drug ineffective, Epistaxis, Eye pain
Clinical narrative: tested positive for COVID; tested positive for COVID; Nosebleed; Severe pain; Problems with her eyes; pain in eyes, neck, and back; pain in eyes, neck, and back; pain in eyes, neck, and back; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown, Expiration date: Unknown) 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. The patient experienced tested positive for covid, nosebleed, severe pain, problems with her eyes (ocular discomfort), pain in eyes, neck, and back (eye pain) , pain in eyes, neck, and back (neck , pain in eyes, neck, and back pain on an unspecified date. The patient underwent lab tests and procedures which included covid-19: positive on an unknown date. She stated she is having severe pain in her eyes. The pain is also in her neck and back. She is also having nose bleeds. She further mentioned after the first dose she had a few pains in her eye and nose bleeds. However, this time after the second dose the nose bleeding is more and severe in her eye and neck. She also tested positive for COVID after getting the first dose of the vaccine. The patient stated she was not the only one with these problems. Another lady had the same problems she had. She further explained after the COVID Vaccine she took the last one and she had problems with her eyes and severe pain. She also had pain in right shoulder up to her back and neck. The patient explained she knows someone else who experienced the same problems she had after getting the COVID Vaccine. Patient tested positive after getting the COVID Vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Ocular discomfort, Pain, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; Nosebleed; Severe pain; Problems with her eyes; pain in eyes, neck, and back; pain in eyes, neck, and back; pain in eyes, neck, and back; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown, Expiration date: Unknown) 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. The patient experienced tested positive for covid, nosebleed, severe pain, problems with her eyes (ocular discomfort), pain in eyes, neck, and back (eye pain) , pain in eyes, neck, and back (neck , pain in eyes, neck, and back pain on an unspecified date. The patient underwent lab tests and procedures which included covid-19: positive on an unknown date. She stated she is having severe pain in her eyes. The pain is also in her neck and back. She is also having nose bleeds. She further mentioned after the first dose she had a few pains in her eye and nose bleeds. However, this time after the second dose the nose bleeding is more and severe in her eye and neck. She also tested positive for COVID after getting the first dose of the vaccine. The patient stated she was not the only one with these problems. Another lady had the same problems she had. She further explained after the COVID Vaccine she took the last one and she had problems with her eyes and severe pain. She also had pain in right shoulder up to her back and neck. The patient explained she knows someone else who experienced the same problems she had after getting the COVID Vaccine. Patient tested positive after getting the COVID Vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills after 2nd dose.  Lasted for approximately 8 hours but resolved after taking motrin; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 14Feb2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's has no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162B2 dose 1 via an unspecified route of administration on 24Jan2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. It was reported that chills after 2nd dose on 14Feb2021. Lasted for approximately 8 hours but resolved after taking motrin. The outcome of the event was recovered on an unspecified date.  Information about lot/batch number has been requested
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache
Clinical narrative: Headaches, getting worse.; getting worse; This is a spontaneous report from a contactable consumer. A 76-year-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 14:00 (Batch/Lot Number: EL5318) at single dose for covid-19 immunisation. Medical history included bradycardia and overweight. Concomitant medication(s) included amlodipine; hydrochlorothiazide; rosuvastatin and potassium chloride. The patient experienced headaches, getting worse on 15Feb2021. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Gastrointestinal disorder, Headache, Illness
Clinical narrative: I had an upset stomach with gastrointestinal problems and a headache; I had an upset stomach with gastrointestinal problems and a headache; I just sick; I had a headache; I had tiredness; whole body aches; This is a spontaneous report from a contactable consumer. This 69-years-old female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EM9809), via an unspecified route of administration on 18Feb2021 in left arm at single dose for covid-19 immunization. The patient's medical history included arthritis, thyroid, sleep and Cholesterol. Historical vaccine included bnt162b2 (dose-1) for covid-19 immunisation. Concomitant medications included Sertraline 100 mg once a day; nortriptyline at 10 mg once a day for It helps her to sleep, meloxicam at 7.5 mg once a day for arthritis pain, rosuvastatin 10 mg once a day for cholesterol and levothyroxine 25 mg once a day for thyroid.  On 19Feb2021, the patient had tiredness and the whole-body aches. On 20Feb2021, she had a headache and on 23Feb2021, she had an upset stomach with gastrointestinal problems, and she was just sick. The outcome of the event tiredness and the whole-body aches was resolved on 20Feb2021, whereas the event headache was not resolved whereas other events was not resolved.  No follow-up attempts are possible; No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I had an upset stomach with gastrointestinal problems and a headache; I had an upset stomach with gastrointestinal problems and a headache; I just sick; I had a headache; I had tiredness; whole body aches; This is a spontaneous report from a contactable consumer. This 69-years-old female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EM9809), via an unspecified route of administration on 18Feb2021 in left arm at single dose for covid-19 immunization. The patient's medical history included arthritis, thyroid, sleep and Cholesterol. Historical vaccine included bnt162b2 (dose-1) for covid-19 immunisation. Concomitant medications included Sertraline 100 mg once a day; nortriptyline at 10 mg once a day for It helps her to sleep, meloxicam at 7.5 mg once a day for arthritis pain, rosuvastatin 10 mg once a day for cholesterol and levothyroxine 25 mg once a day for thyroid.  On 19Feb2021, the patient had tiredness and the whole-body aches. On 20Feb2021, she had a headache and on 23Feb2021, she had an upset stomach with gastrointestinal problems, and she was just sick. The outcome of the event tiredness and the whole-body aches was resolved on 20Feb2021, whereas the event headache was not resolved whereas other events was not resolved.  No follow-up attempts are possible; No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Chills, Dizziness
Clinical narrative: Headache; Tiredness; Difficulty breathing; Dizziness; Weakness; Nauseated; blood pressure was up; Teeth chattering/chills; couldn't hardly stand up; This is a spontaneous report from a contactable consumer (patient reported herself). A 77-year-old female patient received first dose of BNT162B2 (COVID shot, Solution for injection, NDC number: Unknown) via an unspecified route of administration to her right arm on 24Feb2021 3 PM (Batch number: EN6201) as single dose for Covid-19 immunization. Vaccination Facility Type: Hospital. The patient's medical history included bladder issue (she had just been to see her doctor for bladder issues, this was prior to taking the COVID shot). Concomitant medications was reported as none. On 24Feb2021, the patient experienced blood pressure was up, teeth chattering and could not hardly stand up. On 24Feb2021 3 PM, she experienced nauseated. On 25Feb2021, she experienced headache, chills, tiredness, difficulty breathing, dizziness and weakness. Caller, reporting on the COVID shot, said that she had a reaction and had to go to the hospital. She was calling to report. It was explained that she was sick all over which she clarified as being nauseated. At first she said it started an hour to hour and a half after the shot but then clarified she got the shot at 3 PM and the event started that night. The caller was treated and released. She went to the hospital about 6 PM and was sent her home about 9 PM. She was given a steroid shot, Benadryl, her teeth were chattering and was given a pill for that. It was noted while at the hospital she could not hardly stand up. Also, her blood pressure was up and they had to get that down before she left; she was given a pill to get that down. Her blood pressure was 225 but she did not know the bottom number. She was taking the medication given and taking it easy. She was having headache, chills, tiredness, difficulty breathing, dizziness, and weakness. This all started today. The nausea was ongoing from yesterday. The caller explained that she did not think that she should take the second dose if this was what she experienced after the first dose. It was reported that the patient went to emergency room. Relevant tests were none. Outcome of the events nauseated, headache, chills, tiredness, dizziness, weakness was not recovered; blood pressure was up was recovered on 24Feb2021; and other events was unknown.  No follow-up attempts are possible; No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Dysstasia, Fatigue, Headache, Nausea
Clinical narrative: Headache; Tiredness; Difficulty breathing; Dizziness; Weakness; Nauseated; blood pressure was up; Teeth chattering/chills; couldn't hardly stand up; This is a spontaneous report from a contactable consumer (patient reported herself). A 77-year-old female patient received first dose of BNT162B2 (COVID shot, Solution for injection, NDC number: Unknown) via an unspecified route of administration to her right arm on 24Feb2021 3 PM (Batch number: EN6201) as single dose for Covid-19 immunization. Vaccination Facility Type: Hospital. The patient's medical history included bladder issue (she had just been to see her doctor for bladder issues, this was prior to taking the COVID shot). Concomitant medications was reported as none. On 24Feb2021, the patient experienced blood pressure was up, teeth chattering and could not hardly stand up. On 24Feb2021 3 PM, she experienced nauseated. On 25Feb2021, she experienced headache, chills, tiredness, difficulty breathing, dizziness and weakness. Caller, reporting on the COVID shot, said that she had a reaction and had to go to the hospital. She was calling to report. It was explained that she was sick all over which she clarified as being nauseated. At first she said it started an hour to hour and a half after the shot but then clarified she got the shot at 3 PM and the event started that night. The caller was treated and released. She went to the hospital about 6 PM and was sent her home about 9 PM. She was given a steroid shot, Benadryl, her teeth were chattering and was given a pill for that. It was noted while at the hospital she could not hardly stand up. Also, her blood pressure was up and they had to get that down before she left; she was given a pill to get that down. Her blood pressure was 225 but she did not know the bottom number. She was taking the medication given and taking it easy. She was having headache, chills, tiredness, difficulty breathing, dizziness, and weakness. This all started today. The nausea was ongoing from yesterday. The caller explained that she did not think that she should take the second dose if this was what she experienced after the first dose. It was reported that the patient went to emergency room. Relevant tests were none. Outcome of the events nauseated, headache, chills, tiredness, dizziness, weakness was not recovered; blood pressure was up was recovered on 24Feb2021; and other events was unknown.  No follow-up attempts are possible; No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: injection arm pain; Body aches from head to toe; headache; fever; fatigue; This is a spontaneous report from a contactable pharmacist (Patient). A 51-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included BNT162B2 for covid-19 immunisation (dose 1). The patient experienced injection arm pain (non-serious) on an unspecified date, body aches from head to toe on an unspecified date, headache on an unspecified date, fever on an unspecified date, fatigue on an unspecified date; all (non-serious). Description of Event: C-19 2nd dose response, 51yo WM, 8 hrs post injection arm pain at site of injection. Body aches from head to toe, moderate in severity, headache, moderate, low grade fever, 99.5 peak, fatigue. Symptoms lasted approximately 24 hours and then were resolved by 48 hrs post injection. Event took place after use of product. The outcome of event was recovered on an unspecified date.  Information about lot/batch was requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection arm pain; Body aches from head to toe; headache; fever; fatigue; This is a spontaneous report from a contactable pharmacist (Patient). A 51-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included BNT162B2 for covid-19 immunisation (dose 1). The patient experienced injection arm pain (non-serious) on an unspecified date, body aches from head to toe on an unspecified date, headache on an unspecified date, fever on an unspecified date, fatigue on an unspecified date; all (non-serious). Description of Event: C-19 2nd dose response, 51yo WM, 8 hrs post injection arm pain at site of injection. Body aches from head to toe, moderate in severity, headache, moderate, low grade fever, 99.5 peak, fatigue. Symptoms lasted approximately 24 hours and then were resolved by 48 hrs post injection. Event took place after use of product. The outcome of event was recovered on an unspecified date.  Information about lot/batch was requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Muscle spasms, Muscle tightness
Clinical narrative: spasms in her head; tightened muscles in her whole neck; breathing was difficult; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 10Feb2021 (Batch/Lot Number: EL3249; Expiration Date: May2021) as single dose for COVID-19 immunisation. Medical history included quadriplegia from 1992 and ongoing which leads to disability, where patient doesn't have a lot of mobility and need a wheelchair. Concomitant medication(s) included baclofen taken for muscle relaxant therapy from 1997 and ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in Feb2021, the patient experienced spasms in her head, tightened muscles in her whole neck and breathing was difficult. The events were considered as non-serious. Reporter state that patient does not want to repeat the same experience as patient was due for second dose of vaccine and unsure if it would be advisable for patient to get the second dose. The outcome of all the events was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 via PCR test; Tested positive for COVID-19 via PCR test; This is a spontaneous report from a contactable other healthcare professional. A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: H3248) via intramuscular in left arm on 12Jan2021 at 6:00 pm as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included Bentyl, Zoloft and Sprintec. Historical vaccine included first dose of BNT162B2(lot number=EK9231, lot unknown=False, administration date=22Dec2020, administration time=06:00 PM, administrator route=Intramuscular, vaccine location=Left arm). On 03Jan21 and 01Mar2021, patient tested positive for COVID-19 via pcr test. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Covid test type post vaccination=Nasal Swab covid test name post vaccination=PCR covid test date=01Mar2021 covid test result=Positive. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number could not be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID- 19 despite having received his second Pfizer vaccine dose; tested positive for COVID- 19 despite having received his second Pfizer vaccine dose; This is a spontaneous report from a contactable consumer. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 05Jan2021 (Batch/Lot number was not reported) at the age of 74-years-old in the right arm, and second dose, on 26Jan2021 (Batch/Lot number was not reported) at the age of 74-years-old in the arm; both via an unspecified route of administration at single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks. The reporter stated that her father tested positive for COVID today (02Mar2021) (also reported as 01Mar2021; pending clarification) despite having received his second Pfizer vaccine dose on 25Jan2021 (also reported as 26Jan2021, pending clarification). No treatment was received. The patient had no COVID prior vaccination. The patient was tested for COVID post vaccination which was a nasal swab/polymerase chain reaction (PCR) with positive result on 01Mar2021. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood thyroid stimulating hormone, Body temperature, Fatigue, Headache
Clinical narrative: cold sensitivity; flu like symptoms- headache, body aches, severe fatigue, cold sensitivity and (transiently) overreaction to loud sounds; headache; body aches; severe fatigue; overreaction to loud sounds; This is a spontaneous report from a contactable physician (patient). A 72-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581), via unspecified route of administration in left arm, on 16Feb2021 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. The patient medical history included postural orthostatic tachycardia syndrome, depression and hypothyroidism. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (nasal swab) on 01Mar2021 and resulted in negative. The patient concomitant medication included levothyroxine sodium, morphine and sertraline. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FL3249) via unspecified route of administration in right arm, on 25Jan2021 (at the age of 72-year-old) and had no initial reaction. It was reported that a week after the second dose that was on 24Feb2021, at 08:00 the patient developed flu like symptoms- headache, body aches, severe fatigue, cold sensitivity and (transiently) overreaction to loud sounds. The patient underwent laboratory tests and results were as follows on an unknown date in 2021, the patient had no fever, blood pressure and pulse normal, chem panel, tsh and crp all normal. The patient received increase in pain medication as a treatment to events. The outcome of the events was not resolved.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate normal, Hyperacusis, Influenza like illness, Investigation, Metabolic function test
Clinical narrative: cold sensitivity; flu like symptoms- headache, body aches, severe fatigue, cold sensitivity and (transiently) overreaction to loud sounds; headache; body aches; severe fatigue; overreaction to loud sounds; This is a spontaneous report from a contactable physician (patient). A 72-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581), via unspecified route of administration in left arm, on 16Feb2021 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. The patient medical history included postural orthostatic tachycardia syndrome, depression and hypothyroidism. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (nasal swab) on 01Mar2021 and resulted in negative. The patient concomitant medication included levothyroxine sodium, morphine and sertraline. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FL3249) via unspecified route of administration in right arm, on 25Jan2021 (at the age of 72-year-old) and had no initial reaction. It was reported that a week after the second dose that was on 24Feb2021, at 08:00 the patient developed flu like symptoms- headache, body aches, severe fatigue, cold sensitivity and (transiently) overreaction to loud sounds. The patient underwent laboratory tests and results were as follows on an unknown date in 2021, the patient had no fever, blood pressure and pulse normal, chem panel, tsh and crp all normal. The patient received increase in pain medication as a treatment to events. The outcome of the events was not resolved.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test negative, Temperature intolerance
Clinical narrative: cold sensitivity; flu like symptoms- headache, body aches, severe fatigue, cold sensitivity and (transiently) overreaction to loud sounds; headache; body aches; severe fatigue; overreaction to loud sounds; This is a spontaneous report from a contactable physician (patient). A 72-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581), via unspecified route of administration in left arm, on 16Feb2021 (at the age of 72-year-old) as a single dose for COVID-19 immunisation. The patient medical history included postural orthostatic tachycardia syndrome, depression and hypothyroidism. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (nasal swab) on 01Mar2021 and resulted in negative. The patient concomitant medication included levothyroxine sodium, morphine and sertraline. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FL3249) via unspecified route of administration in right arm, on 25Jan2021 (at the age of 72-year-old) and had no initial reaction. It was reported that a week after the second dose that was on 24Feb2021, at 08:00 the patient developed flu like symptoms- headache, body aches, severe fatigue, cold sensitivity and (transiently) overreaction to loud sounds. The patient underwent laboratory tests and results were as follows on an unknown date in 2021, the patient had no fever, blood pressure and pulse normal, chem panel, tsh and crp all normal. The patient received increase in pain medication as a treatment to events. The outcome of the events was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: EL9266) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included unspecified statins. Patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 21Jan2021 (Lot Number: EL9262) as a single dose for COVID-19 immunization, and experienced tired/fatigued. It was reported that routine blood work (unknown results) was done on 18Feb2021 and added antibody test that showed results of negative antibodies. There was a plan on repeating the antibody test again in April. It was reported that patient is "not the only older patient that reporter has seen this in". Patient also experienced sore arm on an unspecified date in 2021 after second dose. Patient's primary doctor checks blood work every 3 months since she is on medications, they have to check her blood work to check her liver enzymes to see if they are elevated or not since she takes statins. The patient knew that when you get the vaccine, both times with Pfizer, you have to get Pfizer the first time and Pfizer the second time, same with the (company name). The patient's antibodies were showing negative, which the doctor has seen other patients who are elderly who have had negative antibodies too. When she had the blood work done it would have already been 3-4 weeks from the first dose. The patient's doctor was not sure why that is, he seemed to think that after the first dose there should be some sign but however he was saying, an article said it may take older people a little longer before there is an immunity against the virus from the vaccine. The patient didn't know if it should be from the time you take the second shot, or the time of the first shot. The patient said there's an article saying one dose of the vaccine should give you immunity. The patient wanted to know if she got the shot right. The patient was a nervous wreck because she knew she can't go get it again. Her mind was doing nothing but racing. The outcome of event was unknown.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: it itch like crazy but the itch only lasted 5 minutes then it goes away; Hives; This is a spontaneous report from a contactable consumer (patient).  A 88-years-old male patient second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9807), via an unspecified route of administration as single dose for COVID-19 immunisation. The patient's medical was not reported. patient was Allergic to Penicillin. The concomitant medication was not reported. the patient received first dose of vaccine (historic vaccine), BNT162B2 (Lot EL1283) at Left Shoulder on 25Jan2021. He experienced hives on the next day and that lasted for 3 days. The patient got Second Dose on 15Feb2021 and experienced hives the next morning, which lasted for 11 days, it is still there but going. He did not do anything to treat them, he just left them alone, it itches like crazy but the itch only lasted 5 minutes then it goes away and then different one comes up. There is no cure for Hives, that's what the doctor said. The outcome of event urticaria was resolving, whereas the outcome of event itch was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for virus 5 days after receiving vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route in left arm on 22Feb2021 at 12:00 (age at vaccination 61 years) at single dose for covid-19 immunization. Medical history included diabetes. Patient have known allergies with Augmentin. Other medications taken by patient in two weeks were Metformin, Atorvastatin (Lipitor), Hydrochlorothiazide, Lisinopril (Lisinopril HCTZ). The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 26Feb2021 at 12:00, the patient tested positive for virus 5 days after receiving vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. It was unknown if the treatment was taken for adverse event. COVID was tested post vaccination. Test type for COVID was nasal swab done on 27Feb2021 with positive results. Reporter assessed case as non-serious. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Has headache; This is a spontaneous report from a Pfizer-sponsored program Support. An unspecified age of female patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection), via unspecified route of administration on 24Feb2021 to 24Feb2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that caller received first dose of vaccine today, has headache and would like to know if she can take anything for it or if it will affect the effectiveness of the vaccine- declined ISI - cold transfer due to wait times to PSCC for AE: side effects, will fax . The outcome of event was "unknown".  Information on lot number/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling a little tired; This is a spontaneous report from a contactable consumer. This 74-year-old (at the time of vaccination) male consumer reported that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19, solution for injection) via an unspecified route of administration on 23Feb2021 at single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 for covid-19 immunisation. Patient received second dose of COVID-19 vaccine on 23Feb2021 and reports feeling a little tired on an unknown date in Feb2021. Event took place after use of product. The outcome of event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: first dose of the covid vaccine yesterday and is having side effects; This is a spontaneous report from a Pfizer-sponsored program . A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing Previously had covid 90 days prior. The patient's concomitant medications were not reported. Caller took the first dose of the covid vaccine yesterday and is having side effects. Previously had covid 90 days prior and wanted to know if the side effects that she is feeling is because of her having covid. No FAQ. Read ISI. Cold transferred to due to hold times. Will fax AE from CEP: 159558. The outcome of the event was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: muscle soreness at injection site; This is a spontaneous report from a contactable pharmacist (Patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (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. It was reported that received COVID-19 vaccine and approximately 9 hrs late the patient experienced muscle soreness at injection site on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. An unspecified age of contactable female consumer reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced vertigo, dizziness, and some headaches. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Inappropriate schedule of product administration
Clinical narrative: Scheduled for second COVID-19 Vaccine in 19 days; Had a serious heart condition; This is a spontaneous report from a contactable consumer. A male patient (consumer's brother) of an unspecified age received first dose of BNT162B2 (COVID-19 Vaccine, Solution for injection, NDC number: Unknown) via an unspecified route of administration on an unspecified date (Batch/lot number: Unknown, Expiry Date: Unknown) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that scheduled for second COVID-19 vaccine in 19 days and had a serious heart condition on an unspecified date. She was also concerned because she read online the COVID-19 vaccine may not be as effective if the second dose is received less than 21 days from the first dose. Her brother had his first COVID-19 Vaccine  and was scheduled for his second dose in 19 days. Wants to confirm this information. Had no NDC/Lot/Expiration to provide for her brother's COVID-19 Vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.